Morningstar | ALNY Updated Forecasts and Estimates from 15 Feb 2019
No-moat Alnylam finished fiscal 2018 with over $12 million in fourth-quarter revenue from its recently launched, first FDA-approved RNAi therapy, Onpattro, as well as about $9 million in revenue from collaborations. While this represents a 13% decline in revenue from last year, we anticipate a significant jump in fiscal 2019 as Onpattro continues to roll out. Operating spend came in within management's previous guidance at about $242 million. Management's guidance for 2019 operating spend came in slightly higher than anticipated, so we adjusted both our research and development and selling, general, and administrative costs upward. We'll revisit our model after the firm files its full-year results, but we do not anticipate a material change to our fair value estimate. Management has not yet provided revenue guidance, but we're currently modeling over $140 million in Onpattro sales, which implies over 550 patients on treatment.Management noted that over 200 patients worldwide were on commercial treatment at the end of 2018. We believe the addition of over 350 new patients is feasible as the Onpattro launch continues. Looking forward, 2019 will be an important year for several of the company's late-stage candidates. The company will be presenting top-line pivotal trial data for givosiran (for acute hepatic porphyria) in March, with potential to file in mid-2019. Interim results indicated solid efficacy over placebo, and we currently model givosiran with an 80% probability of approval. We estimate the target population to be about 5,000 patients worldwide and believe the drug could launch in 2020, if approved. We also expect readouts from phase III trials for inclisiran (hypercholesterolemia, partnered with the Medicines Company), fitusiran (hemophilia, partnered with Sanofi), and lumasiran (primary hyperoxaluria) during 2019.
Alnylam Pharmaceuticals is a commercial-stage biopharmaceutical company developing therapeutics based on RNA interference (RNAi). RNAi is a biological pathway within cells for sequence-specific silencing and regulation of gene expression. The company has two RNAi-based medicines, ONPATTRO? (patisiran) and GIVLAARI? (givosiran). ONPATTRO is approved by the United States Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and has also been approved in the European Union, Japan, Canada and Switzerland. GIVLAARI is approved by FDA for the treatment of adults with acute hepatic porphyria.
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