Latest news with #PrixGalienAward


Business Upturn
12-08-2025
- Health
- Business Upturn
TRYVIO nominated for the 2025 Prix Galien USA 'Best Pharmaceutical Product'
Allschwil, Switzerland – August 12, 2025 Idorsia Ltd (SIX: IDIA) announced today that The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, has nominated TRYVIO™ (aprocitentan) in the category of 'Best Pharmaceutical Product' in the 2025 Prix Galien USA awards. The winner will be announced during the Prix Galien USA Awards Ceremony on October 30, 2025. To qualify for the Prix Galien Award, each candidate must be US Food and Drug Administration (FDA) approved for marketing within the last five years and demonstrate tremendous potential to improve human health. Advertisement TRYVIO, the first systemic hypertension treatment to target a new pathway in over 30 years, is a dual endothelin receptor antagonist (ERA) indicated for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Martine Clozel, MD, Chief Scientific Officer and Head of Research atf Idorsia, commented: 'We are very proud to have been nominated for this prestigious award. TRYVIO is unique in many aspects. It is the result of many years of work on the endothelin pathway and represents a true therapeutic breakthrough with impressive clinical data. TRYVIO's blood pressure lowering effect was consistent in all studied subgroups of patients, and notably those whose hypertension is notoriously difficult to treat, such as African Americans, elderly patients, and patients with obesity or diabetes. These patients sometimes remain hypertensive despite two, three, or more anti-hypertensive therapies. Plus, TRYVIO provides significant blood pressure lowering for patients with hypertension and chronic kidney disease, a condition affecting millions of patients who are often underserved with the current guideline directed therapies, without risking aggravation of renal function or hyperkalemia.' Despite progress in improving patient outcomes, hypertension remains a major global health issue, and the number one modifiable risk factor of early morbidity/mortality, affecting an estimated 50% of adults in the US alone, with 50% of those patients not well controlled despite being on medication. These patients face significantly higher risks of cardiovascular events, including heart attack, stroke and kidney failure, and have a markedly increased risk of premature mortality compared to those with controlled blood pressure. Difficult-to-control hypertension is defined as above-goal elevated blood pressure in a patient despite the concurrent use of multiple antihypertensive drug classes. About The Prix Galien Award The Prix Galien Award recognizes outstanding achievements in improving the global human condition through the development of innovative drugs and other treatments. The Prix Galien was created in 1970 in honor of Galien, the father of medical science and modern pharmacology. Worldwide, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research. For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Notes to the editor About aprocitentan Aprocitentan is Idorsia's once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO™ in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO™ for the treatment of resistant hypertension in combination with other antihypertensives in the European Union and the UK and marketing authorization applications are under review in Canada, and Switzerland. About Idorsia The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact: Investor & Media Relations Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 [email protected] – [email protected] – The above information contains certain 'forward-looking statements', relating to the company's business, which can be identified by the use of forward-looking terminology such as 'intend', 'estimates', 'believes', 'expects', 'may', 'are expected to', 'will', 'will continue', 'should', 'would be', 'seeks', 'pending' or 'anticipates' or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Yahoo
01-03-2025
- Business
- Yahoo
Butterfly Network Inc (BFLY) Q4 2024 Earnings Call Highlights: Strong Revenue Growth and ...
Revenue: $82.1 million for 2024, representing 25% growth. Q4 Revenue: $22.4 million, a 35% increase year-over-year. US Revenue: $14.5 million in Q4, up 32% year-over-year. International Revenue: $5.5 million in Q4, a 19% increase year-over-year. Product Revenue: $14.7 million in Q4, up 45% year-over-year. Software and Other Services Revenue: $7.6 million in Q4, a 20% increase year-over-year. Gross Profit: $13.7 million in Q4, a 45% increase year-over-year. Gross Margin: 61% in Q4, up from 57% in the prior year period. Adjusted EBITDA Loss: $38.9 million for 2024, a 42% improvement from 2023. Operating Expenses: 16% reduction for the full year 2024. Cash and Cash Equivalents: $92.8 million at year-end 2024. 2025 Revenue Guidance: $96 million to $100 million, approximately 20% growth. 2025 Adjusted EBITDA Loss Guidance: $37 million to $42 million. Warning! GuruFocus has detected 5 Warning Signs with BFLY. Release Date: February 28, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Butterfly Network Inc (NYSE:BFLY) reported a 25% increase in revenue for 2024, reaching $82.1 million, with a significant improvement in adjusted EBITDA by 42%. The launch of the iQ3 device was a commercial success, representing 50% of 2024 sales and receiving the prestigious Prix Galien Award. Butterfly Network Inc (NYSE:BFLY) expanded its international presence with EU MDR certification for iQ+ and iQ3, facilitating European and Asian market penetration. The company successfully raised $81.7 million in a follow-on offering, providing a financial bridge to cash flow independence. Butterfly Network Inc (NYSE:BFLY) is actively developing strategic partnerships, including five new partners in areas like neuroscience and generative AI, expected to contribute revenue in 2025. Despite revenue growth, Butterfly Network Inc (NYSE:BFLY) still reported an adjusted EBITDA loss of $38.9 million for 2024. The company faces ongoing challenges with higher production and warranty costs impacting gross margins. Butterfly Network Inc (NYSE:BFLY) has not yet included potential revenue from new initiatives like Octiv or HomeCare in its 2025 guidance, indicating uncertainty in these areas. The transition from pilot to commercial revenue in the HomeCare channel remains uncertain, with no specific timeline provided. The company is still awaiting the EU Commission's decision on the revocation process for lead exemption in piezoelectric handheld ultrasound devices, which could impact future operations. Q: Can you provide an update on your confidence level in reaching the $500 million revenue target set during the 2024 Investor Day? A: Joseph DeVivo, CEO, expressed strong confidence in reaching the target, highlighting that the company is on track with its growth initiatives. He emphasized the potential of the Octiv and HomeCare businesses to contribute significantly to future growth, noting that Octiv's pipeline is expanding with larger partners, and the HomeCare business is proving its model with promising pilot results. Q: What steps are required to transition the HomeCare pilot into a revenue-generating franchise, and what timelines can you share? A: Joseph DeVivo explained that the transition involves training partner staff rather than hiring new personnel, which accelerates the process. The pilot is designed for 200 patients, and the company is seeing positive results. The scalability of the model, using telemedicine and remote follow-up, suggests a promising future for commercial opportunities. Q: Can you provide an update on the development of the wearable ultrasound device and its potential market impact? A: Joseph DeVivo stated that the wearable device is in active development, but the focus is on building the use case first. As the HomeCare business gains traction, the wearable will be introduced to meet the demand. The strategy is to develop the market and user base before launching the device. Q: How does the FY25 guidance account for new revenue streams like Octiv and HomeCare? A: Heather Getz, CFO, clarified that the guidance includes existing Octiv contracts but excludes new contracts or revenue from HomeCare and other new business initiatives. The guidance focuses on traditional revenue streams from iQ+ and iQ3 devices and existing software and services. Q: What evidence supports the claim that Butterfly's image quality is as good as competitors'? A: Joseph DeVivo explained that the iQ3 has closed the gap in image quality with other handheld devices, as evidenced by internal surveys and market feedback. The iQ3 is now part of the conversation among top devices, with users expressing preferences for its image quality, which was not the case before. 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