<PAGE>
SUBJECT TO COMPLETION, OCTOBER 22, 1999
THE INFORMATION CONTAINED IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED.
THESE SECURITIES MAY NOT BE SOLD UNTIL THE REGISTRATION STATEMENT FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION IS DECLARED EFFECTIVE. THIS PROSPECTUS IS NOT
AN OFFER TO SELL THESE SECURITIES, AND IT IS NOT SOLICITING AN OFFER TO BUY
THESE SECURITIES, IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
2,000,000 SHARES
[LOGO]
COMMON STOCK
$ PER SHARE
- --------------------------------------------------------------------------------
Progenics is offering 2,000,000 shares with this prospectus. This is a firm
commitment underwriting.
Our common stock is traded on the Nasdaq National Market under the symbol
'PGNX.' On October 21, 1999, the closing sale price of the common stock on
Nasdaq was $18.875 per share.
INVESTING IN THE COMMON STOCK INVOLVES RISKS. SEE 'RISK FACTORS' BEGINNING ON
PAGE 8.
<TABLE>
<CAPTION>
PER SHARE TOTAL
--------- ------------
<S> <C> <C>
Price to Public....................................... $ $
Underwriting Discount.................................
Proceeds to Progenics.................................
</TABLE>
We have granted an over-allotment option to the underwriters. Under this option,
the underwriters may elect to purchase a maximum of 300,000 additional shares
from us within 30 days following the date of this prospectus to cover
over-allotments.
- --------------------------------------------------------------------------------
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS
PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
CIBC WORLD MARKETS
ROBERTSON STEPHENS
PRUDENTIAL VECTOR HEALTHCARE
a unit of Prudential Securities
GERARD KLAUER MATTISON & CO., INC.
PUNK, ZIEGEL & COMPANY
The date of this Prospectus is , 1999.
<PAGE>
[DIAGRAM DEPICTING PROGENICS' PRODUCT PIPELINE]
2
<PAGE>
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
Prospectus Summary.......................................... 4
Risk Factors................................................ 8
Use of Proceeds............................................. 18
Forward-Looking Statements.................................. 19
Price Range of Common Stock................................. 19
Dividend Policy............................................. 19
Capitalization.............................................. 20
Selected Financial Data..................................... 21
Management's Discussion and Analysis of Financial Condition
and Results of Operations................................. 22
Business.................................................... 26
Management.................................................. 47
Principal Stockholders...................................... 50
Underwriting................................................ 52
Legal Matters............................................... 53
Experts..................................................... 53
Where Can You Find More Information......................... 53
Incorporation by Reference.................................. 54
Index to Financial Statements............................... F-1
</TABLE>
- ------------------------
Progenics was incorporated in December 1986. Our principal executive
offices are located at 777 Old Saw Mill River Road, Tarrytown, New York 10591,
and our telephone number is (914) 789-2800. Our world wide web site address is
www.progenics.com. We do not intend to incorporate the information in our web
site as a part of this prospectus.
3
<PAGE>
PROSPECTUS SUMMARY
After you read the following summary, you should read and consider
carefully the more detailed information and financial statements and related
notes appearing elsewhere in this prospectus. Unless otherwise indicated, all
information in this prospectus assumes no exercise of the underwriters'
over-allotment option. If you invest in the common stock, you are assuming a
high degree of risk. See 'Risk Factors.'
OUR COMPANY
Progenics is a biopharmaceutical company focusing on the development and
commercialization of innovative products for the treatment and prevention of
cancer and viral and other life-threatening diseases. We apply our immunology
expertise to develop biopharmaceuticals that induce an immune response or that
mimic natural immunity in order to fight cancers, such as malignant melanoma,
and viral diseases, such as HIV infection. Our most advanced product candidate,
GMK, is a therapeutic vaccine that has completed enrollment of a pivotal
Phase III clinical trial for the treatment of melanoma, the deadliest form of
skin cancer. Our second vaccine product candidate, MGV, is being developed for
the treatment of various cancers and is entering Phase II clinical trials. We
have a collaboration with Bristol-Myers Squibb Company to develop and
commercialize GMK and MGV. Based on our participation in the discoveries of two
major receptors for HIV, we are engaged in the research and development of
therapeutic products designed to block entry of HIV into human immune system
cells. We have completed two Phase I/II clinical trials of one of these product
candidates, PRO 542, and a Phase I clinical trial of another product candidate,
PRO 367. We plan to initiate in the first half of 2000 a Phase II clinical trial
of PRO 542 and a Phase I/II clinical trial of PRO 367. We are also engaged in a
program with the Roche Group of Basel, Switzerland to discover and develop novel
small-molecule HIV therapeutics that target the fusion co-receptors of the
virus.
CANCER THERAPEUTICS
Our GMK and MGV cancer therapeutics are based on proprietary ganglioside
conjugate vaccine technology designed to stimulate the immune system to destroy
cancer cells. This technology is exclusively licensed to us by Memorial
Sloan-Kettering Cancer Center. Our lead product candidate, GMK, is designed to
prevent recurrence of melanoma in patients who are at risk of relapse after
surgery. The American Cancer Society estimates that 44,200 patients in the
United States will be newly diagnosed with melanoma in 1999. In August 1996, we
commenced a pivotal, randomized, multicenter Phase III clinical trial of GMK.
This trial is being conducted in the United States by cooperative cancer
research groups supported by the National Cancer Institute and completed patient
enrollment in September 1999. We expect that a second Phase III clinical trial
of GMK will be conducted in a number of countries outside of the United States.
This trial is expected to commence by early 2000 and will be conducted in
Europe, South Africa, Canada, South America and Australia under the guidance of
the European Organization for Research and Treatment of Cancer.
MGV is being developed to treat a wide range of cancers, including
colorectal cancer, lymphoma, small cell lung cancer, sarcoma, gastric cancer and
neuroblastoma. The American Cancer Society estimated that there would be over
260,000 new cases of these cancers in the United States during 1998. We believe
that MGV, which incorporates two ganglioside antigens that are abundant in these
and other types of cancer cells, may be an attractive adjunctive therapy to
prevent recurrence after the cancer is removed surgically or reduced by
chemotherapy or radiation therapy. We completed Phase I/II clinical trials with
MGV at Sloan-Kettering in 1999 and expect that Phase II clinical trials will
commence by early 2000.
In July 1997, Progenics and Bristol-Myers Squibb Company entered into a
collaboration under which we granted BMS an exclusive worldwide license to GMK
and MGV. Upon signing the
4
<PAGE>
agreement, BMS made cash payments to us of $13.3 million and agreed to make
further payments of up to $61.5 million upon the achievement of specified
milestones. In June 1998 and September 1999 we recognized payments under our
collaboration with BMS for achieving clinical milestones in the development of
GMK. In addition, BMS is required to fund continued clinical development of GMK
and MGV and to pay royalties on any sales of licensed products.
We are also engaged in a research and development program relating to
vaccine and antibody immunotherapeutics based on Prostate Specific Membrane
Antigen. PSMA is a novel target that we think has promising applications in
immunotherapeutics for prostate cancer and potentially for other types of
cancer. This program is being conducted in collaboration with CYTOGEN
Corporation.
HIV THERAPEUTICS
We are engaged in a number of novel HIV drug development programs that are
designed to prevent infection of healthy immune system cells by targeting
specific extracellular receptors and the viral protein that binds to these
receptors. Binding of HIV to the CD4 receptor and to the CCR5 or CXCR4
co-receptor is necessary for attachment, fusion and entry of the virus into the
cell. We believe that, because the portion of the viral protein that binds to
CD4 and to the fusion co-receptors does not often change, the likelihood of drug
resistance to our product candidates through viral mutation is reduced.
Additionally, the molecular structures of CD4, CCR5 and CXCR4 do not vary from
person to person, making these receptors particularly appealing targets for drug
development.
Our PRO 542 and PRO 367 product candidates utilize our proprietary CD4
receptor technology. We are developing PRO 542 to selectively target HIV and
prevent it from infecting healthy cells by binding to the sites on the virus
that are required for entry into the cell. PRO 542 is being developed as an
immunotherapy to treat asymptomatic HIV-positive individuals. We have completed
two Phase I/II clinical trials of PRO 542 and plan to initiate a larger scale
Phase II clinical trial in the first half of 2000.
We are developing PRO 367 as a therapeutic agent designed to kill
HIV-infected cells. PRO 367 consists of an antibody-like molecule linked to a
therapeutic radioisotope. This product is designed to bind to and destroy
HIV-infected cells by delivering a lethal dose of radiation. We have completed a
Phase I clinical trial of PRO 367 and plan to initiate a larger scale
Phase I/II clinical trial in the first half of 2000.
In December 1997 we entered into a collaboration with the Roche Group of
Basel, Switzerland to discover and develop novel small-molecule HIV therapeutics
that target the fusion co-receptors, including CCR5 and CXCR4. Under the terms
of the collaboration, we granted to Roche an exclusive worldwide license to
certain aspects of our HIV co-receptor technology. To date, Roche has made an
upfront and a milestone payment to us. Under the terms of the collaboration,
Roche is obligated to make additional milestone payments to us upon achievement
of specified milestones, fund research for up to three years and pay royalties
on the sale of any products commercialized as a result of the collaboration.
We also are developing monoclonal antibodies against CCR5 capable of
blocking virus-cell fusion. One of these antibodies, which we have designated
PRO 140, inhibited HIV fusion in vitro. Assuming successful completion of the
program to humanize PRO 140, we plan to initiate a Phase I/II clinical trial of
PRO 140 in the second half of 2000.
5
<PAGE>
THE OFFERING
<TABLE>
<S> <C>
Common stock offered......................... 2,000,000 shares
Common stock to be outstanding after the
offering................................... 11,562,270 shares (1)
Use of proceeds.............................. To fund research and development, in-licensing of
technology, clinical trials and expansion of our
research and development and manufacturing facilities
as well as for working capital and general corporate
purposes, including potential acquisitions of
technologies, product candidates or companies.
Nasdaq National Market symbol................ PGNX
Risk factors................................. This offering involves a high degree of risk. See
'Risk Factors.'
</TABLE>
- ------------
(1) Based on the number of shares outstanding at September 30, 1999. Excludes as
of such date 3,110,479 shares of common stock issuable upon exercise of
outstanding options and warrants at a weighted average exercise price of
$7.20 per share.
6
<PAGE>
SUMMARY FINANCIAL DATA
(in thousands, except per share data)
<TABLE>
<CAPTION>
SIX MONTHS
YEARS ENDED DECEMBER 31, ENDED JUNE 30,
--------------------------- ----------------
1996 1997 1998 1998 1999
---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C>
STATEMENT OF OPERATIONS DATA:
Revenues:
Contract research and development........... $ 318 $14,591 $11,135 $5,329 $ 4,860
Research grants............................. 203 665 1,251 581 423
Product sales............................... 98 57 180 36 35
Interest income............................. 106 301 1,455 664 593
------- ------- ------- ------ -------
Total revenues......................... 725 15,614 14,021 6,610 5,911
------- ------- ------- ------ -------
Expenses:
Research and development.................... 3,700 7,364 8,296 3,912 5,321
General and administrative.................. 2,808 2,222 3,841 1,937 1,976
Loss in joint venture....................... -- -- -- -- 1,797
Interest expense............................ 51 312 43 18 29
Depreciation and amortization............... 309 319 388 164 305
------- ------- ------- ------ -------
Total expenses......................... 6,868 10,217 12,568 6,031 9,428
------- ------- ------- ------ -------
Operating (loss) income................ (6,143) 5,397 1,453 579 (3,517)
Income taxes..................................... -- 258 -- -- --
------- ------- ------- ------ -------
Net (loss) income........................... $(6,143) $ 5,139 $ 1,453 $ 579 $(3,517)
------- ------- ------- ------ -------
------- ------- ------- ------ -------
Per share amounts on net (loss) income:
Basic....................................... $ (2.68) $ 1.64 $ 0.16 $ 0.06 $ (0.37)
------- ------- ------- ------ -------
------- ------- ------- ------ -------
Diluted..................................... $ (2.68) $ 0.66 $ 0.14 $ 0.05 $ (0.37)
------- ------- ------- ------ -------
------- ------- ------- ------ -------
Weighted average number of common shares
outstanding:
Basic....................................... 2,295 3,128 9,068 9,009 9,401
Diluted..................................... 2,295 7,804 10,727 10,913 9,401
</TABLE>
<TABLE>
<CAPTION>
JUNE 30, 1999
---------------------
AS
ACTUAL ADJUSTED(1)
------ -----------
<S> <C> <C>
BALANCE SHEET DATA:
Cash, cash equivalents and marketable securities, including
non-current portion....................................... $22,840 $57,825
Working capital............................................. 19,955 54,940
Total assets................................................ 26,079 61,064
Capital lease obligations, long-term portion................ 66 66
Total stockholders' equity.................................. 23,103 58,088
</TABLE>
- ------------
(1) Gives effect to the sale of 2,000,000 shares of common stock in this
offering, assuming a public offering price of $18.875 per share, and our
receipt of the net proceeds after deducting the underwriting discount and
estimated offering expenses. See 'Capitalization.'
7
<PAGE>
RISK FACTORS
An investment in our common stock is speculative in nature and involves a
high degree of risk. In addition to the other information contained in this
prospectus, you should carefully consider the following risk factors in
evaluating our company and its business and prospects.
IF WE CANNOT ADVANCE OUR PRODUCTS BEYOND THE EARLY STAGES OF PRODUCT DEVELOPMENT
OR DEMONSTRATE CLINICAL EFFICACY, WE WILL NEVER COMMERCIALIZE A PRODUCT.
Most of our products are at an early stage of development. The successful
commercialization of our products will require significant further research,
development, testing and regulatory approvals and additional investment. If we
cannot advance our products beyond the early stages of product development or
demonstrate clinical efficacy, we will never commercialize a product. There are
a number of technological challenges that we must successfully address to
complete most of our development efforts. We cannot assure you that any of our
products in the research or preclinical development stage will yield results
that would permit or justify clinical testing or that products that advance to
clinical testing will be commercialized.
OUR PRODUCT DEVELOPMENT PROGRAMS ARE NOVEL AND, CONSEQUENTLY, INHERENTLY RISKY.
We are subject to the risks of failure inherent in the development of
product candidates based on new technologies. These risks include the
possibility that:
the technologies we use will not be effective;
our product candidates will be unsafe or otherwise fail to receive the
necessary regulatory approvals;
our product candidates will be hard to manufacture on a large scale or
will be uneconomical to market; or
we do not successfully overcome technological challenges presented by our
products.
To our knowledge, no cancer therapeutic vaccine and no drug designed to
treat HIV infection by blocking viral entry has been approved for marketing. Our
other research and development programs involve similarly novel approaches to
human therapeutics. Consequently, there is no precedent for the successful
commercialization of products based on our technologies. We cannot assure you
that any of our products will be successfully developed.
A SETBACK IN OUR GMK PROGRAM WOULD CAUSE A SHARP DROP IN OUR STOCK PRICE.
We have an ongoing Phase III clinical trial for GMK and expect that a
second Phase III clinical trial will commence by early 2000. Both of these
trials are designed to be pivotal, which means that they are designed to produce
results sufficient to support regulatory approval. If the results of these
trials are not satisfactory, we would need to conduct additional clinical trials
or abandon our GMK program. Since GMK is our most advanced product, a setback of
this nature would almost certainly cause a sharp drop in our stock price.
Moreover, failure of our GMK program could reflect adversely on our MGV program.
Although we have completed patient enrollment in our first pivotal Phase
III clinical trial involving GMK, a considerable amount of time will elapse
before we know the results of this trial. This time is required to conduct
patient follow-up and then to analyze the data. We cannot predict how long this
will take, although we do not expect to know the results much before the second
half of 2000, and it is just as likely that we will not know the results before
2001 or later.
OUR CLINICAL TRIALS COULD TAKE LONGER TO COMPLETE THAN WE EXPECT.
Although for planning purposes we forecast the commencement and completion
of clinical trials, the actual timing of these events can vary dramatically due
to factors such as delays, scheduling conflicts with participating clinicians
and clinical institutions and the rate of patient accruals. Our most advanced
product candidates are intended for treating patients with relatively early
stage cancer and are designed to delay or prevent the recurrence of disease. As
a
8
<PAGE>
consequence, clinical trials involving these product candidates are likely to
take longer to complete than clinical trials involving other types of
therapeutics. We cannot assure you that clinical trials involving our product
candidates will commence or be completed as forecasted.
We have limited experience in conducting clinical trials. In certain
circumstances we rely on corporate collaborators, academic institutions or
clinical research organizations to conduct, supervise or monitor some or all
aspects of clinical trials involving our products. In addition, certain clinical
trials for our products will be conducted by government-sponsored agencies and
consequently will be dependent on governmental participation and funding. We
will have less control over the timing and other aspects of these clinical
trials than if we conducted them entirely on our own. We cannot assure you that
these trials will commence or be completed as we expect or that they will be
conducted successfully. Failure to commence or complete, or delays in, any of
our planned clinical trials could shake investors' confidence in our ability to
develop products, which would likely cause our stock price to decrease.
IF TESTING DOES NOT YIELD SUCCESSFUL RESULTS, OUR PRODUCTS WILL FAIL.
If preclinical and clinical testing of one or more of our products does not
yield successful results, those products will fail. To achieve the results we
need, we or our collaborators must demonstrate a product's safety and efficacy
in humans through extensive preclinical and clinical testing. Numerous
unforeseen events may arise during, or as a result of, the testing process,
including the following:
the results of preclinical studies may be inconclusive, or they may not be
indicative of results that will be obtained in human clinical trials;
potential products may not have the desired effect or may have undesirable
side effects or other characteristics that preclude regulatory approval or
limit their commercial use if approved;
results attained in early human clinical trials may not be indicative of
results that are obtained in later clinical trials;
after reviewing test results, we or our collaborators may abandon projects
which we might previously have believed to be promising, some of which may
be described in this prospectus; and
we, our collaborators or regulators may suspend or terminate clinical
trials if the participating subjects or patients are being exposed to
unacceptable health risks.
Clinical testing is very expensive and can take many years. The failure to
adequately demonstrate the safety and efficacy of a therapeutic product under
development would delay or prevent regulatory approval of the product, which
could adversely affect our profitability and credibility.
EVEN IF WE GET OUR PRODUCTS APPROVED, THEY MIGHT NOT BE ACCEPTED IN THE
MARKETPLACE.
The commercial success of our products will depend upon their acceptance by
the medical community and third party payors as clinically useful, cost
effective and safe. Even if our products obtain regulatory approval, we cannot
assure you that they will achieve market acceptance of any significance. If any
of our products do not achieve market acceptance, we will likely lose our entire
investment in that product.
MARKETPLACE ACCEPTANCE WILL DEPEND IN PART ON COMPETITION IN OUR INDUSTRY, WHICH
IS INTENSE.
The extent to which any of our products achieve market acceptance will
depend on competitive factors. Competition in our industry is intense, and it is
accentuated by the rapid pace of technological development. Products currently
exist in the market that will compete with the products that we are developing.
Many of our competitors have substantially greater research and development
capabilities and experience and greater manufacturing, marketing, financial and
9
<PAGE>
managerial resources than do we. These competitors may develop products that are
superior to those we are developing and render our products or technologies
non-competitive or obsolete. If our product candidates receive marketing
approval but cannot compete effectively in the marketplace, our profitability
and financial position would suffer.
IF WE LOSE OUR COLLABORATIVE PARTNERS, OR IF THEY DO NOT APPLY ADEQUATE
RESOURCES TO OUR COLLABORATIONS, OUR PRODUCT DEVELOPMENT AND PROFITABILITY MAY
SUFFER. IN PARTICULAR, ADVERSE DEVELOPMENTS IN OUR RELATIONSHIP WITH
BRISTOL-MYERS SQUIBB COMPANY CAN HAVE A SIGNIFICANT AND ADVERSE EFFECT ON US AND
OUR STOCK PRICE.
Our business strategy includes entering into collaborations with corporate
partners, primarily pharmaceutical companies, for one or more of the research,
development, manufacturing, marketing and other commercialization activities
relating to certain of our product candidates. If we lose our collaborative
partners, or if they do not apply adequate resources to our collaborations, our
product development and profitability may suffer.
We have entered into a significant corporate collaboration with
Bristol-Myers Squibb Company covering our most advanced product candidates, GMK
and MGV. Adverse developments in our relationship with BMS can have a
significant and adverse effect on us and our stock price. Pursuant to our
agreements with BMS, we have granted to them the exclusive worldwide license to
manufacture, use and sell GMK and MGV and any other products to which we have
rights that include the GM2 or GD2 ganglioside antigens for the treatment or
prevention of human cancer. As a result of the governing agreements, we are
dependent on BMS to fund testing, to make certain regulatory filings and to
manufacture and market existing and any future products resulting from this
collaboration.
We have also entered into a collaboration with the Roche Group of Basel,
Switzerland pursuant to which we granted Roche an exclusive worldwide license to
certain applications of our HIV co-receptor technology. This collaboration is
subject to the same risks, to the extent of the product development program it
covers, as our collaboration with BMS. We have also entered into collaborations
with other partners.
The amount and timing of resources dedicated by BMS or our other
collaborators to their collaborations with us is not within our control. If any
collaborator breaches or terminates its agreements with us, or fails to conduct
its collaborative activities in a timely manner, the commercialization of our
product candidates could be slowed down or blocked completely. We cannot assure
you that BMS or our other collaborative partners will not change their strategic
focus or pursue alternative technologies or develop alternative products, either
on their own or in collaboration with others, as a means for developing
treatments for the diseases targeted by these collaborative programs. For
example, both BMS and Roche market products that may compete against products
being developed in their collaborations with us. Our revenues and earnings also
will be affected by the effectiveness of our corporate partners in marketing any
successfully developed products.
We cannot assure you that our collaborations with BMS or others will
continue or be successful or that we will receive any further research funding
or milestone or royalty payments. If our partners do not develop products under
these collaborations, we cannot assure you that we would be able to do so on our
own. Disputes may arise between us and BMS or our other collaborators as to a
variety of matters, including financial or other obligations under our
contracts, the most promising scientific or regulatory route to pursue or
ownership of intellectual property rights. These disputes may be both expensive
and time-consuming and may result in delays in the development and
commercialization of product candidates.
WE MAY NOT BE ABLE TO NEGOTIATE ADDITIONAL COLLABORATIVE AGREEMENTS, WHICH COULD
REDUCE OUR RATE OF PRODUCT DEVELOPMENT.
We intend to continue to enter into new collaborative agreements in the
future. However, we cannot assure you that we will negotiate any additional
collaborative arrangements or that any of these relationships, if established,
will be scientifically or commercially successful. Any additional
10
<PAGE>
collaborations would likely subject us to some or all of the risks described
above with respect to our current collaborations.
WE HAVE A HISTORY OF OPERATING LOSSES, AND WE MAY NEVER BE PROFITABLE.
We have a history of operating losses, and we may never be profitable. We
have incurred substantial losses since our inception. As of June 30, 1999, we
had an accumulated deficit of approximately $20.7 million. These losses have
resulted principally from costs incurred in our research and development
programs and from our general and administrative costs. We have derived no
significant revenues from product sales or royalties, and we do not expect to
achieve significant product sales or royalty revenue for a number of years, if
ever. We may incur additional operating losses in the future, which could
increase significantly as we expand development and clinical trial efforts.
Our ability to achieve long-term profitability is dependent in part on
obtaining regulatory approvals for products and entering into agreements for
commercialization of our products. However, we cannot assure you that our
operations will be profitable even if any of our products under development is
commercialized.
WE ARE LIKELY TO NEED ADDITIONAL FINANCING, BUT OUR ACCESS TO CAPITAL FUNDING IS
UNCERTAIN.
Our current and anticipated development projects require substantial
capital. We may require substantial additional funds to conduct research
activities, preclinical studies, clinical trials and other activities relating
to the successful commercialization of potential products. However, our access
to capital funding is uncertain. We do not have committed external sources of
funding for most of our drug discovery and development projects, and we cannot
assure you that we will be able to obtain additional funds on acceptable terms,
if at all. If adequate funds are not available, we may be required to:
delay, reduce the scope of or eliminate one or more of our programs;
obtain funds through arrangements with collaborative partners or others
that may require us to relinquish rights to technologies, product
candidates or products that we would otherwise seek to develop or
commercialize ourselves; or
license rights to technologies, product candidates or products on terms
that are less favorable to us than might otherwise be available.
If we raise additional funds by issuing equity securities, further dilution
to stockholders may result, and new investors could have rights superior to
existing stockholders.
WE HAVE LIMITED MANUFACTURING CAPABILITIES, WHICH COULD ADVERSELY IMPACT OUR
ABILITY TO COMMERCIALIZE PRODUCTS.
We have limited manufacturing capabilities, which may result in increased
costs of production or delay product development or commercialization. In order
to commercialize our product candidates successfully, we or our collaborators
must be able to manufacture products in commercial quantities, in compliance
with regulatory requirements, at acceptable costs and in a timely manner. The
manufacture of some or all of our product candidates can be complex, difficult
to accomplish even in small quantities, difficult to scale-up when large scale
production is required and subject to delays, inefficiencies and poor or low
yields of quality products. The cost of manufacturing certain of our products
may make them prohibitively expensive. The contamination or loss of a supply of
our product candidates, adjuvants or related materials could seriously delay
clinical trials, since these materials are time-consuming to manufacture and
cannot be readily obtained from third-party sources. We have constructed two
pilot-scale manufacturing facilities, one for the production of vaccines and one
for the production of recombinant proteins, which we believe will be sufficient
to meet our initial needs for clinical trials. These facilities may be
insufficient for late-stage clinical trials and for commercial-scale
manufacturing requirements. We intend to use a portion of the proceeds from this
offering to expand our facilities for additional
11
<PAGE>
manufacturing capacity. Nevertheless, we may be required to expand further our
manufacturing staff and facilities, obtain new facilities or contract with
corporate collaborators or other third parties to assist with production.
In the event that we decide to establish a commercial-scale manufacturing
facility, we will require substantial additional funds and will be required to
hire and train significant numbers of employees and comply with applicable
regulations, which are extensive. We cannot assure you that we will be able to
develop a manufacturing facility that both meets regulatory requirements and is
sufficient for all clinical trials or commercial-scale manufacturing.
We have entered into arrangements with third parties for the manufacture of
certain of our products. We cannot assure you that this strategy will result in
a cost-effective means for manufacturing products. In employing third-party
manufacturers, we will not control many aspects of the manufacturing process. We
cannot assure you that we will be able to obtain adequate supplies from
third-party manufacturers in a timely fashion for development or
commercialization purposes or that commercial quantities of products will be
available from contract manufacturers at acceptable costs.
WE ARE SUBJECT TO EXTENSIVE REGULATION, WHICH CAN BE COSTLY, TIME CONSUMING AND
SUBJECT US TO UNANTICIPATED DELAYS.
We and our products are subject to comprehensive regulation by the Food and
Drug Administration in the United States and by comparable authorities in other
countries. These national agencies and other federal, state and local entities
regulate, among other things, the preclinical and clinical testing, safety,
effectiveness, approval, manufacture, labeling, marketing, export, storage,
record keeping, advertising and promotion of pharmaceutical products. Violations
of regulatory requirements at any stage, whether before or after marketing
approval is obtained, may result in fines, forced removal of a product from the
market and other adverse consequences.
WE DO NOT YET HAVE, AND MAY NEVER OBTAIN, THE REGULATORY APPROVALS WE NEED TO
SUCCESSFULLY MARKET OUR PRODUCTS.
Our products have not yet been approved by applicable regulatory
authorities for commercialization. The process of obtaining FDA and other
required regulatory approvals, including foreign approvals, often takes many
years and can vary substantially based upon the type, complexity and novelty of
the products involved. We have had only limited experience in filing and
pursuing applications necessary to gain regulatory approvals. We cannot
guarantee that any of our products under development will be approved for
marketing by the FDA. Even if regulatory approval of a product is granted, we
cannot be certain that we will be able to obtain the labeling claims necessary
or desirable for the promotion of those products. Even if we obtain regulatory
approval, we may be required to undertake post-marketing trials. In addition,
identification of side effects after a drug is on the market or the occurrence
of manufacturing problems could cause subsequent withdrawal of approval,
reformulation of the drug, additional preclinical testing or clinical trials,
changes in labeling of the product, and additional marketing applications. If we
receive regulatory approval, we will also be subject to ongoing FDA obligations
and continued regulatory review. Delays in receipt of or failure to receive
regulatory approvals, or the loss of previously received approvals, would delay
or prevent product commercialization, which would adversely affect our financial
results.
WE ARE DEPENDENT ON OUR PATENTS AND PROPRIETARY RIGHTS. THE VALIDITY,
ENFORCEABILITY AND COMMERCIAL VALUE OF THESE RIGHTS ARE HIGHLY UNCERTAIN.
Our success is dependent in part on obtaining, maintaining and enforcing
patent and other proprietary rights. The patent position of biotechnology and
pharmaceutical firms is highly uncertain and involves many complex legal and
technical issues. There is no clear policy involving the breadth of claims
allowed in such cases, or the degree of protection afforded under such patents.
Accordingly, we cannot assure you that patent applications owned by or licensed
to us will
12
<PAGE>
result in patents being issued or that, if issued, the patents will give us an
advantage over competitors with similar technology.
We own or have licenses to certain issued patents. However, the issuance of
a patent is not conclusive as to its validity or enforceability. The validity or
enforceability of a patent after its issuance by the patent office can be
challenged in litigation. We cannot assure you that our patents will not be
successfully challenged. Moreover, the cost of litigation to uphold the validity
of patents and to prevent infringement can be substantial. If the outcome of
litigation is adverse to us, third parties may be able to use our patented
invention without payment to us. Moreover, we cannot assure you that our patents
will not be infringed or successfully avoided through design innovation.
There may be patent rights belonging to others that require us to alter our
products, pay licensing fees or cease certain activities. If our products
conflict with patent rights of others, they could bring legal actions against us
claiming damages and seeking to enjoin manufacturing and marketing of the
affected products. If these legal actions are successful, in addition to any
potential liability for damages, we could be required to obtain a license in
order to continue to manufacture or market the affected products. We cannot
assure you that we would prevail in any such action or that any license required
under any such patent would be made available on acceptable terms or at all.
The research, development and commercialization of a biopharmaceutical
often involves alternative development and optimization routes, which are
presented at various stages in the development process. The preferred routes
cannot be predicted at the outset of a research and development program because
they will depend on subsequent discoveries and test results. There are numerous
third-party patents in our field, and it is possible that to pursue the
preferred development route of one or more of our products we will need to
obtain a license to a patent, which would decrease the ultimate profitability of
the applicable product. If we cannot negotiate a license, we might have to
pursue a less desirable development route or terminate the program altogether.
The Aaron Diamond AIDS Research Center is a co-owner with us of one of the
patent applications relating to the HIV co-receptor CCR5 and upon which our HIV
co-receptor/fusion program is based. Unless we acquire from ADARC an exclusive
license to ADARC's rights in this patent application, we cannot assure you that
ADARC will not license such patent to a competitor of ours. Additionally, we
have filed a number of U.S. and foreign patent applications, one of which is
owned jointly with ADARC, relating to the discovery of the HIV co-receptor CCR5.
We are aware that other groups have claimed discoveries similar to those covered
by our patent applications. We do not expect to know for several years the
relative strength of our patent position as compared to these other groups.
We are required to make substantial cash payments and achieve certain
milestones and satisfy certain conditions, including filing investigational new
drug applications, obtaining product approvals and introducing products, to
maintain our rights under our licenses, including our licenses from Memorial
Sloan-Kettering Cancer Center and Columbia University. We cannot assure you that
we will be able to maintain our rights under these licenses. Termination of any
of these licenses could result in our being unable to commercialize any related
product.
In addition to the intellectual property rights described above, we also
rely on unpatented technology, trade secrets and confidential information. We
cannot assure you that others will not independently develop substantially
equivalent information and techniques or otherwise gain access to our technology
or disclose such technology, or that we can effectively protect our rights in
unpatented technology, trade secrets and confidential information. We require
each of our employees, consultants and advisors to execute a confidentiality
agreement at the commencement of an employment or consulting relationship with
us. We cannot assure you, however, that these agreements will provide effective
protection for our information in the event of unauthorized use or disclosure of
this confidential information.
13
<PAGE>
WE ARE DEPENDENT ON THIRD PARTIES FOR A VARIETY OF FUNCTIONS; WE CANNOT ASSURE
YOU THAT THESE ARRANGEMENTS WILL PROVIDE US WITH THE BENEFITS WE EXPECT.
In addition to our reliance on corporate collaborators, we rely in part on
third parties to perform a variety of functions, including research and
development, manufacturing, clinical trials management and regulatory affairs.
As of September 30, 1999, we had only 45 full-time employees. We are party to
several agreements which place substantial responsibility on third parties for
clinical development of our products. We also in-license technology from medical
and academic institutions in order to minimize investments in early research,
and we enter into collaborative arrangements with certain of these entities with
respect to clinical trials of product candidates. We cannot assure you that we
will be able to maintain any of these relationships or establish new ones on
beneficial terms, that we can enter into these arrangements without undue delays
or expenditures or that these arrangements will allow us to compete
successfully.
WE LACK SALES AND MARKETING EXPERIENCE, WHICH MAKES US DEPENDENT ON THIRD
PARTIES FOR THEIR EXPERTISE IN THIS AREA.
Assuming receipt of required regulatory approvals, we expect to market and
sell our products principally through distribution, co-marketing, co-promotion
or licensing arrangements with third parties. Our agreements with Bristol-Myers
Squibb Company, the Roche Group and CYTOGEN Corporation grant these
collaborators exclusive marketing rights with respect to products resulting from
their respective collaborations with us. We have no experience in sales,
marketing or distribution. To the extent that we enter into distribution,
co-marketing, co-promotion or licensing arrangements for the marketing and sale
of our products, any revenues we receive will depend primarily on the efforts of
these third parties. We will not control the amount and timing of marketing
resources such third parties devote to our products. In addition, if we market
products directly, significant additional expenditures and management resources
would be required to develop an internal sales force. We cannot assure you that
we would be able to establish a successful sales force should we choose to do
so.
IF WE LOSE KEY MANAGEMENT AND SCIENTIFIC PERSONNEL ON WHOM WE DEPEND, OUR
BUSINESS COULD SUFFER.
We are dependent upon our key management and scientific personnel. In
particular, the loss of Dr. Maddon, our Chief Executive Officer and Chief
Science Officer, or Mr. Prentki, our President, could cause our management and
operations to suffer unless a qualified replacement could be found. We maintain
a key man life insurance policy on Dr. Maddon in the amount of $2.5 million. We
have an employment agreement with Dr. Maddon that expires in December 2001 and
one with Mr. Prentki that expires in March 2001.
Competition for qualified employees among companies in the
biopharmaceutical industry is intense. Our future success depends upon our
ability to attract, retain and motivate highly skilled employees. In order to
commercialize our products successfully, we may be required to expand
substantially our personnel, particularly in the areas of manufacturing,
clinical trials management, regulatory affairs, business development and
marketing. We cannot assure you that we will be successful in hiring or
retaining qualified personnel.
IF SUFFICIENT QUANTITIES OF THE RAW MATERIALS NEEDED TO MAKE OUR PRODUCTS ARE
NOT AVAILABLE, PRODUCT DEVELOPMENT AND COMMERCIALIZATION COULD BE SLOWED OR
STOPPED.
We cannot assure you that sufficient quantities of the raw materials needed
to make our products will be available to support continued research,
development or commercial manufacture of our products. We currently obtain
supplies of critical raw materials used in production of GMK and MGV from single
sources. In particular, commercialization of GMK and MGV requires an adjuvant,
QS-21, available only from Aquila Biopharmaceuticals Inc. We have entered into a
license and supply agreement with Aquila pursuant to which Aquila agreed to
supply us with all of our QS-21 requirements for use in certain
ganglioside-based cancer vaccines, including GMK
14
<PAGE>
and MGV. In connection with our collaboration with Bristol-Myers Squibb Company,
we granted to BMS a non-exclusive sublicense under our license and supply
agreement with Aquila, and BMS entered into a supply agreement with Aquila. We
cannot assure you that Aquila will be able to supply sufficient quantities of
QS-21 or that we or BMS will have the right or capability to manufacture
sufficient quantities of QS-21 to meet our needs if Aquila is unable or
unwilling to do so. We cannot assure you that we will not be subject to delays
or disruption in the supply of this component. Any delay or disruption in the
availability of raw materials could slow or stop product development and
commercialization of the relevant product.
A SUBSTANTIAL PORTION OF OUR FUNDING COMES FROM FEDERAL GOVERNMENT GRANTS; WE
CANNOT RELY ON THESE GRANTS AS A CONTINUING SOURCE OF FUNDS.
A substantial portion of our revenues to date has been derived from federal
research grants. We cannot rely on these grants as a continuing source of funds.
The government's obligation to make payments under these grants is subject to
appropriation by the United States Congress for funding in each year. Moreover,
it is possible that Congress or the government agencies that administer these
government research programs will decide to scale back these programs or
terminate them. Consequently, we cannot assure you that we will be awarded
research grants in the future or that any amounts derived from them will not be
less than those received to date.
WE ARE SUBJECT TO THE UNCERTAINTY RELATED TO HEALTH CARE REFORM MEASURES AND
REIMBURSEMENT POLICIES.
In recent years, there have been numerous proposals to change the health
care system in the United States. Some of these proposals have included measures
that would limit or eliminate payments for medical procedures and treatments or
subject the pricing of pharmaceuticals to government control. In addition, as a
result of the trend towards managed health care in the United States, as well as
legislative proposals to reduce government insurance programs, third-party
payors are increasingly attempting to contain health care costs by limiting both
coverage and the level of reimbursement of new drug products. Consequently,
significant uncertainty exists as to the reimbursement status of newly-approved
health care products. If we or any of our collaborators succeeds in bringing one
or more of our products to market, we cannot assure you that third-party payors
will establish and maintain price levels sufficient for realization of an
appropriate return on our investment in product development. Significant changes
in the health care system in the United States or elsewhere, including changes
resulting from adverse trends in third-party reimbursement programs, could have
a material adverse effect on our profitability. Such changes also could have a
material adverse effect on our ability to raise capital. Furthermore, our
ability to commercialize products may be adversely affected to the extent that
these proposals affect our collaborators.
WE ARE EXPOSED TO PRODUCT LIABILITY CLAIMS, AND IT IS UNCERTAIN THAT IN THE
FUTURE INSURANCE AGAINST THESE CLAIMS WILL BE AVAILABLE TO US AT A REASONABLE
RATE.
Our business exposes us to potential product liability risks, which are
inherent in the testing, manufacturing, marketing and sale of pharmaceutical
products. We cannot assure you that we will be able to avoid product liability
exposure. Product liability insurance for the biopharmaceutical industry is
generally expensive, when available at all. We have obtained product liability
insurance coverage in the amount of $5.0 million per occurrence, subject to a
$5.0 million aggregate limitation. However, we cannot assure you that our
present insurance coverage is now or will continue to be adequate. In addition,
some of our license and collaborative agreements require us to obtain product
liability insurance. It is possible that future license and collaborative
agreements may also include such a requirement. We cannot assure you that
adequate insurance coverage will be available to us at a reasonable cost in the
future or that a product liability claim or recall would not have a material
adverse effect on our financial position.
15
<PAGE>
WE DEAL WITH HAZARDOUS MATERIALS AND MUST COMPLY WITH ENVIRONMENTAL LAWS AND
REGULATIONS, WHICH CAN BE EXPENSIVE AND RESTRICT HOW WE DO BUSINESS. WE COULD
ALSO BE LIABLE FOR DAMAGES, PENALTIES OR OTHER FORMS OF CENSURE IF WE ARE
INVOLVED IN A HAZARDOUS WASTE SPILL OR OTHER ACCIDENT.
Our research and development work and manufacturing processes involve the
use of hazardous, controlled and radioactive materials. We are subject to
federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of these materials. Despite precautionary
procedures that we implement for handling and disposing of these materials, the
risk of accidental contamination or injury cannot be eliminated. In the event of
a hazardous waste spill or other accident, we could also be liable for damages,
penalties or other forms of censure. Although we believe that we are in
compliance in all material respects with applicable environmental laws and
regulations, we cannot assure you that we will not be required to incur
significant costs to comply with environmental laws and regulations in the
future or that we will not be materially and adversely affected by current or
future environmental laws or regulations.
OUR STOCK PRICE HAS A HISTORY OF VOLATILITY. YOU SHOULD CONSIDER AN INVESTMENT
IN OUR STOCK AS RISKY AND INVEST ONLY IF YOU CAN WITHSTAND A SIGNIFICANT LOSS.
Our stock price has a history of significant volatility. This volatility
has existed even in the absence of significant news or developments relating to
Progenics. Moreover, the stocks of biotechnology companies and the stock market
generally have been subject to dramatic price swings in recent years. Factors
that may have a significant impact on the market price of our common stock
include:
the results of preclinical studies and clinical trials by us, our
collaborators or our competitors;
announcements of technological innovations or new commercial products by
us, our collaborators or our competitors;
governmental regulation;
changes in reimbursement policies;
health care legislation;
developments in patent or other proprietary rights;
developments in our relationships with collaborative partners;
public concern as to the safety and efficacy of products developed by us,
our collaborators or our competitors;
fluctuations in our operating results; and
general market conditions.
In addition, the market prices of equity securities generally have experienced
significant volatility in the recent past, with the stock of small
capitalization companies, like us, experiencing the greatest volatility. These
price swings, both as to our stock and as to our industry and the stock market
generally, are apt to continue. As a result, you could be subject to significant
losses in your investment in our stock even if we successfully execute on our
business plan. Moreover, the experiences of other companies would lead us to
expect a severe decline in our stock price if we experience an adverse
development in our business. As described above, our business plan is risky, and
so there is a very real possibility that we will not succeed in achieving our
goals. In sum, you should consider an investment in our stock as risky and
invest only if you can withstand the loss of a significant portion, if not all,
of your investment.
ANTI-TAKEOVER PROVISIONS MAY DISCOURAGE HOSTILE BIDS FOR CONTROL OF OUR COMPANY
THAT MAY BE BENEFICIAL TO OUR SHAREHOLDERS.
Certain of our stockholders, including Dr. Maddon and stockholders
affiliated with Tudor Investment Corporation, beneficially own or control a
substantial portion of our outstanding shares
16
<PAGE>
of common stock and therefore may have the ability, acting together, to elect
all of our directors, to determine the outcome of corporate actions requiring
stockholder approval and otherwise control our business. This control could have
the effect of delaying or preventing a change in control of our company and,
consequently, could adversely affect the market price of our common stock. In
addition, our Board of Directors is authorized, without further stockholder
action, to issue from time to time shares of preferred stock in one or more
designated series or classes. The issuance of preferred stock, as well as
provisions in certain of our stock options which provide for acceleration of
exercisability upon a change of control, and Section 203 and other provisions of
the Delaware General Corporation Law, could make the takeover of Progenics or
the removal of our board of directors or management more difficult, discourage
hostile bids for control of Progenics in which stockholders may receive a
premium for their shares of common stock or otherwise dilute the rights of
holders of common stock and depress the market price of our common stock.
SALES OF COMMON STOCK MAY HAVE AN ADVERSE IMPACT ON THE MARKET PRICE OF OUR
COMMON STOCK.
A substantial number of outstanding shares of common stock and shares of
common stock issuable upon exercise of outstanding options and warrants are
eligible for sale in the public market. Sales of substantial numbers of shares
of common stock could adversely affect prevailing market prices. Some of our
stockholders are entitled to require us to register their shares of common stock
for offer or sale to the public. We have filed a Form S-8 registration statement
registering shares issuable pursuant to our stock option plans. Any sales by
existing stockholders or holders of options or warrants may have an adverse
effect on our ability to raise capital and may adversely affect the market price
of the common stock.
IF YOU PURCHASE COMMON STOCK, YOU WILL INCUR IMMEDIATE AND SUBSTANTIAL DILUTION
IN THE BOOK VALUE OF YOUR SHARES.
The public offering price for our shares will be substantially higher than
our net tangible book value per share, which at June 30, 1999 was $2.45 per
share. Investors purchasing our common stock in this offering will suffer
immediate, substantial net tangible book value dilution of $13.80 per share, or
$13.48 per share if the underwriters' over-allotment option is exercised in
full, assuming a public offering price of $18.875 per share. In addition, this
dilution will increase to the extent that holders of outstanding options and
warrants to purchase common stock at prices below our net tangible book value
per share after this offering exercise such options or warrants.
WE FACE UNCERTAINTY WITH YEAR 2000 COMPLIANCE.
The Year 2000 issue is the result of computer programs being written using
two digits rather than four to define the applicable year. Any of our computer
programs or hardware that have date-sensitive software or embedded chips may
recognize a date using '00' as the year 1900 rather than the year 2000. This may
result in a system failure or miscalculations causing disruptions of operations,
including, among other things, the inability to receive supplies from our
vendors, or operate our accounting and other internal systems. If our software
vendors are unable to address the Year 2000 compliance of their products, or
should our suppliers' operations be disrupted by the Year 2000 issue, then our
ability to serve collaborative partners and develop products may be affected.
17
<PAGE>
USE OF PROCEEDS
We estimate that the net proceeds from the sale of the shares of common
stock in this offering, assuming a public offering price of $18.875 per share
and after deducting the underwriting discount and estimated expenses payable by
us, will be approximately $35.0 million, or $40.3 million if the underwriters'
over-allotment option is exercised in full. We expect to use the net proceeds
from this offering to fund:
research and development;
in-licensing of technology;
clinical trials; and
expansion of our research and development and manufacturing facilities.
We also plan to use the proceeds for working capital and general corporate
purposes, including potential acquisitions of technologies, product candidates
or companies. Although in the ordinary course of our business we engage in
discussions regarding acquisitions, we are not currently a party to any
definitive agreement or letter of intent regarding any material acquisition.
Pending our use of the net proceeds from this offering as described above, we
intend to invest the net proceeds in interest bearing investment grade
securities.
We believe that the net proceeds from this offering, together with our
existing capital resources, should be sufficient to fund our operations at least
through 2001. However, this is a forward-looking statement based on our current
operating plan and the assumptions on which it relies. We cannot assure you that
there will not be any change in our plans or that our assumptions will not turn
out to be incorrect, in which event we could use up our assets before such time.
Even if the funds described above last through 2001 as we expect, we are
likely to need substantial additional funds to conduct research activities,
preclinical studies, clinical trials and other activities relating to the
development and commercialization of potential products. We cannot currently
estimate with any accuracy the amount of these additional funds because it may
vary significantly depending on, among other factors:
the results of research and development and product testing;
our potential relationships with in-licensors and collaborators;
changes in the focus and direction of our research and development
programs;
potential acquisitions;
the cost of filing, prosecuting, defending and enforcing patent claims;
the regulatory approval process; and
manufacturing, marketing and other costs associated with commercialization
of products.
We anticipate that we will seek any required additional funds from external
sources, such as future offerings of equity or debt securities or agreements
with corporate partners and collaborators. There can be no assurance, however,
that we will be able to negotiate such arrangements or obtain additional funds
on acceptable terms, if at all.
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<PAGE>
FORWARD-LOOKING STATEMENTS
This prospectus contains certain forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995. Any statements contained
herein that are not statements of historical fact may be deemed to be
forward-looking statements. When we use the words 'believes,' 'anticipates,'
'plans,' 'expects,' 'intends' and similar expressions, we are identifying
forward-looking statements. We make these forward-looking statements based on
information available to us as of the date of this prospectus and various
assumptions that we believe are reasonable. We do not, however, represent these
forward-looking statements as guarantees of future performance or results. There
are a number of important factors, including those described above under the
caption 'Risk Factors,' that could cause our actual results to differ materially
from those indicated by our forward-looking statements.
PRICE RANGE OF COMMON STOCK
Our common stock is quoted on the Nasdaq National Market under the symbol
'PGNX.' The following table sets forth for the periods indicated the high and
low sales price per share of the common stock, as reported on the Nasdaq
National Market. Such prices reflect inter-dealer prices, without retail
mark-up, mark-down or commission and may not represent actual transactions.
<TABLE>
<CAPTION>
HIGH LOW
---- ---
<S> <C> <C>
Year Ended December 31, 1997:
Fourth quarter (from November 19)...................... $15 5/16 $ 8
Year Ended December 31, 1998:
First quarter.......................................... 22 5/8 13
Second quarter......................................... 22 13
Third quarter.......................................... 15 3/4 8 1/2
Fourth quarter......................................... 16 1/2 9
Year Ended December 31, 1999:
First quarter.......................................... 16 3/4 10 5/8
Second quarter......................................... 15 1/4 11 3/8
Third quarter.......................................... 31 3/8 12 1/2
Fourth quarter (through October 21).................... 24 3/8 15 1/2
</TABLE>
On October 21, 1999, the last sale price for the common stock as reported
by Nasdaq was $18.875. There were approximately 162 holders of record of the
common stock as of October 11, 1999.
DIVIDEND POLICY
We have not paid any dividends since our inception and presently anticipate
that all earnings, if any, will be retained for development of our business and
that no dividends on our common stock will be declared in the foreseeable
future.
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<PAGE>
CAPITALIZATION
The following table sets forth our actual and as adjusted capitalization at
June 30, 1999, as described below. The as adjusted column gives effect to the
sale of the shares of common stock in this offering, assuming a public offering
price of $18.875 per share, and the receipt of the net proceeds therefrom after
deducting the underwriting discount and estimated offering expenses. The table
below does not reflect:
2,858,104 shares of common stock issuable upon exercise of outstanding
options at a weighted average exercise price of $7.13 per share;
314,592 shares of common stock issuable upon exercise of outstanding
warrants at a weighted average exercise price of $6.08; and
617,576 shares of common stock available for future issuance under our
stock option and employee stock purchase plans.
This table should be read in conjunction with our financial statements and
the related notes, which are included elsewhere in this prospectus.
<TABLE>
<CAPTION>
JUNE 30, 1999
---------------------------
ACTUAL AS ADJUSTED
------ -----------
<S> <C> <C>
Cash, cash equivalents and marketable securities, including
non-current portion....................................... $ 22,840,257 $ 57,825,257
------------ ------------
------------ ------------
Capital lease obligations, long-term portion................ $ 65,667 $ 65,667
------------ ------------
Stockholders' equity:
Preferred stock, $.001 par value; 14,320,174 shares
authorized; none issued or outstanding................ -- --
Common stock, $.0013 par value; 40,000,000 shares
authorized; 9,446,366 shares issued and outstanding,
actual; and 11,446,366 shares issued and outstanding,
as adjusted........................................... 12,280 14,880
Additional paid-in capital............................. 44,705,439 79,687,839
Unearned compensation.................................. (851,080) (851,080)
Accumulated deficit.................................... (20,724,758) (20,724,758)
Accumulated other comprehensive loss................... (38,659) (38,659)
------------ ------------
Total stockholders' equity........................ 23,103,222 58,088,222
------------ ------------
Total capitalization........................................ $ 23,168,889 $ 58,153,889
------------ ------------
------------ ------------
</TABLE>
20
<PAGE>
SELECTED FINANCIAL DATA
(in thousands, except per share data)
The selected financial data presented below as of December 31, 1997 and
1998 and for each of the three years in the period ended December 31, 1998 are
derived from our financial statements, which are included elsewhere and
incorporated by reference in this prospectus and which have been audited by
PricewaterhouseCoopers LLP. The selected financial data presented below as of
December 31, 1994, 1995 and 1996 and for each of the two years in the period
ended December 31, 1995 are derived from our audited financial statements that
are not included in this prospectus. The selected financial data presented below
as of June 30, 1999 and for the six months ended June 30, 1998 and 1999 have
been derived from our unaudited financial statements which are included
elsewhere and incorporated by reference in this prospectus and, in our opinion,
reflect all adjustments, consisting only of normal recurring accruals, necessary
for a fair presentation of our financial position and results of operations.
Operating results for the six months ended June 30, 1999 are not necessarily
indicative of results that may be expected for any other interim period or for
the year ending December 31, 1999. The data set forth below should be read in
conjunction with 'Management's Discussion and Analysis of Financial Condition
and Results of Operations' and the Financial Statements and related notes
included elsewhere and incorporated by reference in this prospectus.
<TABLE>
<CAPTION>
SIX MONTHS
YEARS ENDED DECEMBER 31, ENDED JUNE 30,
----------------------------------------------- -----------------
1994 1995 1996 1997 1998 1998 1999
---- ---- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C> <C> <C>
STATEMENT OF OPERATIONS DATA:
Revenues:
Contract research and development....... $ -- $ 200 $ 318 $14,591 $11,135 $ 5,329 $ 4,860
Research grants......................... 504 525 203 665 1,251 581 423
Product sales........................... 52 50 98 57 180 36 35
Interest income......................... 108 46 106 301 1,455 664 593
------- ------- ------- ------- ------- ------- -------
Total revenues..................... 664 821 725 15,614 14,021 6,610 5,911
------- ------- ------- ------- ------- ------- -------
Expenses:
Research and development................ 2,859 3,852 3,700 7,364 8,296 3,912 5,321
General and administrative.............. 878 1,094 2,808 2,222 3,841 1,937 1,976
Loss in joint venture................... -- -- -- -- -- -- 1,797
Interest expense........................ 50 87 51 312 43 18 29
Depreciation and amortization........... 289 291 309 319 388 164 305
------- ------- ------- ------- ------- ------- -------
Total expenses..................... 4,076 5,324 6,868 10,217 12,568 6,031 9,428
------- ------- ------- ------- ------- ------- -------
Operating (loss) income............ (3,412) (4,503) (6,143) 5,397 1,453 579 (3,517)
Income taxes................................. -- -- -- 258 -- -- --
------- ------- ------- ------- ------- ------- -------
Net (loss) income.................. $(3,412) $(4,503) $(6,143) $ 5,139 $ 1,453 $ 579 $(3,517)
------- ------- ------- ------- ------- ------- -------
------- ------- ------- ------- ------- ------- -------
Per share amounts on net (loss) income:
Basic................................... $ (1.52) $ (1.99) $ (2.68) $ 1.64 $ 0.16 $ 0.06 $ (0.37)
Diluted................................. $ (1.52) $ (1.99) $ (2.68) $ 0.66 $ 0.14 $ 0.05 $ (0.37)
Weighted average number of common shares
outstanding:
Basic................................... 2,250 2,265 2,295 3,128 9,068 9,009 9,401
Diluted................................. 2,250 2,265 2,295 7,804 10,727 10,913 9,401
</TABLE>
<TABLE>
<CAPTION>
DECEMBER 31,
--------------------------------------------- JUNE 30,
1994 1995 1996 1997 1998 1999
---- ---- ---- ---- ---- ----
<S> <C> <C> <C> <C> <C> <C>
BALANCE SHEET DATA:
Cash, cash equivalents and marketable securities,
including non-current portion................... $2,275 $ 559 $ 647 $23,624 $24,650 $22,840
Working capital................................... 2,019 19 (1,109) 20,562 25,137 19,955
Total assets...................................... 3,489 1,736 1,633 24,543 27,900 26,079
Capital lease obligations and deferred lease
liability, long-term portion.................... 235 213 156 141 117 66
Total stockholders' equity (deficit).............. 2,827 852 (385) 23,034 26,079 23,103
</TABLE>
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<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
Progenics is a biopharmaceutical company focusing on the development and
commercialization of innovative products for the treatment and prevention of
cancer and viral and other life-threatening diseases. We commenced principal
operations in late 1988 and since that time have been engaged primarily in
research and development efforts, development of our manufacturing capabilities,
establishment of corporate collaborations and raising capital. In order to
commercialize the principal products that we have under development, we will
need to address a number of technological challenges and comply with
comprehensive regulatory requirements. Accordingly, it is not possible to
predict the amount of funds that will be required or the length of time that
will pass before we receive revenues from sales of any of these products. To
date, product sales have consisted solely of limited revenues from the sale of
research reagents. We expect that sales of research reagents in the future will
not significantly increase over current levels. Our other sources of revenues
through June 30, 1999 have been payments received under our collaboration
agreements, research grants and contracts related to our cancer and HIV programs
and interest income.
To date, a majority of our expenditures have been for research and
development activities. We expect that our research and development expenses
will increase significantly as our programs progress and we make filings for
related regulatory approvals. With the exception of the years ended
December 31, 1997 and 1998, we have had recurring losses and had, at June 30,
1999, an accumulated deficit of approximately $20,725,000. We have financed our
operations primarily through the private sale and issuance of equity securities,
a line of credit that has since been repaid and terminated, payments received
under our collaboration with the Bristol-Myers Squibb Company beginning in July
1997, payments received under our collaboration with the Roche Group beginning
in January 1998, funding under research grants and contracts, the proceeds of
our initial public offering in November 1997 and the proceeds from the exercise
of outstanding options and warrants. We will require additional funds to
complete the development of our products, to fund the cost of clinical trials
and to fund operating losses that are expected to continue for the foreseeable
future. We do not expect our products under development to be commercialized in
the near future.
RESULTS OF OPERATIONS
Six Months Ended June 30, 1999 and 1998
Contract research and development revenue decreased to approximately
$4,860,000 for the six months ended June 30, 1999 from approximately $5,329,000
for the six months ended June 30, 1998 as we received milestone payments
pursuant to the BMS and Roche agreements in 1998. Revenues from research grants
decreased to approximately $423,000 for the six months ended June 30, 1999 from
approximately $581,000 for the six months ended June 30, 1998. The decrease was
due to the funding of fewer grants in the first half of 1999. Sales of research
reagents were essentially unchanged at approximately $35,000 for the six months
ended June 30, 1999 and $36,000 for the six months ended June 30, 1998 as orders
for such reagents remained constant. Interest income decreased to approximately
$593,000 for the six months ended June 30, 1999 from approximately $664,000 for
the six months ended June 30, 1998 due to the decrease in cash available for
investing.
Research and development expenses increased to approximately $5,321,000 for
the six months ended June 30, 1999 from approximately $3,911,000 for the six
months ended June 30, 1998. The increase was principally due to the payment of
license fees and the hiring of new scientists as we expanded our research and
development programs in 1999 and the additional costs in 1999 of conducting our
Phase III clinical trials, as the number of patients enrolled in the trials
increased significantly.
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<PAGE>
General and administrative expenses increased to approximately $1,977,000
for the six months ended June 30, 1999 from approximately $1,937,000 for the six
months ended June 30, 1998. The increase was principally due to the hiring of
additional administrative staff.
We recognized a loss in our joint venture with CYTOGEN Corporation of
approximately $1,797,000 for the six months ended June 30, 1999 as the joint
venture expensed license fees.
Interest expense increased to approximately $29,000 for the six months
ended June 30, 1999 from approximately $18,000 for the six months ended
June 30, 1998. The increase was principally due to the recognition of interest
expense as we discounted future capital contributions to the joint venture.
Depreciation and amortization expense increased to approximately $305,000
for the six months ended June 30, 1999 from approximately $164,000 for the six
months ended June 30, 1998. The increase was principally due to the purchase of
additional fixed assets and leasehold improvements that are amortized over the
life of the lease that expires in December 2000.
Our net loss for the six months ended June 30, 1999 was approximately
$3,517,000 compared to net income of approximately $579,000 for the six months
ended June 30, 1998.
Years Ended December 31, 1998 and 1997
Contract research and development revenue decreased from $14,591,000 in
1997 to $11,135,000 in 1998. In connection with our collaboration with BMS, we
received a licensing fee in 1997 and a milestone payment in 1998 and
reimbursement of clinical development during both years. Revenues from research
grants increased from $665,000 in 1997 to $1,251,000 in 1998. The increase
resulted from the funding of a greater number of grants in 1998. Sales of
research reagents increased from $57,000 in 1997 to $180,000 in 1998 resulting
from increased orders for such reagents during 1998. Interest income increased
from $301,000 in 1997 to $1,455,000 in 1998 due to the increase in cash
available for investing as we received continued funding under our collaboration
with BMS and invested the proceeds of our initial public offering completed in
November 1997.
Research and development expenses increased from $7,364,000 in 1997 to
$8,296,000 in 1998. The increase was principally due to additional costs of
manufacturing GMK and monitoring clinical trials during 1998, and additional
costs of manufacturing PRO 542.
General and administrative expenses increased from $2,222,000 in 1997 to
$3,841,000 in 1998. The increase was principally due to the increase of
professional fees associated with the negotiation of potential license
agreements and increased costs of investor relations associated with operating
as a public entity for the full year of 1998. Interest expense decreased from
$312,000 in 1997 to $43,000 in 1998 as borrowings under a line of credit that
commenced in March 1997 were repaid in July 1997. We also had more interest
expense on capitalized leases during 1997. Depreciation and amortization
increased from $319,000 in 1997 to $388,000 in 1998. We purchased additional
laboratory and office equipment in 1998.
In 1998, we were able to utilize net operating loss carryforwards to offset
our income and, therefore, had no provision for income taxes. In 1997, we
recognized a provision for income taxes of $258,000, which was based upon
prevailing federal and state tax rates reduced by the utilization of net
operating loss carryforwards to the extent permitted by the alternative minimum
tax rules.
Our net income in 1997 was $5,139,000 compared to net income of $1,453,000
in 1998.
Years Ended December 31, 1997 and 1996
Contract research and development revenue increased from $318,000 in 1996
to $14,591,000 in 1997 as we received a licensing fee and reimbursement of
clinical development costs in connection with our collaboration with BMS.
Revenues from research grants increased from $203,000 in 1996 to $665,000 in
1997. The increase resulted from the funding of a greater number of grants in
1997. Sales of research reagents decreased from $98,000 in 1996 to $57,000 in
1997 resulting from decreased orders for such reagents during 1997. Interest
income increased from $106,000 in 1996 to $301,000 in 1997 due to the increase
in cash available for investing as we received funding from our collaboration
with BMS in July 1997 and our initial public offering in November 1997.
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<PAGE>
Research and development expenses increased from $3,700,000 in 1996 to
$7,364,000 in 1997. The increase was principally due to payments to licensors in
connection with our collaboration with BMS, additional costs of manufacturing
GMK in 1997 in connection with clinical testing and compensation expense related
to the issuance of stock options to employees and consultants.
General and administrative expenses decreased from $2,808,000 in 1996 to
$2,222,000 in 1997. The decrease was principally due to the reduction of
professional fees and printing costs that were associated with our unsuccessful
efforts to sell common stock in a registered public offering in 1996. Interest
expense increased from $51,000 in 1996 to $312,000 in 1997 as a result of
borrowings commencing in March 1997 under a line of credit. Depreciation and
amortization remained relatively unchanged from $309,000 in 1996 to $319,000 in
1997.
In 1997, we recognized a provision for income taxes of $258,000 which was
based upon prevailing federal and state tax rates reduced by the utilization of
net operating loss carryforwards to the extent permitted by the alternative
minimum tax rules.
Our net loss in 1996 was $6,143,000 compared to net income of $5,139,000 in
1997.
LIQUIDITY AND CAPITAL RESOURCES
We have funded our operations since inception primarily through private
placements of equity securities, loans that were subsequently converted into
equity securities, a line of credit that was repaid and terminated, payments
received under collaboration agreements, including those with BMS and Roche, an
initial public offering, funding under research grants and contracts, interest
on investments, and the proceeds from the exercise of outstanding options and
warrants.
In March 1997, we entered into a credit agreement with Chase Capital Bank,
which provided for borrowings of up to $2,000,000. We borrowed the full amount
available under this facility in drawings made between March and June 1997. Our
borrowings had a stated interest rate of prime and were used to fund working
capital. We repaid all outstanding borrowings in July 1997 from proceeds of
payments we received under our collaboration with BMS. Upon repayment, the line
of credit terminated. Our obligations under the Chase loan agreement were
guaranteed by two of our affiliates, and in consideration of such guarantee
these affiliates were issued between March and July 1997 warrants to purchase an
aggregate of 70,000 shares of common stock at an exercise price of $4.00 per
share. At June 30, 1999, all 70,000 warrants were outstanding and fully
exercisable.
In November 1997, we sold 2,300,000 shares of common stock in our initial
public offering. After deducting underwriting discounts and commissions and
other expenses, we received net proceeds of $16,015,000. The net proceeds were
invested in short-term, interest bearing investment grade securities pending
further application.
At June 30, 1999, we had cash, cash equivalents and marketable securities,
including non-current portion, totaling approximately $22,840,000 compared with
approximately $24,650,000 at December 31, 1998. Our facility lease has been
extended to December 2000. In connection with the extended facility lease, we
expended approximately $1.2 million for equipment and leasehold improvements
during the period from January 1, 1998 to June 30, 1999 and expect to spend an
additional $400,000 to enhance our manufacturing capabilities for clinical
trials during the remainder of 1999. We intend to use a portion of the proceeds
from this offering to expand our facilities for additional research and
development and manufacturing capacity. In addition, we are obligated, under the
terms of our joint venture with CYTOGEN Corporation, to contribute to the joint
venture an additional $1.5 million in license fees through December 31, 2001 and
to fund research and development of up to $3.0 million.
We believe that the net proceeds from this offering, together with our
existing capital resources, should be sufficient to fund operations at least
through 2001. However, this is a forward-looking statement based on our current
operating plan and the assumptions on which it relies. There could be changes
that would consume our assets before such time. We will require substantial
funds to conduct research and development activities, preclinical studies,
clinical trials and other activities relating to the commercialization of any
potential products. In addition, our cash requirements may vary materially from
those now planned because of results of research and
24
<PAGE>
development and product testing, potential relationships with in-licensors and
collaborators, changes in the focus and direction of our research and
development programs, competitive and technological advances, the cost of
filing, prosecuting, defending and enforcing patent claims, the regulatory
approval process, manufacturing and marketing and other costs associated with
the commercialization of products following receipt of regulatory approvals and
other factors. We have no committed external sources of capital and, as
discussed above, expect no significant product revenues for a number of years as
it will take at least that much time, if ever, to bring our products to the
commercial marketing stage. We may seek additional financing, such as through
future offerings of equity or debt securities or agreements with corporate
partners and collaborators with respect to the development of our technology, to
fund future operations. We cannot assure you, however, that we will be able to
obtain additional funds on acceptable terms, if at all.
YEAR 2000 COMPLIANCE
The 'Year 2000' problem relates to many currently installed computers and
software as well as other equipment that relies on embedded computer technology.
If these systems are not capable of distinguishing 21st century dates from 20th
century dates they will experience operating difficulties subsequent to
December 31, 1999 unless they are modified, upgraded, or replaced to adequately
process information involving, related to or dependent upon the century change.
If a system used by us or a third party dealing with us fails because of the
inability of the system to properly read a 21st century date, the results could
have a material adverse effect on our operations. We recognize the need to
ensure our operations will not be adversely impacted by Year 2000 systems
failures. A team of our personnel has reviewed our internal infrastructure and
identified substantially all of the major systems used in connection with our
internal operations. We believe that we have identified and corrected any
potential Year 2000 problems by modifying, upgrading or replacing the necessary
hardware and software in these major systems. We cannot assure you, however,
that we identified all Year 2000 non-compliant business systems on which we rely
or adequately remediated non-compliant systems that we have identified.
Costs incurred to date to correct Year 2000 problems have been immaterial.
While we continue to monitor our systems for Year 2000 problems, we believe the
cost to complete any additional modifications, upgrades or replacements of any
affected systems will not have a material impact on our business or results of
operations. This cost estimate is based on our current analysis and may be
revised, if necessary, if additional Year 2000 problems are identified. We also
recognize the risk that suppliers of products, services, and collaborators with
whom we transact business may not comply with Year 2000 requirements. We have
initiated communications with our significant suppliers and collaborators to
determine the extent to which we are vulnerable if these third parties fail to
remediate their own Year 2000 issues. The review is ongoing and we are unable to
determine, at this time, the probability that any material supplier or
collaborator will not be able to correct any Year 2000 problem in a timely
manner. In the event any such third parties cannot provide us with products or
services or continue collaborations with us, our results of operations could be
materially adversely affected. Based on the above, we have yet to develop a
comprehensive contingency plan with respect to the Year 2000 problem. We will
continue to monitor our own systems and, to the extent possible, evaluate the
systems of our third party suppliers and collaborators to ensure progress on
this critical matter. However, if we identify significant risks related to the
Year 2000 compliance or progress deviates from anticipated timelines, we will
develop contingency plans as deemed necessary at that time.
IMPACT OF THE ADOPTION OF RECENTLY ISSUED ACCOUNTING STANDARD
In September 1998, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards No. 133, 'Accounting for Derivatives
and Hedging Activities' ('SFAS No. 133'). SFAS No. 133 as amended by
SFAS No. 137 establishes a comprehensive standard on accounting for derivatives
and hedging activities and is effective for periods beginning after
September 15, 1999. We do not believe that the future adoption of SFAS No. 133
will have a material effect on our financial position and results of operations.
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<PAGE>
BUSINESS
OVERVIEW
Progenics is a biopharmaceutical company focusing on the development and
commercialization of innovative products for the treatment and prevention of
cancer and viral and other life-threatening diseases. We apply our immunology
expertise to develop biopharmaceuticals that induce an immune response or that
mimic natural immunity in order to fight cancers, such as malignant melanoma,
and viral diseases, such as HIV infection. Our most advanced product candidate,
GMK, is a therapeutic vaccine that has completed enrollment of a pivotal
Phase III clinical trial for the treatment of melanoma, the deadliest form of
skin cancer. Our second vaccine product candidate, MGV, is being developed for
the treatment of various cancers and is entering Phase II clinical trials. We
have a collaboration with Bristol-Myers Squibb Company to develop and
commercialize GMK and MGV. Based on our participation in the discoveries of two
major receptors for HIV, we are engaged in the research and development of
therapeutic products designed to block entry of HIV into human immune system
cells. We have completed two Phase I/II clinical trials of one of these product
candidates, PRO 542, and a Phase I clinical trial of another product candidate,
PRO 367. We plan to initiate in the first half of 2000 a Phase II clinical trial
of PRO 542 and a Phase I/II clinical trial of PRO 367. We are also engaged in a
program with the Roche Group of Basel, Switzerland to discover and develop novel
small-molecule HIV therapeutics that target the fusion co-receptors of the
virus.
PRODUCT DEVELOPMENT
We apply our expertise in immunology to the development of therapeutic
biopharmaceuticals that use components of the immune system, particularly
antibodies, to fight diseases. Our principal programs are directed towards
cancer and HIV. In the case of cancer, we are developing vaccine products that
are designed to induce specific antibody responses to cancer antigens. In the
case of HIV, we are developing therapeutic products by genetically engineering
molecules that function as antibodies and selectively target HIV and
HIV-infected cells for neutralization or destruction. We are also actively
engaged in research and discovery of compounds based on the HIV receptor, CD4,
and HIV co-receptors, including CCR5 and CXCR4, and their roles in viral
attachment, fusion and entry. We are also actively seeking out other promising
products and technologies around which to build a program.
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<PAGE>
The following table summarizes the status of our principal development
programs and product candidates and identifies any related corporate
collaborator.
<TABLE>
<CAPTION>
CORPORATE
PROGRAM/PRODUCT INDICATION/USE STATUS(1) COLLABORATOR
- ---------------------------- ---------------------- ------------------------------- ------------
<S> <C> <C> <C>
CANCER THERAPEUTICS
GMK Vaccine for melanoma Phase III BMS
MGV Vaccine for colorectal Phase II expected to BMS
cancer, lymphoma, commence by early 2000
small cell lung
cancer, sarcoma,
gastric cancer and
neuroblastoma
PSMA Immunotherapeutics for Research CYTOGEN(2)
prostate and
potentially other
cancers
HIV THERAPEUTICS
PRO 542 HIV therapy Phase II expected to commence --
in first half of 2000
PRO 367 HIV therapy Phase I/II expected to commence --
in the first half of 2000
PRO 140 HIV therapy Preclinical; Phase I/II --
expected to commence in the
second half of 2000
Small-molecule drugs:
Co-receptor/fusion HIV therapy Research Roche
HIV attachment HIV therapy Research AHP(3)
Pharmacopeia
ProVax HIV vaccine Research --
OTHER THERAPEUTICS
DHA Alzheimer's disease, Preclinical; Phase I/II --
stroke and other expected to commence in the
diseases of oxidative second half of 2000
stress
</TABLE>
- ------------
(1) 'Research' means initial research related to specific molecular targets,
synthesis of new chemical entities, assay development or screening for the
identification of lead compounds.
'Preclinical' means that a lead compound is undergoing toxicology,
formulation and other testing in preparation for clinical trials.
Phase I-III clinical trials denote safety and efficacy tests in humans as
follows:
'Phase I': Evaluation of safety.
'Phase I/II': Evaluation of safety with some measure of efficacy.
'Phase II': Evaluation of safety, dosing and efficacy.
'Phase III': Larger scale evaluation of safety and efficacy.
See 'Business -- Government Regulation.'
(2) Collaboration is in the form of a joint venture.
(3) 'AHP' means the Wyeth-Ayerst Research Division of American Home Products
Corporation.
THE HUMAN IMMUNE SYSTEM
The human immune system protects the body from disease by specifically
recognizing and destroying invading viruses, bacteria and other pathogens. In
addition, the immune system is capable of recognizing and eliminating from the
body abnormal cells, such as cancer cells and cells infected with viruses and
bacteria. This recognition function relies on the immune system's ability to
recognize as foreign specific molecular configurations, which are referred to
generically as antigens. White blood cells, particularly B and T lymphocytes,
have the ability to recognize
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antigens made by infectious agents and abnormal cells and react to them. For
example, B lymphocytes produce antibodies that recognize specific antigens.
Antibodies are complex protein molecules that can bind to these antigens and
neutralize or eliminate infectious agents and cancer cells.
Vaccines are designed to induce the production of antibodies against
specific antigens on infectious agents and abnormal cells and thereby protect
the body from illness. Although vaccines have historically been used
prophylactically to prevent the contraction of an infectious disease, more
recently vaccines are also being developed as therapeutics to fight ongoing
diseases. In addition, genetic engineering techniques have enabled the
production of antibodies or antibody-like molecules in the laboratory. These
genetically designed molecules are intended to mimic the body's own immune
response in situations where the immune response has been suppressed or
otherwise compromised.
CANCER THERAPEUTICS
Cancer is a set of different diseases, each of which is characterized by
aberrations in cell growth and differentiation. The establishment and spread of
a tumor is a function of its growth characteristics and its ability to suppress
or evade the body's normal defenses, including surveillance and elimination of
cancer cells by the immune system. Eradication of malignant cells which can
metastasize, or spread, to vital organs, leading to death, is central to the
effective treatment of cancer.
Despite recent advances in treatment, therapies for many types of cancer
continue to suffer from serious limitations. The principal therapies for cancer
have historically been surgery, radiation and chemotherapy. A significant
drawback to conventional anti-cancer therapy is that both occult, or hidden, and
residual disease is difficult or impossible to eliminate fully, which can lead
to relapse.
GANGLIOSIDE CONJUGATE VACCINES
Our principal cancer vaccine programs, GMK and MGV, involve the use of
purified gangliosides as cancer antigens. Gangliosides are chemically-defined
molecules composed of carbohydrate and lipid components. Certain gangliosides
are usually found in low amounts in normal human tissue, but are abundant in
certain cancers, such as melanoma, colorectal cancer, lymphoma, small cell lung
cancer, sarcoma, gastric cancer and neuroblastoma.
Our cancer vaccines use known amounts of chemically-defined antigens, not
dead cancer cells or crude extracts from cancer cells. As a result, we are able
to measure specific immune responses to the gangliosides in our vaccines. We
also believe that there is a reduced likelihood of variability in our products
as compared to vaccines which are prepared from dead cancer cells or crude
extracts from cancer cells or which require complicated manufacturing processes.
Because gangliosides alone do not normally trigger an immune response in
humans, we attach gangliosides to large, highly immunogenic carrier proteins to
form 'conjugate' vaccines designed to trigger specific immune responses to
ganglioside antigens. To further augment this immune response, we add an
immunological stimulator, known as an 'adjuvant,' to our ganglioside-carrier
protein conjugate.
Our ganglioside conjugate vaccines stimulate the immune system to produce
specific antibodies to ganglioside antigens. These antibodies have been shown
in vitro to recognize and destroy cancer cells. In vitro refers to tests
conducted in an artificial environment, like a test tube or culture media, as
opposed to in vivo, which refers to tests in animals or otherwise in a living
body, or ex vivo, which refers to tests conducted outside the body on samples of
blood or other tissue that have been removed from the patient. Based on the
in vitro results and the clinical trial results described below, we believe that
vaccination of cancer patients with ganglioside conjugate vaccines will delay or
prevent recurrence of cancer and prolong overall survival.
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GMK: THERAPEUTIC VACCINE FOR MALIGNANT MELANOMA
Our most advanced product under development is GMK, a proprietary
therapeutic vaccine for melanoma that is currently in a pivotal Phase III
clinical trial. We are collaborating with Bristol-Myers Squibb Company on this
program. GMK, which is the first cancer vaccine based on a defined cancer
antigen to enter Phase III clinical trials, is designed to prevent recurrence of
melanoma in patients who are at risk of relapse after surgery. GMK is composed
of the ganglioside GM2 conjugated to the carrier protein keyhole limpet
hemocyanin, or KLH, and combined with the adjuvant QS-21. QS-21 is the lead
compound in the StimulonTM family of adjuvants developed and owned by Aquila
Biopharmaceuticals, Inc.
Target Market
Melanoma is a highly lethal cancer of the skin cells that produce the
pigment melanin. In early stages melanoma is limited to the skin, but in later
stages it spreads to the lungs, liver, brain and other organs. We estimate that
there are 300,000 melanoma patients in the United States today. The American
Cancer Society estimates that 44,200 patients in the United States will be newly
diagnosed with melanoma in 1999. Melanoma has one of the fastest growing
incidence rates of any cancer in the United States. Projections indicate that
for Americans living in the year 2000 the lifetime risk of developing melanoma
is one in 75, compared to one in 135 in 1987 and one in 250 in 1980. Increased
exposure to the ultraviolet rays of the sun may be an important factor
contributing to the increase in new cases of melanoma.
Melanoma patients are categorized according to the following staging
system.
<TABLE>
<CAPTION>
MELANOMA STAGING
----------------
STAGE I STAGE II STAGE III STAGE IV
------- -------- --------- --------
<S> <C> <C> <C>
lesion less than 1.5 mm lesion greater metastasis to regional distant
thickness than 1.5 mm draining lymph nodes metastasis
thickness
no apparent metastasis local spread from regional spread from
primary cancer primary cancer site
site
</TABLE>
GMK is designed for the treatment of patients with Stage II or Stage III
melanoma. It is estimated that these patients comprise approximately 50% of the
total number of melanoma patients and, accordingly, we estimate that there are
currently 150,000 Stage II and III melanoma patients in the United States.
According to the American Cancer Society, an estimated 60% to 80% of Stage III
melanoma patients will experience recurrence of their cancer and die within five
years after surgery.
Current Therapies
Standard treatment for melanoma patients includes surgical removal of the
cancer. Thereafter, therapy varies depending on the stage of the disease. For
Stage I and II melanoma patients, treatment generally consists of close
monitoring for recurrence. The only approved treatment for Stage III melanoma
patients is high-dose alpha interferon. In a reported study, the median
recurrence-free survival period after surgery for patients treated with
high-dose alpha interferon was 20 months versus 12 months for patients who
received no treatment. In addition, the median overall survival period after
surgery was 46 months for the treated group versus 34 months for the untreated
group. However, treatment with high-dose alpha interferon causes substantial
toxicities, requires an intensive treatment over twelve months (intravenous
administration five days a week for the first month followed by subcutaneous
injections three times a week for the remaining eleven months) and costs about
$35,000 for the drug alone.
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<PAGE>
Other approaches for treatment of Stage II or III melanoma patients are
currently under investigation, but none has been approved for marketing. These
experimental therapies include chemotherapy, low-dose alpha interferon and other
vaccines.
Clinical Trials
GMK entered a pivotal Phase III clinical trial in the United States in
August 1996. A pivotal clinical trial is one that is designed to produce results
sufficient to support regulatory approval. An additional, international pivotal
Phase III clinical trial of GMK in earlier stage melanoma patients is also
planned. We expect that this second trial will commence by early 2000. GMK is
administered in the studies on an out-patient basis by 12 subcutaneous
injections over a two-year period.
The ongoing U.S. Phase III clinical trial compares GMK with high-dose alpha
interferon in Stage IIb (advanced Stage II) and Stage III melanoma patients who
have undergone surgery but are at high risk for recurrence. This randomized
trial, which had achieved its targeted enrollment of 851 patients by September
1999, is being conducted nationally by the Eastern Cooperative Oncology Group in
conjunction with the Southwest Oncology Group and other major cancer centers,
cooperative cancer research groups, hospitals and clinics. ECOG and SWOG are
leading cooperative cancer research groups supported by the National Cancer
Institute and are comprised of several hundred participating hospitals and
clinics, primarily in the United States. The primary endpoint of the U.S. trial
is to compare the recurrence of melanoma in patients receiving GMK versus in
patients receiving high-dose alpha interferon. The study will also compare
quality of life and overall survival of patients in both groups.
The second planned pivotal Phase III clinical trial is a randomized study
in Stage II (IIa and IIb) melanoma patients who have undergone surgery but are
at intermediate risk for recurrence. This trial, which we expect will commence
by early 2000, will be conducted in Europe, South Africa, Canada, South America
and Australia under the guidance of the European Organization for Research and
Treatment of Cancer, Europe's largest cooperative cancer research group.
Patients will be randomized to receive either GMK or observation with no
treatment. The primary endpoint of this trial is to compare the recurrence of
melanoma in patients receiving GMK versus in patients receiving observation with
no treatment. The study will also compare overall survival of patients in both
groups. In order to accelerate clinical development of GMK outside of the United
States, we and BMS have agreed to integrate a previously scheduled third
Phase III clinical trial into this trial.
A predecessor of GMK, called GM2-BCG, which combined the GM2 ganglioside
with the adjuvant BCG, underwent clinical testing at Memorial Sloan-Kettering
Cancer Center in the late 1980s. In a double-blind, randomized Phase II study in
122 Stage III melanoma patients, subjects in the treated group received GM2-BCG
for six months after surgery; subjects in the control group received the same
regimen with BCG alone. The median recurrence-free survival period after surgery
for patients treated with GM2-BCG was 33 months versus 17 months for the
patients in the control group. In addition, the median overall survival period
after surgery for patients in the treated group was 70 months versus 30 months
for patients in the control group. Approximately 85% of treated patients
developed antibodies to the GM2 ganglioside. The presence of these antibodies
significantly correlated with improved recurrence-free survival and overall
survival of patients.
Phase I/II clinical trials of GMK under institutional INDs, or
investigational new drug applications, were conducted at Sloan-Kettering. In
these studies, approximately 120 patients, most of whom had Stage III melanoma,
were treated with GMK. All patients receiving GMK at the dose level being used
in the current Phase III trials of GMK developed antibodies to GM2 ganglioside,
which killed melanoma cells. Patients treated with GMK had levels of antibody to
GM2 ganglioside that were on average four times higher and also were longer
lasting than in patients treated with GM2-BCG in the GM2-BCG Phase II trial. In
addition, GMK was well tolerated by all patients in these studies, and no
clinically significant side effects attributable to the vaccine were observed.
30
<PAGE>
MGV: THERAPEUTIC VACCINE FOR CERTAIN CANCERS
Our second ganglioside conjugate vaccine in development, MGV, is a
proprietary therapeutic vaccine for cancers which express GD2 or GM2
gangliosides. These cancers include colorectal cancer, lymphoma, small cell lung
cancer, sarcoma, gastric cancer and neuroblastoma. We are collaborating with
Bristol-Myers Squibb Company on this program. MGV has three components: (i)
GM2-KLH, or GM2 ganglioside conjugated to KLH; (ii) GD2-KLH, or GD2 ganglioside
conjugated to KLH; and (iii) QS-21 adjuvant. MGV is designed to prevent
recurrence of cancer and prolong overall survival of patients after their cancer
has been removed by surgery or reduced by chemotherapy or radiation therapy.
Target Market
MGV targets cancers that the American Cancer Society estimated would have
an aggregate incidence in the United States of over 260,000 during 1998. The
American Cancer Society also estimated that over 135,000 persons would die from
these targeted cancers, representing nearly 25% of all expected deaths from any
cancer during 1998.
Clinical Trials
MGV completed a Phase I/II clinical trial in 1999 under an institutional
IND at Sloan-Kettering. The primary objectives of the study were to establish
the safety of MGV and the ability of the vaccine to induce specific immune
responses to both GD2 and GM2 gangliosides in patients with different cancer
types. In addition, a goal of the study was to find the best ratio of GD2 and
GM2 gangliosides in MGV to be used in future clinical trials.
In this clinical trial, 31 patients with high-risk melanoma and sarcoma
were immunized with MGV over a period of nine months. Patients were randomly
assigned to five groups receiving a fixed dose of GM2-KLH and QS-21 adjuvant and
one of a number of escalating doses of GD2-KLH. This study showed that the
combination of GM2-KLH/GD2-KLH/QS-21 could produce antibodies to GM2 and GD2 and
was well-tolerated. We expect that Phase II clinical trials of MGV will commence
by early 2000.
PSMA
We are engaged in a research and development program relating to vaccine
and antibody immunotherapeutics based on Prostate Specific Membrane Antigen.
PSMA is a protein that is abundantly expressed on the surface of prostate cancer
cells. We believe this antigen may have applications in immunotherapeutics for
prostate cancer and potentially for other types of cancer. We will focus on
developing products which either target, or stimulate a response to, cells
expressing PSMA on their surface. We have initiated a research and development
program to pursue these applications. Our PSMA program is being conducted in
collaboration with CYTOGEN Corporation.
Prostate cancer is the most common form of cancer affecting U.S. males and
is the second leading cause of cancer deaths in men each year. The American
Cancer Society estimates that in 1999 over 37,000 persons will die from prostate
cancer and 179,000 new cases will be diagnosed. Conventional therapies include
radical prostectomy, in which the prostate gland is surgically removed,
radiation and hormone therapies, chemotherapy and 'watchful waiting.' Surgery
and radiation therapy are associated with urinary incontinence and impotence.
Hormone therapy and chemotherapy are generally not intended to be curative and
are not actively used to treat localized, early-stage prostate cancer.
HIV THERAPEUTICS
HIV infection causes a slowly progressive deterioration of the immune
system which results in AIDS. HIV specifically infects cells that have the CD4
receptor on their surface. Cells with the CD4 receptor are critical components
of the immune system and include T lymphocytes,
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monocytes, macrophages and dendritic cells. The devastating effects of HIV are
largely due to the multiplication of the virus in these cells and the resulting
dysfunction and destruction of these cells.
Viral infection occurs when the virus binds to a host cell, enters the cell
and, by commandeering the host cell's own reproductive machinery, creates
thousands of copies of itself within the host cell. This process is called viral
replication. Our scientists and their collaborators have made important
discoveries in understanding how HIV enters human cells and initiates viral
replication.
In the 1980s, our scientists, in collaboration with researchers at Columbia
University, the Institute of Cancer Research in London and the Centers for
Disease Control and Prevention, demonstrated that the initial step of HIV
infection involves the specific attachment of the virus to the CD4 receptor on
the surface of human immune system cells. These researchers also showed that a
specific glycoprotein, gp120, located on the surface of the virus, binds with
high affinity to the CD4 receptor. Although these researchers demonstrated that
binding to CD4 was necessary for HIV attachment, further discoveries have shown
that attachment alone is not sufficient to enable the virus to enter the cell
and initiate viral replication.
Our scientists, in collaboration with researchers at the Aaron Diamond AIDS
Research Center, described in an article in Nature the discovery of a
co-receptor for HIV on the surface of human immune system cells. This
co-receptor, CCR5, enables fusion of HIV with the cell membrane after binding of
the virus to the CD4 receptor. This fusion step results in entry of the viral
genetic information into the cell and subsequent viral replication. Our
scientists, in collaboration with researchers at ADARC, demonstrated that it is
the gp120 glycoprotein that binds to the CCR5 co-receptor as well as to the CD4
receptor. By a sophisticated process known as mutational analysis, these
scientists further determined that the gp120 binding site on CCR5 is a discrete
region at one end of the CCR5 molecule.
PROGENICS' HIV RECEPTOR TECHNOLOGIES
Based on our participation in the discoveries of CD4 and CCR5, we are
pursuing several approaches in the research and development of products designed
to block entry of HIV into human immune system cells. Our PRO 542 and PRO 367
product candidates and our viral attachment programs are based on the CD4
receptor, and our PRO 140 and HIV co-receptor/fusion programs are based on the
CCR5 and CXCR4 co-receptors.
Because HIV must first attach to the CD4 receptor to infect human cells, we
believe that the part of the gp120 glycoprotein that attaches to the CD4
receptor must remain constant across all strains of the virus. The gp120
glycoprotein is located on the exterior of both HIV and HIV-infected cells.
PRO 542 and PRO 367 incorporate a part of the CD4 receptor into genetically
engineered molecules that function like antibodies and are designed to bind
specifically to the gp120 glycoprotein of HIV or HIV-infected cells. In
in vitro tests, these molecules have demonstrated the ability to bind with high
affinity to gp120 glycoproteins from a wide range of HIV strains, including the
strains most prevalent in the United States and the rest of the world. Because
this technology is targeted to a part of HIV that is believed to be necessary
for the virus to enter cells and not to mutate, we believe that our technology
may address the obstacles presented by the high mutation rate of the virus.
We have developed a panel of monoclonal antibodies against CCR5 that have
been shown to block the ability of HIV to infect cells isolated from healthy
individuals by inhibiting virus-cell fusion. One of these monoclonal antibodies,
which we have designated PRO 140, inhibited HIV fusion in vitro at
concentrations that had no apparent effect on the normal function of CCR5.
Target Market
Our HIV therapeutic product candidates are designed primarily for use in
asymptomatic HIV-positive individuals. Accordingly, the target population for
these products is patients who are aware of their infection but do not yet have
AIDS. Although there are few signs of disease in an
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HIV-positive individual during the asymptomatic period, the virus is replicating
in the body by infecting healthy cells. The World Health Organization estimated
that as of the end of 1998, 1.4 million people in North America and Western
Europe and 33.4 million people worldwide were infected with HIV. According to
WHO, approximately 74,000 people in North America and Western Europe were newly
infected with HIV during 1998.
Current Therapies
At present, two classes of products have received marketing approval from
the FDA, the agency that regulates new drug approvals in the United States, for
the treatment of HIV infection and AIDS: reverse transcriptase inhibitors and
protease inhibitors. Both types of drugs are inhibitors of viral enzymes and
have shown efficacy in reducing the concentration of HIV in the blood and
prolonging asymptomatic periods in HIV-positive individuals, especially when
administered in combination.
While combination therapy slows the progression of disease, it is not a
cure. HIV's rapid mutation rate results in the development of viral strains that
are resistant to reverse transcriptase and protease inhibitors. The potential
for resistance is exacerbated by interruptions in dosing which lead to lower
drug levels and permit increased viral replication. Non-compliance is common in
patients on combination therapies, since these drug regimens require more than a
dozen tablets to be taken at specific times each day. An additional problem is
that currently approved drugs produce toxic side-effects in many patients,
affecting a variety of organs and tissues, including the peripheral nervous
system and gastrointestinal tract. These side-effects often result in patients
interrupting or discontinuing therapy.
PRO 542: HIV THERAPY
We are developing PRO 542 for the treatment of HIV infection. PRO 542 is a
proprietary antibody-like product with four binding sites for the gp120
glycoprotein on HIV. PRO 542 is designed to neutralize HIV through one of two
mechanisms: (i) binding to the gp120 glycoprotein and thereby preventing
infection of healthy cells; or (ii) binding to and detaching the gp120
glycoprotein from the virus.
In in vitro and ex vivo tests we conducted in collaboration with scientists
at the Aaron Diamond AIDS Research Center and the Centers for Disease Control
and Prevention, PRO 542 neutralized a wide variety of clinical strains of HIV as
well as viruses in the blood of HIV-positive individuals. In comparative
in vitro studies at ADARC using a panel of neutralizing antibodies to HIV,
PRO 542 was found to be more potent and broadly neutralizing than the antibodies
to which it was compared. In further studies at ADARC, PRO 542 protected severe
combined immune deficient mice transplanted with human peripheral blood
lymphocytes against infection by the three HIV strains tested, including strains
of the virus isolated from HIV-positive individuals.
We completed two dose-escalation Phase I/II clinical trials of PRO 542 in
1999. Both trials were designed to measure the safety, pharmacokinetics,
immunogenicity and antiviral activity of PRO 542. Pharmacokinetics studies
analyze how the body acts on a drug once the drug is administered and will
determine, for example, how long the drug persists in the body. Immunogenicity
studies analyze to what extent a patient's immune system mounts a response to
the drug, which could impair the drug's ability to have its desired therapeutic
effect and could, in some cases, have serious health consequences to the
patient. Immunogenicity can be a serious problem, particularly for
antibody-based drugs.
Our first dose-escalation clinical trial of PRO 542 was conducted in 15
HIV-positive adult patients at Mount Sinai Medical Center in New York City.
Findings indicated peak and one-week serum concentrations of PRO 542 compared
favorably with preclinical models, approximating drug levels previously shown to
neutralize clinical HIV strains in vitro. Data from this trial demonstrated that
in patients receiving the highest dosage of PRO 542, infectious HIV was reduced
to undetectable levels for prolonged periods following treatment. Data from this
trial also indicated that administration of a single dose of PRO 542 was able to
produce a statistically
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significant reduction in viral load in patients treated with the highest dose.
Viral load means the concentration of virus nucleic acid, or genetic material,
in the blood and is a widely used indicator of infection levels. In addition,
PRO 542 was well-tolerated and non-immunogenic in all patients treated. PRO 542
serum concentrations remained above HIV inhibitory levels for greater than one
week. We believe that these results support expanded clinical testing of this
agent as a non-toxic therapy for HIV infection.
The second dose-escalation Phase I/II clinical trial was conducted in
HIV-positive children at Baylor College of Medicine in Houston, the University
of California at San Francisco and the University of Pennsylvania by the AIDS
Clinical Trials Group, a leading cooperative HIV research group supported by the
National Institute of Allergy and Infectious Diseases. The results of this trial
are expected to be released in the first half of 2000.
In September 1997, we entered into a collaboration agreement with Genzyme
Transgenics Corporation with the objective of developing a transgenic source of
PRO 542 using Genzyme Transgenics' proprietary technology. This collaboration is
designed to result in commercial-scale manufacture by producing PRO 542 in the
milk of transgenic goats. By establishing this production arrangement, we can
potentially advance PRO 542's development through Phase III clinical trials
without the need for a commercialization collaboration.
PRO 367: HIV THERAPY
We are developing PRO 367 as a therapeutic agent designed to destroy
HIV-infected cells. PRO 367 is composed of a proprietary antibody-like molecule
with two binding sites for the gp120 glycoprotein linked to a therapeutic
radioisotope, which is a particle that emits radiation. PRO 367 is designed to
bind with high affinity specifically to the gp120 glycoprotein on HIV-infected
cells and to destroy these cells by delivering a lethal dose of radiation.
In in vitro tests, PRO 367 bound with high affinity specifically to the
gp120 glycoprotein on the cell surface. In addition, a pilot Phase I clinical
trial in AIDS patients of a trace-labeled precursor of PRO 367 was conducted
under an institutional IND at Sloan-Kettering. This trial assessed the safety
and pharmacology of the compound with low doses of the radioisotope iodine-131.
The compound was well tolerated by all patients, no clinically significant side
effects attributable to the compound were observed and the compound exhibited
suitable pharmacokinetics for further development. We plan to initiate
dose-escalation Phase I/II clinical trials of PRO 367 in the first half of 2000
subject to obtaining necessary regulatory clearances. The study is expected to
assess safety, pharmacokinetics, biodistribution, immunogenicity and antiviral
effects of PRO 367 in HIV-positive adult patients. In these trials, we plan to
use a new and highly potent type of radioisotope known as alpha-emitters.
PRO 140: HIV THERAPY
In May 1999, we announced the development of a panel of proprietary
anti-CCR5 monoclonal antibodies created at Progenics and evaluated in
collaboration with the Aaron Diamond AIDS Research Center. These antibodies
blocked the ability of HIV to infect cells isolated from healthy individuals by
inhibiting virus-cell fusion, an approach not targeted by current HIV therapies.
One monoclonal antibody, which we have designated PRO 140, inhibited HIV
infection at concentrations that had no apparent effect on the normal function
of CCR5. These properties were correlated with PRO 140's ability to bind to a
distinct site on CCR5.
Effective April 1999, we entered into a development and license agreement
with Protein Design Labs, Inc. for PDL to develop a humanized version of
PRO 140 that retains PRO 140's antiviral activity but which is more suitable for
chronic use in humans. Assuming successful completion of the humanization
program, we expect that the humanized PRO 140 will enter Phase I/II clinical
trials in the second half of 2000.
Recently we announced the findings from a preclinical study carried out in
collaboration with ADARC in which PRO 140 potently blocked 17 of 17 primary HIV
isolates that use CCR5 as a fusion co-receptor. These viruses are important for
person-to-person transmission of HIV and
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predominate during the early stages of infection, when antiviral therapies have
proven to be most effective. The test viruses were selected for their genetic
and geographic diversity. PRO 140 was shown in these in vitro models to be
effective at protecting primary T cells and macrophages, immune system cells
that provide the major targets for HIV infection in vivo.
SMALL-MOLECULE DRUGS
Co-Receptor/Fusion: HIV Therapy
Our HIV co-receptor programs are based on the CCR5 and CXCR4 co-receptors
and the important role these molecules play in virus-cell fusion and subsequent
viral replication. CCR5 and CXCR4 belong to a larger family of cellular
receptors, known as 7-transmembrane G-protein-coupled receptors. These receptors
have been successfully exploited as drug targets by commercialized
pharmaceuticals addressing a wide range of human diseases. Additionally, studies
have indicated that a naturally-occurring genetic mutation that disables the
CCR5 co-receptor prevents HIV infection without compromising immune function.
For these reasons, we believe that our co-receptor/fusion technology offers
significant commercial opportunities.
We have developed proprietary fusion assays based on our HIV co-receptor
technology. These assays model fusion of HIV with human cells rapidly,
automatically, sensitively and without the use of infectious virus. In December
1997 we entered into a collaboration with the Roche Group of Basel, Switzerland
to use these assays to discover and develop small-molecule HIV therapeutics that
target the fusion co-receptors, including CCR5 and CXCR4. Under the terms of the
collaboration, we granted to Roche an exclusive worldwide license to our HIV
co-receptor technology. Roche made an up-front payment and a milestone payment
and is obligated to make further milestone payments, fund research for up to
three years and pay royalties on the sale of any products commercialized as a
result of the collaboration.
HIV Attachment Drug Screen: HIV Therapy
As part of a collaborative research project with the Wyeth-Ayerst Research
Division of American Home Products Corporation, we are using our proprietary HIV
attachment assay to identify small-molecule compounds that inhibit attachment of
HIV to the CD4 receptor. This assay has been used in a high-throughput screening
program, and the compounds discovered are undergoing additional studies by
Progenics and AHP to evaluate further their antiviral activity.
In June 1998 we entered into a collaboration with Pharmacopeia, Inc. to
discover small-molecule HIV therapeutics that block the attachment of the virus
to its primary cellular receptor, CD4. Pursuant to this collaboration, we have
provided proprietary technologies for high-throughput screening of compounds
that inhibit the attachment of HIV to the CD4 receptor. Pharmacopeia has
contributed proprietary combinatorial chemistry libraries of small-molecule drug
candidates and medicinal chemistry expertise. We are currently in discussions
with Pharmacopeia to expand this research collaboration.
PROVAX: HIV VACCINE
We are conducting research with respect to our ProVax vaccine, a vaccine
candidate which we believe may be useful as a preventative or a therapeutic
treatment for HIV-positive individuals. We are currently performing
government-funded research and development of the ProVax vaccine in
collaboration with the Aaron Diamond AIDS Research Center.
OTHER THERAPEUTICS: DHA
In February 1999 we licensed from Memorial Sloan-Kettering Cancer Center
patent rights and technology relating to dehydroascorbic acid, a derivative of
vitamin C. We have obtained exclusive worldwide rights to use DHA for treatment
of disease involving oxidative damage to tissue, including tissues of the
central nervous system.
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Antioxidants are compounds that act as scavengers of free
radicals -- highly unstable molecules that play a role in certain diseases that
damage tissue. Studies have shown that antioxidants can slow the progression of
degenerative neurological diseases, such as Alzheimer's disease. Vitamin C is a
potent antioxidant, but does not easily cross from the circulatory system into
the brain. David W. Golde, M.D., Physician-in-Chief of Memorial Hospital, and
his colleagues at Sloan-Kettering have shown that DHA readily crosses the
blood-brain barrier and, once in the brain, is converted into vitamin C. As a
result of these properties, we believe that DHA is a promising drug candidate
for a broad range of neurodegenerative diseases caused by oxidative stress. We
have initiated a research and development program to pursue these applications.
BUSINESS STRATEGY
Our strategy is to develop and commercialize innovative products for the
treatment and prevention of cancer and viral and other life-threatening
diseases. Key elements of our strategy are as follows:
Establish Timely Collaborations to Optimize Commercial Potential. We have
entered into collaborations designed to mitigate the cost of drug
development and increase the likelihood of a successful commercial
introduction. By collaborating with Bristol-Myers Squibb Company on the
clinical development of GMK and MGV, following the launch of Phase III
clinical trials of GMK, we were able to contract for a combination of
significant payments, milestones and royalties from a world leader in
cancer therapies. In our HIV collaboration with Roche, we chose a strong
partner with an important franchise in virology that has the necessary
chemistry and small-molecule drug development resources to accelerate the
commercial development of therapies using our HIV co-receptor discoveries.
Retain Specific Product Rights for Internal Development. We have not
partnered our lead HIV product candidates, PRO 542, PRO 367 and PRO 140,
in order to further their clinical development on our own to preserve the
value of these candidates for our shareholders. We have also retained the
rights to certain ganglioside conjugate vaccine technology that may lead
to cancer vaccines beyond the lead product candidates, GMK and MGV, that
are partnered with BMS. By selectively pursuing the development of product
candidates on our own or through joint ventures we employ a flexible
approach in determining the timing and nature of our alliances in an
effort to optimize their value to us.
Leverage Core Proprietary Technologies. We intend to continue developing a
portfolio of therapeutic cancer vaccines and HIV treatments utilizing our
proprietary ganglioside conjugate vaccine and HIV receptor and
co-receptor/fusion technologies and intellectual property. Our license
agreement with Sloan-Kettering covers certain potential developments in
the cancer vaccine field resulting from work performed in a laboratory at
Sloan-Kettering beyond the MGV and GMK vaccine products. Therefore, we are
screening a variety of cancers in order to develop further ganglioside
conjugate vaccines. In the HIV area, we are continuing our research based
on the CD4 receptor and the CCR5 and CXCR4 co-receptors and their roles in
viral attachment, fusion and entry.
In-license or Acquire Additional Product Candidates and Technologies. We
intend to continue in-licensing technologies and product candidates that
complement our existing capabilities. In-licensing arrangements may
include the establishment of collaborations with third parties to exploit
the licensed technology. Sources for these technologies range from
academic institutions and research organizations to other biotechnology
and pharmaceutical companies. Through our joint venture with CYTOGEN, we
are able to capitalize on our expertise in vaccines and antibodies in
developing products for prostate cancer and potentially for other types of
cancer targeting and using an exciting antigen, PSMA. In addition we have
expanded our collaboration with Sloan-Kettering beyond cancer to include
the exclusive use of DHA for the development of therapeutics for diseases
involving oxidative tissue damage. We believe our strategy regarding
in-licensing, joint ventures and acquisitions will enable us to bring
products to market more quickly, efficiently and at lower cost while we
focus our expertise on product development and preclinical trial design
and implementation.
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CORPORATE COLLABORATIONS
BRISTOL-MYERS SQUIBB COMPANY
In July 1997, Progenics and Bristol-Myers Squibb Company entered into a
series of related agreements. Pursuant to these agreements, we granted to BMS an
exclusive, worldwide license to make, have made, use, sell, have sold and
develop GMK and MGV and any other product to which we have rights that include
the GM2 or GD2 ganglioside antigens and are used for the treatment or prevention
of human cancer. BMS is entitled under these agreements to grant sublicenses,
subject to restrictions.
Pursuant to our agreements, BMS has made payments to us and is required to
make milestone payments and pay royalties on any sales of licensed products. In
July 1997, BMS paid us approximately $13.3 million, representing $11.5 million
as reimbursement for expenses previously incurred by us in the development of
GMK and MGV and licensing fees and $1.8 million as reimbursement of our clinical
development costs for the period from April 15, 1997 to September 30, 1997. BMS
is also required to make payments of up to $61.5 million upon achievement of
specified milestones relating to the development and regulatory approval of GMK,
MGV or other products that include the GM2 or GD2 ganglioside antigens. In June
1998, we announced that we had received the first such payment for achieving a
clinical milestone in the development of GMK. We recognized an additional
clinical milestone payment in September 1999. BMS is also required to pay
royalties on any sale of licensed products and to fund ongoing development,
clinical trials and regulatory activities of GMK and MGV pursuant to plans
agreed to by the parties.
In connection with our agreements with BMS, we granted to them sublicenses
to the technology and other rights licensed to Progenics from each of
Sloan-Kettering, The Regents of the University of California and Aquila
Biopharmaceuticals under the licenses with these entities discussed under
' -- Licenses.' These sublicenses are exclusive as to the Sloan-Kettering and
the Regents sublicenses and non-exclusive as to the Aquila sublicense and are
intended, in general, to make available to BMS the technology licensed by us
from these entities and used to make GMK and MGV. BMS is entitled under these
sublicenses to grant further sublicenses, subject to certain restrictions.
In connection with payments made by BMS to us under our agreements with
BMS, we made payments to licensors as an inducement to these licensors to enter
into agreements with us and BMS amending certain provisions of the prime
licenses and granting to BMS certain related rights. Future payments made by BMS
to us under our agreements with BMS also trigger payment obligations to these
licensors. See ' -- Licenses.'
Our agreements with BMS terminate at various times related, in general, to
the expiration or abandonment of the related patents or to the first commercial
sale of products. The agreements can also be terminated by either party upon a
material, uncured breach by the other party. BMS has the further right to
terminate our principal agreement with BMS (including its funding and milestone
obligations) as to specified licensed products at specified times.
ROCHE GROUP
In December 1997, we entered into a collaboration agreement with the Roche
Group of Basel, Switzerland to discover and develop novel HIV therapeutics that
target the recently identified fusion co-receptors of the virus. This
collaboration, among other things, provides for Roche to apply its library of
small-molecule compounds to our original screening assays in order to identify
inhibitors of the interaction between HIV co-receptors and HIV. This program is
in the early stage of drug discovery.
Under the terms of the Roche agreement, we have granted to Roche a license
covering products to which we have rights or that are developed as a result of
the collaboration and which have been identified as, or developed for the
purpose of, inhibiting the interaction between chemokine receptors that act as
HIV co-receptors, including CCR5 and CXCR4, and HIV, which
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interaction results in fusion of HIV with cells. The license does not extend to
certain classes of molecules, as to which we have retained rights. Pursuant to
this license, Roche has an exclusive worldwide right to develop, make, have
made, use, sell, offer to sell and import any covered products for the therapy
of HIV infection. Subject to specified restrictions, Roche retains the right to
grant sublicenses under the Roche agreement.
Pursuant to the Roche agreement, Roche made an up-front payment and a
milestone payment and is obligated to make further milestone payments, fund
research for up to three years and pay royalties on the sale of any products
commercialized as a result of the collaboration. We are also entitled to
contingent licensing rights.
The collaboration remains in full force, subject to the exceptions
identified below, until the expiration of all obligations to pay royalties
pursuant to any of the licenses granted therein. The Roche agreement can be
terminated by either party upon a material, uncured breach by the other party.
Roche has the further right to terminate the Roche agreement or the
collaboration contemplated under the Roche agreement at specified times;
however, in either case, Roche will not be relieved of certain minimum research
funding obligations.
CYTOGEN CORPORATION
We have entered into a collaboration with CYTOGEN Corporation to develop
vaccine and antibody-based immunotherapeutic products based on Prostate Specific
Membrane Antigen. This collaboration is a joint venture structured in the form
of a mutually owned limited liability company. All patents and know how
currently owned or acquired in the future by Progenics or CYTOGEN and useful in
the development of PSMA-based antibody or vaccine immunotherapeutics have been
licensed to the joint venture. The principal patents licensed initially are
several patents owned by Sloan-Kettering that cover PSMA. By the terms of the
agreement, we are responsible for preclinical and clinical development, and
CYTOGEN is principally responsible for product marketing. In addition, we have
certain co-promotion rights. This program is in the initial phase of product
research and development.
The joint venture aspects of the collaboration are governed by a limited
liability company agreement. This agreement provides generally for joint
management. We are obligated to provide the initial $3.0 million in research and
development funding and $2.0 million in payments the joint venture is required
to pay CYTOGEN over time. Any other funding obligations are to be shared 50/50,
with voting and ownership dilution resulting if a party fails to fund its share.
The license agreement terminates on the last to expire or terminate of any
licensable rights to patents or patent applications licensed by Progenics or
CYTOGEN to the joint venture.
LICENSES
We are a party to license agreements under which we have obtained rights to
use certain technologies in our cancer and HIV programs, as well as certain
other human therapeutics. Set forth below is a summary of these licenses.
Sloan-Kettering. We are party to a license agreement with Sloan-Kettering
under which we obtained the worldwide, exclusive rights to certain technology
relating to ganglioside conjugate vaccines, including GMK and MGV, and their use
to treat or prevent cancer. The Sloan-Kettering license terminates upon the
expiration of the last of the licensed patents or 15 years from the date of the
first commercial sale of a licensed product pursuant to the agreement, whichever
is later. In addition to patent applications, the Sloan-Kettering license
includes the exclusive rights to use certain relevant technical information and
know-how. A number of Sloan-Kettering physician-scientists also serve as
consultants to Progenics. We are also a party to a license agreement with
Sloan-Kettering under which we obtained an exclusive, worldwide license to
certain patent rights relating to DHA. The license continues for 20 years or to
the end of the term for which the patent rights are granted.
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Regents of the University of California. We are party to a license
agreement with the Regents of the University of California under which we
obtained the exclusive rights to an issued U.S. patent covering certain
ganglioside conjugate vaccines. The license agreement terminates upon the
expiration of the patent.
Columbia University. We are party to a license agreement with Columbia
University under which we obtained exclusive, worldwide rights to certain
technology and materials relating to CD4 and its use to treat or prevent HIV
infection. The license agreement will terminate upon the expiration of the last
of the licensed patents.
Aquila Biopharmaceuticals. We have entered into a license and supply
agreement with Aquila Biopharmaceuticals, Inc. pursuant to which Aquila agreed
to supply us with all of our requirements for the QS-21 adjuvant for use in
certain ganglioside-based cancer vaccines, including GMK and MGV. QS-21 is the
lead compound in the Stimulon family of adjuvants developed and owned by Aquila.
The license terminates upon the expiration of the last of the licensed patents.
Protein Design Labs. We have entered into a development and license
agreement with PDL for the humanization by PDL of PRO 140. Pursuant to the
agreement PDL granted us certain exclusive and nonexclusive worldwide licenses
under relevant patents, patent applications and know how covering or relating to
the humanized PRO 140. The licensing agreement terminates on the later of ten
years from the first commercial sale or the last date on which there is an
unexpired patent or a patent application that has been pending for less than ten
years. Thereafter the license is fully paid up.
The research, development and commercialization of a biopharmaceutical
often involves alternative development and optimization routes, which are
presented at various stages in the development process. The preferred routes
cannot be predicted at the outset of a research and development program because
they will depend on subsequent discoveries and test results. There are numerous
third-party patents in our field, and it is possible that to pursue the
preferred development route of one or more of our products we will need to
obtain a license to a patent, which would decrease the ultimate profitability of
the applicable product. If we cannot negotiate a license, we might have to
pursue a less desirable development route or terminate the program altogether.
The licenses to which we are a party impose various milestone,
commercialization, sublicensing, royalty and other payment, insurance,
indemnification and other obligations on us and are subject to certain
reservations of rights. Our failure to comply with these requirements could
result in the termination of the applicable agreement, which would likely cause
us to terminate the related development program and cause a complete loss of our
investment in that program.
In connection with our collaboration with Bristol-Myers Squibb Company, we
granted to BMS sublicenses to the technology and other rights licensed to us
from each of Sloan-Kettering, the Regents and Aquila under the licenses with
these entities described above. See ' -- Corporate
Collaborations -- Bristol-Myers Squibb Company.'
GOVERNMENT GRANTS AND CONTRACTS
Through June 30, 1999, we had been awarded government grants aggregating
approximately $5,407,000 under the Small Business Innovation Research program of
the National Institutes of Health for our commercial development of PRO 542,
PRO 367, ProVax vaccine and fusion assays. Through June 30, 1999, we had
recognized approximately $3,900,000 of such amount as revenue. In the third
quarter of 1999, we were awarded two new grants totalling $3.0 million from
National Institute of Allergy and Infectious Diseases. The first grant provides
approximately $2.0 million in funding for the development of monoclonal
antibodies that target cellular co-receptors of HIV, like CCR5 and CXCR4. The
second grant will fund continued development of HIV vaccines.
In general, under the terms of these grants we have, subject to certain
rights of the government described below, all right, title and interest to all
patents, copyrights and data pertaining to any product developed. However, under
existing regulations, the government receives a royalty-free license for federal
government use with respect to patents developed by grant
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recipients. In addition, the government may, in certain circumstances, require
us to license technology resulting from the funded projects to third parties and
may require that we manufacture substantially all of the products resulting from
a particular grant in the United States.
The government's obligation to make payments under these grants and
contracts is subject to appropriation by the United States Congress for funding
in each such year. Moreover, it is possible that Congress or the government
agencies that administer these government research programs will decide to scale
back these programs or terminate them. In addition, while we intend to pursue
additional government grants related to our areas of research and development,
we cannot assure you that we will be awarded grants in the future or that any
new grant funding will not be less than grant funding received to date.
In September 1997, we were awarded a two-year, protein manufacturing
contract from the NIH; this contract was subsequently amended to provide for a
total term of three years and aggregate payments of $2,426,870. Through
June 30, 1999 we had recognized approximately $1,356,000 of such amount as
revenue.
PATENTS AND PROPRIETARY TECHNOLOGY
Our policy is to protect our proprietary technology, and we consider the
protection of our rights to be important to our business. In addition to seeking
U.S. patent protection for many of our inventions, we generally file patent
applications in Canada, Japan, Western European countries and additional foreign
countries on a selective basis in order to protect the inventions deemed to be
important to the development of our foreign business.
Under a license agreement with Sloan-Kettering, we obtained worldwide,
exclusive rights to certain technology relating to ganglioside conjugate
vaccines, including GMK and MGV, and their use to treat or prevent cancer. This
technology is the subject of a patent application filed by Sloan-Kettering in
the United States and 25 foreign countries claiming composition of matter and
methods of production and use of certain ganglioside conjugate vaccines for the
treatment or prevention of human cancer.
Under a license agreement with Columbia University, we obtained worldwide,
exclusive rights to certain technology relating to CD4 and its use to treat or
prevent HIV infection. This technology is the subject of issued U.S. and
European patents and several related U.S. and foreign patent applications filed
by Columbia University. The issued patents and the patent applications claim
composition of matter and methods of production and use of certain CD4-based
products for the treatment or prevention of HIV infection. We have also filed a
number of U.S. and foreign patent applications on our HIV attachment assay
technology, our technology relating to PRO 542 and PRO 367, our ProVax
technology and clinical uses of these technologies. We have also filed a number
of U.S. and foreign patent applications, one of which is owned jointly with the
Aaron Diamond AIDS Research Center, relating to the discovery of an HIV
co-receptor, CCR5.
Under a license agreement with Sloan-Kettering, we obtained worldwide,
exclusive rights to certain technology relating to dehydroascorbic acid and its
use to increase the concentration of vitamin C in tissues, including the brain,
for treating neurodegenerative and neurovascular diseases. This technology is
the subject of a patent application filed by Sloan-Kettering in the United
States and as an international application claiming methods for increasing the
vitamin C concentration in the cells of a subject by administering to the
subject dehydroascorbic acid.
The enactment of the legislation implementing the General Agreement on
Tariffs and Trade has resulted in certain changes to U.S. patent laws that
became effective on June 8, 1995. Most notably, the term of patent protection
for patent applications filed on or after June 8, 1995 is no longer a period of
seventeen years from the date of grant. The new term of U.S. patents will
commence on the date of issuance and terminate twenty years from the earliest
effective filing date of the application. Because the time from filing to
issuance of patent applications is often more than three years, a twenty-year
term from the effective date of filing may result in a substantially shortened
term of patent protection, which may adversely impact our patent position.
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GOVERNMENT REGULATION
Progenics and our products are subject to comprehensive regulation by the
Food and Drug Administration in the United States and by comparable authorities
in other countries. These national agencies and other federal, state and local
entities regulate, among other things, the preclinical and clinical testing,
safety, effectiveness, approval, manufacture, labeling, marketing, export,
storage, record keeping, advertising and promotion of our products. None of our
product candidates has received marketing or other approval from the FDA or any
other similar regulatory authority.
FDA approval of our products, including a review of the manufacturing
processes and facilities used to produce such products, will be required before
such products may be marketed in the United States. The process of obtaining
approvals from the FDA can be costly, time consuming and subject to
unanticipated delays. We cannot assure you that approvals of our proposed
products, processes, or facilities will be granted on a timely basis, or at all.
If we experience delays in obtaining, or do not obtain, approvals for our
products, commercialization of our products would be slowed or stopped.
Moreover, even if we obtain regulatory approval, the approval may include
significant limitations on indicated uses for which the product could be
marketed or other significant marketing restrictions.
The process required by the FDA before our products may be approved for
marketing in the United States generally involves:
preclinical laboratory and animal tests;
submission to the FDA of an investigational new drug application, or IND,
which must become effective before clinical trials may begin;
adequate and well-controlled human clinical trials to establish the safety
and efficacy of the product for its intended indication;
submission to the FDA of a marketing application; and
FDA review of the marketing application in order to determine, among other
things, whether the product is safe and effective for its intended uses.
Preclinical tests include laboratory evaluation of product chemistry and
animal studies to gain preliminary information about a product's pharmacology
and toxicology and to identify any safety problems that would preclude testing
in humans. Products must generally be manufactured according to current Good
Manufacturing Practices, and preclinical safety tests must be conducted by
laboratories that comply with FDA regulations regarding good laboratory
practices. The results of the preclinical tests are submitted to the FDA as part
of an IND. An IND is a submission which the sponsor of a clinical trial of an
investigational new drug must make to the FDA and which must become effective
before clinical trials may commence. The IND submission must include, among
other things:
a description of the sponsor's investigational plan;
protocols for each planned study;
chemistry, manufacturing, and control information;
pharmacology and toxicology information; and
a summary of previous human experience with the investigational drug.
Unless the FDA objects to, makes comments or raises questions concerning, an
IND, the IND will become effective 30 days following its receipt by the FDA, and
initial clinical studies may begin, although companies often obtain affirmative
FDA approval before beginning such studies. We cannot assure you that submission
of an IND will result in FDA authorization to commence clinical trials.
A New Drug Application, or NDA, is an application to the FDA to market a
new drug. The NDA must contain, among other things:
information on chemistry, manufacturing, and controls;
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nonclinical pharmacology and toxicology;
human pharmacokinetics and bioavailability; and
clinical data.
The new drug may not be marketed in the United States until the FDA has approved
the NDA.
A Biologic License Application, or BLA, is an application to the FDA to
market a biological product. The BLA must contain, among other things, data
derived from nonclinical laboratory and clinical studies which demonstrate that
the product meets prescribed standards of safety, purity and potency, and a full
description of manufacturing methods. The biological product may not be marketed
in the United States until a biologic license is issued.
Clinical trials involve the administration of the investigational new drug
to healthy volunteers or to patients under the supervision of a qualified
principal investigator. Clinical trials must be conducted in accordance with the
FDA's Good Clinical Practice requirements under protocols that detail, among
other things, the objectives of the study, the parameters to be used to monitor
safety, and the effectiveness criteria to be evaluated. Each protocol must be
submitted to the FDA as part of the IND. Further, each clinical study must be
conducted under the auspices of an Institutional Review Board. The Institutional
Review Board will consider, among other things, ethical factors, the safety of
human subjects, the possible liability of the institution and the informed
consent disclosure which must be made to participants in the clinical trial.
Clinical trials are typically conducted in three sequential phases,
although the phases may overlap. During Phase I, when the drug is initially
administered to human subjects, the product is tested for safety, dosage
tolerance, absorption, metabolism, distribution and excretion. Phase II involves
studies in a limited patient population to:
evaluate preliminarily the efficacy of the product for specific, targeted
indications;
determine dosage tolerance and optimal dosage; and
identify possible adverse effects and safety risks.
When a new product is found to have an effect and to have an acceptable safety
profile in Phase II evaluation, Phase III trials are undertaken in order to
further evaluate clinical efficacy and to further test for safety within an
expanded patient population. The FDA may suspend clinical trials at any point in
this process if it concludes that clinical subjects are being exposed to an
unacceptable health risk.
The results of the preclinical studies and clinical studies, the chemistry
and manufacturing data, and the proposed labeling, among other things, are
submitted to the FDA in the form of an NDA or BLA, approval of which must be
obtained prior to commencement of commercial sales. The FDA may refuse to accept
the application for filing if certain administrative and content criteria are
not satisfied, and even after accepting the application for review, the FDA may
require additional testing or information before approval of the application.
Our analysis of the results of our clinical studies is subject to review and
interpretation by the FDA, which may differ from our analysis. We cannot assure
you that our data or our interpretation of data will be accepted by the FDA. In
any event, the FDA must deny an NDA or BLA if applicable regulatory requirements
are not ultimately satisfied. In addition, delays or rejections may be
encountered based upon changes in applicable law or FDA policy during the period
of product development and FDA regulatory review. Moreover, if regulatory
approval of a product is granted, such approval may be made subject to various
conditions, including post-marketing testing and surveillance to monitor the
safety of the product, or may entail limitations on the indicated uses for which
it may be marketed. Finally, product approvals may be withdrawn if compliance
with regulatory standards is not maintained or if problems occur following
initial marketing.
Both before and after approval is obtained, a product, its manufacturer,
and the sponsor of the marketing application for the product are subject to
comprehensive regulatory oversight. Violations of regulatory requirements at any
stage, including the preclinical and clinical testing process, the approval
process, or thereafter, may result in various adverse consequences, including
FDA delay in approving or refusal to approve a product, withdrawal of an
approved product from
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the market or the imposition of criminal penalties against the manufacturer or
sponsor. In addition, later discovery of previously unknown problems may result
in restrictions on such product, manufacturer, or sponsor, including withdrawal
of the product from the market. Also, new government requirements may be
established that could delay or prevent regulatory approval of our products
under development.
Whether or not FDA approval has been obtained, approval of a pharmaceutical
product by comparable government regulatory authorities in foreign countries
must be obtained prior to marketing such product in such countries. The approval
procedure varies from country to country, and the time required may be longer or
shorter than that required for FDA approval. Although there are some procedures
for unified filing for certain European countries, in general, each country has
its own procedures and requirements. We do not currently have any facilities or
personnel outside of the United States.
In addition to regulations enforced by the FDA, we are also subject to
regulation under the Occupational Safety and Health Act, the Environmental
Protection Act, the Toxic Substances Control Act, the Resource Conservation and
Recovery Act and various other present and potential future federal, state or
local regulations. Our research and development involves the controlled use of
hazardous materials, chemicals, viruses and various radioactive compounds.
Although we believe that our safety procedures for storing, handling, using and
disposing of such materials comply with the standards prescribed by applicable
regulations, we cannot completely eliminate the risk of accidental
contaminations or injury from these materials. In the event of such an accident,
we could be held liable for any legal and regulatory violations as well as
damages that result. Any such liability could have a material adverse effect on
Progenics.
MANUFACTURING
We currently manufacture GMK, MGV, PRO 542, PRO 367 and PRO 140 in our
pilot production facilities in Tarrytown, New York. One of these facilities is
for the production of vaccines and the other is for the production of
recombinant proteins. We believe that our existing production facilities will be
sufficient to meet our initial needs for clinical trials. However, these
facilities may be insufficient for all of our late-stage clinical trials and for
our commercial-scale requirements. We intend to use a portion of the proceeds
from this offering to expand our facilities for additional manufacturing
capacity. Nevertheless, we may be required to expand further our manufacturing
staff and facilities, obtain new facilities or contract with third parties or
corporate collaborators to assist with production. In the event we decide to
establish a full-scale commercial manufacturing facility, we will require
substantial additional funds and will be required to hire and train significant
numbers of employees and comply with the extensive FDA regulations applicable to
such a facility.
SALES AND MARKETING
We plan to market products for which we obtain regulatory approval through
co-marketing, co-promotion, licensing and distribution arrangements with third
party collaborators. We believe that this approach will both increase market
penetration and commercial acceptance of our products and enable us to avoid
expending significant funds to develop a large sales and marketing organization.
BMS, Roche and CYTOGEN have marketing rights with respect to the products
covered by their respective collaborations with us.
COMPETITION
Competition in the biopharmaceutical industry is intense and characterized
by ongoing research and development and technological change. We face
competition from many companies and major universities and research institutions
in the United States and abroad. We will face competition from companies
marketing existing products or developing new products for diseases targeted by
our technologies. Many of our competitors have substantially greater resources,
experience in conducting preclinical studies and clinical trials and obtaining
regulatory approvals
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for their products, operating experience, research and development and marketing
capabilities and production capabilities than we do. We cannot assure you that
our products under development will be able to compete successfully with
existing products or products under development by other companies, universities
and other institutions. Our competitors may succeed in obtaining FDA approval
for products more rapidly than we do. Drug manufacturers that are first in the
market with a therapeutic for a specific indication generally obtain and
maintain a significant competitive advantage over later entrants. Accordingly,
the speed with which we can develop products, complete the clinical trials and
approval processes and ultimately supply commercial quantities of the products
to the market is expected to be an important competitive factor.
With respect to GMK, the FDA and certain other regulatory authorities have
approved high-dose alpha interferon for marketing as a treatment for patients
with high-risk melanoma. High-dose alpha interferon has demonstrated some
efficacy for this indication. With respect to our products for the treatment of
HIV infection, two classes of products made by our competitors have been
approved for marketing by the FDA for the treatment of HIV infection and AIDS:
reverse transcriptase inhibitors and protease inhibitors. Both types of drugs
have shown efficacy in reducing the concentration of HIV in the blood and
prolonging asymptomatic periods in HIV-positive individuals, especially when
administered in combination.
A significant amount of research in the biopharmaceutical field is also
being carried out at academic and government institutions. Our strategy is to
in-license technology and product candidates from academic and government
institutions. These institutions are becoming increasingly sensitive to the
commercial value of their findings and are becoming more aggressive in pursuing
patent protection and negotiating licensing arrangements to collect royalties
for use of technology that they have developed. These institutions may also
market competitive commercial products on their own or in collaboration with
competitors and will compete with us in recruiting highly qualified scientific
personnel. Any resulting increase in the cost or decrease in the availability of
technology or product candidates from these institutions may adversely affect
our business strategy.
Competition with respect to our technologies and product candidates is and
will be based, among other things, on:
capabilities of our collaborators;
efficacy and safety of our products;
timing and scope of regulatory approval;
product reliability and availability;
marketing and sales capabilities;
reimbursement coverage from insurance companies and others;
degree of clinical benefits of our product candidates relative to
their costs;
method of administering a product;
price; and
patent protection.
Our competitive position will also depend upon our ability to attract and
retain qualified personnel, to obtain patent protection or otherwise develop
proprietary products or processes, and to secure sufficient capital resources
for the often substantial period between technological conception and commercial
sales. Competitive disadvantages in any of these factors could materially harm
our business and financial condition.
PRODUCT LIABILITY
The testing, manufacturing and marketing of our products involves an
inherent risk of product liability attributable to unwanted and potentially
serious health effects. To the extent we elect to test, manufacture or market
products independently, we will bear the risk of product liability directly. We
have obtained insurance in the amount of $5.0 million against the risk of
product liability. This insurance is subject to certain deductibles and coverage
limitations. There is no guarantee that insurance will continue to be available
at a reasonable cost, or at all, or that the amount of such insurance will be
adequate.
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HUMAN RESOURCES
At September 30, 1999, we had 45 full-time employees, five of whom,
including Dr. Maddon, hold Ph.D. degrees or foreign equivalents and two of whom,
including Dr. Maddon, hold M.D. degrees. At such date, 35 employees were engaged
in research and development, medical and regulatory affairs and manufacturing
activities and ten were engaged in finance, administration and business
development. We consider our relations with our employees to be good. None of
our employees is covered by a collective bargaining agreement.
FACILITIES
We sublease approximately 24,000 square feet of laboratory, manufacturing
and office space in Tarrytown, New York. We sublease this space pursuant to a
sublease which terminates in December 2000. We have pilot production facilities
within these leased facilities for the manufacture of products for clinical
trials. Although we believe that these facilities are adequate for our current
needs, we intend to use a portion of the proceeds from this offering to expand
our facilities for additional research and development and manufacturing
capacity.
LEGAL PROCEEDINGS
We are not a party to any material legal proceedings.
SCIENTIFIC ADVISORY BOARDS AND CONSULTANTS
An important component of our scientific strategy is our collaborative
relationship with leading researchers in cancer and virology. Certain of these
researchers are members of our two Scientific Advisory Boards, one in cancer and
one in virology. The members of each SAB attend periodic meetings and provide us
with specific expertise in both research and clinical development. In addition,
we have collaborative research relationships with certain individual SAB
members. All members of the SABs are employed by employers other than us and may
have commitments to or consulting or advisory agreements with other entities
that may limit their availability to us. These companies may also compete with
us. Several members of the SABs have, from time to time, devoted significant
time and energy to our affairs. However, no member is regularly expected to
devote more than a small portion of time to Progenics. In general, our
scientific advisors are granted stock options in Progenics and receive financial
remuneration for their services.
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The following table sets forth information with respect to our Scientific
Advisory Boards.
CANCER SCIENTIFIC ADVISORY BOARD
<TABLE>
<CAPTION>
NAME POSITION/AFFILIATION
- ---- --------------------
<S> <C>
Alan N. Houghton, M.D. (Chairman)....... Chairman, Immunology Program, Sloan-Kettering and
Professor, Cornell University Medical College
('CUMC')
Angus G. Dalgleish, M.D., Ph.D. ........ Chairman and Professor of Medical Oncology, St.
George's Hospital, London
Samuel J. Danishefsky, Ph.D. ........... Kettering Professor and Head, Bioorganic
Chemistry, Sloan-Kettering Institute and Professor
of Chemistry, Columbia University
David R. Klatzmann, M.D., Ph.D. ........ Professor of Immunology, Pitie-Salpetriere
Hospital, Paris
Philip O. Livingston, M.D. ............. Member, Sloan-Kettering and Professor, CUMC
John Mendelsohn, M.D. .................. President, The University of Texas M. D. Anderson
Cancer Center
David A. Scheinberg, M.D., Ph.D. ....... Chief, Leukemia Service, Sloan-Kettering and
Professor, CUMC
David B. Agus, M.D. .................... Assistant Attending Physician, Sloan-Kettering and
Assistant Professor, CUMC
VIROLOGY SCIENTIFIC ADVISORY BOARD
NAME POSITION/AFFILIATION
- ---- --------------------
Stephen P. Goff, Ph.D. (Chairman)....... Professor of Biochemistry, Columbia University
Mark Alizon, M.D., Ph.D. ............... Director of Research, Institute Cochin, Paris
Lawrence A. Chasin, Ph.D. .............. Professor of Biological Sciences, Columbia
University
Leonard Chess, M.D. .................... Professor of Medicine, Columbia University
Wayne A. Hendrickson, Ph.D. ............ Professor of Biochemistry, Columbia University
Israel Lowy, M.D., Ph.D. ............... Assistant Professor of Medicine, Mount Sinai
Medical Center
J. Steven McDougal, M.D. ............... Chief, Immunology Branch, CDC, Atlanta
Sherie L. Morrison, Ph.D. .............. Professor of Microbiology, UCLA
Robin A. Weiss, Ph.D. .................. Professor and Director of Research, ICR, Royal
Cancer Hospital, London
OTHER SCIENTIFIC CONSULTANTS
David W. Golde, M.D. ................... Physician-in-Chief, Sloan-Kettering and Professor,
CUMC
</TABLE>
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MANAGEMENT
DIRECTORS, EXECUTIVE OFFICERS AND KEY MANAGEMENT
Our directors, executive officers and key management are as follows:
<TABLE>
<CAPTION>
NAME AGE POSITION
---- --- --------
<S> <C> <C>
Paul J. Maddon, M.D., Ph.D(1)............... 40 Chairman of the Board, Chief Executive
Officer and Chief Science Officer
Ronald J. Prentki, M.B.A.................... 42 President and Director
Robert J. Israel, M.D....................... 43 Vice President, Medical Affairs
Robert A. McKinney, CPA..................... 43 Vice President, Finance & Operations and
Treasurer
William C. Olson, Ph.D...................... 37 Senior Director, Research and Development
Kenneth G. Surowitz, Ph.D................... 40 Senior Director, Quality & Regulatory
Affairs
Patricia C. Fazio........................... 40 Senior Director, Project Management and
Health & Safety
Charles A. Baker(1)(2)...................... 66 Director
Kurt W. Briner(3)........................... 55 Director
Mark F. Dalton(1)(2)........................ 48 Director
Stephen P. Goff, Ph.D.(3)................... 47 Director
Paul F. Jacobson(2)(3)...................... 44 Director
David A. Scheinberg, M.D., Ph.D.(1)......... 43 Director
</TABLE>
- ------------
(1) Member of Executive Committee
(2) Member of Compensation Committee
(3) Member of Audit Committee
Paul J. Maddon, M.D., Ph.D. is our founder and has served in various
capacities since our inception, including Chairman of the Board of Directors,
Chief Executive Officer, President and Chief Science Officer. From 1981 to 1988,
Dr. Maddon performed research at the Howard Hughes Medical Institute at Columbia
University in the laboratory of Dr. Richard Axel. Dr. Maddon serves on two NIH
scientific review committees and is a member of the editorial board of the
Journal of Virology. He received a B.A. in biochemistry and mathematics and a
M.D. and a Ph.D. in biochemistry and molecular biophysics from Columbia
University. Dr. Maddon has been an Adjunct Assistant Professor of Medicine at
Columbia University since 1989.
Ronald J. Prentki, M.B.A. joined us as our President in July 1998 and
became a director in September 1998. Prior to joining Progenics, Mr. Prentki had
been Vice President of Business Development and Strategic Planning at
Hoffmann-La Roche Inc. from 1996 to 1998. Mr. Prentki spent from 1990 to 1996 at
Sterling Winthrop (subsequently acquired by Sanofi Pharmaceuticals), most
recently serving as Vice President of Business Development. From 1985 to 1990
Mr. Prentki was with Bristol-Myers Squibb International Division, initially
supporting the marketing of that company's oncology products and later as
Director of Cardiovascular Products. Mr. Prentki started his career in 1979 in
the Ames Diagnostic Division of Miles Laboratories holding a series of sales,
marketing and product development positions before leaving Miles Laboratories in
1985. Mr. Prentki received a B.S. in Microbiology and Public Health from
Michigan State University and an M.B.A. from the University of Detroit.
Robert J. Israel, M.D. joined us in October 1994 and has been Vice
President, Medical Affairs since that time. From 1991 to 1994, Dr. Israel was
Director, Clinical Research-Oncology and Immunohematology at Sandoz
Pharmaceuticals Corporation. From 1988 to 1991, he was Associate Director,
Oncology Clinical Research at Schering-Plough Corporation. Dr. Israel is a
licensed physician and is board certified in both internal medicine and medical
oncology. He received a B.A. in physics from Rutgers University and a M.D. from
the University of Pennsylvania and completed an oncology fellowship at
Sloan-Kettering. Dr. Israel has been a consultant to the Solid Tumor Service at
Sloan-Kettering since 1987.
Robert A. McKinney, CPA joined us in September 1992. Mr. McKinney served as
Director, Finance and Operations and Treasurer from 1992 to January 1993, when
he was appointed Vice
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President, Finance and Operations and Treasurer of Progenics. From 1991 to 1992,
he was Corporate Controller at VIMRx Pharmaceuticals, Inc., a biotechnology
research company. From 1990 to 1991, Mr. McKinney was Manager, General
Accounting at Micrognosis, Inc., a software integration company. From 1985 to
1990, he was an audit supervisor at Coopers & Lybrand LLP, an international
accounting firm. Mr. McKinney studied finance at the University of Michigan,
received a B.B.A. in accounting from Western Connecticut State University, and
is a Certified Public Accountant.
William C. Olson, Ph.D. joined us in May 1994 and presently serves as
Senior Director, Research and Development. From 1989 to 1992, Dr. Olson served
as a Research Scientist at Johnson & Johnson, and from 1992 until 1994 he was a
Development Scientist at MicroGeneSys, Inc., a biotechnology company. Dr. Olson
received a Ph.D. from the Massachusetts Institute of Technology and a B.S. from
the University of North Dakota. Both degrees were awarded in the field of
chemical engineering.
Kenneth G. Surowitz, Ph.D. joined us in January 1999 and presently serves
as Senior Director, Quality & Regulatory Affairs. From 1988 to 1999,
Dr. Surowitz was employed at the Wyeth-Lederle Vaccines and Pediatrics unit of
American Home Products Corp. in a number of position within the organization,
most recently as Director of Global Regulatory Affairs. From 1985 to 1988, he
was employed as a Product Development Microbiologist at Proctor and Gamble.
Dr. Surowitz received Ph.D. and M.S. degrees from Ohio State University in the
field of microbiology and an A.B. degree from Lafayette College in biology.
Patricia C. Fazio joined us in August 1992. Ms. Fazio has served in various
management positions at Progenics, most recently as Senior Director, Project
Management and Health & Safety. From 1987 to 1992, she was Senior Research
Technician and Laboratory Manager at the Howard Hughes Medical Institute at
Columbia University. From 1982 to 1987, Ms. Fazio was Chief Laboratory
Technologist in the Department of Pathology at Columbia Presbyterian Medical
Center. She received a B.S. in biology and chemistry at the College of New
Rochelle.
Charles A. Baker has been a director of Progenics since January 1994.
Mr. Baker has been the Chairman, President and Chief Executive Officer of The
Liposome Company, Inc., a biotechnology company located in Princeton, NJ, since
1989. Mr. Baker is currently a director of Regeneron Pharmaceuticals, Inc., a
biotechnology company. He is a member of the Council of Visitors of the Marine
Biological Laboratory at Woods Hole, Massachusetts. Mr. Baker has more than 30
years of pharmaceutical industry experience, and has held senior management
positions at Pfizer, Abbott Laboratories, Squibb Corporation, and A.L.
Laboratories. Mr. Baker received a B.A. from Swarthmore College and a J.D. from
Columbia University.
Kurt W. Briner has been a director of Progenics since September 1998.
Mr. Briner is retired President and Chief Executive Officer of Sanofi Pharma
S.A. in Geneva, Switzerland, a position he held from 1988. He has nearly 30
years' experience in the pharmaceutical industry. He attended Humanistisches
Gymnasium in Basel and Ecole de Commerce in Basel and Lausanne.
Mark F. Dalton has been a director of Progenics since July 1990.
Mr. Dalton has been the President and a director of Tudor Investment
Corporation, an investment advisory company, and its affiliates since 1988. From
1979 to 1988, he served in various senior management positions at Kidder,
Peabody & Co. Incorporated, including Chief Financial Officer. Mr. Dalton is
currently a director of several private companies as well as a closed-end
investment fund traded on the Irish Stock Exchange. Mr. Dalton received a B.A.
from Denison University and a J.D. from Vanderbilt University.
Stephen P. Goff, Ph.D. has been a director of Progenics since February
1993. Dr. Goff has been a member of our Virology Scientific Advisory Board since
1988 and its Chairman since April 1991. Dr. Goff has been the Higgins Professor
in the Departments of Biochemistry and Microbiology at Columbia University since
June 1990. He received an A.B. in biophysics from Amherst College and a Ph.D. in
biochemistry from Stanford University. Dr. Goff performed post-doctoral research
at the Massachusetts Institute of Technology in the laboratory of Dr. David
Baltimore.
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Paul F. Jacobson has been a director of Progenics since July 1990.
Mr. Jacobson, a private investor, was a Managing Director of fixed income
securities at Deutsche Bank from January 1996 to November 1997. He was President
of Jacobson Capital Partners from 1993 to 1996. From 1986 to 1993, Mr. Jacobson
was a partner at Goldman, Sachs, where he was responsible for government
securities trading activities. Mr. Jacobson received a B.A. from Vanderbilt
University and an M.B.A. from Washington University.
David A. Scheinberg, M.D., Ph.D. has been a director of Progenics since May
1996 and has been a member of our Cancer Scientific Advisory Board since 1994.
Dr. Scheinberg has been associated with Sloan-Kettering since 1986, where he has
held the positions of Associate Professor (since 1994) and Chief (since 1992),
Leukemia Service, Member of the Clinical Immunology Service (since 1987) and
Head, Laboratory of Hematopoietic Cancer Immunochemistry, Sloan-Kettering
Institute (since 1989). He also has held the position of Associate Professor of
Medicine and Molecular Pharmacology, Cornell University Medical College (since
1994). He received a B.A. from Cornell University, and an M.D. and a Ph.D. in
pharmacology and experimental therapeutics from The Johns Hopkins University.
COMMITTEES OF THE BOARD OF DIRECTORS
Our Board of Directors has an Audit Committee, a Compensation Committee and
an Executive Committee. The Audit Committee reviews our annual financial
statements prior to their submission to the Board of Directors, consults with
our independent auditors, and examines and considers such other matters in
relation to the internal and external audit of our account and in relation to
our financial affairs and its accounts, including the selection and retention of
independent auditors. The Compensation Committee makes recommendations
concerning salaries and incentive compensation for our employees and
consultants, establishes and approves salaries and incentive compensation for
certain senior officers and employees and administers and grants stock options
pursuant to our stock option plans. The Executive Committee is authorized to
exercise, during the intervals between the meetings of the Board of Directors,
all the powers of the Board in the management and direction of the business and
affairs of Progenics, subject to certain limited exceptions.
COMPENSATION COMMITTEE INTERLOCKS AND INSIDER PARTICIPATION
No interlocking relationship exists between our Board of Directors or
Compensation Committee and the board of directors or compensation committee of
any other company, nor has any such interlocking relationship existed in the
past. The members of the Compensation Committee are Charles A. Baker, Mark F.
Dalton and Paul F. Jacobson.
49
<PAGE>
PRINCIPAL STOCKHOLDERS
The following table sets forth certain information, as of September 30,
1999, regarding the beneficial ownership of our common stock by: (i) each person
or group known to us to be the beneficial owner of more than 5% of our common
stock outstanding, (ii) each of our directors, (iii) each of our executive
officers named below and (iv) all of our directors and executive officers as a
group.
<TABLE>
<CAPTION>
PERCENTAGE OF SHARES
NUMBER OF BENEFICIALLY OWNED(2)
SHARES ----------------------
BENEFICIALLY BEFORE AFTER
NAME(1) OWNED(2) OFFERING OFFERING
- ------- -------- -------- --------
<S> <C> <C> <C>
Entities affiliated with Tudor Investment Corporation(3) ... 2,384,314 24.4% 20.3%
600 Steamboat Road with
Greenwich, CT 06830
Paul Tudor Jones, II(4) .................................... 2,930,439 30.0% 24.9%
600 Steamboat Road
Greenwich, CT 06830
Entities affiliated with Biotechnology Value Fund, 573,000 6.0% 5.0%
L.P.(5) ..................................................
227 West Monroe Street
Chicago, Illinois 60606
State of Wisconsin Investment Board(6) ..................... 500,000 5.2% 4.3%
P.O. Box 7842
Madison, Wisconsin 53707
Paul J. Maddon, M.D., Ph.D.(7).............................. 1,519,402 14.8% 12.4%
Charles A. Baker(8)......................................... 63,750 * *
Kurt W. Briner(9)........................................... 17,500 * *
Mark F. Dalton(10).......................................... 2,496,314 25.5% 21.2%
Stephen P. Goff, Ph.D.(11).................................. 71,000 * *
Paul F. Jacobson(12)........................................ 196,539 2.1% 1.7%
David A. Scheinberg, M.D., Ph.D.(13)........................ 159,288 1.6% 1.4%
Ronald J. Prentki(14)....................................... 45,191 * *
Robert J. Israel, M.D.(15).................................. 80,693 * *
Robert A. McKinney(16)...................................... 59,503 * *
All directors and executive officers as a group(17)......... 4,709,180 43.0% 36.4%
</TABLE>
- ------------
* Less than one percent.
(1) Unless otherwise specified, the address of each beneficial owner is c/o
Progenics, 777 Old Saw Mill River Road, Tarrytown, New York 10591.
(2) Except as indicated and pursuant to applicable community property laws,
each stockholder possesses sole voting and investment power with respect to
the shares of common stock listed. The number of shares of common stock
beneficially owned includes the shares issuable pursuant to stock options
and warrants that may be exercised within 60 days after September 30, 1999.
Shares pursuant to such options and warrants are deemed outstanding for
computing the percentage of beneficial ownership of the person holding such
options and warrants but are not deemed outstanding for computing the
percentage of beneficial ownership of any other person.
(3) Based on a Schedule 13G/A filed February 11, 1999, the number of shares
owned by entities affiliated with Tudor Investment Corporation ('TIC')
consists of 1,704,501 shares held of record by Tudor BVI Futures, Ltd., an
international business company organized under the law of the British
Virgin Islands ('Tudor BVI'), 142,851 shares of common stock issuable to
Tudor BVI upon the exercise of currently exercisable warrants, 287,813
shares held of record by TIC, 164,499 shares held of record by Tudor
Arbitrage Partners L.P. ('TAP'), 41,125 shares of common stock issuable to
TAP upon the exercise of currently exercisable warrants, 22,500 shares held
of record by Tudor Proprietary Trading, LLC ('TPT'), 5,625 shares of common
stock issuable to TPT upon the exercise of currently exercisable warrants
and 15,400 shares of common stock issuable to Tudor Global Trading LLC
('TGT') upon the override of currently exercisable warrants. In addition,
because TIC provides investment advisory services to Tudor BVI, it may be
deemed to beneficially own the shares held by such entity. TIC disclaims
beneficial ownership of such shares. TGT is the general partner of TAP. TGT
disclaims beneficial ownership of shares held by TAP. The number set forth
does not include shares owned of record by Mr. Jones and Mr. Dalton. See
Notes 4 and 10.
(4) Includes 2,384,314 shares beneficially owned by entities affiliated with
TIC. Mr. Jones is the Chairman and principal stockholder of TIC, the
Chairman and indirect principal equity owner of TGT, the indirect principal
equity owner of TAP and the Chairman and indirect principal equity owner of
TPT. Mr. Jones may be deemed the beneficial owner of shares beneficially
owned, or deemed beneficially owned, by entities affiliated with TIC.
Mr. Jones disclaims beneficial ownership of such shares. See Note 3.
(footnotes continued on next page)
50
<PAGE>
(footnotes continued from previous page)
(5) Based on a Schedule 13G/A filed February 3, 1999, Biotechnology Value Fund,
L.P. shares voting and dispositive power with respect to 283,713 shares and
BVF Partner, L.P. and BVF Inc. each share voting and dispositive power with
respect to 573,000 shares.
(6) Based on a Schedule 13G/A filed February 2, 1999.
(7) Includes 724,774 shares subject to stock options held by Dr. Maddon and
exercisable within 60 days of the date hereof.
(8) Represents 3,750 shares of common stock issuable to the Baker Family
Limited Partnership ('BFLP') upon the exercise of currently exercisable
warrants, 15,000 shares owned by the BFLP, and 45,000 shares subject to
stock options held by Mr. Baker and exercisable within 60 days of the date
hereof.
(9) Represents 17,500 shares subject to stock options held by Mr. Briner
exercisable within 60 days of the date hereof.
(10) Represents 88,000 shares held of record directly by Mr. Dalton, 16,500
shares of record held by DF Partners, a family partnership of which
Mr. Dalton is the managing general partner with a 5% interest, and 7,500
shares subject to options held by Mr. Dalton exercisable within 60 days of
the date hereof. The remaining 95% partnership interest is held by trusts
for the benefit of Mr. Dalton's children. As to such 95% interest,
Mr. Dalton disclaims beneficial interest. The number set forth includes
2,384,314 shares beneficially owned by entities affiliated with TIC.
Mr. Dalton is President of TIC, TGT and TPT. Mr. Dalton disclaims
beneficial ownership of shares beneficially owned, or deemed beneficially
owned, by entities affiliated with TIC. See Note 3.
(11) Includes 37,500 shares subject to stock options held by Dr. Goff
exercisable within 60 days of the date hereof.
(12) Includes 3,750 shares of common stock issuable to Mr. Jacobson upon the
exercise of currently exercisable warrants and 7,500 shares subject to
stock options held by Mr. Jacobson exercisable within 60 days of the date
hereof.
(13) Includes 938 shares of common stock issuable to Dr. Scheinberg upon the
exercise of currently exercisable warrants and 154,600 shares subject to
stock options held by Dr. Scheinberg exercisable within 60 days of the date
hereof.
(14) Includes 38,000 shares subject to stock options held by Mr. Prentki
exercisable within 60 days of the date hereof.
(15) Includes 79,064 shares subject to stock options held by Dr. Israel
exercisable within 60 days of the date hereof.
(16) Includes 58,500 shares subject to stock options held by Mr. McKinney
exercisable within 60 days of the date hereof.
(17) Includes shares held by affiliated entities as set forth in the above table
and 1,383,377 shares in the aggregate issuable upon the exercise of stock
options or warrants held by officers or directors or entities deemed
affiliates of certain directors.
51
<PAGE>
UNDERWRITING
Progenics Pharmaceuticals, Inc. has entered into an underwriting agreement
with the underwriters named below. CIBC World Markets Corp., BancBoston
Roberston Stephens Inc., Prudential Securities Incorporated, Gerard Klauer
Mattison & Co., Inc. and Punk, Ziegel & Company, L.P. are acting as
representatives of the underwriters.
The underwriting agreement provides for the purchase of a specific number
of shares of common stock by each of the underwriters. The underwriters'
obligations are several, which means that each underwriter is required to
purchase a specified number of shares, but is not responsible for the commitment
of any other underwriter to purchase shares. Subject to the terms and conditions
of the underwriting agreement, each underwriter has severally agreed to purchase
the number of shares of common stock set forth opposite its name below:
<TABLE>
<CAPTION>
UNDERWRITERS NUMBER OF SHARES
------------ ----------------
<S> <C>
CIBC World Markets Corp.....................................
BancBoston Robertson Stephens Inc...........................
Prudential Securities Incorporated..........................
Gerard Klauer Mattison & Co., Inc...........................
Punk, Ziegel & Company, L.P.................................
---------
Total.................................................. 2,000,000
---------
---------
</TABLE>
This is a firm commitment underwriting. This means that the underwriters
have agreed to purchase all of the shares offered by this prospectus (other than
those covered by the over-allotment option described below) if any are
purchased. Under the underwriting agreement, if an underwriter defaults in its
commitment to purchase shares, the commitments of non-defaulting underwriters
may be increased or the underwriting agreement may be terminated, depending on
the circumstances.
The representatives have advised us that the underwriters propose to offer
the shares directly to the public at the public offering price that appears on
the cover page of this prospectus. In addition, the representatives may offer
some of the shares to certain securities dealers at such price less a concession
of $ per share. The underwriters may also allow, and such dealers may
reallow, a concession not in excess of $ per share to certain other dealers.
After the shares are released for sale to the public, the representatives may
change the offering price and other selling terms at various times.
We have granted the underwriters an over-allotment option. This option,
which is exercisable for up to 30 days after the date of this prospectus,
permits the underwriters to purchase a maximum of 300,000 additional shares from
us to cover over-allotments. If the underwriters exercise all or part of this
option, they will purchase shares covered by the option at the public offering
price that appears on the cover page of this prospectus, less the underwriting
discount. If this option is exercised in full, the total price to public will be
$ million, and our total proceeds will be approximately $ million.
The underwriters have severally agreed that, to the extent the over-allotment
option is exercised, they will each purchase a number of additional shares
proportionate to the underwriter's initial amount reflected in the foregoing
table.
The following table provides information regarding the amount of the
discount to be given to the underwriters by Progenics.
<TABLE>
<CAPTION>
TOTAL WITHOUT TOTAL WITH
EXERCISE OF FULL EXERCISE OF
PER SHARE OVER-ALLOTMENT OPTION OVER-ALLOTMENT OPTION
--------- --------------------- ---------------------
<S> <C> <C> <C>
Progenics......................... $ $ $
</TABLE>
We will pay all of the expenses of the offering, excluding the underwriting
discount, which expenses we estimate to be approximately $500,000.
We have agreed to indemnify the underwriters against certain liabilities,
including liabilities under the Securities Act of 1933.
52
<PAGE>
We, our officers and directors and certain other shareholders have agreed
to a 90-day 'lock up' with respect to approximately 3.3 million shares of our
common stock and certain other of our securities that they beneficially own and
that are exercisable for shares of common stock. This means that, subject to
certain exceptions, for a period of 90 days following the date of this
prospectus, we and such persons may not offer, sell, pledge or otherwise dispose
of our securities without the prior written consent of CIBC World Markets Corp.
Rules of the Securities and Exchange Commission may limit the underwriters
from bidding for or purchasing shares before the distribution of the shares is
completed. However, the underwriters may engage in the following activities in
accordance with the rules:
Stabilizing transactions -- The representatives may make bids or purchases
for the purpose of pegging, fixing or maintaining the price of the shares,
so long as stabilizing bids do not exceed a specified maximum.
Over-allotments and syndicate covering transactions -- The underwriters
may create a short position in the shares by selling more shares than are
set forth on the cover page of this prospectus. If a short position is
created in connection with the offering, the representatives may engage in
syndicate covering transactions by purchasing shares in the open market.
The representatives may also elect to reduce any short position by
exercising all or part of the over-allotment option.
Penalty bids -- If the representatives purchase shares in the open market
in a stabilizing transaction or syndicate covering transaction, they may
reclaim a selling concession from the underwriters and selling group
members who sold those shares as part of this offering.
Passive market making -- Market makers in the shares who are underwriters
or prospective underwriters may make bids for or purchases of shares,
subject to certain limitations, until the time, if ever, at which a
stabilizing bid is made.
Stabilization and syndicate covering transactions may cause the price of
the shares to be higher than it would be in the absence of such transactions.
The imposition of a penalty bid might also have an effect on the price of shares
if it discourages resales of the shares.
Neither we nor the underwriters make any representation or prediction as to
the effect that the transactions described above may have on the price of the
shares. These transactions may occur on the Nasdaq National Market or otherwise.
If these transactions are commenced, they may be discontinued without notice at
any time.
LEGAL MATTERS
The validity of the common stock being offered hereby will be passed upon
for us by Dewey Ballantine LLP, 1301 Avenue of the Americas, New York, New
York 10019. Certain legal matters will be passed upon for the underwriters by
Hale and Dorr LLP, 60 State Street, Boston, Massachusetts 02109.
EXPERTS
The financial statements as of December 31, 1998 and 1997 and for each of
the three years in the period ended December 31, 1998 included and incorporated
by reference in this Prospectus have been included and incorporated by reference
herein in reliance on the report of PricewaterhouseCoopers LLP, independent
accountants, given on the authority of that firm as experts in accounting and
auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are subject to the reporting requirements of the Securities Exchange Act
of 1934 and in accordance with its requirements file annual and quarterly
reports, proxy statements and other information with the Securities and Exchange
Commission. These reports, proxy statements and other information may be
inspected, and copies of these materials may be obtained upon payment of the
prescribed fees, at the Commission's Public Reference Section, Room 1024, 450
Fifth Street,
53
<PAGE>
Suite 1300, N.W., Washington D.C. 20549, as well as at the Commission's Regional
Offices at Seven World Trade Center, New York, New York 10048, and Citicorp
Center, 500 West Madison Street, Suite 1400, Chicago, Illinois 60661-2511. In
addition, we are required to file electronic versions of these materials with
the Commission through the Commission's Electronic Data Gathering, Analysis and
Retrieval (EDGAR) system. The Commission maintains a World Wide Web site at
http://www.sec.gov that contains reports, proxy and information statements and
other information regarding registrants that file electronically with the
Commission. Our common stock is quoted on the Nasdaq National Market, and
reports and other information concerning us may be inspected at the National
Association of Securities Dealers, Inc. at 1735 K Street, N.W., Washington,
D.C. 20006-1500.
We have filed with the Commission a Registration Statement on Form S-3
under the Securities Act of 1933 with respect to the common stock offered by
this prospectus. This prospectus does not contain all of the information set
forth in the Registration Statement and the exhibits and the schedules thereto.
For further information with respect to us and our common stock, you should read
the Registration Statement, including its exhibits and schedules. Statements
contained in this prospectus, including documents incorporated by reference, as
to the contents of any contract or other document referred to are not
necessarily complete, and, with respect to any contract or other document filed
as an exhibit to the Registration Statement, each such statement is qualified in
all respects by reference to the corresponding exhibit. Copies of the
Registration Statement and its exhibits are on file at the offices of the
Commission and may be obtained upon payment of the prescribed fee or may be
examined without charge at the Commission's Public Reference Section, as well as
at the Commission's Regional Offices in New York 10048 and Chicago, at the
addresses listed above. Copies of these materials can be obtained from the
Public Reference Section of the Commission, upon payment of the prescribed fees
or via the EDGAR database.
INCORPORATION BY REFERENCE
The SEC allows us to incorporate by reference information into this
prospectus. This means that we can disclose important information to you by
referring you to another document filed separately with the SEC. The information
incorporated by reference is deemed to be part of this prospectus, except for
any information superseded by information contained directly in this prospectus.
This prospectus incorporates by reference the documents set forth below that we
have previously filed with the SEC. These documents contain important
information about us and our financial condition.
Our Annual Report on Form 10-K for the year ended December 31, 1998;
Our Quarterly Reports on Form 10-Q for the quarters ended March 31 and
June 30, 1999; and
Our Form 8-A, dated September 29, 1997, with respect to our common stock
All documents filed by us pursuant to Section 13(a), 13(c), 14 or 15(d) of
the Securities Exchange Act of 1934 subsequent to the date of this prospectus
and prior to the completion of the offering of the common stock will be deemed
to be incorporated by reference into this prospectus and to be a part hereof
from the date of filing of such documents.
Any statement contained in a document incorporated or deemed to be
incorporated by reference into this prospectus shall be deemed to be modified or
superseded for purposes of this prospectus to the extent that a statement
contained in this prospectus, or in any other subsequently filed document that
is also incorporated or deemed to be incorporated by reference in this
prospectus, modifies or supersedes the earlier statement. Any statement so
modified or superseded shall not be deemed, except as so modified or superseded,
to constitute a part of this prospectus.
Documents incorporated by reference are available from us without charge,
excluding all exhibits unless specifically incorporated by reference as an
exhibit to this prospectus. Prospective investors may obtain documents
incorporated by reference in this prospectus by requesting them in writing or by
telephone from us at our executive offices at 777 Old Saw Mill River Road,
Tarrytown New York 10591, telephone number (914) 789-2800.
54
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
Report of Independent Accountants........................... F-2
Financial Statements:
Balance Sheets as of December 31, 1997 and 1998 and
June 30, 1999 (unaudited)............................. F-3
Statements of Operations for the Years Ended December
31, 1996, 1997, and 1998 and the Six Months Ended June
30, 1998 (unaudited) and 1999 (unaudited)............. F-4
Statements of Stockholders' (Deficit) Equity for the
Years Ended December 31, 1996, 1997 and 1998 and for
the Six Months Ended June 30, 1999 (unaudited)........ F-5
Statements of Cash Flows for the Years Ended
December 31, 1996, 1997 and 1998 and the Six Months
Ended June 30, 1998 (unaudited) and 1999
(unaudited)........................................... F-6
Notes to Financial Statements............................... F-7
</TABLE>
F-1
<PAGE>
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors and Stockholders of
Progenics Pharmaceuticals, Inc.:
In our opinion, the accompanying balance sheets and the related statements of
operations, stockholders' (deficit) equity and of cash flows present fairly, in
all material respects, the financial position of Progenics Pharmaceuticals, Inc.
(the 'Company') at December 31, 1998 and 1997, and the results of its operations
and its cash flows for each of the three years in the period ended December 31,
1998, in conformity with generally accepted accounting principles. These
financial statements are the responsibility of the Company's management; our
responsibility is to express an opinion on these financial statements based on
our audits. We conducted our audits of these statements in accordance with
generally accepted auditing standards which require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a test basis,
evidence supporting the amounts and disclosures in the financial statements,
assessing the accounting principles used and significant estimates made by
management, and evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for the opinion expressed
above.
PricewaterhouseCoopers LLP
New York, New York
February 16, 1999
F-2
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
BALANCE SHEETS
<TABLE>
<CAPTION>
DECEMBER 31,
--------------------------- JUNE 30,
1997 1998 1999
---- ---- ----
(UNAUDITED)
<S> <C> <C> <C>
ASSETS:
Current assets:
Cash and cash equivalents....................... $ 21,737,925 $ 14,437,263 $ 13,384,326
Marketable securities........................... 10,212,876 6,721,736
Accounts receivable............................. 164,308 1,634,480 1,439,619
Interest receivable............................. 260,599
Other current assets............................ 26,483 555,862 257,222
------------ ------------ ------------
Total current assets....................... 21,928,716 26,840,481 22,063,502
Marketable securities................................ 1,886,200 2,734,195
Fixed assets, at cost, net of accumulated
depreciation and amortization...................... 688,174 1,045,389 1,167,992
Investment in joint venture.......................... 100,000
Security deposits and other assets................... 39,521 13,745 13,745
------------ ------------ ------------
Total assets............................... $ 24,542,611 $ 27,899,615 $ 26,079,434
------------ ------------ ------------
------------ ------------ ------------
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities:
Accounts payable and accrued expenses........... $ 1,226,248 $ 1,595,665 $ 1,498,868
Income taxes payable............................ 57,770
Amount due to joint venture..................... 500,000
Capital lease obligations, current portion...... 82,859 107,346 109,142
------------ ------------ ------------
Total current liabilities.................. 1,366,877 1,703,011 2,108,010
Amount due to joint venture.......................... 802,535
Capital lease obligations............................ 141,402 117,166 65,667
------------ ------------ ------------
Total liabilities.......................... 1,508,279 1,820,177 2,976,212
------------ ------------ ------------
Commitments and contingencies (Note 7)
Stockholders' equity:
Preferred stock, $.001 par value; 14,320,174 shares
authorized; issued and outstanding -- none
Common stock, $.0013 par value; 40,000,000 shares
authorized; shares issued and outstanding 9,001,553
in 1997, 9,358,207 in 1998 and 9,446,366 in 1999... 11,702 12,166 12,280
Additional paid-in capital........................... 43,444,701 44,377,193 44,705,439
Unearned compensation................................ (1,761,381) (1,111,018) (851,080)
Accumulated deficit.................................. (18,661,030) (17,207,993) (20,724,758)
Accumulated other comprehensive (loss) income........ 340 9,090 (38,659)
------------ ------------ ------------
Total stockholders' equity................. 23,034,332 26,079,438 23,103,222
------------ ------------ ------------
Total liabilities and stockholders'
equity................................... $ 24,542,611 $ 27,899,615 $ 26,079,434
------------ ------------ ------------
------------ ------------ ------------
</TABLE>
The accompanying notes are an integral part of the financial statements.
F-3
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
FOR THE SIX MONTHS ENDED
YEARS ENDED DECEMBER 31, JUNE 30,
--------------------------------------- -------------------------
1996 1997 1998 1998 1999
---- ---- ---- ---- ----
(UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C>
Revenues:
Contract research and
development............. $ 318,370 $14,591,505 $11,135,026 $5,329,217 $ 4,859,832
Research grants........... 202,559 664,983 1,250,908 580,710 423,000
Product sales............. 98,049 56,531 180,204 36,446 34,815
Interest income........... 105,808 300,966 1,454,844 663,736 593,111
----------- ----------- ----------- ---------- -----------
Total revenues....... 724,786 15,613,985 14,020,982 6,610,109 5,910,758
----------- ----------- ----------- ---------- -----------
Expenses:
Research and
development............. 3,700,204 7,364,117 8,296,559 3,911,441 5,320,634
General and
administrative.......... 2,807,668 2,221,667 3,840,737 1,936,983 1,976,668
Loss in joint venture..... 1,796,934
Interest expense.......... 50,706 311,522 42,729 18,292 28,505
Depreciation and
amortization............ 308,882 319,486 387,920 164,390 304,782
----------- ----------- ----------- ---------- -----------
Total expenses..... 6,867,460 10,216,792 12,567,945 6,031,106 9,427,523
----------- ----------- ----------- ---------- -----------
Operating (loss) income... (6,142,674) 5,397,193 1,453,037 579,003 (3,516,765)
Income taxes................... 257,770
----------- ----------- ----------- ---------- -----------
Net (loss) income......... $(6,142,674) $ 5,139,423 $ 1,453,037 $ 579,003 $(3,516,765)
----------- ----------- ----------- ---------- -----------
----------- ----------- ----------- ---------- -----------
Net (loss) income per share --
basic........................ $(2.68) $1.64 $0.16 $0.06 $(0.37)
------- ----- ----- ----- -------
------- ----- ----- ----- -------
Net (loss) income per share --
diluted...................... $(2.68) $0.66 $0.14 $0.05 $(0.37)
------- ----- ----- ----- -------
------- ----- ----- ----- -------
</TABLE>
The accompanying notes are an integral part of the financial statements.
F-4
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY
FOR THE YEARS ENDED DECEMBER 31, 1996, 1997 AND 1998
AND FOR THE SIX MONTHS ENDED JUNE 30, 1999 (UNAUDITED)
<TABLE>
<CAPTION>
PREFERRED STOCK COMMON STOCK ADDITIONAL
------------------- ------------------- PAID-IN
SHARES AMOUNT SHARES AMOUNT CAPITAL
------ ------ ------ ------ -------
<S> <C> <C> <C> <C> <C>
Balance at December 31,
1995.................... 4,715,014 $4,715 2,294,675 $2,983 $19,025,723
Issuance of compensatory
stock options........... 60,000
Sale of Series C
Preferred Stock units
for cash, net of
expenses ($20.00 per
unit)................... 964,812 965 4,776,359
Amortization of unearned
compensation............
Net loss for the year
ended December 31,
1996....................
--------- ------- --------- ------- -----------
Balance at December 31,
1996.................... 5,679,826 5,680 2,294,675 2,983 23,862,082
Issuance of compensatory
stock options and
warrants................ 2,634,950
Amortization of unearned
compensation............
Exercise of stock options
($1.33 per share)....... 27,000 35 35,875
Issuance of common stock
in July in consideration
for an amendment to an
agreement ($7.50 per
share).................. 120,000 156 899,844
Issuance of common stock
in an initial public
offering ($8.00 per
share), net of
expenses................ 2,300,000 2,990 16,011,808
Conversion of preferred
stock to common stock as
the result of the
initial public
offering................ (5,679,826) (5,680) 4,259,878 5,538 142
Net income for the year
ended December 31,
1997....................
Net unrealized gain on
marketable securities...
--------- ------- --------- ------- -----------
Balance at December 31,
1997.................... -- -- 9,001,553 11,702 43,444,701
Amortization of unearned
compensation............
Sale of Common Stock
under employee stock
purchase plans and
exercise of stock
options................. 356,654 464 907,667
Other adjustments to
stockholders' equity.... 24,825
Net income for the year
ended December 31,
1998....................
Changes in unrealized
gain on marketable
securities..............
--------- ------- --------- ------- -----------
Balance at December 31,
1998.................... -- -- 9,358,207 12,166 44,377,193
Amortization of unearned
compensation
(unaudited).............
Issuance of compensatory
stock options
(unaudited)............. 48,332
Sale of common stock
under employee stock
purchase plans and
exercise of stock
options and warrants
(unaudited)............. 88,159 114 279,914
Net loss for the six
months ended June 30,
1999 (unaudited)........
Change in unrealized gain
on marketable securities
(unaudited).............
--------- ------- --------- ------- -----------
Balance at June 30, 1999
(unaudited)............. -- $ -- 9,446,366 $12,280 $44,705,439
--------- ------- --------- ------- -----------
--------- ------- --------- ------- -----------
<CAPTION>
ACCUMULATED
OTHER
UNEARNED ACCUMULATED COMPREHENSIVE COMPREHENSIVE
COMPENSATION DEFICIT INCOME TOTAL (LOSS) INCOME
------------ ------- ------ ----- -------------
<S> <C> <C> <C> <C> <C>
Balance at December 31,
1995.................... $ (523,915) $(17,657,779) $ 851,727
Issuance of compensatory
stock options........... (60,000)
Sale of Series C
Preferred Stock units
for cash, net of
expenses ($20.00 per
unit)................... 4,777,324
Amortization of unearned
compensation............ 128,963 128,963
Net loss for the year
ended December 31,
1996.................... (6,142,674) (6,142,674) $ (6,142,674)
------------ ------------- --------- ------------ ------------
Balance at December 31,
1996.................... (454,952) (23,800,453) (384,660) $ (6,142,674)
------------
------------
Issuance of compensatory
stock options and
warrants................ (2,634,950)
Amortization of unearned
compensation............ 1,328,521 1,328,521
Exercise of stock options
($1.33 per share)....... 35,910
Issuance of common stock
in July in consideration
for an amendment to an
agreement ($7.50 per
share).................. 900,000
Issuance of common stock
in an initial public
offering ($8.00 per
share), net of
expenses................ 16,014,798
Conversion of preferred
stock to common stock as
the result of the
initial public
offering................
Net income for the year
ended December 31,
1997.................... 5,139,423 5,139,423 $ 5,139,423
Net unrealized gain on
marketable securities... $ 340 340 340
------------ ------------- --------- ------------ ------------
Balance at December 31,
1997.................... (1,761,381) (18,661,030) 340 23,034,332 $ 5,139,763
------------
------------
Amortization of unearned
compensation............ 650,363 650,363
Sale of Common Stock
under employee stock
purchase plans and
exercise of stock
options................. 908,131
Other adjustments to
stockholders' equity.... 24,825
Net income for the year
ended December 31,
1998.................... 1,453,037 1,453,037 $ 1,453,037
Changes in unrealized
gain on marketable
securities.............. 8,750 8,750 8,750
------------ ------------- --------- ------------ ------------
Balance at December 31,
1998.................... (1,111,018) (17,207,993) 9,090 26,079,438 $ 1,461,787
------------
------------
Amortization of unearned
compensation
(unaudited)............. 259,938 259,938
Issuance of compensatory
stock options
(unaudited)............. 48,332
Sale of common stock
under employee stock
purchase plans and
exercise of stock
options and warrants
(unaudited)............. 280,028
Net loss for the six
months ended June 30,
1999 (unaudited)........ (3,516,765) (3,516,765) $ (3,516,765)
Change in unrealized gain
on marketable securities
(unaudited)............. (47,749) (47,749) (47,749)
------------ ------------- --------- ------------ ------------
Balance at June 30, 1999
(unaudited)............. $ (851,080) $(20,724,758) $ (38,659) $ 23,103,222 $ (3,564,514)
------------ ------------- --------- ------------ ------------
------------ ------------- --------- ------------ ------------
</TABLE>
Securities issued for non-cash consideration were valued based upon the Board of
Directors' estimate of fair value of the securities issued at the time the
services were rendered.
The accompanying notes are an integral part of the financial statements.
F-5
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
<TABLE>
<CAPTION>
SIX MONTHS ENDED
YEARS ENDED DECEMBER 31, JUNE 30,
--------------------------------------- -------------------------
1996 1997 1998 1998 1999
---- ---- ---- ---- ----
(UNAUDITED)
<S> <C> <C> <C> <C> <C>
Cash flows from operating activities:
Net (loss) income.................................. $(6,142,674) $ 5,139,423 $ 1,453,037 $ 579,003 $(3,516,765)
Adjustments to reconcile net (loss) income to net
cash (used in) provided by operating activities:
Depreciation and amortization.................. 308,882 319,486 387,920 164,390 304,782
Amortization of premiums, net of discounts, on
marketable securities........................ 132,406 62,889 61,733
Amortization of discounts on amounts due to
joint venture................................ 5,601
Loss in joint venture.......................... 1,796,934
Expenses incurred in connection with issuance
of common stock, stock options and
warrants..................................... 128,963 1,328,521 650,363 350,006 308,270
Stock issued in consideration for amending an
agreement.................................... 900,000
Other.......................................... 24,825
Changes in assets and liabilities:
Decrease (increase) in accounts
receivable............................... 30,756 (50,197) (1,470,172) (602,322) 194,861
(Increase) in other current assets......... (34,723) (5,433) (529,379) 38,041
Decrease (increase) in security deposits
and other assets......................... 40,906 (1,309) 25,776
Increase (decrease) in accounts payable and
accrued expenses......................... 1,270,099 (559,596) 410,376 (407,937) (77,104)
Decrease in deferred lease liability....... (4,349) (16,735)
Increase in investment in LLC.............. (600,000)
Increase (decrease) in income taxes
payable.................................. 57,770 (57,770) (25,000)
----------- ----------- ----------- ----------- -----------
Net cash (used in) provided by
operating activities.................. (4,402,140) 7,111,930 1,027,382 121,029 (1,483,647)
----------- ----------- ----------- ----------- -----------
Cash flows from investing activities:
Capital expenditures............................... (96,672) (69,784) (767,688) (447,078)
Purchase of marketable securities.................. (1,886,036) (9,295,332) (164,461) (6,307,537)
Sale of marketable securities...................... 845,000 (8,099,171) 6,955,000
Other.............................................. 80,732
----------- ----------- ----------- ----------- -----------
Net cash used in investing
activities............................ (96,672) (1,955,820) (9,137,288) (8,263,632) 200,385
----------- ----------- ----------- ----------- -----------
Cash flows from financing activities:
Proceeds from issuance of equity securities, net of
offering expenses................................ 4,777,324 16,050,708 908,131
Proceeds from the exercise of stock options and
other adjustments to stockholders' equity........ 176,601 280,028
Payment of capital lease obligations............... (191,142) (115,557) (98,887) (46,075) (49,703)
Proceeds from notes payable........................ 2,000,000
Repayments of notes payable........................ (2,000,000)
----------- ----------- ----------- ----------- -----------
Net cash provided by financing
activities............................ 4,586,182 15,935,151 809,244 130,526 230,325
----------- ----------- ----------- ----------- -----------
Net increase (decrease) in cash and
cash equivalents.................... 87,370 21,091,261 (7,300,662) (8,012,077) (1,052,937)
Cash and cash equivalents at beginning of period....... 559,294 646,664 21,737,925 21,737,925 14,437,263
----------- ----------- ----------- ----------- -----------
Cash and cash equivalents at end of
period................................ $ 646,664 $21,737,925 $14,437,263 $13,725,848 $13,384,326
----------- ----------- ----------- ----------- -----------
----------- ----------- ----------- ----------- -----------
Supplemental disclosure of cash flow information:
Cash paid for interest............................. $ 50,706 $ 83,655 $ 42,729
----------- ----------- -----------
----------- ----------- -----------
Cash paid for income taxes......................... $ 200,000 $ 140,000
----------- -----------
----------- -----------
Supplemental disclosure of noncash investing and
financing activities:
Increase in capital lease obligations.............. $ 89,000 $ 95,000 $ 99,138
----------- ----------- -----------
----------- ----------- -----------
Fixed assets included in accounts payable and
accrued expenses................................. $ 40,959 $ 20,743 $ 60,652
----------- ----------- -----------
----------- ----------- -----------
</TABLE>
The accompanying notes are an integral part of the financial statements.
F-6
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS
(INTERIM DATA IS UNAUDITED)
1. ORGANIZATION AND BUSINESS
Progenics Pharmaceuticals, Inc. (the 'Company') is a biopharmaceutical
company focusing on the development and commercialization of innovative products
for the treatment and prevention of cancer, viral diseases, including human
immunodeficiency virus ('HIV') infection, and other diseases. Prior to
July 1997, the Company was in the development stage. The Company was
incorporated in Delaware on December 1, 1986. The Company has no products
approved for sale by the U.S. Food and Drug Administration. In addition to the
normal risks associated with a new business venture, there can be no assurance
that the Company's research and development will be successfully completed, that
any products developed will obtain necessary government regulatory approval or
that any approved products will be commercially viable. In addition, the Company
operates in an environment of rapid change in technology and is dependent upon
the continued services of its current employees, consultants and subcontractors.
As of December 31, 1998, the Company had cash, cash equivalents and
marketable securities of $24.6 million. The Company estimates that this amount
will enable it to continue to operate beyond one year. In the future, the
Company will need to raise additional financing through public or private equity
financings, collaborative or other arrangements with corporate sources, or other
sources of financing to fund operations. There can be no assurance that such
additional financing, if at all available, can be obtained on terms reasonable
to the Company. In the event the Company is unable to raise additional capital,
operations will need to be scaled back or discontinued.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
REVENUE RECOGNITION
The Company has derived all of its product revenue from the sale of
research reagents to four customers. Product sales revenue is recognized at the
time reagents are shipped. The reagents are products of the Company's research
and development efforts.
The Company maintains no inventory of reagents and cost of product sales is
not material. The Company has been awarded government research grants from the
National Institutes of Health (the 'NIH'). The NIH grants are used to subsidize
the Company's research projects ('Projects') regarding HIV. NIH revenue is
recognized on a pro rata basis as subsidized Project costs are incurred. Such
method approximates the straight-line basis over the lives of the Projects.
Payments from Bristol-Myers Squibb Company, Hoffmann-LaRoche, the
Department of Defense, Aaron Diamond AIDS Research Center and the National
Institutes of Health (collectively the 'Collaborators') (See Note 7) for
contract research and development are used to subsidize the Company's research
and development efforts. Such amounts are recognized as revenue as the related
services are performed by the Company, provided the collection of the resulting
receivable is probable. In situations where the Company receives payments in
advance of performance of services, such amounts are deferred and recognized as
revenue as the related services are performed.
Upon the achievement of defined events certain Collaborators are required
to make milestone payments to the Company. Such amounts are included in contract
research and development revenue and are recognized as revenue upon the
achievement of the event and when collection of the resulting receivable is
probable.
Interest income is recognized as earned.
For each of the three years in the period ended December 31, 1998, all of
the Company's research grant revenue and contract research and development
revenue came from the NIH and the Collaborators, respectively.
F-7
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
CONCENTRATIONS OF CREDIT RISK
Financial instruments which potentially subject the Company to
concentrations of credit risk consist of cash, cash equivalents, marketable
securities and receivables from the NIH and the Collaborators. The Company
invests its excess cash in investment grade securities issued by corporations
and governments. The Company has established guidelines that relate to credit
quality, diversification and maturity and that limit exposure to any one issue
of securities.
FIXED ASSETS
Leasehold improvements, furniture and fixtures, and equipment are stated at
cost. Furniture, fixtures, and equipment are depreciated on a straight-line
basis over their estimated useful lives. Leasehold improvements are amortized on
a straight-line basis over the life of the lease or of the improvement,
whichever is shorter. Expenditures for maintenance and repairs which do not
materially extend the useful lives of the assets are charged to expense as
incurred. The cost and accumulated depreciation of assets retired or sold are
removed from the respective accounts and any gain or loss is recognized in
operations. The estimated useful lives of fixed assets are as follows:
<TABLE>
<S> <C>
Machinery and equipment....................... 5-7 years
Furniture and fixtures........................ 5 years
Leasehold improvements........................ Life of lease
</TABLE>
PATENTS
As a result of research and development efforts conducted by the Company,
it has applied, or is applying, for a number of patents to protect proprietary
inventions. All costs associated with patents are expensed as incurred.
CASH AND CASH EQUIVALENTS
The Company considers all highly liquid investments which have maturities
of three months or less, when acquired, to be cash equivalents. The carrying
amount reported in the balance sheet for cash and cash equivalents approximates
its fair value. Cash and cash equivalents subject the Company to concentrations
of credit risk. At December 31, 1998 and 1997, the Company had invested
approximately $14,208,000 and $20,787,000 in funds with two major investment
companies and held approximately $229,000 and $951,000 in a single commercial
bank, respectively.
NET (LOSS) INCOME PER SHARE
The Company prepares its per share data in accordance with Statement of
Financial Accounting Standards No. 128, 'Earnings Per Share' ('SFAS No. 128').
Basic net (loss) income per share is computed on the basis of net (loss)
income for the period divided by the weighted average number of shares of common
stock outstanding during the period. Diluted net (loss) income per share
includes, where dilutive, the number of shares issuable upon exercise of
outstanding options and warrants and the conversion of preferred stock.
Disclosures required by SFAS No. 128 have been included in Note 12.
INCOME TAXES
The Company accounts for income taxes in accordance with the provisions of
Statement of Financial Accounting Standards No. 109, 'Accounting for Income
Taxes' ('SFAS No. 109'). SFAS No. 109 requires that the Company recognize
deferred tax liabilities and assets for the expected
F-8
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
future tax consequences of events that have been included in the financial
statements or tax returns. Under this method, deferred tax liabilities and
assets are determined on the basis of the difference between the tax basis of
assets and liabilities and their respective financial reporting amounts
('temporary differences') at enacted tax rates in effect for the years in which
the temporary differences are expected to reverse.
RISKS AND UNCERTAINTIES
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the financial statements and
accompanying notes. Significant estimates relate to the recoverability of fixed
assets and deferred taxes. Actual results could differ from those estimates. See
also Notes 1 and 7(c).
STOCK-BASED COMPENSATION
The accompanying financial position and results of operations of the
Company have been prepared in accordance with APB Opinion No. 25, 'Accounting
for Stock Issued to Employees' ('APB No. 25'). Under APB No. 25, generally, no
compensation expense is recognized in the financial statements in connection
with the awarding of stock option grants to employees provided that, as of the
grant date, all terms associated with the award are fixed and the fair value of
the Company's stock, as of the grant date, is equal to or less than the amount
an employee must pay to acquire the stock. The Company will recognize
compensation expense in situations where the terms of an option grant are not
fixed or where the fair value of the Company's common stock on the grant date is
greater than the amount an employee must pay to acquire the stock.
Disclosures required by Statement of Financial Accounting Standards No.
123, 'Accounting for Stock-Based Compensation' ('SFAS No. 123'), including pro
forma operating results had the Company prepared its financial statements in
accordance with the fair-value-based method of accounting for stock-based
compensation, have been included in Note 8.
The fair value of options and warrants granted to non-employees for
financing, goods or services are included in the financial statements and
expensed over the life of the debt, as the goods are utilized or the services
performed, respectively.
COMPREHENSIVE (LOSS) INCOME
For the year ended December 31, 1998, the Company adopted statement of
Financial Accounting Standards No. 130, 'Reporting Comprehensive Income' ('SFAS
No. 130'). Comprehensive (loss) income represents the change in net assets of a
business enterprise during a period from transactions and other events and
circumstances from non-owner sources. Comprehensive (loss) income of the Company
includes net (loss) income adjusted for the change in net unrealized gain or
loss on marketable securities. The net effect of income taxes on comprehensive
(loss) income is immaterial. The disclosures required by SFAS No. 130 for the
years ended December 31, 1996, 1997 and 1998 have been included in the
Statements of Stockholders' (Deficit) Equity.
RECLASSIFICATIONS
Certain reclassifications have been made to the 1996 and 1997 financial
statements to conform with the 1998 presentation.
F-9
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
3. MARKETABLE SECURITIES
The Company considers its marketable securities to be 'available-for-sale,'
as defined by Statement of Financial Accounting Standards No. 115, 'Accounting
for Certain Investments in Debt and Equity Securities', and, accordingly,
unrealized holding gains and losses are excluded from operations and reported as
a net amount in a separate component of stockholders' equity.
As of December 31, 1997 and 1998, marketable securities had maturities of
less than three years. The following table summarizes the amortized cost basis,
the aggregate fair value, and gross unrealized holding gains and losses at
December 31, 1997 and 1998:
<TABLE>
<CAPTION>
UNREALIZED HOLDING
AMORTIZED FAIR ---------------------------
COST BASIS VALUE GAINS (LOSSES) NET
---------- ----- ----- -------- ---
<S> <C> <C> <C> <C> <C>
1997:
Corporate debt securities... $ 1,885,860 $ 1,886,200 $ 1,496 $(1,156) $ 340
----------- ----------- ------- ------- ------
----------- ----------- ------- ------- ------
1998:
Corporate debt securities... $10,203,786 $10,212,876 $12,296 $(3,206) $9,090
----------- ----------- ------- ------- ------
----------- ----------- ------- ------- ------
</TABLE>
For the years ended December 31, 1997 and 1998, there were no realized
gains and losses from the sale of marketable securities. The Company computes
the cost of its investments on a specific identification basis. Such cost
includes the direct costs to acquire the securities, adjusted for the
amortization of any discount or premium. The fair value of marketable securities
has been estimated based on quoted market prices.
4. FIXED ASSETS
Fixed assets, including amounts under capitalized lease obligations,
consist of the following:
<TABLE>
<CAPTION>
DECEMBER 31,
-------------------------
1997 1998
---- ----
<S> <C> <C>
Machinery and equipment.................................... $ 1,702,892 $ 1,813,726
Furniture and fixtures..................................... 138,415 216,810
Leasehold improvements..................................... 29,702 399,477
----------- -----------
1,871,009 2,430,013
Less, Accumulated depreciation and amortization....... (1,182,835) (1,384,624)
----------- -----------
$ 688,174 $ 1,045,389
----------- -----------
----------- -----------
</TABLE>
5. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
<TABLE>
<CAPTION>
DECEMBER 31,
-------------------------
1997 1998
---- ----
<S> <C> <C>
Accounts payable........................................... $ 517,714 $ 1,140,442
Fees payable to Scientific Advisory Board members.......... 38,500 16,000
Accrued payroll and related costs.......................... 330,480 144,615
Legal and accounting fees payable.......................... 322,819 294,608
Deferred lease liability, current portion.................. 16,735
----------- -----------
$ 1,226,248 $ 1,595,665
----------- -----------
----------- -----------
</TABLE>
F-10
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
6. STOCKHOLDERS' EQUITY
Subsequent to the Company's initial public offering of its common stock as
discussed below, the Company is authorized to issue 40,000,000 shares of common
stock, par value $.0013 ('Common Stock'), and 14,320,174 shares of preferred
stock, par value $.001. The Board has the authority to issue common and
preferred shares, in series, with rights and privileges determined by the Board.
Prior to the Company's initial public offering ('IPO'), 4,000,000 preferred
shares were designated as Series A Preferred Stock ('Series A'), 2,500,000
shares were designated as Series B Preferred Stock ('Series B') and 3,750,000
shares were designated as Series C Preferred Stock ('Series C') (collectively
the 'Preferred Stock').
In connection with the issuance of Series C stock in 1995 and 1996, the
Company issued 347,249 five-year warrants (the 'C Warrants'). Each C Warrant,
subsequent to the IPO, entitles the holder to purchase .75 share of Common Stock
at $6.67. The number of C Warrants and their exercise price are subject to
adjustment in the event the Company issues additional shares of Common Stock at
below defined per share prices. As of December 31, 1998, 347,249 C Warrants were
issued and outstanding and fully exercisable into 260,455 shares of Common
Stock.
During November 1997, the Company completed an IPO of 2,300,000 shares of
its Common Stock, in which the Company raised approximately $16 million, net of
expenses and underwriting discount. Concurrent with the IPO, all outstanding
shares of Preferred Stock, were converted into 4,259,878 shares of Common Stock
and thereafter retired.
7. COMMITMENTS AND CONTINGENCIES
I. OPERATING LEASES
The Company leased office and laboratory space under noncancelable lease
agreements (the 'Leases'). The Leases provided for escalations of the minimum
rent during the lease term as well as additional charges based upon usage of
certain utilities in excess of defined amounts ('Additional Utility Charges').
The Company recognized rental expense from the Leases on the straight-line
basis. During the years ended December 31, 1996, 1997 and 1998, approximately
$4,000, $33,000 and $17,000, respectively, of previously recognized rent
expense, which had been included as a deferred lease liability, was paid.
On January 27, 1998, the Company entered into a sublease agreement
('Sublease') consolidating and extending the Leases for office and laboratory
space from May 1, 1998 through December 31, 1999. Fixed monthly rental expense
totals approximately $54,000. The Sublease can be extended at the option of the
Company for three additional one-year terms; however, the second and third
options are subject to approval by the landlord.
The Company also leases office equipment and an automobile under
noncancelable operating leases. The leases expire at various times through March
2002.
F-11
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
As of December 31, 1998, future minimum annual payments under all operating
lease agreements, including the Sublease, are as follows:
<TABLE>
<CAPTION>
MINIMUM
YEARS ENDING ANNUAL
DECEMBER 31, PAYMENTS
------------ --------
<S> <C>
1999................................................. $657,829
2000................................................. 8,569
2001................................................. 7,534
2002................................................. 1,521
--------
$675,453
--------
--------
</TABLE>
Rental expense totaled approximately $645,000, $628,000 and $672,000 for
the years ended December 31, 1996, 1997 and 1998, respectively. Additional
Utility Charges, were not material for these periods.
II. CAPITAL LEASES
The Company leases certain equipment under various noncancelable capital
lease agreements. The leases are for periods ranging from three to five years,
after which the Company: (i) either has the option or is required to purchase
the equipment at defined amounts or (ii) may extend the lease for up to one
additional year at defined monthly payments or (iii) is required to return the
equipment, as per the respective lease agreements.
As of December 31, 1998, minimum annual payments under all capital leases,
including required payments to acquire leased equipment, are as follows:
<TABLE>
<CAPTION>
MINIMUM
YEARS ENDING ANNUAL
DECEMBER 31, PAYMENTS
------------ --------
<S> <C>
1999.................................................... $146,644
2000.................................................... 102,994
2001.................................................... 37,069
2002.................................................... 5,175
--------
291,882
Less, Amounts representing interest.................. 67,370
--------
Present value of net minimum capital lease
payments........................................ $224,512
--------
--------
</TABLE>
Leased equipment included as a component of fixed assets was approximately
$835,000 and $388,000 at December 31, 1997 and 1998, respectively; related
accumulated depreciation was approximately $473,000 and $148,000 for the same
respective periods.
III. LICENSING AND CORPORATE COLLABORATION AGREEMENTS
i. UNIVERSITIES
The Company (as licensee) has a worldwide licensing agreement with Columbia
University ('Columbia'). The license, as amended during October 1996, provides
the Company with the exclusive right to use certain technology developed on
behalf of Columbia. According to the terms of the agreement, the Company is
required to pay nonrefundable licensing fees ('Licensing Fees'), payable in
installments by defined dates or, if earlier, as certain milestones associated
with product development ('Milestones') occur, as defined, which include the
manufacture and distribution of a product which uses the licensed technology by
2004. The Company expenses Licensing Fees when
F-12
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
they become payable by the Company to Columbia. In addition, the Company is
required to remit royalties based upon the greater of minimum royalties, as
defined, or a percentage of net sales of products which utilize the licensed
technology and a portion of sublicensing income, as defined. The licensing
agreement may be terminated by Columbia under certain circumstances which
includes the Company's failure to achieve the Milestones; however, Columbia
shall not unreasonably withhold its consent to revisions to the due dates for
achieving the Milestones under certain circumstances. If not terminated early,
the agreement shall continue until expiration, lapse or invalidation of
Columbia's patents on the licensed technology. The Company has the right to
terminate the agreement at any time upon 90 days prior written notice. The
termination of the license could have a material adverse effect on the business
of the Company. Although the Company intends to use its best efforts to comply
with the terms of the agreement, there can be no assurances that the agreement
will not be terminated.
The Company (as licensee) also has a non-exclusive licensing agreement with
Stanford University whereby the Company has the non-exclusive, non-transferable
right to use certain technology owned by the university. According to the terms
of the agreement, the Company will be required to remit royalties based upon the
greater of minimum royalties, as defined or various percentages of sales of
products resulting from the use of licensed patent rights, as defined. Royalties
shall continue to be payable, irrespective of termination of this license
agreement, until such time as all sales of products which utilize the licensed
technology shall have ceased.
In September 1996, the Company (as licensee) entered into a licensing
agreement with The Regents of the University of California ('Regents').
According to the terms of the agreement, the Company is required to remit
royalties based upon the greater of minimum of royalties or a percentage of
product sales and a portion of sublicensing income, as defined. The agreement
can be terminated by the Company upon 90 days notice or by Regents in the event
the Company fails to perform, which includes the achievement of certain defined
milestones; otherwise the agreement terminates upon the lapse of Regents' patent
regarding the licensed technology. Early termination of the agreement could have
a material adverse effect on the business of the Company. Although the Company
intends to use its best efforts to comply with the terms of the agreement, there
can be no assurances that the agreement will not be terminated.
ii. SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH
In November 1994, the Company (as licensee) entered into a worldwide
exclusive licensing agreement with Sloan-Kettering Institute for Cancer Research
('Sloan-Kettering') whereby the Company has the exclusive right to use certain
technology owned by Sloan-Kettering. Certain employees of Sloan-Kettering are
consultants to the Company (see Note 7(d)). The Company is required to remit
royalties based upon the greater of minimum royalties, as defined, or as a
percentage of sales of any licensed product, as defined ('Product Royalties'),
and sublicense income, as defined, earned under sublicenses granted by the
Company in accordance with this licensing agreement ('Sublicense Royalties'). In
the event that no Product Royalties or Sublicense Royalties are due in a given
calendar year, then a defined percentage of that year's minimum royalty will be
creditable against future Product Royalties or Sublicense Royalties due Sloan-
Kettering. The licensing agreement may be terminated by Sloan-Kettering in the
event that the Company fails to achieve certain defined objectives, which
include the manufacture and distribution of a product which uses the licensed
technology, by 2004, or if the Company fails to satisfy certain other
contractual obligations ('Early Termination'); otherwise the agreement shall
terminate either upon the expiration or abandonment of Sloan-Kettering's patents
on the technology licensed, or 15 years from the date of first commercial sale,
as defined, whichever is later. With regard to Early Termination,
Sloan-Kettering shall not unreasonably withhold its consent to revisions to the
due dates for achieving the defined objectives under certain circumstances. The
Company has the right
F-13
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
to terminate the agreement at any time upon 90 days prior written notice
('Company Termination'). In the event of Early Termination or Company
Termination, all licensing rights under the agreement would revert to
Sloan-Kettering. Early Termination of the license could have a material adverse
effect on the business of the Company. Although the Company intends to use its
best efforts to comply with the terms of the license, there can be no assurance
that the licensing agreement will not be terminated.
iii. AQUILA BIOPHARMACEUTICALS, INC.
In August 1995, the Company (as licensee) entered into a license and supply
agreement (the 'L&S Agreement') with Aquila Biopharmaceuticals, Inc. ('Aquila').
Under the terms of the L&S Agreement, the Company obtained a coexclusive license
to use certain technology and a right to purchase QS-21 adjuvant (the 'Product')
from Aquila for use in the Company's research and development activities. In
consideration for the license, the Company paid a nonrefundable, noncreditable
license fee and issued 45,000 restricted shares of the Company's Common Stock
('Restricted Shares') to Aquila. The Restricted Shares are nontransferable with
this restriction lapsing upon the Company's achievement of certain milestones
('L&S Milestones'), as defined. In the event that any one or more L&S Milestones
do not occur, the underlying Restricted Shares would be returned to the Company.
As of December 31, 1998, the restrictions on 11,250 shares of common stock have
lapsed. The fair value of the Restricted Shares, combined with the noncreditable
license fee, were expensed during 1995 as research and development. In addition,
the Company will be required to remit royalties based upon the net sales of
products sold using the licensed technology ('Licensed Products') and a defined
percentage of any sublicense fees and royalties payable to the Company with
respect to Licensed Products. The L&S Agreement may be terminated by Aquila in
the event that the Company fails to achieve certain defined objectives, which
include the manufacture and distribution of a Licensed Product, by 2004 ('Early
Termination'); otherwise the L&S Agreement shall terminate upon the expiration
of Aquila's patents on the technology licensed. With regard to Early
Termination, Aquila shall not unreasonably withhold its consent to revisions to
the due dates for achieving the L&S Milestones under certain circumstances. The
Company has the right to terminate the L&S Agreement at any time upon 90 days
prior written notice ('Company Termination'), as defined. In the event of Early
Termination or Company Termination, all licensing rights under the agreement
would revert to Aquila. Early termination of the L&S Agreement would have a
material adverse effect on the business of the Company. Although the Company
intends to use its best efforts to comply with the terms of the L&S Agreement,
there can be no assurance that the agreement will not be terminated.
iv. BRISTOL-MYERS SQUIBB COMPANY
In July 1997, the Company and Bristol-Myers Squibb Company ('BMS') entered
into a Joint Development and Master License Agreement (the 'BMS License
Agreement') under which BMS obtained an exclusive worldwide license to
manufacture, use and sell products resulting from development of the Company's
products related to certain therapeutic cancer vaccines (the 'Cancer Vaccines').
Upon execution of the agreement, BMS made non-refundable cash payments of $9.5
million, as reimbursement for expenses previously incurred by the Company in the
development of the Cancer Vaccines, $2.0 million as a licensing fee and
approximately $1.8 million as reimbursement of the Company's budgeted clinical
development costs for the Cancer Vaccines for the period April 15, 1997 through
September 30, 1997. In addition, BMS is obligated to make future non-refundable
payments as defined upon the achievement of specified milestones and pay
royalties on any product sales. BMS is also required to subsidize ongoing
development, clinical trials and regulatory filings ('Development Costs')
conducted by the Company on a time and
F-14
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
material basis related to the Cancer Vaccines. BMS's funding of future
Development Costs are refundable by the Company only to the extent that the
Company receives such funding in advance and fails to expend such amounts for
their intended purposes. The Company recognized as revenue the reimbursement of
prior expenses and the licensing fee upon receipt of the funds. The Company
recognizes revenue for the funding of Development Costs on a pro rata basis as
the related expenses are incurred.
The BMS License Agreement and related sublicenses terminate at various
times, generally upon the expiration or abandonment of the related patents. The
agreements can also be terminated by either party upon a material uncured breach
by the other party. BMS has the further right to terminate the BMS License
Agreement (including its funding and milestone obligations) as to specified
licensed products at specified times.
v. F. HOFFMANN-LA ROCHE LTD.
On December 23, 1997 (the 'Effective Date'), the Company entered into an
agreement (the 'Roche Agreement') to conduct a research collaboration with F.
Hoffmann-La Roche Ltd. and Hoffmann-La Roche, Inc. (collectively 'Roche') to
identify novel HIV therapeutics. The Roche Agreement grants to Roche an
exclusive worldwide license to use certain of the Company's intellectual
property rights related to HIV to develop, make, use and sell products resulting
from the collaboration.
The terms of the Roche Agreement require Roche to pay the Company an
upfront fee and defined amounts annually for the first year, with annual
adjustments thereafter, for the funding of research conducted by the Company.
Roche's annual payment is made quarterly in advance. Such funding will continue
for a minimum of two years from the Effective Date. In addition, the Company
will receive non-refundable milestone payments and royalty payments based on
achievement of certain events and a percentage of worldwide sales of products
developed from the collaboration, respectively. The Company recognizes as
revenue milestone payments as earned and research reimbursements on a pro rata
basis as the underlying costs are incurred. The collaboration has a term of
three years and may be extended by mutual agreement. The Roche Agreement shall
remain in force until the expiration of all obligations to pay royalties
pursuant to any licenses specified by the Roche Agreement. Roche may terminate
the Roche Agreement at any time with prior written notice, at which time the
license granted by the Company will terminate. Either party may terminate the
Roche Agreement if the other party defaults on its obligations and such default
is not cured within sixty days of written notice of such default.
In connection with all the agreements discussed above, the Company has
recognized research and development expenses, including transaction costs,
totaling approximately $170,500, $1,901,000 and $550,000 for the years ended
December 31, 1996, 1997 and 1998, respectively. Such expenses include the fair
value of the Restricted Shares and 120,000 shares of Common Stock issued in
July 1997. In addition, as of December 31, 1998, remaining payments associated
with milestones and defined objectives with respect to the above agreements
total $650,000. Future annual minimum royalties under the licensing agreements
described in (i) through (iii) above are not significant.
IV. CONSULTING AGREEMENTS
As part of the Company's research and development efforts it enters into
consulting agreements with external scientific specialists ('Scientists') and
others. These Agreements contain varying terms and provisions including fees to
be paid by the Company and royalties, in the event of future sales, and
milestone payments, upon achievement of defined events, payable to the Company.
Certain Scientists, some of who are members of the Company's Scientific Advisory
F-15
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
Board, have purchased Common Stock or received stock options which are subject
to vesting provisions, as defined. The Company has recognized expenses with
regards to these consulting agreements totaling approximately $268,000,
$971,000, and $482,000 for the years ended December 31, 1996, 1997 and 1998,
respectively. Such expenses include the fair value of stock options of
approximately $112,000, $772,000 and $329,000 for the years ended December 31,
1996, 1997 and 1998, respectively.
8. STOCK OPTION AND EMPLOYEE STOCK PURCHASE PLANS
The Company adopted three stock option plans, the Non-Qualified Stock
Option Plan, the Stock Option Plan and the Amended Stock Incentive Plan
(individually the '89 Plan,' '93 Plan' and '96 Plan,' respectively, or
collectively, the 'Plans'). Under the 89 Plan, the 93 Plan and the 96 Plan as
amended, a maximum of 375,000, 750,000 and 2,000,000 shares of Common Stock,
respectively, are available for awards to employees, consultants, directors and
other individuals who render services to the Company (collectively,
'Optionees'). The Plans contain certain anti-dilution provisions in the event of
a stock split, stock dividend or other capital adjustment as defined. The
89 Plan and 93 Plan provide for the Board, or the Compensation Committee
('Committee') of the Board, to grant stock options to Optionees and to determine
the exercise price, vesting term and expiration date. The 96 Plan provides for
the Board or Committee to grant to Optionees stock options, stock appreciation
rights, restricted stock performance awards or phantom stock, as defined
(collectively 'Awards'). The Committee will also determine the term and vesting
of the Award and the Committee may in its discretion accelerate the vesting of
an Award at any time. Options granted under the Plans generally vest pro rata
over five to ten year periods and have terms of ten to twenty years. Except as
noted below, the exercise price of outstanding awards was equal to the fair
value of the Company's Common Stock on the dates of grant. Under the 89 Plan,
for a period of ten years following the termination for any reason of an
Optionee's employment or active involvement with the Company, as determined by
the Board, the Company has the right to repurchase any or all shares of Common
Stock held by the Optionee and/or any or all of the vested but unexercised
portion of any option granted to such Optionee at a purchase price defined by
the 89 Plan. The 89 Plan terminated in April, 1994 and the 93 Plan and the 96
Plan will terminate in December, 2003 and October, 2006, respectively; however,
options granted before termination of the Plans will continue under the
respective Plans until exercised, cancelled or expired.
The following table summarizes stock option information for the Plans as of
December 31, 1998:
<TABLE>
<CAPTION>
OPTIONS OUTSTANDING OPTIONS EXERCISABLE
------------------------------------- -----------------------
WEIGHTED-
AVERAGE WEIGHTED- WEIGHTED-
RANGE OF REMAINING AVERAGE AVERAGE
EXERCISE NUMBER CONTRACTUAL EXERCISE NUMBER EXERCISE
PRICES OUTSTANDING LIFE PRICE EXERCISABLE PRICE
- ------------- ----------- ----------- --------- ----------- ---------
<S> <C> <C> <C> <C> <C>
$ 1.33 188,859 5.5 yrs. $ 1.33 176,109 $ 1.33
$ 3.67-$5.33 1,164,139 6.5 yrs. $ 4.47 671,723 $ 4.55
$ 6.67-$10.00 377,500 9.7 yrs. $ 9.26 3,000 $ 6.67
$10.50-$14.50 541,800 10.0 yrs. $12.03 2,300 $14.07
$17.00-$19.38 16,000 9.2 yrs. $18.34 5,332 $18.34
--------- -------
$ 1.33-$19.28 2,288,298 7.8 yrs. $ 6.89 858,464 $ 4.01
--------- -------
--------- -------
</TABLE>
F-16
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
Transactions involving stock option awards under the Plans during 1996,
1997 and 1998 are summarized as follows:
<TABLE>
<CAPTION>
WEIGHTED-AVERAGE
NUMBER EXERCISE PRICE
OF SHARES (2)
--------- ---
<C> <S> <C> <C>
Balance outstanding, December 31, 1995..................... 970,736 $ 4.39
1996: Granted............................................. 94,500 $ 6.56
Cancelled........................................... (24,000) $ 5.33
---------
Balance outstanding, December 31, 1996......... 1,041,236 $ 4.57
1997: Granted(1).......................................... 848,000 $ 4.00
Cancelled(1)........................................ (302,888) $ 5.36
Exercised........................................... (27,000) $ 1.33
---------
Balance outstanding, December 31, 1997......... 1,559,348 $ 4.17
1998: Granted............................................. 930,800 $11.07
Cancelled........................................... (10,700) $ 7.89
Exercised........................................... (191,150) $ 4.54
---------
Balance outstanding, December 31, 1998......... 2,288,298 $ 6.89
---------
---------
</TABLE>
- ------------
(1) Includes 216,225 options repriced, as discussed below
(2) For all options granted in 1996 and 1998 and 2,100 in 1997, the option
exercise price equaled the fair value of the Company's common stock on the
date of grant. For 1997, 845,900 options were granted, with an exercise
price below the fair market value of the Company's common stock on the date
of grant.
------------------------
As of December 31, 1996, 1997 and 1998, 488,553, 818,586, and 858,464
options with weighted average exercise prices of $3.59, $3.92 and $4.01,
respectively, were exercisable under the Plans.
As of December 31, 1998, shares available for future grants under the 93
Plan and the 96 Plan amounted to 35,362 and 560,700, respectively.
The Company, during 1997, granted 520,900 stock options (including 216,225
options repriced as discussed below) to employees, with an average exercise
price of $4.00, which was below the estimated fair value of the Common Stock on
the date of grant. Accordingly, the Company is recognizing compensation expense
on a pro rata basis over the respective options' vesting periods, of one to five
years, for the difference between the estimated fair value of the Common Stock
on the date the option was granted and the exercise price ('Unamortized
Compensation'). The Unamortized Compensation as of December 31, 1997 and 1998
has been included within stockholders equity. For the years ended December 31,
1997 and 1998, the annual amortization of Unearned Compensation for employees
totaled $322,296 and $314,902. As of December 31, 1998 the unamortized portion
of Unearned Compensation for employees totaled $417,502.
The Company since its inception has granted an aggregate of 1,082,000
options with a weighted-average exercise price of $3.86 to consultants in
consideration for services. The fair values of these options have been included
as Unearned Compensation and are being amortized as compensation expense on a
pro rata basis over the service period ranging from four years to ten years. For
the years ended December 31, 1996, 1997 and 1998 the annual amortization of
Unearned Compensation for consultants totaled $128,963, $778,358 and $335,461,
respectively. The above amounts included the fair value of stock options issued
to consultants as discussed in
F-17
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
Note 7(d). As of December 31, 1998, the unamortized portion of Unearned
Compensation for consultants totaled $693,516.
On April 1, 1997, the exercise price of 216,225 options granted under the
Plans, having exercise prices in excess of $4.00 per share, were reduced to
$4.00 per share. The exercise price of the repriced options was less than the
fair value of the underlying stock on the date of repricing. Accordingly, the
Company is recognizing compensation expense on a pro rata basis over the
respective remaining options' vesting periods of one to five years for the
difference between the estimated fair value of the Common Stock on the date the
option was repriced and $4.00. All other aspects of the options remain
unchanged.
During 1993, the Company adopted an Executive Stock Option Plan (the
'Executive Plan'), under which a maximum of 750,000 shares of Common Stock,
adjusted for stock splits, stock dividends, and other capital adjustments, as
defined, are available for stock option awards. Awards issued under the
Executive Plan may qualify as incentive stock options ('ISOs'), as defined by
the Internal Revenue Code, or may be granted as non-qualified stock options.
Under the Executive Plan, the Board may award options to senior executive
employees (including officers who may be members of the Board) of the Company,
as defined. The Executive Plan will terminate on December 15, 2003; however, any
option outstanding as of the termination date shall remain outstanding until
such option expires in accordance with the terms of the respective grant.
During December 1993, the Board awarded a total of 750,000 stock options
under the Executive Plan to one officer, of which 664,774 were non-qualified
options ('NQOs') and 85,226 were ISOs. The NQOs and ISOs have a term of ten
years and entitle the officer to purchase an equal number of shares of Common
Stock at prices of $5.33 and $5.87 per share, respectively, which represented
the estimated fair market value and 110% of the estimated fair market value of
the Company's Common Stock at the date of grant, as determined by the Board of
Directors. 375,000 of the options vest pro rata over a period of four years,
with the remaining 375,000 options vesting in full on the tenth anniversary of
the date of grant; however, vesting with respect to the options vesting on the
tenth anniversary will be accelerated in the event of the effective date of an
initial public offering of the Company's Common Stock that yields certain gross
per share amounts, as defined, or immediately before the closing of an
acquisition of the Company. As the result of the Company's IPO and subsequent
increase in the fair market value of the Company's Common Stock, 300,000 options
vested. During 1998, 275,226 options, with a weighted-average exercise price of
$5.50 per share, were exercised.
The following table summarizes stock option information for the Executive
Plan as of December 31, 1998:
<TABLE>
<CAPTION>
OPTIONS OUTSTANDING OPTIONS EXERCISABLE
----------------------------------------------- -------------------------------
WEIGHTED-
RANGE OF AVERAGE WEIGHTED- WEIGHTED-
EXERCISE NUMBER REMAINING AVERAGE NUMBER AVERAGE
PRICES OUTSTANDING CONTRACTUAL LIFE EXERCISE PRICE EXERCISABLE EXERCISE PRICE
------ ----------- ---------------- -------------- ----------- --------------
<S> <C> <C> <C> <C> <C>
$5.33 474,774 5.0 yrs. $5.33 399,774 $5.33
</TABLE>
As of December 31, 1996, 1997 and 1998, 300,000, 450,000 and 399,774
options with weighted-average exercise prices of $5.45, $5.43 and $5.33,
respectively, were exercisable under the Executive Plan.
On May 1, 1998, the Company adopted two employee stock purchase plans (the
'Purchase Plans'), the 1998 Employee Stock Purchase Plan (the 'Qualified Plan)'
and the 1998 Non-Qualified Employee Purchase Plan (the 'Non-Qualified'). The
Purchase Plans provide for the grant to all employees of options to use up to
25% of their quarterly compensation, as such percentage is determined by the
Board of Directors prior to the date of grant, to purchase shares
F-18
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
of the Common Stock at a price per share equal to the lesser of the fair market
value of the Common Stock on the date of grant or 85% of the fair market value
on the date of exercise. Options are granted automatically on the first day of
each fiscal quarter and expire six months after the date of grants. The
Qualified Plan is not available for employees owning more than 5% of the Common
Stock and imposes certain other quarterly limitations on the option grants.
Options under the Non-Qualified Plan are granted to the extent the option grants
are restricted under the Qualified Plan. The Qualified and Non-Qualified Plans
provide for the issuance of up to 150,000 and 50,000 shares of Common Stock,
respectively.
Purchases of Common Stock during the year ended December 31, 1998 are
summarized as follows:
<TABLE>
<CAPTION>
QUALIFIED PLAN NON-QUALIFIED PLAN
- ------------------------------------ ------------------------------------
SHARES PURCHASED PRICE RANGE SHARES PURCHASED PRICE RANGE
- ---------------- ----------- ---------------- -----------
<S> <C> <C> <C>
3,494 $10.63 -- $12.96 -- --
</TABLE>
At December 31, 1998, shares reserved for future purchases under the
Qualified and Non-Qualified Plans were 146,506 and 50,000, respectively.
The following table summarizes the pro forma operating results of the
Company had compensation costs for the Plans, the Executive Plan and the
Purchase Plans been determined in accordance with the fair value based method of
accounting for stock based compensation as prescribed by SFAS No. 123. Since
option grants awarded during 1996, 1997 and 1998 vest over several years and
additional awards are expected to be issued in the future, the pro forma results
shown below are not likely to be representative of the effects on future years
of the application of the fair value based method.
<TABLE>
<CAPTION>
YEARS ENDED DECEMBER 31,
-------------------------------------
1996 1997 1998
----------- ---------- ----------
<S> <C> <C> <C>
Pro forma net (loss) income...................... $(6,189,086) $5,016,206 $1,138,602
----------- ---------- ----------
----------- ---------- ----------
Pro forma net (loss) income per share, basic..... $ (2.70) $ 1.60 $ 0.13
----------- ---------- ----------
----------- ---------- ----------
Pro forma net (loss) income per share, diluted... $ (2.70) $ 0.65 $ 0.11
----------- ---------- ----------
----------- ---------- ----------
</TABLE>
For the purpose of the above pro forma calculation, the fair value of each
option granted was estimated on the date of grant using the Black-Scholes option
pricing model. The weighted-average fair value of the options granted during
1996, 1997 and 1998 was $4.60, $3.91 and $6.87 respectively. The following
assumptions were used in computing the fair value of option grants: expected
volatility of 81% in 1996 and 1997 and 71% in 1998, expected lives of 5 years
after vesting; zero dividend yield and weighted-average risk-free interest rates
of 6.0% in 1996, 6.72% in 1997 and 4.45% in 1998.
9. EMPLOYEE SAVINGS PLAN
The Company, during 1993, adopted the provisions of the amended and
restated Progenics Pharmaceuticals 401(k) Plan (the 'Amended Plan'). The terms
of the Amended Plan, among other things, allow eligible employees, as defined,
to participate in the Amended Plan by electing to contribute to the Amended Plan
a percentage of their compensation to be set aside to pay their future
retirement benefits, as defined. The Company has agreed to match 25% of up to
the first 8% of compensation that eligible employees contribute to the Amended
Plan, as defined. In addition, the Company may also make a discretionary
contribution, as defined, each year on behalf of all participants who are
non-highly compensated employees, as defined. The Company made
F-19
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
matching contributions of approximately $10,000, $9,000 and $27,000 to the
Amended Plan for the years ended December 31, 1996, 1997 and 1998, respectively.
10. INCOME TAXES
There is no tax provision for the year ended December 31, 1998 as the
Company was able to utilize net operating loss carryforwards that previously had
been fully provided for. The effects of the alternative minimum tax on the 1998
provision were immaterial.
The tax provision for the year ended December 31, 1997 has been computed
based upon the prevailing federal and state tax rates, offset by the utilization
of net operating loss carryforwards to the extent permitted by the alternative
minimum tax rules of the federal and state tax codes. There is no benefit for
federal or state income taxes for the year ended December 31, 1996, since the
Company has incurred operating losses and has established a valuation allowance
equal to the total deferred tax asset.
The differences between the Company's effective income tax rate, (benefit)
provision, and the Federal statutory rate is reconciled below:
<TABLE>
<CAPTION>
YEARS ENDED
DECEMBER 31,
----------------------
1996 1997 1998
---- ---- ----
<S> <C> <C> <C>
Federal statutory rate............................... (34)% 34 % 34 %
State income taxes, net of Federal benefit........... (6) 6 6
Research and experimental tax credit................. (2) (3) (17)
Change in valuation allowance........................ 42 (32) (23)
--- --- ---
-- % 5 % -- %
--- --- ---
--- --- ---
</TABLE>
The tax effect of temporary differences, net operating losses and tax
credits carryforwards as of December 31, 1997 and 1998 are as follows:
<TABLE>
<CAPTION>
DECEMBER 31,
-------------------------
1997 1998
----------- -----------
<S> <C> <C>
Deferred tax assets and valuation allowance:
Net operating loss carry-forwards..................... $ 1,638,783 $ 2,669,911
Fixed assets.......................................... 98,894 108,500
Deferred charges...................................... 5,726,342 4,762,978
Research and experimental tax credit carry-forwards... 831,670 1,083,944
Alternative minimum tax credit........................ 211,384 211,384
Valuation allowance................................... (8,507,073) (8,836,717)
----------- -----------
-- --
----------- -----------
----------- -----------
</TABLE>
The Company does not recognize deferred tax assets considering the history
of taxable losses and the uncertainty regarding the Company's ability to
generate sufficient taxable income in the future to utilize these deferred tax
assets.
As of December 31, 1998, the Company has available, for tax purposes,
unused net operating loss carryforwards of approximately $6.5 million which will
expire in various years from 2002 to 2013. The Company's research and
experimental tax credit carryforwards expire in various years from 2003 to 2013.
In addition, the Company's alternative minimum tax credit can be carried forward
indefinitely. Future ownership changes may limit the future utilization of these
net operating loss and tax credit carryforwards as defined by the federal and
state tax codes.
F-20
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
11. LINE OF CREDIT
During March 1997 the Company obtained a line of credit ('Line') from a
bank. The terms of the Line provide for the Company to borrow up to $2 million.
Outstanding borrowings accrue interest, payable monthly, at the bank's prime
rate of interest. The Line expired on July 31, 1997. The repayment of the Line
was guaranteed by two affiliates of a stockholder of the Company ('Affiliates').
In consideration for the guarantee of the Line, the Company issued 70,000
warrants to the Affiliates. Such warrants vested immediately and expire after
five years. The exercise price was determined to be $4.00 per share in November
1997 upon completion of the Company's IPO. The aggregate fair value of the
warrants totaled $227,867, which was expensed during the year ended
December 31, 1997.
12. NET (LOSS) INCOME PER SHARE
The Company's basic net (loss) income per share amounts have been computed
by dividing net (loss) income by the weighted-average number of common shares
outstanding during the period. For the year ended December 31, 1996, the Company
reported net losses and, therefore, common stock equivalents were not included
since such inclusion would have been anti-dilutive. For the years ended
December 31, 1997 and 1998, the Company reported net income and, therefore, all
common stock equivalents, with exercise prices less than the average fair market
value of the Company's Common Stock for the year, have been included in the
calculation, as follows:
<TABLE>
<CAPTION>
NET INCOME (LOSS) SHARES PER SHARE
(NUMERATOR) (DENOMINATOR) AMOUNT
----------------- ------------- ---------
<S> <C> <C> <C>
1998:
Basic:
Net income................................. $ 1,453,037 9,067,594 $0.16
----------- ---------
----------- ---------
Effect of Dilutive Securities:
Options.................................... 1,465,119
Warrants................................... 194,420
----------
Diluted:
Amounts used in computing per share data... $ 1,453,037 10,727,133 $0.14
----------- ---------- ---------
----------- ---------- ---------
1997:
Basic:
Net income................................. $ 5,139,423 3,127,855 $1.64
----------- ---------
----------- ---------
Effect of Dilutive Securities:
Options.................................... 829,156
Warrants................................... 77,211
Effect of conversion of preferred stock.... 3,769,700
----------
Diluted:
Amounts used in computing per share data... $ 5,139,423 7,803,922 $0.66
----------- ---------- ---------
----------- ---------- ---------
1996:
Basic and Diluted:
Net (loss)................................. $(6,142,674) 2,294,675 ($2.68)
----------- ---------- ---------
----------- ---------- ---------
</TABLE>
F-21
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
For the years ended December 31, 1996, 1997 and 1998 common stock
equivalents which have been excluded from diluted per share amounts because
their effect would have been anti-dilutive, include the following:
<TABLE>
<CAPTION>
1996 1997 1998
--------------------- ----------------- -----------------
WEIGHTED WEIGHTED WEIGHTED
AVERAGE AVERAGE AVERAGE
EXERCISE EXERCISE EXERCISE
NUMBER PRICE NUMBER PRICE NUMBER PRICE
--------- --------- ------ -------- ------ --------
<S> <C> <C> <C> <C> <C> <C>
Options and
Warrants................... 2,051,691 $5.14 -- -- 16,000 $18.34
Convertible
Preferred
Stock...................... 4,259,878
</TABLE>
13. NOTE TO INTERIM FINANCIAL STATEMENTS FOR THE SIX MONTHS ENDED JUNE 30, 1999
AND 1998 (UNAUDITED)
BASIS OF PRESENTATION
The interim financial statements as of and for the six months ended June
30, 1999 and 1998 are unaudited and reflect adjustments, consisting only of
normal recurring accruals, which are, in the opinion of the Company's
management, necessary for a fair presentation of the financial position and
results of operations for the periods presented. Operating results for any
interim period are not necessarily indicative of the results for the full year.
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses as of June 30, 1999 consist of the
following:
<TABLE>
<CAPTION>
JUNE 30,
1999
----
<S> <C>
Accounts payable........................................ $1,300,761
Accrued payroll and related costs....................... 41,107
Legal and accounting fees payable....................... 157,000
----------
$1,498,868
----------
----------
</TABLE>
NET INCOME (LOSS) PER SHARE
The Company's basic net income (loss) per share amounts have been computed
by dividing net income (loss) by the weighted average number of common shares
outstanding during the respective periods. For the six months ended June 30,
1999, the Company reported net losses and, therefore, no common stock
equivalents were included in the computation of diluted per share amounts since
such inclusion would have been antidulutive. For the six months ended June 30,
1998, the Company reported net income and, therefore, the calculation of diluted
per share amounts includes all common stock equivalents with exercise prices
below the average per share price of the Company's common stock for the
respective periods. The calculations of basic and diluted net income (loss) per
share are as follows:
F-22
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
<TABLE>
<CAPTION>
NET INCOME (LOSS) SHARES PER SHARE
(NUMERATOR) (DENOMINATOR) AMOUNT
----------------- ------------- ---------
<S> <C> <C> <C>
1999:
Six months-ended June 30, 1999:
Basic and Diluted:................. $(3,516,765) 9,400,728 ($0.37)
1998:
Six months-ended June 30, 1998:
Basic:............................. $ 579,003 9,008,623 $0.06
Effect of Dilutive Securities:
Options....................... 1,691,153
Warrants...................... 213,174
-----------
Diluted............................ $ 579,003 10,912,950 $0.05
-----------
-----------
</TABLE>
Options and warrants which have been excluded from the diluted per share
amounts because their effect would have been antidilutive include the following:
<TABLE>
<CAPTION>
SIX MONTHS ENDED JUNE 30,
------------------------------------------
1999 1998
-------------------- -------------------
WEIGHTED WEIGHTED
WEIGHTED AVERAGE WEIGHTED AVERAGE
AVERAGE EXERCISE AVERAGE EXERCISE
NUMBER PRICE NUMBER PRICE
--------- -------- -------- --------
<S> <C> <C> <C> <C>
Options and warrants with exercise prices
below the average fair market value of the
company's common stock for the respective
periods..................................... 3,045,487 $ 6.59
Options and warrants with exercise prices
above the average fair market value of the
company's common stock for the respective
periods..................................... 83,713 $14.88 3,729 $19.06
</TABLE>
FORMATION OF PSMA DEVELOPMENT COMPANY LLC
On June 15, 1999, the Company and CYTOGEN Corporation ('CYTOGEN')
(collectively, the 'Members') formed a joint venture in the form of a limited
liability company (the 'LLC') for the purposes of conducting research,
development, manufacturing and marketing of products related to the
prostate-specific membrane antigen ('PSMA'). In connection with the formation of
the LLC, the Members entered into a series of agreements, including an LLC
Agreement, a License Agreement and a Services Agreement (collectively, the
'Agreements'). Each Member made an initial capital contribution of $100,000. In
general, each Member has equal representation on the LLC's management committee
and equal voting rights and rights to profits and losses of the LLC.
Under the LLC Agreement, as long as the Company is a Member, the Company is
required to pay to the LLC $2 million in supplemental capital contributions at
certain defined dates or upon the achievement of defined milestones by the LLC,
$500,000 of which was paid during June 1999. Such payments will, in turn, by
paid by the LLC to CYTOGEN in consideration for CYTOGEN granting to the LLC,
under the License Agreement, an exclusive worldwide license under certain
patents and patent applications to make, use, develop and sell products in the
field. During the six months ended June 30, 1999, the Company recognized its
allocated share of the LLC's loss of approximately $1.8 million, representing
the present value of the $2 million payments in connection with the LLC
Agreement. The discount on the investment in the LLC will be amortized as
interest expense over the term of the remaining payments.
F-23
<PAGE>
PROGENICS PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- (CONTINUED)
(INTERIM DATA IS UNAUDITED)
The Company will engage in a research program on behalf of the LLC under
the Services Agreement and will be compensated for its services based on agreed
upon terms. The Company is required to fund the cost of research up to $3
million. All inventions made by the Company in connection with the Services
Agreement will be assigned to the LLC for its use and benefit.
The Agreements generally terminate upon the last to expire of the patents
granted by the Members to the LLC or upon breach by either party, which is not
cured within 60 days of written notice.
The Company accounts for its investment in the LLC in accordance with the
equity method of accounting. Selected operating statement data of the LLC for
the six months ended June 30, 1999 are as follows:
<TABLE>
<CAPTION>
SIX MONTHS ENDED
JUNE 30, 1999
-------------
<S> <C>
Total expenses...................................... $ 1,796,934
-----------
Net loss............................................ $(1,796,934)
-----------
-----------
</TABLE>
DEVELOPMENT AND LICENSE AGREEMENT WITH PROTEIN DESIGN LABS, INC.
Effective April 30, 1999, the Company and Protein Design Labs, Inc. ('PDL')
entered into a Development and License Agreement (the 'License Agreement') under
which PDL agreed to develop a humanized antibody (the 'Technology') on behalf of
the Company and granted to the Company an exclusive worldwide license under
certain patents and patent applications to develop, use and sell products
arising from the Technology directed against the specific target of the antibody
('Products'). PDL also granted to the Company non-exclusive licenses to PDL
technical information, as defined, and sublicenses to PDL licenses from third
parties to the extent necessary to enable the Company to make, use and sell
Products. In addition, in June 1999 the Company exercised its right under the
License Agreement to acquire an option to obtain a sublicense to certain
additional patents and paid PDL a fee in connection therewith.
Upon the achievement by PDL of certain performance-based milestones, as
defined, the Company is required to make non-refundable payments to PDL. The
Company is also required to pay royalties based on a percentage of net sales, as
defined, of all Products for a specified period and non-refundable annual
maintenance fees under certain conditions. During the six months ended June 30,
1999, the Company recognized an expense of $667,000 in connection with the
License Agreement.
The Company has the ability to terminate the License Agreement upon 60 days
prior written notice. If terminated prior to payment of the second milestone,
the Company will reimburse PDL for costs and expenses to the date of
termination. Either party may terminate the License Agreement upon 10 or 30 days
written notice of default in making scheduled payments or other breach,
respectively, that is not cured by the other party. Otherwise, the License
Agreement will continue until expiration of the Company's obligation to pay
royalties to PDL.
F-24
<PAGE>
- --------------------------------------------------------------------------------
[Logo]
2,000,000 SHARES
COMMON STOCK
---------------------------
PROSPECTUS
---------------------------
, 1999
CIBC WORLD MARKETS
ROBERTSON STEPHENS
PRUDENTIAL VECTOR HEALTHCARE
A UNIT OF PRUDENTIAL SECURITIES
GERARD KLAUER MATTISON & CO., INC.
PUNK, ZIEGEL & COMPANY
- --------------------------------------------------------------------------------
YOU SHOULD RELY ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS. NO DEALER,
SALESPERSON OR OTHER PERSON IS AUTHORIZED TO GIVE INFORMATION THAT IS NOT
CONTAINED IN THIS PROSPECTUS. THIS PROSPECTUS IS NOT AN OFFER TO SELL NOR IS
IT SEEKING AN OFFER TO BUY THESE SECURITIES IN ANY JURISDICTION WHERE THE
OFFER OR SALE IS NOT PERMITTED. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS
CORRECT ONLY AS OF THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF THE
DELIVERY OF THIS PROSPECTUS OR ANY SALE OF THESE SECURITIES.
