1
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 for the quarterly period ended September 30, 2000.
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 for the transition period from __________to
_________.
Commission File Number: 0-19290
[COR THERAPEUTICS, INC. LOGO]
(Exact name of Registrant as specified in its charter)
DELAWARE
(State or other jurisdiction of incorporation or organization)
94-3060271
(I.R.S. employer identification no.)
(650) 244-6800
(Registrant's telephone number, including area code)
256 EAST GRAND AVENUE, SOUTH SAN FRANCISCO, CALIFORNIA 94080
(Address of principal executive offices and zip 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] [No]
As of September 30, 2000, the number of outstanding shares of the
Registrant's Common Stock was 54,424,184.
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COR THERAPEUTICS, INC.
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INDEX
Page
Section Contents No.
- ------- -------- ---
PART I FINANCIAL INFORMATION
Item 1. Condensed Financial Statements and Notes
Condensed Balance Sheets - September 30, 2000 and December
31, 1999 3
Condensed Statements of Operations - for the three
and nine months ended September 30, 2000 and 1999 4
Condensed Statements of Cash Flows - for the nine months ended
September 30, 2000 and 1999 5
Notes to Condensed Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial Condition and 10
Results of Operations
Item 3. Financial Market Risks 17
PART II OTHER INFORMATION
Item 1. Legal Proceedings 18
Item 6. Exhibits and Reports on Form 8-K 18
SIGNATURES 19
INTEGRILIN(R) (eptifibatide) Injection, COR THERAPEUTICS(R), and COR(R) are
registered trademarks of COR Therapeutics, Inc.
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COR THERAPEUTICS, INC.
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PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS AND NOTES
CONDENSED BALANCE SHEETS
(in thousands)
September 30, December 31,
2000 1999
------------- ------------
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 75,538 $ 12,780
Short-term investments 264,486 32,973
Contract receivables 7,818 5,751
Prepaid copromotion expenses 43,941 30,747
Other current assets 956 791
--------- ---------
Total current assets 392,739 83,042
Property and equipment, net 3,989 4,855
Other assets 9,874 --
--------- ---------
$ 406,602 $ 87,897
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 9,390 $ 11,020
Accrued interest payable 1,250 --
Accrued compensation 7,484 4,525
Accrued development costs 2,232 1,768
Accrued copromotion costs 1,383 1,291
Deferred revenue 37,919 27,480
Other accrued liabilities 507 511
Capital lease obligations--current portion 1,331 1,621
--------- ---------
Total current liabilities 61,496 48,216
Capital lease obligations--noncurrent portion 1,970 2,925
Convertible subordinated notes 300,000 --
Stockholders' equity 276,029 251,990
Accumulated deficit (232,893) (215,234)
--------- ---------
Total stockholders' equity 43,136 36,756
--------- ---------
$ 406,602 $ 87,897
========= =========
See accompanying notes.
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CONDENSED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
----------------------- -----------------------
2000 1999 2000 1999
-------- -------- -------- --------
Contract revenues:
Copromotion revenue $ 27,840 $ 9,711 $ 67,725 $ 22,823
Milestone revenue -- 12,000 -- 12,000
Development and other contract revenue 2,073 1,759 5,166 5,175
-------- -------- -------- --------
Total contract revenues 29,913 23,470 72,891 39,998
-------- -------- -------- --------
Expenses:
Cost of copromotion revenue 14,034 6,885 37,302 14,081
Research and development 10,246 8,755 32,990 28,613
Marketing, general and administrative 8,082 7,651 23,490 19,957
-------- -------- -------- --------
Total expenses 32,362 23,291 93,782 62,651
-------- -------- -------- --------
Income (loss) from operations (2,449) 179 (20,891) (22,653)
Interest income 5,597 691 13,516 2,287
Interest expense (4,369) (120) (10,284) (388)
-------- -------- -------- --------
Net income (loss) $ (1,221) $ 750 $(17,659) $(20,754)
======== ======== ======== ========
Basic net income (loss) per share $ (0.02) $ 0.02 $ (0.33) $ (0.42)
======== ======== ======== ========
Shares used in computing basic net income (loss) per share 54,067 49,940 52,969 49,386
======== ======== ======== ========
Diluted net income (loss) per share $ (0.02) $ 0.01 $ (0.33) $ (0.42)
======== ======== ======== ========
Shares used in computing diluted net income (loss) per share 54,067 53,992 52,969 49,386
======== ======== ======== ========
See accompanying notes.
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CONDENSED STATEMENTS OF CASH FLOWS
Increase (decrease) in cash and cash equivalents
(unaudited, in thousands)
Nine Months Ended
September 30,
-------------------------
2000 1999
--------- ---------
Cash flows provided by (used in) operating activities:
Net loss $ (17,659) $ (20,754)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 2,760 2,433
Changes in assets and liabilities:
Contract receivables (2,067) (6,384)
Prepaid copromotion expenses (13,194) (7,211)
Other current assets (165) (114)
Accounts payable (1,630) 3,122
Accrued interest payable 1,250 --
Accrued compensation 2,959 274
Accrued development costs 464 (1,912)
Accrued copromotion costs 92 173
Deferred revenue 10,439 9,982
Other accrued liabilities (4) (365)
--------- ---------
Total adjustments 904 (2)
--------- ---------
Net cash used in operating activities (16,755) (20,756)
--------- ---------
Cash flows provided by (used in) investing activities:
Purchases of short-term investments (366,337) (17,735)
Sales of short-term investments 68,443 40,427
Maturities of short-term investments 66,996 7,961
Additions to property and equipment (859) (1,319)
--------- ---------
Net cash provided by (used in) investing activities (231,757) 29,334
--------- ---------
Cash flows provided by (used in) financing activities:
Proceeds from capital lease obligations -- 1,175
Repayment of capital lease obligations (1,245) (1,657)
Proceeds from convertible subordinated notes, net of issuance costs 289,228 --
Issuance of common stock 23,287 5,966
--------- ---------
Net cash provided by financing activities 311,270 5,484
--------- ---------
Net increase in cash and cash equivalents 62,758 14,062
Cash and cash equivalents at the beginning of the period 12,780 10,532
--------- ---------
Cash and cash equivalents at the end of the period $ 75,538 $ 24,594
========= =========
See accompanying notes.
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COR THERAPEUTICS, INC.
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NOTES TO CONDENSED FINANCIAL STATEMENTS
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
COR Therapeutics, Inc. was incorporated in Delaware on February 4, 1988. COR
develops and commercializes pharmaceutical products to treat and prevent severe
cardiovascular diseases. INTEGRILIN(R) (eptifibatide) Injection is our first
product taken from discovery to commercialization.
Interim financial information
We prepared the accompanying unaudited condensed financial statements in
accordance with generally accepted accounting principles for interim financial
information and with the instructions for Form 10-Q and Article 10 of Regulation
S-X. In our opinion, these condensed financial statements include all
adjustments, consisting only of normal recurring adjustments, that we consider
necessary to fairly state the company's financial position and the results of
its operations and its cash flows. We derived the condensed balance sheet at
December 31, 1999 from the audited financial statements at that date. The
condensed balance sheet at December 31, 1999 does not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements. The accompanying condensed financial
statements should be read in conjunction with the financial statements and notes
included in our annual report on Form 10-K for the year ended December 31, 1999.
The results of operations for any interim period are not necessarily indicative
of the results of operations for any other interim period or for a full fiscal
year.
Contract revenues
Contract revenues include copromotion revenue, milestone revenue, and
development and other contract revenue. We record milestone revenue and
development and other contract revenue as earned based on the performance
requirements of the contract, and expense-related costs as they are incurred.
Other contract revenue includes recognition of reimbursement to us by
Schering-Plough Ltd. and Schering Corporation, which we refer to together as
"Schering", of certain manufacturing-related expenses for materials used outside
copromotion territories at the time the reimbursement is realizable and earned.
We generally recognize copromotion revenue when Schering ships related product
to wholesalers, net of allowances, if any, that we believe are necessary.
Copromotion revenue includes our share of profits from the sale of INTEGRILIN by
Schering, and the reimbursement by Schering of our costs of copromotion revenue,
which we record when the reimbursement is realizable and earned. Our costs of
copromotion revenue consist of certain manufacturing-related and marketing
expenses used within copromotion territories. We defer certain
manufacturing-related expenses until the time Schering ships related product to
its customers inside and outside copromotion territories. Deferred revenue
includes payments from Schering received prior to the period in which the
related contract revenues are earned.
Prepaid copromotion expenses
Prepaid copromotion expenses represent materials on-hand, valued at cost, and
prepayments to third-party suppliers associated with manufacturing-related
copromotion expenses. Prepaid copromotion expenses consist of the following (in
thousands):
September 30, December 31,
2000 1999
-------- --------
Deposits and prepayments $ 9,671 $ 5,626
Bulk materials 20,766 15,728
Finished goods 13,504 9,393
-------- --------
$ 43,941 $ 30,747
======== ========
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Other assets
Other assets represent issuance costs, net of related amortization, associated
with our sale of $300,000,000 aggregate principal amount of 5.0% convertible
subordinated notes in February 2000. These issuance costs are being amortized to
interest expense over the seven-year life of the notes.
Information concerning market and source of supply concentration
COR and Schering co-promote INTEGRILIN(R) (eptifibatide) Injection in the United
States and share any profits or losses. We have exclusively licensed Schering to
market INTEGRILIN outside the United States, and Schering pays us royalties
based on sales of INTEGRILIN outside the United States. INTEGRILIN has received
regulatory approval in the European Union as well as a number of countries
outside the European Union and the United States. We have long-term supply
arrangements with two suppliers for the bulk product and with another two
suppliers for the filling and final packaging of INTEGRILIN.
Advertising and promotion costs
Advertising and promotion costs are expensed in the period they are incurred.
Advertising and promotion costs totaled $3,859,000 and $10,751,000 for the three
and nine months ended September 30, 2000 compared to $2,419,000 and $7,930,000
for the corresponding periods in 1999.
Reclassification
We have reclassified certain prior year balances to conform to the current year
presentation.
Comprehensive income (loss)
Statement of Financial Accounting Standards No. 130, "Reporting Comprehensive
Income" requires unrealized gains and losses on available-for-sale securities to
be included in other comprehensive income (loss). Unrealized gains or losses
were not material during the three and nine months ended September 30, 2000 and
1999, and total comprehensive loss closely approximated net loss in each period.
Stock split
On August 15, 2000, we effected a two-for-one stock dividend, in which our
stockholders of record at the close of business on July 31, 2000 received one
additional share of our common stock for every share of common stock then held.
The effect of the two-for-one stock split has been reflected throughout this
report, including the share and per share amounts for all periods presented.
Segment information
Statement of Financial Accounting Standards No. 131, "Disclosures about Segments
of an Enterprise and Related Information" ("SFAS No. 131") establishes standards
for the way that public business enterprises report information about operating
segments in annual financial statements and requires that those enterprises
report selected information about operating segments in interim financial
reports. SFAS No. 131 also establishes standards for related disclosures about
products and services, geographic areas and major customers.
Our business activities include the discovery, development and commercialization
of novel cardiovascular pharmaceutical products and have been organized into one
operating segment. All of our operating assets are located in the United States.
All of our revenues are derived from within the United States, except for
royalty revenue earned on sales of INTEGRILIN by Schering outside of the United
States.
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Recent accounting pronouncements
In December 1999, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 101, "Revenue Recognition in Financial Statements" ("SAB 101"). The
Commission has subsequently amended SAB 101 twice to postpone the effective date
of implementation to the fourth fiscal quarter of 2000. SAB 101 summarizes
certain areas of the Staff's views in applying generally accepted accounting
principles to revenue in financial statements and specifically addresses revenue
recognition for non-refundable up-front fees received in connection with
collaboration agreements. We are currently evaluating the impact of SAB 101 on
our revenue recognition policy related to milestone and license fees received
from Schering.
In June 1998, the Financial Accounting Standards Board issued Statement of
Financial Accounting Standards No. 133, "Accounting for Derivative Instruments
and Hedging Activities" ("SFAS No. 133"). SFAS No. 133 requires us to recognize
all derivatives on the balance sheet at fair value. Derivatives that are not
hedges must be adjusted to fair value through net income. SFAS No. 133 is
effective for the year ending December 31, 2001. We do not currently hold any
derivatives and do not anticipate holding any derivatives in the future.
Accordingly, we do not expect this pronouncement to materially impact results of
future operations.
2. FINANCIAL INSTRUMENTS
We used the following methods and assumptions in estimating the fair value
disclosures for financial instruments:
Cash and cash equivalents: The carrying amount of cash and cash equivalents
reported on the balance sheet approximates its fair value.
Short-term investments: Short-term investments consist of marketable government
and other debt securities and are classified as available-for-sale. These
investments are carried at fair value and any unrealized gains and losses are
reported in a separate component of stockholders' equity. The fair values are
based upon quoted market prices.
At September 30, 2000, the amortized cost and estimated fair value of short-term
investments, classified by contractual maturity, are (in thousands):
Amortized Estimated
Cost Fair Value
---------- ----------
Due in one year or less $161,976 $162,021
Due after one year and in less than 101,998 102,465
three years
---------- ----------
$263,974 $264,486
========== ==========
During the three and nine months ended September 30, 2000, we sold short-term
investments with a fair value of $28,979,000 and $68,443,000 resulting in gross
realized gains of $53,000 and $136,000 and gross realized losses of $0 and
$21,000, respectively.
Long and short-term debt: The carrying amounts of borrowings under secured debt
agreements approximate their fair values. The fair values are estimated using a
discounted cash flow analysis based on current incremental borrowing rates for
similar types of borrowing arrangements.
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3. EARNINGS PER SHARE
In accordance with Statement of Financial Accounting Standards No. 128,
"Earnings Per Share" we have computed basic net income (loss) per share using
the weighted average number of shares of common stock outstanding during the
period. Diluted net income (loss) per share also includes the effect of any
potentially dilutive securities, consisting of stock options for the three
months ended September 30, 1999. Had we been in a net income position during the
three months ended September 30, 2000 or the nine months ended September 30,
2000 and 1999, diluted earnings per share (EPS) would have included the shares
used in the computation of basic net income per share as well as the impact of
5,553,000, 6,032,000 and 2,240,000 net shares issued upon the assumed exercise
of outstanding stock options. We have excluded the impact of our convertible
subordinated notes from the computation of diluted shares outstanding because
the impact of an assumed conversion of these convertible notes is anti-dilutive
for all periods presented. The following is a reconciliation of the numerators
and denominators of the basic and diluted EPS computations for the three and
nine months ended September 30, 2000 and 1999 (in thousands).
Three Months Nine Months
Ended September 30, Ended September 30,
----------------------- -----------------------
2000 1999 2000 1999
-------- -------- -------- --------
Numerator for basic and diluted EPS:
Net income (loss) $ (1,221) $ 750 $(17,659) $(20,754)
======== ======== ======== ========
Denominator:
Denominator for basic EPS -
weighted-average shares 54,067 49,940 52,969 49,386
Effect of dilutive securities -
stock options -- 4,052 -- --
-------- -------- -------- --------
Denominator for diluted EPS - adjusted
weighted-average shares and assumed
conversions 54,067 53,992 52,969 49,386
======== ======== ======== ========
4. CONVERTIBLE SUBORDINATED NOTES
In February 2000 we completed a private placement of $300,000,000 aggregate
principal amount of 5.0% convertible subordinated notes due March 1, 2007. The
notes are unsecured and subordinated in right of payment to all existing and
future senior debt as defined in the indenture governing the notes. We pay
interest on the notes semi-annually on March 1 and September 1 of each year. The
conversion rate is 29.6056 shares of common stock per $1,000 principal amount of
notes. This is equivalent to a conversion price of $33.78 per share. The
conversion rate is subject to adjustment in certain events. We have reserved
8,880,000 shares of authorized common stock for issuance upon conversion of the
notes. We may redeem the notes on or after March 1, 2003 and prior to maturity,
at a premium. We incurred issuance costs related to this offering of
approximately $10,800,000, including placement fees and commissions. These
issuance costs are recorded as other assets and are being amortized to interest
expense over the seven-year life of the notes.
5. CONTINGENCIES
In October 1997 a patent opposition was filed in Europe by another company
against the claims of a patent granted to us in Europe covering broad, generic
claims for INTEGRILIN(R) (eptifibatide) Injection, as well as numerous related
compounds that are not part of our core technology. The opposition asserts that
all claims of the patent are unpatentable. In July 2000 the Opposition Division
of the European Patent Office confirmed the validity of our patent claims
without requiring us to limit or otherwise amend our claims. The opposition has
not yet exhausted its ability to appeal this decision.
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COR THERAPEUTICS, INC.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
In addition to historical information, this report contains forward-looking
statements regarding the Company's performance that involve risks and
uncertainties. Actual results may differ materially from the anticipated results
discussed in such forward-looking statements, due to factors such as the
commercial success of INTEGRILIN(R) (eptifibatide) Injection and other factors
discussed below and under the caption "Risk Factors." Forward-looking statements
are based on our current expectations, and we do not intend to update such
information to reflect future events or developments.
OVERVIEW
COR develops and commercializes pharmaceutical products to treat and prevent
severe cardiovascular diseases. INTEGRILIN is our first product taken from
discovery to commercialization. In May 1998 the United States Food and Drug
Administration approved INTEGRILIN to treat patients who undergo a procedure
known as angioplasty to open blood vessels. The FDA has also approved INTEGRILIN
to treat patients with intermittent chest pains known as unstable angina and
patients suffering from a kind of heart attack known as non-Q-wave myocardial
infarction, whether the doctor intends to treat these patients with medicines
alone or with a subsequent angioplasty. INTEGRILIN is the only drug in its class
that the FDA has approved for use in all these indications.
COR and Schering co-promote the drug in the United States and share any profits
or losses. We have exclusively licensed Schering to market INTEGRILIN outside
the United States, and Schering pays us royalties based on sales of INTEGRILIN
outside the United States. INTEGRILIN has also received regulatory approval in a
number of countries outside the European Union and the United States.
COR and Schering are conducting or have conducted clinical trials of INTEGRILIN
with different drugs that dissolve blood clots in patients suffering heart
attacks. COR and Schering also sponsor clinical trials of INTEGRILIN in a
variety of clinical settings.
In addition to our commercial activities we continue to pursue a wide array of
research and development programs. We are developing an oral drug, called
cromafiban, to prevent blood clotting. We have shown in clinical trials that
cromafiban remains active in the body long enough to allow patients to take the
drug only once a day. We also observed in these trials that the level of
activity of the drug in the body does not vary greatly throughout a twenty-four
hour period, and that the drug can be taken with or without food. The most
common complication we observed during these trials was minor bleeding. We also
are conducting preclinical research and development in several other
cardiovascular programs.
RESULTS OF OPERATIONS
Three and nine months ended September 30, 2000 and 1999
Total contract revenues, which include copromotion, milestone and development
and other contract revenue, were $29,913,000 and $72,891,000 for the three and
nine months ended September 30, 2000 compared to $23,470,000 and $39,998,000 for
the corresponding periods in 1999. Copromotion revenue related to the sales of
INTEGRILIN by Schering was $27,840,000 and $67,725,000 for the three and nine
months ended September 30, 2000 compared to $9,711,000 and $22,823,000 for the
corresponding periods in 1999.
Total sales of INTEGRILIN, as reported to us by Schering, were $51,794,000 and
$121,282,000 for the three and nine months ended September 30, 2000, compared to
$17,200,000 and $43,900,000 for the corresponding periods in 1999. Product sales
reported by Schering for any period are not necessarily indicative of product
sales for any future period.
Of the total reported for the three months ended September 30, 2000, sales of
INTEGRILIN in the United States were $48,000,000, an increase of $9,100,000 over
sales of INTEGRILIN in the United States for the three months ended June 30,
2000. Approximately half of the quarter-to-quarter increase of $9,100,000 in
sales in the United States
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COR THERAPEUTICS, INC.
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was attributable to overall market growth as well as increased market share for
INTEGRILIN(R) (eptifibatide) Injection. The remainder may have been due to some
inventory stocking at the wholesaler level. In contrast to the third quarter
results from previous years, the total number of patients treated with a GP
IIb-IIIa inhibitor increased over the second quarter and INTEGRILIN increased
its share of those patients.
Milestone revenue for the three and nine months ended September 30, 1999
includes $12,000,000 related to the marketing authorization granted to
INTEGRILIN in the European Union for certain indications. No milestone revenue
was recognized for the three and nine months ended September 30, 2000.
Development and other contract revenue was $2,073,000 and $5,166,000 for the
three and nine months ended September 30, 2000 compared to $1,759,000 and
$5,175,000 for the corresponding periods in 1999. Development and other contract
revenue varies due to fluctuations in clinical trial and other development
activities. We expect total contract revenues to continue to fluctuate in the
future.
Cost of copromotion revenue was $14,034,000 and $37,302,000 for the three and
nine months ended September 30, 2000 compared to $6,885,000 and $14,081,000 for
the corresponding periods in 1999, consistent with increased sales of INTEGRILIN
in 2000. Cost of copromotion revenue includes certain manufacturing-related and
marketing expenses incurred in connection with our collaboration with Schering.
Research and development expenses were $10,246,000 and $32,990,000 for the three
and nine months ended September 30, 2000 compared to $8,755,000 and $28,613,000
for the corresponding periods in 1999. The increase in 2000 compared to 1999 was
due to the timing of clinical trial activities and to increases in headcount and
other research, development and clinical activities associated with product
candidates. Research and development expenses are expected to increase over the
next several years, although the timing of certain of these expenses may depend
on the timing and phase of, and indications pursued in, additional clinical
trials of INTEGRILIN and product candidates in development.
Marketing, general and administrative expenses were $8,082,000 and $23,490,000
for the three and nine months ended September 30, 2000, compared to $7,651,000
and $19,957,000 for the corresponding periods in 1999. The increase in 2000 was
primarily due to the addition of marketing and sales personnel for the
commercialization of INTEGRILIN, as well as increased staffing and
administrative expenses associated with general corporate activities. We expect
marketing, general and administrative costs to continue to increase over the
next several years.
Interest income (net) was $1,228,000 and $3,232,000 for the three and nine
months ended September 30, 2000 compared to $571,000 and $1,899,000 for the
corresponding periods in 1999. The increase in 2000 compared to 1999 was
primarily due to changes in average cash and investment balances and average
outstanding debt obligations, including the issuance of $300,000,000 aggregate
principal amount of 5.0% convertible subordinated notes in February 2000. See
"Note 4 of Notes to Condensed Financial Statements".
LIQUIDITY AND CAPITAL RESOURCES
We had available cash, cash equivalents and short-term investments of
$340,024,000 at September 30, 2000. Cash in excess of immediate requirements is
invested with the primary objective of preserving principal while at the same
time maximizing yields without significantly increasing risk. We have funded our
operations primarily through public and private debt and equity financings and
proceeds from research and development and commercialization collaboration
agreements. Additional funding has come from grant revenues, interest income and
property and equipment financings.
Net cash used in operating activities and additions to property and equipment
was $17,614,000 for the nine months ended September 30, 2000, compared to
$22,075,000 for the nine months ended September 30, 1999. The decrease in 2000
compared to 1999 was primarily due to the timing of activities related to our
agreement with Schering and to the effect of reduced losses from operations.
Cash requirements for operating activities and additions to property and
equipment may increase in future periods. The timing of these cash requirements
may vary from period to period depending on the timing and phase of, and
indications pursued in, additional clinical trials of INTEGRILIN and other
product candidates in development and depending on our debt service obligations.
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Cash provided by financing activities was $311,270,000 for the nine months ended
September 30, 2000 compared to $5,484,000 for the nine months ended September
30, 1999. The increase in 2000 compared to 1999 is the result of the issuance of
$300,000,000 aggregate principal amount of 5.0% convertible subordinated notes
in February 2000. See "Note 4 of Notes to Condensed Financial Statements".
We expect our cash requirements will increase in future periods due to
anticipated expansion of research and development, including clinical trials,
increased marketing, sales, and general and administrative activities and to
interest expense on our convertible subordinated notes. Existing capital
resources and interest earned thereon are expected to meet these increased cash
requirements for the next several years. However, cash requirements may change
depending on numerous factors, including the progress of anticipated research
and development programs, the scope and results of preclinical and clinical
studies and the number and nature of the indications pursued in clinical
studies. Cash requirements may also change due to the timing of regulatory
approvals, technological advances, determinations as to the commercial potential
of future products and the status of competitive products. Finally, the
establishment and maintenance of collaboration relationships with other
companies, the availability of financing and other unexpected factors may
require additional funds that may not be available on favorable terms, if at
all.
RISK FACTORS
Our business faces significant risks. Stockholders and potential investors in
our securities should carefully consider the following risk factors, in addition
to other information in this report. We are identifying these risk factors as
important factors that could cause our actual results to differ materially from
those contained in any forward-looking statements made by or on behalf of us.
These risks may not be the only risks we face. Additional risks that we do not
yet know of or that we currently think are immaterial also may impair our
business. We are relying upon the safe-harbor for forward-looking statements and
any such statements made by or on behalf of COR are qualified by reference to
the following cautionary statements, as well as to those set forth elsewhere in
this report.
RISKS RELATED TO OUR DRUG DEVELOPMENT AND COMMERCIALIZATION ACTIVITIES
If INTEGRILIN(R) (eptifibatide) Injection does not achieve commercial success,
we will not be able to generate the revenues necessary to support our business.
Our business depends on the commercial success of INTEGRILIN, which has been on
the market in the United States only two years and currently is our only
marketed product. Marketing outside the United States commenced only within the
last year and INTEGRILIN has not yet achieved acceptance in foreign markets.
Although sales of INTEGRILIN have increased since its launch, if they fail to
continue to increase over current levels, our business will not become
profitable, and we will be forced to scale back our operations and research and
development programs.
We may not be able to compete effectively in the cardiovascular disease market.
Due to the incidence and severity of cardiovascular diseases, the market for
therapeutic products that address these diseases is large, and competition is
intense and expected to increase. Our most significant competitors are major
pharmaceutical companies and more established biotechnology companies. The two
products that compete with INTEGRILIN are ReoPro(R), which is produced by
Johnson & Johnson and sold by Johnson & Johnson and Eli Lilly & Co., and
Aggrastat(R), which is produced and sold by Merck & Co., Inc. In addition, F.
Hoffman-La Roche, Ltd. is currently developing a product, lamifiban, to treat
patients with symptoms of unstable angina. If the FDA approves lamifiban, it may
also directly compete with INTEGRILIN. Our competitors operate large,
well-funded cardiovascular research and development programs and have
significant expertise in manufacturing, testing, regulatory matters and
marketing. We also must compete with academic institutions, governmental
agencies, and other public and private research organizations that conduct
research in the cardiovascular field, seek patent protection for their
discoveries and establish collaborative arrangements for product and clinical
development and marketing.
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We may not be able to obtain the regulatory approvals necessary to market new
products and market of INTEGRILIN(R) (eptifibatide) Injection for additional
therapeutic uses.
We must satisfy stringent governmental regulations in order to develop,
commercialize and market our products. INTEGRILIN is the only product we have
submitted to the FDA for approval for commercial sale, and it has been approved
for a specific set of therapeutic uses. To grow our business, we will need to
obtain regulatory approval to be able to promote INTEGRILIN for additional
therapeutic uses and to commercialize new product candidates. A company cannot
market a pharmaceutical product in the United States until it has completed
rigorous pre-clinical testing and clinical trials of the product and an
extensive regulatory clearance process that the FDA implements. It typically
takes many years to satisfy regulatory requirements, depending upon the type,
complexity and novelty of the product. The process is very expensive. Of
particular significance are the requirements covering research and development,
testing, manufacturing, quality control, labeling and promotion of drugs for
human use.
Before we can receive FDA clearance to market a product, we must demonstrate
that the product is safe and effective for the patient population that will be
treated. Pre-clinical and clinical data are susceptible to varying
interpretations that could delay, limit or prevent regulatory clearances. In
addition, we may encounter delays or rejections from additional government
regulation, from future legislation or administrative action or changes in FDA
policy during the period of product development, clinical trials and FDA
regulatory review. Failure to comply with applicable FDA or other applicable
regulatory requirements may result in criminal prosecution, civil penalties,
recall or seizure of products, total or partial suspension of production or
injunction, as well as other regulatory action against our potential products or
us. If a product receives regulatory clearance, its marketing will be limited to
those disease states and conditions for which clinical trials demonstrate that
the product is safe and effective. Any compound we develop may not prove to be
safe and effective in clinical trials and may fail to meet all of the regulatory
requirements needed to receive marketing clearance.
Outside the United States, our ability to market a product depends on our
receiving a marketing authorization from the appropriate regulatory authorities.
This foreign regulatory approval process includes all of the risks associated
with FDA clearance described above.
We depend on our collaborative relationship with Schering to market and sell
INTEGRILIN, and our business will suffer if Schering fails to perform under the
collaboration.
Our strategy is to work with collaborative partners to develop product
candidates and commercialize products. Generally, collaborations with
established pharmaceutical companies provide funding for product development and
the benefit of an established sales and marketing organization. In particular,
our ability to successfully commercialize INTEGRILIN depends on our
collaboration with Schering. Under this collaboration, Schering has agreed to:
- co-market INTEGRILIN with us in the United States and market the product
as our exclusive licensee in certain other markets, including Europe;
- share the profits and pay royalties to us on sales of INTEGRILIN;
- design and conduct advanced clinical trials;
- fund promotional activities with us; and
- pay us fees upon achievement of certain milestones.
Schering's performance under the collaboration is outside our control. If
Schering fails to perform its obligations diligently and in a timely manner,
commercialization of INTEGRILIN will be impaired and our business will not
become profitable.
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If we do not establish additional collaborative relationships, our ability to
develop and commercialize new products will be impaired.
In addition to INTEGRILIN(R) (eptifibatide) Injection, we have various product
candidates in preclinical and clinical trials and other product candidates in
various stages of research and development. We are a party to numerous research
agreements related to these product candidates, most of which do not contemplate
taking a product candidate through development and commercialization. We will
need to enter into additional collaborations to develop and commercialize these
and additional product candidates. We face significant competition in seeking
appropriate collaborative partners. Negotiating these arrangements is complex
and time consuming. If we are successful in establishing a collaboration, the
collaboration may not be successful. If we fail to establish collaborative
partnerships for our product candidates, we may have to terminate, delay or cut
back development programs.
If our clinical trials are unsuccessful, or if they experience significant
delays, our ability to commercialize products will be impaired.
We must provide the FDA and foreign regulatory authorities with preclinical and
clinical data that demonstrate that our products are safe and effective before
they can be approved for commercial sale. Clinical development, including
preclinical testing, is a long, expensive and uncertain process. It may take us
several years to complete our testing, and failure can occur at any stage of
testing. Interim results of preclinical or clinical studies do not necessarily
predict their final results, and acceptable results in early studies might not
be seen in later studies. Any preclinical or clinical test may fail to produce
results satisfactory to the FDA. Preclinical and clinical data can be
interpreted in different ways, which could delay, limit or prevent regulatory
approval. Negative or inconclusive results from a preclinical study or clinical
trial or adverse medical events during a clinical trial could cause a
preclinical study or clinical trial to be repeated or a program to be
terminated, even if other studies or trials relating to the program are
successful.
We may not complete our planned preclinical or clinical trials on schedule or at
all. In addition, due to the substantial demand for clinical trial sites in the
cardiovascular area, we may have difficulty obtaining a sufficient number of
appropriate patients or clinician support to conduct our clinical trials as
planned. If so, we may have to expend substantial additional funds to obtain
access to resources or delay or modify our plans significantly. Our product
development costs will increase if we have delays in testing or approvals.
Significant clinical trial delays could allow our competitors to bring products
to market before we do and impair our ability to commercialize our product or
potential products. Even if regulators approve a product for marketing, it may
not be commercially successful.
If our third party manufacturers fail to deliver sufficient quantities of
INTEGRILIN or product candidates on schedule, we may be unable to meet demand
for INTEGRILIN and may experience delays in product development.
We have no manufacturing facilities and, accordingly, rely on third parties for
clinical and commercial production of INTEGRILIN and for clinical production of
product candidates. We have only two manufacturers producing bulk product, and
two manufacturers performing packaging, of INTEGRILIN. We have additional
manufacturers producing product candidates for clinical trials. If the
third-party manufacturers or suppliers were to cease production or otherwise
fail to supply us, or if we were unable to renew our manufacturing contracts or
contract for additional manufacturing services on acceptable terms, our ability
to produce INTEGRILIN and to conduct preclinical testing and clinical trials of
product candidates would be impaired. If we do not have adequate supplies of
INTEGRILIN to meet market demand, we may lose potential revenues, and the health
care community may turn to competing products. If we cannot obtain adequate
supplies of product candidates for preclinical and clinical trials, regulatory
approval and development of product candidates may be delayed.
Our ability to generate revenues will be diminished if we fail to obtain
acceptable prices or an adequate level of reimbursement from third party payors.
Health care insurers, including the United States Health Care Financing
Administration, managed care providers, private health insurers and other
organizations set aggregate dollar amounts that they will reimburse to hospitals
for
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the medicines and care the hospitals administer to treat particular conditions.
These insurers adjust the amounts periodically, and could lower the amount that
they will reimburse hospitals to treat the conditions for which the FDA has
approved of INTEGRILIN(R) (eptifibatide) Injection. If they do, pricing levels
or sales volumes of INTEGRILIN may decrease and cause a reduction in sales and a
loss of potential revenues. In foreign markets a number of different
governmental and private entities determine the level at which hospitals will be
reimbursed for administering INTEGRILIN to insured patients. If these levels are
set, or reset, too low, it may not be possible to sell INTEGRILIN at a profit in
these markets. Each of our product candidates, if approved for marketing, will
face the same risk.
If we are unable to protect our patents and proprietary rights, we may not be
able to compete successfully.
We rely on patent and trade secret protection for significant new technologies,
products and processes because of the long development time, uncertainty and
high cost associated with bringing a new product to the marketplace. Our success
will depend in part on our ability to obtain and enforce patent protection for
our technology both in the United States and other countries. While we are
seeking and/or maintaining patents for INTEGRILIN and our product candidates,
patents may not issue and issued patents may afford limited or no protection.
We may be required to obtain licenses to patents or other proprietary rights
from third parties. Licenses required under any patents or proprietary rights
may not be made available on terms acceptable to us, if at all. If we do not
obtain required licenses, we may encounter delays in product development while
attempting to redesign products or methods or we could find the development,
manufacture or sale of such products requiring licenses to be foreclosed.
Further, we could incur substantial costs in defending any patent litigation
brought against us or in asserting our patent rights, including those rights
licensed to us by others.
If product liability lawsuits are successfully brought against us, we may incur
substantial liabilities.
The testing, marketing and sale of human pharmaceutical products expose us to
significant and unpredictable risks of product liability claims in the event
that the use of our technology or products is alleged to have resulted in
adverse effects. Our products are administered to patients with serious
cardiovascular disease who have a high incidence of mortality. A successful
product liability suit against us could impair our financial condition and force
us to limit commercialization of products.
If we do not attract and retain key employees and consultants, our business
could be impaired.
We are highly dependent on the principal members of our scientific and
management staff. In addition, we rely on consultants to assist us in
formulating our research and development strategy. Attracting and retaining
qualified personnel is critical to our success. Competition for scientific and
managerial personnel is particularly intense in the San Francisco Bay Area where
we, together with numerous other life sciences companies, universities and
research institutions, maintain our operations. Failure to continue to attract
these individuals, or the loss of key personnel, could impair the progress of
our programs.
RISKS RELATED TO OUR FINANCES
We have a history of operating losses and are uncertain of future profitability.
Historically, our expenses have exceeded our revenues. As of September 30, 2000,
we had an accumulated deficit of approximately $232,893,000. The extent of
future losses and timing of future profitability are uncertain, even taking into
account our share of revenues from sales of INTEGRILIN. We continue to incur
significant expenses for research and development and to develop, train,
maintain and manage our sales force, and these expenses continue to exceed our
share of INTEGRILIN product revenues. We may never achieve profitability.
If we fail to obtain needed funds, we will be unable to successfully develop and
commercialize products.
We will require significant funds to market INTEGRILIN and conduct the costly
and time-consuming research, preclinical testing and clinical trials necessary
to develop and optimize our technology and potential products, to
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establish manufacturing, marketing and sales capabilities for product candidates
and to bring any such products to market. We may raise these funds through
public or private equity offerings, debt financings or additional corporate
collaborations and licensing arrangements. We may find that additional funding
may not be available to us when we need it, on acceptable terms or at all.
If we raise capital by issuing equity securities, our stockholders may
experience dilution. To the extent we raise additional funds through
collaborative arrangements, we may be required to relinquish some rights to our
technologies or product candidates or grant licenses on terms that are not
favorable to us. If we are unable to obtain adequate funding when needed,
commercialization of INTEGRILIN(R) (eptifibatide) Injection may be impaired and
we may be required to curtail one or more development programs.
Our indebtedness and debt service obligations may adversely affect our cash
flow.
At September 30, 2000 we had $303,301,000 of outstanding debt, including
primarily our convertible subordinated notes. During each of the last five years
and the nine months ended September 30, 2000, our earnings were insufficient to
cover our fixed charges and are likely to continue to be insufficient to cover
fixed charges for at least 12 months. During each of the next three years, our
debt service obligations on our convertible subordinated notes will be
approximately $15 million in interest payments. If we are unable to generate
sufficient cash to meet these obligations and have to use other cash reserves,
we may have to delay or curtail research and development programs.
We intend to fulfill our debt service obligations both from cash generated by
our operations and from our general fund. We may add additional lease lines to
finance capital expenditures and may obtain additional long-term debt and lines
of credit.
Our indebtedness could have significant additional negative consequences,
including:
- increasing our vulnerability to general adverse economic and industry
conditions;
- limiting our ability to obtain additional financing;
- requiring the dedication of a substantial portion of our expected cash
flow from operations to service our indebtedness, thereby reducing the
amount of our expected cash flow available for other purposes, including
capital expenditures;
- limiting our flexibility in planning for, or reacting to, changes in our
business and the industry in which we compete; and
- placing us at a possible competitive disadvantage to less leveraged
competitors and competitors that have better access to capital
resources.
RISKS RELATED TO AN INVESTMENT IN OUR SECURITIES
Our common stock price is volatile, and an investment in our securities could
suffer a decline in value.
Our stock price has been highly volatile and may continue to be highly volatile
in the future. Our stock price depends on a number of factors, some of which are
beyond our control, which could cause the market price of our common stock to
fluctuate substantially. These factors include:
- fluctuations in our financial and operating results;
- whether our financial results are consistent with securities analysts'
expectations;
- the results of preclinical and clinical trials;
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- announcements of technological innovations or new commercial products by
us or our competitors;
- developments concerning proprietary rights; and
- publicity regarding actual or potential performance of products under
development by us or our competitors.
In the past, stockholders have filed securities class action lawsuits against
companies after the market price of the company's stock has fallen
precipitously. Such a lawsuit could cause us to incur significant defense costs
and divert management's attention and other resources. Any adverse determination
could subject us to significant liabilities.
In addition, the stock market in general has from time to time experienced
extreme price and volume fluctuations. These broad market fluctuations may lower
the market price of our common stock. Moreover, during periods of stock market
price volatility, share prices of many biotechnology companies have often
fluctuated in a manner not necessarily related to the companies' operating
performance. Accordingly, our common stock may be subject to greater price
volatility than the stock market as a whole and you could lose all or part of
your investment.
Because our convertible subordinated notes are convertible into shares of our
common stock, their value may be affected by these factors as well.
Anti-takeover provisions in our charter documents and under Delaware law may
make it more difficult to acquire us, even though an acquisition may be
beneficial to our stockholders.
Provisions of our certificate of incorporation and bylaws could make it more
difficult for a third party to acquire us, even if doing so would benefit our
stockholders. These provisions:
- authorize the issuance of "blank check" preferred stock that could be
issued by our board of directors to increase the number of outstanding
shares and thwart a takeover attempt; and
- limit who may call a special meeting of stockholders.
In January 1995, our board of directors adopted a preferred share purchase
rights plan, commonly known as a "poison pill." The provisions described above,
our poison pill and provisions of the Delaware General Corporation Law relating
to business combinations with interested stockholders may discourage, delay or
prevent a third party from acquiring us, even if our stockholders might receive
a premium for their shares in the acquisition over then current market prices.
ITEM 3. FINANCIAL MARKET RISKS
We are exposed to interest rate risk on our investments of excess cash. The
primary objective of our investment activities is to preserve principal while at
the same time maximizing yields without significantly increasing risk. To
achieve this objective, we invest in highly liquid and high quality government
and other debt securities. To minimize the exposure due to adverse shifts in
interest rates, we invest in short-term securities with maturities of less than
three years. If a 10% change in interest rates were to have occurred on
September 30, 2000, such a change would not have had a material effect on the
fair value of the investment portfolio as of that date. Due to the short holding
period of short-term investments, we have concluded that we do not have a
material financial market risk exposure.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In October 1997 a patent opposition was filed in Europe by another company
against the claims of a patent granted to us in Europe covering broad, generic
claims for INTEGRILIN(R) (eptifibatide) Injection, as well as numerous related
compounds that are not part of our core technology. The opposition asserts that
all claims of the patent are unpatentable. In July 2000 the Opposition Division
of the European Patent Office confirmed the validity of our patent claims
without requiring us to limit or otherwise amend our claims. The opposition has
not yet exhausted its ability to appeal this decision.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
EXHIBITS
Number Exhibit
------ -------
3.1 Restated Certificate of Incorporation of the Registrant, as
amended through June 9, 2000.
10.1 Amendment dated July 27, 2000 to Second Amendment to Collaboration
Agreement, dated November 5, 1999, between Schering-Plough Ltd.
and Schering Corporation and the Registrant.
10.2 Amendment dated August 31, 2000 to Second Amendment to
Collaboration Agreement, dated November 5, 1999, between
Schering-Plough Ltd. and Schering Corporation and the Registrant.
10.3 (1) Registrant's 1991 Equity Incentive Plan, as amended July 28, 2000.
27.1 Financial Data Schedule.
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(1) Filed as an exhibit to the Registrant's Registration Statement on Form
S-8 (Reg No. 333-48668) and incorporated herein by reference.
REPORTS ON FORM 8-K
There were no reports on Form 8-K filed for the three months ended September 30,
2000.
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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.
Date: November 8, 2000
COR THERAPEUTICS, INC.
Signature Title
- --------------------------- ----------------------------------------------------------
/s/ VAUGHN M. KAILIAN President, Chief Executive Officer and Director
- --------------------------- (Principal Executive Officer)
Vaughn M. Kailian
/s/ PETER S. RODDY Senior Vice President, Finance and Chief Financial Officer
- --------------------------- (Principal Financial Officer)
Peter S. Roddy
/s/ JOHN M. SCHEMBRI Director, Finance and Controller
- --------------------------- (Principal Accounting Officer)
John M. Schembri
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EXHIBITS LIST
Number Exhibit
------ -------
3.1 Restated Certificate of Incorporation of the Registrant, as
amended through June 9, 2000.
10.1 Amendment dated July 27, 2000 to Second Amendment to Collaboration
Agreement, dated November 5, 1999, between Schering-Plough Ltd.
and Schering Corporation and the Registrant.
10.2 Amendment dated August 31, 2000 to Second Amendment to
Collaboration Agreement, dated November 5, 1999, between
Schering-Plough Ltd. and Schering Corporation and the Registrant.
10.3 (1) Registrant's 1991 Equity Incentive Plan, as amended July 28, 2000.
27.1 Financial Data Schedule.
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(1) Filed as an exhibit to the Registrant's Registration Statement on Form
S-8 (Reg No. 333-48668) and incorporated herein by reference.