– Achieved Full Year 2022 Preliminary Global
Net Product Revenues of $894 Million for ONPATTRO®, AMVUTTRA®,
GIVLAARI®, and OXLUMO®, Representing 35% Annual Growth (43% Using
Constant Exchange Rate**) –
– Strength of AMVUTTRA Launch Drove 37% Total
TTR Annual Revenue Growth –
– Maintained Strong Balance Sheet with Year-End
Cash and Investments Balance of Approximately $2.2 Billion –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today announced its preliminary* fourth
quarter and full year 2022 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 2022 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 $122 million and
$69 million, respectively, representing 12% total TTR quarterly
growth compared to Q3 2022, and for the full year 2022 were
approximately $558 million and $94 million, respectively,
representing 37% total TTR annual growth compared to full year
2021.
- As of year-end 2022, over 2,975 patients worldwide were
receiving commercial ONPATTRO or AMVUTTRA.
GIVLAARI® (givosiran)
- Preliminary global net product revenues for the fourth quarter
and full year 2022 were approximately $47 million and $173 million,
respectively, representing quarterly and annual growth of 3% and
35% compared to Q3 2022 and full year 2021, respectively.
- As of year-end 2022, over 520 patients worldwide were receiving
commercial GIVLAARI.
OXLUMO® (lumasiran)
- Preliminary global net product revenues for the fourth quarter
and full year 2022 were approximately $24 million and $70 million,
respectively, representing quarterly and annual growth of 45% and
17% compared to Q3 2022 and full year 2021, respectively.
- As of year-end 2022, over 280 patients worldwide were receiving
commercial OXLUMO.
Further, at December 31, 2022, Alnylam had preliminary cash,
cash equivalents, and marketable securities of approximately $2.2
billion, as compared to $2.4 billion at December 31, 2021.
“We are pleased to have closed out 2022 on a very strong note
with continued execution across our commercial portfolio,
delivering top-line revenue in line with our guidance range. These
preliminary results reflect healthy patient demand for our
transformative products and strong commercial execution by our
teams in delivering these important medicines to patients in need
around the world. In 2022 we were particularly excited to celebrate
the approval and global launch of AMVUTTRA, which has demonstrated
an impressive commercial performance in its first two full quarters
of launch,” said Yvonne Greenstreet, MBChB, Chief Executive Officer
of Alnylam. “As we consider our commercial and financial
performance, combined with robust execution on the R&D front,
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 41st Annual J.P. Morgan Healthcare Conference
in San Francisco, California tomorrow, Monday, January 9, 2023 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 20 years ago, 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 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, expectations regarding Alnylam’s aspiration to become a
leading biotech company and the planned achievement of its “Alnylam
P5x25” strategy, 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
products, and Alnylam’s projected commercial and financial
performance 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: 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 and the effectiveness
or timeliness of Alnylam’s efforts to mitigate the impact of the
pandemic; the potential impact of the January 2022 leadership
transition on Alnylam’s ability to attract and retain talent and to
successfully execute on its “Alnylam P5x25” strategy; the
finalization and audit of Alnylam’s fourth quarter and 2022 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 its product candidates; 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; successfully launching,
marketing and selling its approved products globally; delays,
interruptions or failures in the manufacture and supply of its
product candidates or its marketed products; obtaining, maintaining
and protecting intellectual property; Alnylam’s ability to
successfully expand the indication for ONPATTRO or 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; Alnylam’s
ability to maintain strategic business collaborations; Alnylam's
dependence on third parties for the development and
commercialization of certain products, including Novartis, Sanofi,
Regeneron and Vir; the outcome of litigation; the potential impact
of a current government investigation and the risk of future
government investigations; and unexpected expenditures; 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 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
difference between the reported 35% annual GAAP growth rate and 43%
annual CER growth rate is due to the inclusion of 8% additional net
product revenue growth in the CER growth rate had exchange rates
remained unchanged from 2021.
____________________________
* 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 2023.
** CER = Constant Exchange Rate,
representing growth calculated as if the exchange rates had
remained unchanged from those used during 2021. CER is a Non-GAAP
financial measure.
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version on businesswire.com: https://www.businesswire.com/news/home/20230108005048/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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