ALNY · ALNYLAM PHARMACEUTICALS, INC.

371 filings

ALNY SEC Filings

ALNYLAM PHARMACEUTICALS, INC. - 371 total filings

Filing record · 2016–202610-K1110-Q328-K121

Showing 1–50 of 371 filings

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Jul 30, 2026)

Alnylam reported Q2 2026 total revenues of $1,290.9 million, up 67% year over year, with total net product revenues of $1,172.1 million (up 74%). Growth was driven primarily by TTR franchise sales: AMVUTTRA net product revenue reached $1,011.8 million (up 106%), and total TTR net product revenues were $1,030.2 million (up 89%), with the U.S. ATTR-CM launch the main contributor. GAAP income from operations was $231.4 million versus a loss of $16.2 million a year earlier, and GAAP net income was $164.5 million, or $1.21 per diluted share. Cash, cash equivalents and marketable securities rose to $3.3 billion from $2.9 billion at year-end 2025. The most important investor item is a cut to full-year 2026 guidance. Total TTR net product revenue guidance was lowered to $4.2–4.5 billion from $4.4–4.7 billion, and total net product revenue guidance was lowered to $4.7–5.1 billion from $4.9–5.3 billion. Management attributed the change to normalization of second-line U.S. AMVUTTRA demand after a pent-up demand benefit in the early launch period. Collaboration and royalty revenue guidance was raised to $575–625 million from $400–500 million, and non-GAAP R&D and SG&A guidance was reiterated. Pipeline and business development activity continued, including Phase 2 starts for ALN-6400 (von Willebrand disease) and mivelsiran (Down syndrome-associated Alzheimer's disease), a China commercialization agreement for AMVUTTRA with BeOne Medicines, and an AI collaboration with Inceptive. Regeneron's cemdisiran NDA for generalized myasthenia gravis has a target FDA action date in November 2026. The filing does not disclose a cause for the guidance cut beyond management's commentary, and the rising interest expense and royalty-financing liabilities warrant continued monitoring.

Jul 30, 2026 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2026

Alnylam Pharmaceuticals, Inc. reported strong financial performance for the six months ended June 30, 2026, driven by significant growth in net product revenues, primarily from AMVUTTRA. The company achieved a substantial increase in net product revenues, up 94% year-over-year, reaching $2.21 billion, with AMVUTTRA sales more than doubling to $1.90 billion. This growth is largely attributed to the expansion of AMVUTTRA for ATTR-CM in the US and other global markets. While net revenues from collaborations decreased by 20%, this was primarily due to the completion of certain collaboration activities and the wind-down of research terms, partially offset by increased revenue from the Roche collaboration. The company reported a net income of $370.5 million for the six-month period, a significant improvement from a net loss of $90.5 million in the prior year, indicating a strong shift towards profitability. The balance sheet shows healthy liquidity with $1.71 billion in cash and cash equivalents and $1.60 billion in marketable debt securities.

Jul 30, 2026 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (May 27, 2026)

Alnylam Pharmaceuticals, Inc. (ALNY) has filed an 8-K report detailing key governance and shareholder decisions made at its recent Annual Meeting and a board expansion. The company has appointed Dr. Benjamin F. Cravatt to its Board of Directors as a Class III director, effective June 1, 2026, filling a newly created vacancy and also serving on the Science and Technology Committee. This appointment is accompanied by a standard non-employee director compensation package, including an annual cash retainer and initial and ongoing equity awards, designed to align director interests with shareholders. Furthermore, the filing provides an update on the outcomes of the Annual Meeting, including the re-election of three Class I directors, a strong advisory vote of approval for executive compensation, and the ratification of PricewaterhouseCoopers LLP as the independent auditor for the fiscal year ending December 31, 2026. These events reflect the company's commitment to robust corporate governance and shareholder engagement.

May 27, 2026 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2026

Alnylam Pharmaceuticals, Inc. demonstrated significant financial performance in the first quarter of 2026, reporting a substantial increase in total revenues to $1.17 billion, primarily driven by a robust surge in net product revenues, which grew by 121% to $1.04 billion. This growth was largely attributed to AMVUTTRA, which saw a remarkable 187% increase in total net product revenues, notably in the U.S. for ATTR-CM treatment. Despite a rise in operating costs and expenses, which increased by 56% to $898.5 million, the company achieved a strong income from operations of $268.6 million, a significant improvement from the prior year's quarter. The company's balance sheet shows a healthy liquidity position with $1.71 billion in cash and cash equivalents. However, the increased interest expense due to liabilities related to the sale of future royalties and development funding, coupled with ongoing significant investments in research and development, indicates a continued focus on pipeline expansion. Management believes existing resources are sufficient for at least the next 12 months, but future capital needs may arise for continued commercialization and pipeline advancement.

Apr 30, 2026 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Apr 30, 2026)

Alnylam Pharmaceuticals reported first quarter 2026 results on April 30, 2026, with total revenues of $1,167 million, up 96% year over year (93% at constant exchange rates). Total net product revenues reached $1,036 million, up 121%, driven by AMVUTTRA (vutrisiran) for ATTR-CM, which generated $890 million, up 187%. Management highlighted that this was the first quarter in company history with over $1 billion in product revenue, marking one year since the U.S. launch of AMVUTTRA for ATTR-CM. Total TTR net product revenue was $910 million, while Rare disease products (GIVLAARI and OXLUMO) contributed $126 million, up 15%. ONPATTRO declined 59% to $20 million as patients shifted to AMVUTTRA. Profitability improved sharply. GAAP income from operations rose to $269 million from $18 million a year earlier, and GAAP net income was $206 million, or $1.51 per diluted share, versus a net loss of $18 million in the prior-year period. Non-GAAP net income was $273 million, or $1.99 per diluted share. Gross margin pressure is visible, with cost of goods sold rising to 20% of net product revenues from 15%, reflecting higher AMVUTTRA royalty obligations. R&D and SG&A expenses increased, driven by Phase 3 trials (ZENITH, TRITON-CM, TRITON-PN) and commercial launch spending. Cash, cash equivalents and marketable securities totaled $3.0 billion at quarter end, and stockholders' equity rose to $1,075 million from $789 million. Management reiterated full-year 2026 guidance: total net product revenues of $4.9 billion to $5.3 billion, including $4.4 billion to $4.7 billion from TTR products, and non-GAAP R&D and SG&A expenses of $2.7 billion to $2.8 billion. The company also expanded the TRITON-CM Phase 3 trial of nucresiran from 1,250 to about 1,750 patients due to faster-than-expected enrollment, while still targeting a 2030 launch. Several clinical readouts are expected in the second half of 2026.

Apr 30, 2026 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Mar 4, 2026)

Alnylam Pharmaceuticals, Inc. announced on March 4, 2026, the grant of a significant special equity award to its CEO, Yvonne Greenstreet, M.D., M.B.A. This award, effective March 2, 2026, is designed to retain and incentivize Dr. Greenstreet over the next several years, aligning her compensation with substantial future stock price appreciation. The Board recognizes her critical role in the company's recent successes, including nearly 100% stockholder return, key product launches like AMVUTTRA, and the achievement of the 'Alnylam P5x25' goals, including profitability in 2025. The special award is entirely performance-based, with vesting contingent upon the company's stock price reaching specific, ambitious thresholds by December 31, 2029. The award has a target value of $18.0 million, represented by 55,373 performance share units. The terms stipulate that 50% of the target shares vest if the average stock price reaches $500, and 200% vest if it reaches $800, with linear interpolation for performance in between. Importantly, no shares will vest if the stock price does not reach a baseline threshold of $500, which is above the all-time high at the grant date. This structure strongly links executive compensation to significant long-term value creation for shareholders.

Mar 4, 2026 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Feb 12, 2026)

Alnylam reported fourth quarter and full year 2025 results on February 12, 2026, marking a major inflection point: the company reached GAAP and non-GAAP profitability for the full year. Q4 2025 total net product revenues were $995 million, up 121% year over year (119% at constant exchange rates), driven overwhelmingly by AMVUTTRA's ATTR-CM launch in the U.S. AMVUTTRA alone generated $827 million in Q4 and $2.31 billion for the full year. Full-year total revenues reached $3.71 billion, up 65%, and GAAP income from operations swung to $502 million from a $177 million loss in 2024. Q4 GAAP net income was $112 million, or $0.82 per diluted share. The balance sheet strengthened meaningfully, with cash, cash equivalents and marketable securities of $2.91 billion at year-end, up from $2.69 billion. Stockholders' equity rose to $789 million from $67 million. Management also introduced its five-year "Alnylam 2030" strategy and provided 2026 guidance calling for total net product revenues of $4.9 billion to $5.3 billion (64% to 77% growth), with Rare product revenues of $500 million to $600 million and collaboration and royalty revenues of $400 million to $500 million. Non-GAAP R&D and SG&A expenses are guided to $2.7 billion to $2.8 billion, excluding $300 million to $400 million of stock-based compensation. Key considerations for investors include the concentration of growth in AMVUTTRA, rising cost of goods sold as a share of product sales due to the associated increase in the blended royalty rate payable on AMVUTTRA, and continued reliance on sale-of-royalty and development-funding liabilities (about $1.69 billion combined at year-end). The company also disclosed a planned $250 million investment in a new enzymatic-ligation manufacturing facility in Norton, Massachusetts, and a 2026 pipeline slate of clinical readouts and new trial initiations, with several key data updates expected in the second half of the year.

Feb 12, 2026 10-K

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2025

Alnylam Pharmaceuticals reported its first full year of GAAP profitability in 2025, with total revenues of $3.71 billion (up 65% year over year) and net income of $313.7 million, compared with a net loss of $278.2 million in 2024. The growth was driven overwhelmingly by AMVUTTRA, whose net product revenue rose 138% to $2.31 billion following FDA approval for ATTR cardiomyopathy (ATTR-CM) in March 2025. Total net product revenues reached $2.99 billion, while collaboration revenue of $553 million included a one-time $300 million Roche milestone that management expects will not recur, so collaboration revenue is guided lower in 2026. Investors should weigh the quality of earnings against several headwinds. Cost of goods sold rose to 22.7% of product revenue from 18.6%, because royalties owed to Sanofi on AMVUTTRA escalate in tiers up to 30%, and management expects that ratio to rise further in 2026. Operating expenses grew 32% to $3.21 billion, and the company carries about $2.5 billion of debt-like obligations, including $1.01 billion of convertible notes and roughly $2.95 billion of liabilities tied to sales of future royalties and development funding. The balance sheet is stronger, with $2.91 billion in cash and marketable securities and stockholders' equity turning positive at $789 million, but a $1.15 billion repurchase of 2027 Notes and a new $500 million revolver show active liability management. The 2030 'Alnylam 2030' goals call for 25%+ revenue CAGR and roughly 30% non-GAAP operating margin. Key risk items include Leqvio generic (Paragraph IV) challenge, competition from lower-priced oral TTR therapies, pricing and healthcare reform exposure, a U.S. Attorney's Office subpoena on government price reporting, and continued reliance on third-party manufacturers and collaborators. Pipeline catalysts include nucresiran Phase 3 trials, the ZENITH outcomes trial for zilebesiran, and the HHT Phase 2 program for ALN-6400.

Feb 12, 2026 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Jan 12, 2026)

On January 11, 2026, Alnylam Pharmaceuticals (ALNY) announced its new five-year strategy, "Alnylam 2030," alongside preliminary unaudited fourth-quarter and full-year 2025 global net product revenues of approximately $995 million and $2,987 million, respectively (full-year up 81% year over year). Growth was driven primarily by the Total TTR franchise (AMVUTTRA and ONPATTRO), which generated preliminary full-year 2025 revenues of approximately $2,487 million, up 103%. The Total Rare franchise (GIVLAARI and OXLUMO) contributed about $499 million for the year, up 18%, with Q4 Rare revenue growing 26%. The headline forward-looking item is 2026 combined net product revenue guidance of $4,900 million to $5,300 million, implying roughly 71% growth at the midpoint. Total TTR guidance is $4,400 million to $4,700 million (about 83% growth at the midpoint), while Total Rare guidance of $500 million to $600 million implies only about 10% growth. Alnylam 2030 targets include leading the TTR market in revenue by 2030, launching the next-generation silencer nucresiran in polyneuropathy by 2028 and cardiomyopathy by 2030, a 25%+ total revenue CAGR through 2030, and roughly 30% non-GAAP operating margin. Investors should note that the revenue figures are preliminary, unaudited, and subject to adjustment, with full results due in February 2026. Collaboration and royalty revenue and operating expense guidance were not provided and are expected with the full-year 2025 earnings release. The information in Item 2.02 and Exhibit 99.1 is furnished rather than filed, and the forward-looking statements carry the usual risks, including execution on the 2030 strategy, clinical trial outcomes, and regulatory and reimbursement risk.

Jan 12, 2026 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Dec 11, 2025)

Alnylam Pharmaceuticals (ALNY) disclosed in an 8-K filed December 11, 2025 that it entered into privately negotiated repurchase agreements on December 10, 2025 to buy back approximately $34.4 million in principal of its 1.00% convertible senior notes due 2027, for a total cash cost of about $51.9 million including accrued interest. The implied price is roughly 151% of par, a premium that reflects accrued interest and the conversion value of the notes, which means the company is paying above face value to retire this debt. The final cash price is not fixed. Part of the payment will be tied to the daily VWAP of Alnylam's common stock over a measurement period starting December 11, 2025, so the ultimate cost will move with the share price. The repurchases are expected to close shortly after that period ends, subject to customary conditions. Once they close, about $362.8 million of the notes will remain outstanding. The capped call transactions tied to the original issuance are expected to stay in effect. For investors, the transaction is a modest deleveraging step that reduces the convertible overhang and potential future dilution, consistent with the company's stated goal of building a self-sustainable financial profile under its "Alnylam P5x25" strategy. The filing does not disclose the funding source, the cash balance impact, or the accounting gain or loss, so those details should be checked in the next quarterly report.

Dec 11, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Dec 3, 2025)

Alnylam Pharmaceuticals (ALNY) disclosed in an 8-K filed December 3, 2025 that two directors, Michael W. Bonney and Carolyn Bertozzi, Ph.D., resigned from the Board effective December 2, 2025. Neither resignation involved a disagreement with the company. The Board reduced its size from eleven to ten seats and elected Stuart A. Arbuckle as a non-employee Class I director, effective January 5, 2026. Mr. Arbuckle is a former Vertex Executive Vice President and Chief Operating Officer, bringing commercial and operational experience from the company's perspective of scaling its business. For investors, the filing is primarily a governance update rather than a financial event, and no financial results or guidance are disclosed. Dr. Bertozzi's departure is attributed in the press release to her recent election to the board of Eli Lilly (effective December 8, 2025), and she will remain a scientific advisor to Alnylam. Mr. Bonney, a long-tenured director and former Board Chair and Executive Chair, was in a Class I seat due to expire at the 2026 annual meeting, so his exit removes a historically influential voice from the Board. Mr. Arbuckle's compensation package is standard for a non-employee director: a $75,000 annual cash retainer, a one-time stock option grant with a $600,000 Black-Scholes grant-date fair value vesting over three years, and eligibility for the regular annual equity award (currently $200,000 in RSUs and $200,000 in options). The company frames the changes as supporting its "Alnylam P5x25" strategy and its evolution toward a multi-product biotechnology company, but the filing itself offers no quantitative financial impact.

Dec 3, 2025 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2025

Alnylam Pharmaceuticals, Inc. (ALNY) reported a strong third quarter of 2025, showcasing significant revenue growth driven by its TTR franchise, particularly AMVUTTRA, and substantial increases in collaboration revenues, largely due to a significant milestone payment from Roche for the zilebesiran program. Total revenues more than doubled year-over-year for both the quarter and the nine-month period, indicating robust commercial execution and successful strategic partnerships. The company demonstrated substantial progress in its financial position, with a significant increase in cash and cash equivalents, largely due to proceeds from the issuance of new convertible senior notes and strong operating cash flow. Despite increased operating costs and expenses, including higher R&D and SG&A spending to support pipeline advancement and commercial expansion, Alnylam achieved operating income and net income for the quarter, a notable improvement from the prior year's loss. The company also strategically managed its debt by repurchasing a portion of its 2027 convertible notes and issuing new 2028 notes, alongside establishing a new revolving credit facility, enhancing its financial flexibility. Key developments in the pipeline include positive results and initiation of Phase 3 trials for nucresiran and zilebesiran, respectively, alongside continued progress in other key programs. The company's commercial products, particularly AMVUTTRA, are showing strong growth, and collaborations with partners like Roche and Regeneron are contributing significantly to revenue, underscoring Alnylam's strategy of building a multi-product, global biopharmaceutical company.

Oct 30, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Oct 30, 2025)

Alnylam reported third-quarter 2025 results on October 30, 2025 that showed a sharp acceleration in its commercial business. Total revenues were $1.249 billion, up 149% year over year, and total net product revenues were $851 million, up 103% (99% at constant exchange rates). The growth was driven primarily by AMVUTTRA for ATTR-CM, which generated $685 million in Q3 net product revenue, up 165%. Total TTR net product revenues reached $724 million (+135%). Collaboration revenue of $352 million was lifted by a $300 million Roche milestone tied to the first patient dosed in the ZENITH Phase 3 trial of zilebesiran. The company reported GAAP net income of $251 million (diluted EPS $1.84) versus a net loss in Q3 2024, and non-GAAP operating income of $476 million. Note that the quarter's GAAP results include a $300 million one-time milestone and a $39 million loss on convertible debt repurchase, so the underlying profitability trend should be read with that in mind. Alnylam raised its full-year 2025 guidance. Total net product revenues are now expected at $2.95 billion to $3.05 billion (up from $2.65 billion to $2.80 billion), and TTR net product revenues at $2.475 billion to $2.525 billion. The company also reiterated its goal of achieving non-GAAP operating profitability for 2025. Balance sheet activity was significant: Alnylam issued $661 million of 0.00% convertible notes due 2028, repurchased $638 million of its 1.00% notes due 2027, and entered into a $500 million revolving credit facility. Cash and marketable securities totaled $2.7 billion at quarter-end. Investors should also note that the company disclosed a subpoena from the U.S. Attorney's Office for the District of Massachusetts concerning government price reporting for several of its products, including fee and discount arrangements with distributors. The outcome and potential financial impact of that inquiry are not yet known. On the pipeline side, the company began the TRITON-PN Phase 3 trial of nucresiran in hATTR polyneuropathy, with topline results expected in 2028, and the ZENITH Phase 3 cardiovascular outcomes trial of zilebesiran is underway. Regeneron's cemdisiran met its primary endpoint in the Phase 3 NIMBLE trial in generalized myasthenia gravis. Management plans to initiate a Phase 2 trial of mivelsiran in Alzheimer's disease in Q4 2025.

Oct 30, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Oct 3, 2025)

Alnylam Pharmaceuticals, Inc. (ALNY) has announced the execution of a new Credit Agreement, establishing a $500.0 million revolving line of credit set to mature on September 30, 2030. This facility, with a $150.0 million letter of credit sublimit, is intended to support working capital and general corporate purposes. The agreement allows for potential incremental borrowings, subject to customary conditions, and provides flexibility in interest rate options including base rate, Term SOFR, or an alternative currency rate, with margins tied to the Company's Total Leverage Ratio. The credit facility is secured by substantially all of Alnylam's and its material domestic subsidiaries' assets, with guarantees from these subsidiaries. Key financial covenants include maintaining a Total Net Leverage Ratio of no more than 3.75:1.00 (with a potential 0.50:1.00 step-up post-Material Acquisition) and an interest coverage ratio of at least 3.00:1.00. The maturity date could be accelerated under specific conditions related to 'Springing Maturity Debt.' This new credit line provides Alnylam with significant financial flexibility and resources to fund its ongoing operations and strategic initiatives.

Oct 3, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Sep 12, 2025)

Alnylam Pharmaceuticals, Inc. (ALNY) announced the completion of a significant financing event through the issuance of $661.25 million in aggregate principal amount of 0.00% Convertible Senior Notes due 2028. These notes, issued at a substantial premium to the company's stock price, offer flexibility for conversion into Alnylam's common stock under specific conditions, with the company retaining the option to settle conversions in cash, stock, or a combination thereof. The company also strategically entered into capped call transactions, costing approximately $35.3 million, intended to mitigate potential dilution and offset cash outlays associated with note conversions. In conjunction with this offering, Alnylam also repurchased approximately $637.8 million of its existing 1.00% convertible senior notes due 2027 for a total cost of approximately $1,105.8 million. This move indicates a proactive approach to managing its capital structure and debt obligations, potentially reducing future interest expenses and optimizing its financial position. Investors should monitor the conversion rate, potential dilution from stock issuance, and the effectiveness of the capped call strategy.

Sep 12, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Sep 10, 2025)

On September 8, 2025, Alnylam Pharmaceuticals announced a proposed private offering of $500 million of convertible senior notes due 2028 under Rule 144A, and on September 9, 2025 it priced an upsized $575 million offering of 0.00% convertible senior notes due September 15, 2028, with a 13-day option for initial purchasers to buy up to an additional $86.25 million. The notes carry no regular interest and do not accrete, and the initial conversion price is approximately $670.11 per share, a roughly 40% premium to the $478.6327 VWAP on September 9, 2025. Net proceeds are estimated at about $561.6 million, or about $645.9 million if the option is exercised in full. The offering is expected to close September 12, 2025. A central feature of the transaction is the use of proceeds: Alnylam is using approximately $30.7 million to fund capped call transactions (cap price of about $837.61 per share, a 75% premium to the reference VWAP) and is applying the remainder, together with cash on hand, to repurchase about $637.8 million of its 1.00% convertible senior notes due 2027 for a total cost of about $1,105.8 million including accrued interest. Those repurchases were negotiated with certain existing noteholders, and hedged holders are expected to unwind equity hedges by buying common stock or entering into derivative transactions, which could push the share price up and raise the effective conversion price of the new notes. For investors, the transaction swaps expensive 1.00% debt maturing in 2027 for zero-coupon debt maturing in 2028 with a lower cash interest burden, while adding dilution protection through the capped calls and a meaningful conversion premium. Investors should weigh the potential dilution if the notes convert, the cash cost of the repurchase and capped calls, the 2028 maturity and redemption features, and the near-term share price effects from hedging activity, as described in the filing.

Sep 10, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Jul 31, 2025)

Alnylam Pharmaceuticals reported second quarter 2025 results on July 31, 2025, showing a strong commercial inflection driven by the first full quarter of AMVUTTRA sales in ATTR-CM. Total net product revenues rose 64% year-over-year to $672 million, and total TTR net product revenues reached $544 million (up 77%), with AMVUTTRA contributing $492 million (up 114%) while ONPATTRO declined 32% as patients switched to AMVUTTRA. Total revenues grew 17% to $774 million, though collaboration revenue fell 73% to $61 million because Q2 2024 included $185 million of Regeneron revenue tied to a one-time license modification. Rare disease products (GIVLAARI and OXLUMO) grew 24% to $128 million. Profitability remained mixed. GAAP operating results swung to a loss of $16 million from income of $49 million a year earlier, while non-GAAP operating income fell 31% to $95 million. GAAP net loss was $66 million ($0.51 per share) versus a $17 million loss in the prior-year quarter, driven by higher SG&A (up 30%), R&D (up 10%), and cost of goods sold (up 111%), along with a $31 million tax provision and $40 million of interest expense, including accretion on the Leqvio royalty liability. Stock-based compensation of $112 million was a significant contributor to the GAAP-to-non-GAAP gap. Cash, cash equivalents and marketable securities rose to $2.86 billion from $2.63 billion in the prior quarter. Management raised full-year 2025 guidance meaningfully: total net product revenues are now expected at $2.65-$2.80 billion (up from $2.05-$2.25 billion, roughly a 27% increase at the midpoint), with TTR revenues at $2.175-$2.275 billion. Management reiterated collaboration and royalty revenue guidance, non-GAAP operating expense guidance, and the goal of achieving non-GAAP operating profitability, while GAAP R&D and SG&A guidance was increased to $2.445-$2.575 billion, mainly reflecting higher stock-based compensation. Investors will be watching whether AMVUTTRA ATTR-CM uptake continues at its early pace and whether the company converts that growth into sustained profitability.

Jul 31, 2025 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2025

Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the six months ended June 30, 2025, up 19% year-over-year to $1.37 billion. This growth was primarily driven by a substantial 47% increase in net product revenues, reaching $1.14 billion, largely attributable to the strong performance of AMVUTTRA, particularly in the treatment of ATTR amyloidosis with cardiomyopathy. ONPATTRO saw a decline in revenue, likely due to patient switching to AMVUTTRA. Conversely, collaboration revenues decreased by 54% to $160.7 million, mainly due to the recognition of a large milestone payment in the prior year's comparable period for the Regeneron collaboration, partially offset by a payment from Vir Biotechnology. Despite revenue growth, the company reported a net loss of $123.8 million for the six months, a widening from the $82.8 million loss in the same period of 2024. This increase in net loss, despite higher revenues, is due to a significant rise in operating costs and expenses, which grew by 19% to $1.37 billion, outpacing revenue growth. The company's balance sheet shows a healthy cash position of $1.11 billion as of June 30, 2025, providing sufficient liquidity for at least the next 12 months. The increase in cash is supported by strong net cash provided by operating activities, which, despite a decrease from the prior year, remains positive at $35.4 million. However, the company continues to incur substantial R&D and SG&A expenses, reflecting ongoing investments in pipeline development and commercialization efforts. The ongoing patent litigation with Moderna and Pfizer remains a notable contingent liability, with recent rulings unfavorable to Alnylam, although the financial impact is not yet quantifiable.

Jul 31, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Jun 18, 2025)

Alnylam Pharmaceuticals (ALNY) filed an 8-K on June 18, 2025 disclosing an internal reorganization of its R&D function. The Research and Early Development group and the Development group are being combined into a single R&D organization. Pushkal Garg, M.D., the current Chief Medical Officer and EVP, Development and Medical Affairs, is being promoted to Executive Vice President, Chief Research and Development Officer, and will oversee the integrated organization. Kevin Fitzgerald, Ph.D., the current EVP, Chief Scientific Officer and Head of Research and Early Development, has his responsibilities expanded to include external innovation. The filing and accompanying press release frame the change as a way to accelerate pipeline progress through earlier cross-functional collaboration and faster decision-making, following the launch of AMVUTTRA in ATTR-CM. From a compensation standpoint, the Committee approved several changes. Dr. Garg's base salary is set at $825,000 with a 65% target annual incentive, and his long-term incentive award will be set at a later date. Dr. Fitzgerald's target annual incentive rises to 60% of base salary, and he receives a one-time RSU grant with a $2.5 million grant-date value, effective July 1, 2025, vesting in three equal annual installments. These amounts are modest relative to typical large-cap biotech executive packages, and the RSU grant is the most notable retention-oriented element. For investors, the key takeaways are that this is an organizational and leadership change rather than a financial or clinical disclosure, with no new pipeline data, guidance, or financial results included. The stated goal of delivering RNAi therapeutics to all major tissues by 2030 signals management's long-term ambition, which investors may track against future pipeline and execution updates.

Jun 18, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Bylaw Amendment (May 13, 2025)

This Form 8-K filing from Alnylam Pharmaceuticals, Inc. details the outcomes of their 2025 Annual Meeting of Stockholders held on May 8, 2025. Key to investors is the stockholder approval and subsequent filing of an amendment to the Company's Certificate of Incorporation to allow for officer exculpation. This change aims to further protect the company's officers from certain liabilities, a common governance enhancement. Additionally, the filing reports on the re-election of four Class III directors, the approval of the Second Amended and Restated 2018 Stock Incentive Plan, and the ratification of PricewaterhouseCoopers LLP as the independent auditor for fiscal year 2025. The approval of executive compensation in a non-binding advisory vote also indicates stockholder sentiment on executive remuneration. These outcomes generally reflect stable corporate governance and continued investor confidence in the company's leadership and operational structure. The re-election of directors and approval of incentive plans suggest a continuity in strategy and management oversight. The focus on officer exculpation, while a governance matter, is often viewed positively by management and potentially by investors as it can aid in attracting and retaining qualified leadership by mitigating personal financial risk related to their service. The ratification of the auditor also signals confidence in the company's financial reporting processes.

May 13, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Exhibit Filing (May 1, 2025)

Alnylam Pharmaceuticals reported first quarter 2025 results on May 1, 2025, led by strong commercial momentum in its transthyretin (TTR) franchise. Global net product revenues reached $469 million, up 28% year over year (30% at constant exchange rates), driven by AMVUTTRA, which generated $310 million, up from prior periods on increased patient demand. Total revenues were $594 million, up 20%. Total TTR net product revenues rose 36% to $359 million, while Total Rare revenues grew 8% to $109 million. The company also reported its first quarter GAAP income from operations of $18 million, compared with a loss of $43 million a year earlier, and non-GAAP operating income of $75 million. GAAP net loss narrowed to $57 million, or $0.44 per share, from $66 million, or $0.52 per share. The quarter was marked by U.S. FDA approval of AMVUTTRA for ATTR-CM (cardiomyopathy of transthyretin-mediated amyloidosis), an important expansion of the franchise, and by Sanofi's FDA approval of Qfitlia (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in the U.S. Management reiterated full-year 2025 guidance of $2.05 billion to $2.25 billion in combined net product revenues and expects to achieve non-GAAP operating profitability for the year. Collaboration revenue declined 16% to $99 million because a $65 million Roche milestone recognized in the prior-year period did not recur, partially offset by Regeneron growth and a $30 million Vir Biotechnology payment. The balance sheet remains substantial but carries significant obligations. Cash, cash equivalents and marketable securities totaled $2.63 billion at March 31, 2025, down from $2.69 billion at year-end 2024, primarily due to operating cash use. Other expense included a $58.9 million non-cash charge from the fair value change of the development derivative liability, which management attributed to the ATTR-CM approval. Total stockholders' equity improved to $115 million from $67 million, and the company continues to carry large liabilities tied to the Leqvio royalty sale and its development derivative.

May 1, 2025 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2025

Alnylam Pharmaceuticals, Inc. reported solid top-line growth for the first quarter of 2025, with total revenues increasing by 20% year-over-year to $594.2 million. This growth was primarily driven by a significant 28% increase in net product revenues, reaching $468.5 million, largely due to strong performance from AMVUTTRA, which saw a 59% increase in total sales across regions. ONPATTRO's sales declined by 29%, attributed to patient switching to AMVUTTRA. While collaboration revenues decreased by 16% mainly due to a large milestone payment received in the prior year from the Roche collaboration, royalty revenue saw a substantial 149% increase, driven by higher royalties from Leqvio. The company narrowed its net loss to $57.5 million from $65.9 million in the prior year's first quarter, indicating progress towards profitability, although significant R&D and SG&A expenses continue to weigh on the bottom line. The company ended the quarter with a robust cash and cash equivalents balance of over $1 billion, providing ample liquidity.

May 1, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Mar 21, 2025)

On March 20, 2025, Alnylam Pharmaceuticals (Nasdaq: ALNY) announced that the U.S. FDA approved a supplemental New Drug Application for AMVUTTRA (vutrisiran) to treat the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults, reducing cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits. The approval is a significant commercial and clinical milestone: AMVUTTRA becomes the first and only FDA-approved therapy for both ATTR-CM and hATTR polyneuropathy (hATTR-PN), substantially expanding its addressable U.S. market. The company estimates ATTR-CM affects roughly 150,000 people in the U.S. and over 300,000 worldwide, a population that is largely undiagnosed and untreated, which suggests a large opportunity for growth. The approval is based on the Phase 3 HELIOS-B trial, which met all 10 pre-specified primary and secondary endpoints. In the overall population, AMVUTTRA reduced the risk of all-cause mortality and recurrent cardiovascular events by 28% over up to 36 months of double-blind treatment, and reduced mortality by 36% through 42 months in a secondary analysis. The monotherapy subgroup showed a 33% risk reduction in the double-blind period and a 35% mortality reduction through 42 months. The company reported no new safety concerns in HELIOS-B; the safety profile is drawn from the hATTR-PN experience, with the most common adverse reactions being pain in extremity (15%), arthralgia (11%), dyspnea (7%), and decreased vitamin A (7%). The label requires vitamin A supplementation at the recommended daily allowance. For investors, the key considerations are commercial execution and payer dynamics. Management expects broad coverage and mostly $0 out-of-pocket costs for ATTR-CM patients, based on the ~99% insurer coverage and majority $0 out-of-pocket experience in hATTR-PN. Marketing applications based on HELIOS-B are under review at the EMA, ANVISA, and PMDA, with additional global submissions planned for 2025. This filing is an Item 8.01 disclosure of the press release, and it contains no financial statements or quantitative financial guidance.

Mar 21, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Mar 5, 2025)

Alnylam Pharmaceuticals (ALNY) disclosed in this 8-K, filed March 5, 2025, that director Phillip A. Sharp, Ph.D., co-founder of the company and a 1993 Nobel laureate, will retire from the Board of Directors effective May 8, 2025. The filing states the retirement was not caused by any disagreement with the company on operations, policies, or practices, which is a standard but important confirmation for investors. Dr. Sharp will continue as a member of the Company's Scientific Advisory Board, so his scientific involvement with the company is retained. The event is a board-level governance change rather than a financial or operational one. The filing contains no financial results, guidance, pipeline updates, or compensatory arrangements, and no replacement director is named. Management and board commentary in the attached press release focuses on Dr. Sharp's historical contributions to RNAi science and the company's founding, with CEO Yvonne Greenstreet and Board Chair Amy W. Schulman praising his role. For investors, the materiality is low. The retirement reflects the planned transition of a long-tenured founder-scientist off the board, and the continued advisory role limits any loss of scientific expertise. Investors may wish to watch for the company's announcement of any new board appointments or changes to board composition, though the filing itself does not indicate any such plans.

Mar 5, 2025 10-K

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2024

Alnylam Pharmaceuticals (ALNY) enters 2025 as a commercial-stage RNAi company with five approved products and a stated goal of becoming a self-sustainable, top-tier biotech by the end of 2025 under its Alnylam P5x25 strategy. FY2024 total revenues rose 23% to $2.25 billion, driven by net product revenues of $1.65 billion (up 33%), led by AMVUTTRA at $970.5 million (up 74%). ONPATTRO declined 29% to $252.9 million as patients switched to AMVUTTRA, while GIVLAARI ($255.9 million) and OXLUMO ($167.1 million) grew. Collaboration revenue fell 7% to $510.2 million, largely because of a one-time Roche license recognition in 2023, and royalty revenue more than doubled to $91.8 million on Leqvio sales by Novartis. Profitability improved sharply but the company remains unprofitable. The net loss narrowed to $278.2 million from $440.2 million, helped by a $99.2 million tax benefit from releasing a Swiss valuation allowance, and operating loss narrowed to $176.9 million. Operating cash flow was roughly breakeven at negative $8.3 million, and cash, equivalents and marketable securities reached $2.69 billion against $1.04 billion of 1% convertible notes due 2027 and a $1.45 billion liability related to the Blackstone royalty sale. Management believes existing cash supports operations for at least 12 months and expects to reach self-sustainability by end-2025 without equity financing, though that depends on product and royalty growth. Key near-term catalysts and risks include the March 23, 2025 PDUFA date for AMVUTTRA in ATTR cardiomyopathy following positive HELIOS-B data, the March 28, 2025 PDUFA for Sanofi's fitusiran, a July 2025 trial date in the Pfizer/BioNTech patent litigation, and a new University of Texas patent suit against ONPATTRO. Heavy reliance on collaborators, a 2023 FDA CRL for patisiran in ATTR-CM, and a Blackstone royalty step-up risk if Leqvio sales lag are also material.

Feb 13, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Exhibit Filing (Feb 13, 2025)

Alnylam Pharmaceuticals reported strong fourth quarter and full year 2024 results, with global net product revenues of $451 million in Q4 (up 30% year over year) and $1,646 million for the full year (up 33%). Growth was driven primarily by AMVUTTRA, whose sales rose to $970 million for 2024 from $558 million in 2023, partially offset by an expected decline in ONPATTRO as patients switch to AMVUTTRA. The company reported a full-year GAAP net loss of $278 million, narrowing from $440 million in 2023, and a non-GAAP operating income of $95 million for the year, compared with a non-GAAP operating loss of $60 million in 2023. Q4 non-GAAP operating loss narrowed to $14 million, and the company reiterated its goal of achieving non-GAAP profitability in 2025. The most important near-term catalyst is the March 23, 2025 PDUFA date for the supplemental NDA for vutrisiran (AMVUTTRA) in ATTR amyloidosis with cardiomyopathy (ATTR-CM), which was filed using a Priority Review Voucher. Management's 2025 guidance assumes approval by that date. Management guided to 2025 total net product revenues of $2.05 billion to $2.25 billion (25% to 37% growth at currency rates as of December 31, 2024), with collaboration and royalty revenues of $650 million to $750 million. That guidance includes a $300 million milestone from Roche tied to initiation of a Phase 3 cardiovascular outcomes trial for zilebesiran, and royalties from Sanofi's fitusiran, which has a March 28, 2025 PDUFA date. The balance sheet strengthened, with cash, cash equivalents and marketable securities of $2.69 billion at year-end 2024, up from $2.44 billion a year earlier. Total stockholders' equity moved to a positive $67 million from a deficit of $221 million. Investors should note that 2024 collaboration revenue declined by $36 million year over year because 2023 included a $310 million upfront from Roche, and that Q4 GAAP results were affected by elevated stock-based compensation and higher royalty rates payable on AMVUTTRA sales. The company will also host an R&D Day on February 25, 2025.

Feb 13, 2025 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Jan 13, 2025)

Alnylam Pharmaceuticals (ALNY) furnished a Form 8-K on January 12, 2025 (Item 2.02, Exhibit 99.1) announcing preliminary unaudited fourth quarter and full year 2024 global net product revenues. Full year 2024 net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO were approximately $1,646 million, up 33% year over year and at the high end of the company's revised guidance range. Fourth quarter net product revenues were approximately $451 million. Growth was led by the Total TTR franchise (ONPATTRO and AMVUTTRA), which rose 34% for the year to about $1,223 million, while the Total Rare franchise (GIVLAARI and OXLUMO) grew 29% to about $423 million. The more consequential disclosure is forward-looking guidance. Alnylam guided 2025 combined net product revenues of $2,050 million to $2,250 million, implying roughly 31% growth at the midpoint, and expects to reach non-GAAP operating income profitability in 2025. The TTR guidance of $1,600 million to $1,725 million depends heavily on the expected U.S. launch of AMVUTTRA for ATTR-CM, with the PDUFA target action date of March 23, 2025. Investors should note that the guidance explicitly assumes FDA approval by that date, so a delay or refusal would materially affect the outlook. Collaboration and royalty revenue and operating expense guidance were deferred to the fourth quarter and full year 2024 earnings release. The release also laid out 2025 pipeline milestones, including a Phase 3 start for nucresiran, KARDIA-3 Phase 2 results for zilebesiran, interim Phase 1 data and a Phase 2 start for mivelsiran, and a Phase 2 start for ALN-6400. Partner-led catalysts include Sanofi's fitusiran PDUFA date of March 28, 2025. All financial figures are preliminary, unaudited and subject to adjustment ahead of the February 2025 full results. The information is furnished under Item 2.02 and is not deemed filed for Exchange Act liability purposes.

Jan 13, 2025 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2024

Alnylam Pharmaceuticals, Inc. (ALNY) reported a net loss of $111.6 million for the third quarter of 2024, compared to a net income of $147.8 million in the same period last year. This shift is largely due to a significant decrease in collaboration revenues, primarily from the Roche collaboration, which included a substantial upfront payment recognized in Q3 2023. Despite the net loss, product revenues saw robust growth, increasing by 34% year-over-year to $420.1 million, driven by strong performance from AMVUTTRA and growth in GIVLAARI and OXLUMO, partially offset by a decline in ONPATTRO sales. For the nine months ended September 30, 2024, Alnylam reported a net loss of $194.4 million, an improvement from the $302.4 million net loss in the prior year period. Total revenues increased by 19% to $1.66 billion, with net product revenues up 34% to $1.20 billion. However, the company's operating costs and expenses also rose by 11% to $1.73 billion. The company ended the quarter with a strong cash position of $1.10 billion, providing ample liquidity for at least the next 12 months. Management remains focused on advancing its pipeline, with key submissions for AMVUTTRA in cardiomyopathy and positive interim results for mivelsiran in Alzheimer's disease.

Oct 31, 2024 8-K

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

Alnylam Pharmaceuticals reported third quarter 2024 results on October 31, 2024, led by global net product revenues of $420.1 million, 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 million, 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 million 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 billion 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.

Oct 31, 2024 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Exhibit Filing (Aug 1, 2024)

Alnylam Pharmaceuticals reported second quarter 2024 results on August 1, 2024, led by strong commercial execution in its TTR franchise. Global net product revenues reached $410 million, up 34% year over year (35% at constant exchange rates), with AMVUTTRA growing 74% to $230 million and total TTR revenues rising 37% to $307 million. Rare disease products (GIVLAARI and OXLUMO) grew 25% to $103 million. Total revenues were $660 million, but this figure was inflated by roughly $185 million of previously deferred collaboration revenue recognized upon the amended Regeneron agreement, so the headline top line overstates underlying run-rate growth. Profitability improved markedly. GAAP operating income was $48.6 million versus a loss of $229.8 million a year earlier, and GAAP net loss narrowed to $16.9 million ($0.13 per share) from $276.0 million ($2.21 per share). Non-GAAP net income was $73.8 million ($0.56 per diluted share). Cost of goods sold fell to 16.4% of net product revenues from 24.6%. Operating expenses rose, with GAAP R&D up 18% and GAAP SG&A up 16%, reflecting clinical startup costs for zilebesiran and mivelsiran, higher TTR marketing spend, and higher stock-based compensation. Cash, cash equivalents and marketable securities totaled $2.62 billion at June 30, 2024. The most consequential development is positive topline data from the HELIOS-B Phase 3 study of vutrisiran in ATTR cardiomyopathy, which met its primary endpoint with a 28% reduction in the composite of all-cause mortality and recurrent cardiovascular events (33% in the monotherapy population) and a 35-36% reduction in all-cause mortality. Management raised full-year 2024 combined net product revenue guidance to $1.575-1.650 billion from $1.400-1.500 billion. Investors should note that the revenue guidance raise is driven by the strong AMVUTTRA trajectory, while full data from HELIOS-B are not yet available and the cardiomyopathy indication is not approved.

Aug 1, 2024 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2024

Alnylam Pharmaceuticals, Inc. reported robust top-line growth in its second quarter of 2024, with total revenues increasing by 107% year-over-year to $659.8 million. This surge was primarily driven by a significant increase in net product revenues, which rose by 34% to $410.1 million, led by strong performance from AMVUTTRA. Collaboration revenues also saw a substantial increase, growing from $5.8 million in the prior year period to $227.3 million, largely due to the amended collaboration agreement with Regeneron Pharmaceuticals and milestone achievements with Roche. Despite the strong revenue growth, the company reported a net loss of $16.9 million for the quarter, an improvement from the $276.0 million net loss in the second quarter of 2023. This improved net loss reflects the significant increase in revenue and a more favorable cost of goods sold as a percentage of net product revenues. Research and development expenses increased by 18% year-over-year, reflecting ongoing investments in pipeline expansion, particularly for zilebesiran and mivelsiran. The company maintains a strong liquidity position with $971.2 million in cash, cash equivalents, and restricted cash as of June 30, 2024, which management believes is sufficient to meet operating needs for at least the next 12 months.

Aug 1, 2024 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Shareholder Vote Results (May 20, 2024)

Alnylam Pharmaceuticals, Inc. (ALNY) held its 2024 Annual Meeting of Stockholders on May 16, 2024, with a filing on May 20, 2024, detailing the outcomes of key votes. The meeting saw the overwhelming re-election of four Class II directors: Dennis A. Ausiello, M.D., Olivier Brandicourt, M.D., Peter N. Kellogg, and David E.I. Pyott, each receiving substantial support from shareholders to serve until the 2027 annual meeting. This demonstrates continued confidence in the board's leadership and strategic direction. Furthermore, Alnylam's stockholders overwhelmingly approved the compensation of the company's named executive officers in a non-binding advisory vote, indicating shareholder alignment with the company's executive compensation policies. The appointment of PricewaterhouseCoopers LLP as the independent auditor for the fiscal year ending December 31, 2024, was also overwhelmingly ratified, reinforcing the company's commitment to robust financial oversight and transparent reporting. The strong voting results across these critical matters suggest a stable and supportive shareholder base.

May 20, 2024 8-K

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

Alnylam Pharmaceuticals reported first quarter 2024 results on May 2, 2024, led by strong commercial execution. Global net product revenues reached $365.2 million, 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 million 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 million 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 billion 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.

May 2, 2024 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2024

Alnylam Pharmaceuticals, Inc. reported a substantial increase in total revenues for the first quarter of 2024, driven by strong performance in both net product revenues and collaboration revenues. Net product revenues saw a 32% increase year-over-year, primarily fueled by the robust growth of AMVUTTRA, alongside continued strength from GIVLAARI and OXLUMO. Collaboration revenues more than doubled, largely due to revenue recognized from the Roche collaboration, including a significant milestone payment related to the zilebesiran program, and increased activity with Regeneron. Despite the revenue growth, the company reported a net loss of $65.9 million, an improvement from the previous year's loss of $174.1 million, indicating progress in narrowing the operational loss. Research and development expenses increased by 13%, reflecting continued investment in pipeline advancement, particularly for zilebesiran and the HELIOS-B study. Selling, general, and administrative expenses also rose, driven by marketing investments and headcount growth. The company's liquidity remains strong, with cash, cash equivalents, and marketable securities sufficient for at least the next 12 months, according to management.

May 2, 2024 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Mar 4, 2024)

This 8-K filing from Alnylam Pharmaceuticals, Inc. details the separation of its former Executive Vice President, Chief Legal Officer, and Secretary, Indrani L. Franchini, effective March 1, 2024. The company has entered into a separation and release agreement with Ms. Franchini, outlining the terms of her departure and ongoing engagement as a consultant. This agreement is significant for investors as it clarifies the financial and operational implications of a key executive's exit.

Mar 4, 2024 10-K

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2023

Alnylam Pharmaceuticals, Inc. (ALNY) reported its 2023 financial and operational results, showcasing significant revenue growth driven by its expanding portfolio of RNAi therapeutics. The company's net product revenues reached $1.24 billion, up 39% year-over-year, primarily due to the strong performance of AMVUTTRA and continued growth in GIVLAARI and OXLUMO, partially offset by a decline in ONPATTRO sales as patients transitioned to AMVUTTRA. Collaboration revenues also saw a substantial increase, largely from the new agreement with Roche for zilebesiran and increased royalties from Novartis on Leqvio. Alnylam continues to invest heavily in research and development, with expenses increasing by 14% to $1.0 billion, reflecting progress in its pipeline, including the development of zilebesiran for hypertension and ALN-APP for Alzheimer's disease. The company ended the year with $2.44 billion in cash, cash equivalents, and marketable securities, providing a solid liquidity position. Despite a net loss of $440 million, Alnylam is progressing towards its P5x25 strategic goals, aiming for profitability and a leading biotech profile by the end of 2025.

Feb 15, 2024 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Feb 15, 2024)

Alnylam Pharmaceuticals reported fourth quarter and full year 2023 results on February 15, 2024, highlighted by full-year global net product revenues of $1,241 million, up 39% year over year. Growth was driven by the TTR franchise, where total net product revenues rose 40% to $912 million, led by AMVUTTRA ($558 million, up from $94 million in 2022 after its mid-2022 launch) and partly offset by ONPATTRO, which declined to $355 million from $558 million. The Ultra-Rare franchise (GIVLAARI and OXLUMO) grew 35% to $329 million combined. Full-year net revenues from collaborations surged to $546 million from $135 million, largely reflecting the Roche zilebesiran collaboration executed in July 2023, which included a $310 million upfront payment, and Novartis milestone revenue. Profitability improved at the operating line but the company remained loss-making. GAAP operating loss narrowed to $282 million from $785 million in 2022, and GAAP net loss improved to $440 million ($3.52 per share) from $1,131 million ($9.30 per share). Non-GAAP operating loss was $60 million for the year, compared with $554 million in 2022. Cost of goods sold rose to 21.6% of net product revenues from 15.7%, reflecting AMVUTTRA royalty tiers and inventory write-downs tied to ONPATTRO's unapproved cardiomyopathy indication. Cash, cash equivalents and marketable securities ended 2023 at $2.44 billion, up from $2.19 billion, supported by the Roche upfront payment, a $100 million Regeneron milestone, and roughly $150 million from employee option exercises. Looking ahead, management guided to 2024 combined net product revenues of $1.40 billion to $1.50 billion (13% to 21% growth), collaboration and royalty revenue of $325 million to $425 million, and GAAP R&D plus SG&A expenses of $1.90 billion to $2.05 billion. Key catalysts include topline results from the HELIOS-B Phase 3 study of vutrisiran in late June or early July 2024 (with an updated statistical analysis plan) and the KARDIA-2 Phase 2 zilebesiran data at ACC in April 2024. Investors should note that the company still reported a GAAP net loss and a stockholders' deficit of $221 million at year end, and that much of the 2023 revenue step-up was from one-time collaboration payments.

Feb 15, 2024 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Jan 19, 2024)

This 8-K filing from Alnylam Pharmaceuticals, Inc. announces the upcoming departure of its Executive Vice President, Chief Legal Officer, and Secretary, Indrani L. Franchini, effective March 1, 2024. Ms. Franchini will transition from her role, and a formal separation agreement outlining severance and transition terms is expected to be finalized by her Separation Date. Investors should monitor future filings for details on the successor and any impact on the company's legal and corporate governance functions. While this filing primarily pertains to an executive departure, it's important for investors to note that significant leadership changes can sometimes signal shifts in strategy or internal focus. However, the provided details are limited, and no immediate operational or financial impacts are detailed within this specific report. The filing also includes standard exhibit information.

Jan 19, 2024 8-K

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

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 million 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 million 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.

Jan 8, 2024 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Nov 2, 2023)

Alnylam Pharmaceuticals reported third quarter 2023 results on November 2, 2023, led by net product revenues of $313.2 million, up 35% year over year (33% at constant exchange rates). Growth was driven by the launch of AMVUTTRA (vutrisiran), which generated $148.7 million in the quarter, while ONPATTRO fell 44% to $81.6 million as patients switched to AMVUTTRA. GIVLAARI ($54.1 million, +19%) and OXLUMO ($28.7 million, +75%) also contributed. Total revenues were $750.5 million, boosted by $427.5 million in collaboration revenue, including $310 million of Roche's upfront payment for zilebesiran and $65 million from a cumulative adjustment tied to the $100 million Regeneron ALN-APP milestone. GAAP operating income was $213.9 million and GAAP net income was $147.8 million ($1.15 per diluted share), compared with GAAP losses in the prior-year quarter. Non-GAAP net income was $228.5 million ($1.74 per diluted share). The most important negative item is that the FDA issued a Complete Response Letter for the supplemental NDA for patisiran (ONPATTRO) in the treatment of ATTR cardiomyopathy. This led to an inventory impairment that pushed cost of goods sold to 25.4% of net product revenues, up from 15.7% a year earlier. Management said it remains on track for HELIOS-B Phase 3 topline data for vutrisiran in cardiomyopathy in early 2024. Full-year 2023 net product revenue guidance of $1,200 million to $1,285 million was reiterated, while collaboration and royalty revenue guidance was raised to $575 million to $625 million from $100 million to $175 million. Balance sheet liquidity improved, with cash, cash equivalents and marketable securities of $2.41 billion at September 30, 2023, up from $2.19 billion at year-end 2022, mainly due to the Roche upfront payment. The company still carries a stockholders' deficit of $165.9 million and total liabilities of $4.0 billion, including $1.0 billion of convertible debt and $1.3 billion of liabilities related to the sale of future royalties. Management also highlighted KARDIA-1 Phase 2 positive topline results for zilebesiran, an upcoming AHA late-breaker presentation on November 11, 2023, and an R&D Day on December 13, 2023.

Nov 2, 2023 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2023

Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the third quarter and first nine months of 2023, driven by strong growth in net product revenues and substantial collaboration revenues, particularly from the new Roche agreement and an early clinical milestone from Regeneron. Net product revenues saw a notable increase of 35% year-over-year in Q3, primarily due to the launch and uptake of AMVUTTRA, offsetting a decline in ONPATTRO sales as patients switched to the newer therapy. The company also reported positive momentum across its other key products, GIVLAARI and OXLUMO. Operationally, the company's focus remains on advancing its pipeline, with significant R&D expenses supporting various clinical programs. Despite an increase in Cost of Goods Sold, largely due to an inventory impairment related to ONPATTRO's ATTR cardiomyopathy indication, the company achieved a net income of $147.8 million in Q3 2023, a significant turnaround from a net loss in the prior year's quarter. This improved profitability reflects the substantial collaboration revenue and disciplined expense management. The company maintains sufficient liquidity and believes its current cash and cash equivalents will support operations for at least the next 12 months.

Nov 2, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Oct 10, 2023)

On October 9, 2023, Alnylam Pharmaceuticals (ALNY) disclosed in a Form 8-K that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) seeking an expanded indication for patisiran (ONPATTRO) in the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. The FDA stated that the clinical meaningfulness of patisiran's effects in this population had not been established, and that the sNDA could not be approved in its present form. The agency identified no issues with clinical safety, study conduct, drug quality, or manufacturing. As a result, Alnylam will no longer pursue a U.S. expanded indication for patisiran in cardiomyopathy. The CRL does not affect the existing approved indication of ONPATTRO for hereditary ATTR polyneuropathy in adults, which remains commercially available. The company will continue to supply patisiran to patients in the APOLLO-B open-label extension and the U.S. expanded access protocol. This decision came despite a September 13, 2023 FDA Cardiovascular and Renal Drugs Advisory Committee vote of 9 to 3 that patisiran's benefits outweigh its risks for this use. The company's pipeline focus shifts to vutrisiran (AMVUTTRA), a quarterly subcutaneous RNAi therapeutic being evaluated in the HELIOS-B Phase 3 study for ATTR cardiomyopathy, with topline results expected in early 2024, and to ALN-TTRsc04, an annual-dosing candidate using the IKARIA platform. For investors, the key question is whether HELIOS-B can support a cardiomyopathy label for vutrisiran, which would be the main near-term catalyst for the franchise.

Oct 10, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Executive Changes (Sep 28, 2023)

Alnylam Pharmaceuticals, Inc. (ALNY) has reported a change in its Board of Directors structure. Marsha H. Fanucci will be resigning from the Board effective September 29, 2023. This departure is explicitly stated as not being due to any disagreements regarding the company's operations, policies, or practices, which suggests a smooth transition. Following Ms. Fanucci's resignation, Peter N. Kellogg is set to assume the role of Chair of the Audit Committee. The Board has confirmed Mr. Kellogg's qualification as an "audit committee financial expert," a key designation for financial oversight. Concurrently, the size of the Board will be reduced from thirteen to twelve members. These changes, while administrative, are important for investors to note regarding board composition and audit committee leadership.

Sep 28, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Aug 3, 2023)

Alnylam Pharmaceuticals reported Q2 2023 results on August 3, 2023, led by strong commercial execution. Global net product revenues reached $305.7 million, up 43% year over year (44% at constant exchange rates), driven by the launch of AMVUTTRA (vutrisiran), which generated $132.1 million in the quarter. Total TTR product revenue grew 46%, and U.S. TTR growth accelerated to 72%, the fourth consecutive quarter above 70%. Ultra-rare products GIVLAARI and OXLUMO grew 28% and 62%, respectively. Profitability remains distant: GAAP net loss was $276.0 million ($2.21 per share), and non-GAAP net loss was $201.6 million. Cash, cash equivalents and marketable securities declined to $2.06 billion from $2.19 billion at year-end 2022, and total stockholders' deficit widened to $(408) million. Management reiterated full-year 2023 combined net product revenue guidance of $1,200 million to $1,285 million, which assumes FDA approval of patisiran for ATTR cardiomyopathy by the October 8, 2023 PDUFA date. Key pipeline and business developments include a global strategic collaboration with Roche to co-develop and co-commercialize zilebesiran, an FDA advisory committee meeting for patisiran's cardiomyopathy sNDA set for September 13, 2023, and closure of a U.S. Attorney's Office investigation into ONPATTRO marketing with no action taken. The company also disclosed that President Akshay Vaishnaw will transition to a part-time Chief Innovation Officer role effective October 2, 2023, with a base salary of $377,000 and no longer serving as an officer. Investors should weigh the strong revenue momentum and pending regulatory catalysts against continued heavy operating losses, rising cost of goods sold as a percentage of revenue, and a balance sheet carrying substantial debt and royalty-sale liabilities.

Aug 3, 2023 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2023

Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the second quarter of 2023, reaching $318.8 million, a 42% increase year-over-year, primarily driven by strong net product revenues. Net product revenues surged by 43% to $305.7 million, largely due to the successful launch and uptake of AMVUTTRA, alongside continued growth from GIVLAARI and OXLUMO. ONPATTRO revenue saw a decline, attributed to patient switches to AMVUTTRA. Collaboration revenues experienced a decrease, mainly due to revised assumptions for the Regeneron collaboration, while royalty revenue from Leqvio significantly increased. Despite revenue growth, the company reported a net loss of $276.0 million for the quarter, reflecting ongoing substantial investments in research and development and selling, general, and administrative expenses. The company's cash position remains robust, providing at least 12 months of operating runway.

Aug 3, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Material Agreement (Jul 26, 2023)

On July 21, 2023, Alnylam Pharmaceuticals entered into a worldwide Collaboration and License Agreement with Roche (F. Hoffmann-La Roche Ltd. and Genentech) for zilebesiran, its Phase 2 siRNA therapy targeting angiotensinogen (AGT) for hypertension. Roche pays an upfront payment of $310 million, and Alnylam is eligible for up to $2.5 billion in contingent development, regulatory, and sales-based milestones. The press release describes a potential total deal value of up to $2.8 billion, which includes the upfront payment. The structure splits economics by geography. Alnylam and Roche co-commercialize zilebesiran in the U.S. (the Shared Territory) with 50/50 sharing of profits, losses, and commercialization costs. Roche holds exclusive rights outside the U.S. and pays Alnylam tiered, low double-digit royalties on net sales. Alnylam leads the global development plan for the first indication, including a cardiovascular outcomes trial, and bears 40% of development costs that support regulatory approval in both territories, with Roche covering 60%. Alnylam also remains solely responsible for costs of clinical trials ongoing as of the Effective Date. For investors, the deal provides non-dilutive capital and shifts a meaningful share of late-stage development and ex-U.S. commercialization costs to Roche, while Alnylam retains U.S. economics and ex-U.S. royalties. Roche can terminate on specified events, and the milestone and royalty figures are contingent on successful development, so realized value depends on clinical and regulatory outcomes. The full agreement is not attached and is expected to be filed as an exhibit to the Q3 2023 Form 10-Q.

Jul 26, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Corporate Update (Jun 30, 2023)

On June 30, 2023, Alnylam Pharmaceuticals (ALNY) filed an 8-K disclosing that the U.S. FDA has scheduled a September 13, 2023 meeting of its Cardiovascular and Renal Drugs Advisory Committee to review the company's supplemental New Drug Application for ONPATTRO (patisiran) as a potential treatment for the cardiomyopathy of transthyretin-mediated (ATTR) amyloidosis. The filing is an informational Item 8.01 disclosure rather than a financial report, and it contains no new financial results, guidance, or transaction terms. The key regulatory milestone is the advisory committee meeting, which is non-binding but can signal the FDA's view of the efficacy and safety data ahead of the October 8, 2023 PDUFA action date that the company previously disclosed. Investors should treat the committee's vote and discussion as a meaningful gauge of approval likelihood, since a favorable outcome would open a substantial new indication for ONPATTRO, while a negative outcome would weigh on expectations for the cardiomyopathy opportunity. The press release also restates ONPATTRO's currently approved indication, the polyneuropathy of hereditary ATTR amyloidosis, and its safety profile, including infusion-related reactions (19% vs. 9% placebo) and reduced serum vitamin A levels requiring supplementation. The company explicitly notes that patisiran has not been approved for ATTR cardiomyopathy and that no conclusions about its safety or effectiveness in that population should be drawn.

Jun 30, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Shareholder Vote Results (May 23, 2023)

This 8-K filing from Alnylam Pharmaceuticals, Inc. details the outcomes of their Annual Meeting of Stockholders held on May 18, 2023. The key takeaways for investors are the overwhelmingly positive shareholder support for the company's board of directors, executive compensation, and auditor ratification. All proposed director nominees received substantial 'for' votes, indicating shareholder confidence in the current leadership. Furthermore, shareholders approved executive compensation in a non-binding vote and recommended an annual frequency for such votes, aligning with management's intent. The ratification of PricewaterhouseCoopers LLP as the independent auditor for fiscal year 2023 also received strong endorsement. These results suggest a stable governance environment and shareholder alignment with the company's strategic direction and financial oversight, which are crucial factors for investor confidence and long-term value creation.

May 23, 2023 10-Q

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2023

Alnylam Pharmaceuticals, Inc. reported significant top-line growth in the first quarter of 2023, with total revenues increasing by 50% year-over-year to $319.3 million. This growth was driven by a substantial 48% increase in net product revenues, primarily due to the successful launch and uptake of AMVUTTRA in the U.S., alongside continued growth for GIVLAARI and OXLUMO. Collaboration revenues also saw a healthy increase of 41%, largely attributed to enhanced activity with Regeneron Pharmaceuticals. Despite the strong revenue performance, the company continued to operate at a net loss of $174.1 million, though this represents a 28% improvement compared to the same period last year, indicating progress in managing operational costs relative to revenue growth. Operationally, Alnylam is advancing its pipeline with ONPATTRO receiving FDA acceptance for an sNDA for ATTR amyloidosis cardiomyopathy, and AMVUTTRA continuing its global rollout. The company maintains a solid liquidity position with $2.07 billion in cash, cash equivalents, and marketable securities as of March 31, 2023, which it believes is sufficient for at least the next 12 months. While the company continues to invest heavily in R&D, the strong revenue growth suggests a positive trajectory towards its Alnylam P5x25 strategy.

May 4, 2023 8-K

ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (May 4, 2023)

Alnylam Pharmaceuticals reported first quarter 2023 results on May 4, 2023, led by net product revenues of $276.3 million, up 48% year over year (52% at constant exchange rates). Growth was driven by the U.S. launch of AMVUTTRA (vutrisiran) in Q3 2022, which contributed $101.8 million in its first full quarter of reporting, alongside growth in GIVLAARI and OXLUMO. Total TTR franchise revenue (ONPATTRO plus AMVUTTRA) reached $204.3 million, up 49%, though ONPATTRO alone declined 25% as patients shifted to AMVUTTRA. Total revenues were $319.3 million, including $36.5 million from collaborations and $6.5 million in royalties. Profitability remained negative. GAAP net loss narrowed to $174.1 million ($1.40 per share) from $240.3 million ($2.00 per share) a year earlier, helped by lower non-cash losses on marketable equity securities and reduced interest expense. Non-GAAP net loss was $131.9 million ($1.06 per share). GAAP R&D rose 36% to $230.6 million and SG&A rose 19% to $183.7 million, reflecting pipeline investment and the AMVUTTRA launch. Cash, cash equivalents and marketable securities declined to $2.07 billion from $2.19 billion at year-end 2022, mainly due to the operating loss. Stockholders' deficit widened to $259.2 million. Management reiterated full-year 2023 guidance of $1.200 to $1.285 billion in combined net product revenues (34% to 44% growth) and $100 to $175 million in collaboration and royalty revenue. The company highlighted positive interim Phase 1 data for ALN-APP in early-onset Alzheimer's disease, described as the first clinical demonstration of RNAi-mediated gene silencing in the human brain. Key upcoming catalysts include topline Phase 2 KARDIA-1 data for zilebesiran in mid-2023 and an FDA PDUFA date of October 8, 2023 for patisiran in ATTR cardiomyopathy, a date the revenue guidance assumes will be met.

May 4, 2023