Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today reported its consolidated financial results for the third quarter 2012, and company highlights.
"The highlights of this quarter include the positive results we reported in our clinical programs and our continued execution on our 'Alnylam 5x15' product strategy. Specifically, we reported positive data from a Phase I study and continued enrollment in our Phase II study of ALN-TTR02. We also showed encouraging pre-clinical data in programs using our GalNAc conjugate delivery platform that enables subcutaneous administration of RNAi therapeutics; these include ALN-TTRsc for the treatment of ATTR and ALN-AT3 for the treatment of hemophilia. Finally, we were pleased to report complete results from a Phase IIb trial of ALN-RSV01 for the treatment of respiratory syncytial virus infection in lung transplant patients," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "Continued execution on our 'Alnylam 5x15' product strategy remains our core focus, and we aim to complete our Phase II trial for ALN-TTR02 in mid-2013 and initiate our Phase III trial by the end of 2013. In addition, we expect to file an IND for ALN-TTRsc by end of this year and an IND for ALN-AT3 by mid-2013. With our recent accomplishments in our pipeline efforts, we have strengthened confidence that we can advance RNAi therapeutics toward genetically defined targets for diseases that currently have limited treatment options for patients and their caregivers."
"In addition to the substantial progress in our 'Alnylam 5x15' efforts, we have also advanced our business development efforts through new collaborations with Genzyme, Monsanto, and Ascletis," said Barry Greene, President and Chief Operating Officer of Alnylam. "Notably, we formed a strategic alliance with Genzyme to advance ALN-TTR in Japan and the broader Asian-Pacific region. ATTR is an endemic disease in Japan, and we believe this new alliance promises to bring our ALN-TTR program to these patients sooner and to reach this market faster. We are also excited about the alliance we formed with Monsanto, a leader in the field of agriculture. This collaboration facilitates broad use of our intellectual property and technology in agricultural applications and enables additional value creation for Alnylam outside of our focus on human therapeutics. Finally, we formed a strategic collaboration with Ascletis to develop ALN-VSP for the treatment of liver cancers in China, while we retain rights in the rest of the world."
Cash, Cash Equivalents and Total Marketable Securities
At September 30, 2012, Alnylam had cash, cash equivalents and total marketable securities of $295.8 million, as compared to $260.8 million at December 31, 2011.
The net loss according to accounting principles generally accepted in the U.S. (GAAP) for the third quarter of 2012 was $19.5 million, or $0.38 per share on both a basic and diluted basis (including $3.4 million, or $0.07 per share of non-cash stock-based compensation expense), as compared to a net loss of $13.2 million, or $0.31 per share on both a basic and diluted basis (including $4.3 million, or $0.10 per share of non-cash stock-based compensation expense), for the same period in the previous year.
Revenues were $16.8 million for the third quarter of 2012, as compared to $20.8 million for the same period last year. Revenues for the third quarter of 2012 included $9.3 million of collaboration revenues related to the company's alliance with Roche (which assigned its rights and obligations to Arrowhead Research Corporation during 2011), $5.5 million of revenues from the company's alliance with Takeda Pharmaceuticals Company Limited, and $2.0 million of expense reimbursement, amortization, and/or license fee revenues from Cubist Pharmaceuticals, Inc., Monsanto, InterfeRx™, research reagent and services licensees, and other sources. Looking ahead, Alnylam expects revenues to decrease due to the completion of amortization of Roche/Arrowhead deferred revenue during the third quarter of 2012.
Research and Development Expenses
Research and development (R&D) expenses were $22.1 million in the third quarter of 2012, which included $2.3 million of non-cash stock-based compensation, as compared to $24.3 million in the third quarter of 2011, which included $2.8 million of non-cash stock-based compensation. The decrease in R&D expenses in the third quarter of 2012 as compared to the prior year period was due primarily to lower clinical trial and manufacturing expenses related to the company's ALN-RSV and ALN-VSP programs, partially offset by additional expenses related to the advancement of the company's ALN-TTR program. Alnylam expects R&D expenses will remain consistent for the remainder of 2012.
General and Administrative Expenses
General and administrative (G&A) expenses were $12.8 million in the third quarter of 2012, which included $1.1 million of non-cash stock-based compensation, as compared to $9.0 million in the third quarter of 2011, which included $1.5 million of non-cash stock-based compensation. The increase in G&A expenses for the third quarter of 2012 as compared to the prior year period was due primarily to an increase in consulting and professional services related to business and legal activities. Alnylam expects G&A expenses will remain consistent for the remainder of 2012.
Equity in loss of joint venture was $1.6 million and $0.5 million for the third quarter of 2012 and 2011, respectively, related to our share of the net losses incurred by Regulus.
Interest income was $0.3 million for the third quarter of 2012 and 2011.
2012 Financial Guidance
Alnylam now expects that its cash, cash equivalents and total marketable securities balance will be greater than $280 million at December 31, 2012, as compared with its previous guidance of year-end cash of greater than $250 million. The company's increase to its year-end cash guidance is due to upfront payments from new alliances with Monsanto and Genzyme.
"Alnylam continues to maintain a solid financial profile, ending the third quarter with approximately $296 million in cash, which excludes the upfront payment of $22.5 million from our recent alliance with Genzyme which was received in the fourth quarter," said Michael Mason, Vice President, Finance and Treasurer of Alnylam. "Due to our successful business development activities, we now believe we will end 2012 with greater than $280 million in cash, which will continue to provide us with a strong balance sheet as we advance our RNAi therapeutics through clinical trials and toward the market."
Third Quarter 2012 and Recent Significant Corporate Highlights
Key "Alnylam 5x15" Program Highlights