Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q2 2021 Earnings Presentation
24 slides from Theravance Biopharma's earnings presentation, Aug 3, 2021
Slide 1: Second Quarter 2021 Financial Results and Business Update
Second Quarter 2021 Financial Results and Business Update August 3, 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 pa
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: Agenda
Agenda 3 Introduction Gail B. Cohen Vice President, Corporate Communications Overview Rick E Winningham Chief Executive Officer Development and Commercial Update Richard A. Graham Senior Vice President, Development Frank Pasqualone Senior Vice President, Chief Business Officer Financial Update Andre
Slide 4: Theravance Biopharma difference: Targeting disease with organ selective medicines
Theravance Biopharma difference: Targeting disease with organ selective medicines TI, therapeutic index. 4 Target disease biology Optimize effect in the organ where the disease is active Expand TI with the goal of maximizing efficacy and limiting systemic side effects TI TI Disease Therapeutic Index
Slide 5: Economic interest and pipeline overview
TBPH holds 85% economic interest in upward - tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC Agreement over the next four fiscal quarters). 75% of TRC income received is pledged to service ou
Slide 6: Respiratory market trends across nebulized and handheld
Respiratory market t rends across n ebulized and handheld YUPELRI and TRELEGY with strong YoY growth while respective markets declined or remained flat 6 1. IQVIA XPO Excl. LTC (Retail) and SolutionsRx (DME / Med B FFS) through 4/30/2021 2. COPD Handheld Market Excludes BREZTRI (newly launched produ
Slide 7: Izencitinib oral gut-selective pan-JAK inhibitor
Izencitinib (TD - 1473/JNJ - 8398) Oral gut - selective pan - JAK inhibitor to treat inflammatory bowel diseases
Slide 8: Izencitinib: Phase 2b Induction study in ulcerative colitis
Izencitinib : Phase 2b Induction study in ulcerative colitis *3 izencitinib doses. NCT03758443 aMS , adapted Mayo Score; tMS , total Mayo Score; UC, ulcerative colitis. 8 Program Status ‣ Ph 3 Maintenance ongoing Randomization Q3’21 Ph 2b Induction Study data readout Placebo Izencitinib * Ph 2b dose
Slide 9: Ampreloxetine for symptomatic nOH
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor to treat symptomatic neurogenic orthostatic hypotension ( nOH )
Slide 10: Ampreloxetine: Phase 3 randomized, double-blind, placebo-controlled study
Ampreloxetine : Phase 3 Randomized, double - blind, placebo - controlled study Note: Ampreloxetine Phase 3 registrational program is comprised of Studies 0169, 0170 and safety data from 0171 will be included *Orthostatic Hypotension Symptom Assessment Question 1: negative change indicates improvemen
Slide 11: YUPELRI FDA-approved for maintenance treatment of COPD
FDA - approved for the maintenance treatment of COPD First and only once - daily, nebulized maintenance medicine for COPD
Slide 12: YUPELRI (revefenacin) inhalation solution
YUPELRI ® (revefenacin) inhalation solution 1. Global Strategy for Diagnosis, Management, and Prevention of COPD, 2018. 2. TBPH market research (N = 160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist. 12 Once - daily LA
Slide 13: TBPH implied 35% of YUPELRI US net sales by quarter
TBPH implied 35% of YUPELRI ® US net sales by quarter See TBPH 10K filed February 26, 2021 for greater detail re TBPH implied 35%. 13 TBPH implied 35% of YUPELRI US net sales represents TBPH’s portion of the combined TBPH and VIATRIS net revenue TBPH Implied 35% of Total Net Sales ($M) $3.2 $5.8 $10
Slide 14: YUPELRI hospital sales and community TRx trends
YUPELRI ® hospital sales and community TRx trends Continued market share growth across both the hospital and retail channels 0.3% 1.1% 2.2% 3.4% 5.4% 6.5% 6.3% 7.4% 7.8% 8.8% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Hospital LA - NEB Market S
Slide 15: YUPELRI hospital accounts and new-to-product prescriptions
15 15 YUPELRI 815 hospital accounts have ordered 2 ‣ 69% have ordered more than once 91% formulary win rate 3 Highest number of formulary support presentations in Q2’21 since launch 75% commercial coverage 4 Positive growth trends for YUPELRI ® continuing into 2H2021 1. Symphony Health, Metys , 01/0
Slide 16: 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 17: Economic interest in GSK's TRELEGY
0 50 100 150 200 250 300 350 400 450 500 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 TRx Volume (Thousands) Month Post Launch Strongest US ELLIPTA Launch ANORO ELLIPTA ARNUITY ELLIPTA BREO ELLIPTA INCRUSE ELLIPTA TRELEGY Launched in US in November 2017 Source: GSK, Symphony Healt
Slide 18: Second quarter 2021 financial highlights
Second quarter 2021 financial highlights 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. 18 $ 265.0 million cash 1 as of June 30, 2021 Research and development operating expense excluding share - based compensation 43,778 54,306 103,456 112,454 Sel
Slide 19: Differentiated pipeline, partnerships and economic interest
Differentiated, Wholly - Owned Pipeline Viatris Partnership Janssen Collaboration Economic Interest • TRELEGY: Triple combo for COPD and Asthma 1 • 5.5% to 8.5% of global net sales 2 • Global Partnership for YUPELRI ® : nebulized bronchodilator for COPD • US profit share (35% TBPH / 65% VIATRIS) • E
Slide 20: Upcoming milestones and pipeline
TBPH holds 85% economic interest in upward - tiering royalty stream of 6.5% – 10% payable by GSK (net of TRC expenses paid and the amount of cash, if any, expected to be used by TRC pursuant to the TRC Agreement over the next four fiscal quarters). 75% of TRC income received is pledged to service ou
Slide 21: Q&A Session
Q&A Session Rick E Winningham Chairman and Chief Executive Officer Andrew A. Hindman Senior Vice President, Chief Financial Officer Frank Pasqualone Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Development
Slide 22: Theravance Biopharma: Medicines That Make a Difference
Theravance “kX Biopharma A Medicines That Make a Differ;
Slide 23: 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 24: 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