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8-K - 8-K - Astex Pharmaceuticals, Inca12-17231_18k.htm

EXHIBIT 99.1

 

GRAPHIC

News Release

 

Astex Pharmaceuticals Reports 2012 Second Quarter Financial Results

 

Dacogen Royalty Revenue Increased 25% from Prior Year

$5.4 Million Earned on Phase I Trial Initiation of FGFR Kinase Inhibitor

Dacogen Receives Positive Regulatory Recommendation in the EU for Treatment of Elderly AML

 

DUBLIN, Calif., July 30, 2012 - Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), today reported financial results for the second quarter ended June 30, 2012.  The Company reported net income for the 2012 second quarter of $1.2 million, or $0.01 per basic and diluted share, compared with $903,000, or $0.01 per basic and diluted share, for the same prior year period.  The Company reported net income for the six months ended June 30, 2012 of $5.5 million, or $0.06 per basic and $0.05 per diluted share, compared with a net income of $6.4 million, or $0.11 per basic and $0.10 per diluted share, for the same prior year period.

 

Highlights of 2012 Second Quarter:

 

·                  Dacogen® (decitabine) for Injection received a positive regulatory recommendation in the European Union (EU) for the treatment of elderly Acute Myeloid Leukemia (AML).  If approved, Dacogen would receive 10 years of market exclusivity in the EU and the Company would earn a milestone payment of $5.0 million.

 

·                  Dacogen second quarter royalty revenue increased 25% from the prior year’s second quarter, from $11.5 million to $14.4 million.

 

·                  Earned $5.4 million on Phase I trial initiation of a Fibroblast Growth Factor Receptor (FGFR) kinase inhibitor from the collaborative drug discovery program with Janssen Pharmaceutica NV.

 

·                  Ended 2012 second quarter with $121 million in cash & marketable securities.

 

·                  Revised 2012 financial guidance from a forecasted net loss of $15 million to a net loss of $5 million with the potential to be operationally cash flow positive.

 

“Astex’s financial position remains strong, and our operating performance for 2012 to date is positive.  Pipeline products in development continue to advance in Phase II trials with expected trial result readouts in the near future,” said

 



 

James S.J. Manuso, PhD, chairman and chief executive officer of Astex Pharmaceuticals.  “We plan to initiate new Phase II clinical proof-of-concept trials for our prioritized products, AT13387 and SGI-110, in solid tumors during the second half of 2012.”

 

Dr. Manuso continued, “We were pleased to learn that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval of Dacogen for the treatment of elderly AML.  The CHMP’s reference to the impact of Dacogen on overall survival in elderly AML was gratifying.  If Dacogen is approved in the EU it would become the first drug ever to be approved for the elderly AML indication.”

 

2012 Second Quarter Financial Results

 

Total revenues for the 2012 second quarter were $19.9 million compared with $11.7 million for the same prior year period.  Total revenues for the 2012 second quarter include royalty revenue of $14.4 million compared with $11.5 million for the same prior year period.  Total revenues for the 2012 second quarter also include development and license revenue of $5.4 million compared with $127,000 for the same prior year period.  Development and license revenue for the 2012 second quarter reflects revenue earned from a collaborative drug discovery program with Janssen Pharmaceutica NV and was triggered when the partner received clearance to commence a Phase I clinical trial of a FGFR kinase inhibitor.

 

Excluding the gain on sale of products, total operating expenses for the 2012 second quarter were $21.0 million, compared with $11.5 million for the same prior year period.  The primary reasons for the increase in total operating expenses for the 2012 second quarter compared with the same prior year period are the consolidation of research and development and general and administrative costs related to the acquisition of Astex Therapeutics Limited effective July 20, 2011, increased research and development activities from product development and clinical trial programs associated with SGI-110, AT13387, and amuvatinib, and the amortization of intangible assets related to the acquisition.  The non-cash amortization of intangible assets was $1.9 million for the 2012 second quarter while there was no amortization expense for the same prior year period.  Stock-based compensation expense, a non-cash expense that is included in operating expenses, was $810,000 for the 2012 second quarter, compared with $744,000 for the same prior year period.

 

The gain on sale of products for the 2012 second quarter was $700,000 compared with the same amount for the same prior year period.  The gain on sale of products relates to the receipt of the last contractual payment resulting from the 2007 sale of the worldwide rights for Nipent® (pentostatin for injection) to Mayne Pharma (acquired by Hospira, Inc. in February 2007).

 



 

The Company reported net income for the 2012 second quarter of $1.2 million, or $0.01 per basic and diluted share, compared with net income of $903,000, or $0.01 per basic and diluted share, for the same prior year period.  The net income for the 2012 second quarter includes an income tax benefit of $1.6 million compared with an income tax provision of $6,000 for the same prior year period.  The income tax benefit for the 2012 second quarter was primarily due to the recognition of a tax benefit associated with the amortization of deferred tax liabilities resulting from the acquisition and foreign research and development tax credits related to the UK subsidiary.

 

Financial Position

 

As of June 30, 2012, the Company had $120.8 million in cash, cash equivalents, and current and non-current marketable securities compared to $126.2 million at March 31, 2012.

 

Operational Highlights

 

During April 2012, the Company presented interim Phase I/II clinical data showing that subcutaneous SGI-110, a novel hypomethylating agent and follow on to Dacogen, demonstrated a differentiated pharmacokinetic (PK) profile, good tolerability, and preliminary complete responses in heavily pretreated AML patients enrolled in the Phase I segment of the trial.  The data were presented at an oral session at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL and were featured in a joint AACR-Stand Up To Cancer (SU2C) media forum.  SU2C has provided funding for the Epigenetics Dream Team that is collaborating on the scientific and clinical evaluation of SGI-110.

 

During June 2012, the Company announced it had initiated the Phase II dose expansion segment of the clinical trial of SGI-110 in patients with intermediate-2 or high risk myelodysplastic syndromes (MDS) or elderly AML. Treatment-naive MDS and AML (>65 years) will be enrolled in the dose expansion.  Enrollment in the Phase II segment is currently open, and the first patient has been dosed.  The Phase II segment includes expansion to approximately 90 patients treated on the five day subcutaneous dosing schedule to better evaluate both efficacy and safety in MDS and AML patients.

 

In June 2012, the Company and the National Cancer Institute (NCI) presented data from the two Phase I trials of our HSP90 inhibitor AT13387 at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, IL. The trials defined the maximum tolerated dose (MTD) of the drug using different schedules and demonstrated that the drug was well tolerated at the MTD. In study AT13387-0l, three of the seven refractory gastrointestinal stromal tumor (GIST) patients recruited into the study achieved Partial Response or Stable Disease for more than 6 months.

 

Also in June 2012, the Company announced that Janssen Pharmaceutica NV had received clearance to commence a Phase I clinical trial of a FGFR kinase inhibitor from its cancer drug discovery collaboration with Astex. The regulatory approval required to take the compound into Phase I triggered a payment obligation to Astex of £3.5 million (US$5.4 million).  Astex is eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration.  The FGFR inhibitor program originated from a collaboration between Astex, the Cancer Research

 



 

UK Drug Discovery Group at the Newcastle Cancer Centre (NCC), and the Northern Institute for Cancer Research, Newcastle University, UK.  As part of the collaboration, the Company applied its fragment-based drug discovery approach, Pyramid™, to identify lead compounds inhibiting FGFR kinase. The partnership with Janssen was entered into in June 2008.  Janssen is responsible for the clinical and regulatory development of all products arising from the collaboration and for their global commercialization.

 

During July 2012, the Company announced that Janssen-Cilag International NV was notified that the CHMP of the EMA granted a positive opinion recommending approval of Dacogen for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary AML that according to the World Health Organization (WHO) classification are not candidates for standard induction chemotherapy.  Janssen is the licensee for Dacogen in territories outside of the United States, Canada and Mexico.  The CHMP is the committee responsible for the scientific assessment of products seeking centralized marketing authorization throughout the EU. The CHMP’s positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission later in the 2012 third quarter.  If approved, Dacogen will become the first drug to be approved for the elderly AML indication, and clinicians and patients in Europe would have access to this new treatment option.  As an Orphan Drug, Dacogen would have ten years of market exclusivity for the elderly AML indication in the EU.  In addition, Astex would earn a $5.0 million milestone payment upon first commercialization of the drug in addition to earning future royalty revenue.

 

2012 Revised Financial Guidance

 

The revised financial guidance for 2012 is presented in the table below:

 



 

 

 

2012 Financial Guidance

 

 

 

(In $000’s)

 

 

 

Prior

 

Revised

 

Revenues:

 

 

 

 

 

Royalty revenue

 

$

67,000

 

$

70,000

 

Development & license revenue

 

1,400

 

6,900

 

 

 

68,400

 

76,900

 

Operating expenses: **

 

 

 

 

 

Research & development

 

67,000

 

65,000

 

Amortization of intangibles

 

8,500

 

8,500

 

General & administrative

 

15,000

 

15,000

 

Gain on sale of products

 

(700

)

(700

)

 

 

89,800

 

87,800

 

Loss from operations

 

(21,400

)

(10,900

)

Other income (expense), net

 

400

 

(100

)

Income tax benefit

 

6,000

 

6,000

 

Net income (loss)

 

$

(15,000

)

$

(5,000

)

 

 

 

 

 

 

Weighted average shares outstanding

 

93,000

 

93,000

 

 


** Includes recurring non-cash charges of approximately $12 million.

 

Conference Call Information

 

Astex Pharmaceuticals will host a conference call to discuss the 2012 second quarter financial results today at 1:30 p.m. PT / 4:30 p.m. ET.  A live webcast of the conference call is accessible via the investor relations section of the Company’s website at http://www.astx.com.  A webcast replay of the conference call will be available for 30 days.

 

About Astex Pharmaceuticals

 

Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology.  The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies.  Astex Pharmaceuticals developed Dacogen and receives significant royalties on global sales.

 

For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com.

 



 

Forward-Looking Statements

 

This press release contains “forward-looking” statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created thereby.  Actual results could differ materially from those projected in the forward-looking statements as a result of a number of risks and uncertainties.  These forward-looking statements include, but are not limited to, statements regarding expectations regarding the completion of drug candidate optimization and advancement of drug candidates in the clinic; expectations regarding our clinical trials including the production and timing of clinical data from these trials; expectations regarding the potential growth of worldwide sales of Dacogen, expectations regarding the ability of the Company to expand and develop our pipeline of products in the years ahead; the Company’s ability to develop the current and future pipeline into commercially viable drugs; the expectations regarding our clinical trials including the timing of clinical proof of concept data from these trials; the sufficiency of our operating cash to fund our development initiatives this year and thereafter; expectations about increases in royalty revenue; expectations regarding research and development expenses and general and administrative expenses; expectations regarding development and license revenue; estimates of 2012 net income or losses and anticipated tax benefits; statements about expected losses or profitability; estimates regarding our total expected shares outstanding; and expectations regarding Eisai’s and Janssen’s plans for Dacogen including with respect to submissions to the EMA.  Important factors that could cause actual results to differ materially from the expectations reflected in the forward-looking statements include, but are not limited to: the ultimate outcome of the submission of the European regulatory filing;  the ability of Eisai and Janssen to generate global sales of Dacogen; the outcomes of the on-going clinical trials; risks and uncertainties related to the achievement of developmental milestones with respect to the compounds in development; the research and development of amuvatinib, AT13387, SGI-110, and other programs; the decision by certain strategic partners whether or not to license and then develop and commercialize the products that are the subject of our collaboration with them and whether any of those products will be commercially successful.  In general, our future success is dependent upon numerous factors, including our ability to generate pre-clinical development candidates for selection into clinical testing, obtaining regulatory approval of product development programs, conducting and completing clinical trials, obtaining regulatory approval of our products and product candidates, our ability to successfully partner with leading pharmaceutical companies, and creating opportunities for future commercialization of compounds.  Our future revenue and operating and net loss or income could be worse than anticipated if demand for our products is less than expected, if our partnerships and collaborations with other parties are not successful, if our drug pipeline does not progress, or if the introductions of new products are delayed, for any reason, including regulatory delay.  References made to the discussion of risk factors are detailed in the Company’s filings with the Securities and Exchange Commission including reports on its most recently filed

 



 

Form 10-K and Form 10-Q.  These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update or revise the information contained in any such forward-looking statements, whether as a result of new information, future events or otherwise.

 

Contacts:

 

Timothy L. Enns

Astex Pharmaceuticals, Inc.

Senior Vice President

Corporate Communications & Marketing

Tel:  +1 (925) 560-2810

E-mail:  tim.enns@astx.com

Susanna Chau

Astex Pharmaceuticals, Inc.

Manager

Investor Relations

Tel:  +1 (925) 560-2845

E-mail:  susanna.chau@astx.com

Alan Roemer

The Trout Group

Managing Director

Tel:  +1 (646) 378-2945

E-mail: aroemer@troutgroup.com

Kari Watson

MacDougall Biomedical Communications

Senior Vice President

Tel: +1 (781) 235-3060

E-mail: kwatson@macbiocom.com

 

Condensed Consolidated Statements of Operations and Balance Sheets to follow

 



 

ASTEX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three months ended

 

Six months ended

 

 

 

June 30,

 

June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

14,441

 

$

11,539

 

$

35,035

 

$

28,510

 

Development and license revenue

 

5,439

 

127

 

6,868

 

254

 

Total revenues

 

19,880

 

11,666

 

41,903

 

28,764

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

15,394

 

7,992

 

29,458

 

15,985

 

General and administrative

 

3,650

 

3,532

 

7,992

 

7,152

 

Amortization of intangibles

 

1,941

 

 

4,098

 

 

Gain on sale of products

 

(700

)

(700

)

(700

)

(700

)

Total operating expenses

 

20,285

 

10,824

 

40,848

 

22,437

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(405

)

842

 

1,055

 

6,327

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

45

 

57

 

87

 

106

 

Other income (expense)

 

(31

)

10

 

(75

)

10

 

Income (loss) before income taxes

 

(391

)

909

 

1,067

 

6,443

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit (provision)

 

1,630

 

(6

)

4,413

 

(50

)

 

 

 

 

 

 

 

 

 

 

Net income

 

$

1,239

 

$

903

 

$

5,480

 

$

6,393

 

Net income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.01

 

$

0.01

 

$

0.06

 

$

0.11

 

Diluted

 

$

0.01

 

$

0.01

 

$

0.05

 

$

0.10

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

93,135

 

60,399

 

93,103

 

60,382

 

Diluted

 

102,722

 

61,070

 

103,355

 

61,044

 

 



 

ASTEX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

 

 

June 30,

 

December 31,

 

 

 

2012

 

2011

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

26,338

 

$

39,788

 

Marketable securities

 

92,942

 

86,444

 

Accounts receivable

 

6,041

 

5,189

 

Income tax receivable

 

4,413

 

2,963

 

Prepaid expenses and other current assets

 

2,329

 

2,186

 

Total current assets

 

132,063

 

136,570

 

 

 

 

 

 

 

Marketable securities, non-current

 

1,518

 

1,819

 

Property, plant and equipment, net

 

6,870

 

7,013

 

Goodwill

 

45,256

 

44,794

 

Other intangible assets, net

 

83,045

 

86,198

 

Other assets

 

554

 

554

 

Total assets

 

$

269,306

 

$

276,948

 

 

 

 

 

 

 

LIABILITIES & STOCKHOLDERS’ EQUITY

 

 Current liabilities:

 

 

 

 

 

Accounts payable

 

$

7,113

 

$

7,529

 

Accrued compensation

 

3,703

 

5,324

 

Other accrued liabilities

 

613

 

613

 

Deferred acquisition consideration

 

4,404

 

17,353

 

Deferred tax liability

 

3,377

 

3,342

 

Deferred revenue

 

 

509

 

Total current liabilities

 

19,210

 

34,670

 

 

 

 

 

 

 

Warrant liability

 

195

 

187

 

Deferred acquisition consideration, non-current

 

14,586

 

11,624

 

Deferred tax liability, non-current

 

6,915

 

9,545

 

Deferred revenue, non-current

 

 

921

 

Total liabilities

 

40,906

 

56,947

 

 

 

 

 

 

 

Total stockholders’ equity

 

228,400

 

220,001

 

Total liabilities and stockholders’ equity

 

$

269,306

 

$

276,948