Theravance Biopharma, Inc.
Theravance Biopharma, Inc. Q1 FY2024 earnings call
May 13, 2024 · fiscal period ended 2024-03
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2024-05-13
Management highlights
- Commercial Progress: YUPELRI had $55.2M net sales in Q1 with 18% Y/Y growth; hospital doses up 31% Y/Y.
- Ampreloxetine Updates: Upcoming virtual investor event on May 23, ongoing CYPRESS study enrollment, and preparation for NDA filing post-CYPRESS results.
- Financials: Limited cash burn, ended Q1 with $100M cash and no debt. TRELEGY's strong performance boosts optimism.
- Strategic Imperatives: Continue YUPELRI growth, expand profitability, and prepare for ampreloxetine's potential launch based on CYPRESS study results.
Segment performance
YUPELRI: In the first quarter, YUPELRI achieved $55.2 million in net sales in partnership with Viatris, representing 18% year-on-year growth. U.S. YUPELRI sales increased 12% to $229 million over the past 12 months, and collaboration revenues from Viatris grew 27%. Hospital doses shipped in the first quarter increased 31% year-on-year. Ampreloxetine: Progressing with the registrational Phase III CYPRESS study, aiming to enroll the last patient in the second half of 2024, and preparing for an NDA filing post-CYPRESS results. A virtual investor event on May 23 will discuss ampreloxetine's potential to address unmet needs in nOH and MSA patients.
Guidance
- YUPELRI expected to continue growth in 2024, with potential launch in China midyear.
- CYPRESS study top line data expected in 2025; if successful, plan to act on regulatory and precommercialization strategies for ampreloxetine.
- TRELEGY's strong performance increases confidence in achieving milestones in 2024, 2025, and 2026, with potential $50M to $100M in milestones over those years.
Risks
- Retail channel impact from cyber incident at Change Healthcare, with need for more time to assess full impact on prescriptions.
- Dependence on regulatory approvals for YUPELRI in China and ampreloxetine's CYPRESS study results for successful launch and milestones.
Q&A highlights
Q: Douglas Tsao asked about YUPELRI's retail channel performance and the impact of Change Healthcare's cyber incident.
A: Rhonda Farnum stated it's too early to determine if scripts were lost permanently, but April numbers show a rebound, and they're monitoring closely.
Q: Julian Harrison inquired about YUPELRI's operating leverage and CYPRESS data disclosure.
A: Aziz Sawaf explained that collaboration revenue growth outpaced net sales growth due to efficiencies, and they'll wait for the conclusion of the randomized withdrawal period in CYPRESS to disclose data.
Q: David Risinger asked about YUPELRI's prospects and operating leverage.
A: Rick Winningham and Aziz Sawaf noted expected operating leverage from YUPELRI's growth, driven by execution across hospital and community channels, and discussed milestones like YUPELRI's $25M sales milestone and ampreloxetine's potential.
Q: Marc Frahm asked about non-GAAP breakeven and capital allocation.
A: Aziz Sawaf confirmed non-GAAP breakeven excludes milestones, and Rick Winningham mentioned the board looks at cash position and excess capital for potential shareholder returns.
Q: Jingming Chen (on behalf of Liisa Bayko) asked about the percentage of accounts with therapeutic interchange strategies.
A: Rhonda Farnum replied roughly 35% of accounts have therapeutic interchanges in place, predominantly in nebulization accounts.
Key numbers
Reported versus consensus
Earnings calendar feed
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Transcript
May 13, 2024Full transcript unavailable for redistribution
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