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Benzinga
Benzinga
Technology
Vandana Singh

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

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.
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