TBPH Theravance Biopharma Inc

 

 

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): August 5, 2024

 

 

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, Inc.

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 August 5, 2024, Theravance Biopharma, Inc. (the “Company”) issued a press release and is holding a conference call regarding its financial results for the quarter ended June 30, 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 August 5, 2024

 

99.2	Slide deck entitled Second Quarter 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:  August 5, 2024	By:	/s/ Aziz Sawaf
		Aziz Sawaf
		Senior Vice President and Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

Theravance Biopharma, Inc. Reports Second Quarter 2024
Financial Results and Provides Business Update

 

·

Q2 2024 YUPELRI® (revefenacin) net sales of $54.5 million, recognized by Viatris, decreased 1% from Q2 20231

·

Viatris collaboration revenue of $14.3 million, increased 4% versus Q2 2023

·

Partner Viatris submitted YUPELRI NDA in China; $7.5 million milestone if approved

·

Now expecting last patient into the open label portion of CYPRESS in mid-2025, top line data anticipated approximately 6 months later

·

Q2 2024 TRELEGY net sales of $1.065 billion, increasing the likelihood of achieving up to $50 million of milestones in 2024

·

Q2 2024 ending cash balance of $96.1 million

 

DUBLIN, IRELAND – AUG. 5, 2024 – Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today announced financial and operational results for the second quarter of 2024.

 

“YUPELRI net sales decreased 1% from the prior quarter, owing to near-term headwinds from an evolved channel mix and a lower realized net price,” said Rick Winningham, Theravance Biopharma CEO. “We are disappointed with this quarter’s net sales result, but remain confident in our ability to continue to grow YUPELRI in the future, given strong and consistent demand generation.” He continued, “In addition, while we have activated over 80% of study sites in CYPRESS and achieved solid enrollment in the quarter, we now anticipate enrolling the last patient into the open-label portion of the study in mid-2025. We continue to prioritize delivering a high-quality study in pursuit of making ampreloxetine available to those MSA patients suffering without viable treatment options for their symptomatic nOH. Finally, we are pleased with another exceptional quarter for TRELEGY, which increases our confidence in achieving milestones in 2024, which would contribute to our existing balance sheet strength.”

 

Second Quarter 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):

 

·

Realized total net sales of $54.5 million for the quarter, a decrease of 1% compared with the same period in 2023.1

·

Generated a robust 13% increase in customer demand (Q2 2024 vs Q2 2023).2

·

Increased hospital doses sold by 43% (Q2 2024 vs Q2 2023).3

 

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 Source: Viatris Customer Demand (Q2’24).

³ Source: IQVIA DDD, HDS, VA and Non-Reporting Hospital through Jun ’24.

 

 

 

·

Increased share of the long-acting nebulized segment of the COPD market, with hospital share surpassing 18% and community share reaching 32%, both all-time highs.4

·

Granted an additional method of use patent for YUPELRI on July 30, 2024, with an expiration date of August 2039. Listed in the FDA Orange Book.

 

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):

 

·

Achieved steady progress in CYPRESS enrollment, with over 80% of planned sites now activated, including a number of global academic institutions, tertiary care centers and MSA Centers of Excellence.

·

Updated anticipated completion of enrollment into the open-label portion of the study to mid-2025. Target completion impacted by lengthier timelines to site activation, and to ensure sufficient patients progress to the randomized withdrawal portion of the study.

·

Top line data anticipated to be available approximately 6 months after enrollment is completed in the open label portion of the study.

 

TRELEGY Update:

 

·

GSK posted second quarter 2024 global net sales of approximately $1.1 billion (up 40% from $760 million reported in the second quarter of 2023), bringing year-to-date TRELEGY global net sales to approximately $1.8 billion (up 37% from the same period in 2023).

·

As of June 30, 2024, Theravance Biopharma is eligible to receive a total of $200 million in milestone payments from Royalty Pharma, should TRELEGY achieve certain sales thresholds. The next milestone payment of $25 million will be achieved if TRELEGY global net sales reach approximately $2.9 billion in 2024 (requiring second half 2024 sales of approximately $1.1 billion), and a second $25 million milestone payment (for a total of $50 million) will be achieved if TRELEGY global net sales exceed approximately $3.2 billion in 2024 (requiring second half 2024 sales of approximately $1.4 billion).

 

Second Quarter Financial Results

 

·

Revenue: Total revenue for the second quarter of 2024 was $14.3 million, consisting entirely of Viatris collaboration revenue. Viatris collaboration revenue increased by $0.5 million, or 4%, in the second quarter compared to the same period in 2023 due primarily to lower costs incurred by Viatris. 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 second quarter of 2024 was $19.1 million which represented a 1% decrease compared to the same period in 2023.

 

⁴ Hospital LA-NEB Market Share - IQVIA DDD through Jun ’24. Community LA-NEB Market Share includes Retail + DME / Med B FFS through May ’24.

 

 

 

·

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2024 were $10.0 million, compared to $9.4 million in the same period in 2023. Second quarter R&D expenses included total non-cash share-based compensation of $1.2 million.

 

·

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2024 were $17.1 million, compared to $19.3 million in the same period in 2023. Second quarter SG&A expenses included total non-cash share-based compensation of $4.2 million.

 

·

Non-Cash Impairment of Long-Lived Assets: As the R&D lab space leasing market in South San Francisco continued to soften in the second quarter, the Company incurred a non-cash impairment charge of $3.0 million on its long-lived assets (consisting primarily of its operating leases) in the second quarter of 2024.

 

·

Share-Based Compensation: Share-based compensation expenses for the second quarter of 2024 was $5.4 million, compared to $6.3 million in the same period in 2023. Share-based compensation expenses consisted of $1.2 million for R&D and $4.2 million for SG&A in the second quarter of 2024, compared to $1.9 million and $4.4 million, respectively, in the same period in 2023.

 

·

Net Loss and Non-GAAP Net Loss from Operations5: Net loss was $16.5 million in the second quarter of 2024 compared to $15.6 million in the same period in 2023. The net loss in the second quarter of 2024 was impacted by the $3.0 million non-cash impairment charge on the Company’s long-lived assets. Non-GAAP net loss from operations was $6.3 million in the second quarter 2024 compared to a non-GAAP net loss from operations of $7.4 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 $96.1 million as of June 30, 2024.

 

Updated 2024 Financial Guidance

 

·

Operating Expenses (excluding share-based compensation): The Company continues to expect full year 2024 R&D expenses of $30 million to $36 million and SG&A expenses of $45 million to $55 million, in each case excluding share-based compensation.

 

⁵ Non-GAAP profit (loss) consists of GAAP net income (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.

 

 

 

·

Share-Based Compensation: The Company continues to expect full year share-based compensation expenses of $18 million to $22 million.

 

·

Non-GAAP Net Profit / Loss: The Company now expects levels of both non-GAAP losses and cash burn to be similar to first half actuals 2024.

 

Corporate Initiatives to Maximize Shareholder Value

 

Pursuant to a recently-completed review of its substantial Irish tax assets, the Company is engaging tax and financial advisors to explore opportunities through which to unlock value, given the gap between our share price and the value of our diverse and unique portfolio, including YUPELRI, ampreloxetine, TRELEGY and the Company’s tax assets. We will provide further updates as appropriate.

 

Intellectual Property Updates

 

Patent Infringement Suits

Patent litigation is pending against four companies, along with certain affiliates; we previously disclosed litigation involving three of these companies. In June 2024, the Company filed a patent infringement suit in the U.S. District Court for the Eastern District of Pennsylvania against a subsequent filer of an abbreviated new drug application (ANDA) for a generic version of YUPELRI. As a result of this lawsuit, a 30-month stay of approval through November 2026 would be expected to be automatically granted by the FDA on the subsequent filer’s ANDA pending any adverse court decision. As of July 31, 2024, the Company has settled litigation with four companies pursuant to individual agreements in which we granted these companies a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market their respective generic versions of YUPELRI inhalation solution in the US on or after the licensed launch date of April 23, 2039, subject to certain exceptions as is customary in these type of agreements. As required by law, the settlements are subject to review by the U.S. Department of Justice and the Federal Trade Commission.

 

Additional Patent

An additional method of use patent for YUPELRI was granted on July 30, 2024, which expires in August 2039, and is listed in the FDA Orange Book.

 

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, Events and Presentations.

 

A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through September 4, 2024.

 

 

 

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 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).

 

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).⁶ There are approximately 50,000 MSA patients in the US⁷ and 70-90% of MSA patients experience nOH symptoms.⁸ Despite available therapies, many MSA patients remain symptomatic with nOH.

 

⁶ https://medlineplus.gov/genetics/condition/multiple-system-atrophy/

⁷ UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).

⁸ Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).

 

 

 

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.

 

 

 

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 and objectives, future growth of YUPELRI sales, future royalty payments, 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, 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 May 15, 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 profit (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 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.

 

Please see the appendix attached to this press release for a reconciliation of non-GAAP net profit (loss) from operations to its corresponding measure, net profit (loss) from operations. A reconciliation of non-GAAP net profit (loss) from operations 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

 

 

 

THERAVANCE BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
		June 30,				December 31,
		2024				2023
		(Unaudited)				(1)
Assets
Current assets:
Cash and cash equivalents and short-term marketable securities		$	96,078			$	102,426
Receivables from collaborative arrangements			14,299				17,474
Prepaid clinical and development services			2,646				2,038
Other prepaid and current assets			6,284				11,603
Total current assets			119,307				133,541
Property and equipment, net			8,142				9,068
Operating lease assets			31,815				36,287
Future contingent milestone and royalty assets			194,200				194,200
Restricted cash			836				836
Other assets			7,729				8,067
Total assets		$	362,029			$	381,999
Liabilities and Shareholders' Equity
Current liabilities		$	22,946			$	24,767
Long-term operating lease liabilities			42,441				45,236
Future royalty payment contingency			29,061				27,788
Unrecognized tax benefits			69,007				65,294
Other long-term liabilities			4,885				5,919
Shareholders' equity			193,689				212,995
Total liabilities and shareholders’ equity		$	362,029			$	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.

 

 

 

THERAVANCE BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
		(Unaudited)								(Unaudited)
Revenue:
Viatris collaboration agreement (1)		$	14,256			$	13,743			$	28,759			$	24,154
Collaboration revenue			-				6				-				12
Total revenue			14,256				13,749				28,759				24,166
Costs and expenses:
Research and development (2)			9,954				9,425				18,922				23,997
Selling, general and administrative (2)			17,056				19,278				33,798				38,461
Impairment of long-lived assets (non-cash)			2,951				-				2,951				-
Restructuring and related expenses (2)			-				1,169				-				2,743
Total costs and expenses			29,961				29,872				55,671				65,201
Loss from operations			(15,705	)			(16,123	)			(26,912	)			(41,035	)
Interest expense (non-cash)			(644	)			(568	)			(1,273	)			(1,118	)
Interest income and other income (expense), net			1,128				2,504				2,562				5,483
Loss before income taxes			(15,221	)			(14,187	)			(25,623	)			(36,670	)
Provision for income tax expense			(1,308	)			(1,458	)			(2,570	)			(1,063	)
Net loss		$	(16,529	)		$	(15,645	)		$	(28,193	)		$	(37,733	)
Net loss per share:
Basic and diluted net loss per share		$	(0.34	)		$	(0.28	)		$	(0.58	)		$	(0.63	)
Shares used to compute basic and diluted net loss per share			48,747				56,682				48,515				59,791
Non-GAAP net loss		$	(6,250	)		$	(7,355	)		$	(10,795	)		$	(22,267	)

 

(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 June 30,								Six Months Ended June 30,
(In thousands)		2024				2023				2024				2023
YUPELRI net sales (100% recorded by Viatris)		$	54,530			$	55,038			$	109,756			$	101,993
YUPELRI net sales (Theravance Biopharma implied 35%)			19,085				19,263				38,415				35,697

 

(2)

Amounts include share-based compensation expense as follows:

 

		Three Months Ended June 30,								Six Months Ended June 30,
(In thousands)		2024				2023				2024				2023
Research and development		$	1,151			$	1,855			$	2,616			$	4,296
Selling, general and administrative			4,225				4,409				7,988				8,632
Restructuring and related expenses			-				-				-				357
Total share-based compensation expense		$	5,376			$	6,264			$	10,604			$	13,285

 

 

 

THERAVANCE BIOPHARMA, INC.
Reconciliation of GAAP to Non-GAAP Net Loss
(In thousands)
		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
		(Unaudited)								(Unaudited)
GAAP net loss		$	(16,529	)		$	(15,645	)		$	(28,193	)		$	(37,733	)
Adjustments:
Share-based compensation expense			5,376				6,264				10,604				13,285
Non-cash impairment of long-lived assets			2,951				-				2,951				-
Non-cash interest expense			644				568				1,273				1,118
Income tax expense			1,308				1,458				2,570				1,063
Non-GAAP net loss		$	(6,250	)		$	(7,355	)		$	(10,795	)		$	(22,267	)

 

 

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. © 2024 Theravance Biopharma. All rights reserved. Theravance Biopharma Second Quarter 2024 Financial Results and Business Update August 5, 2024

2 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 forward - loo king 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 Securiti es Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s expectations regarding its future profitability, ex pen ses and uses of cash, the Company’s goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future royalty payments, 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, the status of patent infringement litigation ini tia ted 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 intere sts 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 mana gem ent 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 fact ors 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 result s 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 b eyo nd 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 compl eti ng 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 de cisions 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 approv als 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 mainta ini ng sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual prop ert y 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 May 15, 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 profit (loss) from continuing operations provide meaningful information to assist investors in assessing prospects f or 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 res ults 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 standard ized, 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 profit (loss) from continuing operati ons to its corresponding measure, net profit (loss) from continuing operations. A reconciliation of non - GAAP net profit (loss) from continuing operations to its corresponding GAAP measure is not a vailable 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 Welcome / Opening Remarks Rick Winningham : Chairman and Chief Executive Officer YUPELRI ® / Commercial Overview Rhonda Farnum: Senior Vice President, Chief Business Officer Ampreloxetine / CYPRESS Update Dr. Áine Miller: Senior Vice President, Development Operating Results / Financial Update Closing Remarks / Q&A Aziz Sawaf: Senior Vice President, Chief Financial Officer Rick Winningham / Team

4 Strategic Objectives: Q2 2024 Progress 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. Source: Viatris Customer Demand (Q2’24) . 3 . Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Jun’24 , retail + DME / Med B FFS through May’24. 4. Source: GSK - reported Net Sales in USD. 5. As of 6/30/24, Theravance stands to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma (RP). The first $25 million payment will be triggered if RP receives $240 mi llion or more in royalty payments from GSK, based on 2024 TRELEGY global net sales, with an additional payment of $25 million (for a total of $50 mil lio n) triggered if Royalty Pharma receives $275 million or more in royalty payments from GSK based on 2024 TRELEGY global net sales. We expect RP to receive these payments should 2024 TRELEGY global net sales reach ap proximately $2.9 billion and $3.2 billion, respectively. 4 • Q2 YUPELRI reported net sales reached $54.5M down 1% Y/Y 1 • Customer demand up 6% Q/Q and 13% Y/Y 2 • Continued strong hospital sales growth (+ 43 % Y/Y) and LA - Neb market share gains 3 x Viatris submitted China NDA in June; potential for $7.5M milestone upon approval x KOL - led investor event held May 23 rd ( link ) • Expect to enroll last patient in the open label portion of CYPRESS in mid - ’25 • CYPRESS top line data anticipated ~ 6 months after the last patient enters the open label period Ampreloxetine Corporate • $96.1M Q2 ending cash balance • $1.065B Q2 TRELEGY net s ales (+ 40 % Y/Y) 4 ; $1.814B YTD ( + 37% Y/Y) • TRELEGY 2024 m ilestone thresholds: 5 • $25M @ ~$2.9B in Net Sales • $50M @ ~$3.2B in Net Sales

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) Rhonda Farnum Senior Vice President, Chief Business Officer

6 YUPELRI ® Net Sales Performance 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). 6 $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 $54.5 0 10 20 30 40 50 60 70 Q3'19 Q4'19 Q1'20 Q2'20 Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Total YUPELRI Net Sales ($M) Net sales decreased 1% Q2’24 vs. Q2’23

7 Strong Theravance Hospital Growth Accelerated 1. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through Jun’24. Preliminary data subject to revision upon receipt of fi nal data. 7 19K 30K 54K 34K 47K 54K 56K 70K 78K 93K 98K 108K 113K 138K 162K 158K 162K 191K 213K 226K 0K 50K 100K 150K 200K 250K 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 YUPELRI Hospital Doses Hospital sales (doses) increased 43% Q2’24 vs. Q2’23 1

8 YUPELRI ® Market Share Continues to Grow 1. Joint VTRS/TBPH Market Research (Jun’24). * Hospital LA - NEB Market Share - IQVIA DDD through Jun’24. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through May’24. 8 9.5% 10.8% 11.3% 11.6% 13.3% 12.5% 15.0% 15.2% 16.1% 16.7% 16.6% 18.3% 0% 5% 10% 15% 20% 25% 30% 35% Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Hospital LA - NEB Market Share* YUPELRI Hospital LA-NEB Market Share Patients continue treatment in the community setting which is inclusive of both the retail and DME channels 22.5% 23.2% 24.1% 25.3% 26.4% 27.1% 28.0% 29.1% 30.5% 31.1% 31.0% 32.0% 0% 5% 10% 15% 20% 25% 30% 35% 40% Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Community LA - NEB Market Share † YUPELRI Community 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 †

9 Substantial Opportunity for Further YUPELRI ® Growth YUPELRI may be appropriate for ~2M maintenance patients in U.S. 1 1. Addressable patient population quantifies the number of patients within the intended target profile. 2. Estimated communit y p atients on YUPELRI in 2023. Sources: Citeline Pharma Custom Intelligence Primary Research April 2023, Symphony Health METYS Prescription Dashboard, SolutionsRx Med B FFS. COPD, chronic obstructive pulmonary disease . 9 Current COPD Patients on Nebulized Maintenance Therapy COPD Patients Who Could Potentially Benefit from Nebulized Maintenance Therapy Estimated Patients on YUPELRI Currently 2 ~65K ~200K Current Long - Acting Neb Patients ~200K Patients Inappropriately Using Short - Acting Nebs for Maintenance Therapy ~1.5M Patients on Handheld - Only Maintenance Regimens that remain symptomatic with Cognitive / Dexterity Challenges and/or Reduced Inspiratory Flow

10 The YUPELRI ® China Opportunity 1. IQVIA Institute Global Use of Medicines 2024; 2. Wang C, Xu, J, Yang L, et al., The Lancet, 2018; 3. Yin P, Wang H, Vos T, et al., Chest, 2013, 4. Baipharm Monthly Report: New Drug Approvals, internal analysis (Jan ’23 – May ’24); 5. Source: Viatris (2021); 6. As of June 30, 2024, Theravance Biopharma is eligible to receive potential development and sales milestones totali ng $52.5 million related to Viatris ’ development and commercialization of nebulized revefenacin in China and adjacent territories, with $45.0 million associated with YUPELRI mono the rapy and $7.5 million associated with future potential combination products; refer to our SEC filings for further information. COPD, Chronic Obstructive Pulmonary Disease. • #2 pharmaceutical market g lobally 1 • Nearly 100M individuals with COPD; ~43% suffer from moderate to severe disease 2,3 • 15 - month median NDA/BLA review time, ranging from 6 months to >24 months 4 • Viatris is the 8 th largest multinational company in China, with a sales force of ~4,200 covering >70K hospitals and 400K pharmacies in over 300 cities 5 • Economics 6 : • $7.5M milestone on approval • $37.5M of sales milestones • 14 - 20% tiered royalties Partner Viatris Filed NDA June, 2024

11 YUPELRI ® Value Proposition 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). 2. As of June 30, 2024, Theravance Biopharma is eligible to receive from Viatris potential global development, regulatory and sales milestone payments (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 June 30, 2024, Theravance Biopharma is e lig ible 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 associated wi th YUPELRI monotherapy and $7.5 million associated with future potential combination products; refer to our SEC filings for further information . 4. Refer to our SEC filings for further information. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic agent . 11 • Only Once - Daily Nebulized LAMA COPD Maintenance Treatment • Significant Commercial Opportunity Going Forward: • U.S. YUPELRI Co - Promote 1 : Last Twelve Months’ sales of $229M as of 6/30/24 • Brand profitable, with expanding profit margins • Significant potential milestones and royalties: • U.S. Monotherapy: Up to $150M in sales milestones 2 ; first $25M for $250M of net sales in any calendar year • China Monotherapy: Up to $45M in development and sales milestones; 14 - 20% tiered royalties 3 • OUS (ex - China): Low double - digit to mid - teens royalties 4 • IP protection granted to 2039 in the US , with an additional 2039 patent granted July 2024

Ampreloxetine: Investigational once - daily norepinephrine transporter (NET) inhibitor For symptomatic neurogenic orthostatic hypotension ( nOH ) in multiple system atrophy (MSA) patients Dr. Áine Miller Senior Vice President, Development

13 CYPRESS Approach Focus on high - quality study prioritizing Centers of Excellence CYPRESS EXECUTION MSA, multiple system atrophy; RW, randomized withdrawal. Prioritize Academic Institutions and MSA Centers of Excellence (COE) Site Selection Leverage experienced sites to select appropriate patients and support them through the study Robust oversight to ensure quality, develop strong ties within the community Direct study management , e xtensive engagement with MSA advocacy groups and community Trial management Similar RW design as with Study 0170, optimized for prior experience Protocol Design Confirm compelling, durable benefit observed in MSA patients in Study 0170

14 Study Progress and Key Milestones Significant Acceleration in Sites Activations in Recent Quarters CYPRESS EXECUTION OL, open label 0 10 20 30 40 50 60 70 80 Q1 '23 Q2 '23 Q3 '23 Q4 '23 Q1 '24 Q2 '24 CYPRESS Site Activations First Patient Enrolled (US) Recruitment Opens >80% of Sites Activated Top Line Data Expected Last Patient Expected into OL First Patient Enrolled (EU) CYPRESS Timeline ~6 mo. H1 ‘24 H1 ‘23 H2 ‘23 H2 ‘24 H1 ‘25 H2 ‘25

15 CYPRESS Study: Randomized Withdrawal Study Design in Patients with MSA MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, open label; RW, randomized withdrawal. Entry Endpoint 8 - week double blind RW 12 - week open - label Baseline Randomization Ampreloxetine 10 mg Ampreloxetine 10 mg Placebo OL Entry Criteria Week 8 Enrichment RW Entry Criteria Completers Enter 2 Year Long Term Extension n~100 To be enrolled n~60 Completers CYPRESS Change in OHSA Composite Score Primary Endpoint

Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer

17 Second Quarter 2024 Financials (Unaudited) 1. Amounts include share - based compensation. 2. Non - GAAP net profit (loss) from continuing operations consists of GAAP net loss before taxes excluding share - based compensation expense, non - cash interest expense and non - cash impairment expense; see reconciliation on Slide 18 and the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. 17 ($, in thousands) Revenue: Viatris collaboration agreement $ 14,256 $ 13,743 $ 28,759 $ 24,154 Collaboration revenue - 6 - 12 Total revenue 14,256 13,749 28,759 24,166 Costs and expenses: Research and development (1) 9,954 9,425 18,922 23,997 Selling, general and administrative (1) 17,056 19,278 33,798 38,461 Impairment of long-lived assets (non-cash) 2,951 - 2,951 - Restructuring and related expenses (1) - 1,169 - 2,743 Total costs and expenses 29,961 29,872 55,671 65,201 Loss from operations (before tax and other income & expense) $ (15,705) $ (16,123) $ (26,912) $ (41,035) Share-based compensation expense: Research and development 1,151 1,855 2,616 4,296 Selling, general and administrative 4,225 4,409 7,988 8,632 Restructuring and related expenses - - - 357 Total share-based compensation expense 5,376 6,264 10,604 13,285 Operating expense excl. share-based compensation: R&D operating expense (excl. share-based compensation) 8,803 7,570 16,306 19,701 SG&A operating expense (excl. share-based compensation) 12,831 14,869 25,810 29,829 Total operating expenses excl. share-based compensation $ 21,634 $ 22,439 $ 42,116 $ 49,530 Non-GAAP net loss (2) $ (6,250) $ (7,355) $ (10,795) $ (22,267) Three Months Ended June 30, 2024 2023 (Unaudited) Six Months Ended June 30, 2024 2023 (Unaudited)

18 Second Quarter 2024 Financials (Unaudited) (Cont’d) 18 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss $ (16,529) $ (15,645) $ (28,193) $ (37,733) Adjustments: Share-based compensation expense 5,376 6,264 10,604 13,285 Non-cash impairment of long-lived assets 2,951 - 2,951 - Non-cash interest expense 644 568 1,273 1,118 Income tax expense 1,308 1,458 2,570 1,063 Non-GAAP Net Loss $ (6,250) $ (7,355) $ (10,795) $ (22,267) Non-GAAP Net Loss per Share Basic and diluted non-GAAP net loss per share $ (0.13) $ (0.13) $ (0.22) $ (0.37) Shares used to compute basic and diluted non-GAAP net loss per share 48,747 56,682 48,515 59,791 (Unaudited) Reconciliation of GAAP to Non-GAAP Net Loss (In thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (Unaudited)

19 Q2 2024 Financial Highlights Operating from a position of financial strength 1. Non - GAAP net profit (loss) from continuing operations consists of GAAP net income (loss) before taxes less share - based compen sation expense, non - cash interest expense, and non - cash impairment expense; see reconciliation on Slide 18 and the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. 2. Cash, ca sh equivalents and marketable securities. SBC, Share - Based Compensation. 19 Metric Q2 ‘24 (M) Q2 ‘23 (M) Note VIATRIS Collaboration Revenue $14.3 $13.7 • Representing 4% YoY growth SG&A and R&D Expense, ex - SBC $21.6 $22.4 Share - Based Compensation $5.4 $6.3 GAAP Net Loss from Operations ($15.7) ($16.1) • Q2’24 impacted by ~$3.0M non - cash long - lived asset impairment charge Non - GAAP Net Loss from Operations 1 ($6.3) ($7.4) Cash and Cash Equivalents 2 (as of quarter - end) $96.1 $167.5 • Buyback program completed in Jan’24 Debt (as of quarter - end) $0.0 $0.0 Shares Outstanding (as of quarter - end) 48.9 53.7

20 2024 Financial Guidance 1. Non - GAAP net profit (loss) from continuing operations is expected to consist of GAAP net income (loss) before taxes less shar e - based compensation expense and non - cash interest expense; the section titled “Non - GAAP Financial Measures” on Slide 2 for more information. 2. The Company previously recognized a portion ($46.9M) of the to tal potential $250M milestones at the time of sale in July 2022; as a result, the Company will not recognize any additional milestone income until the cumulative milestone payments exceed the $46.9M previous ly recognized. 3. 2024 Estimates assume mid - point of Guidance. 20 32.6 33.0 53.1 50.0 25.4 20.0 2.4 3.0 113.5 106.0 $0 $20 $40 $60 $80 $100 $120 $140 2023A 2024E R&D SG&A Share-Based Comp One-time Items Operating Expenses ($M) 2024 OPEX Guidance : • R&D (excluding share - based comp): $30M - $36M • SG&A (excluding share - based comp): $45M - $55M: • Includes G&A Y/Y reduction of ~20% • Share - Based Compensation: $18M - $22M, ~20% Y/Y decrease 2024 Non - GAAP Profitability / Loss Guidance 1 : • Expects levels of both non - GAAP losses and cash burn to be similar to first half actuals 2024 • Excludes potential milestones If achieved, TRELEGY milestones recognized as Other Income: • Cash received will be full amount of the milestone(s) • Accounting recognition will be less than the full amount due to already recognizing a portion of the milestones at time of sale 2 ; we will recognize: • $0M of Other Income if $25M milestone is achieved • $3M of Other Income if $50M milestone is achieved • For 2024 milestones, expected cash receipt in 1H’25 3

21 21 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 2021 2022 2023 2024 E 2025 E 2026 E Consensus Forecast 3 Actuals 2 Net Sales ($M) Annual upper - tier threshold 1 Annual lower - tier threshold 1 TRELEGY Global Net Sales ($M) $50M $25M $50M $25M $100M $50M $1,674 $2,142 $2,739 $3,3 74 $3,7 28 $3,992 28% growth 28% growth 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. GSK - reported Ne t Sales in USD. 3. Bloomberg Consensus as of 08/02/2024, Theravance stands to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma. In each year from 2024 to 2026, a first payment will be triggered if Roya lt y Pharma (RP) receives a minimum royalty payment from GSK and an additional payment will be triggered if Royalty Pharma receives a higher royalty payment from GSK. In 2024, we expect these respective thresholds to be met, should 2024 TRELEGY global net sales exceed approximately $2.9 billion and $3.2 billion. 4. Eligibility generally ends 15 years after first launch in an eligible ter ritory: U.S. royalties are expected to end late 2032, while ex - U.S. royalties are expected to end in the mid - 2030s on a country - by - country basis. 5. Total royalties owed are 6.5% to 10.0% of global net sales in eligible territori es; Theravance receives 85% of royalties owed. Royalty Schedule: ‣ Royalties return to Theravance 4 : – Ex - US royalties return Jul. 1, ௗ 2029 – US royalties return after Jan. 1, ௗ 2031 ‣ Royalty rate of 5.5 - 8.5% 5 ‣ Paid directly by Roy alty Pharma Milestone Eligibility TRELEGY Continues to Experience Strong Growth

22 Theravance's Strategic FocusGrow YUPELRI, maximize ampreloxetine, optimize financial returns 1. As of June 30, 2024, Theravance Biopharma is eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding China and adjacent territories) totaling up to $205.0 million in the aggregate; refer to our SEC filings for further information. 2. As of June 30, 2024, 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 associated with YUPELRI monotherapy and $7.5 million associated with future potential combination products; refer to our SEC filings for further information. 3. Theravance stands to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma. The first payment, of $25 million, will be triggered if Royalty Pharma (RP) receives $240 million or more in royalty payments from GSK based on 2024 TRELEGY global net sales, which we expect would occur should TRELEGY global net sales reach approximately $2.9 billion. A second payment of $25 million (for a total of $50 million) will be triggered if Royalty Pharma receives $275 million or more in royalty payments from GSK, which we expect would occur should 2024 TRELEGY global net sales exceed approximately $3.2 billion. 22 o Grow YUPELRI in the United States; realize value through China expansion: oDrive U.S. hospital growth as part of overall brand maximization strategy oAchieve up to $150M in U.S. monotherapy sales milestones; first $25M for $250M of net sales in any given year1 oRealize up to $45M in China monotherapy development and sales milestones, 14-20% tiered royalties2 o Successfully develop and commercialize ampreloxetine globally: oRetain U.S. rights, partner ex-U.S. o Achieve Up to $200M in TRELEGY sales milestones, beginning in '24, with royalties returning in '293 o Maintain financial strength 1 2 3 4

Rick Winningham Chairman and 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

Appendix

Appendix I: YUPELRI LE0

28 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.” 28 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

Appendix II: Ampreloxetine

30 MSA Prevalence in the United States: ~50K Patients Recent data confirm significant population with unmet needs 1. Fanciulli A, Wenning GK. N Eng J Med 2015:372:249 – 63. 2. “Estimating the prevalence and incidence of multiple system atrophy in the USA: Insights from a national claims database”, Parkinsonism and Related Disorders 11/4/2023. 3. UC San Diego Dept. of Neurosciences (25K - 75K): https://neurosciences.ucsd.edu/centers - programs/movement - disorders/community/disease - overview/msa.html ; Thelansis nOH Market Report 2023 ; Internal claims analyses (IQVIA, Veeva, Real Chemistry). 4. Kalra DK, et al. Clin Med Insights: Cardiol. 2020 (70% - 90%);14:1179546820953415. 5. Delveinsight MSA Market Forecast (2023); Sy mptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. 30 ~14K MSA Patients: Outdated View MSA Patients: Real - World Data ~50K Outdated estimates of MSA prevalence rely on limited reviews of health care practice data or door - to - door surveys 1,2 UCSD Dept. of Neurosciences estimates 50K MSA patients 1 ; multiple U.S. claims analyses support this approximation 2,3 MSA Patients w/ nOH ~40K Ampreloxetine’s addressable population: ~80% of MSA patients with symptomatic nOH 4,5

31 Ampreloxetine ex - U.S. Opportunity Significant unmet needs in leading therapeutics markets 1. Thelansis nOH Market Report 2023; TBPH Internal Analysis. nOH graphics reflect the mid - point of the provided ranges. 2. Prevalen ce estimate for Germany, France, UK, Italy and Spain. MSA, multiple system atrophy; nOH neurogenic orthostatic hypotension. 31 Prevalence in Europe 1,2 ~65,000 ~53,000 MSA Patients MSA Patients w/ nOH 45 - 60K MSA Patients with nOH Prevalence in China & Japan 1 ~150,000 ~98,000 MSA Patients MSA Patients w/ nOH 90 - 105K MSA Patients with nOH

32 High Unmet Need in Symptomatic nOH in MSA Many patients suffer debilitating symptoms without adequate therapy 1 . The Neurological Alliance, 2021/2022. 2 . Merola A, et al., Mov Disord 2018 . 3. Claassen DO, et al., BMC Neurol 2018. ME/CFS, myalgic encephalomyelitis/chronic fatigue syndrome; MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; PSP, progressive supranuclear palsy. Impact of MSA ‣ MSA is an uncurable, progressive, neurological disorder impacting autonomic functioning, movement, speech and balance ‣ Among neurological disorders, MSA ranks as having the second most severe impact on quality of life 1 Impact of Neurological Conditions on Quality of Life 1 Rank Condition 1 ME/CFS 2 MSA 3 PSP … 12 Huntington’s Disease 13 Traumatic Brain Injury … 34 Parkinson’s Disease 35 Encephalitis Burden of nOH on Patients 87% 42% 87% of nOH patients report a reduced ability to perform activities 2,3 42% claim nOH has robbed them of their independence 2,3

33 Droxidopa Ampreloxetine Indication Symptomatic nOH in PD, PAF and MSA patients Symptomatic nOH in MSA patients [intended indication] Efficacy Durability OHSA#1(dizziness, lightheadedness only) Clinical effectiveness >2 weeks not established OHSA Composite (all six symptoms) Clinically meaningful and durable responses >20 weeks Dosing 3 times per day , titration to effect Once - daily Safety Black box warning for supine hypertension No signal for supine hypertension Opportunity Low market penetration in MSA 2 Expected improved adherence and adoption Orphan pricing potential Ampreloxetine Offers Unique Hope Potential significant advantages over current options without a direct comparator 1. NORTHERA® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 2. IQVIA Patient - Level Claims, 2019. 3. Reflects Ther avance 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. MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, orthostatic hypotension symptom assessment; PAF, pure autonomic failure; PD, Parkinson’s disease. 33 Droxidopa 1 Ampreloxetine 3

34 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. 34

35 Durable, Clinically - significant Symptom Improvements in MSA Demonstrated in Initial Phase 3 Program CI, confidence interval; DB, double - blind; MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; OL, o pen label; RW, randomized withdrawal. BL1 2 3 4 0 2 4 6 8 BL 4 8 12 16 BL 18 20 22 time (weeks) OHSA Composite Score Mean (95% CI) Placebo Ampreloxetine 33 33 20 18 34 32 20 20 64 42 n, Placebo n, Ampreloxetine BL, Baseline 0169 DB 0170 OL 0170 RW

36 Increased Norepinephrine, Prevented Blood Pressure Drop and Symptoms Worsening in MSA Patients 1, 2 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, st andard error of mean. 36 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

37 Study 0170 OHQ Questionnaire Composite Score and Individual Items in MSA Individual item score analyses are post - hoc, except for dizziness. CI, confidence interval; LS, least squares; MSA, multiple system atrophy; OHDAS, orthostatic hypotension daily activity scale ; OHQ, orthostatic hypotension questionnaire; OHSA, orthostatic hypotension symptom assessment. -4 -2 0 2 4 OHQ composite score - Walking long time - Walking short time - Standing long time - Standing short time Daily activities composite score - Head/neck discomfort - Trouble concentrating - Fatigue - Weakness - Vision - Dizziness Symptom composite score LS Mean difference (95% CI) -1.6 (-2.7, -0.5) -1.5 (-3.2, 0.2) -1.7 (-3.2, -0.3) -0.7 (-2.3, 0.9) -1.5 (-3.1, 0.1) -1.8 (-3.3, -0.4) -2.2 (-3.7, -0.7) -0.8 (-2.1, 0.4) -2.0 (-3.6, -0.4) -0.3 (-1.8, 1.2) -0.7 (-2.4, 1.0) 0.4 (-1.2, 2.1) -1.2 (-2.3, -0.2) OHSA OHDAS Favors ampreloxetine Favors placebo OHQ composite score

38 Prevented Worsening of Standing SBP in MSA Patients with No Impact on Supine SBP • Standing blood pressure improvement of 18.5 mmHg compared to placebo during randomized withdrawal phase • No difference in supine blood pressure relative to placebo Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. Standing SBP measured at 3 min and supine SB P measured at 10 min. Line represents the mean +/ - standard deviation. MSA, multiple system atrophy; SBP, systolic blood pressure; SD, standard deviation. 38 Placebo Ampreloxetine -40 -20 0 20 40 60 M e a n C h a n g e , m m H g ( S D ) Supine SBP No Difference + 1.6 + 0.5 -40 -20 0 20 40 60 M e a n C h a n g e , m m H g ( S D ) - 12.4 + 6.1 Standing SBP Worsening No Signal for Supine Hypertension Observed in Safety Database of Over 800 Patients and Healthy Subjects

Appendix III: Corporate

40 Several Near and Mid - Term Catalysts and Value Creating Milestones Product Catalyst Value Date Milestone for U.S. Net Sales > $250M in any calendar year $25M TBD Submission of China Application in COPD N/A June - 2024 Milestone for China Approval in COPD $7.5M TBD Ampreloxetine Last Patient In for Phase 3 (CYPRESS) Study for nOH in MSA -- Mid - 2025 Top - line Data Readout for Phase 3 (CYPRESS) Study for nOH in MSA -- TBD Milestone for FDA Approval in U.S. for nOH in MSA $15M TBD TRELEGY 1 TRELEGY Milestone for Net Sales of $2.9B / $3.2B $25M / $50M 2024 TRELEGY Milestone for Net Sales of $3.2B / $3.4B $25M / $50M 2025 TRELEGY Milestone for Net Sales of $3.2B / $3.5B $50M / $100M 2026 1. Theravance stands to receive up to $200 million in Trelegy sales milestones paid directly from Royalty Pharma. The first payment, of $25 million, will be triggered if Royalty Pharma (R P) receives $240 million or more in royalty payments from GSK based on 2024 TRELEGY global net sales, which we expect would occur should TRELEGY global net sa les reach approximately $2.9 billion. A second payment of $25 million (for a total of $50 million) will be triggered if Royalty Pharma receives $275 million or more in royalty payments from GSK, which we expect wou ld occur should 2024 TRELEGY global net sales exceed approximately $3.2 billion.

41 COPD, Chronic obstructive pulmonary disease; nOH, neurogenic orthostatic hypotension; PTE, patent term extensions. 41 Granted Patent Protection Into Late 2030s Compound Invention Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter 2028 (once PTE awarded) Polymorph 2030 - 2031 Method for the maintenance treatment of COPD patients 2039 (additional patent with 2039 expiry issued July 2024) Ampreloxetine Composition of Matter 2030 (plus PTE of up to 5 years) Method of Treating nOH 2037

42 Progress Against Financial Targets Reduction in expense base combined with YUPELRI® net sales growth, and no debt 1. 2024 Estimates assume mid - point of Guidance; excludes $3.0M non - cash impairment charge incurred in Q2’24. 42 $0 $50 $100 $150 $200 $250 $300 $350 2021 2022 2023 2024E R&D SG&A Share-Based Comp Severance & Restructuring Significant Expense Reductions $ millions $ millions $0 $50 $100 $150 $200 $250 2020 2021 2022 2023 35% Share Total YUPELRI Net Sales Increased Net Sales $0 $100 $200 $300 $400 $500 $600 $700 2020 2023 Total Debt $ millions Debt Free 1

43 Net Sales 2 : Q2’24 of $1.065B, +40% Y/Y ; 1H’24 of $1.814B, +37% Y/Y Outer - Year Royalties 3 return in 2029: ▪ Ex - US royalties return Jul. 1, ௗ 2029 ▪ US royalties return after Jan. 1, ௗ 2031 ▪ Calculated on global net sales of eligible territories ▪ Share of royalties received equivalent to an upwardly tiered rate of 5.5 - 8.5% 4 ▪ Paid directly to Theravance from Roy alty Pharma TRELEGY ELLIPTA Milestones and Royalties GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): first and only once - daily single inhaler triple therapy 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Source: GSK - reported Net Sales in USD. 3. U.S. royalties expected to end late 2032; ex - U.S. royalties expected to end mid - 2030s and are country specific. 4. Total royalties owed are 6.5% to 10.0% of global net sales in eligible territories; Theravance receives 85% of royalties o wed . FF, Fluticasone Furoate; UMEC, Umeclidinium; VI, Vilanterol. 43 Milestones Royalties $200M in potential sales - based milestones 1 from 2024 to 2026: GSK remains exclusively responsible for commercialization of TRELEGY ELLIPTA Year Royalty Threshold 2 Global Net Sales Equivalent Milestone to Theravance 2024 1 $240M $2,863M $25M $275M $3,213M $50M 2025 1 $260M $3,063M $25M $295M $3,413M $50M 2026 1 $270M $3,163M $50M $305M $3,513M $100M

v3.24.2.u1

Cover	Aug. 05, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 05, 2024
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, Inc.
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
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
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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