UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
Current Report Pursuant
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Item 2.02. Results of Operations and Financial Condition.
On May 8, 2023, Theravance Biopharma, Inc. issued a press release and is holding a conference call regarding its financial results for the quarter ended March 31, 2023 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 8, 2023 |
| 99.2 | Slide deck entitled First Quarter 2023 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 8, 2023 | By: | /s/ Aziz Sawaf |
| Aziz Sawaf | ||
| Senior Vice President and Chief Financial Officer | ||
Exhibit 99.1
Theravance Biopharma, Inc. Reports First Quarter 2023 Financial Results and Provides Business Update
| · | Q1 2023 YUPELRI® (revefenacin) net sales of $47.0 million, recognized by Viatris, up 8% from Q1 20221 |
| · | Q1 2023 YUPELRI retail new patient starts and total prescriptions up 61% and 29%, respectively, year-over-year, reaching all-time highs2 |
| · | CYPRESS Phase 3 study of ampreloxetine recruiting; anticipate completing enrollment during H2 2024 |
| · | On track to complete $325 million capital return program by year-end; completed $215 million of share repurchases from inception through 4/30/23 |
| · | Jim Kelly, Managing Director at Weiss Asset Management, joins Board of Directors |
DUBLIN, IRELAND – May 8, 2023 – Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today announced financial and operational results for the first quarter of 2023.
“Through the beginning of 2023, we sharpened our commercial and development focus at Theravance, with YUPELRI retail new patient starts growing 61% and achieving a sixth consecutive quarter of record highs. We also delivered an important clinical milestone, having initiated enrollment for CYPRESS, our Phase 3 study for ampreloxetine, since our last update”, said Rick E Winningham, Chief Executive Officer. “With the transformation we began nearly two years ago largely completed, we are well positioned to drive an acceleration in YUPELRI performance made possible by its unique value proposition to COPD patients in both the hospital and community settings. We are determined to deliver on this opportunity, while returning substantial capital to shareholders and driving our ampreloxetine study to completion.”
“For MSA patients suffering with symptomatic neurogenic orthostatic hypotension (nOH), ampreloxetine has the potential to improve symptoms which impact their quality of life”, said Richard Graham, SVP and Head of R&D. “CYPRESS is a focused Phase 3 study designed to confirm the clinical improvements ampreloxetine has demonstrated in MSA patients with symptomatic nOH in Study 0170. We plan to complete enrollment in CYPRESS during the second half of 2024 and provide guidance on timing for top-line results as enrollment progresses.”
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), achieved $47.0 million Q1 2023 sales, increasing 8% year-over-year (Q1 2023 vs Q1 2022)1 and increased its share of the long-acting nebulized COPD market to 27.7% through January 2023, up from 27.1% in Q4 2022. The PIFR-2 study remains on track for completion during the second half of 2023. |
| · | Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvements, and no signal for supine hypertension. The Company presented findings at three scientific sessions at the 2022 American Autonomic Society meeting.3 Theravance has aligned with the FDA on a new Phase 3 study (CYPRESS) to support a full approval, which was initiated in Q1 2023 and is actively recruiting. |
1 In the US, Viatris is leading the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to the Company).
2 Symphony Health METYS Prescription Dashboard.
3 November 2022, Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Poster 4
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| · | $325 Million Return of Capital Program: |
| o | Through 3/31/23: $55 million of share buybacks in Q1 2023 and $183 million since inception in September 2022 through March 2023. As of 3/31/23, we had $142 million remaining. |
| o | Through 4/30/23: $215 million since inception in September 2022 through April 2023. As of 4/30/23, we had $110 million remaining. |
| o | Expect to complete the program by the end of 2023. |
| · | TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD and asthma) GSK posted first quarter 2023 global net sales of $567 million (up from $454 million, or 25%, from first quarter of 2022).4 Theravance Biopharma is entitled to a milestone payment from Royalty Pharma of $50 million if TRELEGY global net sales are equal to or exceed $2.9 billion5 in 2023, the first of $250 million of potential milestones that can be achieved between 2023 and 2026. |
First Quarter Financial Results
| · | Revenue: Total revenue for the first quarter of 2023 was $10.4 million, consisting almost entirely of Viatris collaboration revenue. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises 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, Theravance Biopharma’s implied 35% share of net sales of YUPELRI for the first quarter of 2023 was $16.4 million which represents an 8% increase compared to the same period in 2022. Viatris collaboration revenue decreased by $0.3 million in the first quarter compared to the same period in 2022 due primarily to timing of higher Viatris costs incurred. |
Total revenue for the first quarter represents a $2.8 million decrease compared to the same period in 2022, primarily due to a $2.5 million non-recurring milestone payment received in the first quarter of 2022 related to the Company’s licensing arrangement with Pfizer.
| · | Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2023 were $14.6 million, compared to $23.3 million in the same period in 2022. First quarter R&D expenses included total non-cash share-based compensation of $2.4 million. |
4 Source: GSK-reported Net Sales in USD.
5 The first milestone payment of $50.0 million will be triggered if Royalty Pharma receives $240.0 million or more in royalty payments from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion. Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to 10%.
Page 2 of 8
| · | Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2023 were $19.2 million, compared to $17.8 million in the same period in 2022. First quarter SG&A expenses included total non-cash share-based compensation of $4.2 million. |
| · | Stock Based Compensation: Share-based compensation expenses for the first quarter of 2023 were $7.0 million, compared to $14.5 million in the same period in 2022. Excluding restructuring-related expenses, share-based compensation expenses were $6.7 million and $10.0 million for the first quarter of 2023 and 2022, respectively. Share-based compensation expenses consisted of $2.5 million for R&D and $4.2 million for SG&A in the first quarter of 2023, compared to $4.5 million and $5.5 million, respectively, in the same period in 2022. The significant reduction in total share-based compensation expenses was primarily driven by our 2021 restructuring, which was substantially completed in early 2022. |
| · | Restructuring Expenses and Related Expenses: Restructuring expenses and related expenses for the first quarter of 2023 were $1.6 million compared to $9.3 million in the same period in 2022. These expenses primarily comprised severance costs, termination-related benefits, and share-based compensation expense related to the Company’s 2023 strategic actions, announced in February 2023, and the Company’s 2021 restructuring announced in September 2021. Cash restructuring expenses related to the 2023 strategic actions were $1.2 million and non-cash restructuring expenses were $0.4 million in the first quarter of 2023. We do not expect any additional employee-related restructuring expenses, including share-based compensation expenses, after the first quarter of 2023. |
| · | Net Loss from Operations and Non-GAAP Net Loss (from continuing operations):6 Net loss from continuing operations was $22.1 million in the first quarter of 2023 compared to $40.3 million in the same period in 2022, and non-GAAP net loss from continuing operations was $14.9 million in the first quarter of 2023 compared to $25.2 million in the same period in 2022. Non-GAAP net loss from continuing operations consists of GAAP net income (loss) from operations, excluding share-based compensation expense, non-cash interest expense, and income tax expense (benefit). See the section titled "Non-GAAP Financial Measures" for more information. |
| · | Cash Position: Cash, cash equivalents and marketable securities totaled $260.0 million as of March 31, 2023. |
2023 Financial Guidance
| · | Operating Expenses (excluding share-based compensation and one-time restructuring costs): The Company continues to expect full year 2023 R&D expense of $35 million to $45 million and SG&A expense of $45 million to $55 million. |
| · | The Company reaffirms its expectation that it will generate non-GAAP profit in 2H 20236. |
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 register here. 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.
6 Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less share-based compensation expense and non-cash interest expense. See the section titled "Non-GAAP Financial Measures" for more information.
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A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through June 7, 2023.
About Theravance Biopharma
Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in multiple system atrophy patients. The Company is committed to creating/driving shareholder value.
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 U.S. 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.
Forward-Looking Statements
This press release 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, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s repurchase of its ordinary shares by way of an open market share repurchase program, the impact of recent headcount reductions in connection with focusing investments in research, the Company’s governance policies and plans, the Company’s expectations regarding its allocation of resources and maintenance of expenditures, the Company’s goals, designs, strategies, plans and objectives, future YUPELRI sales, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investigational therapy, and contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release 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: whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, 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 recent restructuring actions on its employees, partners and others, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company’s shares, and general economic and market conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-K filed with the SEC on March 1, 2023, 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.
Page 4 of 8
Non-GAAP Financial Measures
Theravance Biopharma provides a non-GAAP profitability target and a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net loss from operations provide meaningful information to assist investors in assessing prospects for future performance and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Company's cash position. Because non-GAAP financial targets and metrics, such as non-GAAP profitability and non-GAAP net loss from operations, are not standardized, it may not be possible to compare these measures with other companies' non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results and other targets.
Contact:
investor.relations@theravance.com
650-808-4045
Page 5 of 8
THERAVANCE BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents and short-term marketable securities | $ | 241,263 | $ | 327,484 | ||||
| Receivables from collaborative arrangements | 12,270 | 16,785 | ||||||
| Prepaid clinical and development services | 1,524 | 1,513 | ||||||
| Other prepaid and current assets | 6,281 | 7,682 | ||||||
| Total current assets | 261,338 | 353,464 | ||||||
| Long-term marketable securities | 18,776 | - | ||||||
| Property and equipment, net | 12,103 | 11,875 | ||||||
| Operating lease assets | 39,204 | 40,126 | ||||||
| Future contingent milestone and royalty assets | 194,200 | 194,200 | ||||||
| Restricted cash | 836 | 836 | ||||||
| Other assets | 12,093 | 6,899 | ||||||
| Total assets | $ | 538,550 | $ | 607,400 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current liabilities | $ | 26,184 | $ | 28,715 | ||||
| Long-term operating lease liabilities | 43,763 | 45,407 | ||||||
| Future royalty payment contingency | 25,988 | 25,438 | ||||||
| Unrecognized tax benefits | 64,191 | 64,191 | ||||||
| Other long-term liabilities | 7,865 | 1,849 | ||||||
| Shareholders' equity | 370,559 | 441,800 | ||||||
| Total liabilities and shareholders’ equity | $ | 538,550 | $ | 607,400 | ||||
(1) The condensed consolidated balance sheet as of December 31, 2022 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, 2022.
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THERAVANCE BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| Revenue: | ||||||||
| Viatris collaboration agreement (1) | $ | 10,411 | $ | 10,687 | ||||
| Collaboration revenue | 6 | 9 | ||||||
| Licensing revenue | - | 2,500 | ||||||
| Total revenue | 10,417 | 13,196 | ||||||
| Costs and expenses: | ||||||||
| Research and development (2) | 14,572 | 23,253 | ||||||
| Selling, general and administrative (2) | 19,183 | 17,842 | ||||||
| Restructuring and related expenses (2) | 1,574 | 9,324 | ||||||
| Total costs and expenses | 35,329 | 50,419 | ||||||
| Loss from operations | (24,912 | ) | (37,223 | ) | ||||
| Interest expense | (550 | ) | (2,137 | ) | ||||
| Interest income and other income (expense), net | 2,979 | (375 | ) | |||||
| Loss from continuing operations before income taxes | (22,483 | ) | (39,735 | ) | ||||
| Provision for income tax benefit (expense) | 395 | (524 | ) | |||||
| Net loss from continuing operations | (22,088 | ) | (40,259 | ) | ||||
| Income from discontinued operations before income taxes | - | 14,313 | ||||||
| Provision for income tax benefit (expense) | - | - | ||||||
| Net income from discontinued operations | - | 14,313 | ||||||
| Net loss | $ | (22,088 | ) | $ | (25,946 | ) | ||
| Net income (loss) per share: | ||||||||
| Continuing operations - basic and diluted | $ | (0.35 | ) | $ | (0.53 | ) | ||
| Discontinued operations - basic and diluted | $ | - | $ | 0.19 | ||||
| Net income (loss) - basic and diluted | $ | (0.35 | ) | $ | (0.34 | ) | ||
| Shares used to compute per share calculations - basic and diluted | 62,934 | 75,247 | ||||||
| Non-GAAP net loss from continuing operations | (14,912 | ) | (25,190 | ) | ||||
| (1) | While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a 35% share of the net profit (loss) pursuant to a co-promotion agreement with Viatris as presented below: |
| Three Months Ended March 31, | ||||||||
| (In thousands) | 2023 | 2022 | ||||||
| YUPELRI net sales (100% recorded by Viatris) | $ | 46,955 | $ | 43,666 | ||||
| YUPELRI net sales (Theravance Biopharma implied 35%) | 16,434 | 15,283 | ||||||
| (2) | Amounts include share-based compensation expense as follows: |
| Three Months Ended March 31, | ||||||||
| (In thousands) | 2023 | 2022 | ||||||
| Research and development | $ | 2,441 | $ | 4,530 | ||||
| Selling, general and administrative | 4,223 | 5,498 | ||||||
| Restructuring and related expenses | 357 | 4,517 | ||||||
| Total share-based compensation expense | $ | 7,021 | $ | 14,545 | ||||
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THERAVANCE BIOPHARMA, INC.
Reconciliation of GAAP to Non-GAAP Net Income from Continuing Operations
(In thousands, except per share data)
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| GAAP Net Loss from Continuing Operations | $ | (22,088 | ) | $ | (40,259 | ) | ||
| Adjustments: | ||||||||
| Share-based compensation expense | 7,021 | 14,545 | ||||||
| Non-cash interest expense | 550 | - | ||||||
| Income tax expense (benefit) | (395 | ) | 524 | |||||
| Non-GAAP Net Loss from Continuing Operations | $ | (14,912 | ) | $ | (25,190 | ) | ||
| Non-GAAP Net Loss per Share from Continuing Operations | ||||||||
| Net loss - basic and diluted | $ | (0.24 | ) | $ | (0.33 | ) | ||
| Shares used to compute per share calculations - basic and diluted | 62,934 | 75,247 | ||||||
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Exhibit 99.2
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. First Quarter 2023 Financial Results and Business Update May 8 , 2023 © 2023 Theravance Biopharma. All rights reserved.
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 Biopharma, Inc. (the “Company”) intends such fo rward - 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, as amended, an d the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s repurchase of its ordinary shares by way of an open ma rket share repurchase program, the impact of recent headcount reductions in connection with focusing investments in research, the Company’s governance policies and plans, the Co mpa ny’s expectations regarding its allocation of resources and maintenance of expenditures, the Company’s goals, designs, strategies, plans and objectives, future YUPELRI sal es, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investiga tio nal therapy, and contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma. These statements are based on the current es timates and assumptions of the management of the Company as of the date of this presentation and are subject to risks, uncertainties, changes in circumstances, assumptions an d o ther factors that may cause the actual results of the Company to be materially different from those reflected in the forward - looking statements. Important factors that could cause ac tual results to differ materially from those indicated by such forward - looking statements include, among others, risks related to: whether the milestone thresholds can be achieved, delay s or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non - clinical studies indicate the Company's product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical st udi es, 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 a nd commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporti ng infrastructure, ability to retain key personnel, the impact of the Company’s recent restructuring actions on its employees, partners and others, the ability of the Company to protect and t o e nforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company’s shares, and general economic and market conditions. Other risks affecting the Company are in the Company's Form 10 - K filed with the SEC on March 1, 2023, 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 Bi opharma'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 un due 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. Non - GAAP Financial Measures Theravance Biopharma provides a non - GAAP profitability target and a non - GAAP metric in this presentation. Theravance Biopharma b elieves that the non - GAAP profitability and non - GAAP net loss from operations provide meaningful information to assist investors in assessing prospects for future performanc e a nd actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Co mpany's cash position. Because non - GAAP financial targets and metrics, such as non - GAAP profitability and non - GAAP net loss from operations, are not standardized, it may not be p ossible to compare these measures with other companies' non - GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non - GAAP measures should be considered in addition to, not as a substitute for, in in isolation from, the company's actual GAAP results and other targets 2
Introduction and 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 Aziz Sawaf Senior Vice President, Chief Financial Officer Closing Remarks Rick E Winningham Chief Executive Officer Agenda 3
2023 Targets 4 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 Measure" for more information. 2. The first milestone payment, of $50.0 million, will be triggered if Royalty Pharma receives $240.0 million or more in roya lty payments from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion. MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension ; PIFR, peak inspiratory flow rate. Financial ‣ Expanded Capital Return Program to $325M , and expect to complete by end of 2023 ‣ Generate Non - GAAP 1 Profit in 2H’23 ‣ $50M potential milestone for TRELEGY Net Sales of ~$2.86B 2 ‣ Initiate Phase 3 CYPRESS trial in MSA patients with symptomatic nOH in Q1’23 ‣ Submit orphan drug designation request in early 2023 Ampreloxetine ‣ Continue YUPELRI Net Sales growth by executing on targeted strategies to capture sizeable niche market ‣ Complete PIFR - 2 study and provide top - line results in 2H’23
‣ Total YUPELRI reported net sales reach $47.0M up 8% Y/Y 1 ‣ Retail new patient starts and total prescriptions up 61% and 29% Y/Y, accelerating from Q4 ‣ YUPELRI market shares again reac h new h ighs ‣ On track to complete PIFR - 2 study and provide top - line results in 2H’23 ‣ Continue YUPELRI Net Sales growth by executing on targeted strategies to capture sizeable niche market ‣ Complete PIFR - 2 study and provide top - line results in 2H’23 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance Biopharma). PIFR, peak inspiratory flow rate. Progress Against 2023 YUPELRI ® Targets Strong Demand Growth in Both Hospital and Community Settings Progress Target 5
MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension . Progress Against 2023 Ampreloxetine Targets Milestones Achieved with CYPRESS Study ‣ Initiate Phase 3 CYPRESS trial in MSA patients with symptomatic nOH in Q1’23 ‣ Submit orphan drug designation request in early 2023 Target ‣ Initiated Phase 3 CYPRESS trial in MSA patients with symptomatic nOH in Q1’23 ‣ Submitted orphan drug designation request in early 2023 ‣ Anticipate completing CYPRESS enrollment in 2H‘24 Progress 6
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 Measure" for more information. 2. The first milestone payment, of $50.0 million, will be triggered if Royalty Pharma receives $240.0 million or more in roya lty payments from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion. Target ‣ Expanded Capital Return Program to $325M , and expect to complete by end of 2023 ‣ Generate Non - GAAP 1 Profit in 2H’23 ‣ $50M potential milestone for TRELEGY Net Sales of ~$2.86B 2 Progress ‣ On track for 2023 completion; $87M completed YTD through 4/30/23, with $110M remaining ‣ Remain on track to generate Non - GAAP 1 Profit in 2H’23 ‣ $567M TRELEGY Net Sales in Q1’23 Progress Against 2023 Financial Targets Substantial Progress Made on Buyback Program 7
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)
97,770 107,790 113,220 137,760 158,550 K 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K 180 K Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 $43.7 $49.1 $53.4 $55.7 $47.0 0 10 20 30 40 50 60 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 YUPELRI ® | Growing Net Sales and Hospital Volume 9 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance Biopharma). Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 3/31/2023. YUPELRI Hospital Doses Hospital doses sold increased 62% Q1’23 vs. Q1’22 Total YUPELRI Net Sales ($M) Net sales increased 8% Q1’23 vs. Q1’22 1 22% rolling 4 - quarter growth through Q1’23 52% rolling 4 - quarter growth through Q1’23
YUPELRI ® Hospital and Community Share Trends 10 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 3/31/2023. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through Jan’23 ǂRetail TRx Volume - Symphony Health METYS Prescription Dashboard through 3/31/2023. 6.6% 6.6% 7.6% 7.6% 8.6% 9.5% 10.8% 11.3% 11.6% 13.3% 12.5% 15.0% 0% 5% 10% 15% 20% 25% 30% Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Hospital LA - NEB Market Share* YUPELRI LA-NEB Market Share TRx volume represents retail only which is typically 33% of Retail + DME Reported DME volume, while lagged, typically follows Retail volume trends 16.3% 17.4% 18.7% 19.7% 21.4% 22.5% 23.2% 24.1% 25.3% 26.4% 27.1% 27.7% 0K 5K 10K 15K 20K 25K 0% 5% 10% 15% 20% 25% 30% Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Retail TRx Volume ǂ Community LA - NEB Market Share † Retail TRx YUPELRI LA-NEB Market Share Most patients who receive YUPELRI ® in the hospital are discharged with an Rx 1 LA - NEB Market: YUPELRI, BROVANA, LONHALA, PERFOROMIST, arformoterol, formoterol Hospital LA - NEB Market Share Community LA - NEB Market Share with TRx
Continued Record - High Retail New Patient Starts 61% Y/Y and 23% Q/Q growth; Key Driver of Future Brand Performance 11 1. Retail data serves as a proxy for the total community (Retail + DME) Source: Symphony Health METYS Prescription Dashboard through 3/31/2023 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 2021-Q1 2021-Q2 2021-Q3 2021-Q4 2022-Q1 2022-Q2 2022-Q3 2022-Q4 2023-Q1 Retail New to Product TRx YUPELRI ® Retail New to Product TRx Trends 1 +13% - 6% +10% +0% +11% +5% +23% +12% +8%
Development YUPELRI PIFR - 2 Top - line results anticipated H2 ‘23 CYPRESS (ampreloxetine) Last patient enrolled anticipated H2 ‘24
PIFR - 1 Experience Informed PIFR - 2 Design Chronic Obstr Pulm Dis . 2019; 6(4): 321 – 331. Note: The ns shown are the numbers in the analysis set or subset. Evaluable ns are 90 (Tio) and 89 (Rev) for the ITT analysis an d 70 (Tio) and 70 (Rev) for the subset analysis. FEV1, forced expiratory volume in one second; FVC, forced vital capacity; IC, inspiratory capacity; ITT, intent - to - treat; LS, le ast squares; PIFR, peak inspiratory flow rate; REV, revefenacin ; SE, standard error; TIO, tiotropium. P = 0.4461 LS Difference (SE) = 17.0 (22.3) LS Mean Change From Baseline (mL) ITT: GOLD 2/3/4 PIFR < 60 L/min P =0.0248 LS Difference (SE) = 49.1 (21.6) GOLD 3/4 40.9 57.9 0 10 20 30 40 50 60 70 80 90 100 Trough FEV1 TIO 18 μ g (n=104) REV 175 μg (n=102) 23.2 72.3 0 10 20 30 40 50 60 70 80 90 100 Trough FEV1 TIO 18 μ g (n=81) REV 175 μg (n=80) 13
Randomization 1:1 Results YUPELRI SPIRIVA ® via HH* Once - daily treatment: 12 weeks Run - in YUPELRI ® : Phase 4 Randomized, Double - Blind, Parallel - Group Study (PIFR - 2) 14 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal Inspiratory Flow Rate. *Dry powder inhaler (Spiriva ® HandiHaler ® ). FEV 1 , forced expiratory volume in 1 second; PIFR, peak inspiratory flow rate. Endpoints ‣ Primary: Change from baseline in trough FEV 1 ( Day 85) ‣ Key secondary: Trough overall treatment effect on FEV 1 Sample size ‣ N = Up to 488 ‣ Top - line results 2H‘23
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension ( nOH ) in multiple system atrophy (MSA) patients
16 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Our CYPRESS Study is Now Recruiting
Untreated nOH NE Release Systolic Blood Pressure Ampreloxetine: Designed to Reduce Symptoms in MSA 17 Palma JA, Kaufmann H. Mov Disord Clin Pract 2017;4:298 - 308. 1. Data from MSA patients reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. MSA, multiple system atrophy; NE, norepinephrine; NET, norepinephrine transporters; nOH , neurogenic orthostatic hypotension. Vasodilation Blood pressure Vasoconstriction Blood pressure Syncope Normal x Potentiates endogenous norepinephrine 1 x Increases blood pressure 2 x Leads to durable effectiveness 2 NE A XON TERMINAL D ENDRITE + Ampreloxetine Ampreloxetine Reduction in syncope Normal
18 Effective Treatment Requires Intact Peripheral Nerves REFERENCES: Fanciulli A, Wenning GK. Multiple - system atrophy. N Engl J Med. 2015;372(3):249 - 263. Jordan J, Shibao C, Biaggioni I. Multiple system atrophy: using clinical pharmacology to reveal pathophysiology. Clin Auton Res . 2015;25(1):53 - 59. MSA, multiple system atrophy.
Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA 1, 2 19 1. Data from MSA patients. Error bars represent SE. * p < 0.05 comparison to baseline reported after 4 weeks of ampreloxetine administration in study 0169. 2. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. BP, blood pressure; DHPG, dyhydroxyphenylglycol ; LS, least - squares; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; SE, standard error; SEM, standard error of mean. Placebo Ampreloxetine 0.0 0.5 1.0 1.5 2.0 G e o m e t r i c M e a n R a t i o C h a n g e f r o m B a s e l i n e Mechanism of Action 1 3 min Standing BP Response 2 * * +57% - 0.03 p=0.0056 LS Mean Change in OHSA Composite (SEM) Worsening +1.54 Symptoms OHSA Composite 2 0.0 - 0.5 0.5 1.0 1.5 2.0 2.5 - 40 - 20 0 20 40 60 Worsening - 12.4 +6.1 Mean Change, mmHg (SE) Placebo Ampreloxetine Norepinephrine DHPG
Study 0170 OHQ Questionnaire Scores LS Mean (95% CI) OHSA Symptoms 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) The Unique Benefits of Ampreloxetine Treatment 20 Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in development and not approved for any indication. Data on file. 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. 2. NORTHERA ® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 3. ProAmatine ® (midodrine hydrochloride) [Warning Ref 4052798]. Lexington, MA: Shire. 2017. CI, confidence interval; MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale; OHQ, orthostatic hypotension questionnaire; OHSA, Orthostatic Hypotension Symptom Assessmen t. Supine hypertension with droxidopa and midodrine 2,3 Absence of a signal would be a differentiator: • Available to patients with supine hypertension • Can be taken anytime of day/night • Potential to be combined with other drugs Differentiated safety profile Unique efficacy and durability MSA patients may have difficulty swallowing : • Once - daily dosing, single 10mg tablet • Low dosing frequency improves compliance • Decreases caregiver burden Patient - friendly dosing Improvement in activities of daily living that require w alking and standing for a short time 1 which could favorably impact caregiver burden Clinically meaningful and durable effectiveness well beyond 2 weeks First - in - class therapy effective in treating a constellation of cardinal symptoms in MSA patients: -4 -2 0 2 4 Favors ampreloxetine Favors placebo
Study 0197 (CYPRESS): Phase 3 randomized withdrawal study in patients with MSA Primary endpoint: change in OHSA composite score Offering Hope to MSA Patients with Symptomatic nOH 21 Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Gu ida nce for Industry https://www.fda.gov/media/121320/download MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessment; RWD, randomized withdrawal design. Streamlined operational infrastructure Optimized country/site selection Aligned with FDA Randomization 1:1 Results Ampreloxetine 10 mg Placebo Once - daily treatment: 8 weeks Ampreloxetine 10 mg Open - Label Once - daily treatment: 12 weeks Double - blind RWD Q1’23 Entry n~100 To be enrolled n~60 Completers
New Era in Treating MSA Symptoms: Product Positioning 22 Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in development and not approved for any indication. Data on file. 1. U CS D 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 multiple systems atrophy, CJ Mathias (1999). 3. NORTHER A ® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 4. ProAmatine ® (midodrine hydrochloride) [Warning Ref 4052798]. Lexington, MA: Shire. 2017. MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, Orthostatic Hypotension Symptom Assessment. Droxidopa 3 Midodrine 4 Ampreloxetine Indication Symptomatic nOH OH Symptomatic nOH associated with MSA Efficacy / Durability OHSA#1; clinical effectiveness >2 weeks not established Increase in systolic blood pressure 1 min after standing OHSA composite ; clinically meaningful and durable response >20 weeks Dosing 3x daily, titration to effect 3x daily Once - daily Safety Black box warning for supine hypertension No signal for supine hypertension ~50K MSA patients in U.S. 1 (considered orphan disease) MSA Prevalence 70% - 90% of MSA patients experience nOH symptoms 2 Prevalence of nOH in MSA Patients 35K – 45K MSA patients with nOH symptoms Addressable Patient Population Unique Treatment Profile Current Treatment Landscape
Financial Update
First Quarter 2023 Financials 24 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 expen se and non - cash interest expense]; see reconciliation on Slide 25 and the section titled "Non - GAAP Financial Measure“ on Slide 2 for more information. ($, in thousands) Revenue: Viatris collaboration agreement $ 10,411 $ 10,687 Collaboration revenue 6 9 Licensing revenue - 2,500 Total revenue 10,417 13,196 Costs and expenses: Research and development (1) 14,572 23,253 Selling, general and administrative (1) 19,183 17,842 Restructuring and related expenses (1) 1,574 9,324 Total costs and expenses 35,329 50,419 Loss from continuing operations (before tax and other income & expense) (24,912) (37,223) Income from discontinued operations (before tax) - 14,313 Share-based compensation expense: Research and development 2,441 4,530 Selling, general and administrative 4,223 5,498 Restructuring and related expenses 357 4,517 Total share-based compensation expense 7,021 14,545 Operating expense excl. share-based compensation and one-time expenses: R&D operating expense (excl. share-based comp and restructuring exp.) 12,131 18,723 SG&A operating expense (excl. share-based comp and restructuring exp.) 14,960 12,344 Total operating expenses excl. share-based compensation and one-time expenses 27,092 31,067 Non-GAAP net loss from continuing operations (2) (14,912) (25,190) Three Months Ended March 31, 2023 2022 (Unaudited)
First Quarter 2023 Financials (Cont’d) 25 GAAP Net Loss from Continuing Operations $ (22,088) $ (40,259) Adjustments: Share-based compensation expense 7,021 14,545 Non-cash interest expense 550 - Income tax expense (benefit) (395) 524 Non-GAAP Net Loss from Continuing Operations $ (14,912) $ (25,190) Non-GAAP Net Loss per Share from Continuing Operations Net loss - basic and diluted $ (0.24) $ (0.33) Shares used to compute per share calculations - basic and diluted 62,934 75,247 (Unaudited) Reconciliation of GAAP to Non-GAAP Net Income from Continuing Operations (In thousands, except per share data) Three Months Ended March 31, 2023 2022 See the section titled "Non - GAAP Financial Measure" on Slide 2 for more information.
Q1 2023 Financial Highlights Significant Capital Returns from a Position of Strength 26 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 25 and the section titled "Non - GAAP Financial Measure“ on Slide 2 for more information. 2. Cash, cash equivalents and marketable securities. SBC, Share - Based Compensation. Metric Q1 ‘23 (M) Q1 ’22 (M) Note VIATRIS Collaboration Revenue $10.4 $10.7 SG&A and R&D Expense, ex - SBC & One - time Items $27.1 $31.1 Share - Based Compensation $6.7 $10.0 • Excluding restructuring expenses Non - GAAP Loss from Continuing Operations 1 ($14.9) ($25.2) Cash and Cash Equivalents 2 (as of quarter - end) $260.0 $147.5 • $55M of share buybacks in Q1’23 Debt (as of quarter - end) $0.0 $621.5 Shares Outstanding (as of quarter - end) 60.5 76.1 • ~5.2M shares repurchased in Q1’23
x ~$95M: Purchased GSK's equity stake in Theravance (Sep’22) and completed Dutch auction tender offer (Nov’22) x ~$33M completed in Dec’22 x ~$55M completed in 2023, through 3/31/23 x ~$87M completed in 2023, through 4/30/23 $325 Million Capital Return Program On Track to Complete Program by Year - End 27 Complete ($95M) Open Market Share Buybacks Complete ($120M) As of 3/31/23: $183M complete; $142M remaining As of 4/30/23: $215M complete; $110M remaining
2023 Financial Guidance Expected to Generate Non - GAAP 1 Profit in 2H 2023 28 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 Measure" for more information. • 2023 OPEX Guidance Range: • R&D: $35M - $45M • SG&A: $45M - $55M • Guidance Excludes: • Non - cash share - based compensation • One - time severance and termination costs associated with 2023 headcount reduction: • Incurred $1.6M in Q1’23 • No further severance and termination costs expected • Share - Based Compensation: • Expected to decline materially in 2023 vs. 2022 • Q1’23 down 34% year - over - year, excluding restructuring costs, and 52%, including restructuring
Theravance Biopharma: Positioned for Value Creation MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Ampreloxetine for nOH new era in treating MSA symptoms Substantial opportunity for further growth Potential to offer a unique, first in class treatment benefit Retained future value of TRELEGY in milestones and certain outer year royalties Retained Value Positioned to create value from a foundation of financial strength Three distinct drivers of value over the near, mid, and long - term 29
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
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 . 31 OATP, organic anion transporting polypeptide.
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 . 32 1. TBPH market research (N=160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist.
Appendix
Patent Protection Into Late 2030s 34 COPD, Chronic obstructive pulmonary disease ; nOH , neurogenic orthostatic hypotension; PTE, patent term extensions. Compound Invention Granted / Pending Application Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter Granted US 2028 (once PTE awarded) Polymorph Granted US 2030 - 2031 Method for the maintenance treatment of COPD patients Granted US 2039 Ampreloxetine Composition of Matter Granted US 2030 (plus PTE of up to 5 years) Method of Treating nOH Granted US 2037
35 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 the balance sheet as “Receivables from collaborative arrangements”. Viatris Collaboration Agreement Revenue Cash amount receivable from Viatris 1,2 Payment of shared Viatris expenses (35%) Reimbursement of shared Theravance expenses (65%) 35% of YUPELRI ® Net Sales Collaboration Revenue, in any given period can fluctuate by the absolute and relative expenses incurred by Viatris and Theravance, in addition to the Net Sales generated in the period
Q1’23 Net Sales of $ 567M | FY 2022 Net Sales of $2.1B 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 36 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Based on 10 0% of TRELEGY ELLIPTA royalties. 3. 85 % of TRELEGY ELLIPTA royalties return to Theravance Biopharma beginning July 1, ್ 2029 ್ for sales ex - U.S., and January 1, ್ 2031 ್ for sales within the U.S.; U.S. royalties expected to end late 2032; ex - U.S. royalties expected to end mid - 2030s and are country specific. 4. Source: GSK - reported Net Sales in USD FF, Fluticasone Furoate; UMEC, Umeclidinium; VI, Vilanterol. Mid - Term Value Long - Term Value • Ex - US royalties return Jul. 1, ௗ 2029 • US royalties return after Jan. 1, ௗ 2031 • Paid directly from Roy alty Pharma Up to $250M of Sales - based milestones 1,2 between 2023 – 2026: GSK remains exclusively responsible for commercialization of TRELEGY ELLIPTA
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 37 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 expected to end late 2032; ex - U.S. royalties expected to end mid - 2030s and are country specific. Ampreloxetine (Unsecured Royalty) • Outer Year Royalty (“OYR”): 85% of royalties for TRELEGY ELLIPTA return to Theravance Biopharma: – On and after January 1, ௗ 2031 ௗ for U.S. sales 3 – On and after July 1, ௗ 2029 ௗ for ex - U.S. sales 3 • Upfront payment: $25M (Received) • 1st Regulatory approval milestone: $15M – Approval by either FDA or first of the EMA or all four Germany, France, Italy and Spain • Future royalties paid to Royalty Pharma: – 2.5% on annual global net sales up to $500M – 4.5% on annual global net sales > $500M
Substantial Opportunity for Further YUPELRI ® Growth Once - Daily Nebulized LAMA COPD treatment represents a sizeable niche market 38 1. American Lung Association. 2. Clarivate COPD Disease Landscape & Forecast US 2021. 3. Revefenacin COPD Joint Venture Research 2016. COPD, chronic obstructive pulmonary disease; DME, durable medical equipment; LAMA, long - acting muscarinic antagonist; PIFR, peak inspiratory flow rate. YUPELRI may be appropriate for COPD patients, including but not limited to: ► Moderate - to - very - severe COPD (73 – 92% 4 ); once - daily LAMAs are first - line therapy for moderate - to - very severe COPD patients ► Patients with suboptimal PIFR (19 – 78% of COPD patients 5 ) ► Patients with cognitive or dexterity challenges ~36% of COPD patients present episodes of cognitive impairment; ~33% of elderly patients have inadequate hand strength for inhalers 6 ► Patients inappropriately using short - acting nebulized treatment as maintenance therapy ► Patients transitioning from hospital to home care after being stabilized on nebulized treatment during hospitalization Growth opportunities within numerous patient segments 4. Safka KA, et al. Chronic Obstr Pulm Dis 2017. 5. Mahler DA, et al. Chronic Obstr Pulm Dis 2019. 6. Armitage JM, Williams SJ Inhaler technique in the elderly. Age Ageing 1988 17:275 - 278. Estimated 2021 YUPELRI Patient Funnel (US) ► COPD is under - diagnosed 1 ► COPD patients with or without symptoms may be treated with rescue and/or maintenance therapies ► Estimated patient counts from volume using average ‘days of therapy’ assumptions vary considerably across DME and retail channels Patent No 11,484,531, methods of treating COPD, expiring in 2039, is now listed in the Approved Drug Products with Therapeutic Equivalence Evaluations
Offering Hope to MSA Patients with Symptomatic nOH 39 MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. 33rd International Symposium on the Autonomic Nervous System November 2 – 5, 2022: Sheraton Maui , Hawaii Kaufmann H, et al. Abstract 33 / Virtual Poster 117 Blood pressure and pharmacodynamic response of ampreloxetine, a norepinephrine reuptake inhibitor, in patients with symptomatic nOH Biaggioni I, et al. Abstract 34 / Virtual Poster 106 A phase 3, 22 - week, multi - center, randomized withdrawal study of ampreloxetine in treating symptomatic nOH Freeman R, et al. Abstract 30 / Virtual Poster 4 Longitudinal analysis of ampreloxetine for the treatment of symptomatic nOH in subset of patients with MSA Platform Presentations, Session 1, November 2, 2022
Shift Toward Broad Symptomatic Improvement for MSA Patients 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. 2. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Poster 4. MSA, Multiple System Atrophy; nOH , neurogenic orthostatic hypotension; OHDAS, orthostatic hypotension daily activity scale; OHQ, orthostatic hypotension questionnaire; OHSA, Orthostatic Hypotension Symptom Assessment ; PAF, Pure Autonomic Failure; PD, Parkinson’s Disease. “Old” Ampreloxetine Program “New” MSA - focused Ampreloxetine Program MSA PAF MSA PD “Dizziness” based indication for short - term effectiveness Constellation of symptoms - based indication In study 0170, ampreloxetine prevented blood pressure drop and symptoms worsening in MSA 1 Support from the scientific and medical community with 3 scientific presentations presented at the American Autonomic Society meeting 2 Aligned with FDA on new Phase 3 study for approval with OHSA composite as primary endpoint Durable effectiveness 40
‣ Sold TRELEGY ELLIPTA royalty interests for $1.1B upfront , while retaining value through milestones and certain outer - year royalties ‣ Eliminated all debt, ~$650 million ‣ Completed financial restructuring ‣ Initiated $250 million capital return program , of which ~62% was completed as of February 27, 2023 ‣ In study 0170, prevented blood pressure drop and symptoms worsening in MSA 2 ‣ Aligned with FDA on new Phase 3 study for NDA filing with OHSA composite score as primary endpoint ‣ Three scientific platform presentations at American Autonomic Society meeting 3 ‣ Secured up to $40 million from Royalty Pharma for funding ampreloxetine development; $25M to fund majority of new P3 study ‣ Three consecutive quarters of all - time ್ high Net Sales and Profit in Q2 - Q4 ‣ Continued community market share growth every quarter since launch ‣ 53% Y/Y growth in hospital volume , a key driver of overall brand performance 1 ‣ Initiated PIFR - 2 study 2022: A Year of Transformation 41 1. Year - to - date through Q4’22; 2. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170; 3. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 1 17; Freeman R, et al. Abstract 30 / Virtual Poster 4. MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; PIFR, peak inspiratory flow rate. Financial Ampreloxetine