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UNITED STATES
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 September 30, 1997
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: 0-19311
IDEC PHARMACEUTICALS CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 33-0112644
- ------------------------------- --------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
11011 Torreyana Road, San Diego, CA 92121
---------------------------------------------------
(Address of principal executive offices) (Zip code)
(619) 550-8500
---------------------
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes [X] No [ ]
As of October 31, 1997, the Registrant had 19,092,493 shares of its common
stock, $.001 par value, issued and outstanding.
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IDEC PHARMACEUTICALS CORPORATION
FORM 10-Q -- QUARTERLY REPORT
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 1997
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Consolidated Balance Sheets -- September 30, 1997 and December 31, 1996 ..................1
Condensed Consolidated Statements of Operations -- Three months ended September 30, 1997 and
1996 and nine months ended September 30, 1997 and 1996 .........................................2
Condensed Consolidated Statements of Cash Flows -- Nine months ended September 30, 1997 and
1996 ...........................................................................................3
Notes to Condensed Consolidated Financial Statements ...............................................4
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations ..............6
Risk Factors .......................................................................................9
PART II OTHER INFORMATION
Item 1. Legal Proceedings .................................................................................15
Item 2. Changes in Securities .............................................................................15
Item 3. Defaults upon Senior Securities ...................................................................15
Item 4. Submission of Matters to a Vote of Security Holders ...............................................15
Item 5. Other Information .................................................................................15
Item 6. Exhibits and Reports on Form 8-K ..................................................................15
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PART I -- FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS.
IDEC PHARMACEUTICALS CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
September 30, December 31,
1997 1996
---------- -----------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 7,389 $ 25,337
Securities available-for-sale 41,033 53,390
Current portion of note receivable 672 804
Contract research revenue receivables 3,549 3,635
Due from related party 6,790 1,532
Inventories 6,917 4,384
Prepaid expenses and other current assets 1,473 2,533
--------- ---------
Total current assets 67,823 91,615
Property and equipment, net 23,310 21,453
Note receivable, less current portion -- 445
Investment and other assets 3,365 316
--------- ---------
$ 94,498 $ 113,829
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Current portion of notes payable $ 4,520 $ 3,830
Accounts payable 915 3,106
Due to related party, current 800 800
Accrued expenses and other liabilities 8,017 5,951
Deferred revenue 1,804 --
--------- ---------
Total current liabilities 16,056 13,687
Notes payable, less current portion 4,374 5,015
Other long-term liabilities 1,889 1,513
Due to related party, noncurrent 1,000 1,000
Stockholders' equity:
Convertible preferred stock, $.001 par value -- --
Common stock, $.001 par value 19 18
Additional paid-in capital 178,767 176,448
Unrealized losses on securities available-for-sale (113) (37)
Accumulated deficit (107,494) (83,815)
--------- ---------
Total stockholders' equity 71,179 92,614
--------- ---------
$ 94,498 $ 113,829
========= =========
See accompanying notes to condensed consolidated financial statements.
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IDEC PHARMACEUTICALS CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
Three months Nine months
ended September 30, ended September 30,
----------------------- -----------------------
1997 1996 1997 1996
-------- -------- -------- --------
Revenues:
Revenue from unconsolidated joint business $ 2,332 $ -- $ 4,210 $ --
Contract research revenues 2,595 2,902 7,783 8,902
License fees 1,500 -- 6,500 9,500
Sales -- -- -- 1,505
-------- -------- -------- --------
6,427 2,902 18,493 19,907
Operating expenses:
Manufacturing expenses 5,261 -- 10,475 1,384
Research and development 7,988 6,292 25,754 19,011
Selling, general and administrative 3,477 1,844 8,183 5,305
-------- -------- -------- --------
16,726 8,136 44,412 25,700
-------- -------- -------- --------
Loss from operations (10,299) (5,234) (25,919) (5,793)
Interest income (expense), net 723 730 2,240 (354)
-------- -------- -------- --------
Net loss $ (9,576) $ (4,504) $(23,679) $ (6,147)
======== ======== ======== ========
Net loss per share common share $ (0.51) $ (0.26) $ (1.27) $ (0.38)
======== ======== ======== ========
Shares used in computing net loss
per common share 18,875 17,528 18,601 16,127
======== ======== ======== ========
See accompanying notes to condensed consolidated financial statements.
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IDEC PHARMACEUTICALS CORPORATION AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
Nine months ended
September 30,
-------------------------
1997 1996
-------- --------
Cash flows from operating activities:
Net cash used in operating activities $(25,146) $ (5,926)
-------- --------
Cash flows from investing activities:
Purchase of property and equipment (4,729) (1,993)
Investment in Cytokine Networks, Inc. (3,000) --
Purchase of securities available-for-sale (27,141) (31,324)
Sales and maturities of securities available-for-sale 39,434 14,274
-------- --------
Net cash provided by (used in) investing activities 4,564 (19,043)
-------- --------
Cash flows from financing activities:
Proceeds from issuance of common stock 2,585 47,513
Proceeds from issuance of preferred stock -- 12,500
Proceeds from notes payable 3,003 1,790
Payments on notes payable (2,954) (2,557)
-------- --------
Net cash provided by financing activities 2,634 59,246
-------- --------
Net increase (decrease) in cash and cash equivalents (17,948) 34,277
Cash and cash equivalents, beginning of period 25,337 18,828
-------- --------
Cash and cash equivalents, end of period $ 7,389 $ 53,105
======== ========
See accompanying notes to condensed consolidated financial statements.
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IDEC PHARMACEUTICALS CORPORATION AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The information at September 30, 1997, and for the three and nine month
periods ended September 30, 1997 and 1996, is unaudited. In the opinion of
management, these condensed consolidated financial statements include all
adjustments, consisting of normal recurring adjustments, necessary for a fair
presentation of results for the interim periods presented. Interim results are
not necessarily indicative of results for a full year. These financial
statements should be read in conjunction with IDEC Pharmaceuticals(R)
Corporation's (the "Company") Annual Report to Shareholders incorporated by
reference in the Company's Annual Report on Form 10-K for the year ended
December 31, 1996, which was filed with the United States Securities and
Exchange Commission on March 31, 1997.
New Accounting Standard
On March 3, 1997, the Financial Accounting Standards Board issued Statement
of Financial Accounting Standards No. 128 "Earnings per Share" ("Statement No.
128"). Statement No. 128 supersedes Accounting Principles Board Opinion No. 15
("APB No. 15") and replaces "primary" and "fully diluted" earnings per share
("EPS") under APB No. 15 with "basic" and "diluted" EPS. Unlike primary EPS,
basic EPS excludes the dilutive effects of options, warrants and other
convertible securities. Diluted EPS reflects the potential dilution of
securities that could share in the earnings of an entity, similar to fully
diluted EPS. Statement No. 128 is effective for years ending after December 15,
1997. The Company is currently evaluating the impact of the implementation of
Statement No. 128.
Reclassification
The prior year balances in preferred stock, common stock and additional
paid-in capital have been reclassified to effect the change in par value to
$.001 per share resulting from stockholder approval on May 22, 1997, of a change
in the state of incorporation of the Company from the State of California to the
State of Delaware.
NOTE 2. RELATED PARTY ARRANGEMENTS
In March 1995, the Company and Genentech, Inc. ("Genentech") entered into a
collaborative agreement for the clinical development and commercialization of
the Company's anti-CD20 monoclonal antibody, Rituxan(TM) (formerly IDEC-C2B8),
for the treatment of non-Hodgkin's B-cell lymphomas. Concurrent with the
collaborative agreement, the Company and Genentech also entered into an
expression technology license agreement for a proprietary gene expression
technology developed by the Company and a preferred stock purchase agreement
providing for certain equity investments in the Company by Genentech. Under the
terms of these agreements, the Company may receive payments totaling
$57,000,000, subject to the attainment of certain milestone events. Genentech
may terminate this agreement for any reason. For the nine months ended September
30, 1997, the Company recognized $1,500,000, in license fees under these
agreements.
In addition, the Company and Genentech will co-promote Rituxan in the United
States under a joint business arrangement, with the Company receiving a share of
the profits. Additionally, the Company has an obligation to supply Rituxan for
the first two years after regulatory approval of Rituxan with an option to
continue supplying Rituxan thereafter. Included in inventories at September 30,
1997, is $3,002,000 in finished goods inventory that will be sold to Genentech.
Included in revenue from unconsolidated joint business for the three and nine
months ended September 30, 1997 is $2,332,000 and $4,210,000, respectively, for
bulk Rituxan sold to Genentech.
Under the terms of separate agreements with Genentech, commercialization of
Rituxan outside the United States will be the responsibility of F. Hoffmann-La
Roche Ltd, except in Japan where Zenyaku Kogyo Co., Ltd. ("Zenyaku") will be
responsible for development, marketing and sales. The Company will receive
royalties on sales outside the U.S. and Canada. Additionally, the Company will
receive royalties on sales of any Genentech products manufactured using the
Company's proprietary gene expression system.
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IDEC PHARMACEUTICALS CORPORATION AND SUBSIDIARY
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE 3. STOCKHOLDERS EQUITY
In September 1997, the Company entered into an agreement with a financial
institution under which the Company purchased in a private transaction a capped
call option, exercisable only at maturity, representing the Company's right to
purchase from the financial institution up to 600,000 shares of the Company's
common stock. The Company has the right to settle the capped call option with
cash or stock. The capped call option which the Company purchased is expected to
be settled, if exercised, with cash paid to the Company in an amount equal to
the difference between the strike price and the market price, subject to caps
which will limit the total amount of cash the Company could receive.
Simultaneously, the Company sold to the same financial institution a call
option, exercisable only at maturity, entitling the financial institution to
purchase from the Company up to 900,000 shares of the Company's common stock.
The Company has the right to settle the call option with cash or stock and, if
exercised, the Company expects the call option to be settled by the issuance of
up to 900,000 shares of the Company's common stock. The financial institution
has advised the Company that it has engaged, and may engage, in transactions,
including buying and selling shares of the Company's common stock, to offset its
risk relating to the call options, which could affect the market price of the
Company's common stock.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS.
OVERVIEW
IDEC Pharmaceuticals Corporation (the "Company") is primarily engaged in the
research and development of targeted therapies for the treatment of cancer and
autoimmune and inflammatory diseases. To date, the Company has not received any
revenues from the commercial sale of its products. The Company has funded its
operations primarily through the sale of equity securities as well as through
contract research and license fee revenues received in connection with
collaborative arrangements entered into with the Company's strategic partners.
The Company has incurred increasing annual operating expenses and, as the
Company prepares for product commercialization, it expects such trends to
continue. The Company has incurred annual operating losses since its inception
in 1985, and the transition of the Company to profitability will be dependent
upon the timing of regulatory approval and the commercial success of
Rituxan(TM)(formerly IDEC-C2B8). As of September 30, 1997, the Company had an
accumulated deficit of $107.5 million.
RESULTS OF OPERATIONS
Revenue from unconsolidated joint business consist of bulk Rituxan sales to
Genentech, Inc. ("Genentech"), the Company's development partner.
Contract research revenues for the three and nine months ended September 30,
1997 totaled $2.6 million and $7.8 million, respectively, compared to $2.9
million and $8.9 million for the comparable periods in 1996. The decrease in
contract research revenues for the three and nine months ended September 30,
1997 is primarily due to the expiration in December 1996 of a collaborative and
license agreement with Mitsubishi Chemical Corporation.
License fees for the three months ended September 30, 1997, totaled $1.5
million and decreased to $6.5 million from $9.5 million for the nine months
ended September 30, 1997 and 1996, respectively. License fees for the three
months ended September 30, 1997 resulted from the achievement of a product
development milestone event under the Company's collaboration with Seikagaku
Corporation ("Seikagaku") for the development of PRIMATIZED(R) anti-CD23
antibodies. License fees for the nine months ended September 30, 1997 consist of
a license fee received from Boehringer Ingelheim GmbH for the license of the
Company's proprietary gene expression technology for the manufacture of
recombinant proteins ("gene expression technology") and the aforementioned
development milestone from Seikagaku. License fees for the nine months ended
September 30, 1996, resulted from the achievement of product development
milestone events under collaborations with Genentech and Seikagaku, a license
fee from Chugai Pharmaceutical Co., Ltd. for the Company's gene expression
technology and a license fee from Genentech for the expansion of its
collaboration with the Company. The Company continues to pursue other
collaborative and license arrangements; however, no assurance can be given that
discussions in this regard will result in any such arrangements or that the
Company will receive significant revenues from any such collaborative or license
arrangements.
Sales for the nine months ended September 30, 1996 were a result of the
Company completing a contract manufacturing arrangement.
Manufacturing expenses for the three months ended September 30, 1997, totaled
$5.2 million and increased to $10.5 million from $1.4 million for the nine
months ended September 30, 1997 and 1996, respectively. Manufacturing expenses
for 1997 consist of manufacturing costs related to production of bulk Rituxan
sold to Genentech and includes a charge of approximately $2.0 million made
during the second quarter of 1997, for costs associated with the start-up of the
Company's manufacturing facility. Manufacturing expenses for 1996 were a result
of the Company completing a contract manufacturing arrangement. The Company
expects to continue incurring substantial additional manufacturing expenses as
the Company continues to build Rituxan inventory in anticipation of marketing
clearance from the United States Food and Drug Administration.
Research and development expenses totaled $8.0 million and $25.8 million for
the three and nine months ended September 30, 1997, respectively, compared to
$6.3 million and $19.0 million for the comparable periods in 1996. Research and
development expenses for the three months ended September 30, 1997 increased
primarily due to a
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license fee payment for Anti-MIF antibody technology rights and the completion
of contract manufacturing for IDEC-Y2B8 in preparation for a Phase III trial in
1998. Research and development expenses for the nine months ended September 30,
1997 increased primarily due to a $3.0 million up-front licensing fee to
Pharmacia & Upjohn for exclusive rights to 9-aminocamptothecin, a broad spectrum
anti-cancer agent, the aforementioned license fee payment for Anti-MIF antibody
technology rights and contract manufacturing costs for IDEC-Y2B8. Research and
development expenses for the three and nine months ended September 30, 1997 were
partially offset by the utilization of the Company's manufacturing facility for
bulk production of Rituxan inventory in 1997 compared to research and
development manufacturing production in 1996 of clinical material used for
clinical trials. The Company expects to continue incurring substantial
additional research and development costs in the future, due to expansion or
addition of research and development programs; technology inlicensing costs and
regulatory-related costs; preclinical and clinical testing of the Company's
various products under development; and production scale-up and manufacturing of
products used in clinical trials.
Selling, general and administrative expenses totaled $3.5 million and $8.2
million for the three and nine months ended September 30, 1997, compared to $1.8
million and $5.3 million for the comparable periods in 1996. Selling, general
and administrative expenses increased in 1997 due to higher personnel costs to
support expanded manufacturing operations and initial costs incurred for the
creation of a marketing and sales organization. Selling, general and
administrative expenses necessary to support expanded manufacturing capacity,
expanded clinical trials, research and development and the potential expansion
of the marketing and sales organization are expected to increase in the
foreseeable future.
Net interest income totaled $0.7 million and $2.2 million for the three and
nine months ended September 30, 1997, respectively, compared to net interest
income of $0.7 million for the three months ended September 30, 1996 and net
interest expense of $0.4 million for the nine months ended September 30, 1996.
The increase in net interest income for the nine months ended September 30, 1997
from net interest expense for the nine months ended September 30, 1996 is due to
higher balances in cash, cash equivalents and securities available-for-sale, a
decrease in noncash interest charges for common stock warrants issued in
connection with certain debt financings and a decrease in interest expense due
to lower balances in notes payable.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations and capital expenditures since
inception principally through the sale of equity securities, license fees,
contract research revenues, lease financing transactions and interest income.
The Company expects to finance its current and planned operating requirements
principally through cash on hand, funds from the commercialization of Rituxan
and with funds from existing collaborative agreements and contracts which the
Company believes will be sufficient to meet its near-term operating
requirements. Existing agreements and contracts, however, could be canceled by
the contracting parties. In addition, the Company may pursue additional capital
through a combination of new collaborative agreements, strategic alliances and
equity and debt financings. However, no assurance can be provided that
additional capital will be obtained through these sources on favorable terms or
at all. Should the Company not enter into any such arrangements, the Company
anticipates its cash, cash equivalents and securities available-for-sale,
together with the existing agreements and contracts, will be sufficient to
finance the Company's currently anticipated needs for operating and capital
expenditures through early commercialization of its first product. If adequate
funds are not available from additional sources of financing, or if the
commercialization of Rituxan is not approved or delayed, the Company's business
could be materially and adversely affected.
The Company's working capital and capital requirements will depend upon
numerous factors, including the progress of the Company's preclinical and
clinical testing; manufacturing; research and development programs; timing and
cost of obtaining regulatory approvals; levels of resources that the Company
devotes to the development of manufacturing and marketing capabilities;
technological advances; status of competitors; and the ability of the Company to
establish collaborative arrangements with other organizations.
Until required for operations, the Company's policy under established
guidelines is to keep its cash reserves in bank deposits, certificates of
deposit, commercial paper, corporate notes, United States government instruments
and other readily marketable debt instruments, all of which are investment-grade
quality.
At September 30, 1997, the Company had $48.4 million in cash, cash
equivalents and securities available-for-sale compared to cash, cash equivalents
and securities available-for-sale of $78.7 million at December 31, 1996. Sources
of cash, cash equivalents and securities available-for-sale during the nine
months ended September 30, 1997
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include $2.6 million from the issuance of common stock under employee stock
option and employee stock purchase plans and $3.0 million from funding under a
loan to finance equipment purchases. Uses of cash, cash equivalents and
securities available-for-sale during the nine months ended September 30, 1997
include $25.1 million used in operations, $4.7 million used to purchase capital
equipment, a $3.0 million preferred equity investment in Cytokine Networks, Inc.
and $3.0 million used to pay notes payable.
In September 1997, the Company entered into an agreement with a financial
institution under which the Company purchased in a private transaction a capped
call option, exercisable only at maturity, representing the Company's right to
purchase from the financial institution up to 600,000 shares of the Company's
common stock. The Company has the right to settle the capped call option with
cash or stock. The capped call option which the Company purchased is expected to
be settled, if exercised, with cash paid to the Company in an amount equal to
the difference between the strike price and the market price, subject to caps
which will limit the total amount of cash the Company could receive.
Simultaneously, the Company sold to the same financial institution a call
option, exercisable only at maturity, entitling the financial institution to
purchase from the Company up to 900,000 shares of the Company's common stock.
The Company has the right to settle the call option with cash or stock and, if
exercised, the Company expects the call option to be settled by the issuance of
up to 900,000 shares of the Company's common stock. The financial institution
has advised the Company that it has engaged, and may continue to engage, in
transactions, including buying and selling shares of the Company's common stock,
to offset its risk relating to the call option, which could affect the market
price of the Company's common stock.
In August 1995, the Company completed receipt of funding under a $10.0
million lease financing agreement to finance both equipment and facility
improvements. Terms of the financing agreement require final principal payments
of $1.1 million and $0.4 million in July 1998 and January 1999, respectively.
This quarterly report contains predictions, estimates and other
forward-looking statements within the meaning of Section 27A of the Securities
Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934,
as amended, that involve a number of risks and uncertainties. Such risk and
uncertainties are set forth below under the caption "Risk Factors" and elsewhere
in this report and in the Company's Annual Report on Form 10-K for the fiscal
year ended December 31, 1996. While this outlook represents our current judgment
on the future direction of the business, such risks and uncertainties could
cause actual results to differ materially from any future performance suggested
above.
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RISK FACTORS
Lengthy Regulatory Process; No Assurance of Regulatory Approvals
The testing, manufacturing, labeling, advertising, promotion, export, and
marketing, among other things, of IDEC Pharmaceuticals Corporation's ("IDEC
Pharmaceuticals" or the "Company") products are subject to extensive regulation
by governmental authorities in the United States and other countries. In the
United States, pharmaceutical products are regulated by the United States Food
and Drug Administration ("FDA") under the Federal Food, Drug, and Cosmetic Act
and other laws, including, in the case of biologics, the Public Health Service
Act. The nature and extent of regulation by governmental authorities in the
United States differs with respect to different products. At the present time,
with the exception of 9-aminocamptothecin ("9-AC"), the Company believes that
its products will be regulated by the FDA as biologics. 9-AC will be regulated
by the FDA as a drug which will require the submission of a New Drug Application
("NDA") for approval by the FDA. The regulatory approval process for a NDA is
similar to the approval process for a BLA discussed below. Manufacturers of
biologics and drugs may also be subject to state regulations.
The steps required before a biologic may be approved for marketing in the
United States generally include (i) preclinical laboratory tests and animal
tests, (ii) the submission to the FDA of an Investigational New Drug application
("IND") for human clinical testing, which must become effective before human
clinical trials may commence, (iii) adequate and well-controlled human clinical
trials to establish the safety and efficacy of the product, (iv) the submission
to the FDA of a Biological License Application ("BLA"), (v) FDA review of the
BLA, and (vi) satisfactory completion of a FDA inspection of the manufacturing
facility or facilities at which the product is made to assess compliance with
current Good Manufacturing Practices ("cGMP"). The testing and approval process
requires substantial time, effort and financial resources and there can be no
assurance that any approval will be granted on a timely basis, if at all. The
FDA may suspend clinical trials at any time on various grounds, including a
finding that the subjects or patients are being exposed to an unacceptable
safety risk.
The results of the preclinical studies and clinical studies, together with
detailed information on the manufacture and composition of the product, are
submitted to the FDA in the form of a BLA requesting approval to market the
product. Before approving a BLA, the FDA will inspect the facilities at which
the product is manufactured, and will not approve the product unless safety and
efficacy criteria and cGMP compliance is satisfactory. The FDA may deny a BLA if
applicable regulatory criteria are not satisfied, may require additional testing
or information, and/or may require postmarketing testing and surveillance to
monitor the safety or efficacy of a product. There can be no assurance that FDA
approval of any BLA submitted by the Company will be granted on a timely basis,
if at all. Also, if regulatory approval of a product is granted, such approval
may entail limitations on the indicated uses for which the product may be
marketed.
Both before and after approval is obtained, violations of regulatory
requirements may result in various adverse consequences, including the FDA's
delay in approving or refusal to approve a product, withdrawal of an approved
product from the market, and/or the imposition of criminal penalties against the
manufacturer and/or license holder. For example, license holders are required to
report certain adverse reactions among patients who use the Company's products
to the FDA, and to comply with certain requirements concerning advertising and
promotional labeling for their products. Also, quality control and manufacturing
procedures must continue to conform to cGMP regulations after approval, and the
FDA periodically inspects manufacturing facilities to assess compliance with
cGMP. Accordingly, manufacturers must continue to expend time, monies and effort
in the area of production and quality control to maintain cGMP compliance. In
addition, discovery of problems may result in restrictions on a product,
manufacturer or holder, including withdrawal of the product from the market.
Also, new government requirements may be established that could delay or prevent
regulatory approval of the Company's products under development.
The Company will also be subject to a variety of foreign regulations
governing clinical trials and sales of its products. Whether or not FDA approval
has been obtained, approval of a product by the comparable regulatory
authorities of foreign countries must be obtained prior to the commencement of
marketing of the product in those countries. The approval process varies from
country to country and the time may be longer or shorter than that required for
FDA approval. At least initially, the Company intends, to the extent possible,
to rely on foreign licensees, other than in Canada, to obtain regulatory
approval for marketing its products in foreign countries.
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In February 1997, the Company and Genentech, Inc. ("Genentech") submitted
BLAs to the FDA for Rituxan(TM) (formerly IDEC-C2B8) as a single agent therapy
for the treatment of relapsed low grade or follicular non-Hodgkin's lymphoma and
in July 1997, Rituxan was recommended unanimously for marketing clearance by the
Biological Response Modifiers Advisory Committee to the FDA. F. Hoffmann-La
Roche Ltd ("Hoffmann-La Roche"), also submitted, through one of its subsidiaries
in the European Union, a Marketing Authorization Application ("MAA") with the
European Medicines Evaluation Agency ("EMEA") for marketing Rituxan in Europe
under the trade name Mabthera. There can be no assurance that the FDA and the
EMEA approval of the BLAs and MAA submitted by the Company, Genentech and
Hoffmann-La Roche will be granted on a timely basis, if at all, and delays in
receipt or failure to receive regulatory approval could have a material adverse
effect on the Company's business, financial condition and results of operations.
Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs
intended to treat a "rare disease or condition," which generally is a disease or
condition that affects fewer than 200,000 individuals in the United States.
Orphan drug designation must be requested before submitting a BLA. After the FDA
grants orphan drug designation, the generic identity of the therapeutic agent
and its potential orphan use are publicly disclosed by the FDA. Orphan drug
designation does not convey any advantage in, or shorten the duration of, the
regulatory review and approval process. If a product that has an orphan drug
designation subsequently receives FDA approval for the indication for which it
has such designation, the product is entitled to orphan drug status, i.e., the
FDA may not approve any other applications to market the same drug for the same
indication, except in certain very limited circumstances, for a period of seven
years.
In 1994, the Company obtained orphan drug designation for Rituxan, IDEC-Y2B8
and IDEC-In2B8 from the FDA to treat low grade B-cell lymphoma. There can be no
assurance that any of these compounds will receive orphan drug status for the
low grade B-cell lymphoma indication, and it is possible that competitors of the
Company could obtain approval, and attendant orphan drug status, for these same
compounds for the low grade B-cell lymphoma indication, thus precluding the
Company from marketing its products for the same indication in the United
States. In addition, even if the Company does obtain orphan drug status for any
of its compounds for low grade B-cell lymphoma, there can be no assurance that
competitors will not receive approval of other, different drugs or biologics for
low grade B-cell lymphoma. Although obtaining FDA approval to market a product
with orphan drug status can be advantageous, there can be no assurance that the
scope of protection or the level of marketing exclusivity that is currently
afforded by orphan drug status will remain in effect in the future.
Reliance on Third Party Development and Marketing Efforts
The Company has adopted a research, development and product commercialization
strategy that is dependent upon various arrangements with strategic partners and
others. The success of the Company's products is substantially dependent upon
the success of these outside parties in performing their obligations, which
include, but are not limited to, providing funding, performing research and
development, fulfilling long term manufacturing demands and marketing,
distribution and sales with respect to the Company's products. The Company's
strategic partners may also develop products that may compete with the Company.
Although the Company believes that its partners have an economic incentive to
succeed in performing their contractual obligations, the amount and timing of
resources that they devote to these activities is not within the control of the
Company. There can be no assurance that these parties will perform their
obligations as expected or that any revenue will be derived from such
arrangements. The Company has entered into collaborative research and
development and license agreements with Genentech, Zenyaku Kogyo, Ltd.
("Zenyaku"), SmithKline Beecham p.l.c. ("SmithKline Beecham"), Mitsubishi
Chemical Corporation ("Mitsubishi"), Seikagaku Corporation ("Seikagaku") and
Eisai Co., Ltd. ("Eisai"). These agreements generally may be terminated at any
time by the strategic partner, typically on short notice to the Company. If one
or more of these partners elect to terminate their relationship with the
Company, or if the Company or its partners fail to achieve certain milestones,
it could have a material adverse effect on the Company's ability to fund the
related programs and to develop and market any products that may have resulted
from such collaborations. There can be no assurance that these collaborations
will be successful. In addition, some of the Company's current partners have
certain rights to control the planning and execution of product development and
clinical programs, and there can be no assurance that such partners' rights to
control aspects of such programs will not impede the Company's ability to
conduct such programs in accordance with the schedules currently contemplated by
the Company for such programs and will not otherwise impact the Company's
strategy.
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Limited Manufacturing Experience and Dependence on Contact Manufacturer
The Company has not yet commercialized any therapeutic products. To conduct
clinical trials on a timely basis, to obtain regulatory approval and to be
commercially successful, the Company must manufacture its products either
directly or through third parties in commercial quantities in compliance with
regulatory requirements and at an acceptable cost. Although the Company has
produced its products in the laboratory, scaled its production process to pilot
levels and has the ability to manufacture limited commercial bulk quantities of
certain of its products, the Company has not received regulatory approval for
such commercial production. The Company anticipates that production of its
products in commercial quantities will create technical as well as financial
challenges for the Company. The Company has limited experience in manufacturing
and no fill/finish experience and capacity. No assurance can be given as to the
ultimate performance of the Company's manufacturing facility in San Diego, its
suitability for approval for commercial production or the Company's ability to
make a successful transition to commercial production.
The Company has an obligation to supply Rituxan in the United States for
the first two years after regulatory approval of Rituxan. The Company has the
ability to manufacture limited commercial bulk quantities of Rituxan and is
dependent upon Genentech to manufacture worldwide requirements and to complete
all the fill/finish production of Rituxan. There can be no assurance that the
Company and/or Genentech can manufacture sufficient quantities of Rituxan to
meet yet undetermined market demands or that Genentech will be able to
fill/finish Rituxan on a timely and costs effective basis to avoid an
insufficient supply of Rituxan inventory, any of which could materially and
adversely affect the Company's business. In addition, there can be no assurance
that there will be sufficient sales of Rituxan, if approved, to achieve
profitable operations.
The Company is dependent upon Genentech to fulfill fill/finish and long term
manufacturing demands for Rituxan and SmithKline Beecham to fulfill all of the
manufacturing requirements for IDEC-CE9.1 and/or IDEC-151. Genentech is
currently constructing a larger manufacturing plant to satisfy long term demands
for Rituxan and SmithKline Beecham has constructed a larger manufacturing plant
for IDEC-CE9.1 and/or IDEC-151. The Company is considering the addition of
another manufacturing facility to meet its long term requirements for additional
products under development. Failure by the Company or its strategic partners to
establish additional manufacturing capacity on a timely basis would have a
material adverse effect on the Company.
The Company is also dependent upon contract manufacturers to fulfill the
Company's manufacturing demands for clinical quantities of 9-aminocamptothecin
("9-AC") and long term manufacturing demands for IDEC-Y2B8 and IDEC-In2B8. There
can be no assurance that the Company will be able to establish any such contract
manufacturing arrangements or that contract manufacturers will be able to
complete any such manufacturing contracts in a timely or cost-effective manner,
if at all, or that the Company could obtain such capacity from others. Failure
by the Company to establish contract manufacturing arrangements or failure by
contract manufacturers to meet the Company's manufacturing needs will result in
delayed clinical trials for 9-AC and may have a material adverse effect on the
Company.
Patents and Proprietary Rights
The Company's success will depend, in large part, on its ability to maintain
a proprietary position in its products through patents, trade secret and orphan
drug status. The Company has title or exclusive rights to four issued and 16
allowed United States patents, 19 United States patent applications and numerous
corresponding foreign patent applications, and has licenses to patents or patent
applications of other entities. No assurance can be given, however, that the
patent applications of the Company or the Company's licensors will be issued or
that any issued patents will provide competitive advantages for the Company's
products or will not be successfully challenged or circumvented by its
competitors. Moreover, there can be no assurance that any patents issued to the
Company or the Company's licensors will not be infringed by others or will be
enforceable against others. In addition, there can be no assurance that the
patents, if issued, would not be held invalid or unenforceable by a court of
competent jurisdiction. Enforcement of the Company's patents may require
substantial financial and human resources. Moreover, the Company may have to
participate in interference proceedings if declared by the United States Patent
and Trademark Office to determine priority of inventions, which typically take
several years to resolve and could result in substantial cost to the Company.
A substantial number of patents have already been issued to other
biotechnology and biopharmaceutical companies. Particularly in the monoclonal
antibody field, competitors may have filed applications for or have been issued
patents and are likely to obtain additional patents and proprietary rights
relating to products or processes competitive with or similar to those of the
Company. To date, no consistent policy has emerged regarding the breadth of
claims allowed in biopharmaceutical patents, however, patents may issue with
claims that conflict with the Company's own patent filings or read on its own
products. There can be no assurance that patents do not already exist in the
United States or in foreign countries or that patents will not be issued that
would entail substantial costs to challenge and that, if unsuccessfully
challenged, would have a material adverse effect on the Company's ability to
market its products. Specifically, the Company is aware of several patents and
patent applications which may affect the Company's ability to make, use and sell
its products. Accordingly, the Company expects that commercializing monoclonal
antibody-based products may require licensing and/or cross-licensing of patents
with other companies in
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this field. There can be no assurance that the licenses, which might be required
for the Company's processes or products, would be available, if at all, on
commercially acceptable terms. The ability to license any such patents and the
likelihood of successfully contesting infringement or validity of such patents
are uncertain and the costs associated therewith may be significant. If the
Company is required to acquire rights to valid and enforceable patents but
cannot do so at a reasonable cost, the Company's ability to manufacture or
market its products would be materially adversely affected.
The owners, or licensees of the owners, of these patents may assert that one
or more of the Company's products infringe one or more claims of such patents.
If legal action is commenced against the Company to enforce any of these patents
and the plaintiff in such action prevails, the Company could be prevented from
practicing the subject matter claimed in such patents. In such event or under
other appropriate circumstances, the Company may attempt to obtain licenses to
such patents. However, no assurance can be given that any owner would license
the patents to the Company at all or on terms that would permit
commercialization of the Company's products. An inability to commercialize such
products could have a material adverse effect on the Company's operations and
ability to pursue its long term objectives.
Limited Sales and Marketing Experience
Commercialization of the Company's products is expensive and time-consuming.
The Company has adopted a strategy of pursuing collaborative agreements with
strategic partners that provide for co-promotion of certain of the Company's
products. In the event that the Company elects to participate in co-promotion
efforts in the United States or Canada, and, in those instances where the
Company has retained exclusive marketing rights in specified territories, the
Company will need to build a sales and marketing capability in the targeted
markets. The Company currently has limited marketing and sales personnel. There
can be no assurance that the Company will be able to establish a successful
direct sales and marketing capability in any or all targeted markets or that it
will be successful in gaining market acceptance for its products. To the extent
that the Company enters into co-promotion or other licensing arrangements, any
revenues received by the Company will be dependent on the efforts of third
parties and there can be no assurance that such efforts will be successful.
Outside of the United States and Canada, the Company has adopted a strategy to
pursue collaborative arrangements with established pharmaceutical companies for
marketing, distribution and sale of its products. There can be no assurance that
any of these companies or their sublicensees will successfully market,
distribute or sell the Company's products or that the Company will be able to
establish and maintain successful co-promotion or distribution arrangements.
Failure to establish a sales capability in the United States or outside the
United States may have a material adverse effect on the Company.
Uncertainties Associated with Clinical Trials
The Company has conducted and plans to continue to undertake extensive and
costly clinical testing to assess the safety, efficacy and applicability of its
potential products. The rate of completion of the Company's clinical trials is
dependent upon, among other factors, the rate of patient enrollment. Patient
enrollment is a function of many factors, including the nature of the Company's
clinical trial protocols, existence of competing protocols, size of the patient
population, proximity of patients to clinical sites, changes in managed care and
eligibility criteria for the study. Delays in patient enrollment will result in
increased costs, which could have a material adverse effect on the Company. The
Company cannot ensure that patients enrolled in the Company's clinical trials
will respond to the Company's product candidates. Setbacks are to be expected in
conducting human clinical trials. Failure to comply with the FDA regulations
applicable to such testing can result in delay, suspension or cancellation of
such testing, and/or refusal by the FDA to accept the results of such testing.
In addition, the FDA may suspend clinical trials at any time if it concludes
that the subjects or patients participating in such trials are being exposed to
unacceptable health risks. Thus, there can be no assurance that Phase I, Phase
II or Phase III testing will be completed successfully within any specific time
period, if at all, with respect to any of the Company's potential products.
Further, there can be no assurance that human clinical testing will show any
current or future product candidate to be safe and effective or that data
derived therefrom will be suitable for submission to the FDA or will support the
Company's submission of a BLA/NDA.
Additional Financing Requirements and Uncertain Access to Capital Markets
The Company has expended and will continue to expend substantial funds to
complete the research, development, manufacturing and marketing of its products.
The Company may seek additional funding for these purposes through a combination
of new collaborative arrangements, strategic alliances, additional equity or
debt
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financings or from other sources. There can be no assurance that such additional
funds will be available on acceptable terms, if at all. Even if available, the
cost of funds may result in substantial dilution to current stockholders. If
adequate funds are not available from operations or additional sources of
financing, the Company's business could be materially and adversely affected.
History of Operating Losses; Accumulated Deficit
The Company has incurred annual operating losses since its inception in
1985. As of September 30, 1997, the Company's accumulated deficit was
approximately $107.5 million. Such losses have been and will be principally the
result of the various costs associated with the Company's research and
development, clinical and manufacturing activities. The Company has not
generated operating profits from the sale of its products. All revenues to date
have resulted from collaborative research, development and licensing
arrangements, contract manufacturing arrangements, research grants and interest
income. The Company has no products approved by the FDA or any foreign authority
and does not expect to achieve profitable operations on an annual basis unless
product candidates now under development receive FDA and foreign regulatory
approval and are thereafter commercialized successfully.
Possible Volatility of Stock Price
The stock market has from time to time experienced significant price and
volume fluctuations that may be unrelated to the operating performance of
particular companies. In addition, the market price of the Company's common
stock, like the stock prices of many publicly traded biotechnology companies,
has been highly volatile. Announcements of technological innovations or new
commercial products by the Company or its competitors, developments or disputes
concerning patent or proprietary rights, publicity regarding actual or potential
medical results relating to products under development by the Company or its
competitors, regulatory developments in both the United States and foreign
countries, public concern as to the safety of biotechnology products and
economic and other external factors, as well as period-to-period fluctuations in
financial results may have a significant impact on the market price of the
Company's common stock. It is likely that, in some future quarter, the Company's
operating results will be below the expectations of public market analysts and
investors. In such event, the price of the Company's common stock would likely
be materially adversely affected.
Uncertainties Regarding Health Care Reimbursement and Reform
The future revenues and profitability of biopharmaceutical companies as well
as the availability of capital may be affected by the continuing efforts of
government and third party payors to contain or reduce costs of health care
through various means. For example, in certain foreign markets pricing or
profitability of prescription pharmaceuticals is subject to government control.
In the United States, there have been, and the Company expects that there will
continue to be, a number of federal and state proposals to implement similar
government controls. While the Company cannot predict whether any such
legislative or regulatory proposals will be adopted, the announcement or
adoption of such proposals could have a material adverse effect on the Company's
business, financial condition or prospects.
The Company's ability to commercialize its products successfully will depend,
in part, on the extent to which appropriate reimbursement levels for the cost of
such products and related treatment are obtained from governmental authorities,
private health insurers and other organizations, such as health maintenance
organizations ("HMOs"). Third party payors are increasingly challenging the
prices charged for medical products and services. Also, the trend toward managed
health care in the United States and the concurrent growth of organizations such
as HMOs, which could control or significantly influence the purchase of health
care services and products, as well as legislative proposals to reform health
care or reduce government insurance programs may all result in lower prices for
the Company's products. The cost containment measures that health care payors
and providers are instituting and the effect of any health care reform could
materially adversely affect the Company's ability to operate profitably.
Product Liability Exposure
Clinical trials, manufacturing, marketing and sale of any of the Company's
or its strategic partners' pharmaceutical products or processes licensed by the
Company may expose the Company to product liability claims. The Company
currently carries limited product liability insurance. There can be no assurance
that the Company or its strategic partners will be able to continue to maintain
or obtain additional insurance or, if available, that sufficient coverage can be
acquired at a reasonable cost. An inability to obtain sufficient insurance
coverage at an
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acceptable cost or otherwise protect against potential product liability claims
could prevent or inhibit the commercialization of pharmaceutical products
developed by the Company or its strategic partners. A product liability claim or
recall would have a material adverse effect on the business and financial
condition of the Company.
Environmental Concerns
The Company's research and development involves the controlled use of
hazardous materials, chemicals and radioactive compounds. 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 completely
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, disposal of radioactive materials used by the Company
in its research efforts may only be made at approved facilities. Approval of a
site in California has been delayed indefinitely. The Company currently stores
such radioactive materials on site. The Company may incur substantial cost to
comply with environmental regulations.
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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. None
ITEM 5. OTHER INFORMATION. None
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits.
The following exhibits are referenced.
Exhibit
Number Description
4.10* Agreement Regarding Registration Rights and
Related Obligations pursuant to the ISDA Master
Agreement between the Company and Swiss Bank
Corporation, London Branch.
10.72 ISDA Master Agreement between the Company
and Swiss Bank Corporation, London Branch dated
August 26, 1997, together with Schedules thereto.
10.73* Confirmation for Contract A entered into pursuant
to the ISDA Master Agreement between the Company
and Swiss Bank Corporation, London Branch.
10.74* Confirmation for Contract B entered into pursuant
to the ISDA Master Agreement between the Company
and Swiss Bank Corporation, London Branch.
27.1 Financial Data Schedule.
-----------
* Confidential treatment requested as to certain portions
of this agreement.
(b) Report on Form 8-K. None
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SIGNATURES
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.
IDEC PHARMACEUTICALS CORPORATION
Date: November 12, 1997 By: /s/ William H. Rastetter
---------------- -------------------------------
William H. Rastetter
Chairman of the Board,
President and Chief Executive
Officer (Principal Executive
Officer)
Date: November 12, 1997 By: /s/ Phillip M. Schneider
----------------- -------------------------------
Phillip M. Schneider
Vice President and
Chief Financial Officer
(Principal Financial and
Accounting Officer)
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