Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (June 2019)
41 slides from Theravance Biopharma's investor presentation, Jun 14, 2019
Slide 1: Forward Looking Statements
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 may cause actual results to diff
Slide 2: Theravance Biopharma Strategic Objective
Transform the treatment of serious diseases with novel, locally acting organ-selective therapies 3 Theravance Biopharma Strategic Objective
Slide 3: Organ-selective Approach
4 Conventional Systemic Compound EFFECTIVE NON-EFFECTIVE DOSE-LIMITING SAFETY NON-EFFECTIVE DOSE-LIMITING SAFETY EFFECTIVE Theravance Biopharma Organ-selective Compound Illustrated example: lung selectivity Opportunity to increase dose for improved efficacy, without cost of systemic safety risk Expa
Slide 4: Portfolio of Organ-selective Projects
LUNG GI EYE COPD Crohn’s Disease Diabetic Macular Edema (DME) Moderate-Severe Asthma Ulcerative Colitis Lung Transplant Rejection Celiac Disease Idiopathic Pulmonary Fibrosis (IPF) 5 Portfolio of Organ-selective Projects
Slide 5: YUPELRI (revefenacin) inhalation solution
YUPELRI® (revefenacin) inhalation solution Nebulized long-acting muscarinic antagonist (LAMA)
Slide 6: YUPELRI: Formal Commercial Launch Underway
YUPELRI®: Formal Commercial Launch Underway FDA-APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 7 YUPELRI® (revefenacin) inhalation solution. Approved for the maintenance treatment of patients with COPD. COPD = Chronic Obstructive Pulmonary Disease. 1 Global Strategy for Diagnosis, Management, and Pr
Slide 7: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once-Daily Nebulized LAMA ENDURING PATIENT NICHE AND SIGNIFICANT MARKET OPPORTUNITY 8 Enduring patient niche 9% of COPD patients currently use nebulizers for ongoing maintenance therapy 1 >100M patient treatment days in nebulized COPD segment 2 41% of COPD patients use nebulizers
Slide 8: Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity
Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity 9 HD = hospital discharge HCPs = health care providers Targeting HCPs at key intersections in the patient’s disease management process Hospital is an important site of care for patients with worsening of COPD symptoms Therava
Slide 9: Use of YUPELRI Consistent with GOLD Guidelines
1 Global Strategy for Diagnosis, Management, and Prevention of COPD. 2 GOLD 2019. 3 Tashkin 2017. Use of YUPELRI® Consistent with GOLD Guidelines LAMAs RECOMMENDED AS FIRST-LINE TREATMENT 1 Use of a nebulized treatment is optimal for many COPD patients At least 2/3 of patients make at least one erro
Slide 10: Insufficient Peak Inspiratory Flow Rate Associated with Increased Burden
PIFR is the measure of patient inspiratory effort during a maximal effort Effective DPI use requires patients generate sufficient inspiratory flow rate to overcome internal resistance of a particular devise in order to deaggregate powdered drug into fine particles for optimal peripheral airway and l
Slide 11: YUPELRI Launch Update
YUPELRI® Launch Update ENCOURAGING INITIAL MARKET RESPONSE 12 32 Wins (equates to 104 accounts) ~80 Reviews Scheduled (~320 potential accounts) 100% medical support requests fulfilled <30 days FORMULARY Field force productivity goals exceeded ~4,500 patients prescribed (thru 1Q19) PATIENT 100% Medic
Slide 12: Opportunity for YUPELRI in China
Opportunity for YUPELRI® (revefenacin) in China POTENTIAL TO ADDRESS LARGE AND UNDERSERVED COPD PATIENT POPULATION 13 18 Expansion of development and commercialization agreement Mylan granted exclusive development and commercialization rights to revefenacin in China and adjacent territories Theravan
Slide 13: NDA Supported by Positive Phase 3 Results
NDA Supported by Positive Phase 3 Results TWO REPLICATE EFFICACY STUDIES, PLUS 12-MONTH SAFETY STUDY 14 Pooled analysis. Effective as single agent or on top of LABA or LABA/ICS Primary endpoint achieved in replicate efficacy studies Robust and sustained improvements in FEV1, 24 hour efficacy Study i
Slide 14: Consistent Treatment Effect Maintained with QD Dosing in Phase 3
Consistent Treatment Effect Maintained for 24 Hours with QD Dosing in Phase 3 Efficacy 15 Source: Phase 3 efficacy studies of revefenacin (TD-4208). PD: pre-dose. Note: 24-hour spirometry was assessed at baseline and after 12 weeks’ treatment in a subset of subjects in both studies. Dose dependent e
Slide 15: Low Incidence of Adverse Events Comparable to Placebo
Low Incidence of Adverse Events and Comparable to Placebo in Phase 3 Efficacy 16 Source: Phase 3 efficacy studies of revefenacin (TD-4208). 1 Sudden death in placebo group attributed as cardiovascular by independent adjudication. n=1229 unique subjects; 1 subject was randomized to 175 mcg but also r
Slide 16: Most Frequently Reported Adverse Events in Phase 3 Efficacy Studies
Most Frequently Reported Adverse Events (AEs) in Phase 3 Efficacy Studies 17 Source: Phase 3 efficacy studies of revefenacin (TD-4208). Description Placebo (N=418) 88 mcg (N=417) 175 mcg (N=395) Exacerbation of COPD 48 (11.5%) 42 (10.1%) 42 (10.6%) Cough 17 (4.1%) 17 (4.1%) 17 (4.3%) Dyspnea 23 (5.4
Slide 17: TD-1473 JAK Inhibitor Program
TD-1473 JAK Inhibitor Program Investigational oral gut-selective pan-Janus kinase (JAK) inhibitor for ulcerative colitis and other inflammatory intestinal diseases
Slide 18: Gut-selective Design
Gut-selective Design INFLAMMATION TREATED AT THE TISSUE OF INTEREST 19 Metabolism Gut-selective JAK inhibitor Absorption Metabolism Absorption Systemic JAK inhibitor To feces Gut wall & mucosa Liver Portal vein Intestine To feces Gut wall & mucosa Liver Portal vein Intestine Systemic Circulation Sys
Slide 19: TD-1473: Innovative Approach in Treating IBD
TD-1473: Innovative Approach in Treating IBD compelling Preclinical PACKAGE AND ENCOURAGING Phase 1b DATA 20 Gut selectivity Potent inhibition of Tyk2 Anti-inflammatory activity in disease model Lumen Vehicle treated control TD-1473 treatment Inhibitory potency (pKi) Tyk2 7.5 8 8.5 9 9.5 10 Tofaciti
Slide 20: Differentiated and Potential Breakthrough Approach
Differentiated and Potential Breakthrough Approach ADVANCING IN COLLABORATION WITH JANSSEN IN UC AND CROHN’S 21 TD-1473 program objectives: Oral pan-JAK inhibitor that distributes selectively throughout the intestines to treat inflammatory intestinal disease locally, with minimal systemic exposure o
Slide 21: Encouraging Findings in Phase 1b Study
Encouraging Findings in Phase 1b Study 4-WEEK TREATMENT IN 40 PATIENTS WITH ULCERATIVE COLITIS 22 Detailed results presented in oral late-breaker at UEGW 2018 1 Clinical response as measured by both partial and full Mayo. 2 Surrogate biomarkers include C-reactive protein (CRP) and fecal calprotectin
Slide 22: TD-1473 Clinical Program
Phase 3 induction, 2 arms (N=640) Dose-confirming induction, 8 weeks Phase 2b induction, 4 arms (N=240) Dose-finding induction, 8 weeks 23 Phase 3 maintenance 44 weeks Phase 2b/3 study in ulcerative colitis Phase 2 study in Crohn’s disease Phase 2 study, 3 arms (N=160) Dose-finding induction, 12 wee
Slide 23: Global Collaboration Agreement for TD-1473
Global Collaboration Agreement for TD-1473 PURPOSED TO MAXIMIZE VALUE OF PROGRAM 24 Shared belief in TD-1473 as gut-selective with potential to transform the treatment landscape in inflammatory intestinal disease Meaningful program enhancements Accelerate clinical development and advance UC and Croh
Slide 24: Ampreloxetine (TD-9855)
Ampreloxetine (TD-9855) Investigational once-daily norepinephrine reuptake inhibitor (NRI) for neurogenic orthostatic hypotension (nOH)
Slide 25: Neurogenic Orthostatic Hypotension: Unmet Need
26 1 Existing options associated with one or both therapies noted above; Northera prescribing information. MSA: multiple system atrophy. PD: Parkinson’s disease. PAF: pure autonomic failure. TID: three times per day. nOH characterized by a sustained drop in blood pressure upon standing, due to body
Slide 26: NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone
NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone 27 1 Includes Phase 1 SAD/MAD, elderly, and PET studies in healthy subjects and Phase 2a studies in fibromyalgia and ADHD patients. NET: norepinephrine transporter. QD: once-daily. A path to treating symptomatic
Slide 27: Overview of Phase 2 Study in nOH
Overview of Phase 2 Study in nOH DESIGNED TO EVALUATE INITIAL AND DURABLE RESPONSE TO THERAPY 28 Purpose: To evaluate the effect of ampreloxetine in improving blood pressure and key nOH symptoms Part C: Responders in Part A eligible for open-label treatment for up to 5 months Designed to assess dura
Slide 28: Top-line Phase 2 Results in nOH: Parts A and B
29 Part B change from baseline systolic blood pressure (n=10) LS Mean+ / - SE Change from Baseline (mmHg) Top-line Phase 2 Results in nOH PARTS A and B: SINGLE-ASCENDING DOSE, AMPRELOXETINE OR PLACEBO Initial responses observed A Responses reported in majority of patients treated 27 of 34 patients e
Slide 29: Top-line Phase 2 Results in nOH: Part C
30 Top-line Phase 2 Results in nOH PART C: REPEAT DOSE EXTENSION PHASE Durability of effect observed out to 4 weeks 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 OHSA #1 = 2
Slide 30: Ampreloxetine Clinical Program
Ampreloxetine Clinical Program PHASE 3 REGISTRATIONAL PROGRAM IN SYMPTOMATIC NOH 31 De Novo Study 0169 4 weeks (N=188) Randomized, double-blind, placebo-controlled, parallel group study Study 0170 22 weeks (N=258) Randomized 6-week withdrawal phase (preceded by 4-month open label) Supportive 5-month
Slide 31: TD-8236 Lung-selective Inhaled JAK Inhibitor
TD-8236 Investigational, lung-selective inhaled JAK inhibitor for moderate-to-severe asthma regardless of Th2 phenotype
Slide 32: TD-8236: Lung-selective Pan-JAK Inhibitor
JAK/STAT cytokines implicated in severe asthma Th2-high Th2-low IL-4 IL-23/IL-12 IL-13 IL-6 IL-5 IL-27 TSLP IFN- 34 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma Th2-low Th2-high Bold denotes biologics in development or approved Novel approved
Slide 33: Economic Interest in TRELEGY ELLIPTA
Economic Interest GSK’s FDA-approved TRELEGY ELLIPTA (FF/UMEC/VI): First and only once-daily single inhaler triple therapy
Slide 34: GSK's TRELEGY ELLIPTA Economic Interest
GSK’s TRELEGY ELLIPTA FIRST AND ONLY ONCE-DAILY SINGLE INHALER TRIPLE THERAPY 36 Economic interest in TRELEGY ELLIPTA Upward-tiering royalty of ~5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Growth continues after first full year on market Available in 30
Slide 35: Non-recourse PhaRMA 9% Fixed Rate Term Notes
Non-recourse PhaRMASM 9% Fixed Rate Term Notes SECURITIZED BY ROYALTIES DUE ON NET SALES OF TRELEGY ELLIPTA 37 TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active components of Breo (FF/VI) and Anoro (UMEC/VI). 1Net proceeds (excludi
Slide 36: Arbitration Against Innoviva, Inc.
Arbitration Against Innoviva, Inc. (INVA) TBPH INTENDS TO ENFORCE ALL RIGHTS TO TRELEGY ELLIPTA ROYALTIES1 38 TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active components of Breo (FF/VI) and Anoro (UMEC/VI). 1TBPH holds 85% economi
Slide 37: Opportunities for Value Creation
Opportunities for Value Creation Upcoming milestones
Slide 38: Focus on Strategic Priorities
Significant existing cash resources to fund strategic priorities2 Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES 40 1 TBPH holds 85% economic interest in upward-tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC LLC expenses paid and the amount of cash,
Slide 39: About YUPELRI (revefenacin) inhalation solution
About YUPELRI® (revefenacin) inhalation solution YUPELRI® (revefenacin) inhalation solution is a novel once-daily nebulized LAMA approved for the maintenance treatment of COPD in the US. Market research by Theravance Biopharma indicates approximately 9% of the treated COPD patients in the US use neb
Slide 40: YUPELRI Important Safety Information (US)
YUPELRI® (revefenacin) inhalation solution Important Safety Information (US) YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product. YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes
Slide 41: YUPELRI Important Safety Information (US)
YUPELRI® (revefenacin) inhalation solution Important Safety Information (US) ‘YUPELRI is contraindicated in patients wth hypersensitivity fo revefenacin or any component of this product ‘YUPELRI should not be initiated in patients during acutely deteriorating or potently life-threatening episodes of
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