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Alnylam (ALNY) Q1 Loss Narrower Than Expected, Sales Rise Y/Y
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Alnylam Pharmaceuticals (ALNY - Free Report) reported first-quarter 2024 adjusted loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 75 cents, primarily due to higher collaboration revenues. The company had incurred a loss of $1.06 per share in the year-ago quarter.
The adjusted figure excluded items like stock-based compensation expenses and realized and unrealized (gain) loss on marketable equity securities.
Alnylam recorded total revenues of $494 million in the quarter, which surpassed the Zacks Consensus Estimate of $421 million. In the year-ago quarter, total revenues were $319 million. Net product revenues were $365 million, up 32% year over year on a reported basis, as well as at constant exchange rate, driven by increased patient numbers for Givlaari (givosiran), Oxlumo (lumasiran) and the newly approved Amvuttra (vutrisiran).
Net revenues from collaborators were $119 million, up 225% from $36 million reported in the year-ago quarter. The uptick was primarily driven by revenues recognized under the company’s licensing agreement with Roche (RHHBY - Free Report) , which included a $65 million milestone payment that Alnylam received upon dosing the first patient in the zilebesiran KARDIA-3 clinical study for hypertension indication.
Increased revenues recognized under the company’s collaboration agreement with Regeneron (REGN - Free Report) also contributed to higher total collaboration revenues. Higher collaboration revenues recognized by Alnylam were fueled by an increase in activities under the company’s research services arrangement and licensed programs with REGN.
Please note that Alnylam entered into a strategic collaboration with Roche to co-develop and co-commercialize zilebesiran for the treatment of hypertension in July 2023. The upfront payment amount received from RHHBY, together with several milestone payments, amounts to a potential deal value of up to $2.8 billion.
On the other hand, Alnylam, in partnership with Regeneron, is developing ALN-APP for treating early-onset Alzheimer’s disease. The company, in collaboration with REGN, is also advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases.
ALNY also earns revenues under its ongoing collaboration agreementwith Novartis (NVS - Free Report) . Per the agreement, Alnylam has granted Novartis exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for the treatment of hypercholesterolemia and other human diseases, including Leqvio (inclisiran).
Novartis has also received FDA approval to expand Leqvio’s label to include earlier use in patients with elevated LDL-C who have an increased risk of heart disease as an adjunct to diet and statin therapy.
During the first quarter of 2024, the company recorded royalty revenues of $11 million. In the year-ago quarter, the company recorded royalty revenues of $7 million.
Year to date, shares of Alnylam have plunged 21.5% compared with the industry’s decline of 7.6%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $69 million in the reported quarter, down 32% on a reported basis. However, Onpattro sales beat the Zacks Consensus Estimate as well as our model estimate of $63 million.
In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy in September.
Amvuttra generated sales worth $195 million in the first quarter, up 92% on a reported basis. The initial uptake for the product has been encouraging, with new patients starting treatment, as well as several patients switching from Onpattro. Amvuttra sales beat the Zacks Consensus Estimate of $184 million as well as our model estimate of $180 million.
Givlaari (givosiran), approved for the treatment of acute hepatic porphyria, recorded sales of $58 million, reflecting a year-over-year increase of 21% on a reported basis. Givlaari sales missed the Zacks Consensus Estimate as well as our estimate of $60 million and $61 million, respectively.
Oxlumo (lumasiran) recorded global net product revenues of about $43 million in the first quarter of 2024, reflecting a year-over-year increase of 77% on a reported basis. Oxlumo sales beat the Zacks Consensus Estimate of $33 million and our estimate of $35 million.
Adjusted research and development (R&D) expenses increased 13% year over year to $242 million, primarily driven by a rise in expenses associated with the KARDIA-2 and KARDIA-3 clinical studies evaluating zilebesiran to treat patients with hypertension at high cardiovascular risk. The uptick was also due to greater costs incurred in connection with the phase III HELIOS-B study on vutrisiran for the treatment of patients with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
The top-line data readout from the HELIOS-B study is expected in late June or early July 2024, which, if positive, could form the basis for a regulatory filing by the year's end. A potential label expansion of Amvuttra for the testament of ATTR amyloidosis with cardiomyopathy will increase the eligible patient population of the drug, further boosting sales.
Adjusted selling, general and administrative (SG&A) expenses increased 15% year over year to $185 million, mainly due to ramped-up marketing activities for the promotion of Onpattro and Amvuttra globally.
Cash, cash equivalents and marketable securities as of Mar 31, 2024, amounted to $2.37 billion compared with $2.44 billion recorded as of Dec 31, 2023.
Alnylam Pharmaceuticals, Inc. Price and EPS Surprise
The company reiterated its previously announced financial guidance for 2024.
Alnylam expects net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1.4-$1.5 billion.
Net revenues from collaborations and royalties are expected in the range of $325-$425 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,675-$1,775 million.
Image: Bigstock
Alnylam (ALNY) Q1 Loss Narrower Than Expected, Sales Rise Y/Y
Alnylam Pharmaceuticals (ALNY - Free Report) reported first-quarter 2024 adjusted loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 75 cents, primarily due to higher collaboration revenues. The company had incurred a loss of $1.06 per share in the year-ago quarter.
The adjusted figure excluded items like stock-based compensation expenses and realized and unrealized (gain) loss on marketable equity securities.
Alnylam recorded total revenues of $494 million in the quarter, which surpassed the Zacks Consensus Estimate of $421 million. In the year-ago quarter, total revenues were $319 million. Net product revenues were $365 million, up 32% year over year on a reported basis, as well as at constant exchange rate, driven by increased patient numbers for Givlaari (givosiran), Oxlumo (lumasiran) and the newly approved Amvuttra (vutrisiran).
Net revenues from collaborators were $119 million, up 225% from $36 million reported in the year-ago quarter. The uptick was primarily driven by revenues recognized under the company’s licensing agreement with Roche (RHHBY - Free Report) , which included a $65 million milestone payment that Alnylam received upon dosing the first patient in the zilebesiran KARDIA-3 clinical study for hypertension indication.
Increased revenues recognized under the company’s collaboration agreement with Regeneron (REGN - Free Report) also contributed to higher total collaboration revenues. Higher collaboration revenues recognized by Alnylam were fueled by an increase in activities under the company’s research services arrangement and licensed programs with REGN.
Please note that Alnylam entered into a strategic collaboration with Roche to co-develop and co-commercialize zilebesiran for the treatment of hypertension in July 2023. The upfront payment amount received from RHHBY, together with several milestone payments, amounts to a potential deal value of up to $2.8 billion.
On the other hand, Alnylam, in partnership with Regeneron, is developing ALN-APP for treating early-onset Alzheimer’s disease. The company, in collaboration with REGN, is also advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases.
ALNY also earns revenues under its ongoing collaboration agreementwith Novartis (NVS - Free Report) . Per the agreement, Alnylam has granted Novartis exclusive and worldwide rights to manufacture and commercialize RNAi therapeutics targeting PCSK9 for the treatment of hypercholesterolemia and other human diseases, including Leqvio (inclisiran).
Novartis has also received FDA approval to expand Leqvio’s label to include earlier use in patients with elevated LDL-C who have an increased risk of heart disease as an adjunct to diet and statin therapy.
During the first quarter of 2024, the company recorded royalty revenues of $11 million. In the year-ago quarter, the company recorded royalty revenues of $7 million.
Year to date, shares of Alnylam have plunged 21.5% compared with the industry’s decline of 7.6%.
Image Source: Zacks Investment Research
Quarter in Detail
Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $69 million in the reported quarter, down 32% on a reported basis. However, Onpattro sales beat the Zacks Consensus Estimate as well as our model estimate of $63 million.
In June 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy in September.
Amvuttra generated sales worth $195 million in the first quarter, up 92% on a reported basis. The initial uptake for the product has been encouraging, with new patients starting treatment, as well as several patients switching from Onpattro. Amvuttra sales beat the Zacks Consensus Estimate of $184 million as well as our model estimate of $180 million.
Givlaari (givosiran), approved for the treatment of acute hepatic porphyria, recorded sales of $58 million, reflecting a year-over-year increase of 21% on a reported basis. Givlaari sales missed the Zacks Consensus Estimate as well as our estimate of $60 million and $61 million, respectively.
Oxlumo (lumasiran) recorded global net product revenues of about $43 million in the first quarter of 2024, reflecting a year-over-year increase of 77% on a reported basis. Oxlumo sales beat the Zacks Consensus Estimate of $33 million and our estimate of $35 million.
Adjusted research and development (R&D) expenses increased 13% year over year to $242 million, primarily driven by a rise in expenses associated with the KARDIA-2 and KARDIA-3 clinical studies evaluating zilebesiran to treat patients with hypertension at high cardiovascular risk. The uptick was also due to greater costs incurred in connection with the phase III HELIOS-B study on vutrisiran for the treatment of patients with transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.
The top-line data readout from the HELIOS-B study is expected in late June or early July 2024, which, if positive, could form the basis for a regulatory filing by the year's end. A potential label expansion of Amvuttra for the testament of ATTR amyloidosis with cardiomyopathy will increase the eligible patient population of the drug, further boosting sales.
Adjusted selling, general and administrative (SG&A) expenses increased 15% year over year to $185 million, mainly due to ramped-up marketing activities for the promotion of Onpattro and Amvuttra globally.
Cash, cash equivalents and marketable securities as of Mar 31, 2024, amounted to $2.37 billion compared with $2.44 billion recorded as of Dec 31, 2023.
Alnylam Pharmaceuticals, Inc. Price and EPS Surprise
Alnylam Pharmaceuticals, Inc. price-eps-surprise | Alnylam Pharmaceuticals, Inc. Quote
2024 Financial Guidance Reaffirmed
The company reiterated its previously announced financial guidance for 2024.
Alnylam expects net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1.4-$1.5 billion.
Net revenues from collaborations and royalties are expected in the range of $325-$425 million. Adjusted R&D and SG&A expenses are anticipated in the band of $1,675-$1,775 million.
Zacks Rank
Alnylam currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.