Prothena(PRTA) - 2025 Q2 - Quarterly Results

Press Release Overview Prothena announced Q2 and H1 2025 financial results, highlighting progress in neurodegenerative and amyloidosis programs, and outlining future milestones and financial guidance Introduction and CEO Statement Prothena reported Q2 and H1 2025 financial results and business highlights, with CEO emphasizing prasinezumab's Phase III entry and upcoming PRX012 data - Prothena's partner Roche expects to advance prasinezumab into Phase III clinical development for early Parkinson's disease by late 2025, potentially becoming the first disease-modifying therapy for 10 million Parkinson's patients worldwide[3] - The company plans to share preliminary data from its wholly-owned PRX012 program's Phase I ASCENT clinical trial in Alzheimer's disease in August 2025[3] - Prothena anticipates up to $105 million in clinical milestone payments in 2026, contingent on Novo Nordisk advancing coramitug and Bristol Myers Squibb advancing PRX019[3] Second Quarter 2025 Business Highlights Prothena's Q2 2025 net cash used in operating and investing activities was $46.4 million, with $372.3 million in cash and restricted cash at quarter-end 2025 Second Quarter and First Half Cash Usage | Metric | Second Quarter (million USD) | First Half (million USD) | | :-------------------------------- | :--------------------------- | :----------------------- | | Net cash used in operating and investing activities | 46.4 | 99.8 | - Prothena expects to convene an Extraordinary General Meeting of Shareholders by late 2025 to propose a capital reduction to create distributable reserves, supporting a potential share redemption program[4] - Roche will advance prasinezumab into Phase III development for early Parkinson's disease, expected to commence by late 2025[4] - Preliminary data from the PRX012 Phase I ASCENT clinical trial is anticipated in August 2025[4] Business Highlights and Upcoming Milestones Prothena's pipeline includes programs for neurodegenerative and rare peripheral amyloid diseases, with key milestones expected for prasinezumab, PRX012, and coramitug Neurodegenerative Diseases Portfolio Prothena's neurodegenerative portfolio includes therapies for Parkinson's, Alzheimer's, and other diseases, featuring collaborations with Roche and Bristol Myers Squibb Parkinson's Disease Prasinezumab, a potential first-in-class antibody for Parkinson's disease developed with Roche, is expected to enter Phase III development by late 2025 with over $3 billion peak sales potential - Partner Roche expects to advance prasinezumab into Phase III development for early Parkinson's disease by late 2025[10] - Roche indicates prasinezumab has a peak sales potential exceeding $3 billion and could be the first disease-modifying therapy for 10 million Parkinson's patients globally[10] Alzheimer's Disease Prothena's Alzheimer's pipeline includes PRX012 (Fast Track, Phase I data in August), BMS-986446 (Phase II/I with Bristol Myers Squibb), and PRX123 (Fast Track, IND approved) - PRX012 has received U.S. FDA Fast Track designation, with preliminary data from its Phase I ASCENT clinical trial expected in August 2025[6][10] - Bristol Myers Squibb is conducting a Phase II TargetTau-1 clinical trial for BMS-986446 (expected completion 2027) and a Phase I subcutaneous formulation clinical trial (expected completion H2 2025)[10] - PRX123 has received FDA IND approval and Fast Track designation, with Prothena planning to advance the program through non-dilutive and capital-efficient structures[8] Other Neurodegenerative Diseases (PRX019) PRX019, exclusively licensed to Bristol Myers Squibb in 2024, is in Phase I clinical trials expected to complete in 2026, with potential future milestone payments - Bristol Myers Squibb obtained exclusive worldwide rights to PRX019 in 2024 and is conducting a Phase I clinical trial, expected to complete in 2026[9][15] - Prothena is eligible for clinical milestone payments in 2026 if Bristol Myers Squibb decides to further develop PRX019[15] Rare Peripheral Amyloid Disease Prothena's primary program in rare peripheral amyloid disease is coramitug, a potential first-in-class amyloid-clearing antibody for ATTR amyloidosis with cardiomyopathy, developed by Novo Nordisk ATTR Amyloidosis (Coramitug) Novo Nordisk completed a Phase II trial for coramitug, with results expected in H2 2025, and Prothena is eligible for milestone payments upon advancement to Phase IIb or III - Novo Nordisk has completed the Phase II clinical trial for coramitug, with results expected in the second half of 2025[16] - Coramitug is currently undergoing an open-label extension study[16] - Prothena is eligible for clinical milestone payments in 2026 when Novo Nordisk meets pre-specified enrollment criteria in Phase IIb or Phase III clinical trials[16] Second Quarter and First Six Months of 2025 Financial Results Prothena reported net losses of $125.8 million and $186.0 million for Q2 and H1 2025, primarily due to restructuring and non-cash income tax expenses Overview of Financial Performance Prothena reported Q2 and H1 2025 net losses of $125.8 million and $186.0 million, respectively, impacted by restructuring and non-cash income tax expenses 2025 Second Quarter and First Half Net Income (Loss) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | H1 2025 (million USD) | H1 2024 (million USD) | | :-------------------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | Net income (loss) | (125.8) | 66.9 | (186.0) | (5.4) | | Net income (loss) per share | (2.34) | 1.22 | (3.45) | (0.10) | - Q2 and H1 2025 net losses primarily include $32.6 million in restructuring costs (related to birtamimab program termination and workforce reduction) and $44.9 million in non-cash income tax expense (for full valuation allowance against federal deferred tax assets)[12] Revenue Prothena's total revenue for Q2 and H1 2025 was $4.4 million and $7.2 million, a significant decrease from 2024, primarily from PRX019 clinical trial performance 2025 Second Quarter and First Half Total Revenue | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | H1 2025 (million USD) | H1 2024 (million USD) | | :----------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | Total revenue | 4.4 | 132.0 | 7.2 | 132.1 | - Total revenue for Q2 and H1 2025 primarily resulted from partial performance under the PRX019 Phase I clinical trial collaboration with Bristol Myers Squibb[13] Operating Expenses Prothena's operating expenses in Q2 and H1 2025 saw reduced R&D costs due to lower clinical and manufacturing expenses, offset by a significant increase in restructuring costs Research and Development (R&D) Expenses R&D expenses for Q2 and H1 2025 were $40.5 million and $91.3 million, respectively, a decrease from 2024, mainly due to lower clinical trial and manufacturing costs 2025 Second Quarter and First Half R&D Expenses | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | H1 2025 (million USD) | H1 2024 (million USD) | | :----------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | R&D expenses | 40.5 | 57.5 | 91.3 | 121.6 | - The decrease in R&D expenses was primarily due to lower clinical trial expenses, manufacturing expenses, and personnel costs[14] General and Administrative (G&A) Expenses G&A expenses for Q2 and H1 2025 were $15.9 million and $33.5 million, respectively, remaining relatively consistent with the prior year 2025 Second Quarter and First Half G&A Expenses | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | H1 2025 (million USD) | H1 2024 (million USD) | | :-------------------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | G&A expenses | 15.9 | 16.1 | 33.5 | 33.6 | Restructuring Costs Restructuring costs for Q2 and H1 2025 were $32.6 million, primarily from employee termination benefits and contract termination fees related to the birtamimab program 2025 Second Quarter and First Half Restructuring Costs | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | H1 2025 (million USD) | H1 2024 (million USD) | | :-------------------- | :-------------------- | :-------------------- | :-------------------- | :-------------------- | | Restructuring costs | 32.6 | 0 | 32.6 | 0 | - Restructuring costs primarily include employee termination benefits related to the June 2025 workforce reduction and contract termination fees with a third-party manufacturer for birtamimab commercial supply[18] Cash Position and Shares Outstanding As of June 30, 2025, Prothena held $372.3 million in cash, cash equivalents, and restricted cash, with approximately 53.8 million common shares outstanding as of July 25, 2025 Cash Position and Shares Outstanding | Metric | Amount | | :------------------------------------------------ | :-------------------- | | Cash, cash equivalents, and restricted cash as of June 30, 2025 | $372.3 million | | Common shares outstanding as of July 25, 2025 | Approximately 53.8 million shares | 2025 Financial Guidance Prothena projects full-year 2025 net cash used in operating and investing activities between $170 million and $178 million, with an estimated year-end cash balance of $298 million 2025 Full-Year Financial Guidance | Metric | Projected Amount (million USD) | | :------------------------------------------ | :----------------------------- | | Net cash used in operating and investing activities | 170 - 178 | | Year-end cash, cash equivalents, and restricted cash | Approximately 298 (midpoint) | | Projected net loss | 240 - 248 | | Non-cash share-based compensation expense | Approximately 36 | | Non-cash income tax expense | 44.9 | Share Redemption Program Prothena plans an Extraordinary General Meeting by late 2025 to approve a capital reduction, creating distributable reserves to support a potential share redemption program - Prothena expects to convene an Extraordinary General Meeting of Shareholders by late 2025 to propose a capital reduction to create distributable reserves, supporting a potential share redemption program[21] - The Board aims to gain flexibility to return capital to shareholders through open market purchases or other permitted means[21] About Prothena Prothena is a late-stage clinical biotechnology company focused on protein dysregulation, developing therapies for neurodegenerative and rare peripheral amyloid diseases - Prothena is a late-stage clinical biotechnology company focused on protein dysregulation, dedicated to developing therapies for neurodegenerative and rare peripheral amyloid diseases[22] - The company's pipeline includes wholly-owned and partnered programs covering ATTR amyloidosis with cardiomyopathy, Alzheimer's disease, Parkinson's disease, and other neurodegenerative conditions[22] Forward-Looking Statements This press release contains forward-looking statements regarding financial outlook, pipeline progress, clinical milestones, and potential share redemption, subject to various risks and uncertainties - This press release contains forward-looking statements regarding the company's cash position, R&D pipeline progress, clinical trial milestones, therapeutic potential of investigational drugs, financial guidance, and potential share redemption program[23] - These statements are based on estimates, forecasts, and assumptions, and actual results may differ materially due to known and unknown risks, uncertainties, and other factors[23] - The company undertakes no obligation to publicly update any forward-looking statements[23] Condensed Consolidated Financial Statements This section presents Prothena's condensed consolidated financial statements, including statements of operations and balance sheets for specified periods Condensed Consolidated Statements of Operations Prothena's condensed consolidated statements of operations for Q2 and H1 2025 and 2024 detail collaboration revenue, operating expenses, and net income (loss) Condensed Consolidated Statements of Operations (Unaudited - Amounts in thousands, except per share data) | | Three Months Ended | | | Six Months Ended | | | :----------------------------------- | :---------------- | :---------------- | :---------------- | :---------------- | | | June 30, 2025 | June 30, 2024 | June 30, 2025 | June 30, 2024 | | Collaboration revenue | 4,420 | 132,014 | 7,198 | 132,014 | | License and intellectual property revenue | — | — | 50 | 50 | | Total revenue | 4,420 | 132,014 | 7,248 | 132,064 | | Operating expenses: | | | | | | Research and development | 40,517 | 57,510 | 91,328 | 121,624 | | General and administrative | 15,910 | 16,127 | 33,508 | 33,591 | | Restructuring costs | 32,609 | — | 32,609 | — | | Total operating expenses | 89,036 | 73,637 | 157,445 | 155,215 | | Operating income (loss) | (84,616) | 58,377 | (150,197) | (23,151) | | Other income, net | 3,651 | 6,470 | 7,859 | 13,558 | | Income (loss) before income taxes | (80,965) | 64,847 | (142,338) | (9,593) | | Income tax provision (benefit) | 44,802 | (2,039) | 43,624 | (4,240) | | Net income (loss) | (125,767) | 66,886 | (185,962) | (5,353) | | Basic net income (loss) per share | (2.34) | 1.24 | (3.45) | (0.10) | | Diluted net income (loss) per share | (2.34) | 1.22 | (3.45) | (0.10) | | Shares used in computing basic net income (loss) per share | 53,827 | 53,767 | 53,827 | 53,740 | | Shares used in computing diluted net income (loss) per share | 53,827 | 55,043 | 53,827 | 53,740 | Condensed Consolidated Balance Sheets Prothena's condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024, present assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (Unaudited - Amounts in thousands) | | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :-------------- | :---------------- | | Assets | | | | Cash and cash equivalents | 371,435 | 471,388 | | Prepaid expenses and other current assets | 14,040 | 14,024 | | Total current assets | 385,475 | 485,412 | | Property, plant and equipment, net | 2,690 | 3,081 | | Operating lease right-of-use assets | 9,563 | 10,708 | | Restricted cash, noncurrent | 860 | 860 | | Other noncurrent assets | 478 | 47,047 | | Total noncurrent assets | 13,591 | 61,696 | | Total assets | 399,066 | 547,108 | | Liabilities and Stockholders' Equity | | | | Accrued research and development | 10,929 | 13,428 | | Deferred revenue, current | 5,100 | 8,850 | | Restructuring liability | 30,330 | — | | Lease liabilities, current | 2,853 | 2,610 | | Other current liabilities | 18,595 | 23,613 | | Total current liabilities | 67,807 | 48,501 | | Deferred revenue, noncurrent | — | 3,448 | | Lease liabilities, noncurrent | 6,928 | 8,233 | | Total noncurrent liabilities | 6,928 | 11,681 | | Total liabilities | 74,735 | 60,182 | | Total stockholders' equity | 324,331 | 486,926 | | Total liabilities and stockholders' equity | 399,066 | 547,108 | Contact Information Mark Johnson, CFA, Vice President of Investor Relations, serves as Prothena's contact for investor inquiries - Investor Relations Contact: Mark Johnson, CFA, Vice President, Investor Relations[26]