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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

 

 

FORM 8-K

 

 

Current Report Pursuant

to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event Reported): February 26, 2025

 

 

THERAVANCE BIOPHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Cayman Islands   001-36033   98-1226628
(State or Other Jurisdiction of   (Commission File Number)   (I.R.S. Employer Identification
Incorporation)       Number)

 

C/O Theravance Biopharma US, LLC

901 Gateway Boulevard

South San Francisco, CA 94080

(650) 808-6000

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading
Symbol(s)
  Name of each exchange
on which registered
Ordinary Share $0.00001 Par Value   TBPH   NASDAQ Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company    ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On February 26, 2025, Theravance Biopharma, Inc. (the “Company”) issued a press release and is holding a conference call regarding its financial results for the quarter and full year ended December 31, 2024 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 February 26, 2025
     
99.2 Slide deck entitled Fourth Quarter & Full Year 2024 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:  February 26, 2025 By: /s/ Aziz Sawaf  
    Aziz Sawaf
    Senior Vice President and Chief Financial Officer

 

 

 

 

 

 

 

Exhibit 99.1

 

 

Theravance Biopharma, Inc. Reports Record Fourth Quarter and Full Year 2024 Financial Results

 

·YUPELRI® (revefenacin) US net sales, recognized by Viatris, reached an all-time high of $66.7 million in Q4 2024 and $238.6 million in FY 2024, up 10% and 8%, respectively, compared with 20231

 

·FY 2024 TRELEGY Net Sales, as reported by GSK, of $3.46 billion, up 26% compared with 2023 and triggering a $50 million milestone to Theravance Biopharma2,3

 

·CYPRESS study on track to enroll final patient in the open label portion by mid-2025

 

·Ended Q4 2024 with $88 million in cash, excluding the $50 million TRELEGY milestone, with cash receipt in February 2025

 

DUBLIN, IRELAND – FEB 26, 2025 – Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today announced financial and operational results for the fourth quarter and full-year ended December 31, 2024.

 

“Theravance Biopharma ended 2024 on a high note, having collaborated closely with Viatris to deliver record fourth quarter YUPELRI net sales and profitability, while achieving $50 million in TRELEGY related sales milestones,” said Rick E Winningham, Theravance Biopharma CEO. “Our hospital-based commercial organization executed particularly well through the end of the year, positioning us to continue driving YUPELRI growth in 2025 and beyond. These achievements, coupled with steady progress towards enrolling the last patient in the open label portion of our pivotal CYPRESS Study by mid-2025 and additional potential YUPELRI and TRELEGY milestones in the coming 12-24 months, highlight the multiple components of value created by our ongoing strategy.”

 

Portfolio Highlights

 

YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long- acting muscarinic agent) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):

 

·Achieved total US net sales of $66.7 million in Q4 2024, increasing 10% year-over-year (Q4 2024 vs Q4 2023), driven by increased customer demand.1,4

 

·Achieved 2024 total US net sales of $238.6 million, up 8% year-over-year; Theravance Biopharma stands to receive a one-time $25 million milestone payment from Viatris for the first calendar year in which YUPELRI achieves at least $250 million in US net sales, which would represent 4% growth from 2024 levels.

 

·Reached launch-to-date highs in brand profitability during the fourth quarter and full year 2024.

 

 

1 In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co-promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma).

2 GSK-reported Net Sales in USD.

3 A first payment of $25 million was triggered when Royalty Pharma (RP) became eligible to receive $240 million or more in royalty payments from GSK based on 2024 TRELEGY global net sales and a second payment of $25 million (for a total of $50 million) was triggered when RP became eligible to receive $275 million or more in royalty payments from GSK. Both royalty thresholds were achieved in the fourth quarter of 2024.

4 Source: Viatris Customer Demand (Q4’24).

 

Page 1 of 10

 

 

 

 

·Grew customer demand 9% for the quarter (Q4 2024 vs Q3 2024) and 11% for the year.4

 

·Grew Q4 2024 doses sold into the hospital channel by 49% year-over-year (Q4 2024 vs Q4 2023), capping off a record year for hospital performance.5

 

TRELEGY

 

GSK posted Q4 2024 and FY 2024 global TRELEGY net sales of $853 million and $3.46 billion, up 16% and 26%, respectively, compared with prior-year periods.2

 

·FY 2024 global net sales of $3.46 billion sufficient to trigger $50M milestone from Royalty Pharma, with cash received in February 2025.

 

·FY 2024 global net sales of $3.46 billion would exceed the threshold required to achieve $50 million of milestones in 2025 (based on $3.41 billion of net sales) with only 2% growth required to achieve $100 million of milestones in 2026 (based on $3.51 billion of net sales).

 

·Royalties of up to 8.5% on TRELEGY net sales return to Theravance Biopharma in eligible territories beginning mid-2029, a significant driver of long-term value.

 

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):

 

·On track to enroll the final patient in the open label portion of the CYPRESS in mid-2025, with top-line data anticipated to be available approximately six months later.

 

·Continue to prepare for an expedited NDA filing post CYPRESS readout and plan to request a priority review.

 

·Recent successful interaction with FDA confirming agreement on the content of a complete application, solidifying our path to an NDA.

 

·Two abstracts accepted for oral presentation at the American Academy of Neurology 2025 Annual Meeting taking place April 5–9, 2025, in San Diego:

 

o“The Impact of Ampreloxetine on Supine Hypertension: An Ambulatory Blood Pressure Monitoring Study”

 

o“NET-Inhibition with Ampreloxetine, Blood Pressure, and Catecholamines in Patients with Neurogenic Orthostatic Hypotension”

 

·Continued launch readiness activities, including primary provider-focused research. Initial findings confirm strong need for more effective therapies with greater durability in nOH in MSA, as well as existence of many MSA patients with persistent symptoms despite available therapies.

 

Fourth Quarter Financial Results

 

·Revenue: Total revenue for the fourth quarter of 2024 was $18.8 million, consisting entirely of Viatris collaboration revenue. Viatris collaboration revenue increased by $1.4 million, or 8%, in the fourth quarter compared to the same period in 2023 due primarily to higher net sales. 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 fourth quarter of 2024 was $23.3 million which represents a 10% increase compared to the same period in 2023.

 

 

5 Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Dec ’24.

 

Page 2 of 10

 

 

 

 

·Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $9.5 million, compared to $8.3 million in the same period in 2023. Fourth quarter R&D expenses included total non-cash share-based compensation of $1.4 million. In terms of Financial Guidance, full year 2024 R&D expenses excluding non-cash share-based compensation were $32.5 million which was within our Financial Guidance of $30 million to $36 million.

 

·Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2024 were $18.5 million, compared to $15.5 million in the same period in 2023. Fourth quarter SG&A expenses included total non-cash share-based compensation of $4.4 million. In terms of Financial Guidance, full year 2024 SG&A expenses excluding non-cash share-based compensation were $52.9 million which was within our Financial Guidance of $45 million to $55 million.

 

·Share-Based Compensation: Share-based compensation expenses for the fourth quarter of 2024 were $5.8 million, compared to $5.8 million in the same period in 2023. Share-based compensation expenses consisted of $1.4 million for R&D and $4.4 million for SG&A in the fourth quarter of 2024, compared to $1.7 million and $4.1 million, respectively, in the same period in 2023. In terms of Financial Guidance, full year 2024 share-based compensation expenses were $21.4 million which was within our Financial Guidance of $18 million to $22 million.

 

·Net Loss and Non-GAAP Net Income (Loss) from Operations6: Net loss was $15.5 million in the fourth quarter of 2024 compared to $8.5 million in the same period in 2023, and non-GAAP net loss was $2.5 million in the fourth quarter 2024 compared to a non-GAAP net income of $1.4 million in the same period in 2023. See the section titled "Non-GAAP Financial Measures" for more information.

 

·Cash Position: Cash, cash equivalents and marketable securities totaled $88.4 million as of December 31, 2024.

 

Strategic Review Committee

 

Theravance Biopharma announced on November 12th, 2024, that the Board of Directors had formed a Strategic Review Committee (the “Committee”) composed entirely of independent directors to assess all strategic alternatives available to the Company. The Committee is continuing to evaluate a range of alternatives with the objective of unlocking shareholder value. Until this review is complete, we are not in a position to provide additional details on the review process.

 

 

6 Non-GAAP profit (loss) consists of GAAP net loss before taxes less share-based compensation expense, non-cash interest expense, and non-cash impairment expense. See the section titled "Non-GAAP Financial Measures" for more information.

 

Page 3 of 10

 

 

 

 

2025 Financial Guidance

 

·Operating Expenses (excluding share-based compensation): The Company expects full year 2025 R&D expense of $32 million to $38 million and SG&A expense of $50 million to $60 million, in each case excluding share-based compensation.

 

·Share-Based Compensation: The Company expects full year share-based compensation expense of $18 million to $20 million.

 

·Non-GAAP Loss from Operations and Cash Burn6: The Company expects minimal levels of Non-GAAP Losses from Operations and Cash Burn in 2025, similar to levels incurred in 2024.

 

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 GMT. 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.

 

A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through March 28, 2025.

 

About Ampreloxetine

 

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 in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the US, the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.

 

About CYPRESS (Study 0197), a Phase 3 Study

 

Study 0197 (NCT05696717) is currently enrolling. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).

 

Page 4 of 10

 

 

 

 

About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)

 

MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).7 There are approximately 50,000 MSA patients in the US8 and 70-90% of MSA patients experience nOH symptoms.9 Despite available therapies, many MSA patients remain symptomatic with nOH.

 

Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of  >20 mm Hg or diastolic blood pressure of  >10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.

 

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 once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA 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 in this press release are the property of their respective owners.

 

 

7 https://medlineplus.gov/genetics/condition/multiple-system-atrophy/

8 UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).

9 Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).

 

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Forward-Looking Statements

 

This press release 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, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s expectations regarding its future profitability, expenses and uses of cash, the Company’s goals, designs, strategies, plans, potential, and objectives, future growth of YUPELRI sales, future milestone and royalty payments, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, potential or possible safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts; contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma, and expectations around the use of OHSA scores as endpoints for clinical trials. 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 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: factors that could increase the Company’s cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, 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, 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-Q filed with the SEC on November 14, 2024, 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.

 

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 income (loss) 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 continuing 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.

 

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Please see the appendix attached to this press release for a reconciliation of non-GAAP net income (loss) to its corresponding measure, net income (loss). A reconciliation of non-GAAP net income (loss) to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding, and the potential variability of, expenses and other factors in the future.

 

Contact:

investor.relations@theravance.com

650-808-4045

 

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THERAVANCE BIOPHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

 

   December 31,   December 31, 
   2024   2023 
   (Unaudited)   (1) 
Assets          
Current assets:          
Cash and cash equivalents and short-term marketable securities  $88,350   $102,426 
Receivables from collaborative arrangements   18,440    17,474 
Receivables from milestone and royalty assets   50,000    - 
Prepaid clinical and development services   73    2,038 
Other prepaid and current assets   4,204    11,603 
Total current assets   161,067    133,541 
Property and equipment, net   7,418    9,068 
Operating lease assets   28,354    36,287 
Future contingent milestone and royalty assets   144,200    194,200 
Restricted cash   836    836 
Other assets   12,286    8,067 
Total assets  $354,161   $381,999 
           
Liabilities and Shareholders' Equity          
Current liabilities  $32,085   $24,767 
Long-term operating lease liabilities   39,108    45,236 
Future royalty payment contingency   30,334    27,788 
Unrecognized tax benefits   75,199    65,294 
Other long-term liabilities   1,890    5,919 
Shareholders' equity   175,545    212,995 
Total liabilities and shareholders’ equity  $354,161   $381,999 

 

 

(1)The condensed consolidated balance sheet as of December 31, 2023 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, 2023.

 

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THERAVANCE BIOPHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

 

   Three Months Ended December 31,   Year Ended December 31, 
   2024   2023   2024   2023 
                 
   (Unaudited)   (Unaudited) 
Revenue:                    
Viatris collaboration agreement (1)  $18,754   $17,360   $64,381   $57,201 
Viatris royalties (Non-US)   -    7    -    7 
Collaboration revenue   -    198    -    216 
Total revenue   18,754    17,565    64,381    57,424 
                     
Costs and expenses:                    
Research and development (2)   9,452    8,314    37,643    40,621 
Selling, general and administrative (2)   18,502    15,492    69,174    70,095 
Impairment of long-lived assets (non-cash)   -    -    4,513    - 
Restructuring and related expenses (2)   -    -    -    2,743 
Total costs and expenses   27,954    23,806    111,330    113,459 
Loss from operations   (9,200)   (6,241)   (46,949)   (56,035)
Interest expense (non-cash)   (643)   (623)   (2,546)   (2,350)
Interest income and other income, net   902    1,847    4,881    9,116 
Loss before income taxes   (8,941)   (5,017)   (44,614)   (49,269)
Provision for income tax expense   (6,587)   (3,494)   (11,804)   (5,924)
Net loss  $(15,528)  $(8,511)  $(56,418)  $(55,193)
                     
Net loss per share:                    
Basic and diluted net loss per share  $(0.31)  $(0.17)  $(1.15)  $(1.00)
Shares used to compute basic and diluted net loss per share   49,306    49,415    48,847    55,303 
                     
Non-GAAP net income (loss)  $(2,472)  $1,431   $(16,162)  $(21,548)

 

(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 December 31,   Year Ended December 31, 
(In thousands)  2024   2023   2024   2023 
YUPELRI net sales (100% recorded by Viatris)  $66,680   $60,644   $238,626   $220,962 
YUPELRI net sales (Theravance Biopharma implied 35%)   23,338    21,225    83,519    77,337 

 

(2) Amounts include share-based compensation expense as follows:

 

   Three Months Ended December 31,   Year Ended December 31, 
(In thousands)  2024   2023   2024   2023 
Research and development  $1,377   $1,747   $5,104   $8,048 
Selling, general and administrative   4,449    4,078    16,289    16,966 
Restructuring and related expenses   -    -    -    357 
Total share-based compensation expense  $5,826   $5,825   $21,393   $25,371 

 

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THERAVANCE BIOPHARMA, INC.

Reconciliation of GAAP to Non-GAAP Net Income (Loss)

(In thousands) 

 

   Three Months Ended December 31,   Year Ended December 31, 
   2024   2023   2024   2023 
                 
   (Unaudited)   (Unaudited) 
GAAP net loss  $(15,528)  $(8,511)  $(56,418)  $(55,193)
Adjustments:                    
Share-based compensation expense   5,826    5,825    21,393    25,371 
Non-cash impairment of long-lived assets   -    -    4,513    - 
Non-cash interest expense   643    623    2,546    2,350 
Income tax expense   6,587    3,494    11,804    5,924 
Non-GAAP net income (loss)  $(2,472)  $1,431   $(16,162)  $(21,548)

 

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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. © 2025 Theravance Biopharma. All rights reserved. Theravance Biopharma Fourth Quarter & Full Year 2024 Financial Results and Business Update February 26, 2025

 

 

2 Forward Looking Statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events . Theravance Biopharma, Inc . (the “Company”) intends such forward - looking statements to be covered by the safe harbor provisions for forward - looking statements contained in Section 21 E 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 expectations regarding its future profitability, expenses and uses of cash, the Company’s goals, designs, strategies, plans, potential, and objectives, future growth of YUPELRI sales, future milestone and royalty payments, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, potential or possible safety, efficacy or differentiation of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts ; contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma, and expectations around the use of OHSA scores as endpoints for clinical trials . 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 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 : factors that could increase the Company’s cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, 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, 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 the Company are in the Company’s Form 10 - Q filed with the SEC on November 14 , 2024 , 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 . 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 income (loss) 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 income (loss) 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 . Please see the appendix attached to this presentation for a reconciliation of non - GAAP net income (loss) to its corresponding measure, net income (loss) . A reconciliation of non - GAAP net income (loss) to its corresponding GAAP measure is not available on a forward - looking basis without unreasonable effort due to the uncertainty regarding, and the potential variability of, expenses and other factors in the future .

 

 

3 Agenda Opening & Closing Remarks Rick Winningham : Chief Executive Officer Commercial Updates Rhonda Farnum: Senior Vice President, Chief Business Officer TRELEGY & Financial Updates Aziz Sawaf: Senior Vice President, Chief Financial Officer Q&A Team Development & Regulatory Updates Dr. Áine Miller: Senior Vice President, Development

 

 

4 Strong Finish to 2024 Across P ortfolio of Value D rivers 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2. Source: Viatris Customer Demand (Q4’24) . 3 . Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Dec’24. 4. Source: GSK - reported Net Sales in USD. As of 12/31/24, Theravance stood to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma (RP). A first payment of $25 million was trigge red when Royalty Pharma (RP) became eligible to receive $240 million or more in royalty payments from GSK based on 2024 TRELEGY global net sales and a second payment of $25 million (for a total of $50 million) was tr iggered when RP became eligible to receive $275 million or more in royalty payments from GSK. Both royalty thresholds were achieved in the fourth quarter of 2024. MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. 4 • Reported Q4 net sales increased 10 % Y/Y, to $66.7M 1 , an all - time high • Achieved highest launch - to - date brand profitability during Q4 • Q4 demand also an all - time high, up 9 % Y/Y 2 • Excellent h ospital performance, with Q4 doses up 49% Y/Y 3 • CYPRESS enrollment on track, positioning company to reiterate development timelines • Recent successful interaction with FDA confirming agreement on the content of a complete application • New market research reinforces the significant value of a product with ampreloxetine’s profile in addressing nOH symptoms in MSA Ampreloxetine TRELEGY / Corporate • 2024 TRELEGY net sales reached $3.46 B (+26% YoY) , triggering $50M milestone 4 • Minimal 2024 cash burn of $14M, ending year with $88M of cash, excluding $50M TRELEGY cash milestone received in Feb’25 • Expenses managed to within all guidance ranges

 

 

5 Near - and - Mid - Term Strategic Priorities Maximizing YUPELRI ® and TRELEGY value, while driving to major inflection point in CYPRESS 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). In China, Viatris is responsible for YUPELRI commercialization, with Theravance Biopharma eligible to receive milestones and roy alt ies on net sales. Refer to our SEC filings for further information. 2. Pursuant to the Equity Purchase and Funding Agreement, dated as of July 13, 2022, by and between Theravance Biopharma, Inc. and Royalty Pharma Inves tme nts 2019 ICAV. 3. On a country - by - country basis, Theravance will be entitled to royalties until the expiration of the longest - lived patent or 15 years after commercial launch, whichever comes later. Based on 15 years from launch, US royalties extend through 2032 and through mid - 2030s ex - US. Total royalties owed are 6.5% to 10.0% of global net sales in eligible territories; Theravance receives 85% of royalties owed . MSA, multiple system atrophy; NDA, new drug application; nOH, neurogenic orthostatic hypotension. 5 • Continue growing YUPELRI and progress towards key economic milestones in the US and China 1 • Next potential US milestone: $25M milestone for first calendar year in which YUPELRI sales reach $250M (4% growth) • Next potential China milestone: $7.5M on approval (Viatris filed NDA in June 2024) • Drive increased brand margins • Complete pivotal CYPRESS Phase 3 Study • Expect to enroll last patient in the open label portion of CYPRESS in mid - ’25, with top - line data anticipated ~ 6 mo. later • Prepare for expedited NDA filing and request priority review • Build awareness regarding nOH in patients with MSA by partnering with opinion leaders and caregiver community and educating on disease state; optimize access strategy Ampreloxetine TRELEGY / Corporate • Up to $150M in near - term TRELEGY sales milestones 2 : • Up to $50M in 2025 • Up to $100M in 2026 • TRELEGY royalties returning in 2029 2 and extend through mid - 2030s 3 • Commitment to return excess capital to shareholders • Exercise capital discipline

 

 

The Only Once - Daily, Nebulized LAMA Maintenance Medicine for COPD Co - promotion agreement with VIATRIS TM (35% / 65% Profit Share) Rhonda Farnum Senior Vice President, Chief Business Officer COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist

 

 

7 Strong YUPELRI ® Quarterly Net Sales Performance in the US In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). $16.5 $29.6 $36.8 $30.3 $37.0 $38.7 $36.9 $41.8 $39.4 $43.8 $43.7 $49.1 $53.4 $55.7 $47.0 $55.0 $58.3 $60.6 $55.2 $54.5 $62.2 $66.7 0 10 20 30 40 50 60 70 80 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Net sales increased 10% Q4 ’24 / Q4 ’23 Total YUPELRI Net Sales ($M)

 

 

8 Exceptional US Hospital Growth +49% Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Dec’24. Preliminary data subject to revision upon receipt of final data. 19 K 30 K 54 K 34 K 47 K 54 K 56 K 70 K 78 K 93 K 98 K 108 K 113 K 138 K 163 K 158 K 162 K 191 K 214 K 227 K 227 K 285 K 0K 50K 100K 150K 200K 250K 300K Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 YUPELRI Hospital Doses Hospital doses increased 49 % Q4 ’24 / Q4 ’23

 

 

9 Considerable Added Potential in China o NDA submitted in China (June 2024) o $7.5M approval milestone, up to $37.5M in monotherapy sales milestones; 14 - 20% tiered royalties 3 o Nearly 100M individuals with COPD; ~43% suffer from moderate to severe disease 4,5 Significant YUPELRI ® Future Potential 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2. As of 12/31/24, Theravance Biopharma is eligible to receive from Viatris potential global development, regulatory and sales milestone payment s (excluding China and adjacent territories) totaling up to $205.0 million in the aggregate; refer to our SEC filings for further information. 3. As of 12 /31/24, Theravance Biopharma is eligible to receive potential development and sales milestones totaling $52.5 million related to Viatris’ development and commercialization of nebulized revefenacin in China and adjacent territories, with $45.0 million ass oci ated with YUPELRI monotherapy and $7.5 million associated with future potential combination products; refer to our SEC filings for further information . 4. Wang C, Xu, J, Yang L, et al., The Lancet, 2018. 5. Yin P, Wang H, Vos T, et al., Chest, 2013. COPD, chronic obstructive pulmonary disease; NDA, new drug application . Significant Financial Returns from US Growth o 2024 US net sales up 8% to $239M o Brand profitable, with expanding margins; Theravance receives 35% of US profits 1 o Up to $150M in total monotherapy sales milestones, including $25M for 1 st year in which US net sales > $250M 2 o As many as 1.9M patients could benefit from YUPELRI in the US IP Protection Granted to 2039 in the US

 

 

The First And Only Once - Daily Triple Therapy In a Single Inhaler For Adult Patients With COPD Or Asthma Milestone and royalty agreement with Royalty Pharma Aziz Sawaf Senior Vice President, Chief Financial Officer GSK’s TRELEGY COPD, chronic obstructive pulmonary disease

 

 

11 Up to $150M in TRELEGY Sales Milestones in 2025 and 2026 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone, payable by Roya lty Pharma (RP) pursuant to the Equity Purchase and Funding Agreement, dated as of July 13, 2022, by and between Theravance Biopharma, Inc. and Royalty Pharma Investments 2019 ICAV. 2. Based on 100% of TRE LEG Y ELLIPTA royalties. 3. GSK - reported Net Sales in USD. 4. Bloomberg Consensus as of 02/25/25. Milestone to Theravance Royalty Threshold 2 Global Net Sales Equivalent Year $25M $260M $3,063M 2025 1 $50M $295M $3,413M $50M $270M $3,163M 2026 1 $100M $305M $3,513M 2025 and 202 6 Sales Milestones 1 $0 $500 $1,000 $1,500 $2,000 $2,500 $3,000 $3,500 $4,000 $4,500 2021 2022 2023 2024 2025 E 2026 E Consensus Forecast 4 Actuals 3 Net Sales ($M) $50M $25M $100M $50M $1,674 $2,142 $2,739 $3,456 $3,814 $4,006 28% growth 28% growth Strong TRELEGY Global Net Sales Trends ($M) 26% growth

 

 

12 TRELEGY Royalties Returning in 2029 Represent a Significant Source of Value Beginning in 2029, royalties from 5.5% - 8.5% on TRELEGY net sales return to Theravance Biopharma 1 1. Total royalties owed are 6.5% to 10.0% of global net sales in eligible territories; Theravance Biopharma receives 85% of r oya lties owed. Royalties return pursuant to the Equity Purchase and Funding Agreement, dated as of July 13, 2022, by and between Theravance Biopharma, Inc. and Royalty Pharma Investments 2019 ICAV. 2. Sou rce: Bloomberg consensus estimates as of 02/25/25. Total Global TRELEGY Net Sales ($M) (Consensus Estimates 2 ) 0 500 1,000 1,500 2,000 2,500 3,000 3,500 2029 2030 2031 2032 2033 2034 Ex-US US • Ex - US royalties return July 1, 2029 and extend through mid - 2030s, based on 15 years from launch • US royalties return January 1, 2031 and extend through 2032, based on 15 years from launch Royalties extend until longest - lived patent or 15 years after commercial launch, whichever is later Potential for longer duration if longest - lived patent is after 2032 US and mid - 2030s ex - US Overview of Royalty Terms

 

 

The first once - daily, selective norepinephrine reuptake inhibitor in development to treat symptomatic nOH in MSA Dr. Áine Miller Senior Vice President, Development Rhonda Farnum Senior Vice President, Chief Business Officer MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension AMPRELOXETINE

 

 

14 Ampreloxetine 2025 Outlook NDA Preparations • Recent interaction with FDA re - affirms our regulatory strategy • Well positioned to finalize key modules in advance of CYPRESS readout • Preparations facilitate expedited filling post readout, with plans to request priority review CYPRESS Study • On track to complete open label enrollment mid - 2025; top - line data expected to be available approximately 6 months after • Oral presentations highlighting the impact of ampreloxetine on supine hypertension and blood pressure at upcoming American Academy of Neurology Annual Meeting in April 2025

 

 

15 New Market Research Supports Need for Improved nOH Therapy Significant opportunity for ampreloxetine to provide a new option for physicians and patients Survey Questions: 1. Based on your experience in managing MSA patients with symptomatic nOH, please indicate your level of ag ree ment with the following statements. Please use a 7 - point scale where 1=Do not agree at all and 7=Strongly agree. 2. Of the following attributes, which do you consider the most important in the selection of a treatment for your MSA patient s w ith symptomatic nOH and which do you consider the least important? (total of 36 attributes presented). N=200 board certified neurologists (n=150) and cardiologists (n=50) trea tin g MSA patients and familiar with nOH diagnosis and treatment. MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. Perceptions of nOH Treatment in Patients with MSA There is significant need for better therapies for patients with symptomatic nOH and MSA 1 71% 62% 27% 38% Neurologists Cardiologists Disagree Somewhat Agree Strongly Agree Survey Scale nOH Product Attribute Ranking These attributes were the most important in selecting an nOH treatment in patients with MSA 2 Efficacy in improving nOH symptoms 1 Improvement in patient quality of life 2 Durability in maintaining nOH symptom improvement 3 Good safety and tolerability 4 Does not exacerbate supine hypertension 5 10 15 17 18 19 Mean Rank Score out of 36 attributes (Higher Score = More Important)

 

 

16 Unique Target Product Profile Aligns with Physicians’ Desired nOH Product Attributes 1. Reflects Theravance Biopharma’s expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in dev elopment and is not approved for any indication. 2. N=200 board certified neurologists and cardiologists treating MSA patients and familiar with nOH diagnosis and treatment; Survey Question: Assuming coverage and co st to the patient is on par with existing treatments, and assuming full FDA approval, how likely would you be to prescribe Product X [ampreloxetine] in the future? Survey queried respondents regarding “Product X,” which had the attributes of ampreloxetine’s target product p rof ile. 3. If FDA - approved. MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension; OHSA, Orthostatic Hypotension Symptom Assessment; TPP, target product profile. Ampreloxetine’s Unique Product Features 1 If approved, ampreloxetine may provide a differentiated, new treatment option: ‣ Meaningful improvement in the OHSA Composite Score demonstrates effectiveness in treating constellation of nOH symptoms ‣ Impact on daily activities of living , as measured by patients’ ability to stand or walk for a short time ‣ Durable effectiveness , based on 20 - week CYPRESS study design ‣ Differentiated safety profile , no worsening of underlying supine hypertension ‣ Convenient, once - daily dosing provides a better experience; patients with MSA may have difficulty swallowing 9% 18% 22% 22% 68% 58% Neurologists Cardiologists Physician Response on a 1 - 7 Scale Very likely to prescribe (6,7) 5 4

 

 

Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer

 

 

18 Fourth Quarter 2024 Financials (Unaudited) 1. Amounts include share - based compensation. 2. Non - GAAP net income (loss) consists of GAAP net loss before taxes excluding share - based compensation expense, non - cash interest expense and non - cash impairment expense (if any); see reconciliation on Slide 19 and the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. 18 ($, in thousands) Revenue: Viatris collaboration agreement $ 18,754 $ 17,360 $ 64,381 $ 57,201 Viatris royalties (Non-US) - 7 - 7 Collaboration revenue - 198 - 216 Total revenue 18,754 17,565 64,381 57,424 Costs and expenses: Research and development (1) 9,452 8,314 37,643 40,621 Selling, general and administrative (1) 18,502 15,492 69,174 70,095 Impairment of long-lived assets (non-cash) - - 4,513 - Restructuring and related expenses (1) - - - 2,743 Total costs and expenses 27,954 23,806 111,330 113,459 Loss from operations (before tax and other income & expense) $ (9,200) $ (6,241) $ (46,949) $ (56,035) Share-based compensation expense: Research and development 1,377 1,747 5,104 8,048 Selling, general and administrative 4,449 4,078 16,289 16,966 Restructuring and related expenses - - - 357 Total share-based compensation expense 5,826 5,825 21,393 25,371 Operating expense excl. share-based compensation: R&D operating expense (excl. share-based compensation) 8,075 6,567 32,539 32,573 SG&A operating expense (excl. share-based compensation) 14,053 11,414 52,885 53,130 Total operating expenses excl. share-based compensation $ 22,128 $ 17,981 $ 85,424 $ 85,703 Non-GAAP net income (loss) (2) $ (2,472) $ 1,431 $ (16,162) $ (21,548) Three Months Ended December 31, 2024 2023 (Unaudited) Year Ended December 31, 2024 2023 (Unaudited)

 

 

19 Fourth Quarter 2024 Financials (Unaudited) (Cont’d) 19 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss $ (15,528) $ (8,511) $ (56,418) $ (55,193) Adjustments: Share-based compensation expense 5,826 5,825 21,393 25,371 Non-cash impairment of long-lived assets - - 4,513 - Non-cash interest expense 643 623 2,546 2,350 Income tax expense 6,587 3,494 11,804 5,924 Non-GAAP Net Income (Loss) $ (2,472) $ 1,431 $ (16,162) $ (21,548) Non-GAAP Net Income (Loss) per Share Basic and diluted non-GAAP net income (loss) per share $ (0.05) $ 0.03 $ (0.33) $ (0.39) Shares used to compute basic and diluted non-GAAP net income (loss) per share 49,306 49,415 48,847 55,303 (Unaudited) Reconciliation of GAAP to Non-GAAP Net Income (Loss) (In thousands, except per share data) Three Months Ended December 31, Year Ended December 31, 2024 2023 2024 2023 (Unaudited)

 

 

20 Fourth Quarter 2024 Financial Highlights 1. Non - GAAP net income (loss) consists of GAAP net loss before taxes less share - based compensation expense, non - cash interest ex pense, and non - cash impairment expense (if any); see reconciliation on Slide 19 and the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. 2. Cash, cash equivalents and marketable s ecurities. SBC, Share - Based Compensation. Note Q4 ‘23 (M) Q4 ‘24 (M) Metric $17.4 $18.8 VIATRIS Collaboration Revenue Full year results within guidance ranges $18.0 $22.1 SG&A and R&D Expense, ex - SBC Full year results within guidance range $5.8 $5.8 Share - Based Compensation ($8.5) ($15.5) GAAP Net Loss $1.4 ($2.5) Non - GAAP Net Income (Loss) 1 $88.4M of cash excludes $50M TRELEGY milestone (received in Feb’25) $102.4 $88.4 Cash and Cash Equivalents 2 (as of quarter - end) $0.0 $0.0 Debt (as of quarter - end) 48.1 49.5 Shares Outstanding (as of quarter - end)

 

 

21 1. Non - GAAP net income (loss) consists of GAAP net loss before taxes less share - based compensation expense, non - cash interest ex pense, and non - cash impairment expense (if any); see the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. 2. The Company previously recognized $194M of the potential miles tones and royalties at the time of sale in July 2022; as a result, the Company will not recognize any additional income until the cumulative milestone payments exceed the $194M previously recogniz ed. 3. 2025 Estimates assume mid - point of Guidance. 4. One - time items consist of impairment of long - lived assets (non - cash). SBC, Share - Based Compensation. 2025 Financial Guidance 2025 OPEX Guidance : • R&D (excluding share - based comp): $32M - $38M • SG&A (excluding share - based comp): $50M - $60M • Share - Based Compensation: $18M - $20M 2025 Non - GAAP Loss and Cash Burn Guidance 1 : • Non - GAAP Loss and Cash Burn similar to 2024 • Guidance excludes potential milestones for TRELEGY & YUPELRI TRELEGY Milestone Accounting: • Accounting guidelines require cumulative milestone cash payments greater than $194M be recognized as Other Income (not Revenue) on P&L 2 • Therefore, no Other Income will be recognized until $194M of cumulative milestones are achieved; no Other Income expected until 2026, at the earliest • No impact to cash with receipt in Q1 4.5 21.4 19.0 52.9 55.0 32.5 35.0 111.3 109.0 $0 $20 $40 $60 $80 $100 $120 $140 2024A 2025E R&D SG&A SBC One-time Items 3 Operating Expenses ($M) 4

 

 

22 Ampreloxetine Registrational Program Nearing Completion with Transformative Potential Growing Contribution from YUPELRI Only once - daily nebulized LAMA: currently <5% penetrated addressable market 2 $239M 2024 US net sales , with 35% share of profits; $25 million milestone for first calendar year net sales reach $250 million 3 Viatris China filing June 2024; $7.5M to Theravance on approval, 14 - 20% royalties 4 Anticipated completion of CYPRESS open label enrollment mid - 2025, top - line data ~6 mo. later , expedited NDA filing Potential to deliver meaningful clinical benefits and address key deficiencies of existing therapeutic alternatives 100% owned with Orphan Drug Designation, ~40,000 patients with MSA and symptoms of nOH in th e US 5,6 Strong Cash Generation; Significant Upside Potential with Ampreloxetine 1. Payments from Royalty Pharma (RP) will be triggered if RP receives certain minimum royalty payments from GSK based on TREL EGY global net sales. On a country - by - country basis, Theravance will be entitled to royalties until the expiration of the longest - lived patent or 15 years after commercial launch, whichever comes later. Based on 15 years from launch, US royalties ext end through 2032 and through mid - 2030s ex - US. 2. Sources: Citeline Pharma Custom Intelligence Primary Research April 2023, Symphony Health METYS Prescription Dashboard, SolutionsRx Med B FFS. 3. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). Refer to our SEC filings for further information 4. R efer to our SEC filings for further information. 5 . Kalra DK, et al. Clin Med Insights: Cardiol. 2020 (70% - 90%);14:1179546820953415. 6. Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multi ple systems atrophy, CJ Mathias (1999). LAMA, long - acting muscarinic antagonist; MSA, multiple system atrophy; NDA, new drug application; nOH, neurogenic orthostatic hypotension. Compelling Financial Profile $88.4 million in cash at year end , $50 million milestone received Q1 2025, no debt , and limited cash use anticipated Up to $150M in additional TRELEGY milestones possible through 2026 ; royaltie s returning from 2029, extending through mid - 2030s 1 Commitment to return excess capital to shareholders

 

 

Rick Winningham Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda Farnum Senior Vice President, Chief Business Officer Áine Miller Senior Vice President, Development Q&A Session

 

 

24 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. 24

 

 

25 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. 25

 

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Cover
Feb. 26, 2025
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Document Type 8-K
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Document Period End Date Feb. 26, 2025
Entity File Number 001-36033
Entity Registrant Name THERAVANCE BIOPHARMA, INC.
Entity Central Index Key 0001583107
Entity Tax Identification Number 98-1226628
Entity Incorporation, State or Country Code E9
Entity Address, Address Line One C/O Theravance Biopharma US, LLC
Entity Address, Address Line Two 901 Gateway Boulevard
Entity Address, City or Town South San Francisco
Entity Address, Country CA
Entity Address, Postal Zip Code 94080
City Area Code 650
Local Phone Number 808-6000
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Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Ordinary Share $0.00001 Par Value
Trading Symbol TBPH
Security Exchange Name NASDAQ
Entity Emerging Growth Company false

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Theravance Biopharma (NASDAQ:TBPH)
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De Mar 2024 à Mar 2025 Plus de graphiques de la Bourse Theravance Biopharma