Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Stifel Global Healthcare Conference 2014
17 slides from Theravance Biopharma's conference presentation, Nov 18, 2014
Slide 1: Stifel Global Healthcare Conference 2014
18 November 2014 Stifel Global Healthcare Conference 2014
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance Biopharma intends such fo
Slide 3: Theravance Biopharma Today
Theravance Biopharma Today (NASDAQ: TBPH) Theravance Biopharma was established to create value from a unique and diverse set of assets: an approved product; late stage, commercially attractive product candidates; a pipeline of high-value assets; and a productive research platform with potential for
Slide 4: The Theravance Biopharma Difference
The Theravance Biopharma Difference † TBPH holds economic interest in future payments that may be made by GlaxoSmithKline plc (GSK) relating to certain programs, including “Closed Triple” (FF/UMEC/VI) (Fluticasone Furoate/Umeclidinium/Vilanterol), MABA/FF (‘081), MABA monotherapy and other future pr
Slide 5: Product Pipeline
Product Pipeline Best-in-Class Opportunities in Large, Underserved Markets Program Phase 1 Phase 2 Phase 3 Marketed Axelopran (TD-1211): Opioid-Induced Constipation TD-9855: Fibromyalgia CNS/Pain TD-8954 (selective 5-HT agonist) Velusetrag (TD-5108): Gastroparesis GI Motility Dysfunction “Closed Tri
Slide 6: VIBATIV (telavancin) Once-Daily Antibiotic With Dual Mechanism of Action
FDA-approved for treatment of adults with cSSSI or HABP/VABP caused by susceptible isolates of Staphylococcus aureus (including MSSA and MRSA; in HABP/VABP, use when alternative treatments are not suitable) Approved in the EU for nosocomial (hospital-acquired) pneumonia, including ventilator-associa
Slide 7: TD-4208 for COPD
TD-4208 for COPD First-in-class: No approved once-daily nebulized bronchodilators for COPD in any class Unmet Need: Once-daily (QD) LAMAs are recommended standard therapy for moderate to severe COPD patients† Currently only available in handheld devices 2013 net sales of~$5B for most commonly prescr
Slide 8: TD-4208 for COPD
TD-4208 for COPD Note: COPD = Chronic Obstructive Pulmonary Disease. AE = Adverse Event. Small number of serious adverse events reported across both studies; all assessed as either not related or very low likelihood of being related to study treatment. Potential First-in-Class Nebulized, Once-a-Day
Slide 9: TD-4208 Study 0117 Met Primary Endpoint at Doses of 88 mcg and Above
TD-4208 for COPD Study 0117 Met Primary Endpoint at Doses of 88 mcg and Above TD-4208 (mcg) p-values versus placebo: <0.001*** Change from Baseline in FEV1 44 mcg 88 mcg 175 mcg 350 mcg Difference from placebo (mL) 52 187 167 171 Multiplicity-adjusted p-value 0.141 <0.001 <0.001 <0.001 Note: FEV1 =
Slide 10: Study 0117: Placebo-corrected Spirometry Profiles on Day 28
TD-4208 for COPD Study 0117: Placebo-corrected Spirometry Profiles on Day 28 Note: FEV1 = forced expiratory volume in one second. PD = pre-dose. Sustained Bronchodilation Over 24 Hours 0 50 100 150 200 250 PD 1 2 3 4 6 8 10 12 15 21 23.75 Time point (hours) Adjusted LS Mean FEV1 Change from Baseline
Slide 11: Axelopran for OIC: Significant Market Opportunity
Axelopran for OIC Significant Market Opportunity in Opioid-Induced Constipation Millions of afflicted patients currently under physician care Note: Sources include longitudinal opioid market assessment and patient market research commissioned by company in 2011. US patients using chronic opioids (>1
Slide 12: Axelopran for OIC Phase 2b: Met Primary Endpoint
Axelopran for OIC Phase 2b: Met Primary Endpoint in Doses of 10 and 15 mg Baseline Wk 2-5 Baseline Wk 2-5 Baseline Wk 2-5 LS mean difference = 0.97 p=0.043 LS mean difference = 1.61 p=0.0010 LS mean difference = 1.79 p=0.0003 Note: Results above reflect Efficacy Analysis (EA) population. CSBM = Comp
Slide 13: Economic Interest in GSK Respiratory Programs
Economic Interest in GSK Respiratory Programs TBPH is entitled to an 85% economic interest† in future payments made by GSK from certain potential products: “Closed Triple” (FF/UMEC/VI): Upward-tiering from 6.5% to 10% of annual global net sales Phase 3 study in 10,000 patients with COPD initiated Ju
Slide 14: Other Pipeline Assets in Development
Other Pipeline Assets in Development † Plus certain other countries. ‡ Subjects with maximum decline less than limit of detection imputed as LOD/2 on log10 scale. Note: NSRI = Norepinephrine and serotonin reuptake inhibitor. GT= genotype. Compelling Market Opportunities, with Unmet Medical Needs Vel
Slide 15: The Theravance Biopharma Difference
The Theravance Biopharma Difference Theravance Biopharma discovers, develops and commercializes medicines to improve the lives of patients and with the potential to make meaningful improvements in the standard of care in areas of serious medical need. 15
Slide 16: Thank You
Theravance “kX Biopharma A Medicines that make a difference THANK YOU
Slide 17: VIBATIV (telavancin) Important Safety Information (US)
VIBATIV® (telavancin) Important Safety Information (US) Mortality Patients with pre-existing moderate/severe renal impairment (CrCl <50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus v
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