Cubist
Pharmaceuticals, Inc. (NASDAQ: CBST) today announced results for the
third quarter ended September 30, 2010.
Third Quarter 2010 Highlights:
-
GAAP Basic and Diluted Net Income of $0.53 and $0.50 per share,
respectively, for 3Q10
-
Non-GAAP Basic and Diluted Net Income of $0.83 and $0.72 per share,
respectively, for 3Q10
-
Raising operating income guidance range for full year to $185 - $195
million
-
Tightening total revenue guidance range to $645 - $650 million
-
Earnings’ conference call & webcast today (with slides) at 5:00 p.m. ET
Cubist’s total net revenues for the third quarter of 2010 increased 13%
to $162.1 million from $143.5 million in the third quarter of 2009. This
increase was attributable primarily to Cubist’s net sales of CUBICIN®
(daptomycin for injection) in the United States, which increased 12% to
$154.5 million in the third quarter of 2010 from $137.7 million in the
third quarter of 2009. Cubist’s net product revenues from international
sales of CUBICIN for the third quarter of 2010 were $6.0 million, an
increase of 53% over the third quarter of 2009. In Q3 2010 there were no
service revenues recorded as Cubist’s exclusive agreement with
AstraZeneca to promote and provide other support in the United States
for MERREM® I.V. (meropenem for injection) ended in June.
Net income for the third quarter of 2010 on a GAAP basis was $31.2
million, or $0.53 and $0.50 per basic and diluted share, respectively,
as compared to $25.4 million, or $0.44 and $0.42 per basic and diluted
share, respectively, for the third quarter of 2009.
Cubist's non-GAAP net income for the third quarter of 2010 was $49.1
million, or $0.83 and $0.72 per basic and diluted share, respectively,
which represents an increase of $5.9 million in non-GAAP net income
compared to the third quarter of 2009. A reconciliation between GAAP and
non-GAAP net income is provided in the Condensed Consolidated Statements
of Income Non-GAAP table included with this release.
As of September 30, 2010, Cubist had $605.1 million in cash, cash
equivalents and investments. The total number of Cubist's common shares
outstanding as of September 30, 2010, was 59,145,736.
Clinical Pipeline Update
-
CXA-201 -- A novel cephalosporin/tazobactam combination product
(combination of CXA-101 and tazobactam) being developed for the
treatment of infections due to drug-resistant Pseudomonas aeruginosa
and other Gram-negative pathogens:
-
Positive Phase 2 complicated urinary tract infection data (for
CXA-101 alone) presented at ICAAC in September
-
Enrollment continues in Phase 2 CXA-201 complicated
intra-abdominal infection trial
-
Remain on track with clinical plan, which, assuming success, will
allow for an NDA filing for 2 indications by YE 2013
-
CB-183,315 -- A potent, oral, bactericidal lipopeptide being developed
for the treatment of Clostridium difficile-associated diarrhea
(CDAD):
-
Positive preclinical data presented at ICAAC in September
-
Phase 2 dose-ranging trial continues to enroll
-
Expect to have data to share in 2H 2011
Use of Non-GAAP Financial Measures
Non-GAAP net income and non-GAAP net income per share exclude
non-operational activities. Cubist uses these measures to assess and
analyze its operational results and trends and to make financial and
operational decisions. Cubist believes these non-GAAP financial measures
are useful to investors because they provide greater transparency
regarding Cubist's operating performance. These non-GAAP financial
measures should not be considered an alternative to measurements
required by GAAP, such as net income and net income per share, and
should not be considered measures of Cubist's liquidity. In addition,
these non-GAAP financial measures are unlikely to be comparable with
non-GAAP information provided by other companies. A reconciliation
between non-GAAP financial measures and GAAP financial measures is
included in the tables accompanying this press release after the
unaudited condensed consolidated financial statements.
******************CONFERENCE CALL & WEBCAST INFORMATION******************
WHEN: Thursday, October 14, 2010 at 5:00 p.m. ET
LIVE DOMESTIC &
CANADA CALL-IN: 877-407-8289
LIVE INTERNATIONAL CALL-IN:
201-689-8341
24-HOUR REPLAY DOMESTIC & CANADA: 1-877-660-6853
24-HOUR REPLAY
INTERNATIONAL: / 1-201-612-7415
REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK):
ACCOUNT #: 351
CONFERENCE ID #: 356880
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT:
www.cubist.com
(Investor Relations page)
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 unmet medical needs in the acute care environment.
In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the
first antibiotic in a class of anti-infectives called lipopeptides. The
Cubist clinical product pipeline currently consists of a Phase 2 program
focused on the development of a novel cephalosporin to address certain
serious infections caused by multi-drug resistant (MDR) Gram-negative
organisms; and a Phase 2 program for the treatment of CDAD (Clostridium
difficile-associated diarrhea). Cubist is also working on several
pre-clinical programs being developed to address areas of significant
medical needs. These include an anti-infective program for the treatment
of respiratory syncytial virus (RSV) in children, therapies to treat
various serious bacterial infections, and agents to treat acute pain.
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 regarding our
2010 guidance for operating income and net revenues and our pipeline
programs. There are many factors that could cause actual results to
differ materially from those in these forward-looking statements. These
factors include the following: (i) the level of acceptance of CUBICIN by
physicians, patients, third-party payors and the medical community; (ii)
the ability to increase market penetration of CUBICIN, particularly as
the growth of the market for CUBICIN slows or even declines; (iii) any
changes in the current or anticipated market demand or medical need for
CUBICIN; (iv) any unexpected adverse events related to CUBICIN,
particularly as CUBICIN is used in the treatment of a growing number of
patients around the world; (v) the results of the patent infringement
lawsuit that Cubist has filed against Teva Parenteral Medicines, Inc.
and its affiliates in response to Teva's Abbreviated New Drug
Application, or ANDA, with the U.S. Food and Drug Administration, or
FDA, regarding CUBICIN and any litigation related thereto, and any other
litigation that we file to defend and/or assert our patents; (vi) the
effectiveness of our sales force and our sales force's ability to access
targeted physicians; (vii) competition in the markets in which we and
our partners market CUBICIN, including marketing approvals for new
products that will be competitive with CUBICIN; (viii) the ability of
our third party manufacturers, including our single source provider of
API, to manufacture sufficient quantities of CUBICIN in accordance with
Good Manufacturing Practices and other requirements of the regulatory
approvals for CUBICIN and at an acceptable cost; (ix) the effect that
the results of ongoing or future clinical trials of CUBICIN may have on
its acceptance in the medical community; (x) changes in government
reimbursement for our or our competitors' products; (xi) our dependence
upon collaborations with our partners and our partners' ability to
execute on development and regulatory expectations; (xii) our ability to
execute successful, adequate and well-controlled clinical trials of our
pipeline products in a timely manner; (xiii) unanticipated safety or
efficacy data from clinical trials of our product candidates; (xiv) our
ability, and our partners' ability, to protect the proprietary
technologies and intellectual property related to our product
candidates; (xv) whether the FDA accepts proposed clinical trial
protocols in a timely manner for our product candidates; (xvi)
legislative and policy changes in the U.S. and other jurisdictions where
our products are sold that may affect the ability to get a new product
or a new indication approved; (xvii) unexpected delays or expenses
related to our ongoing capital projects and pipeline programs; and
(xviii) a variety of risks common to our industry, including ongoing
regulatory review, securing adequate supplies of drug product and drug
substance of our product candidates on a timely and cost-effective
basis, and public and investment community perception of the industry,
legislative or regulatory changes. Drug development involves a high
degree of risk. Success in pre-clinical trials or early stage clinical
trials does not mean that later stage trials will be successful.
Additional factors that could cause actual results to differ materially
from those projected or suggested in any forward-looking statements are
contained in Cubist's recent annual and quarterly reports with the
Securities and Exchange Commission, including those factors discussed
under the caption "Risk Factors" in such filings, which are incorporated
in this press release by this reference. Forward-looking statements
speak only as of the date of this release, and Cubist undertakes no
obligation to update or revise these statements, except as may be
required by law.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals,
Inc.
Tables Follow
|
CUBIST PHARMACEUTICALS, INC.
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
UNAUDITED
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2010
|
|
2009
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
Cash, cash equivalents and investments
|
|
$
|
605,107
|
|
$
|
496,163
|
|
Accounts receivable, net
|
|
|
61,304
|
|
|
57,827
|
|
Inventory
|
|
|
25,590
|
|
|
25,497
|
|
Property and equipment, net
|
|
|
75,202
|
|
|
68,382
|
|
Deferred tax assets, net
|
|
|
4,880
|
|
|
33,387
|
|
In-process research and development
|
|
|
194,000
|
|
|
194,000
|
|
Other assets
|
|
|
130,493
|
|
|
102,419
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
1,096,576
|
|
$
|
977,675
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
82,629
|
|
$
|
104,131
|
|
Deferred tax liabilities, net
|
|
|
41,125
|
|
|
31,205
|
|
Deferred revenue
|
|
|
23,846
|
|
|
20,891
|
|
Contingent consideration
|
|
|
85,389
|
|
|
101,600
|
|
Debt and other long-term liabilities, net
|
|
|
265,427
|
|
|
249,205
|
|
Total liabilities
|
|
|
498,416
|
|
|
507,032
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
598,160
|
|
|
470,643
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
|
$
|
1,096,576
|
|
$
|
977,675
|
|
|
|
|
|
|
|
CUBIST PHARMACEUTICALS, INC.
|
|
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
|
|
UNAUDITED
|
|
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. product revenues, net
|
|
$
|
154,486
|
|
|
|
$
|
137,660
|
|
|
|
$
|
444,744
|
|
|
|
$
|
376,180
|
|
|
International product revenues
|
|
|
6,009
|
|
|
|
|
3,928
|
|
|
|
|
18,983
|
|
|
|
|
8,877
|
|
|
Service revenues
|
|
|
-
|
|
|
|
|
1,500
|
|
|
|
|
8,500
|
|
|
|
|
9,050
|
|
|
Other revenues
|
|
|
1,556
|
|
|
|
|
446
|
|
|
|
|
2,426
|
|
|
|
|
1,316
|
|
|
Total revenues, net
|
|
|
162,051
|
|
|
|
|
143,534
|
|
|
|
|
474,653
|
|
|
|
|
395,423
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues
|
|
|
37,000
|
|
|
|
|
30,771
|
|
|
|
|
105,178
|
|
|
|
|
83,329
|
|
|
Research and development
|
|
|
36,955
|
|
|
|
|
35,527
|
|
|
|
|
115,984
|
|
|
|
|
118,440
|
|
|
Contingent consideration
|
|
|
1,094
|
|
|
|
|
-
|
|
|
|
|
3,789
|
|
|
|
|
-
|
|
|
Sales and marketing
|
|
|
20,587
|
|
|
|
|
18,883
|
|
|
|
|
63,466
|
|
|
|
|
60,020
|
|
|
General and administrative
|
|
|
14,284
|
|
|
|
|
12,857
|
|
|
|
|
43,037
|
|
|
|
|
36,446
|
|
|
Total costs and expenses
|
|
|
109,920
|
|
|
|
|
98,038
|
|
|
|
|
331,454
|
|
|
|
|
298,235
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
52,131
|
|
|
|
|
45,496
|
|
|
|
|
143,199
|
|
|
|
|
97,188
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
|
(678
|
)
|
|
|
|
(4,170
|
)
|
|
|
|
(11,379
|
)
|
|
|
|
(12,492
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes
|
|
|
51,453
|
|
|
|
|
41,326
|
|
|
|
|
131,820
|
|
|
|
|
84,696
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income taxes
|
|
|
20,225
|
|
|
|
|
15,947
|
|
|
|
|
52,045
|
|
|
|
|
27,765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
31,228
|
|
|
|
$
|
25,379
|
|
|
|
$
|
79,775
|
|
|
|
$
|
56,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share
|
|
$
|
0.53
|
|
|
|
$
|
0.44
|
|
|
|
$
|
1.36
|
|
|
|
$
|
0.99
|
|
|
Diluted net income per common share
|
|
$
|
0.50
|
|
1
|
|
|
$
|
0.42
|
|
1
|
|
|
$
|
1.29
|
|
1
|
|
|
$
|
0.98
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share
|
|
|
59,047,880
|
|
|
|
|
57,842,403
|
|
|
|
|
58,621,263
|
|
|
|
|
57,673,057
|
|
|
Diluted net income per common share
|
|
|
69,780,060
|
|
|
|
|
68,534,597
|
|
|
|
|
69,312,849
|
|
|
|
|
68,322,580
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
¹ Includes add back of interest expense, debt issuance costs and
debt discount on 2.25% notes to income, net of tax effect
|
|
|
|
CUBIST PHARMACEUTICALS, INC.
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF INCOME - NON-GAAP
|
|
|
UNAUDITED
|
|
|
(in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income
|
|
$
|
31,228
|
|
|
|
$
|
25,379
|
|
|
|
$
|
79,775
|
|
|
|
$
|
56,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense
|
|
|
4,027
|
|
|
|
|
3,710
|
|
|
|
|
11,938
|
|
|
|
|
10,194
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash debt discount amortization
|
|
|
3,622
|
|
|
|
|
3,332
|
|
|
|
|
10,642
|
|
|
|
|
9,790
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
|
|
|
1,094
|
|
|
|
|
-
|
|
|
|
|
3,789
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payments related to external collaborations
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
20,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of Auction Rate Securities
|
|
|
(2,309
|
)
|
|
|
|
-
|
|
|
|
|
(2,309
|
)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash tax expense
|
|
|
14,896
|
|
|
|
|
13,450
|
|
|
|
|
41,561
|
|
|
|
|
23,420
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax effect of Non-GAAP adjustments
|
|
|
(3,443
|
)
|
|
|
|
(2,647
|
)
|
|
|
|
(10,640
|
)
|
|
|
|
(14,326
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP proforma net income
|
|
$
|
49,115
|
|
|
|
$
|
43,224
|
|
|
|
$
|
134,756
|
|
|
|
$
|
106,009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per common share
|
|
$
|
0.83
|
|
|
|
$
|
0.75
|
|
|
|
$
|
2.30
|
|
|
|
$
|
1.84
|
|
|
|
Non-GAAP diluted net income per common share
|
|
$
|
0.72
|
|
1
|
|
|
$
|
0.65
|
|
1
|
|
|
$
|
1.99
|
|
1
|
|
|
$
|
1.61
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income per common share
|
|
|
59,047,880
|
|
|
|
|
57,842,403
|
|
|
|
|
58,621,263
|
|
|
|
|
57,673,057
|
|
|
|
Non-GAAP diluted net income per common share
|
|
|
69,780,060
|
|
|
|
|
68,534,597
|
|
|
|
|
69,312,849
|
|
|
|
|
68,322,580
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
¹ Includes add back of interest expense and debt issuance costs on
2.25% notes to income, net of tax effect
|
