Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2019)
36 slides from Theravance Biopharma's investor presentation, Sep 4, 2019
Slide 1: Theravance Biopharma Investor Presentation
Theravance Biopharma, Inc. (NASDAQ: TBPH) Investor Presentation September 4, 2019 © 2019 Theravance Biopharma. All rights reserved. THERAVANCE ® , the Cross/Star logo, and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies. YUPELRI ® is a Unit
Slide 2: 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 t
Slide 3: Insight and Innovation in Novel Organ-selective Medicine
3 Application of organ - selective expertise to biologically compelling targets ‣ Medicines designed to act locally at site of disease, with minimal systemic exposure, to expand therapeutic index – Improved efficacy and safety to offer transformational value to payers, patients and HCP’s – Difficult
Slide 4: 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 safe
Slide 5: Differentiated Pipeline to Drive Future Growth
5 Clinical opportunities underpinned by economic interest in TRELEGY ELLIPTA, potential Janssen milestones and YUPELRI ® launch Program Pre - clinical Early Proof of Concept Pivotal Collaborator TD - 1473 ( gut - selective pan - JAK) Ulcerative colitis Crohn’s disease Ampreloxetine (TD - 9855) S ymp
Slide 6: Economic Interest: GSK's TRELEGY ELLIPTA
Economic Interest GSK’s FDA - approved TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 7: GSK's TRELEGY ELLIPTA
GSK’s TRELEGY ELLIPTA FIRST AND ONLY ONCE - DAILY SINGLE INHALER TRIPLE THERAPY 7 Economic interest in TRELEGY ELLIPTA ‣ Upward - tiering royalty of ~5.5% - 8.5% of worldwide net sales 1 ‣ Passive economic interest; no product cost obligations Growth continues after first full year on market Availab
Slide 8: YUPELRI (revefenacin) inhalation solution
YUPELRI ® ( revefenacin ) inhalation solution Nebulized long - acting muscarinic antagonist (LAMA)
Slide 9: YUPELRI: Formal Commercial Launch Underway
YUPELRI ® : Formal Commercial Launch Underway FDA - APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 9 YUPELRI ® (revefenacin) inhalation solution. Approved for the maintenance treatment of patients with COPD. COPD = Chronic Obstructive P ulm onary Disease. 1 Global Strategy for Diagnosis, Management,
Slide 10: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once - Daily Nebulized LAMA ENDURING PATIENT NICHE AND SIGNIFICANT MARKET OPPORTUNITY 10 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 n
Slide 11: Partnership with Mylan Brings Commercial Strength
Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity 11 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 ‣ Th
Slide 12: YUPELRI Launch Update
YUPELRI ® Launch Update ENCOURAGING INITIAL MARKET RESPONSE 12 42 Wins (equates to 136 accounts) ~93 Reviews Scheduled (~405 potential accounts) 100% medical support requests fulfilled <30 days FORMULARY Field force productivity goals exceeded ~7,000 patients prescribed (thru 2Q19) PATIENT 100% Medi
Slide 13: Opportunity for YUPELRI in China
Opportunity for YUPELRI ® (revefenacin) in China POTENTIAL TO ADDRESS LARGE AND UNDERSERVED COPD PATIENT POPULATION 13 15 Expansion of development and commercialization agreement ‣ Mylan granted exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territo
Slide 14: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor (NRI) for neurogenic orthostatic hypotension ( nOH )
Slide 15: Neurogenic orthostatic hypotension and existing options
15 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 16: NET Inhibition with Ampreloxetine
NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone 16 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 symptomat
Slide 17: Ampreloxetine Phase 2 Study in nOH
Ampreloxetine: Phase 2 Study in nOH DESIGNED TO EVALUATE INITIAL AND DURABLE RESPONSE TO THERAPY 17 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 asse
Slide 18: Top-line Phase 2 Results in nOH
18 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 patien
Slide 19: Ampreloxetine Phase 2 Results in nOH, Part C
19 Ampreloxetine: Phase 2 Results in nOH PART C: MEAN CHANGE FROM BASELINE IN OHSA AND OHDAS COMPOSITE SCORES (SYMPTOMATIC SUBJECTS 1 ) 1 Baseline OHSA #1 >4 points. Kaufman, et. al. ENC. 2019. Negative change indicates improvement. OHDAS, Orthostatic Hypotension Daily Activity Scale; OHSA, Orthosta
Slide 20: Ampreloxetine Clinical Program
Ampreloxetine Clinical Program PHASE 3 REGISTRATIONAL PROGRAM IN SYMPTOMATIC NOH 20 Phase 2 data supportive of ongoing Phase 3 program; Phase 3 4 - week efficacy data expected 2H 2020 Study 0169: 4 weeks (N=188) Randomized, double - blind, placebo - controlled, parallel group Study 0170: 22 weeks (N
Slide 21: TD-1473 JAK Inhibitor Program
TD - 1473 JAK Inhibitor Program Oral gut - selective pan - Janus kinase (JAK) inhibitor for ulcerative colitis and other inflammatory intestinal diseases
Slide 22: Differentiated and Potential Breakthrough Approach
Differentiated and Potential Breakthrough Approach ADVANCING IN COLLABORATION WITH JANSSEN IN UC AND CROHN’S 22 TD - 1473 program objectives: Oral pan - JAK inhibitor that distributes selectively throughout the intestines to treat inflammatory intestinal disease locally, with minimal systemic exposu
Slide 23: Encouraging Findings in Phase 1b Study
Encouraging Findings in Phase 1b Study 4 - WEEK TREATMENT IN 40 PATIENTS WITH ULCERATIVE COLITIS 23 Encouraging Phase 1b data and preclinical package including daily dose administration for 6 & 9 months 1 Clinical response as measured by both partial and full Mayo. 2 Surrogate biomarkers include C -
Slide 24: TD-1473: Late Stage Studies in UC and Crohn's
TD - 1473: Gut - selective oral JAK inhibitor LATE STAGE STUDIES IN ULCERATIVE COLITIS AND CROHN’S DISEASE 1 Maintenance phase of the study will have induction responder subjects re - randomized to active doses compared to placebo at 44 w eeks Crohn’s disease Ulcerative colitis Phase 2 (N=160) Dose
Slide 25: Global Collaboration Agreement for TD-1473
Global Collaboration Agreement for TD - 1473 PURPOSED TO MAXIMIZE VALUE OF PROGRAM 25 ‣ 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
Slide 26: TD-8236
TD - 8236 Potential first inhaled non - steroidal anti - inflammatory for moderate - to - severe asthma regardless of Th2 phenotype
Slide 27: Small portion of US patients cause high proportion of cost
27 Small portion of US patients cause high proportion of cost Severe 14% Moderate 16% Severe 61 % Moderate 25% 16M diagnosed asthma cases 1 Healthcare utilization 2 Patient population ‣ 4.9M moderate - to - severe diagnosed patients in US 1 Current treatments ‣ Inhaled steroids, which often fail to
Slide 28: TD-8236: Lung-selective Inhaled 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 - γ 28 38 19 29 7 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma 1 Th2 - low Th2 - high Bold denotes biologics in
Slide 29: TD-8236: Phase 1 Clinical Trial Design
TD - 8236: Phase 1 Clinical Trial Design PART A PART B PART C SAD ( Healthy volunteers) Safety and PK MAD ( Mild asthmatics) Safety, PK, and PD ( FeNO ) MoA Biomarkers (Moderate - to - severe asthmatics) • MoA biomarkers to be assessed in target patient population • Goal: to build confidence in comp
Slide 30: TD-5202 Gut-Selective Irreversible JAK3 Inhibitor
TD - 5202 Investigational Gut - Selective Irreversible JAK3 Inhibitor for Inflammatory Intestinal Diseases
Slide 31: JAK3-Dependent Cytokines in T-cell Mediated Disease
? Proof - of - relevance from positive Phase 2 data with systemic JAK3 inhibitor in alopecia areata, a T - cell mediated disease 1 ? Localized JAK3 inhibition important to avoid systemic immunosuppression (genetic JAK3 deficiency leads to severe immunodeficiency) 31 IE - CTL, intraepithelial cytotox
Slide 32: JAK3 Selectivity
32 PBMC IC 50 ( nM ) IL - 2 pSTAT5 IL - 10 pSTAT3 JAK Pairing JAK1/3 JAK1/TYK2 Tofacitinib 25 56 TD - 5202 100 >10000 JAK3 Selectivity Unique among JAK family, JAK3 has cysteine residue allowing for JAK3 - selective irreversible inhibitor Allows covalent bond with inhibitor Potential benefits includ
Slide 33: Opportunities for Value Creation
Opportunities for Value Creation
Slide 34: Focus on Strategic Priorities
Key programs drive near - and long - term value - creating events Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES 34 TRELEGY ELLIPTA is FF/UMEC/VI or fluticasone furoate/umeclidinium/vilanterol; comprised of ICS, LAMA, and LABA, active compon ent s of Anoro (UMEC/VI).
Slide 35: 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
Slide 36: 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 epis
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