23 unchanged sentences
various factors, including those discussed under the section entitled “ Risk Factors ” of this Annual Report.
−Removed: These and other
−Removed: factors could cause our future performance to differ materially from our assumptions and estimates.
−Removed: Some market and other data included
−Removed: herein, as well as the data of competitors as they relate to us, are also based on our good faith estimates.
+Added: and other factors could cause our future performance to differ materially from our assumptions and estimates.
+Added: Some market and other data
+Added: included herein, as well as the data of competitors as they relate to us, are also based on our good faith estimates.
fiscal year ends on December 31st.
5 unchanged sentences
the context requires otherwise, references to the “Company,” “we,” “us,” and “our” refer
−Removed: specifically to Scienture Holdings, Inc., formerly known as TRxADE HEALTH, INC., and its consolidated subsidiaries.
−Removed: addition, unless the context otherwise requires and for the purposes of this Annual Report only:
−Removed: Act” refers to the Securities Exchange Act of 1934, as amended;
−Removed: refers to the United States Securities and Exchange Commission;
−Removed: ● “Securities
−Removed: Act” refers to the Securities Act of 1933, as amended.
−Removed: file annual, quarterly, and current reports, proxy statements and other
−Removed: information with the SEC.
−Removed: Our SEC filings are available to the public over the Internet at the SEC’s website at http://www.sec.gov and
−Removed: are available for download, free of charge, soon after such reports are filed with or furnished to the SEC, on the “Investors”
−Removed: page of our website at www.scientureholdings.com.
−Removed: Copies of documents filed by us with the SEC are also available from us without charge,
−Removed: upon oral or written request to our Secretary, who can be contacted at the address and telephone number set forth on the cover page of
−Removed: this Annual Report.
−Removed: Our website addresses are www.scientureholdings.com, www.scienture.com, www.trxadehealth.com and www.rxintegra.com.
−Removed: Information on our websites is not incorporated by reference into this Annual Report.
−Removed: The information on, or that may be accessed through,
−Removed: our websites not incorporated by reference into this Annual Report and should not be considered a part of this Annual Report.
+Added: specifically to Scienture Holdings, Inc., and its consolidated subsidiaries.
+Added: file annual, quarterly, and current reports, proxy statements and other information with the SEC.
+Added: Our SEC filings are available to the
+Added: public over the Internet at the SEC’s website at http://www.sec.gov and are available for download, free of charge, soon after
+Added: such reports are filed with or furnished to the SEC, on the “Investors” page of our website at www.scientureholdings.com.
+Added: Copies of documents filed by us with the SEC are also available from us without charge, upon oral or written request to our Secretary,
+Added: who can be contacted at the address and telephone number set forth on the cover page of this Annual Report.
+Added: Our website addresses are
+Added: www.scientureholdings.com, www.scienture.com, www.trxadehealth.com and www.rxintegra.com.
+Added: The information on, or that may be accessed through, our websites is not, and shall not be deemed to be, part of this Annual Report or incorporated by reference into any other filings
+Added: we make with the SEC, except as expressly set forth by specific reference in any such filings.
+Added: All website addresses in this Annual Report
+Added: are intended to be inactive textual references only.
Business – Scienture LLC
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Scienture’s principal executive offices are located in Commack, New York.
−Removed: LLC is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of CNS and CVS diseases.
−Removed: Scienture LLC is developing a broad range of novel product candidates including new potential treatments for hypertension, migraine,
−Removed: pain and thrombosis and other related disorders.
+Added: LLC is a specialty pharmaceutical company focused on the commercialization and development of products for the treatment of cardiovascular
+Added: (“CVS”) and Central Nervous System (“CNS”) diseases.
+Added: Scienture LLC launched its first commercial product for hypertension and is in the process
+Added: of commercializing its second product for the treatment of opioid overdose.
+Added: Its development pipeline consists of a broad range of novel
+Added: product candidates including new potential treatments for migraine, thrombosis, pain and other related disorders.
LLC’s Strategy
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Scienture LLC’s vision is to be a
−Removed: leader in the industry by developing and commercializing new medicines for the treatment of CNS and CVS diseases.
+Added: leader in the industry by commercializing and developing new medicines for the treatment of CNS and CVS diseases.
Key elements of Scienture
5 unchanged sentences
Food and Drug Administration (the “FDA”).
−Removed: Scienture LLC has obtained regulatory
−Removed: approval of its first product candidate, SCN-102.
+Added: Scienture LLC obtained regulatory
+Added: approval of its first product candidate, SCN-102 ( Arbli TM ) in the first quarter of 2025.
growth and profitability.
−Removed: Using dedicated sales and marketing resources in the U.S., which Scienture LLC is in the process of
−Removed: building, Scienture LLC will seek to drive the revenue growth of its product candidates approved for marketing by the FDA.
−Removed: to grow pipeline.
−Removed: Scienture LLC will continue to evaluate and seek to develop additional product candidates that it believes
−Removed: have significant commercial potential through Scienture LLC’s internal research and development efforts.
−Removed: strategic business development opportunities.
+Added: Using dedicated sales and marketing resources in the U.S., Scienture LLC will seek to drive the revenue
+Added: growth of its product candidates approved for marketing by the FDA and will also evaluate and seek additional commercial ready product
+Added: opportunities through acquisitions and partnerships to expand its marketed portfolio.
+Added: Scienture, LLC completed the acquisition of
+Added: the commercial ready product asset REZENOPY TM in the first quarter of 2025.
+Added: Target strategic business development opportunities.
Scienture LLC is exploring a broad range of strategic opportunities.
−Removed: This may include
−Removed: in-licensing products and entering into co-promotion and co-development partnerships for Scienture LLC’s product candidates,
−Removed: although no agreements have been reached.
−Removed: and Development and Product Portfolio
−Removed: LLC is committed to the development of innovative product candidates in the CNS and CVS therapeutic areas.
−Removed: The process by which Scienture
−Removed: LLC intends to bring its product candidates to market and the anticipated launch dates of its product candidates is depicted in the following
−Removed: The progress of Scienture LLC’s products through this process is represented by checkmarks in the table.
−Removed: LLC does not have any product candidates approved for sale and has not generated any revenue from product sales.
−Removed: Scienture LLC
−Removed: will not generate revenue from product sales unless and until it successfully obtains regulatory approval for its product candidates.
−Removed: Scienture LLC is engaged in a variety of research and development efforts including development of a pipeline of novel product candidates
−Removed: for the treatment of various disease conditions.
−Removed: Scienture LLC has devoted and will continue to devote significant resources to research
−Removed: and development activities, and expects to incur significant expenses as Scienture LLC continues advancing its product candidates towards
−Removed: FDA approval and expanding product indications for approved products and its intellectual property portfolio.
−Removed: Scienture LLC’s expectations
−Removed: regarding its research and development programs are subject to risks, including the risk that Scienture LLC’s financial condition
−Removed: and results of operations for fiscal year 2024 and beyond may be materially and adversely affected by delays and failures in the completion
−Removed: of clinical development of its product candidates, which could increase its costs or delay or limit our ability to generate revenues.
−Removed: (ARBLI TM - Losartan Oral Suspension)
+Added: This may include acquiring, in-licensing and entering into
+Added: co-promotion partnerships for commercial products to expand its marketed portfolio.
+Added: to grow its development pipeline.
+Added: Scienture LLC will continue to evaluate and seek to develop additional product candidates that
+Added: it believes have significant commercial potential through Scienture LLC’s internal research and development efforts and through
+Added: co-development partnerships.
+Added: Commercial Product Portfolio
+Added: Scienture LLC is committed to
+Added: building and leveraging its strong commercial platform and infrastructure to launch its FDA approved product candidates in the U.S.
+Added: The progress of Scienture LLC’s
+Added: products through this process is represented in the table below.
+Added: Arbli TM (SCN-102 - Losartan Potassium
+Added: Oral Suspension, 10mg/mL)
+Added: 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
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Currently, there are no FDA-approved liquid formulations of losartan potassium.
+Added: Arbli TM (SCN-102)
+Added: is the first and only FDA approved oral liquid formulation of losartan on the market.
+Added: Scienture LLC submitted an Investigational New
+Added: Drug (“IND”) application to the FDA in September 2022.
+Added: Multiple human pharmacokinetics studies were performed, showing close
+Added: comparability with the oral solid dosage form.
+Added: In October 2023, Scienture LLC submitted a New Drug Application (“NDA”) for
+Added: losartan potassium oral suspension to the FDA.
+Added: In December 2023, the FDA accepted the NDA for review and assigned a Prescription Drug
+Added: User Fee Act (“PDUFA”) target action date of August 19, 2024.
+Added: Despite responding during the FDA’s review to information
+Added: requests related to chemistry, manufacturing, and controls (“CMC”), pharmacovigilance, clinical, microbiology and labeling,
+Added: the FDA issued a Complete Response Letter to Scienture LLC focused on the CMC information submitted.
+Added: Scienture LLC prepared the requested
+Added: information and resubmitted the NDA to the FDA on September 17, 2024.
+Added: In October 2024, the FDA accepted the resubmitted NDA for review
+Added: and assigned a PDUFA target action date of March 17, 2025.
+Added: On March 13, 2025, the FDA approved the SCN-102 NDA to be launched as ARBLI TM
+Added: (losartan potassium) Oral Suspension, 10mg/mL.
+Added: Scienture LLC commercially launched the product in the third quarter of 2025.
+Added: (SCN-102) is the first FDA approved oral liquid formulation of losartan on the market.
Phase I PK study has shown that SCN-102 has close comparability to the immediate-release tablet as depicted in the data below:
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data obtained in the study is similar to the PK study data for the immediate release tablet.
−Removed: approved, SCN-102 would be the first FDA approved oral liquid formulation of losartan on the market.
−Removed: Scienture LLC submitted an Investigational New Drug (“IND”)
−Removed: application to the FDA in September 2022.
−Removed: Multiple human pharmacokinetics studies were performed, showing close comparability with the
−Removed: oral solid dosage form.
−Removed: In October 2023, Scienture LLC submitted an NDA for losartan potassium oral suspension to the FDA.
−Removed: 2023, the FDA accepted the NDA for review and assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of August
−Removed: Despite responding during the FDA’s review to information requests related to chemistry, manufacturing, and controls (“CMC”),
−Removed: pharmacovigilance, clinical, microbiology and labeling, the FDA issued a Complete Response Letter to Scienture LLC focused on the CMC
−Removed: information submitted.
−Removed: Scienture LLC prepared the requested information and resubmitted the NDA to the FDA on September 17, 2024.
−Removed: 2024, the FDA accepted the resubmitted NDA for review and assigned a PDUFA target action date of March 17, 2025.
−Removed: On March 13, 2025, the
−Removed: FDA approved the SCN-102 NDA to be launched as ARBLI TM (losartan potassium) Oral Suspension, 10mg/mL Scienture LLC anticipates
−Removed: that it will commercially launch and bring to market SCN-102 during the third quarter of 2025.
−Removed: SCN-102 will be the first FDA approved
−Removed: oral liquid formulation of losartan on the market.
+Added: (SCN-110 – Naloxone HCl Nasal Spray, 10mg)
+Added: LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with Summit Biosciences Inc.,
+Added: a wholly-owned subsidiary of Kindeva, on March 4, 2025, pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable,
+Added: non-sublicensable right and license to commercialize REZENOPY TM (Nalaxone HCI nasal spray 10mg/0.11mL) within the United States
+Added: and its territories.
+Added: Scienture LLC intends to use the exclusive right and license to price, launch, promote, market, distribute, and
+Added: educate the public on REZENOPY TM .
+Added: a pharmacokinetic study in 30 healthy adult subjects, the relative bioavailability of one nasal spray of a 10 mg total dose (0.11
+Added: mL of 91 mg/mL naloxone hydrochloride solution) was compared to a single dose of 0.4 mg naloxone hydrochloride intramuscular injection
+Added: and a single dose of 2 mg naloxone hydrochloride intravenous injection.
+Added: The studies showed that REZENOPY TM provided exposures
+Added: comparable to the reference treatments, supporting the efficacy of the product.
+Added: The studies further demonstrated the safety and tolerability
+Added: of the product, including testing to evaluate nasal irritation and impact on olfactory ability.
+Added: and Development Pipeline
+Added: LLC is committed to the development of innovative product candidates in the CNS and CVS therapeutic areas.
+Added: The process by which Scienture
+Added: LLC intends to bring its product candidates to market and the anticipated launch dates of its product candidates is depicted in the following
+Added: Scienture LLC is
+Added: engaged in a variety of research and development efforts including development of a pipeline of novel product candidates for the treatment
+Added: of various disease conditions.
+Added: Scienture LLC has devoted and will continue to devote significant resources to research and development
+Added: activities, and expects to incur significant expenses as it continues advancing its product candidates towards FDA approval
+Added: and expanding product indications for approved products and its intellectual property portfolio.
+Added: Scienture LLC’s expectations regarding
+Added: its research and development programs are subject to risks, including the risk that Scienture LLC’s financial condition and results
+Added: of operations may be materially and adversely affected by delays and failures in the completion of clinical
+Added: development of its product candidates, which could increase its costs or delay or limit our ability to generate revenues.
(Multi-dose Dihydroergotamine Mesylate (“DHE”) injection pen)
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LLC has conducted two preclinical studies of SCN-104 and the SCN-104 injection pen:
−Removed: (i) a 30-day repeated dose toxicity study of dimethyl
−Removed: sulfoxide and caffeine following thrice daily, 3 times per week subcutaneous administration in Sprague-Dawley rats and (ii) a 30-day
−Removed: repeated dose toxicity study of dimethyl sulfoxide and caffeine following thrice daily, 3 times per week subcutaneous administration
−Removed: in Göttingen minipigs.
−Removed: The objective of each study was to evaluate the safety and tolerability of the test items with and without
−Removed: DHE to the subject animals, providing information on important potential toxic effects, target organs, progressive toxic effects, characterization
−Removed: of a possible dose-response relationship, and an estimate the No-Observed-Adverse-Effect Level.
−Removed: Both studies were designed for the qualification
−Removed: of the excipients.
−Removed: The animals treated either with DHE + DMSO + caffeine or DMSO + Caffeine formulations did not reveal any changes attributable
−Removed: to treatment at the end of the treatment/recovery periods.
−Removed: As such, both studies support a conclusion that SCN-102 is considered to have
−Removed: no toxicological significance across the following attributes – Hematology, Coagulation Parameters, Clinical Chemistry and Urinalysis.
+Added: (i) a 30-day repeated dose toxicity study of
+Added: dimethyl sulfoxide and caffeine following thrice daily, 3 times per week subcutaneous administration in Sprague-Dawley rats and (ii)
+Added: a 30-day repeated dose toxicity study of dimethyl sulfoxide and caffeine following thrice daily, 3 times per week subcutaneous
+Added: administration in Göttingen minipigs.
+Added: The objective of each study was to evaluate the safety and tolerability of the test items
+Added: with and without DHE to the subject animals, providing information on important potential toxic effects, target organs, progressive
+Added: toxic effects, characterization of a possible dose-response relationship, and an estimate of the No-Observed-Adverse-Effect Level.
+Added: Both studies were designed for the qualification of the excipients.
+Added: The animals treated either with DHE + Dimethyl Sulfoxide
+Added: (“DMSO”) + caffeine or DMSO + caffeine formulations did not reveal any changes attributable to treatment at the end of
+Added: the treatment/recovery periods.
+Added: As such, both studies support a conclusion that SCN-102 is considered to have no toxicological
+Added: significance across the following attributes – Hematology, Coagulation Parameters, Clinical Chemistry and
LLC believes the SCN-104 injection pen may offer a significant improvement, in terms of usability and patient acceptability, to the current
24 unchanged sentences
In this regard, Scienture LLC entered into a Master Services Agreement with Anthem on October 29, 2024 (the “Anthem Agreement”).
−Removed: The following is a summary of the Anthem Agreement, which is qualified in its entirety by the full text of the Anthem Agreement,
−Removed: which is filed as an exhibit to this Annual Report.
+Added: The following is a summary of the Anthem Agreement, which is qualified in its entirety by the full text of the Anthem Agreement, which
+Added: is filed as an exhibit to this Annual Report.
the Anthem Agreement, Anthem has agreed to diligently complete the services associated with SCN-106 as included in work orders to be
attached to the Anthem Agreement.
−Removed: In performing these services, Anthem has agreed to strictly comply with the specifications in the Anthem
−Removed: Agreement, the work order, standard operating procedures approved in writing by Scienture LLC, and relevant professional standards, and
−Removed: any regulatory authority requirements, including current Good Laboratory Practices (“GLPs”) and current Good Manufacturing
−Removed: Practices (“GMPs”) promulgated by the FDA, and any other applicable laws, rules, and regulations.
−Removed: In carrying-out its services,
−Removed: Anthem will only allow those employees and personnel under Anthem’s direct control to perform such services and will obtain the
−Removed: Scienture LLC’s consent prior to delegating or subcontracting any portion of the services.
−Removed: Anthem is required to provide prompt
−Removed: written reports to Scienture LLC the status of the services provided by Anthem under the Anthem Agreement and any work order.
−Removed: Anthem Agreement, Scienture LLC is responsible for paying Anthem the amounts designated on any attached work order.
−Removed: These amounts are
−Removed: to be paid on the schedule stated on the work order and Anthem is responsible for invoicing Scienture LLC for such amounts.
−Removed: late payments incur interest at the rate of 18% per annum payable until the date of actual payment.
+Added: In performing these services, Anthem has agreed to strictly comply with the specifications in the
+Added: Anthem Agreement, the work order, standard operating procedures approved in writing by Scienture LLC, and relevant professional
+Added: standards, and any regulatory authority requirements, including current Good Laboratory Practices (“GLPs”) and current
+Added: Good Manufacturing Practices (“GMPs”) promulgated by the FDA, and any other applicable laws, rules, and regulations.
+Added: carrying-out its services, Anthem will only allow those employees and personnel under Anthem’s direct control to perform such
+Added: services and will obtain Scienture LLC’s consent prior to delegating or subcontracting any portion of the services.
+Added: required to provide prompt written reports to Scienture LLC on the status of the services provided by Anthem under the Anthem
+Added: Agreement and any work order.
+Added: Under the Anthem Agreement, Scienture LLC is responsible for paying Anthem the amounts designated on
+Added: any attached work order.
+Added: These amounts are to be paid on the schedule stated on the work order and Anthem is responsible for
+Added: invoicing Scienture LLC for such amounts.
+Added: Undisputed late payments incur interest at the rate of 18% per annum payable until the
+Added: date of actual payment.
project or work order in effect under the Anthem Agreement may be terminated by Scienture LLC without cause upon thirty (30) days’
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Multiple clones of
−Removed: CHO cells have been produced to synthesize lots of SCN-106 which were screened for similarity to the reference product for several key
+Added: 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.
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3 clinical trial to support submission of a marketing application.
−Removed: 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
−Removed: an initial assessment of safety and tolerability of SCN-107.
+Added: LLC anticipates submitting an IND and, if cleared by the FDA, initiating a Phase 1 single dose study in healthy adults in 2026 to
+Added: conduct an initial assessment of safety and tolerability of SCN-107.
+Added: Scienture LLC entered into a Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies,
+Added: (“Innocore”) on May 26, 2020 (as amended on December 2, 2022, the “Innocore License”), for certain intellectual
+Added: property rights associated with SCN-107.
+Added: Under the Innocore License, Innocore granted Scienture LLC a worldwide exclusive, milestone,
+Added: royalty-bearing and sublicensable license to certain patent rights for the research and development of SCN-107 in postsurgical local and
+Added: regional analgesia.
+Added: Pursuant to the Innocore License, Scienture LLC is required to make low single-digit percentage royalty payments based
+Added: on annual net sales of licensed products for the first three years of sales on a country-by-country basis, subject to a low single digit
+Added: increase as of the fourth year of sales on a country-by-country basis.
and Marketing
5 unchanged sentences
LLC’s products .
−Removed: Once approved , this sales
−Removed: and marketing organization will include a combination of field teams, virtual sales representatives and omnichannel marketing to effectively
−Removed: reach health care providers and offer patient education.
−Removed: Scienture LLC’s promotional efforts are expected to further include developing
−Removed: a market access strategy to obtain commercial and government payor coverage for its products.
−Removed: In addition, Scienture LLC intends to partner
−Removed: with a third-party logistics provider ( “ 3PL ” )
−Removed: and have internal sales operations and analytics teams to provide state-of-the-art distribution capabilities to wholesalers, pharmacies,
−Removed: institutional buying groups and hospitals.
−Removed: Scienture LLC believes its commercial operations infrastructure,
−Removed: once established, will enable it to effectively target healthcare providers to support and grow its products subsequent to market entry.
+Added: This sales and marketing organization will include a combination of
+Added: field teams, virtual sales representatives and omnichannel marketing to effectively reach health care providers and offer patient education.
+Added: Scienture LLC’s promotional efforts are expected to further include developing a market access strategy to obtain commercial and
+Added: government payor coverage for its products.
+Added: In addition, Scienture LLC intends to partner with a third-party logistics provider and have
+Added: internal sales operations and analytics teams to provide state-of-the-art distribution capabilities to wholesalers, pharmacies, institutional
+Added: buying groups and hospitals.
+Added: Scienture LLC believes its commercial operations infrastructure, will
+Added: enable it to effectively target healthcare providers to support and grow its products subsequent to market entry.
majority of Scienture LLC’s product sales, if its products are approved by the FDA, are expected to be to pharmaceutical wholesalers,
8 unchanged sentences
(high blood pressure) is a CVS condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher).
−Removed: According to the
−Removed: Centers for Disease Control, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million
−Removed: Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher.
−Removed: Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S.
−Removed: Factors that increase the risk
−Removed: of having high blood pressure include:
−Removed: older age, genetics, being overweight or obese, not being physically active, high-salt diet and
−Removed: drinking too much alcohol.
−Removed: Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic
−Removed: blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
+Added: the Centers for Disease Control, hypertension, or high blood pressure, affects nearly half of adults in the U.S.
+Added: approximately 119.9 million people).
+Added: Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood
+Added: pressure of 90 mmHg or higher.
+Added: Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the
+Added: Factors that increase the risk of having high blood pressure include:
+Added: older age, genetics, being overweight or obese, not being
+Added: physically active, high-salt diet and drinking too much alcohol.
+Added: Hypertension is clinically diagnosed if, when blood pressure is
+Added: measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood
+Added: pressure readings on both days is ≥ 90 mmHg.
hypertension market has increased with the commercial launch of several branded products in recent years, as well as the launch of generic
3 unchanged sentences
II receptor blockers (“ARBs”), Beta-Blockers, Diuretics and Calcium Channel Blockers.
−Removed: LLC’s product candidate SCN-102, ARBLI TM (Losartan Oral Suspension 10mg/mL), is a ready to use oral suspension of losartan
+Added: 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.
3 unchanged sentences
can be further compounded to a liquid formulation.
−Removed: Scienture LLC believes that ARBLI TM is the first liquid formulation of losartan on
−Removed: the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage.
+Added: Scienture LLC believes that Arbli TM is the first liquid formulation of
+Added: losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage.
+Added: opioid overdose epidemic remains a significant public health issue and continues to rise exponentially in the U.S.
+Added: According to the
+Added: 2024 National Survey on Drug Use and Health, among people aged 12 or older in 2024, 2.7 percent (or 7.8 million people) misused
+Added: opioids in the prior year.
+Added: Additionally, according to the Centers for Disease Control, new
+Added: preliminary data predicts that there were 71,542 drug overdose deaths for the 12 months ending in October 2025 .
+Added: The majority of those deaths involved highly potent
+Added: synthetic opioids and their analogues.
+Added: These synthetic opioids are highly powerful, with fentanyl and carfentanil estimated to be up
+Added: to 100 and 10,000 times more potent than morphine, respectively.
+Added: While fentanyl has been available in prescription form as an
+Added: analgesic for some time, data indicates that the dramatic rise in drug overdose deaths in recent years can be attributed primarily
+Added: to the influx of illicitly manufactured synthetic opioids.
+Added: by the FDA in 1971, naloxone is considered the standard of care and has been shown to be effective in opioid overdose reversals.
+Added: opioid overdose reversal market (specifically for naloxone-based products) includes several branded and generic products across nasal
+Added: spray, auto-injector, and injectable formulations.
+Added: Most growth in recent years has been in intranasal products, such as Narcan 4mg, RiVive
+Added: 3mg and Kloxxado 8mg, which are needle free and easier for bystanders and community responders to use.
+Added: Real world studies suggest the
+Added: need for multiple naloxone administrations (“MNA”) using these products among bystanders and EMS providers continues to increase.
+Added: the increase of synthetic opioids and the rapid onset of effect, evidence is emerging suggesting the need for increased doses of naloxone
+Added: to reverse opioid toxicity.
+Added: (Naloxone HCl Nasal Spray, 10mg) is the highest FDA-approved nasal spray dose available in the U.S.
+Added: The product provides maximum
+Added: naloxone protection in a single easy-to-use device and caters to the segment of patients who need multiple doses of lower strength for
+Added: stabilization in emergency situations.
+Added: REZENOPY TM provides potential longer duration of opioid receptor block, improves chances
+Added: of quicker reversal and possible coverage against multiple abuse agents inclusive of synthetic opioids and combinations, through a single
+Added: dose administration of 10mg naloxone hydrochloride.
+Added: High dose REZENOPY™ improves the chances of reversing potent opioids quickly
+Added: and reducing the requirement of MNA.
is a painful, complex neurological disorder consisting of recurring painful attacks that can significantly impact quality of life.
57 unchanged sentences
risks associated with manufacturing and supply of its products and product candidates.
−Removed: May 26, 2020, Scienture LLC entered into Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies,
−Removed: (“Innocore”), as amended on December 2, 2022 (the “Innocore License”), for certain intellectual property
−Removed: Under the Innocore License, Innocore granted Scienture LLC a worldwide exclusive, milestone, royalty-bearing and sublicensable
−Removed: license to certain patent rights for the research and development of SCN-107 in postsurgical local and regional analgesia.
−Removed: the Innocore License, Scienture LLC is required to make low single-digit percentage royalty payments based on annual net sales of licensed
−Removed: products for the first three years of sales on a country-by-country basis, subject to a low single digit increase as of the fourth year
−Removed: of sales on a country-by-country basis.
−Removed: Scienture LLC is required to remunerate Innocore for the development of the licensed product,
−Removed: subject to a limit of $0.4 million for certain safety and toxicity studies which will be deducted from certain development and regulatory
−Removed: milestones as described below.
−Removed: Scienture LLC is required to make development and regulatory milestone payments up to €2.7 million
−Removed: in the aggregate, commercial sale milestone payments of up to €18.875 million in the aggregate, and maintenance fees of €0.25
−Removed: million annually, subsequent to the first regulatory filing, until the date that Scienture LLC begins making royalty payments based on
−Removed: annual net sales, up to €0.5 million of which may be credited toward the regulatory milestone payments.
−Removed: As of October 25, 2024,
−Removed: the Company had made aggregate payments to Innocore of $1,021,089.37 in connection with the Innocore License.
−Removed: Innocore License is terminable by either the Company or Innocore on thirty (30) days’ prior written notice if the terminating party
−Removed: determines in good faith, that it is technically or legally not feasible, or commercially not viable to jointly develop a formulation
−Removed: which meets the specifications described in the Innocore License.
−Removed: The Innocore License can also be terminated for any material breach
−Removed: of the Innocore License that remains uncured after thirty (30) days and if either party files for insolvency under any applicable foreign,
−Removed: federal or state law.
LLC continues to build its intellectual property portfolio to provide protection for its technologies,
12 unchanged sentences
if granted, will sustain a legal challenge.
−Removed: SCN-102 will soon have two orange book listable formulation composition and method of use patents in the U.S.
−Removed: of them are already issued (Patent #:
+Added: Arbli TM (SCN-102)
+Added: has two orange book listed formulation composition and method of use patents in the U.S.
11,890,273, Issue Date:
−Removed: February 6, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS
−Removed: OF USE”, Expiration Date:
+Added: February 6, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE”, Expiration
October 7, 2041 and Patent #:
12,156,869, Issue Date:
−Removed: December 03, 2024, titled “LOSARTAN LIQUID
−Removed: FORMULATIONS AND METHODS OF USE”, Expiration Date:
+Added: December 03, 2024, titled “LOSARTAN LIQUID FORMULATIONS AND METHODS
+Added: OF USE”, Expiration Date:
October 7, 2041.
2 unchanged sentences
on or after October 7, 2041).
+Added: REZENOPY TM (SCN-110)
+Added: SCN-110 has an issued orange
+Added: book listed formulation composition and method of use patent in the U.S.
+Added: 12,514,854, Issue Date:
+Added: January 6, 2026, titled “DRUG
+Added: PRODUCTS FOR INTRANASAL ADMINISTRATION AND USES THEREOF”, Expiration Date:
+Added: February 5, 2041.
+Added: A second application is pending in
+Added: March 12, 2024;
+Added: Expiration Date:
+Added: February 5, 2041).
has a formulation composition and method of use application pending in the U.S.
1 unchanged sentence
June 15, 2035).
−Removed: is a potential biosimilar and considered by the Company to be part of its product development portfolio, however the Company is not pursuing
−Removed: patent protection for this product.
+Added: is a potential biosimilar and considered by Scienture LLC to be part of its product development portfolio, however Scienture LLC is
+Added: not pursuing patent protection for this product.
has a formulation composition and method of use application pending in the U.S.
−Removed: October 24, 2022;
Expiration Date:
1 unchanged sentence
Applications in Canada and Europe are currently pending.
−Removed: As described above, the Company
−Removed: licenses certain patent rights from Innocore for the research and development of SCN-107.
+Added: As described above,
+Added: Scienture LLC licenses certain patent rights from Innocore for the research and development of SCN-107.
Collaborations
and Licensing Arrangements
−Removed: Pharma Corporation (“Kesin”)
−Removed: LLC entered into exclusive license and commercial agreements on August 28, 2022 and April 24, 2023, with Kesin, a related party, pursuant
−Removed: to which Scienture LLC granted the exclusive license rights to commercialize SCN-102 and SCN-104, respectively to Kesin for use in the
−Removed: United States of America (together, the “Kesin Agreement”).
−Removed: In consideration of the rights granted, Scienture LLC received
−Removed: milestone payments and reimbursement of costs actually incurred related to SCN-102 and SCN-104.
−Removed: March 13, 2024, the parties terminated the Kesin Agreement by entering a Confidential Termination Agreement (the “Kesin Termination
−Removed: Agreement”), and the parties agreed that Scienture LLC would pay Kesin a total gross amount of $1.285 million upon commercialization
−Removed: of either SCN-102 or SCN-104 via a royalty arrangement.
−Removed: The Kesin Termination Agreement also requires that if the full $1.285 million
−Removed: 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,
−Removed: then interest will accrue prospectively at a rate of 8% annually on the unpaid balance.
−Removed: August 2024, Kesin demanded immediate payment of the full amount under the Kesin Termination Agreement, alleging the full amount is payable
−Removed: in connection with the consummation Scienture LLC’s business combination with the Company.
−Removed: Scienture LLC has disputed that the
−Removed: amount is payable, and the parties entered into discussions to resolve the issue.
−Removed: March 11, 2025, Kesin filed a complaint against Scienture LLC in the United States District Court for the Eastern District of New York
−Removed: seeking payment of the disputed $1.285 million.
−Removed: There can be no assurance that an amicable resolution will be obtained.
−Removed: Scienture LLC
−Removed: intends to vigorously defend itself in the litigation.
Drug Delivery L.P.
−Removed: LLC entered into an Exclusive Commercial and Supply Agreement (the “Kindeva Agreement”) with Summit Biosciences Inc.,
−Removed: a wholly-owned subsidiary of Kindeva, a company engaged in the research, development, and manufacturing of pharmaceutical products, on
−Removed: March 4, 2025, pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable, non-sublicensable right and license to
−Removed: commercialize REZENOPY® (Nalaxone HCI Nasal spray 10mg/0.11mL) (the “Product”) within the United States and its territories.
−Removed: Scienture LLC intends to use the exclusive right and license to price, launch, promote, market, distribute, and educate the public on
−Removed: earlier terminated, the term of the Kindeva Agreement will remain in effect for 10 years from the date of first commercial sale of the
−Removed: Product in the United States and its territories to an unaffiliated third-party.
−Removed: The Kindeva Agreement will automatically renew for successive
−Removed: 1-year periods unless either party terminates the agreement in accordance with its terms.
−Removed: Either party may terminate the Agreement if
−Removed: (i) the other party materially breaches the Kindeva Agreement and has not cured such breach during a period of 90 days following notice
−Removed: 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
−Removed: by the FDA is issued, or there are material safety concerns that could significantly impact the commercial viability of the Product,
−Removed: or (iii) the Product is the subject of a mass tort liability action or is subject to material health and public safety concerns.
−Removed: LLC may terminate the Kindeva Agreement upon 120 days prior written notice if Scienture LLC determines that the Product is compromised
−Removed: by an adverse and material change in the market or other adverse and material business conditions.
−Removed: The Kindeva Agreement is also terminable
−Removed: by either party upon the occurrence of certain bankruptcy related events pertaining to the other party.
+Added: LLC entered into the Kindeva Agreement on March 4, 2025,
+Added: pursuant to which Kindeva granted Scienture LLC an exclusive, non-transferrable, non-sublicensable right and license to commercialize
+Added: REZENOPY TM (Nalaxone HCI Nasal spray 10mg/0.11mL) (the “Product”) within the United States and its territories.
+Added: LLC intends to use the exclusive right and license to price, launch, promote, market, distribute, and educate the public on the Product.
+Added: earlier terminated, the term of the Kindeva Agreement will remain in effect for 10 years from the date of first commercial sale of
+Added: the Product in the United States and its territories to an unaffiliated third-party.
+Added: The Kindeva Agreement will automatically renew
+Added: for successive 1-year periods unless either party terminates the agreement in accordance with its terms.
+Added: Either party may terminate
+Added: the Kindeva Agreement if (i) the other party materially breaches the Kindeva Agreement and has not cured such breach during a period
+Added: 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
+Added: the FDA, a voluntary recall by the FDA is issued, or there are material safety concerns that could significantly impact the
+Added: commercial viability of the Product, or (iii) the Product is the subject of a mass tort liability action or is subject to material
+Added: health and public safety concerns.
+Added: Scienture LLC may terminate the Kindeva Agreement upon 120 days prior written notice if Scienture
+Added: LLC determines that the Product is compromised by an adverse and material change in the market or other adverse and material
+Added: business conditions.
+Added: The Kindeva Agreement is also terminable by either party upon the occurrence of certain bankruptcy related
+Added: events pertaining to the other party.
to the Kindeva Agreement, Scienture LLC is exclusively responsible, at its expense, for the commercializing the Product in the United
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to the Kindeva Agreement, Kindeva will retain control of all activities associated with manufacturing the Product, and be responsible
−Removed: for any non-clinical or clinical studies regard the Product.
+Added: for any non-clinical or clinical studies regarding the Product.
Kindeva will provide a copy of the NDA for the Product to Scienture LLC
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year after the launch of the Product to account for any increased manufacturing costs.
−Removed: the Kindeva Agreement, Scienture LLC and Kindeva agreed to form a joint steering committee within 30 days to oversee and coordinate their
−Removed: respective activities under the Kindeva Agreement with respect to any additional regulatory or development requirements needed to obtain
−Removed: any regulatory approvals needed for Scienture LLC to fulfill its commercialization responsibilities.
−Removed: The joint steering committee will
−Removed: be comprised of four members, with 2 members to be appointed by each of Scienture LLC and Kindeva.
−Removed: The joint steering committee is responsible
−Removed: for establishing timelines for the launch of the Product, overseeing the development and commercialization of the Product, providing
−Removed: strategic direction and performance criteria, and resolving disputes that might arise under and in connection with the KindevaAgreement.
−Removed: The joint steering committee will meet 4 times per year, unless Scienture LLC and Kindeva agree to a different schedule.
+Added: the Kindeva Agreement, Scienture LLC and Kindeva agreed to form a joint steering committee within 30 days to oversee and coordinate
+Added: their respective activities under the Kindeva Agreement with respect to any additional regulatory or development requirements needed
+Added: to obtain any regulatory approvals needed for Scienture LLC to fulfill its commercialization responsibilities.
The joint steering
−Removed: committee must act by unanimous vote of the members present at a meeting, provided that at least 1 member from each of Scienture LLC
−Removed: and Kindeva must be present at such meeting, or may otherwise act by a written consent signed by all members.
+Added: committee will be comprised of four members, with 2 members to be appointed by each of Scienture LLC and Kindeva.
+Added: The joint steering
+Added: committee is responsible for establishing timelines for the launch of the Product, overseeing the development and commercialization
+Added: of the Product, providing strategic direction and performance criteria, and resolving disputes that might arise under and in
+Added: connection with the Kindeva Agreement.
+Added: The joint steering committee will meet 4 times per year, unless Scienture LLC and Kindeva
+Added: agree to a different schedule.
+Added: The joint steering committee must act by unanimous vote of the members present at a meeting, provided
+Added: that at least 1 member from each of Scienture LLC and Kindeva must be present at such meeting, or may otherwise act by a written
+Added: consent signed by all members.
exchange for the exclusive rights to develop and commercialize the Products, Scienture LLC agreed to pay Kindeva certain milestone payments,
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profit-sharing payments representing 5% of the net sales until the total cumulative payments equals Kindeva’s cost of developing
−Removed: and receiving NDA approval of the Product, which was $12.8 million as of the date of the Agreement.
−Removed: the Agreement, Scienture LLC agreed to place minimum order quantities of the Product of 3 batches of 450,000 units per year beginning
−Removed: in 2027 or, alternatively, pay Kindeva $1.242 million per year unless Scienture LLC elects to terminate the Agreement pursuant to its
+Added: and receiving NDA approval of the Product, which was $12.8 million as of the date of the Kindeva Agreement.
+Added: the Kindeva Agreement, Scienture LLC agreed to place minimum order quantities of the Product of 3 batches of 450,000 units per year
+Added: beginning in 2027 or, alternatively, pay Kindeva $1.242 million per year unless Scienture LLC elects to terminate the Kindeva
+Added: Agreement pursuant to its terms.
+Added: Pharma Corporation (“Kesin”)
+Added: LLC entered into exclusive license and commercial agreements on August 28, 2022 and April 24, 2023, with Kesin, a related party, pursuant
+Added: to which Scienture LLC granted the exclusive license rights to commercialize SCN-102 and SCN-104, respectively, to Kesin for use in the
+Added: United States (together, the “Kesin Agreement”).
+Added: In consideration of the rights granted, Scienture LLC received
+Added: milestone payments and reimbursement of costs actually incurred related to SCN-102 and SCN-104.
+Added: March 13, 2024, the parties terminated the Kesin Agreement by entering a Confidential Termination Agreement (the “Kesin Termination
+Added: Agreement”), and the parties agreed that Scienture LLC would pay Kesin a total gross amount of $1.285 million upon commercialization
+Added: of either SCN-102 or SCN-104 via a royalty arrangement.
+Added: The Kesin Termination Agreement also requires that if the full $1.285 million
+Added: 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,
+Added: then interest will accrue prospectively at a rate of 8% annually on the unpaid balance.
+Added: August 2024, Kesin demanded immediate payment of the full amount under the Kesin Termination Agreement, alleging the full amount is payable
+Added: in connection with the consummation Scienture LLC’s business combination with the Company.
+Added: Scienture LLC has disputed that the
+Added: amount is payable, and the parties entered into discussions to resolve the issue.
+Added: March 11, 2025, Kesin filed a complaint against Scienture LLC in the United States District Court for the Eastern District of New York
+Added: seeking payment of the disputed $1.285 million.
+Added: The case was voluntarily dismissed on October 1, 2025.
+Added: The Company and Kesin entered
+Added: into a Settlement Agreement and Release on October 27, 2025, whereby Kesin agreed to unconditionally release and discharge the Company
+Added: from all actions related to the complaint in exchange for the Company paying $1.285 million plus 8% interest from March 13, 2025, and
+Added: legal fees and costs related to the complaint according to a payment schedule through December 2026.
Drug Development Process
742 unchanged sentences
Environmental
−Removed: LLC’s operations and those of its third-party manufacturers and suppliers are subject to national, state and local environmental
−Removed: Scienture LLC has made, and intends to continue to make, expenditures and undertake efforts to comply with applicable laws.
−Removed: LLC believes the safety procedures utilized by it for the handling and disposing hazardous materials comply with the standards prescribed
−Removed: by applicable laws and regulations.
−Removed: LLC’s success begins and ends with our people.
−Removed: Scienture LLC’s solid progress to date reflects the talent and hard work of
−Removed: all of its employees.
−Removed: Scienture LLC considers the intellectual capital of its employees to be an essential driver of its business and
−Removed: key to its future prospects.
−Removed: Attracting, developing, and retaining talented people in technical, marketing, sales, research, and other
−Removed: positions is crucial to executing its strategy and its ability to compete effectively.
+Added: Company and Scienture LLC’s operations and those of its third-party manufacturers and suppliers are subject to national, state
+Added: and local environmental laws.
+Added: Scienture LLC has made, and intends to continue to make, expenditures and undertake efforts to comply
+Added: with applicable laws.
+Added: Scienture LLC believes the safety procedures utilized by it for the handling and disposing hazardous materials
+Added: comply with the standards prescribed by applicable laws and regulations.
+Added: Company’s success begins and ends with its people.
+Added: The Company’s solid progress to date reflects the talent and hard
+Added: work of all of its employees.
+Added: The Company considers the intellectual capital of its employees to be an essential driver of its
+Added: business and key to its future prospects.
+Added: Attracting, developing, and retaining talented people in technical, marketing, sales,
+Added: research, and other positions is crucial to executing its strategy and its ability to compete effectively.
Acquisition, Retention and Development
−Removed: LLC’s key human capital objectives are to attract, retain and develop the highest quality talent.
−Removed: Scienture LLC employs various
−Removed: human resource programs in support of these objectives.
−Removed: Scienture LLC’s ability to recruit and retain such talent depends on a
−Removed: number of factors, including compensation and benefits, talent development and career opportunities, and the work environment.
−Removed: LLC attracts and rewards its employees by providing market competitive compensation and benefit packages, including incentives and recognition
+Added: Company’s key human capital objectives are to attract, retain and develop the highest quality talent.
+Added: The Company employs
+Added: various human resource programs in support of these objectives.
+Added: The Company’s ability to recruit and retain such talent
+Added: depends on a number of factors, including compensation and benefits, talent development and career opportunities, and the work
+Added: 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.
4 unchanged sentences
off and family leave, an Employee Assistance Program, and mental health services.
−Removed: LLC is committed to the safety, health, and security of its employees.
−Removed: Scienture LLC believes a hazard-free environment is critical for
−Removed: the success of its business.
−Removed: Throughout Scienture LLC’s operations, Scienture strives to ensure that all its employees have access
−Removed: to safe workplaces that allow them to succeed in their jobs.
−Removed: Scienture LLC’s experience and
−Removed: continuing focus on workplace safety has enabled it to preserve business continuity without sacrificing its commitment to keeping its
−Removed: colleagues and workplace visitors safe.
−Removed: and Diversity
−Removed: LLC places a strong value on collaboration, inclusion, and diversity, and believes that working
−Removed: together leads to better outcomes for its customers.
−Removed: This extends to the way Scienture LLC employees treat
−Removed: each other as team members.
−Removed: Scienture LLC strives to create an environment where innovative
−Removed: ideas can flourish by demonstrating respect for each other and valuing the diverse opinions, backgrounds, and viewpoints of employees.
−Removed: Scienture LLC believes a diverse and inclusive workplace results in business growth and
−Removed: encourages increased innovation, retention of talent, and a more engaged workforce.
−Removed: LLC’s corporate headquarters is located at 20 Austin Blvd, Commack, NY 11725, which is 2,000 square feet of office space with a
+Added: Company is committed to the safety, health, and security of its employees.
+Added: The Company believes a hazard-free environment is
+Added: critical for the success of its business.
+Added: Throughout the Company’s operations, it strives to ensure that all its
+Added: employees have access to safe workplaces that allow them to succeed in their jobs.
+Added: The Company’s experience
+Added: and continuing focus on workplace safety has enabled it to preserve business continuity without sacrificing its commitment to
+Added: keeping its colleagues and workplace visitors safe.
+Added: The Company’s corporate headquarters is located at 20 Austin Blvd, Commack, NY 11725, which is 2,000 square feet of office space with a
lease termination date of July 31, 2026.
−Removed: Scienture LLC believes its facilities are sufficient to meet its current needs for the foreseeable
−Removed: time to time, Scienture LLC may be involved in various claims and legal proceedings.
+Added: The Company believes its facilities are sufficient to meet its current needs for the foreseeable
+Added: time to time, the Company may be involved in various claims and legal proceedings.
March 11, 2025, Kesin filed a complaint against Scienture LLC in the United States District Court for the Eastern District of New York
10 unchanged sentences
then interest will accrue prospectively at a rate of 8% annually on the unpaid balance.
−Removed: August 2024, Kesin demanded immediate payment of the full amount under the Kesin Termination Agreement, alleging the full amount is payable
−Removed: in connection with the consummation Scienture LLC’s business combination with the Company.
−Removed: Scienture LLC has disputed that the
−Removed: amount is payable, and the parties entered into discussions to resolve the issue.
−Removed: Nevertheless, Kesin filed its complaint on March 11,
−Removed: 2025, seeking payment of the disputed $1.285 million.
−Removed: There can be no assurance that an amicable resolution will be obtained.
−Removed: the Company and Scienture LLC collectively employ approximately fourteen (14) full-time employees and five (5) part time employees.
+Added: August 2024, Kesin demanded immediate payment of the full amount under the Kesin Termination Agreement, alleging the full amount is
+Added: payable in connection with the consummation Scienture LLC’s business combination with the Company.
+Added: Scienture LLC disputed that
+Added: the amount was payable, and the parties entered into discussions to resolve the issue.
+Added: Nevertheless, Kesin filed its complaint on
+Added: March 11, 2025, seeking payment of the disputed $1.285 million.
+Added: The case was voluntarily dismissed on October 1, 2025.
+Added: and Kesin entered into a Settlement Agreement and Release on October 27, 2025, whereby Kesin agreed to unconditionally release and
+Added: discharge the Company from all actions related to the complaint in exchange for the Company paying $1.285 million plus 8% interest
+Added: from March 13, 2025, and legal fees and costs related to the complaint according to a payment schedule through December
+Added: the Company and Scienture LLC collectively employ approximately four (4) full-time employees and five (5) part-time employees.
are not a party to any collective bargaining agreements and have not experienced any strikes or work stoppages.
3 unchanged sentences
it leads to an increased demand for certain generic pharmaceuticals.
−Removed: currently exist as a holding company directly owning 100% of the equity interests of Scienture LLC, Softell, Bonum Health, and Bonum
−Removed: and indirectly owning 100% of the equity interests in IPS.
+Added: We currently exist as a holding
+Added: company directly owning 100% of the equity interests of Scienture LLC.
Scienture LLC is a specialty pharmaceutical company focused on
−Removed: developing and commercializing products for the treatment of central nervous system (“CNS”) and cardiovascular (“CVS”)
−Removed: Softell is a holding company owning 100% of IPS.
−Removed: IPS is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug
−Removed: products to customers that include, but are not limited to, healthcare markets including government organizations, hospitals, clinics
−Removed: and independent pharmacies nationwide.
−Removed: Bonum Health, Inc.
−Removed: and Bonum Health did not engage in business during the year ending December
−Removed: 31, 2024, and we anticipate these entities will be dissolved.
−Removed: In addition, the Company is in the process of determining a divestment and winddown plan for Softell and IPS.
−Removed: January 25, 2025, the Company’s Board of Directors approved the preparation of a divestment and winddown plan for the winddown of
−Removed: each of Softell, IPS, Bonum Health, Inc., and Bonum.
+Added: the commercialization and development of products for the treatment of Cardiovascular (CVS) and Central Nervous System (CNS) diseases.
+Added: Scienture LLC launched its first commercial product for hypertension and is in the process of commercializing its second product for the
+Added: treatment of opioid overdose.
+Added: Its development pipeline consists of a broad range of novel product candidates including new potential treatments
+Added: for migraine, thrombosis, pain and other related disorders.
LLC (“SOSRx”) was formed on February 15, 2022.
The Company entered into a relationship with Exchange Health, LLC (“Exchange
−Removed: Health”), a technology company providing an online platform for manufacturers and suppliers to sell and purchase pharmaceuticals.
−Removed: SOSRx, a Delaware limited liability company, was formed, which was owned 51% by the Company and 49% by Exchange Health.
+Added: 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.
SOSRx did not
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allegedly appointed Rainforest as its exclusive distributor for Superlatus’ portfolio of consumer packaged goods brands in certain
−Removed: The Company later learned and announced that neither
−Removed: the Company’s management nor the Company’s Board of Directors authorized or approved the organization of Superlatus PD Holding
−Removed: Company, Inc.
+Added: The Company later learned and announced that neither the Company’s management nor the Company’s Board of Directors
+Added: authorized or approved the organization of Superlatus PD Holding Company, Inc.
or the entry into the supplier agreement.
−Removed: Instead, the Company’s management determined that certain representatives
−Removed: of a former subsidiary of the Company likely unilaterally took actions related to the supplier agreement.
+Added: Company’s management determined that certain representatives of a former subsidiary of the Company likely unilaterally took actions
+Added: related to the supplier agreement.
January 8, 2024, the Company entered into Amendment No.
9 unchanged sentences
Pursuant to the Superlatus SPA, the Company sold all of the issued and outstanding stock of Superlatus to the Buyer.
−Removed: The $1.00 purchase
−Removed: price for the Stock was delivered to the Company at the closing, which occurred simultaneously with the execution of the Superlatus SPA.
+Added: A $1.00 purchase
+Added: price was delivered to the Company at the closing, which occurred simultaneously with the execution of the Superlatus SPA.
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.
−Removed: historically focused on health services IT assets and operations aimed at digitalizing the retail pharmacy experience via an online pharmaceutical
−Removed: marketplace, with our primary operations conducted through IPS.
−Removed: began operations as Trxade Group, Inc., a Nevada corporation (“Trxade Nevada”) in August of 2010 and spent over two years
−Removed: creating and enhancing our web-based services.
−Removed: The Company changed its name on June 1, 2021, from “Trxade Group, Inc” to
−Removed: “TRxADE HEALTH, Inc.” Our services provided pricing transparency, purchasing capabilities and other value-added services
−Removed: on a single platform focused on serving the nation’s approximately 19,397 independent pharmacies with annual purchasing power of
−Removed: $67.1 billion (according to the National Community of Pharmacists Association’s 2021 Digest).
−Removed: Our national wholesale supply partners
−Removed: and manufacturers were able to fulfill orders on our platform in real-time and provide pharmacies and wholesale suppliers with cost-saving
−Removed: payment terms and next-day delivery capabilities in unrestrictive states.
−Removed: We have expanded significantly since 2015 and served approximately
−Removed: 14,400+ registered members on our sales platform.
−Removed: previously operated the Company’s web-based pharmaceutical marketplace engaged in promoting and enabling commerce among independent
−Removed: pharmacies, small chains, hospitals, clinics, and alternate dispensing sites with large pharmaceutical suppliers nationally.
−Removed: That marketplace
−Removed: had over 60 national and regional pharmaceutical suppliers providing over 120,000 branded and generic drugs, including over-the-counter
−Removed: drugs (OTCs), and drugs available for purchase by pharmacists.
−Removed: Generic drugs are copies of brand-name drugs that have exactly the same
−Removed: dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.
−Removed: approximately 14,400+ registered members, providing access to Trxade’s proprietary pharmaceutical database and data analytics regarding
−Removed: medication pricing.
−Removed: We generated revenue from these services by charging a transaction fee to the seller of the products for sales conducted
−Removed: via the Trxade platform.
−Removed: The buyers did not bear the cost of transaction fees for the purchases that they made, nor did they pay a fee
−Removed: to join or register with our platform.
−Removed: In February 2024 we divested substantially all of our assets related to our web-based pharmaceutical
−Removed: marketplace previously operated through Softell.
−Removed: Substantially all of our revenues during Fiscal 2023, Fiscal 2022, and Fiscal 2021 were
−Removed: from platform revenue generated on www.rx.trxade.com , product sales through IPS, and prescription sales through Community Specialty
−Removed: Pharmacy, LLC.
−Removed: previously had a number of products and services focused on the US market in operation and business assets, which are described below.
−Removed: Pharma Solutions, LLC.
−Removed: IPS is intended to serve as our logistics company for pharmaceutical distribution.
−Removed: We currently distribute
−Removed: through our manufacturer and strategic distribution partners prescription medication, medical devices and over the counter medication
−Removed: to over 1,600 pharmacies and medical clinics across 38 states.
−Removed: Trxade Prime previously allowed pharmacy members on the Trxade platform to process, consolidate and ship purchase orders that
−Removed: were placed directly with Trxade suppliers via Trxade Prime.
−Removed: This service was provided at no cost, with the goal of offering a single
−Removed: tool with one low order minimum, one invoice, one package and one delivery from multiple quality wholesalers and distributors.
−Removed: had been generated from this service through our IPS subsidiary, which provided the consolidation of the orders.
−Removed: Health Application.
−Removed: The “Bonum Health app,” previously provided an overall healthcare experience comparable to a primary
−Removed: care practitioner, and an online portal as a personal electronic medical record and scheduling system was available on a subscription
−Removed: basis, primarily as a stand-alone telehealth software application that could be licensed on a business-to-business (B2B) model to clients
−Removed: as an employment health benefit for the clients’ employees.
−Removed: Revenue was generated from this service through our Bonum Health subsidiary.
−Removed: Business to Business (B2B).
−Removed: Bonum+ previously bundled telehealth, a COVID-19 risk assessment tool and a Personal Protective Equipment
−Removed: (“PPE”) purchasing tool, through a secure mobile dashboard for corporate clients.
−Removed: The B2B platform eased pressure on employees
−Removed: who were required to report any relevant health issues daily, centralizing communication and contact tracing to deliver risk scores.
−Removed: This allowed employers to monitor employee COVID-19 risk profiles and streamlined the ordering of new PPE as needed.
−Removed: An integrated artificial
−Removed: intelligence (AI) tool offered health recommendations and connects employees with board certified physicians, as needed.
−Removed: No revenue was
−Removed: generated from this product.
−Removed: On February 15, 2022, the Company entered into a relationship with Exchange Health, LLC (“Exchange Health”), a technology
−Removed: company providing an online platform for manufacturers and suppliers to sell and purchase pharmaceuticals.
−Removed: SOSRx, LLC (“SOSRx”)
−Removed: was formed, which was owned 51% by the Company and 49% by Exchange Health.
−Removed: SOSRx did not generate material revenue and in February of
−Removed: 2023, the Company voluntarily withdrew from the joint venture agreement.
−Removed: As of December 31, 2023, Superlatus was a wholly owned subsidiary of the Company as a result of a merger transaction that closed
−Removed: in July 2023.
−Removed: On January 8, 2024, the Company entered into Amendment No.
−Removed: 1 to the Amended and Restated Agreement and Plan of Merger (the
−Removed: “Superlatus Amendment”) as not all of the closing conditions of the Superlatus Merger Agreement were met.
−Removed: Under the terms
−Removed: of the Superlatus Amendment, the merger consideration to the shareholders of Superlatus was adjusted downward and the shareholders of
−Removed: Superlatus agreed to surrender back to the Company shares of the Company’s Series B Preferred Stock.
−Removed: On March 5, 2024, the Company
−Removed: entered in a Stock Purchase Agreement (“Superlatus SPA”) with Superlatus Foods Inc.
−Removed: (the “Buyer”).
−Removed: the Superlatus SPA, the Company sold all of the issued and outstanding stock of Superlatus to the Buyer.
−Removed: The $1.00 purchase price for
−Removed: the Stock was delivered to the Company at the closing, which occurred simultaneously with the execution of the Superlatus SPA.
−Removed: of the transaction Superlatus is no longer a subsidiary of the Company, and the rights and assets of Superlatus together with various
−Removed: liabilities and obligations that were specific to Superlatus became rights and obligations of the Buyer.
+Added: Legacy Subsidiaries
+Added: Company also previously owned 100% of Softell Inc.
+Added: (f/k/a Trxade Inc.) (“Softell”), Integra Pharma Solutions, LLC
+Added: (“IPS”), Bonum Health, Inc., and Bonum Health, LLC.
+Added: & IPS Entities
+Added: 4, 2024, the Company and Softell entered into an Assignment and Assumption of Membership
+Added: Interests (the “IPS Assignment Agreement”), pursuant to which the Company transferred, and Softell accepted, 100% of the membership
+Added: interests of IPS.
+Added: As a result, IPS became a wholly-owned subsidiary of Softell.
+Added: 8, 2025, the Company entered into a Membership Interest Purchase Agreement (the “IPS MIPA”) with Tollo Health, Inc.
+Added: pursuant to which Tollo agreed to purchase and the Company agreed to sell all of the Company’s membership interests in IPS.
+Added: Ajjarapu, the Company’s former Chief Executive Officer, and Prashant Patel, the Company’s former President and Chief Operating
+Added: Officer, each have a beneficial interest in Tollo.
+Added: On April 8, 2025, the Company
+Added: also entered into a Stock Purchase Agreement (the “Softell SPA”) with Tollo, pursuant to which Tollo agreed to purchase and
+Added: the Company agreed to sell all issued and outstanding shares of common stock of Softell.
+Added: Health Entities
+Added: 8, 2025, the Company also entered into a Stock Purchase Agreement (the “Bonum SPA”)
+Added: with Tollo, pursuant to which Tollo agreed to purchase and the Company agreed to sell all issued and outstanding shares of common stock
+Added: of Bonum Health, Inc.
+Added: In November 2025, the Company
+Added: dissolved Bonum Health, LLC.
+Added: divestitures described above are part of a broader strategic realignment at the Company designed to sharpen operational focus and
+Added: unlock long-term value.
+Added: It is aligned with the Company’s commitment to streamline its core operations, optimize its portfolio,
+Added: and accelerate growth in the Branded and Specialty Pharma markets.
+Added: The Company intends to use the proceeds obtained from the
+Added: divestment to facilitate the high-growth commercial and strategic product development activities at its Scienture LLC
and Organizational History
6 unchanged sentences
necessary to implement its business strategy, and never generated any revenue.
−Removed: November 22, 2013, Trxade Group, Inc., a Nevada corporation (“Trxade Nevada”) and wholly owned subsidiary of Trxade, Inc.,
−Removed: a Florida corporation (“Trxade Florida”), acquired a controlling interest of 80,000,000 shares of XCEL common stock pursuant
−Removed: to a Purchase and Sale Agreement dated November 7, 2013.
−Removed: At the time of the sale, XCEL had 104,160,000 shares of common stock issued
−Removed: and outstanding, including the 80,000,000 shares of stock acquired by Trxade Nevada (prior to the Merger Reverse Split and Reverse Stock
−Removed: Split(s) (each discussed and defined below).
−Removed: Trxade Florida was formed in August 2010 under the name PharmaCycle LLC, a Nevada limited
−Removed: liability company (“PharmaCycle”).
−Removed: PharmaCycle was formed by Prashant Patel, our President, Chief Operating Officer, and
−Removed: former Interim Principal Financial/Accounting Officer and Director, to serve as a web-based market platform designed to enable trading
−Removed: among healthcare buyers and sellers of pharmaceuticals, accessories and services.
−Removed: In January 2013, PharmaCycle converted into a Florida
−Removed: corporation and changed its name to Trxade, Inc.
−Removed: In May 2013, Trxade Florida formed Trxade Nevada as a wholly owned subsidiary.
−Removed: Subsequently,
−Removed: Trxade Nevada acquired Trxade Florida pursuant to a reverse triangular merger, resulting in Trxade Florida becoming a wholly-owned subsidiary
−Removed: of Trxade Nevada (the “Nevada-Florida Merger”).
−Removed: The sole purpose of the Nevada-Florida Merger was to provide for a holding
−Removed: company to own Trxade Florida, the operating company.
−Removed: Immediately following the Nevada-Florida Merger, Surendra Ajjarapu, the Company’s
−Removed: Chairman of the Board, Chief Executive Officer, and Secretary, and Mr.
−Removed: Patel collectively owned 99% of Trxade Nevada.
−Removed: December 16, 2013, Trxade Nevada and XCEL entered into a definitive merger agreement providing for the merger of Trxade Nevada with and
−Removed: into XCEL, with XCEL continuing as the surviving corporation (the “XCEL Merger”).
+Added: November 22, 2013, Trxade Group, Inc., a Nevada corporation (“Trxade Nevada”) and wholly owned subsidiary of Trxade,
+Added: Inc., a Florida corporation (“Trxade Florida”), acquired a controlling interest of XCEL common stock pursuant to a
+Added: Purchase and Sale Agreement dated November 7, 2013.
+Added: Trxade Florida was formed in August 2010 under the name PharmaCycle LLC, a
+Added: Nevada limited liability company (“PharmaCycle”).
+Added: PharmaCycle was formed by Prashant Patel, our former President and Chief
+Added: Operating Officer.
+Added: In January 2013,
+Added: PharmaCycle converted into a Florida corporation and changed its name to Trxade, Inc.
+Added: In May 2013, Trxade Florida formed Trxade
+Added: Nevada as a wholly owned subsidiary.
+Added: Subsequently, Trxade Nevada acquired Trxade Florida pursuant to a reverse triangular merger,
+Added: resulting in Trxade Florida becoming a wholly-owned subsidiary of Trxade Nevada (the “Nevada-Florida Merger”).
+Added: following the Nevada-Florida Merger, Surendra Ajjarapu, the Company’s former Chief Executive Officer, and Mr.
+Added: Patel, the Company’s former President and Chief Operating Officer, collectively owned 99% of Trxade Nevada.
+Added: December 16, 2013, Trxade Nevada and XCEL entered into a definitive merger agreement providing for the merger of Trxade Nevada with
+Added: and into XCEL, with XCEL continuing as the surviving corporation (the “XCEL Merger”).
The XCEL Merger closed in January
−Removed: As a result of the XCEL Merger, XCEL acquired Trxade Nevada and Trxade Nevada’s wholly owned subsidiaries, including Integra Pharma
−Removed: Solutions, LLC, formerly known as Pinnacle Tek, Inc., a Florida corporation (“IPS”).
−Removed: IPS was founded in 2011 and initially
−Removed: served as a technology consultant provider supporting programming needs and providing research on pharmaceutical pricing and shortages
−Removed: in acute care and retail settings.
−Removed: the terms of the Merger Agreement, XCEL amended its certificate of incorporation, changed its name to “Trxade Group, Inc.,”
−Removed: and changed our trading symbol to “TRXD”.
−Removed: In connection with closing of the XCEL Merger, we conducted a reverse stock split
−Removed: of our issued and outstanding stock at the ratio of one for one thousand (1:1,000) shares (the “XCEL Merger Reverse Split”).
−Removed: In connection with the XCEL Merger Reverse Split, 104,160,000 outstanding shares of our common stock, including the 80,000,000 shares
−Removed: held by Trxade Nevada, were exchanged for 104,160 post-Merger Reverse Split shares of common stock.
−Removed: September 2019, we formed Bonum Health, LLC, a Delaware limited liability company (“Bonum Health”) that was meant to hold
−Removed: certain telehealth assets.
−Removed: In October 2020, we formed BONUM HEALTH, INC., a Delaware non-stock corporation (“Bonum”) to provide an overall healthcare experience comparable to a Primary Care
−Removed: practitioner, and an online portal as a personal electronic medical record and scheduling system was available on a subscription basis,
−Removed: primarily as a stand-alone telehealth software application that can be licensed on a business-to-business (B2B) model to clients as an
−Removed: employment health benefit for the clients’ employees.
−Removed: We anticipate that we will wind-down these entities in the near future.
−Removed: February 2020, we effected another reverse stock split of our issued and outstanding stock at the ratio of one for six (1-for-6) shares
−Removed: to allow us to meet the initial listing criteria of The Nasdaq Capital Market tier of The Nasdaq Stock Market LLC (“Nasdaq”).
+Added: As a result of the XCEL Merger, XCEL acquired Trxade Nevada and Trxade Nevada’s wholly owned subsidiaries, including
+Added: In connection with the XCEL Merger, XCEL changed its name to “Trxade Group, Inc.” and changed its trading
+Added: symbol to “TRXD”.
Our common stock was approved for listing on Nasdaq under the symbol “MEDS” on February 13, 2020.
June 1, 2021, we changed our corporate name from “Trxade Group, Inc.” to “TRxADE HEALTH, Inc.”
−Removed: June 2023, we effected another reverse stock split of our issued and outstanding stock at the ratio of one for 15 (1-for-15) shares.
−Removed: February 16, 2024, we, Trxade, Inc., and Micro Merchant Systems, Inc.
−Removed: (“MMS”) entered into and closed on an asset purchase
−Removed: agreement (the “MMS APA”) under which MMS agreed to purchase for cash substantially all of the assets of Trxade, Inc.
−Removed: September 20, 2024, Trxade, Inc.
−Removed: changed its corporate name to Softell Inc.
−Removed: On October 4, 2024, we entered into
−Removed: an Assignment and Assumption of Membership Interests (the “IPS Assignment Agreement”) with Softell, pursuant to which we
−Removed: transferred, and Softell accepted, 100% of the membership interests of IPS.
−Removed: As a result, Softell currently exists as a wholly owned subsidiary
−Removed: of the Company and IPS exists as a wholly owned subsidiary of Softell through which Softell conducts its primary operations.
−Removed: portion of the quarter ended March 31, 2024, Softell, operated a web-based market platform that enabled commerce among healthcare buyers
−Removed: and sellers of pharmaceuticals, accessories and services.
−Removed: Today, IPS sells brand, generic and non-drug products to customers as a licensed
−Removed: pharmaceutical wholesaler.
−Removed: A wholesaler typically is the first purchaser of a drug product – direct from the manufacturer.
−Removed: Wholesalers buy large quantities and then resell either direct to provider-purchasers (like a large health system, pharmacy or pharmacy
−Removed: chain), or resell to smaller, regional distributors for regional or local distribution to retail pharmacies and hospitals.
July 25, 2024, the Company entered into and closed an Agreement and Plan of Merger (the “Scienture Merger Agreement”) with
2 unchanged sentences
with Merger Sub I, the “Merger Subs”), and Scienture LLC.
−Removed: The business of Scienture LLC is described in detail below.
to the Scienture Merger Agreement, (i) Merger Sub I merged with and into Scienture LLC (the “First Merger”), with Scienture
5 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.