Introduction
Revefenacin, marketed as YUPELRI, is a once-daily, nebulized long-acting muscarinic agent (LAMA) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key milestones, sales performance, and future outlook.
Market Position and Growth
Market Share
YUPELRI has consistently demonstrated strong market share growth within the long-acting nebulized segment of the COPD market. As of Q4 2023, YUPELRI held a 31.0% market share in community settings and a 16.6% share in hospital settings, up from 27.1% and 12.5%, respectively, in Q4 2022[1].
Sales Performance
The sales of YUPELRI have shown significant growth over the past few years. In Q4 2023, net sales reached an all-time high of $60.6 million, a 9% increase from Q4 2022 and a 4% increase from Q3 2023[1]. For Q1 2024, net sales were $55.2 million, representing an 18% year-over-year increase from Q1 2023[3][5].
Hospital Channel Growth
The hospital channel has been a key driver of YUPELRI's sales growth. In Q4 2023, doses sold into the hospital channel increased by 37% year-over-year, and in Q1 2024, this growth continued with a 31% year-over-year increase[1][3].
Customer Demand and Market Expansion
Customer demand for YUPELRI has been robust. Despite a slight decrease in net sales in Q2 2024 due to channel mix and pricing factors, customer demand increased by 13% compared to Q2 2023[4]. This demand, coupled with effective commercial execution, has helped YUPELRI expand its market presence.
Financial Performance
Revenue and Profitability
In Q4 2023, Theravance Biopharma achieved a Non-GAAP net profit of $1.4 million, marking a significant milestone in profitability. This was driven by YUPELRI's growth and effective expense management[1].
Collaboration Revenue
The collaboration with Viatris has been lucrative. In Q1 2024, Viatris collaboration revenue increased by 39% year-over-year to $14.5 million, reflecting margin improvements[5].
Capital Return Program
Theravance Biopharma completed a $325 million capital return program in early 2024, reducing shares outstanding by 37%. This move has enhanced shareholder value and reflects the company's strong financial position[1].
Future Outlook and Milestones
Ampreloxetine and Other Pipeline Developments
While YUPELRI is the current flagship product, Theravance Biopharma is also advancing other pipeline assets, such as ampreloxetine. Ampreloxetine, an investigational norepinephrine reuptake inhibitor, is in Phase 3 trials for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The company expects to enroll the last patient in the open-label portion of the CYPRESS study by mid-2025, with top-line data anticipated approximately six months later[4].
TRELEGY Milestones
Theravance Biopharma is also eligible for milestone payments from Royalty Pharma based on the sales performance of TRELEGY, another product in its portfolio. If TRELEGY achieves certain sales thresholds, Theravance Biopharma could receive up to $200 million in milestone payments, with the next milestone payment of $25 million achievable if TRELEGY global net sales reach approximately $2.9 billion in 2024[1][4].
Regulatory and Patent Developments
Additional Method of Use Patent
In July 2024, YUPELRI was granted an additional method of use patent, further strengthening its intellectual property position[4].
NDA Submission in China
Viatris submitted a New Drug Application (NDA) for YUPELRI in China, with a potential milestone payment of $7.5 million if approved[4].
Challenges and Headwinds
Near-Term Headwinds
In Q2 2024, YUPELRI net sales decreased by 1% due to near-term headwinds from an evolved channel mix and a lower realized net price. However, the company remains confident in the product's long-term growth potential[4].
Key Takeaways
- Strong Sales Growth: YUPELRI has consistently shown strong sales growth, driven by increasing customer demand and hospital channel expansion.
- Market Share Expansion: The drug has increased its market share within the long-acting nebulized segment of the COPD market.
- Financial Performance: Theravance Biopharma achieved Non-GAAP profitability in Q4 2023 and has a robust financial position.
- Pipeline Advancements: The company is making progress with ampreloxetine and other pipeline assets.
- Regulatory Milestones: Additional patents and NDA submissions in new markets are expected to further enhance YUPELRI's market position.
FAQs
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What is YUPELRI used for?
YUPELRI is used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
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How has YUPELRI's sales performance been in recent quarters?
YUPELRI's sales have shown significant growth, with Q4 2023 sales reaching an all-time high of $60.6 million and Q1 2024 sales increasing by 18% year-over-year.
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What are the key drivers of YUPELRI's sales growth?
The key drivers include increasing customer demand and significant growth in the hospital channel.
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What is the current status of ampreloxetine?
Ampreloxetine is in Phase 3 trials for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), with enrollment expected to complete by mid-2025.
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What are the potential milestone payments related to TRELEGY?
Theravance Biopharma is eligible for up to $200 million in milestone payments from Royalty Pharma based on TRELEGY's sales performance, with the next milestone payment achievable if TRELEGY global net sales reach approximately $2.9 billion in 2024.
Sources
- Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update - Investor Relations, Theravance Biopharma.
- Theravance Biopharma, Inc. Highlights 2022 Accomplishments and 2023 Key Targets - PR Newswire.
- Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update - PR Newswire.
- Theravance Biopharma, Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update - PR Newswire.
- Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update - Theravance Biopharma.
