Analyst Conference Summary

biotechnology

conference date: February 11, 2021 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2020 (fourth quarter, Q4)

It is late in the morning on Thursday and someone forgot to post the replay of the confernce, so this is from the press release. May or may not get back for a listen and add to these notes. -WM

Forward-looking statements

Overview: Rapid revenue growth, but still in the red. New vision presented.

Basic data (GAAP):

Revenue was $164 million, up 30% sequentially from $126 million, but up 128% from $72 million year-earlier.

Net income was negative $244 million, up sequentially from negative $253 million, and up from negative $276 million year-earlier.

Diluted EPS was negative $2.09, up sequentially from negative $2.18, and up from negative $2.47 year-earlier. Combined SG&A and R&D expenses $1.335 to $1.455 billion GAAP; $1.175 to $1.275 billion non-GAAP.

Guidance:

For the full year 2021 proeduct revenue estimated between $610 and $660 million. Collaboration and royalty revenue $150 to $200 million.

Conference Highlights:

John Maraganore, CEO of Alnylam, said: "In the fourth quarter we celebrated the regulatory approvals of our third and fourth commercial medicines: Oxlumo, in the EU and U.S.; and Leqvio, in the EU. We also reported positive topline results from the Helios-A Phase 3 study of vutrisiran, our fifth investigational medicine to achieve that important milestone. Having exceeded our Alnylam 2020 vision and goals, we now look to the next chapter of our Company’s story, and are excited to have recently launched our new five-year vision, Alnylam P5x25. We aim to bring transformative medicines in both rare and common diseases to patients around the world, while advancing a robust and high-yielding pipeline of first and/or best-in-class product candidates from our organic research engine, and delivering exceptional financial performance."

Givlaari (Givosiran) for AHP (actue hepatic porphyria) in Q4 2020 continued launch in Germany, market access in Italy and temporary approval in France.

Oxlumo started sales in the U.S. following FDA approval in November 2020. Working on EU approval and reimbursement.

Onpattro (patisiran) is making progress ex-US with new launches or getting reimbursement; got approval in Taiwan in Q4 2020.

Cash and equivalents balance at the end of the quarter was $1.91 billion, up sequentially from $1.83 billion. $191 million long-term debt, and $1.07 billion liability related to sales of future royalties.

Non-GAAP net income negative $186 million, down sequentially from negative $184 million, and up from negative $221 million year-earlier. EPS negative $1.60, down sequentially from negative $1.58, and down from negative $1.98 year-earlier.

Onpattro (patisiran) continued enrollment in the APOLLO-B Phase 3 study in ATTR amyloidosis patients with cardiomyopathy, with plans to complete enrollment in early 2021

Fitusiran for hemophilia and rare bleeding disorders Phase 3 ATLAS pivotal study continued. Sanofi Genzyme is a partner in the program. In Q4 2020 received Fast Track Designation from the FDA.

Vutrisiran (ALN-TTRsc02) reported positive topline results from the HELIOS-A Phase 3 study in hATTR amyloidosis patients with polyneuropathy, and plans to file an NDA with the FDA in early 2021. Continued the HELIOS-B Phase 3 study in patients with hereditary and wild-type ATTR amyloidosis with cardiomyopathy.

Oxlumo (Lumasiran) for PH1 (primary hyperoxaluria type 1) was approved by the FDA on November 4, 2020. In Q4 2020 presented positive complete results from ILLUMINATE-B, a global Phase 3 pediatric study of lumasiran in PH1 patients less than six years of age, including infants, with preserved renal function.

Inclisiran, now Leqvio, for hypercholesterolemia, licensed to Novartis, received marketing authorization for Leqvio from the European Commission in December 2020. But the FDA issued a Complete Response Letter.

In Q2 2020 filed a Clinical Trial Application for ALN-HSD, an investigational RNAi therapeutic targeting HSD17B13 in development for the treatment of nonalcoholic steatohepatitis (NASH). ALN-HSD is being advanced in collaboration with Regeneron.

ALN-GO1 for primary hyperoxaluria type 1 (PH1) Phase 1/2 study continued.

ALF-F12 targeting factor XII is now in development for the treatment of hereditary angioedema and for thromboprophylaxis.

In Q4 2020 began Phase 1 dosing of ALN-HSD, an investigational RNAi therapeutic targeting HSD17B13 for the treatment of non-alcoholic steatohepatitis (NASH), in collaboration with Regeneron.

In May 2020 announced positive initial topline results from the ongoing Phase 1 study (N=48) of ALN-AGT in hypertension. On November 13, 2020 released interim Phase 1 results at AHA.

See also Alnylam pipeline.

Operating expenses of $358 million consisted of: $23 million for cost of goods sold; $168 million for research and development; and $166 million for general and administrative expense. Operating loss $194 million. Interest & other expense was $49 million. $0 million income tax.

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