Alnylam Pharmaceuticals Announces Q2 2024 Financial Results and Recent Activity

Alnylam Pharmaceuticals, Inc., based in Cambridge, Massachusetts, has disclosed its financial results for the second quarter ending June 30, 2024. The company's Chief Executive Officer, Yvonne Greenstreet, highlighted significant achievements, including a 34% year-over-year growth in global net product revenues, reaching $410 million. This growth was mainly driven by the company's Transthyretin (TTR) therapeutics business. On the clinical front, positive results were reported from the HELIOS-B Phase 3 study of vutrisiran, indicating improvements in cardiovascular outcomes for patients with ATTR cardiomyopathy.

Second Quarter 2024 Key Corporate Highlights

Commercial Performance
- Total TTR (ONPATTRO® and AMVUTTRA®): The TTR business continued its growth trajectory, achieving global net product revenues of $77 million for ONPATTRO and $230 million for AMVUTTRA in the second quarter. This represents a 16% growth from the first quarter of 2024 and a 37% annual growth, with a 40% increase in the U.S.
- Total Rare (GIVLAARI® and OXLUMO®): Global net product revenues for GIVLAARI and OXLUMO were $62 million and $41 million, respectively. This marks a 2% quarterly growth and a 25% annual growth.

Research and Development Highlights
- The HELIOS-B Phase 3 study of vutrisiran for ATTR amyloidosis with cardiomyopathy (ATTR-CM) met its primary endpoint, showing significant reductions in all-cause mortality and recurrent cardiovascular events.
- Positive results from the KARDIA-2 Phase 2 study of zilebesiran for hypertension were reported.
- Initiation of dosing in the cAPPricorn-1 Phase 2 study of mivelsiran for cerebral amyloid angiopathy (CAA) and Part B of the Phase 1 study of ALN-KHK for Type 2 diabetes mellitus.
- Collaboration partner Sanofi filed regulatory submissions for fitusiran in multiple countries, including the U.S.
- Vir Biotechnology, another partner, presented new data on elebsiran and received Fast Track Designation for hepatitis delta treatment candidates.

Additional Business Developments
- Alnylam updated its collaboration agreements with Regeneron and amended the license agreement for cemdisiran, granting Regeneron exclusive rights to its monotherapy. In exchange, Alnylam received a $10 million upfront payment and will earn royalties on sales.
- Alnylam regained global rights to mivelsiran, as Regeneron opted out of further co-development.

Financial Performance
- For Q2 2024, Alnylam reported net product revenues of $410 million, up from $305.7 million in Q2 2023.
- Net revenues from collaborations surged to $227.3 million from $5.8 million, mainly due to a modified agreement with Regeneron.
- The company reported a GAAP net loss of $16.9 million, a significant improvement from the $276 million loss in Q2 2023. Non-GAAP net income stood at $73.8 million compared to a loss of $201.6 million in the previous year.

Operational Costs
- Cost of goods sold decreased as a percentage of net product revenues.
- Research and Development (R&D) expenses increased due to higher costs in preclinical activities and clinical research.
- Selling, General, and Administrative (SG&A) expenses rose, attributed to increased marketing investments and employee compensation.

Financial Position
- Alnylam's cash, cash equivalents, and marketable securities totaled $2.62 billion as of June 30, 2024, up from $2.44 billion as of December 31, 2023.
- The improvement in financial position was driven by strong net product revenues and proceeds from stock option exercises.

Updated Financial Guidance for 2024
- Alnylam has revised its combined net product revenue guidance for 2024 to a range of $1.575 billion to $1.650 billion from the previous $1.400 billion to $1.500 billion.
- The company also updated its guidance for net revenues from collaborations and royalties to $575 million to $650 million from $325 million to $425 million.
- GAAP R&D and SG&A expenses are now expected to range between $2.0 billion and $2.15 billion, with non-GAAP expenses projected between $1.775 billion and $1.875 billion.

Alnylam continues to demonstrate robust financial and operational performance, positioning itself for sustained growth and advancement in its strategic goals.

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