SCIENTURE Issues Shareholder Letter Highlighting Sequential Revenue Growth, Two FDA-Approved Commercial Products, And Continued Progress Toward Profitability In 2027

(MENAFN- GlobeNewsWire - Nasdaq) Preliminary Unaudited Third Quarter Revenue Increased 256% Sequentially to Approximately $1.22 Million, Supported by Continued Arbli ^TM Growth and the Commercial Launch of REZENOPY ^TM

Two FDA-Approved Commercial Products Position Company for Continued Sequential Revenue Growth

High Gross Margins and Established Commercial Infrastructure Provide Operating Leverage Potential as Company Targets Profitability in 2027

COMMACK, NY, Oct. 22, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) (“Scienture”), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today issued the following letter to shareholders.

Key Commercial and Financial Achievements During the First Nine Months of 2026

• 256% Sequential Revenue Growth: Reported preliminary, unaudited third-quarter 2026 revenue of approximately $1.22 million, compared to $343,639 in the second quarter, reflecting accelerating commercial momentum following the launch of the Scienture's second commercial product.
  
• Successful Launch of Second FDA-Approved Product: Commercially launched REZENOPY^TM in August 2026, with initial wholesale shipments contributing to third-quarter revenue and establishing a second commercial revenue stream.
  
• 74% Sequential Increase in Arbli ^TM Wholesale Unit Sales: Continued to drive commercial adoption and increasing wholesale demand for Arbli^TM during the third quarter of 2026.
  
• Expanded Institutional Adoption: Secured formulary additions for Arbli^TM at more than ten (10) leading U.S. pediatric academic medical centers, strengthening the product's presence within important healthcare institutions.
  
• Expanded REZENOPY ^TM Distribution: Advanced commercialization through a strategic distribution partnership focused on addiction treatment centers, broadening the product's potential market reach.
  
• High Gross Margin Profile: Reported gross margins of approximately 97.7% in the second quarter of 2026, supporting the potential for meaningful operating leverage as revenue increases.
  
• Broad Commercial Market Access: REZENOPY^TM GPO agreements provide access to more than 5,000 healthcare facilities, with commercial payer and government access potentially reaching over 100 million covered lives, while Arbli^TM continues to expand its formulary placements and payer coverage, supporting broader adoption of both products.
  
• Strengthened Intellectual Property Portfolio: Secured U.S. patent protection for REZENOPY^TM extending into 2041, complementing Arbli^TM patent protection until 2041.

Dear Fellow Shareholders,

The first nine months of 2026 have marked a transformational period for Scienture as we transitioned into a multi-product commercial pharmaceutical company, accelerated revenue growth, and expanded the market presence of our two FDA-approved products. We believe these achievements have established a strong foundation for the next phase of our growth and represent meaningful progress toward our objective of achieving profitability in 2027.

Our preliminary, unaudited third-quarter 2026 revenue reached approximately $1.22 million, representing a 256% sequential increase over the second quarter. This performance was supported by continued commercial growth in Arbli^TM, including a 74% sequential increase in wholesale unit sales, alongside initial wholesale shipments of REZENOPY^TM following its August 2026 commercial launch.

Importantly, we believe this momentum is only beginning to reflect the commercial potential of our expanding product portfolio. We believe the continued commercial traction of Arbli^TM, combined with the early-stage commercialization of REZENOPY^TM, positions us well to deliver continued sequential revenue growth as both products scale.

Over the past several quarters, we have invested in establishing the commercial infrastructure necessary to support our products, including sales resources, wholesale distribution, institutional market access, and payer relationships. As revenue increases, we believe this existing infrastructure, combined with our historically high gross margins, provides an opportunity to meaningfully improve operating performance without a proportionate increase in expenses.

Building Momentum Across Two FDA-Approved Commercial Products

Arbli ^TM Continues to Expand Its Commercial Footprint

Arbli^TM (losartan potassium) Oral Suspension is the first and only FDA-approved, ready-to-use oral liquid formulation of losartan, addressing an established U.S. market representing approximately $218 million in annual sales and more than 73 million prescriptions, according to August 2026 IQVIA data.

This mature market has long been dominated by oral solid (tablet) formulations from generic manufacturers, with the original branded product (Cozaar) now largely genericized. The vast majority of prescriptions are tablets, leaving a meaningful underserved segment of patients, particularly elderly individuals, pediatric patients age six and older, and others with dysphagia or difficulty swallowing, who previously relied on inconsistent pharmacy compounding.

Arbli^TM addresses this unmet need through a standardized, FDA-approved oral liquid formulation that eliminates the variability associated with pharmacy compounding while offering flexible dosing, convenient room-temperature storage, and an approved 24-month shelf life. We believe these attributes provide meaningful advantages for physicians, patients, and healthcare institutions seeking consistent and convenient treatment options.

During the third quarter of 2026, Arbli^TM wholesale unit sales increased 74% sequentially, reflecting continued progress in expanding commercial demand. We have also secured the addition of Arbli^TM to the formularies of more than ten (10) leading U.S. pediatric academic medical centers, an important milestone in establishing the product within key institutional treatment settings.

We believe these developments provide a foundation for continued market share gains as we pursue additional formulary placements, broaden physician awareness, and expand patient access. Arbli^TM also benefits from U.S. patent protection extending into 2041, supporting its long-term commercial potential.

REZENOPY ^TM Establishes a Second Revenue Growth Opportunity

The commercial launch of REZENOPY^TM (naloxone hydrochloride) Nasal Spray 10 mg in August 2026 represented another important milestone in Scienture's evolution into a multi-product commercial pharmaceutical company.

According to IQVIA data (August 2026), the U.S. naloxone nasal spray market represents approximately $137 million in annual sales, with approximately 9 million units sold annually, has historically been led by lower-dose products, including Narcan® 4 mg, alongside other approved formulations and generic alternatives. The ongoing opioid crisis, particularly the prevalence of potent synthetic opioids such as fentanyl, continues to underscore the importance of access to opioid overdose reversal treatments.

REZENOPY^TM is the highest-dose FDA-approved naloxone nasal spray available in the United States, delivering 10 mg of naloxone in a single-use device for the emergency treatment of known or suspected opioid overdose. The product combines the established naloxone molecule and familiar nasal spray delivery method with a differentiated higher-dose formulation, providing an additional treatment option for healthcare providers and emergency responders.

Through our collaboration with Summit Biosciences, a subsidiary of Kindeva Drug Delivery, Scienture holds exclusive U.S. commercialization rights to REZENOPY^TM, supporting our strategy to establish a differentiated presence in the naloxone market.

Initial wholesale shipments contributed to our third-quarter revenue growth, and we are focused on expanding distribution and adoption through our strategic commercialization relationships, including channels serving addiction treatment centers and healthcare institutions.

As REZENOPY^TM progresses beyond its initial launch phase, we believe increasing market access and product adoption can support continued revenue growth alongside Arbli^TM. REZENOPY^TM also benefits from U.S. patent protection extending into 2041, supporting its long-term commercial potential.

High Gross Margins and Operating Leverage Support Our Path Toward Profitability

Beyond our commercial achievements, we view one of the most compelling aspects of Scienture's business model as the potential for significant operating leverage as revenue scales.

We believe we have made meaningful progress in improving our financial performance and operating cost structure. During the second quarter of 2026, operating expenses decreased approximately 41% to $3.0 million, compared to $5.2 million in the prior-year period. Our operating loss improved approximately 48% to $2.7 million, compared to $5.2 million in the second quarter of 2025, while net loss narrowed approximately 58% to $2.8 million, compared to $6.7 million in the prior-year period.

Importantly, we reported gross margins of approximately 97.7% during the second quarter of 2026, demonstrating the attractive economics of our commercial product portfolio. We believe these historically high gross margins, combined with continued revenue growth and disciplined expense management, provide an opportunity to further reduce operating losses as sales scale.

We have already established much of the commercial infrastructure required to support both products, including national sales resources, wholesale distribution relationships, and institutional market access. As sales volumes increase, we believe we can leverage these existing capabilities without a proportionate increase in operating expenses.

Our focus remains on maximizing the revenue potential of the commercial platform we have built while maintaining financial discipline. We believe the combination of accelerating revenue growth, high gross margins, and an improved operating cost structure positions Scienture to make meaningful progress toward our objective of achieving profitability in 2027.

Expanding Market Access and Strengthening Our Commercial Platform

A key component of our strategy has been establishing the distribution and market access capabilities necessary to support sustained commercial growth of both Arbli^TM and REZENOPY^TM.

For REZENOPY^TM, group purchasing organization (“GPO”) agreements provide access to more than 5,000 healthcare facilities, while commercial payer coverage and government access through CMS have the potential to reach more than 100 million covered lives.

Arbli^TM also continues to gain commercial traction, with wholesale unit sales increasing 74% sequentially in the third quarter. We secured additional formulary placements, expanded commercial access, and built on prior GPO and payer coverage wins, including expansions reaching approximately 12.5 million additional covered lives.

Together, these developments, supported by our national sales resources and wholesale distribution capabilities, strengthen our commercial platform. We believe this infrastructure will enable us to scale revenue more efficiently, improve operating leverage, and support our goal of achieving profitability in 2027.

Competitive Advantages Position Scienture for Continued Market Share Gains

We believe Scienture is well positioned to capture market share in established pharmaceutical markets through a combination of differentiated FDA-approved products, long-term intellectual property protection, and an established commercial infrastructure.

Our competitive advantage is built on three key strengths: differentiated 505(b)(2)-style formulations that address unmet patient needs within large, established markets; U.S. patent protection extending into 2041 for Arbli^TM and REZENOPY^TM; and a focused commercial platform encompassing national sales resources, GPO and payer relationships, wholesale distribution, institutional formulary access, and patient support capabilities.

Our strategy for increasing market share centers on expanding institutional and hospital formulary adoption, broadening payer coverage, strengthening physician engagement, and increasing product utilization across retail and institutional channels. We believe these initiatives will help drive continued sequential sales growth while leveraging our existing commercial infrastructure.

Importantly, both products address established markets with meaningful opportunities for penetration. Even modest market share gains within the approximately $218 million U.S. losartan market, combined with increasing adoption in the approximately $137million naloxone nasal spray market, could translate into meaningful incremental revenue. Given our historically high gross margins, we believe these opportunities can contribute significantly to improving operating performance as sales scale.

Early commercial results, including the 74% sequential increase in Arbli^TM wholesale unit sales and initial REZENOPY^TM revenue contributions, reinforce our confidence in this strategy.

Looking Ahead: Continued Revenue Growth and Profitability in 2027

As we move through the remainder of 2026 and into 2027, our priorities remain centered on accelerating revenue growth, expanding commercial adoption, and improving operating performance.

For Arbli^TM, we intend to build on recent institutional formulary wins, broaden physician engagement, and increase patient access across pediatric and cardiovascular treatment settings.

For REZENOPY^TM, our focus is on expanding distribution, increasing institutional and treatment-center adoption, and building upon the initial commercial revenue generated following its launch.

We believe the combination of these initiatives positions Scienture to sustain sequential revenue growth as both products continue to scale. Our historically high gross margins and established commercial infrastructure provide the potential for meaningful operating leverage as sales increase, supporting our objective of achieving profitability in 2027.

Positioned for the Next Phase of Growth

Scienture today is a fundamentally different company than it was at the beginning of 2026. We have two FDA-approved products generating commercial revenue, expanding institutional adoption, established distribution and market access capabilities, and a high-margin business model designed to benefit from increasing sales volumes.

We believe the next phase of our growth will be defined by our ability to translate these commercial achievements into sustained revenue growth, improving financial performance, and ultimately profitability.

While meaningful work remains ahead, we are encouraged by the progress we have made and confident in the opportunities before us. Our focus remains on disciplined execution, responsible capital allocation, and building a sustainable specialty pharmaceutical company capable of delivering long-term shareholder value.

We thank our shareholders for their continued confidence and support and look forward to providing additional updates as we advance our commercial and financial objectives.

Sincerely,

Narasimhan Mani
President and Co-Chief Executive Officer

Shankar Hariharan
Executive Chairman and Co-Chief Executive Officer

About Arbli ^TM

Arbli^TM is a novel proprietary formulation of losartan, a widely prescribed angiotensin receptor blocker (ARB) for hypertension. It is the first and only 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. Arbli^TM is FDA-approved for the treatment of hypertension in patients greater than six years old, for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for treating diabetic nephropathy in certain patients with type 2 diabetes. By offering a safe, effective, and convenient liquid alternative, Arbli^TM provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, Arbli^TM provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. Arbli^TM has two issued patents from the USPTO, which are also listed in the FDA Orangebook.

Arbli^TM is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli^TM comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration and has been approved for a shelf life of 24 months from the date of manufacture when stored at room temperature.

INDICATION

Arbli^TM is an angiotensin II receptor blocker (ARB) indicated for:

• Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  
• Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
  
• Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
  

IMPORTANT SAFETY INFORMATION

• Do not take Arbli ^TM when pregnant. When pregnancy is detected, discontinue Arbli ^TM as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Arbli^TM can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
  
• Do not co-administer Arbli^TM with aliskiren in patients with diabetes. Avoid use of aliskiren with Arbli^TM in patients with renal impairment (GFR <60 mL/min).
  
• Do not administer Arbli^TM in patients with severe hepatic impairment. Arbli^TM has not been studied in patients with severe hepatic impairment.
  
• The most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.
  

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.

Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.

About Hypertension

Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or approximately 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. 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.

About REZENOPY ^TM

REZENOPY^TM (naloxone hydrochloride) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.

REZENOPY^TM nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.

IMPORTANT SAFETY INFORMATION

REZENOPY^TM (naloxone hydrochloride) Nasal Spray 10 mg is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present and is not a substitute for emergency medical care.

Important Safety Information

• Contraindications: REZENOPY^TM nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
  
• Warnings and Precautions:
  
  • Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
    
  • Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
    
  • Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
    
  • Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
    
• Adverse Reactions: The following adverse reactions were observed in a REZENOPY^TM nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.
  

For complete product information, including Patient Information, please refer to the full Prescribing Information.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), through its wholly owned subsidiary, 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 are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: and .

Cautionary Statements Regarding 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, the success those products may have in the marketplace, such as Arbli^TM and REZENOPY^TM, and our strategies related to those products. 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,” 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 Stock Market LLC; 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, as amended, and subsequent reports filed with the Securities and Exchange Commission.

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.

Contact:

SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
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