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Ascendis Pharma(ASND) - 2022 Q4 - Annual Report
2023-02-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 American Depositary Shares, each representing one ordinary share, nominal value DKK 1 per share ASND The Nasdaq Stock Market LLC FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF TH ...
Ascendis Pharma(ASND) - 2022 Q3 - Earnings Call Transcript
2022-11-05 02:15
Ascendis Pharma A/S (ASND) Q3 2022 Earnings Conference Call November 2, 2022 4:30 PM ET Company Participants Tim Lee - Senior Director, Investor Relations Jan Mikkelsen - President & Chief Executive Officer Scott Smith - Senior Vice President & Chief Financial Officer Stina Singel - Head of Clinical Development Oncology Birgitte Volck - Senior Vice President Head of Clinical Development & Medical Affairs Endocrinology Rare Diseases Joe Kelly - Head of US Commercial Endocrinology Conference Call Participants ...
Ascendis Pharma(ASND) - 2022 Q3 - Quarterly Report
2022-09-29 16:00
R E F. 7 0 4 4 9 - 6 5 1 2 9 Sep t e m b e r 2 0 2 2 E x h i b i t 1 . 1 A r t i c l e s o f A s s o c i a t i o n of A s c e n d i s P h a r m a A / S ( C V R - n r. 2 9 9 1 8 7 9 1 ) (R eg is t r a t i o n n o 2 9 9 1 8 7 9 1) Name, Registered Office and Objects of the Company: Article 1 The company's name is Ascendis Pharma A/S. Article 2 [Deleted by resolution of the shareholders on 23 April 2015] Article 3 The object of the company is to develop ideas and preparations for the combating of disease medic ...
Ascendis Pharma(ASND) - 2022 Q2 - Earnings Call Transcript
2022-08-11 02:36
Ascendis Pharma A/S (ASND) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Tim Lee - Senior Director, Investor Relations Jan Mikkelsen - President and Chief Executive Officer Scott Smith - Senior Vice President and Chief Financial Officer Dana Pizzuti - Head, Development Operations and Chief Medical Officer Stina Singel - Head, Clinical Development Oncology Joe Kelly - Head, U.S. Commercial Endocrinology Conference Call Participants Jessica Fye - JPMorgan Josh Schimmer - Eve ...
Ascendis Pharma(ASND) - 2022 Q1 - Earnings Call Transcript
2022-05-12 03:29
Ascendis Pharma A/S (ASND) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Jan Mikkelsen – President and Chief Executive Officer Scott T. Smith – Senior Vice President and Chief Financial Officer Timothy J. Lee – Senior Director of Investment Officer Dr. Dana Pizzuti – Head of Development Operations and Chief Medical Officer Dr. Stina Singel – Senior Vice President, Head of Clinical Development, Oncology Conference Call Participants Jessica Fye – JPMorgan Josh Schimmer – Everco ...
Ascendis Pharma(ASND) - 2022 Q1 - Quarterly Report
2022-05-10 16:00
Capital Structure - The company's share capital is DKK 56,958,391, fully paid up, divided into shares of DKK 1 each[3]. - A total of 11,885,200 warrants have been issued, with 4,821,745 having been exercised, annulled, or lapsed as of May 10, 2022[8]. - The company issued convertible notes for a total of up to USD 575,000,000, which may convert into up to nominal value DKK 3,456,776 shares[19]. - The Board of Directors is authorized to increase the company's share capital by up to nominal DKK 9,000,000 without pre-emptive rights for existing shareholders until May 2026[13]. - The company has the authority to issue warrants for a total nominal value of DKK 4,000,000 without pre-emptive rights for existing shareholders until May 2023[23]. - The company resolved to increase its share capital by nominal DKK 2,875,000 by issuing 2,875,000 shares on September 1, 2021[13]. - The company’s existing shareholders do not have pre-emptive rights to subscribe for shares issued upon the conversion of the convertible bonds[20]. - New shares subscribed through the exercise of warrants will have the same rights as existing shares, with no pre-emptive rights for shareholders[156]. Warrant Issuance and Exercise - The exercise price for warrants is determined by the Board of Directors and must equal at least the market price of the shares at the time of issuance[23]. - Each warrant allows subscription for nominal DKK 1 share, with the exercise price converted into DKK using the official exchange rate on the exercise day[88][89][90]. - Ascendis Pharma has introduced a warrant incentive scheme for employees, consultants, and board members, granting options to subscribe for new ordinary shares at a predetermined exercise price[137]. - Each warrant allows the subscription for nominal DKK 1 ordinary share at the exercise price set by the Board of Directors on the issuance date[137]. - Warrants will lapse automatically on the tenth anniversary of the grant date without prior notice[129]. - The exercise of warrants is conditional upon the Owner's status as an employee or board member at the time of exercise[4]. - If the employment is terminated by Ascendis Pharma for good reason, the Owner can only exercise vested warrants at termination[117]. - Adjustments to warrants will occur if there are changes in Ascendis Pharma's capital structure to maintain the potential gain[118]. - If dividends exceed 10% of equity capital, the exercise price of warrants will be adjusted accordingly[121]. - In the event of a merger, the Owner may exercise all non-exercised warrants immediately before the merger[123]. - Ascendis Pharma will cover all costs associated with granting and exercising warrants, estimated at DKK 50,000[132]. - The tax implications related to the subscription or exercise of warrants are not the concern of Ascendis Pharma[10]. - 25% of warrants granted to employees and consultants vest one year after the grant, with the remaining 75% vesting at a rate of 1/36 per month thereafter[139]. - Warrants can only be exercised during four exercise periods each year, starting two full trading days after the public release of quarterly earnings reports[140]. - In the event of termination due to justified dismissal, the owner can only exercise vested warrants in the first coming exercise period after termination[142]. - Adjustments to warrants will be made to maintain the potential gain attached to them in case of changes in Ascendis Pharma's capital structure[143]. - If Ascendis Pharma is liquidated, all non-exercised warrants will have their vesting time changed to allow for exercise immediately before the transaction[149]. - In case of a merger, warrants will remain unaffected unless capital is increased at a price other than the market price, in which case adjustments will be made[149]. - If more than 50% of the share capital is sold, owners may exercise all non-exercised warrants immediately before the sale[150]. - The company has issued a total of 566,504 warrants, with 484,512 warrants exercised and 32,354 warrants lapsed[184]. - The exercise price per warrant is USD 32.45, and the estimated costs associated with the issuance of warrants and related capital increase are DKK 50,000[179][184]. - A total of 11,885,200 warrants were granted, with 4,024,996 warrants exercised and 777,169 warrants lapsed[189]. - The exercise price for the warrants ranges from USD 82.64 to USD 176.28, with the highest exercise price recorded at USD 176.28[188]. - The company has a total of 1,022,500 warrants vesting at a rate of 1/48 per month starting from December 11, 2018[193]. - The company has a structured vesting schedule for warrants, with various dates and percentages outlined for future vesting[194]. - The company continues to issue warrants regularly, indicating ongoing employee incentive programs and potential future dilution of shares[194]. - The vesting of warrants is spread over multiple years, ensuring a long-term incentive alignment with employee performance[196]. - The company has a systematic approach to warrant vesting, with specific monthly vesting rates established for different grants[194]. Financial Performance and Projections - The company reported a significant increase in revenue, reaching $1.5 billion, representing a 20% year-over-year growth[199]. - User data showed an increase in active users to 10 million, up from 8 million last year, indicating a 25% growth in user base[200]. - The company provided guidance for the next quarter, expecting revenue to be between $1.6 billion and $1.8 billion, which translates to a growth rate of 7% to 20%[199]. - New product launches are anticipated to contribute an additional $200 million in revenue over the next fiscal year[200]. - The company is investing $50 million in research and development for new technologies aimed at enhancing user experience[199]. - Market expansion plans include entering three new international markets by the end of the year, projected to increase market share by 15%[200]. - The company is considering strategic acquisitions to bolster its product offerings, with a budget of $100 million allocated for potential deals[199]. - A new marketing strategy is set to roll out, aiming to increase brand awareness and customer engagement by 30%[200]. - The company reported a net profit margin of 15%, up from 12% in the previous year, reflecting improved operational efficiency[199]. - The company plans to enhance its customer support services, investing $10 million to improve response times and service quality[200].
Ascendis Pharma(ASND) - 2021 Q4 - Annual Report
2022-03-01 16:00
Executive Summary & Business Update [Company Introduction & Vision](index=1&type=section&id=Company%20Introduction%20%26%20Vision) Ascendis Pharma aims to become a viable, sustainable, and profitable biopharmaceutical company, targeting a **US$10 billion** global market potential in endocrinology rare diseases - Ascendis Pharma's CEO, Jan Mikkelsen, stated that 2021 was an extraordinary year and 2022 is expected to be even stronger, attributing this to the regulatory approvals of TransCon hGH in the U.S. and Europe[1](index=1&type=chunk) - The company is progressing towards its Vision 3x3, aiming to become a viable, sustainable, and profitable biopharmaceutical company[2](index=2&type=chunk) - Ascendis Pharma estimates its first therapeutic area of endocrinology rare disease alone represents a combined **US$10 billion** global market potential[2](index=2&type=chunk) [Corporate 2021 Highlights & Anticipated 2022 Milestones](index=1&type=section&id=Corporate%202021%20Highlights%20%26%20Anticipated%202022%20Milestones) Ascendis Pharma achieved significant 2021 milestones and outlined key 2022 expectations across its TransCon pipeline, including commercial launches, regulatory authorizations, and clinical trial advancements [TransCon hGH (SKYTROFA®)](index=1&type=section&id=TransCon%20hGH%20(SKYTROFA%C2%AE)) SKYTROFA® launched commercially in the U.S. in Fall 2021 and received EU marketing authorization in January 2022, with a Turner Syndrome protocol submission planned for Q2 2022 - SKYTROFA® (lonapegsomatropin-tcgd) was commercially launched in the U.S. in Fall 2021 as the only FDA-approved once-weekly treatment for pediatric growth hormone deficiency[3](index=3&type=chunk) - **SKYTROFA® Prescriptions (as of Feb 28, 2022)** | Metric | Value | | :-------------------------------------- | :---- | | SKYTROFA® Prescriptions Written | 708 | | Number of Prescribers | ~263 | | Prescribers writing for multiple patients | **44%** | - In January 2022, the Company received marketing authorization for Lonapegsomatropin Ascendis Pharma in the European Union for the treatment of children and adolescents with growth failure due to insufficient endogenous growth hormone[3](index=3&type=chunk) - Ascendis Pharma plans to submit a protocol to the FDA in Q2 2022 to evaluate TransCon hGH for Turner Syndrome, expecting to evaluate higher doses compared to pediatric or adult GHD[4](index=4&type=chunk) - The ongoing conflict in Ukraine and Russia may affect timelines for the foresiGHt Trial (Phase 3 trial in adult growth hormone deficiency), but currently has no material business impact[4](index=4&type=chunk) [TransCon PTH](index=2&type=section&id=TransCon%20PTH) TransCon PTH demonstrated stable serum and urinary calcium levels in Phase 2, with Phase 3 top-line results expected in Q1 2022, leading to planned NDA and MAA submissions - Week-84 data from the Phase 2 PaTH Forward Trial showed subjects treated with TransCon PTH maintained stable and normal mean serum calcium levels and urinary calcium excretion, with all subjects free from active vitamin D and **93%** taking less than **600 mg/day** of calcium supplements[5](index=5&type=chunk) - Top-line results from PaTHway, a Phase 3 randomized, double-blind placebo-controlled clinical trial for TransCon PTH in adults with HP, are expected in the first quarter of 2022[5](index=5&type=chunk) - If Phase 3 trial results are positive, Ascendis Pharma plans to submit a New Drug Application (NDA) to the FDA in Q3 2022 and a Marketing Authorisation Application (MAA) to the European Medicines Agency in Q4 2022[6](index=6&type=chunk) - Top-line results from PaTHway Japan, a single-arm Phase 3 trial, are expected in Q3 2022, and initiation of a pediatric HP program is planned for Q4 2022[6](index=6&type=chunk) [TransCon CNP](index=2&type=section&id=TransCon%20CNP) Enrollment for the Phase 2 ACcomplisH Trial was completed in December 2021, with top-line data anticipated in Q4 2022, and an IND application for infants planned for Q2 2022 - Enrollment in the Phase 2 ACcomplisH Trial for TransCon CNP in achondroplasia (ages 2–10) was completed in December 2021, with **42%** of enrolled subjects between 2 and 5 years old[6](index=6&type=chunk) - Top-line data from the ACcomplisH Trial are expected in the fourth quarter of 2022[6](index=6&type=chunk) - The Company plans to file an Investigational New Drug (IND) application or similar for the ACcomplisH Infants Trial (ages 0–2) during the second quarter of 2022[7](index=7&type=chunk) [Oncology Pipeline (TransCon TLR7/8 Agonist & TransCon IL-2 ß/g)](index=2&type=section&id=Oncology%20Pipeline%20(TransCon%20TLR7%2F8%20Agonist%20%26%20TransCon%20IL-2%20%C3%9F%2Fg)) Ascendis Pharma's oncology pipeline showed early clinical activity, with top-line data for monotherapy and combo-therapy dose escalation expected in Q3 and Q4 2022, and a Phase 2 cohort expansion IND planned for Q4 2022 - Initial first-in-human results from transcendIT-101 (Phase 1/2 study of TransCon TLR7/8 Agonist) demonstrated early signs of clinical activity in **three out of three** efficacy-evaluable cancer patients treated as monotherapy or in combination with pembrolizumab[7](index=7&type=chunk) - Top-line data from monotherapy and combo-therapy dose escalation for TransCon TLR7/8 Agonist are expected in the third quarter of 2022[8](index=8&type=chunk) - The IL-ßeliege Trial (Phase 1/2 clinical trial for TransCon IL-2 ß/g in advanced cancer) was initiated in Q3 2021, with top-line monotherapy data expected in Q4 2022[8](index=8&type=chunk) - Ascendis Pharma plans to submit an IND or similar for Phase 2 cohort expansion for the combination of TransCon TLR7/8 Agonist and TransCon IL-2 ß/g during the fourth quarter of 2022[8](index=8&type=chunk) [Corporate Governance & Financial Position Update](index=3&type=section&id=Corporate%20Governance%20%26%20Financial%20Position%20Update) Rafaèle Tordjman was elected to the board in November 2021, and the company concluded 2021 with a strong cash position of **€789.6 million** - Rafaèle Tordjman, Founder & CEO of Jeito Capital, was elected to Ascendis Pharma's board in November 2021[8](index=8&type=chunk) - **Cash Position (as of Dec 31, 2021)** | Metric | Amount | | :---------------------------------------- | :------------- | | Cash, cash equivalents, and marketable securities | **€789.6 million** | Full Year 2021 Financial Performance [Overview of Financial Results](index=3&type=section&id=Overview%20of%20Financial%20Results) Ascendis Pharma reported a net loss of **€383.6 million** for 2021, an improvement from 2020, with increased revenue driven by SKYTROFA sales and higher R&D and SG&A expenses - **Full Year Financial Highlights (EUR millions)** | Financial Metric | 2021 | 2020 | Change (YoY) | | :--------------- | :------ | :------ | :----------- | | Total Revenue | **7.8** | **7.0** | **+11.4%** | | R&D Costs | **295.9** | **260.9** | **+13.4%** | | SG&A Expenses | **160.2** | **76.7** | **+108.9%** | | Net Profit / (Loss) of Associate | **12.0** | **(9.5)** | N/A | | Net Finance Income / (Expense) | **55.8** | **(79.0)** | N/A | | Net Loss | **(383.6)** | **(419.0)** | **-8.4%** | | EPS (Basic & Diluted) | **(7.00)** | **(8.28)** | **-15.5%** | | Cash, Cash Equivalents, & Marketable Securities (Dec 31) | **789.6** | **834.1** | **-5.3%** | - Revenues for 2021 include U.S. SKYTROFA sales, and license, clinical supply and services provided to third parties, primarily VISEN Pharmaceuticals[10](index=10&type=chunk) - Higher R&D costs in 2021 reflect continued advancement of development programs and an increase in personnel-related costs to support them[10](index=10&type=chunk) - Higher SG&A expenses were primarily due to an increase in commercial and administrative personnel as well as an increase in commercial and IT costs[10](index=10&type=chunk) - The net profit of associate for 2021 included a non-cash gain of **€42.3 million** as a result of a financing round in VISEN[11](index=11&type=chunk) [Consolidated Statements of Profit or Loss and Comprehensive Income / (loss)](index=6&type=section&id=Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Income%20%2F%20(loss)) The consolidated statement shows a net loss of **€383.6 million** for 2021, an improvement from **€419.0 million** in 2020, despite increased operating loss, due to positive finance income and associate profit - **Consolidated Statements of Profit or Loss and Comprehensive Income / (loss) (EUR'000s)** | Metric | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :------------------------------------------------------ | :---------------------- | :---------------------- | | Revenue | **7,778** | **6,953** | | Cost of sales | **3,523** | - | | Gross profit | **4,255** | **6,953** | | Research and development costs | **295,867** | **260,904** | | Selling, general and administrative expenses | **160,180** | **76,669** | | Operating profit / (loss) | **(451,792)** | **(330,620)** | | Share of profit / (loss) of associate | **12,041** | **(9,524)** | | Finance income | **59,718** | **1,812** | | Finance expenses | **3,911** | **80,842** | | Profit / (loss) before tax | **(383,944)** | **(419,174)** | | Tax on profit / (loss) for the year | **367** | **219** | | Net profit / (loss) for the year | **(383,577)** | **(418,955)** | | Attributable to owners of the Company | **(383,577)** | **(418,955)** | | Other comprehensive income / (loss) (net of tax) | **3,855** | **(42)** | | Total comprehensive income / (loss) for the year, net of tax | **(379,722)** | **(418,997)** | [Consolidated Statements of Financial Position](index=7&type=section&id=Consolidated%20Statements%20of%20Financial%20Position) Total assets increased to **€1,084.9 million** in 2021 from **€979.8 million** in 2020, driven by growth in property, plant and equipment, investment in associate, inventories, and marketable securities - **Consolidated Statements of Financial Position (EUR'000s)** | Metric | Dec 31, 2021 | Dec 31, 2020 | | :------------------------------------------ | :------------ | :------------ | | **Assets** | | | | Non-current assets | **279,035** | **239,660** | | Intangible assets | **5,272** | **5,717** | | Property, plant and equipment | **126,049** | **108,112** | | Investment in associate | **38,345** | **9,176** | | Other receivables (non-current) | **1,808** | **1,375** | | Marketable securities (non-current) | **107,561** | **115,280** | | Current assets | **805,886** | **740,133** | | Inventories | **75,405** | - | | Trade receivables | **2,200** | **387** | | Income tax receivable | **893** | - | | Other receivables (current) | **20,093** | **6,957** | | Prepayments | **25,231** | **13,994** | | Marketable securities (current) | **235,797** | **134,278** | | Cash and cash equivalents | **446,267** | **584,517** | | **Total assets** | **1,084,921** | **979,793** | | **Equity and liabilities** | | | | Equity | **883,635** | **838,711** | | Share capital | **7,646** | **7,217** | | Distributable equity | **875,989** | **831,494** | | Non-current liabilities | **100,930** | **88,278** | | Lease liabilities (non-current) | **97,966** | **85,116** | | Contract liabilities (non-current) | **2,964** | - | | Other liabilities (non-current) | - | **3,162** | | Current liabilities | **100,356** | **52,804** | | Lease liabilities (current) | **6,995** | **6,859** | | Contract liabilities (current) | **2,601** | **363** | | Trade payables and accrued expenses | **59,417** | **21,897** | | Other liabilities (current) | **29,952** | **23,384** | | Income tax payables | **198** | **301** | | Provisions | **1,193** | - | | **Total liabilities** | **201,286** | **141,082** | | **Total equity and liabilities** | **1,084,921** | **979,793** | Additional Information [Conference Call and Webcast Information](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Information) Ascendis Pharma hosted a conference call and webcast on March 2, 2022, to discuss its full year 2021 financial results, with dial-in and webcast access details provided - **Conference Call Details** | Detail | Information | | :-------------------------- | :----------------------------------------- | | Date | Wednesday, March 2, 2022 | | Time | 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time | | Dial In (U.S.) | 844-290-3904 | | Dial In (International) | 574-990-1036 | | Access Code | 2009938 | | Webcast Link | www.ascendispharma.com (Investors and News section) | [About Ascendis Pharma A/S](index=4&type=section&id=About%20Ascendis%20Pharma%20A%2FS) Ascendis Pharma A/S is a global biopharmaceutical company leveraging its innovative TransCon platform technology to develop potentially best-in-class therapies - Ascendis Pharma applies its innovative platform technology to build a leading, fully integrated, global biopharmaceutical company focused on making a meaningful difference in patients' lives[14](index=14&type=chunk) - The company uses its TransCon technologies to create new and potentially best-in-class therapies, guided by its core values of patients, science and passion[14](index=14&type=chunk) - Ascendis is headquartered in Copenhagen, Denmark, with additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey[14](index=14&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding Ascendis Pharma's future operations, plans, and objectives, which involve substantial risks and uncertainties - The press release contains forward-looking statements that involve substantial risks and uncertainties regarding Ascendis' future operations, plans, and objectives[15](index=15&type=chunk) - Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements due to various important factors[15](index=15&type=chunk) - Key risks include dependence on third-party manufacturers and distributors, unforeseen safety or efficacy results in development programs, unforeseen expenses related to commercialization and development, delays in development programs, uncertainty regarding market-size estimates and profitability, ability to obtain additional funding, and the effects of the worldwide COVID-19 pandemic[15](index=15&type=chunk)[16](index=16&type=chunk) - Ascendis does not assume any obligation to update any forward-looking statements, except as required by law[16](index=16&type=chunk) [Contact Information](index=8&type=section&id=Contact%20Information) Contact details for investor relations and media inquiries are provided for Ascendis Pharma, including specific personnel and their contact information - **Investor and Media Contacts** | Role | Name | Contact Information | | :--------------- | :------------ | :-------------------------- | | Investor Contact | Tim Lee | +1 (650) 374-6343, tle@ascendispharma.com | | Media Contact | Melinda Baker | +1 (650) 709-8875, media@ascendispharma.com | | Media Contact | Patti Bank | +1 (415) 513-1284, patti.bank@westwicke.com | | General Investor Relations | N/A | ir@ascendispharma.com |