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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of report (date of earliest event reported): OCTOBER 28, 2003
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VIVUS, INC.
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(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
COMMISSION FILE NUMBER: 0-23490
DELAWARE 94-3136179
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(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NUMBER)
1172 CASTRO STREET
MOUNTAIN VIEW, CA 94040
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(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
(650) 934-5200
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(REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE)
N/A
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(FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR,
IF CHANGED SINCE LAST REPORT)
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ITEM 5. OTHER EVENTS.
On October 28, 2003, the Company issued a press release announcing
resolution of its arbitration claim against Janssen Pharmaceutica International
with the American Arbitration Association related to payments owing to the
Company under a previously terminated distribution agreement between the
companies. The arbitration panel awarded the Company $4.0 million. The Company
also revised its financial statements for the third quarter ended September 30,
2003 based on the resolution of the arbitration.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
EXHIBIT
NUMBER DESCRIPTION
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99.1 Press Release dated October 28, 2003 announcing resolution of its
arbitration claim against Janssen Pharmaceutica International with the
American Arbitration Association related to payments owing to the
Company under a previously terminated distribution agreement between
the companies and revised financial statements for the third quarter
ended September 30, 2003 based on the resolution of the arbitration.
ITEM 12. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
The Company revised its September 30, 2003 financial statements based
on the resolution of its arbitration claim against Janssen Pharmaceutica
International with the American Arbitration Association. A press release issued
by the Company dated October 28, 2003 has been attached as Exhibit 99.1 hereto.
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: October 28, 2003 VIVUS, Inc.
/s/ Larry J. Strauss
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Larry J. Strauss
Vice President and Chief Financial Officer
/s/ Leland F. Wilson
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Leland F. Wilson
President and Chief Executive Officer
VIVUS, INC.
INDEX TO EXHIBITS The
following exhibits are filed herewith:
EXHIBIT DESCRIPTION
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99.1 Press Release dated October 28, 2003 announcing resolution of its
arbitration claim against Janssen Pharmaceutica International
with the American Arbitration Association related to payments
owing to the Company under a previously terminated distribution
agreement between the companies and revised financial statements
for the third quarter ended September 30, 2003 based on the
resolution of the arbitration.
EXHIBIT 99.1
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VIVUS
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For More Information:
Investors: Christina Weisgerber
(650) 934-5240 or weisgerber@vivus.com
Media: Nathan Kaiser
(415) 318-4235 or kaisern@fleishman.com
FOR IMMEDIATE RELEASE
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VIVUS AWARDED $4.0 MILLION IN JANSSEN ARBITRATION
REVISED 2003 THIRD QUARTER FINANCIAL RESULTS
MOUNTAIN VIEW, CALIF. (OCTOBER 28, 2003) -- VIVUS, INC. (NASDAQ NM: VVUS), today
announced resolution of its arbitration claim against Janssen Pharmaceutica
International (Janssen) with the American Arbitration Association related to
payments owing to VIVUS under a previously terminated distribution agreement
between the companies. The arbitration panel awarded VIVUS $4.0 million. The
award consisted of $3.7 million for manufactured inventory and lost profits, and
$323,000 for legal fees and other related expenses. The Company is awaiting
payment from Janssen.
"Although this arbitration process was a lengthy one, we feel vindicated in our
pursuit of a fair settlement for the Company," said Leland Wilson President and
CEO of VIVUS. "The Company will use these funds to augment our clinical
development efforts for Phase 3 trials for ALISTA and Phase 2 trials for
TA-1790."
REVISED FINANCIAL RESULTS
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For the three months ended September 30, 2003, VIVUS reports revised net income
of $3.9 million, $0.10 net income per share, compared to a previously reported
net loss of ($1.5) million, ($0.04) net loss per share.
Total revenue for the three months and nine months ended September 30, 2003
increased by a total $5.0 million when compared to the revenue figures
previously reported by the Company prior to receiving the award. $3.7 million of
the additional revenue represents amounts due from Janssen under the award. The
remaining $1.3 million results from recognizing Janssen related revenue that was
previously deferred pending the outcome of the arbitration.
Total operating expenses for the three months ended September 30, 2003 decreased
$323,000 from the previously reported figures due to the final arbitration award
including reimbursement of legal fees and other expenses related to the
arbitration.
For the nine months ended September 30, 2003, VIVUS reports a revised net loss
of ($2.2) million, ($0.06) net loss per share, compared to a previously reported
net loss of ($7.6) million, ($0.22) net loss per share.
Accounts receivable as of September 30, 2003 was $5.9 million, an increase of
$4.0 million compared to previously reported accounts receivable of $1.9
million.
Cash, cash equivalents and available-for-sale securities was not affected by the
arbitration panel award.
ABOUT VIVUS
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VIVUS, Inc., (Nasdaq NM: VVUS) is a pharmaceutical company engaged in the
development of innovative therapies for the treatment of quality-of-life
disorders in men and women, with a focus on sexual dysfunction. Current
development programs target Female Sexual Dysfunction (FSD), Erectile
Dysfunction (ED) and Premature Ejaculation (PE). VIVUS developed and markets in
the U.S. MUSE(R) (alprostadil) and ACTIS(R), two innovations in the treatment of
erectile dysfunction, and has partnered with Meda AB (Stockholm: MEDAa.ST) for
the international marketing and distribution of its male transurethral ED
products. In Canada, VIVUS has partnered exclusively with Paladin Labs (TSE:
PLB) to market and distribute MUSE. For more information, please visit the
Company's Web site at: www.vivus.com.
Financial Tables Follow
VIVUS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
THREE MONTHS ENDED NINE MONTHS ENDED
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SEPTEMBER 30 SEPTEMBER 30 SEPTEMBER 30 SEPTEMBER 30
2003 2002 2003 2002
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(unaudited) (unaudited) (unaudited) (unaudited)
Revenue
US product, net $ 4,071 $ 3,375 $ 10,150 $ 13,436
International product 1,426 155 3,264 1,024
Other revenue 5,033 -- 5,033 --
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Total revenue 10,530 3,530 18,447 14,460
Cost of goods sold 3,002 2,292 8,210 7,196
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Gross profit 7,528 1,238 10,237 7,264
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Operating expenses:
Research and development 1,821 2,707 5,951 9,460
Selling, general and administrative 2,255 2,607 7,319 8,007
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Total operating expenses 4,076 5,314 13,270 17,467
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Income (loss) from operations 3,452 (4,076) (3,033) (10,203)
Interest and other income 202 354 571 1,015
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Income (loss) before benefit for income taxes 3,654 (3,722) (2,462) (9,188)
Benefit for income taxes 219 -- 219 268
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Net income (loss) $ 3,873 $ (3,722) $ (2,243) $ (8,920)
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Net income (loss) per share:
Basic $ 0.10 $ (0.11) $ (0.06) $ (0.27)
Diluted $ 0.10 $ (0.11) $ (0.06) $ (0.27)
Shares used in per share computation
Basic 37,653 32,950 35,263 32,882
Diluted 38,064 32,950 35,263 32,882
VIVUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amount)
SEPTEMBER 30 DECEMBER 31
2003 2002*
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(unaudited)
Current assets:
Cash and cash equivalents $ 7,671 $ 12,296
Available-for-sale securities 13,626 11,206
Accounts receivable 5,935 3,592
Inventories 1,320 1,358
Prepaid expenses and other assets 1,624 1,497
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Total current assets 30,176 29,949
Property and equipment 8,637 10,084
Restricted cash 3,324 3,324
Available-for-sale securities, non-current 19,670 6,324
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Total assets $ 61,807 $ 49,681
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Current liabilities:
Accounts payable $ 1,636 $ 1,866
Accrued and other liabilities 7,207 9,109
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Total current liabilities 8,843 10,975
Accrued and other long-term liabilities 4,208 4,321
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Total liabilities 13,051 15,296
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Stockholders' equity:
Common stock; $.001 par value; shares
authorized 200,000; shares outstanding -
September 30, 2003 37,653;
December 31, 2002 32,999; 38 33
Additional paid-in capital 151,791 135,005
Accumulated other comprehensive income 104 281
Accumulated deficit (103,177) (100,934)
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Total stockholders' equity 48,756 34,385
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Total liabilites and stockholder's equity $ 61,807 $ 49,681
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* The Condensed Consolidated Balance Sheet at December 31, 2002 has been
derived from the Company's audited financial statements at that date.