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Clovis Oncology Announces 2012 Operating Results and 2013 Objectives

  Clovis Oncology Announces 2012 Operating Results and 2013 Objectives

Business Wire

BOULDER, Colo. -- February 28, 2013

Clovis Oncology, Inc. (NASDAQ:CLVS) today reported financial results for its
quarter and year ended December 31, 2012, and provided an update on the
expected milestones for its clinical development programs for 2013.

“2012 was an important and eventful year for Clovis, despite the disappointing
outcome of the LEAP study in pancreatic cancer,” said Patrick J. Mahaffy,
President and CEO of Clovis Oncology. “During the year we advanced CO-1686 to
treat non-small cell lung cancer (NSCLC) and rucaparib for ovarian cancer into
Phase I/II monotherapy studies and we also initiated a discovery program for a
novel KIT inhibitor to treat gastrointestinal cancer. Our progress in 2012 set
the stage for a meaningful 2013, a year in which we anticipate demonstrating
initial evidence of efficacy for both CO-1686 and rucaparib and plan to
initiate a pivotal trial for rucaparib.”

2012 Financial Results and 2013 Financial Outlook

Clovis reported a net loss of $21.1 million for the fourth quarter of 2012,
and $74.0 million for the year ended December 31, 2012. This compares to a net
loss of $14.9 million for the fourth quarter and $55.6 million for the year
ended December 31, 2011. Net loss attributable to common stockholders for the
fourth quarter of 2012 was $0.81 per share, compared to $1.30 per share for
the fourth quarter of 2011, and $2.97 per share for the year ended December
31, 2012, compared to $14.42 per share for the year ended December 31, 2011.

Research and development expenses totaled $18.3 million for the fourth quarter
of 2012 and $58.9 million for full year 2012, compared to $12.4 million for
the fourth quarter of 2011 and $40.7 million for the full year 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 fourth
quarter of 2012 and $10.6 million for the full year 2012, compared to $2.0
million for the fourth quarter of 2011 and $6.9 million for the full year
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.

Clovis recorded $4.3 million of acquired in process research and development
expenses in 2012, related primarily to a development milestone paid in the
first quarter of the year for CO-1686.

Operating expenses for the fourth quarter of 2012 include $1.3 million of
stock compensation expense, compared to $0.5 million of stock compensation
expense for the fourth quarter of 2011. Operating expenses for the full year
2012 included $4.9 million of stock compensation expense, compared to $1.3
million of stock compensation expense for the comparable period in 2011.

As of December 31, 2012, Clovis had $144.1 million in cash and cash
equivalents and 26.2 million outstanding shares of common stock. The Company
expects a cash burn of $53 to $57 million for 2013, and to end the year with
approximately $90 million in cash.

2013 Key Milestones and Objectives

The Company has a number of important clinical, regulatory and development
objectives planned for 2013 for each of its key products:

CO-1686

  *Complete dose escalation portion of Phase I/II study to establish dose and
    schedule;
  *Initiate Phase II expansion cohorts to assess efficacy in 2^nd line T790M+
    NSCLC patients and in 1^st line EGFR NSCLC patients;
  *Complete development of new tablet formulation of CO-1686;
  *Advance development path in preparation for registration study in 2^nd
    line T790M+ NSCLC patients in the first half of 2014.

Rucaparib

  *Complete dose escalation portion of Phase I/II study to establish
    monotherapy dose and schedule;
  *Initiate Phase II expansion cohort to assess efficacy in selected ovarian
    cancer patients;
  *Advance development of diagnostic to identify patients most likely to
    respond to rucaparib;
  *Initiate HRD biomarker validation study in platinum-sensitive ovarian
    cancer patients in the third quarter of 2013;
  *Initiate pivotal study in platinum-sensitive ovarian cancer patients in
    late 2013.

Mutant cKIT Inhibitor

  *Identify a product candidate in late 2013 or early 2014.

Clovis will hold a conference call to discuss 2012 results this afternoon,
February 28, 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 866.362.4829, International participants 617.597.5346, passcode:
15081308.

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.


CLOVIS ONCOLOGY, INC
CONSOLIDATED FINANCIAL RESULTS
(in thousands, except per share amounts)
                                                              
                   Three Months Ended December 31,   Years Ended December 31,
                   2012            2011             2012         2011
                                                                   
Revenues           $  -             $  -             $ -           $ -
                                                                   
Expenses:
Research and          18,284           12,440          58,894        40,726
development
General and           2,771            2,036           10,638        6,860
administrative
Acquired
in-process           -             -             4,250      7,000   
research and
development
Operating loss       (21,055  )     (14,476  )     (73,782 )   (54,586 )
                                                                   
Other income         (4       )     (405     )     (228    )   (957    )
(expense), net
Loss before          (21,059  )     (14,881  )     (74,010 )   (55,543 )
income taxes
                                                                   
Income taxes         -             (27      )     27         (27     )
Net loss           $  (21,059  )   $  (14,908  )    $ (73,983 )  $ (55,570 )
                                                                   
Basic and
diluted net loss   $  (0.81    )    $  (1.30    )    $ (2.97   )   $ (14.42  )
per common share
                                                                   
Basic and
diluted weighted
average common        25,948           11,498          24,915        3,854
shares
outstanding
                                                                   
                                                                   
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
                                                                   
                   December 31,    December 31,
                   2012             2011
                                                                   
Cash, cash
equivalents and    $  144,097       $  140,248
available for
sale securities
Working capital       132,712          130,519
Total assets          145,994          143,445
Common stock and
additional            317,925          242,243
paid-in capital
Total
stockholders'         133,496          131,793
equity
                                                                   

Contact:

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