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Alnylam (ALNY) Up as Q2 Earnings Beat on Collaboration Revenues
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Alnylam Pharmaceuticals (ALNY - Free Report) reported second-quarter 2024 adjusted earnings of 56 cents per share against the Zacks Consensus Estimate of a loss of 74 cents. The improvement was primarily driven by the recognition of a payment of approximately $185 million, which was previously deferred, upon modifying Alnylam’s ongoing collaboration with Regeneron (REGN - Free Report) . The company had incurred a loss of $1.62 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 $660 million in the quarter, which surpassed the Zacks Consensus Estimate of $448 million. In the year-ago quarter, total revenues were $319 million. The top line surged more than 100% year over year.
Net product revenues were $410 million, up 34% year over year on a reported basis and 35% at a constant exchange rate, driven by strong growth in patient demand for the newly approved drug, Amvuttra (vutrisiran), as well as for Givlaari (givosiran) and Oxlumo (lumasiran).
Net revenues from collaborators were $227 million, up significantly from $6 million reported in the year-ago quarter. The uptick was primarily driven by revenues recognized under the company’s licensing agreement withRegeneron. Alnylam, in partnership with Regeneron, is developing mivelsiran (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.
Higher collaboration revenues recognized from Regeneron during the reported quarter were on account of a payment received for a modification to Alnylam’s existing agreement with REGN regarding cemdisiran. Per the modified agreement, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as monotherapy for complement-mediated indications.
Alnylam now has full global development and commercialization rights to mivelsiran in all indications, as Regeneron opted out of further co-development and co-commercialization of mivelsiran, in development for cerebral amyloid angiopathy (CAA) and Alzheimer's disease. Regeneron will be eligible to receive low double-digit royalties on sales of mivelsiran if approved.
Alnylam also recognizes collaboration revenues from Roche (RHHBY - Free Report) . Last year, the company entered into a strategic collaboration with Roche to co-develop and co-commercialize zilebesiran to treat hypertension. The total value of the zilebesiran deal with Roche is approximately $2.8 billion.
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 treating 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 second quarter of 2024, the company recorded royalty revenues of $22 million, driven by higher Leqvio sales as Novartis continues to grow demand for the drug worldwide. In the year-ago quarter, the company recorded royalty revenues of $7 million.
The stock climbed 13.1% on Aug 1, as investors were impressed by the better-than-expected second-quarter results, along with an increase in the financial guidance for 2024. Year to date, shares of Alnylam have soared 40.3% against the industry’s decline of 0.5%.
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 $77 million in the reported quarter, down 16% on a reported basis. However, Onpattro sales beat the Zacks Consensus Estimate of $58 million as well as our model estimate of $55 million.
In 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission also approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy.
Amvuttra generated sales worth $230 million in the second quarter, up 74% on a reported basis. The 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 $205 million as well as our model estimate of $194 million.
Givlaari (givosiran), approved for the treatment of acute hepatic porphyria, recorded sales of $62 million, reflecting a year-over-year increase of 7% on a reported basis. Givlaari sales also surpassed the Zacks Consensus Estimate as well as our estimate of $61 million and $58 million, respectively.
Oxlumo (lumasiran) recorded global net product revenues of $41 million in the reported quarter, reflecting a year-over-year increase of 68% on a reported basis. Oxlumo sales beat the Zacks Consensus Estimate of $37 million but missed our estimate of $44 million.
Adjusted research and development (R&D) expenses increased 14% year over year to $246 million, primarily driven by a rise in expenses associated with the KARDIA-3 clinical study evaluating zilebesiran to treat patients with hypertension at high cardiovascular risk. The uptick was also due to greater costs incurred in connection with the development program for mivelsiran, which was being evaluated to treat early-onset Alzheimer’s disease and CAA in separate early to mid-stage studies.
Adjusted selling, general and administrative (SG&A) expenses increased 21% year over year to $207 million, mainly due to ramped-up marketing activities for the promotion of Onpattro and Amvuttra globally.
Cash, cash equivalents and marketable securities as of Jun 30, 2024, amounted to $2.62 billion compared with $2.37 billion recorded as of Mar 31, 2024.
2024 Financial Guidance Raised
Alnylam now expects combined net product revenues from Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1.575-$1.650 billion compared with the previous guidance of $1.4-$1.5 billion.
The company also raised its guidance for net revenues from collaborations and royalties to $575-$650 million from $325-$425 million.
Alnylam also expects higher adjusted R&D and SG&A expenses in the range of $1.775-$1.875 billion for 2024 compared with the previously guided range of $1.675-$1.775 billion.
In late June, Alnylam reported positive top-line results from a late-stage study evaluating Amvuttra for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy.
The phase III HELIOS-B study, seeking to expand the label of Amvuttra, met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular events in the overall population as well as the monotherapy population.
The study also demonstrated statistically significant improvements across all secondary endpoints in both the overall and monotherapy populations.
Alnylam is gearing up to proceed with global regulatory submissions starting later in 2024, including filing a supplemental new drug application with the FDA using a Priority Review Voucher.
Image: Bigstock
Alnylam (ALNY) Up as Q2 Earnings Beat on Collaboration Revenues
Alnylam Pharmaceuticals (ALNY - Free Report) reported second-quarter 2024 adjusted earnings of 56 cents per share against the Zacks Consensus Estimate of a loss of 74 cents. The improvement was primarily driven by the recognition of a payment of approximately $185 million, which was previously deferred, upon modifying Alnylam’s ongoing collaboration with Regeneron (REGN - Free Report) . The company had incurred a loss of $1.62 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 $660 million in the quarter, which surpassed the Zacks Consensus Estimate of $448 million. In the year-ago quarter, total revenues were $319 million. The top line surged more than 100% year over year.
Net product revenues were $410 million, up 34% year over year on a reported basis and 35% at a constant exchange rate, driven by strong growth in patient demand for the newly approved drug, Amvuttra (vutrisiran), as well as for Givlaari (givosiran) and Oxlumo (lumasiran).
Net revenues from collaborators were $227 million, up significantly from $6 million reported in the year-ago quarter. The uptick was primarily driven by revenues recognized under the company’s licensing agreement withRegeneron. Alnylam, in partnership with Regeneron, is developing mivelsiran (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.
Higher collaboration revenues recognized from Regeneron during the reported quarter were on account of a payment received for a modification to Alnylam’s existing agreement with REGN regarding cemdisiran. Per the modified agreement, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as monotherapy for complement-mediated indications.
Alnylam now has full global development and commercialization rights to mivelsiran in all indications, as Regeneron opted out of further co-development and co-commercialization of mivelsiran, in development for cerebral amyloid angiopathy (CAA) and Alzheimer's disease. Regeneron will be eligible to receive low double-digit royalties on sales of mivelsiran if approved.
Alnylam also recognizes collaboration revenues from Roche (RHHBY - Free Report) . Last year, the company entered into a strategic collaboration with Roche to co-develop and co-commercialize zilebesiran to treat hypertension. The total value of the zilebesiran deal with Roche is approximately $2.8 billion.
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 treating 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 second quarter of 2024, the company recorded royalty revenues of $22 million, driven by higher Leqvio sales as Novartis continues to grow demand for the drug worldwide. In the year-ago quarter, the company recorded royalty revenues of $7 million.
The stock climbed 13.1% on Aug 1, as investors were impressed by the better-than-expected second-quarter results, along with an increase in the financial guidance for 2024. Year to date, shares of Alnylam have soared 40.3% against the industry’s decline of 0.5%.
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 $77 million in the reported quarter, down 16% on a reported basis. However, Onpattro sales beat the Zacks Consensus Estimate of $58 million as well as our model estimate of $55 million.
In 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission also approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy.
Amvuttra generated sales worth $230 million in the second quarter, up 74% on a reported basis. The 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 $205 million as well as our model estimate of $194 million.
Givlaari (givosiran), approved for the treatment of acute hepatic porphyria, recorded sales of $62 million, reflecting a year-over-year increase of 7% on a reported basis. Givlaari sales also surpassed the Zacks Consensus Estimate as well as our estimate of $61 million and $58 million, respectively.
Oxlumo (lumasiran) recorded global net product revenues of $41 million in the reported quarter, reflecting a year-over-year increase of 68% on a reported basis. Oxlumo sales beat the Zacks Consensus Estimate of $37 million but missed our estimate of $44 million.
Adjusted research and development (R&D) expenses increased 14% year over year to $246 million, primarily driven by a rise in expenses associated with the KARDIA-3 clinical study evaluating zilebesiran to treat patients with hypertension at high cardiovascular risk. The uptick was also due to greater costs incurred in connection with the development program for mivelsiran, which was being evaluated to treat early-onset Alzheimer’s disease and CAA in separate early to mid-stage studies.
Adjusted selling, general and administrative (SG&A) expenses increased 21% year over year to $207 million, mainly due to ramped-up marketing activities for the promotion of Onpattro and Amvuttra globally.
Cash, cash equivalents and marketable securities as of Jun 30, 2024, amounted to $2.62 billion compared with $2.37 billion recorded as of Mar 31, 2024.
2024 Financial Guidance Raised
Alnylam now expects combined net product revenues from Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $1.575-$1.650 billion compared with the previous guidance of $1.4-$1.5 billion.
The company also raised its guidance for net revenues from collaborations and royalties to $575-$650 million from $325-$425 million.
Alnylam also expects higher adjusted R&D and SG&A expenses in the range of $1.775-$1.875 billion for 2024 compared with the previously guided range of $1.675-$1.775 billion.
Alnylam Pharmaceuticals, Inc. Price and Consensus
Alnylam Pharmaceuticals, Inc. price-consensus-chart | Alnylam Pharmaceuticals, Inc. Quote
Pipeline Updates
In late June, Alnylam reported positive top-line results from a late-stage study evaluating Amvuttra for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy.
The phase III HELIOS-B study, seeking to expand the label of Amvuttra, met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular events in the overall population as well as the monotherapy population.
The study also demonstrated statistically significant improvements across all secondary endpoints in both the overall and monotherapy populations.
Alnylam is gearing up to proceed with global regulatory submissions starting later in 2024, including filing a supplemental new drug application with the FDA using a Priority Review Voucher.
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.