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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Jan 8, 2024)

Reports
Earnings & Results·Exhibits & Filings
Filing Date
Filed January 8, 2024
Period End
January 7, 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 January 8, 2024. Cited figures are marked; the original filing is the authoritative source.

Alnylam Pharmaceuticals (ALNY) filed this Form 8-K on January 8, 2024 (press release dated January 7, 2024) to furnish preliminary fourth-quarter and full-year 2023 results ahead of its J.P.

Morgan Healthcare Conference presentation. Preliminary global net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO totaled approximately $1,241 milliona for full-year 2023, representing 39% annual growth (39% at constant exchange rates). Fourth-quarter revenue was roughly $346 million across the four products, with ONPATTRO at about $79 million and AMVUTTRA at about $175 million, implying 10% sequential growth in total TTR (transthyretin) products.

Ultra-rare products GIVLAARI and OXLUMO generated about $59 millionb and $33 million in Q4, respectively, with full-year totals of $219 million and $110 million, reflecting 35% annual growth and 11% sequential quarterly growth. The company reported preliminary cash, cash equivalents and marketable securities of approximately $2.4 billion at December 31, 2023, up from $2.2 billion a year earlier. Management characterized the results as delivering top-line revenue within guidance, and highlighted 2023 clinical progress including zilebesiran for hypertension and ALN-APP, which demonstrated the first clinical gene silencing in the human brain using an RNAi therapeutic.

The company also flagged that HELIOS-B Phase 3 data for vutrisiran are expected in early 2024. Investors should note that all figures are unaudited, preliminary and subject to adjustment until full results are announced in February 2024.

The information is furnished rather than filed under the Exchange Act, and the release includes forward-looking statements and a non-GAAP constant exchange rate measure. The filing does not disclose full earnings, margins, or 2024 guidance, so those items remain to be addressed in the February report.

02—Key points

Key Highlights

  1. Preliminary FY2023 global net product revenues of approximately $1,241 million, up 39% year over year (39% at constant exchange rates).
  2. AMVUTTRA generated approximately $175 million in Q4 2023 and $558 million for full year 2023; ONPATTRO generated approximately $79 million in Q4 and $355 million for the year.
  3. Total TTR franchise (ONPATTRO and AMVUTTRA) grew 10% sequentially in Q4 2023 and 40% annually in 2023.
  4. Ultra-rare franchise (GIVLAARI and OXLUMO) generated approximately $219 million and $110 million for FY2023, growing 35% annually, with 11% sequential growth in Q4.
  5. Over 4,060 patients worldwide were receiving commercial ONPATTRO or AMVUTTRA at year-end 2023; over 650 on GIVLAARI and over 430 on OXLUMO.
  6. Preliminary cash, cash equivalents and marketable securities of approximately $2.4 billion at December 31, 2023, versus $2.2 billion a year earlier.
  7. Upcoming catalyst: HELIOS-B Phase 3 results for vutrisiran expected in early 2024; figures remain unaudited until full results in February 2024.

03—Questions

Frequently Asked Questions

  1. Why did Alnylam release preliminary results before its full earnings report?

    The company announced preliminary revenue and cash figures on January 7, 2024, timed ahead of its presentation at the 42nd J.P. Morgan Healthcare Conference on January 8, 2024. The numbers are approximations, unaudited and subject to adjustment, with complete audited results scheduled for February 2024.

  2. How strong was the revenue growth in 2023?

    Preliminary global net product revenues of about $1,241 million represented 39% annual growth, or 39% at constant exchange rates, a non-GAAP measure that strips out currency effects. The TTR franchise grew 40% and the ultra-rare franchise grew 35% for the year.

  3. Which product drove the most growth?

    AMVUTTRA was the largest contributor, with preliminary Q4 2023 revenue of about $175 million and full-year revenue of about $558 million, while ONPATTRO contributed about $355 million for the year. The filing does not break out year-over-year growth for each individual product.

  4. Is Alnylam financially stable heading into 2024?

    The company reported preliminary cash, cash equivalents and marketable securities of about $2.4 billion at year-end 2023, up from $2.2 billion in 2022. The filing does not disclose cash burn, debt, or profitability, so a full assessment must wait for the February 2024 financial statements.

  5. What are the key pipeline catalysts to watch?

    Management pointed to HELIOS-B Phase 3 data for vutrisiran expected in early 2024, and cited 2023 progress with zilebesiran in hypertension and ALN-APP in Alzheimer's disease. Investors should note that the release provides no timeline or probability assessments for these programs.

04—Continue

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