Theravance Biopharma, Inc. · NASDAQ:TBPH
Theravance Biopharma — Q3 2023 Earnings Presentation
39 slides from Theravance Biopharma's earnings presentation, Nov 7, 2023
Slide 1: Third Quarter 2023 Financial Results and Business Update
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 property of their respective owners. T
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Ref orm Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance B
Slide 3: Agenda
Introduction Rick E Winningham Chief Executive Officer Ampreloxetine Overview Rick E Winningham Chief Executive Officer Richard A. Graham Senior Vice President, Research and Development YUPELRI ® Update Rhonda F. Farnum Senior Vice President, Chief Business Officer Financial Update Aziz Sawaf Senior
Slide 4: Strategic Objectives: Q3 and YTD Progress
Strategic Objectives: Q3 and YTD Progress 4 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2 . Non - GAAP profit is expected to consist o
Slide 5: 51. In the US,Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co
51. In the US,Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co promotes the product under a profit and loss sharing arrangement (65% to Viatris ; 35% to Theravance Biopharma). 2. NonGAAP net loss from continuing operations consists of GAAP net loss before taxes exclud
Slide 6: Ampreloxetine Value Proposition
Ampreloxetine Value Proposition 6 1. UCSD Neurological Institute (25K - 75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Str oke (15K - 50K). 2. Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure
Slide 7: Ampreloxetine Worldwide Opportunity: MSA Patients with Symptomatic nOH
7 Source: Thelansis nOH Market Report 2023; TBPH Internal Analysis 1 China & Japan United States Europe Ampreloxetine Worldwide Opportunity: Multiple System Atrophy (MSA) Patients with Symptomatic nOH MSA patients: ~50K Total Addressable Pop. w/ nOH: ~35 - 45K MSA patients: ~65K Total Addressable Po
Slide 8: Ampreloxetine Value Proposition
Ampreloxetine Value Proposition81. UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).2. Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and mul
Slide 9: Differentiated Profile in Symptomatic nOH in MSA: High Unmet Need
Differentiated Profile in Symptomatic nOH in MSA: High Unmet Need, Significant Potential Impact 1. Merola A, et al., Mov Disord 2018 . 2. Claassen DO, et al., BMC Neurol 2018. 3. NORTHERA ® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 4 . ProAmatine® (midodrine hydrochloride) [Warnin
Slide 10: Ampreloxetine: High Probability of Success
Ampreloxetine: High Probability of Success 10 ‣ Technical: Strong mechanistic rationale supported by late - stage clinical data • Intact peripheral nerves in MSA patients • NE increase prevents decrease in blood pressure which leads to improvement in debilitating symptoms • Clinically meaningful (1.
Slide 11: YUPELRI FDA-approved for maintenance treatment of COPD
FDA - approved for maintenance treatment of COPD First and only once - daily, LAMA (long - acting muscarinic agent) nebulized maintenance medicine for COPD Co - promotion agreement with VIATRIS TM (35% / 65% Profit Share)
Slide 12: YUPELRI Value Proposition
YUPELRI Value Proposition121. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co-promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2. As ofSeptember 30, 2023, the Company is eligible to receive fro
Slide 13: YUPELRI Continued Net Sales Growth
YUPELRI ® Continued Net Sales Growth 13 In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). $9.1 $16.5 $29.6 $36.8 $30.3 $37.0 $38.7 $36.9 $41.8 $
Slide 14: Theravance Hospital Execution Drives Value
Theravance Hospital Execution Drives Value 14 1. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 9/30/2023. Preliminary data subject to revision upon receipt of final data. 10K 19K 30K 54K 34K 47K 54K 56K 70K 78K 93K 98K 108K 113K 138K 160K 157K 160K 0K 20K 40K 60K 80K 100K 120K 140K
Slide 15: YUPELRI Market Share Gains Continue
YUPELRI ® Market Share Gains Continue 15 1. Joint VTRS/TBPH Market Research (Aug’23). * Hospital LA - NEB Market Share - IQVIA DDD through 9/30/2023. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through July’23. 7.6% 7.6% 8.6% 9.5% 10.7% 11.3% 11.6% 13.3% 12.5% 14.9% 15.2% 16.1
Slide 16: YUPELRI Retail Trends
16 Source: Symphony Health METYS Prescription Dashboard through 9/30/2023. 10% 7% - 2% 10% 5% 4% 7% 8% 9% K 5 K 10 K 15 K 20 K 25 K 30 K Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI ® Retail Trends Retail TRx Continue to Reach
Slide 17: Financial Update
Financial Update
Slide 18: Progress Against Financial Targets
18 1 . 2023 projected expenses based on the mid - point of stated guidance. Progress Against Financial Targets Reduction in expense base combined with YUPELRI ® Net Sales growth, and no debt $0 $50 $100 $150 $200 $250 $300 $350 $400 2020A 2021A 2022A 2023E R&D SG&A Share-Based Comp Significant Expen
Slide 19: Third Quarter 2023 Financials
Third Quarter 2023 Financials 19 1. Amounts include share - based compensation. 2. Non - GAAP net loss from continuing operations consists of GAAP net loss before taxes excluding share - based compensation expens e and non - cash interest expense; see reconciliation on Slide 20 and the section title
Slide 20: Third Quarter 2023 Financials (Cont'd)
Third Quarter 2023 Financials (Cont’d) 20 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss from Continuing Operations $ (8,950) $ (16,023) $ (46,683) $ (78,568) Adjustments: Share-based compensation expense 6,262 8,530 19,547 32,784 Non-cash inter
Slide 21: Q3 2023 Financial Highlights
Q3 2023 Financial Highlights Significant Capital Returns from a Position of Strength 21 1. Non - GAAP loss from continuing operations consists of GAAP loss before taxes excluding share - based compensation expense and no n - cash interest expense; see reconciliation on Slide 20 and the section title
Slide 22: 2023 Financial Guidance
2023 Financial Guidance Expected to Generate Non - GAAP 1 Profit in 2H 2023 22 1. Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interes t expense; see the section titled "Non - GAAP Financial Measures" on Slide 2 for more
Slide 23: TRELEGY ELLIPTA Milestones and Royalties
Q3’23 Net Sales of $ 675M | YTD Net Sales of $2.0B 4 Outer - Year Royalties 3 return in 2029: TRELEGY ELLIPTA Milestones and Royalties GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy 23 1. If both milestones are achieved in a given year, Theravance Bioph
Slide 24: Theravance's Future: Focused on Value Creation
24Theravance'sFuture: Focused on Value CreationoGrow YUPELRIoSuccessfully develop and commercializeampreloxetine worldwide:oRetain US rightsoPartner exUSoAchieve Up to $250M in TRELEGY sales milestones, with royalties returning in 2029oAchieve Potential YUPELRI milestones and royaltiesoMaintain fina
Slide 25: Q&A Session
Rick E Winningham Chairman and Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Q&A Session
Slide 26: YUPELRI (revefenacin) 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
Slide 27: 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 28: Appendix
Theravance WX Biopharma AK. Medicines That Make a Difference” Appendix
Slide 29: Track Record of Decisive Action
29 1. 2023 projected expenses based on the mid - point of stated guidance. From ‘20 - ’23, OpEx Reduced from $370M to $115M 1 Strategic Restructurings Received $1.1B Upfront + Future Milestones and Royalties TRELEGY Royalty Interest Monetization Mitigated Risk in Rising Interest Rate Environment Deb
Slide 30: $325 Million Capital Return Program
x ~$95M: Purchased GSK's equity stake in Theravance (Sep’22) and completed Dutch auction tender offer (Nov’22) x >$31M completed in Q3 2023 $325 Million Capital Return Program On Track to Complete Program by Year - End 30 Complete ($95M) Open Market Share Buybacks Complete ($200M) At 9/30/23: ~$295M
Slide 31: YUPELRI PIFR-2: Anticipated top-line disclosures
YUPELRI ® PIFR - 2: Phase 4 Randomized, Double - Blind, Parallel - Group Study: Anticipated top - line disclosures 31 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal Inspiratory Flo w Rate. *Dry powder inhaler (Spiriva ® HandiH
Slide 32: Substantial Opportunity for Further YUPELRI Growth
32 Substantial Opportunity for Further YUPELRI ® Growth Long - Acting Nebulized Maintenance Patients Patients Using Short - Acting Nebulized Therapy ~200K Current Long - Acting Neb Patients ~200K Patients Inappropriately Using Short - Acting Nebulized Treatments for Maintenance Therapy Current COPD
Slide 33: Granted Patent Protection Into Late 2030s
Granted Patent Protection Into Late 2030s 33 COPD, Chronic obstructive pulmonary disease ; nOH, neurogenic orthostatic hypotension; PTE, patent term extensions. Compound Invention Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter 2028 (once PTE awarded) Polymorph 2030 - 2031 Meth
Slide 34: Viatris Collaboration Agreement Revenue
34 Viatris Collaboration Agreement Revenue Theravance Entitled to Share of US profits (65% to Viatris; 35% to Theravance) 1. Any reimbursement from Viatris attributed to the 65% cost - sharing of our R&D expenses is characterized as a reduction of R&D expense. 2. Amount included as a receivable on t
Slide 35: TRELEGY ELLIPTA Theravance and Royalty Pharma Deal Summary
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 35 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Based on 100% of TRELEGY ELLIPTA royalties. 3. U.S. royalties
Slide 36: High Unmet Need Supports Significant Commercial Potential
High Unmet Need Supports Significant Commercial Potential 36 Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in deve lop ment and not approved for any indication. Data on file. 1. UCSD Neurological Institute (25K - 75K, with ~10K
Slide 37: Durable, Clinically-significant Symptom Improvements in MSA Patients
37 BL, baseline; CI, confidence interval; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; RWD, r and omized withdrawal. Demonstrated Durable, Clinically - significant Symptom Improvements in MSA Patients 33 34 31 32 64 42 20 20 18 20 0 0 4 0 4 8 12 16 18 20 22 2 4 6 8
Slide 38: Increased Norepinephrine, Prevented Blood Pressure Drop in MSA Patients
Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA Patients 1, 2 38 1. Data from MSA patients. Error bars represent SE. * p < 0.05 comparison to baseline reported after 4 weeks of ampreloxetine ad ministration in study 0169. 2. Data from MSA patients at week 6 of t
Slide 39: Prevented Worsening of Standing SBP in MSA Patients
Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. Standing SBP measured at 3 min and supine SB P measured at 10 min. Line represents the mean +/ - standard deviation. MSA, multiple system atrophy; SBP, systolic blood pressure; SD, standard deviation. Prevented Worse