Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2018 Earnings Presentation
11 slides from Theravance Biopharma's earnings presentation, Aug 1, 2018
Slide 1: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company are subject to risks and uncertainties that m
Slide 2: TD-9855: Overview of Phase 2 Study in nOH
TD-9855: Overview of Phase 2 Study in nOH Study in patients with neurogenic orthostatic hypotension Extension phase Open label design Up to 24 weeks (20 weeks dosing, 4 week wash out) Primary endpoint at 4 weeks C Single ascending dose portion of TD-9855 (up to 20 mg) Testing blood pressure response
Slide 3: TD-9855: Top-line Phase 2 Results in nOH Parts A and B
TD-9855: Top-line Phase 2 Results in nOH Parts A and B Initial responses observed A Responses reported in majority of patients treated 27 of 34 patients enrolled in Part A showed improvements in SBP and/or standing time Responses observed above 5 mg Confirmation vs. placebo B Statistically significa
Slide 4: TD-9855: Top-line Phase 2 Results in nOH Part C (extension phase)
TD-9855: Top-line Phase 2 Results in nOH Part C (extension phase) Durability of effect observed in repeat dose extension phase C 16 of 21 patients (76%) completed four weeks of treatment Reductions in symptom severity, with most pronounced benefit in patients with symptomatic nOH1 Mean reduction in
Slide 5: TD-1473: Encouraging Findings in Phase 1b Study
TD-1473: Encouraging Findings in Phase 1b Study 4-week treatment in 40 patients with ulcerative colitis 1 Clinical response as measured by both partial and full Mayo 2 Surrogate biomarkers include C-reactive protein (CRP) and fecal calprotectin Key Findings Favorable overall safety and tolerability
Slide 6: NDA supported by Phase 3 efficacy and safety studies
NDA supported by Phase 3 efficacy and safety studies Primary endpoint achieved for both doses in replicate efficacy studies Robust and sustained improvements in FEV1 Effective as monotherapy and as add-on to LABA or LABA/ICS Generally well tolerated in 12-month safety study YUPELRITM: PDUFA Date Nov
Slide 7: 2Q 2018 Financial Highlights
2Q 2018 Financial Highlights Three Months Ended, June 30, 2018 2017 ($, in thousands) Unaudited Total Revenue 23,476 3,509 Cost of Goods Sold (1,448) 1,364 Research and Development1 48,621 42,927 Selling, General and Administrative1 25,007 24,339 Total Costs and Expenses 72,180 68,630 Operating Loss
Slide 8: Economic interest in Trelegy Ellipta serves as an important strategic asset
Economic interest in Trelegy Ellipta serves as an important strategic asset Upward-tiering royalty 5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Program Summary Approved for COPD in US and EU2 FF/UMEC/VI: Comprise of ICS, LAMA, and LABA, active components
Slide 9: Opportunities to Create Transformational Medicines
Opportunities to Create Transformational Medicines YUPELRITM (revefenacin) Nebulized LAMA in COPD (PDUFA date November 13, 2018) TD-1473 Intestinally-restricted JAK inhibitor for inflammatory intestinal diseases TD-9855 NSRI in symptomatic neurogenic orthostatic hypotension TD-8236 Inhaled JAK inhib
Slide 10: Focus on Strategic Priorities
Focus on Strategic Priorities Commitment to developing transformational medicines YUPELRI™ (revefenacin) TD-1473, Opportunities to Create Transformational TD-9855 Medicines TD-8236 Strategic Asset Trelegy Ell Managed by GSK and Innoviva’ Theravance Biopharma 7
Slide 11: Q&A Thank you
Theravance ik’ Biopharma A. Medicines That Make a Difference” Q&A Thank you Theravance uv Biopharma 7’.