Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2018)
27 slides from Theravance Biopharma's investor presentation, Jan 8, 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: Theravance Biopharma Investment Highlights
Theravance Biopharma Investment Highlights 1 Approximately $390M in cash, cash equivalents, and marketable securities as of 12/31/17 (preliminary, unaudited financials). Productive Research Engine Validated in Multiple Disease Areas Pipeline Internally-Discovered High Value Assets Robust Business Mo
Slide 3: Milestones Anticipated in 2018
Advancing Multiple Opportunities for Value Creation Milestones Anticipated in 2018 1 Peak inspiratory flow rate. 2 Economic interests. Regulatory and clinical milestones as reported by GlaxoSmithKline. Trelegy Ellipta previously referred to as the Closed Triple. FF/UMEC/VI= Fluticasone Furoate/Umecl
Slide 4: Economic Interests
Economic Interests GSK’s FDA-approved Trelegy Ellipta (FF/UMEC/VI) FF/UMEC/VI= Fluticasone Furoate/Umeclidinium/Vilanterol
Slide 5: Economic interest serves as an important strategic asset
Economic interest serves as an important strategic asset Upward-tiering royalty 5.5% - 8.5% of worldwide net sales2 Passive economic interest with no cost obligations to TBPH GSK’s Trelegy Ellipta Offers Significant Potential Now Approved in US and Europe for Treatment of COPD1 All statements based
Slide 6: JAK Inhibitor Program
JAK Inhibitor Program Oral intestinally-restricted pan-Janus kinase (JAK) inhibitors for ulcerative colitis and other inflammatory intestinal diseases
Slide 7: Intestinally Restricted JAK Program Represents a Potential Breakthrough Approach to Treating IBD
1 Tofacitinib (Xeljanz®) - an oral, systemically available, JAK inhibitor, which has demonstrated efficacy in treating moderate to severe ulcerative colitis patients. Estimated to be 900K cases of ulcerative colitis in 2017 in the US. Source: Ulcerative Colitis Epidemiology, November 2016 Intestinal
Slide 8: Vision for TD-1473 in UC: Transform Treatment Paradigm
Vision for TD-1473 in UC: Transform Treatment Paradigm Safe enough for mild-moderate, effective enough for moderate-severe Tofacitinib TD-1473 Filgotinib/Upadacitinib Mesalamine Systemic or topical steroids Immunomodulators Biologics Surgery Ozanimod * Decision Resources, Ulcerative colitis 2015; **
Slide 9: TD-1473: Phase 1b Study Progressing in Ulcerative Colitis Patients
Purpose: Provide compelling, directional evidence of 1473 target product profile in patients to inform dose selection and enable progression into a larger induction and maintenance study Primary endpoint: To evaluate safety, tolerability, PK and PD of TD-1473 in moderately-to-severely active UC pati
Slide 10: Results from First Cohort of Patients
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 11: TD-9855
TD-9855 Dual norepinephrine and serotonin reuptake inhibitor (NSRI) for neurogenic orthostatic hypotension (nOH)
Slide 12: 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 13: Current Approved Therapies in 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 14: 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 15: TD-9855: Phase 2a Study in nOH In Progress
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 16: Velusetrag (TD-5108)
Velusetrag (TD-5108) Highly selective 5-HT4 agonist for gastroparesis
Slide 17: Velusetrag in Gastroparesis
Velusetrag in Gastroparesis Highly selective 5-HT4 receptor agonist with high intrinsic activity Partnered ex-US with Alfasigma2 FDA Fast Track designation in gastroparesis Long term tox and carc studies complete Two studies complete in gastroparesis Symptom improvements at 5 mg dose Reduced gastric
Slide 18: Velusetrag: Phase 2b Study Provides First Clinical Evaluation
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 30 mg doses did not improve symptoms, likely due to side effects at high doses All doses sig
Slide 19: Late Stage & Commercial Assets, Acute Care
Late Stage & Commercial Assets, Acute Care Revefenacin (TD-4208): Nebulized Long-Acting Muscarinic Antagonist (LAMA) VIBATIV® (telavancin): Commercial, Once-Daily, Dual Mechanism Antibiotic
Slide 20: Acute Care Commercial Infrastructure Positioned to Support VIBATIV and Revefenacin
Acute Care Commercial Infrastructure Positioned to Support VIBATIV® and Revefenacin Label Expansion Strategy for VIBATIV Growth Complementary Products to Optimize the Acute Care Organization Potential for broadest set of indications of any branded anti-MRSA antibiotic Approval in cSSSI and HABP/VABP
Slide 21: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once-Daily Nebulized LAMA Enduring Patient Niche and Significant Market Opportunity Unmet Need for Nebulized LAMA Therapy Once-daily LAMAs are first-line therapy for moderate to severe COPD1 No nebulized LAMAs available today; only available in handheld devices Nebulized therapy
Slide 22: Revefenacin: NDA Submitted to FDA in November 2017 for Treatment of COPD
NDA supported by Phase 3 efficacy and safety studies Primary endpoint achieved for both doses in both replicate efficacy studies Robust and sustained improvements in FEV1 Effective as monotherapy and as add-on to LABA or LABA/ICS Generally well tolerated Generally well tolerated in 12-month safety s
Slide 23: Opportunities for Value Creation Upcoming Milestones
Opportunities for Value Creation Upcoming Milestones
Slide 24: Milestones Anticipated in 2018
Advancing Multiple Opportunities for Value Creation Milestones Anticipated in 2018 1 Peak inspiratory flow rate. 2 Economic interests. Regulatory and clinical milestones as reported by GlaxoSmithKline. Trelegy Ellipta previously referred to as the Closed Triple. FF/UMEC/VI= Fluticasone Furoate/Umecl
Slide 25: 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 26: 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 27: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patents wih pre-exsting moderatelsevere renal impairment (CrC 0 mLimi) who were eoted wih VIBATIV® fr hospts-acquired bacterial peumoni/venlatr associated Dactral pneumonia had increased morally served versus vancomycin. Use of VIBATI
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