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Yahoo
10-04-2025
- Health
- Yahoo
AAN 2025: Lundbeck highlights sustained efficacy of Vyepti for migraine prevention
On 9 April, at the American Academy of Neurology (AAN) 2025 annual meeting, three posters highlighting the sustained long-term efficacy and real-world impact of Lundbeck's anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) Vyepti (eptinezumab) for migraine prevention were presented. Vyepti was approved by the FDA for the prevention of migraine in adults in 2020. As the last of the anti-CGRP mAbs to enter the migraine market, Vyepti has seen moderate uptake since its approval, with the majority of key opinion leaders (KOLs) previously interviewed by GlobalData indicating that one of the subcutaneously administered anti-CGRP mAbs would be their first choice, highlighting the intravenous administration of Vyepti as a logistical challenge. The posters show that early response to Vyepti can be predictive of sustained treatment response, as well as highlighting meaningful benefits of Vyepti treatment. Post hoc analysis of the long-term, open-label Phase III PREVAIL (NCT02985398) study evaluating two-year safety and patient-reported outcomes with Vyepti in adults with chronic migraine was presented in a poster at AAN 2025. The analysis showed that the majority of the participants who achieved 50% or greater headache response or 75% or greater headache response in the first 12 weeks after receiving their first dose of Vyepti were able to maintain that level of response up to Week 84. Sustained treatment response was further demonstrated in another poster presenting post hoc analysis of data from the randomized, placebo-controlled Phase III DELIVER (NCT04418765) trial. In this study, patients had either chronic migraine or high-frequency episodic migraine, and they had failed to respond to two to four prior migraine preventive treatments. Up to 83% of patients who responded to Vyepti treatment within the first one to 24 weeks of the trial (i.e., having received the first two doses of Vyepti) were able to maintain that response over the 72-week trial. These analyses highlight that early treatment response with Vyepti may be able to predict long-term sustained treatment response. A third poster focused on patient-reported impact of Vyepti treatment in adults with chronic migraine. It presented a post hoc analysis of the impact of a 75% or greater increase in good days/month in patients treated with Vyepti from a real-world, observational, US-based study. Approximately two-thirds of the patients in the study reported a 75% or greater increase in good days/month, and this was correlated with higher satisfaction regarding the effects of Vyepti on migraine symptom severity, frequency, and duration; daily activities, such as being able to participate in social/family life, being productive, and ability to plan; and overall wellbeing when compared with patient with less than 75% increase in good days/month. Prior to treatment, the prevalence of brain fog was similar across the treatment response subgroups; however, following Vyepti treatment, 76.6% of the patients with a 75% or greater increase in good days/month reported moderate-to-complete improvement in brain fog, compared with 42.3% of patients with less than 75% increase in good days/month. These results highlight the meaningful benefits that patients experience following Vyepti treatment and will help Lundbeck with its focus on 'raising the bar around preventive treatment expectations in migraine.' Historically, migraine prevention has been managed with a wide variety of drug classes, such as beta-adrenergic receptor blockers, calcium antagonists, antidepressants, and anti-epileptics. However, many of these oral preventive treatments have been associated with poor side-effect profiles, and KOLs previously interviewed by GlobalData reported that low efficacy of oral preventive treatment was common among patients, meaning that patients often cycle through the different drug classes of oral preventive treatments. The first preventive therapies developed specifically for the treatment of migraine were the anti-CGRP mAbs, followed by the oral gepants; however, they are typically prescribed as second- or third-line options for many patients due to reimbursement restrictions requiring failure with the oral preventives before they can be prescribed. In the US, a 2024 statement was published by the American Headache Society recommending that the anti-CGRP mAbs and gepants should be used as first-line preventive options due to their superior efficacy and tolerability compared with the oral preventive options. Long-term sustained efficacy data and demonstration of meaningful benefit for patients, such as was presented for Vyepti at AAN 2025, are likely to further cement the case for first-line adoption of the anti-CGRP mAbs; however, given the comparative costs of the oral preventives and the mAbs, whether this recommendation will be implemented by insurance companies remains to be seen. Vyepti faces significant competition from three other anti-CGRP mAbs: Amgen's Aimovig (erenumab), Eli Lilly's Emgality (galcanezumab), and Teva's Ajovy (fremanezumab). Additional competition also comes from two orally administered gepants: Pfizer's Nurtec (rimegepant) and AbbVie's Qulipta (atogepant). KOLs agreed that the CGRP mAbs had similar efficacy profiles, with treatment choice often based on side effects, dosing schedule, or patient preference. As the only intravenously administered mAb, Vyepti may be at a disadvantage among patients who prefer to self-administer one of the other mAbs, and therefore highlighting the long-term efficacy, particularly with a focus on some of the patient-reported meaningful benefits, will be crucial in helping Vyepti to remain competitive in the migraine prevention market. "AAN 2025: Lundbeck highlights sustained efficacy of Vyepti for migraine prevention" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
06-02-2025
- Business
- Yahoo
H. Lundbeck AS (HLUBF) (FY 2024) Earnings Call Highlights: Record Revenue and Strategic Growth ...
Revenue: DKK22 billion, growing 14% at constant exchange rates. Adjusted Gross Margin: 88.4%, increasing 0.1 percentage points. Sales and Distribution Costs: Increased 10% to DKK8.1 billion. Administrative Expenses: Increased 11% to DKK1.4 billion. R&D Costs: Increased by 30% to DKK4.5 billion. Adjusted EBITDA: Increased by 20%, with a margin of 28.8%. EBIT: Increased by 15% to DKK3.3 billion. Net Financials: Income of DKK450 million, an increase of 322%. Effective Tax Rate: Dropped to 15.5% from 23.5%. Net Profit: Increased by 37% to DKK3.1 billion. Cash Flow from Operating Activities: Inflow of DKK3.3 billion. Net Debt: Increased to DKK12.2 billion. Net Debt-to-EBITDA Ratio: 2.4%. Vyepti Revenue: DKK2.909 billion, 72% growth year-on-year. Rexulti Revenue: Global revenue increased 16% in 2024. Brintellix Revenue: 14% growth to DKK4.847 billion. Abilify Franchise Revenue: Grew 10% to DKK3.5 billion. Warning! GuruFocus has detected 2 Warning Signs with HLUBF. Release Date: February 05, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. H. Lundbeck AS (HLUBF) reported a record revenue of DKK22 billion for 2024, marking a 14% growth at constant exchange rates. Strategic brands, including Rexulti and Vyepti, showed strong performance with a 21% growth, contributing significantly to the company's revenue. The company has a robust pipeline with late-stage developments, including the progression of bexicaserin and anti-PACAP programs. Vyepti's global net revenue grew by 72% year-on-year, with strong adoption in both the US and international markets. The company maintains a healthy financial dynamic with an adjusted EBITDA margin greater than 30%, despite increased R&D investments. H. Lundbeck AS (HLUBF) faced increased administrative expenses due to high legal provisions for ongoing litigations. R&D costs rose by 30%, reaching DKK4.5 billion, driven by investments in new programs and an impairment loss recognized in Q3 2024. The company anticipates generic competition for Brintellix in Canada and Abilify in Europe, which could impact future revenue. There was some destocking observed for both Rexulti and Vyepti, affecting inventory levels and potentially impacting short-term sales figures. The effective tax rate dropped significantly to 15.5%, which may not be sustainable in the long term, affecting future profitability. Q: Can you explain the recent dip in Vyepti's performance and any seasonal effects that might have influenced it? Also, how do you see the competitive dynamics in the major depressive disorder space affecting Rexulti and Brintellix in FY25? A: Charl Van Zyl, CEO, noted that fluctuations are normal, and the underlying trend for Vyepti remains solid, supporting confidence for 2025. Thomas Gibbs, EVP, added that Vyepti is the fastest-growing anti-CGRP, with December's performance being the highest all year. Regarding Rexulti, it has shown strong growth in MDD, and the competitive landscape is evolving with CAPLYTA's expected MDD indication in late 2025. The acquisition of intracellular by J&J is not expected to significantly change the competitive dynamics. Q: What is the status of recruitment for Amlenetug, and how do you plan to address potential challenges in patient recruitment? A: Johan Luthman, EVP of R&D, stated that the Phase II program for Amlenetug had strong recruitment, and they expect similar enthusiasm for Phase III. The trial is expanding to more sites and geographies, and there is significant interest from clinicians and patients, which should aid recruitment efforts. Q: Have you received any updates from the FDA regarding the AdCom for brexpiprazole in PTSD? A: Johan Luthman mentioned that the FDA has communicated the need for an AdCom, which is not routine but understandable given the lack of new treatments for PTSD in over two decades. The date for the AdCom and a potential new PDUFA date are yet to be set. Q: Could you provide more details on the destocking of Vyepti and Rexulti and its impact on Q4 results? A: Thomas Gibbs explained that inventory levels for both products were at the lower end of the normal range by the end of Q4, but they have since rebounded to normal levels in January. This destocking was a temporary fluctuation and not indicative of underlying demand. Q: What are your expectations for the tax rate in 2025, given the significant drop in 2024? A: Joerg Hornstein, CFO, stated that the tax rate for 2025 is expected to be in the range of 21% to 24%, aligning with historical levels. The drop in 2024 was due to a reversal of an uncertain tax position. Q: How do you plan to commercialize Vyepti in Asia, and will it involve a partner? A: Michala Fischer-Hansen, EVP, mentioned that they are exploring options for Vyepti's commercialization in Asia, which may include partnerships, depending on regulatory timelines and market dynamics. Q: Can you elaborate on the competitive landscape for MSA and the potential impact of new developments? A: Johan Luthman noted that while the MSA space is not crowded, recent developments, such as an oral agent showing promise, are being monitored. Lundbeck welcomes more activity in the space, as it can increase awareness and interest in MSA treatments. Q: What are the expected conversion rates for Abilify Maintena to the two-month formulation, and how do you see this impacting growth? A: Michala Fischer-Hansen stated that they expect a conversion rate of 20% to 25% from the one-month to the two-month formulation, with additional conversions from oral medications. This is expected to drive growth, particularly in the US and Europe. 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
