Core Insights - The launch of Arbli (losartan potassium) Oral Suspension, 10mg/mL, represents a significant advancement in hypertension treatment, particularly for patients with dysphagia, as it is the first FDA-approved ready-to-use liquid formulation of losartan [1][2][3] - The U.S. losartan market is valued at approximately $256 million annually, with 71 million prescriptions, indicating a substantial market opportunity for Arbli [2][3] - The availability of Arbli through established pharmaceutical distribution channels enhances treatment adherence and addresses the needs of underserved patient populations, including the elderly and children [2][3] Company Overview - Scienture Holdings, Inc. is focused on developing and commercializing novel specialty products to meet unmet market needs, with Arbli being a key product in their portfolio [1][9] - The company aims to convert regulatory milestones into market results, viewing the launch of Arbli as a driver for near-term revenue growth and a validation of their patient-focused strategy [3][9] Product Details - Arbli is a peppermint-flavored oral liquid formulation that does not require refrigeration and has a shelf life of 24 months when stored at room temperature [4] - It is indicated for the treatment of hypertension in adults and children over six years old, and it helps reduce the risk of cardiovascular events [6][8]

Core Viewpoint - Scienture Holdings, Inc. has entered into an agreement to fully discharge all outstanding balances on secured convertible debentures with Arena Investors, marking a significant step in strengthening its financial position and capital structure [1][3][4]. Group 1: Agreement Details - The agreement involves amending the conversion price of the debentures to $2.4861 per share of common stock, with Arena Investors agreeing to convert the remaining amounts owed into shares [2]. - Following the conversion, all obligations under the debentures and related documents are deemed paid in full, and all associated liens and security interests will be released [3]. Group 2: Strategic Implications - The conversion of the debentures is seen as a pivotal step in advancing the company's long-term strategic objectives, eliminating interest-bearing obligations, and optimizing the capital structure [4]. - The company aims to build on recent commercial momentum from its first product launch, positioning itself for accelerated growth [5].

Core Insights - Scienture Holdings, Inc. has formalized multiple GPO agreements for Arbli, its FDA-approved losartan oral suspension, providing access to over 2500 healthcare institutions, which represents a potential penetration into approximately 20% of the U.S. institutional market [1][2][4] - The U.S. losartan market is valued at approximately $256 million annually, with 71 million prescriptions, indicating a significant opportunity for Arbli as the first ready-to-use oral suspension of losartan [1][3] Company Overview - Scienture Holdings, Inc. focuses on developing, commercializing, and distributing novel specialty pharmaceutical products that address unmet market needs [1][9] - The company aims to create long-term value for shareholders by expanding GPO partnerships and direct contracts to deepen institutional market penetration [2] Product Details - Arbli is a proprietary formulation of losartan, the first and only liquid formulation that does not require compounding, offering reduced dosing volume and a long shelf life at room temperature [2][4] - It is FDA-approved for treating hypertension in patients over six years old, reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and treating diabetic nephropathy in certain type 2 diabetes patients [5] Market Opportunity - The GPO agreements serve as a strategic gateway for rapid adoption of Arbli across member institutions, enhancing its market presence [4] - The liquid formulation of losartan addresses the risks and inconsistencies associated with compounded prescriptions, providing a safe and effective alternative for patients [2][4]

Core Insights - Scienture Holdings, Inc. has formalized multiple commercial group purchasing organization (GPO) agreements for its new drug, Arbli, which will provide access to over 2,500 healthcare institutions across the U.S. [1][5] - The company aims to penetrate approximately 20% of the U.S. institutional market with Arbli, a novel liquid formulation of losartan potassium, a widely prescribed hypertension medication [2][4]. - The U.S. losartan market is valued at around $256 million in annual sales, with a prescription volume of 71 million, and currently, all marketed products are in oral solid form [6]. Company Developments - Arbli is FDA-approved for treating hypertension in patients over six years old and for reducing stroke risk in patients with hypertension and left ventricular hypertrophy, as well as treating diabetic nephropathy in certain type 2 diabetes patients [4]. - Arbli is the first and only FDA-approved, ready-to-use oral liquid losartan available in the U.S., which does not require compounding, offering reduced dosing volume and a long-term shelf life at room temperature [5]. - The company recently announced a registered direct offering of 3.225 million shares at $1.20 per share, generating gross proceeds of approximately $3.9 million [6]. Market Position - The agreements with GPOs and Pharmacy Benefit Managers (PBMs) are significant for securing formulary access with health plans covering over 100 million lives [3]. - Scienture's stock was down 0.16% at $0.84 during premarket trading, near its 52-week low of $0.69 [7].

Core Insights - Scienture Holdings, Inc. has announced a significant rebate agreement with a Pharmacy Benefit Manager (PBM) led Group Purchasing Organization (GPO) to enhance access to its product Arbli, a ready-to-use liquid formulation of losartan, for over 100 million lives [1][5] - Arbli is the first and only FDA-approved oral liquid formulation of losartan in the U.S., designed for patients who require or prefer a liquid alternative for hypertension treatment [2][3] - The U.S. losartan market is valued at approximately $256 million in annual sales, with a prescription volume of 71 million [4][5] Company Overview - Scienture Holdings, Inc. focuses on developing, commercializing, and distributing novel specialty pharmaceutical products to meet unmet market needs [1][11] - The company aims to provide enhanced value to patients, physicians, and caregivers through its innovative products [11] Product Details - Arbli is indicated for the treatment of hypertension in patients over six years old, reducing the risk of stroke and treating diabetic nephropathy in certain type 2 diabetes patients [2][8] - The product is available in a 165 mL bottle as a peppermint-flavored suspension, with a shelf life of 24 months at room temperature [6] Market Position - The rebate agreement is expected to facilitate rapid adoption of Arbli in the competitive $256 million U.S. losartan market, expanding patient access and reducing reimbursement barriers [5] - The product's unique formulation eliminates the need for compounding, ensuring consistent quality and dosing accuracy [3][5]

Core Insights - Scienture Holdings, Inc. has formalized a commercial Pharmacy Benefit Manager (PBM) led Group Purchasing Organization (GPO) rebate agreement, enhancing formulary access for its product Arbli, which targets health plans covering over 100 million lives [1] - Arbli is FDA-approved for treating hypertension in patients over six years old and for reducing stroke risk in patients with hypertension and left ventricular hypertrophy, as well as treating diabetic nephropathy in certain type 2 diabetes patients [2] - Arbli is the first and only FDA-approved ready-to-use oral liquid losartan in the U.S., offering advantages such as reduced dosing volume and long-term shelf life at room temperature [3] Market Context - The U.S. losartan market is valued at approximately $256 million in annual sales with a prescription volume of 71 million, with all currently marketed products available only in oral solid form [4] - Scienture recently announced a registered direct offering of 3.225 million shares at $1.20 per share, generating gross proceeds of about $3.9 million [4] - As of the latest check, SCNX stock was down 4.01% at $0.94 during the premarket session [4]

Core Viewpoint - Scienture Holdings, Inc. has announced a registered direct offering to institutional investors, aiming to raise approximately $3.9 million by selling 3,225,000 shares of common stock at $1.20 per share, with the offering expected to close on August 15, 2025 [1]. Group 1: Offering Details - The offering involves 3,225,000 shares at an offering price of $1.20 per share, with gross proceeds expected to be around $3.9 million before fees and expenses [1]. - Maxim Group LLC is acting as the sole placement agent for this offering [2]. - The offering is made under an effective shelf registration statement on Form S-3, filed with the SEC on August 1, 2025, and declared effective on August 8, 2025 [3]. Group 2: Company Overview - Scienture Holdings, Inc. operates through its subsidiary, Scienture, LLC, focusing on developing and distributing novel specialty pharmaceutical products to meet unmet market needs [5]. - The company is committed to enhancing value for patients, physicians, and caregivers through its unique specialty products [5]. - Scienture's assets in development span various therapeutic areas and market segments [5].

Core Viewpoint - Scienture Holdings, Inc. has announced the shipment of launch quantities of Arbli (losartan potassium) Oral Suspension, marking a significant milestone for the company as it prepares for the commercial launch of this novel product aimed at treating hypertension and related conditions [1][5]. Product Overview - Arbli is the first and only FDA-approved ready-to-use oral liquid formulation of losartan in the U.S. market, designed for patients over 6 years old [2][6]. - The product is indicated for the treatment of hypertension, reduction of stroke risk in patients with hypertension and left ventricular hypertrophy, and treatment of diabetic nephropathy in certain type 2 diabetes patients [8][10]. - Arbli offers a tailored approach for patients who require or prefer a liquid option, ensuring easier and safer dosing without the need for compounding [3][4]. Market Context - Losartan is classified as an angiotensin receptor blocker (ARB) and is one of the most prescribed medications for hypertension, with total annual sales of approximately $276 million and a prescription volume of 69 million in the U.S. as of March 2025 [4]. - The global market for losartan potassium was valued at approximately $1.5 billion in sales in 2024 [4]. Company Strategy - The shipment of Arbli to the distribution center and the receipt of the first order are seen as critical milestones in Scienture's efforts to deliver the product to healthcare providers [5]. - The company emphasizes its commitment to quality by ensuring compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) standards [5]. Product Specifications - Arbli is available in a 165 mL bottle as a peppermint-flavored suspension that does not require refrigeration and has a shelf life of 24 months when stored at room temperature [6].

PART I: FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Scienture Holdings divested legacy businesses, now focused on specialty pharma, but faces critical liquidity and a $9.8M net loss, raising going concern doubts Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $15,391 | $308,096 | | Total current assets | $856,625 | $6,305,477 | | Goodwill | $21,372,960 | $21,372,960 | | Intangible assets, net | $76,400,000 | $76,400,000 | | Total assets | $104,294,834 | $104,853,805 | | **Liabilities & Equity** | | | | Total current liabilities | $7,688,199 | $7,906,893 | | Total liabilities | $26,434,370 | $25,781,684 | | Accumulated deficit | $(48,823,543) | $(39,038,973) | | Total stockholders' equity | $77,860,464 | $79,072,121 | Condensed Consolidated Statements of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $18,699 | $10,258 | $18,699 | | Total operating expenses | $5,157,906 | $1,494,988 | $8,729,896 | $6,987,959 | | Net loss from continuing operations | $(6,720,573) | $(1,624,741) | $(9,784,570) | $(8,258,163) | | Net (loss) income | $(6,720,573) | $(1,833,902) | $(9,784,570) | $19,412,131 | | Basic Net loss per share (continuing ops) | $(0.48) | $(1.16) | $(0.83) | $(6.75) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity (Six Months Ended June 30) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,990,704) | $(5,967,718) | | Net cash provided by investing activities | $0 | $27,431,815 | | Net cash provided by (used in) financing activities | $4,697,999 | $(13,896,011) | | **Net change in cash** | **$(292,705)** | **$7,568,086** | | Cash at end of period | $15,391 | $7,719,993 | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail corporate changes, legacy divestiture, Scienture acquisition, a 'Going Concern' warning due to low cash and deficit, and significant legal proceedings - The company completed the sale of its legacy subsidiaries (IPS, Softell, and Bonum Health, Inc.) on April 30, 2025, to Tollo Health, LLC, an entity with beneficial interests held by the company's former CEO and President. The consideration was a **$5 million promissory note**, resulting in a recognized loss on disposition of **$385,528**[30](index=30&type=chunk)[34](index=34&type=chunk) - Management has expressed substantial doubt about the company's ability to continue as a going concern due to its accumulated deficit of **$48.8 million** and cash balance of only **$15,391** as of June 30, 2025. The company will need to raise additional capital to meet its funding requirements for the next 12 months[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) - The company is facing two significant legal challenges: a complaint from Eat Well Investment Group seeking over **$8.5 million** in stock and other damages related to the prior Superlatus acquisition, and a complaint from Kesin Pharma Corporation seeking payment of a disputed **$1.285 million** termination fee[149](index=149&type=chunk)[151](index=151&type=chunk)[153](index=153&type=chunk) - Subsequent to the quarter's end, in July and August 2025, the company initiated a capital raise of up to **$3.0 million**, and as of August 6, 2025, had received approximately **$1.3 million** in proceeds from the sale of **754,716 shares** of common stock at **$1.59 per share**[163](index=163&type=chunk)[164](index=164&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=36&type=section&id=ITEM%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) MD&A details the strategic pivot to specialty pharma, focusing on Scienture's pipeline, with critically low liquidity and surging expenses reinforcing going concern uncertainty [Company Overview and Strategy](index=36&type=section&id=Company%20Overview%20and%20Strategy) Following legacy divestiture and Scienture acquisition, the company transformed into a specialty pharmaceutical firm focused on CNS/cardiovascular diseases, advancing its pipeline including FDA-approved SCN-102 - The company has completed a strategic realignment by divesting its legacy subsidiaries (IPS, Softell, Bonum Health) to sharpen its focus on the high-growth Branded and Specialty Pharma markets through its Scienture subsidiary[178](index=178&type=chunk) - Scienture's lead product candidate, SCN-102 (Arbli), an oral liquid formulation of losartan, was approved by the FDA in March 2025. It is the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market[189](index=189&type=chunk) Scienture's Development Pipeline | Product Candidate | Description | Development Stage/Key Milestone | | :--- | :--- | :--- | | **SCN-102 (Arbli)** | Losartan Oral Suspension for hypertension | FDA approved in March 2025 | | **SCN-104** | Multi-dose DHE injection pen for migraine | Planning Phase 1 study in 2026 post-IND submission | | **SCN-106** | Potential Biosimilar (thrombolytic agent) | Completed Biosimilar Initial Advisory meeting with FDA | | **SCN-107** | Bupivacaine Long-Acting Injection for pain | Anticipates IND submission and Phase 1 study initiation in 2025 | [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is precarious, with cash falling 95% to $15,391 and working capital deteriorating to a $6.8M deficit, necessitating capital raises and reinforcing going concern doubts Key Liquidity Metrics | Metric | June 30, 2025 | December 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Cash | $15,391 | $308,096 | -95% | | Current Assets | $856,625 | $6,305,477 | -86% | | Current Liabilities | $7,688,199 | $7,906,893 | -3% | | Working Capital | $(6,831,574) | $(1,601,416) | -327% | - The company's primary sources of liquidity have shifted from operations and asset sales to prospective sales of equity and debt securities following the divestiture of its legacy businesses[206](index=206&type=chunk) - A 'Going Concern' warning is explicitly stated, citing the accumulated deficit of **$48.8 million**, a cash balance of only **$15,391**, and the need to raise additional capital to fund operations over the next 12 months[209](index=209&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) [Results of Operations](index=45&type=section&id=Results%20of%20Operations) Operational results reflect strategic transformation, with revenues near zero and surging operating expenses, including R&D and interest, leading to a significantly wider net loss from continuing operations Comparison of Operations for the Three Months Ended June 30, 2025 and 2024 | Line Item | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $0 | $18,699 | -100% | | Total operating expenses | $5,157,906 | $1,494,988 | +245% | | Research and development | $843,549 | $0 | N/A | | Interest expense | $653,493 | $4,949 | +13104% | | Net loss from continuing operations | $(6,720,573) | $(1,624,741) | +314% | Comparison of Operations for the Six Months Ended June 30, 2025 and 2024 | Line Item | 2025 | 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $10,258 | $18,699 | -45% | | Total operating expenses | $8,729,896 | $6,987,959 | +25% | | Research and development | $1,418,228 | $0 | N/A | | Interest expense | $1,324,277 | $103,464 | +1180% | | Net loss from continuing operations | $(9,784,570) | $(8,258,163) | +18% | - The increase in operating expenses is primarily due to the addition of personnel and R&D activities from the Scienture acquisition, which did not exist in the prior-year period. R&D expenses for Q2 2025 were **$843,549**[220](index=220&type=chunk)[224](index=224&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=50&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) As a "smaller reporting company," the company is not required to provide quantitative and qualitative disclosures about market risk - As a "smaller reporting company," Scienture Holdings, Inc. is not required to provide the information for this item[244](index=244&type=chunk) [Controls and Procedures](index=50&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective[246](index=246&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[249](index=249&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=52&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is involved in significant legal proceedings, including claims from Eat Well Investment Group and Kesin Pharma Corporation, with management acknowledging inherent litigation uncertainty - The company is subject to ongoing litigation, with details provided in Note 12 of the financial statements, which includes significant claims from Eat Well and Kesin Pharma[252](index=252&type=chunk) - Management does not currently expect pending litigation to have a material adverse effect, but notes that outcomes are uncertain and could change[251](index=251&type=chunk)[253](index=253&type=chunk) [Risk Factors](index=52&type=section&id=ITEM%201A.%20RISK%20FACTORS) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have been made to the risk factors disclosed in the company's Form 10-K[254](index=254&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=52&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) In Q2 2025, the company issued 3,002,086 shares for services, and post-quarter, raised $1.3 million by selling 754,716 shares in an unregistered capital raise - In Q2 2025, the company issued **3,002,086 shares** of common stock for services, including to directors, officers, and consultants[257](index=257&type=chunk)[258](index=258&type=chunk) - Post-quarter, the company raised approximately **$1.3 million** by selling **754,716 shares** of common stock in a private placement as part of an approved capital raise of up to **$3 million**[255](index=255&type=chunk)[256](index=256&type=chunk) [Defaults Upon Senior Securities](index=53&type=section&id=ITEM%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) None reported - The company reported no defaults upon senior securities[261](index=261&type=chunk) [Mine Safety Disclosures](index=53&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) Not applicable - The company reported no mine safety disclosures[262](index=262&type=chunk) [Other Information](index=53&type=section&id=ITEM%205.%20OTHER%20INFORMATION) No material Form 8-K information was omitted, nor were there changes to stockholder nomination procedures or officer/director 10b5-1 trading plans - No material information was omitted from Form 8-K filings during the quarter[263](index=263&type=chunk) [Exhibits](index=54&type=section&id=ITEM%206.%20EXHIBITS) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, material agreements, and officer certifications

Core Viewpoint - Scienture Holdings, Inc. has announced a bridge funding raise of up to $3 million, with approximately $1.2 million already secured, aimed at supporting upcoming product launches and pipeline development efforts [1][2]. Group 1: Funding Details - The bridge funding will not include any dilutive securities such as warrants or options, indicating strong investor confidence in the company's strategy [2]. - The capital raised will be allocated to support the commercial launches of products and development of the pipeline program [2]. Group 2: Management Commentary - The Executive Chairman emphasized the importance of obtaining funding on favorable terms, highlighting investor belief in the company's mission and future prospects [3]. - The Co-Chief Executive Officer expressed excitement over the recognition from sophisticated investors regarding the company's growth potential and mission [3]. Group 3: Company Overview - Scienture Holdings, Inc. operates as a holding company for pharmaceutical entities focused on developing and distributing specialty products to meet unmet market needs [1][4]. - The company, through its subsidiary Scienture, LLC, aims to provide enhanced value to patients and healthcare systems with a diverse range of therapeutic products [4].