Nexavar Revenue Up 34% Over First Quarter; More than 150% Over Same Period
Last Year
EMERYVILLE, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX) today reported its financial results
for the three and six months ended June 30, 2007. Onyx reported a net loss
of $10.8 million, or $0.22 per share, for the second quarter of 2007
compared to a net loss of $31.5 million, or $0.76 per share, in the same
period in the prior year.
Nexavar net revenue was $81.3 million for the quarter ended June 30,
2007, which represents more than a 150% increase over the $32.2 million
reported in the same period last year and a 34% increase over the $60.9
million reported in the three months ended March 31, 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. In accordance with
Onyx's collaboration agreement with Bayer, Bayer recognizes all revenue
from the sale of Nexavar.
"Onyx had a tremendous second quarter driven by increased domestic
sales, as well as continued expansion and penetration of the Nexavar
franchise outside of the United States," said Hollings C. Renton, president
and CEO of Onyx. "We anticipate continued positive momentum over the next
18 months, with top-line sales growth, potential regulatory actions in
liver cancer, results from ongoing Phase 3 and Phase 2 clinical trials, and
the continued expansion of our clinical development program."
The net loss for the quarter ended June 30, 2007, includes employee
stock- based compensation expense of $3.6 million, or $0.08 per share. The
net loss for the quarter ended June 30, 2006, included employee stock-based
compensation expense of $3.7 million, or $0.09 per share.
Net Expense due (from) to Unconsolidated Joint Business
Onyx reports the net expense due (from) to 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 (from) to unconsolidated joint
business is shown in the table following the summary financial information.
In the second quarter of 2007, Onyx reported a net amount due from Bayer of
$7.5 million compared to a net amount due to Bayer of $12.4 million for the
second quarter of 2006. This change is primarily due to an increase in
Nexavar revenue recognized by Bayer, and the reduction of combined research
and development expenses, which is partially offset by an increase in the
combined commercial expenses for Nexavar.
Operating Expenses
In the second quarter of 2007, research and development expenses were
$6.4 million, a decrease of $2.2 million as compared to the second quarter
of 2006. This decrease was due to a reduction in activities in the melanoma
program.
In the second quarter of 2007, selling, general and administrative
expenses were $15.7 million, an increase of $2.3 million over the second
quarter of 2006. This was due to an increase in employees in administrative
functions to support the company's planned growth, as well as increased
marketing expenses.
Cash, Cash Equivalents and Marketable Securities
As of June 30, 2007, the company had cash, cash equivalents, short and
long-term marketable securities of $454.4 million compared to $271.4
million at December 31, 2006. This increase is primarily due to financing
activities offset by cash used in operations in the first half of 2007.
Six-Month Results
For the six months ended June 30, 2007, Onyx recorded a net loss of
$23.0 million, or $0.49 per share, compared with a net loss of $51.8
million, or $1.25 per share, for the same period in 2006. Nexavar net
sales, as recorded by Bayer, were $142.2 million and $55.9 million for the
six months ended June 30, 2007 and 2006, respectively.
Conference Call with Management Today
Onyx's management will host a teleconference and web cast to discuss
second 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 August 7, 2007. Interested parties may access a live web cast of
the presentation at:
http://events.streamlogics.net/conferenceplus/onyx/event002/index.asp or by
dialing 847-413-3235 and using the passcode 18558774. A replay of the
presentation will be available on the Onyx website or by dialing
630-652-3044 and using the passcode 18558774 approximately one hour after
the teleconference concludes. The replay will be available through
September 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 Nexavar(R), a small molecule drug, with
Bayer HealthCare Pharmaceuticals Inc. Nexavar has been approved for the
treatment of advanced kidney cancer. For more information about Onyx's
pipeline and activities, visit the company's website at:
http://www.onyx-pharm.com.
NOTE: 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 the
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. (See attached tables.)
ONYX PHARMACEUTICALS, INC.
SUMMARY FINANCIAL INFORMATION
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
Three Months Ended Six Months Ended
June 30 June 30
2007 2006 2007 2006
Total revenue $- $150 $- $150
Operating expenses:
Net expense due (from) to
unconsolidated joint business (7,470) 12,449 (10,495) 16,551
Research and development(1) 6,448 8,693 11,982 16,493
Selling, general and
administrative(2) 15,712 13,421 28,895 25,044
Total operating expenses 14,690 34,563 30,382 58,088
Loss from operations (14,690) (34,413) (30,382) (57,938)
Interest income 3,864 2,939 7,361 6,112
Net loss $(10,826) $(31,474) $(23,021) $(51,826)
Basic and diluted net loss
per share $(0.22) $(0.76) $ (0.49) $(1.25)
Shares used in computing
basic and diluted net
loss per share 48,242 41,422 47,265 41,357
CONDENSED BALANCE SHEETS
(In thousands)
June 30, Dec. 31,
2007 2006
(unaudited) (3)
Assets
Cash, cash equivalents
and marketable securities $454,423 $266,958
Other current assets 13,654 12,940
Total current assets 468,077 279,898
Property and equipment, net 3,387 1,478
Other assets 530 4,870
Total assets $471,994 $286,246
Liabilities and
stockholders' equity
Current liabilities 11,338 23,466
Advance from
collaboration partner 40,000 40,000
Other long term
liabilities 727 -
Stockholders' equity 419,929 222,780
Total liabilities and
stockholders' equity $471,994 $286,246
(1) Includes employee stock-based compensation expense of $0.7 million
each in the condensed, unaudited statement of operations for the three
months ended June 30, 2007 and 2006. For the six months ended June 30, 2007
and 2006, includes stock-based compensation expense of $1.3 million and
$1.4 million, respectively.
(2) Includes employee stock-based compensation expense of $2.9 million
and $3.0 million respectively, in the condensed, unaudited statement of
operations for the three months ended June 30, 2007 and 2006, respectively.
For the six months ended June 30, 2007 and 2006, includes stock-based
compensation expense of $5.4 million and $6.0 million respectively.
(3) 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 (FROM) TO UNCONSOLIDATED JOINT BUSINESS
Three Months Ended Six Months Ended
June 30 June 30
2007 2006 2007 2006
Product revenue, net $81,332 $32,190 $142,212 $55,937
Combined cost of goods sold,
distributed, selling, general
and administrative expenses 49,285 26,175 85,734 43,883
Combined research and
development expenses 34,856 49,362 68,146 79,393
Combined collaboration loss $2,809 $43,347 $11,668 $67,339
Onyx's share of
collaboration loss $1,405 $21,674 $5,834 $33,670
Reimbursement of Onyx's direct
development and marketing
expenses (8,875) (9,225) (16,329) (17,119)
Onyx net expense due (from)
to unconsolidated joint
business $(7,470) $12,449 $(10,495) $16,551
SOURCE Onyx Pharmaceuticals, Inc.
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Related links:
http://www.onyx-pharm.com/
CONTACT:
Julie Wood, Vice President, Investor
Relations, +1-510-597-6505, or Greg W. Schafer, Chief Financial
Officer, +1-510-597-6684
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