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ALNY · ALNYLAM PHARMACEUTICALS, INC.

50 filings

10-Q

ALNY 10-Q Quarterly Reports

ALNYLAM PHARMACEUTICALS, INC. - 50 quarterly reports

Filing 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 · May ’17May ’17
  2. Leadership change8-K · Jul ’19Jul ’19
  3. Leadership change8-K · Dec ’21Dec ’21
  4. Material agreement8-K · Oct ’25Oct ’25
  1. 2026-Q2

    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
  2. 2026-Q1

    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
  3. 2025-Q3

    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
  4. 2025-Q2

    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
  5. 2025-Q1

    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
  6. 2024-Q3

    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
  7. 2024-Q2

    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. 2024-Q1

    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
  9. 2023-Q3

    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
  10. 2023-Q2

    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
  11. 2023-Q1

    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
  12. 2022-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2022

    Alnylam Pharmaceuticals, Inc. reported strong year-over-year growth in net product revenues for the third quarter and first nine months of 2022, driven by increased patient uptake of its key products ONPATTRO, GIVLAARI, OXLUMO, and AMVUTTRA. Total revenues increased by 41% and 20% for the respective periods. However, the company also experienced a significant increase in its net loss, primarily due to a substantial loss on the extinguishment of debt, increased R&D and SG&A expenses, and a marked increase in the fair value of its development derivative liability. The company has successfully issued $1.04 billion in convertible senior notes to bolster its financial position. Despite the widening net loss, Alnylam believes its current cash and cash equivalents are sufficient to fund operations for at least the next 12 months, supported by ongoing product sales and alliance revenues.

    Oct 27, 2022
  13. 2022-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2022

    Alnylam Pharmaceuticals, Inc. reported total revenues of $224.8 million for the second quarter of 2022, a modest 2% increase year-over-year. This growth was primarily driven by a strong 33% increase in Net Product Revenues to $213.5 million, largely from ONPATTRO and GIVLAARI, partially offset by a significant decline in collaboration revenues, notably from Regeneron. The company's Net Loss widened by 46% to $277.4 million for the quarter, reflecting increased operating costs and expenses, particularly in research and development and selling, general, and administrative functions. Despite the widening net loss, the company maintains a substantial cash position and believes it has sufficient liquidity for the next 12 months, supported by ongoing product sales and collaborations. Investors should note the significant decrease in collaboration revenue and the increased operational expenses, while also monitoring the continued growth in product sales and the pipeline's advancement.

    Jul 28, 2022
  14. 2022-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2022

    Alnylam Pharmaceuticals, Inc. reported total revenues of $213.3 million for the first quarter of 2022, a 20% increase compared to the same period in the previous year. This growth was primarily driven by a significant 38% increase in net product revenues, reaching $186.9 million, with ONPATTRO, GIVLAARI, and OXLUMO all showing strong year-over-year performance. The company experienced a net loss of $240.3 million for the quarter, widening from $200.3 million in Q1 2021, largely due to increased operating expenses, particularly in selling, general, and administrative categories, as well as higher interest expenses. Despite the increased net loss, Alnylam's cash position remains robust, with cash, cash equivalents, and marketable securities totaling $2.24 billion as of March 31, 2022, providing adequate runway for at least the next 12 months. The company continues to advance its pipeline, with notable progress in the vutrisiran New Drug Application (NDA) review by the FDA, which has an extended PDUFA goal date of July 14, 2022. OXLUMO also received FDA acceptance for a supplemental NDA for advanced PH1, with an action date in October 2022. These developments, coupled with strong commercial performance of its existing products, position Alnylam for continued growth, although strategic investments in R&D and SG&A are expected to impact near-term profitability.

    Apr 28, 2022
  15. 2021-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2021

    Alnylam Pharmaceuticals, Inc. reported strong revenue growth in the third quarter and first nine months of 2021, driven by increasing net product revenues from its approved therapies ONPATTRO, GIVLAARI, and OXLUMO, alongside growth in collaboration revenues. Net product revenues increased by 68% year-over-year for the quarter and 86% for the nine-month period, reflecting successful commercial expansion and new product launches. Collaboration revenues saw a 51% increase for the nine months, primarily due to increased activity with Regeneron. Despite top-line growth, the company continues to incur significant operating losses, with a net loss of $204.5 million for the quarter and $594.4 million for the nine months. Research and development expenses remain substantial, increasing by 20% for the quarter to support a robust pipeline. The company ended the period with a solid cash position of approximately $2.33 billion, providing ample liquidity to advance its "Alnylam P5x25" strategy. The company is also progressing well with its late-stage clinical programs, notably vutrisiran, with positive topline results and ongoing submissions for regulatory approval.

    Oct 28, 2021
  16. 2021-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2021

    Alnylam Pharmaceuticals, Inc. (ALNY) reported significant revenue growth in its second quarter of 2021, with total revenues nearly doubling year-over-year to $220.6 million. This increase was driven by strong performance in net product revenues, which more than doubled to $160.8 million, primarily from ONPATTRO and GIVLAARI, along with the new contribution from OXLUMO. Collaboration revenues also saw substantial growth, more than doubling to $59.4 million, largely due to increased activities with Regeneron Pharmaceuticals and Novartis AG. Despite the revenue growth, the company reported a net loss of $189.6 million for the quarter, a slight increase from the $179.2 million net loss in the prior year's second quarter. This was driven by higher operating costs and expenses, particularly in research and development, and increased interest expense related to its financing collaborations. The company's cash position remains strong, with $745.8 million in cash and cash equivalents, providing at least 12 months of operating runway according to management. Alnylam continues to advance its pipeline, with key updates on vutrisiran, including an NDA submission to the FDA and plans for an EU MAA based on positive Phase 3 data. The company's strategic therapeutic areas (STArs) and Alnylam P5x25 strategy remain on track, focusing on delivering transformative medicines and driving profitability.

    Aug 3, 2021
  17. 2021-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2021

    Alnylam Pharmaceuticals reported a significant increase in total revenues for the first quarter of 2021, driven by strong growth in net product revenues from its marketed products ONPATTRO, GIVLAARI, and OXLUMO. Total revenues reached $177.6 million, a 79% increase year-over-year, primarily due to the expanding global reach of ONPATTRO and GIVLAARI, and the recent launch of OXLUMO. Collaboration revenues also saw a substantial boost, particularly from agreements with Regeneron and Novartis, indicating increased partnership activity and support for key products. Despite revenue growth, the company continued to report a net loss of $200.3 million for the quarter. This loss is attributed to significant investments in research and development ($185.9 million) and selling, general, and administrative expenses ($146.9 million), which increased to support its "Alnylam P5x25" strategy aimed at becoming a top five biotech company by market capitalization by 2025. The company's liquidity remains strong, with approximately $1.71 billion in cash, cash equivalents, and marketable securities as of March 31, 2021, which management believes is sufficient to support operations for at least the next 12 months.

    Apr 29, 2021
  18. 2020-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2020

    Alnylam's Q3 2020 10-Q shows a company in rapid commercial ramp but still deeply loss-making. Total revenues for the quarter were $125.9 million (up 80% year over year), driven by net product revenues of $99.2 million (ONPATTRO $82.5 million, GIVLAARI $16.7 million) and $26.6 million in collaboration revenue. Operating expenses rose 23% to $351.1 million, mainly from higher SG&A (up 39%, partly due to a $28 million increase in the Ionis arbitration contingent liability) and flat R&D of $161.8 million. Net loss widened to $253.3 million, or $2.18 per share, versus $208.5 million a year earlier. Interest expense of $28.7 million on the Blackstone royalty sale liability weighed on results. The balance sheet and financing picture changed materially in 2020. Cash, cash equivalents and marketable securities totaled about $1.83 billion at September 30, 2020, supported by the April 2020 Blackstone strategic financing: $500 million received for 50% of inclisiran royalties and 75% of commercial milestones, with a further $500 million receivable due September 30, 2021, plus a $700 million term loan facility (not yet drawn) and $150 million of development funding. Management states this funding should allow the company to reach self-sustainability without future equity financing, and it characterizes 2019 as its peak net loss year. Accumulated deficit reached $4.34 billion, and total stockholders' equity fell to $1.22 billion as losses accumulated. For investors, the key tensions are the pace of revenue growth against continued large operating losses, the significant debt-like obligations now on the balance sheet (the $1.04 billion royalty liability, the Blackstone credit facility and the development derivative), and the dependence on near-term catalysts such as the lumasiran FDA action date of December 3, 2020, the EC decision on lumasiran, and the pending Ionis arbitration damages determination. Management also flags ongoing COVID-19 effects on patient demand and trial enrollment.

    Nov 5, 2020
  19. 2020-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2020

    Alnylam's Q2 2020 10-Q shows a company in rapid commercial transition. Total revenues rose 133% year over year to $104.0 million in the quarter (161% for the six months to $203.4 million), driven by net product revenues of $77.5 million (ONPATTRO $66.5 million, GIVLAARI $11.0 million) and collaboration revenues of $26.4 million, led by Regeneron. Net loss narrowed to $179.2 million from $219.5 million, and the company describes 2019 as its peak net loss year. Operating expenses still grew 8% as SG&A rose 13% and R&D fell 5%, and the period included $27.2 million of non-cash interest expense tied to the Blackstone royalty sale. The balance sheet was strengthened by the April 2020 Blackstone strategic financing: $500.0 million was received for 50% of inclisiran royalties and 75% of commercial milestones, with another $500.0 million receivable due September 30, 2021, and a $1.00 billion liability was recorded at an effective 11% rate. Cash, cash equivalents and marketable securities reached about $1.93 billion, up from $1.54 billion at year-end 2019, and Alnylam sold 963,486 shares to Blackstone affiliates for $100.0 million. The company also disclosed a $700.0 million delayed-draw term loan (not yet drawn, with tranches due by 2021) and management's belief that Blackstone funding should allow self-sustainability without future equity financing. Key near-term catalysts include the FDA action date of December 3, 2020 for lumasiran (PH1, Priority Review), ILLUMINATE-B topline data expected mid-2020, and inclisiran review in the U.S. and EU under partner MDCO (now Novartis). Risks highlighted include COVID-19 effects on ONPATTRO demand and trial enrollment, a pending Ionis arbitration over technology access fees, securities class actions, and continued operating losses. Income from unrealized gains on Vir and other equity holdings also boosted other income.

    Aug 6, 2020
  20. 2020-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2020

    Alnylam's Q1 2020 10-Q shows a company in rapid commercial ramp with heavy investment and a large financing package. Total revenues rose 199% year over year to $99.5 million, driven by net product revenues of $71.9 million (ONPATTRO $66.7 million, GIVLAARI $5.3 million in its first full quarter after launch) and collaboration revenue of $27.5 million, which was boosted by Regeneron. However, operating expenses rose 39% to $309.6 million, so the loss from operations widened to $210.2 million. Net loss was essentially flat at $182.2 million, helped by a $24.1 million unrealized gain on marketable equity securities that was recorded in other income. Accumulated deficit reached $3.91 billion. Liquidity fell during the quarter. Cash, cash equivalents, and marketable securities declined to $1.34 billion from $1.54 billion, and operating cash burn was $246.2 million. Management says 2019 was its peak net loss year and that the April 2020 Blackstone strategic financing collaboration, worth up to $2.0 billion, should allow the company to reach self-sustainability without future equity financing. That package includes $1.0 billion for 50% of inclisiran royalties and 75% of commercial milestones, a up to $750 million senior secured term loan, up to $150 million for vutrisiran and ALN-AGT development, and a $100 million common stock purchase. These are subsequent events and are not yet reflected in the Q1 balance sheet. Investors should weigh several risks. The COVID-19 pandemic is expected to reduce ONPATTRO sales in Q2 2020 by about 10%, and APOLLO-B enrollment completion has shifted into 2021. The company also faces two securities class actions, one dismissed without prejudice and the other pending, and an arbitration with Ionis that is set for hearing in the first half of 2020. Blackstone's financing adds secured debt with a $100 million minimum liquidity covenant and inclisiran royalty dilution after 2029 if sales targets are missed.

    May 6, 2020
  21. 2019-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2019

    Alnylam's Q3 2019 10-Q shows a company in a rapid commercial transition, with ONPATTRO net product revenue reaching $46.1 million in the quarter (up from $0.5 million a year earlier) and $110.6 million year-to-date. Total revenues rose to $70.1 million for the quarter, helped by $24.0 million in collaborator revenue, most of it from the Regeneron collaboration. Operating expenses grew 12% to $286.4 million, so the operating loss narrowed to $216.3 million from $254.6 million, and the net loss narrowed to $208.5 million from $245.3 million. Nine-month net loss widened to $609.9 million, driven by higher R&D (up 21%) and SG&A (up 18%) as the company builds out its global launch and late-stage pipeline. Liquidity improved materially. Cash, cash equivalents and marketable debt securities totaled $1.72 billion at September 30, 2019, up from $1.08 billion at year-end 2018, reflecting the $400 million Regeneron equity purchase, the $381.9 million January 2019 public offering, and $399.6 million of deferred revenue from the Regeneron upfront payment. Operating cash burn was $82.4 million for the nine months, versus $412.2 million a year earlier, largely because of that upfront payment. Management states that current resources are sufficient for at least the next 12 months and, in the MD&A, for multiple years. The company also repaid its $30 million Wells Fargo term loan in September 2019. Key risks flagged in the filing include two securities class actions (one pending since September 2018 tied to ONPATTRO efficacy and safety statements, and a September 2019 Securities Act suit tied to the APOLLO Phase 3 results), an arbitration with Ionis over alleged technology access fees with a hearing set for the first half of 2020, and dependence on collaborators. Near-term catalysts include the givosiran NDA PDUFA date of February 4, 2020, the EMA review of the givosiran MAA, and the ILLUMINATE-A lumasiran Phase 3 readout expected by year-end 2019.

    Oct 31, 2019
  22. 2019-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2019

    Alnylam Pharmaceuticals' Q2 2019 10-Q shows a company in an early commercial phase that is still deeply loss-making but materially better funded. Total revenues rose 50% to $44.7 million for the quarter (51% to $78.0 million for the first half), driven by $38.2 million of ONPATTRO net product revenue, which is the company's first product sales following its August 2018 approvals. Collaboration revenue fell 78% year over year to $6.5 million as reimbursable activities under the Sanofi Genzyme and Vir agreements declined. Operating expenses rose 26% to $281.0 million, with R&D up 19% and SG&A up 33%, so the net loss widened 34% to $219.5 million for the quarter ($2.02 per share). The accumulated deficit reached $3.24 billion. The balance sheet strengthened substantially. Cash, cash equivalents and marketable debt securities totaled $1.93 billion at June 30, 2019, up from $1.08 billion at year-end 2018. This was driven by a $381.9 million net public offering in January 2019, a $400.0 million upfront payment and equity purchase by Regeneron in May 2019, and $100.2 million of operating cash inflow for the first half, which benefited from the Regeneron payment and $399 million in deferred revenue growth. Management states that resources are sufficient for at least the next 12 months and for multiple years under the current operating plan, while noting it may need additional funds earlier if commercialization or development costs exceed expectations. The filing also highlights several catalysts and risks. Givosiran (AHP) received FDA Priority Review with a February 4, 2020 PDUFA date and an EMA accelerated assessment. Regeneron's April 2019 collaboration covers eye and CNS programs with up to $200 million in milestones. A securities class action, Leavitt v. Alnylam, was filed in September 2018, and the company has moved to dismiss it. An arbitration with Ionis over alleged technology access fees is set for a hearing in the first half of 2020. Ongoing ONPATTRO sales growth, the trajectory of operating expenses, and the outcome of givosiran review are the primary items investors should watch.

    Aug 6, 2019
  23. 2019-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2019

    Alnylam Pharmaceuticals, Inc. reported a significant increase in total revenues for the first quarter of 2019, reaching $33.3 million, a 52% rise compared to the same period last year. This growth is primarily driven by the successful commercialization of ONPATTRO®, their first RNAi therapeutic, which generated $26.3 million in net product revenues. While this marks a positive step, the company continues to operate at a loss, with an operating loss of $188.8 million and a net loss of $181.9 million for the quarter. This reflects substantial ongoing investment in research and development, crucial for advancing their broad pipeline of RNAi therapeutics across four strategic therapeutic areas. The company also bolstered its financial position through a $381.9 million public offering of common stock in January 2019 and entered into a significant global collaboration with Regeneron, which includes a $400 million upfront payment and potential future milestones, further strengthening their cash reserves.

    May 2, 2019
  24. 2018-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2018

    Alnylam's Q3 2018 10-Q marks a pivotal transition from development-stage biotech to commercial company, following FDA approval of ONPATTRO (patisiran) on August 10, 2018 and EC approval on August 30, 2018. Product revenue was modest at $0.5 million for the quarter, as launch sales in the U.S. began in August and European sales started in Germany in October. Total revenues for the quarter were $2.1 million, down sharply from $17.1 million a year earlier, as collaboration revenue fell after the substantial completion of Sanofi Genzyme obligations. Net loss widened to $245.3 million ($2.43 per share) from $122.9 million, driven by R&D of $139.9 million and SG&A of $116.5 million, the latter including $42.2 million of stock-based compensation tied to performance-based awards triggered by the approval and givosiran progress. Management said stock-based compensation should decline significantly in Q4. The balance sheet remains strong but is shrinking. Cash, cash equivalents and marketable debt securities totaled about $1.22 billion at September 30, 2018, versus $1.70 billion at year-end 2017, and nine-month operating cash burn was $412 million. Management states that current resources, plus expected product and alliance revenue, will fund operations for at least 12 months, though it cautions that it may need significant additional capital sooner. The January 2018 restructuring of the Sanofi Genzyme alliance gave Alnylam exclusive global rights to TTR products, including ONPATTRO, while Sanofi Genzyme took fitusiran. Alnylam now funds TTR commercialization costs itself, which shifts future economics toward higher margins but larger near-term spending. The adoption of ASC 606 cut deferred revenue by $68.2 million at January 1, 2018 and materially lowered reported collaboration revenue for 2018. Key risks include a securities class action filed September 26, 2018, patent litigation with Silence Therapeutics in the UK, Portugal and the Netherlands, a pending arbitration demand from Ionis, and the early-stage commercial ramp of ONPATTRO. The Silence UK hearing is set for December 10, 2018, and a Dutch preliminary relief hearing is set for January 23, 2019. Regulatory milestones include a Japanese NDA submitted in September 2018 with a decision expected mid-2019, and a givosiran NDA rolling submission planned for 2018 and 2019.

    Nov 7, 2018
  25. 2018-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2018

    Alnylam's Q2 2018 10-Q shows a company in heavy investment mode with a sharply higher net loss, while the top line was flattered by one-time and accounting-driven items. Net loss widened to $163.6 million for the quarter (vs. $118.4 million a year earlier) and $304.8 million for the six months (vs. $225.7 million). Total operating expenses rose 63% in the quarter to $222.3 million, driven by R&D ($137.6 million) and G&A ($84.7 million), with management citing manufacturing build-out, headcount growth and commercial/medical affairs spending ahead of a possible patisiran launch. Quarterly revenue of $29.9 million was up from $15.9 million, but the increase was largely driven by the $50 million fitusiran milestone booked in Q1 and the new revenue standard, which cut reported collaboration revenue by $16.3 million in Q2 and $49.4 million year-to-date versus the prior standard. Management explicitly guided to significantly lower collaboration revenue in the second half of 2018. The balance sheet and liquidity picture weakened. Cash, cash equivalents and marketable debt securities totaled about $1.44 billion at June 30, 2018, down from $1.70 billion at year-end 2017, and operating cash burn was $258.4 million for the first half. Stockholders' equity fell $145.6 million to $1.62 billion, and the accumulated deficit reached $2.38 billion. The company says current resources fund its strategy for at least the next 12 months (in Note 1) and 'at least the next few years' (in MD&A), and it flags that it may need significant additional funds sooner than expected. Equity raised from stock option exercises ($47.7 million) was the only meaningful financing inflow this half. The filing's main catalysts are regulatory and clinical. An FDA PDUFA date of August 11, 2018 for patisiran (priority review) and a CHMP positive opinion in the EU, with an EC decision expected in September 2018, set up a potential first launch. Risk factors also highlight ongoing litigation with Silence Therapeutics over patent claims touching patisiran, a Dicerna settlement that brought in $20.6 million of other income, and the Sanofi Genzyme restructuring (which shifted patisiran rights to Alnylam globally and fitusiran to Sanofi). Investors should weigh the expected 2018 approval and launch against a rapidly growing cost base, lumpy and declining collaboration revenue, and continued dependence on capital markets.

    Aug 2, 2018
  26. 2018-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2018

    Alnylam's Q1 2018 10-Q shows a company in an investment-heavy build-out phase, with a headline revenue increase driven by a one-time accounting shift rather than underlying growth. Net revenues from collaborators rose to $21.9 million from $19.0 million, but under the prior revenue standard they would have been $55.0 million. The adoption of ASC 606 on January 1, 2018 cut deferred revenue by $68.2 million, with a matching accumulated-deficit adjustment, and this compressed reported Q1 revenue. Net loss widened to $141.2 million from $107.3 million, and operating expenses rose 35% to $169.3 million, with G&A up 88% on commercial and launch preparation for patisiran. Liquidity declined meaningfully. Cash and cash equivalents fell to $396.1 million and total cash plus marketable securities was about $1.57 billion, down from $1.70 billion at year-end 2017. Operating cash burn was $155.7 million in the quarter, and investing outflows were driven by net purchases of securities and manufacturing facility spending. Management states that existing resources and alliance cash should fund operations for at least the next 12 months, while also warning that significant additional funding may be needed earlier if the company's plans change. The filing's main catalysts are the January 2018 restructuring of the Sanofi Genzyme collaboration, which gives Alnylam global rights to patisiran and ALN-TTRsc02 but makes it responsible for their full development and commercialization costs, and the $50.0 million fitusiran milestone recognized in the quarter. Patisiran has an FDA action date of August 11, 2018, and the April 2018 Dicerna settlement brings $25.0 million in value, of which $12.0 million is cash or equity. The Silence Therapeutics patent litigation in multiple jurisdictions remains an open risk.

    May 4, 2018
  27. 2017-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2017

    Alnylam Pharmaceuticals' Q3 2017 10-Q shows a company spending heavily ahead of a potential first product launch. For the nine months ended September 30, 2017, net loss widened to $348.6 million (from $297.2 million), driven by a sharp rise in general and administrative expense to $131.9 million (from $61.5 million) as commercial and medical affairs headcount grew. Collaboration revenue rose to $52.0 million from $29.7 million, mainly from Sanofi Genzyme cost-sharing reimbursements, but R&D spending was roughly flat at $272.9 million. Net cash used in operations reached $279.7 million, and capital expenditures of $83.5 million went largely to the Norton, Massachusetts drug substance manufacturing facility. Liquidity improved materially during the period. The May 2017 public offering raised $355.2 million net, and total stock issuances and option exercises added further cash, lifting cash, cash equivalents and fixed income marketable securities to $999.8 million at September 30, 2017, versus $942.6 million at year-end 2016. Management says these resources are sufficient for at least the next few years, though it notes that significant additional funds may be needed earlier if development plans change. Stockholders' equity rose to $1.06 billion and the accumulated deficit reached $2.01 billion. The filing's main investor focus is pipeline risk and near-term catalysts. Patisiran's positive APOLLO Phase 3 topline results (reported September 2017, with full results in early November) support plans to file an NDA by year-end 2017 and an MAA shortly after. Dosing of fitusiran was temporarily suspended in September 2017 after a fatal thrombotic serious adverse event, which delays a $25.0 million Sanofi Genzyme milestone and adds uncertainty to that program. The company also faces litigation with Silence Therapeutics over patent supplementary protection certificates and with Dicerna over trade secrets, and it has adopted change-in-control agreements for its management board.

    Nov 7, 2017
  28. 2017-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2017

    Alnylam Pharmaceuticals' Q2 2017 10-Q shows a company in heavy investment mode, with net loss widening to $118.4 million for the quarter (vs. $90.1 million a year earlier) and $225.7 million for the six months. Revenue from collaborators rose to $15.9 million in the quarter and $34.9 million year-to-date, driven mainly by Sanofi Genzyme cost reimbursements tied to programs it has opted into, but this remains small relative to operating expenses of $136.4 million in the quarter. The increase in spending was led by general and administrative costs, which nearly tripled to $45.8 million as the company built commercial and medical affairs capabilities ahead of a potential first launch, and by manufacturing costs for late-stage trials and construction of the Norton, Massachusetts drug substance facility. Balance sheet strength improved materially. Cash and cash equivalents rose to $408.7 million and total cash, equivalents and fixed income securities reached about $1.10 billion, up from $942.6 million at year-end 2016, primarily due to a May 2017 public offering of 5.0 million shares at $71.87 (net proceeds $355.2 million) and a $21.4 million private placement to Sanofi Genzyme. Management states that existing resources are sufficient to advance the Alnylam 2020 strategy for at least the next few years, while also cautioning that additional funds may be needed earlier than expected. The accumulated deficit reached $1.88 billion. Key near-term catalysts include top-line APOLLO Phase 3 data for patisiran expected in mid-2017, with a planned NDA and MAA by year-end 2017, the start of the ATLAS Phase 3 program for fitusiran (triggering a $25.0 million milestone upon first patient dosing), and planned Phase 3 initiation for givosiran in late 2017. Risks highlighted include the October 2016 discontinuation of revusiran for safety concerns, the Dicerna litigation (trial scheduled for April 2018, with a new federal antitrust complaint filed August 8, 2017), a patent-related claim threatened by Silence Therapeutics, and continued reliance on partners Sanofi Genzyme and The Medicines Company.

    Aug 9, 2017
  29. 2017-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2017

    Alnylam Pharmaceuticals' Q1 2017 10-Q shows a company in a heavy investment phase, with net loss widening to $107.3 million (vs. $103.0 million in Q1 2016) on revenue of $19.0 million (up from $7.3 million). Operating expenses rose to $125.5 million, driven mainly by a $17.4 million increase in G&A, which management attributes to commercial and medical affairs headcount build-out ahead of a potential product launch. R&D fell $9.3 million year over year, largely because Q1 2016 included performance-based stock option vesting tied to APOLLO enrollment, plus reduced clinical trial spending after the October 2016 revusiran discontinuation. Liquidity is the key investor watch item. Cash, cash equivalents and fixed income marketable securities were $812.2 million, down from $942.6 million at year-end 2016, and operating cash burn was $100.3 million in the quarter. Stockholders' equity declined to $830.9 million from $920.2 million. Capital spending accelerated, with $36.2 million of PP&E purchases tied to the Norton, Massachusetts drug substance manufacturing facility, and the company carries $150.0 million of term loans, fully collateralized by restricted investments. Management states resources are sufficient for at least the next 12 months, while acknowledging it may need significant additional funds earlier than expected. The near-term catalysts are clinical and regulatory. Management expects top-line APOLLO Phase 3 data for patisiran in mid-2017 and plans to file an NDA and MAA by year-end 2017 if the data are positive. Fitusiran is expected to advance into Phase 3 during 2017, and the MDCO partnership on inclisiran continues. Investors should weigh these catalysts against the cash runway, the company's dependence on Sanofi Genzyme and MDCO, the revusiran safety issues, and continued dilution risk.

    May 5, 2017
  30. 2016-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2016

    Alnylam Pharmaceuticals' Q3 2016 10-Q shows a company in heavy investment mode with a meaningful setback. Net loss widened to $104.1 million for the quarter (vs. $76.8 million a year earlier) and $297.2 million for the nine months (vs. $199.4 million), driven by R&D expense growth of 43% for the nine months to $277.4 million as the company advances its Genetic Medicine pipeline, including the patisiran Phase 3 APOLLO trial. Collaboration revenue remained small at $29.7 million year-to-date, down from $33.5 million, reflecting completed Monsanto and Takeda obligations. Liquidity is adequate but declining: cash, cash equivalents and fixed income securities total about $1.04 billion, down from $1.28 billion at year-end 2015, and cash burn from operations was $229.4 million over nine months. The company also took on $150 million of term debt in April 2016 to fund a drug substance manufacturing facility in Norton, Massachusetts, which is secured by an equal amount of restricted cash. The most important development is the October 2016 decision, which falls after the balance sheet date, to discontinue the revusiran program after the ENDEAVOUR Phase 3 Data Monitoring Committee recommended suspending dosing due to an observed mortality imbalance versus placebo. The company states the decision does not affect patisiran, which is in Phase 3 with the APOLLO DMC recommending continuation without modification. The financial effect of the discontinuation has not yet been estimated, and management indicated that revenue recognition for the Sanofi Genzyme collaboration will be extended from six to five years, which should accelerate deferred revenue recognition in future quarters. Management also acknowledged that the revusiran decision and resulting stock price decline could make future financing and talent acquisition more difficult. For investors, the key questions are the timing and data readout of patisiran Phase 3 results (expected 2017), the potential for the revusiran safety issue to affect the broader RNAi platform, the company's ability to fund its Alnylam 2020 goals without significant dilution, and the outcome of ongoing litigation, including the Dicerna trade secret case and the University of Utah fee appeal.

    Nov 3, 2016
  31. 2016-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2016

    Alnylam Pharmaceuticals, Inc. reported its financial results for the quarter and six months ended June 30, 2016. The company continues to experience significant operating losses, with a net loss of $90.1 million for the quarter and $193.1 million for the six months. This is largely driven by substantial investments in research and development, which increased by 24% and 44% respectively for the periods compared to the prior year, reflecting advancements in their RNAi therapeutic pipeline, particularly in Genetic Medicines. Despite the ongoing losses, Alnylam's cash position remains strong, with cash and cash equivalents totaling $271.1 million at quarter-end, bolstered by recent financing activities including a $150 million term loan facility. Key collaborations with Sanofi Genzyme and The Medicines Company continue to generate revenue, though overall collaboration revenues saw a decrease in the six-month period due to the completion of certain agreements. The company is advancing its 'Alnylam 2020' plan, aiming for three marketed products and ten clinical programs by the end of 2020. Progress in key therapeutic areas, including positive data from patisiran and fitusiran studies, highlights the ongoing development efforts. The company also announced an amendment to its lease for a manufacturing facility, extending the term through August 2022.

    Aug 4, 2016
  32. 2016-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2016

    Alnylam Pharmaceuticals' Q1 2016 10-Q shows a company in heavy investment mode. Net loss widened to $103.0 million (EPS of -$1.21) from $50.8 million a year earlier, as R&D rose to $96.3 million (up 66%) and G&A rose to $21.1 million. Total revenue from collaborators fell to $7.3 million from $18.5 million, mainly because the Monsanto and Takeda revenue recognition has ended. Stock-based compensation was a significant driver, reaching $23.5 million in the quarter versus $8.2 million a year earlier, and the company reported a $5.2 million realized gain on Regulus shares included in other income. Liquidity remains solid but is declining. Cash, cash equivalents and fixed income marketable securities totaled about $1.21 billion at March 31, 2016, down from $1.28 billion at year-end 2015. Operating cash burn was $83.6 million for the quarter. The company's accumulated deficit reached $1.35 billion. Management expects R&D expense to keep rising from the Q1 level as the pipeline advances toward the 'Alnylam 2020' goals. Alnylam also disclosed a planned Norton, Massachusetts drug-substance manufacturing facility, with about $100 million of expected 2016 capital spending, and in April 2016 it signed credit agreements providing a $150 million term loan facility secured by cash collateral. Clinical and legal milestones are a key focus. The APOLLO Phase 3 trial of patisiran completed enrollment with 225 patients, with data expected in mid-2017 and an NDA targeted by the end of 2017. Phase 3 trials for fitusiran are planned to start in mid and late 2016. The University of Utah inventorship case has been resolved, with only a fee-reimbursement appeal pending, and a ruling is expected by Q3 2016. The Dicerna trade secret suit continues, with discovery scheduled to close September 30, 2016. Sanofi Genzyme holds about 12% of the company and continues to exercise its anti-dilution rights.

    May 4, 2016
  33. 2015-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2015

    Alnylam Pharmaceuticals, Inc. reported its financial results for the quarter ended September 30, 2015, showcasing a strong balance sheet with total assets of $1.44 billion, bolstered by substantial cash and marketable securities. The company continues to invest heavily in research and development, with R&D expenses increasing by 48% for the quarter and 56% year-to-date, reflecting progress across its Genetic Medicines, Cardio-Metabolic Disease, and Hepatic Infectious Disease Strategic Therapeutic Areas (STArs). Despite significant operating losses typical for a clinical-stage biopharmaceutical company, Alnylam secured substantial funding through a public offering of $496.4 million in net proceeds in January 2015, alongside concurrent private placements with Genzyme. This financial strengthening is crucial for advancing its ambitious "Alnylam 2020" plan, which targets three marketed products and ten clinical-stage programs by 2020. Key partnerships, particularly with Genzyme, continue to be a significant driver, with Genzyme opting into the ALN-AT3 program. Investors should monitor clinical trial progress, collaboration milestones, and the company's ability to manage its substantial R&D investments.

    Nov 9, 2015
  34. 2015-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2015

    Alnylam Pharmaceuticals, Inc. (ALNY) reported its financial results for the quarter and six months ended June 30, 2015. The company continues to invest heavily in research and development, as evidenced by a significant increase in R&D expenses year-over-year, reflecting its commitment to advancing its RNAi therapeutic pipeline across its three Strategic Therapeutic Areas (STArs): Genetic Medicines, Cardio-Metabolic Disease, and Hepatic Infectious Disease. This investment is crucial for achieving its "Alnylam 2020" guidance, which aims for three marketed products and ten clinical programs by the end of 2020. Financially, Alnylam ended the period with a strong cash position, bolstered by a successful public offering in January 2015 that raised approximately $496.4 million in net proceeds. Despite ongoing operating losses, which are typical for a clinical-stage biopharmaceutical company, the company's substantial cash reserves and existing strategic alliances provide a runway to fund its ambitious development goals. Key partnerships, particularly with Genzyme and The Medicines Company, are critical for revenue generation and development progress. Investors should monitor the progress of key clinical trials, especially for patisiran and revusiran, and the potential for future collaborations and regulatory milestones.

    Aug 7, 2015
  35. 2015-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2015

    Alnylam Pharmaceuticals, Inc. reported its first quarter 2015 financial results, showcasing significant progress in its cash position due to a successful public offering. The company raised approximately $496.4 million in net proceeds from the offering in January 2015, bolstering its cash and cash equivalents to $306.6 million as of March 31, 2015. This strong liquidity provides substantial runway to fund its ambitious "Alnylam 2020" plan, which aims for three marketed products and ten clinical programs by 2020. Operationally, Alnylam reported increased net revenues from collaborators to $18.5 million, up from $8.3 million in the prior year's quarter, driven by contributions from Monsanto, Takeda, and Genzyme. While research and development expenses rose to $58.0 million, reflecting pipeline advancement, the overall operating expenses decreased significantly year-over-year due to the absence of a large in-process R&D charge recorded in the prior year's quarter. The company continues to advance its diverse pipeline of RNAi therapeutics across its Genetic Medicine, Cardio-Metabolic Disease, and Hepatic Infectious Disease therapeutic areas.

    May 8, 2015
  36. 2014-Q1-A

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report (Amendment) for Q1 Ended Mar 31, 2014

    This filing is an amendment (Amendment No. 1) to Alnylam Pharmaceuticals, Inc.'s previously filed Quarterly Report on Form 10-Q for the period ended March 31, 2014. The amendment's sole purpose is to include the Fifth Amendment to Lease, dated March 27, 2014, as an exhibit (Exhibit 10.5). This lease amendment was inadvertently omitted from the original filing. The company states that the material terms of this lease amendment were already disclosed in a prior Form 8-K filing on April 2, 2014. Investors should note that this amendment does not alter any other financial or operational disclosures made in the original Form 10-Q filing. The amendment is effective as of the original filing date and does not incorporate any information or events that have occurred since then. Therefore, for a comprehensive understanding of Alnylam's financial performance and operational status as of March 31, 2014, investors should refer to the original Form 10-Q filing.

    Jan 9, 2015
  37. 2014-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2014

    Alnylam Pharmaceuticals, Inc. reported a strong increase in cash and cash equivalents, reaching $82.7 million by September 30, 2014, up from $53.2 million at the end of 2013. This financial strengthening is largely attributed to a significant $700 million cash infusion from Genzyme in February 2014 as part of a strategic collaboration, alongside an additional $23 million Genzyme investment later in March. Despite this robust financing, the company continued to operate at a loss, with a net loss of $44.0 million for the third quarter and $339.0 million for the first nine months of 2014, reflecting substantial ongoing investment in research and development. The company's R&D expenses increased significantly, particularly due to a $220.8 million charge for in-process R&D related to the acquisition of Sirna Therapeutics' RNAi assets. Alnylam is advancing its core product strategy, the "Alnylam 5x15," with several candidates in clinical development, including patisiran (ALN-TTR02) in Phase 3 trials and revusiran (ALN-TTRsc) in Phase 2. The Genzyme collaboration, a key strategic alliance, is central to the company's global commercialization efforts for its genetic medicine programs.

    Nov 6, 2014
  38. 2014-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2014

    Alnylam Pharmaceuticals, Inc. (ALNY) reported its financial results for the quarter and six months ended June 30, 2014. The company significantly increased its cash position, primarily driven by a substantial $700 million cash infusion from Genzyme as part of a strategic collaboration. This collaboration also involves Genzyme acquiring a significant equity stake in Alnylam. Financially, Alnylam continues to operate at a loss, with a net loss of $44.1 million for the quarter and $295.0 million for the six-month period, reflecting ongoing investments in research and development. A notable item impacting expenses was a substantial charge of $220.8 million recognized as in-process research and development related to the acquisition of Sirna Therapeutics' RNAi assets from Merck. Despite the net loss, the company's balance sheet strengthened considerably, ending the period with over $955 million in cash, cash equivalents, and marketable securities, providing ample runway for its development programs.

    Aug 8, 2014
  39. 2014-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2014

    Alnylam Pharmaceuticals, Inc. (ALNY) reported its first quarter 2014 financial results, showcasing significant advancements in its RNA interference (RNAi) therapeutic pipeline and a substantial strengthening of its financial position. The company's strategic focus on developing novel RNAi therapeutics, particularly under its "Alnylam 5x15" program, continues to drive its R&D efforts. The period was marked by a major strategic collaboration with Genzyme, a Sanofi company, which significantly bolstered ALNY's cash reserves and provided substantial validation for its genetic medicine pipeline. Financially, Alnylam reported a substantial increase in cash and cash equivalents, largely due to the upfront payment and equity investment from Genzyme. While the company continues to incur significant operating losses, driven by substantial investments in research and development, particularly a notable in-process R&D charge related to the Sirna acquisition, the strong liquidity position provides ample runway for continued development. The Genzyme collaboration, alongside other strategic alliances, is expected to be a primary source of future revenue through milestone payments and royalties.

    May 9, 2014
  40. 2013-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2013

    Alnylam Pharmaceuticals, Inc. reported its financial results for the quarterly period ended September 30, 2013. The company continues to operate at a net loss, with a loss of $29.7 million for the third quarter and $56.9 million for the first nine months of the year. This reflects significant ongoing investment in research and development, which increased by 56% and 25% year-over-year for the respective periods. Despite the losses, Alnylam bolstered its financial position by raising approximately $173.6 million in net proceeds from a public offering in January 2013, contributing to a total cash and marketable securities balance of $367.1 million as of September 30, 2013. Operationally, the company is advancing its 'Alnylam 5x15' strategy, focusing on five RNAi therapeutic programs in clinical development by the end of 2015. Key updates include positive interim results from the Phase II trial of patisiran (ALN-TTR02) for transthyretin-mediated amyloidosis (ATTR) and promising early data for ALN-TTRsc, demonstrating human translation of its GalNAc-siRNA conjugate platform. The company also filed an application to initiate a Phase I clinical trial for ALN-AT3 and identified a development candidate for ALN-AS1. Revenue from research collaborators decreased compared to the prior year, primarily due to the completion of the Roche/Arrowhead alliance, though this was partially offset by recognition of deferred revenue from the Cubist agreement termination and new revenues from Monsanto and The Medicines Company.

    Nov 7, 2013
  41. 2013-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2013

    Alnylam Pharmaceuticals, Inc. (ALNY) reported its financial results for the quarter ended June 30, 2013. The company continued to advance its RNAi therapeutic pipeline, with a focus on its core product strategy, 'Alnylam 5x15.' Significant progress was noted in the ALN-TTR program, with promising interim results from the Phase II clinical trial of ALN-TTR02 demonstrating dose-dependent and durable knockdown of serum TTR levels. Additionally, ALN-TTRsc showed robust knockdown in healthy volunteers from its Phase I trial. The company secured substantial proceeds from a public offering in January 2013, bolstering its cash position to $24.975 million and overall liquidity with marketable securities. While net revenues from research collaborators decreased year-over-year, primarily due to the completion of obligations under the Roche/Arrowhead alliance, this was partially offset by new revenues from agreements with Monsanto and The Medicines Company (MDCO). Alnylam also reported increased research and development expenses, reflecting continued investment in its pipeline and drug delivery technologies, while general and administrative expenses decreased due to the resolution of litigation. Despite ongoing net losses, Alnylam's substantial cash reserves and strategic alliances provide a runway for continued development. The company's focus on a genetically defined target strategy and its robust intellectual property portfolio position it to navigate the competitive biopharmaceutical landscape.

    Aug 9, 2013
  42. 2013-Q1-A

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report (Amendment) for Q1 Ended Mar 31, 2013

    This amended 10-Q filing from Alnylam Pharmaceuticals, Inc. for the quarter ended March 31, 2013, primarily serves to provide an updated Exhibit 10.2, a License and Collaboration Agreement with The Medicines Company dated February 3, 2013. Investors should note that this amendment does not alter the financial performance or operational updates previously reported in the original filing of May 7, 2013. The core financial and business disclosures remain as previously filed. While specific financial figures for the quarter are not detailed in this amendment, the filing confirms Alnylam's status as an accelerated filer. Investors interested in the specifics of the collaboration with The Medicines Company will need to review the revised Exhibit 10.2, which has undergone confidential treatment for certain sections, indicating the sensitive nature of the agreement's terms. The overall focus of this amendment is on regulatory compliance and the clarification of contractual documentation rather than reporting new financial results.

    Jul 26, 2013
  43. 2013-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2013

    Alnylam Pharmaceuticals, Inc. reported its financial results for the quarter ended March 31, 2013. The company continues to operate at a loss, with a net loss of $9.0 million for the quarter, an improvement from $11.4 million in the same period last year. This improvement was largely driven by increased revenue from new and existing collaborations, particularly offset by a significant decrease in revenue from the Roche/Arrowhead alliance. The company successfully raised approximately $173.6 million in net proceeds from a public offering in January 2013, bolstering its cash position to $97.8 million.

    May 7, 2013
  44. 2012-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2012

    Alnylam Pharmaceuticals, Inc. reported its financial and operational results for the quarter and nine months ended September 30, 2012. The company continues to focus on its core 'Alnylam 5x15' strategy, aiming to have five RNAi therapeutic programs in clinical development by the end of 2015. During this period, Alnylam raised approximately $86.8 million in net proceeds from a public offering in February 2012, bolstering its cash position. The company is advancing its lead programs, ALN-TTR02 for transthyretin-mediated amyloidosis (ATTR) and ALN-AT3 for hemophilia, with ALN-TTR02 showing robust TTR protein knockdown in Phase I trials and a Phase II trial initiated. Significant developments also include progress in pre-clinical stages for other core programs and continued partner-based development. The company also reported progress in significant litigation matters, including the ongoing Tekmira patent infringement case. While revenues from research collaborators saw a decline due to the completion of performance obligations under the Roche/Arrowhead alliance, the company remains focused on advancing its pipeline. Operating expenses were impacted by a strategic corporate restructuring in January 2012, which reduced the workforce by approximately 33% to lower operating expenses. Despite incurring net losses, Alnylam believes its current cash and marketable securities, combined with expected alliance revenues, will be sufficient to fund operations through at least the end of 2014. Key subsequent events include Regulus Therapeutics' IPO in October 2012 and a license and collaboration agreement with Genzyme for ALN-TTR therapeutics.

    Nov 5, 2012
  45. 2012-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2012

    Alnylam Pharmaceuticals' second-quarter 2012 10-Q shows a company in transition after its January 2012 restructuring, which cut its workforce by about 33% to roughly 115 employees and targets roughly $20.0 million in annual operating expense savings. For the six months ended June 30, 2012, net loss narrowed to $24.3 million from $30.1 million a year earlier, and operating expenses fell 8% to $64.4 million, driven mainly by lower clinical trial and manufacturing spending on ALN-RSV and ALN-VSP. Revenue was flat at $41.5 million, almost entirely from collaboration revenue recognized from prior upfront payments (Roche/Arrowhead and Takeda). Cash, cash equivalents and marketable securities were $292.8 million at June 30, 2012, up from $260.8 million at year-end 2011, after net proceeds of about $86.8 million from a February 2012 equity offering. Management says these resources, together with expected alliance cash, fund operations through at least the end of 2014. The key forward-looking issue for investors is revenue. Management expects collaboration revenue to fall significantly after the third quarter of 2012, when the Roche/Arrowhead performance obligations are completed, and deferred revenue stood at $103.5 million at June 30, 2012. Stock-based compensation, research and development spending and G&A are guided to remain roughly flat for the rest of 2012. Meanwhile, G&A rose 16% for the six months, largely from legal fees tied to the Tekmira and University of Utah disputes. Litigation is the main contingent risk. In the Tekmira trade-secret case, the plaintiffs' expert estimates damages of about $61 million to $446 million on aggregated theories, and potentially up to $1.3 billion if trebling applies. The company believes the likelihood of loss is more than remote but less than probable and has not accrued a loss estimate. A trial is expected in October 2012. Clinically, ALN-TTR02 is advancing into Phase II, ALN-AT3 was designated as the hemophilia development candidate, and the ALN-RSV01 Phase IIb missed its primary endpoint on an intent-to-treat basis, though it reached statistical significance on other analyses.

    Aug 8, 2012
  46. 2012-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2012

    Alnylam Pharmaceuticals, Inc. reported its first quarter 2012 financial results, indicating continued investment in its RNAi therapeutic pipeline. The company's net revenue from research collaborators remained relatively stable year-over-year, primarily driven by its alliances with Roche/Arrowhead and Takeda. However, operating expenses, particularly in research and development, saw a decrease compared to the prior year, largely due to a strategic restructuring and workforce reduction implemented in early 2012, which is expected to yield significant cost savings throughout the year. Financially, Alnylam ended the quarter with a solid cash position, bolstered by a public offering of common stock in February 2012 that raised approximately $86.8 million in net proceeds. This capital infusion is earmarked for advancing its clinical pipeline, including the ALN-TTR02 and ALN-APC programs. Despite ongoing net losses, typical for an early-stage biopharmaceutical company, the company appears well-positioned to fund its operations through at least the end of 2013, with potential for further funding through existing or new strategic alliances.

    May 3, 2012
  47. 2011-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2011

    Alnylam Pharmaceuticals' Q3 2011 10-Q shows a company still in heavy investment mode with no product revenue. Net revenues from research collaborators were $20.8 million in the quarter (down from $27.7 million a year earlier) and $62.3 million for the nine months (down from $78.8 million), reflecting the completion of the Novartis research term in October 2010 and the end of the NIAID government contract. Operating expenses fell 9% in the quarter to $33.2 million, but the net loss widened slightly in the nine-month period to $43.3 million ($1.02 per share) versus $36.6 million a year earlier, largely because revenue declined faster than costs. Accumulated deficit reached $386.7 million. Liquidity is the key investor concern. Cash, cash equivalents and marketable securities totaled $286.2 million at September 30, 2011, down from $349.9 million at year-end 2010. Operating cash burn was $61.9 million for the nine months, driven partly by a $50.6 million drawdown of deferred revenue, which is non-cash in the sense that it reflects previously received upfront payments being recognized. Deferred revenue totaled $160.5 million, a large portion of which relates to the Roche, Takeda and Cubist alliances. Management states existing resources are sufficient to fund planned operations for at least the next several years, but it may need significant additional funds earlier and filed a $150 million shelf registration in July 2011. The filing also highlights several risk and event items: ongoing litigation with Tekmira/Protiva and a University of Utah inventorship suit over the Tuschl patents (no loss accrued), the Roche license being transferred to Arrowhead in October 2011, a Phase I trial initiated for ALN-PCS in September 2011, and a VaxiRNA collaboration with GSK formed in October 2011. The company's near-term value depends on advancing its ALN-TTR, ALN-PCS and ALN-RSV01 programs and on converting partnerships into durable revenue.

    Nov 3, 2011
  48. 2011-Q2

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2011

    Alnylam Pharmaceuticals, Inc. (ALNY) reported its financial results for the quarter and six months ended June 30, 2011. The company continues to operate at a loss, a common characteristic of early-stage biopharmaceutical firms. For the six months ended June 30, 2011, Alnylam reported a net loss of $30.1 million, a slight increase from the $26.9 million net loss in the same period of 2010. Total net revenues from research collaborators decreased to $41.5 million for the six months ended June 30, 2011, down from $51.1 million in the prior year, primarily due to the planned completion of the Novartis collaboration. Operating expenses also decreased slightly, driven by lower general and administrative costs, including reduced legal expenses. The company's balance sheet shows a decrease in cash and cash equivalents and marketable securities, totaling $316.0 million at June 30, 2011, down from $349.9 million at December 31, 2010. This decrease is largely attributable to net cash used in operating activities, which was $32.9 million for the first six months of 2011, despite net cash provided by investing activities from the sale of marketable securities. Alnylam ended the period with $136.6 million in stockholders' equity. The company highlights its core "Alnylam 5x15" product strategy and the advancement of key programs like ALN-TTR and ALN-PCS, with ALN-PCS filing a clinical trial application in the UK. Investors should monitor progress in clinical trials, partnership developments, and cash burn rate, as the company remains in a pre-revenue stage.

    Aug 3, 2011
  49. 2011-Q1

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q1 Ended Mar 31, 2011

    Alnylam Pharmaceuticals' Q1 2011 10-Q shows a company still reliant on collaboration revenue and funding to cover a large operating loss. Net revenues from research collaborators fell 15% year over year to $20.9 million (from $24.6 million), driven by the completion of the Novartis research program in October 2010 and the end of the NIAID government contract in December 2010. Operating expenses rose slightly to $36.6 million, with R&D up $1.6 million on clinical trial and manufacturing costs for ALN-RSV, ALN-VSP and ALN-TTR, partly offset by lower stock-based compensation after the September 2010 restructuring. The net loss widened to $16.3 million, or $0.38 per share, from $12.3 million, or $0.29 per share a year earlier. Liquidity is adequate but declining. Cash, cash equivalents and marketable securities totaled $342.8 million at March 31, 2011, versus $349.9 million at year-end 2010. Operating cash burn was $6.3 million for the quarter, cushioned by a $10.7 million income tax refund received in March 2011. Total deferred revenue of $201.2 million is a meaningful non-cash liability that will be recognized over the coming years, and management states its resources should fund operations for at least the next several years. The accumulated deficit reached $359.6 million. The filing also discloses three new litigation matters in March 2011: a settled Tuschl patent dispute, a trade secret lawsuit from Tekmira and Protiva, and a University of Utah inventorship claim. The company has recorded no liability for the Tekmira or Utah matters, and it incurred $3.3 million in Tuschl-related legal costs in the quarter. Investors should weigh the clinical pipeline, the $10.0 million Takeda milestone received in March 2011, and the Regulus stake against the revenue decline and litigation exposure.

    May 5, 2011
  50. 2010-Q3

    ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2010

    Alnylam Pharmaceuticals' Q3 2010 10-Q shows a company in transition. Nine-month net revenues were $78.8 million (up about 7% year over year), but the quarter included a 25% workforce reduction tied to the planned end of the Novartis research program in October 2010. Management expects revenues to decline significantly beginning in Q4 2010 as Novartis and NIAID funding winds down, and it projects about $25 million of 2011 operating expense savings. Net loss for the nine months narrowed to $36.6 million from $39.8 million, driven mainly by lower R&D (license fees paid to Isis fell sharply), though G&A rose on legal costs tied to the Tuschl patent litigation. Balance sheet liquidity declined. Cash, cash equivalents and marketable securities totaled $371.9 million at September 30, 2010, versus $435.3 million at year-end 2009, and operating cash burn was $64.0 million for the nine months. Deferred revenue of $230.9 million (current plus long-term) is a large non-cash cushion that will be recognized over time, and it is the main reason the company's reported losses are smaller than its cash burn. Management states that existing resources should fund planned operations for at least the next several years, but it also warns that it may need additional capital sooner and that future financings could dilute shareholders. Key risks for investors include the lead RSV program (ALN-RSV01) in a Phase IIb trial, early-stage clinical data on the systemic ALN-VSP program (including one treatment-related death), the uncertain outcome of the Tuschl patent litigation with a jury trial expected in early 2011, and dependence on partners such as Roche, Takeda and Cubist. Subsequent events include the November 2010 CHDI/Medtronic collaboration on ALN-HTT, which gives Alnylam a 50-50 US partnership and shares development funding.

    Nov 4, 2010