UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Item 2.02. Results of Operations and Financial Condition.
On May 5, 2022, Theravance Biopharma, Inc. issued a press release and is holding a conference call regarding its financial results for the quarter ended March 31, 2022 and a business update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and a copy of materials that will accompany the call is furnished as Exhibit 99.2 to this Current Report.
The information in Item 2.02 and in Item 9.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act of 1934”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Press Release dated May 5, 2022 | |
| 99.2 | Slide deck entitled First Quarter 2022 Financial Results and Business Update | |
| 104 | Cover Page Interactive Data File (cover page XBRL tags embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| THERAVANCE BIOPHARMA, INC. | ||
| Date: May 5, 2022 | By: |
/s/ Andrew Hindman |
| Andrew Hindman | ||
| Senior Vice President and Chief Financial Officer | ||
Exhibit 99.1
Theravance Biopharma, Inc. Reports First Quarter 2022 Financial Results and Provides Business Update
| ● | Implied 35% share of YUPELRI® (revefenacin) net sales1: $15.3M Q1 2022 up 19% from Q1 2021 |
| ● | TRELEGY Q1 2022 global net sales: $454M, up 33% from Q1 20212 |
| ● | Results from a Phase 3 study of ampreloxetine showed a benefit in study patients with multiple system atrophy (MSA) |
| ● | Restructuring process completed in Q1 2022 |
DUBLIN, IRELAND – MAY 5, 2022 – Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today reported financial results for the first quarter of 2022.
“We continue to execute against our business plan, stay disciplined in capital allocation, and 2022 remains on track to become sustainably cash-flow positive by the second half of this year and going forward on an annual basis,” said Rick E Winningham, Chief Executive Officer. “Our team’s perseverance as demonstrated by YUPELRI’s hospital sales performance and continued gain of hospital and community market share creates a strong base for future growth. Considering the benefit that ampreloxetine provided to MSA patients in our Study 0170, we will define a path forward through ongoing discussions with regulators and strategic partners. We plan to continue to unlock value from our pipeline throughout 2022.”
Quarterly Highlights
| ● | YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), continued to increase its share of the long-acting nebulized COPD market, increasing to 23.5% through January 2022, up from 23.2% in October 2021, and net sales increased by 19% year-over-year (Q1 2022 vs Q1 2021). |
| ● | Ampreloxetine, an investigational, Theravance Biopharma-discovered, potent, long-acting, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). Phase 3 results (Study 0170) showed a benefit to MSA patients in the study that was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment (OHSA) composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1. (Read more about the data here). |
1 While Viatris, Inc. (“Viatris”) records the total YUPELRI net sales, the Company is entitled to a 35% share of the profits and losses pursuant to a co-promotion agreement with Viatris.
2 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles the Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC (TRC) expenses paid and the amount of cash, if any, expected to be used by TRC over the next four fiscal quarters). 75% of the income from the Company’s investment in TRC is pledged to service outstanding notes and 25% of income from the Company’s investment in TRC is retained by the Company.
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Economic Interest
| ● | TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted first quarter 2022 global net sales of $454 million (up from $341 million, 33%, in first quarter of 2021); Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3 |
First Quarter Financial Results
| ● | Revenue: Total revenue for the first quarter of 2022 was $13.2 million, primarily comprised of licensing revenue of $2.5 million related to a development milestone payment from Pfizer for the first patient dosed in a Phase 1 clinical trial of the skin-selective pan-Janus kinase (JAK) inhibitor program and $10.7 million in Viatris collaboration revenue. Total revenue for the first quarter represents a $1.1 million decrease over the same period in 2021 driven by the completion of the recognition of non-cash Janssen collaboration revenue in 2021, resulting from the planned close-out of the izencitinib program. |
| ● | YUPELRI: The Viatris collaboration revenue of $10.7 million for the first quarter of 2022 represents amounts receivable from Viatris and is comprised of the Company’s 35% share of net sales of YUPELRI as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, our implied 35% share of net sales of YUPELRI for the first quarter of 2022 was $15.3 million, up 19% from the first quarter of 2021. We achieved 19% year-over-year growth in net sales, however, due to accounting guidelines, our Viatris collaboration revenue increased by only 3% due to lower costs incurred by Theravance Biopharma as a result of the corporate restructuring, which improves YUPELRI profitability but lowers Viatris collaboration revenue. |
| ● | Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2022 were $23.3 million, compared to $67.6 million in the same period in 2021. First quarter R&D expenses included total non-cash share-based compensation of $4.5 million. |
| ● | Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2022 were $19.1 million, compared to $30.6 million in the same period in 2021. First quarter SG&A expenses included total non-cash share-based compensation of $5.5 million. |
| ● | Restructuring and Related Expenses: Restructuring expenses for the first quarter of 2022 were $9.3 million and primarily comprised of severance costs, termination-related benefits, one-time retention costs, and share-based compensation expense. Cash restructuring expenses were $4.8 million for the first quarter of 2022; and non-cash restructuring expenses were $4.5 million for the first quarter of 2022. |
| ● | Operating Loss: Operating loss for the first quarter of 2022 was $38.5 million compared to $83.9 million in the same period of 2021. |
| ● | Cash Position: Cash, cash equivalents and marketable securities totaled $147.5 million as of March 31, 2022. |
3 As reported by Glaxo Group Limited or one of its affiliates (GSK); reported sales converted to USD; economic interest related to TRELEGY (the combination of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI), jointly developed by GSK and Innoviva, Inc.) entitles the Company to upward tiering payments equal to approximately 5.5% to 8.5% on worldwide net sales of the product (net of Theravance Respiratory Company, LLC (TRC) expenses paid and the amount of cash, if any, expected to be used by TRC over the next four fiscal quarters). 75% of the income from the Company’s investment in TRC is pledged to service outstanding notes and 25% of income from the Company’s investment in TRC is retained by the Company.
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2022 Financial Guidance
| ● | Operating Expenses (excluding share-based compensation and one-time restructuring costs): The Company expects full year 2022 R&D expense of $45 million to $55 million and SG&A expense of $35 million to $45 million. |
| ● | The Company expects to be sustainably cash-flow positive beginning 2H 2022 and going forward on an annual basis. |
Conference Call and Live Webcast Today at 5:00 pm ET
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 10:00 pm IST. To participate in the live call by telephone, please dial (800) 225-9448 from the US, or (203) 518-9783 for international callers, using the confirmation code TBPH0505. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investors section, Presentations and Events.
A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through June 4, 2022. An audio replay will also be available through 11:59 pm ET on May 12, 2022, by dialing (800) 839-1337 from the US, or (402) 220-0489 for international callers.
About Theravance Biopharma
Theravance Biopharma, Inc. is a biopharmaceutical company primarily focused on the discovery, development and commercialization of respiratory medicines. Its core purpose is to create medicines that make a difference® in people’s lives.
In pursuit of its purpose, Theravance Biopharma leverages decades of respiratory expertise to discover and develop transformational medicines that make a difference. These efforts have led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Its respiratory pipeline of internally discovered programs is targeted to address significant patient respiratory needs.
Theravance Biopharma has an economic interest in potential future payments from Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain programs, including TRELEGY.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the US and certain other countries).
YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris Company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
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Forward-Looking Statements
This press release contains and the conference call will contain 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, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: 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 or will be partnered successfully, 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. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: 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. In addition, while we expect the effects of COVID-19 to continue to adversely impact our business operations and financial results, the extent of the impact on our ability to generate revenue from YUPELRI® (revefenacin), our clinical development programs, and the value of and market for our ordinary shares, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time. These potential future developments include, but are not limited to, the ultimate duration of the COVID-19 pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, other measures taken by us and those we work with to help protect individuals from contracting COVID-19, and the effectiveness of actions taken globally to contain and treat the disease, including vaccine availability, distribution, acceptance and effectiveness. Other risks affecting Theravance Biopharma are in the Company's Form 10-K filed with the SEC on February 28, 2022, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma's results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Contact: Gail
B. Cohen
Corporate Communications / 917-214-6603
Page 4 of 6
| THERAVANCE BIOPHARMA, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands) | ||||||||
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents and short-term marketable securities | $ | 147,516 | $ | 173,465 | ||||
| Receivables from collaborative arrangements | 12,277 | 14,065 | ||||||
| Amounts due from TRC, LLC | 35,559 | 43,534 | ||||||
| Prepaid clinical and development services | 4,742 | 10,245 | ||||||
| Other prepaid and current assets | 4,542 | 8,561 | ||||||
| Total current assets | 204,636 | 249,870 | ||||||
| Property and equipment, net | 13,236 | 13,657 | ||||||
| Operating lease assets | 39,349 | 39,690 | ||||||
| Equity in net assets of TRC, LLC | 94,108 | 67,537 | ||||||
| Restricted cash | 836 | 837 | ||||||
| Other assets | 3,194 | 3,228 | ||||||
| Total assets | $ | 355,359 | $ | 374,819 | ||||
| Liabilities and Shareholders' Deficit | ||||||||
| Current liabilities | $ | 44,201 | $ | 58,587 | ||||
| Convertible senior notes due 2023, net | 228,303 | 228,035 | ||||||
| Non-recourse notes due 2035, net | 384,161 | 371,359 | ||||||
| Long-term operating lease liabilities | 47,415 | 52,681 | ||||||
| Other long-term liabilities | 2,729 | 2,730 | ||||||
| Shareholders' deficit | (351,450 | ) | (338,573 | ) | ||||
| Total liabilities and shareholders’ deficit | $ | 355,359 | $ | 374,819 | ||||
(1) The condensed consolidated balance sheet as of December 31, 2021 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021.
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| THERAVANCE BIOPHARMA, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (In thousands, except per share data) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Revenue: | ||||||||
| Viatris collaboration agreement | $ | 10,687 | $ | 10,385 | ||||
| Collaboration revenue | 9 | 3,872 | ||||||
| Licensing revenue | 2,500 | - | ||||||
| Total revenue | 13,196 | 14,257 | ||||||
| Costs and expenses: | ||||||||
| Research and development (1) | 23,253 | 67,599 | ||||||
| Selling, general and administrative (1) | 19,121 | 30,550 | ||||||
| Restructuring and related expenses (1) | 9,324 | - | ||||||
| Total costs and expenses | 51,698 | 98,149 | ||||||
| Loss from operations | (38,502 | ) | (83,892 | ) | ||||
| Income from investment in TRC, LLC | 25,110 | 16,547 | ||||||
| Interest expense | (11,655 | ) | (11,873 | ) | ||||
| Interest income and other income (expense), net | (375 | ) | (234 | ) | ||||
| Loss before income taxes | (25,422 | ) | (79,452 | ) | ||||
| Provision for income tax expense | (524 | ) | (227 | ) | ||||
| Net loss | $ | (25,946 | ) | $ | (79,679 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted net loss per share | $ | (0.34 | ) | $ | (1.24 | ) | ||
| Shares used to compute basic and diluted net loss per share | 75,247 | 64,493 | ||||||
(1) Amounts include share-based compensation expense as follows:
| Three Months Ended March 31, | ||||||||
| (In thousands) | 2022 | 2021 | ||||||
| Research and development | $ | 4,530 | $ | 7,921 | ||||
| Selling, general and administrative | 5,498 | 7,911 | ||||||
| Restructuring and related expenses | 4,517 | - | ||||||
| Total share-based compensation expense | $ | 14,545 | $ | 15,832 | ||||
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Exhibit 99.2
First Quarter 2022 Financial Results and Business Update May 5, 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 or will be partnered successfully, 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 - K filed with the SEC on February 28 , 2022 , and other periodic reports filed with the SEC . Forward - looking statements 2
Agenda 3 Introduction Gail B. Cohen Corporate Communications Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Rhonda F. Farnum Senior Vice President, Chief Business Officer 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 focused and streamlined 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 respiratory opportunities Leverage partnerships to unlock value of pipeline assets Overarching goal: maximize shareholder value
Key pillars of focused value creation plan 1. 1. Source: TBPH Analysts Consensus [8] December 9, 2021. 2. Source: Bloomberg GSK Analyst Consensus April 27, 2022. 3. TBPH h old s 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 Agree men t 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 o n or before 2035. 2. LAMA, long - acting muscarinic antagonist; PIFR, peak inspiratory flow rate. 5 YUPELRI ® Maximize growing value of YUPELRI ‣ Consensus US peak year sales of ~$400 million 1 ‣ Demonstrated growth and strong cash flow generation ‣ Unique value proposition for the only once daily nebulized LAMA ‣ PIFR - 2 study intended to strengthen competitive advantage and capture more of the addressable market ‣ Long patent life Pipeline Limited strategic investments to advance pipeline ‣ Leveraging our internal expertise in development of inhaled lung - selective agents ‣ Mid - year meeting with FDA to align on approval path for ampreloxetine ‣ Pursuing strategic collaborations across pipeline to optimize value Economic interest in GSK's TRELEGY 3 TRELEGY ‣ Consensus global peak year sales of ~$ 3.5 billion 2 ‣ Q1 2022 net sales of $ 454 million implies run rate annual sales of ~$ 1.8 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
8 Quarterly YUPELRI Hospital Doses 53,880 34,470 47,010 54,210 56,250 70,170 78,180 93,420 97,410 K 20 K 40 K 60 K 80 K 100 K 120 K Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 YUPELRI ® hospital performance accelerating despite pandemic Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 3/31/2022. Doses sold increased 73% Q1’22 vs. Q1’21
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% 11.3% 0% 5% 10% 15% 20% 25% 30% Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 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 3/31/2022. ** Community LA - NEB Market Share - IQVIA XPO Excl. LTC (Retail) and SolutionsRx (DME / Med B FFS) through 1/31/2022 (Q1’22 Community LA - NEB Market Share Incomplete). *** Retail TRx Volume - Symphony Health METYS Prescription Dashboard through 3/31/2022. 9 TRx volume represents retail only which is typically 33% of Retail + DME Reported DME volume, while lagged, typically follows Retail volume trends 6.1% 9.8% 13.1% 15.2% 16.3% 17.4% 18.7% 19.7% 21.4% 22.7% 23.2% 23.5% 0K 5K 10K 15K 20K 25K 0% 5% 10% 15% 20% 25% 30% Q2'19 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 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 Jan’22 LA - NEB Market: YUPELRI, BROVANA, LONHALA, PERFOROMIST, arformoterol , formoterol
TBPH implied 35% of YUPELRI ® US net sales by quarter See TBPH 10K filed February 28, 2022 for greater detail re TBPH implied 35%. 10 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 $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 Q1'22 Net sales increased 19% Q1’22 vs. Q1’21
A new focused and streamlined 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; 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. 1 1 Program Indication US Patients 1 Research Phase 1 Phase 2 Phase 3 Filed Marketed Phase 4 Collaborator Commercial Asset YUPELRI ® ( revefenacin ) LAMA COPD patients with suboptimal PIFR >8mm Pipeline Assets Nezulcitinib (TD - 0903) Inhaled JAKi Acute and chronic lung inflammation, fibrotic disease >32mm Inhaled JAKi Asthma ~25mm Inhaled ALK5i Idiopathic pulmonary fibrosis ~140k Ampreloxetine (TD - 9855) NRI S ymptomatic nOH ~350k Economic Interests TRELEGY 2 FF/UMEC/VI COPD > 8mm GSK & Innoviva , Inc. Asthma ~25mm Skin - selective JAKi Dermatological diseases >8mm Phase 3 Phase 2 Marketed Phase 4 PIFR - 2 Study Marketed Phase 1 Marketed Phase 1 Phase 1
Ampreloxetine Phase 3 program overview 12 Study 0169: 4 weeks Randomized, double - blind, placebo controlled, parallel group Phase 3 Registrational Program Extension Study All patients who complete 0169 may enroll into 0170 All patients who complete 0170 may enroll into 0171 + de novo Study 0170*: 22 weeks Randomized 16 - week open label, 6 - week randomized, double - blind, placebo - controlled withdrawal Study 0171*: 3.5 years Long - term, open - label extension study *After Study 0169 did not meet its primary endpoint, the Company took actions to close out the ongoing clinical program; stud y 0 170 was more than 80% enrolled at this point.
Study 0170 design and patient population NCT03829657 *n=154 planned; n =number of subjects enrolled in the randomized withdrawal period. RWD, randomized withdrawal design. 13 Disease type Placebo n=64 Ampreloxetine n=64 Total n=128* (%) Multiple system atrophy (MSA) 20 20 40 (31%) Parkinson’s disease (PD) 34 34 68 (53%) Pure autonomic failure (PAF) 10 10 20 (16%) Entry Endpoint 6 - week double blind RWD 0169 Rollovers 16 - week open - label Baseline Randomization De - novo Ampreloxetine 10 mg Placebo Ampreloxetine 10 mg Ampreloxetine 10 mg Placebo Study 0170
OHDAS LS Mean Difference (95% CI) Overall (n=112) - 0.0 ( - 0.6, 0.6) MSA (n=36) - 0.8 ( - 2.1, 0.4) PD (n=58) 0.1 ( - 0.6, 0.9) PAF (n=18) 1.4 ( - 0.3, 3.0 ) Odds Ratio (95% CI) Overall (n=128 ) 0.60 (0.27, 1.29) MSA (n=40) 0.28 (0.05, 1.22) PD (n=68) 0.79 (0.26, 2.30) PAF (n=20) 0.89 (0.09, 8.41) OHSA #1 LS Mean Difference (95% CI) Overall (n=114) - 0.5 ( - 1.3, 0.4) MSA (n=38) - 1.5 ( - 3.2, 0.2) PD (n=58) 0.0 ( - 1.1, 1.1) PAF (n=18) 0.9 ( - 1.7, 3.4) Study 0170 pre - specified subgroup analyses: Patient reported outcomes The number of analyzable patients differ between analyses due to missing data. Missing data is imputed as treatment failure f or the primary endpoint. Missing data for OHSA composite, OHSA#1 and OHDAS composite scores are assumed missing at random and analyzed through a mixed model repeated measures analysis. n=128; n =number of subjects enrolled in the randomized withdrawal period. CI, confidence interval; MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale; OHSA, Orthostatic Hy potension Symptom Assessment; PAF, pure autonomic failure; PD, Parkinson’s disease; PGI - S, Patient Global Impression of Severity. 14 0.01 0.1 1 10 -4 -2 0 2 4 Favors ampreloxetine Favors placebo Favors ampreloxetine Favors placebo Treatment Failure (worsening of OHSA#1 & PGI - S) OHSA Composite LS Mean Difference (95% CI) Overall (n=114) - 0.6 ( - 1.2, 0.0) MSA (n=38) - 1.6 ( - 2.7, - 0.5) PD (n=58) - 0.2 ( - 0.9, 0.6) PAF (n=18) 0.1 ( - 1.4, 1.6) -3 -2 -1 0 1 2 3 Favors ampreloxetine Favors placebo -3 -2 -1 0 1 2 3 Favors ampreloxetine Favors placebo
LS Mean (95% CI) OHSA Symptom composite score - 1.6 ( - 2.7, - 0.5) Dizziness - 1.5 ( - 3.2, 0.2) Vision - 1.7 ( - 3.2, - 0.3) Weakness - 0.7 ( - 2.3, 0.9) Fatigue - 1.5 ( - 3.1, 0.1) Trouble concentrating - 1.8 ( - 3.3, - 0.4) Head/neck discomfort - 2.2 ( - 3.7, - 0.7) OHDAS Daily activities composite score - 0.8 ( - 2.1, 0.4) Standing short time - 2.0 ( - 3.6, - 0.4) Standing long time - 0.3 ( - 1.8, 1.2) Walking short time - 0.7 ( - 2.4, 1.0) Walking long time 0.4 ( - 1.2, 2.1) OHQ composite score - 1.2 ( - 2.3, - 0.2) -4 -2 0 2 4 Study 0170 OHQ questionnaire composite scores and individual items for MSA patients CI, confidence interval; MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale; OHQ, orthostatic hyp otension questionnaire; OHSA, Orthostatic Hypotension Symptom Assessment. Individual item score analyses are post - hoc, except for dizziness. 15 Favors ampreloxetine Favors placebo
Ampreloxetine longitudinal analysis of OHSA composite score for MSA patients 16 33 34 33 33 33 33 31 33 31 32 64 60 51 44 42 20 20 19 17 20 19 18 20 0 0 4 0 4 8 12 16 18 20 22 2 4 6 8 0169 4 - week double - blind 0170 6 - week RW period 0170 16 - week open label period Placebo, n= Ampreloxetine, n= Week OHSA Composite Score Mean (95% CI) CI, confidence interval; MSA, multiple system atrophy; OHSA, Orthostatic Hypotension Symptom Assessment; OL, open - label; RW, ran domized withdrawal. BL BL BL Ampreloxetine OL Ampreloxetine Placebo
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). 1 8 TRELEGY Upward - tiering royalties of ~5.5 – 8.5% of global net sales 1 Q1 global net sales of $454M Year - over - year sales growth of 33% from the same period in 2021 0 100 200 300 400 500 600 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 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 Mar ’22. TRELEGY Mortality Ad Comm TRELEGY Asthma Approval BREO Asthma Approval TRELEGY
First quarter 2022 financial highlights 1. Cash, cash equivalents and marketable securities. 2. Amounts include share - based compensation. 19 $147.5 million cash 1 as of March 31, 2022 ($, in thousands) Revenue: Viatris collaboration agreement $ 10,687 $ 10,385 Collaboration revenue 9 3,872 Licensing revenue 2,500 - Total revenue 13,196 14,257 Costs and expenses: Research and development (2) 23,253 67,599 Selling, general and administrative (2) 19,121 30,550 Restructuring and related expenses (2) 9,324 - Total costs and expenses 51,698 98,149 Loss from operations (38,502) (83,892) Share-based compensation expense: Research and development 4,530 7,921 Selling, general and administrative 5,498 7,911 Restructuring and related expenses 4,517 - Total share-based compensation expense 14,545 15,832 Operating expense excluding share-based compensation and one-time restructuring expense: Research and development operating expense (excl. share-based comp & restructuring expense) 18,723 59,678 Selling, general and administrative operating expense (excl. share-based comp & restructuring expense) 13,623 22,639 Three Months Ended March 31, 2022 2021 (Unaudited)
Financial Guidance 20 Reiterating 2022 OPEX guidance: – R&D: range of $45 – 55M – SG&A: range of $35 – 45M 2022 guidance includes ~$10M in non - recurring spend: – Majority in Q1 to support completion of late - stage programs – OPEX Q2 and onward will reflect recurring spend only Guidance excludes non - cash share - based compensation (SBC) and one - time restructuring, severance & termination costs: – Restructuring costs of $12.8M in 2022 ($9.3M 2 Q1 / $3.5M 3 Q2) Theravance Biopharma is projected to be sustainably cash - flow positive beginning in 2H 2022 1.) Excludes non - cash share - based compensation (SBC) and one - time restructuring, severance & termination costs. 2.) $4.8M of cash related expenses and $4.5M of non - cash expenses. 3.) Estimated $0.8M of cash related expenses and $2.7M of non - cash expenses remaining (majority of which will be recognized in Q 2) .
Rapid transition to a focused and streamlined Theravance Biopharma 21 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 respiratory opportunities Leverage partnerships to unlock value of pipeline 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, Chief Business Officer 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. 23
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. 24