Exhibit 99.1

 

 

Theravance Biopharma, Inc. Reports First Quarter 2018 Financial Results and Provides Business Update

 

Focusing on Advancement of Highest Priority Programs

 

DUBLIN, IRELAND — MAY 8, 2018 —

Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today reported financial results for the first quarter ended March 31, 2018. Revenue for the first quarter of 2018 was $8.3 million. The Company’s first quarter operating loss was $65.0 million or $51.0 million excluding share-based compensation expense. Cash, cash equivalents, and marketable securities totaled $435.5 million as of March 31, 2018 and includes the $100 million upfront payment associated with the global development and commercialization agreement with Janssen Biotech, Inc. (Janssen) for TD-1473.

 

Rick E Winningham, Chairman and Chief Executive Officer, commented: “We are very pleased with our achievements in the first quarter of 2018, led by our global collaboration with Janssen for the development and commercialization of TD-1473 in inflammatory intestinal diseases. As we look to the remainder of 2018, we are enhancing our focus on the most important strategic priorities for the Company, which are those programs where we think there is the greatest opportunity to create transformational medicines. For revefenacin, our commercial readiness activities are underway in anticipation of approval in the US for COPD later this year. With TD-1473 for ulcerative colitis and Crohn’s disease and TD-9855 for neurogenic orthostatic hypotension, we are advancing two highly differentiated assets through mid-stage development. In research, we are preparing to progress a novel inhaled JAK inhibitor for serious respiratory diseases into the clinic. These assets, combined with our strong balance sheet and emerging cash flows from our economic interest in Trelegy Ellipta, position us to advance all segments of our business — from research to commercial — with the goal of creating transformational medicines.”

 

Program Updates

 

·                  Trelegy Ellipta (first once-daily single inhaler triple therapy for chronic obstructive pulmonary disease (COPD))1:  GSK reported first quarter 2018 net sales of $14.6 million; Theravance Biopharma entitled to approximately 5.5% to 8.5% of worldwide net sales of the product

 

·                  U.S. Food and Drug Administration (FDA) approved an expanded indication of Trelegy Ellipta for treatment of a broader population of COPD patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms

·                  Expanded indication based on the positive results of the landmark 10,355 patient IMPACT study, which was recently published in the New England Journal of Medicine

·                  Boxed warning removed from Trelegy Ellipta prescribing information

 

·                  Velusetrag (TD-5108; 5-HT4 agonist):  Collaboration partner Alfasigma S.p.A. (Alfasigma), which funded majority of Phase 2 gastroparesis program costs, has exercised its option to develop and commercialize velusetrag

 

·                  Alfasigma opt-in decision results in $10 million payment to Company and right to receive future potential development, regulatory and sales milestone payments and royalties

 

1


The following information was filed by Theravance Biopharma, Inc. (TBPH) on Tuesday, May 8, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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