Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (January 2019)
30 slides from Theravance Biopharma's investor presentation, Jan 7, 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: Insight and Innovation Drive Long-term Growth
3 Focus on discovering transformational medicines Create value from strategic integration of key functional insights Focus on transformative products to deliver value to payers, patients and HCP’s Pursue medicines with difficult-to-replicate design characteristics for long term competitive advantage
Slide 3: Organ-selectivity Aimed to Expand Therapeutic Index
4 Conventional Oral Compound Permeability Solubility Bioavailability, % Systemic Clearance GI Tissue : Plasma Ratio Organ-selectivity Aimed to Expand Therapeutic Index EFFECTIVE NON-EFFECTIVE DOSE-LIMITING SAFETY NON-EFFECTIVE DOSE-LIMITING SAFETY EFFECTIVE Theravance Biopharma Organ-selective Compo
Slide 4: 2018 milestones and accomplishments
5 First patient dosed in Phase 2 study in Crohn’s TD-1473 Patient screening in Phase 2b/3 study in UC TD-1473 Completion of Phase 2a study in nOH Ampreloxetine Sites initiated for Phase 3 program enrollment Ampreloxetine Global collaboration agreement with Janssen TD-1473 Completion of Phase 1b stud
Slide 5: Commercial organization to concentrate on YUPELRI
6 Commercial organization to concentrate on YUPELRITM Economic interest in TRELEGY ELLIPTA serves as an important strategic asset1 Strong launch following approvals in US and EU in late 2017 TD-1473, ampreloxetine, and YUPELRITM each internally discovered and developed by R&D engine which serves as
Slide 6: YUPELRI (revefenacin) inhalation solution
YUPELRITM (revefenacin) inhalation solution Nebulized long-acting muscarinic antagonist (LAMA)
Slide 7: YUPELRI: Now Commercially Available
YUPELRITM: Now Commercially Available FDA-APPROVED FOR THE MAINTENANCE TREATMENT OF COPD 8 FEV1: forced expiratory volume in one second. LABA: long-active beta agonist. ICS: inhaled corticosteroid. Single cycle approval ahead of expected PDUFA date, without an Advisory Committee Higher of two doses
Slide 8: NDA Supported by Positive Phase 3 Results
NDA Supported by Positive Phase 3 Results TWO REPLICATE EFFICACY STUDIES, PLUS 12-MONTH SAFETY STUDY 9 Pooled analysis. Primary endpoint achieved for both doses in replicate efficacy studies Robust and sustained improvements in FEV1 Study included use as monotherapy as well as add-on to LABA or LABA
Slide 9: Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity
Partnership with Mylan Provides Commercial Strength in Nebulized Opportunity 10 1 IMS Health information service: NSP for period MAT May, 2015. Excludes nebulized SABAs. IMS expressly reserves all rights, including rights of copying, distribution and republication. 2 TBPH market research (N = 160 ph
Slide 10: 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 11: Differentiated and Potential Breakthrough Approach
Differentiated and Potential Breakthrough Approach ADVANCING IN COLLABORATION WITH JANSSEN IN UC AND CROHN’S 12 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 12: Encouraging Findings in Phase 1b Study
Encouraging Findings in Phase 1b Study 4-WEEK TREATMENT IN 40 PATIENTS WITH ULCERATIVE COLITIS 13 Detailed results presented in oral late-breaker at UEGW 2018; Phase 2 in Crohn’s disease underway and progressing into Phase 2b/3 in UC 1 Clinical response as measured by both partial and full Mayo. 2 S
Slide 13: Late-stage Studies of TD-1473 in UC and Crohn's Disease
Phase 3 induction, 2 arms (N=640) Dose-confirming induction, 8 weeks Phase 2b induction, 4 arms (N=240) Dose-finding induction, 8 weeks 14 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 14: Global Collaboration Agreement for TD-1473
Global Collaboration Agreement for TD-1473 PURPOSED TO MAXIMIZE VALUE OF PROGRAM 15 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 15: Ampreloxetine (TD-9855)
Ampreloxetine (TD-9855) Once-daily dual norepinephrine and serotonin reuptake inhibitor (NSRI) for neurogenic orthostatic hypotension (nOH)
Slide 16: nOH: Orphan indication with unmet need
17 1 Existing options associated with one or both therapies noted above; Northera prescribing information. MSA: multiple system atrophy. PD: Parkinson’s disease. PAF: primary autonomic failure. TID: three times per day. nOH characterized by a sustained drop in blood pressure upon standing, due to bo
Slide 17: NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone
NET Inhibition with Ampreloxetine Offers Potential to Restore Vascular Sympathetic Tone 18 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 18: Overview of Phase 2 Study in nOH
Overview of Phase 2 Study in nOH DESIGNED TO EVALUATE INITIAL AND DURABLE RESPONSE TO THERAPY 19 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 19: Top-line Phase 2 Results in nOH: Parts A and B
20 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, TD-9855 OR PLACEBO Initial responses observed A Responses reported in majority of patients treated 27 of 34 patients enrolle
Slide 20: Top-line Phase 2 Results in nOH: Part C
21 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 21: TD-8236
TD-8236 Potential first inhaled non-steroidal anti-inflammatory for moderate-to-severe asthma regardless of Th2 phenotype
Slide 22: Small portion of US patients cause high proportion of cost
23 Small portion of US patients cause high proportion of cost Severe 14% Moderate 16% Severe 61% Moderate 25% 16M diagnosed asthma cases1 Healthcare utilization2 Patient population 4.9M moderate-to-severe diagnosed patients in US1 Current treatments Inhaled steroids, which often fail to control dise
Slide 23: Potential for Inhaled pan-JAKi to Address Needs of Patients Regardless of Th2 Phenotype
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- 24 Mixed granulocytic Eosinophilic Neutrophilic Paucigranulocytic Patient heterogeneity in severe asthma Th2 Low Th2 High Bold denotes biologics in development or approved Novel approved
Slide 24: TD-8236 is Optimized for Dry Powder Delivery to the Lung
Potent pan-JAKi Lung selective Long duration of action 25 Therapeutic Index High TD-8236 levels and long residence time in mouse lung Low levels in blood Time (h) Concentration (g/g, g/mL) TD-8236’s profile supports a once-daily inhaled product with minimal systemic exposure TD-8236 is Optimized for
Slide 25: 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 26: GSK's TRELEGY ELLIPTA: Strong Early Trajectory
GSK’s TRELEGY ELLIPTA: Strong Early Trajectory FIRST AND ONLY ONCE-DAILY SINGLE INHALER TRIPLE THERAPY 27 Economic interest in TRELEGY ELLIPTA Upward-tiering royalty of approximately 5.5% - 8.5% of worldwide net sales1 Passive economic interest; no product cost obligations Impressive progress follow
Slide 27: Opportunities for Value Creation: Upcoming milestones
Opportunities for Value Creation Upcoming milestones
Slide 28: Development Pipeline Advancing Forward
29 Multiple programs advancing into pivotal studies, underpinned by future potential cash flows from TRELEGY ELLIPTA royalties, potential Janssen milestones and YUPELRITM launch Shading denotes studies planned to begin in respective development stage. Program Pre-clinical Early Proof of Concept Pivo
Slide 29: About YUPELRI (revefenacin) inhalation solution
About YUPELRITM (revefenacin) inhalation solution YUPELRITM (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 n
Slide 30: 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
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