On January 8, 2023 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported 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 (Press release, Alnylam, JAN 8, 2023, View Source [SID1234626028]).
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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.
* 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.
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.