Q1 2026 Financial Highlights Compared to Q1 2025:
- Revenue increased to approximately
$56 thousand for the three months endedMarch 31, 2026 , compared to approximately$10 thousand in the prior-year three-month period, representing an increase of approximately 449% year-over-year, reflecting incremental product orders for ArbliTM in addition to the initial launch quantities ordered in the fourth quarter of 2025 - Gross profit increased substantially to approximately
$54 thousand , compared to approximately$673 in the prior-year three-month period, representing an increase of approximately 7900% year-over-year, primarily as a result of the increase in ArbliTM product orders - Gross margin expanded to approximately 95.6% for the three months ended
March 31, 2026 , compared to approximately 6.6% in the prior-year three-month period, also as a result of the increase in ArbliTM product orders
Key Operational Highlights in Q1 2026 and Subsequent Events:
- United States Patent and Trademark Office (USPTO) granted a third patent covering ArbliTM (losartan potassium) oral suspension, further strengthening the product’s intellectual property portfolio and extending expected market exclusivity through 2041
- Received an Orange Book-listable patent for REZENOPYTM (naloxone HCl) nasal spray 10 mg, the highest-dose FDA-approved naloxone HCl nasal spray for emergency opioid overdose treatment
- Formalized multiple commercial GPO agreements for REZENOPYTM, expanding access to over 5,000 healthcare institutions and reaching approximately 60% of the
U.S. institutional market, including first responders, EMS providers, and rehabilitation centers - Secured
$11.0 Million in non-dilutive debt financing to accelerate growth of approved product portfolio and advancement of R&D pipeline
“During the quarter, we experienced continued month-over-month growth in both prescriptions and units sold for ArbliTM. We are actively working to enhance our promotional and commercial activities around the product to further increase physician awareness and market penetration. We also continue to advance key commercial initiatives to support the planned launch of REZENOPYTM. Our sales force is scheduled to begin operations on
“In addition, we recently secured
Q1 2026 Financial Summary
Revenue for the year three months ended
Total operating expenses remained relatively consistent at approximately
About ArbliTM
ArbliTM 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. ArbliTM 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, ArbliTM provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, ArbliTM provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. ArbliTM has two issued patents from the USPTO, which are also listed in the FDA Orangebook.
ArbliTM is the first and only oral liquid formulation of losartan approved by the
INDICATION
ArbliTM 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 ArbliTM when pregnant. When pregnancy is detected, discontinue ArbliTM as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ArbliTM 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 ArbliTM with aliskiren in patients with diabetes. Avoid use of aliskiren with ArbliTM in patients with renal impairment (GFR <60 mL/min).
- Do not administer ArbliTM in patients with severe hepatic impairment. ArbliTM 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
About REZENOPYTM
REZENOPYTM (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.
REZENOPYTM 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
REZENOPYTM (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: REZENOPYTM 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.
- 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.
- Adverse Reactions: The following adverse reactions were observed in a REZENOPYTM 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
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 ArbliTM and REZENOPYTM, 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
Forward-looking statements speak only as of the date they are made.
Contact:
Phone: (866) 468-6535
Email: IR@Scienture.com
Condensed Consolidated Balance Sheets
As of
(Unaudited)
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,542,754 | $ | 6,662,008 | ||||
| Accounts receivable, net | 722,545 | 731,328 | ||||||
| Inventory | 210,934 | 213,408 | ||||||
| Prepaid expenses | 250,427 | 262,278 | ||||||
| Deferred offering costs | 47,384 | 47,384 | ||||||
| Total current assets | 4,774,044 | 7,916,406 | ||||||
| Property, plant and equipment, net | 15,000 | 15,500 | ||||||
| Notes receivable | 5,000,000 | 5,000,000 | ||||||
| Interest receivable | 343,750 | 250,000 | ||||||
| Intangible assets, net | 70,519,218 | 70,973,064 | ||||||
| Operating lease right-of-use assets | 9,693 | 23,360 | ||||||
| Total assets | $ | 80,661,705 | $ | 84,178,330 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,404,794 | $ | 1,443,266 | ||||
| Accrued liabilities | 703,872 | 657,034 | ||||||
| Operating lease liability - current | 10,004 | 24,137 | ||||||
| Warrant liability | - | 10,914 | ||||||
| Development agreement liability - current portion | 685,000 | 600,000 | ||||||
| Total current liabilities | 2,803,670 | 2,735,351 | ||||||
| Development agreement liability | - | 285,000 | ||||||
| Deferred tax liability | 11,037,595 | 11,037,595 | ||||||
| Total liabilities | 13,841,265 | 14,057,946 | ||||||
| Commitments and contingencies (Note 15) | ||||||||
| Stockholders’ equity: | ||||||||
| Series A preferred stock, | ||||||||
| and outstanding as of both | - | - | ||||||
| Series B preferred stock, | ||||||||
| and outstanding as of both | - | - | ||||||
| Series C preferred stock, | ||||||||
| outstanding as of both | - | - | ||||||
| Series X preferred stock, | ||||||||
| outstanding as of both | - | - | ||||||
| Common stock, | ||||||||
| shares issued and outstanding as of | ||||||||
| 1,015,000 and 1,015,000 shares unvested as of | ||||||||
| respectively | 406 | 406 | ||||||
| Additional paid-in capital | 150,773,535 | 150,671,215 | ||||||
| Accumulated deficit | (83,953,501 | ) | (80,551,237 | ) | ||||
| Total stockholders’ equity | 66,820,440 | 70,120,384 | ||||||
| Total liabilities and stockholders’ equity | $ | 80,661,705 | $ | 84,178,330 | ||||
Condensed Consolidated Statements of Operations
For the Three Months Ended
(Unaudited)
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Revenues | $ | 56,325 | $ | 10,258 | ||||
| Cost of sales | 2,475 | 9,585 | ||||||
| Gross profit | 53,850 | 673 | ||||||
| Operating expenses: | ||||||||
| Wage and salary expense | 420,008 | 696,068 | ||||||
| Professional fees | 932,552 | 412,850 | ||||||
| Accounting and legal expense | 326,178 | 470,825 | ||||||
| Technology expense | 15,763 | 61,620 | ||||||
| General and administrative | 1,074,864 | 1,355,948 | ||||||
| Research and development | 793,984 | 574,679 | ||||||
| Total operating expenses | 3,563,349 | 3,571,990 | ||||||
| Operating loss | (3,509,499 | ) | (3,571,317 | ) | ||||
| Non-operating income (expense): | ||||||||
| Change in fair value of warrant liability | 10,910 | 645,986 | ||||||
| Change in fair value of derivative liability | - | 603,322 | ||||||
| Loss on conversion of note payable | - | (96,646 | ) | |||||
| Interest income | 133,344 | 25,442 | ||||||
| Interest expense | (37,019 | ) | (670,784 | ) | ||||
| Total non-operating expense | 107,235 | 507,320 | ||||||
| Benefit (provision) for income taxes | - | - | ||||||
| Net loss | $ | (3,402,264 | ) | $ | (3,063,997 | ) | ||
| Net loss per common share | ||||||||
| Basic | $ | (0.08 | ) | $ | (0.33 | ) | ||
| Diluted | $ | (0.08 | ) | $ | (0.33 | ) | ||
| Weighted average common shares outstanding | ||||||||
| Basic | 40,630,815 | 9,425,751 | ||||||
| Diluted | 40,630,815 | 9,425,751 | ||||||
