Tuesday, Ascendis Pharma A/S ASND reported second-quarter sales of $38.76 million (35.9 million euros), missing the consensus of $92.7 million, down from 47.4 million euros reported a year ago.Results in the quarter were primarily impacted by a negative adjustment to prior periods' estimates and assumptions for sales deductions of 27.1 million euros, where 19.5 million euros and 7.6 million euros were attributable to the three months ended March 31, 2024, and periods before January 1, 2024, respectively.Als ...

Financial Data and Key Metrics Changes - In Q2 2024, SKYTROFA volume more than doubled compared to Q2 2023, but reported revenue decreased by 27% year-over-year to EUR 26.2 million due to higher sales deductions and adjustments to prior sales accruals [22][24] - Total revenue for Q2 2024 was EUR 36 million, including EUR 4.6 million from services and license revenue [24] - R&D costs decreased by 21% to EUR 83.5 million in Q2 2024 compared to EUR 105 million in Q2 2023, while SG&A expenses increased to EUR 74.3 million from EUR 70.3 million [25] - Net finance income increased to EUR 29.4 million in Q2 2024 from EUR 26.4 million in Q2 2023 [26] Business Line Data and Key Metrics Changes - YORVIPATH revenue for Q2 2024 was EUR 5.2 million, reflecting the first full quarter of commercial revenue in Germany and Austria, up from EUR 1.5 million in Q1 2024 [24] - SKYTROFA revenue for the first half of 2024 totaled EUR 91.2 million, a 35% year-over-year increase compared to EUR 67.4 million in the same period in 2023 [23] - The number of patients on YORVIPATH treatment in Germany and Austria increased to over 250, with a retention rate of 98% [14][42] Market Data and Key Metrics Changes - The US growth hormone market is estimated to be around $1.4 billion, with SKYTROFA positioned as a premium product with a net value per patient approximately three times that of daily growth hormone [30] - By the end of Q2 2024, SKYTROFA penetration in the US pediatric growth hormone deficiency treated patient population was 18% [23] Company Strategy and Development Direction - The company aims to achieve approval for all three endocrinology rare disease product candidates by the end of 2025, with a focus on expanding into larger therapeutic areas such as oncology and obesity [10][11] - The strategy for SKYTROFA includes simplifying market access and expanding the product label to include adult growth hormone deficiency [15][17] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformative impact of YORVIPATH for patients with hypoparathyroidism and highlighted the strong retention rates for the product [21][42] - The company expects to achieve operating cash flow breakeven on a quarterly basis in 2024 or 2025, depending on the launch timing of YORVIPATH in the US [27] Other Important Information - The company announced a new capped synthetic royalty funding agreement with Royalty Pharma for $150 million in exchange for a 3% royalty on net sales of YORVIPATH in the US [26] - The company plans to submit a supplemental BLA for adult growth hormone deficiency for SKYTROFA in Q3 2024 [17] Q&A Session Summary Question: How does the company project getting SKYTROFA to a blockbuster in the US? - Management indicated that the US growth hormone market is about $1.4 billion and SKYTROFA has a net value per patient three times that of daily growth hormone, with plans for label expansion [30][31] Question: What are the competitive dynamics regarding SKYTROFA's pricing? - Management acknowledged that there are two other long-acting products in the US market but emphasized SKYTROFA's best-in-class potential and strong market position [34][35] Question: What feedback has been received from payers regarding YORVIPATH pricing? - Management reported no negative feedback on the responsible pricing strategy for YORVIPATH, which aims to support all patients with hypoparathyroidism [39] Question: How is the penetration of YORVIPATH tracking in Germany and Austria? - Management noted that the uptake is strong, with around 125 prescribers and a retention rate of 98%, indicating a positive trajectory for the product [41][42] Question: What assumptions led to the lower guidance for SKYTROFA? - Management explained that the guidance was based on observed growth in volume and the reset of market access, with expectations for continued growth in the second half of the year [48][50] Question: What is the expected run rate for SKYTROFA moving into Q3? - Management indicated that the reported net sales for Q2, adjusted for true-ups, would provide a good basis for expectations in Q3 and Q4 [81]

COPENHAGEN, Denmark and NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) and Royalty Pharma plc (Nasdaq: RPRX) today announced that Ascendis Pharma Bone Diseases A/S, a wholly-owned subsidiary of Ascendis Pharma A/S, has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of YORVIPATH. “We are pleased to again partner with Royalty Pharma, a leading funder of innovation across the biopharma industry, as we launch YO ...

Core Insights - Ascendis Pharma has received FDA approval for YORVIPATH, the first and only treatment for hypoparathyroidism in adults, highlighting the company's commitment to addressing unmet medical needs [2][4] - The company reported a second quarter revenue of €36 million, a decrease from €47.4 million in the same period last year, primarily due to negative adjustments in sales deductions [9][10] - SKYTROFA revenue for Q2 2024 was €26 million, reflecting a 27% year-over-year decrease, although there was a 134% increase in volume [3][9] - The company anticipates full-year 2024 SKYTROFA revenue to be between €220 million and €240 million [8] Financial Performance - Total revenue for Q2 2024 was €36 million, down from €47.4 million in Q2 2023, impacted by a negative adjustment of €27.1 million in sales deductions [9][10] - YORVIPATH generated €5.2 million in revenue during its first full quarter of commercial launch in Germany and Austria [4] - Research and development costs for Q2 2024 were €83.5 million, a decrease from €105 million in Q2 2023, attributed to lower external development costs [11][12] - The net loss for Q2 2024 was €109.4 million, or €1.91 per share, compared to a net loss of €121.4 million, or €2.16 per share, in Q2 2023 [12][19] Product Development and Pipeline - The company is preparing for the U.S. launch of YORVIPATH and expects initial supply to be available in Q1 2025, with potential earlier introduction in Q4 2024 [4][8] - Topline results from the pivotal ApproaCH Trial for TransCon CNP are expected in the coming weeks, with plans to submit a New Drug Application to the FDA for children with achondroplasia in Q1 2025 [5][6] - Ascendis Pharma is on track to submit a supplemental Biologics License Application for adult growth hormone deficiency for SKYTROFA in Q3 2024 [3][8] Market Position and Strategy - Ascendis Pharma's focus on rare endocrine diseases is underscored by the approval of two out of three of its TransCon product candidates, positioning the company for potential blockbuster status in the U.S. market [2][4] - The company has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma related to YORVIPATH sales in the U.S. [8]

COPENHAGEN, Denmark, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report second quarter 2024 financial results and provide a business update on Tuesday, September 3, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on September 3, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2024 financial results. Those who would like to participate may access the live webcast here, or ...

Shares of Ascendis Pharma A/S (ASND) were up 8.7% on Aug 13 after the company announced that the FDA had approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism.Yorvipath (developed as TransCon PTH) is a hormone replacement therapy for treating adults with hypoparathyroidism, a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone causes deficiencies of calcium and phosphorus compounds in the blood, r ...

Company Overview - Ascendis Pharma A/S (ASND) shares increased by 8.7% to close at $139.66, following a notable trading volume that exceeded typical levels [1] - The stock had previously experienced a 6.3% decline over the past four weeks [1] Recent Developments - The FDA approved Ascendis Pharma's hormone replacement therapy, Yorvipath (palopegteriparatide; developed as TransCon PTH), for treating adults with hypoparathyroidism, which likely contributed to the recent share price rally [1] - The company is projected to report a quarterly loss of $1.51 per share, reflecting a year-over-year increase of 35.7% [1] - Expected revenues for the upcoming quarter are $95.8 million, representing an 85.7% increase compared to the same quarter last year [1] Earnings Estimates and Market Sentiment - The consensus EPS estimate for Ascendis Pharma has remained unchanged over the last 30 days, indicating a lack of upward revisions in earnings estimates [2] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [2] - Trends in earnings estimate revisions are strongly correlated with near-term stock price movements, indicating the importance of monitoring future revisions [2] Industry Context - Ascendis Pharma operates within the Zacks Medical - Biomedical and Genetics industry [2] - Another company in the same industry, CollPlant Biotechnologies Ltd. Sponsored ADR (CLGN), saw a 0.2% decline in its stock price, closing at $4.44, with a return of -12.1% over the past month [2] - CollPlant Biotechnologies' consensus EPS estimate for the upcoming report has remained unchanged at -$0.35, which represents a significant year-over-year decline of 171.4% [3] - CollPlant Biotechnologies also holds a Zacks Rank of 3 (Hold) [3]

da-kuk Ascendis Pharma A/S (ASND), based in Copenhagen, Denmark, is a biopharmaceutical company that utilizes its proprietary TransCon technology platform to develop advanced therapeutics for endocrinology, rare diseases, and oncology. This TransCon system aims to deliver best-in-class therapies with controlled drug release, optimized effects, and less toxicity. The company’s FDA-approved product, Skytrofa, is indicated for pediatric growth hormone deficiency [GHD] and is proof of the efficacy of TransC ...

• Data demonstrate significant improvements in well-being and physical functioning compared to placebo in patients treated for 1 year with TransCon CNP at the pivotal 100μg/kg/week dose • Improvements could not be explained by changes in linear growth only, supporting a potential additional direct treatment effect of TransCon CNP beyond linear growth COPENHAGEN, Denmark, June 24, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced the oral presentation of data from its Phase 2 ACcomp ...

COPENHAGEN, Denmark, June 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that company executives will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 8:00 a.m. ET in Miami, Florida. A live webcast of the fireside chat will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after co ...