A month has gone by since the last earnings report for Theravance Biopharma (TBPH) . Shares have added about 2.2% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Theravance Bio due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Theravance's Q2 Loss Wider Than Expect ...

Core Viewpoint - Theravance Biopharma reported a wider adjusted net loss in Q2 2024 compared to estimates, with total revenues missing expectations despite a year-over-year increase due to collaboration revenues from Viatris [1][2]. Financial Performance - The adjusted net loss for Q2 2024 was 13 cents per share, exceeding the Zacks Consensus Estimate of a loss of 9 cents per share, and matching the loss reported in the same quarter last year [1] - Total revenues were $14.3 million, falling short of the Zacks Consensus Estimate of $16 million, but representing a 4.4% increase year-over-year [2] - The reported loss, including share-based compensation and other expenses, was 34 cents per share [2] Collaboration and Revenue Breakdown - Revenues were entirely derived from collaboration with Viatris related to Yupelri (revefenacin) sales, with Theravance receiving 35% of the profits from this collaboration [3][4] - Viatris recognizes product sales from Yupelri and also holds a stake in Theravance [4] Expense Analysis - Research and development expenses (excluding share-based compensation) totaled $8.8 million, an increase of 17.3% from the previous year [6] - Selling, general and administrative expenses (excluding share-based compensation) decreased by 13.4% year-over-year to $12.9 million [6] Cash Position and Guidance - As of June 30, 2024, Theravance had cash, cash equivalents, and marketable securities amounting to $96.1 million, down from $100 million as of March 31, 2024 [7] - The company expects adjusted R&D expenses to be in the range of $30-$36 million and adjusted SG&A expenses between $45 million and $55 million for 2024 [7] - Theravance anticipates that adjusted losses and cash burn for the remainder of 2024 will match the first half of the year, contrary to earlier expectations of breakeven in the second half [8] Pipeline Developments - Theravance is developing ampreloxetine (TD-9855) for neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), which has received Orphan Drug designation from the FDA [9] - The phase III CYPRESS study for ampreloxetine began in Q1 2024, with patient enrollment expected to complete by mid-2025, and top-line data anticipated six months post-enrollment [10]

Financial Data and Key Metrics Changes - The company reported $54.5 million in net sales for YUPELRI, reflecting a 1% year-over-year decrease despite a 43% increase in hospital doses and a 13% increase in overall customer demand [3][8][10] - Collaboration revenue was reported at $14.3 million, representing a 4% year-over-year growth, although this was below internal expectations due to pricing dynamics affecting net sales [29][30] - The company ended the quarter with $96 million in cash and no debt, with operating expenses and cash burn metrics in line with expectations [7][30] Business Line Data and Key Metrics Changes - YUPELRI's net sales performance showed a 1% decline quarter-on-quarter and year-on-year, driven by lower realized net prices due to an evolved channel mix [8][10] - Hospital doses shipped increased by 43% year-on-year, reaching an all-time high, indicating strong demand generation [11] - The company reported an increase in market share for long-acting net market, with hospital share surpassing 18% and community share reaching 32% [12] Market Data and Key Metrics Changes - The company anticipates a more stable pricing environment for YUPELRI in 2025 and beyond, with continued demand growth expected across all patient fulfillment channels [4][10] - The potential introduction of YUPELRI in China is highlighted as a significant opportunity, with the market being the second largest globally for respiratory medications [16][17] Company Strategy and Development Direction - The company aims to grow YUPELRI in the U.S. and sees a clear path forward, focusing on hospital strategies and concomitant messaging to drive adoption [34] - The company is executing a well-designed development regulatory strategy for Ampreloxetine, with expectations for key milestones in the CYPRESS study [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of YUPELRI, despite short-term pricing challenges, and anticipates improvements in pricing dynamics in 2025 [37][50] - The company remains optimistic about achieving significant milestones in the near term, particularly related to Trelegy, with sales trajectory showing positive trends [34] Other Important Information - The company incurred a $3 million non-cash impairment charge due to the write-down in the value of operating lease assets, which is expected to be a one-time charge [30] - The company is managing the CYPRESS study internally to ensure high-quality results and has encountered longer timelines for site activations [20][24] Q&A Session Summary Question: Update on YUPELRI pricing dynamics - Management noted that the channel mix has shifted, impacting gross to net pricing, and anticipates slight price increases in the second half of the year [36][37] Question: Details on channel mix effects - Management explained that varied discounting ranges across different channels contribute to the channel mix dynamics [38][39] Question: Update on Paragraph IV litigations for YUPELRI - Management provided a brief update on ongoing litigation, noting settlements with some litigants and the addition of a new patent for YUPELRI [43][44] Question: Clarification on CYPRESS study timeline - Management confirmed that top-line data from the CYPRESS study is expected approximately six months after the last patient is enrolled in mid-2025 [47][54]

About Theravance Biopharma 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). DUBLIN, July 25, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 6 at 12:00 pm ET (9:00 am PT/5:00 pm IST). Members of Theravance Biopharma senior management will also be hosting one-on-one meeti ...

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

Prioritizing Resource Allocation Toward Ampreloxetine: Theravance is prioritizing the development of ampreloxetine, a norepinephrine reuptake inhibitor, for the treatment of symptomatic nOH in patients with MSA. The FDA has granted Orphan Drug designation to ampreloxetine for the treatment of symptomatic nOH in patients with MSA. Theravance has collaborated with Viatris (VTRS) for the commercialization of Yupelri, as a once-daily, nebulized treatment of chronic obstructive pulmonary disease (COPD) in the Un ...

Table of Contents Form 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36033 (Mark One) Cayman Islands 98-1226628 (State or Other Jurisdiction of (I.R.S. Employer Incorporation or Organizatio ...

Theravance Biopharma, Inc. (NASDAQ:TBPH) Q1 2024 Earnings Call Transcript May 13, 2024 5:00 PM ET Company Participants Rick Winningham - Chief Executive Officer Aine Miller - Head, Development Rhonda Farnum - Chief Business Officer Aziz Sawaf - Chief Financial Officer Conference Call Participants Douglas Tsao - H.C. Wainwright Julian Harrison - BTIG David Risinger - Leerink Partners Marc Frahm - TD Cowen Operator Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Theravance Biopharma ...

[Company Overview and Q1 2024 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q1%202024%20Highlights) The company reports solid Q1 2024 performance driven by YUPELRI sales growth and progress in its ampreloxetine clinical trial [CEO Commentary](index=1&type=section&id=CEO%20Commentary) The CEO highlights strong YUPELRI sales execution and ongoing progress in the ampreloxetine CYPRESS study - The CEO emphasizes a continued focus on **YUPELRI growth** and CYPRESS study execution, with plans to share ampreloxetine progress at an upcoming investor event[3](index=3&type=chunk) [First Quarter Operational Highlights](index=1&type=section&id=First%20Quarter%20Operational%20Highlights) YUPELRI showed significant Q1 growth in sales and market share, while the ampreloxetine CYPRESS study continues global enrollment YUPELRI Q1 2024 Performance | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | YUPELRI Net Sales (Viatris) | $55.2 million | N/A | +18% | | Hospital Doses Sold | N/A | N/A | +31% | | Community LA-NEB Market Share | 30.5% | 28.0% | +2.5 pp | | Hospital LA-NEB Market Share | 16.6% | 15.0% | +1.6 pp | - Enrollment for the ampreloxetine CYPRESS study continues globally, expanding to Latin America and Asia Pacific, with open-label period completion expected in **H2 2024**[7](index=7&type=chunk) [First Quarter Financial Highlights](index=1&type=section&id=First%20Quarter%20Financial%20Highlights) The company reports an 18% increase in YUPELRI net sales and a 39% rise in Viatris collaboration revenue for Q1 2024 Q1 2024 Financial Metrics | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | YUPELRI Net Sales (Viatris) | $55.2 million | N/A | +18% | | Viatris Collaboration Revenue | $14.5 million | N/A | +39% | | Ending Cash Balance | $100 million | N/A | N/A | [Product Updates and Pipeline Progress](index=1&type=section&id=Product%20Updates%20and%20Pipeline%20Progress) This section details the strong commercial performance of YUPELRI, clinical development progress for ampreloxetine, and royalty updates for TRELEGY [YUPELRI (revefenacin) Performance](index=1&type=section&id=YUPELRI%20(revefenacin)%20inhalation%20solution) YUPELRI demonstrated robust Q1 2024 growth with an 18% year-over-year increase in net sales and expanded market share YUPELRI Q1 2024 Performance Metrics | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | YUPELRI Net Sales (Viatris) | $55.2 million | $46.955 million | +18% | | YUPELRI Implied 35% Share | $19.3 million | $16.434 million | +18% | | Hospital Doses Sold | N/A | N/A | +31% | | Community LA-NEB Market Share | 30.5% | 28.0% | +2.5 pp | | Hospital LA-NEB Market Share | 16.6% | 15.0% | +1.6 pp | [Ampreloxetine Development](index=1&type=section&id=Ampreloxetine%20Development) The Phase 3 CYPRESS study for ampreloxetine is advancing with global enrollment for treating symptomatic nOH in MSA patients - Enrollment for the CYPRESS study is ongoing globally, with expansion into Latin America and Asia Pacific, and the open-label period is expected to conclude in the **second half of 2024**[7](index=7&type=chunk) - Ampreloxetine has received **Orphan Drug Designation** in the US for symptomatic nOH in MSA patients, with plans for an NDA filing if Phase 3 CYPRESS study results are supportive[15](index=15&type=chunk) [About Ampreloxetine](index=3&type=section&id=About%20Ampreloxetine) Ampreloxetine is an investigational norepinephrine reuptake inhibitor for symptomatic neurogenic orthostatic hypotension in MSA patients - Ampreloxetine is an investigational, once-daily norepinephrine reuptake inhibitor for symptomatic nOH in MSA patients[4](index=4&type=chunk)[15](index=15&type=chunk) - Benefits observed in Study 0170 included increased norepinephrine levels, favorable blood pressure impact, clinically meaningful and durable symptom improvement, and **no signal for supine hypertension**[15](index=15&type=chunk) [About CYPRESS (Study 0197), a Phase 3 Study](index=4&type=section&id=About%20CYPRESS%20(Study%200197)%2C%20a%20Phase%203%20Study) The CYPRESS study is a registrational Phase 3 trial evaluating ampreloxetine's efficacy and durability in MSA patients with symptomatic nOH - CYPRESS is a registrational Phase 3, multi-center, randomized withdrawal study evaluating ampreloxetine in MSA patients with symptomatic nOH[18](index=18&type=chunk) - The primary endpoint is the change in the **Orthostatic Hypotension Symptom Assessment (OHSA) composite score**, with secondary measures including OHDAS items 1 and 3[18](index=18&type=chunk) [About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH)](index=4&type=section&id=About%20Multiple%20System%20Atrophy%20(MSA)%20and%20Symptomatic%20Neurogenic%20Orthostatic%20Hypotension%20(nOH)) MSA is a progressive brain disorder where nOH is a frequent and debilitating symptom affecting a significant portion of patients - MSA is a progressive brain disorder affecting movement, balance, and the autonomic nervous system, with nOH as a frequent symptom[19](index=19&type=chunk) - nOH affects **70-90% of the estimated 50,000 MSA patients in the US**, causing debilitating symptoms like dizziness and fainting, with many patients remaining symptomatic despite current treatments[19](index=19&type=chunk)[20](index=20&type=chunk) [TRELEGY Royalty Update](index=2&type=section&id=TRELEGY%20Update) TRELEGY global net sales grew 32% year-over-year, positioning the company for potential milestone payments from Royalty Pharma TRELEGY Q1 2024 Net Sales | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | TRELEGY Global Net Sales (GSK) | $749 million | $567 million | +32% | - Theravance Biopharma is eligible for up to **$200 million in milestone payments** from Royalty Pharma for TRELEGY sales[8](index=8&type=chunk) - The next **$25 million milestone payment** is expected if TRELEGY global net sales reach approximately **$2.9 billion in 2024** (5% increase YoY), with another $25 million if sales exceed $3.2 billion (17% increase YoY)[8](index=8&type=chunk)[10](index=10&type=chunk) [First Quarter Financial Results](index=2&type=section&id=First%20Quarter%20Financial%20Results) The company reports a 39% increase in total revenue and a significant reduction in operating expenses and net loss for Q1 2024 [Revenue and Collaboration Income](index=2&type=section&id=Revenue) Total revenue rose 39% year-over-year to $14.5 million, driven by higher YUPELRI net sales and lower associated costs Q1 Revenue Details | Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenue | $14,503 | $10,417 | +39% | | Viatris Collaboration Revenue | $14,503 | $10,411 | +39% | | Implied 35% Share of YUPELRI Net Sales | $19,329 | $16,434 | +18% | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses decreased significantly due to lower R&D and SG&A spending, reflecting improved cost management Q1 Operating Expenses | Expense Category | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $8,968 | $14,572 | -38.4% | | SG&A Expenses | $16,742 | $19,183 | -12.5% | | Restructuring & Related Expenses | $0 | $1,574 | -100% | | Total Share-Based Compensation | $5,229 | $7,021 | -25.6% | [Net Loss and EPS](index=3&type=section&id=Net%20Loss%20and%20Non-GAAP%20Net%20Loss%20from%20Operations) The company substantially narrowed its GAAP and non-GAAP net losses in Q1 2024 compared to the prior year period Q1 Net Loss Summary | Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY) | | :--- | :--- | :--- | :--- | | GAAP Net Loss | $(11,664) | $(22,088) | -47.2% | | Non-GAAP Net Loss | $(4,544) | $(14,912) | -69.5% | | Basic & Diluted Net Loss Per Share | $(0.24) | $(0.35) | N/A | [Cash Position](index=3&type=section&id=Cash%20Position) The company maintained a solid cash position, ending the first quarter of 2024 with $100.0 million in cash and marketable securities Cash and Equivalents | Metric | March 31, 2024 (in thousands) | December 31, 2023 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Cash, Cash Equivalents & Marketable Securities | $99,975 | $102,426 | $(2,451) | [2024 Financial Guidance](index=3&type=section&id=2024%20Financial%20Guidance) The company reaffirms its full-year 2024 operating expense guidance and projects approaching non-GAAP breakeven in the second half [Operating Expenses Outlook](index=3&type=section&id=Operating%20Expenses%20(excluding%20share-based%20compensation)) The company maintains its full-year 2024 guidance for R&D and SG&A expenses, excluding share-based compensation 2024 Operating Expense Guidance | Expense Category (Excl. Share-Based Comp.) | Full Year 2024 Guidance | | :--- | :--- | | R&D Expenses | $30 million - $36 million | | SG&A Expenses | $45 million - $55 million | [Share-Based Compensation Outlook](index=3&type=section&id=Share-Based%20Compensation%20Outlook) Full-year 2024 share-based compensation expenses are projected to be between $18 million and $22 million 2024 Share-Based Compensation Guidance | Expense Category | Full Year 2024 Guidance | | :--- | :--- | | Share-Based Compensation Expenses | $18 million - $22 million | [Non-GAAP Net Profit / Loss Outlook](index=3&type=section&id=Non-GAAP%20Net%20Profit%20%2F%20Loss) The company anticipates a non-GAAP net loss in H1 2024, moving towards breakeven in H2 2024 with limited annual cash burn - The company expects a **non-GAAP net loss in H1 2024** and to approach **non-GAAP breakeven in H2 2024**[17](index=17&type=chunk) - **Limited cash burn** is expected for the full year 2024[17](index=17&type=chunk) [Non-GAAP Financial Measures Explanation](index=6&type=section&id=Non-GAAP%20Financial%20Measures) This section explains the company's use of non-GAAP metrics to supplement GAAP results for performance analysis [Non-GAAP Financial Measures Explanation](index=6&type=section&id=Non-GAAP%20Financial%20Measures%20Explanation) The company utilizes non-GAAP metrics, excluding certain non-cash items, to provide investors with additional insight into core performance - Non-GAAP profit (loss) is defined as GAAP net income (loss) before taxes, less share-based compensation expense and non-cash interest expense[16](index=16&type=chunk) - Non-GAAP measures are used to provide better metrics for analyzing business performance by excluding items not indicative of core operating results and cash position[26](index=26&type=chunk) - These non-GAAP measures are not standardized and should be considered in addition to, not as a substitute for, GAAP results[26](index=26&type=chunk) [Corporate Information](index=4&type=section&id=Corporate%20Information) This section provides an overview of the company's mission, key products, and standard forward-looking statement disclaimers [About Theravance Biopharma](index=4&type=section&id=About%20Theravance%20Biopharma) The company is focused on developing impactful medicines, highlighted by its approved COPD therapy YUPELRI and late-stage asset ampreloxetine - Theravance Biopharma's mission is to deliver **"Medicines that Make a Difference"** in people's lives[21](index=21&type=chunk) - Key products include FDA-approved **YUPELRI** for COPD and late-stage investigational **ampreloxetine** for symptomatic nOH in MSA patients, which has potential as a first-in-class therapy[21](index=21&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially - The press release contains forward-looking statements regarding future profitability, expenses, YUPELRI sales growth, royalty payments, clinical study timing, and regulatory strategies[24](index=24&type=chunk) - These statements are based on current estimates and assumptions and are subject to risks, uncertainties, and changes in circumstances that may cause actual results to differ materially[24](index=24&type=chunk) - Important factors include risks related to cash requirements, clinical study delays, product safety/efficacy, regulatory decisions, third-party dependencies, intellectual property, and general economic conditions[24](index=24&type=chunk) [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the company's unaudited balance sheets, statements of operations, and reconciliation of GAAP to non-GAAP net loss [Condensed Consolidated Balance Sheets](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets stood at $371.3 million as of March 31, 2024, with cash and equivalents at $100.0 million Balance Sheet Summary | Balance Sheet Item (in thousands) | March 31, 2024 | December 31, 2023 | Change | | :--- | :--- | :--- | :--- | | Total Assets | $371,307 | $381,999 | $(10,692) | | Cash and cash equivalents and short-term marketable securities | $99,975 | $102,426 | $(2,451) | | Receivables from collaborative arrangements | $14,664 | $17,474 | $(2,810) | | Future contingent milestone and royalty assets | $194,200 | $194,200 | $0 | | Total Liabilities | $166,439 | $163,704 | $2,735 | | Shareholders' Equity | $204,868 | $212,995 | $(8,127) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The company reported a net loss of $11.7 million on total revenues of $14.5 million for the first quarter of 2024 Q1 2024 Statement of Operations | Income Statement Item (in thousands) | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | Total Revenue | $14,503 | $10,417 | +39.2% | | Research and Development | $8,968 | $14,572 | -38.4% | | Selling, General and Administrative | $16,742 | $19,183 | -12.7% | | Total Costs and Expenses | $25,710 | $35,329 | -27.2% | | Loss from Operations | $(11,207) | $(24,912) | -55.0% | | Net Loss | $(11,664) | $(22,088) | -47.2% | | Basic and Diluted Net Loss Per Share | $(0.24) | $(0.35) | N/A | Q1 2024 Share-Based Compensation | Share-Based Compensation (in thousands) | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | Research and Development | $1,465 | $2,441 | -40.1% | | Selling, General and Administrative | $3,764 | $4,223 | -10.9% | | Restructuring and Related Expenses | $0 | $357 | -100% | | Total Share-Based Compensation Expense | $5,229 | $7,021 | -25.6% | [Reconciliation of GAAP to Non-GAAP Net Loss](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Net%20Loss) The non-GAAP net loss for Q1 2024 was $4.5 million, a 69.5% improvement from the $14.9 million loss in Q1 2023 GAAP to Non-GAAP Reconciliation | Metric (in thousands) | Q1 2024 | Q1 2023 | Change (YoY) | | :--- | :--- | :--- | :--- | | GAAP Net Loss | $(11,664) | $(22,088) | -47.2% | | Share-Based Compensation Expense | $5,229 | $7,021 | -25.6% | | Non-Cash Interest Expense | $629 | $550 | +14.4% | | Income Tax Expense (Benefit) | $1,262 | $(395) | N/A | | Non-GAAP Net Loss | $(4,544) | $(14,912) | -69.5% |

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-36033 THERAVANCE BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Cayman Islands 98-1226628 (Sta ...