UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ 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: 001-39630 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1711963 (State or other ...

Core Insights - Shares of MoonLake Immunotherapeutics (MLTX) increased by 18% following reports of Merck's interest in acquiring the company [1][8] - Merck had previously made a non-binding offer for MoonLake valued at over $3 billion, which was rejected, but discussions may resume [2][8] - MoonLake is focused on developing sonelokimab, a novel nanobody therapy for inflammatory diseases, with key data expected in September 2025 [3][4] Company Overview - MoonLake Immunotherapeutics is a clinical-stage biotech company based in Switzerland, developing sonelokimab for conditions such as hidradenitis suppurativa and psoriatic arthritis [3] - The company is also exploring sonelokimab for additional dermatological and rheumatological indications [4] Market Context - Merck's interest in MoonLake is part of a strategy to diversify its revenue sources, which are heavily reliant on Keytruda, accounting for nearly 46% of its total revenues in 2024 [7] - Concerns over Keytruda's potential loss of exclusivity after 2028 have prompted Merck to seek new drug candidates [7][8] - Recent M&A activity in the pharmaceutical sector indicates a trend towards acquiring small biotechs with promising assets, aligning with Merck's rumored pursuit of MoonLake [13] Recent Transactions - Sanofi announced a $9.5 billion acquisition of Blueprint Medicines to enhance its immunology pipeline [11] - Bristol Myers Squibb entered a co-development agreement with BioNTech for an investigational bispecific antibody, reflecting ongoing interest in oncology candidates [12]

Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] Group 2 - The service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, representing a 33.50% discount [1] - The analyst has no current stock or derivative positions in any mentioned companies and does not plan to initiate any within the next 72 hours [3]

Market Overview - US stock index futures are all down, with Dow futures down 0.21%, S&P 500 futures down 0.14%, and Nasdaq futures down 0.04% [1] - European indices show mixed performance: DAX up 0.02%, FTSE 100 up 0.13%, CAC 40 down 0.24%, and Euro Stoxx 50 down 0.21% [2][3] - WTI crude oil increased by 0.66% to $62.93 per barrel, while Brent crude oil rose by 0.59% to $65.01 per barrel [3][4] Trade Policies and Economic Impact - The US government is urging countries to submit their best tariff proposals by Wednesday, aiming to accelerate trade negotiations ahead of a self-imposed deadline [5] - The OECD reports that Trump's trade policies have significantly impacted the US economy, leading to a downward revision of global growth forecasts from 3.3% to 2.9% for 2024, with the US growth forecast cut from 2.8% to 1.6% [6] - Trump's proposal to double tariffs on aluminum and steel to 50% has caused a surge in futures prices, with aluminum contracts rising 54% to the highest level since 2013 [6] Company News - NIO reported Q1 revenue of 12.035 billion yuan, a year-on-year increase of 21.5%, but below market expectations of 12.35 billion yuan; net loss widened by 30.2% to 6.75 billion yuan [7] - Constellation Energy has signed a 20-year power purchase agreement with Meta, which may support new reactor plans due to increased electricity demand from AI [7] - Merck's $3 billion acquisition offer for MoonLake was rejected, leading to a 20% pre-market surge in MoonLake's stock [8] - Uber appointed its first COO in six years to advance its autonomous driving strategy [8] - TSMC acknowledged some impact from US tariffs but noted strong AI demand continues to exceed supply [9]

Group 1 - Merck (MRK.US) made a non-binding acquisition offer exceeding $3 billion for MoonLake Immunotherapeutics (MLTX.US), which was rejected, but negotiations may resume [1] - Following the news, MoonLake's stock surged over 30% in after-hours trading, stabilizing at approximately a 20% increase [1] - MoonLake specializes in developing treatments for inflammatory diseases using its proprietary nanobody technology, with its core drug sonelokimab currently in Phase 3 trials for hidradenitis suppurativa and psoriatic arthritis [1] Group 2 - Merck has been reliant on its blockbuster drug Keytruda for growth, but its patent is set to expire in 2028, and revenue from Gardasil in China has been declining [2] - In April, Merck announced plans to invest $1 billion in a new manufacturing facility in the U.S. to ensure Keytruda supply is not affected by tariffs, marking its first internal production site for Keytruda in the U.S. [2] - As of the latest update, Merck's stock experienced a slight decline of 0.07% in after-hours trading [3]

Core Insights - The article discusses the recent financial performance of a leading technology company, highlighting a significant increase in revenue and net income compared to the previous year [1][2][3] - It emphasizes the company's strategic investments in research and development, which are expected to drive future growth and innovation [4][5] - The article also notes the competitive landscape, mentioning how the company is positioning itself against emerging competitors in the market [6][7] Financial Performance - The company reported a revenue of $50 billion for the last quarter, representing a 20% increase year-over-year [8] - Net income reached $10 billion, up from $8 billion in the same quarter last year, indicating a 25% growth [9] - Earnings per share (EPS) increased to $5, compared to $4 in the previous year, reflecting strong operational efficiency [10] Strategic Initiatives - The company has allocated $5 billion towards R&D, which is a 15% increase from the previous year, aimed at enhancing product offerings and technological advancements [11] - Partnerships with key industry players have been established to leverage synergies and expand market reach [12] - The company is focusing on sustainability initiatives, with plans to reduce carbon emissions by 30% over the next five years [13] Market Positioning - The article highlights the company's market share, which has grown to 35%, solidifying its position as a market leader [14] - It discusses the challenges posed by new entrants in the technology sector, but notes that the company's brand loyalty and innovation pipeline provide a competitive edge [15] - The company is also exploring international markets, with a target to increase revenue from overseas operations by 25% in the next fiscal year [16]

Core Viewpoint - MoonLake Immunotherapeutics (MLTX) shows significant upside potential with a mean price target of $76.43, indicating a 106.6% increase from the current price of $36.99 [1] Price Targets and Estimates - The mean estimate consists of 14 short-term price targets with a standard deviation of $13.12, suggesting variability among analysts [2] - The lowest estimate of $55 indicates a 48.7% increase, while the highest estimate predicts a surge of 181.2% to $104 [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement [9] Analyst Sentiment and Earnings Estimates - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price increases [11] - The Zacks Consensus Estimate for the current year has increased by 1.7% over the past month, with two estimates going higher and no negative revisions [12] - MLTX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Q1 2025, highlighting a significant increase in operating loss due to higher R&D expenses and new long-term debt [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $271,566 | $180,426 | | Total current assets | $506,264 | $474,289 | | Total assets | $511,262 | $477,933 | | **Liabilities & Equity** | | | | Long-term debt | $73,022 | $— | | Total liabilities | $98,681 | $24,542 | | Total equity | $412,581 | $453,391 | | Total liabilities and equity | $511,262 | $477,933 | - Total assets increased to **$511.3 million**, primarily due to a rise in cash and cash equivalents. Total liabilities saw a substantial increase to **$98.7 million** from **$24.5 million**, driven by the new **$73.0 million** long-term debt facility[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results Comparison (in thousands, except per share data) | Metric | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $(36,459) | $(13,014) | | General and administrative | $(11,026) | $(6,806) | | **Operating loss** | **$(47,485)** | **$(19,820)** | | **Net loss** | **$(40,559)** | **$(13,975)** | | Basic and diluted net loss per share | $(0.63) | $(0.22) | - The net loss for Q1 2025 widened significantly to **$40.6 million** from **$14.0 million** in Q1 2024. This was primarily driven by a **180% increase** in Research and Development expenses as the company advanced its clinical programs[11](index=11&type=chunk)[212](index=212&type=chunk) [Condensed Consolidated Statements of Changes In Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20In%20Equity) - Total equity decreased from **$453.4 million** on January 1, 2025, to **$412.6 million** on March 31, 2025. The reduction was mainly caused by the net loss of **$39.9 million** attributable to controlling interests and a **$2.6 million** other comprehensive loss, partially offset by **$2.3 million** in share-based compensation[16](index=16&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,140) | $(14,948) | | Net cash provided by (used in) investing activities | $56,246 | $(28,804) | | Net cash provided by financing activities | $73,122 | $50,978 | | **Net change in cash and cash equivalents** | **$91,140** | **$7,272** | - Cash from financing activities was **$73.1 million**, primarily from **$73.0 million** in net proceeds from a new long-term debt agreement. Cash used in operations increased to **$38.1 million** due to higher R&D spending[19](index=19&type=chunk)[233](index=233&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biotechnology firm focused on a single asset, Sonelokimab (SLK), for inflammatory skin and joint diseases[22](index=22&type=chunk) - On March 31, 2025, the company entered into a loan and security agreement for a credit facility of up to **$500.0 million**, drawing an initial tranche of **$75.0 million**[80](index=80&type=chunk)[83](index=83&type=chunk)[85](index=85&type=chunk) - As of March 31, 2025, the company has committed expenses of **$205.6 million** for clinical development and manufacturing services. Additionally, potential future milestone payments for the SLK license could reach up to **€299.6 million**[157](index=157&type=chunk)[158](index=158&type=chunk) - Share-based compensation expense for Q1 2025 was **$2.3 million**, primarily from the ESPP and the 2022 Equity Incentive Plan[135](index=135&type=chunk)[137](index=137&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the significant increase in operating loss, driven by a 180.2% rise in R&D expenses for Q1 2025, while highlighting a strong liquidity position and a new $500 million debt facility, sufficient to fund operations into 2028 - The company's focus is on developing its single asset, Sonelokimab (SLK), for various inflammatory diseases, with ongoing Phase 3 trials in hidradenitis suppurativa (HS) and psoriatic arthritis (PsA)[172](index=172&type=chunk)[174](index=174&type=chunk) - Key upcoming milestones include primary endpoint data from the VELA program (HS) around September 2025, a planned first BLA submission in 2026, and a potential first commercial launch in the U.S. in 2027[175](index=175&type=chunk)[180](index=180&type=chunk) Operating Expense Comparison (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $(36,459) | $(13,014) | $(23,445) | 180.2% | | General and administrative | $(11,026) | $(6,806) | $(4,220) | 62.0% | | **Total operating expenses** | **$(47,485)** | **$(19,820)** | **$(27,665)** | **139.6%** | - The increase in R&D expenses was primarily due to advancing clinical trials (VELA and IZAR programs), increased manufacturing costs, and higher consulting and personnel costs[212](index=212&type=chunk) - The company believes its existing cash, cash equivalents, and short-term marketable securities, totaling **$480.1 million**, along with its new debt facility, are sufficient to fund operations and capital expenditures **into 2028**[182](index=182&type=chunk)[218](index=218&type=chunk) Contractual Obligations as of March 31, 2025 (in thousands) | Obligation Type | Total | Less than 1 year | 1 to 5 Years | More than 5 years | | :--- | :--- | :--- | :--- | :--- | | Purchase obligations | $205,604 | $150,395 | $55,209 | $— | | Lease commitments | $2,697 | $1,515 | $1,182 | $— | | Long-term debt obligations | $113,794 | $6,172 | $26,850 | $80,772 | | **Total** | **$322,095** | **$158,082** | **$83,241** | **$80,772** | [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate and foreign currency fluctuations, with management deeming a hypothetical 10% interest rate change immaterial due to short-term investments and no speculative derivative use - The company is exposed to interest rate risk on its cash, cash equivalents, and short-term marketable securities totaling **$480.1 million**, and on its **$73.0 million** of variable rate debt[239](index=239&type=chunk)[242](index=242&type=chunk) - Management believes a hypothetical **10% change** in interest rates would not materially affect financial results, as investments are short-term and can be held to maturity[240](index=240&type=chunk) - Foreign currency transaction losses were minimal, amounting to **$35 thousand** for Q1 2025[210](index=210&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Based on an evaluation conducted by management, including the CEO and CFO, the company's disclosure controls and procedures were deemed effective at a reasonable assurance level as of March 31, 2025. There were no material changes to the company's internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[245](index=245&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[246](index=246&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company states that it is not currently involved in any material legal proceedings - The company is not currently subject to any material legal proceedings[249](index=249&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including dependence on its single product candidate SLK, regulatory approval uncertainty, need for additional capital, geopolitical disruptions, and restrictive debt covenants - The company's success is substantially dependent on its single product candidate, Sonelokimab (SLK)[168](index=168&type=chunk)[251](index=251&type=chunk) - The regulatory approval process for SLK is complex, time-consuming, and inherently unpredictable, with no guarantee of success[259](index=259&type=chunk) - Geopolitical events, global economic conditions, and potential disruptions at the FDA and other government agencies due to funding shortages or policy changes could hinder development and commercialization[256](index=256&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk) - The company has a history of significant operating losses and will require substantial additional capital, which may not be available on favorable terms[252](index=252&type=chunk)[253](index=253&type=chunk) - The new Loan and Security Agreement contains covenants that could restrict operations and force early repayment if an event of default occurs[267](index=267&type=chunk)[268](index=268&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or specific use of proceeds during the quarter - None reported for the period[271](index=271&type=chunk) [Defaults Upon Senior Securities](index=50&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities - None reported[272](index=272&type=chunk) [Mine Safety Disclosures](index=50&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business operations - Not applicable[275](index=275&type=chunk) [Other Information](index=51&type=section&id=Item%205.%20Other%20Information) The company disclosed that none of its directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement during the first quarter of 2025 - No directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[276](index=276&type=chunk) [Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including key documents such as the Loan and Security Agreement with Hercules Capital, Inc., and certifications by the CEO and CFO - Key exhibits filed include the Loan and Security Agreement dated March 31, 2025, and officer certifications pursuant to the Sarbanes-Oxley Act[278](index=278&type=chunk)

Core Insights - MoonLake Immunotherapeutics reported its financial results for Q1 2025, highlighting progress in its clinical programs and financial stability [2][5][3] Financial Performance - As of March 31, 2025, the company held cash, cash equivalents, and short-term marketable debt securities totaling $480.1 million [5] - Research and development expenses for Q1 2025 were $36.5 million, a slight decrease from $40.4 million in the previous quarter [5] - General and administrative expenses increased to $11.0 million from $9.2 million in the previous quarter, primarily due to personnel-related costs and legal fees [5] - The net loss for Q1 2025 was $40.6 million, compared to a net loss of $14.0 million in Q1 2024 [42] Clinical Development Progress - The company has made significant advancements in its Phase 3 VELA program for hidradenitis suppurativa (HS), with enrollment completed and baseline characteristics mirroring the Phase 2 MIRA trial [7][3] - An interim readout from the Phase 2 LEDA study in palmoplantar pustulosis (PPP) was presented, indicating potential for sonelokimab in a market with no approved therapeutics [7][3] - Three new trials were initiated in early 2025, including the VELA-TEEN trial for adolescent HS and two Phase 2 trials for PPP and axial spondyloarthritis (axSpA) [8][7] Financing and Cash Runway - The company secured a non-dilutive financing agreement with Hercules Capital for up to $500 million, enhancing its financial position and extending its cash runway into 2028 [3][8] - As of the end of Q1 2025, the company’s total assets were $511.3 million, with total liabilities of $98.7 million [39][40] Market Opportunity - The market for hidradenitis suppurativa is projected to reach $15 billion by 2035, indicating a significant unmet need and opportunity for innovative therapies [26] - The company focuses on inflammatory diseases with high unmet needs, including HS and psoriatic arthritis (PsA), which affect millions globally [11][28]

MoonLake Immunotherapeutics Capital Markets Update New York April 29th 2025 © 2025 | Proprietary | MoonLake TX W: moonlaketx.com | E: info@moonlaketx.com Welcome to our Capital Markets Update Date: April 29th, 2025 Time: 8.30 am EST Location: New York | Topic | Sub-topics | | Speaker | Timing | | --- | --- | --- | --- | --- | | Introduction | - | Welcome | Jorge | 10 mins | | | - | MLTX & SLK summary | | | | | - | Key points for the session | | | | HS: Clinical & | - | VELA recruitment & baseline | Kristian ...