Scienture Holdings, Inc. Issues Annual Letter to Shareholders

Rhea-AI Summary

Scienture Holdings (NASDAQ: SCNX) has transformed from a health services IT company to a specialty pharmaceutical company through strategic moves in 2024-2025. The company completed a $22.5M sale of TRXaDE Inc. assets and merged with Scienture Inc. in a $103M all-stock transaction.

The company now has two FDA-approved commercial products scheduled for launch in H2 2025: ArbliTM (in-house developed) and REZENOPY® (acquired in March 2025). The company's pipeline includes multiple products under development:

• SCN-104: Injectable pen for migraine treatment
• SCN-106: CVS therapeutic biosimilar
• SCN-107: Non-opioid post-surgical pain management

REZENOPY®, a 10mg naloxone HCl nasal spray, targets a market with annual sales of $189M. The combined market opportunity for their two commercial products is $481M, based on IQVIA data (December 2024).

Positive

• Two FDA-approved products ready for commercial launch in H2 2025
• Strong patent protection for ArbliTM until 2041
• Large market opportunity of $481M annually for approved products
• Successful transformation to specialty pharma through $103M merger
• Diverse product pipeline across multiple therapeutic areas

Negative

• Currently no revenue from pharmaceutical products until H2 2025 launch
• Significant investment needed for commercial launch and pipeline development
• Divestment of legacy operations may impact current revenue streams

Insights

Pharmaceutical Industry Analyst

Scienture Holdings' shareholder letter reveals a complete strategic transformation from a healthcare IT company to a specialty pharmaceutical enterprise with two FDA-approved products ready for commercial launch in H2 2025. This represents significant positive development for the $12M market cap company.

The company's two commercial-ready assets target substantial markets: REZENOPY® (naloxone HCl nasal spray 10mg) enters a $189M market as the highest-potency formulation available, while Arbli™ (losartan) addresses a $292M market. Both launches are scheduled for second half of 2025, marking the company's first potential revenue streams from pharmaceutical products.

The strategic repositioning included divesting TRXaDE assets for $22.5M and completing an all-stock acquisition of Scienture valued at $103M. This transformation represents a fundamental business model shift toward higher-margin specialty pharmaceuticals.

The company's development strategy leverages the 505b-2 NDA pathway, which reduces development timelines by utilizing existing safety/efficacy data while adding proprietary improvements. Their pipeline includes injectable migraine treatment (SCN-104), a cardiovascular biosimilar (SCN-106), and a non-opioid pain management product (SCN-107)—all representing potential future growth drivers.

Most crucially, the company has assembled commercial infrastructure for product launches while simultaneously divesting legacy operations to focus resources. The two approved products with 2025 launch timelines provide near-term catalysts that could dramatically alter the company's financial trajectory.

Financial Strategist

This shareholder letter signals a pivotal inflection point for Scienture Holdings as it transitions from a low-margin healthcare IT business to a specialty pharmaceutical company with imminent commercialization potential. The strategic transformation appears well-executed with two critical value-creating transactions: the $22.5M sale of legacy assets and the $103M acquisition of Scienture.

The company now possesses two FDA-approved products targeting a combined $481M market opportunity, with launches slated for H2 2025. Particularly noteworthy is REZENOPY®, which enters the naloxone market with a competitive advantage as the highest-potency formulation available—a potential differentiator in a market increasingly challenged by potent synthetic opioids.

The development strategy employing 505b-2 and BLA regulatory pathways is financially prudent, allowing for expedited approvals with lower capital requirements than traditional drug development programs. The company has secured intellectual property protection for key assets, including patents for Arbli™ that extend to 2041, creating long-term exclusivity value.

The divestiture of legacy operations streamlines the business model while commercial infrastructure development demonstrates preparation for execution phase. For a $12M market cap company, having two approved products indicates significant underlying asset value that appears disconnected from current valuation.

This transformation represents a textbook case of strategic repositioning toward higher-value pharmaceutical assets with substantial near-term revenue potential that could fundamentally reframe the company's financial profile when commercial launches commence in late 2025.

TAMPA, FL, April 03, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to provide this annual update from its Chief Executive Officer, Surendra Ajjarapu, to its stockholders.

This time last year, Scienture Holdings, Inc. (f.k.a. TRxADE Health, Inc.). was focused on health services IT assets and operations aimed at digitalizing the retail pharmacy experience. The primary operations were conducted through our wholly-owned subsidiary, Integra Pharma Solutions, LLC (“IPS”), which is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to customers. We completed a sale of assets of our subsidiary TRXaDE Inc. to Micro Merchant Systems for $22.5 million in Q1 2024 and entered into a business combination with Scienture, Inc., a private branded and specialty pharmaceutical company, in an all-stock transaction valued at $103 million. This completed our transformation to a company focused on the development of a novel and innovative specialty product pipeline that provides comprehensive access and disease management solutions to patients, caregivers and the healthcare system.

Today, we are a fully fitted branded and specialty pharmaceutical company through our wholly-owned Scienture, LLC subsidiary, with two (2) FDA approved commercial products to be launched in the second half of 2025. We received NDA approval for our first in-house product (Arbli^TM) from the FDA and completed the strategic acquisition of a previously approved product (REZENOPY^®) in March 2025. We have put together an accomplished commercial operations infrastructure and go to market capabilities, for bringing novel and innovative brand products to the market. Our R&D focus continues to be in place with our proprietary product pipeline in development by leveraging the 505b-2 NDA and BLA regulatory pathways, identifying and contracting with key technology partners and service providers for product development, manufacturing and clinical operations. We are also in the process of divesting our legacy subsidiaries related to healthcare IT and pharmaceutical wholesaler operations, to fully focus on the branded and specialty pharma segment.

Scienture, LLC’s Story

Scienture, LLC (previously known as Scienture, Inc.) was founded in June 2019 as a branded specialty pharmaceutical company with a mission to address critical gaps in patient care by challenging treatment paradigms, product safety and efficacy limitations, access and adherence hurdles, to deliver better patient solutions. It is committed to creating value by developing robust in-house platforms, acquiring or in-licensing differentiated products and nuanced commercialization, that address the needs of patients and caregivers. Central to Scienture, LLC’s vision is its well thought out and diverse product pipeline under development, which spans multiple therapeutic areas, indications, and market segments. Its agile commercialization model and capabilities in sales and marketing, ensures flexibility and broad reach in delivering impactful results. Executing and supporting this comprehensive vision are its founding and executive management teams and strategic partners, who have several years of industry experience and an impeccable track record of building and growing successful companies.

Key Accomplishments to Date

Through Scienture, LLC, we have demonstrated a strong track record of success in the achievement of several key and critical milestones associated with product development, regulatory filings and approvals, proprietary intellectual property filings, business development activities and structuring commercial operations and go to market infrastructure.

Product Development

No.	Item	Accomplishments
1.	SCN-102 (ArbliTM)	Completed all development activities and the filing and receiving final approval of the NDA from the FDA Finalized contract with strategic partner for the manufacturing and commercial supply of finished product. Filed three (3) Intellectual Property filings resulting in two (2) granted patents and one (1) patent application pending, which provide coverage till 2041 in the US market. The patents are eligible for listing in the FDA Orangebook.
2.	SCN-104	Devised an innovative product strategy for an injectable pen formulation and device to treat migraine patients Successfully completed all initial development activities and initial meeting with the FDA to finalize regulatory pathway for approval. Contracted with strategic partner based in US, Germany and Canada for all development and manufacturing activities, inclusive of pen device and cartridge filling. Continued product development, paving the way for targeting registration NDA batches for the product in 2025 and potential NDA filing in 2026. Filed Intellectual Property applications and work is ongoing to facilitate patent issuance.
3.	SCN-106	Identified and initiated development activities on a value added biosimilar product in the CVS therapeutic area. Successfully contracted with a strategic partner with accomplished biologics development and manufacturing capabilities based in India for the development and manufacturing of the product. Completed successful FDA meetings for the determination of next steps of development and the full pathway to BLA approval. Continue to lead the execution of the product in 2025 and beyond to accomplish potential BLA filing in 2028.
4.	SCN-107	Established an innovative product concept and development program for the non-opioid management of post-surgical pain, offering significant value to patients and caregivers. Structured a strategic collaboration with an EU-based partner for leveraging using novel, unique polymers and microsphere processing technologies. Completed successful FDA meetings for next steps of development and to formalize full development pathway for NDA filing and approval. Successfully filed Intellectual Property applications and work is ongoing to facilitate patent issuance.

Business Development

On March 4 of this year, Scienture, LLC executed a Definitive Agreement for the for the exclusive U.S. rights to commercially launch REZENOPY^® (naloxone HCl) Nasal Spray 10mg, an opioid antagonist that was approved by the FDA on April 19, 2024. REZENOPY^® is the most potent (highest strength) version of naloxone HCl available in the market. The product leverages the proven use of the active ingredient and form factor, with increased effectiveness against potent opioids. IQVIA data (MAT December 2024) indicates a total annual sales of $189 million, unit volume of $10.0 million (eaches) for Naloxone in the US market.

Commercial Operations

We have a robust and nimble commercial operations strategy and program to successfully launch Scienture, LLC’s commercial products, Arbli^TM and REZENOPY^®, in 2025 and other products in the future, as it continues to grow. Our experienced internal leadership and industry leading partners provide a strong platform across several key functional areas focused on driving market performance:

1. Field Operations, Virtual Promotion, Digital Marketing and CRM
2. Branding, Promotional Materials and Website Management
3. Payor Contracting and Market Access
4. Distribution and Logistics Provider; GTN and O2C mgmt.
5. Data Analytics and Market Intelligence
6. Broad Channel Access – Retail, Institutional and DTC
7. Government Contracting and Access
   

What’s Next

Over the next 12 months, we will be focused on:

• Successful launches of Scienture, LLC’s two (2) commercial products to obtain meaningful market share and providing a platform for growth and profitability. IQVIA data (December 2024) indicates a combined total annual sales of $481 million for Losartan ($292 million) and Naloxone ($189 million) in the US market.
• Continue to execute seamlessly on all our product development initiatives and drive relentlessly through to regulatory filings and approval
• Continue to leverage our deep industry networks to identify and close on potential revenue and margin opportunities through business development and licensing.
• Continue to empower and strategically enhance our workforce to deliver strong results

Why Us and Why does it matter

We are a holding company of a fully fitted specialty pharma company passionate about delivering innovative solutions across the healthcare landscape. Our unique model brings a confluence of talent, experience and a culture of success across product development, manufacturing, commercial operations and strategic partnerships. Even with the advent of ground-breaking technologies and treatment options, the pharmaceutical industry continues to face challenges in providing adequate care due to an aging population, rising healthcare expenditure, increasing prevalence of chronic diseases, stringent regulatory requirements and high development costs. Our value added approach to reinventing existing molecules through innovative technology provides elegant options to overcome these limitations. We seek to expand access and improve clinical outcomes through safe and efficacious products using targeted delivery mechanisms, which should enhance patient compliance and convenience and provide overall cost savings to the healthcare system. Scienture, LLC’s well thought out product pipeline continues to expand, starting with our near term and upcoming commercial launches. Scienture, LLC’s flexible and modular commercial model drives efficiency and synergies through all our operations while retaining its comprehensive go to market capabilities.

Final Thoughts

This year was about enhancing and building on the strong foundation that was laid for our company. The years ahead will involve focusing on the execution, growth and expansion of our differentiated capabilities to create value to patients, caregivers, healthcare system and our shareholders.

Thank you for your continued support as we endeavor on this journey of bringing meaningful products and innovation to the specialty pharma landscape.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiaries, including Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture, LLC are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit and www.scienture.com.

Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under 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 of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements 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. Such 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, including for the products we may launch and the success those products may have in the marketplace. 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, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “seek,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

For more information, please contact:
IR@Scienture.com

FAQ

When will SCNX launch its two FDA-approved products?

Scienture Holdings plans to launch both ArbliTM and REZENOPY® in the second half of 2025.

What is the market size for SCNX's approved products?

The combined market opportunity is $481M annually, with Losartan at $292M and Naloxone at $189M (IQVIA data, December 2024).

How much did SCNX receive from the TRXaDE Inc. asset sale?

SCNX received $22.5 million from selling TRXaDE Inc. assets to Micro Merchant Systems in Q1 2024.

What is the patent protection period for SCNX's ArbliTM product?

ArbliTM has two granted patents and one pending application, providing coverage until 2041 in the US market.

When does SCNX expect to file the BLA for its SCN-106 biosimilar product?

SCNX plans to file the Biologics License Application (BLA) for SCN-106 in 2028.