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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Exhibit Filing (May 2, 2024)

Reports
Exhibits & Filings
Filing Date
Filed May 2, 2024
Period End
May 2, 2024
Security
ALNY
In the record · 2016–202610-K1110-Q328-K121

ALNY filed 11 annual reports (10-K), 32 quarterly reports (10-Q) and 121 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Apr ’18Apr ’18
  2. Material agreement8-K · Apr ’20Apr ’20
  3. Leadership change8-K · Aug ’22Aug ’22
  4. Leadership change8-K · May ’26May ’26

01—Abstract

Summary

Summary of the 8-K filed May 2, 2024. Cited figures are marked; the original filing is the authoritative source.

Alnylam Pharmaceuticals reported first quarter 2024 results on May 2, 2024, led by strong commercial execution.

Global net product revenues reached $365.2 milliona, up 32% year over year (32% at constant exchange rates). Growth was driven by AMVUTTRA, whose sales rose 92% to $195.2 million, while total TTR products grew 29% to $264.5 million. Rare disease products GIVLAARI and OXLUMO grew 40% combined to $100.7 million.

ONPATTRO declined 32% to $69.2 millionb as patients shifted to AMVUTTRA. Total revenues were $494.3 million, up 55%, helped by $118.5 million in collaboration revenue, which included a $65 million milestone from Roche tied to the start of the KARDIA-3 zilebesiran study. Profitability improved sharply but the company remains loss-making on a GAAP basis.

The GAAP operating loss narrowed to $43.4 millionc from $149.8 million a year earlier, and the non-GAAP operating result was a small gain of $1.9 million. GAAP net loss was $65.9 million, or $0.52 per share, compared with $174.1 million, or $1.40 per share, in Q1 2023. Non-GAAP net loss was $20.7 million, or $0.16 per share.

Cash, cash equivalents and marketable securities totaled $2.37 billiond at quarter end, down from $2.44 billion at year end, primarily reflecting the operating loss. Management reiterated full-year 2024 guidance: combined net product revenues of $1.40 to $1.50 billion (13% to 21% growth), collaboration and royalty revenue of $325 to $425 million, and GAAP R&D plus SG&A expenses of $1.90 to $2.05 billion.

The key near-term catalyst is topline data from the Phase 3 HELIOS-B study of vutrisiran in ATTR cardiomyopathy, expected in late June or early July 2024. The company also updated the statistical analysis plan for that trial, adjusting the primary and secondary endpoints and the analysis period.

02—Key points

Key Highlights

  1. Global net product revenues of $365.2M, up 32% YoY, with AMVUTTRA up 92% to $195.2M, the main growth driver
  2. ONPATTRO revenue fell 32% to $69.2M, reflecting the ongoing shift of patients to AMVUTTRA
  3. Total revenues of $494.3M, up 55% YoY, boosted by a $65M Roche milestone tied to the zilebesiran KARDIA-3 study start
  4. GAAP operating loss narrowed to $43.4M from $149.8M; non-GAAP operating result was a $1.9M gain
  5. GAAP net loss of $65.9M ($0.52 per share) vs. $174.1M ($1.40) a year earlier; non-GAAP net loss of $20.7M ($0.16 per share)
  6. Cash, cash equivalents and marketable securities of $2.37B at March 31, 2024, down from $2.44B at year-end 2023
  7. 2024 guidance reiterated: net product revenues of $1.40–$1.50B; HELIOS-B Phase 3 topline results expected late June or early July 2024

03—Questions

Frequently Asked Questions

  1. What drove Alnylam's revenue growth in the first quarter of 2024?

    Growth was driven mainly by AMVUTTRA, whose net product revenue nearly doubled to $195.2M on increased patient demand. Rare disease products GIVLAARI and OXLUMO also grew 40% combined. Collaboration revenue rose 225% to $118.5M, largely due to a $65M milestone from Roche tied to the start of the KARDIA-3 study. That milestone is a one-time item, so it should not be extrapolated.

  2. Is Alnylam profitable?

    Not on a GAAP basis. The Q1 2024 GAAP net loss was $65.9M, though this was much smaller than the $174.1M loss in Q1 2023. On a non-GAAP basis, which excludes stock-based compensation and certain investment gains and losses, the company was close to break-even at the operating line, with a $1.9M operating gain, and reported a non-GAAP net loss of $20.7M.

  3. What are the key upcoming catalysts?

    The most important near-term event is topline data from the Phase 3 HELIOS-B study of vutrisiran in patients with ATTR cardiomyopathy, expected in late June or early July 2024. The company also plans to start a Phase 2 study of mivelsiran in cerebral amyloid angiopathy and to begin Part B of the ALN-KHK Phase 1 study. The updated statistical analysis plan for HELIOS-B adjusts the primary and secondary endpoints and the analysis period, which investors should review when assessing the readout.

  4. How is the company's cash position?

    Cash, cash equivalents and marketable securities were $2.37B at March 31, 2024, down from $2.44B at year-end 2023. The decline was mainly due to the operating loss in the quarter. Total liabilities of $4.04B exceed total assets of $3.82B, resulting in a stockholders' deficit of $219.3M.

  5. What is the outlook for 2024?

    Management reiterated guidance for combined net product revenues of $1.40–$1.50B, representing 13% to 21% growth over 2023. It also expects collaboration and royalty revenue of $325–$425M and GAAP R&D plus SG&A expenses of $1.90–$2.05B. The guidance assumes January 31, 2024 FX rates.

04—Continue

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