10-K: Theravance Biopharma Reports YUPELRI Sales Growth and Advances Ampreloxetine Phase 3 Trial in 2024

Theravance Biopharma's 2024 10-K filing highlights YUPELRI's net sales growth, continued progress in the Ampreloxetine Phase 3 clinical study, and a strategic review to unlock shareholder value.

Summary

• Theravance Biopharma's 2024 Form 10-K reveals an 8% increase in YUPELRI net sales, reaching $238.6 million, driven by hospital volume growth of 41%.
• The company is progressing with its Ampreloxetine Phase 3 clinical study (CYPRESS) for MSA patients with symptomatic nOH, with enrollment expected to complete in mid-2025 and data anticipated six months later.
• A $50.0 million milestone payment was received from Royalty Pharma due to TRELEGY's 2024 global net sales reaching $3.46 billion.
• A Strategic Review Committee has been formed to assess strategic alternatives for the company, including YUPELRI, Ampreloxetine, and TRELEGY.
• The company reported a net loss of $56.4 million for the year ended December 31, 2024, and had cash, cash equivalents, and marketable securities of $88.4 million as of the same date.

Sentiment

Score: 6

Explanation: The document presents a mixed sentiment. While there's positive growth in YUPELRI sales and progress in the Ampreloxetine clinical trial, the company still faces a net loss and is exploring strategic alternatives, indicating some uncertainty.

Positives

• YUPELRI experienced net sales growth and reached launch-to-date highs in annual net sales and brand profitability.
• Hospital volumes for YUPELRI grew 41% in 2024, contributing significantly to overall net sales growth.
• The Ampreloxetine Phase 3 clinical study is progressing as expected.
• The company received a $50.0 million milestone payment from Royalty Pharma.
• The formation of a Strategic Review Committee indicates a focus on unlocking shareholder value.

Negatives

• The company reported a net loss of $56.4 million for the year ended December 31, 2024.
• The company's cash, cash equivalents, and marketable securities decreased to $88.4 million as of December 31, 2024.

Risks

• The strategic review process may not result in a transaction.
• The company faces competition from other pharmaceutical companies.
• The company is subject to extensive regulation by the FDA and other governmental authorities.
• The company's reliance on third-party manufacturers poses a risk to its supply chain.
• The company may face competition from generic versions of YUPELRI.

Future Outlook

The company anticipates continued YUPELRI demand growth in 2025 and beyond and expects sales, marketing, and medical affairs expenditures may increase in 2025 as it prepares for the potential commercial launch of ampreloxetine.

Industry Context

The company operates in the competitive biopharmaceutical industry, facing competition from companies with greater resources and experience. YUPELRI competes with short-acting nebulized bronchodilators, while Ampreloxetine, if approved, would compete with generic droxidopa and midodrine.

Comparison to Industry Standards

• Verona Pharma plcs ensifentrine, a selective inhaled dual inhibitor of PDE3 and PDE4, was launched in the US in June 2024 as a maintenance treatment for adults with COPD.
• Sanofi and Regeneron Pharmaceutical, Inc.s IL-4/IL-13 monoclonal antibody (mAb) Dupixent (dupilumab) recently received approval in the US for COPD for maintenance treatment for patients with moderate-to-severe COPD, who are uncontrolled with current SOC triple therapy (LAMA + LABA + ICS) and have evidence of Type 2 inflammation and frequent exacerbation history.
• For treatment of COPD, Trelegy competes in all major markets with AstraZenecas Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate, dosed twice per day).
• Trimbow (beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide, dosed twice per day) from Chiesi Farmaceutici is an additional COPD competitor in Europe.
• For treatment of asthma, TRELEGY is the only triple therapy approved in the US and competes in Japan with Novartiss Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate, dosed once daily).

Legal Proceedings

• The company is involved in patent infringement litigation against generic companies seeking to market a generic version of YUPELRI.
• As of February 28, 2025, the company has settled all litigation with Accord Healthcare, Inc.; Lupin Pharmaceuticals, Inc.; Orbicular Pharmaceutical Technologies Private Limited; Qilu Pharmaceuticals Co., Ltd.; and Teva Pharmaceuticals, Inc.

Stakeholder Impact

• Shareholders may be impacted by the strategic review process and any potential transactions resulting from it.
• Employees may be affected by potential changes in the company's structure or operations.
• Patients may benefit from the continued development and commercialization of YUPELRI and Ampreloxetine.
• The company's financial performance and strategic decisions may impact its relationships with suppliers and creditors.

Next Steps

• Complete enrollment in the Ampreloxetine Phase 3 clinical study (CYPRESS) in mid-2025.
• Await top-line data from the Ampreloxetine Phase 3 clinical study approximately six months after enrollment completion.
• Continue the strategic review process to assess all strategic alternatives to the Company.

Key Dates