Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2018 Earnings Presentation
11 slides from Theravance Biopharma's earnings presentation, May 8, 2018
Slide 1: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements Under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the com
Slide 2: Portfolio Advancements in Early 2018
Portfolio Advancements in Early 2018 Economic interest in Trelegy serves as an important strategic asset1 Promising initial launch by GSK following approvals in US and EU in late 2017 Expanded indication approved by FDA, supported by data from IMPACT study Entitled to upward-tiering royalty of 5.5%
Slide 3: Velusetrag in Gastroparesis
Velusetrag in Gastroparesis Partnered with Alfasigma, which funded majority of Phase 2 program for gastroparesis velusetrag Dialogue with US and EU regulatory authorities complete Alfasigma has exercised its option to develop and commercialize velusetrag Decisions within existing collaboration agree
Slide 4: Enhancing Focus on Strategic Priorities in 2018
Enhancing Focus on Strategic Priorities in 2018 Commitment to developing transformational medicines 1 Economic interest. FF/UMEC/VI= Fluticasone Furoate/Umeclidinium/Vilanterol. Innoviva formerly Theravance, Inc. NSRI = norepinephrine serotonin reuptake inhibitor; COPD = chronic obstructive pulmonar
Slide 5: TD-1473: Global Collaboration Agreement with Janssen Biotech
TD-1473: Global Collaboration Agreement with Janssen Biotech Shared belief in TD-1473 as a localized medicine with potential to transform the treatment landscape in inflammatory intestinal disease Meaningful program enhancements for TD-1473 Apply Janssen expertise in IBD to optimize clinical strateg
Slide 6: TD-9855: Exploratory Results Expected Mid-Year
TD-9855: Exploratory Results Expected Mid-Year Intention to seek expedited development path Purpose: Phase 2a study to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance Understanding totality of symptoms encompasses tests of function, orthostatic hypotension status, and
Slide 7: Revefenacin: NDA for Treatment of COPD in FDA Review
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 Revefenacin: NDA for Trea
Slide 8: 1Q 2018 Financial Highlights
1Q 2018 Financial Highlights Three Months Ended, March 31, 2018 2017 ($, in thousands) Unaudited Total Revenue 8,319 3,087 Cost of Goods Sold 826 565 Research and Development1 47,765 40,565 Selling, General and Administrative1 24,704 20,786 Total Costs and Expenses 73,295 61,916 Operating Loss (64,9
Slide 9: 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 10: Advancing Multiple Opportunities for Value Creation
Advancing Multiple Opportunities for Value Creation Programs in Focus in 2018 TD-1473 Intestinally restricted JAK inhibitor TD-9855 NSRI in nOH Revefenacin (TD-4208) Nebulized LAMA in COPD Inhaled JAK inhibitor Serious respiratory diseases Trelegy Ellipta (FF/UMEC/VI) Single inhaler triple therapy I
Slide 11: Advancing Multiple Opportunities for Value Creation
Advancing Multiple Opportunities for Value Creation Programs in Focus in 2018 Managed by Theravance Biopharma: TD-1473 * Initiation of Phase 2b/3 induction and maintenance study in UC + Initiation of Phase 2 induction study in Crohn's disease Intestinally restricted JA\ + Phase 2a results in symptom