1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 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, 1997
or
_____ Transition report pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
COMMISSION FILE NUMBER: 0-19454
ANERGEN, INC.
(Exact name of registrant as specified in its charter)
CALIFORNIA 77-0183594
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
301 PENOBSCOT DRIVE, 94063
REDWOOD CITY, CALIFORNIA (Zip Code)
(Address of principal executive offices)
Telephone number: (415) 361-8901
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___
At March 31, 1997, Registrant had outstanding 18,788,925 shares of Common
Stock.
2
ANERGEN, INC.
INDEX
PART I - FINANCIAL INFORMATION Page No.
--------
ITEM 1. Financial Statements
Condensed balance sheets - March 31, 1997
and December 31, 1996 . . . . . . . . . . . . . . . . 3
Condensed statements of operations - three months
ended March 31, 1997 and 1996 . . . . . . . . . . . . 4
Condensed statements of cash flows - three months
ended March 31, 1997 and 1996 . . . . . . . . . . . . 5
Notes to condensed financial statements . . . . . . . . . 6
ITEM 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations . . . . 7
PART II - OTHER INFORMATION
ITEM 4. Submission of Matters to a Vote of Security Holders. . . . 17
ITEM 6. Exhibits and Reports on Form 8-K . . . . . . . . . . . . 18
Signatures . . . . . . . . . . . . . . . . . . . . . . . 19
2
3
PART I - FINANCIAL INFORMATION
ANERGEN, INC.
CONDENSED BALANCE SHEETS
(IN THOUSANDS EXCEPT SHARE AMOUNTS)
ASSETS
MARCH 31, DECEMBER 31,
1997 1996
-------- --------
Current assets:
Cash and cash equivalents ......................................... $ 3,103 $ 3,963
Short-term investments ............................................ 11,050 12,437
Contract receivables .............................................. 1,315 320
Prepaid expenses .................................................. 185 208
-------- --------
Total current assets ................................. 15,653 16,928
Property and equipment, net ........................................... 1,593 1,459
Other assets .......................................................... 36 36
-------- --------
$ 17,282 $ 18,423
======== ========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities ......................... $ 2,000 $ 1,326
Current portion of capital lease obligations and debt ............. 616 728
-------- --------
Total current liabilities ............................ 2,616 2,054
Long-term portion of capital lease obligations and debt ............... 472 366
Commitments
Shareholders' equity:
Preferred stock, no par value; 10,000,000 shares authorized; none
issued and outstanding ..................................... -- --
Common stock, no par value; 40,000,000 shares authorized;
18,788,925 shares issued and outstanding (18,780,697 at
December 31, 1996) ......................................... 57,514 57,484
Additional paid-in-capital ........................................ 659 659
Unrealized gain (loss) on investments ............................. (49) (34)
Accumulated deficit ............................................... (43,930) (42,106)
-------- --------
Total shareholders' equity ........................... 14,194 16,003
-------- --------
$ 17,282 $ 18,423
======== ========
Note: The actual balance sheet at March 31, 1997 is derived from unaudited
financial statements. The December 31, 1996 information is derived
from audited financial statements.
See accompanying notes.
3
4
ANERGEN, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
THREE MONTHS ENDED
MARCH 31,
-------------------
1997 1996
-------- --------
Revenues:
Contract revenues ............................. $ 1,808 $ 783
Interest income ............................... 182 139
-------- --------
1,990 922
-------- --------
Expenses:
Research and development ...................... 2,887 1,895
General and administrative .................... 884 503
Interest expense .............................. 43 55
-------- --------
3,814 2,453
-------- --------
Net loss .......................................... $ (1,824) $ (1,531)
======== ========
Net loss per share ................................ $ (0.10) $ (0.10)
======== ========
Shares used in calculating net loss per share ..... 18,781 14,984
======== ========
See accompanying notes.
4
5
ANERGEN, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED
MARCH 31,
-------------------
1997 1996
-------- --------
Cash flows used in operating activities:
Net loss .............................................. $ (1,824) $ (1,531)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation and amortization ....................... 199 267
Changes in operating assets and liabilities:
Contract receivables ................................ (995) 32
Prepaid expenses .................................... 23 (1)
Accounts payable and accrued liabilities ............ 674 (151)
-------- --------
Net cash used in operating activities ................... (1,923) (1,384)
Cash flows provided by investing activities:
Purchase of investments available-for-sale ............ (9,887) (1,554)
Sale of investments available-for-sale ................ 11,259 3,201
Purchase of property and equipment .................... (333) (143)
-------- --------
Net cash provided by investing activities ............... 1,039 1,504
Cash flows provided by (used in) financing activities:
Proceeds from facility and equipment debt financing ... 224 --
Repayments of capital lease obligations and debt ...... (230) (319)
Issuance of common stock, net ......................... 30 41
-------- --------
Net cash provided by (used in) financing activities ..... 24 (278)
-------- --------
Net decrease in cash and equivalents .................... (860) (158)
Cash and equivalents at beginning of period ............ 3,963 468
-------- --------
Cash and equivalents at end of period .................. 3,103 310
Short-term investments at end of period ................. 11,050 9,343
-------- --------
Cash and equivalents and short-term investments
at end of period .................................... $ 14,153 $ 9,653
======== ========
See accompanying notes.
5
6
ANERGEN, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
MARCH 31, 1997
(UNAUDITED)
1. NATURE OF BUSINESS
Anergen, Inc. ( the "Company") was incorporated on April 26, 1988 for
the purpose of developing therapies using biopharmaceutical compounds
for the treatment of autoimmune diseases.
2. BASIS OF PRESENTATION
The interim financial statements included herein have been prepared by
the Company and have not been audited, pursuant to the rules and
regulations promulgated by the Securities and Exchange Commission (the
"Commission"). Certain information and footnote disclosures, normally
included in financial statements prepared in accordance with generally
accepted accounting principles, have been omitted pursuant to
Commission rules and regulations; nevertheless, the Company believes
that the disclosures are adequate to make the information presented
not misleading. These condensed financial statements should be read
in conjunction with the audited financial statements and notes
thereto contained in the Company's Annual Report on Form 10-K for the
year ended December 31, 1996. In the opinion of management, all
adjustments, consisting only of normal recurring adjustments,
necessary to present fairly the financial position of the Company
(subject to year-end adjustments) with respect to the interim
financial statements, and of the results of its operations and cash
flows for the interim periods then ended, have been included. The
results of operations for the interim periods are not necessarily
indicative of the results for the full year.
Net Loss Per Share
Net loss per share is computed using the weighted average number of
shares of common stock outstanding. In February 1997, the Financial
Accounting Standards Board issued Statement 128, Earnings per Share,
which is required to be adopted on December 31, 1997. At that time,
the Company will be required to change the method currently used to
compute loss per share and to restate all prior periods. Under the
new requirements for calculating primary earnings per share, the
dilutive effect of stock options will be excluded. The Company
currently excludes common equivalent shares from outstanding stock
options and warrants from the computation as their effect is
anti-dilutive. The Company does not expect there to be an impact on
the net loss per share calculation upon adoption of Statement 128.
6
7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Management's Discussion and Analysis of Financial Condition and
Results of Operations contains certain forward-looking statements which involve
risks and uncertainties. The Company's actual results could differ materially
from the results anticipated in these forward-looking statements as a result of
certain factors set forth hereunder and in the Company's Annual Report as filed
on Form 10-K filed with the Securities and Exchange Commission for the year
ended December 31, 1996.
LIQUIDITY AND CAPITAL RESOURCES
To date, the Company has financed its operations primarily through
private placements of its equity securities with venture capitalists
(which raised an aggregate of approximately $7.6 million in net
proceeds), through the sale of its Common Stock to Novo Nordisk A/S
(which raised approximately $8 million in net proceeds), through the
issuance of its Common Stock and Warrants to purchase shares of Common
Stock through a private placement in exchange for $1.5 million in
proceeds, and through public offerings of its Common Stock which have
raised an aggregate of $38.8 million in net proceeds, including $9.4
million in net proceeds from the sale of 3.5 million shares of Common
Stock to the public in August 1996 and approximately $500,000 from the
underwriters' exercise of the over-allotment option in September 1996.
The Company's cash, cash equivalents and short-term investments at
March 31, 1997 were approximately $14.2 million. Accounts payable and
accrued liabilities increased to $2,000,000 at March 31, 1997 from
$1,326,000 at December 31, 1996. Long-term debt increased from
$366,000 at December 31, 1996 to $472,000 at March 31, 1997 due to the
debt financing of equipment purchases. The Company had shareholders'
equity at March 31, 1997 of approximately $14.2 million.
The Company anticipates that its current cash, cash equivalents,
short-term investments and expected revenues under its collaborative
agreements will be sufficient to fund its operations through
approximately 1998. Thereafter, the Company will require substantial
additional funds to continue its operations. The Company anticipates
that its current resources will be primarily used to fund clinical
testing of AnervaX(TM) for Rheumatoid Arthritis ("RA"), manufacturing
of GMP grade material for the Phase I clinical trial of the Company's
Anergix(TM) for Multiple Sclerosis ("MS") and the conduct of such
clinical trial, and continued research and development and preparation
for clinical testing of AnergiX for the treatment of RA, Type I
Diabetes and Myasthenia Gravis. The balance of such resources will be
used to fund continued limited research on other autoimmune diseases
and general and administrative activities, including those associated
with seeking collaborative arrangements to enable the Company to
increase its research and development activities in other autoimmune
diseases. These foregoing forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially. In
particular, the Company's capital requirements will vary depending on
numerous factors many of which are outside the Company's control.
These factors include the progress of the Company's research and
development programs, manufacturing activities, the progress of the
Company's clinical programs, the results of laboratory testing, the
time and cost required to seek regulatory approvals to commence
clinical trials for the Company's initial products, the need to obtain
licenses to other proprietary rights, any required adjustments to the
Company's operating plan to respond to competitive pressures or
technological advances, developments with respect to the Company's
existing or future collaborative arrangements, and the availability of
various methods of financing. The Company expects to seek to raise
additional capital through equity or debt financing, research and
development collaborations with other pharmaceutical companies or
through other sources. Any additional equity financing may be dilutive
to shareholders, and debt financing, if available, may involve
restrictions on stock dividends and other restrictions on the Company.
Adequate funds for the Company's operations, whether from equity or
debt, collaborative or other arrangements with corporate partners or
from other sources, may not be available when needed or on terms
attractive to the Company. Insufficient funds may require the Company
to delay, scale back or eliminate some or all of its research and
product development programs or to license third parties to
commercialize products or technologies that the Company would otherwise
seek to develop itself. The Company's liquidity will be reduced as
amounts are expended for continuing research and development.
7
8
RESULTS OF OPERATIONS
The Company's net loss increased by 19% to $1,824,000 in the fiscal
quarter ended March 31, 1997 compared to a $1,531,000 loss in the
corresponding period in the previous year. The increase was due to
expenses that increased 55% to $3,814,000 in the fiscal quarter ended
March 31, 1997 compared to $2,453,000 in the corresponding period in
the previous year partially offset by an increase in revenues of 116%
to $1,990,000 in the fiscal quarter ended March 31, 1997 compared to
$922,000 in the corresponding period in the previous year. Total
expenses increased primarily due to increased expenses for research and
development related to clinical trials and corporate development
activities associated with the Company's collaborative arrangement with
N. V. Organon. Research and development expenses increased 52% to
$2,887,000 for the quarter ended March 31, 1997 from $1,895,000 in the
corresponding period in the previous year. This is due to an increase
in clinical activities related to the Company's AnergiX for MS which is
in Phase I testing, and to an increase in clinical costs associated
with the Company's ongoing Phase IIa clinical trial of AnervaX for RA.
The Company expects total operating expenses to increase as it
increases research and development efforts.
General and administrative expenses increased 76% to $884,000 for the
quarter ended March 31, 1997 compared to $503,000 in the corresponding
period in the previous year primarily due to compensation costs
associated with an expanded management team, recruitment efforts and
increased corporate development activities.
The increase in revenues was primarily due to revenues recorded in the
first quarter related to the Company's collaborative agreement with N.
V. Organon. Interest income increased to $182,000 for the quarter ended
March 31, 1997 as compared to $139,000 in the corresponding period in
the previous year due to higher average cash balances in 1997.
Interest income is expected to decline gradually over future periods as
invested capital is used for operating activities. Interest expense
decreased to $43,000 for the quarter ended March 31, 1997 as compared
to $55,000 in the corresponding period in the previous year due to
lower debt balances.
The Company expects to incur substantial and increasing operating
losses for at least the next several years. The Company's losses on a
quarter-by-quarter basis may vary depending upon a variety of factors,
any of which may fluctuate, including the level of research
activities, the timing of hiring of additional scientific and
management personnel, the retention of consultants, the purchase or
leasing of laboratory equipment, the licensing of any required
technology and other factors. Accordingly, the Company believes that
quarter-by-quarter losses will not be a useful indicator of the
performance of the Company.
RISK FACTORS THAT MAY AFFECT FUTURE OPERATING PERFORMANCE
EARLY STAGE OF PRODUCT DEVELOPMENT; LACK OF COMMERCIAL PRODUCTS; NO ASSURANCE
OF SUCCESSFUL PRODUCT DEVELOPMENT
The Company was founded in 1988 to discover and develop
biopharmaceutical compounds for the treatment of autoimmune diseases. To
achieve profitable operations, the Company, alone or with others, must
successfully develop, obtain regulatory approval for, manufacture and market
products. The Company does not have any products available for sale nor does
it expect to have any products commercially available for at least several
years, if at all. The Company's potential products are at the early stages of
research and development, with only limited human testing of certain of the
Company's products undertaken to date. The products currently under
development by the Company will require significant additional research,
laboratory testing and clinical trials and investment of capital prior to their
commercialization. There can be no assurance that any potential products will
be successfully developed, prove to be safe and efficacious in clinical trials,
meet applicable regulatory standards, be capable of being produced in
commercial quantities at acceptable costs or be successfully marketed.
8
9
LIMITED OPERATING HISTORY; HISTORY OF LOSSES
The Company has experienced significant net losses every year since
its inception in 1988. Net losses for the quarters ended March 31, 1997
and 1996 were approximately $1.8 million and $1.5 million, respectively, and
the Company had an accumulated deficit of approximately $43.9 million as of
March 31, 1997. The Company expects to incur substantial and increasing
operating losses for at least the next several years. The amount of net losses
and the time required by the Company to reach profitability are highly
uncertain. There can be no assurance that the Company will ever be able to
generate product revenue or achieve profitability on a substantial basis or at
all. See "Management's Discussion and Analysis of Financial Condition and
Results of Operations."
FUTURE REQUIREMENT FOR SIGNIFICANT ADDITIONAL CAPITAL
The Company anticipates that its current cash, cash equivalents,
short-term investments and expected revenues under its collaborative agreements
will be sufficient to fund its operations through approximately 1998.
Thereafter, the Company will require substantial additional funds to continue
its operations. The Company anticipates that its current resources will be
primarily used to fund clinical testing of AnervaX for RA and AnergiX for MS,
and continued research and development and preparation for clinical testing of
AnergiX for the treatment of RA, IDDM and MG. The balance of such resources
will be used to fund continued limited research on other autoimmune diseases
and general and administrative activities, including those associated with
seeking collaborative arrangements to enable the Company to increase its
research and development activities in other autoimmune diseases. The
Company's working capital requirements over the next two years may vary
depending upon numerous factors, including the progress of the Company's
research and development programs, manufacturing activities, the progress of
the Company's clinical programs, the results of laboratory testing, the time
and cost required to seek regulatory approvals to commence clinical trials for
the Company's initial products, the need to obtain licenses to other
proprietary rights, any required adjustments to the Company's operating plan to
respond to competitive pressures or technological advances, developments with
respect to existing or future collaborative arrangements and the availability
of various methods of financing. The Company expects to seek to raise
additional capital through equity or debt financing, research and development
collaborations with corporate partners or through other sources. Any
additional equity financing may be dilutive to shareholders, and debt
financing, if available, may involve restrictions on stock dividends and other
restrictions on the Company. Adequate funds for the Company's operations,
whether from equity or debt financings, collaborative or other arrangements
with corporate partners or from other sources, may not be available when needed
or on terms attractive to the Company. Insufficient funds may require the
Company to delay, scale back or eliminate some or all of its research and
product development programs or to license third parties to commercialize
products or technologies that the Company would otherwise seek to develop
itself. The Company's liquidity will be reduced as amounts are expended for
continuing research and development. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations -- Liquidity and Capital
Resources."
UNCERTAINTIES RELATED TO PRECLINICAL AND CLINICAL TRIALS
Before obtaining regulatory approvals for the commercial sale of any
of its products under development, the Company must demonstrate through
preclinical studies and clinical trials that the product is safe and
efficacious for use in each target indication. The results from preclinical
studies and early clinical trials may not be predictive of results that will be
obtained in large-scale testing, and there can be no assurance that the
Company's clinical trials will demonstrate the safety and efficacy of any
products or will result in any marketable products. A number of companies in
the biotechnology industry have suffered significant setbacks in advanced
clinical trials, even after promising results in earlier trials. The failure
to adequately demonstrate the safety and efficacy of a therapeutic product
under development could delay or prevent regulatory approval of the product and
could have a material adverse effect on the Company.
The rate of completion of the Company's clinical trials is dependent
upon, among other factors, the FDA's willingness to allow Anergen to proceed;
the results of Anergen's continued research and development, including test
results and success in producing the epitopes and HLA molecules for each
AnergiX compound; the number of skilled scientists, clinicians, and consultants
the Company is able to employ in its efforts and the general interest in the
medical community in a therapeutic using the Company's approach for treatment
of the diseases targeted by the Company. Currently, the Company does not
anticipate establishing its own clinical trials facility. The rate of
completion of clinical trials is also dependent on patient enrollment, which is
a function of many
9
10
factors, including the size of the patient population, the proximity of patients
to clinical sites and the existence of competitive trials. If the Company is
unable to successfully complete its clinical trials, its business, financial
condition and results of operations could be materially and adversely affected.
UNCERTAINTY OF MARKET ACCEPTANCE
Even if the requisite regulatory approvals are obtained for the
Company's potential products or for products developed in collaboration with
the Company, uncertainty exists as to whether such products will be accepted by
the market. A number of factors also may limit the market acceptance of a
product which may be developed by, or discovered through collaboration with,
the Company, including the rate of adoption by health care practitioners, the
indications for which the product is approved, the rate of the product's
acceptance by the target population, the timing of market entry relative to
competitive products, the availability of alternative therapies, the price of
the Company's product relative to alternative therapies, the availability of
third-party reimbursement and the extent of marketing efforts by the Company
and third-party distributors or agents retained by the Company. Side effects
or unfavorable publicity concerning a Company product or any similar product
could have an adverse effect on the Company's ability to obtain physician,
patient or third-party payor acceptance and on efforts to sell that product.
There can be no assurance of the Company's ability, or the length of time
required, to achieve commercialization of the Company's products or that
physicians, patients or third party payors will accept any of the Company's
products as readily as alternative therapies, or at all.
GOVERNMENT REGULATION; NO ASSURANCE OF OBTAINING PRODUCT APPROVALS
The Company's research and development activities are subject to
regulation by numerous governmental authorities in the United States and other
countries. Further, the future production and marketing of any products
developed by the Company would also be regulated, particularly as to safety and
efficacy. In the United States, vaccines, drugs and biologics are subject to
rigorous FDA review. The Federal Food, Drug, and Cosmetic Act, the Public
Health Service Act and other federal statutes and regulations govern or
influence the testing, manufacture, safety, labeling, storage, record keeping,
approval, advertising and promotion of such products. Noncompliance with
applicable requirements can result in fines, recall or seizure of products,
clinical study holds, total or partial suspension of production, refusal of the
government to approve NDAs, PLAs, ELAs or allow the Company to enter into
supply contracts and criminal prosecution. The FDA also has the authority to
revoke PLAs and ELAs previously granted.
In order to obtain FDA approval of a new biological product, the
Company must submit proof of safety, purity, potency and efficacy. In most
cases such proof entails extensive pre-clinical, laboratory, and clinical
tests. The testing, preparation of necessary marketing applications and
processing of those applications by the FDA is expensive and time consuming,
can vary based on the type of product, and may take several years to complete.
There is no assurance that the FDA will act favorably or quickly in making such
reviews, and significant difficulties or costs may be encountered by the
Company in its efforts to obtain FDA approvals that could delay or preclude the
Company from marketing any products it may develop or furnish an advantage to
competitors. The FDA may also require post-marketing testing and surveillance
to monitor the effects of approved products or place conditions on any
approvals that could restrict the commercial applications of such products.
Product approvals may be withdrawn if compliance with regulatory standards is
not maintained or if problems occur following initial marketing. In addition,
delays imposed by the governmental approval process may materially reduce the
period during which the Company may have the exclusive right to exploit
patented products or technologies.
The FDA approval process for a new biological drug involves completion
of pre-clinical studies which include laboratory tests and animal studies to
assess safety and effectiveness of the drug. Among other things, the results
of these studies as well as how the product will be manufactured, are submitted
to the FDA in an IND and, unless the FDA objects, the IND becomes effective 30
days following receipt by the FDA. FDA cleared human clinical trials may then
be conducted. The results of the clinical trials are submitted to the FDA as
part of a PLA. In addition to obtaining FDA approval for each AnergiX
indication, an ELA must be filed and the FDA must approve the manufacturing
facilities for the product. Product sales may commence only if the PLA and ELA
are approved. Regulatory requirements for obtaining such FDA approvals are
rigorous and there can be no assurance that such approvals will be obtained on
a timely basis or at all.
Sales of pharmaceutical products outside the United States are subject
10
11
to foreign regulatory requirements that vary widely from country to country.
The time required to obtain approvals required by foreign countries may be
longer or shorter than that required for FDA approval, and requirements for
licensing may differ from FDA requirements.
If approval is obtained, the Company will be subject to continuing FDA
obligations. When manufacturing biologics, the Company will be required to
adhere to regulations setting forth current Good Manufacturing Practices
("GMP"), which require that the Company manufacture its products and maintain
its records in a prescribed manner with respect to manufacturing, testing and
quality control activities. Further, the Company must pass a preapproval
inspection of its manufacturing facilities by the FDA before obtaining
approval.
Satisfaction of these FDA requirements, or similar requirements by
foreign regulatory agencies, typically takes several years and the time needed
to satisfy them may vary substantially, based upon the type, complexity and
novelty of the pharmaceutical product. The effect of government regulation may
be to delay or to prevent marketing of potential products for a considerable
period of time and to impose costly procedures upon the Company's activities.
There can be no assurance that the FDA or any other regulatory agency will
grant approval for any products or indications being developed by the Company
on a timely basis, or at all. Success in preclinical or early stage clinical
trials does not assure success in later stage clinical trials. Data obtained
from preclinical and clinical activities are susceptible to varying
interpretations which could delay, limit or prevent regulatory approval. If
regulatory approval of a product is granted, such approval may impose
limitations on the indicated uses for which a product may be marketed.
Further, even if regulatory approval is obtained, later discovery of previously
unknown problems with a product may result in restrictions on the product,
including withdrawal of the product from the market. Delay in obtaining or
failure to obtain regulatory approvals would have a material adverse effect on
the Company's business, financial condition and results of operations.
DEPENDENCE UPON COLLABORATIVE PARTNERS
The Company's strategy for the development, clinical trials,
manufacturing and commercialization of its products includes maintaining and
entering into various collaborations with corporate partners, licensors,
licensees and others. To date, the Company has entered into collaborative
arrangements with Novo Nordisk with respect to the Company's AnergiX compounds
for the treatment of MS, MG and IDDM, and with Organon with respect to an
AnergiX compound for the treatment of RA. There can be no assurance that the
interests and motivations of the Company's collaborators are, or will remain,
aligned with those of the Company or that such collaborators will successfully
perform their development, regulatory compliance, manufacturing or marketing
functions or that such collaborations in whole or in part will continue. There
can also be no assurance that the Company will be able to negotiate additional
collaborative arrangements in the future on acceptable terms, if at all, or
that any such collaborative arrangements will be successful. To the extent
that the Company is not able to maintain or establish such arrangements, the
Company would be required to undertake such activities at its own expense,
which would significantly increase the Company's capital requirements and limit
the programs the Company is able to pursue. In addition, the Company may
encounter significant delays in introducing its products into certain markets
or find that the development, manufacture or sale of its products in such
markets is adversely affected by the absence of such collaborative agreements.
The Company cannot control the amount and timing of resources which
its collaborative partners devote to the Company's program or potential
products, which can vary because of factors unrelated to the potential product.
Collaborator participation will depend not only on the achievement of research
objectives by the Company and its collaborators, which cannot be assured, but
also on each collaborator's own financial, competitive, marketing and strategic
considerations, which are outside the Company's control. Such strategic
considerations may include the relative advantages of alternative products
being marketed or developed by others, including relevant patent and
proprietary positions. The Company's collaborative partners may develop,
either alone or with others, products that compete with the development and
marketing of the Company's products. Competing products, either developed by
the collaborative partners or to which the collaborative partners have rights,
may result in their withdrawal of support with respect to all or a portion of
the Company's technology, which would have a material adverse effect on the
Company's business, financial condition and results of operations. If Novo
Nordisk, Organon or any future collaborative partner breaches or terminates
their agreements with the Company or otherwise fails to conduct their
collaborative activities in a timely manner, the preclinical or clinical
development or commercialization of product candidates or research programs
will be delayed, and the Company will be required to devote additional
resources to product development and commercialization or terminate certain
development programs. There also can be no assurance that disputes will not
arise in the future with
11
12
respect to the ownership of rights to any technology developed with third
parties. These and other possible disagreements between collaborators and the
Company could lead to delays in the collaborative research, development and
commercialization of certain product candidates or could require or result in
litigation or arbitration, which would be time consuming and expensive, and
would have a material adverse effect on the Company's business, financial
condition and results of operations. See "Management's Discussion and Analysis
of Financial Condition and Results of Operations -- Liquidity and Capital
Resources."
UNCERTAINTY RELATING TO PATENTS AND PROPRIETARY RIGHTS
The Company's success will depend in significant part on its ability
to maintain patent protection for its therapeutic approach and for any
developed products, to preserve its trade secrets and to operate without
infringing the proprietary rights of third parties. Although the Company has
obtained patents covering certain aspects of its technology, no assurance can
be given that additional patents will be issued or, if issued, that the scope
of any patent protection will be significant, or that the patents will be held
valid if subsequently challenged. Moreover, the Company cannot ascertain with
certainty that no patent conflict will exist with other products or processes
which could compete with the Company's approaches.
Because of the length of time and expense associated with bringing new
products through development and to the marketplace, and the length of time
required for the governmental approval process, the pharmaceutical industry has
traditionally placed considerable importance on obtaining and maintaining
patent and trade secret protection for significant new technologies, products
and processes. The Company and other biotechnology and pharmaceutical firms
have applied, and are applying, for patents for their products and certain
aspects of their technologies. The enforceability of patents issued to
biotechnology and pharmaceutical firms is highly uncertain. Federal court
decisions indicating legal considerations surrounding the validity of patents
in the field are in transition, and there can be no assurance that the
historical legal standards surrounding questions of validity will continue to
be applied or that current defenses as to issued patents in the field will
offer protection in the future. In addition, there can be no assurance as to
the degree and range of protection any patents will afford, whether patents
will issue or the extent to which the Company will be successful in not
infringing patents granted to others.
While the Company pursues patent protection for products and processes
where appropriate, it also relies on trade secrets, know-how and continuing
technological advancement to develop and maintain its competitive position. The
Company's policy is to have each employee enter into an agreement that contains
provisions prohibiting the disclosure of confidential information to anyone
outside the Company. Research and development contracts and relationships
between the Company and its scientific consultants provide access to aspects of
the Company's know-how that is protected generally under confidentiality
agreements with the parties involved. There can be no assurance, however, that
these confidentiality agreements will be honored or that the Company can
effectively protect its rights to its unpatented trade secrets. Moreover, there
can be no assurance that others will not independently develop substantially
equivalent proprietary information and techniques or otherwise gain access to
the Company's trade secrets.
The Company may be required to obtain licenses to patents or other
proprietary rights from third parties. There can be no assurance that any
licenses required under any patents or proprietary rights will be made
available on terms acceptable to the Company, if at all. If the Company does
not obtain required licenses, it could encounter delays in product development
while it attempts to redesign products or methods or it could find that the
development, manufacture or sale of products requiring such licenses could be
foreclosed.
The Company is aware of a European patent and corresponding U.S. and
Australian patents which contain claims that relate to certain of the Company's
proposed products and their uses. In accordance with European Patent Office
("EPO") procedures, third parties can oppose an EPO patent grant by presenting
information which they believe justifies narrowing or revoking the grant of the
patent. The Company is opposing the aforementioned grant in the EPO. There
can, however, be no assurance that the granted EPO claims will be revoked or
significantly narrowed in scope as a result of the opposition proceeding. If
valid claims in these patents are found to be infringed by the Company's
products, the Company's ability to make, use, offer to sell, or sell, such
products could be materially and adversely affected.
In addition, the Company could incur substantial costs in defending
any patent litigation brought against it or in asserting the Company's patent
rights, including those licensed to the Company by others, in a suit against
12
13
another party. The United States Patent and Trademark Office (the "USPTO")
could institute interference proceedings in connection with one or more of the
Company's patents or patent applications which proceedings could result in an
adverse decision as to priority of an invention. The USPTO also could
institute reexamination proceedings in connection with one or more of the
Company's patents or patent applications, which could result in an adverse
decision as to the patents' validity or scope.
NEED TO DEVELOP MANUFACTURING CAPABILITIES
The Company has no volume manufacturing capacity or experience in
volume manufacturing of pharmaceutical or other biological products.
Establishing its own volume manufacturing capabilities would require
significant scale-up expenses and additions to facilities and personnel. In
addition, the Company must successfully develop the process required for volume
manufacturing. The pharmaceutical products under development by the Company
have never been manufactured on a commercial scale and there can be no
assurance that such products can be manufactured at a cost or in quantities to
make them commercially viable. The Company will be required to establish
arrangements with contract manufacturers to supply a portion of its compounds
for subsequent clinical trials as well as the manufacture, packaging, labeling
and distribution of finished products. If the Company is unable to contract
for sufficient supply of a portion of its compounds on acceptable terms, and it
is unable to develop the capability to produce the epitopes internally, the
Company's human clinical testing schedule would be delayed, resulting in the
delay of submission of products for regulatory approval and initiation of new
development programs, which would have a material adverse effect on the
Company. If the Company should encounter delays or difficulties in
establishing relationships with manufacturers to produce, package and
distribute its finished products, market introduction and subsequent sales of
such products would be adversely affected. Moreover, contract manufacturers
that the Company may use must adhere to current GMP regulations enforced by the
FDA through its facilities inspection program. If these facilities cannot pass
a pre-approval plant inspection, the FDA pre-market approval of the products
will be adversely affected.
LACK OF MARKETING EXPERIENCE; DEPENDENCE ON THIRD PARTIES
The Company currently has no sales, marketing or distribution
capability. The Company intends to rely on relationships with one or more
pharmaceutical companies with established distribution systems and direct sales
forces to market its products. In the event that the Company is unable to
reach agreement with one or more pharmaceutical companies to market its
products, it may be required to market its products directly and to develop a
marketing and sales force with technical expertise and supporting distribution
capability. There can be no assurance that the Company will be able to
establish in-house sales and distribution capabilities or relationships with
third parties, or that it will be successful in gaining market acceptance for
its products. To the extent that the Company decides to utilize existing or
future co-promotion or other licensing arrangements, the Company must develop
its own sales, marketing or distribution capability, and there can be no
assurance that such efforts will be successful.
COMPETITION AND TECHNOLOGICAL CHANGE
The biotechnology and pharmaceutical industries are characterized by
rapidly evolving technology and intense competition. The Company's competitors
include major pharmaceutical, chemical and specialized biotechnology companies,
most of which have financial, technical, research and development,
manufacturing, clinical and marketing resources significantly greater than those
of the Company. The Company believes that these other entities recognize the
need for effective therapies for the autoimmune diseases targeted by the Company
and are highly motivated to develop such therapies. In addition, many
specialized biotechnology companies have formed collaborations with large,
established companies to support research, development and commercialization of
products that may be competitive with those of the Company. Academic
institutions, governmental agencies and other public and private research
organizations are also conducting research activities and seeking patent
protection and may commercialize products on their own or through joint
ventures. The Company is aware of certain products in development by
competitors that are intended to be used for the prevention or treatment of
certain diseases the Company has targeted for product development.
The existence of these products, or other products or treatments of
which the Company is not aware, or products or treatments that may be developed
in the future which may be more effective, may adversely affect the
commercialization or marketability of products which may be developed by the
Company or potentially render the Company's technology obsolete or
non-competitive.
13
14
The Company's competitive position will depend on its ability to
attract and retain qualified scientific and other personnel, develop effective
proprietary products, implement production and marketing plans, obtain patent
protection and secure adequate capital resources. In addition, the first
pharmaceutical product to reach the market in a therapeutic or preventive area
is often at a significant competitive advantage relative to later entrants to
the market. The Company expects its products, if approved for sale, to compete
primarily on the basis of product efficacy, safety, patent position,
reliability, price and patient convenience.
UNCERTAINTY RELATED TO PHARMACEUTICAL PRICING AND REIMBURSEMENT
Political, economic and regulatory influences are subjecting the
health care industry in the United States to fundamental change. Initiatives
to reduce the federal deficit and to reform health care delivery are increasing
these cost containment efforts. The Company anticipates that Congress, state
legislatures and the private sector will continue to review and assess
alternative benefits, controls on health care spending through limitations on
the growth of private health insurance premiums and Medicare and Medicaid
spending, the creation of large insurance purchasing groups, price controls on
pharmaceuticals and other fundamental changes to the health care delivery
system. Any such proposed or actual changes could cause existing and potential
partners of the Company to limit or eliminate spending on collaborative
development projects. Legislative debate is expected to continue in the
future, market forces are expected to demand reduced costs and Anergen cannot
predict what impact the adoption of any federal or state health care reform
measures or future private sector reforms may have on its business.
In both domestic and foreign markets, sales of the Company's proposed
products will depend in part upon the availability of reimbursement from
third-party payors, such as government health administration authorities,
private health insurers and other organizations. In addition, other
third-party payors are increasingly challenging the price and cost
effectiveness of medical products and services. Significant uncertainty exists
as to the reimbursement status of newly approved health care products. There
can be no assurance that the Company's potential products or products
discovered in collaboration with the Company will be considered cost-effective
or that adequate third-party reimbursement will be available to enable Anergen
to maintain price levels sufficient to realize an appropriate return on its
significant investment in product research and development. Legislation and
regulations affecting the pricing of pharmaceuticals may change before the
Company's proposed products are approved for marketing. Adoption of such
legislation could further limit reimbursement for medical products. If
adequate coverage and reimbursement levels are not provided by the government
and third-party payors for the Company's products, the market acceptance of
these products would be adversely affected, which would have a material adverse
effect on the Company's business, financial condition and results of
operations.
DEPENDENCE ON AND NEED FOR ADDITIONAL KEY PERSONNEL; RELIANCE ON ACADEMIC
COLLABORATORS
The success of the Company and of its business strategy is dependent
in large part on the ability of the Company to attract and retain key
management and operating personnel. Such persons are in high demand and are
often subject to competing offers. The Company will need to develop expertise
and add skilled employees or retain consultants in such areas as research and
development, clinical testing, government approvals, marketing and
manufacturing in the future. There can be no assurance that the Company will
be able to attract and retain the qualified personnel or develop the expertise
needed for its business. The loss of the services of one or more of the
Company's officers or other members of the research or management group or the
inability to hire additional personnel and develop expertise as needed would
have a material adverse effect on the Company.
A significant portion of the Company's research and development and
clinical trials is conducted under sponsored research programs with several
universities. The Company depends on the availability of the principal
investigator for each such program, and the Company cannot assure that these
individuals or their research staffs will be available to conduct research and
development or clinical trials. The Company's academic collaborators are not
employees of the Company. As a result, the Company has limited control over
their activities and can expect that only limited amounts of their time will be
dedicated to Company activities. In addition, the Company's academic
collaborators are employed by major institutions which have collaborative
relationships with other parties, some of which may be competitors of the
Company. Accordingly, there can be no assurance that research and development,
preclinical and clinical testing performed by these collaborators will be
completed in a timely manner, if at all, and any inability to do so could have a
material adverse effect on the Company.
14
15
POTENTIAL PRODUCT LIABILITY
The testing, marketing and sale of human health care products entail
an inherent risk of exposure to product liability claims in the event that the
use of the Company's technology or prospective products is alleged to have
resulted in adverse effects. While the Company has taken, and will continue to
take, what it believes are appropriate precautions to minimize exposure to
product liability, there can be no assurance that it will avoid significant
liability. The Company possesses limited general liability and product
liability insurance related to its clinical trials of AnervaX for RA and
intends to seek such insurance related to its clinical trials of AnergiX for MS
and certain other types of insurance customarily obtained by business
organizations. There can be no assurance that the existing insurance coverage
is adequate or that it will avoid liability. The Company intends to seek
insurance against product liability risks associated with the testing,
manufacturing or marketing of its products. However, there can be no assurance
that it will be able to obtain such insurance in the future, or that if
obtained, such insurance will be sufficient in amount. Consequently, a product
liability claim or other claims with respect to uninsured liabilities or in
excess of insured liabilities could have a material adverse effect on the
business or financial condition of the Company.
HAZARDOUS MATERIALS; ENVIRONMENTAL MATTERS
The Company is subject to regulation by the Occupational Safety and
Health Administration ("OSHA") and the Environmental Protection Agency ("EPA")
and to regulation under the Toxic Substances Control Act, the Resource
Conservation and Recovery Act and other regulatory statutes, and may in the
future be subject to other federal, state or local regulations. Although the
Company believes that it has complied with these laws, regulations and policies
in all material respects and has not been required to take any significant
action to correct any material noncompliance, there can be no assurance that
the Company will not be required to incur significant costs to comply with
environmental and health and safety regulations in the future. The Company's
research and development involves the controlled use of hazardous materials,
including but not limited to certain hazardous chemicals and radioactive
materials. Although the Company believes that its safety procedures for
handling and disposing of such materials comply with the standards prescribed
by state and federal regulations, the risk of accidental contamination or
injury from these materials cannot be eliminated. In the event of such an
accident, the Company could be held liable for any damages that result and any
such liability could exceed the resources of the Company. In addition,
regulations may be promulgated governing biotechnology that may affect the
Company's research and development programs. The Company is unable to predict
whether any agency will adopt any regulation which would have a material
adverse effect on the Company's business, financial condition and results of
operations.
VOLATILITY OF STOCK PRICE
The market price of the Company's Common Stock, similar to the
securities of other biotechnology companies, has been and is likely to continue
to be highly volatile. Announcements regarding the results of regulatory
approval filings, clinical trials or other testing, technological innovations
or new commercial products by the Company or its competitors, patents and
intellectual property rights by the Company or its competitors, developments as
to current or future collaborations by the Company or its competitors,
government regulations, the status of health care reform initiatives,
fluctuations in operating results, changes in recommendations by financial
analysts, and general market conditions for biotechnology stocks could have a
significant impact on the future price of the Common Stock. Trading volume of
the Company's Common Stock has been relatively limited and sales of substantial
amounts of Common Stock could have an adverse effect on the price of the Common
Stock.
CONTROL BY EXISTING STOCKHOLDERS
The Company's officers, directors and principal shareholders, namely
Warburg, Pincus Ventures, L.P. ("Warburg"), International Biotechnology Trust
PLC ("IBT"), and Novo Nordisk, collectively beneficially own approximately 50%
of the Company's outstanding Common Stock. Under a March 1995 common stock
purchase agreement with Warburg and IBT ("Warburg/IBT Purchase Agreement"), the
Company is currently obligated to include in the slate of nominees recommended
by the Company's Board of Directors and management, at each election of
directors, two candidates selected by Warburg, one candidate selected by IBT
and one candidate mutually agreed to by IBT and Warburg. Additionally, while
not obligated to do so, since
15
16
1993, the Company has included a representative of Novo Nordisk in its slate of
nominees for the Board of Directors. The ownership of the Company's Common
Stock, and the ability to designate candidates for the Company's recommended
slate of nominees for the Board of Directors, of Warburg, IBT and Novo Nordisk
will enable such shareholders to have significant influence over major corporate
transactions as well as the election of directors of the Company and control
over board decisions and could have the effect of delaying, deterring or
preventing a change in control of the Company.
ANTI-TAKEOVER PROVISIONS; POSSIBLE ISSUANCE OF PREFERRED STOCK OR ACCELERATION
OF OPTION VESTING
The Board of Directors has authority, without further action by
shareholders, to issue up to 10,000,000 shares of Preferred Stock with rights,
preferences and privileges designated by the Board of Directors. This
Preferred Stock could be issued quickly with terms calculated to delay or
prevent a change in control of the Company or to make removal of management
more difficult. In certain circumstances, such issuance could have the effect
of decreasing the market price of the Common Stock or of delaying, deterring or
preventing a change in control of the Company. The Company has no present plan
to issue any shares of Preferred Stock. Further, pursuant to the Company's
option plans, in the event of certain mergers of the Company with other
entities, transfers of voting control of the Company's capital stock or sale of
all or substantially all of the Company's assets, the Company's Board of
Directors has the right under certain circumstances to cause all outstanding
options to become fully vested prior to the event causing such acceleration and
all unexercised options will terminate upon completion of such event.
16
17
ANERGEN, INC.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
None
Item 2. Changes in Securities
None
Item 3. Defaults upon senior securities
None
Item 4. Submission of Matters to a Vote of Security Holders
(a) Annual Meeting of Shareholders on May 2, 1997.
On May 2, 1997 the Company held its Annual Meeting of
Shareholders to (i) elect seven directors to serve for one year and
until their successors are duly elected ("Proposal 1"), (ii) approve
the 1996 Stock Plan and to approve 1,000,000 shares reserved for
issuance under the plan ("Proposal 2"), and (iii) confirm the
appointment of Ernst & Young LLP as independent auditors for the
fiscal year ending December 31, 1997 ("Proposal 3").
The names of the persons nominated for director and the voting
results are as follows:
NOMINEE FOR WITHHELD
------- --- --------
Bruce L.A. Carter 17,469,097 434,025
Nicholas J. Lowcock 17,467,632 435,490
Harden M. McConnell 17,468,197 434,925
Harry H. Penner, Jr. 17,468,897 434,225
Barry M. Sherman 17,445,181 457,941
James E. Thomas 17,469,097 434,025
Nicole Vitullo 17,468,732 434,390
Proposal 2 sought shareholder approval of the 1996 Stock Plan
and to approve 1,000,000 shares reserved for issuance under the
plan. The voting results for Proposal 2 were as follows:
13,475,387 shares cast "for", 988,739 shares cast "against", 38,785
shares abstained, and 3,400,211 broker non-votes were cast.
Proposal 3 sought shareholder confirmation of the selection of Ernst
& Young LLP to audit the financial statements of the Company for the
year ending December 31, 1997. The voting results for Proposal 3
were as follows: 17,881,142 shares cast "for", 10,780 shares cast
"against", 11,200 shares abstained, and no broker non-votes were
cast. For additional detail as to the matters submitted for
shareholder vote at the Annual Meeting, refer to the definitive
proxy materials relating to the 1997 Annual Meeting of Shareholders
which were sent to the Commission on April 1, 1997.
Item 5. Other Information
None
17
18
Item 6. Exhibits and reports on Form 8-K
a) Exhibits
Exhibit Description
------- -----------
3.1(1) Restated and Amended Articles of Incorporation.
3.2(1) Bylaws, as amended.
4.1(1) Form of Common Stock Certificate.
27.1 Financial Data Schedule
(1) Incorporated by reference to the exhibit filed with
Registrant's Registration Statement on Form S-1 (No.
33-42107), as amended.
(b) Reports on Form 8-K. No reports on Form 8-K were filed by the
Company during the quarter ended March 31, 1997.
18
19
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.
ANERGEN, INC.
Date: May 13, 1997 By: /s/ BARRY M. SHERMAN, M.D.
-------------------------------------
Barry M. Sherman, M.D.
President and Chief Executive Officer
on behalf of the Company and
as principal financial and chief
accounting officer
19
20
EXHIBIT INDEX
EXHIBIT
NO. DESCRIPTION
------- -----------
27 FINANCIAL DATA SCHEDULE