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8-K - 8-K - Astex Pharmaceuticals, Inca12-6428_18k.htm

Exhibit 99.1

 

GRAPHIC

News Release

 

Astex Pharmaceuticals Reports 2011 Fourth Quarter and Year-End Financial Results

 

Reports Annual Net Income of $5.5 Million

Dacogen Royalty Revenue Increases 15% from Prior Year

Ends Year with $128 Million in Cash & Marketable Securities

 

DUBLIN, Calif., March 5, 2012 - Astex Pharmaceuticals, Inc. (NASDAQ: ASTX), today reported financial results for the fourth quarter and year ended December 31, 2011.

 

The Company reported net income for the 2011 fourth quarter of $220,000, or $0.00 per basic and diluted share, compared with net income of $6.7 million, or $0.11 per basic and diluted share, for the same prior year period.  The Company reported net income for the year ended December 31, 2011 of $5.5 million, or $0.07 per basic and diluted share, compared with net income of $16.3 million, or $0.27 per basic and diluted share, for the same prior year period.

 

Company Highlights of 2011 include:

 

·                  Dacogen® (decitabine) for Injection royalty revenue was $60.5 million for 2011 compared to $52.5 million for 2010, an increase of approximately 15% from the prior year.

·                  The Company ended 2011 with unrestricted cash, cash equivalents, and current and non-current marketable securities totaling $128.1 million compared to $120.4 million at December 31, 2010.

·                  The Company completed the acquisition of Astex Therapeutics Limited in July 2011, and the operating results of the acquisition have been consolidated in the Company’s operating results effective July 20, 2011.

·                  The Company expanded its product pipeline following the Astex acquisition to include four company-sponsored phase II programs and four partner-sponsored clinical programs.

·                  In September 2011, the Company changed its name from SuperGen, Inc. to Astex Pharmaceuticals, Inc., trading on NASDAQ with ticker symbol “ASTX.”

 



 

“In 2011 Astex Pharmaceuticals assembled all the tools necessary for spurring growth: rationalized operations, a prioritized portfolio that includes a deep clinical pipeline, a strong financial footing,  and a proven discovery engine,” said James S.J. Manuso, PhD, chairman and chief executive officer of Astex Pharmaceuticals.  “We are pleased the worldwide sales of Dacogen have continued to grow steadily.  In addition, we are initially anticipating our operational results for 2012 being near cash flow neutral. “

 

Dr. Harren Jhoti, president of Astex Pharmaceuticals, added, “We have much to look forward to in 2012, as we advance our discovery and development collaborations with our partners GSK, AstraZeneca, Janssen and Novartis.  Within the first half of 2012 we expect to complete the optimization of lead drug candidates arising from our internal discovery efforts.”

 

Dr. Mohammad Azab, chief medical officer of Astex Pharmaceuticals, commented, “New clinical data for SGI-110, our new hypomethylating agent, has been submitted for presentation at the upcoming AACR meeting, and for AT13387, our second-generation HSP90 inhibitor, at this year’s ASCO conference.  This year we will initiate an SGI-110 phase II dose expansion clinical trial in MDS/AML and a phase II program in solid tumors.  By the end of 2012, we expect several clinical-stage programs currently in phase II trials to produce clinical data.”

 

2011 Fourth Quarter Financial Results

 

Total revenues for the 2011 fourth quarter were $21.2 million compared with $15.3 million for the same prior year period.  Total revenues for the 2011 fourth quarter includes royalty revenue of $15.4 million compared with $15.2 million for the same prior year period.  Royalty revenue is earned pursuant to the license agreement entered into with MGI PHARMA (acquired by Eisai Corporation of North America in January 2008) during 2004, which granted MGI PHARMA exclusive rights to the development, manufacture, commercialization and distribution of Dacogen.  The Company generally recognizes royalty revenue when it is received.  Total revenues for the 2011 fourth quarter also include development and license revenue of $5.8 million compared with $127,000 for the same prior year period.  Development and license revenue represents both milestones earned and the amortization of deferred revenue relating to payments received pursuant to various collaborative research and license arrangements.  Development and license revenue for the 2011 fourth quarter includes multiple milestones earned of $4.4 million related to our GSK collaboration while there were no milestones earned for the same prior year period.

 

Total operating expenses for the 2011 fourth quarter were $21.9 million, compared with $8.8 million for the same prior year period.  The primary reasons for the increase in total operating expenses for the 2011 fourth 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; amortization of intangible assets and impairment charge; severance costs related to a reduction in force; and an increase in stock-based compensation expense. A non-cash charge for amortization of intangible assets including an impairment charge was $3.0 million for the 2011 fourth quarter while there was no similar amortization expense or impairment charge for the same prior year period.  Severance costs associated with a reduction in force were $216,000 for the 2011 fourth quarter while there were no severance costs for the same prior year period.  Stock-based compensation expense, a non-cash expense that is included in operating expenses, was $769,000 for the 2011 fourth quarter, compared with $183,000 for the same prior year period.

 

The Company reported net income for the 2011 fourth quarter of $220,000, or $0.00 per basic and diluted share, compared with net income of $6.7 million, or $0.11 per basic and diluted share, for the same prior year period.  The net income for the 2011 fourth quarter includes an income tax benefit of $986,000 compared with an income tax provision of $26,000 for the same prior year period.  The income tax benefit for the 2011 fourth quarter was primarily due to the recognition of a tax benefit associated with the amortization of deferred tax liabilities resulting from the acquisition and a foreign research and development tax credit related to the UK subsidiary.

 

2011 Year-End Financial Results

 

Total revenues for 2011 were $66.9 million compared with $53.0 million for the same prior year period.  Total revenues for 2011 includes royalty revenue of $60.5 million compared with $52.5 million for the same prior year period.  Total revenues for 2011 also include development and license revenue of $6.4 million compared with $509,000 for the same prior year period.  Development and license revenue represents both milestones earned and the amortization of deferred revenue relating to payments received pursuant to various collaborative research and license arrangements.  Development and license revenue for 2011 includes multiple milestones earned of $4.4 million related to our GSK collaboration while there were no milestones earned for the same prior year period.

 

Excluding the gain on sale of products, total operating expenses for 2011 were $65.2 million compared with $37.8 million for the same prior year period.  The primary reasons for the increase in total operating expenses for 2011 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; amortization of intangible assets and impairment charge; incremental transaction costs associated with the acquisition; severance costs related to a reduction in force; and an increase in stock-based

 



 

compensation expense.  Approximately $3.5 million of transaction costs associated with the acquisition were charged to general and administrative expenses during 2011.  A non-cash charge for amortization of intangible assets including an impairment charge was $4.5 million for 2011 while there was no similar amortization expense or impairment charge for the same prior year period.  Severance costs associated with a reduction in force were $995,000 for 2011 while there were no severance costs for the same prior year period.  Stock-based compensation expense, a non-cash expense that is included in operating expenses, was $3.1 million for 2011 compared with $1.4 million for the same prior year period.

 

The gain on sale of products for 2011 was $700,000 compared with $750,000 for the same prior year period.  The gain on sale of products relates to the receipt of additional contractual payments 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 2011 of $5.5 million, or $0.07 per basic and diluted share, compared with net income of $16.3 million, or $0.27 per basic and diluted share, for the same prior year period.  Net income for 2011 included in other expenses a net foreign currency transaction loss of $422,000 while there was no similar loss for the same prior year period.  Net income for 2011 includes an income tax benefit of $3.3 million compared with an income tax provision of $39,000 for the same prior year period.  The income tax benefit for 2011 was primarily due to the recognition of a tax benefit associated with the amortization of deferred tax liabilities resulting from the acquisition and a foreign research and development tax credit related to the UK subsidiary.

 

Financial Position

 

As of December 31, 2011, the Company had $128.1 million in unrestricted cash, cash equivalents, and current and non-current marketable securities compared to $120.4 million at December 31, 2010.

 

Operational Highlights

 

In 2012 the Company will learn the outcomes of our Dacogen partner Eisai’s supplemental New Drug Application (sNDA) and Marketing Authorization Application (MAA) submissions to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), respectively, seeking approval for Dacogen in the elderly acute myeloid leukemia (AML) indication.  Eisai was advised that the PDUFA date for the sNDA is March 6, 2012.  It is expected that the EMA will determine the outcome of the MAA, filed by Janssen-Cilag International NV, within the second half of 2012.

 



 

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10 to 3 with one person abstaining that data in the sNDA for Dacogen did not support a favorable benefit-risk profile for the treatment of AML in adults 65 years of age or older who are not considered candidates for induction therapy.  The FDA has the option of seeking the advice of its advisory committees when it is reviewing a new drug application, although it is not obliged to follow the committee’s recommendation.

 

Astex’s pipeline products continue to advance favorably in the clinic.  Four products in or entering phase II trials are expected to produce data from clinical proof of concept trials in the next 12  months including AT13387, SGI-110, and amuvatinib.  In addition, new phase II clinical proof of concept trials are expected to be initiated in the second half of 2012 for AT13387 and SGI-110 in solid tumors.

 

Among our partnered programs, AstraZeneca commenced a phase I study of AZD3839, a clinical candidate selected in October 2010 and derived from the collaborative program on beta-secretase - a key enzyme implicated in the progression of Alzheimer’s disease. Janssen Pharmaceutica NV selected a development candidate from the collaborative drug discovery program aimed at identifying novel, small molecule inhibitors of Fibroblast Growth Factor Receptor (FGFR), for the treatment of cancer.

 

2012 Financial Guidance

 

The initial financial guidance for 2012 is as follows:

 

·                  Royalty revenue for Dacogen is expected to increase up to 10% from the prior year to a range from $64 million to $67 million.

·                  Development and license revenue is estimated at $1.4 million and represents the recognition of deferred revenue relating to prior payments received pursuant to a research and license agreement with GSK.

·                  The last remaining payment of $700,000 related to the sale of Nipent to Hospira to be classified as gain on sale of products is expected to be received during 2012.

·                  Research and development expenses are expected to increase from the prior year to a range from $62 million to $67 million.

·                  Amortization of intangible assets, a non-cash charge, is estimated at $7.6 million.

·                  General and administrative expenses are expected to decrease from the prior year to a range from $14 million to $15 million.

·                  An estimated income tax benefit associated primarily with the amortization of deferred tax liabilities resulting from the acquisition and a foreign research and development tax credit related to the UK subsidiary is anticipated to be in a range from $4 million to $5 million for the year.

·                  A net loss is forecasted in a range from $13 million to $15 million for the year.

 



 

·                  In addition to the amortization of intangible assets included in total operating expenses are other recurring non-cash operating charges such as stock-based compensation expense and depreciation estimated at $3.5 million for the year.

·                  Average annual shares outstanding are expected to be approximately 93 million common shares.

 

Conference Call Information

 

Astex Pharmaceuticals will host a conference call to discuss the 2011 fourth quarter and year-end 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 the continued growth of worldwide sales of Dacogen, expectations regarding the completion of drug candidate optimization and advancement of drug candidates in the clinic; expectations regarding our clinical trials including the production of clinical data from these trials; expectations regarding the anticipated generation of shareholder value as a result of the acquisition of Astex Therapeutics Limited and the ability of the combined company to expand and develop the Company’s 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 progress of our collaborations with strategic partners and other programs added through the acquisition; 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, and gains from sales of products from the previous sale of our commercial business; estimates of 2012 net losses and anticipated tax benefits; statements about expected losses or profitability; estimates about the amortization of intangible assets, estimates of non-cash stock-based compensation and other recurring non-cash items; and expectations regarding Eisai’s and Janssen’s plans for Dacogen including with respect to submissions to the FDA and 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 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 added by the acquisition; 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; the outcome of Eisai’s and Janssen’s examination of Dacogen clinical trial data and the submission of US and European regulatory filings; and the risks and uncertainties associated with the post-merger company.  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, 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: (925) 560-2810
E-mail: tim.enns@astx.com

 

Susanna Chau
Astex Pharmaceuticals, Inc.
Manager
Investor Relations
Tel: (925) 560-2845
E-mail: susanna.chau@astx.com

 

 

 

Alan Roemer
The Trout Group
Managing Director
Tel: (646) 378-2945
E-mail: aroemer@troutgroup.com

 

Melanie Toyne-Sewell (Europe)
Rebecca Skye Dietrich (US)
College Hill
Tel: +44 20 7866 7866
Tel: (857) 241-0795
E-mail: astex@collegehill.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

 

Year ended

 

 

 

December 31,

 

December 31,

 

 

 

2011

 

2010

 

2011

 

2010

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

Royalty revenue

 

$

15,371

 

$

15,157

 

$

60,519

 

$

52,463

 

Development and license revenue

 

5,833

 

127

 

6,395

 

509

 

Total revenues

 

21,204

 

15,284

 

66,914

 

52,972

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

14,365

 

6,528

 

43,895

 

28,394

 

General and administrative

 

4,595

 

2,320

 

16,842

 

9,442

 

Amortization of intangibles and impairment charge

 

2,980

 

 

4,465

 

 

Gain on sale of products

 

 

(50

)

(700

)

(750

)

Total operating expenses

 

21,940

 

8,798

 

64,502

 

37,086

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

(736

)

6,486

 

2,412

 

15,886

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

72

 

42

 

226

 

182

 

Other income (expense)

 

(102

)

244

 

(384

)

244

 

Income (loss) before income taxes

 

(766

)

6,772

 

2,254

 

16,312

 

 

 

 

 

 

 

 

 

 

 

Income tax benefit (provision)

 

986

 

(26

)

3,288

 

(39

)

 

 

 

 

 

 

 

 

 

 

Net income

 

$

220

 

$

6,746

 

$

5,542

 

$

16,273

 

Net income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

0.00

 

$

0.11

 

$

0.07

 

$

0.27

 

Diluted

 

$

0.00

 

$

0.11

 

$

0.07

 

$

0.27

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

92,930

 

60,334

 

75,072

 

60,287

 

Diluted

 

93,382

 

60,771

 

75,751

 

60,635

 

 



 

ASTEX PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

 

 

December 31,

 

December 31,

 

 

 

2011

 

2010

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

39,788

 

$

25,554

 

Marketable securities

 

86,444

 

89,699

 

Accounts receivable

 

5,189

 

615

 

Income tax receivable

 

2,963

 

40

 

Prepaid expenses and other current assets

 

2,186

 

715

 

Total current assets

 

136,570

 

116,623

 

 

 

 

 

 

 

Marketable securities, non-current

 

1,819

 

5,124

 

Property, plant and equipment, net

 

7,013

 

3,932

 

Goodwill

 

45,980

 

731

 

Other intangible assets, net

 

84,611

 

 

Restricted cash

 

 

2,134

 

Other assets

 

554

 

554

 

Total assets

 

$

276,547

 

$

129,098

 

 

 

 

 

 

 

LIABILITIES & STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

7,529

 

$

1,198

 

Accrued compensation

 

5,324

 

3,556

 

Other accrued liabilities

 

613

 

794

 

Deferred acquisition consideration

 

17,353

 

 

Deferred tax liability

 

3,342

 

 

Deferred revenue

 

509

 

509

 

Total current liabilities

 

34,670

 

6,057

 

 

 

 

 

 

 

Warrant liability

 

187

 

 

Deferred acquisition consideration, non-current

 

11,624

 

 

Deferred tax liability, non-current

 

9,144

 

 

Deferred revenue, non-current

 

921

 

1,429

 

Total liabilities

 

56,546

 

7,486

 

 

 

 

 

 

 

Total stockholders’ equity

 

220,001

 

121,612

 

Total liabilities and stockholders’ equity

 

$

276,547

 

$

129,098