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Cubist Announces Full-Year 2012 Revenues and Provides Business Update

  Cubist Announces Full-Year 2012 Revenues and Provides Business Update

  *2012 Total Net Revenues of $926.4 Million, Up 23% Over 2011
  *Q4 Total Net Revenues of $245.9 Million, Up 16% Over 2011
  *Data Readouts for Two Phase 3 Trials Expected in 2H13
  *Company Presenting at J.P. Morgan Healthcare Conference on Jan. 10, 2013

Business Wire

LEXINGTON, Mass. -- January 7, 2013

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced unaudited fourth
quarter and full-year 2012 revenues and provided business updates, including
the expected timing of data readouts for two ongoing Phase 3 clinical trials
of CXA-201 (ceftolozane/tazobactam).

Cubist continued to deliver double-digit total revenue growth in the fourth
quarter. Fourth quarter and year-end 2012 unaudited revenue results include:

  *Total net revenues for Q4 2012 of $245.9 million were up 16% compared to
    Q4 of 2011. Full-year 2012 total net revenues were $926.4 million, up 23%
    compared to $754.0 million in 2011.
  *U.S. CUBICIN® (daptomycin for injection) net product revenues in Q4 2012
    increased 14% to $216.0 million from $190.1 million in Q4 2011. Full-year
    2012 total U.S. CUBICIN net product revenues were $809.2 million, up 16%
    compared to $698.8 million in 2011.
  *International CUBICIN revenues for Q4 2012 increased 34% to $14.5 million
    from $10.8 million in Q4 2011. Full-year 2012 total international CUBICIN
    revenues were $50.5 million, up 38% compared to $36.7 million in 2011.
  *ENTEREG® (alvimopan) net product revenues were $10.9 million in the fourth
    quarter of 2012. Full-year 2012 total ENTEREG net product revenues were
    $40.2 million.
  *Service revenues for DIFICID® (fidaxomicin) in the fourth quarter of 2012
    were $3.7 million. Full-year 2012 total services revenues for DIFICID were
    $23.2 million.

Cubist also provided an update regarding ceftolozane/tazobactam, currently
being studied in pivotal Phase 3 trials as a first-line intravenous therapy
for the treatment of complicated intra-abdominal infections (cIAI) and
complicated urinary tract infections (cUTI) caused by Gram-negative bacterial
infections, including those caused by multi-drug resistant Pseudomonas
aeruginosa. Top-line data readouts from these two clinical trials are expected
in the second-half of 2013. This timing incorporates a reduction of patient
enrollment requirements and reflects the Company’s recent consultation with
the Food and Drug Administration (FDA), following the release by the FDA in
late September of new draft guidance for cIAI registration trials. Cubist
anticipates filing a New Drug Application (NDA) for ceftolozane/tazobactam in
cUTI and cIAI approximately six months after announcing top-line results from
the Phase 3 trials. As recently announced, the FDA granted
ceftolozane/tazobactam a Qualified Infectious Disease Products (QIDP)
designation, qualifying it for priority review and fast-track status at the
FDA. If ultimately approved by the FDA, it would also receive a five-year
extension of Hatch-Waxman exclusivity.

“We had another strong year in 2012, driven in large measure by the continued
growth of CUBICIN. As we enter 2013, and anticipate Phase 3 data for
ceftolozane/tazobactam, we expect to begin the next significant chapter of
Cubist’s growth story,” said Michael Bonney, Chief Executive Officer. “We
continue to demonstrate the value of our differentiated focus on the acute
care market. We are advancing three Phase 3 product candidates, including
ceftolozane/tazobactam, which we believe has blockbuster potential based on
its unique attributes and the significant need for new antibiotics to treat
infections caused by multi-drug resistant Gram-negative pathogens. As we move
forward in 2013, we will continue to focus on driving shareholder value by
executing against our Building Blocks of Growth five-year goals.”

Mr. Bonney will present to investors at the 31st Annual J.P. Morgan Healthcare
Conference at 2:00 p.m. ET / 11:00 a.m. PT on January 10th, 2013. The
presentation will be available via webcast at www.cubist.com. During his
presentation, Mr. Bonney will discuss the Company’s unaudited 2012 revenue
results, the company’s business strategy and market opportunities, and will
highlight additional recent pipeline developments, including:

  *The updated timing for anticipated top-line data from
    ceftolozane/tazobactam’s Phase 3 studies in cUTI and cIAI;
  *CB-315’s recent QIDP designation, and Phase 3 trials now underway in
    Clostridium difficile-associated diarrhea (CDAD); and
  *The bevenopran (CB-5945) Phase 3 program to develop a potential therapy
    for patients with opioid-induced constipation (OIC) which began in October
    2012 with the initiation of a large, well-controlled, long-term safety
    trial. Three Phase 3 efficacy trials are planned to begin in the first
    half of 2013.

The Company will host a conference call to discuss complete financial results
for fourth quarter and year-end 2012 on January 23, 2013 at 5:00 p.m. ET. The
conference call and webcast information is below.

******************Q4 2012 CONFERENCE CALL & WEBCAST
INFORMATION******************
Cubist will host a conference call and live audio webcast to discuss both its
fourth quarter and
full-year 2012 financial results, business activities and financial outlook.

WHEN: Wednesday, January 23, 2013 at 5:00 p.m. ET
LIVE DOMESTIC & CANADA CALL-IN: (855) 319-7654
LIVE INTERNATIONAL CALL-IN: (484) 756-4327
Attendee Passcode: 83986357

24-HOUR REPLAY DOMESTIC & CANADA: (855) 859-2056
24-HOUR REPLAY INTERNATIONAL: (404) 537-3406

REPLAY PASSCODE:
Conference ID: 83986357

CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
www.cubist.com
Replay will be available for 90 days via the Internet at www.cubist.com
**********************************************************************

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
research, development, and commercialization of pharmaceutical products that
address significant unmet medical needs in the acute care environment. Cubist
is headquartered in Lexington, Mass. Additional information can be found at
Cubist’s web site at www.cubist.com.

Cubist Safe Harbor Statement

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and other federal
securities laws. Any statements contained herein which do not describe
historical facts, including but not limited to, statements regarding (i) our
unaudited expected fourth quarter and full-year 2012 financial results, (ii)
the expected timing of data readouts for our two ongoing Phase 3 clinical
trials of CXA-201, (iii) the expected timing of our NDA for
ceftolozane/tazobactum in cUTI and cIAI, (iv) the expected five-year extension
of Hatch-Waxman exclusivity for ceftolozane/tazobactum, (v) our belief in the
blockbuster potential of ceftolozane/tazobactum, (vi) the expected timing of
beginning Phase 3 efficacy trials for CB-5945 and (vii) our plan to execute
against our Building Blocks of Growth five-year goals, are forward-looking
statements which involve risks and uncertainties that could cause actual
results to differ materially from those discussed in such forward-looking
statements.

Such risks and uncertainties include: the risk that our final fourth quarter
and 2012 full-year audited financial results will differ materially from our
expected results disclosed in this release; our ability to continue to grow
revenues from the sale of CUBICIN, the ability of our third-party suppliers to
produce and deliver adequate amounts of CUBICIN; competition from generic drug
companies such as Teva and Hospira; our ability to successfully market and
sell ENTEREG, our ability to successfully develop, gain marketing approval for
and commercially launch ceftolozane/tazobactam and our other product
candidates for their planned indications and on the timelines that we expect;
our ability to in-license or acquire new products and product candidates; our
ability to achieve and manage our growth in our business; and those additional
factors discussed in our most recent quarterly report on Form 10-Q filed with
the Securities and Exchange Commission. We caution investors not to place
considerable reliance on the forward-looking statements contained in this
press release. These forward-looking statements speak only as of the date of
this document, and we undertake no obligation to update or revise any of these
statements.

Contact:

INVESTORS:
Cubist Pharmaceuticals, Inc.
Eileen C. McIntyre, 781-860-8533
Senior Director, Investor Relations
eileen.mcintyre@cubist.com
or
MEDIA:
Cubist Pharmaceuticals, Inc.
Julie DiCarlo, 781-860-8063
Senior Director, Corporate Communications
julie.dicarlo@cubist.com
 
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