COMMACK, NY, April 06, 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 developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, today provided an annual update from its Co-Chief Executive Officers, Narasimhan Mani and Shankar Hariharan, to its shareholders:

To Our Valued Shareholders,

This past year marked a pivotal period for Scienture, as we advanced our strategy to build a differentiated, branded specialty pharmaceutical platform. We are pleased to share this annual update and highlight the progress we have made in executing our mission to deliver innovative therapies that improve patient outcomes while creating long-term shareholder value.

Scienture is focused on the commercialization and development of branded pharmaceutical products that address unmet needs through improved disease management, convenience, and patient access. Our portfolio currently includes two FDA-approved products and three pipeline candidates targeting large and growing markets, including migraine, thrombosis, and post-operative pain.

2025 Operational Highlights

During the year, we achieved several key milestones that position the company for continued growth:

• Completed the strategic acquisition of REZENOPY^™ in March 2025
• Received FDA approval for Arbli^™, our first internally developed product, in March 2025
• Successfully commercially launched Arbli^™ in September 2025
  
  

Arbli™, the first and only FDA-approved liquid formulation of losartan for hypertension, has been successfully introduced to the market, positioning us to drive revenue growth into 2026 and beyond.

Looking ahead, we expect to launch REZENOPY^™ in the second quarter of 2026. As the highest-dose FDA-approved naloxone nasal spray for emergency treatment of opioid overdose, REZENOPY^™ is expected to expand our commercial portfolio and strengthen our revenue base.

We have built a scalable and established commercial infrastructure designed to support current and future product launches.

Commercial Execution and Market Traction

We are seeing encouraging early traction from the Arbli^™ launch in the approximately $241 million U.S. losartan market, which represents approximately 72 million annual prescriptions (IQVIA MAT December 2025). Our commercial strategy is focused on targeted engagement with high-value healthcare professionals who account for approximately 80% of prescription volume.

Key commercial capabilities for Arbli^™ include:

• Sales & Marketing: Field, virtual, and digital capabilities, with anticipated sales force expansion from 9 to 16 representatives in the second quarter of 2026
• Channel Access: Broad reach across retail, institutional, government, and direct-to-consumer channels
• Market Access: Established commercial insurance coverage and placement within major national formularies
• Distribution: Nationwide availability through full-line wholesalers
• Patient Support: Comprehensive hub services, co-pay assistance, and access programs
  
  

In preparation for the REZENOPY^™ launch, we have recently secured group purchasing organization (GPO) agreements, providing access to more than 5,000 healthcare facilities and approximately 60% of the U.S. institutional market. With a U.S. naloxone market of approximately $141 million and 9.4 million annual prescription units (IQVIA MAT January 2026), we believe REZENOPY^™ is well positioned to drive adoption and capture market share.

R&D Pipeline and Long-Term Growth Strategy

We are building a differentiated, capital-efficient R&D platform designed to support sustained long-term growth and value creation. Our strategy focuses on leveraging established regulatory pathways, targeting large addressable markets, and advancing product candidates with meaningful clinical and commercial potential. This approach is reflected in the following key initiatives:

• Leveraging efficient 505(b)(2) NDA and BLA regulatory pathways
• Partnering with leading organizations across development, manufacturing, and clinical operations
• SCN-102 (Migraine): NDA filing expected in the second half of 2027
• SCN-106 (Thrombosis): BLA filing expected in the second half of 2028
• Continued expansion of our intellectual property portfolio
  
  

In parallel, we are actively evaluating strategic acquisition opportunities to further expand our portfolio and enhance long-term growth.

2025 Financial Summary and Highlights Compared to 2024:

• Net revenue increased 216% year-over-year to $431,609 from $136,643, driven by the commercial launch of Arbli^™
• Gross Margin expanded over the previous year by 7,240 Basis Points to 76.8%
• Research and Development expenses decreased 13% year-over-year to $2.0 million
• As of December 31, 2025, the company had cash and cash equivalents of approximately $6.7 million and positive working capital of approximately $5.2 million
  
  

Net loss from continuing operations, net of tax, was approximately $41.5 million for the year ended December 31, 2025, compared to approximately $18.2 million in 2024. The increase was primarily driven by a one-time, non-cash impairment charge of $26.3 million recorded in 2025, with no comparable charge in the prior year. In addition, for the year ended December 31, 2024, income from discontinued operations, net of tax, was approximately $27.3 million, primarily from the gain on the sale of certain assets and the disposition of a former subsidiary in the first half of 2024.

Excluding the one-time, non-cash impairment charge, net loss from continuing operations, net of tax, improved to approximately $15.2 million, reflecting underlying operational progress. Adjusted EBITDA was approximately $(5.4) million in 2025, compared to approximately $17.8 million in 2024. This change reflects the company’s transition from a diversified operating model in 2024 to a focused specialty pharmaceutical business in 2025, with initial Arbli^™ revenues commencing in the third quarter and increased investment in commercial infrastructure.

Importantly, we maintained a disciplined approach to capital management throughout the year. We fully repaid legacy debt obligations, funded our working capital needs, and strengthened our balance sheet. As of year-end, the company had approximately $6.7 million in cash and positive working capital of approximately $5.2 million, providing an estimated 12-month runway to support ongoing operations and growth initiatives while preserving financial flexibility.

Nasdaq Compliance

As previously disclosed, the company has until April 13, 2026 to regain compliance with Nasdaq’s minimum bid price requirement. If we do not regain compliance during this initial compliance period, we may be eligible for an additional 180-calendar day compliance period, subject to maintaining compliance with all other applicable Nasdaq Capital Market listing standards. We believe we are well positioned to meet the requirements for this additional compliance period and intend to request the extension, if necessary. The Company remains focused on executing initiatives to support compliance; however, any such extension is subject to Nasdaq’s review and approval, and there can be no assurance that it will be granted.

2026 Outlook

We entered 2026 with a strong commercial platform, a focused product strategy, a solid scientific foundation, and an experienced leadership team. With key building blocks now in place, we believe Scienture is well positioned to drive continued innovation, improve patient outcomes, and deliver long-term shareholder value.

Over the next 12 months, we will focus on:

• Maximizing commercial performance by expanding market penetration of our existing products and broadening our portfolio
• Advancing our pipeline efficiently to achieve key clinical and regulatory milestones and bring new therapies to market
• Scaling our infrastructure to support sustainable, long-term growth
• Investing in our sales team, further strengthening our organization to drive execution and performance
  
  

Conclusion

Over the past year, we have made meaningful progress across both our commercial portfolio and research and development pipeline. Our commercial products have been well received by customers and stakeholders, and we are executing a clear strategy to drive adoption, expand market presence, and deepen engagement with healthcare providers and patients.

At the same time, we have continued to invest in our R&D engine, advancing a thoughtfully constructed pipeline across multiple therapeutic areas. Based on our analysis of market dynamics, patient needs, and the broader healthcare landscape, we believe our pipeline has the potential to address significant unmet medical needs while expanding our long-term revenue opportunities.

We remain committed to the highest standards of execution, transparency, and governance, and we appreciate your continued support as we advance our mission to deliver innovative therapies and drive long-term shareholder value.

Sincerely,
Co-Chief Executive Officers
Narasimhan Mani and Shankar Hariharan

Non-GAAP Financial Measures

In addition to our financial results determined in accordance with the generally accepted accounting principles in the United States (“GAAP”), our management uses earnings before interest, taxes, depreciation, and amortization expenses to net income (“EBITDA”), a non-GAAP measure, as a key measure in operating our business. We use adjusted EBITDA as a measure of our operating performance. Management believes that the non-GAAP measures used in this press release provide investors with important perspectives on the company’s ongoing business and financial performance and are helpful to provide investors with an understanding of our core operating results.

The non-GAAP financial measures disclosed by the company should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. Neither EBITDA nor adjusted EBITDA represents net income (loss) or cash flows provided by operating activities as determined in accordance with GAAP and should not be considered as alternative measures of profitability or liquidity. Our use of non-GAAP financial measures has certain limitations in that the non-GAAP financial measures we use may not be directly comparable to those reported by other companies due to potential differences in methods of calculation and items being excluded. A reconciliation is provided below for adjusted EBITDA to the most directly comparable financial measure presented in accordance with GAAP. Investors are encouraged to review the related GAAP financial measure and the reconciliation of adjusted EBITDA to its most directly comparable GAAP financial measure.

For the year ended December 31, 2025, adjusted EBITDA was $(5,384,274), compared to adjusted EBITDA of $17,820,898 for the year ended December 31, 2024. The decrease reflects the transition from a diversified operating business (which included asset-sale activities in 2024) to a focused specialty pharmaceutical company in 2025, with initial Arbli^™ revenues commencing in the third quarter of 2025 and higher operating costs associated with the build-out of commercialization infrastructure. Excluding the non-cash impairment charges of $26,346,050 recognized in 2025, adjusted EBITDA was $(5,384,274), reflecting the early-stage commercial nature of the business. The following table reconciles net loss from continuing operations to adjusted EBITDA for the years ended December 31, 2025 and 2024.

		Year Ended
		December 31,
		2025					2024
Net (loss) income		$	(41,512,264	)			$	9,065,798
Depreciation and amortization			491,781					53,361
Benefit for income taxes			1,994,878
Interest expense			4,083,206					1,335,631
Other non-operating expenses (income)			(3,166,906	)				2,742,230
Stock based compensation (non-cash)			6,378,981					4,623,878
Impairment loss			26,346,050					-
Adjusted EBITDA		$	(5,384,274	)			$	17,820,898

About Arbli^™

Arbli^™ 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^™ 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^™ provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, Arbli^™ provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. Arbli^™ has two issued patents from the USPTO, which are also listed in the FDA Orangebook.

Arbli^™ is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli^™ 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^™ 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^™ when pregnant. When pregnancy is detected, discontinue Arbli^™ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Arbli^™ 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^™ with aliskiren in patients with diabetes. Avoid use of aliskiren with Arbli^™ in patients with renal impairment (GFR <60 mL/min).
• Do not administer Arbli^™ in patients with severe hepatic impairment. Arbli^™ 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 www.fda.gov/medwatch, 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^™

REZENOPY^™ (naloxone HCl) 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^™ 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^™ (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^™ 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^™ 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: www.scientureholdings.com and www.scienture.com.

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, 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 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
Phone: (866) 468-6535
Email: IR@Scienture.com