<PAGE>
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 1999
OR
[ ] 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 0-14656
REPLIGEN CORPORATION
(exact name of registrant as specified in its charter)
<TABLE>
<S> <C>
Delaware 04-2729386
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
117 Fourth Avenue
Needham, Massachusetts 02494
(Address of principal executive offices) (Zip Code)
</TABLE>
Registrant's telephone number, including area code: (781) 449-9560
-----------------------------------------------------------------
(Former name, former address and former fiscal year, if
changed since last report.)
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 January 31, 1999.
<TABLE>
<CAPTION>
COMMON STOCK, PAR VALUE $.01 PER SHARE 22,320,310
-------------------------------------- ----------------
<S> <C>
Class Number of Shares
</TABLE>
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REPLIGEN CORPORATION
INDEX
<TABLE>
<CAPTION>
PART I. FINANCIAL INFORMATION PAGE
<S> <C> <C>
Item 1. Financial Statements
Balance Sheets as of December 31, 1999 and March 31, 1999 (Unaudited) 3
Statements of Operations for the Three and Nine Months Ended
December 31, 1999 and 1998 (Unaudited) 4
Statement of Cash Flows for the Nine Months Ended
December 31, 1999 and 1998 (Unaudited) 5
Notes to Financial Statements (Unaudited) 6
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 8
PART II. OTHER INFORMATION
Item 1. Legal Proceedings 12
Item 2. Changes in Securities 12
Item 3. Defaults Upon Senior Securities
None
Item 4. Submissions of Matters to a Vote of Security Holders
None
Item 5. Other Information
None
Item 6. Exhibits and Reports on Form 8-K 12
Signature 13
Exhibit Index 14
Exhibits 15
</TABLE>
2
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PART I. FINANCIAL INFORMATION
ITEM I. FINANCIAL STATEMENTS
REPLIGEN CORPORATION
BALANCE SHEETS
(Unaudited)
<TABLE>
<CAPTION>
ASSETS DECEMBER 31, 1999 MARCH 31, 1999
----------------- --------------
<S> <C> <C>
Current assets:
Cash and cash equivalents ................................... $ 9,295,868 $ 3,250,751
Accounts receivable ......................................... 614,675 429,720
Inventories ................................................. 457,698 630,329
Prepaid expenses and other current assets ................... 173,847 181,617
------------- -------------
Total current assets ...................................... 10,542,088 4,492,417
Property and equipment, at cost:
Equipment ................................................... 1,092,831 944,644
Furniture and fixtures ...................................... 157,475 101,376
Leasehold improvements ...................................... 473,288 460,319
------------- -------------
1,723,594 1,506,339
Less: accumulated depreciation and amortization ............. 1,103,051 862,934
------------- -------------
620,543 643,405
Other assets, net ............................................. 81,382 88,472
------------- -------------
$ 11,244,013 $ 5,224,294
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable ............................................ $ 164,111 $ 268,708
Accrued expenses ............................................ 346,577 313,926
Unearned income ............................................. -- 49,969
------------- -------------
Total current liabilities ................................ 510,688 632,603
Commitments and contingencies ................................. -- --
Stockholders' equity:
Preferred stock, $.01 par value --authorized - 5,000,000
shares --outstanding - none ................................ -- --
Common stock, $.01 par value --authorized - 40,000,000 shares
--outstanding - 22,322,310 shares at December 31, 1999 and
18,264,285 shares at March 31, 1999 ...................... 223,222 182,642
Additional paid-in capital .................................. 140,335,660 131,272,607
Accumulated deficit ......................................... (129,825,557) (126,863,558)
------------- -------------
Total stockholders' equity ............................... 10,733,325 4,591,691
------------- -------------
$ 11,244,013 $ 5,224,294
============= =============
</TABLE>
See accompanying notes to financial statements.
3
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REPLIGEN CORPORATION
STATEMENT OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
THREE-MONTHS ENDED DECEMBER 31, NINE-MONTHS ENDED DECEMBER 31,
1999 1998 1999 1998
---- ---- ---- ----
<S> <C> <C> <C> <C>
Revenues:
Product ....................................... $ 558,028 $ 248,723 $ 1,369,494 $ 674,872
Research and development ...................... 160,446 275,238 771,292 1,013,676
Investment income ............................. 131,406 50,730 334,191 169,912
Other ......................................... 14,438 14,437 59,532 85,274
------------ ------------ ------------ ------------
864,318 589,128 2,534,509 1,943,734
------------ ------------ ------------ ------------
Costs and expenses:
Research and development ...................... 1,864,437 421,623 3,085,684 1,352,648
Selling, general and administrative ........... 442,743 317,770 1,636,126 1,029,013
Cost of products sold ......................... 291,782 175,528 774,699 429,801
------------ ------------ ------------ ------------
2,598,962 914,921 5,496,509 2,811,462
------------ ------------ ------------ ------------
Net loss ...................................... $ (1,734,644) $ (325,793) $ (2,962,000) $ (867,728)
============ ============ ============ ============
Basic and diluted net loss per share .......... $ (0.08) $ (0.02) $ (0.14) $ (0.05)
============ ============ ============ ============
Basic and diluted weighted average
common shares outstanding .................. 22,193,696 18,001,785 20,950,890 18,001,785
============ ============ ============ ============
</TABLE>
See accompanying notes to financial statements.
4
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REPLIGEN CORPORATION
STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Nine-Months Ended December 31,
--------------------------------------------
1999 1998
-------------------- ------------------
<S> <C> <C>
Cash flows from operating activities
Net loss ......................................................................... $(2,962,000) $ (867,728)
Adjustments to reconcile net loss to net cash used in operating activities -
Depreciation and amortization .................................................... 240,118 198,437
Non cash charge for warrant issuance ............................................. 188,265 --
Changes in assets and liabilities -
Accounts receivable ............................................................. (184,955) (114,707)
Inventories ..................................................................... 172,632 (21,183)
Prepaid expenses and other current assets ....................................... 7,769 (110,111)
Accounts payable ................................................................ (104,596) (48,179)
Accrued expenses ................................................................ 32,652 48,499
Unearned income ................................................................. (49,969) 27,418
----------- -----------
Net cash used in operating activities ......................................... (2,660,084) (887,554)
Cash flows from investing activities
Purchases of property and equipment, at cost .................................... (217,257) (141,357)
Changes in other assets ......................................................... 7,090
----------- -----------
Net cash used in investing activities ........................................ (210,167) (141,357)
Cash flows from financing activities:
Proceeds from the issuance of common stock and warrants, net of
issuance costs .................................................................. 8,915,368 --
----------- -----------
Net cash provided by financing activities .................................... 8,915,368 --
----------- -----------
Net increase (decrease) in cash and cash equivalents ............................... 6,045,117 (1,028,911)
Cash and cash equivalents, beginning of period ..................................... 3,250,751 4,725,544
----------- -----------
Cash and cash equivalents, end of period ........................................... $ 9,295,868 $ 3,696,633
=========== ===========
</TABLE>
See accompanying notes to financial statements.
5
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REPLIGEN CORPORATION
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
The financial statements included herein have been prepared by Repligen
Corporation (the "Company" or "Repligen"), pursuant to the rules and regulations
of the Securities and Exchange Commission for quarterly reports on Form 10-Q and
do not include all of the information and footnote disclosures required by
generally accepted accounting principles. These financial statements should be
read in conjunction with the audited financial statements and notes thereto
included in the Company's Form 10-K for the year ended March 31, 1999.
In the opinion of management, the accompanying unaudited financial
statements include all adjustments, consisting of only normal, recurring
adjustments, necessary to present fairly, the consolidated financial position,
results of operations and cash flows of the Company. The results of operations
for the interim periods presented are not necessarily indicative of results to
be expected for the entire year.
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates.
2. NET LOSS PER SHARE
The Company has adopted Statement of Financial Accounting Standards
(SFAS) No. 128, EARNINGS PER SHARE, effective December 15, 1998. SFAS No. 128
establishes standards for computing and presenting earnings per share and
applies to entities with publicly held common stock or potential common stock.
The Company has applied the provisions of SFAS No. 128, retroactively to all
periods presented. Basic and diluted net loss per share represents net loss
divided by the weighted average number of common shares outstanding during the
period. The dilutive effect of the potential common shares consisting of
outstanding stock options and warrants is determined using the treasury stock
method in accordance with SFAS No. 128. Diluted weighted average shares
outstanding at December 31, 1999 and 1998 excluded the potential common shares
from warrants and stock options because to do so would be antidilutive for the
periods presented. At December 31, 1999, there are 1,332,791 options outstanding
with a weighted average exercise price of $1.83 and 3,307,050 warrants
outstanding with a weighted average exercise price of $3.18. At December 31,
1998, there are 1,030,500 options outstanding with a weighted average exercise
price of $1.34 and 2,832,000 warrants outstanding with a weighted average
exercise price of $3.97.
3. CASH AND CASH EQUIVALENTS
The Company considers highly liquid investments purchased with original
maturities at the date of acquisition of three months or less to be cash
equivalents. Cash equivalents consist of the following at December 31, 1999 and
March 31, 1999:
<TABLE>
<CAPTION>
Three Months Ended
December 31, 1999 March 31, 1999
(Unaudited)
<S> <C> <C>
U.S. Government and Agency securities ................ $2,184,547 $1,197,624
Commercial paper ..................................... 4,824,225 1,136,119
Money markets ........................................ 2,044,889 802,755
Cash ................................................. 242,208 114,253
---------- ----------
Total cash and cash equivalents ................. $9,295,868 $3,250,751
========== ==========
</TABLE>
6
<PAGE>
4. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out) or
market and consist of the following:
<TABLE>
<CAPTION>
Three Months Ended
December 31, 1999 March 31, 1999
(Unaudited)
<S> <C> <C>
Raw materials and work-in-process $322,520 $412,480
Finished goods .................. 135,178 217,849
-------- --------
Total ...................... $457,698 $630,329
======== ========
</TABLE>
Work in process and finished goods inventories consist of material,
labor, outside processing costs and manufacturing overhead.
5. COMPREHENSIVE INCOME
Effective January 1, 1998, the Company adopted SFAS No. 130 REPORTING
COMPREHENSIVE INCOME, effective January 1, 1998. SFAS No. 130 establishes
standards for reporting and display of comprehensive income and its components
in financial statements. Comprehensive income includes all changes in equity
during a period except those resulting from investments by owners and
distributions to owners. The comprehensive net loss is the same as net loss for
all periods presented.
6. DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND SIGNIFICANT
CUSTOMERS
The Company has adopted SFAS No. 131, DISCLOSURES ABOUT SEGMENTS OF AN
ENTERPRISE AND RELATED INFORMATION, in the fiscal year ended March 31, 1999.
SFAS No. 131 establishes standards for reporting information regarding operating
segments in annual financial statements and requires selected information for
those segments to be presented in interim financial reports issued to
stockholders. SFAS No. 131 also establishes standards for related disclosures
about products and services and geographic areas. Operating segments are
identified as components of an enterprise about which separate discrete
financial information is available for evaluation by the chief operating
decision maker, or decision making group, in making decisions now to allocate
resources and assess performance. To date, the Company has viewed its operations
and manages its business as principally one operating segment. As a result, the
financial information disclosed herein, represents all of the material financial
information related to the Company's principal operating segment.
The following table represents the Company's revenue by country:
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
December 31, December 31,
1999 1998 1999 1998
---- ---- ---- ----
<S> <C> <C> <C> <C>
US ............................... 72% 60% 75% 63%
Europe ........................... 23% 38% 22% 34%
Other ............................ 5% 2% 3% 3%
--- --- --- ----
Total ............................ 100% 100% 100% 100%
</TABLE>
During the three months ended December 31, 1999, there was one
significant customer who accounted for approximately 30% of the Company's
revenues or $270,000. The related accounts receivable for this customer at
December 31, 1999 was $254,000. During the nine months ended December 31, 1999,
there were two customers who account for approximately 18% and 15% of the
Company's revenues.
7
<PAGE>
7. SALE OF SECURITIES
In October 1999, pursuant to a Common Stock and Warrant Purchase
Agreement dated December 31, 1997, five accredited investors exercised warrants
exercisable at $1.50 per share for an aggregate of 750,000 shares of Repligen
common stock and aggregate consideration of $1,125,000. Because these investors
exercised these warrants pursuant to the "net exercise" provision in the
warrants, Repligen actually issued an aggregate of 425,775 shares of common
stock to such investors upon exercise of the warrants and received no proceeds
from such transaction. Based on representations of the investing parties and a
reasonable belief by Repligen that all such parties were "accredited" (as such
term is defined in Rule 501 of the Securities Act of 1933) and that the parties
were acquiring the shares of common stock of Repligen for investment and not for
resale, the Company issued these securities without registration in reliance
upon Section 4(2) of the Securities Act of 1933. No underwriters were involved
in the offer and sale of the securities.
Pursuant to stock purchase agreements dated April 30, 1999 and May 14,
1999, respectively, Repligen issued to certain accredited investors in a private
placement an aggregate of 3,600,000 shares of common stock for an aggregate
purchase price of approximately $9 million, resulting in net proceeds to
Repligen of approximately $8.9 million. Repligen closed the private placement
transaction on June 23, 1999. There were no underwriters involved in such
private placement transaction. Repligen filed a registration statement with the
Securities and Exchange Commission on Form S-3 on June 16, 1999 for the resale
of the 3,600,000 shares of Common Stock sold to the parties in the private
placement transaction. The Securities and Exchange Commission declared such
resale registration statement effective on June 23, 1999.
8. LICENSING AGREEMENT
In October 1999, Repligen obtained a license from ChiRhoClin Inc., a
private company to commercialize two diagnostic secretin products. These
products have been evaluated in clinical trials for the diagnosis of pancreatic
dysfunction and gastrinoma. A New Drug Application (NDA) was filed with the FDA
in May 1999 seeking approval to market synthetic porcine secretin for these
applications. ChiRhoClin has also conducted clinical studies for these
diagnostic indications with a human form of secretin which ChiRhoClin intends to
submit to the FDA in 2000. Under terms of the agreement, Repligen paid
$1,000,000 upon execution of the agreement and, if the NDAs are approved, the
Company will be required to pay future milestones in cash and Repligen common
stock and royalties. The Company has expensed the $1 million payment at December
31, 1999 as the Company believes that a feasible application does not exist
until NDA approval.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS Cautionary Statement Regarding Forward-Looking Statements
Statements in this Quarterly Report on Form 10-Q as well as oral
statements that may be made by the Company or by officers, directors or
employees of the Company acting on the Company's behalf, that are not historical
facts constitute "forward-looking statements" within the meaning of Section 21E
of the Securities Exchange Act of 1934. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that could cause the
actual results of the Company to be materially different from the historical
results or from any results expressed or implied by such forward-looking
statements. The Company's future operating results are subject to risks and
uncertainties and are dependent upon many factors, including, without
limitation, the Company's ability to (i) meet its working capital and future
liquidity needs, (ii) successfully implement its strategic growth strategies,
(iii) understand, anticipate and respond to rapidly changing technologies and
market trends, (iv) develop, manufacture and deliver high quality,
technologically advanced products on a timely basis to withstand competition
from competitors which may have greater financial, information gathering and
marketing resources than the Company, (v) obtain and protect licensing and
intellectual property rights necessary for the Company's technology and product
development on terms favorable to the Company, (vi) recruit
8
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and retain highly talented professionals in a competitive job market, (vii)
realize future revenues, (viii) maintain a timeline for clinical activity, (ix)
obtain successful results of pending or future clinical trials, (x) continue to
establish collaborative arrangements with third parties, and (xi) compete
against the biotechnology and pharmaceutical industries. Further information on
potential factors that could affect the Company's financial results are included
in filings made by the Company from time to time with the Securities and
Exchange Commission included in the section entitled "Risk Factors" contained in
the Company's Annual Report on Form 10-K for the fiscal year ended March 31,
1999 (File No.000-14656).
OVERVIEW
We develop new drugs for autism, organ transplantation and cancer. To
expand our drug development program, on March 9, 1999, we acquired the exclusive
rights to patent applications for the use of secretin in the treatment of
autism. Autism is a developmental disorder characterized by poor communicative
and social skills, repetitive and restricted behaviors and in some patients,
gastrointestinal problems and irregular sleep patterns. Secretin is a hormone
produced in the small intestine which regulates the function of the pancreas as
part of the process of digestion. A form of secretin derived from pigs is
approved by the FDA for use in diagnosing problems with pancreatic function.
Recent anecdotal reports indicate that secretin may have beneficial effects in
autism, including improvements in sleep, digestive function, communicative and
social behavior. Following media reports of the potential benefits of secretin,
more than 2,000 autistic children have been treated with the pig-derived
hormone. We intend to manufacture a human, synthetic form of secretin and
evaluate it in clinical trials in order to confirm the benefits of secretin in
treating autism and to determine the optimal dosing schedule. There are
currently no drugs approved by the FDA for the treatment of autism.
In October 1999, Repligen obtained a license from ChiRhoClin Inc., a
private company, to commercialize two diagnostic secretin products. These
products have been evaluated in clinical trials for the diagnosis of pancreatic
dysfunction and gastrinoma. A New Drug Application was filed with the FDA in May
1999 by ChiRhoClin, Inc. seeking approval to market synthetic porcine secretin
for these applications. ChiRhoClin has also conducted clinical studies for these
diagnostic indications with a human form of secretin which ChiRhoClin intends to
submit to the FDA in 2000. Under terms of the agreement, Repligen made a payment
of $1,000,000 upon execution of the agreement and, if the FDA approves the New
Drug Applications, the agreement obligates Repligen to pay ChiRhoClin future
milestones in cash and Repligen common stock and royalties.
We are also developing a product named "CTLA4-Ig," which has been shown
to suppress unwanted immune responses in animal models of organ transplants and
autoimmune diseases, such as lupus or multiple sclerosis, in which the immune
system mistakenly attacks the body. Our product candidate is a derivative of a
natural protein whose role is to turn-off an immune response. In animal models
of organ transplantation and autoimmune diseases, CTLA4-Ig has been shown to
block the rejection of a transplanted organ or the effects of the autoimmune
disease. Initial clinical testing of CTLA4-Ig has been carried out in patients
receiving a bone marrow transplant, which is a potential cure for several
diseases of the immune system, including leukemia, myeloma, lymphoma and sickle
cell anemia. Despite the clinical success of bone marrow transplants, a
significant number of patients experience a severe and potentially
life-threatening complication known as Graft Versus Host Disease, in which the
newly transplanted immune system attacks the host (i.e., the patient). In June
1999, results from a Phase 1 clinical trial reported that treatment of bone
marrow from a family member with Repligen's CTLA4-Ig prevented Graft Versus Host
Disease in eight of eleven transplant patients. In September 1999, we signed a
Clinical Trial Agreement with the National Cancer Institute to further evaluate
CTLA4-Ig in a Phase 2 trial in bone marrow transplantation for leukemia.
Repligen has filed patent applications related to compositions of matter and
methods of use of CTLA4-Ig including bone marrow transplant. Certain patents
have been issued to Bristol-Myers Squibb Corporation relating to the use and
manufacture of CTLA4-Ig. We believe that one of our licensees is co-inventor of
one or more of these patents and that the patents issued to Bristol-Myers Squibb
do not extend to the use of CTLA4-Ig in bone marrow transplantation.
We develop, manufacture and market products for the production of
therapeutic antibodies. We currently market a line of products for the
purification of antibodies based on a naturally occurring protein, Protein A,
which can specifically bind to antibodies. Repligen owns composition of matter
patents for
9
<PAGE>
recombinant Protein A in the United States and in Europe. In December 1998, we
entered into a ten year agreement to supply recombinant Protein A to Amersham
Pharmacia Biotech, a leading supplier to the biopharmaceutical market.
RESULTS OF OPERATIONS
REVENUES
Total revenues for the three month period ended December 31, 1999
and 1998 were approximately $864,000 and $589,000, respectively, an increase
of approximately $275,000 or 47%. Year to date total revenues increased
approximately $591,000, or 30%, to $2,535,000 at December 31, 1999 from
$1,944,000 at December 31, 1998. This increase during the three and
nine-months ended December 31, 1999 was largely attributable to increased
product sales of recombinant Protein A and an increase in investment income
due to higher average cash and cash equivalent balances.
Research and development revenues for the three month period ended
December 31, 1999 and 1998 were approximately $160,000 and $275,000,
respectively, a decrease of approximately $115,000 or 42%. Year to date R&D
revenues decreased approximately $243,000 or 24%, to approximately $771,000 from
$1,014,000. This decrease during the three and nine-months ended December 31,
1999 is a result of the discontinuation of research collaborations on Repligen's
drug discovery programs that generated revenue during the three and nine-months
ended December 31, 1998.
Product revenues for the three month period ended December 31, 1999 and
1998 were approximately $558,000 and $249,000, respectively, an increase of
$309,000 or 124%. Year to date product revenues increased 103% or approximately
$694,000 to $1,369,000 from $675,000 at December 31, 1999 and 1998,
respectively. This increase during the three and nine-months ended December 31,
1999 is due to the initiation of product shipments to Amersham Pharmacia Biotech
and strong demand from monoclonal antibody producers during such periods.
Investment income for the three month period ended December 31, 1999
and 1998 was approximately $131,000 and $51,000, respectively, an increase of
approximately $80,000 or 159%. Year to date investment revenue increased 97% or
approximately $164,000 to $334,000 from $170,000. This increase during the three
and nine-months ended December 31, 1999 is largely attributable to higher
average funds available for investment arising principally out of the completion
of a private placement of common stock to certain investors of $8,900,000 on
June 23, 1999.
Other revenues for the three-month period ended December 31, 1999 were
approximately $15,000, the same as the comparable period ended December 31,
1998. Year to date revenue was $60,000 and $85,000 for the nine months ended
December 31, 1999 and 1998, respectively. This decrease is primarily due to
sales of unused equipment during fiscal year 1999.
EXPENSES
Total expenses for the three-month period ended December 31, 1999 and
1998 increased to approximately $2,599,000 from $915,000, an increase of
$1,684,000 or 184%. For the nine months ended December 31, 1999 and 1998,
expenses were $5,497,000 and $2,811,000, respectively, an increase of $2,686,000
or 96%. The increase in expenses during the three and nine-month period ended
December 31, 1999 is attributable to our increased product development expenses
and CRC's licensing fee.
Research and development expenses for the three month period ended
December 31, 1999 and 1998 were approximately $1,864,000 and $422,000,
respectively, an increase of $1,442,000 or 342%. Year to date expenses were
$3,086,000 and $1,353,000 for the nine month period December 31, 1999 and 1998,
respectively. The increase in R&D expenses during the three and nine-months
ended December 31, 1999 was largely attributable to the $1,000,000 payment
associated with the licensing of two diagnostic secretin products. In addition,
the increase in research and development expenses reflects increased costs
associated with Repligen's drug development programs for secretin and CTLA4-Ig.
10
<PAGE>
Selling, general and administrative expenses for the three months ended
December 31, 1999 and 1998 were approximately $443,000 and $318,000,
respectively, an increase of $125,000 or 39%. For the nine-month period ended
December 31, 1999 and 1998, selling, general and administrative expenses were
$1,636,000 and $1,029,000, respectively, an increase of $607,000 or 59%. The
increase in the three-month and nine-month period is a result of increased
spending on shareholder services, legal and patent costs. In addition, included
in the nine-month period ended December 31, 1999 is approximately $293,0000 of
non-recurring expenses associated with a financial advisory agreement signed
during the quarter ended September 30, 1999.
Cost of products sold for the three months ended December 31, 1999 and
1998 were approximately $292,000 and $176,000, respectively, an increase of
$116,000, or 66%. Year to date cost of products sold as of December 31, 1999 and
1998 were $775,000 and $430,000, an increase of $345,000 or 80%. Cost of
products sold in the three months ended December 31, 1999 and 1998 were 52% and
71%, respectively, of product revenues. For the nine months ended December 31,
1999 and 1998, cost of products sold were 57% and 64% of product revenues,
respectively. The decrease in cost of revenues as a percentage of revenues
during the three and nine-months periods ended December 31, 1999 is due
primarily to increased Protein A product sales offset by additional expenses
associated with launch activities related to the Amersham Pharmacia
manufacturing contract.
LIQUIDITY AND CAPITAL RESOURCES
Repligen's total cash and cash equivalents increased to $9,296,000 at
December 31, 1999 from $3,251,000 at March 31, 1999. This increase of $6,045,000
reflects $8,900,000 of proceeds resulting from the sale of Common Stock of
Repligen to certain investors through a private placement that closed during
June 1999, offset by a net loss from operations incurred during the nine month
period ended December 31, 1999 of approximately $2,962,000, an increase in
accounts receivable of $185,000 and an increase in accounts payable of $56,000.
Working capital increased to $10,031,000 at December 31, 1999 from $3,860,000 at
March 31, 1999.
Repligen has entered into agreements with a number of collaborative
partners and licensees. Under the terms of these agreements, Repligen may be
eligible to receive research support, additional milestones or royalty revenue
if these collaborations result in clinical evaluation and commercialization of
products developed. However, we cannot be sure that collaborations will continue
or that we will receive any future payments related to these agreements. In
addition, under terms of the agreement with ChiRhoClin, if the FDA approves the
New Drug Applications, Repligen will be required to pay ChiRhoClin future
milestones in cash and Repligen common stock and royalties.
While Repligen anticipates that the cost of operations will increase in
fiscal 2000 as Repligen expands its investment in proprietary product
development, Repligen believes that it has sufficient funding to satisfy its
working capital and capital expenditure requirements for the next twenty-four
months. Should Repligen need to secure additional financing to meet its future
liquidity requirements, Repligen may not be able to secure such financing, or
obtain such financing on favorable terms because of the volatile nature of the
biotechnology market place.
YEAR 2000
As of the date of this filing, we have not incurred any significant
business disruptions as a result of year 2000 issues. However, while no such
occurrence has developed, year 2000 issues that may arise related to key
suppliers and service providers may not become apparent immediately. We have
received assurances of year 2000 compliance from key suppliers. We have also
received assurances from key service providers such as financial institutions as
to their year 2000 readiness. We can provide no assurance that we will not be
adversely affected by these suppliers and service providers due to noncompliance
in the future.
11
<PAGE>
PART II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
As reported in Form 10-Q dated for the period ended June 30, 1999, on
July 17, 1998, Repligen filed a complaint against Bristol Myers Squibb ("BMS")
at the United States District Court for the District of Massachusetts in Boston,
Massachusetts seeking correction of inventorship of certain United States
patents which claim compositions and methods of use for CTLA4 as well as
unspecified monetary damages. A correction of inventorship would result in the
University of Michigan being designated as a co-assignee on any corrected BMS
patent. Repligen would then have rights to such technology pursuant to a 1992
License Agreement with the University of Michigan, a 1995 Asset Acquisition
Agreement with Genetics Institute, and other related agreements. On July 13,
1999, the court dismissed the complaint without prejudice citing a lack of legal
standing of Repligen to bring such a complaint. We believe that the court's
finding on standing was in error. The court did not rule on the validity of
Repligen's inventorship claim. Repligen continues to believe that the University
of Michigan is a rightful co-assignee of the aforesaid BMS patents and we intend
to continue to pursue the correction of inventorship. Repligen's failure to
obtain shared ownership rights in the patents may restrict Repligen's ability to
commercialize CTLA4-Ig. We have also filed our own patents related to
compositions of matter and methods of use of CTLA4-Ig. In addition, we believe
that the patents issued to Bristol-Myers Squibb do not extend to the use of
CTLA4-Ig in bone marrow transplantation.
Item 2. CHANGES IN SECURITIES
In October 1999, pursuant to a Common Stock and Warrant Purchase
Agreement dated December 31, 1997, five accredited investors exercised warrants
exercisable at $1.50 per share for an aggregate of 750,000 shares of Repligen
common stock and aggregate consideration of $1,125,000. Because these investors
exercised these warrants pursuant to the "net exercise" provision in the
warrants, Repligen actually issued an aggregate of 425,775 shares of common
stock to such investors upon exercise of the warrants and received no proceeds
from such transaction. Based on representations of the investing parties and a
reasonable belief by Repligen that all such parties were "accredited" (as such
term is defined in Rule 501 of the Securities Act of 1933) and that the parties
were acquiring the shares of common stock of Repligen for investment and not for
resale, the Company issued these securities without registration in reliance
upon Section 4(2) of the Securities Act of 1933. No underwriters were involved
in the offer and sale of the securities.
Item 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
<TABLE>
<CAPTION>
EXHIBIT DESCRIPTION
<S> <C>
2.1 * Licensing Agreement by and between ChiRhoClin Inc. and Repligen Corporation (filed
herewith)
3.1 Restated Certificate of Incorporation, dated
June 30, 1992 and filed July 13, 1992, as
amended (filed as Exhibit 3.1 to Repligen
Corporations 10-Q dated September 30, 1999)
3.2 By-laws (filed as Exhibit 3.4 to Repligen Corporation's Form S-1 Registration Statement
No. 33-3959 and incorporated herein by reference)
27.1 Financial Data Schedule (filed herewith)
</TABLE>
*Confidential Treatment has been requested as to omitted portions
pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as
amended. Appendices 1, 2 and 3 to the Licensing Agreement included as EXHIBIT
2.1 are not being filed herewith. The Company undertakes to furnish a copy of
an omitted Appendix to the Commission upon request (except that such Appendices
shall remain confidential). Pursuant to Item 6.01(b)(2) of Regulation S-K, the
Appendices are set forth below.
12
<PAGE>
<TABLE>
<S> <C>
LICENSE AGREEMENT EXHIBIT 2.1
Appendix 1 Confidentiality Agreement
Appendix 2 Activities of CRC
Appendix 3 Insurance Coverage
</TABLE>
(b) Reports on Form 8-K
1. Current Report on Form 8-K filed with the Securities and
Exchange Commission on October 6, 1999 (description of
licensing agreement with ChiRhoClin Inc.).
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.
REPLIGEN CORPORATION
(Registrant)
Date: February 14, 2000 By: /S/ Walter C. Herlihy
--------------------------
Chief Executive Officer and President,
Principal Financial and Accounting Officer
13
<PAGE>
Repligen Corporation
Exhibit Index
<TABLE>
<CAPTION>
EXHIBIT DESCRIPTION
<S> <C>
2.1 * Licensing Agreement by and between ChiRhoClin Inc. and Repligen Corporation
(filed herewith)
3.1 Restated Certificate of Incorporation, dated June 30, 1992 and filed July 13,
1992, as amended (filed as Exhibit 3.1 to Repligen Corporations 10-Q dated
September 30, 1999)
3.2 By-laws (filed as Exhibit 3.4 to Repligen Corporation's Form S-1 Registration
Statement No. 33-3959 and incorporated herein by reference)
27.1 Financial Data Schedule (filed herewith)
</TABLE>
*Confidential Treatment has been requested as to omitted portions
pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as
amended. Appendices 1, 2 and 3 to the Licensing Agreement included as EXHIBIT
2.1 are not being filed herewith. The Company undertakes to furnish a copy of
an omitted Appendix to the Commission upon request (except that such Appendices
shall remain confidential). Pursuant to Item 6.01(b)(2) of Regulation S-K, the
Appendices are set forth below.
<TABLE>
<CAPTION>
<S> <C>
LICENSE AGREEMENT EXHIBIT 2.1
Appendix 1 Confidentiality Agreement
Appendix 2 Activities of CRC
Appendix 3 Insurance Coverage
</TABLE>
14
<PAGE>
EXHIBIT 10.1
WHEREVER CONFIDENTIAL INFORMATION IS OMITTED HEREIN (SUCH OMISSIONS ARE
DENOTED BY AN ASTERISK), SUCH CONFIDENTIAL INFORMATION HAS BEEN SUBMITTED
SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT
LICENSING AGREEMENT
This Agreement is made as of SEPTEMBER 30, 1999 between CHIRHOCLIN INC.
("CRC"), a Maryland corporation with offices at 15500 Gallaudet Avenue, Silver
Spring, MD 20905-4176 and REPLIGEN INC. ("Repligen"), a Delaware corporation,
with offices at 117 Fourth Avenue, Needham, MA 02494.
RECITALS
WHEREAS, CRC is engaged in development of synthetic secretin products
for marketing under the Federal Food, Drug, and Cosmetic Act ("FFDC Act"), and
is the beneficial owner of the INDs and NDAs for the Product(s) (as defined
below); and
WHEREAS, Repligen desires to commercially market the Product(s) and for
that purpose CRC is willing to grant a license to Repligen, on the terms and
conditions set out below;
NOW, THEREFORE, CRC and Repligen do hereby agree as follows:
1. DEFINITIONS
The following expressions have the following meanings:
1.1 "Competitive Product" means any product which is competitive
either with Repligen Secretin Product(s) for treatment of
autism or with Product(s), but does not include changes in the
use or formulation of the Product(s) in accordance with
Paragraph 12.
1.2 "Competitor" means anyone engaged in the development of a
Competitive Product as defined herein.
1.3 "IND" means an Investigational New Drug application made to
the U.S. Food and Drug Administration ("FDA") in support of
the marketing of a drug for human use.
1.4 "NDA" means a New Drug Application made to the U.S. Food and
Drug Administration ("FDA") in support of the marketing of a
drug for human use.
1.5 "NDA Approval" means the combination of: (1) receipt of final
approval from the FDA to market the Product(s) and (2) the
accompanying grant of market exclusivity via Orphan Drug
Status for the Product(s).
1.6 "Net Revenue" means the gross revenue received from Product
sales minus the fully loaded, i.e. direct and indirect, costs
attributable to the manufacturing, marketing, distribution,
and sales of the Product(s), * .
1.7 "Product(s)" means either or both of pSecretin and hSecretin.
1.8 "hSecretin" means that form of synthetic human secretin
developed and clinically evaluated by CRC under its INDs and
NDAs.
1.9 "pSecretin" means that form of synthetic porcine secretin
developed and clinically evaluated by CRC under its INDs and
NDAs.
1.10 "Therapeutic Applications" means the treatment or prevention
of any human disorder with the exception of *.
1.11 "Repligen Secretin Products" means synthetic human secretin
drug substances and finished, formulated, manufactured
products developed independently of CRC by Repligen for
Therapeutic Applications.
1.12 "Orphan Drug Status" means the grant of seven years of
marketing exclusivity for a Product pursuant to the Orphan
Drug Act of 1983.
1.13 *.
* Confidential Treatment Requested
15
<PAGE>
2. GRANT OF LICENSES
2.1 CRC grants to Repligen, and Repligen hereby accepts, for the
duration of this Agreement and subject to the conditions of
this Agreement and in accordance with Paragraphs 12 and 14, a
sole and exclusive worldwide license and right to use, market
and sell the Product(s) for uses outside of Therapeutic
Applications.
2.2 CRC grants to Repligen, and Repligen hereby accepts, for the
duration of this Agreement and subject to the conditions of
this Agreement and in accordance with Paragraphs 11 and 12 an
exclusive option to negotiate an exclusive royalty-bearing
license under a separate agreement to commercialize the
Product(s) for Therapeutic Applications. During the term of
the Agreement, CRC will not offer any third party a license to
commercialize the Product(s) under any terms.
2.3 During the term of this Agreement, CRC will not develop or
market any Competitive Product.
2.4 During the term of this Agreement, Repligen will not develop
or market new products that are competitive with Product(s)
for diagnostic and * indications.
2.5 During the term of this Agreement, Repligen will not
sublicense any rights which it may hold under this Agreement
without CRC's prior written approval, such approval not to be
unreasonably withheld.
2.6 During the term of this Agreement, CRC will not sublicense any
rights which it may hold under this Agreement without
Repligen's prior written approval, such approval not to be
unreasonably withheld.
3. TERM
3.1. This Agreement shall become effective on October 1, 1999.
Unless terminated earlier pursuant to Paragraph 4, the initial
term of this Agreement shall be from the effective date until
the later to occur of: 1) October 1, 2009, or 2) the
expiration of marketing exclusivity of the last indication for
which Orphan Drug Status has been granted subject to this
Agreement including any expansion of Orphan Drug Status
authorized under Paragraph 12; but may be extended thereafter
by mutual agreement according to Paragraph 3.2.
3.2 In the event that this Agreement is not terminated pursuant to
Paragraph 4 prior to its expiration, it may be renewed after
its expiration upon written agreement of the Parties.
3.3 Following termination, Repligen will own the trademark and
vial and carton artwork for Product(s) and CRC will own those
NDAs which relate to diagnostic and *
indications and may market the Product(s) under its own
trademark for diagnostic indications and, if approved, for
ERCP pancreatitis.
3.4 Twelve (12) months prior to the expiration date as defined by
Paragraph 3.1 of this Agreement, each Party must notify the
other in writing of its intent to extend or renew the term of
the Agreement.
4. TERMINATION
4.1 This Agreement shall terminate upon the expiration of the term
under Paragraph 3, unless earlier terminated pursuant to
Paragraph 4.2, 4.3, or 4.8 hereof.
4.2 CRC may, at its option, terminate this Agreement upon:
4.2.1 failure, inability, or refusal by Repligen to perform
any term, covenant, or condition of this Agreement,
which failure, inability, or refusal shall continue
for sixty (60) days following written notice thereof
by CRC specifying such default
4.2.2 sale or transfer of a controlling interest of stock
or assets of Repligen to a Competitor of CRC without
the prior written approval of CRC;
4.2.3. the insolvency of Repligen; an assignment by it for
the benefit of creditors; or, unless vacated or
withdrawn within sixty (60) days of the filing or
appointment thereof, the filing of a petition in
bankruptcy by or against Repligen, or the appointment
of a receiver or trustee of any part of Repligen's
business;
4.2.4. the assignment by Repligen of this Agreement, or any
rights hereunder, without CRC's prior written
approval; or
4.2.5. delinquency of Repligen in making payments for
Product(s) sold under this Agreement or other
payments due hereunder, which delinquency is not
cured within sixty (60) days of receiving notice of
such delinquency from CRC.
4.3. Repligen may, at its option, terminate this Agreement
upon:
* Confidential Treatment Requested
16
<PAGE>
4.3.1. failure, inability, or refusal by CRC to perform any
term, covenant, or condition of this Agreement, which
failure, inability, or refusal shall continue for
sixty (60) days following written notice thereof by
Repligen, specifying such default;
4.3.2. sale or transfer of a controlling interest of stock
or assets of CRC to a Competitor of Repligen without
the prior written approval of Repligen;
4.3.3. the insolvency of CRC; an assignment by it for the
benefit of creditors; or, unless vacated or withdrawn
within sixty (60) days of the filing or appointment
thereof, the filing of a petition in bankruptcy by or
against CRC, or the appointment of a receiver or
trustee of any part of CRC's business;
4.3.4. the assignment by CRC of this Agreement, or any
rights hereunder, without Repligen's prior written
approval;
4.4. Notwithstanding the foregoing, either Party shall have the
right to waive the application of any of the foregoing events
of termination by written notification to the other.
4.5. Upon termination of this Agreement in accordance with
Paragraph 4.1 or 4.2, Repligen will no longer have rights to
market the Product(s), and will at CRC's direction return
remaining Product(s) to CRC for appropriate disposition.
4.6. In the event that this Agreement is terminated by Repligen in
accordance with Paragraph 4.3 prior to the occurrence of any
NDA Approval, CRC hereby agrees to return within one year to
Repligen any and all payments made under Paragraph 7. In the
event of such termination, if Product has been purchased by
Repligen according to Paragraph 14.4, Repligen will return
said Product to CRC and CRC will reimburse Repligen for the
cost of its purchase.
4.7. In the event that this Agreement is terminated by Repligen in
accordance with Paragraph 4.3 following an NDA Approval, CRC
hereby agrees that: 1) Repligen will have the right to recover
all payments made under Paragraph 7 from CRC's share of Net
Revenues, 2) Repligen will retain all rights granted under
Paragraphs 2 and 8 of this Agreement up until such time as all
payments made under Paragraph 7 have been recovered by
Repligen, 3) during the period following such termination up
until such time as all payments made under Paragraph 7 are
recovered by Repligen from CRC's share of Net Revenues,
Repligen's share of Net Revenues pursuant to Paragraph 8 will
continue to flow to Repligen, 4) CRC, its heirs, assigns,
and/or successors, shall provide any and all rights and
enablements required in order to permit Repligen to continue
to market and sell Product(s) without interruption or
restriction during the period following such termination up
until such time as all payments made under Paragraph 7 are
recovered, and 5) after all payments made under Paragraph 7
are recovered by Repligen all rights granted under this
Agreement will revert to CRC.
4.8. From October 1, 1999 up * following the date of submission
to the FDA of the NDA for hSecretin, Repligen shall have the
right to terminate this Agreement unilaterally, thereby
relinquishing all Product rights granted hereunder. In the
event that Repligen terminates the Agreement according to this
Paragraph 4.8, Repligen shall have the right to recover any
and all payments made under Paragraph 7. If termination
according to this Paragraph 4.8 occurs prior to NDA Approval,
CRC shall return said payments made under Paragraph 7 within
one year of the date of such termination. If termination
occurs following NDA Approval, CRC will transfer all Net
Revenues to Repligen until such time as the total of all Net
Revenues transferred equals the payments made by Repligen
under Paragraph 7.
4.9 For the purposes of Paragraphs 4.6, 4.7, and 4.8 herein,
payments made by Repligen under Paragraph 7 shall include both
cash payments and stock granted. In the event of termination
pursuant to any of Paragraphs 4.6, 4.7, and 4.8 and in
addition to the return of any cash payments, CRC shall return
to Repligen any unsold stock and shall repay to Repligen the
face value at time of grant of any stock sold.
5. REVERSION OF RIGHTS
5.1 If, * years following NDA Approval of pSecretin, Repligen
has failed to obtain FDA approval to commercialize a Repligen
Secretin Product; the rights to Product(s) will revert to CRC,
and CRC may terminate this Agreement. Notwithstanding the
foregoing, Repligen will retain rights to any trademarks and
artwork it has obtained for the Product(s).
* Confidential Treatment Requested
17
<PAGE>
6. TERRITORY
6.1 Repligen is authorized to market the Product(s) worldwide for
diagnostic and * indications, provided, that
all necessary marketing authorization shall be registered in
the name of CRC or one of its subsidiaries. Such
authorizations shall be pursued with the written approval of
CRC under terms mutually agreeable to the Parties.
6.2 Notwithstanding the above subparagraph, no Product(s) and
unapproved versions thereof produced outside the United States
may be imported and marketed in the United States by Repligen,
its subsidiaries, affiliates, or permitted assigns without the
prior written consent of CRC.
7. PAYMENTS
7.1. CRC receives licensing/milestone payments from Repligen
totaling * according to the following schedule:
<TABLE>
<CAPTION>
UPFRONT CASH STOCK
<S> <C> <C>
Upon execution of License Agreement $1,000,000
MILESTONES
pSecretin NDA Approval *
The earlier to occur of: 1) FDA Approval of * * shares
or 2) six (6) months following * NDA Approval
FDA Approval of * *
hSecretin NDA Approval *
</TABLE>
Unless otherwise instructed by CRC, Repligen shall make cash
payments via electronic wire transfer to the following
address:
Chevy Chase Bank
15777 Columbia Pike
Burtonsville, MD 20866
Bank ABA or Routing Number: *
Customer's Account Number: *
Customer's Account Title: ChiRhoClin Inc., in care of
Edward D. Purich
7.2 The stock may not be resold for one year following issue after
which it may be sold under the provisions of Rule 144 (17
C.F.R.ss.230.144).
7.3. This Agreement is made in reliance upon CRC's express
representations that 1) the shares of Repligen Common Stock to
be issued to CRC hereunder (the "Shares") are for CRC's own
account for the purpose of investment and not with a view to,
or for sale in connection with, the distribution thereof, nor
with any present intention of distributing or selling the
Shares, 2) the Shares will not be sold without registration
under the Securities Act of 1933, as amended (the "Securities
Act"), or an exemption therefrom, such as Rule 144 as
promulgated under the Securities Act, 3) CRC prior to the
purchase of the Shares has had the opportunity to ask
questions of and receive answers from representatives of
Repligen concerning the finances, operations and business of
Repligen, and 4) CRC is capable of evaluating the merits and
risks of the purchase of the Shares and can afford a complete
loss of its investment. Until such time as the Shares shall
have been registered under the Securities Act, or shall have
been transferred in accordance with an opinion of counsel
satisfactory to Repligen that such registration is not
required, stop transfer instructions shall be issued to
Repligen's transfer agent, and the certificates representing
the Shares shall bear a legend substantially as follows:
"The shares represented by this certificate have not been
registered under the Securities Act of 1933 or applicable
state securities laws. These shares have not been acquired
with a view to distribution or resale, and may not be sold,
mortgaged, pledged, hypothecated or otherwise without an
effective registration statement for such shares under the
Securities Act of 1933 and any applicable state securities
laws, or an opinion of counsel satisfactory to
* Confidential Treatment Requested
18
<PAGE>
Repligen that registration is not required under the
Securities Act of 1933 or under applicable state securities
laws."
CRC further understands and acknowledges that Repligen is
under no obligation to register the Shares under the
Securities Act.
7.4 CRC will maintain diligent efforts to obtain NDA Approval for
both pSecretin and hSecretin and will use best efforts to
complete the preparation of the NDA for hSecretin prior to *.
7.5 The shares shall be duly authorized, validly issued and
non-assessable shares of common stock of Repligen.
8. ROYALTIES
8.1 Royalties on Products will be paid by Repligen to CRC on
the basis of Net Revenue received from Product sales and
according to the following schedule:
<TABLE>
<CAPTION>
--------------------------------------------------------------------------- ------------------------------------
Phase Revenue Share
--------------------------------------------------------------------------- ------------------------------------
<S> <C>
First * of Net Revenue *
Second * of Net Revenue *
Thereafter, until FDA approval of a Repligen Secretin Product *
Following FDA approval of a Repligen Secretin Product and up until the *
expiration of market exclusivity for Products of Net Revenues for last year
prior to FDA approval of a
Repligen Secretin Product, or,
*
of diagnostic and *
use (such volume of use to be
determined according to
Paragraph 8.2), whichever is higher
--------------------------------------------------------------------------- ------------------------------------
</TABLE>
8.2 Following expiration of marketing exclusivity via Orphan Drug
Status for Product(s), so long as Repligen has received NDA
approval for its own secretin product for autism; Repligen
will pay CRC a royalty which is * of the calculated net
revenues based solely on the diagnostic sale of Product(s),
such diagnostic sale volume to be determined according to a
mutually agreeable third party source.
9. REPRESENTATIONS AND WARRANTIES
9.1. CRC hereby represents and warrants that it is entitled to the
property rights necessary to enable it to grant to Repligen
the license referred to herein and that it is the sole and
exclusive owner of said rights.
9.2. CRC will use its best efforts to obtain from the FDA IND and
NDA approval for the Product(s). Notwithstanding any other
provision in this Agreement to the contrary, delay in
obtaining IND or NDA approval for the Product(s) which is not
attributable to lack of diligence by CRC shall not be grounds
for termination by Repligen.
9.3. CRC will use its best efforts to ensure that all Product(s)
manufactured and supplied to Repligen pursuant to this
Agreement conforms to manufacturing specifications. CRC
reserves the right at any time to make changes in any aspect
of the composition, appearance, or formulation of Product(s)
as long as: 1) Repligen has had six months prior notification
of such changes and has approved such changes such approval
not to be unreasonably withheld, and
* Confidential Treatment Requested
19
<PAGE>
2) they are in compliance with all applicable FDA
requirements. CRC at its sole discretion and without prior
notification of Repligen may make changes to the manufacturing
process which are intended solely for the removal or reduction
of impurities. In the event that CRC makes any such changes,
CRC will promptly advise Repligen in writing of the respects
in which the new Product(s) will differ, if at all, from the
then-marketed Product(s).
9.4. CRC will use its best efforts to ensure that manufacturing of
Product(s) designated for U.S. marketing complies with FDA's
requirements relating to current Good Manufacturing Practices
(cGMPs) and any other applicable federal or state regulations
and guidelines.
9.5. Repligen will use its best efforts to ensure that Product(s)
designated for U.S. marketing comply with FDA promotion and
labeling requirements for human drug products.
10. CONFIDENTIALITY
10.1. During the term of this Agreement, The Parties agree to
strictly abide by the terms of the Confidentiality Agreement,
executed August 4, 1999, and attached hereto as APPENDIX 1.
11. IND/NDA PRODUCT DEVELOPMENT
11.1. CRC will have full operational and financial responsibility
for obtaining, and will use best efforts to obtain, NDA
Approval for Product(s) for: 1) diagnosis of a) pancreatic
exocrine function, b) pancreatic cancer through a procedure
for obtaining desquamated pancreatic cells for histopathologic
examination, and c) gastrinoma; and 2) * which will include,
without limitation, best efforts to complete activities
according to APPENDIX 2. At the request of Repligen, CRC
will, with appropriate prior notification, afford qualified
representatives of Repligen the right to review the
hSecretin NDA package, including regulatory correspondence,
prior to NDA Approval for hSecretin. Once each year following
FDA submission of the hSecretin NDA, CRC will, with
appropriate prior notification, afford qualified
representatives of Repligen the right to review all material
correspondence with regulatory authorities regarding the
aforesaid indications to assure ongoing compliance with
regulatory requirements.
11.2. CRC will own the INDs and the approved NDAs for Product(s) and
will have ongoing responsibility for manufacturing and
regulatory affairs with respect to said INDs and NDAs. In the
event and to the extent that CRC fails or is unable to carry
out or fulfill such responsibilities, CRC, its heirs, assigns,
and successors, hereby agree to provide for and/or to Repligen
any and all means as may be required in order to allow such
fulfillment.
11.3. CRC agrees *. CRC and Repligen will identify a mutually
acceptable alternative contractor for the bulk drug substance
manufacture of pSecretin and hSecretin and will use best
efforts to complete at least one production lot of each prior
to March 31, 2000. Repligen will participate in the assessment
of the second manufacturer's cGMP capabilities and may perform
testing of said production lots. During the term of the
Agreement, Repligen will have the right to review the QC and
QA batch records related to product release testing and its QA
group may audit the manufacturing contractors for general
facility related cGMP and regulatory compliance.
11.4. No new clinical studies of Product(s) in Therapeutic
Applications will be initiated by Repligen after the signing
of this Agreement unless the Parties mutually agree on such
initiation. At such time as Repligen and CRC agree to initiate
a new clinical study of Product(s) in a Therapeutic
Application, the Parties will negotiate a separate exclusive
license agreement for the use of Product(s) in said
Therapeutic Application. CRC will then provide Repligen with
the right to reference its relevant INDs and Repligen will
file its own IND and conduct said new study. Repligen
acknowledges that CRC has an ongoing clinical study of
Product(s) in * in non-autistic patients that will remain
under the exclusive control of CRC.
11.5 CRC will keep Repligen fully informed on matters relating to
NDA Approval. In the event that deficiencies are identified in
the NDA, Repligen may, at its option, participate in the NDA
Approval process for the purpose of assisting CRC in remedying
the deficiencies, in which case Repligen will have the right
to recover its costs from CRC's share of Product(s) revenues.
* Confidential Treatment Requested
20
<PAGE>
12 EXPANSION OF PRODUCT APPROVAL
12.1. With respect to new diagnostic applications, CRC will use best
efforts to gain additional approval and expanded Orphan Drug
Status for the Product(s). Administration and financing of
these efforts will be the responsibility of CRC.
12.1.1. In the event that CRC elects not to pursue expanded
approval for a new diagnostic application, Repligen
may proceed under terms mutually agreeable to the
Parties.
12.1.2. Sharing of the revenues received from the expanded
approval will be the same as for previously approved
diagnostic indications following the reimbursement of
those costs (plus interest) incurred by Repligen as
in Paragraph 8.
13. PATENTS
13.1. In the event that CRC obtains rights to any patents or patent
applications that relate to the composition of, method of use,
or process for producing secretin, Repligen shall have a first
option to negotiate an exclusive royalty-bearing license to
such rights for Repligen Secretin Product, said option to
extend for the term of this Agreement. Insofar as Repligen may
require a license to such rights in order to market and sell
Product(s), such license shall be automatically granted and
shall be royalty free.
13.1.1. The royalty rate to be paid by Repligen to CRC
pursuant to said license will be negotiated between
the Parties and become the subject of a separate
agreement. Said royalty rate shall in any case be
generally consistent with industry standards.
13.1.2. The sale volume upon which royalties will be due will
be based upon that fraction of total sales that are
covered by valid claims in the licensed CRC patents
as determined according to a mutually agreeable third
party source.
14. MARKETING OPERATIONS
14.1 Marketing and promotional activities including Product(s)
pricing will be mutually agreed in writing in a draft
marketing plan prior to November 30, 1999, said plan to be
revised and updated by the Parties as needed but at least once
annually thereafter.
14.2 Repligen will have the sole right to authorize the
distribution of Product(s) for all current clinical studies of
Product(s) in Therapeutic Applications and CRC will promptly
share with Repligen all results received from such clinical
studies. To the extent that CRC has the right to publicly use
safety data from such studies, the Parties agree to use such
data as appropriate to support marketing activities.
14.3 Following FDA approval of Repligen's Secretin Product, CRC
will cease and desist from any and all activities related to
the marketing and sale of Product(s) for Therapeutic
Applications if any such activities are ongoing.
14.4 Repligen will purchase from CRC a mutually agreed upon
inventory of launch stock of the Product(s) and will fund any
mutually agreed upon marketing activities that precede the NDA
Approval. These costs will be reimbursed from initial gross
revenues prior to the revenue split as described in Paragraph
8.
14.5 Annual budgets related to each aspect of operations will be
prepared by the responsible Party and will be reviewed and
approved by the other Party. Any deviation from such budget
will require the prior approval of the other Party. The total
expenses of the Parties related to the cost of manufacture,
marketing, distribution, and sales of Product(s) shall not
exceed * of the gross revenues without prior mutual approval.
14.6 Distribution of Product(s) will be accomplished as specified
in the mutually agreed upon marketing plan and revenues will
flow through Repligen. Royalties due to CRC will be reconciled
on a quarterly basis by Repligen. Estimated payments based on
actual revenues received by Repligen from the sale of
Product(s) will be paid to CRC monthly in the first year
following NDA Approval following which payments will be made
quarterly on the basis of actual revenues.
14.7 CRC shall have the right once during each calendar year to
inspect, or have an agent, accountant or other representative
inspect, during normal business hours, and upon reasonable
advance notice (not less than 14 days), such books, records
and other supporting data of Repligen as may be necessary to
verify Repligen's computation of royalties due under this
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Agreement. CRC agrees to maintain the confidentiality of any
information acquired during such inspection or review. Failure
to permit an inspection or audit upon receipt of proper notice
is grounds for breach of this Agreement.
14.8 The Parties will work together to develop a plan to maximize
revenues worldwide.
15. SUPPLY OF PRODUCT
15.1 Following the execution of this Agreement, the Parties agree
to, by December 31, 1999, negotiate and enter into a separate
agreement which will govern the supply and transfer of
Product(s) by and between the Parties. Said agreement shall
include, without limitation: placing and filling of orders for
bulk drug substance and drug product, transfer pricing (if
applicable), and control and ownership of inventory through
the manufacturing and distribution chain, as well as a general
plan for minimizing the cost of goods prior to distribution.
16. PRODUCT BRANDING
16.1 Repligen may at its option market pSecretin under its own
brand name, trade name, trademark, or logo or under a brand
name, trade name, trademark, or logo owned by CRC. For all
other Product(s), Repligen may market the Product(s) under its
own brand name, trade name, trademark or logo, but may not
market the Product(s) under any brand name, trade name,
trademark or logo owned by CRC, or any name which is a
colorable imitation of, or is likely to be confused with, any
names or logos owned by CRC, except as authorized in writing
by CRC. Following termination of this Agreement, CRC may
market the Product(s) under its own brand name, trade name,
trademark or logo, but may not market the Product(s) under any
brand name, trade name, trademark or logo owned by Repligen,
or any name which is a colorable imitation of, or is likely to
be confused with, any names or logos owned by Repligen, except
as authorized in writing by Repligen.
16.2 Subject to subparagraph 16.1, trade names of Product(s) and
all aspects of artwork and design for vial and carton labels
for Product(s) will be owned and controlled exclusively by
Repligen. CRC will have right of review of said artwork and
design to the extent it is required for the maintenance of
regulatory compliance.
17. PUBLICITY
17.1. Press releases related to the announcement of this Agreement
and to NDA Approval as well as any press releases related to
Therapeutic Applications of Product(s), with the exception of
*, will be initiated by Repligen and will originate from
Repligen except as specified herein. CRC will have the right
of prior review and comment on such press releases to insure
accurate representations of subject matter and CRC's
contribution.
17.2 CRC will take the lead on joint release of information related
to diagnostic and * applications of Product(s). Repligen will
have the right of prior review and comment on such press
releases.
18. FORCE MAJEURE
18.1 The obligation of the Parties hereunder shall be suspended by
the occurrence of such unforeseeable events beyond the control
of the Parties as acts of God, war, mobilization, riot,
sabotage, explosion, fire or other casualty, a generalized and
nation-wide inability to obtain suitable and sufficient
materials, or law or regulation restricting performance,
provided, however, that each Party shall take reasonable
measures to remove the disability and resume operation at the
earliest possible date.
19. INDEMNITY
19.1 Repligen agrees to defend, indemnify, and hold CRC harmless
from and against any claim, liability, loss, cost, or expense
(including reasonable counsel fees) in connection with any
claims, suits, actions, demands, or judgments arising out of,
or in connection with, or relating in any manner to, this
Agreement which are attributable to the negligence or reckless
or willful activities of Repligen, its officers, employees,
contractors, and agents.
19.2 CRC agrees to defend, indemnify, and hold Repligen harmless
from and against any claim, liability, loss, cost, or expense
(including reasonable counsel fees) in connection with any
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<PAGE>
claims, suits, actions, demands, or judgments arising out of,
or in connection with, or relating in any manner to, this
Agreement which are attributable to the negligence or reckless
or willful activities of CRC, its officers, employees,
contractors, and agents.
20. INSURANCE
20.1 Each Party agrees to carry comprehensive General Liability
Insurance (including Directors and Officers Liability coverage
and Products Liability coverage) with coverage limits as set
forth in Appendix 3. The coverage limits shall be reviewed
annually by the Parties, and if appropriate, adjusted by
mutual agreement of the Parties. Such policies shall be
carried with responsible insurers and shall specifically
recognize and insure the covered Party against its contractual
liability hereunder. Certificates of such insurance shall be
furnished to each Party and shall provide for at least sixty
(60) days' written notice to a Party of the cancellation or
any material modification thereof.
21. NOTICES
21.1 Any notice or communication under or in connection with this
Agreement shall, unless otherwise provided herein, be in
writing and shall be delivered personally, or by post, telex,
cable, or facsimile to the addresses given in this Agreement
or at such other address as the recipient may have notified to
the other party in writing.
21.2 A notice or other communication shall be deemed effective, in
the case of a letter, on the third day after posting, or, in
the case of a telex, cable, or facsimile, on the day
immediately following the date of dispatch (other than a
Saturday, Sunday, or bank holiday).
21.3 Where delivery of any notice or communication is by post,
delivery shall be by first-class mail, postage prepaid,
addressed to the respective parties as follows:
TO REPLIGEN:
Walter C. Herlihy, Ph.D.
President, Chief Executive Officer
Repligen Inc.
117 Fourth Avenue
Needham, MA 02494
TO CRC:
Edward D. Purich, Ph.D.
Chief Executive Officer
ChiRhoClin Inc.
15500 Gallaudet Avenue
Silver Spring, MD 20905-4176
21.4 Where delivery of any notice or communication is by telex,
cable, facsimile, or other electronic method, such notice or
communication shall also be sent promptly by first-class mail,
as described in subparagraph 21.3 above. Failure to send such
notice by mail shall not, however, render the earlier
electronic notice ineffective, unless such notice is
demonstrably illegible.
22. ARBITRATION
22.1 The Parties agree that in the event a dispute arises out of or
relating to this Agreement, the Parties shall attempt in good
faith to resolve the dispute through discussion and
alternative dispute resolution according to the following
procedure.
22.1.1 Good Faith Discussion - The complaining Party shall
notify the other Party of the dispute. All involved
Parties shall attempt to discuss the dispute in good
faith.
22.1.2 Arbitration - Should the dispute remain unresolved
after good faith discussion for sixty (60) days after
the notice under subparagraph 22.1.1 above, the
Parties agree to arbitrate under the rules of
conciliation and arbitration of the American
Arbitration Association ("AAA"). There shall be three
arbitrators, one being selected by Repligen and one
being selected by CRC, and the third being selected
by the two arbitrators so
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<PAGE>
selected. If a Party fails to nominate an arbitrator
within 15 days from the date of the notification made
to it of the other Party's request for arbitration,
or if the two arbitrators fail within 15 days from
the date of their appointment to reach agreement on
the third arbitrator, then the third arbitrator shall
be appointed in accordance with the AAA rules. The
place of arbitration shall be in New York City, New
York. The arbitration expenses shall be paid by the
losing party. If the arbitrators do not find for one
party's position in its entirety, then the Parties
shall share the arbitration expenses equally between
the Buyer and the Sellers. The Parties shall also be
responsible for their own expenses, including
attorney fees.
22.1.3 Enforceability - This Agreement, including the
arbitration provision in subparagraph 22.1.2 above
and any award, shall be enforceable in any federal or
state court in the United States.
22.1.4 Miscellaneous - The Parties waive the defense of
inconvenient forum and lack of personal jurisdiction
in any proceeding brought in federal or state court
in New York City, New York to enforce the arbitration
provision in subparagraph 22.1.2 above. Further, the
Parties agree that notice under this Agreement shall
constitute acceptable and valid service of process
for all proceedings to enforce the arbitration
provision of subparagraph 22.1.2 above.
23. MISCELLANEOUS
23.1 This instrument and the Appendices hereto constitute the
entire Agreement between the Parties, supersede all prior or
contemporaneous representations, understandings, or
agreements, and shall not be extended, varied, modified, or
supplemented except by an agreement in writing and signed by
the Party to be charged.
23.2 The headings used herein are for ease of reference only and
are not to be used in the interpretation or construction of
this Agreement.
23.3 The prevailing Party in any arbitration or litigation
involving this Agreement shall be entitled to recover its
costs and reasonable counsel fees, in addition to any other
remedy or relief to which it may be entitled.
23.4 Neither Party shall have the right to assign this Agreement or
any interest therein without the prior written consent of the
other. Such consent shall not be unreasonably withheld.
23.5 Repligen shall at all times be, and remain, an independent
contractor and not an agent, partner, or joint venturer of CRC
for any purpose whatsoever and shall have no authority to
create or assume any obligation, express or implied, in the
name of, or on behalf of, CRC, or to bind it in any manner
whatsoever.
23.6 The failure of either Party to enforce at any time, or for any
period of time, any one or more of the provisions hereof,
shall not be construed to be a waiver of such provisions or of
the right of such Party thereafter to enforce each such
provision.
23.7 If any provision of this Agreement shall be held invalid under
any applicable law, such invalidity shall not affect any other
provision of this Agreement.
23.8 This Agreement shall be binding upon, and inure to the benefit
of, the Parties hereto, their successors, and permitted
assigns.
23.9 This Agreement shall be construed in accordance with the laws
of the Commonwealth of Massachusetts, without regard to
applicable statutes or rules regarding conflicts of laws.
23.10 This Agreement may be executed in counterparts by any of the
Parties hereto on two counterparts, each of which shall be
deemed an original, but both of such respective counterparts
shall together constitute one and the same Agreement.
[SIGNATURES FOLLOW]
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<PAGE>
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed
as of the day and year first above written.
CHIRHOCLIN INCORPORATED REPLIGEN INCORPORATED
By /s/ Edward D. Purich By: /s/ Daniel P. Witt
-------------------------------- -------------------------
Edward D. Purich, Ph.D. Daniel P. Witt
Chief Executive Officer Vice President
Date: September 30, 1999 Date: September 30, 1999
-------------------- ------------------
25
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS FINANCIAL INFORMATION EXTRACTED FROM THE FINANCIAL
STATEMENTS FOR REPLIGEN CORPORATION AND IS QUALIFIED IN ITS ENTIRETY BY
REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> MAR-31-2000
<PERIOD-END> DEC-31-1999
<CASH> 9,296
<SECURITIES> 0
<RECEIVABLES> 640
<ALLOWANCES> (25)
<INVENTORY> 458
<CURRENT-ASSETS> 10,542
<PP&E> 1,724
<DEPRECIATION> (1,103)
<TOTAL-ASSETS> 11,244
<CURRENT-LIABILITIES> 511
<BONDS> 0
0
0
<COMMON> 223
<OTHER-SE> 10,510
<TOTAL-LIABILITY-AND-EQUITY> 11,244
<SALES> 1,369
<TOTAL-REVENUES> 2,535
<CGS> 775
<TOTAL-COSTS> 5,497
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> 0
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (2,962)
<EPS-BASIC> (0.14)
<EPS-DILUTED> (0.14)
</TABLE>
