Alkermes Plc Q1 FY2025 earnings call

Management Statement and Operational Highlights

• Richard Pops recognized the passing of colleague Iain Brown and noted Blair Jackson continues as Interim Principal Financial Officer.
• Todd Nichols provided an overview of commercial product performance, noting VIVITROL, ARISTADA, and LYBALVI performance and guidance.
• Blair Jackson reviewed first quarter financial results, discussed macroeconomic conditions, manufacturing footprint, and financial position.
• Craig Hopkinson provided an update on the Orexin portfolio, including progress on ALKS 2680 Phase 2 studies and details on Project Saturn initiative.

Segment Performance

• VIVITROL: In the first quarter, net sales were $101 million. For 2025, the company expects VIVITROL net sales in the range of $440 million to $460 million.
• ARISTADA: First quarter net sales were $73.5 million. Full-year 2025 guidance for ARISTADA is $335 million to $355 million.
• LYBALVI: Net sales grew 23% year-over-year to $70 million in the first quarter. Full-year 2025 guidance for LYBALVI is $320 million to $340 million.
• Manufacturing and Royalty Revenues: Total manufacturing and royalty revenues in the first quarter were $62 million, including $27.8 million from VUMERITY, $17.7 million from long-acting INVEGA products, and approximately $9 million from RISPERDAL CONSTA.

Guidance

• First quarter results were on plan, and the company reiterated financial expectations for the year.
• Q2 net sales from the proprietary portfolio are expected to be in the range of $260 million to $280 million.
• Full-year guidance for VIVITROL ($440M - $460M), ARISTADA ($335M - $355M), and LYBALVI ($320M - $340M) remains in place.

Risks

• Macro-economic conditions and their potential impact on the business.
• Potential tariffs and foreign reference pricing, though the company's U.S.-based manufacturing and supply chain mitigate some risks.
• Regulatory risks, including changes in Medicaid and other policy landscapes.

Q: Joseph Thome asked about the change in endpoints for the NT2 study and flexible dosing in the study.

A: Richard Pops responded that Epworth was elevated to a dual primary endpoint for the NT2 study, and during the double-blind portion, patients are assigned a dose, with open-label extension allowing titration between doses.

Q: Charles Duncan inquired about the split of LYBALVI sales between schizophrenia and bipolar and the importance of potency in ALKS 2680.

A: Todd Nichols said LYBALVI TRx is roughly 50-50 split between schizophrenia and bipolar, with a trend towards bipolar in new patient starts. Richard Pops stated potency is one aspect of ALKS 2680, with other factors like once-daily dosing and wide therapeutic index also important.

Q: Unidentified Analyst asked about safety in the orexin studies and visual disturbances.

A: Richard Pops mentioned an independent data safety monitoring board oversees safety, and they've given a green light with no modifications to the study thus far.

Q: David Amsellem asked about M&A and bolstering the neuroscience pipeline.

A: Blair Jackson stated the company is looking to bring in additional assets to bolster the pipeline if they fit the strategy and add value through development.

Q: Jessica Fye's representative asked about volume vs price contribution to sales and Medicaid coverage of key products.

A: Richard Pops said volume growth is the majority of sales expectation, and Medicaid covers about 45%-50% of VIVITROL, LYBALVI, and ARISTADA.

Q: Leonid Timashev asked about data on cognition and attention in orexin studies and testing for likability.

A: Richard Pops and Blair Jackson mentioned PROs and preclinical data inform potential utility in other indications, with SAD/MAD studies and proof-of-concept work ongoing.

Q: Douglas Tsao asked about decision points for Project Saturn molecules and indication selection.

A: Blair Jackson said they'll decide on indications after getting SAD/MAD data, and Richard Pops noted multiple drugs could advance in different therapeutic areas.