Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2019)
38 slides from Theravance Biopharma's investor presentation, Sep 9, 2019
Slide 1: Theravance Biopharma Investor Presentation
Theravance Biopharma, (NASDAQ: TBPH) Investor Presentation Inc. September 9, 2019 THERAVANCE®, the Cross/Star logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of the Theravance Biopharma group of companies. YUPELRI® is a United States registered trademark of Mylan Specialty L.P.
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 to diff
Slide 3: Insight and Innovation in Novel Organ-selective Medicine
Insight and Innovation in Novel Organ-selective Medicine TRANSFORMING TREATMENT OF SINGLE ORGAN DISEASES 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 Imp
Slide 4: Organ-selective Approach
Organ-selective Approach COMPOUNDS DESIGNED TO FULLY HARNESS INTENDED BIOLOGY Conventional Systemic Compound Theravance Biopharma Organ-selective Compound ‣ ‣ Often unable to achieve maximal due to dose limiting safety efficacy Opportunity to increase dose for improved efficacy, without cost of syst
Slide 5: Differentiated Pipeline to Drive Future Growth
Differentiated Pipeline to Drive Future Growth Program Pre-clinical Early Proof of Concept Pivotal Collaborator Ampreloxetine (TD-9855) Symptomatic neurogenic orthostatic hypotension TD-8236 (lung-selective pan-JAK) Inflammatory lung diseases TD-5202 (gut-selective irreversible JAK3) Inflammatory in
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 Economic interest in TRELEGY ELLIPTA Strongest US ELLIPTA launch to date ‣ ‣ 160 Upward-tiering royalty of ~5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations TRELEGY 140 120 100 80
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 ‣ ‣ First and only once-daily bronchodilator delivered in a nebulizer Higher of two doses approved:175 mcg once daily, for use with any standard jet nebulizer Unmet need for nebulized LAMA therapy ‣ Once-d
Slide 10: Compelling Need for Once-Daily Nebulized LAMA
Compelling Need for Once-Daily Nebulized LAMA ENDURING PATIENT NICHE AND SIGNIFICANT MARKET OPPORTUNITY 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 nebu
Slide 11: Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity
Partnership with Mylan Brings Commercial Strength in Nebulized Opportunity + HD 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 Theravance Biopharma’s established hospital-focus
Slide 12: YUPELRI Launch Update
YUPELRI® Launch Update ENCOURAGING INITIAL MARKET RESPONSE ACCESS FORMULARY PATIENT 42 Wins (equates to 136 accounts) 100% Medicare Part B 1 Field force productivity goals exceeded ~46% Commercial ~93 Reviews Scheduled (~405 potential accounts) ~7,000 patients prescribed (thru 2Q19) Permanent J-CODE
Slide 13: Opportunity for YUPELRI in China
Opportunity for YUPELRI ® (revefenacin) in China POTENTIAL TO ADDRESS LARGE AND UNDERSERVED COPD PATIENT POPULATION 1 Expansion of development and commercialization agreement ‣ Mylan granted exclusive development and commercialization rights to nebulized revefenacin in China and adjacent territories
Slide 14: Ampreloxetine (TD-9855)
Ampreloxetine (TD-9855) Once-daily norepinephrine reuptake inhibitor (NRI) for neurogenic orthostatic hypotension (nOH)
Slide 15: Symptomatic nOH Represents a Significant Unmet Need
Symptomatic nOH Represents a Significant Unmet Need nOH characterized by a sustained drop in blood pressure upon standing, due to body producing insufficient levels of norepinephrine (NE) ‣ ‣ ‣ Associated with several autonomic disorders: MSA, PD, PAF Symptoms include dizziness, fainting, blurred vi
Slide 16: NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone
NET Inhibition with Ampreloxetine Offers Potential Restore Vascular Sympathetic Tone to A path to treating symptomatic 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 co
Slide 17: Ampreloxetine: Phase 2 Study in nOH
Ampreloxetine: Phase 2 Study in nOH DESIGNED TO EVALUATE INITIAL AND DURABLE RESPONSE TO THERAPY Three-part design in patients with nOH: • Up to 24 weeks (20 weeks dosing, Patients started on Part A, and responders moved to Part B and/or Part C (extension phase) Purpose: To evaluate the effect of am
Slide 18: Top-line Phase 2 Results in nOH
Top-line Phase 2 Results in nOH PARTS A and B: SINGLE ASCENDING DOSE, AMPRELOXETINE OR PLACEBO Part B change from baseline systolic blood pressure (n=10) SBP: systolic blood pressure. 18 LS Mean+ / - SE Change from Baseline (mmHg) B Confirmation vs. placebo Statistically significant difference of 30
Slide 19: Ampreloxetine: Phase 2 Results in nOH
Ampreloxetine: Phase 2 Results in nOH PART C: MEAN CHANGE FROM BASELINE IN OHSA AND OHDAS COMPOSITE SCORES (SYMPTOMATIC SUBJECTS1) 4 3 2 1 0 -1 -2 -3 -4 -5 -6 0 (n=17) ↑ Baseline pre-dose 4 (n=13) ↑ Primary efficacy endpoint 8 (n=12) 12 (n=9) 16 (n=9) 20 (n=7) ↑ Last dose ampreloxetine 22 (n=7) 24 (
Slide 20: Ampreloxetine Clinical Program
Ampreloxetine Clinical Program PHASE 3 REGISTRATIONAL PROGRAM IN SYMPTOMATIC NOH De novo study participants 20 Phase 2 data supportive of ongoing Phase 3 program; Phase 3 4-week efficacy data expected 2H 2020 Study 0170: 22 weeks (N=254) Randomized 6-week withdrawal phase (preceded by 4-month open l
Slide 21: TD-1473 Program JAK Inhibitor
TD-1473 Program JAK Inhibitor 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 Encouraging Phase 1b study in UC patients ‣ ‣ Data demonstrated localized biological target engagement with minimal systemic exposure Clinical responses after only 4 weeks of therapy Preclini
Slide 23: Encouraging Findings in Phase 1b Study
Encouraging Findings in Phase 1b Study 4-WEEK TREATMENT IN 40 PATIENTS WITH ULCERATIVE COLITIS 1 Clinical response as measured by both partial and full Mayo. 2 Surrogate biomarkers include C-reactive protein (CRP) and fecal calprotectin. 23 Encouraging Phase 1b data and preclinical package including
Slide 24: TD-1473: Late Stage Studies in Ulcerative Colitis and Crohn's Disease
TD-1473: Gut-selective oral JAK inhibitor LATE STAGE STUDIES IN ULCERATIVE COLITIS AND CROHN’S DISEASE Phase 3 (N=640) 1 Maintenance phase of the study will have induction responder subjects re-randomized to active doses compared to placebo at 44 weeks 24 Phase 2b/3 study in UC and Phase 2 study in
Slide 25: Global Collaboration Agreement for TD-1473
Global Collaboration Agreement for TD-1473 PURPOSED TO MAXIMIZE VALUE OF PROGRAM ‣ 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 Cro
Slide 26: TD-8236
TD-8236 Potential first inhaled non-steroidal anti-inflammatory for moderate-to-severe asthma regardless of Th2 phenotype
Slide 27: High Medical and Economic Burden in Uncontrolled Asthma
High Medical and Economic Burden in Uncontrolled Asthma Patient population Small portion of US patients cause proportion of cost high ‣ 4.9M moderate-to-severe diagnosed patients in US1 16M diagnosed asthma cases1 Moderate 16% Severe 14% Current treatments ‣ ‣ Inhaled steroids, which often fail to c
Slide 28: TD-8236: Lung-selective Inhaled pan-JAK Inhibitor
TD-8236: Lung-selective Inhaled pan-JAK Inhibitor POTENTIAL TO ADDRESS PATIENTS NEEDS REGARDLESS OF TH2 PHENOTYPE JAK/STAT cytokines implicated in severe asthma Patient heterogeneity in severe asthma1 19 Neutrophilic 38 h2-low 29 Eosinophilic Paucigranulocytic Bold denotes biologics in development o
Slide 29: TD-8236: Phase 1 Clinical Trial Design
TD-8236: Phase 1 Clinical Trial Design ONGOING PARTS A & B COMPLETED; PART C PART A PART B PART C SAD (Healthy volunteers) Safety and PK MoA Biomarkers (Moderate-to-severe asthmatics) MAD (Mild asthmatics) Safety, PK, and PD (FeNO) N = 16 active/8 Placebo Study open and enrolling All cohorts: N = 6
Slide 30: TD-8236: Positive Phase 1 Clinical Trial in Healthy Subjects and Mild Asthmatics
TD-8236: Positive Phase 1 Clinical Trial in Healthy Subjects and Mild Asthmatics ECG, electrocardiogram. 30 Data demonstrated evidence of biological activity in the lung with minimal systemic exposure Key Findings Favorable overall safety and tolerability No evidence of local irritation or bronchoco
Slide 31: Preliminary Positive FeNO Data in Patients with Mild Asthma
Preliminary Positive FeNO Data in Patients with Mild Asthma & Elevated FeNO Levels at Baseline 6-Hour Post-Dose FeNO 2 0 -2 -4 -6 -8 -10 -12 -14 -16 ‣ FeNO is an established disease activity biomarker in asthma Reduction in FeNO associated with a decrease in airway inflammation Evidence of biologica
Slide 32: TD-5202
TD-5202 Investigational Gut-Selective Irreversible JAK3 Inhibitor for Inflammatory Intestinal Diseases
Slide 33: JAK3-Dependent Cytokines Play Central Role in T-cell Mediated Disease
JAK3-Dependent Cytokines Play Central Role in Pathogenesis of T-cell Mediated Disease Example: Celiac Glut Disease Pathogenesis IL-2, IL-4, IL-7, IL-9, IL-15, IL-21 α β γ peptides INTESTINAL IE-P IMMUNE CELL AMINA PROPIA JAK1 JAK3 P P STAT NUCLEUS P P GLUTEN-SPECIFIC TH1 CELLS P P ‣ Proof-of-relevan
Slide 34: JAK3 Has Cysteine Residue Allowing for Selective Irreversible Inhibitor
Unique among JAK family, JAK3 has cysteine residue allowing for JAK3-selective irreversible inhibitor JAK3 Selectivity with inhibitor 34 Phase 1 study of TD-5202 in healthy volunteers underway Allows covalent bond Potential benefits include: ‣ Binding specificity ‣ Irreversible inhibition resulting
Slide 35: Opportunities for Value Creation
Opportunities Creation for Value
Slide 36: Focus on Strategic Priorities
Focus on Strategic Priorities COMMITMENT TO CREATING TRANSFORMATIONAL MEDICINES • U.S. commercial launch underway • Registrational Phase 3 program progressing; 4-week efficacy data expected 2H 2020 • Plan to initiate lung allergen challenge 4Q19 • Phase 1 study in healthy subjects underway conventio
Slide 37: 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 38: 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
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