Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2018 Earnings Presentation
10 slides from Theravance Biopharma's earnings presentation, Nov 6, 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: Strategic Focus in 2018
Strategic Focus in 2018 JAK = Janus kinase. NSRI = noreprenephrine serotonin reuptake inhibitor. nOH = neurogenic orthostatic hypotension. SBP = systolic blood pressure. QD = once-daily. LAMA = long-acting muscarinic antagonist. PDUFA = Prescription Drug User Fee Act. YUPELRI is the proposed brand n
Slide 3: TD-9855: Phase 2 Results Support Progression
TD-9855: Phase 2 Results Support Progression Three-part proof of concept study in nOH 1 Symptomatic defined as OSHA #1 > 4. OHSA = Orthostatic Hypotension Symptom Assessment. OHSA #1 measures dizziness (cardinal symptom of nOH), lightheadedness, feeling faint, or feeling of impending black out Key F
Slide 4: TD-1473: Encouraging Findings in Phase 1b Study
TD-1473: Encouraging Findings in Phase 1b Study 4-week treatment in 40 patients with active 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 tolera
Slide 5: YUPELRI: PDUFA Date November 13, 2018
NDA supported by Phase 3 efficacy and safety studies Primary endpoint achieved for both doses in replicate efficacy studies Generally well tolerated in 12-month safety study Additional Phase 3 program results presented at fall meetings ERS International Congress: Descriptive data showed reductions i
Slide 6: 3Q 2018 Financial Highlights
3Q 2018 Financial Highlights Three Months Ended, September 30, 2018 2017 ($, in thousands) Unaudited Total Revenue 12,838 4,275 Cost of Goods Sold 705 985 Research and Development1 52,693 39,343 Selling, General and Administrative1 21,890 20,944 Total Costs and Expenses 75,288 61,272 Operating Loss
Slide 7: Economic interest in Trelegy Ellipta
Economic interest in Trelegy Ellipta Upward-tiering royalty of approximately 5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Program Summary FF/UMEC/VI: Comprise of ICS, LAMA, and LABA, active components of Breo (FF/VI) and Anoro (UMEC/VI) Available in 16 c
Slide 8: Opportunities to Create Transformational Medicines
Opportunities to Create Transformational Medicines YUPELRITM (revefenacin) Nebulized LAMA in COPD PDUFA date November 13, 2018 and commercial launch, if approved TD-1473 Intestinally-restricted JAKi for inflammatory intestinal diseases Initiating Phase 2 study in Crohn’s disease and Phase 2b/3 study
Slide 9: Focus on Strategic Priorities
Focus on Strategic Priorities Commitment to developing transformational medicines YUPELRI™ Nebulized LAMA in COPD NSRI in symptomatic neurogenic orthostatic hypotension Transformational 8855 * Initiating Phase 3 program dicines Eee rnrest maape by SK mn F/OMEC/ I utatne Frater novia ferme Terrance,
Slide 10: Q&A Thank you
Theravance ik’ Biopharma AK. Medicines That Make a Difference® Q&A Thank you jeravance Kt Biopharma 7’.