Exhibit 99.1

 

 

Theravance Biopharma, Inc. Reports Second Quarter 2017 Financial Results and Provides Business Update

 

Meaningful Clinical Readouts Underpin Progress in Key Programs

 

Additional Milestones Anticipated in Remainder of 2017 and 2018

 

DUBLIN, IRELAND — AUGUST 8, 2017 —

Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma” or the “Company”) today reported financial results for the second quarter ended June 30, 2017. Revenue for the second quarter of 2017 was $3.5 million. The second quarter operating loss was $65.1 million, or $54.7 million excluding non-cash share-based compensation expense of $10.4 million. Cash, cash equivalents, and marketable securities totaled $498.3 million as of June 30, 2017.

 

Rick E Winningham, Chairman and Chief Executive Officer, commented: “We are incredibly pleased with our progress to date in 2017, which includes the delivery of meaningful clinical data across a number of our key pipeline programs. We are in an unprecedented period at Theravance Biopharma, driven by the depth and breadth of our portfolio, the talents and insights of our team, and the overall productivity of our R&D engine.”

 

Recent Pipeline Updates

 

·                  Positive results announced from a 12-month Phase 3 safety study of revefenacin (TD-4208), the Company’s once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), partnered with Mylan.

 

·                  Positive results announced in the 5 mg treatment arm of velusetrag (5-HT4 agonist; TD-5108) from a Phase 2b study in patients with gastroparesis.

 

·                  Early evidence of localized target engagement announced from first cohort of Phase 1b study of TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor) in patients with ulcerative colitis.

 

Expected Upcoming Milestones and Events

 

·                  Revefenacin (TD-4208): NDA filing anticipated in 4Q 2017; completion of the Phase 3b PIFR study in the first quarter of 2018, designed to support commercialization; potential regulatory approval in the US for COPD in 2018.

 

·                  Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol)1: Results from the Phase 3 IMPACT study in 2017; potential regulatory approval in the US and EU for COPD in late 2017; Phase 3 CAPTAIN study completion in asthma patients and potential supplementary regulatory submissions for asthma in 2018.

 

·                  VIBATIV: Televancin Observational Use Registry (TOURTM) data to be published throughout remainder of 2017; data from the Phase 3 registrational bacteremia study in 2018 or 2019.

 

·                  TD-1473: Data from the remaining cohorts of the Phase 1b study in patients with ulcerative colitis in 2018; targeting initiation of induction and maintenance study in 2018.

 

1


The following information was filed by Theravance Biopharma, Inc. (TBPH) on Tuesday, August 8, 2017 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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