Alnylam Pharma (NASDAQ: ALNY) reported Q4 EPS of ($1.98), $0.24 better than the analyst estimate of ($2.22). Revenue for the quarter came in at $71.68 million versus the consensus estimate of $71.92 million.

• Achieved Fourth Quarter and Full Year 2019 ONPATTRO® (patisiran) Global Net Product Revenues of $55.8 Million and $166.4 Million, Respectively
• As of Year-End 2019, Over 750 Patients Worldwide Receiving Commercial ONPATTRO, with Over 1,000 Total Patients Worldwide Being Treated with Patisiran
• Observed Strong Initial Demand for GIVLAARI™ (givosiran) in the U.S., with 13 Start Forms Received in First Six Weeks after FDA Approval
• Reported Third Positive 2019 Phase 3 Result with Lumasiran and Initiated Rolling Submission of New Drug Application (NDA) with U.S. Food and Drug Administration (FDA)
• Initiated HELIOS-B Phase 3 Study of Vutrisiran for the Treatment of Hereditary and Wild-Type ATTR Amyloidosis with Cardiomyopathy
• Maintained Strong Balance Sheet with Year-End Cash and Investments Balance of $1.55 Billion
• Provides 2020 ONPATTRO Revenue Guidance and Operating Expense Guidance

“In 2019 we saw continued and steady growth of patients on ONPATTRO, and we expect growth to continue in 2020, driven by new patient finding, geographic expansion, and evidence-generating activities. We also believe that our ongoing APOLLO-B Phase 3 study, if positive, can potentially enable future label expansion for patisiran to treat the cardiomyopathy of hereditary and wild-type ATTR amyloidosis. With the early U.S. approval of GIVLAARI in the fourth quarter, Alnylam became a multi-product commercial company, and we are pleased with the strong initial interest from patients, physicians, and payers in the short period since the drug’s approval by the FDA,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “Also in the fourth quarter, we reported positive topline Phase 3 results with lumasiran, Alnylam’s third program in 2019 to achieve positive Phase 3 results, and we’ve initiated the rolling submission of an NDA, setting us up for a potential approval later this year. In addition, in 2020 we look forward to advancing additional late-stage programs closer to the market, namely vutrisiran – with the HELIOS-A and -B studies in ATTR amyloidosis – and, inclisiran and fitusiran with our partners at Novartis and Sanofi, respectively. With continued execution across these and other programs we are confident that by year-end we’ll achieve our Alnylam 2020 goals of building a multi-product, global biopharma company with a deep clinical pipeline to fuel future growth and a robust product engine for sustainable and organic innovation, a profile rarely achieved in our industry.”

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