Earnings release
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- Theravance Biopharma Medicines That Make a Difference Theravance Biopharma , Inc. Reports First Quarter 2021 Financial Results and Provides Business Update May 4 , 2021 Company completed enrollment for Phase 2 nezulcitinib ( TD - 0903 , COVID lung hyperinflammation ) and Phase 2b izencitinib ( ulcerative colitis ) studies , is near completion of enrollment for ampreloxetine Phase 3 , and reaffirms readout timing for these trials - - Company updates timing for izencitinib ( Crohn's disease ) readout to late Q4 / early Q1 2022 Company's implied 35 % share of YUPELRI® ( revefenacin ) net sales¹ : $ 12.9 million - TRELEGYⓇ Q1 2021 global net sales hit a record $ 341 million , up 37 % from Q1 2020. Company is entitled to tiered royalties of 5.5 % to 8.5 % on TRELEGY net sales² DUBLIN , May 4 , 2021 / PRNewswire / -- Theravance Biopharma , Inc. ( " Theravance Biopharma " or the " Company " ) ( NASDAQ : TBPH ) today reported financial results for the first quarter of 2021 . " 2021 is on track to be a transformational year as we make significant progress towards our business goals , " said Rick E Winningham , Chief Executive Officer . " Our commercial assets provide cash flow to invest in our diversified clinical pipeline . GSK's TRELEGY continues an exceptional , unabated growth trajectory . Our YUPELRI team , with our partner Viatris , continues to drive performance despite pandemic - associated headwinds . While we experienced slightly down sequential quarter - over - quarter net sales results , our January 2021 market share was 19 % -its highest level since launch - andwe ended the quarter on a strong note with March volume demand demonstrating 28 % growth over February . " " Additionally , we are focused on advancing development of our innovative and differentiated pipeline . We continue to progress nezulcitinib , our wholly - owned nebulized lung - selective pan - JAK inhibitor , our potentially best - in - class ampreloxetine for symptomatic neurogenic orthostatic hypotension and izencitinib , our oral gut - selective pan - JAK inhibitor for inflammatory bowel disease that is partnered with Janssen Pharmaceuticals . Our team is looking forward to four significant clinical readouts between now and Q1 2022 : our Phase 2 nezulcitinib trial in Q2 , our Phase 3 ampreloxetine and Phase 2b izencitinib Ulcerative Colitis trials each in Q3 , and the Phase 2 izencitinib Crohn's disease trial in Q4 / Q1 2022. We remain committed to delivering each of these clinical data sets with the highest quality as expeditiously as possible . " Upcoming Clinical Milestones • Q2 2021 : Nezulcitinib ( nebulized lung - selective pan - Janus kinase ( JAK ) inhibitor ) Phase 2 for acute hyperinflammation of the lung in COVID - 19 ( study 0188 ) - enrollment complete and topline results expected in Q2 . • Q3 2021 : Ampreloxetine ( norepinephrine reuptake inhibitor ) Phase 3 for symptomatic neurogenic orthostatic hypotension ( study 0169 ) - enrollment near complete and topline results expected in Q3 . • Q3 2021 : Izencitinib ( gut - selective oral pan - JAK inhibitor for inflammatory intestinal diseases ) Phase 2b in ulcerative colitis ( study 0157 ) - enrollment complete and topline results expected in Q3 . • Q4 2021 / Q1 2022 : Izencitinib ( gut - selective oral pan - JAK inhibitor for inflammatory intestinal diseases ) due to enrollment challenges , Phase 2 in Crohn's disease ( study 0173 ) – enrollment ongoing and topline results now expected in late Q4 2021 / early Q1 2022 . Quarterly Highlight - • YUPELRIⓇ ( revefenacin ) inhalation solution , the first and only once - daily , nebulized bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease ( COPD ) , continued to increase its share of the long - acting nebulized COPD market , increasing to 19.0 % in January 2021 , up from 18.6 % in December 2020 . Economic Interest • TRELEGY ( first once - daily single inhaler triple therapy for COPD and asthma ) , in which the Company holds an economic interest , posted first quarter 2021 global net sales of $ 341 million ( up from $ 249 million , 36.9 % , in the first quarter of 2020 ) ; Theravance Biopharma is entitled to tiered royalties of 5.5 % to 8.5 % of TRELEGY global net sales.³ First Quarter Financial Results • Revenue : Total revenue for the first quarter of 2021 was $ 14.3 million , comprised of non - cash collaboration revenue of $ 3.9 million primarily attributed to our global collaboration with Janssen and $ 10.4 million in Viatris collaboration revenue . Total revenue for the first quarter represents a $ 5.6 million decrease over the same period in 2020 . • YUPELRI : The Viatris collaboration revenue of $ 10.4 million for the first quarter of 2021 represents amounts receivable