– Achieved Full Year 2023 Preliminary Global
Net Product Revenues of $1,241 Million for ONPATTRO®, AMVUTTRA®,
GIVLAARI®, and OXLUMO®, Representing 39% Annual Growth (39% Using
Constant Exchange Rate**) –
– Maintained Strong Balance Sheet with Year-End
Cash and Investments Balance of Approximately $2.4 Billion –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today announced its preliminary* fourth
quarter and full year 2023 global net product revenues for
ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO and provided additional
updates on the products’ commercial launches.
Preliminary Fourth Quarter and Full Year 2023 Commercial and
Financial Performance*
Total TTR: ONPATTRO® (patisiran) & AMVUTTRA®
(vutrisiran)
- Preliminary global net product revenues for ONPATTRO and
AMVUTTRA for the fourth quarter were approximately $79 million and
$175 million, respectively, representing 10% total TTR quarterly
growth compared to Q3 2023, and for the full year 2023 were
approximately $355 million and $558 million, respectively,
representing 40% total TTR annual growth compared to full year
2022.
- As of year-end 2023, over 4,060 patients worldwide were
receiving commercial ONPATTRO or AMVUTTRA.
Total Ultra-Rare: GIVLAARI® (givosiran) & OXLUMO®
(lumasiran)
- Preliminary global net product revenues for GIVLAARI and OXLUMO
for the fourth quarter were approximately $59 million and $33
million, respectively, representing 11% total Ultra-Rare quarterly
growth compared to Q3 2023, and for the full year 2023 were
approximately $219 million and $110 million, respectively,
representing 35% total Ultra-Rare annual growth compared to full
year 2022.
- As of year-end 2023, over 650 patients worldwide were receiving
commercial GIVLAARI and over 430 patients were receiving commercial
OXLUMO.
Further, at December 31, 2023, Alnylam had preliminary cash,
cash equivalents, and marketable securities of approximately $2.4
billion, as compared to $2.2 billion at December 31, 2022.
“We are delighted to have ended the year on a strong note, with
continued execution across our commercial portfolio delivering
top-line product revenue within our guidance range. These
preliminary results reflect growing patient demand for our
transformative products, along with strong commercial execution by
our teams in delivering these important medicines to patients in
need globally. We were also pleased to have reported positive
clinical results across multiple programs in 2023. This includes
zilebesiran, with which we aim to reimagine the treatment of
hypertension, and ALN-APP in Alzheimer’s disease, which provided
the first ever clinical demonstration of gene silencing in the
human brain using an RNAi therapeutic,” said Yvonne Greenstreet,
MBChB, Chief Executive Officer of Alnylam. “As we consider the
progress we made across our business in 2023 and as we look ahead
to reporting results from the HELIOS-B Phase 3 study in early 2024,
we believe we are well on our way to achieving our Alnylam P5x25
goals, positioning Alnylam as a top-tier, global, multi-product
commercial company with a broad pipeline and organic platform
poised to deliver sustainable innovation well into the future, a
profile rarely seen in our industry.”
Alnylam management will discuss these preliminary selected
financial results and commercial updates during a webcast
presentation at the 42nd Annual J.P. Morgan Healthcare Conference
in San Francisco, California tomorrow, Monday, January 8, 2024 at
9:45 a.m. PT (12:45 p.m. ET).
About RNAi Therapeutics RNAi (RNA interference) is a
natural cellular process of gene silencing that represents one of
the most promising and rapidly advancing frontiers in biology and
drug development today. Its discovery has been heralded as “a major
scientific breakthrough that happens once every decade or so,” and
was recognized with the award of the 2006 Nobel Prize for
Physiology or Medicine. By harnessing the natural biological
process of RNAi occurring in our cells, a new class of medicines
known as RNAi therapeutics is now a reality. Small interfering RNA
(siRNA), the molecules that mediate RNAi and comprise Alnylam's
RNAi therapeutic platform, function upstream of today’s medicines
by potently silencing messenger RNA (mRNA) – the genetic precursors
– that encode for disease-causing or disease pathway proteins, thus
preventing them from being made. This is a revolutionary approach
with the potential to transform the care of patients with genetic
and other diseases.
About Alnylam Pharmaceuticals Alnylam Pharmaceuticals
(Nasdaq: ALNY) has led 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 and prevalent
diseases with unmet need. Based on Nobel Prize-winning science,
RNAi therapeutics represent a powerful, clinically validated
approach yielding transformative medicines. Since its founding in
2002, Alnylam has led the RNAi Revolution and continues to deliver
on a bold vision to turn scientific possibility into reality.
Alnylam’s commercial RNAi therapeutic products are ONPATTRO®
(patisiran), AMVUTTRA® (vutrisiran), GIVLAARI® (givosiran), OXLUMO®
(lumasiran), and Leqvio® (inclisiran), which is being developed and
commercialized by Alnylam’s partner, Novartis. Alnylam has a deep
pipeline of investigational medicines, including multiple 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. For more information about our
people, science and pipeline, please visit www.alnylam.com and
engage with us on X (formerly Twitter) at @Alnylam, on LinkedIn, or
on Instagram.
Alnylam Forward Looking Statements This press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. All statements other than historical
statements of fact regarding Alnylam’s expectations, beliefs,
goals, plans or prospects including, without limitation, statements
regarding Alnylam’s aspiration to become a top-tier biotech
company, the potential for Alnylam to identify new potential drug
development candidates and advance its research and development
programs, Alnylam’s ability to obtain approval for new commercial
products or additional indications for its existing commercial
products, and Alnylam’s projected commercial and financial
performance and the planned achievement of its “Alnylam P5x25”
strategy should be considered forward-looking statements. Actual
results and future plans may differ materially from those indicated
by these forward-looking statements as a result of various
important risks, uncertainties and other factors, including,
without limitation, risks and uncertainties relating to: Alnylam’s
ability to successfully execute on its “Alnylam P5x25” strategy;
the finalization and audit of Alnylam’s fourth quarter and 2023
fiscal year financial results which could potentially result in
changes or adjustments to the selected preliminary financial
results presented herein; Alnylam’s ability to discover and develop
novel drug candidates and delivery approaches and successfully
demonstrate the efficacy and safety of its product candidates; the
pre-clinical and clinical results for Alnylam’s product candidates,
including vutrisiran, zilebesiran, and ALN-APP; actions or advice
of regulatory agencies and Alnylam’s ability to obtain and maintain
regulatory approval for its product candidates, including
vutrisiran, as well as favorable pricing and reimbursement;
successfully launching, marketing and selling Alnylam’s approved
products globally; delays, interruptions or failures in the
manufacture and supply of Alnylam’s product candidates or its
marketed products; obtaining, maintaining and protecting
intellectual property; Alnylam’s ability to successfully expand the
approved indications for AMVUTTRA in the future; Alnylam’s ability
to manage its growth and operating expenses through disciplined
investment in operations and its ability to achieve a
self-sustainable financial profile in the future without the need
for future equity financing; the direct or indirect impact of the
COVID-19 global pandemic or any future pandemic on Alnylam’s
business, results of operations and financial condition; Alnylam’s
ability to maintain strategic business collaborations; Alnylam’s
dependence on third parties for the development and
commercialization of certain products, including Roche, Novartis,
Sanofi, Regeneron and Vir; the outcome of litigation; the risk of
future government investigations; and unexpected expenditures; as
well as those risks and uncertainties 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 SEC filings. In addition, any forward-looking
statements represent Alnylam’s views only as of today and should
not be relied upon as representing its views as of any subsequent
date. Alnylam explicitly disclaims any obligation, except to the
extent required by law, to update any forward-looking
statements.
Use of Non-GAAP Financial Measures This press release
contains a non-GAAP financial measure of Constant Exchange Rate
(CER). This measure is not in accordance with, or an alternative
to, GAAP, and may be different from non-GAAP financial measures
used by other companies. Percentage changes in revenue growth at
CER are presented excluding the impact of changes in foreign
currency exchange rates for investors to understand the underlying
business performance. The current period’s foreign currency revenue
values are converted into U.S. dollars using the exchange rates
from the prior period.
__________________________ * The preliminary selected financial
results are unaudited, subject to adjustment, and provided as an
approximation in advance of the Company’s announcement of complete
financial results in February 2024. ** CER = Constant Exchange
Rate, representing growth calculated as if the exchange rates had
remained unchanged from those used during 2022. CER is a Non-GAAP
financial measure.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240107331926/en/
Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom
(Investors and Media) 617-682-4340
Josh Brodsky (Investors) 617-551-8276
Alnylam Pharmaceuticals (NASDAQ:ALNY)
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