Clovis Oncology Announces Third Quarter 2012 Operating Results

  Clovis Oncology Announces Third Quarter 2012 Operating Results

Business Wire

BOULDER, Colo. -- November 05, 2012

Clovis Oncology, Inc. (NASDAQ:CLVS) today reported financial results for the
third quarter 2012, and provided an update on the progress of its clinical
development programs and expected milestones for the rest of the year.

“We had a productive third quarter and we continue to make progress in each of
our three clinical development programs,” said Patrick J. Mahaffy, President
and CEO of Clovis Oncology. “Most importantly, we remain on track to announce
the results from our pivotal LEAP trial of CO-101 in metastatic pancreatic
cancer before the end of the year.”

2012 Financial Results and Outlook

Clovis reported a net loss of $18.3 million for the third quarter of 2012, and
$52.9 million for the first nine months of 2012. This compares to a net loss
of $13.8 million for the third quarter and $40.7 million for the first nine
months of 2011. Net loss attributable to common stockholders for the third
quarter of 2012 was $0.71 per share and $2.15 per share for the year to date,
compared to $10.73 per share for the third quarter and $31.82 per share for
first nine months of 2011.

Research and development expenses totaled $15.5 million for the third quarter
and $40.6 million for first nine months of 2012, compared to $11.6 million for
the third quarter and $28.3 million for the first nine months of 2011. The
increase in research and development expenses over the comparable periods in
2011 was driven by the in-licensing of rucaparib in June 2011, expanded
development activities for CO-101 and an increase in internal resources to
manage the Company’s development programs.

General and administrative expenses totaled $2.8 million for the third quarter
and $7.9 million for the first nine months of 2012, compared to $1.7 million
for the third quarter and $4.8 million for the first nine months of 2011. The
increase in general and administrative expenses over the comparable periods in
2011 was primarily due to increased internal resources and third party costs
to support the activities associated with being a public company.

Operating expenses for the third quarter of 2012 include $1.5 million of stock
compensation expense, compared to $0.4 million of stock compensation expense
for the third quarter of 2011. Operating expenses for the first nine months of
2012 included $3.6 million of stock compensation expense, compared to $0.8
million of stock compensation expense for the comparable period in 2011.

As of September 30, 2012, Clovis had $162.5 million in cash and cash
equivalents and 26.1 million outstanding shares of common stock. The Company
continues to expect a cash burn of $67 to $72 million for 2012, and to end the
year with approximately $140 million in cash.

Recent highlights for Clovis include the following:

  *Signed a diagnostic collaboration with Foundation Medicine for the
    discovery of a companion diagnostic for rucaparib, the Company’s oral,
    small molecule inhibitor of PARP (poly ADP-ribose polymerase) being
    explored for use in patients with tumors with defective BRCA function in
    ovarian and breast cancer;
  *Announced an agreement with Array BioPharma to discover a novel KIT
    inhibitor targeting secondary mutations occurring in the majority of
    gastrointestinal stromal tumor (GIST) patients;
  *Received Orphan Medicinal Product Designation by the European Commission
    for rucaparib for the treatment of ovarian cancer;
  *Initiated commercial planning activities for CO-101, including identifying
    key commercial hires in the US and EU, contingent upon positive results
    from the LEAP trial.

Clovis will hold a conference call to discuss third quarter 2012 results this
afternoon, November 5, at 4:30 p.m. ET. The conference call will be
simultaneously webcast on the Company’s web site at www.clovisoncology.com,
and archived for future review. Dial-in numbers for the conference call are as
follows: US participants 866.277.1182, International participants 617
597.5359, passcode: 57831780.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring,
developing and commercializing innovative anti-cancer agents in the U.S.,
Europe and additional international markets. Clovis Oncology targets
development programs at specific subsets of cancer populations, and
simultaneously develops diagnostic tools that direct a compound in development
to the population that is most likely to benefit from its use. Clovis Oncology
is headquartered in Boulder, Colorado, and has additional offices in San
Francisco, California and Cambridge, UK.

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Clovis Oncology, they are
forward-looking statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements
involve substantial risks and uncertainties that could cause our clinical
development programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
uncertainties inherent in the initiation of future clinical trials,
availability of data from ongoing clinical trials, expectations for regulatory
approvals, development progress of our companion diagnostics, and other
matters that could affect the availability or commercial potential of our drug
candidates or companion diagnostics. Clovis Oncology undertakes no obligation
to update or revise any forward-looking statements. For a further description
of the risks and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as risks relating
to the business of the Company in general, see Clovis Oncology’s reports filed
with the Securities and Exchange Commission, including its Annual Report on
Form 10-K dated for the fiscal year ended December 31, 2011 and in its reports
on Form 10-Q and Form 8-K.

                                                              
CLOVIS ONCOLOGY, INC.
CONSOLIDATED FINANCIAL RESULTS
(in thousands, except per share amounts)
                                                                   
                  Three Months Ended September      Nine Months Ended
                  30,                               September 30,
                  2012            2011             2012          2011
                                                                   
Revenues          $  -             $  -             $  -           $ -
                                                                   
Expenses:
Research and         15,458           11,566           40,610        28,286
development
General and          2,762            1,714            7,867         4,824
administrative
Acquired
in-process          -             -              4,250      7,000   
research and
development
Operating loss      (18,220  )     (13,280  )      (52,727 )   (40,110 )
                                                                   
Other income        (48      )     (555     )      (224    )   (552    )
(expense), net
Loss before         (18,268  )     (13,835  )      (52,951 )   (40,662 )
income taxes
                                                                   
Income taxes        -             -              27         -       
Net loss          $  (18,268  )   $  (13,835  )    $  (52,924 )  $ (40,662 )
                                                                   
Basic and
diluted net       $  (0.71    )    $  (10.73   )    $  (2.15   )   $ (31.82  )
loss per common
share
                                                                   
Basic and
diluted
weighted             25,906           1,289            24,568        1,278
average common
shares
outstanding
                                                                   
                                                                   
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
                                                                   
                  September 30,   December 31,
                  2012             2011
                                                                   
Cash, cash
equivalents and   $  162,479       $  140,248
available for
sale securities
Working capital      151,269          130,519
Total assets         165,319          143,445
Common stock
and additional       316,248          242,243
paid-in capital
Total
stockholders'        152,880          131,793
equity
                                                                   

Contact:

Clovis Oncology, Inc.
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
 
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