EX-99.2 3 tm227247d1_ex99-2.htm EXHIBIT 99.2

Exhibit 99.2

 

 

Fourth Quarter and Full Year 2021 Financial Results and Business Update February 23, 2022 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. © 2022 Theravance Biopharma. All rights reserved.

 

 

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 differ materially from the forward - looking statements or projections . Examples of forward - looking statements in this presentation may include the Company's goals, designs, strategies, plans and objectives, the impact of the Company’s restructuring plan, ability to provide value to shareholders, the Company's regulatory strategies and timing of clinical studies (including the data therefrom), the potential characteristics, benefits and mechanisms of action of the Company's product and product candidates, the potential that the Company's research programs will progress product candidates into the clinic, the Company's expectations for product candidates through development and the market for products being commercialized, the Company's expectations regarding its allocation of resources, potential regulatory actions and commercialization (including differentiation from other products or potential products and addressable market), product sales or profit share revenue and the Company's expectations for its expenses, excluding share - based compensation and other financial results . The company’s forward - looking statements are based on the estimates and assumptions of management as of the date of this presentation and are subject to risks and uncertainties that may cause the actual results to be materially different than those projected, such as risks related to the impacts on the COVID - 19 global pandemic on our business, disagreements with Innoviva , Inc . and TRC LLC, the uncertainty of arbitration and litigation and the possibility that the results of these proceedings could be adverse to the Company, additional future analysis of the data resulting from our clinical trial(s), delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non - clinical studies indicate the Company's compounds, products or product candidates are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, the feasibility of undertaking future clinical trials based on policies and feedback from regulatory authorities, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, ability to retain key personnel, the impact of the Company’s restructuring actions on its employees, partners and others . Other risks affecting Theravance Biopharma are in the company's Form 10 - Q filed with the SEC on November 8 , 2021 , and other periodic reports filed with the SEC . Forward - looking statements 2

 

 

Agenda 3 Introduction Gail B. Cohen Vice President, Corporate Communications Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Rhonda F. Farnum Senior Vice President, Commercial and Medical Affairs Richard A. Graham Senior Vice President, Research and Development Financial Update Andrew A. Hindman Senior Vice President, Chief Financial Officer Closing Remarks Rick E Winningham Chief Executive Officer

 

 

Rapid transition to a streamlined, respiratory focused Theravance Biopharma 4 Significant cost reduction program reduces Company size to become sustainably cash - flow positive beginning 2H 2022 Focus on leveraging expertise in developing and commercializing respiratory therapeutics Streamlined R&D investment to focus on highest value core respiratory opportunities Leverage partnerships to unlock value of pipeline non - core assets Overarching goal: maximize shareholder value

 

 

Key pillars of respiratory - focused value creation plan 1. 1. Source: TBPH Analysts Consensus [8] December 9, 2021. 2. Source: Bloomberg GSK Analysts Consensus February 15, 2022. 3. 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 A gre ement over the next four fiscal quarters). 75% of TRC income received is pledged to service outstanding notes, 25% of royalties retained by TBPH. Our non - recourse Triple II 9.5% Fixed Rate Term Notes a re due on or before 2035. 2. JAK, Janus kinase; PIFR, peak inspiratory flow rate. 5 YUPELRI ® ‣ Consensus US peak year sales of ~$400 million 1 ‣ Q4 2021 net sales of $44 million implies run rate annual sales of ~$ 180 million ‣ YUPELRI remains early in its product lifecycle; has demonstrated quarter - over - quarter market share growth ‣ TBPH hospital - based and Viatris community - based sales forces continue driving growth ‣ PIFR - 2 study intended to capture more of the addressable market and further strengthen its competitive advantage ‣ Long patent life Core Respiratory Pipeline Near - term catalysts will inform upside potential of focused pipeline: ‣ Inhaled JAK inhibitor portfolio, with the most advanced candidate being nezulcitinib (TD - 0903), initially targeting acute lung injury and fibrotic disease ‣ Dry - powder inhaled JAK inhibitors to proceed into clinic with next generation compounds after securing partnership TRELEGY ‣ Consensus global peak year sales of ~$ 3.6 billion 2 ‣ Q4 2021 net sales of $ 479 million implies run rate annual sales of ~$ 1.9 billion 3 ‣ Long patent life ‣ TRELEGY - related cash flows to TBPH to increase substantially (once non - recourse note is fully repaid) 3

 

 

FDA - approved for maintenance treatment of COPD First and only once - daily, LAMA (long - acting muscarinic agent) nebulized maintenance medicine for COPD

 

 

‣ Once - daily LAMAs are first - line therapy for moderate - to - very severe COPD 1 ‣ 9% of COPD patients (~800,000) use nebulizers for ongoing maintenance therapy; 41% use nebulizers at least occasionally for bronchodilator therapy 2 YUPELRI ® ( revefenacin ) inhalation solution 1. Global Initiative for Chronic Obstructive Lung Disease 2022 Report, htttps://goldcopd.org . 2. TBPH market research (N = 160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist. 7 ‣ TBPH and VTRS worldwide strategic collaboration to develop and commercialize nebulized YUPELRI (revefenacin) ‣ Companies co - promote under US profit/loss share 65% 35% FDA - approved for maintenance treatment of COPD First and only once - daily, nebulized maintenance medicine for COPD

 

 

TBPH implied 35% of YUPELRI ® US net sales by quarter See TBPH 10K filed February 26, 2021 for greater detail re TBPH implied 35%. 8 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 $10.4 $12.9 $10.6 $13.0 $13.5 $12.9 $14.6 $13.8 $15.3 0 2 4 6 8 10 12 14 16 18 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21

 

 

YUPELRI ® hospital sales and community TRx trends Continued market share growth across both the hospital and retail channels 1.1% 2.2% 3.4% 5.4% 6.5% 6.6% 7.4% 7.8% 8.7% 9.5% 10.8% 0% 5% 10% 15% 20% 25% Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Hospital LA - NEB Market Share* Hospital Market Share YUPELRI LA-NEB Market Share 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 12/31/2021. ** Community LA - NEB Market Share - IQVIA XPO Excl. LTC (Retail) and SolutionsRx (DME / Med B FFS) through 10/31/2021 (Q4’21 Community LA - NEB Market Share Incomplete). *** Retail TRx Volume - Symphony Health METYS Prescription Dashboard through 12/31/2021. 9 TRx volume represents retail only which is typically 33% of Retail + DME Reported DME volume, while lagged, typically follows Retail volume trends 1.5% 6.1% 9.8% 13.1% 15.2% 16.3% 17.4% 18.7% 19.7% 21.4% 22.7% 23.2% 0K 5K 10K 15K 20K 25K 0% 5% 10% 15% 20% 25% Q1'19 Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Retail TRx Volume*** Community LA - NEB Market Share** Community Market Share with TRx Retail TRx YUPELRI LA-NEB Market Share Most patients who receive YUPELRI ® in the hospital are discharged with an Rx 1 **Community LA - NEB Market Share includes Retail + DME / Med B FFS through Oct’21 LA - NEB Market: YUPELRI, BROVANA, LONHALA, PERFOROMIST, arformoterol , formoterol

 

 

0 2,000 4,000 6,000 8,000 10,000 YULPELRI Weekly Hospital Doses YUPELRI ® hospital volume has returned to growth Source: IQVIA DDD through 12/31/2021. 10 2019 Growth from launch 2020 Flat 2021 Return to growth Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

 

 

Favorable YUPELRI ® outlook in 2022 and beyond 11 1. Data on file from TBPH survey of HCPs October 2020 - October 2021. COPD, chronic obstructive pulmonary disease; PIFR, peak inspiratory flow rate; PPE, personal protective equipment; QD, once a da y. Additional potential growth opportunities Observations from the field 1 ‣ Pulmonologists / other HCPs have resumed routine testing to evaluate and diagnose COPD patients ‣ In office nebulization for COPD patients has resumed ‣ 99% of hospital - based HCPs support nebulization regardless of COVID - 19 status if proper PPE is worn ‣ More hospitals becoming or are “all neb” ‣ QD dosing important to alleviate health systems overwhelmed by rising COVID - 19 cases (over - taxed hospitals and long - term care facilities) ‣ PIFR - 2 study: intended to capture more of the addressable market and further strengthen its competitive advantage ‣ China opportunity : e xclusive rights licensed to Viatris in 2019; p otential development and sales milestones totaling $54M / low double - digit tiered royalties on net sales

 

 

Pipeline focused on highest value core respiratory opportunities 1. Excluding programs that are in the process of being wound down following restructuring. JAK, Janus kinase; PIFR, peak inspiratory flow rate. 12 New Theravance Biopharma: Core Respiratory Focused pipeline of core respiratory programs 1 Implement partnering strategy to maximize value of pipeline assets ‣ PIFR - 2 Phase 4 study intended to capture more of the addressable market and further strengthen its competitive advantage ‣ Inhaled JAK inhibitor portfolio which includes nezulcitinib

 

 

A new, respiratory focused Theravance Biopharma 1. TBPH estimate derived from integrating multiple data sources 2. TBPH holds 85% economic interest in upward - tiering royalty st ream 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 p led ged to service outstanding notes, 25% of royalties received retained by TBPH. All statements concerning TRELEGY ELLIPTA based on publicly available information. ALK5i, transforming growth factor β receptor I kinase inhibitor; CD, Crohn’s di sease; COPD, chronic obstructive pulmonary disease; FF/UMEC/VI, fluticasone furoate/umeclidinium/ vilanterol; JAKi , JAK inhibitor; LAMA, long - acting muscarinic antagonist ; nOH , neurogenic orthostatic hypotension; NRI, norepinephrine reuptake inhibitor; PIFR, peak inspiratory flow rate; UC, ulcerative colitis. 13 Program Indication US Patients 1 Research Phase 1 Phase 2 Phase 3 Filed Marketed Phase 4 Collaborator Respiratory Assets YUPELRI (revefenacin) LAMA COPD patients with suboptimal PIFR >8mm Nezulcitinib (TD - 0903) Inhaled JAKi Acute and chronic lung inflammation, fibrotic disease >32mm Inhaled JAKi Asthma ~25mm Economic Interests TRELEGY 2 FF/UMEC/VI COPD >8mm GSK & Innoviva, Inc. Asthma ~25mm Skin - selective JAKi Dermatological diseases >8mm Non - Core Assets * Ampreloxetine (TD - 9855) NRI S ymptomatic nOH ~350k Izencitinib (TD - 1473) GI JAKi UC ~900k CD ~800k TD - 5202 Irreversible JAK3i Celiac disease UC CD ~5mm Inhaled ALK5i Idiopathic pulmonary fibrosis ~140k Phase 3 Phase 2 Phase 2 Phase 1 Phase 1 Marketed Phase 4 PIFR - 2 Study Marketed Phase 1 Phase 2b/3 Research Marketed *Limited additional capital investment planned post Q1 2022

 

 

Economic interest GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy

 

 

Economic interest in GSK’s TRELEGY 1. 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 outstanding notes, 25% of royalties retained by TBPH. Our non - recourse Triple II 9.5% Fixed Rate Term Notes are due on or before 2035. All statements concerning TRELEGY based on publicly available information. TRELEGY is FF/UMEC/VI or flutic aso ne furoate/umeclidinium/vilanterol; comprised of inhaled corticosteroid, long - acting muscarinic receptor antagonist, and long - acting β2 agonists, active components of Anoro (UMEC/VI). COPD, chronic obstructive pulmonary disease. 15 TRELEGY Upward - tiering royalties of ~5.5 – 8.5% of global net sales 1 Q4 global net sales of $ 479M Year - over - year sales growth of 52 % from the same period in 2020 TRELEGY now has 53 % of US triple therapy patients for COPD and 71 % global share 0 100 200 300 400 500 600 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 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 Monthly TRx Volume (Thousands) Month Post Launch Strongest US ELLIPTA Launch ANORO ELLIPTA ARNUITY ELLIPTA BREO ELLIPTA INCRUSE ELLIPTA Launched in US in November 2017 Source: GSK, Symphony Health Metys monthly TRx data for the time period Sept'13 to Dec'21. TRELEGY Mortality Ad Comm TRELEGY Asthma Approval BREO Asthma Approval TRELEGY

 

 

Fourth quarter 2021 financial highlights 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. 3. Excludes share - based compensation and restructuring expense. 16 $173.5 million cash 1 as of December 31, 2021 Research and development operating expense 3 27,783 57,595 168,023 229,659 Selling, general and administrative operating expense 3 16,403 22,074 71,231 76,979 ($, in thousands) Revenue: Collaboration revenue Licensing revenue Viatris collaboration agreement Total revenue Costs and expenses: Research and development 2 Selling, general and administrative 2 Total costs and expenses Loss from operations Share - based compensation expense: Research and development Selling, general and administrative Total share - based compensation expense Operating expense excluding share - based compensation and one - time restructuring expense: ( 56,167) (76,490) ( 257,784 ) (297,757) 3,442 7,570 25,634 31,294 8,362 8,362 16,917 15,551 62,061 62,976 31,225 65,165 193,657 260,953 21,516 30,055 99,296 108,661 71,112 95,220 313,095 369,614 14,945 18,730 55,311 71,857 $ 2,813 $ 7,083 $ 11,463 $ 26,464 — — — 1,500 12,132 11,647 43,848 43,893 Three Months Ended December 31, 2021 2020 (Unaudited) Year Ended December 31, 2021 2020 (Unaudited) Restructuring and related expenses 2 18,371 — 20,142 — Restructuring and related expenses 5,113 7,981 28,065 3,682 — —

 

 

Financial Guidance 1. Excluding share - based compensation (SBC) and one - time restructuring, severance and termination costs. 17 Execution of cost - cutting initiatives resulted in lower FY 2021 Actuals vs. OPEX guidance 1 : – R&D: $168M Actuals vs. range of $170 – $180M – SG&A: $71M Actuals vs. range of $65 – $75M Reiterating 2022 OPEX guidance 1 : – R&D: range of $45 – 55M – SG&A: range of $35 – 45M 2022 guidance includes ~$10M in non - recurring spend, mostly in R&D: – Majority in Q1 to support completion of late - stage programs – OPEX Q2 and onward will reflect recurring spend only Theravance Biopharma is projected to be sustainably cash - flow positive beginning in 2H 2022

 

 

Rapid transition to a streamlined, respiratory focused Theravance Biopharma 18 Significant cost reduction program reduces Company size to become sustainably cash - flow positive beginning 2H 2022 Focus on leveraging expertise in developing and commercializing respiratory therapeutics Streamlined R&D investment to focus on highest value core respiratory opportunities Leverage partnerships to unlock value of pipeline non - core assets Overarching goal: maximize shareholder value

 

 

Q&A Session Rick E Winningham Chairman and Chief Executive Officer Andrew A. Hindman Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Commercial and Medical Affairs Richard A. Graham Senior Vice President, Research and Development

 

 

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 component of this product . YUPELRI should not be initiated in patients during acutely deteriorating or potentially life - threatening episodes of COPD, or for the relief of acute symptoms, i . e . , as rescue therapy for the treatment of acute episodes of bronchospasm . Acute symptoms should be treated with an inhaled short - acting beta 2 - agonist . As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life - threatening . If paradoxical bronchospasm occurs following dosing with YUPELRI, it should be treated immediately with an inhaled, short - acting bronchodilator . YUPELRI should be discontinued immediately and alternative therapy should be instituted . YUPELRI should be used with caution in patients with narrow - angle glaucoma . Patients should be instructed to immediately consult their healthcare provider if they develop any signs and symptoms of acute narrow - angle glaucoma, including eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema . Worsening of urinary retention may occur . Use with caution in patients with prostatic hyperplasia or bladder - neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur . Immediate hypersensitivity reactions may occur after administration of YUPELRI . If a reaction occurs, YUPELRI should be stopped at once and alternative treatments considered . The most common adverse reactions occurring in clinical trials at an incidence greater than or equal to 2 % in the YUPELRI group, and higher than placebo, included cough, nasopharyngitis, upper respiratory infection, headache and back pain . Coadministration of anticholinergic medicines or OATP 1 B 1 and OATP 1 B 3 inhibitors with YUPELRI is not recommended . YUPELRI is not recommended in patients with any degree of hepatic impairment . OATP, organic anion transporting polypeptide. 20

 

 

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 nebulizers for ongoing maintenance therapy . 1 LAMAs are a cornerstone of maintenance therapy for COPD and YUPELRI ® is positioned as the first once - daily single - agent bronchodilator product for COPD patients who require, or prefer, nebulized therapy . YUPELRI ® ’s stability in both metered dose inhaler and dry powder device formulations suggest that this LAMA could also serve as a foundation for novel handheld combination products . 1. TBPH market research (N=160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist. 21