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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 A/S announced that the FDA accepted its BLA for TransCon hGH, a long-acting prodrug of human growth hormone for treating pediatric growth hormone deficiency (GHD). The PDUFA target date is set for June 25, 2021. Notably, the FDA is not planning to hold an Advisory Committee Meeting regarding this application. TransCon hGH aims to provide a once-weekly injection option, enhancing treatment for clinicians and children. The BLA is backed by results from eight clinical trials involving over 400 subjects. The investigational therapy has received orphan designation in both the U.S. and Europe.
Ascendis Pharma A/S (Nasdaq: ASND) announced two presentations related to its TransCon PTH program for adult hypoparathyroidism at the 22nd European Congress of Endocrinology (e-ECE) 2020. The phase 2 PaTH Forward Trial results showed that 82% of subjects were able to discontinue standard treatments after four weeks of TransCon PTH. The oral presentation is scheduled for September 8, 2020. TransCon PTH is designed as a long-acting hormone replacement therapy, addressing complications from the rare endocrine disorder HP, affecting about 200,000 patients globally.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the 2020 Wells Fargo Virtual Healthcare Conference on September 10, 2020, at 4:00 p.m. ET. The conference will showcase a business overview and updates on the company's pipeline programs, focusing on their innovative TransCon™ technologies aimed at addressing unmet medical needs. A live webcast will be available on the company’s website, with a replay accessible for 30 days post-event. Ascendis Pharma is actively developing therapies for rare endocrine diseases and expanding into oncology.
Ascendis Pharma A/S (Nasdaq: ASND) has submitted a Biologics License Application (BLA) for TransCon™ hGH to the FDA for pediatric growth hormone deficiency, with a European Marketing Authorisation Application (MAA) planned for Q3 2020 after EMA approval of the Pediatric Investigation Plan. New trial data showed TransCon PTH significantly improved quality of life for hypoparathyroidism patients. The company reported a Q2 2020 net loss of €94.9 million, a decline from €58.9 million in Q2 2019, with revenue decreasing to €1.4 million from €3.2 million. Cash reserves total €471.6 million.
Ascendis Pharma A/S (Nasdaq: ASND) announced a conference call on August 27, 2020, at 4:30 PM ET to discuss its Q2 2020 financial results and provide a business update. The live webcast will be accessible on the company’s website, with a replay available for 30 days post-event. Ascendis is focused on developing therapies using its TransCon™ technologies, currently advancing three endocrinology product candidates and expanding into oncology. The company emphasizes patient needs and scientific innovation in its mission.
Ascendis Pharma A/S (Nasdaq: ASND) announced that the European Commission has granted Orphan Designation to its investigational drug, TransCon C-Type Natriuretic Peptide (CNP), for treating achondroplasia. This designation highlights the urgency for effective therapies for this condition, which affects about 250,000 people globally. TransCon CNP received similar status in the U.S. in February 2019. The company's ongoing Phase 2 ACcomplisH Trial aims to develop new treatment options, emphasizing the significance of CNP in promoting bone growth affected by the FGFR3 mutation.
Ascendis Pharma A/S (Nasdaq: ASND) announced the pricing of a public offering of 4,225,352 American Depositary Shares (ADSs) at $142.00 each, aiming to raise approximately $569.2 million. The funds will support clinical development and regulatory approval for TransCon hGH and other endocrinology programs, as well as working capital. The offering is expected to close on or about July 10, 2020, with an option for underwriters to purchase an additional 633,802 ADSs. J.P. Morgan, Morgan Stanley, and others are managing the offering.
Ascendis Pharma A/S (Nasdaq: ASND) announced a public offering of $500 million in American Depositary Shares (ADSs), each representing one ordinary share. A 30-day option for underwriters to purchase up to an additional $75 million is also expected. The offering is subject to market conditions and may vary in terms of size and completion. J.P. Morgan, Morgan Stanley, Evercore, and SVB Leerink are managing the offering. The company aims to address unmet medical needs through its innovative TransCon™ technologies and has a pipeline focused on endocrinology and oncology.
Ascendis Pharma A/S (ASND) announced receiving a positive opinion from the Paediatric Committee of the EMA for its TransCon hGH, a treatment for growth hormone deficiency in children aged 6 months to less than 18 years. This opinion supports the completion of the Paediatric Investigation Plan (PIP) based on extensive non-clinical and clinical trial data. The company is set to submit its European marketing application in Q3 2020, with no additional studies required. This marks a potential advancement in the long-acting growth hormone treatment for pediatric patients.
Ascendis Pharma A/S (Nasdaq: ASND) announced the submission of a Biologics License Application (BLA) for TransCon hGH, a long-acting treatment for pediatric growth hormone deficiency (GHD). This marks the first product candidate from the company's innovative TransCon technology to reach BLA submission after multiple Phase 3 trials. TransCon hGH, with orphan designation in the U.S. and Europe, aims to improve patient adherence by replacing daily injections. Future plans include a Marketing Authorisation Application to the European Medicines Agency and further trials in Japan and Greater China.
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