Core Insights - Scienture Holdings, Inc. is focused on enhancing patient care through the development and commercialization of novel pharmaceutical products, specifically highlighting the upcoming launch of REZENOPY and the growth of ARBLI [1][4][17] Group 1: Product Developments - ARBLI, the first FDA-approved ready-to-use oral liquid formulation of losartan, addresses a significant market need in the U.S. losartan market, which has an annual size of approximately $241 million and 72 million prescriptions [2][8] - The company plans to launch REZENOPY, an opioid overdose emergency treatment, in Q2 2026, targeting a market with annual sales of $143 million and 9.2 million prescriptions [4][14] Group 2: Market Access and Growth Initiatives - Scienture has implemented various initiatives to expand access to ARBLI, including securing GPO agreements and expanding formulary inclusion, which will increase patient and provider access [4][5] - The company has established partnerships with BlinkRx to enhance patient access and adherence through a digital pharmacy platform [5] Group 3: Financial Performance and Outlook - Scienture reported a significant improvement in its balance sheet, with a cash position of approximately $7.0 million as of December 31, 2025, and a reduction in outstanding debt [7] - The company anticipates continued growth in ARBLI prescription volumes and improved commercial efficiency, expecting Q1 2026 to reflect the momentum built in prescriber adoption and patient demand [6][7]

Core Insights - The U.S. naloxone market has annual sales of approximately $154 million, with a unit volume of 9.3 million units, indicating a significant and growing market opportunity for naloxone products [4]. Company Overview - Scienture Holdings, Inc. is a holding company focused on developing, commercializing, and distributing novel specialty pharmaceutical products to address unmet market needs [1][10]. - Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, has entered into an agreement with Summit Biosciences for the exclusive U.S. commercialization rights to REZENOPY, a naloxone HCl nasal spray [2]. Product Details - REZENOPY is the highest dosage naloxone HCl nasal spray approved by the FDA, designed to effectively combat potent opioids [4]. - The product received FDA approval on April 19, 2024, and is indicated for emergency treatment of known or suspected opioid overdose [3][6]. Intellectual Property - The U.S. Patent and Trademark Office issued U.S. Patent No. 12,514,854 B2 for REZENOPY, effective January 6, 2026, with an expiry date of February 5, 2041, providing additional intellectual property protection [1][3]. - The patent is eligible for listing in the FDA's Orange Book, which may further support the product's commercialization in the U.S. [3]. Market Strategy - The patent issuance is viewed as a critical milestone that strengthens the intellectual property supporting REZENOPY and reinforces the value of Scienture's exclusive commercialization rights [5]. - Scienture aims to leverage the growing naloxone market and strong FDA approval status to drive meaningful impact and build long-term shareholder value [5].

Core Insights - The U.S. naloxone market has annual sales of approximately $154 million, with a unit volume of 9.3 million units [3] Company Overview - Scienture Holdings, Inc. is a holding company focused on developing, commercializing, and distributing specialty pharmaceutical products to meet unmet market needs [8] - Scienture, LLC, a wholly owned subsidiary, has entered into an exclusive agreement with Summit Biosciences for the U.S. commercialization rights of REZENOPY [2][8] Product Launch - REZENOPY is a high-strength naloxone HCl nasal spray (10 mg) approved by the FDA, designed for emergency treatment of opioid overdose [3][5] - The product is expected to be ready for wholesale distribution in Q1 2026, with commercial availability anticipated in early Q2 2026 [4] Market Positioning - REZENOPY is positioned as the highest-strength naloxone available, intended for patients who may require multiple doses of lower-strength naloxone [4] - The product aims to address critical needs in overdose situations involving potent opioids [4]

U.S. Losartan market totals $245M annually with 71M prescriptions COMMACK, NY, Dec. 10, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, and Blink Rx LLC (“BlinkRx”), one of the most advanced patient access platforms fo ...

Company Overview - Scienture Holdings, Inc. is a NASDAQ-listed specialty branded pharmaceutical company founded approximately 6 years ago [2] - The company focuses on identifying value within the pharmaceutical branded space by improving existing molecules and addressing deficiencies in standard care across various therapeutic areas [3] Product Development Strategy - Scienture Holdings aims to develop better versions of existing pharmaceutical products that significantly enhance the standard of care [3] - The company leverages extensive experience in R&D, product development, and therapeutic area strategy as part of its management team and partnerships [4] Commercial Operations - In addition to product development, Scienture Holdings has established robust commercial operations, collaborating with partners on branding and promotion strategies [4] - The company focuses on placing products in various classes of trade to drive growth [4]

Core Viewpoint - Scienture Holdings, Inc. is actively participating in the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025, showcasing its focus on developing and commercializing specialty pharmaceutical products to meet unmet market needs [1][4]. Company Overview - Scienture Holdings, Inc. (NASDAQ: SCNX) is a holding company for pharmaceutical operating companies, emphasizing enhanced value for patients, physicians, and caregivers through novel specialty products [1][6]. - The company operates through its subsidiary, Scienture, LLC, which is dedicated to developing unique specialty products across various therapeutic areas and market segments [6]. Conference Participation - Narasimhan Mani, President and co-CEO, will present on December 9, 2025, at 2:00 PM EST, with Shankar Hariharan, Executive Chairman and co-CEO, participating in one-on-one investor meetings on December 10 [2]. - The live webcast of the presentation will be available online, with a replay accessible afterward [3]. Event Details - The iAccess Alpha conference features high-potential small and micro-cap companies, providing a platform for webcast presentations and one-on-one meetings with pre-qualified investors [4][5].

Core Insights - Scienture Holdings, Inc. reported significant revenue growth to $590,050 and a substantial increase in gross profit to $574,621 for Q3 2025 compared to Q3 2024 [2][5][19] - The company launched Arbli, the first FDA-approved ready-to-use liquid formulation of losartan for hypertension, which has been added to key national payor formularies, expanding access to over 100 million covered lives [2][3] - Scienture is preparing to launch REZENOPY, an opioid overdose emergency treatment, in Q1 2026, leveraging a strong commercial infrastructure [2] Financial Performance - Net revenue increased from approximately $65,000 in Q3 2024 to $590,050 in Q3 2025, representing a growth of over 800% [5][19] - Gross profit rose from approximately $4,000 in Q3 2024 to $574,621 in Q3 2025, indicating a significant improvement in profitability [5][19] - The company strengthened its balance sheet by reducing outstanding debt and enhancing its cash position to over $8 million as of November 13, 2025 [2] Product Development - Arbli is a proprietary formulation of losartan, approved for treating hypertension in patients over six years old, and offers a convenient liquid alternative without the need for compounding [3][4] - The product has a shelf life of 24 months at room temperature and is designed to provide consistent quality and dosing accuracy [4] - Scienture's development pipeline remains strong, with ongoing evaluations for additional products to enhance its commercial portfolio [2] Market Position - The launch of Arbli has allowed Scienture to penetrate approximately 20% of the U.S. institutional market through agreements with over 2,500 healthcare institutions [2] - The company aims to create long-term value through sustained adoption of its products across various channels, including retail and long-term care [2]

Financial Performance - Revenues for Q3 2025 reached $590,050, a significant increase from $64,861 in Q3 2024, representing a growth of 810%[17] - Gross profit for Q3 2025 was $574,621, compared to $3,883 in Q3 2024, indicating a substantial improvement[17] - Operating loss for Q3 2025 was $4,361,206, compared to a loss of $3,497,791 in Q3 2024, indicating an increase in losses[17] - Net loss from continuing operations for the nine months ended September 30, 2025, was $13,391,931, compared to $11,441,764 for the same period in 2024[17] - The company reported a net loss per common share from continuing operations of $(0.19) for Q3 2025, compared to $(1.34) for Q3 2024[17] - The company reported a net loss from continuing operations of $3,607,361 for the three months ended September 30, 2025, compared to a loss of $3,183,601 for the same period in 2024[69] - The basic net loss per common share from continuing operations was $(0.19) for the three months ended September 30, 2025, compared to $(1.34) for the same period in 2024[69] Assets and Liabilities - Total current assets decreased to $1,421,074 as of September 30, 2025, down from $6,305,477 as of December 31, 2024[14] - Total liabilities decreased to $22,160,659 as of September 30, 2025, compared to $25,781,684 as of December 31, 2024, reflecting a reduction of approximately 14%[14] - Total stockholders' equity increased to $82,669,631 as of September 30, 2025, up from $79,072,121 as of December 31, 2024[14] - Cash balance increased to $355,692 as of September 30, 2025, from $308,096 as of December 31, 2024[14] Operating Expenses - The company incurred total operating expenses of $4,935,827 in Q3 2025, compared to $3,501,674 in Q3 2024, marking an increase of approximately 41%[17] - For the nine months ended September 30, 2025, the net loss from continuing operations was $13,391,931, compared to a net loss of $11,441,764 for the same period in 2024, representing an increase of approximately 17.0%[22] - The company reported stock-based compensation of $1,820,433 for the nine months ended September 30, 2025, significantly higher than $25,147 in the same period of 2024[22] Cash Flow - Net cash used in operating activities from continuing operations was $8,207,188 for the nine months ended September 30, 2025, compared to $10,585,173 for the same period in 2024, indicating a decrease of approximately 22.5%[22] - The cash at the end of the period for September 30, 2025, was $355,692, down from $579,103 at the end of September 30, 2024[22] Strategic Actions - Scienture Holdings, Inc. changed its legal name from "TRxADE HEALTH, Inc." on September 20, 2024, and acquired Scienture, LLC in July 2024[24] - The company completed the sale of Bonum Health, LLC on April 30, 2025, as part of its strategy to dispose of legacy subsidiaries[25] - The Company completed the sale of its subsidiaries IPS, Softell, and Bonum Health, Inc. to Tollo for a $5 million promissory note[34] - The divestitures are part of a strategic realignment aimed at optimizing the Company's portfolio and accelerating growth in the Branded and Specialty Pharma markets[35] - The Company intends to use proceeds from the divestment to facilitate high-growth commercial and strategic product development activities at its Scienture subsidiary[35] Acquisitions and Goodwill - The Company acquired intangible assets valued at $76.4 million and recognized goodwill of $21.37 million in the Scienture acquisition[55] - Goodwill recognized from the Scienture acquisition amounted to $21,372,960, primarily due to expected go-to-market synergies[82] - As of September 30, 2025, no goodwill impairment was recognized, as management assessed that it was not likely that the fair value of reporting units was less than their carrying values[59] Product Development - The product technologies acquired in the Scienture acquisition include new potential treatments for hypertension, migraine, pain, and thrombosis, which are in various phases of development[60] - Scienture has four primary product candidates in its development pipeline, focusing on novel treatments for hypertension, migraine, pain, and thrombosis[212] - SCN-102 received regulatory approval in March 2025, with commercialization starting in Q3 2025; SCN-104 expected to achieve approval by late 2027 or early 2028[105][106] Debt and Financing - The Company issued convertible debentures totaling up to $12,222,222, with the first tranche of $3,333,333 sold for $3,000,000, reflecting a 10% original issue discount[109][110] - The NVK Loan Agreement with NVK Finance, LLC was for $2,000,000, accruing interest at 15.50%, with an outstanding balance of $2,656,250 as of September 30, 2025[123][124] - The Company issued a senior secured promissory note (Streeterville Note) for $3,911,111.11 with a 9% interest rate and received net proceeds of $3,500,000, which were used for working capital and debt repayment[190] - The Company sold 15,722,759 shares under the ATM Program, generating $15,568,236 in gross proceeds, which were used to fully repay the Streeterville Note[192] Compensation and Employment - Dr. Mani's annual base salary increased from $325,000 to $400,000, and Dr. Hariharan's increased from $175,000 to $400,000 as part of the Employment Amendments effective October 1, 2025[194] - The Company recognized a total stock-based compensation cost of $1,512,995 due to the cancellation of 2,000,000 stock options and the granting of 2,000,000 shares of common stock[164] Legal and Settlement Matters - The Company entered into a Settlement Agreement with Kesin Pharma Corporation, agreeing to pay $1.285 million plus 8% interest and legal fees through December 2026[173] - The Company settled a dispute with Kesin Pharma Corporation for $1.285 million plus 8% interest, with payments scheduled through December 2026[195]

Core Insights - Scienture Holdings, Inc. has successfully added Arbli (losartan potassium) Oral Suspension to key national payors' formularies, expanding access to over 100 million covered lives in the U.S. [1][2][3] Product Overview - Arbli is the first FDA-approved ready-to-use oral suspension formulation of losartan potassium, providing a safe and convenient alternative to solid dosage forms [2][4]. - The U.S. losartan market is valued at approximately $256 million annually, with over 71 million prescriptions written each year, indicating a significant commercial opportunity for Scienture [2][4]. - Arbli is designed for patients over six years old and is indicated for the treatment of hypertension, reducing the risk of stroke, and treating diabetic nephropathy in certain patients with type 2 diabetes [4][7]. Market Impact - The inclusion of Arbli in major national formularies reflects the confidence health plans have in Scienture's products and enhances patient access to affordable treatment options [3][4]. - The product's unique formulation does not require compounding, has a reduced dosing volume, and offers a long shelf life at room temperature, addressing common issues associated with traditional losartan prescriptions [4][5]. Company Strategy - Scienture's leadership emphasizes the commitment to sustainable growth and improving public health outcomes through expanded access to its product portfolio [3][4]. - The company aims to make its specialty products available to millions more patients across the country, indicating a broader strategy for market penetration [3].

Market Overview - Major U.S. indices closed higher, with the Dow Jones Industrial Average up 0.3% at 46,734.61, the S&P 500 advancing nearly 0.6% to 6,738.44, and the Nasdaq climbing about 0.9% to 22,941.79 [1] Intel Corp (NASDAQ: INTC) - Intel's stock surged 3.36% to close at $38.16, reaching an intraday high of $38.4 and a low of $36.43, with a 52-week range of $17.67 to $39.65. In after-hours trading, the stock rose 7.7% to $41.10 [1] - The company's impressive third-quarter earnings included revenue of $13.65 billion, surpassing analyst expectations of $13.14 billion, and adjusted earnings per share of 23 cents, exceeding the predicted one cent, driven by increased demand for compute in the AI sector [2] Scienture Holdings, Inc. (NASDAQ: SCNX) - Scienture Holdings' shares skyrocketed 354.94% to $2.60, with an intraday high of $2.60 and a low of $0.82, and a 52-week range of $0.46 to $9.55. The stock declined 23.8% to $1.98 in after-hours trading [3] - The company announced the commencement of commercial sales for Arbli, a losartan potassium oral suspension, marking the first time the company has brought the drug to market [4] Ford Motor Co. (NYSE: F) - Ford's stock dipped 0.72% to close at $12.34, with an intraday high of $12.49 and a low of $12.19, and a 52-week range of $8.44 to $12.80. In after-hours trading, the stock rose almost 2.6% to $12.66 [5] - The company reported better-than-expected third-quarter earnings, with earnings per share of 45 cents surpassing the 36 cents estimate, and revenue of $47.18 billion also exceeding expectations [5] Deckers Outdoor Corp. (NYSE: DECK) - Deckers Outdoor saw a 1.64% rise in its stock price, closing at $102.54, with an intraday high of $104.08 and a low of $100.93, and a 52-week range from $93.72 to $223.98. In after-hours trading, the stock fell 12.3% to $89.91 [6] - The company's second-quarter earnings report revealed a 16% beat on earnings per share, with figures of $1.82 surpassing the $1.57 estimate. Deckers expects fiscal GAAP EPS between $6.30 and $6.39, slightly above the $6.28 consensus, with revenue projected at $5.35 billion, below analysts' estimate of $5.45 billion [7] Super Micro Computer, Inc. (NASDAQ: SMCI) - Super Micro's stock fell 8.72% to $47.92, with an intraday high of $51.84 and a low of $47.38, and a 52-week range of $17.25 to $66.44. In after-hours trading, the stock rose 1.2% to $48.49 [8] - The decline during regular trading hours followed a disappointing business update, projecting $5 billion in first-quarter revenue, falling short of the previously guided $6 billion to $7 billion [9]