Yahoo Finance Alnylam Pharmaceuticals Inc (ALNY) (Q1 2024) Earnings Call Transcript Highlights: Strong Growth ...
Total Product Revenues: $365 million, 32% growth year-over-year.
TTR Franchise Revenue: $264 million, 29% growth year-over-year.
Rare Franchise Revenue: $101 million, 40% growth year-over-year.
Net Revenue from Collaborations: $119 million, 225% increase year-over-year.
Royalty Revenue: $11 million, 63% increase year-over-year.
Gross Margin on Product Sales: Consistent at 85%.
Non-GAAP R&D Expenses: Increased by 13% year-over-year.
Non-GAAP SG&A Expenses: Increased by 15% year-over-year.
Non-GAAP Operating Gain: $2 million, significant improvement from Q1 2023.
Cash, Cash Equivalents, and Marketable Securities: $2.4 billion, stable from end of 2023.
2024 Revenue Guidance: Anticipated combined net product revenues between $1.4 billion and $1.5 billion.
2024 Collaboration and Royalty Revenue Guidance: Range of $325 million to $425 million.
2024 Combined Non-GAAP R&D and SG&A Expenses Guidance: Between $1.675 billion and $1.775 billion.
Release Date: May 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) reported a robust 32% year-over-year growth in product revenue, reaching $365 million in Q1 2024.
The TTR franchise of Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) showed significant growth, with a 29% increase year-over-year, driven by strong uptake of AMVUTTRA.
Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) presented positive results from the KARDIA-2 Phase II study of zilebesiran, enhancing its potential in the hypertension treatment market.
The company is on track to report top line results from the HELIOS-B Phase III study, which could support a supplemental New Drug Application (sNDA) filing by the end of the year.
Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) demonstrated strong commercial performance internationally, with TTR franchise growth of 23% year-over-year.
Negative Points
Despite overall growth, inventory dynamics decreased reported growth by approximately 4% as inventory for ONPATTRO and AMVUTTRA decreased in Q1.
Pricing pressures in international markets, particularly in Germany, affected revenue growth due to the end of the initial 6-month free pricing period for AMVUTTRA.
There is a significant portion of the patient population (approximately 80% of 25,000 to 30,000 global patients) that remains undiagnosed or untreated, posing a challenge for broader market penetration.
Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) anticipates a reduction in global sales for OXLUMO in Q2 due to the nature and magnitude of Q1 gross to net and partner market timing benefits.
The company faces the need for increased investment in marketing and infrastructure to support potential new launches and existing product growth, which could impact financial resources.
Q & A Highlights
Q: What are your thoughts on the relevant improvement over the control arm in monotherapy, especially in terms of percentage improvement? A: Yvonne L. Greenstreet, CEO & Director of Alnylam Pharmaceuticals, emphasized the importance of demonstrating benefits on clinical outcomes such as death and hospitalization. She noted that the company is focused on delivering these outcomes and believes that if they can show a benefit on outcomes, it will establish the medicine as important. Pushkal Garg, Chief Medical Officer, added that any change in clinical outcomes like death and hospitalization is considered clinically significant due to the progressive nature of the disease.
Q: In the scenario where HELIOS-B is successful, do you anticipate changes in spending guidance or infrastructure ramp-up for the cardiomyopathy launch? Conversely, if HELIOS-B fails, how will this affect your R&D pipeline and financial strategy? A: Jeffrey V. Poulton, CFO, clarified that the current guidance already accounts for a positive HELIOS-B outcome, so no changes in spending guidance are anticipated. However, in the scenario of a failed HELIOS-B, the company would need to prioritize across the business, although they believe this scenario is unlikely.
Q: Can you discuss the trajectory of the placebo arm in HELIOS-B and whether the additional months added to the stats plan could widen the delta in outcomes? A: Yvonne L. Greenstreet responded that the end of the study is a critical period where most events are expected to occur, indicating that this could indeed impact the study's outcomes.
Q: How is Alnylam preparing for the potential launch in cardiomyopathy, and how do you view AMVUTTRA's position in the market relative to competitors like tafamidis? A: Tolga Tanguler, Chief Commercial Officer, expressed confidence in AMVUTTRA's market position, highlighting its rapid action and depth of disease impact. He noted the ongoing efforts to ensure the product is accessible and affordable, emphasizing the company's readiness to leverage its existing commercial infrastructure for a successful launch.
Q: What details will be shared about subpopulations in the HELIOS-B top line results, particularly concerning patients on baseline tafamidis? A: Yvonne L. Greenstreet stated that while the company plans to provide p-values for primary and key secondary endpoints along with safety data, they will also offer some information on subgroups, including those on baseline tafamidis. However, detailed subgroup analyses will likely be reserved for a full presentation at a scientific congress.
Q: Regarding the launch preparations for HELIOS-B, what steps have been taken so far, and what remains to be done pending the trial results? A: Tolga Tanguler detailed that Alnylam is well-prepared for the launch, with a strong commercial team and infrastructure already in place. He highlighted the strategic positioning of AMVUTTRA in treatment centers that handle both cardiomyopathy and polyneuropathy, ensuring a smooth transition should the HELIOS-B results be favorable.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
