Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2017 Earnings Presentation
15 slides from Theravance Biopharma's earnings presentation, Nov 7, 2017
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: Upcoming Milestones
Upcoming Milestones Program Milestone Target TD-1439 (NEP inhibitor) Phase 1a SAD/MAD results in healthy volunteers Revefenacin (TD-4208) Phase 3 long-term safety results in COPD patients Velusetrag (TD-5108) Phase 2b results in Gastroparesis patients TD-1473 (JAK inhibitor) Phase 1b results in UC p
Slide 3: TD-1473: Phase 1b First Cohort Demonstrated Localized Target Engagement and Minimal Systemic Exposure
Objectives Results from First Cohort of Patients at 80 mg Evaluate safety No moderate or severe AEs deemed possibly related to study drug No signal of systemic immunosuppression or changes in lipids Confirm PK in UC patients Plasma levels consistent with healthy volunteer SAD/MAD data, minimal syste
Slide 4: Neurogenic Orthostatic Hypotension (nOH) Represents a Significant Unmet Need
Neurogenic Orthostatic Hypotension (nOH) Represents a Significant Unmet Need nOH is characterized by a sustained drop in blood pressure that occurs upon standing up and is associated with the nervous system, specifically due to the body producing insufficient levels of norepinephrine Associated with
Slide 5: Current Approved Therapies in Neurogenic Orthostatic Hypotension (nOH) Have Limitations
Current Approved Therapies in Neurogenic Orthostatic Hypotension (nOH) Have Limitations 1 Associated with one or both therapies noted above 2 Northera prescribing information Successful nOH therapy would target reduction in symptoms and offer meaningful improvements in quality of life for patients C
Slide 6: NET Inhibition with TD-9855 Has Potential to Normalize Vascular Sympathetic Tone in nOH
NET Inhibition with TD-9855 Has Potential to Normalize Vascular Sympathetic Tone in nOH A path to treating nOH without introducing exogenous NE Blockade of NET in nOH patients inhibits endogenous neuronal NE uptake Increased levels of NE in the synapse cause vasoconstriction and a corresponding incr
Slide 7: TD-9855: Phase 2a Study in nOH In Progress, Results Expected 1H 2018
TD-9855: Phase 2a Study in nOH In Progress, Results Expected 1H 2018 Intention to seek expedited development path Purpose: Proof of concept study to evaluate the effect of TD-9855 in improving symptoms of orthostatic intolerance Key endpoints: Change from placebo in sitting and standing blood pressu
Slide 8: Velusetrag: Phase 2b Study Provides First Clinical Evaluation of Effect on Gastroparesis Symptoms
Velusetrag: Phase 2b Study Provides First Clinical Evaluation of Effect on Gastroparesis Symptoms 5 mg demonstrated statistically significant improvements in gastroparesis symptoms compared to placebo 15 and 30mg doses did not improve symptoms, likely due to side effects at high doses All doses sign
Slide 9: Revefenacin: Phase 3 Registrational Program Complete, with NDA Filing Planned in Late 2017
* P < 0.0001 versus placebo ** P <0.001 versus placebo * ** * * * ** Revefenacin: Phase 3 Registrational Program Complete, with NDA Filing Planned in Late 2017 Primary endpoint achieved for both doses in both replicate efficacy studies Robust and sustained improvements in FEV1 Effective as monothera
Slide 10: Financial Summary
Financial Summary Select Financial Metrics as of September 30, 2017 Three Months Ended September 30, 2017 (in thousands) Product Sales $ 4,140 Revenue from Collaborative Arrangements 135 Total Revenue 4,275 Cost of Goods Sold 985 Research and Development 1 39,343 Selling, General and Administrative
Slide 11: GSK's Trelegy Ellipta Offers Significant Potential
Economic interest serves as an important strategic asset Upward-tiering royalty 5.5% - 8.5% of worldwide net sales2 Expected to launch in US in mid-November Passive economic interest with no cost obligations to TBPH GSK’s Trelegy Ellipta Offers Significant Potential FDA Approval for COPD in Septembe
Slide 12: Upcoming Milestones
Upcoming Milestones Program Milestone Target TD-1439 (NEP inhibitor) Phase 1a SAD/MAD results in healthy volunteers Revefenacin (TD-4208) Phase 3 long-term safety results in COPD patients Velusetrag (TD-5108) Phase 2b results in Gastroparesis patients TD-1473 (JAK inhibitor) Phase 1b results in UC p
Slide 13: About VIBATIV (telavancin)
About VIBATIV® (telavancin) VIBATIV was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including MRSA. VIBATIV is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic
Slide 14: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patients with pre-existing moderate/severe renal impairment (CrCl <50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus v
Slide 15: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patents wih pre-existing moderatelsevere renal impairment (CrC 50 mLini) who were weaed wth VIBATIV® fr hospts-acquired bacterial peumoniaiventiatr associated bactrlal pneumonia had increased morally served versus vancomycin. Use of V