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What changed in Scienture Holdings, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Scienture Holdings, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+300 added−385 removedSource: 10-K (2026-03-30) vs 10-K (2025-03-26)

Top changes in Scienture Holdings, Inc.'s 2025 10-K

300 paragraphs added · 385 removed · 199 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

95 edited+28 added−55 removed261 unchanged
Biggest changeThis may include in-licensing products and entering into co-promotion and co-development partnerships for Scienture LLC’s product candidates, although no agreements have been reached. Research and Development and Product Portfolio Scienture LLC is committed to the development of innovative product candidates in the CNS and CVS therapeutic areas.
Biggest changeScienture, LLC completed the acquisition of the commercial ready product asset REZENOPY TM in the first quarter of 2025. ● Target strategic business development opportunities. Scienture LLC is exploring a broad range of strategic opportunities. This may include acquiring, in-licensing and entering into co-promotion partnerships for commercial products to expand its marketed portfolio. ● Continue to grow its development pipeline.
The objective of each study was to evaluate the safety and tolerability of the test items with and without DHE to the subject animals, providing information on important potential toxic effects, target organs, progressive toxic effects, characterization of a possible dose-response relationship, and an estimate the No-Observed-Adverse-Effect Level. Both studies were designed for the qualification of the excipients.
The objective of each study was to evaluate the safety and tolerability of the test items with and without DHE to the subject animals, providing information on important potential toxic effects, target organs, progressive toxic effects, characterization of a possible dose-response relationship, and an estimate of the No-Observed-Adverse-Effect Level. Both studies were designed for the qualification of the excipients.
In carrying-out its services, Anthem will only allow those employees and personnel under Anthem’s direct control to perform such services and will obtain the Scienture LLC’s consent prior to delegating or subcontracting any portion of the services.
In carrying-out its services, Anthem will only allow those employees and personnel under Anthem’s direct control to perform such services and will obtain Scienture LLC’s consent prior to delegating or subcontracting any portion of the services.
Anthem is required to provide prompt written reports to Scienture LLC the status of the services provided by Anthem under the Anthem Agreement and any work order. Under the Anthem Agreement, Scienture LLC is responsible for paying Anthem the amounts designated on any attached work order.
Anthem is required to provide prompt written reports to Scienture LLC on the status of the services provided by Anthem under the Anthem Agreement and any work order. Under the Anthem Agreement, Scienture LLC is responsible for paying Anthem the amounts designated on any attached work order.
Either party may terminate the Agreement if (i) the other party materially breaches the Kindeva Agreement and has not cured such breach during a period of 90 days following notice of the breach, (ii) the Product is withdrawn from the market as a result of any ruling or requirement by the FDA, a voluntary recall by the FDA is issued, or there are material safety concerns that could significantly impact the commercial viability of the Product, or (iii) the Product is the subject of a mass tort liability action or is subject to material health and public safety concerns.
Either party may terminate the Kindeva Agreement if (i) the other party materially breaches the Kindeva Agreement and has not cured such breach during a period of 90 days following notice of the breach, (ii) the Product is withdrawn from the market as a result of any ruling or requirement by the FDA, a voluntary recall by the FDA is issued, or there are material safety concerns that could significantly impact the commercial viability of the Product, or (iii) the Product is the subject of a mass tort liability action or is subject to material health and public safety concerns.
In consideration of the rights granted, Scienture LLC received milestone payments and reimbursement of costs actually incurred related to SCN-102 and SCN-104.
In consideration of the rights granted, Scienture LLC received milestone payments and reimbursement of costs actually incurred related to SCN-102 and SCN-104.
On March 13, 2024, the parties terminated the Kesin Agreement by entering a Confidential Termination Agreement (the “Kesin Termination Agreement”), and the parties agreed that Scienture LLC would pay Kesin a total gross amount of $1.285 million upon commercialization of either SCN-102 or SCN-104 via a royalty arrangement.
On March 13, 2024, the parties terminated the Kesin Agreement by entering a Confidential Termination Agreement (the “Kesin Termination Agreement”), and the parties agreed that Scienture LLC would pay Kesin a total gross amount of $1.285 million upon commercialization of either SCN-102 or SCN-104 via a royalty arrangement.
The Kesin Termination Agreement also requires that if the full $1.285 million has not been repaid within two years of the earlier of (i) commercial launch of a product or (ii) 120 days after FDA approval of a product, then interest will accrue prospectively at a rate of 8% annually on the unpaid balance.
The Kesin Termination Agreement also requires that if the full $1.285 million has not been repaid within two years of the earlier of (i) commercial launch of a product or (ii) 120 days after FDA approval of a product, then interest will accrue prospectively at a rate of 8% annually on the unpaid balance.
The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery; ● The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious, or fraudulent statements or representations in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; 26 Table of Contents ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates, independent contractors or agents of covered entities, that perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information.
The federal False Claims Act also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the federal False Claims Act and to share in any monetary recovery; ● The federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit a person from knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious, or fraudulent statements or representations in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; 24 Table of Contents ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates, independent contractors or agents of covered entities, that perform services for them that involve the creation, maintenance, receipt, use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information.
The steps required to be completed by the FDA before a drug may be marketed in the United States generally include the following: ● completion of preclinical laboratory tests, animal studies, and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations; ● submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin and must be updated annually or when significant changes are made; ● approval by an independent institutional review board (“IRB”) or ethics committee at each clinical site before the clinical trial is commenced; ● performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practices (“GCPs”) requirements and other clinical-trial related regulations to establish the safety and efficacy of the proposed drug for each indication; ● preparation and submission to the FDA of an NDA or biologics license application (“BLA”), after completion of all pivotal clinical trials, which includes not only the results of the clinical trials, but also, detailed information on the chemistry, manufacture and quality controls for the product candidate and proposed labeling; ● satisfactory completion of an FDA Advisory Committee review, if applicable; 17 Table of Contents ● a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed drug is produced to assess compliance with current good manufacturing practices (“GMPs”) regulations and of selected clinical trial sites to assess compliance with GCPs; and ● FDA review and approval of the NDA or BLA to permit commercial marketing of the product for particular indications for use in the United States.
The steps required to be completed by the FDA before a drug may be marketed in the United States generally include the following: ● completion of preclinical laboratory tests, animal studies, and formulation studies performed in accordance with the FDA’s Good Laboratory Practice (“GLP”) regulations; ● submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin and must be updated annually or when significant changes are made; ● approval by an independent institutional review board (“IRB”) or ethics committee at each clinical site before the clinical trial is commenced; ● performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practices (“GCPs”) requirements and other clinical-trial related regulations to establish the safety and efficacy of the proposed drug for each indication; ● preparation and submission to the FDA of an NDA or biologics license application (“BLA”), after completion of all pivotal clinical trials, which includes not only the results of the clinical trials, but also, detailed information on the chemistry, manufacture and quality controls for the product candidate and proposed labeling; ● satisfactory completion of an FDA Advisory Committee review, if applicable; 15 Table of Contents ● a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review; ● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed drug is produced to assess compliance with current good manufacturing practices (“GMPs”) regulations and of selected clinical trial sites to assess compliance with GCPs; and ● FDA review and approval of the NDA or BLA to permit commercial marketing of the product for particular indications for use in the United States.
In exchange for the exclusive rights to develop and commercialize the Products, Scienture LLC agreed to pay Kindeva certain milestone payments, net sales share payments, and NDA cost reimbursements, including: ● A one-time commercial milestone payment of between $2.5 million and $10 million based on the achievement of certain pre-defined annual net sales targets; ● Milestone payments totaling $1 million, $200,000 of which was due upon executing the Kindeva Agreement, $300,000 of which is due within 3 months of executing the Kindeva Agreement, $250,000 of which is due upon delivery of the initial commercial supply of the Product, and $250,000 of which is due 3 months after receipt of such commercial supply; 16 Table of Contents ● Profit-sharing payments representing 10% of the net sales by Scienture LLC of the Product, which will be reduced to 8% of the net sales on the market entry of a third party generic ANDA for the Product; and ● Additional profit-sharing payments representing 5% of the net sales until the total cumulative payments equals Kindeva’s cost of developing and receiving NDA approval of the Product, which was $12.8 million as of the date of the Agreement.
In exchange for the exclusive rights to develop and commercialize the Products, Scienture LLC agreed to pay Kindeva certain milestone payments, net sales share payments, and NDA cost reimbursements, including: ● A one-time commercial milestone payment of between $2.5 million and $10 million based on the achievement of certain pre-defined annual net sales targets; ● Milestone payments totaling $1 million, $200,000 of which was due upon executing the Kindeva Agreement, $300,000 of which is due within 3 months of executing the Kindeva Agreement, $250,000 of which is due upon delivery of the initial commercial supply of the Product, and $250,000 of which is due 3 months after receipt of such commercial supply; 14 Table of Contents ● Profit-sharing payments representing 10% of the net sales by Scienture LLC of the Product, which will be reduced to 8% of the net sales on the market entry of a third party generic ANDA for the Product; and ● Additional profit-sharing payments representing 5% of the net sales until the total cumulative payments equals Kindeva’s cost of developing and receiving NDA approval of the Product, which was $12.8 million as of the date of the Kindeva Agreement.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or holds on post-approval clinical trials; ● refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals; ● product seizure or detention, or refusal of the FDA to permit the import or export of products; ● consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; ● mandated modification of promotional materials and labeling and the issuance of corrective information; 22 Table of Contents ● the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or ● injunctions or the imposition of civil or criminal penalties.
Other potential consequences include, among other things: ● restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls; ● fines, warning letters or holds on post-approval clinical trials; ● refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals; ● product seizure or detention, or refusal of the FDA to permit the import or export of products; ● consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; ● mandated modification of promotional materials and labeling and the issuance of corrective information; 20 Table of Contents ● the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or ● injunctions or the imposition of civil or criminal penalties.
The Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and both the National Institutes of Health and the FDA have signaled the government’s willingness to begin enforcing those requirements against non-compliant clinical trial sponsors. 25 Table of Contents Other Regulatory Requirements Health Care Laws Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business that may constrain the financial arrangements and relationships through which Scienture LLC researches, as well as sell, market and distribute any products for which Scienture LLC obtains marketing authorization.
The Final Rule on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and both the National Institutes of Health and the FDA have signaled the government’s willingness to begin enforcing those requirements against non-compliant clinical trial sponsors. 23 Table of Contents Other Regulatory Requirements Health Care Laws Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business that may constrain the financial arrangements and relationships through which Scienture LLC researches, as well as sell, market and distribute any products for which Scienture LLC obtains marketing authorization.
Some trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may recommend a clinical trial to be halted if it determines that there is an unacceptable safety risk for subjects or other grounds, such as futility. 18 Table of Contents Clinical trials to support an NDA or BLA for marketing approval are typically conducted in three sequential phases, but the phases may overlap or be combined.
Some trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may recommend a clinical trial to be halted if it determines that there is an unacceptable safety risk for subjects or other grounds, such as futility. 16 Table of Contents Clinical trials to support an NDA or BLA for marketing approval are typically conducted in three sequential phases, but the phases may overlap or be combined.
Additionally, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process. 24 Table of Contents Under the FDA’s breakthrough therapy program, a sponsor may seek FDA designation of its product candidate as a breakthrough therapy if the product candidate is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Additionally, the fast track designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial process. 22 Table of Contents Under the FDA’s breakthrough therapy program, a sponsor may seek FDA designation of its product candidate as a breakthrough therapy if the product candidate is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Scienture LLC has devoted and will continue to devote significant resources to research and development activities, and expects to incur significant expenses as Scienture LLC continues advancing its product candidates towards FDA approval and expanding product indications for approved products and its intellectual property portfolio.
Scienture LLC has devoted and will continue to devote significant resources to research and development activities, and expects to incur significant expenses as it continues advancing its product candidates towards FDA approval and expanding product indications for approved products and its intellectual property portfolio.
On July 31, 2023, the Company completed its acquisition of Superlatus in accordance with the terms and conditions of the Superlatus Merger Agreement (the “Superlatus Merger”), pursuant to which the Company acquired Superlatus by way of a merger of the Merger Sub with and into Superlatus, with Superlatus being a wholly owned subsidiary of the Company and the surviving entity in the Superlatus Merger. 33 Table of Contents Under the terms of the Superlatus Merger Agreement, at the closing of the Superlatus Merger (the “Closing”), shareholders of Superlatus received an aggregate of 136,441 shares of the Company’s common stock and 306,855 shares of the Company’s Series B Preferred Stock, par value $0.00001 per share (the “Series B Preferred Stock”), convertible into 100 shares of the Company’s common stock.
On July 31, 2023, the Company completed its acquisition of Superlatus in accordance with the terms and conditions of the Superlatus Merger Agreement (the “Superlatus Merger”), pursuant to which the Company acquired Superlatus by way of a merger of the Merger Sub with and into Superlatus, with Superlatus being a wholly owned subsidiary of the Company and the surviving entity in the Superlatus Merger. 29 Table of Contents Under the terms of the Superlatus Merger Agreement, at the closing of the Superlatus Merger (the “Closing”), shareholders of Superlatus received an aggregate of 136,441 shares of the Company’s common stock and 306,855 shares of the Company’s Series B Preferred Stock, par value $0.00001 per share (the “Series B Preferred Stock”), convertible into 100 shares of the Company’s common stock.
The FDA reviews an application to determine, among other things, whether the product is safe and effective and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. 19 Table of Contents The FDA may refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee—typically a panel that includes clinicians and other experts—for review, evaluation, and a recommendation as to whether the application should be approved.
The FDA reviews an application to determine, among other things, whether the product is safe and effective and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. 17 Table of Contents The FDA may refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee—typically a panel that includes clinicians and other experts—for review, evaluation, and a recommendation as to whether the application should be approved.
For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product, and (for products administered multiple times) that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. 23 Table of Contents Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date of approval of the reference product.
For the FDA to approve a biosimilar product as interchangeable with a reference product, the agency must find that the biosimilar product can be expected to produce the same clinical results as the reference product, and (for products administered multiple times) that the biologic and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. 21 Table of Contents Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date of approval of the reference product.
In addition, under FDA regulations, combination products are subject to current GMP requirements applicable to both drugs and devices, including the Quality System regulations applicable to medical devices. 21 Table of Contents Post-Approval Requirements Once an NDA or BLA is approved, a product will be subject to pervasive and continuing regulation by the FDA including, among other things, requirements relating to current GMPs, quality controls, record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
In addition, under FDA regulations, combination products are subject to current GMP requirements applicable to both drugs and devices, including the Quality System regulations applicable to medical devices. 19 Table of Contents Post-Approval Requirements Once an NDA or BLA is approved, a product will be subject to pervasive and continuing regulation by the FDA including, among other things, requirements relating to current GMPs, quality controls, record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product.
There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act. ● On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs. 28 Table of Contents Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.
There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act. ● On May 23, 2019, CMS published a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs. 26 Table of Contents Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.
SCN-102 (ARBLI TM - Losartan Oral Suspension) SCN-102 is an oral liquid formulation of losartan potassium in development under the 505(b)(2) pathway, for (i) treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old, (ii) reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy, and (iii) treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
Arbli TM (SCN-102 - Losartan Potassium Oral Suspension, 10mg/mL) Arbli TM (SCN-102) is an oral liquid formulation of losartan potassium in development under the 505(b)(2) pathway, for (i) treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old, (ii) reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy, and (iii) treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and other public and private research organizations are commercializing or pursuing the development of products utilizing the same molecules or compounds or for the same indications that Scienture LLC is currently pursuing or may target in the future. 12 Table of Contents Hypertension Hypertension (high blood pressure) is a CVS condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher).
Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and other public and private research organizations are commercializing or pursuing the development of products utilizing the same molecules or compounds or for the same indications that Scienture LLC is currently pursuing or may target in the future. 11 Table of Contents Hypertension Hypertension (high blood pressure) is a CVS condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher).
As with new NDAs and BLAs, the review process is often significantly extended by requests for additional information or clarification. 20 Table of Contents 505(b)(2) NDA Approval Process Section 505(b)(2) of the FDCA provides an alternate regulatory pathway for the FDA to approve a new product and permits reliance for such approval on published literature or an FDA finding of safety and effectiveness for a previously approved drug product.
As with new NDAs and BLAs, the review process is often significantly extended by requests for additional information or clarification. 18 Table of Contents 505(b)(2) NDA Approval Process Section 505(b)(2) of the FDCA provides an alternate regulatory pathway for the FDA to approve a new product and permits reliance for such approval on published literature or an FDA finding of safety and effectiveness for a previously approved drug product.
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. 27 Table of Contents Ensuring that Scienture LLC’s internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. 25 Table of Contents Ensuring that Scienture LLC’s internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs.
Once approved , this sales and marketing organization will include a combination of field teams, virtual sales representatives and omnichannel marketing to effectively reach health care providers and offer patient education. Scienture LLC’s promotional efforts are expected to further include developing a market access strategy to obtain commercial and government payor coverage for its products.
This sales and marketing organization will include a combination of field teams, virtual sales representatives and omnichannel marketing to effectively reach health care providers and offer patient education. Scienture LLC’s promotional efforts are expected to further include developing a market access strategy to obtain commercial and government payor coverage for its products.
Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. 29 Table of Contents Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement.
Coverage and adequate reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors is critical to new product acceptance. 27 Table of Contents Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement.
Scienture LLC’s product candidate, SCN-106, is a thrombolytic agent currently in development. Scienture LLC plans to develop SCN-106 through the FDA’s 351(k) pathway for biosimilars. 13 Table of Contents Postoperative Pain Post-surgery pain, also known as postoperative pain, is pain that a patient experiences after a surgical procedure.
Scienture LLC’s product candidate, SCN-106, is a thrombolytic agent currently in development. Scienture LLC plans to develop SCN-106 through the FDA’s 351(k) pathway for biosimilars. 12 Table of Contents Postoperative Pain Post-surgery pain, also known as postoperative pain, is pain that a patient experiences after a surgical procedure.
Pursuant to the Kindeva Agreement, Kindeva will retain control of all activities associated with manufacturing the Product, and be responsible for any non-clinical or clinical studies regard the Product. Kindeva will provide a copy of the NDA for the Product to Scienture LLC as well as all related information and data necessary for Scienture LLC to commercialize the Product.
Pursuant to the Kindeva Agreement, Kindeva will retain control of all activities associated with manufacturing the Product, and be responsible for any non-clinical or clinical studies regarding the Product. Kindeva will provide a copy of the NDA for the Product to Scienture LLC as well as all related information and data necessary for Scienture LLC to commercialize the Product.
In August 2024, Kesin demanded immediate payment of the full amount under the Kesin Termination Agreement, alleging the full amount is payable in connection with the consummation Scienture LLC’s business combination with the Company. Scienture LLC has disputed that the amount is payable, and the parties entered into discussions to resolve the issue.
In August 2024, Kesin demanded immediate payment of the full amount under the Kesin Termination Agreement, alleging the full amount is payable in connection with the consummation Scienture LLC’s business combination with the Company. Scienture LLC disputed that the amount was payable, and the parties entered into discussions to resolve the issue.
The animals treated either with DHE + DMSO + caffeine or DMSO + Caffeine formulations did not reveal any changes attributable to treatment at the end of the treatment/recovery periods. As such, both studies support a conclusion that SCN-102 is considered to have no toxicological significance across the following attributes – Hematology, Coagulation Parameters, Clinical Chemistry and Urinalysis.
The animals treated either with DHE + Dimethyl Sulfoxide (“DMSO”) + caffeine or DMSO + caffeine formulations did not reveal any changes attributable to treatment at the end of the treatment/recovery periods. As such, both studies support a conclusion that SCN-102 is considered to have no toxicological significance across the following attributes – Hematology, Coagulation Parameters, Clinical Chemistry and Urinalysis.
As shown below, several pharmacokinetics studies have shown comparability between SCN-104 and the currently available marketed injection product. 9 Table of Contents 10 Table of Contents Scienture LLC is initiating manufacturing activities and planning to conduct bioequivalence studies.
As shown below, several pharmacokinetics studies have shown comparability between SCN-104 and the currently available marketed injection product. 8 Table of Contents 9 Table of Contents Scienture LLC is initiating manufacturing activities and planning to conduct bioequivalence studies.
Currently, there are no FDA-approved liquid formulations of losartan potassium. 7 Table of Contents A Phase I PK study has shown that SCN-102 has close comparability to the immediate-release tablet as depicted in the data below: Summary of Statistical Results for Losartan Potassium Oral Liquid 10 mg/ml (T) versus Losartan Potassium Immediate Release Tablets 100 mg (R) – For Losartan Geometric Means of treatment: Ratio Intra-subject 90% SABE Result – SABE PK Parameter N Test (T) Reference (R) (%) %CV CI of Ratio Bound SWR Log C max (ng/ml) 44 1317.6955 974.6741 135.19 39.6 122.19 – 149.58 0.070 0.3361 LogAUC 0-t (ng.hr/ml) 44 1590.6271 1581.0602 100.61 13.2 97.25 – 104.08 -0.014 0.1576 LogAUC 0-inf (ng.hr/ml) 44 1615.4717 1605.3052 100.63 13.0 97.34 – 104.03 -0.014 0.1549 Summary of Statistical Results for Losartan Potassium Oral Liquid 10 mg/ml (T) versus Losartan Potassium Immediate Release Tablets 100 mg (R) – For Carboxylic Acid Metabolite Geometric Means of treatment: Ratio Intra-subject 90% SABE Result – SABE PK Parameter N Test (T) Reference (R) (%) %CV CI of Ratio Bound SWR Log C max (ng/ml) 44 1160.0978 1056.3253 109.82 25.5 102.91 – 117.20 -0.028 0.2828 LogAUC 0-t (ng.hr/ml) 44 6775.8841 6726.8952 100.73 10.3 98.11 – 103.42 -0.006 0.1099 LogAUC 0-inf (ng.hr/ml) 44 6872.6739 6823.3736 100.72 10.2 98.13 – 103.39 -0.006 0.1071 Specifically, the Phase I PK study showed that SCN-102 was comparable to immediate release tablets based on the following: ● The overall exposure for the Carboxylic Acid metabolite (EXP-3174) meet the confidence interval 80-125% range. ● The overall exposure for Losartan were within the 90% confidence interval. ● The Cmax for Losartan analyte, a pro-drug, for SCN-102 was slightly higher than the immediate release tablets (122.19 - 149.58%).
A Phase I PK study has shown that SCN-102 has close comparability to the immediate-release tablet as depicted in the data below: Summary of Statistical Results for Losartan Potassium Oral Liquid 10 mg/ml (T) versus Losartan Potassium Immediate Release Tablets 100 mg (R) – For Losartan Geometric Means of treatment: Ratio Intra-subject 90% SABE Result – SABE PK Parameter N Test (T) Reference (R) (%) %CV CI of Ratio Bound SWR Log C max (ng/ml) 44 1317.6955 974.6741 135.19 39.6 122.19 – 149.58 0.070 0.3361 LogAUC 0-t (ng.hr/ml) 44 1590.6271 1581.0602 100.61 13.2 97.25 – 104.08 -0.014 0.1576 LogAUC 0-inf (ng.hr/ml) 44 1615.4717 1605.3052 100.63 13.0 97.34 – 104.03 -0.014 0.1549 Summary of Statistical Results for Losartan Potassium Oral Liquid 10 mg/ml (T) versus Losartan Potassium Immediate Release Tablets 100 mg (R) – For Carboxylic Acid Metabolite Geometric Means of treatment: Ratio Intra-subject 90% SABE Result – SABE PK Parameter N Test (T) Reference (R) (%) %CV CI of Ratio Bound SWR Log C max (ng/ml) 44 1160.0978 1056.3253 109.82 25.5 102.91 – 117.20 -0.028 0.2828 LogAUC 0-t (ng.hr/ml) 44 6775.8841 6726.8952 100.73 10.3 98.11 – 103.42 -0.006 0.1099 LogAUC 0-inf (ng.hr/ml) 44 6872.6739 6823.3736 100.72 10.2 98.13 – 103.39 -0.006 0.1071 Specifically, the Phase I PK study showed that SCN-102 was comparable to immediate release tablets based on the following: ● The overall exposure for the Carboxylic Acid metabolite (EXP-3174) meet the confidence interval 80-125% range. ● The overall exposure for Losartan were within the 90% confidence interval. ● The Cmax for Losartan analyte, a pro-drug, for SCN-102 was slightly higher than the immediate release tablets (122.19 - 149.58%).
The Anthem Agreement may only be amended upon the written consent of both parties. 11 Table of Contents The CMC development program is focused on establishing the analytical similarity of SCN-106 to the reference product.
The Anthem Agreement may only be amended upon the written consent of both parties. 10 Table of Contents The CMC development program is focused on establishing the analytical similarity of SCN-106 to the reference product.
Pursuant to the Superlatus SPA, the Company sold all of the issued and outstanding stock of Superlatus to the Buyer. The $1.00 purchase price for the Stock was delivered to the Company at the closing, which occurred simultaneously with the execution of the Superlatus SPA.
Pursuant to the Superlatus SPA, the Company sold all of the issued and outstanding stock of Superlatus to the Buyer. A $1.00 purchase price was delivered to the Company at the closing, which occurred simultaneously with the execution of the Superlatus SPA.
Scienture LLC plans to initiate a Phase 1 single dose study in healthy adults in 2025, following submission of an IND, if the IND is cleared by the FDA.
Scienture LLC plans to initiate a Phase 1 single dose study in healthy adults in 2026, following submission of an IND, if the IND is cleared by the FDA.
SCN-106 SCN-106 is a potential biosimilar and considered by the Company to be part of its product development portfolio, however the Company is not pursuing patent protection for this product. SCN-107 SCN-107 has a formulation composition and method of use application pending in the U.S. (Appl.
SCN-106 SCN-106 is a potential biosimilar and considered by Scienture LLC to be part of its product development portfolio, however Scienture LLC is not pursuing patent protection for this product. SCN-107 SCN-107 has a formulation composition and method of use application pending in the U.S. (Appl.
While we are not aware of any misstatements regarding any third-party information presented in this Annual Report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “Risk Factors” of this Annual Report.
While we are not aware of any misstatements regarding any third-party information presented in this Annual Report, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section entitled “ Risk Factors ” of this Annual Report.
On November 22, 2013, Trxade Group, Inc., a Nevada corporation (“Trxade Nevada”) and wholly owned subsidiary of Trxade, Inc., a Florida corporation (“Trxade Florida”), acquired a controlling interest of 80,000,000 shares of XCEL common stock pursuant to a Purchase and Sale Agreement dated November 7, 2013.
On November 22, 2013, Trxade Group, Inc., a Nevada corporation (“Trxade Nevada”) and wholly owned subsidiary of Trxade, Inc., a Florida corporation (“Trxade Florida”), acquired a controlling interest of XCEL common stock pursuant to a Purchase and Sale Agreement dated November 7, 2013.
The joint steering committee is responsible for establishing timelines for the launch of the Product, overseeing the development and commercialization of the Product, providing strategic direction and performance criteria, and resolving disputes that might arise under and in connection with the KindevaAgreement.
The joint steering committee is responsible for establishing timelines for the launch of the Product, overseeing the development and commercialization of the Product, providing strategic direction and performance criteria, and resolving disputes that might arise under and in connection with the Kindeva Agreement.
Under the Agreement, Scienture LLC agreed to place minimum order quantities of the Product of 3 batches of 450,000 units per year beginning in 2027 or, alternatively, pay Kindeva $1.242 million per year unless Scienture LLC elects to terminate the Agreement pursuant to its terms. Government Regulation U.S.
Under the Kindeva Agreement, Scienture LLC agreed to place minimum order quantities of the Product of 3 batches of 450,000 units per year beginning in 2027 or, alternatively, pay Kindeva $1.242 million per year unless Scienture LLC elects to terminate the Kindeva Agreement pursuant to its terms.
Collaborations and Licensing Arrangements Kesin Pharma Corporation (“Kesin”) Scienture LLC entered into exclusive license and commercial agreements on August 28, 2022 and April 24, 2023, with Kesin, a related party, pursuant to which Scienture LLC granted the exclusive license rights to commercialize SCN-102 and SCN-104, respectively to Kesin for use in the United States of America (together, the “Kesin Agreement”).
Kesin Pharma Corporation (“Kesin”) Scienture LLC entered into exclusive license and commercial agreements on August 28, 2022 and April 24, 2023, with Kesin, a related party, pursuant to which Scienture LLC granted the exclusive license rights to commercialize SCN-102 and SCN-104, respectively, to Kesin for use in the United States (together, the “Kesin Agreement”).
Scienture LLC’s ability to recruit and retain such talent depends on a number of factors, including compensation and benefits, talent development and career opportunities, and the work environment. Scienture LLC attracts and rewards its employees by providing market competitive compensation and benefit packages, including incentives and recognition plans that extend to all levels in its organization.
The Company’s ability to recruit and retain such talent depends on a number of factors, including compensation and benefits, talent development and career opportunities, and the work environment. The Company attracts and rewards its employees by providing market competitive compensation and benefit packages, including incentives and recognition plans that extend to all levels in its organization.
ITEM 1. BUSINESS INTRODUCTION This information included in this Annual Report should be read in conjunction with the consolidated financial statements and related notes in “Item 8. Financial Statements and Supplemental Data” of this Annual Report. Our logo and some of our trademarks and tradenames are used in this Annual Report.
ITEM 1. BUSINESS INTRODUCTION This information included in this Annual Report should be read in conjunction with the consolidated financial statements and related notes in “ Item 8. Financial Statements and Supplemental Data ” of this Annual Report. Our logo and some of our trademarks and tradenames are used in this Annual Report.
Scienture LLC believes its facilities are sufficient to meet its current needs for the foreseeable future. Legal Proceedings From time to time, Scienture LLC may be involved in various claims and legal proceedings.
The Company believes its facilities are sufficient to meet its current needs for the foreseeable future. Legal Proceedings From time to time, the Company may be involved in various claims and legal proceedings.
Multiple clones of CHO cells have been produced to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key biochemical quality attributes as well as overall protein yield and finalization of a lead clone.
Multiple clones of Chinese hamster ovary (“CHO”) cells have been produced to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key biochemical quality attributes as well as overall protein yield and finalization of a lead clone.
Treatment options for hypertension in the U.S. market can be broadly classified across the following product classes, Angiotensin-converting enzyme (ACE) inhibitors, Angiotensin II receptor blockers (ARBs), Beta-Blockers, Diuretics and Calcium Channel Blockers. Scienture LLC’s product candidate SCN-102, ARBLI TM (Losartan Oral Suspension 10mg/mL), is a ready to use oral suspension of losartan for increased patient convenience and ease of dosing.
Treatment options for hypertension in the U.S. market can be broadly classified across the following product classes, Angiotensin-converting enzyme (“ACE”) inhibitors, Angiotensin II receptor blockers (“ARBs”), Beta-Blockers, Diuretics and Calcium Channel Blockers. Scienture LLC’s product, Arbli TM (Losartan Oral Suspension 10mg/mL), is a ready to use oral suspension of losartan for increased patient convenience and ease of dosing.
Both of them are already issued (Patent #: 11,890,273, Issue Date: February 6, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration Date: October 7, 2041) and (Patent #: 12,156,869, Issue Date: December 03, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration Date: October 7, 2041). A third application is pending (Appl.
Patent #: 11,890,273, Issue Date: February 6, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration Date: October 7, 2041 and Patent #: 12,156,869, Issue Date: December 03, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration Date: October 7, 2041. A third application is pending (Appl.
The mechanism of action of SCN-104 is mediated through DHE and is exactly the same as that of DHE. DHE is available in the market as a single dose nasal spray, which has a high degree of variability in clinical outcomes.
SCN-104 is a drug product containing DHE as the active ingredient. The mechanism of action of SCN-104 is mediated through DHE and is exactly the same as that of DHE. DHE is available in the market as a single dose nasal spray, which has a high degree of variability in clinical outcomes.
Scienture LLC is committed to the safety, health, and security of its employees. Scienture LLC believes a hazard-free environment is critical for the success of its business. Throughout Scienture LLC’s operations, Scienture strives to ensure that all its employees have access to safe workplaces that allow them to succeed in their jobs.
The Company is committed to the safety, health, and security of its employees. The Company believes a hazard-free environment is critical for the success of its business. Throughout the Company’s operations, it strives to ensure that all its employees have access to safe workplaces that allow them to succeed in their jobs.
Migraine is estimated to affect over 39 million individuals in the U.S. Current products in the market that are available to treat migraine headaches, include CGRP antagonists (calcitonin gene related peptide), which is a class of products first introduced in 2018 (Nurtec, Ubrelvy), Botox, branded and generic versions of triptans (Imitrex, Maxalt, Relpax), and ergot alkaloids (Ergotamine and Dihydroergotamine (DHE)).
Current products in the market that are available to treat migraine headaches, include CGRP antagonists (calcitonin gene related peptide), which is a class of products first introduced in 2018 (Nurtec, Ubrelvy), Botox, branded and generic versions of triptans (Imitrex, Maxalt, Relpax), and ergot alkaloids (Ergotamine and Dihydroergotamine (DHE)).
Drug Development Process In the United States, pharmaceutical products are subject to extensive regulation by the FDA.
Government Regulation U.S. Drug Development Process In the United States, pharmaceutical products are subject to extensive regulation by the FDA.
Dispositions SOSRx, LLC SOSRx, LLC (“SOSRx”) was formed on February 15, 2022. The Company entered into a relationship with Exchange Health, LLC (“Exchange Health”), a technology company providing an online platform for manufacturers and suppliers to sell and purchase pharmaceuticals. SOSRx, a Delaware limited liability company, was formed, which was owned 51% by the Company and 49% by Exchange Health.
The Company entered into a relationship with Exchange Health, LLC (“Exchange Health”), a technology company providing an online platform for manufacturers and suppliers to sell and purchase pharmaceuticals, pursuant to which SOSRx, a Delaware limited liability company, was formed, which was owned 51% by the Company and 49% by Exchange Health.
Seasonality Our business is not directly affected by seasonal fluctuations but is affected indirectly by the fall and winter flu season, to the extent it leads to an increased demand for certain generic pharmaceuticals. 32 Table of Contents Subsidiaries We currently exist as a holding company directly owning 100% of the equity interests of Scienture LLC, Softell, Bonum Health, and Bonum Health, Inc. and indirectly owning 100% of the equity interests in IPS.
Seasonality Our business is not directly affected by seasonal fluctuations but is affected indirectly by the fall and winter flu season, to the extent it leads to an increased demand for certain generic pharmaceuticals. Subsidiaries We currently exist as a holding company directly owning 100% of the equity interests of Scienture LLC.
According to the Centers for Disease Control, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher.
According to the Centers for Disease Control, hypertension, or high blood pressure, affects nearly half of adults in the U.S. (48.1%, or approximately 119.9 million people). Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher.
Scienture LLC cannot be sure that any patents, if granted, will sustain a legal challenge. Patent Portfolio SCN-102 SCN-102 will soon have two orange book listable formulation composition and method of use patents in the U.S.
Scienture LLC cannot be sure that any patents, if granted, will sustain a legal challenge. Patent Portfolio Arbli TM (SCN-102) SCN-102 has two orange book listed formulation composition and method of use patents in the U.S.
As a result of the transaction Superlatus is no longer a subsidiary of the Company, and the rights and assets of Superlatus together with various liabilities and obligations that were specific to Superlatus became rights and obligations of the Buyer.
As a result of the transaction Superlatus is no longer a subsidiary of the Company, and the rights and assets of Superlatus together with various liabilities and obligations that were specific to Superlatus became rights and obligations of the Buyer. Other Legacy Subsidiaries The Company also previously owned 100% of Softell Inc.
No. 17/996,995; Filing Date: October 24, 2022; Expiration Date: on or after April 22, 2041). Applications in Canada and Europe are currently pending. As described above, the Company licenses certain patent rights from Innocore for the research and development of SCN-107.
No. 17/996,995; Filing Date: October 24, 2022; Expiration Date: on or after April 22, 2041). Applications in Canada and Europe are currently pending. As described above, Scienture LLC licenses certain patent rights from Innocore for the research and development of SCN-107. 13 Table of Contents Collaborations and Licensing Arrangements Kindeva Drug Delivery L.P.
In December 2023, the FDA accepted the NDA for review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August 19, 2024.
In October 2023, Scienture LLC submitted a New Drug Application (“NDA”) for losartan potassium oral suspension to the FDA. In December 2023, the FDA accepted the NDA for review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August 19, 2024.
Scienture LLC anticipates submitting an IND and, if cleared by the FDA, initiating a Phase 1 single dose study in healthy adults in 2025 to conduct an initial assessment of safety and tolerability of SCN-107.
Scienture LLC anticipates submitting an IND and, if cleared by the FDA, initiating a Phase 1 single dose study in healthy adults in 2026 to conduct an initial assessment of safety and tolerability of SCN-107. Scienture LLC entered into a Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies, B.V.
Scienture LLC is in various stages of clinical development for the product candidates in its pipeline, and it intends to move these programs efficiently toward being commercially available to patients, subject to approval by the U.S. Food and Drug Administration (the “FDA”).
Key elements of Scienture LLC’s strategy to achieve this vision include: ● Advance product candidates through clinical studies and toward commercialization. Scienture LLC is in various stages of clinical development for the product candidates in its pipeline, and it intends to move these programs efficiently toward being commercially available to patients, subject to approval by the U.S.
No. 18/061,819; Filing Date: December 5, 2022; Expiration: on or after October 7, 2041). SCN-104 SCN-104 has a formulation composition and method of use application pending in the U.S. (Appl. No. 17/757,924; Filing Date: June 23, 2022; Expiration Date: June 15, 2035).
A second application is pending in the U.S. (18/602,972; Filing Date: March 12, 2024; Expiration Date: February 5, 2041). SCN-104 SCN-104 has a formulation composition and method of use application pending in the U.S. (Appl. No. 17/757,924; Filing Date: June 23, 2022; Expiration Date: June 15, 2035).
Bluebird was originally formed to engage in the exploitation of mineral properties. In December 2008, Bluebird changed its name to “Xcellink International, Inc.” (“XCEL”), and subsequently announced that its business plan was being expanded to include the development and marketing of platform-independent customer-centric payment systems and methodologies.
In December 2008, Bluebird changed its name to “Xcellink International, Inc.” (“XCEL”), and subsequently announced that its business plan was being expanded to include the development and marketing of platform-independent customer-centric payment systems and methodologies. XCEL was unable to raise the funds necessary to implement its business strategy, and never generated any revenue.
Under the Innocore License, Innocore granted Scienture LLC a worldwide exclusive, milestone, royalty-bearing and sublicensable license to certain patent rights for the research and development of SCN-107 in postsurgical local and regional analgesia.
(“Innocore”) on May 26, 2020 (as amended on December 2, 2022, the “Innocore License”), for certain intellectual property rights associated with SCN-107. Under the Innocore License, Innocore granted Scienture LLC a worldwide exclusive, milestone, royalty-bearing and sublicensable license to certain patent rights for the research and development of SCN-107 in postsurgical local and regional analgesia.
(“Kindeva”) Scienture LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with Summit Biosciences Inc., a wholly-owned subsidiary of Kindeva, a company engaged in the research, development, and manufacturing of pharmaceutical products, on March 4, 2025, pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable, non-sublicensable right and license to commercialize REZENOPY® (Nalaxone HCI Nasal spray 10mg/0.11mL) (the “Product”) within the United States and its territories.
(“Kindeva”) Scienture LLC entered into the Kindeva Agreement on March 4, 2025, pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable, non-sublicensable right and license to commercialize REZENOPY TM (Nalaxone HCI Nasal spray 10mg/0.11mL) (the “Product”) within the United States and its territories.
On March 11, 2025, Kesin filed a complaint against Scienture LLC in the United States District Court for the Eastern District of New York seeking payment of the disputed $1.285 million. There can be no assurance that an amicable resolution will be obtained.
On March 11, 2025, Kesin filed a complaint against Scienture LLC in the United States District Court for the Eastern District of New York seeking payment of the disputed $1.285 million. The case was voluntarily dismissed on October 1, 2025.
In addition, Scienture LLC intends to partner with a third-party logistics provider ( “ 3PL ” ) and have internal sales operations and analytics teams to provide state-of-the-art distribution capabilities to wholesalers, pharmacies, institutional buying groups and hospitals.
In addition, Scienture LLC intends to partner with a third-party logistics provider and have internal sales operations and analytics teams to provide state-of-the-art distribution capabilities to wholesalers, pharmacies, institutional buying groups and hospitals. Scienture LLC believes its commercial operations infrastructure, will enable it to effectively target healthcare providers to support and grow its products subsequent to market entry.
We are not a party to any collective bargaining agreements and have not experienced any strikes or work stoppages. We consider our relations with our employees and consultants to be satisfactory.
Employees Currently, the Company and Scienture LLC collectively employ approximately four (4) full-time employees and five (5) part-time employees. We are not a party to any collective bargaining agreements and have not experienced any strikes or work stoppages. We consider our relations with our employees and consultants to be satisfactory.
There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Scienture LLC’s product candidates.
There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of Scienture LLC’s product candidates. Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.
The process by which Scienture LLC intends to bring its product candidates to market and the anticipated launch dates of its product candidates is depicted in the following table. The progress of Scienture LLC’s products through this process is represented by checkmarks in the table.
Research and Development Pipeline Scienture LLC is committed to the development of innovative product candidates in the CNS and CVS therapeutic areas. The process by which Scienture LLC intends to bring its product candidates to market and the anticipated launch dates of its product candidates is depicted in the following table.
Scienture LLC’s expectations regarding its research and development programs are subject to risks, including the risk that Scienture LLC’s financial condition and results of operations for fiscal year 2024 and beyond may be materially and adversely affected by delays and failures in the completion of clinical development of its product candidates, which could increase its costs or delay or limit our ability to generate revenues.
Scienture LLC’s expectations regarding its research and development programs are subject to risks, including the risk that Scienture LLC’s financial condition and results of operations may be materially and adversely affected by delays and failures in the completion of clinical development of its product candidates, which could increase its costs or delay or limit our ability to generate revenues. 7 Table of Contents SCN-104 (Multi-dose Dihydroergotamine Mesylate (“DHE”) injection pen) The SCN-104 injection pen is a disposable, multiple fixed dose, single entity combination product comprised of a small molecule drug, SCN-104, which is administered using a customized injection pen.
On October 4, 2024, we entered into an Assignment and Assumption of Membership Interests (the “IPS Assignment Agreement”) with Softell, pursuant to which we transferred, and Softell accepted, 100% of the membership interests of IPS.
(f/k/a Trxade Inc.) (“Softell”), Integra Pharma Solutions, LLC (“IPS”), Bonum Health, Inc., and Bonum Health, LLC. Softell & IPS Entities On October 4, 2024, the Company and Softell entered into an Assignment and Assumption of Membership Interests (the “IPS Assignment Agreement”), pursuant to which the Company transferred, and Softell accepted, 100% of the membership interests of IPS.
“Fiscal 2024” means the Fiscal year ended December 31, 2024, whereas “Fiscal 2023” means the year ended December 31, 2023. Unless the context requires otherwise, references to the “Company,” “we,” “us,” and “our” refer specifically to Scienture Holdings, Inc., formerly known as TRxADE HEALTH, INC., and its consolidated subsidiaries.
“Fiscal 2025” means the Fiscal year ended December 31, 2025, whereas “Fiscal 2024” means the year ended December 31, 2024. Unless the context requires otherwise, references to the “Company,” “we,” “us,” and “our” refer specifically to Scienture Holdings, Inc., and its consolidated subsidiaries. Available Information We file annual, quarterly, and current reports, proxy statements and other information with the SEC.
Using dedicated sales and marketing resources in the U.S., which Scienture LLC is in the process of building, Scienture LLC will seek to drive the revenue growth of its product candidates approved for marketing by the FDA. ● Continue to grow pipeline.
Using dedicated sales and marketing resources in the U.S., Scienture LLC will seek to drive the revenue growth of its product candidates approved for marketing by the FDA and will also evaluate and seek additional commercial ready product opportunities through acquisitions and partnerships to expand its marketed portfolio.
Scienture LLC has made, and intends to continue to make, expenditures and undertake efforts to comply with applicable laws. Scienture LLC believes the safety procedures utilized by it for the handling and disposing hazardous materials comply with the standards prescribed by applicable laws and regulations. Human Capital Scienture LLC’s success begins and ends with our people.
Scienture LLC believes the safety procedures utilized by it for the handling and disposing hazardous materials comply with the standards prescribed by applicable laws and regulations. Human Capital The Company’s success begins and ends with its people. The Company’s solid progress to date reflects the talent and hard work of all of its employees.
Scienture LLC submitted an Investigational New Drug (“IND”) application to the FDA in September 2022. Multiple human pharmacokinetics studies were performed, showing close comparability with the oral solid dosage form. In October 2023, Scienture LLC submitted an NDA for losartan potassium oral suspension to the FDA.
Currently, there are no FDA-approved liquid formulations of losartan potassium. Arbli TM (SCN-102) is the first and only FDA approved oral liquid formulation of losartan on the market. Scienture LLC submitted an Investigational New Drug (“IND”) application to the FDA in September 2022. Multiple human pharmacokinetics studies were performed, showing close comparability with the oral solid dosage form.
Scienture LLC seeks patent protection, where appropriate, both in the U.S. and internationally for products and product candidates. Scienture LLC’s intended objective is to protect its innovations and proprietary products by, among other things, filing patent applications in the U.S. and abroad, including Europe, Canada, and other countries when appropriate.
Scienture LLC’s intended objective is to protect its innovations and proprietary products by, among other things, filing patent applications in the U.S. and abroad, including Europe, Canada, and other countries when appropriate. Scienture LLC also relies on trade secrets, know-how, proprietary knowledge, continuing technological innovation, and in-licensing opportunities to develop and maintain its proprietary position.
Scienture LLC’s vision is to be a leader in the industry by developing and commercializing new medicines for the treatment of CNS and CVS diseases. Key elements of Scienture LLC’s strategy to achieve this vision include: ● Advance product candidates through clinical studies and toward commercialization.
Scienture LLC’s Strategy Scienture LLC’s mission is to improve the lives of patients suffering from CNS and CVS diseases. Scienture LLC’s vision is to be a leader in the industry by commercializing and developing new medicines for the treatment of CNS and CVS diseases.
In connection with our acquisition in July 2024, Scienture LLC became a wholly owned subsidiary of the Company. Scienture’s principal executive offices are located in Commack, New York. Scienture LLC is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of CNS and CVS diseases.
Scienture’s principal executive offices are located in Commack, New York. Scienture LLC is a specialty pharmaceutical company focused on the commercialization and development of products for the treatment of cardiovascular (“CVS”) and Central Nervous System (“CNS”) diseases.
Scienture LLC believes that ARBLI TM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. Migraine Migraine is a painful, complex neurological disorder consisting of recurring painful attacks that can significantly impact quality of life.
Scienture LLC believes that Arbli TM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. Opioid Abuse The opioid overdose epidemic remains a significant public health issue and continues to rise exponentially in the U.S.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe may not have the financial resources to continue development of Scienture LLC’s product candidates, particularly if Scienture LLC experience any issues that delay or prevent regulatory approval of, or its ability to commercialize, product candidates, including: ● Scienture LLC’s inability to demonstrate to the satisfaction of the FDA or other comparable regulatory authorities that our product candidates are safe and effective; ● insufficiency of our financial and other resources to complete the necessary clinical trials and preclinical studies; 43 Table of Contents ● negative or inconclusive results from Scienture LLC’s clinical trials, preclinical studies or the clinical trials of others for product candidates similar to Scienture LLC, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon a program; ● product-related adverse events experienced by subjects in Scienture LLC’s clinical trials, including unexpected toxicity results, or by individuals using drugs or therapeutic biologics similar to Scienture LLC’s product candidates; ● delays in submitting an Investigational New Drug (“IND”) application or other regulatory submission to the FDA or other comparable regulatory authorities, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced; ● conditions imposed by the FDA or other comparable regulatory authorities regarding the scope or design of Scienture LLC’s clinical trials; ● poor effectiveness of our product candidates during clinical trials; ● better than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from Scienture LLC’s clinical trials; ● delays in enrolling subjects in Scienture LLC’s clinical trials; ● high drop-out rates of subjects from Scienture LLC’s clinical trials; ● inadequate supply or quality of product candidates or other materials necessary for the conduct of Scienture LLC’s clinical trials; ● higher than anticipated clinical trial or manufacturing costs; ● unfavorable FDA or comparable regulatory authority inspection and review of Scienture LLC’s clinical trial sites; ● failure of our third-party contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual obligations in a timely manner, or at all; ● delays and changes in regulatory requirements, policies and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to Scienture LLC’s therapies in particular; or ● varying interpretations of data by the FDA or other comparable regulatory authorities. have a material effect on 15 In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country.
Biggest changeWe may not have the financial resources to continue development of our product candidates, particularly if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, product candidates, including: ● inability to demonstrate to the satisfaction of the FDA or other comparable regulatory authorities that our product candidates are safe and effective; ● insufficiency of our financial and other resources to complete the necessary clinical trials and preclinical studies; 34 Table of Contents ● negative or inconclusive results from clinical trials, preclinical studies or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional clinical trials or preclinical studies or abandon a program; ● product-related adverse events experienced by subjects in our clinical trials, including unexpected toxicity results, or by individuals using drugs or therapeutic biologics similar to our product candidates; ● delays in submitting an IND application or other regulatory submission to the FDA or other comparable regulatory authorities, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial or a suspension or termination, or hold, of a clinical trial once commenced; ● conditions imposed by the FDA or other comparable regulatory authorities regarding the scope or design of our clinical trials; ● poor effectiveness of our product candidates during clinical trials; ● better than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our clinical trials; ● delays in enrolling subjects in our clinical trials; ● high drop-out rates of subjects from our clinical trials; ● inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials; ● higher than anticipated clinical trial or manufacturing costs; ● unfavorable FDA or comparable regulatory authority inspection and review of our clinical trial sites; ● failure of our third-party contractors or investigators to comply with regulatory requirements or the clinical trial protocol or otherwise meet their contractual obligations in a timely manner, or at all; ● delays and changes in regulatory requirements, policies and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our therapies in particular; or ● varying interpretations of data by the FDA or other comparable regulatory authorities.
Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements.
Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements.
Levels of market acceptance for our product could be affected by several factors, including: internal control over financial reporting a. the availability of alternative products from our competitors; b. the prices of our products relative to those of our competitors; c. the timing of our market entry; d. the ability to market our products effectively at the institutional level; e. the perception of patients and the healthcare community, including third-party payers, regarding the safety, efficacy and benefits of our drug products compared to those of competing products; and f. the acceptance of our products by government and private formularies.
Levels of market acceptance for our product could be affected by several factors, including: a. internal control over financial reporting a. the availability of alternative products from our competitors; b. the prices of our products relative to those of our competitors; c. the timing of our market entry; d. the ability to market our products effectively at the institutional level; e. the perception of patients and the healthcare community, including third-party payers, regarding the safety, efficacy and benefits of our drug products compared to those of competing products; and f. the acceptance of our products by government and private formularies.
Our future capital requirements will depend on many factors, including but not limited to: ● the scope, timing, progress, costs and results of discovery, preclinical development and clinical trials for our current or future product candidates; ● the number of clinical trials required for regulatory approval of our current or future product candidates; ● the costs, timing and outcome of regulatory review of any of our current or future product candidates; ● the costs associated with acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses; ● the cost of manufacturing clinical and commercial supplies of our current or future product candidates; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights; ● the effectiveness of our approach at identifying target patient populations and utilizing our approach to enrich our patient population in our clinical trials; ● our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; ● the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● expenses to attract, hire and retain skilled personnel; ● our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; ● the effect of macroeconomic trends including inflation and rising interest rates; ● addressing any potential supply chain interruptions or delays; ● the effect of competing technological and market developments; and ● the extent to which we acquire or invests in business, products and technologies. 40 Table of Contents We anticipate that the sources of capital available to us will be through the sale of equity and debt, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders.
Our future capital requirements will depend on many factors, including but not limited to: ● the scope, timing, progress, costs and results of discovery, preclinical development and clinical trials for our current or future product candidates; ● the number of clinical trials required for regulatory approval of our current or future product candidates; ● the costs, timing and outcome of regulatory review of any of our current or future product candidates; ● the costs associated with acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses; ● the cost of manufacturing clinical and commercial supplies of our current or future product candidates; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights; ● the effectiveness of our approach at identifying target patient populations and utilizing our approach to enrich our patient population in our clinical trials; ● our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement; ● the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval; ● the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● expenses to attract, hire and retain skilled personnel; ● our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; ● the effect of macroeconomic trends including inflation and rising interest rates; ● addressing any potential supply chain interruptions or delays; ● the effect of competing technological and market developments; and ● the extent to which we acquire or invests in business, products and technologies. 33 Table of Contents We anticipate that the sources of capital available to us will be through the sale of equity and debt, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders.
Collaborations involving our product candidates pose a number of risks, including the following: ● collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, which divert resources or create competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates; ● a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products; ● disagreements with collaborators, including disagreements over proprietary rights, including trade secrets and intellectual property rights, contract interpretation, or the preferred course of development might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; 46 Table of Contents ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and ● collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
Collaborations involving our product candidates pose a number of risks, including the following: ● collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators may not perform their obligations as expected; ● collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, which divert resources or create competing priorities; ● collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates; ● a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products; ● disagreements with collaborators, including disagreements over proprietary rights, including trade secrets and intellectual property rights, contract interpretation, or the preferred course of development might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; 36 Table of Contents ● collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and ● collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. 68 Table of Contents If a third party alleges that we infringe its intellectual property rights, we may face a number of issues, including, but not limited to: ● infringement and other intellectual property misappropriation which, regardless of merit, may be expensive and time-consuming to litigate and may divert management’s attention from our core business; ● substantial damages for infringement or misappropriation, which we may have to pay if a court decides that the product or technology at issue infringes on or violates the third-party’s rights, and, if the court finds we have willfully infringed intellectual property rights, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees; ● an injunction prohibiting us from manufacturing, marketing or selling our product candidates, or from using our proprietary technologies, unless the third party agrees to license its patent rights to us; ● even if a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights protecting our product candidates; and ● we may be forced to try to redesign our product candidates or processes so they do not infringe third-party intellectual property rights, an undertaking which may not be possible or which may require substantial monetary expenditures and time.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. 57 Table of Contents If a third party alleges that we infringe its intellectual property rights, we may face a number of issues, including, but not limited to: ● infringement and other intellectual property misappropriation which, regardless of merit, may be expensive and time-consuming to litigate and may divert management’s attention from our core business; ● substantial damages for infringement or misappropriation, which we may have to pay if a court decides that the product or technology at issue infringes on or violates the third-party’s rights, and, if the court finds we have willfully infringed intellectual property rights, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees; ● an injunction prohibiting us from manufacturing, marketing or selling our product candidates, or from using our proprietary technologies, unless the third party agrees to license its patent rights to us; ● even if a license is available from a third party, we may have to pay substantial royalties, upfront fees and other amounts, and/or grant cross-licenses to intellectual property rights protecting our product candidates; and ● we may be forced to try to redesign our product candidates or processes so they do not infringe third-party intellectual property rights, an undertaking which may not be possible or which may require substantial monetary expenditures and time.
If we fail to comply with applicable regulatory requirements, the FDA and other regulatory authorities may, among other things: ● issue warning letters or other regulatory enforcement action; ● impose injunctions, fines or civil or criminal penalties; ● suspend or withdraw regulatory approval; ● suspend any ongoing clinical studies; 55 Table of Contents ● refuse to approve pending applications or supplements to approved applications; ● require revisions to the labeling, including limitations on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; ● impose a Risk Evaluation and Mitigation Strategy, which may include distribution or use restrictions; ● require the conduct of an additional post-market clinical trial or trials to assess the safety of the product; ● impose restrictions on our operations, including closing our contract manufacturers’ facilities where regulatory inspections identify observations of noncompliance requiring remediation; or ● restrict the marketing of the product, require a product recall, seizure or detention, or refuse to permit the import or export of the product.
If we fail to comply with applicable regulatory requirements, the FDA and other regulatory authorities may, among other things: ● issue warning letters or other regulatory enforcement action; ● impose injunctions, fines or civil or criminal penalties; ● suspend or withdraw regulatory approval; ● suspend any ongoing clinical studies; 44 Table of Contents ● refuse to approve pending applications or supplements to approved applications; ● require revisions to the labeling, including limitations on approved uses or the addition of additional warnings, contraindications or other safety information, including boxed warnings; ● impose a Risk Evaluation and Mitigation Strategy, which may include distribution or use restrictions; ● require the conduct of an additional post-market clinical trial or trials to assess the safety of the product; ● impose restrictions on our operations, including closing our contract manufacturers’ facilities where regulatory inspections identify observations of noncompliance requiring remediation; or ● restrict the marketing of the product, require a product recall, seizure or detention, or refuse to permit the import or export of the product.
Other factors that could cause such volatility may include, among other things: ● actual or anticipated fluctuations in our operating results; ● the absence of securities analysts covering us and distributing research and recommendations about us; ● we may have a low trading volume for a number of reasons, including that a large portion of our stock is closely held; ● overall stock market fluctuations; ● announcements concerning our business or those of our competitors; ● actual or perceived limitations on our ability to raise capital when we require it, and to raise such capital on favorable terms; ● conditions or trends in our industry; ● litigation; 72 Table of Contents ● changes in market valuations of other similar companies; ● future sales of common stock; ● departure of key personnel or failure to hire key personnel; and ● general market conditions.
Other factors that could cause such volatility may include, among other things: ● actual or anticipated fluctuations in our operating results; ● the absence of securities analysts covering us and distributing research and recommendations about us; ● we may have a low trading volume for a number of reasons, including that a large portion of our stock is closely held; ● overall stock market fluctuations; ● announcements concerning our business or those of our competitors; ● actual or perceived limitations on our ability to raise capital when we require it, and to raise such capital on favorable terms; ● conditions or trends in our industry; ● litigation; 61 Table of Contents ● changes in market valuations of other similar companies; ● future sales of common stock; ● departure of key personnel or failure to hire key personnel; and ● general market conditions.
We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so. Our current strategy is to outsource all manufacturing of its product candidates to third parties, including in jurisdictions outside of the United States such as China.
We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so. Our current strategy is to outsource all manufacturing of our product candidates to third parties, including in jurisdictions outside of the United States such as China.
Scienture LLC has not yet demonstrated an ability to generate revenues, obtain regulatory approvals, manufacture any product on a commercial scale or arrange for a third party to do so on its behalf or conduct sales and marketing activities necessary for successful product commercialization.
Scienture LLC has not yet demonstrated an ongoing ability to generate revenues, obtain regulatory approvals, manufacture any product on a commercial scale or arrange for a third party to do so on its behalf or conduct sales and marketing activities necessary for successful product commercialization.
Inadequate funding for the FDA and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder such agencies’ ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely. 62 Table of Contents The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes.
Inadequate funding for the FDA and other government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder such agencies’ ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely. 51 Table of Contents The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes.
If we do not maintain its key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our product candidates.
If we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our product candidates.
The FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or a narrower patient population than we originally requested, and the FDA, or applicable foreign regulatory agency, may not approve it with the labeling that we believe is necessary or desirable for the successful commercialization. 54 Table of Contents Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of our product candidates and would materially adversely impact our business and prospects.
The FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or a narrower patient population than we originally requested, and the FDA, or applicable foreign regulatory agency, may not approve it with the labeling that we believe is necessary or desirable for the successful commercialization. 43 Table of Contents Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of our product candidates and would materially adversely impact our business and prospects.
If we or our licensors are unable to secure or maintain patent protection with respect to our product candidates and any proprietary product candidates and technology we develop, our business, financial condition, results of operations, and prospects could be materially harmed. 64 Table of Contents If the scope of the patent protection we or our licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercializing products and technology similar or identical to our product candidates or otherwise maintain a competitive advantage.
If we or our licensors are unable to secure or maintain patent protection with respect to our product candidates and any proprietary product candidates and technology we develop, our business, financial condition, results of operations, and prospects could be materially harmed. 53 Table of Contents If the scope of the patent protection we or our licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercializing products and technology similar or identical to our product candidates or otherwise maintain a competitive advantage.
PBMs are third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans (prescription drug plans), the Federal Employees Health Benefits Program, and state government employee plans 61 Table of Contents Provincial governments in Canada that provide partial funding for the purchase of pharmaceuticals and independently regulate the sale and reimbursement of drugs have sought to reduce the costs of publicly funded health programs.
PBMs are third-party administrator of prescription drug programs for commercial health plans, self-insured employer plans, Medicare Part D plans (prescription drug plans), the Federal Employees Health Benefits Program, and state government employee plans 50 Table of Contents Provincial governments in Canada that provide partial funding for the purchase of pharmaceuticals and independently regulate the sale and reimbursement of drugs have sought to reduce the costs of publicly funded health programs.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to our product candidates. 65 Table of Contents In addition, we rely on certain of our licensors to prosecute patent applications and maintain patents and otherwise protect the intellectual property we license from them and may continue to do so in the future.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to our product candidates. 54 Table of Contents In addition, we rely on certain of our licensors to prosecute patent applications and maintain patents and otherwise protect the intellectual property we license from them and may continue to do so in the future.
Any performance failure on the part of our distributors could delay clinical development or regulatory approval of our product candidates or commercialization of any resulting products, producing additional losses and depriving us of potential product revenue. 47 Table of Contents In addition, we rely on wholesalers and attempt to structure our agreements with such wholesalers to ensure that we are appropriately and predictably compensated for the services we provide.
Any performance failure on the part of our distributors could delay clinical development or regulatory approval of our product candidates or commercialization of any resulting products, producing additional losses and depriving us of potential product revenue. 37 Table of Contents In addition, we rely on wholesalers and attempt to structure our agreements with such wholesalers to ensure that we are appropriately and predictably compensated for the services we provide.
Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. 60 Table of Contents We may at times fail (or be perceived to have failed) in our efforts to comply with our privacy and data security obligations.
Preparing for and complying with these obligations requires us to devote significant resources and may necessitate changes to our services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. 49 Table of Contents We may at times fail (or be perceived to have failed) in our efforts to comply with our privacy and data security obligations.
If we are unsuccessful, we could lose valuable rights in intellectual property that we regard as our own. 69 Table of Contents This is especially relevant as some of our employees and contractors may have been previously employed at, or may have previously provided or may be currently providing consulting services to, universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
If we are unsuccessful, we could lose valuable rights in intellectual property that we regard as our own. 58 Table of Contents This is especially relevant as some of our employees and contractors may have been previously employed at, or may have previously provided or may be currently providing consulting services to, universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
This would increase our reliance on such third-party manufacturer or require us to obtain a license from such third-party manufacturer in order to have another third party manufacture our product candidates. 49 Table of Contents If any of our product candidates are approved by any regulatory agency, we intend to utilize arrangements with third-party contract manufacturers for the commercial production of those products.
This would increase our reliance on such third-party manufacturer or require us to obtain a license from such third-party manufacturer in order to have another third party manufacture our product candidates. 39 Table of Contents If any of our product candidates are approved by any regulatory agency, we intend to utilize arrangements with third-party contract manufacturers for the commercial production of those products.
Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business. 70 Table of Contents If our trademarks and trade names are not adequately protected then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Any of these effects could damage our reputation, result in the loss of valuable property and information, cause us to breach applicable laws and regulations, and adversely impact our business. 59 Table of Contents If our trademarks and trade names are not adequately protected then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Such actions have the potential to significantly reduce the potential market share and profitability of SCN-106. 66 Table of Contents Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
Such actions have the potential to significantly reduce the potential market share and profitability of SCN-106. 55 Table of Contents Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements.
There may be difficulties in scaling up to commercial quantities and formulation of our product candidates, and the costs of manufacturing could be prohibitive. 48 Table of Contents Many of the third-party manufacturers we rely on have only recently begun working with us and have limited or no experience manufacturing our API and final drug products.
There may be difficulties in scaling up to commercial quantities and formulation of our product candidates, and the costs of manufacturing could be prohibitive. 38 Table of Contents Many of the third-party manufacturers we rely on have only recently begun working with us and have limited or no experience manufacturing our API and final drug products.
If we are unable to gain or maintain continued access rights to the desired APIs on commercially reasonable terms or develop suitable alternate APIs, we may not be able to commercialize product candidates from these programs. 50 Table of Contents Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
If we are unable to gain or maintain continued access rights to the desired APIs on commercially reasonable terms or develop suitable alternate APIs, we may not be able to commercialize product candidates from these programs. 40 Table of Contents Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
Changes in the laws and regulations governing patents in other jurisdictions could similarly have an adverse effect on our ability to obtain and effectively enforce our patent rights. 67 Table of Contents If we do not obtain patent term extension for our current product candidates, our business may be materially harmed.
Changes in the laws and regulations governing patents in other jurisdictions could similarly have an adverse effect on our ability to obtain and effectively enforce our patent rights. 56 Table of Contents If we do not obtain patent term extension for our current product candidates, our business may be materially harmed.
We can give no assurance at what time, if ever, our common stock may be classified as a “penny stock” in the future. 71 Table of Contents The exercise of outstanding warrants, options and other securities that are exercisable into shares of our common stock will be dilutive to our existing stockholders.
We can give no assurance at what time, if ever, our common stock may be classified as a “penny stock” in the future. 60 Table of Contents The exercise of outstanding warrants, options and other securities that are exercisable into shares of our common stock will be dilutive to our existing stockholders.
Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product. 57 Table of Contents Generic drug manufacturers may seek to launch generic products following the expiration of any applicable exclusivity period we obtain if any of our products is approved, even if we still have patent protection.
Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product. 46 Table of Contents Generic drug manufacturers may seek to launch generic products following the expiration of any applicable exclusivity period we obtain if any of our products is approved, even if we still have patent protection.
As a result, increasingly high barriers are being erected to the entry of new products. 58 Table of Contents We are developing a drug-device combination product, which may result in additional regulatory risks. Our SCN-104 injection pen will be regulated as a drug-device combination product.
As a result, increasingly high barriers are being erected to the entry of new products. 47 Table of Contents We are developing a drug-device combination product, which may result in additional regulatory risks. Our SCN-104 injection pen will be regulated as a drug-device combination product.
These various privacy and data security laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products. 59 Table of Contents Outside the United States, an increasing number of laws, regulations, and industry standards may govern privacy and data security.
These various privacy and data security laws may impact our business activities, including our identification of research subjects, relationships with business partners and ultimately the marketing and distribution of our products. 48 Table of Contents Outside the United States, an increasing number of laws, regulations, and industry standards may govern privacy and data security.
If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed. 63 Table of Contents Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed. 52 Table of Contents Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
Any predictions you make about our future success or viability may not be as accurate as they would otherwise be if it had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving Scienture LLC’s business objectives.
Any predictions you make about our future success or viability may not be as accurate as they would otherwise be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We may encounter unforeseen expenses, difficulties, complications, delays and other known or unknown factors in achieving our business objectives.
The use of resources for new businesses and new products, services, and technologies, to the extent such new businesses and new products, services, and technologies do not generate revenues or profits may take management’s focus and time away from more profitable endeavors, may require the Company to take significant write-downs or write-offs, may take funding away from the Company’s other operations or growth opportunities, which may ultimately be more profitable, and may have a material adverse effect on the Company’s cash flows, liquidity and revenues, any or all of which may cause the value of the Company’s securities to decline in value or become worthless.
The use of resources for new businesses and new products, services, and technologies, to the extent such new businesses and new products, services, and technologies do not generate revenues or profits may take management’s focus and time away from more profitable endeavors, may require us to take significant write-downs or write-offs, may take funding away from our other operations or growth opportunities, which may ultimately be more profitable, and may have a material adverse effect on our cash flows, liquidity and revenues, any or all of which may cause the value of our securities to decline in value or become worthless.
The collaborator may also consider alternative product candidates or technologies for similar indications that may be available for partnership or collaboration and whether such a partnership or collaboration could be more attractive than the one with the Company for our product candidate.
The collaborator may also consider alternative product candidates or technologies for similar indications that may be available for partnership or collaboration and whether such a partnership or collaboration could be more attractive than the one with us for our product candidate.
Receiving priority review from the FDA does not guarantee approval within the six-month review cycle or at all. 56 Table of Contents We may seek orphan drug designation from the FDA for our product candidates.
Receiving priority review from the FDA does not guarantee approval within the six-month review cycle or at all. 45 Table of Contents We may seek orphan drug designation from the FDA for our product candidates.
Scienture LLC’s limited operating history as a company makes any assessment of its future success and viability subject to significant uncertainty. Scienture LLC will encounter risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields, and Scienture LLC has not yet demonstrated an ability to successfully overcome such risks and difficulties.
Scienture LLC’s limited operating history as a company makes any assessment of its future success and viability subject to significant uncertainty. Scienture LLC encounters risks and difficulties frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields, and Scienture LLC has not yet demonstrated an ability to successfully overcome such risks and difficulties.
In addition, if we are able to obtain regulatory approval for product candidates from foreign regulatory authorities, we may enter into partnerships or collaborations with international biotechnology or pharmaceutical companies for the commercialization of such product candidates. 45 Table of Contents We face significant competition in seeking appropriate collaborators.
In addition, if we are able to obtain regulatory approval for product candidates from foreign regulatory authorities, we may enter into partnerships or collaborations with international biotechnology or pharmaceutical companies for the commercialization of such product candidates. We face significant competition in seeking appropriate collaborators.
As we continue developing product candidates, we will require personnel with medical, scientific, or technical qualifications specific to each program. The loss of any of our officers or directors, in particular our current management team consisting of Shankar Hariharan, Narasimhan Mani, Rahul Surana, Suren Ajjarapu, or Prashant Patel, could have a materially adverse effect upon our business and future prospects.
As we continue developing product candidates, we will require personnel with medical, scientific, or technical qualifications specific to each program. The loss of any of our officers or directors, in particular our current management team consisting of Shankar Hariharan, Narasimhan Mani or Rahul Surana, could have a materially adverse effect upon our business and future prospects.
If Scienture LLC does not address these risks and difficulties successfully, its business will suffer. 38 Table of Contents The success of our business depends primarily upon its ability to identify, develop, and commercialize product candidates, including our existing product candidates: SCN-102, SCN-104, SCN-106, and SCN-107.
If Scienture LLC does not address these risks and difficulties successfully, its business will suffer. The success of our business depends primarily upon its ability to identify, develop, and commercialize product candidates, including our existing product candidates: SCN-102, SCN-104, SCN-106, and SCN-107.
Although we declared special cash dividends in the first and third quarters of 2024, those dividends were declared as the result of a sale various business assets and not paid from cash generated in our operations. The Company has not historically paid or declared any dividends on our common stock or preferred stock.
Although we declared special cash dividends in the first and third quarters of 2024, those dividends were declared as the result of a sale various business assets and not paid from cash generated in our operations. We have not historically paid or declared any dividends on our common stock or preferred stock.
As of the date of this Registration Statement, we had outstanding various warrants, stock options and other securities that are exercisable into shares of our common stock. For the life of the options and warrants, the holders have the opportunity to profit from a rise in the market price of our common stock without assuming the risk of ownership.
As of the date of this Annual Report, we had outstanding various warrants, stock options and other securities that are exercisable into shares of our common stock. For the life of the options and warrants, the holders have the opportunity to profit from a rise in the market price of our common stock without assuming the risk of ownership.
We anticipate that our expenses will increase substantially if, and as, we: ● advance its product candidates through clinical development; ● seek regulatory approvals for Scienture LLC’s product candidates that successfully complete clinical trials; ● hire additional clinical, quality control, medical, scientific and other technical personnel to support the clinical development of Scienture LLC’s product candidates; ● experience an increase in headcount as Scienture LLC expands its research and development organization and market development and pre-commercial planning activities; ● undertake any pre-commercial or commercial activities to establish sales, marketing and distribution capabilities, including in relation to its product candidates; ● seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates; ● maintain, expands and protects its intellectual property portfolio; ● make milestone, royalty or other payments due under any future in-license or collaboration agreements; and ● make milestone, royalty, interest or other payments due under any future financing or other arrangements with third parties.
We anticipate that our expenses will increase substantially if, and as, we: ● advance our product candidates through clinical development; ● seek regulatory approvals for our product candidates that successfully complete clinical trials; ● hire additional clinical, quality control, medical, scientific and other technical personnel to support the clinical development of our product candidates; ● experience an increase in headcount as we expand our research and development organization and market development and pre-commercial planning activities; ● undertake any pre-commercial or commercial activities to establish sales, marketing and distribution capabilities, including in relation to our product candidates; ● seek to identify, acquire and develop additional product candidates, including through business development efforts to invest in or in-license other technologies or product candidates; ● maintain, expand and protect our intellectual property portfolio; and ● make milestone, royalty, interest, or other payments due under any in-license, collaboration agreements; financing agreements, or other arrangements with third parties.
These laws will impact, among other things, our clinical research, as well as our proposed sales and marketing programs. 52 Table of Contents We may be subject to health information privacy and security laws by the federal government, the states and other jurisdictions in which we may conduct our business.
These laws will impact, among other things, our clinical research, as well as our proposed sales and marketing programs. We may be subject to health information privacy and security laws by the federal government, the states and other jurisdictions in which we may conduct our business.
Additionally, it is possible further tariffs may be imposed that could affect imports of any Active Pharmaceutical Ingredients (“APIs”) used in our product candidates in the future, or our business may be adversely impacted by retaliatory trade measures taken by China or other countries, including restricted access to such raw materials used in its product candidates.
Additionally, it is possible further tariffs may be imposed that could affect imports of any APIs used in our product candidates in the future, or our business may be adversely impacted by retaliatory trade measures taken by China or other countries, including restricted access to such raw materials used in its product candidates.
The successful development of Scienture LLC’s pharmaceutical products involves a lengthy and expensive process and is highly uncertain. Successful development of Scienture LLC’s pharmaceutical products involves a lengthy and expensive process, is highly uncertain, and is dependent on numerous factors, many of which are beyond our control.
Successful development of our pharmaceutical products involves a lengthy and expensive process, is highly uncertain, and is dependent on numerous factors, many of which are beyond our control.
Involvement of our officers and directors in other businesses may present a conflict of interest regarding decisions they make for the Company or with respect to the amount of time available for the Company. 44 Table of Contents Given the specialized nature of CNV and CVS diseases and our approach, there is an inherent scarcity of experienced personnel in these fields.
Involvement of our officers and directors in other businesses may present a conflict of interest regarding decisions they make for us or with respect to the amount of time available for us. 35 Table of Contents Given the specialized nature of CNS and CVS diseases and our approach, there is an inherent scarcity of experienced personnel in these fields.
Our business is highly dependent on the success of certain product candidates. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed. Scienture LLC has not completed the development of any product candidates.
Our business is highly dependent on the success of certain product candidates. If we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if we experience delays in doing so, our business will be materially harmed.
In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that our third-party providers comply) with current Good Manufacturing Practices (“cGMPs”) and Good Clinical Practices (“GCPs”) for any clinical trials that we conduct post-approval.
In addition, if any of our product candidates receive marketing approval, we will be subject to significant regulatory obligations regarding the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that our third-party providers comply) with current cGMPs and GCPs for any clinical trials that we conduct post-approval.
At times, including during our 2023 and 2024 fiscal years, we have received deficiency notices from Nasdaq regarding our inability to comply with various of the continued listing rules (including stockholders’ equity requirements, publicly held share requirements, and timely filing requirements).
At times, we have received deficiency notices from Nasdaq regarding our inability to comply with various of the continued listing rules (including stockholders’ equity requirements, publicly held share requirements, and timely filing requirements).
Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including: ● clinical trial results may show the product candidates to be less effective than expected; ● failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis or New Drug Application (“NDA”) or similar foreign application preparation, discussions with the FDA or other comparable regulatory authority, FDA or other comparable regulatory request for additional preclinical or clinical data (such as long-term toxicology studies) or unexpected safety or manufacturing issues; 51 Table of Contents ● preclinical study results may show the product candidate to be less effective than desired or to have harmful side effects; ● failure to receive the necessary post-marketing approval requirements; or ● the proprietary rights of others and their competing products and technologies may prevent our product candidates from being commercialized.
Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons, including: ● clinical trial results may show the product candidates to be less effective than expected; ● failure to receive the necessary regulatory approvals or a delay in receiving such approvals, which, among other things, may be caused by patients who fail the trial screening process, slow enrollment in clinical trials, patients dropping out of trials, patients lost to follow-up, length of time to achieve trial endpoints, additional time requirements for data analysis or NDA or similar foreign application preparation, discussions with the FDA or other comparable regulatory authority, FDA or other comparable regulatory request for additional preclinical or clinical data (such as long-term toxicology studies) or unexpected safety or manufacturing issues; ● preclinical study results may show the product candidate to be less effective than desired or to have harmful side effects; ● failure to receive the necessary post-marketing approval requirements; or ● the proprietary rights of others and their competing products and technologies may prevent our product candidates from being commercialized. 41 Table of Contents Furthermore, the length of time necessary to complete clinical trials and submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product candidate to the next and from one country or jurisdiction to the next and may be difficult to predict.
Although we have enhanced our procedures to ensure compliance, a regulatory agency or tribunal may conclude that our operations are not compliant with applicable laws and regulations.
We are also subject to certain state laws relating to price gouging. Although we have enhanced our procedures to ensure compliance, a regulatory agency or tribunal may conclude that our operations are not compliant with applicable laws and regulations.
While the Company believes that its cash as of the date of this Registration Statement will be sufficient to meet its funding requirements during the next 12 months, this belief may prove to be wrong as we could utilize available capital resources sooner than we expect.
While we believe that our cash as of the date of this Annual Report will be sufficient to meet our funding requirements during the next 12 months, this belief may prove to be wrong as we could utilize available capital resources sooner than we expect.
The shifting compliance environment and the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance and/or reporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements. 53 Table of Contents If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations.
If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations.
We cannot be sure that adequate coverage and reimbursement in the United States, the EU or elsewhere will be available for our products or any products that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future.
We cannot be sure that adequate coverage and reimbursement in the United States, the EU or elsewhere will be available for our products or any products that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future. There is significant uncertainty related to the insurance coverage and reimbursement of newly approved products.
You should carefully consider these risk factors before you decide to invest in our common stock and should not consider this list to be a complete statement of all risks and uncertainties.
ITEM 1A. RISK FACTORS You should be aware that there are substantial risks for an investment in our common stock. You should carefully consider these risk factors before you decide to invest in our common stock and should not consider this list to be a complete statement of all risks and uncertainties.
Additionally, our expenses could increase beyond our expectations if we are required by the FDA or other comparable regulatory authorities to perform clinical trials in addition to those that we currently expect, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing its clinical trials or the development of any of our product candidates.
Additionally, our expenses could increase beyond our expectations if we are required by the FDA or other comparable regulatory authorities to perform clinical trials in addition to those that we currently expect, or if there are any delays in establishing appropriate manufacturing arrangements for or in completing our clinical trials or the development of any of our product candidates. 32 Table of Contents We need additional capital which may not be available when needed or on commercially acceptable terms.
These proposals might result in significant changes in the pharmaceutical value chain as manufacturers, pharmacy benefits managers (“PBMs”, managed care organizations and other industry stakeholders look to implement new transactional flows and adapt their business models.
U.S. lawmakers also have explored proposals to reduce drug prices, including requiring price transparency and drug importation measures. These proposals might result in significant changes in the pharmaceutical value chain as manufacturers, pharmacy benefits managers (“PBMs”, managed care organizations and other industry stakeholders look to implement new transactional flows and adapt their business models.
From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. Such claims, even if lacking merit, could result in the expenditure of significant financial and managerial resources.
From time to time, we may be subject to legal proceedings and claims in the ordinary course of business. Such claims, even if lacking merit, could result in the expenditure of significant financial and managerial resources. The successful development of our pharmaceutical products involves a lengthy and expensive process and is highly uncertain.
If we fail to comply with our obligations under intellectual property licenses with third parties, we could lose license rights that are important to our business. Scienture LLC is a party to a Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies, B.V.
If we fail to comply with our obligations under intellectual property licenses with third parties, we could lose license rights that are important to our business. Scienture LLC is a party to the Innocore License, an exclusive and royalty-bearing intellectual property license agreement.
While the Company believes it will be able to timely regain compliance with Nasdaq’s continued listing requirements, there can be no assurance that the Company will be able to regain compliance with Nasdaq Listing Rule 5620(a) or will otherwise be able to maintain compliance with other Nasdaq listing criteria.
While we believe we will be able to timely regain compliance with Nasdaq’s continued listing requirements, there can be no assurance that we will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be able to maintain compliance with other Nasdaq listing criteria.
In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. In 2010, the ACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. There are continued efforts to challenge the ACA.
In 2010, the ACA was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. There are continued efforts to challenge the ACA. There are also efforts to broaden healthcare coverage.
Because these new ventures are inherently risky, no assurance can be given that such strategies and offerings will be successful and will not adversely affect our reputation, financial condition, and operating results. To date we have taken losses and/or write-downs on several businesses, products, services, and technologies.
Because these new ventures are inherently risky, no assurance can be given that such strategies and offerings will be successful and will not adversely affect our reputation, financial condition, and operating results.
Our failure to secure these arrangements as needed could have a material adverse effect on our ability to complete the development of our product candidates or, to commercialize them, if approved. We may be unable to conclude agreements for commercial supply with third-party manufacturers or may be unable to do so on acceptable terms.
We may not be able to timely secure needed supply arrangements on satisfactory terms, or at all. Our failure to secure these arrangements as needed could have a material adverse effect on our ability to complete the development of our product candidates or, to commercialize them, if approved.
We expect that any future license agreements we may enter into may impose various diligence, milestone payment, royalty, insurance, and other obligations on us.
In connection with our efforts to expand our pipeline of product candidates, we expect to enter into additional license agreements in the future. We expect that any future license agreements we may enter into may impose various diligence, milestone payment, royalty, insurance, and other obligations on us.
If we fail to comply with applicable laws and regulations, we could become liable for damages and suffer civil and criminal penalties, including the loss of licenses or our ability to participate in Medicare, Medicaid and other federal and state healthcare programs.
If we fail to comply with applicable laws and regulations, we could become liable for damages and suffer civil and criminal penalties, including the loss of licenses or our ability to participate in Medicare, Medicaid and other federal and state healthcare programs. 42 Table of Contents In addition, we may be subject to the operating and security standards of the Drug Enforcement Administration, the FDA, various state boards of pharmacy, state health departments, the HHS, the CMS, and other comparable agencies.
Although Scienture LLC has initiated development for product candidates, all of these candidates, other than SCN-102, remain in early-stage clinical or preclinical development. Our future success and ability to generate revenue from Scienture LLC’s product candidates is dependent on our ability to successfully develop, obtain regulatory approval for and commercialize one or more of our product candidates.
Our future success and ability to generate revenue from Scienture LLC’s product candidates is dependent on our ability to successfully develop, obtain regulatory approval for, and commercialize one or more of our remaining product candidates.
As such, we currently rely on third-party manufacturers to provide all of the API and the final drug product formulation of all of our product candidates that are being used in our clinical trials and preclinical studies. If we were to need an alternate manufacturer, we would incur added costs and delays in identifying and qualifying any such replacement.
As such, we currently rely on third-party manufacturers to provide all of the Active Pharmaceutical Ingredients (“API”) and the final drug product formulation of all of our product candidates that are being used in our clinical trials and preclinical studies.
The regulations may be interpreted or applied by a prosecutorial, regulatory, or judicial authority in a manner that could require us to make changes in our operations.
Many of the regulations applicable to us, including those relating to marketing incentives, are vague or indefinite and have not been interpreted by the courts. The regulations may be interpreted or applied by a prosecutorial, regulatory, or judicial authority in a manner that could require us to make changes in our operations.
We seek to support Scienture LLC in rapidly advancing discovery and development of transformational medicines for patients suffering from CNS and CVS diseases. Due to the significant resources required for the development of our product candidates, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to each.
Due to the significant resources required for the development of our product candidates, we must decide which product candidates and indications to pursue and advance and the amount of resources to allocate to each.
In addition, we typically order raw materials, API and drug product and services on a purchase order basis and do not enter into long-term dedicated capacity or minimum supply arrangements with any commercial manufacturer. We may not be able to timely secure needed supply arrangements on satisfactory terms, or at all.
If we were to need an alternate manufacturer, we would incur added costs and delays in identifying and qualifying any such replacement. In addition, we typically order raw materials, API and drug product and services on a purchase order basis and do not enter into long-term dedicated capacity or minimum supply arrangements with any commercial manufacturer.
Such issuances may also serve to enhance existing management’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supporting existing management. 73 Table of Contents For all of the foregoing reasons and others set forth herein, an investment in our securities involves a high degree of risk.
Such issuances may also serve to enhance existing management’s ability to maintain control of the Company because the shares may be issued to parties or entities committed to supporting existing management. 62 Table of Contents
Even though approved by the FDA, SCN-102 will require substantial additional investment for commercialization, clinical development, regulatory review, and approval in one or more jurisdictions. If any of Scienture LLC’s product candidates encounters safety or efficacy problems, development delays, regulatory issues or other problems, our development plans and business would be materially harmed.
If any of Scienture LLC’s product candidates encounters safety or efficacy problems, development delays, regulatory issues, or other problems, our development plans and business would be materially harmed.
For more information, see “ Scienture’s Business– Other Regulatory Requirements–Healthcare Reform .” Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
For more information, see “ Scienture’s Business–Government Regulation–Other Healthcare Laws. ” We also may be subject to extensive, and frequently changing, local, state and federal laws and regulations relating to healthcare fraud, waste and abuse.
We also may be subject to extensive, and frequently changing, local, state and federal laws and regulations relating to healthcare fraud, waste and abuse. Local, state and federal governments continue to strengthen their position and scrutiny over practices involving fraud, waste and abuse affecting Medicare, Medicaid and other government healthcare programs.
Scienture LLC may in the future conduct one or more of its clinical trials with one or more trial sites that are located outside the United States.
In addition, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not guarantee regulatory approval in any other country. We may in the future conduct one or more clinical trials with one or more trial sites that are located outside the United States.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates. Developing biopharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete.
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ITEM 1A. RISK FACTORS Summary Risk Factors Our business is subject to numerous risks and uncertainties, many of which are beyond our control, including those highlighted in the section titled “ Risk Factors ” immediately following this summary.
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Scienture LLC has completed development of SCN-102, which received FDA regulatory approval in March 2025 and commenced commercialization in the third quarter of 2025. The remaining product candidates — SCN-104, SCN-106, and SCN-107 — remain in clinical or preclinical development.
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These risks include, among others, the following: Risks Related to Our Business ● We operate a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate its current business and predict its future success and viability. ● Our executive officers lack experience with the clinical development of therapeutic products for FDA marketing approval. ● We need additional capital which may not be available when needed or on commercially acceptable terms, thereby casting substantial doubt on our ability to continue as a going concern.
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Management expects SCN-104 and SCN-106 to achieve regulatory approval in 2027 or 2028, with commercialization projected to begin in 2028, and SCN-107 to achieve regulatory approval in 2028 or 2029, with commercialization projected to begin in 2029.
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To the extent outstanding loan conversion rights associated with our existing indebtedness are exercised, there will be dilution to our stockholders. ● Indebtedness and liabilities could limit the cash flow available for our operations, including under Scienture LLC’s outstanding secured convertible debt, expose us to risks that could adversely affect our business, financial condition, and results of operations. ● Due to the significant resources required to develop our product pipeline, and depending on our ability to access capital, we must prioritize the development of certain product candidates over others and we may fail to expend our limited resources on product candidates or indications that may have been more profitable or for which there is a greater likelihood of success. ● Our acquisitions and investments in new businesses and new products, services, and technologies is inherently risky, and could disrupt our ongoing businesses. ● Our business is highly dependent on the success of certain product candidates.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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For more information regarding the risks the Company faces from cybersecurity threats, see “Item 1A. Risk Factors––Risks Related to Our Business and Operations––We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.”

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeScienture LLC entered into a lease at 20 Austin Boulevard, Commack, NY 11725 for approximately $29,621 per year ($2,468 per month) under a 22-month agreement, effective October 1, 2023. We believe our current and future facilities are adequate for our current and near-term needs. Additional space may be required as we expand our activities.
Biggest changeITEM 2. PROPERTIES We do not own any real property. Scienture LLC entered into a lease at 20 Austin Boulevard, Commack, NY 11725 for approximately $29,621 per year ($2,468 per month) under a 22-month agreement, effective October 1, 2023. We believe our current and future facilities are adequate for our current and near-term needs.
We do not currently foresee any significant difficulties in obtaining any required additional facilities.
Additional space may be required as we expand our activities. We do not currently foresee any significant difficulties in obtaining any required additional facilities.
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ITEM 2. PROPERTIES We do not own any real property. We entered into a lease for Integra Pharma Solutions, LLC at 6308 Benjamin Road, Tampa, Florida 33634 for approximately $43,000 per year ($3,583 per month) under a five-year lease agreement, effective October 17, 2018, occupying approximately 6,300 square feet.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeFor a description of our material pending legal proceedings, please see “Note 15 – Contingencies”. to the Notes to Consolidated Financial Statements included herein under “Item 8. Financial Statements and Supplemental Data.”
Biggest changeFor a description of our material pending legal proceedings, please see “Note 13 – Commitments and Contingencies” to the Notes to Consolidated Financial Statements included herein under “Item 8. Financial Statements and Supplemental Data.”

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeIn each case, the issuance did not involve a public offering and was made without general solicitation or general advertising, and the recipient of the shares was an accredited investor. Purchases of Equity Securities by the Issuer and Affiliated Purchasers The Company did not repurchase any shares of common stock during the year ended December 31, 2024.
Biggest changePurchases of Equity Securities by the Issuer and Affiliated Purchasers The Company did not repurchase any shares of common stock during the year ended December 31, 2025.
Accordingly, investors have historically relied on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments. Recent Sales of Unregistered Securities During the year ended December 31, 2024, the Company issued 490,698 shares of common stock for services.
Accordingly, investors have historically relied on sales of their common stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments. Recent Sales of Unregistered Securities During the year ended December 31, 2025, the Company issued 3,760,150 shares of common stock for services.
Common Stock and Preferred Stock Outstanding and Holders of Record As of March 26, 2025, we had 12,515,019 shares of common stock outstanding, held by 90 stockholders of record, not including holders who hold their shares in street name as well as 1,575,900 shares of preferred stock issued and outstanding.
Holders of Record As of March 27, 2026, we had 40,630,815 shares of common stock outstanding, held by 66 stockholders of record, not including holders who hold their shares in street name.
The Company relied on the exemption from registration set forth in Section 4(a)(2) of the Securities Act for this issuance.
The Company relied on the exemption from registration set forth in Section 4(a)(2) of the Securities Act for this issuance. Such issuance did not involve a public offering and was made without general solicitation or general advertising, and the recipient of the shares was an accredited investor.
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market for Common Stock Our common stock was approved for listing on Nasdaq on February 13, 2020, under the symbol “MEDS”. On September 24, 2024, in connection with our acquisition of Scienture, Inc. (k/n/a Scienture, LLC), we changed our symbol to “SCNX”.
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market for Common Stock Our common stock is listed on Nasdaq, under the symbol “SCNX”. At present, there is a limited market for our common stock.
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Prior to February 13, 2020, our common stock traded on the OTCQB Market under the symbol “TRXD”. At present, there is a limited market for our common stock.
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The actual number of stockholders is greater than this number of record holders, and includes stockholders who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
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The Company relied on the exemption from registration set forth in Section 4(a)(2) of the Securities Act for this issuance. On July 12, 2024, the Company converted 290 shares of Series C Preferred Stock into 52,158 shares of common stock at the election of the holder.
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On July 25, 2024, as consideration for the acquisition of Scienture LLC, the Company issued to former Scienture, Inc. stockholders an aggregate amount of (i) 291,536 shares of the Company’s common stock and (ii) 6,826,713 shares of the Company’s Series X Non-Voting Convertible Preferred Stock, par value $0.00001 per share (the “Series X Preferred Stock”), each share of which was convertible into one share of common stock.
Removed
On September 20, 2024, all shares of Series X Preferred Stock were converted into a total of 6,826,753 shares of common stock. Such issuances were made in reliance on the exemptions from registration pursuant to Section 4(a)(2) of the Securities Act.
Removed
In August 2024, the Company issued a convertible note of $360,000, for which the Company received $314,000 in net proceeds. The Conversion Price is the lesser of i) $8.36 or (ii) 85% of the lowest volume-weighted average prices of the preceding five trading days. The note matures on August 20, 2025.
Removed
In connection with the note, the Company issued 76,923 warrants to purchase common stock. The warrants have an exercise price of $9.36 per share, are immediately exercisable and have a term of 5 years.
Removed
Such issuances were made in reliance on the exemptions from registration pursuant to Section 4(a)(2) of the Securities Act. 75 Table of Contents Also in August 2024, the Company issued 28,571 shares of common stock pursuant to the exercise of warrants on a cashless basis.
Removed
Such issuances were made in reliance on the exemptions from registration pursuant to Section 4(a)(2) of the Securities Act. On November 22, 2024, the Company issued 55,000 shares of common stock pursuant to a Securities Purchase Agreement dated November 22, 2024.
Removed
On November 25, 2024, the Company issued 70,000 shares of common stock pursuant to purchase agreement dated November 25, 2024. Such issuances were made in reliance on the exemptions from registration pursuant to Section 4(a)(2) of the Securities Act.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

19 edited+63 added−48 removed12 unchanged
Biggest changeYear Ended December 31, 2024, compared to Year Ended December 31, 2023 Year Ended December 31, Percent 2024 2023 Change Change Revenues $ 136,643 1,363,830 (1,227,187 ) -90 % Cost of sales 130,638 1,314,800 (1,184,162 ) -90 % Gross profit 6,005 49,031 (43,026 ) -88 % Operating expenses: Wage and salary expense 2,111,066 626,547 1,484,519 237 % Professional fees 1,458,332 875,136 583,196 67 % Accounting and legal expense 1,807,041 1,506,881 300,160 20 % Technology expense 416,311 100,280 316,031 315 % General and administrative (including stock-based compensation expense) 6,677,580 1,336,637 5,340,943 400 % Research and development 2,236,690 - 2,236,690 100 % Total operating expenses 14,707,020 4,445,482 10,261,538 231 % Change in fair value of warrant liability (182,982 ) (148,420 ) (34,562 ) 23 % Change in fair value of derivative liability 180,383 - 180,383 100 % Investment impairment (2,500,000 ) - (2,500,000 ) -100 % Interest income 135,337 4,198 131,139 3124 % Loss on disposal of asset (374,968 ) (2,798,968 ) 2,424,000 -87 % Interest expense (1,335,631 ) (1,143,223 ) (192,408 ) 17 % Net loss from continuing operations (18,778,876 ) (8,482,864 ) (10,296,011 ) 121 % Benefit / (provision) for income taxes 534,396 - 534,396 100 % Net loss from continuing operations, net of tax (18,244,480 ) (8,482,864 ) (9,761,615 ) 87 % Income (loss) from discontinued operations, net of tax 27,310,278 (9,360,710 ) 36,670,988 -392 % Net income/(loss) $ 9,065,798 $ (17,843,574 ) $ 26,909,372 -151 % 79 Table of Contents There were $136,643 in revenues for the year ended December 31, 2024.
Biggest changeYear Ended December 31, 2025 Compared to Year Ended December 31, 2024 Year Ended December 31, Percent 2025 2024 Change Change Revenues $ 431,609 $ 136,643 294,966 216 % Cost of sales 100,127 130,638 (30,511 ) -23 % Gross profit 331,482 6,005 325,477 5420 % Operating expenses: Wage and salary expense 2,118,568 2,111,066 7,502 0 % Professional fees 2,407,822 1,458,332 949,490 65 % Accounting and legal expense 2,070,337 1,807,041 263,296 15 % Technology expense 97,261 416,311 (319,050 ) -77 % General and administrative (including stock-based compensation expense) 7,926,016 6,677,580 1,248,436 19 % Research and development 1,956,270 2,236,690 (280,420 ) -13 % Impairment loss 26,346,050 - 26,346,050 100 % Total operating expenses 42,922,324 14,707,020 28,215,304 192 % Change in fair value of warrant liability 909,020 (182,982 ) 1,092,002 -597 % Change in fair value of derivative liability 2,296,834 180,383 2,116,451 1173 % Impairment of investment - (2,500,000 ) 2,500,000 -100 % Loss on conversion of note payable (53,446 ) - (53,446 ) -100 % Loss on disposition of subsidiaries (288,204 ) - (288,204 ) -100 % Interest income 302,702 135,337 167,365 124 % Loss on disposal of asset - (374,968 ) 374,968 -100 % Interest expense (4,083,206 ) (1,335,631 ) (2,747,575 ) 206 % Net loss from continuing operations (43,507,142 ) (18,778,876 ) (24,728,266 ) 132 % Benefit / (provision) for income taxes 1,994,878 534,396 1,460,482 273 % Net loss from continuing operations, net of tax (41,512,264 ) (18,244,480 ) (23,267,784 ) 128 % Income from discontinued operations, net of tax - 27,310,278 (27,310,278 ) -100 % Net (loss) income $ (41,512,264 ) $ 9,065,798 $ (50,578,062 ) -558 % Revenues and Gross Profit Revenues for the year ended December 31, 2025 were $431,609, compared to $136,643 for the year ended December 31, 2024, an increase of $294,966, or approximately 216%.
MD&A is organized as follows: ● Company Overview . Discussion of our business and overall analysis of financial and other highlights affecting us, to provide context for the remainder of MD&A. ● Recent Events . Summary of material transactions occurring during year ended December 31, 2024. ● Liquidity and Capital Resources .
MD&A is organized as follows: ● Company Overview . Discussion of our business and overall analysis of financial and other highlights affecting us, to provide context for the remainder of MD&A. ● Recent Events . Summary of material transactions occurring during year ended December 31, 2025. ● Liquidity and Capital Resources .
An analysis of changes in our consolidated balance sheets and cash flows and discussion of our financial condition. ● Results of Operations . An analysis of our financial results comparing the years ended December 31, 2024, and 2023. ● Critical Accounting Policies .
An analysis of changes in our consolidated balance sheets and cash flows and discussion of our financial condition. ● Results of Operations . An analysis of our financial results comparing the years ended December 31, 2025 and 2024. ● Critical Accounting Policies .
Summary of The Information Contained in Management’s Discussion and Analysis of Financial Condition and Results of Operations Our Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is provided in addition to the accompanying consolidated financial statements and notes to assist readers in understanding our results of operations, financial condition, and cash flows.
Summary of The Information Contained in Management’s Discussion and Analysis of Financial Condition and Results of Operations Our Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is provided in addition to the accompanying consolidated financial statements and notes to assist readers in understanding our results of operations, financial condition, and cash flows.
Recently Issued Accounting Standards For more information on recently issued accounting standards, see “NOTE 1 – ORGANIZATION AND BASIS OF PRESENTATION”, to the Notes to Consolidated Financial Statements included herein under “PART I. - ITEM 1. FINANCIAL STATEMENTS”.
Recently Issued Accounting Standards For more information on recently issued accounting standards, see “ N ote 1 – Organization and Basis of Presentation” to the Notes to Consolidated Financial Statements included herein under “ Item 8. Financial Statements and Supplemental Data .”.
(f/k/a Trxade Inc.), Integra Pharma Solutions, LLC and Scienture, LLC (f/k/a Scienture, Inc.). 76 Table of Contents On October 4, 2024, the Company and Softell entered into IPS Assignment Agreement, pursuant to which the Company transferred, and Softell accepted, 100% of the membership interests of IPS. As a result, IPS is now a wholly-owned subsidiary of Softell.
Softell & IPS Entities On October 4, 2024, the Company and Softell entered into the IPS Assignment Agreement, pursuant to which the Company transferred, and Softell accepted, 100% of the membership interests of IPS. As a result, IPS became a wholly-owned subsidiary of Softell.
Stock option forfeitures are recognized at the date of employee termination. Effective January 1, 2019, the Company adopted ASU 2018-07 for the accounting of share-based payments granted to non-employees for goods and services. Off-Balance Sheet Arrangements During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.
Stock option forfeitures are recognized at the date of employee termination. Effective January 1, 2019, the Company adopted ASU 2018-07 for the accounting of share-based payments granted to non-employees for goods and services.
Accounting estimates that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.
Accounting estimates that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts. Company Overview On July 25, 2024, we acquired a wholly-owned subsidiary, Scienture LLC.
Cash provided by investing activities for the year ended December 31, 2024, was $27,552,791 and cash used in investing activities was $275,717 for the year ended December 31, 2023.
Net cash provided by (used in) investing activities from continuing operations was $0 for the year ended December 31, 2025 and $2,379,024 net cash used in investing activities from continuing operations for the year ended December 31, 2024.
In August 2024, the Company received note proceeds of $314,000 and $2,640,000 in net proceeds from convertible debenture in November 2024. Results of Operations The following selected consolidated financial data should be read in conjunction with the unaudited consolidated financial statements and the notes to these statements included above.
Results of Operations The following selected consolidated financial data should be read in conjunction with the audited consolidated financial statements and the notes to these statements included in this Annual Report.
Subsequent to December 31, 2023, we divested our interest in The Urgent Company, Inc. 81 Table of Contents Acquisitions, Goodwill and Other Intangible Assets The Company allocates the cost of an acquired business to the assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition.
The Company does not disclose the value of unsatisfied performance obligations as all contracts have an expected duration of one year or less. 69 Table of Contents Acquisitions, Goodwill and Other Intangible Assets The Company allocates the cost of an acquired business to the assets acquired and liabilities assumed based on their estimated fair values at the date of acquisition.
Cash provided by in financing activities for the year ended December 31, 2024, was ($14,979,770) compared to $1,406,332 of cash provided by financing activities for the year ended December 31, 2023. The change was primarily due to the payment of dividends of $14,858,831 in 2024.
The year ended December 31, 2024 reflected cash used in financing activities primarily due to the payment of special cash dividends of approximately $14,858,000 partially offset by proceeds from convertible note issuances.
Cash Flows The following table summarizes our Consolidated Statements of Cash Flows for the following periods: Year Ended December 31, Percent 2024 2023 Change Change Net cash (used in) provided by operating activities from continuing operations (13,286,163 ) 3,645,257 (16,931,420 ) -464 % Net cash used in operating activities from discontinued operations (979,075 ) (5,870,449 ) 4,891,373 -83 % Operating Activities (14,265,238 ) (2,225,192 ) (12,040,046 ) 541 % Net cash used in investing activities from continuing operations (2,379,024 ) (344,454 ) (2,034,570 ) 591 % Net cash provided by investing activities from discontinued operations 29,931,815 68,737 29,863,078 43445 % Investing Activities 27,552,791 (275,717 ) 27,828,508 -10093 % Net cash (used in) provided by financing activities from continuing operations (12,974,770 ) 1,906,332 (14,881,102 ) -781 % Net cash used in financing activities from discontinued operations (5,000 ) (500,000 ) 495,000 -99 % Financing Activities (12,979,770 ) 1,406,332 (14,386,102 ) -1023 % Net change in cash $ 307,782 $ (1,094,577 ) $ 1,402,358 -128 % 78 Table of Contents Cash used in operating activities for the year ended December 31, 2024, was $14,265,238 compared to $2,225,192 in 2023.
Cash Flows The following table summarizes the Company’s Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024: Year Ended December 31, 2025 Year Ended December 31, 2024 Change % Change Net cash used in operating activities from continuing operations $ (13,382,482 ) $ (13,286,163 ) $ (96,319 ) 1 % Net cash provided by (used in) operating activities from discontinued operations 2,799 (979,075 ) 981,874 -100 % Operating Activities $ (13,379,683 ) $ (14,265,238 ) $ 885,555 -6 % Net cash used in investing activities from continuing operations — $ (2,379,024 ) $ 2,379,024 -100 % Net cash provided by investing activities from discontinued operations — 29,931,815 (29,931,815 ) -100 % Investing Activities $ — $ 27,552,791 $ (27,552,791 ) -100 % Net cash provided by (used in) financing activities from continuing operations $ 19,733,595 $ (12,974,770 ) $ 32,708,365 -252 % Net cash used in financing activities from discontinued operations — (5,000 ) 5,000 -100 % Financing Activities $ 19,733,595 $ (12,979,770 ) $ 32,713,365 -252 % Net change in cash $ 6,353,912 $ 307,782 $ 6,046,130 1,964 % 66 Table of Contents Net cash used in operating activities from continuing operations for the year ended December 31, 2025 was $13,382,482, compared to net cash used in operating activities of approximately $13,286,163 for the year ended December 31, 2024.
In accordance with Financial Accounting Standards Board, or the FASB, Accounting Standards Update No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.
Management evaluated conditions and events in accordance with ASC 205-40 and determined that, based on the factors described below, there is no substantial doubt about the Company’s ability to continue as a going concern for the twelve-month period following the date these financial statements are issued.
Net income from discontinued operations increased by $36,670,988 to a net income of $27,310,278 for the year ended December 31, 2024, compared to a net loss from discontinued operations of $9,360,710 for the year ended December 31, 2023.
Net Loss and Discontinued Operations Net loss from continuing operations, net of tax, was $41,512,264 for the year ended December 31, 2025, compared to a net loss from continuing operations of $15,803,908 for the year ended December 31, 2024.
For the year ended December 31, 2024, cost of goods sold and gross profit were $130,638 and $6,005, and $1,314,800 and $49,031, all respectively for the same period in 2023.
Cost of sales for the year ended December 31, 2025 was $100,127, resulting in gross profit of $331,482 (gross margin: 76.8%), compared to cost of sales of $130,638 and gross profit of $6,005 (gross margin: 4.4%) for the year ended December 31, 2024.
IPS takes orders for products, creates invoices for each order and recognizes revenue at the time the product is shipped to the Customer. Customer returns are not material. Step One: Identify the contract with the Customer – IPS requires that an application and a credit card for payment be completed by the Customer prior to the first order.
IPS takes orders for products, creates invoices for each order and recognizes revenue at the time the product is shipped to the Customer. IPS was divested on April 30, 2025, and its operations are presented as discontinued operations for all periods presented.
Its targeted portfolio consists of short term and long-term opportunities with efficient development, regulatory, and go to market strategies.
Its development pipeline consists of a broad range of novel product candidates including new potential treatments for migraine, thrombosis, pain and other related disorders. Scienture LLC’s mission is to bring to market innovative technology-based products to address unmet medical needs. Its targeted portfolio consists of short term and long-term opportunities with efficient development, regulatory, and go to market strategies.
In the event we require additional funding, we plan to raise that through the sale of debt or equity, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders.
The company also expects to generate revenue from REZENOPY TM which is anticipated to commence in the second quarter of 2026. The Company may also raise additional funding through the sale of debt or equity to fund accelerated pipeline development activities; however, there can be no assurance that such funding will be available on favorable terms, or at all.
Removed
Company Overview On September 20, 2024, the Company filed with the Secretary of State of the State of Delaware an amendment to its Second Amended and Restated Certificate of Incorporation to change the legal name of the Company from “TRxADE HEALTH, Inc.” to “Scienture Holdings, Inc.” The Company owned, as of December 31, 2024, 100% of Softell Inc.
Added
Scienture LLC is a specialty pharmaceutical company focused on the commercialization and development of products for the treatment of Cardiovascular (CVS) and Central Nervous System (CNS) diseases. Scienture LLC launched its first commercial product for hypertension and is in the process of commercializing its second product for the treatment of opioid overdose.
Removed
During the year ended December 31, 2023 and a portion of the quarter ended March 31, 2024, Softell, operated a web-based market platform that enabled commerce among healthcare buyers and sellers of pharmaceuticals, accessories and services. Softell’s current primary operations are conducted through IPS. IPS is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to customers.
Added
Dispositions SOSRx, LLC SOSRx, was formed on February 15, 2022.
Removed
IPS’ customers include all healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide. Bonum Health, LLC was formed to hold certain telehealth assets acquired in October 2019. The “Bonum Health Hub” was launched in February 2020; however, the Company does not anticipate installations moving forward.
Added
The Company entered into a relationship with Exchange Health, LLC (“Exchange Health”), a technology company providing an online platform for manufacturers and suppliers to sell and purchase pharmaceuticals, pursuant to which SOSRx, a Delaware limited liability company, was formed, which was owned 51% by the Company and 49% by Exchange Health.
Removed
The Company is in the process of determining a divestment and winddown plan for Softell and IPS. On January 25, 2025, the Company’s Board of Directors approved the preparation of a divestment and winddown plan for the winddown of each of Softell, IPS, Bonum Health, Inc., and Bonum.
Added
SOSRx did not generate material revenue and in February 2023 the Company voluntarily withdrew from the joint venture agreement.
Removed
Scienture LLC is a New York based branded, specialty pharmaceutical research company which is engaged in the research and development of branded pharmaceutical products. The intellectual property application process was initiated in November 2019 and the product development activities commenced in January 2020.
Added
Community Specialty Pharmacy, LLC and Alliance Pharma Solutions, LLC On January 20, 2023, the Company entered into Membership Interest Purchase Agreements to sell 100% of the outstanding membership interests of the Company’s former subsidiaries, Community Specialty Pharmacy, LLC and Alliance Pharma Solutions, LLC (d.b.a DelivMeds).
Removed
Scienture LLC also plans to foray into commercialization of innovative and branded pharmaceutical products in the US market. Scienture LLC’s assets in development are across therapeutics areas and indications and cater to different market segments. Scienture LLC’s mission is to identify, develop and bring to market innovative technology-based products to address unmet medical needs.
Added
The Company also agreed to enter into a Master Service Agreement to operate the businesses prior to closing. The transactions contemplated by the Membership Interest Purchase Agreements closed on August 22, 2023. 64 Table of Contents Superlatus Inc.
Removed
Acquisitions See ITEM 1 of PART 1 Dispositions See ITEM 1 of PART 1 Recent Events On September 20, 2024, the Company filed with the Secretary of State of the State of Delaware an amendment to its Second Amended and Restated Certificate of Incorporation to change the legal name of the Company from “TRxADE HEALTH, Inc.” to “Scienture Holdings, Inc.” (the “Name Change”).
Added
On July 14, 2023, the Company entered into the Superlatus Merger Agreement with Superlatus Inc., a diversified food technology company, and Merger Sub.
Removed
Other than the Name Change, there were no changes to the Company’s certificate of incorporation or bylaws. Effective September 23, 2024, the Company’s common stock trades under the ticker symbol “SCNX”. The Name Change resulted in a change to the CUSIP number for the Company’s outstanding shares of common stock offered on the Nasdaq Stock Market LLC.
Added
On July 31, 2023, the Company completed its acquisition of Superlatus in accordance with the terms and conditions of the Superlatus Merger Agreement, pursuant to which the Company acquired Superlatus by way of a merger of the Merger Sub with and into Superlatus, with Superlatus being a wholly owned subsidiary of the Company and the surviving entity in the Superlatus Merger.
Removed
Liquidity Outlook Cash Explanation Cash Requirements Our primary objectives for the year of 2025 are expected to be the continued implementation of the Scienture LLC business plan, and to complete potential strategic transactions of our business-to-consumer subsidiaries, which may include a potential sale, spin-off, fund raising, combination or other strategic transaction, and also include the winding down of such entities.
Added
Under the terms of the Superlatus Merger Agreement, at the Closing, shareholders of Superlatus received an aggregate of 136,441 shares of the Company’s common stock and 306,855 shares of the Company’s Series B Preferred Stock, convertible into 100 shares of the Company’s common stock.
Removed
There can be no assurance that our operations will generate significant positive cash flow, or that additional funds will be available to us, through borrowings or otherwise, on favorable terms if required in the future, or at all.
Added
At Closing, the value of the Company’s common stock was $7.30 per share, resulting in a total value of $225,000,169.
Removed
We may also raise additional funding in the future through the sale of equity. 77 Table of Contents We estimate our operating expenses and working capital requirements for the next 12 months to be approximately as follows: Projected Expenses from January 2025 to December 2025 Amount General and administrative (1) $ 9,800,000 Total $ 9,800,000 (1) Includes estimated wages and payroll, legal and accounting, marketing, rent and research and development.
Added
On October 13, 2023, the Company announced that Superlatus PD Holding Company, Inc., a purported subsidiary of Superlatus, entered into a supplier agreement with Rainforest, pursuant to which Superlatus allegedly appointed Rainforest as its exclusive distributor for Superlatus’ portfolio of consumer packaged goods brands in certain markets.
Removed
We may require additional funding in the future to implement on our business plan and potentially to expand or complete acquisitions. The sources of this capital are expected to be equity investments and notes payable.
Added
The Company later learned and announced that neither the Company’s management nor the Company’s Board of Directors authorized or approved the organization of Superlatus PD Holding Company, Inc. or the entry into the supplier agreement. Instead, the Company’s management determined that certain representatives of a former subsidiary of the Company likely unilaterally took actions related to the supplier agreement.
Removed
Our plan for the next twelve months is to continue using the same marketing and management strategies to promote our IPS assets and operations, exploring strategic transactions involving our corporate assets, while also seeking to expand our and Scienture LLC operations organically or through acquisitions, as funding and opportunities arise.
Added
On January 8, 2024, the Company entered into the Superlatus Amendment as not all of the closing conditions of the Superlatus Merger Agreement were met.
Removed
If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate future revenues.
Added
Under the terms of the Superlatus Amendment, the merger consideration to the shareholders of Superlatus was adjusted to the aggregate of 136,441 shares of the Company’s common stock and 15,759 shares of the Company’s Series B Preferred Stock, resulting in a total value of $12,500,089.
Removed
Going Concern The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the consolidated financial statements are issued.
Added
Additionally, the shareholders of Superlatus agreed to surrender back to the Company 291,096 shares of the Company’s Series B Preferred Stock. On March 5, 2024, the Company entered into the Superlatus SPA with the Buyer, Superlatus Foods Inc. Pursuant to the Superlatus SPA, the Company sold all of the issued and outstanding stock of Superlatus to the Buyer.
Removed
As of December 31, 2024, the Company had an accumulated deficit of $39,038,973 and $308,096 in cash. We will need to raise additional capital or secure debt funding to support on-going operations, and to fund the assets and operations of any businesses or assets we acquire.
Added
A $1.00 purchase price was delivered to the Company at the closing, which occurred simultaneously with the execution of the Superlatus SPA.
Removed
The sources of this capital are expected to be the sale of equity and debt, which may not be available on favorable terms, if at all, and may, if sold, cause significant dilution to existing stockholders.
Added
As a result of the transaction Superlatus is no longer a subsidiary of the Company, and the rights and assets of Superlatus together with various liabilities and obligations that were specific to Superlatus became rights and obligations of the Buyer. Other Legacy Subsidiaries The Company also previously owned 100% of Softell, IPS, Bonum Health, Inc., and Bonum Health, LLC.
Removed
If we are unable to access additional capital moving forward, it may hurt our ability to grow and to generate future revenues, our financial position, and liquidity. These factors raise substantial doubt about the ability of the Company to continue as a going concern.
Added
On April 8, 2025, the Company entered into the IPS MIPA with Tollo, pursuant to which Tollo agreed to purchase and the Company agreed to sell all of the Company’s membership interests in IPS. Suren Ajjarapu, the Company’s former Chief Executive Officer, and Prashant Patel, the Company’s former President and Chief Operating Officer, each have a beneficial interest in Tollo.
Removed
Unless Management is able to obtain additional financing, it is unlikely that the Company will be able to meet its funding requirements during the next 12 months. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Added
On April 8, 2025, the Company also entered into the Softell SPA with Tollo, pursuant to which Tollo agreed to purchase and the Company agreed to sell all issued and outstanding shares of common stock of Softell.
Removed
The increase in cash used in operations for the year ended December 31, 2024 was mainly due to our net loss and cash used in operating assets and liabilities in 2024 driven by other receivables, partially offset by non-cash charges.
Added
Bonum Health Entities On April 8, 2025, the Company also entered into the Bonum SPA with Tollo, pursuant to which Tollo agreed to purchase and the Company agreed to sell all issued and outstanding shares of common stock of Bonum Health, Inc. In November 2025, the Company dissolved Bonum Health, LLC.
Removed
The increase in cash provided by investing activities in 2024 was primarily due to the MMS disposition in the first quarter and cash received in acquisition of Scienture, Inc., partially offset by the investment in securities of $2,500,000.
Added
The divestitures described above are part of a broader strategic realignment at the Company designed to sharpen operational focus and unlock long-term value. It is aligned with the Company’s commitment to streamline its core operations, optimize its portfolio, and accelerate growth in the Branded and Specialty Pharma markets.
Removed
Revenues decreased by $1,227,187, compared to the same period ended December 31, 2023 primarily because of the disposition of the assets and operations of Softell completed in February 2024 which resulted in the Company having fewer revenue generating operations when compared to the comparable period in 2023.
Added
The Company intends to use the proceeds obtained from the divestment to facilitate the high-growth commercial and strategic product development activities at its Scienture LLC subsidiary.
Removed
Cost of goods sold decreased by $1,184,162, compared to the same period ended December 31, 2023 primarily because of the disposition of the assets and operations of Softell completed in February 2024 which resulted in the Company having fewer cost of goods sold.
Added
The Company believes that the key benefits of the divestitures include: ● Increased Operational Efficiency : Streamlining the Company’s structure aimed at strengthening its balance sheet, providing for leaner operations and a more agile decision-making framework. ● Realize Synergies : Consolidating overlapping functions and eliminating redundancies intended to cause annualized cost savings. ● Dedicated Focus : Affording the full focus and deployment of resources to the commercial products and the high value product pipeline in development at its Scienture subsidiary. 65 Table of Contents Liquidity Outlook Cash Explanation Cash Requirements As of December 31, 2025, the Company’s primary source of liquidity consisted of $6,662,008 in cash and cash equivalents and the Tollo promissory note with a principal balance of $5,000,000 (bearing interest at the prime rate and maturing June 30, 2030).
Removed
Gross profit as a percentage of sales was 4.39% for the year ended December 31, 2024, compared to 3.60% for the year ended December 31, 2023. Wages and salary expense increased by $1,484,520 for the year ended December 31, 2024 to $2,111,067 compared to $626,547 for the comparable period in 2023.
Added
The Company has financed its operations primarily through equity issuances under its equity line of credit (“ELOC”) and convertible note arrangements. During the year ended December 31, 2025, the Company raised approximately $26.3 million in gross equity proceeds through ELOC and other equity transactions.
Removed
The increase is primarily due to an increase in salary of the COO and CEO of IPS, as well as the increased personnel as a result of the Scienture Merger in July 2024, as compared to the same period in 2023. Professional fees increased by $583,196 to $1,458,332 compared to $875,136 for the comparable period in 2023.
Added
The Company’s principal uses of cash are commercialization of ARBLI™ and REZENOPY TM research and development, general and administrative costs, and debt service.
Removed
The increase was primarily due to increase in Board members’ fees and consulting expense and post- acquisition professional fees of Scienture LLC. Accounting and legal expenses increased by $162,836 for the year ended December 31, 2024 to $1,669,717 compared to $1,506,881 for the comparable period in 2023.
Added
The Company expects to fund its operations for at least the next twelve months from its existing cash balance and revenues generated from ARBLI™ commercialization, which commenced in the third quarter of 2025 and is expected to grow in 2026.
Removed
The increase is primarily due to increase in amount of legal services during the year ended December 31, 2024 as compared to the same period in 2023. General and administrative expenses (including stock-based compensation expense) increased by $5,369,446 for the year ended December 31, 2024, to $6,706,082 compared to $1,336,637 for the comparable period in 2023.
Added
The Company’s ability to continue to fund operations beyond the next twelve months will depend on its ability to grow revenues from the commercialization of ARBLI™ and REZENOPY TM and, if needed, to access additional capital markets. Management continues to evaluate potential strategic transactions and partnerships to accelerate product development and commercialization across the pipeline.
Removed
The increase was mainly due to shares issued for services at fair value of $4,598,294 in 2024. Technology expense increased by $316,031 for the year ended December 31, 2024 to $416,311 compared to $100,280 for the comparable period in 2023. The increase was mainly due to increased software expense and software support expense.
Added
Going Concern The consolidated financial statements have been prepared on a going concern basis. As of December 31, 2025, the Company had cash and cash equivalents of $6,662,008, positive working capital of approximately $5,181,000, and current liabilities of approximately $2,735,000.
Removed
Research and development expense pertaining to Scienture LLC’s operations post-acquisition was $2,236,690 for the year ended December 31, 2024. Research and development expenses was mainly due to contract research organization costs of Scienture LLC.
Added
See also “Note 2 – Going Concern” in the Notes to Consolidated Financial Statements for further discussion. As of December 31, 2025, the Company had an accumulated deficit of $80,551,237 and cash and cash equivalents of $6,662,008.
Removed
Total expenses by program were as follows: Year Ended December 31, Project Codes Product Name 2024 SCN-102 Losartan $ 1,158,130 SCN-104 DHE 703,938 SCN-106 Alteplase 250,000 SCN-107 Bupivacaine 124,621 Total research and development expense $ 2,236,690 We had interest expense of $1,335,631 for the year ended December 31, 2024, compared to interest expense of $1,143,223 for the year ended December 31, 2023.
Added
The Company had current liabilities of $2,735,351 and working capital of approximately $5,181,000, an improvement of approximately $6,782,000 from the working capital deficit of $(1,601,416) as of December 31, 2024.
Removed
The increase is due to the interest expense on Scienture LLC’s convertible debt, the convertible notes issued in August and 2024, and related debt discount amortization on these notes, partially offset by the Superlatus notes no longer being outstanding after its disposition in early 2024. 80 Table of Contents We recognized a loss on the change in the fair value of the warrant liability of $182,982 for the year ended December 31, 2024 compared to a loss of $148,420 during the year ended December 31, 2023, based on the underlying valuation inputs.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Pursuant to Item 305(e) of Regulation S-K (§ 229.305(e)), the Company is not required to provide the information required by this Item as it is a “ smaller reporting company, ” as defined by Rule 229.10(f)(1). 82 Table of Contents ITEM 8.
Biggest changeITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Pursuant to Item 305(e) of Regulation S-K (§ 229.305(e)), the Company is not required to provide the information required by this Item as it is a “smaller reporting company,” as defined by Rule 229.10(f)(1). 70 Table of Contents ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTAL DATA Scienture Holdings, Inc.
FORM 10-K For the Year Ended December 31, 2024 TABLE OF CONTENTS REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM PCAOB ID: 6866 84 CONSOLIDATED BALANCE SHEETS 85 CONSOLIDATED STATEMENTS OF OPERATIONS 86 CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 87 CONSOLIDATED STATEMENTS OF CASH FLOWS 88 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 89 83 Table of Contents PART II: FINANCIAL INFORMATION
FORM 10-K For the Year Ended December 31, 2025 TABLE OF CONTENTS REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID: 6866 ) 72 CONSOLIDATED BALANCE SHEETS 73 CONSOLIDATED STATEMENTS OF OPERATIONS 74 CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 75 CONSOLIDATED STATEMENTS OF CASH FLOWS 76 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 77 71 Table of Contents PART II: FINANCIAL INFORMATION
Removed
FINANCIAL STATEMENTS AND SUPPLEMENTAL DATA Scienture Holdings, Inc. formerly TRxADE HEALTH, INC.

Other SCNX 10-K year-over-year comparisons