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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 (Nasdaq: ASND) will host a conference call and live webcast on April 27, 2023, at 4:30 p.m. ET to discuss its Q1 2023 financial results and provide a business update. Interested participants can access the live event via the company's website. A replay will be available for 30 days post-event. The company is leveraging its innovative TransCon platform technology to advance its biopharmaceutical portfolio, focusing on developing potentially best-in-class therapies. Ascendis operates out of multiple locations, including Denmark and the US, reflecting its global reach and commitment to improving patient outcomes.
Ascendis Pharma A/S (Nasdaq: ASND) announced that initial dose escalation data from its Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ, both alone and with pembrolizumab, has been accepted for online publication at ASCO 2023. TransCon IL-2 β/γ is a long-acting prodrug aimed at overcoming the limitations of current IL-2 therapies, such as short half-life and high Cmax. The trial's primary goals include assessing safety and determining the maximum tolerated dose. If successful, TransCon IL-2 β/γ could become a leading cancer immunotherapy option.
Ascendis Pharma (Nasdaq: ASND) announced that the FDA identified deficiencies in its New Drug Application (NDA) for TransCon PTH, which could delay the regulatory decision. The specific deficiencies were not disclosed. CEO Jan Mikkelsen emphasized the company's commitment to working with the FDA while continuing clinical trials with no new safety signals reported. In parallel, the company is on track for a European Commission decision by Q4 2023 regarding its Marketing Authorisation Application (MAA) for TransCon PTH.
145 of 154 participants in ongoing trials remain treated with TransCon PTH, showcasing the treatment's tolerability.
Ascendis Pharma A/S (Nasdaq: ASND) has announced participation in the Oppenheimer 33rd Annual Healthcare Conference, scheduled for March 15, 2023. The virtual fireside chat will feature Jan Mikkelsen, President & CEO, and Scott Smith, EVP & CFO, discussing the company's innovative TransCon platform aimed at creating leading biopharmaceutical therapies. The event takes place from 12:00-12:30 p.m. Eastern Time and will be streamed live on Ascendis Pharma's website. A replay will be available for 30 days post-event.
Ascendis Pharma reported significant financial results for 2022, with total revenue of €51.2 million, up from €7.8 million in 2021. The increase is largely attributed to SKYTROFA U.S. sales reaching €35.7 million. However, the company incurred a net loss of €583.2 million, compared to €383.6 million in 2021. Key milestones include the PDUFA date for TransCon PTH set for April 30, 2023, and an anticipated launch of SKYTROFA in Germany in Q3 2023. The company ended 2022 with €742.9 million in cash and equivalents, down from €789.6 million in 2021, highlighting the need for ongoing funding amidst rising R&D and SG&A expenses.
Ascendis Pharma A/S (Nasdaq: ASND) will host a conference call and webcast on February 16, 2023, at 4:30 p.m. ET to discuss its 2022 financial results and provide a business update. The event can be accessed through their website or by registering for the teleconference. Ascendis utilizes its innovative TransCon platform to develop therapies aimed at improving patient outcomes, positioning itself as a leading global biopharmaceutical company. However, the company warns of risks related to third-party dependencies, unforeseen expenses, and external market factors impacting its operations.
The report titled "Non-Viral / Intracellular Drug Delivery Systems Market" by ResearchAndMarkets.com highlights the rising demand for efficient drug delivery systems in the biopharmaceutical industry. It notes that over 20% of the proteome resides within cell membranes, necessitating innovative delivery methods for therapeutic intervention. Key advancements include non-viral systems such as exosome-based techniques and cell-penetrating peptides. The report reveals that around 1,300 patents have been filed, indicating substantial innovation, with over 20,000 studies on oligonucleotide-based therapeutics underway. The market is expected to grow significantly in the near term.
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