Nexavar Quarterly Revenue Surpasses $100 Million EMERYVILLE,
Calif., Nov. 6 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc.
(NASDAQ:ONXX) today reported its financial results for the three
and nine months ended September 30, 2007. Onyx reported net income
of $555,000, or $0.01 per share, for the third quarter of 2007
compared to a net loss of $20.1 million, or $0.49 per share, in the
same period in the prior year. Nexavar net revenue was $104.6
million for the quarter ended September 30, 2007, which represents
a 130% increase over the $45.4 million reported in the same period
last year and a 29% increase over the $81.3 million reported in the
three months ended June 30, 2007. Onyx, with its collaborator,
Bayer HealthCare Pharmaceuticals Inc., or Bayer, is marketing and
developing Nexavar(R) (sorafenib) tablets, an anticancer therapy
currently approved for the treatment of advanced kidney cancer in
the U.S., European Union, and other territories internationally.
Nexavar was approved last week by the European Union for the
treatment of patients with liver cancer. In accordance with Onyx's
collaboration agreement with Bayer, Bayer recognizes all revenue
from the sale of Nexavar. "Onyx's revenue growth in the third
quarter was driven by the strong performance of the Nexavar
franchise in both the U.S. and internationally," said Hollings C.
Renton, president and chief executive officer of Onyx. "With a
growing oncology business, a recent regulatory approval in the
European Union and active filings globally for a second indication,
as well as a robust clinical development program, we are well
positioned for continued positive momentum." The net income for the
quarter ended September 30, 2007, included employee stock-based
compensation expense of $3.6 million, or $0.07 per share. The net
loss for the quarter ended September 30, 2006, included employee
stock-based compensation expense of $3.5 million, or $0.08 per
share. Net Expense due to (from) Unconsolidated Joint Business Onyx
reports the net expense due to (from) unconsolidated joint business
for Nexavar as a single line item within the Statement of
Operations. This item consists of Nexavar product revenue and the
reimbursement of Onyx and Bayer for each company's shared expenses
under the collaboration and is, in effect, the net amount due to or
from Bayer to balance the companies' economics under the Nexavar
collaboration. According to the terms of the collaboration, the
companies share all research and development, marketing, and
non-U.S. sales expenses. Onyx and Bayer each bears its own U.S.
sales force and medical science liaison expenses. Bayer recognizes
all revenue under the Nexavar collaboration and incurs the majority
of expenses relating to the development and marketing of Nexavar.
The calculation of the net expense due to (from) unconsolidated
joint business is shown in the table following the summary
financial information. In the third quarter of 2007, Onyx reported
a net amount due from Bayer of $17.6 million compared to a net
amount due to Bayer of $3.6 million for the third quarter of 2006.
This change was primarily due to an increase in Nexavar revenue
recognized by Bayer partially offset by an increase in the combined
commercial expenses for Nexavar. Operating Expenses In the third
quarter of 2007, Onyx's research and development expenses were $7.9
million, an increase of $270,000 as compared to the third quarter
of 2006. The expenses incurred in the third quarter of 2007 were
primarily related to study start-up costs associated with the Phase
2 breast cancer program. In the third quarter of 2007, selling,
general and administrative expenses were $15.2 million, an increase
of $3.3 million as compared to the third quarter of 2006. This was
primarily due to an increase in external marketing expenses to
support Nexavar, as well as increased personnel in the
administrative functions needed to support the company's planned
growth. Cash, Cash Equivalents and Marketable Securities As of
September 30, 2007, the company had cash, cash equivalents, and
short- and long-term marketable securities of $451.2 million
compared to $271.4 million at December 31, 2006. This increase was
primarily due to net proceeds from financing activities offset by
cash used in operations for the nine months ended September 30,
2007. Nine-Month Results For the nine months ended September 30,
2007, Onyx recorded a net loss of $22.5 million, or $0.45 per share
(basic and diluted), compared with a net loss of $72.0 million, or
$1.74 per share, for the same period in 2006. Nexavar net sales, as
recorded by Bayer, were $246.8 million and $101.3 million for the
nine months ended September 30, 2007 and 2006, respectively.
Conference Call with Management Today Onyx's management will host a
teleconference and web cast to discuss third quarter 2007 financial
results and provide a general business overview. The event will
begin at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on
November 6, 2007. Interested parties may access a live web cast of
the presentation at:
http://events.streamlogics.net/conferenceplus/onyx/event003/index.asp
or by dialing 847-413-3235 and using the passcode 19394894. A
replay of the presentation will be available on the Onyx website or
by dialing 630-652-3044 and using the passcode 19394894
approximately one hour after the teleconference concludes. The
replay will be available through December 6, 2007. About Onyx
Pharmaceuticals, Inc. Onyx Pharmaceuticals, Inc. is a
biopharmaceutical company developing innovative therapies that
target the molecular mechanisms that cause cancer. The company is
developing and marketing Nexavar(R), a small molecule drug, with
Bayer HealthCare Pharmaceuticals Inc. Nexavar is approved for the
treatment of advanced kidney cancer in more than 60 countries. More
recently it was approved by the European Union for the treatment of
liver cancer. For more information about Onyx's pipeline and
activities, visit the company's web site at:
http://www.onyx-pharm.com/. Nexavar(R) (sorafenib) tablets is a
registered trademark of Bayer HealthCare Pharmaceuticals Inc. This
news release contains "forward-looking statements" of Onyx within
the meaning of the federal securities laws. These forward-looking
statements include without limitation, statements regarding sales
trends and commercial activities and the timing, progress and
results of clinical development, regulatory filings and actions.
These statements are subject to risks and uncertainties that could
cause actual results and events to differ materially from those
anticipated. Reference should be made to Onyx's Annual Report on
Form 10-K for the year ended December 31, 2006, filed with the
Securities and Exchange Commission under the heading "Risk Factors"
for a more detailed description of such factors, as well as the
Company's subsequent quarterly reports on Form 10-Q. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date of this release. Onyx
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events, or circumstances
after the date of this release except as required by law. ONYX
PHARMACEUTICALS, INC. SUMMARY FINANCIAL INFORMATION CONDENSED
STATEMENTS OF OPERATIONS (In thousands, except per share amounts)
(unaudited) Three Months Ended Nine Months Ended Sept. 30, Sept.
30, 2007 2006 2007 2006 Total revenue $- $100 $- $250 Operating
expenses: Net expense due to (from) unconsolidated joint business
(17,635) 3,596 (28,131) 20,147 Research and development (1) 7,901
7,631 19,883 24,124 Selling, general and administrative (1) 15,245
11,900 44,140 36,944 Total operating expenses 5,511 23,127 35,892
81,215 Loss from operations (5,511) (23,027) (35,892) (80,965)
Interest income 6,066 2,879 13,427 8,991 Net income (loss) $555
$(20,148) $(22,465) $(71,974) Net income (loss) per basic and
diluted share: $0.01 $(0.49) $(0.45) $(1.74) Shares used in
computing net income (loss) per share: Basic 54,836 41,499 49,817
41,405 Diluted 55,785 41,499 49,817 41,405 (1) Includes employee
stock-based compensation charges of: Research and development $785
$629 $2,046 $2,010 Selling, general, and administrative $2,856
$2,878 $8,220 $8,830 Total employee stock-based compensation $3,641
$3,507 $10,266 $10,840 CONDENSED BALANCE SHEETS (In thousands)
Sept. 30, Dec. 31, 2007 2006 (unaudited) (2) Assets Cash, cash
equivalents and marketable securities $451,182 $266,958 Other
current assets 32,226 12,940 Total current assets 483,408 279,898
Property and equipment, net 3,298 1,478 Other assets 290 4,870
Total assets $486,996 $286,246 Liabilities and stockholders' equity
Current liabilities 13,392 23,199 Advance from collaboration
partner 39,127 40,000 Other long term liabilities 1,179 267
Stockholders' equity 433,298 222,780 Total liabilities and
stockholders' equity $486,996 $286,246 (2) Derived from the audited
financial statements included in the Company's Annual Report on
Form 10-K for the year-ended December 31, 2006. ONYX
PHARMACEUTICALS, INC. CALCULATION OF NET EXPENSE DUE TO (FROM)
UNCONSOLIDATED JOINT BUSINESS Three Months Ended Nine Months Ended
Sept. 30 Sept. 30 2007 2006 2007 2006 Product revenue, net $104,605
$45,405 $246,817 $101,342 Combined cost of goods sold, distributed,
selling, general and administrative expenses 55,950 29,895 141,684
73,778 Combined research and development expenses 37,561 40,711
105,707 120,104 Combined collaboration profit (loss) $11,094
$(25,201) $(574) $(92,540) Onyx's share of collaboration profit
(loss) $5,547 $(12,601) $(287) $(46,271) Reimbursement of Onyx's
direct development and marketing expenses (12,088) (9,005) (28,418)
(26,124) Onyx net expense due to (from) unconsolidated joint
business $(17,635) $3,596 $(28,131) $20,147 DATASOURCE: Onyx
Pharmaceuticals, Inc. CONTACT: Julie Wood, Vice President, Investor
Relations, +1-510-597-6505, or Greg W. Schafer, Chief Financial
Officer, +1-510-597-6684, both of Onyx Pharmaceuticals, Inc. Web
site: http://www.onyx-pharm.com/
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