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Theravance Biopharma, Inc. Reports Second Quarter 2018 Financial Results and Provides Business Update
TD-1473 Advancing into Phase 2b/3 Study in Ulcerative Colitis in Fourth Quarter Following Completion of Phase 1b Study and Successful Dialogues with FDA and EMA
TD-1473 Advancing into Phase 2 Study in Crohns Disease in Third Quarter
TD-9855 Advancing into Phase 3 Program in nOH in Late 2018 or Early 2019 Following Positive Data from Phase 2 Study and Successful Dialogue with FDA
DUBLIN, IRELAND AUGUST 1, 2018 Theravance Biopharma, Inc. (Theravance Biopharma or the Company) (NASDAQ: TBPH) today reported financial results for the second quarter ended June 30, 2018. Revenue for the second quarter of 2018 was $23.5 million. The Companys second quarter operating loss was $48.7 million or $34.8 million excluding share-based compensation expense. Cash, cash equivalents, and marketable securities totaled $371.2 million as of June 30, 2018.
Rick E Winningham, Chairman and Chief Executive Officer, commented: We have made exciting progress across our portfolio. Positive data from the TD-1473 Phase 1b study in ulcerative colitis and TD-9855 Phase 2 study in nOH provide strong clinical rationale for the progression into registrational programs, and with regulatory dialogues recently completed, each program now has a clear path into late-stage studies. For YUPELRITM, our brand name for revefenacin, we and our partner Mylan are finalizing launch readiness activities in anticipation of a potential FDA approval later this year. In our early stage pipeline, we are preparing to advance TD-8236, our novel inhaled JAK inhibitor for serious respiratory diseases, into the clinic. These recent pipeline advancements along with a strong balance sheet and emerging cash flows from Trelegy Ellipta position us to continue to deliver growth across our business from research to commercial to drive value for shareholders and maximize the impact we can make on patients lives.
Program Updates and Upcoming Milestones
TD-1473 (intestinally restricted pan-Janus kinase (JAK) inhibitor):
· Phase 1b study in 40 patients with ulcerative colitis complete; results demonstrate localized biologic activity and minimal systemic exposure, with a favorable safety and tolerability profile
· Rates of clinical response were higher on all active doses (20, 80, 270 mg) compared with placebo using both partial and total Mayo definitions, with greatest effect seen at the 270 mg dose
· Rectal bleeding scores improved above placebo at the 80 and 270 mg doses
· Endoscopic improvements and mucosal healing were reported in all active arms, none in placebo arm
· Plasma pharmacokinetic (PK) levels were low and consistent with data from healthy volunteers; local GI tissue PK levels above JAK inhibitory concentrations (IC50) for 80 and 270 mg dose
· TD-1473 was generally well tolerated at all doses
· Company and partner Janssen Biotech, Inc. plan to present full results from the Phase 1b study at a future medical meeting
· Initiation of Phase 2 induction study in Crohns disease planned in third quarter of 2018
The following information was filed by Theravance Biopharma, Inc. (TBPH) on Wednesday, August 1, 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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