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8-K - 8-K - CUBIST PHARMACEUTICALS INCa13-3203_18k.htm

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

 

CUBIST REPORTS FOURTH QUARTER AND FULL YEAR 2012 FINANCIAL RESULTS

 

·      Full Year Total Net Revenues of $926.4 Million, Up 23% Over Previous Year

·      Full Year Non-GAAP Adjusted Operating Income of $274.5 Million, Up 12% Over 2011

·      Full Year GAAP Operating Income of $237.1 Million, Up 79% Over Previous Year

·      Full Year GAAP Diluted EPS Up 304% to $2.10 Compared to $0.52 in 2011; Full Year
Non-GAAP Diluted EPS was $2.65

 

Lexington, Mass., January 23, 2013 — Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced results for the fourth quarter and year ended December 31, 2012. The Company will host a conference call and webcast today at 5:00 p.m. ET to discuss the results and other business updates (details below).

 

Financial highlights for the fourth quarter of 2012 (unaudited):

 

·                  Total net revenues grew 16% to $245.9 million compared to $212.9 million in the fourth quarter of 2011.

·                  GAAP operating income was $45.3 million, up from $43.3 million in the fourth quarter of 2011.

Non-GAAP adjusted operating income was $54.2 million compared to $70.3 million in the fourth quarter of 2011.

·                  GAAP diluted earnings per share (EPS) was $0.51 compared to $0.11 in the fourth quarter of 2011. Non-GAAP diluted EPS was $0.48 compared to $0.60 in the fourth quarter of 2011.

·                  In-process research and development impairment charge of $38.7 million and contingent consideration income of $36.0 million were recorded in the fourth quarter of 2012 due to our decision to delay development of bevenopran (CB-5945) in Europe based on our current assessment of the European commercial opportunity and regulatory environment.

 

Financial highlights for the full year of 2012 (unaudited):

 

·                  Total net revenues grew 23% to $926.4 million compared to $754.0 million in 2011.

·                  GAAP operating income was $237.1 million, up 79% from $132.5 million in 2011. Non-GAAP adjusted operating income increased 12% to $274.5 million from $244.5 million in 2011.

·                  GAAP diluted EPS increased 304% to $2.10 compared to $0.52 in 2011. Non-GAAP diluted EPS was $2.65, an increase of 8% over $2.46 in 2011.

 

“We continued our strong momentum in the fourth quarter of 2012, capping a significant year of growth for Cubist,” said Michael Bonney, Chief Executive Officer.  “With 2012 total revenues of more than $926 million, we grew our top-line by 23%, driven largely by the continued strong performance of the U.S. and international CUBICIN business, as well as a 21% increase in ENTEREG sales.  And with three exciting Phase 3 product candidates in our pipeline, including our potential blockbuster antibiotic candidate for the treatment of certain Gram negative infections, ceftolozane/tazobactam (CXA-201), we believe we are well-positioned to extend our leadership in the hospital and acute care environment for many years to come.”

 

As previously announced, fourth quarter 2012 total U.S. CUBICIN® (daptomycin for injection) net product revenues were $216.0 million, up 14% over fourth quarter 2011, and full year U.S. CUBICIN net product

 

65 Hayden Avenue, Lexington, MA 02421  P 781.860.8660  F 781.861.0566  www.cubist.com

 



 

revenues were $809.2 million, up 16% over 2011. Cubist’s share of full year 2012 international CUBICIN revenues was $50.5 million, which represents a 38% increase over $36.7 million in 2011.  Service revenues for our co-promote of DIFICID® (fidaxomicin) for the fourth quarter were $3.7 million and were $23.2 million for the full year of 2012, a 246% increase over full year 2011. ENTEREG® (alvimopan), acquired through our acquisition of Adolor Corporation in December 2011, net product revenues were $10.9 million in the fourth quarter of 2012 and $40.2 million for the full year, a 21% pro forma increase over the full year of 2011.

 

As of December 31, 2012, Cubist had $979.4 million in cash, cash equivalents and investments. The total number of Cubist’s common shares outstanding as of December 31, 2012, was 64,713,695.

 

Pipeline Update and Milestones

 

Cubist enters 2013 with a robust pipeline. Product candidate status and upcoming milestones include:

 

Ceftolozane/tazobactam — a potential first-line therapy being studied for the treatment of certain serious Gram-negative bacterial infections, including those caused by multi-drug resistant Pseudomonas aeruginosa.

 

·                  Top-line data for ceftolozane/tazobactam Phase 3 trials in complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) are expected in the second half of 2013. This timing reflects a reduction of patient enrollment requirements based on Cubist’s recent consultation with the Food and Drug Administration (FDA).

·                  Cubist anticipates filing a New Drug Application (NDA) for ceftolozane/tazobactam in cUTI and cIAI within approximately six months of announcing top-line results from the Phase 3 trials.

·                  In December, the FDA granted ceftolozane/tazobactam a Qualified Infectious Disease Product (QIDP) designation, qualifying it for priority review and fast-track status at the FDA. If ultimately approved by the FDA, ceftolozane/tazobactam would also receive a five-year extension of Hatch-Waxman exclusivity.

·                  Cubist expects to initiate the Phase 3 program in ventilator-associated bacterial pneumonia (VABP) for ceftolozane/tazobactam around mid-year 2013.

 

Surotomycin (CB-315) — a rapidly bactericidal lipopeptide being studied as a potential treatment for patients with a severe and sometimes life-threatening diarrhea caused by Clostridium difficile known as C. difficile-associated diarrhea (CDAD).

 

·                  In December, the FDA granted surotomycin a QIDP designation, qualifying it for priority review and fast-track status at the FDA. If ultimately approved by the FDA, surotomycin would also receive a five-year extension of Hatch-Waxman exclusivity.

·                  In July, Cubist enrolled its first patient in its Phase 3 trials designed to evaluate the difference in clinical response rates at the end-of-therapy in patients treated with surotomycin versus oral vancomycin, as well as the safety of surotomycin in subjects with CDAD.

·                  Cubist is targeting filing an NDA for surotomycin in 2015.

 

Bevenopran (CB-5945) a novel mu-opioid receptor antagonist being studied as a potential treatment for chronic opioid-induced constipation (OIC).

 

·                  In October, Cubist initiated a Phase 3 long-term safety trial of bevenopran.

·                  Cubist plans to commence three Phase 3 efficacy trials in the first half of 2013.

 

CB-625 — this non-opioid product candidate is a novel small molecule antagonist of the human TRPA1 channel being studied as a potential treatment for post-surgical pain.

 



 

·                  Phase 1 clinical trials for CB-625, discovered in a collaboration between Cubist and Hydra Biosciences, are on-going.

 

Recent Company Highlights

 

·                  Announced that Thomas J. DesRosier will join Cubist as Senior Vice President, Chief Legal Officer and Secretary; Robert J. Perez was promoted to President and Chief Operating Officer (COO); Thomas Rollins was appointed Senior Vice President of Program and Portfolio Management; Michael Tomsicek was promoted to Senior Vice President and Deputy Chief Financial Officer; and Patrick Vink was appointed Senior Vice President and General Manager of International Business;

·                  Announced the appointment of Alison Lawton and Jane E. Henney, M.D. to the Board of Directors;

·                  Announced Cubist’s five-year goals — the Building Blocks of Growth — for top- and bottom-line growth, future pipeline developments, and cultural goals that will position Cubist to deliver long-term, sustainable growth;

·                  Celebrated Cubist Pharmaceuticals’ 20th anniversary; and

·                  Opened a 104,000 square-foot expansion to Cubist’s research and development facility.

 

Use of Non-GAAP Financial Measures

 

Non-GAAP net income and adjusted operating income and non-GAAP diluted EPS exclude non-cash or non-operational activities. As a result, Cubist uses these measures to assess and analyze its operational results and trends and to make financial and operational decisions. Cubist also 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, operating income and EPS, 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. Reconciliations between non-GAAP financial measures and GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

 

******************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 fourth quarter and full-year 2012 financial results, (ii) the expected timing of our Phase 3 clinical trial data readouts and NDA filing for ceftolozane/tazobactam (CXA-201) in cUTI and cIAI, (iii) the expected timing of our NDA filing for surotomycin (CB-315) in CDAD, (iv) the expected benefits from QIDP designation for ceftolozane/tazobactam and surotomycin, (v) our belief in the blockbuster potential of ceftolozane/tazobactam, (vi) the expected timing of beginning our Phase 3 program in ventilator-associated bacterial pneumonia for ceftolozane/tazobactam and Phase 3 efficacy trials for bevenopran (CB-5945) and (vii) 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 our products and product candidates; 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.

 

Contacts:

 

 

INVESTORS:

MEDIA:

Cubist Pharmaceuticals, Inc.

Cubist Pharmaceuticals, Inc.

Eileen C. McIntyre

Julie DiCarlo

Senior Director, Investor Relations

Senior Director, Corporate Communications

(781) 860-8533

(781) 860-8063

eileen.mcintyre@cubist.com

julie.dicarlo@cubist.com

 

Tables Follow

 



 

CUBIST PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

UNAUDITED

(in thousands)

 

 

 

December 31,

 

December 31,

 

 

 

2012

 

2011

 

ASSETS

 

 

 

 

 

Cash, cash equivalents and investments

 

$

979,396

 

$

867,695

 

Accounts receivable, net

 

93,467

 

87,800

 

Inventory

 

79,440

 

75,300

 

Property and equipment, net

 

166,465

 

168,425

 

Deferred tax assets, net

 

14,190

 

16,252

 

In-process research and development

 

272,700

 

311,400

 

Other assets

 

326,727

 

356,643

 

 

 

 

 

 

 

Total assets

 

$

1,932,385

 

$

1,883,515

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Accounts payable and accrued expenses

 

$

209,236

 

$

177,378

 

Deferred tax liabilities, net

 

103,081

 

139,237

 

Deferred revenue

 

40,875

 

31,524

 

Contingent consideration

 

189,213

 

248,234

 

Debt and other liabilities, net

 

399,232

 

487,285

 

Total liabilities

 

941,637

 

1,083,658

 

 

 

 

 

 

 

Total stockholders’ equity

 

990,748

 

799,857

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

1,932,385

 

$

1,883,515

 

 



 

CUBIST PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

UNAUDITED

(in thousands, except share and per share data)

 

 

 

Three months ended

 

Twelve months ended

 

 

 

December 31,

 

December 31,

 

 

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

U.S. CUBICIN product revenues, net

 

$

216,041

 

$

190,113

 

$

809,200

 

$

698,837

 

U.S. ENTEREG product revenues, net

 

10,941

 

2,530

 

40,171

 

2,530

 

Total U.S. product revenues, net

 

226,982

 

192,643

 

849,371

 

701,367

 

International product revenues

 

14,478

 

10,833

 

50,454

 

36,658

 

Service revenues

 

3,705

 

3,705

 

23,249

 

6,725

 

Other revenues

 

754

 

5,724

 

3,285

 

9,222

 

Total revenues, net

 

245,919

 

212,905

 

926,359

 

753,972

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

61,474

 

48,931

 

230,057

 

172,864

 

Research and development

 

89,154

 

56,075

 

277,729

 

184,533

 

Impairment of in-process research and development

 

38,700

 

 

38,700

 

 

Contingent consideration

 

(36,017

)

6,554

 

(29,021

)

91,537

 

Selling, general and administrative

 

47,333

 

48,774

 

171,788

 

163,228

 

Restructuring charges

 

 

9,279

 

 

9,279

 

Total costs and expenses

 

200,644

 

169,613

 

689,253

 

621,441

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

45,275

 

43,292

 

237,106

 

132,531

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

(7,553

)

(7,161

)

(37,510

)

(27,742

)

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

37,722

 

36,131

 

199,596

 

104,789

 

 

 

 

 

 

 

 

 

 

 

(Benefit) provision for income taxes

 

(115

)

29,313

 

45,521

 

71,766

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

37,837

 

$

6,818

 

$

154,075

 

$

33,023

 

 

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

$

0.59

 

$

0.11

 

$

2.42

 

$

0.54

 

Diluted earnings per share

 

$

0.51

(1)

$

0.11

 

$

2.10

(1)

$

0.52

 

 

 

 

 

 

 

 

 

 

 

Shares used in calculating:

 

 

 

 

 

 

 

 

 

Basic earnings per share

 

64,504,616

 

62,108,586

 

63,766,209

 

60,839,128

 

Diluted earnings per share

 

82,030,774

 

64,499,442

 

81,444,658

 

62,937,141

 

 


(1) Includes add back of interest expense, debt issuance costs and debt discount amortization on 2.50% 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

 

Twelve months ended

 

 

 

December 31,

 

December 31,

 

 

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of GAAP net income to non-GAAP proforma net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net income

 

$

37,837

 

$

6,818

 

$

154,075

 

$

33,023

 

 

 

 

 

 

 

 

 

 

 

ENTEREG intangible asset amortization

 

4,565

 

937

 

18,331

 

937

 

 

 

 

 

 

 

 

 

 

 

ENTEREG inventory step-up

 

1,705

 

 

4,033

 

 

 

 

 

 

 

 

 

 

 

 

Impairment of in-process research and development

 

38,700

 

 

38,700

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

(36,017

)

6,554

 

(29,021

)

91,537

 

 

 

 

 

 

 

 

 

 

 

Non-cash debt discount amortization

 

3,800

 

4,739

 

17,244

 

18,446

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of 2.25% notes

 

738

 

 

4,467

 

 

 

 

 

 

 

 

 

 

 

 

Expenses related to the acquisition of Adolor

 

 

10,263

 

5,393

 

10,263

 

 

 

 

 

 

 

 

 

 

 

Restructuring charge

 

 

9,279

 

 

9,279

 

 

 

 

 

 

 

 

 

 

 

Loss on disposal of property and equipment

 

 

 

3,248

 

 

 

 

 

 

 

 

 

 

 

 

Reversal of reserve for uncertain tax positions

 

 

 

(10,961

)

 

 

 

 

 

 

 

 

 

 

 

Non-cash tax adjustment

 

(14,090

)

9,613

 

6,797

 

29,996

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP pro forma net income

 

$

37,238

 

$

48,203

 

$

212,306

 

$

193,481

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP basic earnings per share

 

$

0.58

 

$

0.78

 

$

3.33

 

$

3.18

 

Non-GAAP diluted earnings per share

 

$

0.48

(1)

$

0.60

(1)

$

2.65

(1)

$

2.46

(1)

 

 

 

 

 

 

 

 

 

 

Shares used in calculating:

 

 

 

 

 

 

 

 

 

Non-GAAP basic earnings per share

 

64,504,616

 

62,108,586

 

63,766,209

 

60,839,128

 

Non-GAAP diluted earnings per share

 

82,326,462

 

83,472,974

 

83,406,931

 

81,910,673

 

 


(1) Includes add back of interest expense and debt issuance costs on 2.25% notes and 2.50% notes to income, net of tax effect

 



 

CUBIST PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF INCOME - NON-GAAP

UNAUDITED

(in thousands)

 

 

 

Three months ended

 

Twelve months ended

 

 

 

December 31,

 

December 31,

 

 

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of GAAP operating income to non-GAAP adjusted operating income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

$

45,275

 

$

43,292

 

$

237,106

 

$

132,531

 

 

 

 

 

 

 

 

 

 

 

ENTEREG intangible asset amortization

 

4,565

 

937

 

18,331

 

937

 

 

 

 

 

 

 

 

 

 

 

ENTEREG inventory step-up

 

1,705

 

 

4,033

 

 

 

 

 

 

 

 

 

 

 

 

Impairment of in-process research and development

 

38,700

 

 

38,700

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

(36,017

)

6,554

 

(29,021

)

91,537

 

 

 

 

 

 

 

 

 

 

 

Expenses related to the acquisition of Adolor

 

 

10,263

 

5,393

 

10,263

 

 

 

 

 

 

 

 

 

 

 

Restructuring charges

 

 

9,279

 

 

9,279

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP adjusted operating income

 

$

54,228

 

$

70,325

 

$

274,542

 

$

244,547

 

 



 

CUBIST PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION

UNAUDITED

(in thousands, except share and per share data)

 

 

 

Three months ended

 

Twelve months ended

 

 

 

December 31,

 

December 31,

 

 

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of GAAP basic earnings per share to non-GAAP basic earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP basic net income - from table above

 

$

37,238

 

$

48,203

 

$

212,306

 

$

193,481

 

 

 

 

 

 

 

 

 

 

 

GAAP and Non-GAAP basic shares

 

64,504,616

 

62,108,586

 

63,766,209

 

60,839,128

 

 

 

 

 

 

 

 

 

 

 

GAAP basic earnings per share

 

$

0.59

 

$

0.11

 

$

2.42

 

$

0.54

 

Non-GAAP adjustments - from table above

 

(0.01

)

0.67

 

0.91

 

2.64

 

Non-GAAP basic earnings per share

 

$

0.58

 

$

0.78

 

$

3.33

 

$

3.18

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of GAAP diluted earnings per share to non-GAAP diluted earnings per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP basic net income — from table above

 

$

37,238

 

$

48,203

 

$

212,306

 

$

193,481

 

Non-GAAP dilutive adjustments

 

2,079

(1)

1,902

(1)

9,039

(1)

7,975

(1)

Non-GAAP diluted net income

 

$

39,317

 

$

50,105

 

$

221,345

 

$

201,456

 

 

 

 

 

 

 

 

 

 

 

GAAP diluted shares

 

82,030,774

 

64,499,442

 

81,444,658

 

62,937,141

 

Non-GAAP dilutive adjustments

 

295,688

(2)

18,973,532

(2)

1,962,273

(2)

18,973,532

(2)

Non-GAAP diluted shares

 

82,326,462

 

83,472,974

 

83,406,931

 

81,910,673

 

 

 

 

 

 

 

 

 

 

 

GAAP diluted earnings per share

 

$

0.51

 

$

0.11

 

$

2.10

 

$

0.52

 

Non-GAAP dilutive adjustments

 

(0.03

)

0.49

 

0.55

 

1.94

 

Non-GAAP diluted earnings per share

 

$

0.48

 

$

0.60

 

$

2.65

 

$

2.46

 

 


(1) Includes add back of interest expense and debt issuance costs on 2.25% notes and 2.50% notes to income, net of tax effect

(2) Weighted average shares issued on full conversion