Core Insights - Scienture Holdings, Inc. has transitioned from a health services IT focus to a branded specialty pharmaceutical company, emphasizing the development of innovative specialty products [2][3] - The company has two FDA-approved products set for launch in the second half of 2025, including Arbli and REZENOPY, with a strong commercial operations strategy in place [3][9] - Scienture, LLC aims to address critical gaps in patient care through a diverse product pipeline and strategic partnerships, enhancing value for patients and healthcare systems [4][11] Company Transformation - The company completed a significant transformation by selling assets of its subsidiary TRXaDE Inc. for $22.5 million and merging with Scienture, Inc. in a deal valued at $103 million [2] - The focus has shifted to developing a novel specialty product pipeline, with plans to divest legacy subsidiaries related to healthcare IT and pharmaceutical wholesaling [3] Product Development - Scienture has achieved key milestones in product development, including the filing and approval of the NDA for Arbli and the acquisition of REZENOPY [6][8] - The company is developing multiple products, including an injectable pen for migraine treatment and a non-opioid pain management solution, with regulatory pathways being established [7] Business Development - Scienture has secured exclusive U.S. rights to launch REZENOPY, which is positioned as the most potent naloxone product available, with an estimated annual sales potential of $189 million [8] - The company is leveraging its industry networks to identify revenue opportunities and enhance its business development efforts [15] Commercial Operations - A robust commercial operations strategy is in place to support the launch of Arbli and REZENOPY, focusing on various functional areas such as digital marketing, payor contracting, and distribution [9][10] - The company aims to expand access and improve clinical outcomes through innovative product offerings and a flexible commercialization model [11] Future Outlook - Over the next 12 months, the company will concentrate on executing its commercial strategy, enhancing its workforce, and driving market performance [10][15] - The focus will be on creating value for patients, caregivers, and shareholders through innovative solutions and effective product launches [12]

Revenue and Profitability - The Company reported revenues of $136,643 for the year ended December 31, 2024, a decrease of $1,227,187 or 90% compared to $1,363,830 in 2023, primarily due to the disposition of Softell's assets and operations [463][464]. - Gross profit for 2024 was $6,005, a decrease of $43,026 or 88% from $49,031 in 2023, with a gross profit margin of 4.39% compared to 3.60% in 2023 [465]. - The net loss from continuing operations for 2024 was $18,778,876, an increase of $10,296,011 or 121% compared to $8,482,864 in 2023 [463]. - The company recognized a net loss from continuing operations of $18,244,480 for the year ended December 31, 2024, compared to a net loss of $8,482,864 for the year ended December 31, 2023 [474]. Expenses - Cost of goods sold for 2024 was $130,638, down $1,184,162 or 90% from $1,314,800 in 2023, reflecting fewer revenue-generating operations [465]. - Operating expenses increased to $14,707,020 in 2024, up $10,261,538 or 231% from $4,445,482 in 2023, driven by significant increases in general and administrative expenses [463]. - Wages and salary expense increased by $1,484,520 to $2,111,067 for the year ended December 31, 2024, compared to $626,547 for the same period in 2023 [466]. - Professional fees rose by $583,196 to $1,458,332 compared to $875,136 for the comparable period in 2023, primarily due to increased Board members' fees and consulting expenses [467]. - General and administrative expenses increased by $5,369,446 to $6,706,082 for the year ended December 31, 2024, compared to $1,336,637 for the same period in 2023, mainly due to shares issued for services valued at $4,598,294 [469]. - Research and development expenses related to Scienture LLC's operations post-acquisition totaled $2,236,690 for the year ended December 31, 2024 [471]. Cash Flow and Financial Position - Cash used in operating activities for 2024 was $14,265,238, compared to $2,225,192 in 2023, marking an increase of $12,040,046 or 541% [458][459]. - Cash provided by investing activities for 2024 was $27,552,791, a significant increase from cash used of $275,717 in 2023, primarily due to the MMS disposition and acquisition of Scienture, Inc. [460]. - The Company had an accumulated deficit of $39,038,973 and cash of $308,096 as of December 31, 2024 [456]. - Cash increased to $308,096 as of December 31, 2024, compared to $314 as of December 31, 2023, marking a 98020% increase [477]. - Current assets (excluding cash) rose by $3,244,632 to $5,997,381 for the year ended December 31, 2024, representing a 118% increase compared to $2,752,749 in 2023 [477]. Dividends and Capital Raising - The company declared a special cash dividend of $8.00 per share, totaling $12,671,072, payable on March 22, 2024 [479]. - A second special cash dividend of $1.50 per share was declared, totaling $2,187,759, payable on July 22, 2024 [480]. - The Company plans to raise additional capital through equity and debt to support ongoing operations and potential acquisitions, but there is uncertainty regarding the availability of favorable terms [457][454]. Strategic Decisions - The Company is in the process of determining a divestment and winddown plan for Softell and IPS, with the Board of Directors approving this plan on January 25, 2025 [447]. - Net income from discontinued operations increased by $36,670,988 to $27,310,278 for the year ended December 31, 2024, compared to a net loss of $9,360,710 for the year ended December 31, 2023 [475].

Core Insights - Scienture Holdings, Inc. has appointed Michele Rath as Senior Vice President and Chief Commercial Officer of its subsidiary, Scienture, LLC, to enhance its commercial operations and market reach [1][2] - The company has established a strategic partnership with Syneos Health, which will act as its Contract Sales Organization, aiming to leverage Syneos Health's expertise in outsourced sales solutions [1][3] Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on providing novel specialty pharmaceutical products to meet unmet market needs [5] - Scienture, LLC is dedicated to developing and marketing unique specialty products, with a team experienced in the pharmaceutical industry [5] Leadership and Strategy - Michele Rath brings over 20 years of experience from leading roles at Pfizer, CVS Caremark, and Aurobindo Pharma, focusing on sales strategy and market access [2] - Under Rath's leadership, Scienture, LLC aims to drive revenue growth, strategic partnerships, and customer engagement [2] Collaboration with Syneos Health - The partnership with Syneos Health will enhance Scienture, LLC's commercial capabilities through a comprehensive suite of services, including field sales and tech-enabled engagement strategies [3] - Syneos Health's Kinetic platform will provide predictive and adaptive analytics to streamline commercial solutions for Scienture, LLC [3] Product Launches - Scienture, LLC is preparing to launch two FDA-approved products: Arbli (losartan potassium) oral suspension and Rezenopy (naloxone HCl) nasal spray, with expectations of accelerated growth through the new commercial strategies [4]

Core Viewpoint - Scienture Holdings, Inc. has successfully completed a draw on its Equity Line of Credit (ELOC) to support the commercial launch of its FDA-approved product, Arbli, while temporarily suspending further draws until certain conditions are met [1][2][3]. Financial Strategy - The draw on the ELOC is aimed at providing immediate capital for pre-launch activities of Arbli, the first FDA-approved ready-to-use oral liquid losartan in the U.S. market [2]. - The company has decided to pause further ELOC draws for 30 trading days or until its stock price reaches $10 per share, indicating confidence in its business prospects [3]. Product Information - Arbli is a novel antihypertensive medication indicated for treating hypertension in patients over 6 years old, reducing stroke risk in patients with hypertension and left ventricular hypertrophy, and treating diabetic nephropathy in certain type 2 diabetes patients [4]. - The product is available in a 165 mL peppermint-flavored suspension that does not require refrigeration and has an 18-month shelf life when stored at room temperature [5]. Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on providing enhanced value to patients and healthcare systems by developing and distributing specialty pharmaceutical products [6]. - The company is committed to addressing unmet market needs and has a team of experienced professionals dedicated to bringing unique specialty products to market [6].

TAMPA, FL, March 18, 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 developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the U.S. Food and Drug Administration (FDA) has approved SCN-102, one of the products being developed by Scienture, LLC, a wholly owned ...

Core Viewpoint - Scienture Holdings, Inc. has entered into a definitive agreement with Summit Biosciences for the exclusive U.S. rights to launch REZENOPY, a naloxone HCl nasal spray, aimed at addressing the opioid overdose crisis [1][4]. Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on developing and distributing novel specialty pharmaceutical products to meet unmet market needs [11]. - Scienture, LLC is a specialty pharmaceutical company with a team dedicated to bringing unique products to market [11]. Product Details - REZENOPY (naloxone HCl) Nasal Spray 10mg is the most potent version of naloxone available, designed for emergency treatment of opioid overdose [3][7]. - The product is intended for intranasal use and is supplied in a carton containing two blister packages, each with a single spray device [7]. Collaboration and Manufacturing - Kindeva Drug Delivery will manufacture and supply REZENOPY, while Scienture will own the new drug application and handle sales, marketing, and distribution in the U.S. [2]. - This collaboration is seen as a strategic step to enhance public health initiatives and improve access to life-saving interventions for those at risk of opioid overdose [4][6]. Market Context - The nasal delivery of naloxone HCl is recognized for its efficacy and ease of use, making it a vital tool for first responders and healthcare providers [5]. - According to IQVIA data, the total annual sales for naloxone in the U.S. market reached $189 million, with a unit volume of 10 million [5].

Core Insights - Scienture Holdings, Inc. is participating in the 8th Annual Conference of The Society for the Study of Xenobiotics (SSX) India, focusing on drug discovery and development [1][3] - Dr. Narasimhan Mani will present on technology-driven product innovations and market strategies in the specialty pharmaceutical industry [2][5] - The SSX conference aims to facilitate knowledge sharing among scientists and industry experts in the field of drug discovery [3] Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on providing novel specialty pharmaceutical products to meet unmet market needs [5] - The company is involved in various therapeutic areas and markets, including government organizations, hospitals, and independent pharmacies [5] Conference Details - The SSX 2025 Conference will take place from January 23-25, 2025, at BITS Pilani, Hyderabad Campus [1] - The event will feature expert panels, presentations, and networking opportunities with industry veterans [7]

Core Insights - Scienture Holdings, Inc. is participating in the 8th Annual Conference of The Society for the Study of Xenobiotics (SSX) India, focusing on drug discovery and development [1][3] - Dr. Narasimhan Mani will present on technology-driven product innovations and market strategies to enhance patient access to novel therapies [2][5] - The SSX conference aims to provide a platform for knowledge exchange among scientists in the DMPK/ADMET fields, showcasing trends in the global pharmaceutical industry [3][7] Company Overview - Scienture Holdings, Inc. operates through its subsidiaries, focusing on delivering novel specialty pharmaceutical products to meet unmet market needs [5] - The company is involved in various therapeutic areas and market segments, including government organizations, hospitals, and independent pharmacies [5] Conference Details - The SSX 2025 Conference will take place from January 23-25, 2025, at BITS Pilani, Hyderabad Campus, featuring expert panels and presentations [1][4] - The event has seen a steady increase in participation from industry experts, scientists, and students over the years [3]

Company Overview - Scienture Holdings, Inc. is a specialty pharmaceutical company with a novel pipeline of brand products, focusing on providing enhanced value to patients, physicians, and caregivers through specialty products that address unmet market needs [6] - The company operates through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, which cater to various therapeutic areas and market segments [6] Event Participation - Scienture Holdings will participate in The Microcap Conference 2025, scheduled for January 28-30, 2025, at the Borgata Hotel Spa & Casino in Atlantic City, NJ [1] - The management team will deliver a corporate presentation and engage in one-on-one meetings with institutional and individual investors to discuss recent developments, growth strategy, and investment opportunities [2] Conference Details - The Microcap Conference is the largest independent microcap event in the U.S., providing a platform for companies to showcase their value propositions through presentations and networking opportunities [3] - The 2025 event will feature keynote speakers, expert panels, and entertainment, including a fireside chat with industry figures and insights on investing and market trends [4]

Financial Performance - Revenues for the three months ended September 30, 2024, were $64,861, compared to $83,560 for the same period in 2023, representing a decrease of approximately 22.4%[6] - Gross profit for the nine months ended September 30, 2024, was $39,592, down from $162,990 in 2023, indicating a decline of about 75.8%[6] - The net loss from continuing operations for the three months ended September 30, 2024, was $(3,183,601), compared to $(88,136) in 2023, marking a significant increase in losses[6] - The company reported a net loss per common share from continuing operations of $(1.34) for the three months ended September 30, 2024, compared to $(0.11) in the same period of 2023[6] - The company reported a net loss of $(3,183,601) for the quarter ending September 30, 2024[7] - The company reported a net loss from continuing operations of $11,441,764 for the nine months ended September 30, 2024, compared to a loss of $3,429,112 for the same period in 2023, indicating a significant increase in losses[8] - The net income (loss) on discontinued operations for the three months ended September 30, 2024, was $27,670,294, compared to a loss of $2,748,833 in the same period of 2023[40] - The company reported a loss on the disposition of business amounting to $2,083,742, included in income from discontinued operations, net of tax[37] Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $3,501,674, compared to $801,270 in the same period of 2023, reflecting an increase of approximately 337.5%[6] - Total operating expenses rose by $7,783,789 to $10,489,633, a 355% increase compared to the same period in 2023[85] - Research and development expenses for the three months ended September 30, 2024, were $1,253,983, with no comparable expenses reported in the same period of 2023[6] - Research and development expenses were $1,253,983 for the nine months ended September 30, 2024, compared to $0 in the same period of 2023, due to costs associated with the Scienture merger[85] Cash Flow and Assets - Cash at the end of the period was $579,103 as of September 30, 2024, compared to $34,031 at the end of the previous period[8] - The company has $4,505,797 in other receivables as of September 30, 2024, primarily consisting of short-term advances to Wellgistics Health, Inc.[21] - Cash provided by investing activities for the nine months ended September 30, 2024, was $27,552,791, compared to $74,283 for the same period in 2023[81] - Current assets (excluding cash) rose to $6,676,813 as of September 30, 2024, compared to $2,752,749 at the end of 2023, marking an increase of 143%[77] - Current liabilities decreased to $5,413,438 as of September 30, 2024, from $11,556,355 at the end of 2023, representing a reduction of 53%[77] Equity and Stock Transactions - The company executed a 1:15 reverse stock split on June 21, 2023, to comply with Nasdaq Listing Rule 5550(a)(2)[18] - The company issued common stock for services totaling $4,450,914 during the reporting period[7] - The Company issued 291,536 shares of common stock and 6,826,753 shares of Series X Preferred Stock as part of the Scienture Merger Agreement, with a total fair value of $78,646,184[56] - The Company authorized the issuance of up to 9,211,246 shares of Series X Preferred Stock, convertible into common stock[53] Acquisitions and Mergers - The company completed the acquisition of Superlatus on July 31, 2023, with a total value of $225,000,169, which included 136,441 shares of common stock and 306,855 shares of Series B Preferred Stock[10] - The company entered into a merger agreement with Scienture on July 25, 2024, resulting in the issuance of 291,536 shares of common stock and 6,826,753 shares of Series X Non-Voting Convertible Preferred Stock[11] - The Company acquired Scienture, Inc. for a total purchase consideration of $78,646,184, which included 291,536 shares of common stock and 6,826,753 shares of Series X Preferred Stock[27][28] Strategic Changes - The company anticipates dissolving Bonum Health, LLC, which was formed to hold telehealth assets, indicating a strategic shift in focus[9] - The company plans to commercialize innovative and branded pharmaceutical products in the US market through its subsidiary Scienture, targeting unmet medical needs[9] - The company plans to raise additional funding through equity sales and debt to support ongoing operations and potential acquisitions[79] Legal and Compliance - The company won a legal case against Studebaker Defense Group, LLC, with a court order for $550,000, but no payments have been received as of the filing date[63] - The company has a termination fee liability of $1,285,000 related to the agreement with Kesin Pharma Corporation, which remains outstanding as of September 30, 2024[65] Debt and Financing - The Company entered into a Loan and Security Agreement for $2,000,000 with NVK Finance, LLC, with an interest rate of 15.50% as of September 30, 2024[46] - A convertible note of $360,000 was issued in August 2024, with net proceeds of $314,000 and a monthly amortization payment of $7,200 starting six months after issuance[47] - The Company has accrued interest on its loans totaling $18,432 as of December 31, 2023[51]