<PAGE>
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
/ X / QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934.
For the quarterly period ended MARCH 31, 2000
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934.
For the transition period from ________________ to ______________
Commission file number 0-18006
-------
THE IMMUNE RESPONSE CORPORATION
(Exact Name of Registrant as Specified in its Charter)
DELAWARE 33-0255679
(State or Other Jurisdiction of (IRS Employer Identification Number)
Incorporation or Organization)
5935 DARWIN COURT, CARLSBAD, CA 92008
(Address of Principal Executive Offices) (Zip Code)
TELEPHONE (760) 431-7080
(Registrant's Telephone Number, Including Area Code)
Indicate by check mark whether the Registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the Registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes X No
--- ---
Indicate the number of shares outstanding of each of the Issuer's classes of
common stock, as of the latest practicable date.
As of April 28, 2000, 27,367,878 shares of common stock were outstanding.
<PAGE>
THE IMMUNE RESPONSE CORPORATION
FORM 10-Q
QUARTERLY REPORT
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
----
<S> <C>
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Consolidated Balance Sheets 3
Condensed Consolidated Statements of Operations 4
Condensed Consolidated Statements of Cash Flows 5
Notes to Condensed Consolidated Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 9
Item 3. Quantitative and Qualitative Disclosures about Market Risk 18
PART II - OTHER INFORMATION
Item 2. Changes in Securities 19
Item 6. Exhibits and Reports on Form 8-K 19
Signature 20
</TABLE>
2
<PAGE>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
THE IMMUNE RESPONSE CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands, except share data)
<TABLE>
<CAPTION>
March 31, December 31,
2000 1999
-------------- ------------
Assets (unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 15,792 $ 4,183
Marketable securities-available-for-sale 13,372 18,904
Other current assets 156 202
------------- -----------
Total current assets 29,320 23,289
Property and equipment, net 9,467 10,760
Licensed technology 4,768 4,945
Deposits and other assets 986 1,003
------------- -----------
$ 44,541 $ 39,997
============= ============
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 364 $ 1,536
Accrued expenses 2,979 3,024
License contract payable 711 3,609
Current portion of equipment notes payable 295 287
Deferred rent obligation 118 147
------------- -----------
Total current liabilities 4,467 8,603
Equipment notes payable 1,138 1,221
Redeemable convertible preferred stock 9,697 9,627
Stockholders' equity:
Preferred stock, 5,000,000 shares authorized; none issued --- ---
Common stock, $.0025 par value, 65,000,000 shares authorized,
27,353,237 and 26,370,135 shares issued and outstanding at
March 31, 2000 and December 31, 1999, respectively 68 66
Warrants 2,144 2,144
Additional paid-in capital 211,077 203,131
Accumulated other comprehensive income 2,059 1,735
Accumulated deficit (186,109) (186,530)
------------- -----------
Total stockholders' equity 29,239 20,546
------------- -----------
$ 44,541 $ 39,997
============= ============
</TABLE>
See accompanying notes.
3
<PAGE>
THE IMMUNE RESPONSE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except share data)
(unaudited)
<TABLE>
<CAPTION>
Three months ended March 31,
---------------------------------
2000 1999
-------------- ------------
<S> <C> <C>
Revenue:
Contract research revenue $ 3,000 $ 3,744
Licensed research revenue 333 5,462
-------------- ------------
3,333 9,206
Expenses:
Research and development 5,061 9,550
General and administrative 1,106 1,363
-------------- ------------
6,167 10,913
Other revenue:
Investment income 2,523 380
Other income 732 -
-------------- ------------
Net income (loss) 421 (1,327)
Accretion of preferred stock (70) (70)
Dividends on preferred stock (186) (185)
-------------- ------------
Net income (loss) applicable to common stockholders $ 165 $ (1,582)
============== ============
Basic earnings (loss) per share $ 0.01 $ (0.07)
============== ============
Weighted average common shares outstanding 26,910,444 24,138,629
============== ============
Diluted earnings (loss) per share $ 0.01 $ (0.07)
============== ============
Weighted average common and common equivalent
shares outstanding 31,009,985 24,138,629
============== ============
</TABLE>
See accompanying notes.
4
<PAGE>
THE IMMUNE RESPONSE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(amounts in thousands)
(unaudited)
<TABLE>
<CAPTION>
Three months ended March 31,
-----------------------------------
2000 1999
--------------- -------------
<S> <C> <C>
Operating activities:
Net income (loss) $ 421 $ (1,327)
Adjustments to reconcile net income (loss) to net cash provided
by (used in) operating activities:
Depreciation and amortization 600 389
Deferred rent expense (29) (30)
Gain on sale of assets (732)
Changes in operating assets and liabilities:
Other current assets 46 1,663
Accounts payable (1,172) 1,409
Accrued expenses (43) 152
Licensed contracts payable (234) -
--------------- -------------
Net cash provided by (used in) operating activities (1,143) 2,256
Investing activities:
Sale (purchase) of marketable securities, net 5,856 (3,624)
Purchase of property and equipment (469) (1,614)
Proceeds from sale of land and equipment 2,070 -
Deposits and other assets 17 (1,170)
--------------- -------------
Net cash provided by (used in) investing activities 7,474 (6,408)
Financing activities:
Principal payments under equipment notes payable (75) -
Net proceeds from sale of common stock 1,667 1,539
Net proceeds from exercise of stock options 3,686 1,142
--------------- -------------
Net cash provided by financing activities 5,278 2,681
--------------- -------------
Net increase (decrease) in cash and cash equivalents 11,609 (1,471)
Cash and cash equivalents at beginning of period 4,183 1,889
--------------- -------------
Cash and cash equivalents at end of period $ 15,792 $ 418
============= =============
Supplemental disclosure of cash flow information:
Interest paid $ 70 $ -
============= =============
Supplemental disclosure of noncash investing and financing
activities:
Unrealized gain (loss) on marketable securities $ 323 $ (41)
============= =============
Settlement of license contract payable with equity $ 2,664 $ -
============= =============
Accretion of convertible preferred stock $ 70 $ 70
============= =============
Payment of dividend on convertible preferred stock $ 189 $ 189
============= =============
Declared dividend on convertible preferred stock $ 186 $ 185
============= =============
</TABLE>
See accompanying notes.
5
<PAGE>
THE IMMUNE RESPONSE CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2000
1. BASIS OF PRESENTATION
The condensed consolidated financial statements of The Immune Response
Corporation (the "Company") for the three months ended March 31, 2000 and
1999 are unaudited. These financial statements reflect all adjustments,
consisting of only normal recurring adjustments which, in the opinion of
management, are necessary to fairly present the consolidated financial
position as of March 31, 2000, and the consolidated results of operations
for the three months ended March 31, 2000 and 1999. The results of
operations for the three months ended March 31, 2000 are not necessarily
indicative of the results to be expected for the year ended December 31,
2000. For more complete financial information, these financial
statements, and the notes thereto, should be read in conjunction with the
consolidated audited financial statements for the year ended December 31,
1999 included in the Company's Form 10-K filed with the Securities and
Exchange Commission.
2. RECENT ACCOUNTING PRONOUNCEMENT
In December 1999, the Securities and Exchange Commission issued Staff
Accounting Bulletin ("SAB") No. 101 - "Revenue Recognition in Financial
Statements." The bulletin draws on existing accounting rules and provides
specific guidance on how those accounting rules should be applied and
specifically addresses revenue recognition for non-refundable technology
access fees in the biotechnology industry. Adoption of SAB No. 101 is
required in the second quarter of fiscal year 2000. The Company has not
completed its evaluation of the impact of SAB No. 101 on its financial
statements. However, the impact is expected to be in a pre-tax range of
approximately $10 million to $15 million charged to the Company's results
of operations in the second quarter of fiscal year 2000.
3. EARNINGS PER SHARE
The following table sets forth the computation of basic and diluted
earnings per share for the three months ended March 31, 2000:
<TABLE>
<CAPTION>
<S> <C>
Numerator:
Net income $ 421,053
Accretion of preferred stock (70,000)
Dividends on preferred stock (186,475)
---------------
Numerator for basic earnings per share - income available
to common stockholders 164,578
Effect of dilutive securities:
Accretion of preferred stock 70,000
Dividends on preferred stock 186,475
---------------
Numerator for diluted earnings per share - income available
to common stockholders after assumed conversions $ 421,053
=============
6
<PAGE>
Denominator:
Denominator for basic earnings per share - weighted
average shares 26,910,444
Effect of dilutive securities:
Convertible preferred stock 2,400,600
Stock option plans 1,698,941
-----------
Denominator for diluted earnings per share - adjusted
weighted average shares and assumed conversions 31,009,985
===========
Basic earnings per share $0.01
===========
Diluted earnings per share $0.01
===========
</TABLE>
Options and warrants to purchase 2,494,543 shares of common stock were
outstanding at March 31, 2000, but were not included in the computation
of diluted earnings per share because the option's and warrant's exercise
prices were greater than the average market price of the common shares
for the three months ended March 31, 2000; and therefore, the effect
would be antidilutive.
For the three months ended March 31, 1999 net loss per share is computed
using the weighted average number of common shares outstanding during the
period. Outstanding stock options, warrants and the effect of conversion
of the Series F Convertible Preferred Stock are not included in the
calculation of net loss per share because their effect would be
antidilutive. Therefore, there is no difference between basic and diluted
net loss per share for that period. The weighted average number of shares
outstanding for the three months ended March 31, 1999 was 24,138,629.
4. COMPREHENSIVE INCOME
The Company accounts for comprehensive income in accordance with the
Statement of Financial Accounting Standards ("FAS") No. 130, "Reporting
Comprehensive Income." The components of comprehensive income are as
follows:
<TABLE>
<CAPTION>
Three Months Ended
---------------------------------------------
March 31, March 31,
2000 1999
--------------- -----------------
<S> <C> <C>
Net income (loss) $ 421 $ (1,327)
Net unrealized gain (loss) on
marketable securities 323 (41)
---------------- ----------------
Comprehensive income (loss) $ 744 $ (1,368)
=============== ==============
</TABLE>
5. EQUITY TRANSACTION
During April 1998, the Company sold 200 shares of its Series F
Convertible Preferred Stock ("Series F Stock") in return for gross
proceeds of $10 million. In February 1999, the initial conversion price
of the Series F stock of $14.07 per share of common stock was adjusted
downward to $9.77 per share of common stock. In August 1999, the
conversion price was adjusted downward to $5.87 per share of common
stock. In November 1999, the conversion price was adjusted downward to
$4.17 per share of common stock. The conversion price may be further
adjusted downward at the end of each subsequent three-month period if the
Company's common stock does not trade at prices higher than the
conversion price over a period of time during the applicable three-month
period. The Series F Stock bears a dividend of 7.5% per annum. In
general, the dividend is payable in shares of common stock or cash at the
Company's option. For the three months ended March 31, 2000 and 1999,
49,543 and 12,646 shares of the Company's common stock were issued as
dividends to the Series F shareholders, respectively. The Company has
filed a registration statement with the Securities and Exchange
Commission covering the resale of the common stock issuable upon
conversion of the Series F Stock.
7
<PAGE>
6. COLLABORATION WITH AGOURON PHARMACEUTICALS, INC.
During June 1998, the Company and Agouron Pharmaceuticals, Inc.
("Agouron"), a wholly-owned subsidiary of Warner-Lambert Company, entered
into a binding agreement under which the Company agreed to exclusively
license to Agouron certain rights relating to REMUNE-TM-, its
immune-based therapy under development for the treatment of HIV
infection. Under the terms of the agreement, the Company will manufacture
commercial supplies of REMUNE; and Agouron will have exclusive rights to
market REMUNE in North America, Europe, Japan and certain other
countries, if regulatory approvals are received. As a result of this
agreement, the Company may potentially receive in the aggregate up to $77
million (of which $47 million had been received as of March 31, 2000),
including license and milestone payments of $45 million, payments to
support research and development of $18 million and $14 million for the
purchase of the Company's common stock, priced at a premium to the
market, subject to certain rights of termination by Agouron. In addition,
the two companies will share all profits from the commercialization of
REMUNE on a 50/50 basis, if REMUNE is successfully developed and receives
the necessary regulatory approvals.
As of March 31, 2000, the Company had received a total of $47 million
from Agouron under the agreement. Agouron will make additional payments
upon achievement of certain milestones. In January 2000, the Company
received a $5 million payment from Agouron consisting of $3 million for
research and development and $2 million for the purchase of 266,667
shares of unregistered common stock priced at a premium to the market
price. This was the final payment in a series of six quarterly payments
made by Agouron to fund research and development and to purchase
unregistered common stock under the June 1998 agreement. In the quarter
ended March 1999, Agouron made the second quarterly payment of $5 million
to support research and development and to purchase 149,911 shares of
unregistered common stock priced at a premium to the market. Also in
conjunction with this agreement, the Company received a $5 million
milestone payment in February 1999.
8
<PAGE>
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS
OF OPERATIONS
SUMMARY
The Immune Response Corporation is a biopharmaceutical company developing
immune-based therapies to induce specific immune responses for the treatment of
HIV, autoimmune diseases and cancer. In addition, we are developing a targeted
non-viral delivery technology for gene therapy, which is designed to enable the
delivery of genes directly to the liver via intravenous injection. Our gene
therapy program is focused on diseases of the liver.
This discussion contains forward-looking statements concerning our operating
results and timing of anticipated revenues and expenditures. Such statements are
subject to risks and uncertainties that could cause actual results to differ
materially from those projected. Factors that could cause or contribute to such
differences include those discussed under "Risk Factors". The following should
be read in conjunction with the Condensed Consolidated Financial Statements and
Notes thereto included elsewhere in this Form 10-Q. These forward-looking
statements speak only as of the date hereof. We undertake no obligation to
publicly release the result of any revisions to these forward-looking statements
that may be made to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events.
In January 2000, we received a $5.0 million payment from Agouron
Pharmaceuticals, Inc. ("Agouron"), a wholly-owned subsidiary of Warner-Lambert
Company, consisting of a $3.0 million payment for research and development and a
$2.0 million payment for the purchase of 266,667 shares of unregistered common
stock priced at a premium to the market. This was the final payment in a series
of six quarterly payments made by Agouron to fund research and development and
to purchase unregistered common stock under the June 1998 agreement.
In March 2000, we sold 4.65 acres of undeveloped property adjacent to our
headquarters facility in Carlsbad, California for approximately $2.0 million.
Also in March 2000, we sold for cash approximately $2.3 million of an equity
security held for sale that was acquired through the licensing of technology.
We have not been profitable since inception and had an accumulated deficit of
$186.1 million as of March 31, 2000. To date, we have not recorded any revenues
from the sale of products. Revenues recorded through March 31, 2000 were
primarily received from contract research, licensing of technology, milestone
achievement payments and investment income. We expect our operating losses to
continue, as well as to have quarter-to-quarter fluctuations, some of which
could be significant, due to research, development and clinical trial
activities. There can be no assurance that we will be able to generate
sufficient product revenue to become profitable at all or on a sustained basis.
In December 1999, the Securities and Exchange Commission issued a Staff
Accounting Bulletin regarding revenue recognition in financial statements for
non-refundable technology access fees in the biotechnology industry, which will
impact the Company's financial statements during the second quarter of 2000. See
Note 2 to the Condensed Consolidated Financial Statements.
RESULTS OF OPERATIONS
Revenue for the quarter ended March 2000 was $3.3 million as compared to $9.2
million for the same period in 1999. The decrease in revenue in 2000 was
primarily attributed to a one-time $5.0 million milestone payment from Agouron
and a $1.0 million research collaboration payment from Schering Corporation
(Schering) that were received in 1999. We have received the final quarterly
payment under the agreement with Agouron, and Schering's obligation to fund
under their collaboration with us expired on December 31, 1999. As a result, we
expect no additional revenues unless it is earned through existing corporate
collaborations or new research and development agreements. However, there can be
no assurance that any such collaborations will be entered into. We have not
received any revenues from the commercial sale of products and do not expect to
derive revenue from the sale of products for the foreseeable future.
Research and development expenditures of $5.1 million during the first quarter
of 2000 decreased from $9.6 million during the same period in 1999. The decrease
in research and development spending from 1999 to 2000 was due primarily to
reduced clinical and regulatory costs associated with the discontinuation of a
2,500 patient, Phase 3 clinical trial of REMUNE and reduced spending on REMUNE
clinical trial materials. Also reduced costs
9
<PAGE>
associated with the autoimmune, gene therapy and cancer programs, that were a
result of our workforce reduction in June 1999, contributed to this decreased
spending. With the current U.S. pivotal HIV clinical study being conducted and
paid for by Agouron, future clinical study spending is expected to remain
consistent with this quarter unless new clinical studies are initiated in our
other development programs. However, spending associated with our scale-up of
the manufacturing process for REMUNE and the cost of producing clinical supplies
for ongoing and future REMUNE studies could increase in the foreseeable future.
Future research and development expenditures are expected to remain somewhat
level with the current quarter, but quarter to quarter fluctuations may occur
due to the timing of expenditures. If additional collaborations are entered
into, research and development expenditures would increase over current levels;
but there can be no assurance that any collaborations will be entered into, that
existing collaborations will not end, or that we will be able to obtain other
financing needed to continue our research and development efforts.
General and administrative expenses for the first quarter of 2000 were $1.1
million as compared to $1.4 million for the same period in 1999. This decrease
in spending was primarily attributed to changes affected by our workforce
reduction in June 1999 and somewhat lower professional fees for the current
quarter. Quarterly general and administrative expenses for the remainder of 2000
are expected to remain consistent with first quarter levels.
Investment income increased to $2,523,000 for the quarter ended March 31, 2000
from $380,000 during the same period in 1999. The increase in investment income
in 2000 compared to 1999 was due primarily to the sale of approximately $2.3
million of an equity security held for sale.
Other income of $732,000 for the quarter ended March 31, 2000 was attributable
to the gain recognized from the sale of undeveloped property adjacent to our
headquarters facility in Carlsbad, California for approximately $2.0 million
LIQUIDITY AND CAPITAL RESOURCES
Since our inception through March 31, 2000, we have financed our activities
primarily from public and private sales of equity, funding from collaborations
with corporate partners and investment income. At March 31, 2000, we had working
capital of $24.9 million, including $29.2 million of cash, cash equivalents and
marketable securities. This compares with working capital as of December 31,
1999 of $14.7 million, including $23.1 million of cash, cash equivalents and
marketable securities. Working capital increased as a result of the lower cost
of operations, in particular, the reduced cost of the REMUNE HIV clinical
trials, clinical trial materials and manufacturing supplies, and the sale of
$2.3 million of an equity security held for sale and $2.0 million of undeveloped
property. As of March 31, 2000, we had $1.4 million of available credit
remaining under a $3.0 million equipment line of credit that was put in place
during 1999.
We will need to raise additional funds to conduct research and development,
preclinical studies and clinical trials necessary to bring potential products
to market and to establish manufacturing and marketing capabilities. We
anticipate that for the foreseeable future, the scale-up of the manufacturing
process for REMUNE and the cost of producing clinical supplies for ongoing
and future REMUNE studies will continue to represent a significant portion of
our overall expenditures. We also anticipate that costs related to the
clinical trials of REMUNE will decrease from 1999 levels, as the current U.S.
pivotal study and any future pivotal studies, are expected to be conducted by
Agouron. Overall, future research and development expenditures are expected
to remain somewhat constant to current levels. However, future spending for
research and development may increase if additional collaborations are
entered into, but there can be no assurance that any such collaborations will
be entered into. We anticipate additional capital improvements of
approximately $3.0 million for 2000 related to the scale-up of the
manufacturing process; some of which we anticipate will be funded with debt
financing. Other anticipated costs with respect to REMUNE, including
investment in inventory, will depend on many factors including the results of
clinical trials, the continuation of our collaboration with Agouron and other
factors which will influence our determination of the appropriate continued
investment of our financial resources in this program.
Our future capital requirements will depend on many factors, including continued
scientific progress in our research and development programs, the scope and
results of preclinical studies and clinical trials, the time and costs involved
in obtaining regulatory approvals, the costs involved in filing, prosecuting and
enforcing patent claims, competing technological and market developments, the
cost of manufacturing scale-up and inventories, effective commercialization
activities and arrangements and other factors not within our control. We intend
to
10
<PAGE>
seek additional funding through additional research and development agreements
with suitable corporate collaborators, extensions of existing corporate
collaborations and through public or private financings, if available. However,
there can be no assurance that such collaboration arrangements or any public or
private financings will be available on acceptable terms, if at all. If funds
are raised through equity arrangements, further dilution to stockholders may
result. If adequate funds are not available, we may be required to delay, reduce
the scope of, or eliminate one or more of our research or development programs
or take other measures to cut costs, which could have a material adverse effect
on us. We estimate that our existing capital resources and available equipment
financing will be sufficient to fund our current and planned operations into the
first half of 2001. There can be no assurance, however, that changes in our
research and development plans or other changes affecting our operating expenses
may result in the expenditure of such resources before such time. In any event,
we will need to raise substantial additional capital to fund our operations in
future periods.
YEAR 2000
We have performed a review of our computer applications and equipment related to
their continuing functionality for the year 2000 and beyond. We do not believe
that we have material exposure with respect to the year 2000 issue concerning
our computer applications and equipment. We communicated with third parties,
with which we have a material relationship, to assess our risks with respect to
year 2000 issues. We are not aware, at this time, of any material year 2000
issues with respect to our dealings with such third parties. Year 2000 issues
have not disrupted our operations. Since no significant issues have arisen, we
do not have a contingency plan to address any material year 2000 issues.
RISK FACTORS
OUR FAILURE TO SUCCESSFULLY DEVELOP AND COMMERCIALIZE PRODUCTS MAY CAUSE US TO
CEASE OPERATIONS
We have not completed the development of any products. Our failure to develop
and commercialize products successfully may cause us to cease operations. Our
potential therapies under development will require significant additional
research and development efforts and regulatory approvals prior to potential
commercialization.
The discontinuation of the Phase 3 trial of REMUNE due to lack of efficacy has
had a material adverse effect on us. If Agouron, fails to successfully complete
pivotal trials with REMUNE we may have to abandon REMUNE or seek additional
funding.
Our other therapies and technologies are at earlier stages of development than
REMUNE. Other potential immune-based therapies that we are developing are at an
early stage of clinical testing and may not be shown to be safe or efficacious
or ever receive regulatory approval. Some of our technologies have not yet been
tested in humans. Human testing of potential products based on these
technologies may not be permitted by regulatory authorities. Even if human
testing is permitted, the products based on these technologies may not be
successfully developed or be shown to be safe and efficacious.
The results of our preclinical studies and clinical trials may not be indicative
of future clinical trial results. A commitment of substantial resources to
conduct time-consuming research, preclinical studies and clinical trials will be
required if we are to develop any products. Delays in planned patient enrollment
in our clinical trials may result in increased costs, program delays or both.
None of our potential products may prove to be safe and effective in clinical
trials. FDA or other regulatory approvals may not be obtained and even if
successfully developed and approved, our products may not achieve market
acceptance. Any products resulting from our programs are not expected to be
successfully developed or commercially available for a number of years, if at
all.
Unacceptable toxicities or side effects may occur at any time in the course of
human clinical trials or, if any products are successfully developed and
approved for marketing, during commercial use of our products. The appearance of
any unacceptable toxicities or side effects could interrupt, limit, delay or
abort the development of any of our products or, if previously approved,
necessitate their withdrawal from the market.
11
<PAGE>
OUR ADDITIONAL FINANCING REQUIREMENTS AND LIMITED ACCESS TO FINANCING MAY
ADVERSELY AFFECT OUR ABILITY TO DEVELOP PRODUCTS
We will need to raise additional funds to conduct research and development,
preclinical studies and clinical trials necessary to bring our potential
products to market and establish manufacturing and marketing capabilities. A
failure to raise additional funds would require us to scale back or eliminate
some or all of our research and development programs or license to third
parties products or technologies that we would otherwise seek to develop
ourselves. We estimate that our existing capital resources and available
equipment financing will be sufficient to fund our current and planned
operations into the first half of 2001.
Although we anticipate that the REMUNE development will continue to represent a
significant portion of our overall expenditures, we also anticipate that costs
related to the development of REMUNE will decrease in 2000. Other anticipated
costs with respect to REMUNE will depend on many factors, in particular the
continuation of our collaboration with Agouron.
Our future capital requirements will depend on many factors, including:
- continued scientific progress in our research and development programs;
- the scope and results of preclinical studies and clinical trials, the
time and costs involved in obtaining regulatory approvals;
- the costs involved in filing, prosecuting and enforcing patent claims;
- competing technological and market developments;
- the cost of manufacturing scale-up;
- effective commercialization activities and arrangements, and
- other factors not within our control.
IF AGOURON TERMINATES ITS COLLABORATION WITH US WE MAY HAVE TO ABANDON REMUNE
Our binding letter of intent with Agouron is the primary collaborative
agreement that may provide us with future revenue. However, revenue under
such agreement will only be received if certain milestones are achieved. The
termination of our agreement with Agouron might require us to abandon REMUNE.
Agouron has been acquired by Warner-Lambert Company, which is anticipated to
merge with Pfizer Inc. We do not know which Agouron research products
Warner-Lambert Company or Pfizer Inc. will continue to fund in the future.
WE MAY NOT BE ABLE TO ENTER INTO ADDITIONAL COLLABORATIONS OR MAINTAIN
EXISTING ONES
We intend to seek additional collaborative arrangements to develop and
commercialize our products. We may not be able to negotiate collaborative
arrangements on favorable terms, or at all, in the future and our current or
future collaborative arrangements may not be successful or continue. Under the
Schering Corporation collaboration, Schering Corporation's obligation to fund
expired on December 31, 1999. Without funding arrangements, it may cause us to
abandon some of our products under development.
12
<PAGE>
OUR PATENTS AND PROPRIETARY TECHNOLOGY MAY NOT PROVIDE US WITH ANY BENEFIT AND
THE PATENTS AND PROPRIETARY TECHNOLOGY OF OTHERS MAY PREVENT US FROM
COMMERCIALIZING PRODUCTS
A failure to obtain meaningful patent protection for our potential products and
processes would greatly diminish the value of our potential products and
processes.
In addition, whether or not our patents are issued, or issued with limited
coverage, others may receive patents which contain claims applicable to our
products. We are aware that AstraZeneca PLC has acquired the rights to a patent,
which has been issued in Europe and other countries, that may interfere with our
ability to develop some of our technologies related to autoimmune disease if the
patent is upheld after current opposition proceedings. This patent, and others
that we are not aware of, may adversely affect our ability to develop and
commercialize products.
The patent positions of biotechnology and pharmaceutical companies can be highly
uncertain, and involve complex legal and factual questions. Therefore, the
breadth of claims allowed in biotechnology and pharmaceutical patents cannot be
predicted. We also rely upon unpatented trade secrets and know how, and others
may independently develop substantially equivalent trade secrets or know how.
We also rely on protecting our proprietary technology in part through
confidentiality agreements with our corporate collaborators, employees,
consultants and certain contractors. These agreements may be breached and we may
not have adequate remedies for any breach. In addition, our trade secrets may
otherwise become known or independently discovered by our competitors.
Our products and processes may infringe, or be found to infringe, patents not
owned or controlled by us, such as the patent owned by AstraZeneca PLC. If
relevant claims of third-party patents are upheld as valid and enforceable, we
could be prevented from practicing the subject matter claimed in the patents, or
would be required to obtain licenses or redesign our products or processes to
avoid infringement. Licenses may not be available at all or on terms
commercially reasonable to us and we may not be able to redesign our products or
processes to avoid infringement.
Litigation may be necessary to defend against claims of infringement, to enforce
patents issued to us or to protect trade secrets. Litigation could result in
substantial costs and diversion of management efforts regardless of the results
of the litigation. An adverse result in litigation could subject us to
significant liabilities to third parties, require disputed rights to be licensed
or require us to cease using certain technologies.
OUR HISTORY OF OPERATING LOSSES AND OUR EXPECTATIONS OF CONTINUING LOSSES MAY
HURT OUR ABILITY TO CONTINUE OPERATIONS
As of March 31, 2000 we had a consolidated accumulated deficit of $186.1
million. We have not generated revenues from the commercialization of any
product. We expect to incur substantial net operating losses over the next
several years which may imperil our ability to continue operations. We may not
be able to generate sufficient product revenue to become profitable at all or on
a sustained basis.
THE LENGTHY PRODUCT APPROVAL PROCESS AND UNCERTAINTY OF GOVERNMENT REGULATORY
REQUIREMENTS MAY DELAY OR PREVENT US FROM COMMERCIALIZING PRODUCTS
Clinical testing, manufacture, promotion and sale of our products are subject to
extensive regulation by numerous governmental authorities in the United States,
principally the FDA, and corresponding state and foreign regulatory agencies.
This regulation may delay or prevent us from commercializing products.
Noncompliance with applicable requirements can result in, among other things,
fines, injunctions, seizure of products, total or partial suspension of product
marketing, failure of the government to grant premarket approval, withdrawal of
marketing approvals and criminal prosecution.
The regulatory process for new therapeutic drug products, including the required
preclinical studies and clinical testing, is lengthy and expensive. We may not
receive necessary FDA clearances for any of our potential products
13
<PAGE>
in a timely manner, or at all. The length of the clinical trial process and the
number of patients the FDA will require to be enrolled in the clinical trials in
order to establish the safety and efficacy of our products is uncertain.
Even if additional clinical trials of REMUNE are successfully completed, the FDA
may not approve REMUNE for commercial sale. We may encounter significant delays
or excessive costs in our efforts to secure necessary approvals. Regulatory
requirements are evolving and uncertain. Future United States or foreign
legislative or administrative acts could also prevent or delay regulatory
approval of our products. We may not be able to obtain the necessary approvals
for clinical trials, manufacturing or marketing of any of our products under
development. Even if commercial regulatory approvals are obtained, they may
include significant limitations on the indicated uses for which a product may be
marketed.
In addition, a marketed product is subject to continual FDA review. Later
discovery of previously unknown problems or failure to comply with the
applicable regulatory requirements may result in restrictions on the marketing
of a product or withdrawal of the product from the market, as well as possible
civil or criminal sanctions.
Among the other requirements for regulatory approval is the requirement that
prospective manufacturers conform to the FDA's Good Manufacturing Practices, or
GMP, requirements specifically for biological drugs, as well as for other drugs.
In complying with the FDA's GMP requirements, manufacturers must continue to
expend time, money and effort in production, recordkeeping and quality control
to assure that the product meets applicable specifications and other
requirements. Failure to comply with the FDA's GMP requirements subjects the
manufacturer to possible FDA regulatory action. We or our contract
manufacturers, if any, may not be able to maintain compliance with the FDA's GMP
requirements on a continuing basis. Failure to maintain compliance could have a
material adverse effect on us.
The FDA has not designated expanded access protocols for REMUNE as "treatment"
protocols. The FDA may not determine that REMUNE meets all of the FDA's criteria
for use of an investigational drug for treatment use. Even if REMUNE is allowed
for treatment use, third party payers may not provide reimbursement for the
costs of treatment with REMUNE.
The FDA may not consider REMUNE or any other of our products under development
to be an appropriate candidate for accelerated approval, expedited review or
fast track designation.
To market any drug products outside of the United States, we are also subject to
numerous and varying foreign regulatory requirements, implemented by foreign
health authorities, governing the design and conduct of human clinical trials
and marketing approval. The approval procedure varies among countries and can
involve additional testing, and the time required to obtain approval may differ
from that required to obtain FDA approval. The foreign regulatory approval
process includes all of the risks associated with obtaining FDA approval set
forth above, and approval by the FDA does not ensure approval by the health
authorities of any other country.
TECHNOLOGICAL CHANGE AND COMPETITION MAY RENDER OUR POTENTIAL PRODUCTS OBSOLETE
The biotechnology industry continues to undergo rapid change and competition is
intense and is expected to increase. Competitors may succeed in developing
technologies and products that are more effective or affordable than any which
are being developed by us or which would render our technology and products
obsolete and noncompetitive. Many of our competitors have substantially greater
experience, financial and technical resources and production, marketing and
development capabilities than us. Accordingly, some of our competitors may
succeed in obtaining regulatory approval for products more rapidly or
effectively than us.
OUR LACK OF COMMERCIAL MANUFACTURING AND MARKETING EXPERIENCE MAY PREVENT US
FROM SUCCESSFULLY COMMERCIALIZING PRODUCTS
We have not manufactured our product candidates in commercial quantities. We may
not successfully make the transition from manufacturing clinical trial
quantities to commercial production quantities or be able to arrange for
contract manufacturing and this could prevent us from commercializing products.
Even if REMUNE is successfully developed and receives FDA approval, we have not
demonstrated the capability to manufacture REMUNE in commercial quantities.
Except for REMUNE, we have not demonstrated the ability to manufacture our
treatments
14
<PAGE>
in large-scale clinical quantities, and have not demonstrated the ability to
manufacture any of our treatments in commercial quantities.
We have no experience in the sales, marketing and distribution of pharmaceutical
products. Thus, our products may not be successfully commercialized even if they
are developed and approved for commercialization.
The manufacturing process of our products involves a number of steps and
requires compliance with stringent quality control specifications imposed by us
and by the FDA. Moreover, our products can only be manufactured in a facility
that has undergone a satisfactory inspection by the FDA. For these reasons, we
would not be able quickly to replace our manufacturing capacity if we were
unable to use our manufacturing facilities as a result of a fire, natural
disaster (including an earthquake), equipment failure or other difficulty, or if
such facilities are deemed not in compliance with the FDA's GMP requirements and
the non-compliance could not be rapidly rectified. Our inability or reduced
capacity to manufacture our products would prevent us from successfully
commercializing products.
We may enter into arrangements with contract manufacturing companies to expand
our own production capacity in order to meet requirements for our products, or
to attempt to improve manufacturing efficiency. If we choose to contract for
manufacturing services and encounter delays or difficulties in establishing
relationships with manufacturers to produce, package and distribute our finished
products, clinical trials, market introduction and subsequent sales of the
products would be delayed. Further, contract manufacturers must also operate in
compliance with the FDA's GMP requirements; failure to do so could result in,
among other things, the disruption of product supplies. Our potential dependence
upon third parties for the manufacture of our products may adversely affect our
profit margins and our ability to develop and deliver products on a timely and
competitive basis.
ADVERSE DETERMINATIONS CONCERNING PRODUCT PRICING, REIMBURSEMENT AND RELATED
MATTERS COULD PREVENT US FROM SUCCESSFULLY COMMERCIALIZING PRODUCTS
Our ability to earn sufficient returns on our products will depend in part on
the extent to which reimbursement for the costs of the products and related
treatments will be available from government health administration authorities,
private health coverage insurers, managed care organizations and other
organizations. Failure to obtain appropriate reimbursement could prevent us from
successfully commercializing products. Third party payors are increasingly
challenging the price of medical products and services. If purchasers or users
of our products are not able to obtain adequate reimbursement for the cost of
using the products, they may forego or reduce their use. Significant uncertainty
exists as to the reimbursement status of newly approved health care products,
and whether adequate third party coverage will be available.
PRODUCT LIABILITY EXPOSURE MAY EXPOSE US TO SIGNIFICANT LIABILITY
We face an inherent business risk of exposure to product liability and other
claims in the event that the development or use of our technology or prospective
products is alleged to have resulted in adverse effects. We may not avoid
significant liability exposure. We may not have sufficient insurance coverage
and we may not be able to obtain sufficient coverage, at a reasonable cost. An
inability to obtain product liability insurance at acceptable cost or to
otherwise protect against potential product liability claims could prevent or
inhibit the commercialization of products developed by us. A product liability
claim could hurt our financial performance. Even if we avoid liability exposure,
significant costs could be incurred in our defense that could hurt our financial
performance.
HAZARDOUS MATERIALS AND ENVIRONMENTAL MATTERS COULD EXPOSE US TO SIGNIFICANT
COSTS
Although we do not currently manufacture commercial quantities of our product
candidates, we produce limited quantities of these products for our clinical
trials. We may be required to incur significant costs to comply with current or
future environmental laws and regulations. Our research and development
processes involve the controlled storage, use and disposal of hazardous
materials, biological hazardous materials and radioactive compounds. We are
subject to federal, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of these materials and some waste
products. Although we believe that our safety
15
<PAGE>
procedures for handling and disposing of these materials comply with the
standards prescribed by these laws and regulations, the risk of accidental
contamination or injury from these materials cannot be completely eliminated. In
the event of an accident, we could be held liable for any damages that result,
and any liability could exceed our resources. Our operations, business or assets
may be materially and adversely affected by current or future environmental laws
or regulations.
SUBORDINATION OF COMMON STOCK TO PREFERRED STOCK COULD HURT COMMON STOCKHOLDERS
Our common stock is expressly subordinate to our Series F Convertible Preferred
Stock in the event of our liquidation, dissolution or winding up. If we were to
cease operations and liquidate our assets, there may not be any remaining value
available for distribution to the holders of common stock after providing for
the Series F Convertible Preferred Stock liquidation preference.
YOU COULD SUFFER SUBSTANTIAL DILUTION OF YOUR INVESTMENT IF OUR PREFERRED
STOCK IS CONVERTED INTO COMMON STOCK OR CERTAIN RIGHTS TO PURCHASE COMMON
STOCK ARE EXERCISED
In 1998 we sold 200 shares of Series F Convertible Preferred Stock, or Series
F Stock, in return for gross proceeds of $10 million. These shares of Series
F Stock are currently convertible into at least 2.4 million shares of our
common stock, which number is subject to increase if our common stock does
not meet certain specified price trading levels. Further, as of March 31,
2000 we had reserved 6.3 million shares of our common stock for potential
issuances upon the exercise of stock options and warrants and payment of
dividends on the Series F Stock. Issuance of any of these additional shares
could substantially dilute your interest in our company.
VOLATILITY OF STOCK PRICE AND ABSENCE OF DIVIDENDS MAY HURT COMMON STOCKHOLDERS
The market price of our common stock, like that of the common stock of many
other biopharmaceutical companies, has been and is likely to be highly volatile.
Factors such as:
- - the results of preclinical studies and clinical trials by us, our
collaborators or our competitors;
- - other evidence of the safety or efficacy of our products or our
competitors;
- - announcements of technological innovations or new products by us or our
competitors;
- - governmental regulatory actions;
- - changes or announcements in reimbursement policies;
- - developments with our collaborators;
- - developments concerning patent or other proprietary rights of ours or our
competitors (including litigation);
- - concern as to the safety of our products;
- - period-to-period fluctuations in our operating results;
- - changes in estimates of our performance by securities analysts;
- - market conditions for biopharmaceutical stocks in general; and
- - other factors not within our control
could have a significant adverse impact on the market price of our common stock.
We have never paid cash dividends on our common stock and do not anticipate
paying any cash dividends in the foreseeable future.
CHANGES TO FINANCIAL ACCOUNTING STANDARDS MAY AFFECT OUR REPORTED RESULTS
OF OPERATIONS
We prepare our financial statements to conform with generally accepted
accounting principles, or GAAP. GAAP are subject to interpretation by the
American Institute of Public Accountants, the Securities and Exchange
Commission and various bodies formed to interpret and create appropriate
accounting policies. A change in those policies can have a significant effect
on our reported results and may even affect our reporting of transactions
completed before a change is announced. Accounting policies affecting many
other aspects of our business, including rules relating to purchase and
pooling-of-interests accounting for business combinations, employee stock
option grants and revenue recognition have recently been revised or are under
review. Changes to those rules or the questioning of current practices may
adversely affect our reported financial results or the way we conduct our
16
<PAGE>
business. In addition, our preparation of financial statements in accordance
with GAAP requires that we make estimates and assumptions that affect the
recorded amounts of assets and liabilities, disclosure of those assets and
liabilities and at the date of the financial statements and the recorded amounts
of expenses during the reporting period. A change in the facts and circumstances
surrounding those estimates could result in a change to our estimates and could
impact our future operating results.
17
<PAGE>
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We invest our excess cash primarily in U.S. government securities and money
market accounts. These instruments have maturities of two years or less when
acquired. We do not utilize derivative financial instruments, derivative
commodity instruments or other market risk sensitive instruments, positions or
transactions. Accordingly, we believe that, while the instruments we hold are
subject to changes in the financial standing of the issuer of such securities,
we are not subject to any material risks arising from changes in interest rates,
foreign currency exchange rates, commodity prices, equity prices or other market
changes that affect market risk sensitive instruments.
18
<PAGE>
PART II. OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES
During the first quarter of 2000, the Company sold 266,667 shares of newly
issued Immune Response common stock to Agouron Pharmaceuticals, Inc., priced
at a premium to market, for $2 million. The common stock was sold under the
exemption provided by Section 4(2) of the Securities Act of 1933, as amended.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits
27 Financial Data Schedule
b) Reports on Form 8-K
A report on Form 8-K dated December 8, 1999 was filed by The Immune
Response Corporation reporting under Item 5., Other Events, to disclose the
announcement of the technology licensing agreement with Connetics
Corporation and XOMA, (US) LLC.
19
<PAGE>
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
THE IMMUNE RESPONSE CORPORATION
Date: May 15, 2000 s/Howard Sampson
---------------------------------------
Howard Sampson
Vice President, Finance
Chief Financial Officer
Secretary and Treasurer
20
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONDENSED CONSOLIDATED BALANCE SHEETS AND CONSOLIDATED STATEMENTS OF OPERATIONS
EXTRACTED FROM ITEM 1 OF FORM 10-Q FOR THE PERIOD ENDED MARCH 31, 2000 AND
YEAR-TO-DATE AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL
STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-2000
<PERIOD-START> JAN-01-2000
<PERIOD-END> MAR-31-2000
<CASH> 15,792
<SECURITIES> 13,372
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 29,320
<PP&E> 18,086
<DEPRECIATION> 8,619
<TOTAL-ASSETS> 44,541
<CURRENT-LIABILITIES> 4,467
<BONDS> 0
9,697
0
<COMMON> 68
<OTHER-SE> 27,112
<TOTAL-LIABILITY-AND-EQUITY> 44,541
<SALES> 0
<TOTAL-REVENUES> 6,588
<CGS> 0
<TOTAL-COSTS> 6,167
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 70
<INCOME-PRETAX> 421
<INCOME-TAX> 0
<INCOME-CONTINUING> 421
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 421
<EPS-BASIC> .01
<EPS-DILUTED> .01
</TABLE>
