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Dec 31, 2019
United Therapeutics Q4 2019 Earnings Report
Reported financial results for Q4 and full year 2019.
Key Takeaways
United Therapeutics Corporation reported a decrease in quarterly net revenue by 18% to $311 million compared to the prior year, primarily due to a $43.6 million decrease in purchases of treprostinil-based products by a U.S. distributor adjusting inventory levels.
Full year net revenue growth of 3% excluding Adcirca.
Company expects 2020 full year net revenue growth.
INCREASE study of Tyvaso in PH-ILD met primary and secondary endpoints.
Remunity system cleared by FDA for pharmacy-filled use; launch expected by July 2020.
United Therapeutics
United Therapeutics
Forward Guidance
The company anticipates growth in net revenue over 2019 levels due to the expanded Orenitram label and the expected launch of Remunity.
Positive Outlook
- Expanded Orenitram label reflecting the FREEDOM-EV results.
- Anticipated near-term launch of Remunity.
- Potential expansion of the Tyvaso label following the INCREASE study results.
- Continued progress on new infusion systems for delivery of parenteral treprostinil.
- U.S. patient demand for Remodulin remained strong
Challenges Ahead
- The year-over-year quarterly revenue decline was largely due to an estimated $43.6 million decrease in purchases of our treprostinil-based products in the fourth quarter of 2019 by one U.S. distributor
- Potential extension of the PDUFA date for Trevyent beyond April 2020.
- The FDA may issue a complete response letter for Trevyent.
- Delay in the ISR launch until 2021.
- Phase II/III DISTINCT study did not meet its primary endpoint.