Analyst Conference Summary

biotechnology

conference date: August 3, 2023 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2023 (second quarter, Q2)

Forward-looking statements

Overview: Continued strong revenue growth.

Basic data (GAAP):

Revenue was $319 million, flat sequentially from $319 million, and up 42% from $225 million year-earlier.

Net income was negative $276 million, down sequentially from negative $174 million, and up from negative $277 million year-earlier.

Diluted EPS was negative $2.21, down sequentially from negative $1.40, and down from negative $2.29 year-earlier.

Guidance:

Reiterated product revenue $1.2 to $1.285 billion.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "We had some very important data readouts in the quarter and recent period, including updated interim results from the Phase 1 trial of ALN-APP in patients with early onset Alzheimer's disease, as well as positive 18-month results from the APOLLO-B Phase 3 study of patisiran, that we believe reaffirm the potential of patisiran in ATTR amyloidosis with cardiomyopathy. Furthermore, we entered into an exciting new partnership with Roche for the development and commercialization of zilebesiran." Amvuttra launch is driving revenue growth.

On July 24, 2023 Alnylam announced an agreement with Roche to develop zilebesiran for hypertension in patients with high cardiovascular risk. Will receive $310 upfront and is eligible for $2.8 billion in milestones. Profit sharing 50/50 in the U.S. and royalties on ex-US sales. The drug is currently in a Phase 2 trial. Positive Phase 1 results were published in Q1 2023.

In Q2 2023 Alnylam presented positive interim Phase 1 results in ALN-APP for Alzheimer's.

On August 3, 2023 Alnylam announced an exclusive worldwide license agreement with Agios Pharmaceuticals to develop and commercialize an siRNA targeting TMPRSS6 for polycythemia vera and related iron-overload disorders.

Vir is conducting multiple trials evaluating the potential for ALN-HBV02 (VIR-2218) and VIR-3434 to achieve a functional cure for chronic hepatitis B. Phase 2 data readouts are on track for Q4 2023.

Onpattro (patisiran) Apollo-B Phase 3 study in patients with hereditary and wild-type ATTR amyloidosis with cardiomyopathy topline results were positive (Q3 2022) and sNDA filed. PDUFA date October 8, 2023.

Alnylam will not proceed with regulatory filings for biannual dosing of Amvuttra, instead advancing ALN-TTRsc04, which could work with annual dosing. Began dosing in the Phase 1 trial in Q1 2023.

In August 2023, Massachusetts closed its case on Onpattro marketing with no action taken.

Non-GAAP net income negative $202 million, down sequentially from negative $132 million, and up from negative $246 million year-earlier. EPS negative $1.62, down sequentially from negative $1.06, and up from negative $2.03 year-earlier.

Cash and equivalents balance at the end of the quarter was $2.06 billion, down sequentially from $na billion.

See also Alnylam pipeline.

Operating expenses of $549 million consisted of: $75 million for cost of goods sold; $249 million for research and development; and $215 million for general and administrative expense; $10 million cost of collaboration. Operating loss $230 million. Interest & other expense was $44 million. $2 million income tax.

Q&A Selective Summary:

Onpattro FDA Advisory Committee? We believe it will focus on the meaning of the results on the 6 minute walk test and KCCQ, particularly given the fairly recent FDA guidance around these endpoints in patients with heart failure. We believe the Apollo-b study is compelling across endpoints. We saw stabilization around a series of endpoints.

Roche deal, they said $275 million they expect to spend? We believe it is a potential game-changing therapy. Roche can be strong partner for marketing. Substantial near-term development milestones to us are $365 million. Consists of $65 for initiation of additional Phase 2 and $300 million on first patient in Phase 3. 60% of the cost sharing is for Roche.

Onpattro 18 month data submission, PDUFA date? Believe it will remain October 8.

Onpattro v. Amvuttra share? Some markets still have not seen an Amvuttra launch. Onpattro US patients are switching over. Seeing that now in Japan and beginning in France.

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