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

• Q1 2024 YUPELRI® (revefenacin) net sales of $55.2 million, recognized by Viatris, increased 18% from Q1 2023**1
• Viatris collaboration revenue of $14.5 million, increased 39% versus Q1 2023, reflecting margin improvement
• Continued progress for ampreloxetine CYPRESS enrollment
• Virtual ampreloxetine KOL event scheduled for May 23, 2024
• Q1 2024 ending cash balance of $100 million

DUBLIN, May 13, 2024 — Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced financial and operational results for the first quarter of 2024.

"Building on recent momentum, the Theravance commercial team again delivered a solid quarter of YUPELRI hospital sales execution in the first quarter, setting us on a path to contribute significantly to the product's overall growth in 2024", said Rick E Winningham, Chief Executive Officer. "We remain laser focused on YUPELRI growth and CYPRESS execution and are looking forward to sharing more about our progress and plans for ampreloxetine at a Key Opinion Leader-led virtual investor event scheduled for May 23rd."

First 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):

• Achieved total net sales of $55.2 million for the quarter, increasing 18% year-over-year (Q1 2024 vs Q1 2023).1
• Grew doses sold into the hospital channel by 31% year-over-year (Q1 2024 vs Q1 2023).2
• Increased share within the long-acting nebulized segment of the COPD market. During the quarter, share within the community and hospital settings increased year-over-year to 30.5% and 16.6%, respectively, from 28.0% and 15.0% in Q1 2023.3

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):

• Virtual ampreloxetine KOL event scheduled for May 23, 2024.
• Enrollment continues globally for the CYPRESS study, with footprint expanded to include active sites in Latin America and Asia Pacific.
• CYPRESS enrollment into the open-label period of the study expected to be completed in the second half of 2024.

TRELEGY Update:

• GSK posted first quarter 2024 global net sales of $749 million (up 32% from $567 million reported in the first quarter of 2023). As of January 1, 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 are approximately $2.9 billion in 2024 (an increase of 5% compared with 2023). A second milestone payment of another $25 million (for a total of $50 million) can be achieved if TRELEGY global net sales exceed approximately $3.2 billion in 2024 (an increase of 17% compared with 2023).4

First Quarter Financial Results

• Revenue: Total revenue for the first quarter of 2024 was $14.5 million, consisting entirely of Viatris collaboration revenue. Viatris collaboration revenue increased by $4.1 million, or 39%, in the first quarter compared to the same period in 2023 due primarily to higher net sales and 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 first quarter of 2024 was $19.3 million which represents a 18% increase compared to the same period in 2023.
• Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2024 were $9.0 million, compared to $14.6 million in the same period in 2023. First quarter R&D expenses included total non-cash share-based compensation of $1.5 million.
• Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter of 2024 were $16.7 million, compared to $19.2 million in the same period in 2023. First quarter SG&A expenses included total non-cash share-based compensation of $3.7 million.
• Share-Based Compensation: Share-based compensation expenses for the first quarter of 2024 was $5.2 million, compared to $7.0 million in the same period in 2023. Share-based compensation expenses consisted of $1.5 million for R&D and $3.7 million for SG&A in the first quarter of 2024, compared to $2.4 million and $4.2 million, respectively, in the same period in 2023. In the first quarter of 2023, we also incurred $0.4 million in restructuring-related share-based compensation expenses.
• Net Loss and Non-GAAP Net Loss from Operations5****: Net loss was $11.7 million in the first quarter of 2024 compared to $22.1 million in the same period in 2023, and non-GAAP net loss from operations was $4.5 million in the first quarter 2024 compared to a non-GAAP net loss from operations of $14.9 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 $100.0 million as of March 31, 2024.

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.
• 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 continues to expect Non-GAAP net loss in the first half of 2024 and to approach non-GAAP breakeven in the second half of 2024; limited cash burn expected 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 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 June 12, 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.

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.

THERAVANCE BIOPHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

March 31,

December 31,

2024

2023

Assets

(Unaudited)

(1)

Current assets:

Cash and cash equivalents and short-term marketable securities

$

99,975

$

102,426

Receivables from collaborative arrangements

14,664

17,474

Prepaid clinical and development services

2,086

2,038

Other prepaid and current assets

7,569

11,603

Total current assets

124,294

133,541

Property and equipment, net

8,717

9,068

Operating lease assets

35,364

36,287

Future contingent milestone and royalty assets

194,200

194,200

Restricted cash

836

836

Other assets

7,896

8,067

Total assets

$

371,307

$

381,999

Liabilities and Shareholders' Equity

Current liabilities

$

21,662

$

24,767

Long-term operating lease liabilities

43,840

45,236

Future royalty payment contingency

28,417

27,788

Unrecognized tax benefits

67,075

65,294

Other long-term liabilities

5,445

5,919

Shareholders' equity

204,868

212,995

Total liabilities and shareholders' equity

$

371,307

$

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 March 31,

2024

2023

(Unaudited)

Revenue:

Viatris collaboration agreement (1)

$

14,503

$

10,411

Collaboration revenue

6

Total revenue

14,503

10,417

Costs and expenses:

Research and development (2)

8,968

14,572

Selling, general and administrative (2)

16,742

19,183

Restructuring and related expenses (2)

1,574

Total costs and expenses

25,710

35,329

Loss from operations

(11,207)

(24,912)

Interest expense (non-cash)

(629)

(550)

Interest income and other income (expense), net

1,434

2,979

Loss before income taxes

(10,402)

(22,483)

Provision for income tax (expense) benefit

(1,262)

395

Net loss

$

(11,664)

$

(22,088)

Net loss per share:

Basic and diluted net loss per share

$

(0.24)

$

(0.35)

Shares used to compute basic and diluted net loss per share

48,283

62,934

Non-GAAP net loss

$

(4,544)

$

(14,912)

---

(1) While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a 35% share of the net profit (loss)

pursuant to a co-promotion agreement with Viatris as presented below:

Three Months Ended March 31,

(In thousands)

2024

2023

YUPELRI net sales (100% recorded by Viatris)

$

55,226

$

46,955

YUPELRI net sales (Theravance Biopharma implied 35%)

19,329

16,434

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

Three Months Ended March 31,

(In thousands)

2024

2023

Research and development

$

1,465

$

2,441

Selling, general and administrative

3,764

4,223

Restructuring and related expenses

357

Total share-based compensation expense

$

5,229

$

7,021

THERAVANCE BIOPHARMA, INC.

Reconciliation of GAAP to Non-GAAP Net Loss

(In thousands)

Three Months Ended March 31,

2024

2023

(Unaudited)

GAAP net loss

$

(11,664)

$

(22,088)

Adjustments:

Share-based compensation expense

5,229

7,021

Non-cash interest expense

629

550

Income tax expense (benefit)

1,262

(395)

Non-GAAP net loss

$

(4,544)

$

(14,912)