- 2013 Total Net Revenues of $1.1
Billion, Up 14% Over 2012; Q4 Total Net Revenues of $299.7 Million,
Up 22% Over 2012
- CUBICIN Achieves Blockbuster Status
with 2013 Worldwide Sales of over $1 Billion
- 2013 U.S. CUBICIN Net Product Revenues
of $908.0 Million, Up 12% Over 2012; Q4 U.S. CUBICIN Net Product
Revenues of $248.9 Million, Up 15% Over 2012
Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced
unaudited fourth quarter and full-year 2013 revenues and a pipeline
update as the Company positions itself to achieve its Building
Blocks of Growth long-range goals. Cubist delivered 22% total net
revenue growth in the fourth quarter compared to 2012, and CUBICIN®
(daptomycin for injection) achieved blockbuster status with over $1
billion in worldwide sales for the full year.
Total net revenues for Q4 2013 of $299.7 million, which include
DIFICID® (fidaxomicin) revenues since the completion of Cubist’s
acquisition of Optimer Pharmaceuticals, Inc. on October 24, 2013,
were up 22% compared to $245.9 million in Q4 2012. Full-year 2013
total net revenues were $1.1 billion, up 14% compared to $926.4
million in 2012. U.S. CUBICIN net product revenues in Q4 2013
increased 15% to $248.9 million from $216.0 million in Q4 2012.
Full-year 2013 U.S. CUBICIN net product revenues were $908.0
million, up 12% compared to $809.2 million in 2012.
“With strong revenue growth, two strategic acquisitions, and
excellent progress on our pipeline, 2013 was a remarkable year for
Cubist,” said Michael Bonney, Chief Executive Officer of Cubist.
“CUBICIN’s achievement of blockbuster status is a reminder of the
critical need for safe and effective antibiotics around the world
and underscores the potential of our pipeline advancing toward
commercialization. As we begin 2014, we are more excited than ever
by our future growth prospects, and we expect to continue to drive
our Building Blocks of Growth through internal discovery and
development efforts, as well as through highly focused business
development activities.”
PIPELINE UPDATE
Prioritizing Investments
Entering 2014, Cubist is prioritizing its portfolio investments
in a disciplined manner to optimize those assets with the highest
near-term potential. The prioritization and distribution of
investments in 2014 will allow the Company to maximize the value of
its lead candidates in alignment with Cubist’s Building Blocks of
Growth goals, while continuing to grow its leadership in
antibiotics and acute care. The Company hopes to deliver at least
four new antibiotics in support of the Infectious Diseases Society
of America (IDSA) goal of 10 new antibiotics by 2020.
“In an industry challenged with a lack of productivity in
R&D, Cubist is entering 2014 with a rich pipeline of innovative
and promising drug candidates,” said Mr. Bonney. “As we work to
bring our promising ceftolozane/tazobactam and tedizolid phosphate
antibiotics programs to commercialization on a global basis – and
with other new development programs on the horizon – it is critical
that we prioritize our portfolio investments on programs that offer
the highest near-term potential impact for patients and maximize
the benefit to our shareholders.”
Continuing Momentum of Ceftolozane/tazobactam
Ceftolozane/tazobactam is being developed to treat certain
Gram-negative infections, including those caused by Pseudomonas
aeruginosa, as well as extended-spectrum beta-lactamase
(ESBL)-producing Escherichia coli (E. coli), Klebsiella pneumoniae,
and other Enterobacteriaceae – bacteria classified by the U.S.
Centers for Disease Control and Prevention (CDC) as “serious”
threats. According to the CDC, an estimated 51,000
healthcare-associated Pseudomonas aeruginosa infections occur in
the U.S. each year, and nearly 26,000 healthcare-associated
Enterobacteriaceae infections are caused by ESBL-producing
Enterobacteriaceae.
The Company recently announced that it met the primary endpoints
for its pivotal Phase 3 clinical trials of ceftolozane/tazobactam
in complicated urinary tract infections (cUTI) and complicated
intra-abdominal infections (cIAI). The data from these trials are
being submitted for presentation at the European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) to be held
in May 2014.
Cubist plans to submit a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for approval in the cUTI and
cIAI indications in the first half of 2014. In the second half of
2014, the Company plans to submit a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) in these
indications.
Additionally, in the first half of 2014, the Company expects to
initiate a pivotal Phase 3 trial to assess the safety and efficacy
of ceftolozane/tazobactam in Hospital-Acquired Bacterial Pneumonia
(HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). With
recent FDA guidance creating greater clarity on an expedient route
to registration in the indication – and with opportunities for
synergies with the planned Phase 3 trial of tedizolid in HABP/VABP
– the Company is ending its open label trial of
ceftolozane/tazobactam in HABP/VABP and focusing its resources on
the registrational study.
Advancing Tedizolid Phosphate
Tedizolid phosphate is being developed for the treatment of
certain serious Gram-positive infections, including those caused by
methicillin-resistant Staphylococcus aureus (MRSA). The CDC
categorized MRSA as a “serious” public health
threat, estimating that there are more than 80,000 invasive
MRSA infections and more than 11,000 related deaths per year in the
U.S.
In December 2013 the FDA accepted the Company’s NDA for
tedizolid phosphate with Priority Review. The FDA has assigned a
Prescription Drug User Fee Act (PDUFA) action date of June 20,
2014. In the first half of 2014, the Company plans to submit a MAA
to the EMA.
Tedizolid is also being developed for potential use in
HABP/VABP, with Phase 3 pivotal studies expected to begin in the
first quarter of 2014.
Investments in CDAD Programs – DIFICID and
Surotomycin
Clostridium difficile-associated diarrhea (CDAD) represents a
large, growing market opportunity. Linked to more than 14,000
deaths in the U.S. per year and with deaths related to C. difficile
increasing 400% from 2000 to 2007, the CDC lists C. difficile as
one of three pathogens that represents an “urgent” threat.
Cubist’s commitment to combating CDAD currently includes the
re-launch of DIFICID® (fidaxomicin) in 2014. The Company expects to
target its efforts on positioning the product for appropriate
patients while communicating the significant value of DIFICID.
DIFICID is the first therapy approved for CDAD in more than 25
years and has demonstrated superiority on sustained clinical
response compared to vancomycin. In August 2013, DIFICID received a
one-year extension of the U.S. Centers for Medicare and Medicaid
Services (CMS) new technology add-on payment (NTAP). The NTAP
program, available to new technologies demonstrating a substantial
clinical improvement and meeting specific cost thresholds, is
designed to support timely access of innovative therapies used to
treat Medicare beneficiaries in the inpatient setting.
The Company’s ongoing Phase 3b clinical trial of DIFICID for the
prevention of CDAD in patients undergoing hematopoietic stem cell
transplant, often referred to as bone marrow transplantation, is
progressing as scheduled and Cubist expects to review interim data
in the first quarter of 2014.
CDAD is a relapsing condition in which patients and their
physicians often require multiple therapeutic options. Accordingly,
while the Company invests in DIFICID, it will also continue
disciplined investments in its Phase 3 surotomycin CDAD program.
The Company continues to expect to announce top line data from the
surotomycin Phase 3 studies in 2015. The timeline for regulatory
submissions will be determined following a full review of the Phase
3 data, but the Company expects the NDA submission for surotomycin
will occur later than the previous forecast.
Update on Bevenopran Program
In light of the FDA planned March 2014 Advisory Committee
meeting to discuss the potential for elevated cardiovascular events
related to mu-opioid antagonists, and the challenges associated
with enrolling patients in the current Phase 3 bevenopran trial,
Cubist has decided to suspend its Phase 3 efficacy studies of
bevenopran, a mu-opioid antagonist, in patients with chronic
non-cancer pain and opioid-induced constipation (OIC). Instead, the
Company will focus on the completion of its long-term safety trial
of bevenopran, which is progressing ahead of schedule. Based
on results of the safety trial and, following the Advisory
Committee meeting, further guidance from the FDA on the potential
for a more feasible Phase 3 efficacy study design, a decision will
be made on how to best proceed with the bevenopran program in
2015.
Commitment to Discovery and Early-Stage Development
Cubist’s leadership in infectious diseases includes innovation
in the discovery of new treatments to combat serious and
life-threatening infections.
On January 10, Cubist announced that it submitted a Clinical
Trial Application (CTA) to the Dutch Competent Authority and Ethics
Committee to initiate a first-in-human study of CB-618 in the
Netherlands. CB-618 is a novel, broad-spectrum beta-lactamase
inhibitor (BLI) investigational compound discovered by Cubist. The
purpose of the proposed study will be to evaluate the safety,
tolerability and pharmacokinetics of CB-618. Based on in vitro
pre-clinical studies, CB-618 has been shown to increase the
spectrum of activity of certain beta-lactam antibiotics. If
successful, CB-618 could help combat resistance to certain
beta-lactam antibiotics and serious infections, including those
caused by carbapenem-resistant Enterobacteriaceae (CRE) and
Klebsiella pneumoniae carbapenemases (KPCs). CB-618 is part of a
platform research approach by Cubist to identify new BLIs, which
could potentially restore and expand the utility of certain
existing antibiotics.
Other Pipeline Updates
In February 2013, Cubist entered into an option agreement under
which Cubist has the exclusive right to acquire Adynxx, Inc.
following receipt of data from Adynxx’s Phase 2 trial for its lead
product candidate, AYX1, a potential treatment for the reduction of
acute pain and prevention of persistent and chronic pain following
surgery. Following review of the Phase 2 data, Cubist has decided
to not exercise its right to acquire Adynxx. While AYX1 was
well-tolerated in this trial and the observed clinical response may
warrant continued exploration, the magnitude of the clinical
response did not meet Cubist’s exercise criteria.
The Company plans to host a conference call to discuss complete
fourth quarter and year-end 2013 financial results on January 23rd
at 5:00 p.m. ET. The conference call and webcast information is
below.
*******************CONFERENCE CALL &
WEBCAST INFORMATION********************
Cubist will host a conference call and live
audio webcast to discuss both its fourth quarter andfull-year 2013
financial results, business activities and financial outlook.
WHEN: Thursday, January 23, 2014 at 5:00 p.m.
ET
U.S./CANADA ATTENDEE DIAL-IN: (855)
319-7654INTERNATIONAL ATTENDEE DIAL-IN: (484) 756-4327Attendee
Passcode: 29092793
24-HOUR REPLAY U.S./CANADA: (855)
859-205624-HOUR REPLAY INTERNATIONAL: (404) 537-3406Conference ID:
29092793
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY,
VIA THE WEB
AT:https://cubist.webex.com/cubist/onstage/g.php?t=a&d=625478620Attendee
Password: 01232014
Replay will be available for 30 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, Massachusetts, with a central international office
located in Zurich, Switzerland. Additional information can be found
at Cubist’s web site at www.cubist.com.
Forward Looking Statements
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: our unaudited expected fourth quarter and
full-year 2013 financial results; the therapeutic and commercial
potential of our products and product candidates; the expected
timing for commencing clinical trials, making development
decisions, data readouts and presentations and for regulatory
filings and responses for our products and product candidates; our
Phase 3 clinical data for ceftolozane/tazobactam in cUTI and cIAI;
our Building Blocks of Growth five-year goals through 2017; our
aspirations to achieve a portion of the IDSA goal of 10 new
antibiotics by 2020; and our research efforts, including our
efforts to identify new BLIs for use with existing antibiotics, 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, among others: the risk that our final fourth
quarter and full-year 2013 financial results will differ materially
from our expected results disclosed in this release; risks related
to drug development and commercialization, including the fact that
drug discovery and development is complex, time consuming,
expensive and fraught with a high risk of failure; our ability to
achieve our long-term goals, including as a result of our ability
to continue to grow revenues from the sale of CUBICIN, ENTEREG and
DIFICID, generic and other competition, manufacturing issues, our
ability to successfully develop, gain marketing approval for and
commercially launch our product candidates for their planned
indications and on their expected timelines, and our ability to
discover, in-license or acquire new products and product
candidates; regulatory developments in the United States and
foreign countries, including the risk that the FDA and foreign
regulatory authorities may not agree with our interpretation of the
results from our clinical studies of ceftolozane/tazobactam and
tedizolid, may not approve on a timely basis or at all, our
marketing authorization applications for ceftolozane/tazobactam and
tedizolid phosphate or may require additional data, analysis,
information or further studies that may not be clinically feasible
or financially practicable; the review of our NDA for tedizolid may
take longer than anticipated due to internal FDA constraints; any
marketing approval for any of our product candidates may impose
significant limitations on its use and additional post-marketing
requirements; competitive risks from current and future therapeutic
alternatives to our products and product candidates, including
generic competitors such as Teva, Hospira and Strides; our ability
to maintain and enforce intellectual property protection for our
products and product candidates; additional clinical trials of our
products and product candidates may produce negative or
inconclusive results or may not be initiated or conducted in a
timely manner; technical difficulties or excessive costs relating
to the manufacture or supply of our products and product
candidates, including our ability to work with, and the performance
of our third party contract manufacturers that manufacture and
supply our products and product candidates on our behalf; our
ability to work with, and the performance of our third party
contract research organizations that help us conduct our clinical
trials; the risk that the Dutch Competent Authority and Ethics
Committee may not approve our CTA for CB-618; and those additional
factors discussed in our most recent annual report on Form 10-K and
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.
Cubist Pharmaceuticals, Inc.INVESTORS:Eileen C. McIntyre,
781-860-8533Vice President, Investor
Relationseileen.mcintyre@cubist.comorMEDIA:Julie DiCarlo,
781-860-8063Senior Director, Corporate
Communicationsjulie.dicarlo@cubist.com