UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K
(Mark
One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the Fiscal Year Ended December 31, 2024
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission
File Number: 001-39199
Scienture
Holdings, Inc.
(Exact
name of registrant as specified in its charter)
(Address of principal executive offices) (Zip code)
(800)261-0281
(Registrant’s
telephone number, including area code)
TRxADE
HEALTH, INC.
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Securities
registered pursuant to Section 12(g) of the Act:
None.
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐
No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of the last business day
of the registrant’s most recently completed second fiscal quarter was approximately $10,203,000.
There
were 12,515,019shares
of the registrant’s common stock outstanding on March 26, 2025.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the registrant’s definitive proxy statement relating to its 2024 annual meeting of stockholders (the “2024 Proxy Statement”)
are incorporated by reference into Part III of this Annual Report on Form 10-K (this “Annual Report”) where indicated. The
2024 Proxy Statement was filed with the U.S. Securities and Exchange Commission (the “SEC”) on January 27, 2025, and the
related additional soliciting materials filed with the SEC on February 18, 2025 within 120 days after the end of the fiscal year to which
this Annual Report relates.
TABLE
OF CONTENTS
Page
Cautionary Statement Regarding Forward-Looking Information 3
PART I
Item 1. Business 5
Item 1A. Risk Factors 36
Item 1B. Unresolved Staff Comments 74
Item 1C. Cybersecurity 74
Item 2. Properties 74
Item 3. Legal Proceedings 74
Item 4. Mine Safety Disclosures 74
PART II
Item 6. [Reserved] 76
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 82
Item 8. Financial Statements and Supplemental Data 83
Item 9A. Controls and Procedures 118
Item 9B. Other Information 120
Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 120
PART III
Item 10. Directors, Executive Officers and Corporate Governance 121
Item 11. Executive Compensation 121
Item 14. Principal Accountant Fees and Services 124
PART IV
Item 15. Exhibits, Financial Statements and Schedules 125
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CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Annual Report contains statements that constitute forward-looking statements which are subject to the safe-harbor provisions of the Private
Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section
27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Some of
the statements in this Registration Statement constitute forward-looking statements because they relate to future events or our future
performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current
expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Our forward-looking statements
include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or
strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future
events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, the words “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “ongoing,” “plan,” “potential,” “predict,” “project,”
“should,” or the negative of these terms or other similar expressions, may identify forward-looking statements, but the absence
of these words does not mean that a statement is not forward-looking. These forward-looking statements are subject to known and unknown
risks, uncertainties and assumptions about the Company that may cause the Company’s actual results, levels of activity, performance
or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied
by such forward-looking statements.
Actual
performance or results could differ materially from those expressed in or suggested by the forward-looking statements. Important factors
that could cause such differences include, but are not limited to:
● our ability to manage our growth;
● regulatory and licensing requirement risks;
● risks related to changes in the U.S. healthcare environment;
● risks associated with the operations of our more established competitors;
● changes in laws or regulations relating to our operations;
● our growth strategy;
● compliance with the continued listing requirements of Nasdaq;
● risks relating to the liquidity and trading of our common stock;
● our ability to raise financing in the future;
● demand for our products and services may decline;
● data security breaches, cyber-attacks or other network outages; and
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The
forward-looking statements contained in this Annual Report are based on our current expectations and beliefs concerning future developments
and their potential effects on us. There can be no assurance that future developments affecting us will be those that we have anticipated.
These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions
that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
These
risks and uncertainties include, but are not limited to, those factors described under the section of this Annual Report entitled “Risk
Factors”. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect,
actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to
update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be
required under applicable securities laws.
We
use words such as “anticipates,” “believes,” “expects,” “intends,” “seeks,”
“plans,” “estimates,” “targets” and similar expressions to identify forward-looking statements. The
forward-looking statements contained in this Annual Report involve risks and uncertainties. Our actual results could differ materially
from those implied or expressed in the forward-looking statements for any reason, including the factors set forth in the section entitled
“Risk Factors” in this Annual Report.
Although
we believe that the assumptions on which these forward-looking statements are based are reasonable, any of those assumptions could prove
to be inaccurate, and as a result, the forward-looking statements based on those assumptions also could be inaccurate. In light of these
and other uncertainties, the inclusion of a projection or forward-looking statements in this Annual Report should not be regarded as
a representation by us that our plans and objectives will be achieved.
We
have based the forward-looking statements included in this Annual Report on information available to us on the date of this Annual Report,
and we assume no obligation to update any such forward-looking statements. Although we undertake no obligation to revise or update any
forward-looking statements in this Annual Report, whether as a result of new information, future events or otherwise, you are advised
to consult any additional disclosures that we may make directly to you or through reports that we may file in the future with the Securities
and Exchange Commission (the “SEC”), including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports
on Form 8-K.
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PART I
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. This Annual Report may also include trademarks, tradenames
and service marks that are the property of others. Solely for convenience, trademarks, tradenames and service marks referred to in this
Annual Report may appear without the ®, TM and SM symbols. References to our trademarks, tradenames and service marks are not
intended to indicate in any way that we will not assert to the fullest extent under applicable law our rights or the rights of the applicable
licensors if any, nor that respective owners to other intellectual property rights will not assert, to the fullest extent under applicable
law, their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship
with, or endorsement or sponsorship of us by, any other companies.
The
market data and certain other statistical information used throughout this Annual Report are based on independent industry publications,
reports by market research firms or other independent sources that we believe to be reliable sources. Industry publications and third-party
research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although
they do not guarantee the accuracy or completeness of such information. We are responsible for all of the disclosures contained in this
Annual Report , and we believe these industry publications and third-party research, surveys and studies are reliable. 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. These and other
factors could cause our future performance to differ materially from our assumptions and estimates. Some market and other data included
herein, as well as the data of competitors as they relate to us, are also based on our good faith estimates.
Our
fiscal year ends on December 31st. Interim results are presented on a quarterly basis for the quarters ended March 31st, June 30th, and
September 30th, the first quarter, second quarter and third quarter, respectively, with the quarter ending December 31st being referenced
herein as our fourth quarter. “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.
In
addition, unless the context otherwise requires and for the purposes of this Annual Report only:
● “Exchange Act” refers to the Securities Exchange Act of 1934, as amended;
● “SEC” refers to the United States Securities and Exchange Commission; and
● “Securities Act” refers to the Securities Act of 1933, as amended.
Available
Information
We
file annual, quarterly, and current reports, proxy statements and other
information with the SEC. Our SEC filings are available to the public over the Internet at the SEC’s website at http://www.sec.gov and
are available for download, free of charge, soon after such reports are filed with or furnished to the SEC, on the “Investors”
page of our website at www.scientureholdings.com. Copies of documents filed by us with the SEC are also available from us without charge,
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
this Annual Report. Our website addresses are www.scientureholdings.com, www.scienture.com, www.trxadehealth.com and www.rxintegra.com.
Information on our websites is not incorporated by reference into this Annual Report. The information on, or that may be accessed through,
our websites not incorporated by reference into this Annual Report and should not be considered a part of this Annual Report.
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Current
Business – Scienture LLC
Overview
Scienture
LLC was originally incorporated in Delaware and commenced operations in 2019. 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 LLC is developing a broad range of novel product candidates including new potential treatments for hypertension, migraine,
pain and thrombosis and other related disorders.
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 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:
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Research
and Development and Product Portfolio
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. The progress of Scienture LLC’s products through this process is represented by checkmarks in the table.
Scienture
LLC does not have any product candidates approved for sale and has not generated any revenue from product sales. Scienture LLC
will not generate revenue from product sales unless and until it successfully obtains regulatory approval for its product candidates.
Scienture LLC is engaged in a variety of research and development efforts including development of a pipeline of novel product candidates
for the treatment of various disease conditions. 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’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.
SCN-102
(ARBLITM - 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. Currently, there are no FDA-approved liquid formulations of losartan potassium.
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A
Phase I PK study has shown that SCN-102 has close comparability to the immediate-release tablet as depicted in the data below:
Geometric Means of treatment: Ratio Intra-subject 90% SABE Result – SABE
PK Parameter N Test (T) Reference (R) (%) %CV CI of Ratio Bound SWR
Geometric Means of treatment: Ratio Intra-subject 90% SABE Result – SABE
PK Parameter N Test (T) Reference (R) (%) %CV CI of Ratio Bound SWR
Specifically,
the Phase I PK study showed that SCN-102 was comparable to immediate release tablets based on the following:
● The overall exposure for Losartan were within the 90% confidence interval.
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If
approved, SCN-102 would be the first 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. In October 2023, Scienture LLC submitted an 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. Despite responding during the FDA’s review to information requests related to chemistry, manufacturing, and controls (“CMC”),
pharmacovigilance, clinical, microbiology and labeling, the FDA issued a Complete Response Letter to Scienture LLC focused on the CMC
information submitted. Scienture LLC prepared the requested information and resubmitted the NDA to the FDA on September 17, 2024. In October
2024, the FDA accepted the resubmitted NDA for review and assigned a PDUFA target action date of March 17, 2025. On March 13, 2025, the
FDA approved the SCN-102 NDA to be launched as ARBLITM (losartan potassium) Oral Suspension, 10mg/mL Scienture LLC anticipates
that it will commercially launch and bring to market SCN-102 during the third quarter of 2025. SCN-102 will be the first FDA approved
oral liquid formulation of losartan on the market.
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. 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. DHE is also available in the market as single dose ampoules
for injection, however, Scienture LLC believes that the process of dose withdrawal from the ampoule followed by self-injection at the
time of intense need is cumbersome and difficult for the patient.
Scienture
LLC believes that the SCN-104 multi-dose self-injection pen is easy to use and provides enhanced patient convenience. Furthermore, Scienture
LLC believes that the SCN-104 injection pen provides for consistent and accurate delivery of every dose which results in better exposure
compared to the nasal spray formulation. The SCN-104 injection pen is being developed via the 505(b)(2) regulatory pathway. The SCN-104
injection pen is in development for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster
headache episodes.
As
shown in third party studies of DHE, SCN-104’s mechanism of action for its antimigraine effect is due to its potential action as
an agonist at the serotonin 5-HT1D receptors. SCN-104 is intended for subcutaneous administration. SCN-104 is also intended for acute
use and is not intended for chronic administration.
Scienture
LLC has conducted two preclinical studies of SCN-104 and the SCN-104 injection pen: (i) a 30-day repeated dose toxicity study of dimethyl
sulfoxide and caffeine following thrice daily, 3 times per week subcutaneous administration in Sprague-Dawley rats and (ii) a 30-day
repeated dose toxicity study of dimethyl sulfoxide and caffeine following thrice daily, 3 times per week subcutaneous administration
in Göttingen minipigs. 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 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.
Scienture
LLC believes the SCN-104 injection pen may offer a significant improvement, in terms of usability and patient acceptability, to the current
standard of care in the market (ampoules for injection). The intended pen delivery system was designed with patients in mind to carry
multiple doses, have a lower volume of injection, and utilize shielded needles to avoid unnecessary exposure.
Scienture
LLC has had initial discussions with the FDA to align on a path forward for this development program. As a result of these discussions,
Scienture LLC learned that its proposed plan for manufacturing NDA registration batches and that the reference product and dose selection
of the reference product that Scienture LLC selected for a comparative regulatory study are acceptable. Scienture LLC also received guidance
from the FDA on nonclinical safety studies and stability testing. The formulation has been scaled up to enable future commercial scale
production and the pen has been optimized for commercial use. As shown below, several pharmacokinetics studies have shown comparability
between SCN-104 and the currently available marketed injection product.
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Scienture
LLC is initiating manufacturing activities and planning to conduct bioequivalence studies. 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.
SCN-106
(Potential Biosimilar)
Scienture
LLC is developing a potential biosimilar, SCN-106, based on Cathflo Activase, a reference product that is a thrombolytic agent that binds
to fibrin in clots and converts entrapped plasminogen to plasmin. SCN-106 is a sterile, purified glycoprotein that is synthesized using
the complementary DNA for natural human tPA obtained from a Chinese hamster ovary cell-line.
Scienture
LLC is working with Anthem Biosciences Pvt, Ltd. (“Anthem”) to develop a biosimilar product that utilizes the same mechanism(s)
of action for the proposed condition of use, and has the same route of administration, dosage form, and strength as the reference product.
In this regard, Scienture LLC entered into a Master Services Agreement with Anthem on October 29, 2024 (the “Anthem Agreement”).
The following is a summary of the Anthem Agreement, which is qualified in its entirety by the full text of the Anthem Agreement,
which is filed as an exhibit to this Annual Report.
Under
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. In performing these services, Anthem has agreed to strictly comply with the specifications in the Anthem
Agreement, the work order, standard operating procedures approved in writing by Scienture LLC, and relevant professional standards, and
any regulatory authority requirements, including current Good Laboratory Practices (“GLPs”) and current Good Manufacturing
Practices (“GMPs”) promulgated by the FDA, and any other applicable laws, rules, and regulations. 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. 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. These amounts are
to be paid on the schedule stated on the work order and Anthem is responsible for invoicing Scienture LLC for such amounts. Undisputed
late payments incur interest at the rate of 18% per annum payable until the date of actual payment.
Any
project or work order in effect under the Anthem Agreement may be terminated by Scienture LLC without cause upon thirty (30) days’
prior notice to Anthem. Anthem may terminate the Anthem Agreement without cause upon thirty (30) days’ prior notice to Scienture
LLC. However, Anthem is responsible for delivering all services and deliverables under the Anthem Agreement then required to be performed
by Anthem under a work order prior to any such termination. Either party may terminate the Anthem Agreement upon the breach of the Anthem
Agreement by the other party if the breach remains uncured for a period of thirty (30) days. In the event that performance by Anthem
or Scienture LLC under the Anthem Agreement is delayed due to an event beyond the control of Anthem or Scienture LLC for a period of
ninety (90) days, then the other party can terminate the Anthem Agreement upon written notice.
With
respect to projects to be performed by Anthem under the Anthem Agreement, any and all materials relating to such projects are the property
of Scienture LLC, and are to be protected as such by Anthem. Furthermore, Anthem has agreed to irrevocably assign to Scienture LLC all
right, title, and interest in and to any “Program Technology” (as defined in the Anthem Agreement) and to make any assignments
necessary to ensure that Scienture LLC has such ownership interest. The Anthem Agreement also contains customary confidentiality obligations,
representations and warranties, indemnification provisions, and anti-assignment provisions. The Anthem Agreement may only be amended
upon the written consent of both parties.
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The
CMC development program is focused on establishing the analytical similarity of SCN-106 to the reference product. 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.
Scienture
LLC completed a Biosimilar Initial Advisory meeting with the FDA in June 2023 to discuss the CMC, non-clinical, and clinical studies
required for regulatory approval. As a result of this meeting, Scienture LLC learned that its analytical strategy for initiating analytical
similarity studies between SCN-106 and a proposed biosimilar product is acceptable. Scienture LLC also learned that SCN-106 is suitable
for further development and received guidance from the FDA on a comparable clinical study needed to demonstrate biosimilarity of SCN-106
and the reference product.
SCN-107
(Bupivacaine Long-Acting Injection)
SCN-107
is a long-acting injection suspension formulation of a non-opioid analgesic that is indicated for postsurgical local and regional analgesia.
Scienture LLC’s long-acting formulation, SCN-107,
is a novel microsphere-based formulation of bupivacaine that comprises the drug in polymer-based microspheres and is intended to provide
pain management over a period of 5-7 days. The product candidate is designed to potentially provide longer term post-surgical pain relief
compared to the currently available products in the market.
Based
on initial discussions with FDA regarding this program, Scienture LLC believes this product candidate would require at least one Phase
3 clinical trial to support submission of a marketing application.
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.
Sales
and Marketing
Scienture
LLC intends to market its products through its own sales forces in the U.S. and seek strategic collaborations with other pharmaceutical
companies to commercialize its products outside of the U.S. Scienture LLC is in the process of building a commercial sales and marketing
operation in the U.S., through a partnership with a Contract Sales Organization, to support sales of Scienture
LLC’s products. 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. 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. Scienture LLC believes its commercial operations infrastructure,
once established, will enable it to effectively target healthcare providers to support and grow its products subsequent to market entry.
Customers
The
majority of Scienture LLC’s product sales, if its products are approved by the FDA, are expected to be to pharmaceutical wholesalers,
specialty pharmacies, and distributors who, in turn, would sell such products to pharmacies, hospitals, long term care institutions and
other customers, potentially including federal and state entities.
Market
and Competition
Scienture
LLC is engaged in segments of the pharmaceutical industry
that are highly competitive and rapidly changing. 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.
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Hypertension
Hypertension
(high blood pressure) is a CVS condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). 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.
Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk
of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and
drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic
blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
The
hypertension market has increased with the commercial launch of several branded products in recent years, as well as the launch of generic
versions of branded drugs, such as Prinvil, Lotensin, Cozaar, Cardizem, Apresoline, Nitrostat and Toprol-XL. 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, ARBLITM (Losartan Oral Suspension 10mg/mL), is a ready to use oral suspension of losartan
for increased patient convenience and ease of dosing. Losartan is classified as an ARB for treating hypertension and is one of the highest
prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which
can be further compounded to a liquid formulation. Scienture LLC believes that ARBLITM 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. Migraine
headaches are often characterized by throbbing pain, extreme sensitivity to light or sound, and potentially nausea and vomiting. The
World Health Organization categorizes migraine as one of the most disabling medical illnesses worldwide. The American Research Foundation
categorizes migraine as the third most prevalent illness in the world, and nearly 1 in 4 U.S. households includes someone with migraines.
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)).
Scienture
LLC’s product candidate, SCN-104, is supplied in a multi-dose pen-based delivery system for self-injection and increased patient
convenience. The product candidate is in development for the acute treatment of migraine headaches with or without aura and the acute
treatment of cluster headache episodes.
Thrombotically
Occluded Catheter (CVAD) Management
Catheters,
which are a type of a Central Venous Access Device (“CVAD”), are employed to deliver life-sustaining therapies. They can
be used for short-term or long-term infusion of antibiotics, parenteral nutrition, chemotherapy, blood and blood products in patients
with limited peripheral access. More than 7 million CVADs are inserted each year in patients in the United States. Occlusion of catheters
while in use can complicate patient care by interrupting the administration of medications and solutions, delaying or disrupting therapies
and leading to additional procedures such as catheter replacement. Occlusion is the most common noninfectious complication in the long-term
use of CVADs and may occur soon after insertion of a device or develop at any time. About 58% of catheter occlusions are thrombotic,
resulting from the formation of a thrombus within, surrounding, or at the tip of the catheter.
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.
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Postoperative
Pain
Post-surgery
pain, also known as postoperative pain, is pain that a patient experiences after a surgical procedure. Pain can be caused by a number
of factors, including: the type of procedure, the size of the operation, and medications used during surgery. Chronic pain can negatively
impact a patient’s rehabilitation, quality of life, and the results of the procedure.
Current
drug product treatments available in the market for treating postoperative pain include IV and oral opioids, injectable local anesthetics,
and steroidal and non-steroidal analgesics. Marketed products include branded and generic versions of Celebrex, Ketalar, Exparel, Lyrica,
Neurontin and Astromorph.
Scienture
LLC’s product candidate, SCN-107, is a microsphere based long-acting injection of Bupivacaine, a local anesthetic, in development
for postsurgical analgesia. SCN-107 is designed to be a non-opioid treatment regimen with rapid onset of action and analgesia that is
intended to provide coverage over a period of 5-7 days.
Manufacturing
Scienture
LLC currently depends on third-party commercial manufacturing organizations (“CMOs”) for all manufacturing operations, including
the production of raw materials, finished dosage form product, and product packaging for both its planned commercial scale manufacturer
and the products used in its preclinical and clinical research. Scienture LLC does not own or operate manufacturing facilities for the
production of any of its product candidates nor does Scienture LLC have plans to develop its own manufacturing operations in the foreseeable
future to support clinical trials or commercial production. Scienture LLC currently employs internal resources to manage its manufacturing
contractors.
Scienture
LLC is in discussion with CMOs headquartered in North America, Europe and Asia for its pipeline product candidates. These CMOs offer
a comprehensive range of commercial contract manufacturing and packaging services.
If
Scienture LLC fails to produce its products and product candidates in the volumes that Scienture LLC requires on a timely basis, or fails
to comply with stringent regulations applicable to pharmaceutical drug manufacturers, Scienture LLC may face delays in the development
and commercialization of its products and product candidates or be required to withdraw its products from the marketfor
risks associated with manufacturing and supply of its products and product candidates.
License
Agreements
On
May 26, 2020, Scienture LLC entered into Feasibility Study and Animal Trial Material Manufacturing Agreement with Innocore Technologies,
B.V. (“Innocore”), as amended on December 2, 2022 (the “Innocore License”), for certain intellectual property
rights. 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. Pursuant to
the Innocore License, Scienture LLC is required to make low single-digit percentage royalty payments based 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 increase as of the fourth year
of sales on a country-by-country basis. Scienture LLC is required to remunerate Innocore for the development of the licensed product,
subject to a limit of $0.4 million for certain safety and toxicity studies which will be deducted from certain development and regulatory
milestones as described below. Scienture LLC is required to make development and regulatory milestone payments up to €2.7 million
in the aggregate, commercial sale milestone payments of up to €18.875 million in the aggregate, and maintenance fees of €0.25
million annually, subsequent to the first regulatory filing, until the date that Scienture LLC begins making royalty payments based on
annual net sales, up to €0.5 million of which may be credited toward the regulatory milestone payments. As of October 25, 2024,
the Company had made aggregate payments to Innocore of $1,021,089.37 in connection with the Innocore License.
The
Innocore License is terminable by either the Company or Innocore on thirty (30) days’ prior written notice if the terminating party
determines in good faith, that it is technically or legally not feasible, or commercially not viable to jointly develop a formulation
which meets the specifications described in the Innocore License. The Innocore License can also be terminated for any material breach
of the Innocore License that remains uncured after thirty (30) days and if either party files for insolvency under any applicable foreign,
federal or state law.
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Intellectual
Property
Overview
Scienture
LLC continues to build its intellectual property portfolio to provide protection for its technologies,
products, and product candidates. 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 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 cannot be sure that patents will be granted with respect to its pending patent applications or with respect to any patent
applications filed by it in the future, nor can Scienture LLC be sure that any of its existing patents or any patents that may be granted
to it in the future will be commercially useful in protecting its technology or its products. 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. 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. 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).
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. 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.
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”). 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. 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.
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.
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. Scienture LLC
intends to vigorously defend itself in the litigation.
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Kindeva
Drug Delivery L.P. (“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.
Scienture LLC intends to use the exclusive right and license to price, launch, promote, market, distribute, and educate the public on
the Product.
Unless
earlier terminated, the term of the Kindeva Agreement will remain in effect for 10 years from the date of first commercial sale of the