Alnylam Pharmaceuticals, Inc.’s (ALNY) fourth-quarter 2014 loss of 28 cents per share was much narrower than the Zacks Consensus Estimate of a loss of 66 cents and the year-ago loss of 51 cents per share.
Fourth-quarter revenues jumped 121.4% year over year to $24 million, beating the Zacks Consensus Estimate of $17 million.
Alnylam’s full-year loss widened to $1.88 per share from $1.45 per share in the prior year. However, it was narrower than the Zacks Consensus Estimate of a loss of $5.27.
2014 revenues increased 7.2% to $50.6 million, beating the Zacks Consensus Estimate of $14 million.
The Quarter in Detail
Alnylam’s revenues in the fourth quarter included $8.8 million and $6.9 million from its collaboration with Monsanto Co. (MON) and The Medicines Co. (MDCO), in addition to $2.8 million from other sources.
Research and development (R&D) expenses increased 73% to $55.5 million. The increase was attributable to Alnylam’s efforts to develop its pipeline. 2015 R&D expenses are expected to increase significantly.
General and administrative (G&A) expenses increased 70.2% year over year to $14.2 million, primarily due to an increase in non-cash stock-based compensation expense. 2015 G&A expenses are expected to increase slightly.
Pipeline Update
During the fourth quarter, Alnylam launched the “Alnylam 2020” program wherein it intends to achieve a profile with 3 drugs on the market and 10 RNAi therapeutic clinical programs, including 4 in late stages of development, across 3 strategic therapeutic areas (STArs) – genetic medicines, cardio-metabolic disease and hepatic infectious disease – by the end of 2020.
Meanwhile, Alnylam has made considerable progress with its RNAi therapeutics pipeline. The company continues to enroll patients in a phase III study (APOLLO) on patisiran in transthyretin-mediated amyloidosis patients suffering from familial amyloidotic polyneuropathy. Positive results would allow the company to file for approval in 2017.
Alnylam initiated a phase III study (ENDEAVOUR) on revusiran (familial amyloidotic cardiomyopathy) during the fourth quarter.
Apart from these candidates, Alnylam also made substantial progress with early-stage pipeline candidates like ALN-AT3 (hemophilia and rare bleeding disorders), ALN-AS1 (hepatic porphyrias), ALN-PCSsc (hypercholesterolemia), ALN-CC5 (complement-mediated diseases) and ALN-HBV (hepatitis B virus infection).
2015 Guidance
Alnylam expects to end 2015 with cash, cash equivalents and total marketable securities in excess of $1.2 billion.
Our Take
We are encouraged by Alnylam’s progress with its RNAi therapeutics. With multiple data read-outs on pipeline candidates like revusiran (additional phase II study data expected in March) and patisiran (12-month phase II open-label extension study data expected in April), we expect investor focus to remain on pipeline updates from the company.
Alnylam currently carries a Zacks Rank #1 (Strong Buy). An equally well-ranked stock in the health care sector is Ophthotech Corp. (OPHT).
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