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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 positive topline data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) for children with achondroplasia. The trial met its primary objective, demonstrating superior annualized growth velocity (AGV) compared to placebo:
- Overall AGV difference: 1.49 cm/year (p<0.0001)
- Ages 5-11: 1.78 cm/year difference (p<0.0001)
- Ages 2-<5: 1.02 cm/year difference (p=0.0084)
TransCon CNP also showed improvements in height Z-scores and quality of life measures. The treatment was generally well-tolerated with a safety profile comparable to placebo. Ascendis plans to submit an NDA to the FDA in Q1 2025 and an MAA to the EMA in Q3 2025.
Ascendis Pharma A/S (Nasdaq: ASND) has announced initial data from its Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ in platinum-resistant ovarian cancer (PROC) patients. The study showed anti-tumor clinical responses in 29% (4/14) of efficacy-evaluable patients treated with TransCon IL-2 β/γ in combination with chemotherapy. These results suggest clinical activity in heavily pre-treated PROC patients, including those who had previously progressed on Elahere®. The treatment was generally well-tolerated, with most treatment-emergent adverse events being grade 1 or 2. The data will be presented at ESMO 2024 in Barcelona. This follows promising results in melanoma announced at ASCO 2024, indicating potential efficacy across multiple cancer types.
Ascendis Pharma A/S (Nasdaq: ASND) has received Orphan Drug exclusivity from the U.S. FDA for YORVIPATH® (palopegteriparatide) in treating hypoparathyroidism in adults. This grants seven years of market exclusivity in the United States. YORVIPATH, a once-daily prodrug of parathyroid hormone, is designed to provide continuous PTH exposure over 24 hours.
Hypoparathyroidism, affecting an estimated 70,000 to 90,000 people in the U.S., is a rare endocrine disease caused by insufficient parathyroid hormone levels. YORVIPATH is the first and only FDA-approved treatment for adult hypoparathyroidism, addressing the underlying disease.
Ascendis Pharma and Royalty Pharma have entered into a $150 million capped synthetic royalty funding agreement based on U.S. net sales of YORVIPATH. This deal supports the development and commercialization of Ascendis' Endocrine Rare Disease products, including the U.S. launch of YORVIPATH, the first FDA-approved treatment for hypoparathyroidism in adults.
Key terms of the agreement include:
- Ascendis receives a $150 million upfront payment
- Royalty Pharma gets a 3% royalty on U.S. net sales of YORVIPATH
- Royalty payments cease upon reaching a 2.0x multiple, or 1.65x if achieved by December 31, 2029
This transaction highlights YORVIPATH's value and Ascendis' strategy to reduce capital costs while maintaining flexibility in their global commercial capabilities.
Ascendis Pharma reported Q2 2024 financial results and provided a business update. Key highlights:
1. YORVIPATH approved by FDA for hypoparathyroidism in adults
2. TransCon CNP pivotal trial results expected soon
3. SKYTROFA Q2 revenue of €26 million, 134% YoY volume growth
4. Full year 2024 SKYTROFA revenue outlook revised to €220-240 million
5. Q2 total revenue: €36 million, down from €47.4 million in Q2 2023
6. Net loss of €109.4 million or €1.91 per share
7. Cash position of €259 million as of June 30, 2024
The company expects to be operating cash flow breakeven on a quarterly basis in 2024 or 2025, pending YORVIPATH launch timing in the U.S.
Ascendis Pharma A/S (Nasdaq: ASND) has announced its plans to release second quarter 2024 financial results and provide a business update on Tuesday, September 3, 2024, after the U.S. financial markets close. The company will host a conference call and live webcast at 4:30 p.m. Eastern Time on the same day to discuss the results. Interested parties can access the live webcast or register for the teleconference in advance. The webcast link will also be available on the Investors & News section of the Ascendis Pharma website. A replay of the webcast will be accessible on the company's website for 30 days following the event.
Ascendis Pharma (Nasdaq: ASND) announced FDA approval of YORVIPATH® (palopegteriparatide) for treating hypoparathyroidism in adults. YORVIPATH is the first and only treatment for this rare endocrine disease affecting 70,000 to 90,000 people in the US. It's a once-daily prodrug of parathyroid hormone designed to provide continuous 24-hour exposure.
The approval is based on data from Phase 2 PaTH Forward and Phase 3 PaTHway trials. Ascendis plans to launch YORVIPATH with patient support services through its A.S.A.P. program. Commercial product is expected to be available in Q1 2025, with potential earlier introduction in Q4 2024 pending FDA approval of existing manufactured product.
Ascendis Pharma's Phase 2 ACcomplisH Trial data on TransCon CNP for children with achondroplasia was presented at ICCBH 2024. The trial showed significant improvements in well-being and physical functioning compared to placebo at the 100μg/kg/week dose, suggesting benefits beyond linear growth. Conducted in 57 children aged 2-10, the trial's results highlighted TransCon CNP's potential to enhance health-related quality of life. Statistically significant improvements were noted in daily living functioning and emotional well-being, with no serious adverse events reported.
Ascendis Pharma A/S (Nasdaq: ASND) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference. Company executives will engage in a fireside chat on June 11, 2024, at 8:00 a.m. ET in Miami, Florida. The event will be webcast live on the Ascendis Pharma website, with a replay available for 30 days post-event.
Ascendis Pharma (Nasdaq: ASND) presented new data from the ongoing Phase 1/2 IL-Believe Trial at ASCO 2024. The study evaluates TransCon IL-2 β⁄γ, alone and in combination with TransCon TLR7/8 Agonist, in patients with anti-PD-1 refractory melanoma and other solid tumors.
Key findings include clinical responses in 40% of efficacy-evaluable patients in the initial cohort and 45% in patients with prior disease progression on checkpoint inhibitors. Notably, no new safety signals were reported.
Biomarker analysis linked clinical benefits to CD8+ T cell expansion and activation. The recommended Phase 2 dose is 120 µg/kg administered every three weeks.
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