Bupropion Hydrochloride/Naltrexone Hydrochloride

OSLO, Norway, April 30, 2025 /PRNewswire/ -- In the first quarter of 2025, Navamedic ASA (OSE: NAVA) , a Nordic pharma company and trusted supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies, reported revenues of NOK 132.0 million, representing a 9.2 per cent increase from the same period in 2024. EBITDA reached NOK 12.8 million, up from NOK 8.5 million last year. Gross margin improved to 40.7per cent, compared to 38.7per cent in Q1 2024. The strong performance was primarily driven by the Hospital area, particularly the antibiotics portfolio, supported by two long-term Nordic tenders secured in 2024. The company also experienced double-digit revenue growth in its Prescription Drugs (RX) area, contributing to the overall growth. "After investing in several strategic growth initiatives last year, we are pleased to see strong results already in the first quarter of 2025. The positive impact of the Nordic tender wins for our antibiotics portfolio has just begun to materialize. In addition, several products, including Mysimba® and Imdur® from our Prescription Drugs (RX) segment, delivered strong performance in the quarter," said Kathrine Gamborg Andreassen, CEO of Navamedic. "We are also pleased to announce the renewal of our agreement with TopRidge Pharma, securing the exclusive rights to market and sell Imdur® for another eight years. Over the past few years, we have systematically expanded and matured our product portfolio while investing in initiatives to drive future growth. The strong start to 2025 confirms the progress we are making," she added. Business area update and Q1 key figures During the first quarter, the Prescription Drugs (up 11.5 per cent YoY) and Hospital (up 15.2 per cent YoY) business areas delivered strong growth. Consumer Health had a steady development in the period (up 0.3 per cent YoY). As part of the Prescription Drugs area, revenues of Mysimba® increased by 7.3 per cent YoY. During the quarter, the European Medicines Agency's Human Medicines Committee also announced its review of Mysimba®. It affirmed that the benefits continue to outweigh the risks for weight management in adults with obesity or overweight. Imdur® and Nitrolingual® performed well in the quarter and were up 54 per cent and 22 per cent, respectively. Flexilev®, the company's unique treatment for Parkinson's Disease, delivered sales growth of 13 per cent YoY. Forlax® had a revenue decrease of 45 per cent due increased competition. For the Hospital area, the two tender wins drove sales growth in the antibiotics portfolio, which is up 32 per cent YoY, whilst the Medical Nutrition portfolio maintained steady sales. The company's third business area, Consumer Health, delivered stable results. Revenues of Modifast were steady during Q1, whilst Absolut Torr (up 49 per cent YoY) and ThermaCare (up 8 per cent YoY) experienced strong growth. Eroxon® saw a 9 per cent decrease in revenues, which is explained by a stock build-up in Q1 2024. Operating results (EBIT) for the first quarter of 2025 amounted to NOK 9.1 million, compared to NOK 4.9 million in 2024. Operating costs ended at NOK 40.9 million, compared to NOK 38.3 million last year. Net financial items ended at negative NOK 11 million and profit before tax was negative NOK 1.8 million. Outlook Navamedic continues to see strong growth and new expansion opportunities and reiterates its mid-term ambition of building a NOK 1 billion revenue company. "We have had a strong start to 2025. We have several key hero products across our three business areas, many of which have the potential to succeed internationally. Part of our work moving forward will be to identify growth opportunities for these products to support future growth," Andreassen concluded. Presentation Navamedic will present the results for the first quarter of 2025 at 08.30 today. CEO Kathrine Gamborg Andreassen and CFO Lars Hjarrand will host the presentation, which will take place at Haakon VIIs gate 2 in Oslo. It will be webcast at the following link: Note: EBITDA and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section in the attached presentation. 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 Nordic pharmaceutical company dedicated to enhancing people's quality of life by being a reliable supplier of high-quality prescription, consumer health, and hospital products to hospitals and pharmacies. Our growing product portfolio has been carefully selected to meet current public health concerns, such as obesity, Parkinson's disease, antibiotics and metabolism, to empower people to live healthier and more fulfilling lives. What sets us apart is our deep-rooted commitment to understanding the needs and requirements of the countries where we are present. Our local insight and competence enable us to understand the specific needs of each country where we operate and ultimately to gain market access. This makes us a preferred partner for international companies expanding their footprint across the Nordics and Benelux regions, through either in-licensing or out-licensing. Navamedic has been listed on the Oslo Stock Exchange since 2006 (ticker: NAVA) and is headquartered in Oslo, Norway. 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. This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

At its latest meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use backed five new medicines. After failing to pass muster with England’s drug reimbursement watchdog earlier this month, Eli Lilly’s Alzheimer’s disease med Kisunla (donanemab) also got a rejection from EU regulators.European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against a marketing authorization for the drug’s use in early symptomatic Alzheimer’s disease. The agency argued that the benefits of the treatment “were not large enough” to outweigh the risk of potentially fatal events such as swelling and bleeding of the and brain, a side effect known as amyloid-related imaging abnormalities (ARIA).Lilly will seek a re-examination of the decision. The company hopes to “continue our discussions with the agency to bring donanemab to the millions of people across Europe suffering from this relentless, fatal disease,” EVP and president of Lilly International Ilya Yuffa said in a company statement Friday. The drugmaker “remains confident in the safety and effectiveness of donanemab,”   As Eisai and Biogen can attest, European regulators are cautious about the safety concerns of Alzheimer’s drugs. The partners’ Kisunla-rivaling Leqembi eventually won CHMP’s favor in February, albeit in a restricted patient population of those with mild Alzheimer’s-related cognitive impairment or dementia who carry one or no copies of the ApoE4 gene.The positive opinion there came after the regulator first denied the treatment, citing benefits that “do not counteract the risk of serious adverse events” such as ARIA. The ARIA safety risk is greater in those who have two copies of the ApoE4 gene. Over in England, NICE recently declined to recommend both of the Alzheimer’s drugs for coverage in the region’s National Health Service for the second time, despite both winning approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). The agency cited a review from an independent committee on additional clinical data that ultimately confirmed that the medicines “are not currently cost effective.”In the U.S., both Kisunla and Leqembi are FDA-approved with a black boxed warning label for ARIA risk. Meanwhile with CHMP, several other drugmakers such as Bristol Myers Squibb received good news. The committee issued a positive opinion on the company’s subcutaneous formulation of blockbuster oncology drug Opdivo, clearing the way for an EU approval. Seven drugs—including AstraZeneca’s Calequence, Johnson & Johnson’s Tremfya and Seqirus’ flu vaccine Flucelvax—won label extensions, while Incyte’s Pemazyre was not recommended for one.The committee also wrapped up its review of Orexigen Therapeutics’ Currax-partnered weight loss med Mysimba, which was being evaluated again due to concerns of potential long-term cardiovascular risks. While CHMP determined that the benefits of the drug outweigh the risks, the company must provide more information on long-term use through an ongoing study that should wrap up in 2028. Since the available data only shows that there are no safety concerns when Mysimba is used for up to 12 months, the committee warned that treatment should be stopped after one year if weight loss of at least 5% of initial body weight isn’t maintained, and that doctors should closely monitor a patient’s yearly progress on the med. The drug was first approved in Europe in 2015.