New Risk • Aug 16
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$14m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (110% increase in shares outstanding). Revenue is less than US$1m (US$821k revenue). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$14m). Market cap is less than US$100m (US$18.6m market cap). New Risk • Aug 14
New major risk - Revenue and earnings growth Earnings have declined by 55% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 55% per year over the past 5 years. Shareholders have been substantially diluted in the past year (152% increase in shares outstanding). Revenue is less than US$1m (US$478k revenue). Minor Risk Market cap is less than US$100m (US$18.9m market cap). Announcement • Aug 13
Scienture Holdings Announces Commercial Launch and Fulfillment of Initial Purchase Orders of Rezenopy Nasal Spray 10 Mg Scienture Holdings, Inc. announced the commercial launch of REZENOPY (naloxone hydrochloride) Nasal Spray 10 mg, including the fulfillment of its first purchase orders to U.S. pharmaceutical wholesalers. REZENOPY is the highest-dose FDA-approved naloxone hydrochloride nasal spray available in the United States, delivering 10 mg of naloxone hydrochloride in a single-use nasal spray device for the emergency treatment of known or suspected opioid overdose. Built on the proven naloxone molecule and a familiar nasal spray delivery platform, REZENOPY is designed to provide an important treatment option for overdoses involving highly potent synthetic opioids. According to IQVIA data (MAT June 2026), the U.S. naloxone market generated approximately $143 million in annual sales across 9.8 million units, highlighting a substantial commercial opportunity for REZENOPY. To support the launch, Scienture has deployed a dedicated national sales team focused on driving adoption across hospitals, emergency medical services (EMS), rehabilitation centers, pharmacies, public health agencies, and other key healthcare providers. REZENOPY is further supported by recently announced commercial payer coverage representing the potential to reach more than 100 million covered lives, as well as Group Purchasing Organization (GPO) agreements providing commercial access to more than 5,000 healthcare facilities, representing the potential to penetrate more than 60% of the U.S. institutional naloxone market. As previously disclosed, Scienture, LLC, a wholly-owned subsidiary of Scienture Holdings, Inc., entered into a definitive agreement with Summit Biosciences Inc. (a Kindeva subsidiary) in March 2025, for the exclusive U.S. commercialization rights to REZENOPY (naloxone hydrochloride) Nasal Spray 10 mg, which received FDA approval on April 19, 2024. REZENOPY (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 nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device. Administration: REZENOPY nasal spray is for intranasal use only. Seek emergency medical care immediately after use. Administer a single spray into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Do not administer more than 2 sprays per day. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. 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. Storage and Handling: Store REZENOPY nasal spray in the blister and cartons provided. Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light. REZENOPY nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY nasal spray is frozen and is needed in an emergency, do NOT wait for it to thaw; get emergency medical help right away.