Alnylam first quarter revenues decrease to $20.6 million

Published on May 4, 2012 at 5:15 AM · No Comments

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today reported its consolidated financial results for the first quarter 2012, and company highlights.    

"We made significant clinical and business progress this quarter, including important achievements with our 'Alnylam 5x15' product development and commercialization strategy. First, we reported very encouraging clinical data from our Phase I ALN-PCS trial showing statistically significant and durable reductions of PCSK9 plasma levels of up to 84% and lowering of LDL cholesterol of up to 50%, in addition to demonstrating continued improved efficacy and tolerability for Alnylam's second-generation lipid nanoparticle delivery technology. Further, we initiated dosing in our Phase I clinical trial with ALN-TTR02, an RNAi therapeutic targeting the transthyretin gene for the treatment of transthyretin-mediated amyloidosis, which also utilizes our second-generation lipid nanoparticle delivery technology. We are on track to report clinical data from this study in the third quarter of this year," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "These important accomplishments, combined with the recent strengthening of our balance sheet, gives us great confidence in the continued execution of our 'Alnylam 5x15' product strategy, focused on advancement of RNAi therapeutics for the treatment of genetically defined targets for diseases where there are limited treatment options for patients and caregivers."

"With clear evidence from our ALN-TTR and ALN-PCS Phase I clinical trials that the RNAi pathway can be harnessed as a therapeutic strategy, we continue to focus on our 'Alnylam 5x15' efforts with what we believe to be our highest value opportunities, driving key programs toward pivotal trials," said Barry Greene, President and Chief Operating Officer of Alnylam. "This includes accelerated clinical development plans for ALN-TTR02, which we believe has the potential to become the leading innovative medicine for the treatment of transthyretin-mediated amyloidosis, a devastating and debilitating orphan disease. It also includes our RNAi therapeutic for the treatment of hemophilia, which we believe represents an exciting opportunity that could fundamentally change the management of this inherited orphan bleeding disorder. In addition, we plan to continue to advance additional programs with existing partners and new alliances we intend to form."

Cash, Cash Equivalents and Total Marketable Securities

At March 31, 2012, Alnylam had cash, cash equivalents and total marketable securities of $316.9 million, as compared to $260.8 million at December 31, 2011. In February 2012, Alnylam sold an aggregate of 8,625,000 shares of its common stock through an underwritten public offering at a price to the public of $10.75 per share. As a result of the offering, Alnylam received aggregate net proceeds of approximately $87 million, after deducting underwriting discounts and commissions and other estimated offering expenses of approximately $5.9 million.

Net Loss

The net loss according to accounting principles generally accepted in the U.S. (GAAP) for the first quarter of 2012 was $11.4 million, or $0.25 per share on both a basic and diluted basis (including $3.2 million, or $0.07 per share of non-cash stock-based compensation expense), as compared to a net loss of $16.3 million, or $0.38 per share on both a basic and diluted basis (including $4.1 million, or $0.10 per share of non-cash stock-based compensation expense), for the same period in the previous year.

Revenues

Revenues were $20.6 million for the first quarter of 2012, as compared to $20.9 million for the first quarter of 2011. Revenues for the first quarter of 2012 included $14.0 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 $1.1 million of expense reimbursement, amortization, and/or license fee revenues from Cubist Pharmaceuticals, Inc., InterfeRx(TM), research reagent and services licensees, and other sources.

Research and Development Expenses

Research and development (R&D) expenses were $21.1 million in the first quarter of 2012, which included $2.1 million of non-cash stock-based compensation, as compared to $26.3 million in the first quarter of 2011, which included $2.7 million of non-cash stock-based compensation. The decrease in R&D expenses in the first quarter of 2012 as compared to the prior year period was due primarily to lower clinical trial and manufacturing costs related to our ALN-RSV and ALN-VSP programs, partially offset by additional clinical expenses related to the advancement of our ALN-TTR program. Lab supplies and materials and compensation and related expenses also decreased due primarily to the reduction in workforce in connection with our January 2012 strategic corporate restructuring. Partially offsetting these decreases was a one-time charge of $3.9 million related to the restructuring, including employee severance, benefits and related costs.

General and Administrative Expenses

General and administrative (G&A) expenses were $10.4 million in the first quarter of 2012, which included $1.1 million of non-cash stock-based compensation, as compared to $10.2 million in the first quarter of 2011, which included $1.5 million of non-cash stock-based compensation.

Regulus Therapeutics

Equity in loss of joint venture was $0.9 million and $1.1 million for the first quarter of 2012 and 2011, respectively, related to our share of the net losses incurred by Regulus.

Interest Income

Interest income was $0.2 million for the first quarter of 2012, as compared to $0.4 million for the first quarter of 2011. The decrease in interest income was due primarily to lower average cash, cash equivalents and total marketable securities balances as compared to the prior year.

2012 Financial Guidance

Alnylam expects that its cash, cash equivalents and total marketable securities balance will be greater than $250 million at December 31, 2012.

"Alnylam further strengthened its balance sheet this quarter with a public offering of 8.6 million shares of common stock that resulted in net proceeds of approximately $87 million. This financing, combined with our recent corporate restructuring that included an approximate 33% reduction in workforce, results in a balance sheet and operating plan that we believe will enable us to advance our 'Alnylam 5x15' product strategy," said Michael Mason, Vice President, Finance and Treasurer of Alnylam. "We ended this quarter with approximately $317 million in cash, and expect to end 2012 with greater than $250 million."

First Quarter 2012 and Recent Significant Corporate Highlights

Key "Alnylam 5x15" Program Highlights

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post