SGI-110 Clinical Data Presented at EHA for Phase 1 MDS Patients Second Quarter Royalty Revenue Increased 15% to $16.6 Million Royalty Revenue Guidance Revised From $55 Million to $63 Million for 2013 DUBLIN, Calif., Aug. 1, 2013 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals, Inc. (Nasdaq:ASTX) today announced financial results for the second quarter ended June 30, 2013. The Company reported a net loss for the 2013 second quarter of $4.2 million, or $0.04 per basic and diluted share, compared with net income of $1.2 million, or $0.01 per basic and diluted share, for the same prior year period. The Company reported a net loss for the six months ended June 30, 2013 of $3.7 million, or $0.04 per basic and diluted share, compared with net income of $5.5 million, or $0.06 per basic and $0.05 per diluted share, for the same prior year period. Highlights
- SGI-110 clinical data was presented at the European Hematology Association (EHA) Annual Meeting for Phase 1 refractory myelodysplastic syndrome (MDS) patients. For the 15 patients enrolled an overall 40% response rate was achieved with a median duration of response of 92 days. Additionally, the overall Phase 2 patient accrual was reported to be more than 50% complete, on pace to be completed by year end and scheduled to report on at the upcoming American Society of Hematology (ASH), American Association of Cancer Research (AACR) and American Society of Clinical Oncology (ASCO) meetings. Details of the Phase 1 acute myeloid leukemia (AML) data will be presented in an oral session at the European Cancer Congress (ECCO/ESMO) in September 2013.
- ASTX727 was announced to be the next investigational new drug (IND) candidate. ASTX727 will be an oral, hypomethylating agent (HMA) rounding out the epigenetic franchise started by Dacogen® (decitabine) for Injection and SGI-110.
- Preclinical data from AT13387 showed for the first time that front line HSP90 inhibitor combination treatment with targeted therapy delayed the emergence of resistance. Data were presented at the 8th World Congress of Melanoma.
- Royalty revenue was $16.6 million for the 2013 second quarter compared to $14.4 million for the same prior year period, representing an increase of approximately 15%.
- The Company ended the 2013 second quarter with cash, cash equivalents, and current and non-current marketable securities totaling approximately $134 million, compared to $137 million at March 31, 2013.
2013 Second Quarter Financial ResultsTotal revenues for the 2013 second quarter were $16.6 million compared with $19.9 million for the same prior year period. Total revenues for the 2013 second quarter included royalty revenue of $16.6 million compared with royalty revenue of $14.4 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. There was no development and license revenue reported during the 2013 second quarter compared with $5.4 million for the same prior year period. The prior year period included a milestone earned from a collaborative drug discovery program with Janssen Pharmaceutica NV and was triggered when the partner received clearance to commence a Phase 1 clinical trial of a Fibroblast Growth Receptor (FGFR) kinase inhibitor. Total operating expenses for the 2013 second quarter were $23.7 million compared with $20.3 million for the same prior year period. The primary reasons for the increase in total operating expenses for the 2013 second quarter compared with the same prior year period are increased research and development costs associated with SGI-110, AT13387 and other internal discovery programs. There was no gain on sale of products reported during the 2013 second quarter compared with $700,000 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 non-cash amortization of intangibles was $1.9 million for the 2013 second quarter compared with a similar amount for the same prior year period. Stock-based compensation expense, a non-cash expense, was $841,000 for the 2013 second quarter compared with $810,000 for the same prior year period.
The Company reported a net loss for the 2013 second quarter of $4.2 million, or $0.04 per basic and diluted share, compared with net income of $1.2 million, or $0.01 per basic and diluted share, for the same prior year period. Included in 2013 second quarter net loss is an income tax benefit of $2.9 million compared with an income tax benefit of $1.6 million for the same prior year period. The income tax benefits for the current and prior year second quarters are primarily due to the recognition of tax benefits associated with the amortization of deferred tax liabilities resulting from the acquisition of Astex Therapeutics Limited in 2011, and foreign research and development tax credits related to our UK subsidiary.Financial Position As of June 30, 2013, the Company had approximately $134.0 million in cash, cash equivalents, and current and non-current marketable securities compared to $138.3 million at December 31, 2012. 2013 Operational Guidance Astex has revised its 2013 operational guidance for the following major items:
- Royalty revenue has been revised from $55 million to $63 million for 2013. The increase in royalty revenue is primarily driven by the delayed entry of generic competition after the expiration of market exclusivity for Dacogen in the U.S. on May 2, 2013. A competitor announced the launch of generic decitabine in the U.S. on July 12, 2013.
- Research and development expenses have been revised from $67 million to $70 million for 2013. The increase in research and development expenses is primarily influenced by the acceleration and/or revision of estimated costs associated with the Company's two priority programs SGI-110 and AT13387.
- The net loss estimated for 2013 has been reduced from the previous guidance of $30 million to a revised $25 million. Included in total operating expenses reflected in the revised annual net loss are approximately $12 million of non-cash charges.
|2013 Revised Annual Operational Guidance|
|(In $000's, except per share amount)|
|Royalty revenue||$ 63,000|
|Development & license revenue (a)||--|
|Operating expenses (b):|
|Research & development||70,000|
|Amortization of intangibles||8,000|
|General & administrative||15,000|
|Total operating expenses||93,000|
|Loss from operations||(30,000)|
|Other expense, net||(1,000)|
|Income tax benefit||6,000|
|Net loss||$ (25,000)|
|Net loss per average share outstanding||$ (0.26)|
|Weighted average shares outstanding||96,000|
|(a) Though the Company anticipates earning additional development and license revenue from its partnered programs we do not provide guidance to such revenue due to the general uncertainty around, and timing of, milestone achievements and payments.|
|(b) Includes total non-cash charges of approximately $12 million for 2013.|
|ASTEX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except per share amounts)|
|Three months ended||Six months ended|
|June 30,||June 30,|
|Royalty revenue||$ 16,615||$ 14,441||$ 38,704||$ 35,035|
|Development and license revenue||--||5,439||--||6,868|
|Research and development||18,153||15,394||36,019||29,458|
|General and administrative||3,691||3,650||7,825||7,992|
|Amortization of intangibles||1,883||1,941||3,788||4,098|
|Gain on sale of products||--||(700)||--||(700)|
|Total operating expenses||23,727||20,285||47,632||40,848|
|Income (loss) from operations||(7,112)||(405)||(8,928)||1,055|
|Foreign currency remeasurement loss||(78)||(16)||(1,404)||(20)|
|Other income (expense)||47||(15)||(211)||(55)|
|Income (loss) before income taxes||(7,115)||(391)||(10,474)||1,067|
|Income tax benefit||2,932||1,630||6,779||4,413|
|Net income (loss)||$ (4,183)||$ 1,239||$ (3,695)||$ 5,480|
|Net income (loss) per common share:|
|Basic||$ (0.04)||$ 0.01||$ (0.04)||$ 0.06|
|Diluted||$ (0.04)||$ 0.01||$ (0.04)||$ 0.05|
|Weighted average shares outstanding:|
|ASTEX PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$ 35,644||$ 15,496|
|Income tax receivable||7,392||4,892|
|Prepaid expenses and other current assets||2,201||2,333|
|Total current assets||144,616||146,507|
|Marketable securities, non-current||39||40|
|Property, plant and equipment, net||5,820||5,749|
|Other intangible assets, net||66,425||74,514|
|Total assets||$ 262,560||$ 275,164|
|LIABILITIES & STOCKHOLDERS' EQUITY|
|Accounts payable||$ 7,487||$ 9,238|
|Other accrued liabilities||670||619|
|Deferred acquisition consideration||14,405||2,213|
|Deferred tax liability||1,936||3,494|
|Total current liabilities||28,269||19,640|
|Deferred acquisition consideration, non-current||--||14,763|
|Deferred tax liability, non-current||804||3,543|
|Total stockholders' equity||233,001||236,942|
|Total liabilities and stockholders' equity||$ 262,560||$ 275,164|
CONTACT: Timothy L. Enns Astex Pharmaceuticals, Inc. Senior Vice President Corporate Communications & Marketing Tel: +1 (925) 560-2810 E-mail: firstname.lastname@example.org Susanna Chau Astex Pharmaceuticals, Inc. Manager Investor Relations Tel: +1 (925) 560-2845 E-mail: email@example.com Alan Roemer The Trout Group Managing Director Tel: +1 (646) 378-2945 E-mail: firstname.lastname@example.org