Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q1 2021 Earnings Presentation
28 slides from Theravance Biopharma's earnings presentation, May 4, 2021
Slide 1: First Quarter 2021 Financial Results and Business Update
First Quarter 2021 Financial Results and Business Update May 4, 2021 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 trade
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: Agenda
Agenda Gail B. Cohen Introduction Vice President, Corporate Communications Rick E Winningham Overilew Chief Executive Officer Richard A. Graham Development and Senior Vice President, Development Commercial Update Frank Pasqualone Senior Vice President, Chief Business Officer Andrew A. Hindman Financ
Slide 4: Key programs supported by proven development and commercial expertise
Key programs supported by proven development and commercial expertise ProgramIndicationResearchPhase 1Phase 2Phase 3FiledMarketedCollaborator Ampreloxetine (TD-9855) NRISymptomatic nOH Phase 3 Wholly-owned UC Izencitinib (TD-1473) GI JAKi CD Phase 2b/3 Phase 2 Janssen Biotech, Inc. Organ-Selective I
Slide 5: Multiple potential milestones & value-driving catalysts
Commercial progress of YUPELRI® & GSK’s TRELEGY Q1 TOPLINE 2021 Multiple potential milestones & value-driving catalysts Q2RESULTS Q3 Q4 Nezulcitinib (TD-0903) Phase 2 (0188) COVID-19 Ampreloxetine SEQUOIA (0169) Phase 3 symptomatic nOH Izencitinib RHEA (0157) Phase 2b ulcerative colitis Q1'22 Izenci
Slide 6: Targeting disease with organ selective medicines
Theravance Biopharma difference: Targeting disease with organ selective medicines Pathway DiseaseTherapeutic Index TITI Target disease biologyOptimize effect in the organ where the disease is active Expand TI with the goal of maximizing efficacy and limiting systemic side effects TI, therapeutic ind
Slide 7: Nezulcitinib (TD-0903) Program
Nezulcitinib (TD-0903) Program Nebulized lung-selective pan-JAK inhibitor to treat: ►Acute hyperinflammation of the lung in COVID-19 ►Chronic inflammation for the treatment and prevention of lung transplant rejection
Slide 8: Nezulcitinib: breaking new ground with inhaled JAKi
Nezulcitinib (TD-0903): breaking new ground with inhaled JAKi Focused execution in acute lung injury (ALI) driven by patient need >149M COVID-19 patients globally1; >32M patients in US2 BUILDING A PIPELINE IN A PRODUCT Treatments needed for hospitalized COVID-19 patients with acute lung injury TD-09
Slide 9: Nezulcitinib: a lung-selective inhaled immunotherapy in development
Nezulcitinib: a lung-selective inhaled immunotherapy in development Broadly inhibits the pulmonary inflammatory cascade caused by viral infection Potential therapeutic benefit via three activities: Potent pan-JAK inhibition α βγ JAKJAK P NUCLEUS P P P 100 STAT STAT STAT % Inhibition Protection again
Slide 10: Izencitinib (TD-1473/JNJ-8398)
Izencitinib (TD-1473/JNJ-8398) Oral gut-selective pan-JAK inhibitor to treat inflammatory bowel diseases
Slide 11: Izencitinib's gut-selective approach designed to reduce systemic side effects
Izencitinib’s oral, gut-selective, pan-JAK approach is designed to reduce systemic side effects High margins of systemic safety in nonclinical studies Updated slide to Come Low systemic plasma concentrations in UC patients 140 120 Systemic Safety Margin (Plasma AUC) 10 5 IzencitinibTofacitinib Safet
Slide 12: Izencitinib's approach designed to maximize efficacy in IBD
Izencitinib’s oral, gut-selective, pan-JAK approach is designed to maximize efficacy in IBD Blocks inflammation and penetrates deep within mouse colon Demonstrates improvement in UC patients in Phase 1b Vehicle treated control Izencitinib Placebo (n=9)20 mg (n=10)80 mg (n=10)270 mg (n=11) The gut-se
Slide 13: Ampreloxetine (TD-9855)
Ampreloxetine (TD-9855) Once-daily norepinephrine reuptake inhibitor to treat symptomatic neurogenic orthostatic hypotension
Slide 14: Ampreloxetine: new approach in nOH
Ampreloxetine: new approach in nOH MARKET DYNAMICS SYMPTOMS ~350K US patients1: 70–80% of MSA patients2 30–50% of PD patients3 have nOH4 Specialist network in place: concentrated group of neurologists/ cardiologists treat patients; ‘at risk’ patients already identified and managed by specialty insti
Slide 15: Ampreloxetine: once-daily selective norepinephrine reuptake inhibitor
Ampreloxetine: a once-daily, potent and selective norepinephrine reuptake inhibitor with a differentiated MOA for treating nOH Ampreloxetine is designed to target and correct the norepinephrine imbalance… …with potential for market differentiation… …and demonstrated a clinically meaningful and durab
Slide 16: FDA-approved for the maintenance treatment of COPD
FDA-approved for the maintenance treatment of COPD First and only once-daily, nebulized maintenance medicine for COPD
Slide 17: YUPELRI (revefenacin) inhalation solution
YUPELRI® (revefenacin) inhalation solution FDA-approved for the maintenance treatment of COPD First and only once-daily, nebulized maintenance medicine for COPD Once-daily LAMAs are first-line therapy for moderate-to-very severe COPD1 9% of COPD patients (~800,000) use nebulizers for ongoing mainten
Slide 18: TBPH implied 35% of YUPELRI US net sales by quarter
See TBPH 10K filed February 26, 2021 for greater detail re TBPH implied 35%. 18 TBPH implied 35% of YUPELRI® US net sales by quarter TBPH Implied 35% of Total Net Sales ($M) $13.5 $12.9 $13.0 $12.9 $10.6 $10.4 $5.8 $3.2 14 12 10 8 6 4 2 0 Q2'19Q3'19Q4'19Q1'20Q2'20Q3'20Q4'20Q1'21 TBPH implied 35% of
Slide 19: YUPELRI hospital sales and community TRx trends
YUPELRI® hospital sales and community TRx trends Hospital LA-NEB Market Share* Hospital Market Share 20% 18% 16% 14% 12% 10% 8% 6% 8.0% 8.5% 7.0% 6.7% 5.8% 4% 3.5% 2.2% 2% 0% 1.1% 0.3% Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 YUPELRI LA-NEB Market Share 20% 18% 16% 14% 12% 10% 8% 6% 4%
Slide 20: YUPELRI hospital accounts and formulary progress
11 YUPELRI 719 hospital accounts have ordered2 ?67% have ordered more than once 91% formulary win rate3 Highest number of formulary support presentations in Q1'21 since launch 74% commercial coverage4 Increasing New Patient Starts Continue to Drive LA-NEB Market Share Growth 1 Positive growth trends
Slide 21: Economic interest in GSK's TRELEGY ELLIPTA
Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once-daily single inhaler triple therapy
Slide 22: Economic interest in GSK's TRELEGY
Economic interest in GSK’s TRELEGY Upward-tiering royalties of ~5.5–8.5% of worldwide net sales1 TRELEGY Asthma Approval TRELEGY Mortality Ad Comm BREO Asthma Approval TRELEGY TRELEGY 400 350 TRx Volume (Thousands) 250 200 150 100 50 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Slide 23: First quarter 2021 financial highlights
First quarter 2021 financial highlights $210.0 million cash1 as of March 31, 2021 Three Months Ended March 31, Cash, cash equivalents and marketable securities. Amounts include share-based compensation. 23
Slide 24: Multiple potential milestones & value-driving catalysts
Commercial progress of YUPELRI® & GSK’s TRELEGY Q1 TOPLINE 2021 Multiple potential milestones & value-driving catalysts Q2RESULTS Q3 Q4 Nezulcitinib (TD-0903) Phase 2 (0188) COVID-19 Ampreloxetine SEQUOIA (0169) Phase 3 symptomatic nOH Izencitinib RHEA (0157) Phase 2b ulcerative colitis Q1‘22 Izenci
Slide 25: Q&A Session
Rick E Winningham Chairman and Chief Executive Officer Andrew A. Hindman Senior Vice President, Chief Financial Officer Q&A Session Frank Pasqualone Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Development
Slide 26: Theravance Biopharma: Medicines That Make a Difference
Theravance Biopharm a®® Medicines That Make a Difference ®
Slide 27: YUPELRI market research notes
1. TBPH market research (N=160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long-acting muscarinic antagonist. 27 YUPELRI® (revefenacin) inhalation solution is a once-daily nebulized LAMA approved for the maintenance treatment of COPD in the US. Market
Slide 28: Important Safety Information (US)
OATP, organic anion transporting polypeptide. 28 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