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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Exhibit Filing (Oct 31, 2024)

Reports
Exhibits & Filings
Filing Date
Filed October 31, 2024
Period End
October 31, 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 October 31, 2024. Cited figures are marked; the original filing is the authoritative source.

Alnylam Pharmaceuticals reported third quarter 2024 results on October 31, 2024, led by global net product revenues of $420.1 milliona, up 34% year over year (35% at constant exchange rates).

Growth was driven by the TTR franchise, where AMVUTTRA revenue rose 74% to $258.6 millionb, offsetting a 38% decline in ONPATTRO to $50.3 million as patients switched to AMVUTTRA. The Rare franchise (GIVLAARI and OXLUMO) grew 34% to $111.3 million. Total revenues were $500.9 million, down from $750.5 million a year earlier, because the prior-year quarter included roughly $375 million of collaboration revenue from the Roche upfront and Regeneron milestone recognition, which did not recur at the same scale.

Profitability weakened on a GAAP basis. The company reported a GAAP operating loss of $76.9 millionc and a GAAP net loss of $111.6 million, or $(0.87) per share, compared with GAAP net income of $147.8 million in the prior-year quarter. Non-GAAP net loss was $64.2 million, or $(0.50) per share.

Gross margin improved, with cost of goods sold falling to 19.5% of net product revenues from 25.4%, while R&D and SG&A expenses rose on pipeline spending and pre-launch marketing for AMVUTTRA in ATTR-CM. Cash, cash equivalents and marketable securities totaled $2.78 billiond at quarter-end, up from $2.44 billion at year-end 2023. Management reiterated full-year 2024 guidance of $1,575 million to $1,650 million in combined net product revenues and $575 million to $650 million in collaboration and royalty revenues.

The company also submitted regulatory applications in the U.S. and EU for AMVUTTRA in ATTR-CM, targeting a potential U.S. launch in early 2025, and discontinued development of ALN-KHK. Investors will likely focus on the ATTR-CM launch timing, the pace of ONPATTRO-to-AMVUTTRA conversion, and whether operating expenses can be contained as the company approaches profitability.

02—Key points

Key Highlights

  1. Global net product revenues of $420.1 million, up 34% year over year (35% at CER), driven by AMVUTTRA growth of 74% to $258.6 million.
  2. Total revenues fell to $500.9 million from $750.5 million, mainly because collaboration revenue dropped from $427.5 million to $57.4 million after one-time recognition in the prior-year period.
  3. GAAP net loss of $111.6 million, or $(0.87) per share, versus GAAP net income of $147.8 million a year earlier; non-GAAP net loss was $64.2 million, or $(0.50) per share.
  4. Cost of goods sold improved to 19.5% of net product revenues from 25.4%, though R&D (GAAP $270.9 million) and SG&A (GAAP $221.0 million) increased.
  5. Full-year 2024 guidance reiterated: net product revenues of $1,575–$1,650 million and collaboration/royalty revenues of $575–$650 million.
  6. Regulatory submissions for AMVUTTRA in ATTR-CM filed in the U.S. (sNDA with Priority Review Voucher) and EU, with a potential U.S. launch targeted for early 2025.
  7. Cash, cash equivalents and marketable securities of $2.78 billion at September 30, 2024, up from $2.44 billion at December 31, 2023; ALN-KHK development was suspended as part of portfolio prioritization.

03—Questions

Frequently Asked Questions

  1. Why did total revenue decline year over year despite strong product sales growth?

    Total revenues were $500.9 million versus $750.5 million in Q3 2023. The prior-year quarter included $310 million of revenue recognized from the Roche upfront payment and a $65 million cumulative adjustment from the Regeneron milestone. Collaboration revenue therefore fell from $427.5 million to $57.4 million, which more than offset the 34% increase in net product revenues.

  2. Is the company profitable?

    Not on a GAAP basis in this quarter. Alnylam reported a GAAP operating loss of $76.9 million and a GAAP net loss of $111.6 million, or $(0.87) per share. Non-GAAP net loss was $64.2 million, or $(0.50) per share. Both measures were negative, compared with positive results in Q3 2023 driven by collaboration revenue.

  3. What drove the growth in the TTR franchise, and what is happening with ONPATTRO?

    AMVUTTRA net product revenues grew 74% to $258.6 million, as patients switched from ONPATTRO. ONPATTRO revenues fell 38% to $50.3 million. Combined TTR net product revenues rose 34% to $308.9 million. Investors should watch the mix shift, since AMVUTTRA is the key growth driver ahead of its potential ATTR-CM indication.

  4. What are the key upcoming catalysts?

    The company submitted an sNDA with a Priority Review Voucher to the FDA and a Type II Variation to the EMA for AMVUTTRA in ATTR-CM, with a potential U.S. launch in early 2025 and other markets later in 2025. It also plans to share the Phase 3 development plan for ALN-TTRsc04 in Q1 2025 and to start a Phase 2 study of mivelsiran in Alzheimer's disease around year-end 2024.

  5. Is the company's balance sheet and cash position sufficient to support operations?

    Cash, cash equivalents and marketable securities totaled $2.78 billion at September 30, 2024, up from $2.44 billion at year-end 2023. This increase reflects improved operating performance and stock option proceeds. Total liabilities of $4.17 billion were largely driven by the sale of future royalties and convertible debt, and stockholders' equity was positive at $32.4 million.

04—Continue

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