Analyst Conference Summary

biotechnology

conference date: August 1, 2024 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2024 (second quarter, Q2)

Forward-looking statements

Overview: Remarkable revenue growth driven by collaboration revenue, while pipeline is strong. Net losses decreasing.

Basic data (GAAP):

Revenue was $659 million, up 33% sequentially from $494 million, and up 107% from $319 million year-earlier.

Net income was negative $17 million, up sequentially from $66 million, and up from negative $276 million year-earlier.

Diluted EPS was negative $0.13, up sequentially from $0.52, and up from negative $2.21 year-earlier.

Guidance:

Increased 2024 to net product revenue of $1.575 to $1.65 billion.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "Alnylam delivered strong results across the business in the second quarter. We achieved a robust 34% year-over-year growth, with global net product revenues of $410 million, primarily driven by our TTR business, leading to an upward revision of our combined net product revenue guidance for the year. On the clinical side, we announced positive topline results from the HELIOS-B Phase 3 study of vutrisiran, showing that it improved cardiovascular outcomes, including an impressive 35-36% mortality benefit, in patients with ATTR cardiomyopathy. With these outstanding results in hand, and assuming successful regulatory review and approval, we believe we are positioned to deliver significant long-term topline growth, providing the capacity for strategic investment in our highly productive organic R&D platform, and further advancing us toward our Alnylam P5x25 goals and becoming a leading global biotech company." Still expects to achieve non-GAAP profitability by end of 2025.

Amvutra (Vutrisiran) Phase 3 ATTR amyloidosis with cardiomyopathy positive topline results (Helios-B) reported in July 2024. Will analyse both combined with tafamadis and as monotherapy. Met primary and secondary endpoints. Will give full results on August 30 at ESC. There are perhaps 300,000 potential global patients, with about 80% untreated. Expects to make regulatory submissions in late 2024 with accelerated review in the US.

Zilebesirin for hypertension reported positive Phase 2 topline results in Q2 2024, when added to standard of care to control hypertension. Will partner with Roche for global development and distribution. In Q1 2024 initiated a Phase 2 study in adult patients with high cardiovascular risk and uncontrolled hypertension despite treatment with two to four standard of care hypertension medications.

In Q2 2024 initiated dosing of mivelsiran (ALN-APP) in cerebral amyloid angiopathy patients. In Q1 received FDA approval for Part B of the Phase 1 study of mivelsiran for early-onset Alzheimer's. A Phase 2 study for cerebral amyloid angiopathy is planned for mid 2024. Regeneron opted out, so Alnylam now has full global rights. The Alzheimer's trial could start by end of 2024.

In Q2 2024 began Part B of the Phase 1 study of ALN-KHK, for Type 2 diabetes mellitus.

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.

In Q2 2024 partner Sanofi received a PDUA date of March 28, 2025 for fitusiran. In Q4 2023 Sanofi presented positive Phase 3 extension results for fitusiran for hemophilia A or B.

Net revenue from collaborations was $227 million, up from $6 million year-earlier. Royalty revenue was $22 million, up from $7 million year-earlier.

Non-GAAP net income $74 million, up sequentially from negative $21 million, and up from negative $202 million year-earlier. EPS $0.58, up sequentially from negative $0.16, and up from negative $1.62 year-earlier.

Cash and equivalents balance at the end of the quarter was $2.6 billion, up sequentially from $2.37 billion. Convertible Debt $ billion.

See also Alnylam pipeline.

Operating expenses of $611 million consisted of: $67 million for cost of goods sold; $294 million for research and development; and $248 million for general and administrative expense; $1 million cost of collaboration. Operating income $49 million. Interest & other expense was $60 million. $6 million income tax.

Q&A Selective Summary:

Reimbursement in ATTR cardiomyopathy? Very pleased with commercial performance to date in polyneuropathy. In CM leveraging same principals as neuropathy. Physician administered, so on Part D, an advantage compared to competitive and future products.

First line CM opportunity? Unmet medical need. Amvutra well-positioned for first line. Physicians are excited.

ALN-APP Alzheimer's design? Demonstrated sustained reduction in amyloid alpha and beta. Seeing good safety as well. Working on trial design for Alzheimer's, should be able to share soon, study could start by year end. No plans to licence out.

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