Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Investor Presentation (September 2020)
44 slides from Theravance Biopharma's investor presentation, Sep 14, 2020
Slide 1: Corporate Overview September 2020
Corporate Overview September 2020 THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third party trademarks used herein are the prop
Slide 2: Forward-looking statements
Forward - looking statements 2 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 resul
Slide 3: Creating transformational value for stakeholders
Creating transformational value for stakeholders 1. Cash, cash equivalents and investments as of 6/30/2020. 2. TBPH holds 85% economic interest in upward - tiering royalty stream of 6.5% – 10% payable by Glaxo Group Limited ("GSK") (net of Theravance Respiratory Company (“TRC”) expenses paid and the
Slide 4: Our science: Organ-selective molecules designed to optimize therapeutic index
Our science Organ - selective molecules designed to optimize therapeutic index
Slide 5: Theravance Biopharma difference: right disease with right molecular design
Theravance Biopharma difference: Targeting the right disease with the right molecular design TI, therapeutic index. 5 TI TI α STAT P STAT P STAT JAK β γ JAK N UCLEUS P STAT P STAT
Slide 6: Research and development portfolio of designed molecules: brain, lung, GI and eye
Research and development portfolio of designed molecules: brain, lung, GI and eye 6 Molecular Design Biology Medicinal Chemistry DMPK Development and Commercial Symptomatic nOH (Neurogenic orthostatic hypotension) Asthma Lung Transplant Rejection IPF (idiopathic pulmonary fibrosis) COPD (chronic obs
Slide 7: Key programs supported by proven development and commercial expertise
Program Indication Research Phase 1 Phase 2 Phase 3 Filed Marketed Collaborator Ampreloxetine (TD - 9855) NRI S ymptomatic nOH Wholly - owned Organ - Selective TD - 1473 GI JAKi UC CD TD - 5202 Irreversible JAK3i Inflammatory intestinal diseases YUPELRI ® (revefenacin) LAMA COPD TD - 8236 Inhaled JA
Slide 8: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution First and only once - daily, nebulized maintenance medicine for COPD
Slide 9: YUPELRI FDA-approved for maintenance treatment of COPD
YUPELRI ® (revefenacin) inhalation solution FDA - approved for the maintenance treatment of COPD 1. Global Strategy for Diagnosis, Management, and Prevention of COPD, 2018; 2. TBPH market research (N = 160 physicians); ref ers to US COPD patients 3. Loh CH, et al. Ann Am Thorac Soc. 2017 Aug;14:1305
Slide 10: YUPELRI launch metrics and channel
Majority of YUPELRI ® volume flows through durable medical equipment channel (approximately 3 - month lag in data capture); remaining volume flows thro ugh hospitals, retail and long - term care pharmacies. Wholesale acquisition cost (WAC): $1,066 per month (or ~$35 per day). 1. As of June 30, 2020.
Slide 11: Inhaled JAK inhibitor Portfolio
Inhaled JAK inhibitor Portfolio Potential to transform treatment of respiratory inflammation
Slide 12: Inhaled JAK inhibitors can transform treatment of inflammation-induced respiratory diseases
Inhaled JAK inhibitors can transform treatment of inflammation - induced respiratory diseases IL, interleukin; NF κ B, nuclear factor kappa - light - chain - enhancer of activated B cells; STAT, signal transducer and activator of transcription; TNF, tumor necrosis factor. 12 Time is right for novel
Slide 13: TD-8236 Potential first inhaled JAKi for asthma
TD - 8236 Potential first inhaled JAKi for asthma
Slide 14: High medical and economic burden in uncontrolled asthma
High medical and economic burden in uncontrolled asthma *Asthma that requires high - dosage ICS + LABAs to prevent the disease from being uncontrolled) or asthma that remains uncontrolle d despite treatment. 1. World Health Organization; 2. https://www.aafa.org/asthma - facts/; 3. Sadatsafavi, M., e
Slide 15: TD-8236: Phase 1 clinical trial design
TD - 8236: Phase 1 clinical trial design Parts A & B completed September 2019; Part C data expected 4Q 2020 PART C MoA Biomarkers (Moderate - to - severe asthmatics) • MoA biomarkers to be assessed in target patient population • Goal: build confidence in compound, MoA and dose in early - development
Slide 16: TD-8236: Phase 2 allergen challenge study
TD - 8236: Lung - selective pan - JAK inhibitor Phase 2 allergen challenge study 16 Phase 2 allergen challenge study underway Data expected 4 th Q 2020 TD - 8236 Phase 2 Lung Allergen Challenge 12 weeks (N=21) Dose characterization Randomized, double - blind, placebo - controlled, crossover study
Slide 17: TD-0903 Program
TD - 0903 Program Nebulized lung - selective pan - JAK inhibitor to treat: • Acute hyperinflammation of the lung in COVID - 19 • Chronic inflammation for the prevention of lung transplant rejection
Slide 18: Leveraging respiratory expertise for potential acute treatment in global pandemic
Leveraging respiratory expertise for potential acute treatment in response to a global pandemic 1. https://coronavirus.jhu.edu/map.html , number as of 9/10; 2. IHME. 18 US patients 1 >6M patients become hospitalized 2 ~2.4% No vaccine available Current treatment: Supportive therapy As of July 1, 202
Slide 19: Potential for TD-0903 effect in COVID-19
Potential for TD - 0903 effect Host inflammatory response to COVID - 19 drives ALI and ARDS Adapted from Siddiqi HK, et al. J Heart Lung Transplant 2020 Mar 20. CRP, C - reactive protein; LDH, lactate dehydrogenase; NT - proBNP, ventricular natriuretic peptide; SIRS, severe inflammatory respo nse sy
Slide 20: TD-0903: Development plan designed to progress rapidly
TD - 0903: Development plan designed to progress rapidly SOC, standard of care. 20 Phase 1: Healthy volunteers Dose A Dose B Dose C Phase 2: Hospitalized COVID - 19 patients Dose A Dose B Dose C Single - ascending dose Multiple - ascending dose x 7 days Dose X + SOC Placebo + SOC x x Part 2: Paralle
Slide 21: First-in-disease opportunity for prevention of lung transplant rejection
S TRATEGIC O PPORTUNITY First - in - disease opportunity for the prevention of lung transplant rejection 21 1. http://www.transplant - observatory.org/data - charts - and - tables/ ; 2. United Network for Organ Sharing (UNOS), https://unos.org/data/transplant - trends; 3. Chambers DC et al, JHLT 201
Slide 22: Pan-JAK inhibitors can prevent transplant rejections
Month 6 0 5 10 15 20 F i r s t B P A R R a t e ( % ) Pan - JAK inhibitors can prevent transplant rejections Noninferiority trial of tofacitinib vs cyclosporine (CsA) in kidney transplant recipients 1 ‣ JAK inhibition was superior to cyclosporine in prevention of acute and chronic rejections ‣ Seriou
Slide 23: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor to treat symptomatic neurogenic orthostatic hypotension
Slide 24: Reduced quality of life and limited therapeutic options for symptomatic nOH patients
Reduced quality of life, significant care - giver burden and limited therapeutic options for symptomatic nOH patients 24 1. Mathias C, et al. J Neurol 1999;246:893 - 8; 2. Ha AD, et al. Parkinsonism Relat Disord 2011;17:625 - 8; 3. Not all patients are treated with prescription medication P ATIENT P
Slide 25: Designed to reduce symptoms of nOH by prolonging effect of endogenous norepinephrine
Untreated nOH NE Release at Neurovascular Junction Systolic Blood Pressure Designed to reduce symptoms of nOH by prolonging the effect of endogenous norepinephrine 1. Palma JA, Kaufmann H. Mov Disord Clin Pract 2017;4:298 - 308. NE, norepinephrine; NET, norepinephrine transporters. 25 Vasodilation B
Slide 26: Ampreloxetine: meaningful and durable symptom improvement
Ampreloxetine: Potential to provide meaningful and durable symptom improvement to underserved patients Baseline OHSA #1 (Orthostatic Hypotension Symptom Assessment Question 1) >4 points. Negative change indicates improvement in symptoms; improvement of 1 point is defined as the MCID (minimal clinica
Slide 27: TD-1473 (JNJ-8398) Oral gut-selective pan-JAK inhibitor
TD - 1473 (JNJ - 8398) Oral gut - selective pan - JAK inhibitor to treat inflammatory bowel diseases
Slide 28: Need for new medicines to treat Inflammatory Bowel Disease
Need for new medicines to treat Inflammatory Bowel Disease 28 HRQoL, health - related quality of life; IBD, inflammatory bowel disease. 1. GBD 2017 Inflammatory Bowel Disease Collaborators. Lancet 2020;5:17 - 30; 2. https://www.crohnscolitisfoundation.org/sites/default/files/2019 - 02/Updated%20IBD%
Slide 29: JAK-STAT pathway: orchestrating signaling of pro-inflammatory cytokines
STAT - induced Inflammation α N UCLEUS STAT P STAT P STAT P STAT P STAT JAK β γ JAK JAK inhibitor JAK - STAT pathway: orchestrating signaling of multiple pro - inflammatory cytokines Clark JD, et al. J Med Chem 2014; 57:5023 - 5038. EPO, erythropoietin; GM - CSF, granulocyte - macrophage colony - st
Slide 30: TD-1473 is an oral, gut-selective pan-JAK inhibitor
TD - 1473 is an oral, gut - selective pan - JAK inhibitor Preclinical data package for TD - 1473 represents a potential breakthrough approach to the treatment of IBD Journal of Crohn’s & Colitis April 20, 2020 30 Gut selectivity Potent inhibition of Tyk2 Anti - inflammatory activity in disease model
Slide 31: Systemic exposures low; tissue concentrations at or above JAK inhibition levels
Systemic exposures low; tissue concentrations at or above JAK inhibition levels *Tofacitinib concentrations extracted from J Pharmacol Exp Ther 348:165 – 173, January 2014. BID, twice daily; IC 50 , concentration to produce 50% maximal inhibition; PK, pharmacokinetics. 31 Tofacitinib 10 mg BID* TD -
Slide 32: TD-1473: Late-stage studies in Crohn's disease and ulcerative colitis
TD - 1473: Gut - selective pan - JAK inhibitor Late - stage studies in Crohn’s disease and ulcerative colitis Phase 2 Crohn’s and Phase 2b/3 ulcerative colitis studies ongoing Phase 2 Crohn’s and Phase 2b ulcerative colitis data expected 2021 Global collaboration with Janssen leverages joint develop
Slide 33: TD-5202 Organ-gut selective irreversible JAK3 inhibitor
TD - 5202 Organ - gut selective irreversible JAK3 inhibitor to treat inflammatory intestinal diseases
Slide 34: Celiac disease has no current treatments and serious health consequences
Celiac disease has no current treatments and serious health consequences 34 1. 1% prevalence, BeyondCeliac.org; 2. 2018 US population 327M Census.gov; 3. Theravance Market Research; S TRATEGIC O PPORTUNITY P ATIENT P OPULATION US patients 1,2 3.3M No approved treatment Only available intervention is
Slide 35: JAK3-dependent cytokines play central role in celiac disease
JAK3 - dependent cytokines play central role in pathogenesis of celiac disease ‣ Proof - of - relevance from recent positive Phase 2 data with systemic JAK3 inhibitor in alopecia areata, another T - cell mediated disease ‣ Localized JAK3 inhibition important to avoid systemic immunosuppression (gene
Slide 36: TD-5202 FIH Overall Results Summary
TD - 5202 FIH Overall Results Summary ‣ No serious or severe AEs were reported ‣ All treatment - emergent AEs in TD - 5202 - treated subjects were mild in severity AE, adverse event; C max,ss , maximal steady - state concentration; NK, natural killer. 36 TD - 5202: generally well - tolerated (single
Slide 37: Economic interest GSK's TRELEGY ELLIPTA
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy
Slide 38: Economic interest in GSK's TRELEGY upward-tiering royalties
Economic interest in GSK’s TRELEGY Upward - tiering royalties of ~5.5 – 8.5% of worldwide net sales 1 Q2 net sales of £194m (or $241M) Grew market share with sales up 58% year - over - year Asthma sNDA approved September 9, 2020 1. TBPH holds 85% economic interest in upward - tiering royalty stream
Slide 39: The Theravance Biopharma Difference
The Theravance Biopharma Difference
Slide 40: Multiple potential milestones and value-driving catalysts
GSK’s TRELEGY ELLIPTA 1 ‣ Asthma sNDA asthma approved September 9, 2020 TD - 8236 ‣ Phase 1 Part C data in severe asthmatics ‣ Phase 2 allergen challenge data Ampreloxetine ‣ Phase 3 4 - week efficacy data TD - 1473 ‣ Phase 2b/3 ulcerative colitis topline data ‣ Phase 2 Crohn’s topline data Multiple
Slide 41: Creating transformational value for stakeholders
Creating transformational value for stakeholders 41 Innovative research yielding organ - selective molecular designed assets Proven development and commercial expertise Strategic partnerships Value driving catalysts Strong capital position
Slide 42: Holding steadfast to our mission
Holding steadfast to our mission 42 …treatments for serious diseases to maximize patient benefit while minimizing patient risk Discovering… Developing… Commercializing…
Slide 43: About YUPELRI (revefenacin) inhalation solution
About YUPELRI ® (revefenacin) inhalation solution YUPELRI ® (revefenacin) inhalation solution is a 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 44: YUPELRI indication and Important Safety Information
YUPELRI ® (revefenacin) inhalation solution YUPELRI ® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) . Important Safety Information (US) YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any co
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