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Zealand Pharma Announces Financial Results for the First Half of 2025
GlobeNewswire News Room· 2025-08-14 05:00
Core Insights - Zealand Pharma reported strong financial results for the first half of 2025, with revenue reaching DKK 9,096 million compared to DKK 49 million in the same period last year, indicating significant growth [4] - The collaboration with Roche on petrelintide is progressing well, with expectations for further updates at upcoming corporate events [6][7] - The company is well-positioned for future growth with key leadership appointments and a solid cash position of DKK 16,578 million as of June 30, 2025 [5][13] Financial Performance - Revenue for H1 2025 was DKK 9,096 million, a substantial increase from DKK 49 million in H1 2024 [4] - Operating expenses for H1 2025 were DKK 968 million, up from DKK 559 million in H1 2024, primarily due to increased R&D and transaction-related costs [4][5] - The operating result for H1 2025 was DKK 8,128 million, compared to a loss of DKK 524 million in H1 2024 [4] Collaboration and Development - Zealand Pharma's collaboration with Roche involves co-developing petrelintide, with a total deal consideration of USD 5.3 billion, including upfront cash payments of USD 1.65 billion [8] - The petrelintide program is advancing with Phase 2 trials progressing towards key milestones, and Roche is establishing a new manufacturing facility for obesity medicines [7] - Zealand Pharma submitted a Marketing Authorization Application for glepaglutide in June 2025, with potential regulatory approval expected in the first half of 2026 [9][22] Leadership and Strategic Direction - The company appointed Utpal Singh as Chief Scientific Officer and Steven Johnson as Chief Development Officer to enhance its innovation and development strategies [13] - Zealand Pharma is preparing for a Capital Markets Day in December 2025 to discuss future growth and strategies [17] Upcoming Milestones - Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-1 trial and complete the Phase 2 ZUPREME-2 trial with petrelintide in the first half of 2026 [13] - The company anticipates initiating a Phase 2 trial for dapiglutide in the second half of 2025 [12]
减重赛道全球前沿进展跟踪(一):Amylin布局正当时
KAIYUAN SECURITIES· 2025-08-04 01:10
Investment Rating - The industry investment rating is "Positive" (maintained) [2] Core Insights - The report highlights the significant potential of the amylin market, with major pharmaceutical companies making substantial investments in amylin molecules, indicating a strong growth trajectory [6][9] - Amylin products are showing promising early clinical data in terms of safety and weight loss efficacy, with specific examples demonstrating competitive advantages over existing treatments [7][22] - A dense pipeline of catalysts is expected in the next 6-12 months, with multiple companies set to release critical clinical trial data that could validate the product profiles of amylin candidates [8][29] Summary by Sections Recent Major BD Transactions - AbbVie and Roche have made significant investments in amylin molecules, with AbbVie paying an upfront fee of $350 million and potential milestone payments of up to $1.875 billion for Gubra's amylin molecule [6][17] - Roche has partnered with Zealand to develop petrelintide, with an upfront payment of $1.65 billion and milestone payments reaching $3.6 billion [6][17] Amylin Product Profile - Early data for amylin monotherapy shows excellent safety and weight loss results, with examples like Eli Lilly's Eloralintide demonstrating a maximum weight loss of 11.3% at 12 weeks [7][22] - The report notes that the majority of weight loss from Eloralintide is fat, with preclinical data showing up to 91% of weight loss being fat [23][28] Future Catalysts - A significant number of amylin pipeline data readouts are expected in the next 6-12 months, with major companies like Roche, Eli Lilly, and AstraZeneca anticipated to release phase 2 trial data [8][29] - Companies such as Viking, Structure, and others are also highlighted for their clinical trial progress in the amylin space [8][29] Investment Recommendations - The report recommends focusing on companies like Borui Pharmaceutical and Zhongsheng Pharmaceutical, which are expected to accelerate their presence in the amylin market [9][31] - Beneficiary companies include Viking, Structure, Metsera, and Jiuyuan Gene, which are positioned to gain from advancements in the amylin sector [9][31]
速递|Zealand GLP-1/GLP-2新药,28周减轻11.6%!
GLP1减重宝典· 2025-06-25 03:19
Core Viewpoint - Zealand Pharma A/S announced positive preliminary results for its GLP-1/GLP-2 dual receptor agonist dapiglutide in a Phase I b multi-dose escalation trial, showing significant weight loss without lifestyle interventions [1][4]. Group 1: Trial Results - In the dapiglutide treatment group, participants experienced an average weight loss of 11.6% over 28 weeks, compared to only 0.2% in the placebo group [1][4]. - The trial included 30 participants, predominantly male (approximately 93%), with a median age of 44.5 years and a median starting body mass index (BMI) of 28.8 kg/m² [4][5]. - The trial demonstrated good tolerability at the highest dose of 26 mg, with no severe or serious treatment-related adverse events reported [4][5]. Group 2: Adverse Events - Most adverse reactions were mild gastrointestinal symptoms, such as nausea and vomiting, with two participants withdrawing due to adverse reactions, one related to gastrointestinal discomfort [4][5]. - Injection site reactions were minimal and all were mild, consistent with the profile of similar incretin drugs in other trials [4][5]. Group 3: Drug Mechanism and Future Directions - Dapiglutide is designed to address obesity-related comorbidities driven by chronic low-grade inflammation, combining GLP-1 mediated weight control and GLP-2's improvement of gut barrier function [7]. - Zealand Pharma is advancing a range of differentiated GLP-1 related therapies, including the insulin analog petrelintide, as potential foundational treatments in the weight loss field [4][7]. Group 4: Study Design - The Phase I b trial was a single-center, randomized, double-blind, placebo-controlled study, enrolling participants with a BMI between 27.0 and 39.9 kg/m² [5][6]. - The first part of the trial included 54 participants across three dosage groups, with results indicating an additional weight loss of 8.3% in the dapiglutide group compared to placebo over 13 weeks [5].
速递|礼来最新胰淀素疗法减肥药,12周减重11%!
GLP1减重宝典· 2025-06-16 02:55
Core Viewpoint - Eli Lilly's experimental weight loss drug, eloralintide, shows promising results in initial studies with minimal side effects, indicating progress in the competitive weight loss treatment market [2][5]. Group 1: Drug Efficacy and Research - In a three-month trial, some participants lost over 11% of their body weight, with weight loss ranging from 2.6% to 11.3% [2][5]. - The study involved 100 participants who received different doses of eloralintide or a placebo, with gastrointestinal side effects being relatively mild [5]. - Approximately 10% of participants experienced diarrhea, and 8% reported vomiting, but detailed risk-benefit analysis by dosage was not provided [5]. Group 2: Market Context and Competition - The demand for more tolerable and convenient weight loss medications is increasing, prompting pharmaceutical companies to accelerate their efforts in this rapidly growing market [5]. - Eli Lilly's Zepbound and Novo Nordisk's Wegovy currently dominate the market, but new generation drugs are gaining attention [5]. - Roche and Zealand Pharma entered a $5.3 billion collaboration to develop petrelintide, which has shown early promise, while AbbVie has also invested in this sector [6]. Group 3: Future Developments - Eli Lilly is conducting single-agent tests of eloralintide and exploring its use in combination with Zepbound, similar to Novo Nordisk's approach with CagriSema [7]. - Eli Lilly has several promising next-generation products in late-stage development, including an oral drug named orforglipron and a more potent experimental injectable [6].
“药王”易主!一季度司美格鲁肽大卖超80亿美元
Guo Ji Jin Rong Bao· 2025-05-16 11:59
Core Insights - Novo Nordisk's semaglutide has successfully claimed the title of "king of drugs" in Q1 2024, surpassing Merck's Keytruda in sales [2][3] - The success of semaglutide has sparked a research and development frenzy in the global weight loss market among multinational corporations (MNCs) [1][6] - The competitive landscape in the GLP-1 space is intensifying, particularly with Eli Lilly's strong performance and ongoing clinical trials [4][5] Sales Performance - In Q1 2024, Novo Nordisk's semaglutide products generated a total sales revenue of approximately $8.38 billion, with individual products Wegovy, Ozempic, and Rybelsus contributing $2.63 billion, $4.95 billion, and $0.86 billion respectively [2] - Merck's Keytruda reported Q1 sales of $7.2 billion, indicating that semaglutide has overtaken it in sales for the first time [2] Market Dynamics - Novo Nordisk has lowered its full-year performance outlook due to lower-than-expected penetration rates of its GLP-1 products in the U.S. market, despite achieving an 18% sales growth in Q1 [3] - Eli Lilly's GLP-1 products, Mounjaro and Zepbound, generated combined sales of $6.15 billion in Q1, indicating strong competition in the market [4] R&D Developments - Novo Nordisk is focusing on developing new formulations, with the oral version of Wegovy under FDA review, which could become the first oral GLP-1 treatment for long-term weight management if approved [5] - Pfizer has announced a commitment to weight loss drug development but faced setbacks with the termination of its oral GLP-1 drug Danuglipron due to safety concerns [6] CXO Industry Impact - The surge in GLP-1 research has positively impacted domestic CXO companies, with WuXi AppTec's TIDES business achieving a revenue of 5.8 billion yuan in 2023, a 70.1% increase year-on-year [7] - Notable growth has also been reported by Novotech Biopharma, with Q1 revenue of 566 million yuan, a 58.96% increase, and a projected annual revenue growth of nearly 60% for 2024 [7]
两个月内达成超50亿美元潜在规模交易,诺和诺德疯狂押注新一代减重疗法
Di Yi Cai Jing· 2025-05-14 13:40
Group 1 - Novo Nordisk's market value has decreased by over 50% from its peak a year ago, primarily due to competitive pressures from Eli Lilly's GLP-1 drug, tirzepatide, which has shown superior weight loss efficacy compared to semaglutide [1][3] - Novo Nordisk has made significant investments in weight loss therapies, including a recent collaboration with Septerna to develop oral small molecule drugs for obesity and type 2 diabetes, with a potential deal value of up to $2.2 billion, including a $200 million upfront payment [1][3] - In March, Novo Nordisk entered into a $1 billion licensing agreement with Lexicon Pharmaceuticals for a drug targeting obesity and related metabolic disorders, and also acquired global rights for a three-target agonist weight loss drug from China National Pharmaceutical for up to $2 billion [3] Group 2 - Both Novo Nordisk and Eli Lilly are focusing on next-generation weight loss drugs, including oral formulations, with Novo Nordisk emphasizing its historical innovation in obesity and diabetes treatment [3][4] - The U.S. regulatory agency has accepted Novo Nordisk's application for the oral version of semaglutide, which, if approved, will be the first oral GLP-1 weight loss therapy [4] - Novo Nordisk is also exploring digital health solutions for obesity management, recently partnering with Ping An Health Technology to create a comprehensive service model for obesity management and public health education [4]
Zealand Pharma announces closing of collaboration and license agreement with Roche
Globenewswire· 2025-05-09 04:25
Core Insights - Zealand Pharma has successfully closed a collaboration and license agreement with Roche, which is now effective following the satisfaction of all closing conditions, including regulatory requirements [1] - The partnership is aimed at advancing Zealand Pharma's vision in obesity management, with a focus on the potential of petrelintide to benefit individuals who are overweight or obese [2] Company Overview - Zealand Pharma A/S is a biotechnology company specializing in the discovery and development of peptide-based medicines, with over 10 drug candidates in clinical development, including two that have reached the market and three in late-stage development [3] - Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand Pharma also has a presence in the United States [4]
Zealand Pharma Announces Financial Results for the First Three Months of 2025
Globenewswire· 2025-05-08 05:00
Core Insights - Zealand Pharma has reported significant progress in its clinical pipeline and has established a transformative partnership with Roche for petrelintide, positioning the company for accelerated growth [1][3]. Financial Performance - For Q1 2025, Zealand Pharma reported revenue of DKK 8.1 million, a decrease from DKK 15.1 million in Q1 2024 [4]. - Operating expenses increased to DKK 393.1 million from DKK 266.3 million year-over-year [4]. - The operating result was a loss of DKK 385.5 million compared to a loss of DKK 255.8 million in the same quarter last year [4]. - The net financial items improved to DKK 70.3 million from DKK 25.8 million [4]. - The cash position as of March 31, 2025, was DKK 8,544.5 million, down from DKK 9,022.0 million at the end of 2024 [4]. Strategic Developments - Zealand Pharma entered a collaboration and license agreement with Roche to co-develop and co-commercialize petrelintide, sharing profits and losses on a 50/50 basis [4][5]. - The partnership aims to establish a leading amylin-based franchise for weight management and related indications [5]. - Zealand Pharma completed enrollment in the Phase 2 ZUPREME-1 trial for petrelintide three months after initiation [5][9]. Corporate Updates - Utpal Singh was appointed as Chief Scientific Officer to lead the next wave of innovative medicines [5][10]. - Steven R. Smith was appointed as Senior Global Medical Advisor in Obesity to support obesity research and clinical development programs [8]. Upcoming Milestones - Zealand Pharma expects to submit a Marketing Authorization Application for glepaglutide in the second half of 2025 and initiate a Phase 3 clinical trial [12]. - The company anticipates reporting topline results from the Phase 2 ZUPREME-1 trial in the first half of 2026 [14]. - Zealand Pharma plans to host a Capital Markets Day in London on December 11, 2025 [17]. Financial Guidance - The financial guidance for 2025 remains unchanged, with net operating expenses expected to be between DKK 2,000 million and DKK 2,500 million [18][19].
Inside the deal: Roche and Zealand Pharma's $5.3 billion obesity drug gambit
CNBC· 2025-05-02 05:19
Core Viewpoint - Roche has entered a $5.3 billion deal with Zealand Pharma to develop a new obesity treatment, petrelintide, aiming to compete in the growing obesity drug market dominated by Novo Nordisk and Eli Lilly [1][2]. Company Developments - The Roche-Zealand partnership will involve co-development and co-commercialization of petrelintide, with Zealand receiving $1.65 billion upfront and potential milestone payments up to $5.3 billion based on trial outcomes and sales [6][7]. - Zealand Pharma's stock surged by 38% on the announcement day, while Roche's shares increased by approximately 4% [7]. Product Insights - Petrelintide is an amylin analog, a new class of weight loss treatment that may offer comparable weight reduction to GLP-1 drugs but with better tolerability and preservation of lean muscle [3][4]. - Analysts project that petrelintide could achieve a 15-20% weight loss in phase 3 trials as a monotherapy, with Zealand calling it a potential "future backbone therapy" for weight management [5][6]. Competitive Landscape - The obesity drug market is becoming increasingly competitive, with Roche's deal positioning it against established players like Novo Nordisk and Eli Lilly, who are also advancing their own obesity treatments [15][16]. - Zealand's CEO indicated that the partnership with Roche could accelerate the timeline for bringing petrelintide to market, potentially ahead of competitors [14][17]. Strategic Fit - The collaboration was driven by a strong scientific and cultural alignment between Roche and Zealand, with both companies emphasizing the importance of a true partnership in the development process [12][9]. - Roche has been actively expanding its obesity treatment portfolio, including the acquisition of Carmot Therapeutics to enhance its capabilities in this area [10][11].