Alnylam Reports Fourth Quarter and Fiscal 2021 Global Preliminary * Product Net Revenue and Provides Additional Updates

CAMBRIDGE, Mass .– (COMMERCIAL THREAD) – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced its preliminary * fourth quarter and full year 2021 global net revenues for ONPATTRO, GIVLAARI and OXLUMO and provided additional updates on product marketing. spear.

2021 Preliminary Commercial and Financial Performances *

ONPATTRO® (patisiran), a commercial-stage RNAi targeting transthyretin (TTR) for the treatment of polyneuropathy in adult patients with hATTR amyloidosis.

  • Global preliminary net product sales for the fourth quarter and fiscal 2021 were approximately $ 139 million and $ 475 million, respectively, representing quarterly and annual growth of 15% and 55% per compared to third quarter 2021 and fiscal 2020, respectively.

  • By the end of 2021, more than 2,050 patients worldwide were receiving commercial ONPATTRO.

GIVLAARI® (givosiran), a commercially available RNAi therapeutic for the treatment of adults with acute hepatic porphyria (AHP).

  • Global preliminary net product sales for the fourth quarter and fiscal 2021 were approximately $ 41 million and $ 128 million, respectively, representing quarterly and annual growth of 28% and 132% compared to third quarter 2021 and fiscal 2020, respectively.

  • By the end of 2021, more than 350 patients worldwide were receiving commercial GIVLAARI.

OXLUMO® (lumasiran), a commercial-stage RNAi for the treatment of primary type 1 hyperoxaluria to lower urinary oxalate levels in pediatric and adult patients.

  • Global preliminary net product sales for the fourth quarter and full year 2021 were approximately $ 19 million and $ 60 million, respectively, representing quarterly growth of 29% from the third quarter of 2021 .

  • By the end of 2021, more than 140 patients worldwide were receiving commercial OXLUMO.

Finally, the company announced today that it expects its non-GAAP operating loss for fiscal 2021 to be significantly improved from the previous year as the company continues its transition towards an autonomous financial profile.

In addition, as of December 31, 2021, Alnylam had approximately $ 2.4 billion in cash, cash equivalents and marketable securities, compared to $ 1.9 billion as of December 31, 2020.

“We are delighted to have ended 2021 on a very strong note with continued execution across our trading portfolio, generating blue chip income at the upper end of our forecast range. These preliminary results reflect the dedication of our teams to providing these important medicines to patients in need around the world, despite the varying dynamics posed by the ongoing pandemic. We are also delighted to have ended the year with Leqvio, in partnership with Novartis, becoming the fourth RNAi treatment approved in the United States and the first indicated to treat a major risk factor for a widespread disease, ”said Yvonne Greenstreet, MBChB, Chairman and CEO of Alnylam. “Additionally, as we reflect on the first anniversary of the announcement of our Alnylam P5x25 strategy, we believe we are on track to meet or potentially exceed these ambitious goals, positioning Alnylam as a leading global multi-product trading company with a large pipeline and organic platform ready to deliver sustainable innovation in the future, a profile rarely seen in our industry.

Alnylam management will discuss these preliminary selected financial results and business updates in a webcast presentation at 40e JP Morgan Annual Healthcare Conference, to be held virtually tomorrow, Monday, January 10, 2022 at 9:45 a.m. ET.

About RNAi Therapeutics

RNAi (RNA interference) is a natural cellular gene silencing process that today represents one of the most promising and advanced frontiers in biology and drug development. His discovery was touted as “a major scientific breakthrough that occurs once every ten years or so”, and was awarded the Nobel Prize for Physiology or Medicine in 2006. By harnessing the natural biological process of l With RNAi occurring in our cells, a new class of drugs known as RNAi therapy is now a reality. Small interfering RNAs (siRNAs), the molecules that mediate RNAi and form Alnylam’s RNAi therapeutic platform, work upstream of today’s drugs by potently inhibiting messenger RNA (mRNA) – the precursors genetic – which encode proteins that cause disease or the disease pathway, thus preventing them from being made. It is a revolutionary approach that has the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) leads the translation of RNA interference (RNAi) in a whole new class of innovative drugs with the potential to transform the lives of people with genetic, cardio-metabolic, infectious liver and central nervous system diseases rare (CNS) / eye diseases. Based on Nobel Prize-winning science, RNAi therapies represent a powerful and clinically validated approach for the treatment of a wide range of serious and debilitating diseases. Founded in 2002, Alnylam implements a bold vision to turn scientific possibilities into reality, with a strong RNAi therapy platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran) and Leqvio® (inclisiran) under development and commercialization by Alnylam’s partner, Novartis. Alnylam has an extensive portfolio of investigational drugs, including six product candidates that are in advanced stages of development. Alnylam performs its “Alnylam P5x25”Strategy to deliver transformative drugs for rare and common diseases to benefit patients worldwide through sustainable innovation and exceptional financial performance, resulting in a leading biotechnology profile. Alnylam is headquartered in Cambridge, MA. For more information on our people, science and pipeline, please visit www.alnylam.com and contact us on Twitter at @Alnylam, on LinkedIn or on Instagram.

Alnylam forward-looking statements

Various statements in this press release regarding Alnylam’s expectations, plans, aspirations and objectives, including, without limitation, those related to its unaudited preliminary selected financial results for 2021, and its aspiration to become a business leading biotechnology company, and the expected achievement or potential exceedance of its’ Alnylam P5x25“, constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements due to various material risks, uncertainties and other factors, including, without limitation: the direct or indirect impact of the global COVID-19 pandemic or any future pandemic on Alnylam’s business, results of operations and financial condition and the effectiveness or timeliness of Alnylam’s efforts to mitigate the impact of the pandemic; the potential impact of the recent leadership transition on Alnylam’s ability to attract and retain talent and to execute successfully its “Alnylam P5x25” strategy; the finalization and audit of its financial results for the fourth quarter and fiscal year 2021 which could potentially lead to changes or adjustments to selected preliminary financial results presented here; Alnylam’s ability to discover and develop new drug candidates and delivery approaches and to successfully demonstrate the efficacy and safety of its drug candidates; the preclinical and clinical results of its product candidates; the actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; launch, market and successfully sell its approved products globally; delays, interruptions or failures in the manufacture and supply of its product candidates or its marketed products; obtain, maintain and protect intellectual property; the ability of Alnylam to successfully expand the indication for ONPATTRO (and potentially vutrisiran, if approved) in the future; Alnylam’s ability to manage its growth and operating expenses through disciplined investments in operations and its ability to achieve a self-sustaining financial profile in the future without the need for future equity financing; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products, in particular Novartis, Regeneron and Vir; the outcome of a dispute; the potential impact of an ongoing government investigation and the risk of future government investigations; and unforeseen expenses; as well as those risks more fully discussed in the “risk factors” filed with Alnylam’s most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in its other documents filed with the DRY. In addition, any forward-looking statement represents Alnylam’s views only to date and should not be construed as representing its views at any later date. Alnylam expressly disclaims any obligation, except to the extent required by law, to update any forward-looking statement.

* Selected preliminary financial results are unaudited, are subject to adjustment and are provided for information only prior to the Company’s announcement of full financial results in February 2022.



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