Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — JP Morgan Healthcare Conference 2021
29 slides from Theravance Biopharma's conference presentation, Jan 11, 2021
Slide 1: JP Morgan Healthcare Conference January 13, 2021
JP Morgan Healthcare Conference January 13, 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 trademarks used here
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: Our science
Our science Organ - selective molecules designed to optimize therapeutic index
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: 2021: Three Areas for Transformational Impact
2021: Three Areas for Transformational Impact 5 Development Pipeline Ampreloxetine Izencitinib TD - 0903 Changing Financial Profile
Slide 6: Pipeline programs by indication and phase
Program Indication Research Phase 1 Phase 2 Phase 3 Filed Marketed Collaborator Ampreloxetine (TD - 9855) NRI S ymptomatic nOH Wholly - owned Organ - Selective Izencitinib (TD - 1473) GI JAKi UC CD Janssen Biotech, Inc . TD - 5202 Irreversible JAK3i Inflammatory intestinal diseases YUPELRI ® (revefe
Slide 7: 2021: Three Areas for Transformational Impact
2021: Three Areas for Transformational Impact 7 Development Pipeline Ampreloxetine Izencitinib TD - 0903 Changing Financial Profile
Slide 8: 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 receptor antagonist 8 Once - dai
Slide 9: YUPELRI hospital sales and community TRx trends
YUPELRI ® hospital sales and community TRx trends Continued growth through Q1’20 across both the hospital and retail channels; Signs of recovery to initial growth trajectory leading into 2021 0.3% 1.1% 2.2% 3.4% 5.4% 6.5% 6.3% 7.8% 0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% Q1'19 Q2'19 Q3'19 Q4'19 Q1'20
Slide 10: TBPH implied 35% of YUPELRI US net sales by quarter
TBPH implied 35% of YUPELRI ® US net sales by quarter See TBPH 10Q filed Nov 9, 2020 for greater detail re TBPH implied 35%. 10 TBPH implied 35% of YUPELRI US net sales represents TBPH’s split of the combined TBPH and VIATRIS net revenue Growth in net sales through Q1’20 and recovery in Q3’20 driven
Slide 11: 2021: Three Areas for Transformational Impact
2021: Three Areas for Transformational Impact 11 Development Pipeline Ampreloxetine Izencitinib TD - 0903 Changing Financial Profile
Slide 12: Ampreloxetine (TD-9855)
Ampreloxetine (TD - 9855) Once - daily norepinephrine reuptake inhibitor to treat symptomatic neurogenic orthostatic hypotension
Slide 13: Reduced quality of life and limited therapeutic options for symptomatic nOH patients
Reduced quality of life, significant caregiver burden and limited therapeutic options for symptomatic nOH patients 13 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. APAC, Asian
Slide 14: 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 15: Ampreloxetine Phase 3 registrational program
Ampreloxetine: Potential to provide meaningful and durable symptom improvement to underserved patients All subjects who complete Study 169 may enroll into 170; all subjects who complete 170 may enroll into extension study/171. Baseline OHSA #1 (Orthostatic Hypotension Symptom Assessment Question 1)
Slide 16: Izencitinib (TD-1473/JNJ-8398)
Izencitinib (TD - 1473/JNJ - 8398) Oral gut - selective pan - JAK inhibitor to treat inflammatory bowel diseases
Slide 17: Izencitinib low systemic exposures but high colonic concentrations
Izencitinib results in low systemic exposures but high colonic concentrations above JAK inhibition levels ‣ >10 - fold lower systemic exposure with i zencitinib vs 10 mg BID tofacitinib (based upon published data) ‣ Tissue exposures at 80 and 270 mg of i zencitinib within the range of cellular JAK I
Slide 18: Favorable data from exploratory Phase 1b study
Favorable data from this innovative exploratory Phase 1b study 1 ‣ Confirmed gut selectivity – High colonic concentration with low systemic drug exposures, consistent with pre - clinical data – For the goal of maximized therapeutic index ‣ Demonstrated numerically higher rates of clinical outcomes w
Slide 19: 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 20: TD-0903: Lung-selective inhaled pan-JAKi
TD - 0903: Lung - selective inhaled pan - JAKi ‣ High affinity for JAK1, JAK2, JAK3, and Tyk2 kinase domains ‣ High potency for inhibition of cytokine - induced activation of JAK - STAT signaling pathways – In vitro : human epithelial and immune cells – In vivo : murine inhalation cytokine - challen
Slide 21: TD-0903: Development plan designed to progress rapidly
Phase 2: Hospitalized COVID - 19 patients Dose 3 mg + SOC Placebo + SOC TD - 0903: Development plan designed to progress rapidly SOC, standard of care; PK, pharmacokinetic 21 Part 1: Multiple - ascending dose study x 7 days Repeat - dose safety, tolerability, PK, early dose - dependent efficacy Part
Slide 22: 2021: Three Areas for Transformational Impact
2021: Three Areas for Transformational Impact 22 Development Pipeline Ampreloxetine Izencitinib TD - 0903 Changing Financial Profile
Slide 23: 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 24: Economic interest in GSK's TRELEGY
Economic interest in GSK’s TRELEGY Q3 net sales of £194MM (or $252MM) Sales up 45% year - over - year US asthma indication approved September 9, 2020, and launched 3 rd Q ‣ Results from the CAPTAIN study published in The Lancet Respiratory Medicine 1. TBPH holds 85% economic interest in upward - tie
Slide 25: Multiple potential milestones & value-driving catalysts
Q4 Q2 Q3 Q1 2021 Multiple potential milestones & value - driving catalysts 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
Slide 26: Creating transformational value for stakeholders
Creating transformational value for stakeholders 26 Innovative research yielding organ - selective molecular designed assets Proven development and commercial expertise Strategic partnerships Value driving catalysts Strong capital position
Slide 27: Discovering… Developing… Commercializing…
27 Discovering… Developing… Commercializing…
Slide 28: 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 29: 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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