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8-K - FORM 8-K - ONYX PHARMACEUTICALS INC | f59716e8vk.htm |
Exhibit 99.1
Contact:
Traci McCarty
Senior Director, Investor Relations
650-266-2398
Senior Director, Investor Relations
650-266-2398
Onyx Pharmaceuticals Reports Second Quarter 2011 Financial Results
Global Nexavar Sales Increase to $245.7 Million
Global Nexavar Sales Increase to $245.7 Million
SOUTH SAN FRANCISCO, CA August 3, 2011 Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today
reported its financial results for the second quarter 2011. Onyx reported a non-GAAP net loss of
$27.2 million, or $0.43 per diluted share, for the second quarter 2011 compared to a non-GAAP net
income of $2.9 million, or $0.05 per diluted share, for the same period in 2010. Non-GAAP net loss
excludes, among other items, adjustments to contingent consideration expense in connection with
Onyxs acquisition of Proteolix Inc., or Proteolix; employee stock-based compensation expense;
lease termination exit costs, non-cash imputed interest expense related to the application of
Accounting Standards Codification (ASC) 470-20 and charges associated with the restructuring of
Onyxs development, collaboration, option and license agreement with S*BIO Pte Ltd., or S*BIO.
The quarter was marked by continued progress across our product portfolio, said N. Anthony Coles,
M.D., president and chief executive officer of Onyx. Approved for the treatment of liver cancer
and kidney cancer, Nexavar delivered another quarter of solid operating performance driven by
strong growth in the Asia Pacific region. With five late-stage
clinical trials expected to read-out by the end of 2012, Nexavar is poised to penetrate existing and new markets. Dr Coles
continued, Our Phase 3 confirmatory trials with carfilzomib, ASPIRE and FOCUS, are well underway.
Importantly, we are ramping up preparation for the commercialization of carfilzomib, in
anticipation of a potential U.S. approval next year.
On a GAAP basis, Onyx reported a net loss of $54.5 million, or $0.86 per diluted share, for the
second quarter 2011 compared to a net loss of $97.2 million, or $1.55 per diluted share, for the
same period in 2010. A description of the non-GAAP calculations and reconciliation to comparable
GAAP measures is provided in the accompanying table entitled Reconciliation of GAAP to Non-GAAP
Net Income (Loss).
Revenue from Collaboration Agreement
Global Nexavar net sales, which are recorded by Onyxs collaborator, Bayer HealthCare
Pharmaceuticals Inc., or Bayer, were $245.7 million for the second quarter 2011, an increase of
$9.6 million, or 4%, compared to $236.1 million for the same period in 2010. Onyx and Bayer are
marketing and developing Nexavar® (sorafenib) tablets, an anticancer therapy
currently approved for the treatment of unresectable liver cancer and advanced kidney cancer in
over 100 countries worldwide.
For the second quarter 2011, Onyx reported total revenue from collaboration agreement of $68.0
million compared to $68.8 million for the same period in 2010.
ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
August 3, 2011
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August 3, 2011
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Operating Expenses
Onyx recorded research and development expenses of $63.0 million in the second quarter 2011
compared to $43.3 million for the same period in 2010. The increase in research and development
expense was primarily due to investments in the development of carfilzomib, particularly the Phase
3 ASPIRE and FOCUS trials.
Selling, general and administrative expenses were $38.2 million in the second quarter 2011,
compared to $26.6 million for the same period in 2010. Higher selling, general and administrative
expenses between periods were primarily due to planned increases in employee headcount and related
costs, legal costs, and selected pre-launch spending for carfilzomib.
Onyx recorded $5.8 million of non-cash contingent consideration expense in the second quarter 2011
associated with changes in the fair value of the liability for contingent consideration recorded
for the potential milestone payments under the Proteolix acquisition.
As a result of consolidation of its facilities, Onyx ceased the use of facilities it previously
occupied in Emeryville and in South San Francisco, California. In connection with the exits of
these facilities, the Company recorded $10.7 million of non-cash lease termination exit costs.
Interest Expense
Interest expense of $5.0 million for the second quarter 2011 primarily relates to the 4.0%
convertible senior notes due 2016 issued in August 2009 and includes non-cash imputed interest
expense of $4.9 million as a result of the application of ASC 470-20.
Cash, Cash Equivalents and Marketable Securities
On June 30, 2011, cash, cash equivalents, and current and non-current marketable securities were
$550.6 million compared to $577.9 million at December 31, 2010. This excludes restricted cash of
$31.9 million at December 31, 2010.
Six-Month Results
Nexavar net sales, as recorded by Bayer, were $481.1 million and $450.5 million for the six months
ended June 30, 2011 and 2010, respectively. Non-GAAP net loss for the six months ended June 30,
2011 was $41.4 million, or $0.66 per diluted share, compared to non-GAAP net income of $1.4
million, or $0.02 per diluted share for the same period in 2010. Non-GAAP net income excludes
employee stock-based compensation expense, non-cash imputed interest expense related to the
application of ASC Subtopic 470-20, non-cash items related to the advance funding and impairment of
equity investment in S*BIO, lease termination exit costs and adjustments to contingent
consideration expense in connection with our acquisition of Proteolix. A description of the
non-GAAP calculations is provided below in the accompanying table entitled Reconciliation of GAAP
to Non-GAAP Net Income (Loss). For the six months ended June 30, 2011, on a GAAP basis Onyx
recorded a net loss of $103.7 million, or $1.64 per diluted share, compared with a net loss of
$109.2 million, or $1.75 per diluted share, for the same period in 2010.
Management Conference Call Today
Onyx will host a webcast and teleconference with management to discuss second quarter 2011
financial results, as well as provide a general business, overview on Wednesday, August 3, 2011, at
5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Financial results for the second quarter ended
June 30, 2011 will be released earlier that day.
Interested parties may access a live webcast of the presentation on the companys website at:
http://www.onyx-pharm.com/investors/event-calendar
ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
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August 3, 2011
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or by dialing 847-585-4405 and using the passcode 30130102#. A replay of the presentation will be
available on the Onyx website or by dialing 630-652-3042 and using the passcode 30130102#
approximately one hour after the teleconference concludes. The replay will be available through
August 17, 2011.
About Onyx Pharmaceuticals, Inc.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a
global biopharmaceutical company engaged in the development and commercialization of
innovative therapies for improving the lives of people with cancer and other serious
diseases. The company is focused on developing novel medicines that target key molecular
pathways. For more information about Onyx, visit the companys website at www.onyx-pharm.com.
Nexavar® (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, the timing, progress and results of clinical development,
and the potential expansion of Onyxs product portfolio. These statements are subject to risks and
uncertainties that could cause actual results and events to differ materially from those
anticipated, including, but not limited to, risks and uncertainties related to: Nexavar being our
only approved product; we may never receive marketing approval for carfilzomib; competition;
failures or delays in our clinical trials; dependence on our collaborative relationship with Bayer;
if approved, we may be unsuccessful in launching, maintaining adequate supply of or obtaining
reimbursement for carfilzomib; market acceptance and the rate of adoption of our products;
pharmaceutical pricing and reimbursement pressures; serious adverse side effects, if they are
associated with Nexavar or carfilzomib; government regulation; possible failure to realize the
anticipated benefits of business acquisitions or strategic investments; protection of our
intellectual property; the indebtedness incurred through the sale of our 4.0% convertible senior
notes due 2016; and product liability risks. Reference should be made to Onyxs Annual Report on
Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission,
under the heading Risk Factors for a more detailed description of these and other risks. 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 REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
August 3, 2011
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August 3, 2011
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ONYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue: |
||||||||||||||||
Revenue from collaboration agreement |
$ | 67,956 | $ | 68,773 | $ | 135,101 | $ | 131,676 | ||||||||
Total revenue |
67,956 | 68,773 | 135,101 | 131,676 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development (1) (2) |
63,045 | 43,251 | 125,538 | 86,826 | ||||||||||||
Selling, general and administrative (1) |
38,236 | 26,647 | 72,707 | 51,368 | ||||||||||||
Contingent consideration |
5,755 | 92,037 | 17,250 | 95,485 | ||||||||||||
Lease termination exit costs |
10,727 | | 10,727 | | ||||||||||||
Total operating expenses |
117,763 | 161,935 | 226,222 | 233,679 | ||||||||||||
Loss from operations |
(49,807 | ) | (93,162 | ) | (91,121 | ) | (102,003 | ) | ||||||||
Investment income |
645 | 780 | 1,293 | 1,569 | ||||||||||||
Interest expense |
(5,041 | ) | (4,800 | ) | (10,042 | ) | (9,525 | ) | ||||||||
Other expense (3) |
(340 | ) | | (3,801 | ) | | ||||||||||
Loss before provision (benefit) for income taxes |
(54,543 | ) | (97,182 | ) | (103,671 | ) | (109,959 | ) | ||||||||
Provision (benefit) for income taxes |
| | 32 | (732 | ) | |||||||||||
Net loss |
$ | (54,543 | ) | $ | (97,182 | ) | $ | (103,703 | ) | $ | (109,227 | ) | ||||
Net loss per share: |
||||||||||||||||
Basic |
$ | (0.86 | ) | $ | (1.55 | ) | $ | (1.64 | ) | $ | (1.75 | ) | ||||
Diluted (4) |
$ | (0.86 | ) | $ | (1.55 | ) | $ | (1.64 | ) | $ | (1.75 | ) | ||||
Computation of diluted shares: |
||||||||||||||||
Basic |
63,415 | 62,627 | 63,212 | 62,491 | ||||||||||||
Dilutive effect of options |
| | | | ||||||||||||
Diluted (4) |
63,415 | 62,627 | 63,212 | 62,491 | ||||||||||||
(1) Includes employee stock-based compensation charges of: |
||||||||||||||||
Research and development |
$ | 1,893 | $ | 1,104 | $ | 2,819 | $ | 2,016 | ||||||||
Selling, general, and administrative |
6,451 | 4,672 | 10,880 | 8,702 | ||||||||||||
Total employee stock-based compensation |
$ | 8,344 | $ | 5,776 | $ | 13,699 | $ | 10,718 | ||||||||
(2) | Includes a $12.7 million non-cash expense related to the unamortized balance of funding provided to S*BIO which was recorded in the first quarter of 2011. | |
(3) | Includes a $3.0 million impairment charge which reflects the reassessment of the fair value of Onyxs equity investment in S*BIO during the first quarter of 2011. | |
(4) | Under the if-converted method, interest and issuance costs and potential common shares related to the Companys convertible senior notes were excluded in the computation of diluted per share amounts for the three and six months ended June 30, 2011 and 2010 because their effect would be anti-dilutive. |
ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
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ONYX PHARMACEUTICALS, INC.
CALCULATION OF REVENUE FROM COLLABORATION AGREEMENT
(In thousands, unaudited)
CALCULATION OF REVENUE FROM COLLABORATION AGREEMENT
(In thousands, unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Nexavar product revenue, net (as recorded by Bayer) |
$ | 245,665 | $ | 236,122 | $ | 481,132 | $ | 450,483 | ||||||||
Nexavar revenue subject to profit sharing (as recorded by Bayer) |
$ | 206,600 | $ | 202,979 | $ | 399,770 | $ | 388,846 | ||||||||
Combined cost of goods sold, distribution, selling, general and
administrative expenses |
89,530 | 83,022 | 163,540 | 158,720 | ||||||||||||
Combined collaboration commercial profit |
$ | 117,070 | $ | 119,957 | $ | 236,230 | $ | 230,126 | ||||||||
Onyxs share of collaboration commercial profit |
$ | 58,535 | $ | 59,978 | $ | 118,115 | $ | 115,063 | ||||||||
Reimbursement of Onyxs shared marketing expenses |
6,687 | 6,475 | 11,291 | 12,299 | ||||||||||||
Royalty revenue |
2,734 | 2,320 | 5,695 | 4,314 | ||||||||||||
Revenue from collaboration agreement |
$ | 67,956 | $ | 68,773 | $ | 135,101 | $ | 131,676 | ||||||||
ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
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ONYX PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME (LOSS)
(In thousands, except per share amounts)
(unaudited)
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME (LOSS)
(In thousands, except per share amounts)
(unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
GAAP net (loss) |
$ | (54,543 | ) | $ | (97,182 | ) | $ | (103,703 | ) | $ | (109,227 | ) | ||||
Non-GAAP adjustments: |
||||||||||||||||
Contingent consideration |
5,755 | 92,037 | 17,250 | 95,485 | ||||||||||||
Employee stock-based compensation |
8,344 | 5,776 | 13,699 | 10,718 | ||||||||||||
Imputed interest related to the convertible senior notes due 2016 |
2,509 | 2,222 | 4,944 | 4,379 | ||||||||||||
Advance funding to S*BIO |
| | 12,666 | | ||||||||||||
Impairment of equity investment in S*BIO |
| | 3,000 | | ||||||||||||
Lease termination exit costs |
10,727 | | 10,727 | | ||||||||||||
Non-GAAP net (loss) / income (5) |
$ | (27,208 | ) | $ | 2,853 | $ | (41,417 | ) | $ | 1,355 | ||||||
Computation of non-GAAP diluted net (loss) / income |
||||||||||||||||
Non-GAAP net (loss) / income (5) |
$ | (27,208 | ) | $ | 2,853 | $ | (41,417 | ) | $ | 1,355 | ||||||
Add: |
||||||||||||||||
Interest and issuance costs related to dilutive convertible senior notes (6) |
| | | | ||||||||||||
Non-GAAP net (loss) / income diluted (5) |
$ | (27,208 | ) | $ | 2,853 | $ | (41,417 | ) | $ | 1,355 | ||||||
Computation of non-GAAP diluted shares |
||||||||||||||||
Basic shares |
63,415 | 62,627 | 63,212 | 62,491 | ||||||||||||
Dilutive effect of convertible senior notes (6) |
| 173 | | 222 | ||||||||||||
Non-GAAP diluted shares (5) |
63,415 | 62,800 | 63,212 | 62,713 | ||||||||||||
Non-GAAP net (loss) / income per share (5) |
$ | (0.43 | ) | $ | 0.05 | $ | (0.66 | ) | $ | 0.02 | ||||||
Non-GAAP net (loss) / income per share diluted (5) |
$ | (0.43 | ) | $ | 0.05 | $ | (0.66 | ) | $ | 0.02 |
(5) | This press release includes the following non-GAAP financial measures: non-GAAP net loss, non-GAAP net loss diluted, non-GAAP net loss per share, and non-GAAP net loss per share diluted. The foregoing table reconciles these non-GAAP measures to the most comparable financial measures calculated in accordance with GAAP. | |
Onyx management uses these non-GAAP financial measures to monitor and evaluate our operating results and trends on an on-going basis and internally for operating, budgeting and financial planning purposes. Onyx management believes the non-GAAP information is useful for investors by offering them the ability to better identify trends in our business and better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all items of income and expense that affect Onyx. These non-GAAP financial measures that management uses are not prepared in accordance with, and should not be considered in isolation of, or an as alternative to, measurements required by GAAP. |
These non-GAAP financial measures exclude the following items from GAAP net loss and diluted per
share amounts:
Contingent consideration expense: The effects of contingent consideration expense are
excluded due to the nature of this charge, which is related to the change in fair value of
the liability for contingent consideration in connection with the acquisition of Proteolix;
such exclusion facilitates comparisons of Onyxs operating results to peer companies.
Employee stock-based compensation: The effects of employee stock-based compensation
are excluded because of varying available valuation methodologies, subjective assumptions and
the variety of award types; such exclusion facilitates comparisons of Onyxs operating
results to peer companies.
Imputed interest related to the convertible senior notes due 2016: The effects of
imputed interest related to the convertible senior notes due 2016 are excluded because this
expense is non-cash; such exclusion facilitates
ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
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comparisons of Onyxs cash operating results to peer companies.
Advance funding to S*BIO and impairment of equity investment in S*BIO: The effects of
the termination of the S*BIO collaboration agreement are excluded because they do not relate
to the normal and recurring transactions of Onyxs business; such exclusion allows for a
better representation of the ongoing economics of the business, facilitates comparison to
peer companies and is reflective of how Onyx management internally manages the business.
Lease termination exit costs: The effects of lease termination exit costs are
excluded because they represent non-cash items that relate to Onyxs exit from facilities it
previously occupied in Emeryville and in South San Francisco, California.
(6) | Under the if-converted method, interest and issuance costs and potential common shares related to the Companys convertible senior notes were excluded from non-GAAP diluted per share amounts for the three and six months ended June 30, 2011 and 2010 because their effect would be anti-dilutive. |
ONYX PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
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August 3, 2011
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ONYX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
June 30, | December 31, | |||||||
2011 | 2010 | |||||||
(unaudited) | (7) | |||||||
Assets |
||||||||
Cash, cash equivalents and current marketable securities |
$ | 522,542 | $ | 549,313 | ||||
Other current assets |
65,776 | 95,871 | ||||||
Total current assets |
588,318 | 645,184 | ||||||
Marketable securities, non-current |
28,053 | 28,555 | ||||||
Property and equipment, net |
18,570 | 10,822 | ||||||
Intangible assets in-process research and development |
438,800 | 438,800 | ||||||
Goodwill |
193,675 | 193,675 | ||||||
Other assets |
18,026 | 35,599 | ||||||
Total assets |
$ | 1,285,442 | $ | 1,352,635 | ||||
Liabilities and stockholders equity |
||||||||
Current liabilities |
$ | 47,850 | $ | 72,860 | ||||
Convertible senior notes due 2016 |
157,645 | 152,701 | ||||||
Liability for contingent consideration, non-current |
270,708 | 253,458 | ||||||
Deferred tax liability |
157,090 | 157,090 | ||||||
Other long-term liabilities |
24,561 | 18,952 | ||||||
Lease
termination exit costs, non-current |
7,622 | | ||||||
Stockholders equity |
619,966 | 697,574 | ||||||
Total liabilities and stockholders equity |
$ | 1,285,442 | $ | 1,352,635 | ||||
(7) | Derived from the audited financial statements included in the Companys Annual Report on Form 10-K for the year-ended December 31, 2010. |