Latest news with #NikolajSorensen
Yahoo
07-05-2025
- Business
- Yahoo
Orexo AB (LTS:0H19) Q1 2025 Earnings Call Highlights: Navigating Challenges and Optimizing Growth
Q : Can you provide more details on the transition to the new device for OX124 and the timeline for this process? A : Nikolaj Sorensen, CEO: The transition to the new device for OX124 involves minimal changes, primarily in the handling of the device. We are starting the manufacturing switch now and do not anticipate major work. The timeline depends on FDA discussions, but we are using the delay in receiving the original device component to prepare for the new device. We expect minimal commercial implications and will update once we have FDA feedback. The company experienced a decline in volumes for its main product, Subsol, particularly due to high deductibles and Medicare policy changes. There are ongoing uncertainties with the FDA, causing delays in drug approvals and impacting timelines for product launches. The strengthening of the SEK against the US dollar negatively impacted the company's cash position. Orexo AB ( LTS:0H19 ) faced challenges due to changes in Medicare policies in the US, impacting volume and pricing. The company is optimistic about reaching a partnership agreement for OX640 later this year, which could enhance future growth prospects. Orexo AB ( LTS:0H19 ) has a natural hedge against currency fluctuations due to a significant portion of expenses being in US dollars. Orexo AB ( LTS:0H19 ) reported stable revenue in both SEK and US dollars compared to last year, with a slight increase driven by lower inventory decline. For the complete transcript of the earnings call, please refer to the full earnings call transcript. Financial Outlook for 2025: Subsol net sales expected between USD50 to USD55 million; Group EBITDA expected to be positive for the full year. Story continues Q: Is there any ongoing work for OX640, and what are the next steps for partnering? A: Nikolaj Sorensen, CEO: We are adjusting the manufacturing process for OX640 based on recent study results and preparing to upscale production. We aim to have a partner in place before starting full-scale manufacturing, as some partners may want more control over the supply chain. Discussions with potential partners are ongoing. Q: Can you elaborate on the market position of Suboxone and the reasons for the volume decline? A: Nikolaj Sorensen, CEO: The volume decline is mainly due to United Health Group's high deductibles and Humana's changes in Medicare policy. These factors have historically impacted Q1 volumes. Despite a slight market share decrease, our market position remains stable, and we expect volumes to recover in subsequent quarters. Q: How is the strategic overview of Orexo affected by market volatility, and what are the plans for potential partnerships? A: Nikolaj Sorensen, CEO: We are focusing on optimizing our R&D pipeline and exploring partnering strategies for Amorphox. While the market is volatile, we are not in a hurry to make strategic moves. We are open to discussions with companies interested in partnerships, but we are satisfied with our current US business performance. Q: What is the outlook for Orexo's financial performance and cash flow management? A: Fredrik Jarrsten, CFO: We have a stable financial position with a focus on cash flow optimization. Our US business is profitable, and we are continuously improving cost efficiency. We expect positive cash flow from operations and are comfortable with our working capital position. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
07-02-2025
- Business
- Yahoo
Orexo AB (ORXOY) Q4 2024 Earnings Call Highlights: Strong EBITDA and Strategic Wins Amid Challenges
Total Revenue: SEK160 million in Q4. Zubsolv Revenue: SEK152 million in Q4, slightly up year-over-year by approximately 1%. Group EBITDA: Positive at nearly SEK50 million for the full year; SEK29 million in Q4. Operating Expenses: SEK469 million for the full year, below the guidance of SEK530 million. Cash and Cash Equivalents: SEK123 million at the end of Q4, an increase of SEK8.4 million from Q3. OpEx Reduction: 12% reduction from last year, adjusted OpEx at SEK578 million for the full year. Net Sales Guidance for 2025: Expected between $50 million to $55 million. Market Growth Expectation for 2025: 2% to 5%. Adjusted EBIT: Positive SEK1.2 million in Q4. Parent Company Equity: SEK1,027 million as of December 31. Warning! GuruFocus has detected 4 Warning Signs with ORXOY. Release Date: February 06, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Orexo AB (ORXOY) achieved a full year positive EBITDA, significantly better than the previous year, primarily due to reduced operational expenses. Zubsolv revenues have stabilized after previous declines, maintaining similar levels to the same quarter last year. The company successfully resolved the litigation with Sun Pharmaceuticals, providing more certainty and strategic flexibility. OX640 showed promising clinical data, particularly in patients with allergic rhinitis, enhancing its potential market value. Orexo AB (ORXOY) has maintained strong market access for Zubsolv, with 98% coverage in the commercial segment. The launch of OX124 has been delayed due to supplier issues, creating uncertainty around its FDA resubmission timeline. The company had to impair the value of its digital assets, Vorvida and Deprexis, due to challenges in obtaining reimbursement and CMS guidelines. Legal expenses increased due to ongoing DOJ investigations and IP litigation, impacting overall costs. The digital health programs are not currently ready for FDA 510(k) registration, requiring additional investments. Zubsolv's market growth is challenged by changes in Medicare rebate systems and increased competition from generic products. Q: Can you provide a best and worst-case timeline for receiving the key component from the manufacturer for OX124, and how long after that will it take to resubmit to the FDA? A: The worst-case scenario for receiving the component is by summer, and the best case is early Q2. Once received, it could take more than six months to resubmit to the FDA, potentially by Q1 2026. However, there is high uncertainty due to supplier dependency. - Nikolaj Sorensen, CEO Q: How many feasibility deals do you have for AmorphOX, and when might they reach a go/no-go decision? A: We have several feasibility deals, including one with Sobi at a go/no-go decision stage. The decision is with Sobi, and we continue to deliver data. We also have a collaborative project with Abera, funded by external grants, expecting results in the first half of the year. - Nikolaj Sorensen, CEO Q: How will costs be affected in 2025 following the discontinuation of Deprexis and the write-down of Vorvida? A: The impact on OpEx will be significant due to reduced depreciation of assets. However, net costs were not substantial, around SEK5 million to SEK6 million, mainly related to in-licensing costs. - Nikolaj Sorensen, CEO Q: Why haven't you fully terminated the collaboration with GAIA over Vorvida? A: We are discussing with GAIA the best way to proceed with Vorvida, as there are ongoing opportunities, such as within Veteran Affairs. A collaborative approach is preferred to optimize product opportunities. - Nikolaj Sorensen, CEO Q: Have you noticed any signs from the new US administration that might affect your business? A: Currently, there is no major impact on Zubsolv from the new administration. However, discussions around fentanyl suggest continued support for access to rescue medications and treatment, which could be beneficial. - Nikolaj Sorensen, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
