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Alnylam Pharmaceuticals (ALNY)

Alnylam Pharmaceuticals Inc. is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam's commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), and OXLUMO™ (lumasiran) and Leqvio® (inclisiran) being developed and commercialized by Alnylam's partner Novartis. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its 'Alnylam P5x25' strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

Company profile

Ticker
ALNY
Exchange
Website
CEO
John Maraganore
Employees
Location
Fiscal year end
Former names
ALNYLAM PHARMACEUTICALS INC
SEC CIK
Subsidiaries
Alnylam U.S., Inc. • Alnylam Securities Corporation • Sirna Therapeutics, Inc. • Alnylam Austria GmbH • Alnylam Brasil Farmaceutica Ltda. • Alnylam (Bermuda) Ltd. • Alnylam Canada ULC • Alnylam France SAS • Alnylam Europe AG • Alnylam Germany GmbH ...
IRS number
770602661

ALNY stock data

Calendar

28 Jul 22
28 Sep 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 577.74M 577.74M 577.74M 577.74M 577.74M 577.74M
Cash burn (monthly) (no burn) 14.19M 91.56M 81.55M 40.94M 48.18M
Cash used (since last report) n/a 41.9M 270.26M 240.71M 120.85M 142.23M
Cash remaining n/a 535.84M 307.47M 337.02M 456.89M 435.51M
Runway (months of cash) n/a 37.8 3.4 4.1 11.2 9.0

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
22 Aug 22 Sigal Charles Elliott Stock Option Common Stock Grant Acquire A No No 217.91 4,456 971.01K 4,456
15 Aug 22 Sharp Phillip A Common Stock Sell Dispose S No Yes 232.81 715 166.46K 0
15 Aug 22 Sharp Phillip A Common Stock Sell Dispose S No Yes 231.65 3,853 892.55K 715
15 Aug 22 Sharp Phillip A Common Stock Sell Dispose S No Yes 230.71 16,186 3.73M 4,568
15 Aug 22 Sharp Phillip A Common Stock Sell Dispose S No Yes 229.93 11,600 2.67M 20,754
15 Aug 22 Sharp Phillip A Common Stock Sell Dispose S No Yes 228.33 1,218 278.11K 32,354
15 Aug 22 Sharp Phillip A Common Stock Sell Dispose S No Yes 226.16 98 22.16K 33,572
15 Aug 22 Sharp Phillip A Common Stock Option exercise Acquire M No Yes 63.86 3,670 234.37K 33,670
15 Aug 22 Sharp Phillip A Common Stock Option exercise Acquire M No Yes 30.09 30,000 902.7K 30,000
15 Aug 22 Sharp Phillip A Stock Option Common Stock Option exercise Dispose M No Yes 30.09 30,000 902.7K 0
92.8% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 412 429 -4.0%
Opened positions 52 65 -20.0%
Closed positions 69 57 +21.1%
Increased positions 122 148 -17.6%
Reduced positions 156 142 +9.9%
13F shares Current Prev Q Change
Total value 24.37B 21.85B +11.5%
Total shares 111.36M 112.17M -0.7%
Total puts 1.87M 1.09M +71.8%
Total calls 2.91M 758.4K +283.8%
Total put/call ratio 0.6 1.4 -55.2%
Largest owners Shares Value Change
FMR 14.32M $2.09B -10.7%
Vanguard 11.04M $1.61B +2.0%
Capital World Investors 10.29M $1.5B +71.5%
Baillie Gifford & Co 9.97M $1.45B -1.7%
BLK Blackrock 7.66M $1.12B +0.7%
TROW T. Rowe Price 7M $1.02B +3.0%
Wellington Management 5.81M $847.81M -17.4%
Dodge & Cox 5.26M $767.02M -4.0%
STT State Street 2.99M $435.93M +2.7%
JPM JPMorgan Chase & Co. 2.28M $333.07M -21.8%
Largest transactions Shares Bought/sold Change
Capital World Investors 10.29M +4.29M +71.5%
FMR 14.32M -1.72M -10.7%
Capital International Investors 1.63M +1.63M NEW
Wellington Management 5.81M -1.22M -17.4%
IVZ Invesco 168.83K -799.92K -82.6%
Holocene Advisors 0 -799.22K EXIT
JPM JPMorgan Chase & Co. 2.28M -635.38K -21.8%
Alliancebernstein 675.01K +618.47K +1093.9%
American Century Companies 574.94K -556.9K -49.2%
BX Blackstone 0 -517.39K EXIT

Financial report summary

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Risks
  • The current pandemic of COVID-19 and its variants, and the future outbreak of other highly infectious or contagious diseases, could continue to have an adverse impact on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials and pre-clinical studies.
  • The marketing and sale of ONPATTRO, GIVLAARI, OXLUMO, AMVUTTRA or any future products may be less successful than anticipated, and we may be unable to expand the indications for ONPATTRO, AMVUTTRA or OXLUMO.
  • We have a history of losses and may never become and remain consistently profitable.
  • We will require substantial funds to continue our research, development and commercialization activities and if the funds we require are greater than what we have estimated, we may need to critically limit or significantly scale back or cease our operations.
  • Although we sold a portion of the royalty stream and commercial milestones from the global sales of Leqvio by our collaborator, Novartis, we are entitled to retain the remaining portion of future royalties from the global sales of Leqvio and, if certain specified thresholds are met, to the remaining portion of commercial milestone payments, and any negative developments related to Leqvio could have a material adverse effect on our receipt of those payments.
  • Geopolitical risks associated with the ongoing military conflict between Russia and Ukraine could have an adverse impact on our business, financial condition and results of operations, including our clinical trials.
  • We expect our operating results to fluctuate in future periods, which may adversely affect our stock price.
  • If the estimates we make, or the assumptions on which we rely, in preparing our condensed consolidated financial statements and/or our projected guidance prove inaccurate, our actual results may vary from those reflected in our projections and accruals.
  • The investment of our cash, cash equivalents and marketable securities is subject to risks which may cause losses and affect the liquidity of these investments.
  • Volatility in foreign currency exchange rates could have a material adverse effect on our operating results.
  • Changes in tax law could adversely affect our business and financial condition.
  • We may not be able to execute our business strategy if we are unable to maintain existing or enter into new alliances with other companies that can provide business and scientific capabilities and funds for the development and commercialization of our product candidates. If we are unsuccessful in forming or maintaining these alliances on terms favorable to us, our business may not succeed.
  • If any collaborator materially amends, terminates or fails to perform its obligations under agreements with us, the development and commercialization of our product candidates could be delayed or terminated.
  • We have limited manufacturing experience and resources and we must incur significant costs to develop this expertise and/or rely on third parties to manufacture our products.
  • We rely on third parties to conduct our clinical trials, and if they fail to fulfill their obligations, our development plans may be adversely affected.
  • If we are unable to attract and retain qualified key management and scientists, development, medical and commercial staff, consultants and advisors, in particular following our recent leadership transition, our ability to implement our business plan may be adversely affected.
  • We may have difficulty expanding our operations successfully as we continue our evolution from a U.S.- and EU-based company primarily involved in discovery, pre-clinical testing and clinical development into a global company that develops and commercializes multiple drugs.
  • The use of social media presents risks and challenges.
  • Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or access to our systems.
  • Our business and operations may be negatively impacted by the United Kingdom’s withdrawal from the EU.
  • Any product candidates we or our partners develop may fail in development or be delayed to a point where they do not become commercially viable.
  • We or our partners may be unable to obtain U.S. or foreign regulatory approval for our or our partnered product candidates and, as a result, we or our partners may be unable to commercialize such product candidates.
  • Even if we or our partners obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory oversight. If we or our partners fail to comply with continuing U.S. and foreign requirements, our approvals could be limited or withdrawn, we could be subject to other penalties, and our business would be seriously harmed.
  • We may incur significant liability if enforcement authorities allege or determine that we are engaging in commercial activities or promoting our commercially approved products in a way that violates applicable regulations.
  • Even if we receive regulatory approval to market our product candidates, the market may not be receptive to our product candidates upon their commercial introduction, which could prevent us from becoming profitable.
  • We are a multi-product commercial company and expect to continue to invest significant financial and management resources to continue to build our marketing, sales, market access and distribution capabilities and further establish our global infrastructure. Even if we successfully scale our commercial capabilities, the market may not be receptive to our commercial products.
  • The patient populations suffering from hATTR amyloidosis, AHP and PH1 are small and have not been established with precision. If the actual number of patients is smaller than we estimate, or if we cannot raise awareness of these diseases and diagnosis is not improved, our revenue and ability to achieve profitability from these products may be adversely affected.
  • Any drugs we develop may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Failure to comply with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Governments outside the U.S. may impose strict price controls, which may adversely affect our revenues.
  • If we or our collaborators, CMOs or service providers fail to comply with healthcare laws and regulations, or legal obligations related to privacy, data protection and information security, we or they could be subject to enforcement actions, which could affect our ability to develop, market and sell our products and may harm our reputation.
  • We are subject to governmental regulation and other legal obligations, particularly related to privacy, data protection and information security, and we are subject to consumer protection laws that regulate our marketing practices and prohibit unfair or deceptive acts or practices. Our actual or perceived failure to comply with such obligations could harm our business.
  • Our ability to obtain services, reimbursement or funding from the federal government may be impacted by possible reductions in federal spending and services, and any inability on our part to effectively adapt to such changes could substantially affect our financial position, results of operations and cash flows.
  • There is a substantial risk of product liability claims in our business. If we are unable to obtain sufficient insurance, a product liability claim against us could adversely affect our business.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements or insider trading violations, which could significantly harm our business.
  • If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
  • If we are not able to obtain and enforce patent protection for our discoveries, our ability to develop and commercialize our product candidates will be harmed.
  • We license patent rights from third-party owners. If such owners do not properly or successfully obtain, maintain or enforce the patents underlying such licenses, our competitive position and business prospects may be harmed.
  • Other companies or organizations may challenge our patent rights or may assert patent rights that prevent us from developing and commercializing our products.
  • If we become involved in intellectual property litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, and in the case of such litigation or proceedings against us, substantial liability for damages or be required to stop our product development and commercialization efforts.
  • If we fail to comply with our obligations under any licenses or related agreements, we may be required to pay damages and could lose license or other rights that are necessary for developing, commercializing and protecting our RNAi technology, as well as our approved products and any other product candidates that we develop, or we could lose certain rights to grant sublicenses.
  • Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information.
  • The pharmaceutical market is intensely competitive. If we are unable to compete effectively with existing drugs, new treatment methods and new technologies, we may be unable to commercialize successfully any drugs that we develop.
  • We face competition from other companies that are working to develop novel drugs and technology platforms using technology similar to ours. If these companies develop drugs more rapidly than we do or their technologies, including delivery technologies, are more effective, our ability to successfully commercialize drugs may be adversely affected.
  • If our stock price fluctuates, purchasers of our common stock could incur substantial losses.
  • We may incur significant costs from class action litigation.
  • Future sales of shares of our common stock, including by our significant stockholders, us or our directors and officers, could cause the price of our common stock to decline.
  • Regeneron’s ownership of our common stock could delay or prevent a change in corporate control.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Management Discussion
  • Net product revenues increased during the three and six months ended June 30, 2022, compared to the same periods in 2021, as a result of increased patients on ONPATTRO, GIVLAARI, and OXLUMO therapies, offset by an unfavorable impact from foreign exchange rates on our international revenues.
  • We expect net product revenues to increase during 2022, as compared to 2021, as we continue to add new patients onto our commercial products, including AMVUTTRA which was recently approved, as well as launch these products into additional markets, assuming regulatory approvals.
  • Net revenues from collaborations decreased during the three and six months ended June 30, 2022, as compared to the same periods in 2021, primarily due to a decrease in revenue recognized in connection with our collaboration agreement with Regeneron, attributed to reduced research and manufacturing activities and timing of reimbursable activities.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. senior Avg
New words: AMVUTTRA, answer, AstraZeneca, attendance, BioNTech, bleeding, BPA, bypassing, CHMP, contrary, declaratory, dozen, easily, ebb, eplontersen, Franchise, heightened, hemoglobinuria, IgAN, immunoglobulin, judgement, mg, misuse, nephropathy, nocturnal, paroxysmal, peer, persisted, scrutiny, SE, substantive, symposia, talent, unanimously, unlawful
Removed: adolescent, Appellate, awaiting, compensatory, counsel, dated, denial, Division, emergence, expert, initiative, leave, MAA, plaintiff, prejudice, reargument, recognizing, rescissory, reversing, screening, Southern, speed, stipulation, thereunder, traceable, underway

Patents

Utility
Compositions and methods for inhibition of HAO1 (hydroxyacid oxidase 1 (glycolate oxidase)) gene expression
20 Sep 22
The invention relates to RNAi agents, e.g., double-stranded RNAi agents, targeting the HAO1 gene, and methods of using such RNAi agents to inhibit expression of HAO1 and methods of treating subjects having, e.g., PH1.
Utility
Modified RNA Agents with Reduced Off-Target Effect
15 Sep 22
One aspect of the present invention relates to double-stranded RNA (dsRNA) agent capable of inhibiting the expression of a target gene.
Utility
Compositions and Methods for Inhibiting Expression of the LECT2 Gene
15 Sep 22
The disclosure relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the LECT2 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of LECT2.
Utility
Angiopoietin-like 3 (ANGPTL3) Irna Compositions and Methods of Use Thereof
15 Sep 22
The present invention relates to RNAi agents, e.g., double stranded RNA (dsRNA) agents, targeting the Angiopoietin-like 3 (ANGPTL3) gene.
Utility
Sterol regulatory element binding protein (SREBP) chaperone (SCAP) iRNA compositions and methods of use thereof
6 Sep 22
The invention relates to double stranded ribonucleic acid (dsRNAi) agents and compositions targeting the SCAP gene, as well as methods of inhibiting expression of a SCAP gene and methods of treating subjects having a SCAP-associated disorder, such as nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), using such dsRNAi agents and compositions.