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Ascendis Pharma A/S (NASDAQ: ASND) is a pioneering biotechnology company located at 12 Tuborg Blvd., Hellerup, Capital Region of Denmark, Denmark. Specializing in the development of prodrug therapies, Ascendis Pharma is leveraging its proprietary TransCon technology to create therapies with improved efficacy and safety profiles that address significant unmet medical needs. The company’s diverse product pipeline includes TransCon growth hormone, TransCon peptides, TransCon PTH, and TransCon CNP, among others.
Ascendis Pharma operates across North America, China, and Europe, with the majority of its revenue derived from North American markets. The firm’s flagship product, SKYTROFA, has become the leading growth hormone product by value in the U.S. Ascendis is also rolling out YORVIPATH in Europe, starting with Germany and Austria. In addition, the company is advancing its clinical program for TransCon CNP.
In 2023, Ascendis undertook a significant restructuring to streamline its operations, processes, and expense allocations. President and CEO Jan Mikkelsen maintains that Ascendis is on track to achieve its ambitious Vision 3x3 and Vision 2030 goals, which include achieving blockbuster status for each of its three independent Endocrinology Rare Disease products and expanding its engine for future innovation.
Financially, Ascendis Pharma reported substantial revenue growth in 2023, with total revenue reaching €266.7 million compared to €51.2 million in 2022. This growth was primarily driven by higher SKYTROFA revenue and an upfront payment from Teijin. Research and development (R&D) expenses also increased to €413.5 million in 2023, reflecting ongoing development activities in their TransCon programs. Despite a net loss for the year, the company's financial health remains robust, with cash, cash equivalents, and marketable securities totaling €399.4 million as of December 31, 2023.
Looking ahead, Ascendis Pharma has several key milestones slated for 2024, including the expected commercial launch of TransCon PTH in the U.S. and advancing its oncology and ophthalmology programs. The company also plans to achieve operating cash flow breakeven on a quarterly basis by the end of the year.
Ascendis continues to focus on leveraging its TransCon technology to develop therapies that can make a meaningful difference in patients’ lives. Guided by its core values of Patients, Science, and Passion, Ascendis Pharma is committed to becoming a leading, fully integrated biopharma company.
Ascendis Pharma announced its full-year financial results for 2021, reporting total revenue of €7.8 million, an increase from €7.0 million in 2020. The company incurred a net loss of €383.6 million, or €7.00 per share, improving from €419.0 million, or €8.28 per share, in the prior year. With cash reserves of €789.6 million, Ascendis continues to advance its pipeline, including TransCon PTH, with Phase 3 results expected soon. The company remains optimistic about a strong 2022, driven by the success of SKYTROFA and a robust oncology pipeline.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on March 2, 2022 at 4:30 p.m. ET to discuss its 2021 financial results and provide a business update. Investors can join via the company’s website, where a replay will be available afterward. The company aims to build a leading biopharma firm using its TransCon technologies to deliver potentially best-in-class therapies. However, the release includes forward-looking statements that highlight substantial risks and uncertainties in achieving their operational goals.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 11th Annual SVB Leerink Global Healthcare Conference. The virtual fireside chat will take place on February 16, 2022, from 3:00 to 3:30 p.m. Eastern Time. A live webcast will be accessible through the Investors and News section on Ascendis Pharma's website, with a replay available for 30 days post-event. Ascendis Pharma focuses on innovative therapies through its TransCon technologies, aiming to enhance patient lives.
Ascendis Pharma announced that the European Commission has granted marketing authorization for TransCon hGH, branded as Lonapegsomatropin, aimed at treating pediatric patients aged 3 to 18 with growth hormone deficiency (GHD). This once-weekly injection offers a sustained release of somatropin, improving treatment adherence. The approval is based on positive results from the Phase 3 trials involving over 300 pediatric patients. The company plans to leverage this approval to enhance its market presence in Europe and develop further products for GHD.
Ascendis Pharma (Nasdaq: ASND) provided updates on its Vision 3x3 and upcoming milestones at the J.P. Morgan Healthcare Conference. CEO Jan Mikkelsen reported strong initial demand for SKYTROFA, the FDA-approved treatment for pediatric growth hormone deficiency, noting a 10% prescription rate among targeted prescribers. In 2022, the company anticipates significant clinical data readouts across its endocrinology and oncology pipeline, alongside the introduction of a third therapeutic area by year-end.
Ascendis Pharma A/S (Nasdaq: ASND) will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022. The event is virtual and begins at 3:00 p.m. Eastern Time. Company executives will provide updates on its pipeline programs and business overview. A live webcast will be available on the Ascendis Pharma website, with a replay accessible for 30 days following the event. This presentation highlights Ascendis' commitment to innovative therapies using its TransCon technologies.
Ascendis Pharma A/S (Nasdaq: ASND) announced significant updates on its investigational products during a virtual R&D Program Update. Key highlights include:
- Phase 3 topline results for TransCon PTH expected in Q1 2022, with NDA and MAA submissions planned for Q3 and Q4 2022, respectively.
- Enrollment completed in Phase 2 ACcomplisH Trial for TransCon CNP, with promising preliminary data guiding dose selection for future trials.
- Early clinical activity observed in cancer patients treated with TransCon TLR7/8 Agonist, indicating potential for further development.
Ascendis Pharma A/S (Nasdaq: ASND) will host a virtual R&D Program Update on December 14, 2021, from 9:00 a.m. to 11:30 a.m. Eastern Time. The event will provide updates on the company's endocrinology rare disease programs and its oncology product, TransCon TLR7/8 Agonist. Key speakers include senior management and Dr. Aliya Khan, a recognized expert in parathyroid disease. Investors can access the live webcast on the company's website, with a replay available for 30 days afterward.
Ascendis Pharma (ASND) announced encouraging results from Week 84 of its Phase 2 PaTH Forward Trial for TransCon PTH, an investigational treatment for hypoparathyroidism. The trial observed that 58 out of 59 participants remained in the study, with stable mean serum calcium levels and most participants free from active vitamin D supplementation. TransCon PTH was well-tolerated, with no serious treatment-related adverse events reported. The company expects to release Phase 3 data in Q1 2022, with plans for a potential New Drug Application (NDA) submission if results are positive.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Evercore ISI 4th Annual HealthCONx Conference, scheduled for December 1, 2021. The event is set to be held virtually, with company executives participating in a fireside chat from 3:55 to 4:15 p.m. Eastern Time. A live audio webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma focuses on innovating therapies through its TransCon technologies, aiming to enhance patient outcomes.
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