Ascendis Pharma

Ascendis Pharma A/S is a biopharmaceutical company, which engages in the development of drug candidates. It specializes on its TransCon technologies to create prodrugs that provide for the predictable and sustained release of an unmodified parent drug. The company was founded by Jan Moller Mikkelsen, Dirk Vetter, and Harald Rau in September 2006 and is headquartered in Hellerup, Denmark.

Earnings data Q1 2021

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Earnings data Q3 2023

Earnings data Q4 2023

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Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Ascendis Pharma reports strong revenue growth and market potential

Ascendis Pharma's financial performance in Q4 2022 showed revenue growth but operating losses, with a strong cash position.
Strengths lie in the TransCon technology platform, differentiation of products, and established commercial infrastructure.
Challenges include monitoring requirements, launch strategy comparisons, and market access strategies.
Opportunities arise from potential approvals, market dynamics, and clinical benefits of product candidates.

Ascendis Pharma reports robust Q1 revenue, faces regulatory challenges

Ascendis Pharma delivered a strong financial performance in Q1 2023, driven by revenue growth and strategic initiatives.
The company faces regulatory challenges and market dynamics that require resolution and strategic planning for sustained growth.
Opportunities for market expansion and product development exist through leveraging success factors and addressing regulatory hurdles.
Investor interest in Ascendis Pharma's future prospects is evident through analyst inquiries on growth expectations and market strategies.

Ascendis Pharma reports robust Q2 earnings amidst market challenges

Ascendis Pharma's Q2 performance reflects strong revenue generation and strategic advancements in key product pipelines, positioning the company for future growth.
Despite challenges in market shortages and regulatory processes, Ascendis Pharma's focus on innovation and market differentiation presents opportunities for expansion.
The company's emphasis on TransCon technology's unique benefits and market positioning underscores its competitive strength and growth potential in rare disease therapeutics.

Ascendis Pharma reports strong Q3 revenue growth and pipeline progress

Ascendis Pharma's Q3 2023 performance reflects revenue growth driven by SKYTROFA and progress in key pipeline programs.
The company's strategic focus on innovative therapies and patient-centric approaches positions it for future growth and market leadership.
While facing challenges like supply chain disruptions and market competition, Ascendis Pharma has opportunities for expansion and therapeutic innovation.
Balancing financial performance with pipeline advancement and commercial optimization will be crucial for Ascendis Pharma's sustainable success.

Ascendis Pharma excels in revenue growth and market leadership

Ascendis Pharma's strong performance in 2023, driven by SKYTROFA and TransCon PTH, positions the company for continued growth and success.
Despite challenges in market competition and treatment complexities, the company's strategic focus on patient outcomes and revenue growth is evident.
Opportunities in expanding therapeutic areas and maintaining market share stability offer potential for Ascendis Pharma's long-term success and value creation.

Ascendis Pharma reports robust Q1 performance and eyes global expansion

Ascendis Pharma's Q1 2024 performance reflects strong revenue growth, improved operational efficiency, and successful product launches, positioning the company for sustainable growth.
While facing challenges in market competition and financial targets, Ascendis Pharma's strategic strengths in product development and market expansion present growth opportunities.
The company's focus on innovation, commercial execution, and market positioning underscores its potential to become a leader in growth disorders and metabolic diseases.
Investors should monitor Ascendis Pharma's progress in achieving cash flow breakeven, expanding product portfolios, and navigating regulatory landscapes for future growth potential.

Ascendis Pharma excels in Q2 with YORVIPATH approval and revenue growth

Ascendis Pharma's Q2 2024 earnings call highlighted strong financial performance, successful product approvals, and strategic commercialization efforts.
The company faces challenges in pricing strategies, market dynamics, and ensuring patient uptake, but opportunities exist in expanding market reach and advancing pipeline programs.
Overall, Ascendis Pharma's focus on innovation, patient support, and financial growth positions it well for continued success and market leadership in the biopharmaceutical industry.

Ascendis Pharma reports robust Q3 performance and eyes strategic growth

Ascendis Pharma showcased strong performance across its product portfolio and pipeline candidates, with notable revenue growth and promising clinical outcomes.
While facing challenges in market penetration and regulatory processes, the company is well-positioned to capitalize on growth opportunities through strategic collaborations and upcoming product launches.
By navigating challenges effectively and leveraging opportunities, Ascendis Pharma aims to drive sustainable growth and value creation in the pharmaceutical market.

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COPENHAGEN, Denmark, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide; developed as TransCon PTH) is now commercially available by prescription in the United States. YORVIPATH is a prodrug of parathyroid hormone (PTH [1-34]), administered once-daily, designed to provide continuous exposure to active PTH over the 24-hour dosing period. It is the first and only medicine approved by the U.S. Food & Drug Administration (FDA) for the treatment of hypoparathyroidism in adults.

YORVIPATH® (Palopegteriparatide) Now Commercially Available in the United States for the Treatment of Hypoparathyroidism in Adults

- Results for all three TransCon hGH starting dose cohorts, in first clinical trial of an indication outside of growth hormone deficiency, showed a safety and tolerability profile comparable to daily somatropin

New InsiGHTS Trial of TransCon™ hGH (Lonapegsomatropin) in Turner Syndrome Achieved Primary Objective at Week 26

COPENHAGEN, Denmark, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA® for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of July 27, 2025.

FDA Accepts Ascendis Pharma's Supplemental Biologics License Application for TransCon™ hGH for the Treatment of Adults with Growth Hormone Deficiency

ATHENS, Greece and ALMATY, Kazakhstan, Dec. 10, 2024 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies, today announced that it has extended its exclusive agreement with Danish biopharmaceutical company Ascendis Pharma A/S (Nasdaq: ASND) to commercialize three rare endocrinology disease treatments in selected countries across Eurasia. Er-Kim originally announced its exclusive agreement with Ascendis to distribute these therapies across Central and Eastern Europe and Turkey in January 2024.

Er-Kim Extends Exclusive Distribution Agreement with Ascendis Pharma A/S to Expand Commercialization of Its Endocrinology Portfolio to Eurasian Markets

Ascendis Pharma A/S (ASND) Q3 2024 Earnings Conference Call November 14, 2024 4:30 PM ET Company Participants Jan Mikkelsen - President & Chief Executive Officer Scott Smith - Executive Vice President & Chief Financial Officer Camilla Harder Hartvig - Head of Global Commercial Operation Joe Kelly - US General Manager Conference Call Participants Jessica Fye - JPMorgan Tazeen Ahmad - Bank of America Yaron Werber - TD Cowen Gavin Clark-Gartner - Evercore ISI Li Watsek - Cantor Fitzgerald Joseph Schwartz - Leerink Partners Vikram Purohit - Morgan Stanley Kelly Shi - Jefferies David Lebowitz - Citigroup Inc. Paul Choi - Goldman Sachs Leland Gershell - Oppenheimer Alexander Thompson - Stifel Operator Good day, and thank you for standing by. Welcome to the Ascendis Pharma Third Quarter Earnings Call.

Ascendis Pharma A/S (ASND) Q3 2024 Earnings Call Transcript

– YORVIPATH launching in U.S. with product availability expected mid-January 2025; ex-U.S. YORVIPATH revenue of €8.5 million in Q3

Ascendis Pharma Reports Third Quarter 2024 Financial Results

COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH (marketed as SKYTROFA® (lonapegsomatropin-tcgd) in the U.S. for pediatric growth hormone deficiency) for the treatment of adults with growth hormone deficiency (GHD).

Ascendis Pharma Announces Submission of Supplemental Biologics License Application to FDA for TransCon™ hGH for the Treatment of Adults with Growth Hormone Deficiency

COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) shared 3-year results from the Company's ongoing Phase 2 PaTH Forward Trial of 57 adults with hypoparathyroidism showing that long-term treatment with TransCon™ PTH (palopegteriparatide; marketed as YORVIPATH®) through Week 162 drove bone remodeling into the normal range. Deficiency of parathyroid hormone is associated with low rates of bone remodeling, accumulation of overly mature bone, and higher-than-average bone mineral density that may correspond with poorer overall bone quality compared to that seen in the general population.1,2,3,4 In contrast, these results suggest that long-term palopegteriparatide treatment promotes attainment of skeletal health parameters in line with those expected with states of parathyroid sufficiency.

New 3-Year Skeletal Dynamics Data for Adults with Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide) Presented at ASBMR 2024

COPENHAGEN, Denmark, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced the pricing of its underwritten public offering of 2,000,000 American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis, at a price to the public of $150.00 per ADS. All of the ADSs are being offered by Ascendis. The offering is expected to close on or about September 23, 2024, subject to the satisfaction of customary closing conditions. In addition, Ascendis has granted the underwriters a 30-day option to purchase up to an additional 300,000 ADSs at the public offering price, less the underwriting commissions.

Ascendis Pharma A/S Announces Pricing of Public Offering of ADSs

COPENHAGEN, Denmark, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has commenced an underwritten public offering of $300,000,000 of American Depositary Shares (“ADSs”), each of which represents one ordinary share of Ascendis. All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $45,000,000 of ADSs at the public offering price, less the underwriting commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the proposed offering.

Ascendis Pharma A/S Announces Proposed Public Offering of ADSs

ASND stock surges after data from a study shows that its investigational achondroplasia therapy achieved the primary study goal.

Ascendis Soars on Encouraging Data From Dwarfism Drug Study

Ascendis Pharma (ASND) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions could translate into further price increase in the near term.

Ascendis Pharma (ASND) Moves 17.1% Higher: Will This Strength Last?

Ascendis Pharma A/S ASND released topline data on Monday from a trial that included 84 children with achondroplasia, a genetic disorder that causes dwarfism and disproportionate short stature.

Ascendis Pharma's Rare Dwarfism Candidate Shows Promise In Trial, FDA Submission Expected Next Year

Ascendis Pharma stock rocketed Monday on promising test results for a growth treatment that could rival BioMarin's approved drug, Voxzogo.

Ascendis Rockets — And Hammers BioMarin — On New Results For Growth Drug

–    TransCon CNP demonstrated AGV superior to placebo with LS mean treatment difference of 1.49 cm/year at Week 52 (p

Pivotal ApproaCH Trial of TransCon™ CNP (Navepegritide) Achieved Primary Objective, Demonstrated AGV Superior to Placebo

COPENHAGEN, Denmark, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced initial data showing signs of clinical activity in heavily pre-treated patients with platinum-resistant ovarian cancer (PROC) treated with TransCon IL-2 β/γ in combination with chemotherapy in its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ. First results will be shared in Poster 762P at ESMO 2024, the annual meeting of the European Society of Medical Oncology being held in Barcelona from September 13-17, 2024.

Ascendis to Present First Results from Platinum-Resistant Ovarian Cancer (PROC) Cohort of the Phase 1/2 IL-Believe Trial at ESMO 2024

–   U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in adults

Ascendis Pharma Receives Orphan Drug Exclusivity in the U.S. for YORVIPATH® (Palopegteriparatide) for the Treatment of Hypoparathyroidism in Adults

Shares of Ascendis Pharma are under pressure as the company posted a big Q2 revenue miss, driven by a decision to significantly reduce the net price of Skytrofa. Demand for Skytrofa remains strong and quarterly net sales could go back to new highs in the fourth quarter, if not in Q3 already. Yorvipath's U.S. price is above expectations and could increase long-term sales, but initial uptake and payer pushback need monitoring.

Ascendis Pharma Takes A Big Price Cut On Skytrofa

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.

Ascendis Pharma Faces Challenges With Skytrofa And Yorvipath Pricing: Analysts Weigh In

The biotech released its second-quarter results and likely wishes it hadn't. It missed badly on the consensus analyst estimate for profitability.

Why Ascendis Pharma Stock Tumbled by 11% Today

Ascendis Pharma stock tumbled Wednesday after the firm cut its outlook for its human growth hormone amid marketwide price struggles.

Ascendis Pharma Undercuts 50-Day Line After Pricing Fiasco Prompts Guidance Cut

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.

Rare Disease-Focused Ascendis Pharma Stock Falls On Underwhelming Q2 Earnings, Guidance Cut

Ascendis Pharma A/S (ASND) Q2 2024 Earnings Conference Call September 3, 2024 4:30 PM ET Company Participants Tim Lee - Senior Director, Investor Relations Jan Moller Mikkelsen - President & Chief Executive Officer Scott Smith - Executive Vice President & Chief Financial Officer Camilla Harder Hartvig - Head of Global Commercial Operation Joe Kelly - US General Manager Conference Call Participants Jessica Fye - JPMorgan Tazeen Ahmad - Bank of America Derek Archila - Wells Fargo Li Watsek - Cantor Gavin Clark-Gartner - Evercore ISI Vikram Purohit - Morgan Stanley Kelly Shi - Jefferies David Lebowitz - Citi Alex Thompson - Stifel Paul Choi - Goldman Sachs Yaron Werber - TD Cowen Operator Hello. Thank you for standing by.

Ascendis Pharma A/S (ASND) Q2 2024 Earnings Call Transcript

Proceeds to support continued development and commercialization of Endocrine Rare Disease products, including the YORVIPATH® U.S. commercial launch, and general corporate purposes Proceeds to support continued development and commercialization of Endocrine Rare Disease products, including the YORVIPATH® U.S. commercial launch, and general corporate purposes

Ascendis Pharma and Royalty Pharma Enter into $150 Million Royalty Funding Agreement

COPENHAGEN, Denmark, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced financial results for the second quarter ended June 30, 2024, and provided a business update.

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