United Therapeutics Corp (NASDAQ:UTHR) and its partner MannKind Corp (NASDAQ:MNKD) have received an FDA information request letter for additional information regarding the pulmonary safety of Tyvaso DPI.
- United Therapeutics responded to the agency's information request.
- However, the FDA has considered this response to be a significant amendment to the NDA, extending FDA's review deadline to May 2022 from February 2022.
- Related: United Therapeutics-MannKind's Formulated Tyvaso Shows Benefit In Pulmonary Hypertension Patients.
- United Therapeutics Earnings: Q4 FY21 sales increased 8% Y/Y to $415.2 million, missing the consensus of $427.62 million.
- Treprostinil-based product sales (Tyvaso, Remodulin, and Orenitram) grew by $23.5 million.
- The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting the expansion of the Tyvaso label to include pulmonary hypertension associated with interstitial lung disease.
- Operating income increased from $65.3 million to $169.8 million, and net income improved from $98.8 million to $112.2 million.
- The company posted Q4 adjusted EPS of $3.51 missing the consensus of $3.72.
- Operating expenses declined to $245.4 million, down from $319.6 million on lower R&D and SG&A costs.
- Price Action: UTHR shares closed at $193.11, MNKD shares closed at $3.66 on Wednesday.