<PAGE>
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
( X ) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended MARCH 31, 1998.
( ) 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: 0-21643
------------------------------
CV THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 43-1570294
(State of Incorporation) (I.R.S. Employer Identification No.)
3172 PORTER DRIVE, PALO ALTO, CA 94304
(Address of principal executive offices)
Registrant's telephone number, including area code: (650) 812-0585
Indicate by check whether the Registrant (1) has filed all reports 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 May 04, 1998, there were 11,054,408 shares of the issuer's Common Stock,
$0.001 par value, outstanding.
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<PAGE>
CV THERAPEUTICS, INC.
INDEX
PART I. FINANCIAL INFORMATION
<TABLE>
<CAPTION>
<S> <C>
ITEM 1. FINANCIAL STATEMENTS
Consolidated Balance Sheets as of March 31, 1998 and December 31, 1997 3
Consolidated Statements of Operations for the three months ended
March 31, 1998 and 1997 4
Consolidated Statements of Cash Flows for the three months ended March 31, 1998
and 1997 5
Notes to Consolidated Financial Statements 6
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 8
PART II. OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS 11
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 11
SIGNATURES 12
</TABLE>
2
<PAGE>
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CV THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands)
<TABLE>
<CAPTION>
March 31, 1998 December 31, 1997
----------------- -----------------
(unaudited) (Note 1)
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 13,040 $ 6,286
Short-term investments 6,824 11,862
Other current assets 1,377 1,249
----------------- -----------------
Total current assets 21,241 19,397
Long-term investments 32,742 19,942
Notes receivable from related parties 413 413
Property and equipment, net 2,198 2,277
Intangible and other assets 268 615
----------------- -----------------
$ 56,862 $ 42,644
----------------- -----------------
----------------- -----------------
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 405 $ 683
Accrued liabilities 1,645 1,572
Current portion of long-term debt 2,000 1,500
Current portion of capital lease obligation - 680
Deferred revenue 1,901 2,000
----------------- -----------------
Total current liabilities 5,951 6,435
Long-term debt 4,000 4,500
Capital lease obligation - 552
Deferred revenue - 4,009
Other liabilities 556 591
----------------- -----------------
Total liabilities 10,507 16,087
Commitments
Stockholders' equity:
Common stock 103,713 84,037
Warrants to purchase Common Stock 1,225 1,225
Notes receivable issued for stock (108) (108)
Deferred compensation (1,446) (1,649)
Unrealized (loss) gain on investments (23) 3
Accumulated deficit (57,006) (56,951)
----------------- -----------------
Total stockholders' equity 46,355 26,557
----------------- -----------------
$ 56,862 $ 42,644
----------------- -----------------
----------------- -----------------
</TABLE>
See accompanying notes
3
<PAGE>
CV THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
<TABLE>
<CAPTION>
Three Months Ended March 31,
1998 1997
------------- -------------
<S> <C> <C>
Revenues:
Collaborative research $ 4,183 $ 820
Operating expenses:
Research and development 3,336 1,790
General and administrative 1,008 1,021
------------- -------------
Total operating expenses 4,344 2,811
Loss from operations (161) (1,991)
Interest and other income (expense), net 106 106
------------- -------------
Net loss $ (55) $ (1,885)
------------- -------------
------------- -------------
Basic and diluted net loss per share $ (0.01) $ (0.30)
------------- -------------
------------- -------------
Shares used in computing basic and diluted
net loss per share 10,221 6,346
------------- -------------
------------- -------------
</TABLE>
See accompanying notes
4
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CV THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(unaudited)
<TABLE>
<CAPTION>
Three Months Ended March 31,
1998 1997
---------- ----------
<S> <C> <C>
Cash flows from operating activities:
Net loss $ (55) $ (1,885)
Adjustments to reconcile net loss to net cash used in
operating activities:
Amortization of deferred compensation 163 145
Depreciation and amortization 257 269
Change in assets and liabilities:
Other current assets (128) (112)
Intangible and other assets 347 -
Accounts payable (278) (234)
Accrued and other liabilities 38 (193)
Deferred revenue (4,108) 7,000
---------- ----------
Net cash provided by (used in) operating activities (3,764) 4,990
Cash flows from investing activities:
Purchases of investments (13,860) (17,104)
Maturities of investments 6,000 1,993
Capital expenditures (107) (31)
---------- ----------
Net cash used in investing activities (7,967) (15,142)
Cash flows from financing activities:
Payments on capital lease obligations (1,232) (304)
Borrowings under long-term debt - 3,000
Repayments of long-term debt - (15)
Proceeds from issuance of common stock 19,717 5,181
---------- ----------
Net cash provided by financing activities 18,485 7,862
---------- ----------
Net increase (decrease) in cash and cash equivalents 6,754 (2,290)
Cash and cash equivalents at beginning of period 6,286 19,575
---------- ----------
Cash and cash equivalents at end of period $ 13,040 $ 17,285
---------- ----------
---------- ----------
</TABLE>
See accompanying notes
5
<PAGE>
CV THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1998
(UNAUDITED)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying condensed consolidated financial statements of CV
Therapeutics, Inc. have been prepared in accordance with generally accepted
accounting principles, are unaudited and reflect all adjustments (consisting
solely of normal recurring adjustments) which are, in the opinion of
management, necessary to present fairly the financial position at and results
of operations for the interim periods presented. The results of operations
for the three-month periods ended March 31, 1998 are not necessarily
indicative of the results to be expected for the entire year ending December
31, 1998. The financial information included herein should be read in
conjunction with the Company's Annual Report on Form 10-K for 1997 which
includes the audited consolidated financial statements and the notes thereto
for the year ended December 31, 1997.
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of the Company
and its wholly-owned subsidiary, CV Therapeutics International, which was
incorporated in December 1993 in the Cayman Islands. All significant
intercompany balances have been eliminated.
REVENUE RECOGNITION
Revenue under the Company's collaborative research arrangements is recognized
as based on the performance requirements of the contract. Payments received,
which are still subject to future performance requirements, are recorded as
deferred revenue until earned.
NET LOSS PER SHARE
Net loss per share is computed using the weighted average number of common
shares outstanding. Common equivalent shares are excluded from the
computation as their effect is antidilutive.
2. NEW ACCOUNTING STANDARDS
As of January 1, 1998, the Company adopted Statement 130 (SFAS 130),
"Reporting Comprehensive Income". SFAS 130 establishes new rules for the
reporting and display of comprehensive income and its components; however,
the adoption of SFAS 130 had no impact on the Company's net loss or
stockholders' equity. SFAS 130 requires unrealized gains or losses on the
Company's available-for-sale securities, which prior to adoption were
reported separately in stockholders' equity, to be included in other
comprehensive income.
The components of comprehensive loss for the three months ended March 31,
1998 and 1997 are as follows:
<TABLE>
<CAPTION>
1998 1997
---------- ----------
<S> <C> <C>
(in thousands)
Net loss $ (55) $ (1,885)
Unrealized losses on securities (26) -
---------- ----------
Comprehensive loss (81) (1,885)
---------- ----------
</TABLE>
Accumulated unrealized losses at March 31, 1998 were approximately $23,000
while accumulated gains at December 31, 1997 were approximately $3,000.
6
<PAGE>
CV THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1998
(UNAUDITED)
3. DEFERRED REVENUE
In February 1998, the Company terminated the research component of its
collaboration with Biogen, Inc. and, as a result, $4.0 million of deferred
revenue was recognized during the first quarter of 1998.
4. FOLLOW-ON PUBLIC OFFERING
On January 4, 1998 the Company filed a registration statement with the
Securities and Exchange Commission for a follow-on public offering. The
follow-on public offering closed on January 27, 1998, and the total number
of shares sold, including the exercise of the underwriters' option to
purchase additional shares, was 2,575,000 at a price of $8.25 per share
with net proceeds to the Company of approximately $19,624,000.
7
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CV THERAPEUTICS, INC.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
THIS MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS AND OTHER PARTS OF THIS QUARTERLY REPORT ON FORM 10-Q CONTAIN
FORWARD LOOKING STATEMENTS WHICH INVOLVE RISKS AND UNCERTAINTIES. THE COMPANY'S
ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE DISCUSSED HEREIN. FACTORS
THAT MIGHT CAUSE SUCH A DIFFERENCE INCLUDE, BUT ARE NOT LIMITED TO, THOSE LISTED
BELOW AND THOSE LISTED IN "RISK FACTORS" IN THE COMPANY'S ANNUAL REPORT ON FORM
10-K FOR THE YEAR ENDED DECEMBER 31, 1997.
OVERVIEW
CV Therapeutics, Inc. ("CVT" or the "Company") is an early stage
biopharmaceutical company focused on the application of molecular cardiology to
the discovery, development and commercialization of novel small molecule drugs
for the treatment of cardiovascular disease. Since its inception in December
1990, substantially all of the Company's resources have been dedicated to
research and development. To date, CVT has not generated any product revenue
and does not expect to generate any such revenues for at least several years.
As of March 31, 1998, the Company had an accumulated deficit of approximately
$57.0 million. The Company expects its sources of revenue, if any, for the next
several years to consist of payments under corporate partnerships and interest
income. The process of developing the Company's products will require
significant additional research and development, preclinical testing and
clinical trials, as well as regulatory approval. These activities, together
with the Company's general and administrative expenses, are expected to result
in operating losses for the foreseeable future. The Company will not receive
product revenue unless it or its collaborative partners complete clinical trials
and successfully commercialize one or more of its products.
CVT is subject to risks common to biopharmaceutical companies, including
risks inherent in its research and development efforts and clinical trials,
reliance on collaborative partners, enforcement of patent and proprietary
rights, the need for future capital, potential competition and uncertainty of
regulatory approval. In order for a product to be commercialized, it will be
necessary for CVT and its collaborators to conduct preclinical tests and
clinical trials, demonstrate efficacy and safety of the Company's product
candidates, obtain regulatory clearances and enter into manufacturing,
distribution and marketing arrangements, as well as obtain market acceptance.
There can be no assurance that the Company will generate revenues or achieve and
sustain profitability in the future.
RESULTS OF OPERATIONS
REVENUES. The Company recognized collaborative research revenues of $4.2
million for the quarter ended March 31, 1998, compared to $820,000 for the
quarter ended March 31, 1997. Collaborative research revenue for both the
quarter ended March 31, 1998 and 1997 was earned in connection with the
Company's collaboration with Biogen, Inc. ("Biogen") for the development and
commercialization of CVT-124. The increase in collaborative research revenue in
the quarter ended March 31, 1998, over the same period in 1997, was the result
of $4.0 million of deferred revenue being recognized in conjunction with the
Company's completion of the research component of its collaboration with Biogen.
RESEARCH AND DEVELOPMENT EXPENSES. The Company's research and development
expenses increased to $3.3 million for the quarter ended March 31, 1998,
compared to $1.8 million for the quarter ended March 31, 1997. The increase for
the quarter ended March 31, 1998, over the quarter ended March 31, 1997 was
primarily due to increased outside service expenses associated with ranolazine
clinical trials. The Company expects research and development expenses to
increase significantly over the next several years as the Company expands
research and product development efforts. In particular, expenses will likely
increase due to further clinical trial expenses for ranolazine.
GENERAL AND ADMINISTRATIVE EXPENSES. General and administrative expenses of
$1.0 million for the quarter ended March 31, 1998 were consistent with those of
the quarter ended March 31, 1997. General and administrative personnel expenses
associated with average personnel headcount increased in the quarter ended March
31, 1998, but were offset by a decrease in outside service expenses when
compared to the same quarter in 1997. The Company expects general and
administrative expenses to increase in the future due to increases in the
Company's development activities.
8
<PAGE>
INTEREST AND OTHER INCOME (EXPENSE), NET. Interest and other income
(expense), net of $106,000 for the quarter ended March 31,1998, was consistent
with that of the quarter ended March 31, 1997. Interest income increased due to
higher average investment balances, but was offset by an increase in interest
and other expenses, mainly associated with the early retirement of the Company's
capital lease obligation, in the quarter ended March 31, 1998, when compared to
the same quarter in 1997. The Company expects that interest income (expense),
net will fluctuate with average investment balances.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations since inception primarily through
private placements of preferred and common stock, public offerings of common
stock, equipment and leasehold improvement financing, other debt financing and
payments received under corporate collaborations. In January 1998, the Company
completed a follow-on public offering of 2,575,000 shares of the Company's
common stock and raised net proceeds of approximately $19.6 million.
Cash, cash equivalents and short- and long-term investments at March 31, 1998
totaled $52.6 million compared to $38.1 million at December 31, 1997. The
increase in the first quarter of 1998 was due to the receipt of approximately
$19.6 million in net proceeds from the follow-on public offering that was
completed in January 1998. This increase was partially offset by a $1.4 million
payment in March 1997, for the early retirement of the Company's capital lease
obligation.
Net cash used in operating activities for the three-months ended March 31,
1998 was $3.8 million, compared to $5.0 million provided by operating activities
for the three-months ended March 31, 1997. The increase in cash used in
operating activities in the first quarter of 1998 over the first quarter of 1997
was primarily the result of the $7.0 million upfront payment of deferred revenue
received in the first quarter of 1997 under the collaboration with Biogen, Inc.
The remaining increase of $1.8 million was primarily due to increased research
and development efforts.
From inception through March 31, 1998, the Company had invested approximately
$6.2 million in property and equipment, of which approximately $4.3 million was
financed through equipment and leasehold financings at various times.
The Company will likely require substantial additional funding in order to
complete its research and development activities and commercialize any potential
products. The Company currently estimates that its existing resources and
projected interest income will enable the Company to maintain its current and
planned operations through the fourth quarter of 1999. However, there can be no
assurance that the Company will not require additional funding prior to such
time.
The Company's forecast of the period of time through which its financial
resources will be adequate to support its operations is a forward-looking
statement that involves risks and uncertainties, and actual results could vary
as a result of a number of factors. The Company's future capital requirements
will depend on many factors, including scientific progress in its research and
development programs, the size and complexity of such programs, the scope and
results of preclinical studies and clinical trials, the ability of the Company
to establish and maintain corporate partnerships, the time and costs involved in
obtaining regulatory approvals, the costs involved in filing, prosecuting and
enforcing patent claims, competing technological and market developments, the
cost of manufacturing preclinical and clinical material and other factors not
within the Company's control. There can be no assurance that such additional
financing to meet the Company's capital requirements will be available on
acceptable terms or at all. Insufficient funds may require the Company to
delay, scale back or eliminate some or all of its research or development
programs, to lose rights under existing licenses or to relinquish greater or all
rights to product candidates at an earlier stage of development or on less
favorable terms than the Company would otherwise choose or may adversely affect
the Company's ability to operate as a going concern. If additional funds are
raised by issuing equity securities, substantial dilution to existing
stockholders may result.
9
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ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS
The Company's business, financial condition and results of operations are
subject to various risks, including those described below and elsewhere in this
Quarterly Report on Form 10-Q.
The Company is an early stage company and must be evaluated in light of the
uncertainties and complications present in an early stage biopharmaceutical
company. All of the Company products are at an early stage of development, and
the Company has not generated any product revenue. In addition, the Company has
only two products in clinical development, ranolazine and CVT-124. There can be
no assurance that clinical trials conducted by the Company will demonstrate
sufficient safety and efficacy to obtain the requisite approvals or that
marketable products will result. In addition, the rate of completion of
clinical trials may be delayed by many factors. The Company's product
candidates will require significant additional development, preclinical studies,
clinical trials and regulatory approval prior to commercialization. These
activities may take several years and require the expenditure of substantial
resources. In addition, these activities, together with the Company's general
and administrative expense, are expected to result in operation losses for the
foreseeable future.
The Company's strategy for the research, development and commercialization of
its product candidates has required, and will continue to require, the Company
to enter into various arrangements with corporate and academic collaborators,
licensers, licensees and others, and the Company is dependent upon the success
of these parties in performing their responsibilities. There can be no
assurance that the Company will be able to enter into additional collaborative
arrangements or license agreements on acceptable terms, or at all, or that the
contemplated benefits from any of these agreements will be realized.
The Company's business is affected by other factors, including: uncertainty of
market acceptance, intense competition and rapid technological change,
uncertainty of patent position and proprietary rights, dependence on key
personnel and the need to attract and retain key employees and consultants,
limited manufacturing, marketing and sales experience, significant government
regulation, uncertainty of product pricing and reimbursement, product liability
exposure and the availability of insurance.
10
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CV THERAPEUTICS, INC.
PART II. OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
On November 19, 1996, the Securities and Exchange Commission declared the
Company's Registration Statement (file number 2-12675) effective. The Company
received net proceeds of $11,970,000 from this initial public offering. As of
March 31, 1998, the Company has used approximately $5,072,000 of the net
proceeds from its initial public offering for operating activities. The
Company has used the remainder of the net proceeds from its initial public
offering for temporary investments, including money market and short- and
long-term funds. Such payments were direct or indirect. On January 4, 1998
the Company filed a registration statement with the Securities and Exchange
Commission for a follow-on public offering. The follow-on public offering
closed on January 27, 1998 and the total number of shares sold, including the
exercise of the underwriters' option to purchase additional shares, was
2,575,000 at a price of $8.25 per share with net proceeds to the Company of
approximately $19,624,000. As of March 31, 1998, the Company has used all of
the net proceeds from the follow-on public offering for temporary investments,
including money market and short- and long-term funds. Such payments were
direct or indirect.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits required by Item 601 of Regulation S-K
<TABLE>
<CAPTION>
Exhibit Number Description
-------------- ------------
<S> <C>
27.1 Financial Data Schedule
</TABLE>
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(b) Reports on Form 8-K
None.
11
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this Quarterly Report on Form 10-Q to be signed on
its behalf by the undersigned thereunto duly authorized.
CV THERAPEUTICS, INC.
Date: May 13, 1998
/s/ Louis G. Lange, M.D., Ph.D.
--------------------------------
Louis G. Lange, M.D., Ph.D.
Chairman of the Board & Chief
Executive Officer
(Principal Executive Officer)
/s/ Daniel K. Spiegelman
--------------------------------
Daniel K. Spiegelman
Chief Financial Officer
(Principal Financial and Accounting Officer)
12
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CV THERAPEUTICS, INC.
EXHIBIT INDEX
<TABLE>
<CAPTION>
Sequentially
Exhibit Numbered
Number Description Page
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<S> <C> <C>
27.1 Financial Data Schedule
</TABLE>
13
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED BALANCE SHEET AS OF MARCH 31, 1998 AND THE CONSOLIDATED STATEMENT
OF OPERATIONS FOR THE THREE MONTH PERIOD ENDED MARCH 31, 1998 AND IS QUALIFIED
IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> MAR-31-1998
<CASH> 19,864
<SECURITIES> 0
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 21,241
<PP&E> 6,233
<DEPRECIATION> (4,035)
<TOTAL-ASSETS> 56,862
<CURRENT-LIABILITIES> 5,951
<BONDS> 0
0
0
<COMMON> 103,713
<OTHER-SE> (57,358)
<TOTAL-LIABILITY-AND-EQUITY> 56,862
<SALES> 0
<TOTAL-REVENUES> 4,183
<CGS> 0
<TOTAL-COSTS> 4,344
<OTHER-EXPENSES> 0
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 611
<INCOME-PRETAX> (55)
<INCOME-TAX> 0
<INCOME-CONTINUING> (55)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (55)
<EPS-PRIMARY> (0.01)
<EPS-DILUTED> (0.01)
</TABLE>
