FDA Pushes United Therapeutics-MannKind Tyvaso DPI's Decision Date; United Therapeutics' Q4 Misses Consensus

United Therapeutics Corp UTHR and its partner MannKind Corp 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.