Trinitrate

OSLO, Norway, Feb. 15, 2024 /PRNewswire/ -- Navamedic ASA (OSE: NAVA) , a Nordic pharma company and reliable provider of high-quality products to hospitals and pharmacies, today announced its results for the fourth quarter and for the full year 2023. Revenues for the year was up 34 per cent to NOK 512 million, mainly by organic growth. For the first time all three product categories were above the NOK 100 million mark. The company's gross margin was 38.9 per cent for the year, down from 42.8 per cent in the year before. Adjusted EBITDA (EBITDA less acquisition cost) amounted to NOK 51.6 million, compared with NOK 51.7 million in 2022. Operating results (EBIT) amounted to NOK 23.6 million, compared to NOK 44.4 million in 2022. Operating costs were higher than in 2022, mostly due to continued investments in growth initiatives. Also included in the EBITDA is a negative contribution of 4.8 MNOK from the Sensidose business. "We are looking back at an eventful and transformative year. With the Sensidose acquisition, we gained a promising position in the market for treatment of Parkinson's Disease, and we renewed and secured new marketing and distribution agreements for several other high selling products, including Eroxon®, a clinically proven treatment of erectile dysfunction. Eroxon® was launched in Norway this week and will soon also be available in Sweden," said Kathrine Gamborg Andreassen, CEO of Navamedic. "Furthermore, in the fourth quarter 2023, we signed a term sheet with the Finnish pharmaceutical corporation Orion Pharma, which we are currently finalising into an agreement for a licensing and supply of Flexilev® and OraFID® in Europe, products that were acquired through Sensidose. In Sweden, Norway and Denmark, we will market and sell these products from our own proven platform," Andreassen added. Revenues in the fourth quarter of 2023 was NOK 125 million, up 8.1 percent from the same period last year. Gross margin was 36.5 per cent, down from 42.9 per cent, and Adjusted EBITDA was NOK 7.9 million, compared with NOK 15.7 million in the fourth quarter of 2022. Category update In the Consumer Health category, Modifast cemented its position with continued strong sales in Sweden, and Absolute Torr gained traction with a 54 per cent growth year-over-year in the fourth quarter. Further growth to be achieved through combination of consumer and pharmacy engagement, sale of unique and profitable products in home markets and out-licensing of own products elsewhere. The Hospital category saw double-digit growth year-over-year across the portfolio of antibiotics and medical nutrition products. It also renewed exclusive rights to Vitaflo's medical nutrition products across the Nordic for five more years. Winning new antibiotic tenders is core in the growth strategy, along with initiatives to expand and secure new marketing authorisations. The Prescription Drugs category had strong growth across various therapeutic areas, with continued high demand for Mysimba for obesity treatment, and strong sales of Imdur, Nitrolingual and Forlax. In this category, Navamedic is now preparing rollout of Flexilev with MyFID® and OraFID® in the Nordic countries and out-licensing in the rest of Europe. Outlook Navamedic sees continued strong growth and new expansion opportunities and reiterates its mid-term ambition of building a NOK 1 billion revenue company with a 15 per cent EBITDA margin. "We are building on a solid foundation. We will continue to strengthen our existing business by leveraging our highly scalable market access platform. We will explore opportunities for market expansion with own products and increase company value by acquiring and strengthening own products and brands while increasing gross margins through careful management of our product portfolio," Andreassen concluded. Navamedic will present the results for the fourth quarter and full year 2023 at 08.30 today. The presentation will take place at Dronning Eufemias Gate 16 in Oslo, and will be available to follow via webcast at the following link: Representatives from Navamedic's management team, CEO Kathrine Gamborg Andreassen and CFO Lars Hjarrand will host the presentation. EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the attached presentation on slide 23. For further information, please contact: Kathrine Gamborg Andreassen, CEO, Navamedic Mobile: +47 951 78 680 E-mail: [email protected] Lars Hjarrand, CFO, Navamedic Mobile: +47 917 62 842 E-mail: [email protected] About Navamedic Navamedic ASA is a full-service provider of high-quality healthcare products to hospitals and pharmacies. Navamedic meets the specific medical needs of patients and consumers by leveraging its highly scalable market access platform, leading category competence and local knowledge. Navamedic is present in all the Nordic countries, the Baltics and Benelux, with sales representation in the UK and Greece. Navamedic is headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange (ticker: NAVA). For more information, please visit Navamedic.com. This information is subject to the disclosure requirements pursuant to section 5 -12 of the Norwegian Securities Trading Act. The following files are available for download:

NASHVILLE, Tenn.--( BUSINESS WIRE )--Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today provided a corporate update. The Company previously announced that MELT-300 achieved the primary sedation endpoint in its Phase 2 Pivotal Efficacy and Safety Study in subjects undergoing cataract surgery. MELT‑300, a non-IV, non-opioid tablet that combines fixed doses of midazolam (3mg) and ketamine (50mg), is administered sublingually using Catalent Inc.’s proprietary fast‑dissolving Zydis® delivery technology to rapidly dissolve the tablet for absorption across the very thin sublingual mucosa. Melt Pharmaceuticals recently received a written response from the U.S. Food and Drug Administration (FDA) regarding its planned MELT-300 Phase 3 program. Based on the FDA’s response, Melt Pharmaceuticals expects to begin Phase 3 program activities, which will consist of a single pivotal study comparing MELT-300 to sublingual midazolam and placebo in subjects undergoing cataract surgery, in the first quarter of 2024. Additionally, Melt has now reached an agreement with and paid in full all the outstanding principal and accrued and unpaid interest under its loan facility with Harrow , Inc. (Nasdaq: HROW), Melt’s largest shareholder, through the issuance of shares of Melt’s Series B and Series B-1 Preferred Stock. Following this transaction, in addition to certain royalty rights, Harrow’s equity ownership percentage of Melt is approximately 47%. “ We are very pleased to have received a response from the FDA that supports the investment we are making in our proposed MELT‑300 Phase 3 program,” said Dr. Dillaha. “ This was the last step needed to finalize our program design, paving the way for the commencement of Phase 3 program activities in early 2024. Following the debt settlement with Harrow and our successful efforts to date to secure sufficient funding to commence the Phase 3 program, we can now focus on the advancement of our non-IV, non‑opioid MELT-300 product candidate, which we believe has the potential to revolutionize short‑duration procedural sedation for more than 100 million U.S. medical procedures, enhancing the surgical patient experience by providing greater comfort and reducing reliance on opioids.” About Melt Pharmaceuticals Melt Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing proprietary non-opioid, non-IV, sedation, and analgesia therapeutics for human medical procedures in the hospital, outpatient, and in-office settings. Melt intends to seek regulatory approval through the FDA’s 505(b)(2) regulatory pathway for its proprietary, patented small-molecule product candidates, where possible. Melt’s core intellectual property is the subject of multiple granted patents in North America, Europe, Asia, and the Middle East. Melt Pharmaceuticals, Inc. is a former subsidiary of Harrow, Inc. (Nasdaq: HROW) and was carved out as a separately managed business in 2019. To learn more about Melt, please visit their website, www.meltpharma.com .