Ascendis Pharma AS
For the period ended Dec 31, 2024. Filed Feb 12, 2025.
View on SEC.govAbout this filing
The yearly report of a company based outside the US. It covers much of what a 10-K does, and may follow accounting rules other than US ones.
FY2024 · Filed Feb 12, 2025
Contents
Special Note Regarding Forward-Looking Statements
This annual report contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
the timing or likelihood of regulatory filings and approvals for our product candidates;
our expectations regarding the commercial availability of our approved products;
the commercialization of our products and product candidates, if approved for commercial use;
our commercialization, marketing, and manufacturing capabilities of our products and product candidates and associated devices;
the scope, timing, progress, results and costs of developing our product candidates or any other future product candidates, and conducting preclinical studies and clinical trials;
our pursuit of Oncology as an independent therapeutic area of focus and our development of product candidates related to oncology;
Eyconis’s ability to develop, manufacture, and commercialize TransCon ophthalmology assets globally;
our expectations regarding the potential market opportunities and patient populations for our products and product candidates, if approved for commercial use;
our expectations regarding the potential advantages of our products and product candidates over existing therapies;
our existing collaborations and license agreements and our ability to enter into new collaborations and license agreements;
our expectations with regard to the ability to develop additional product candidates using our TransCon technologies and submit Investigational New Drug Applications (“INDs”) or similar for such product candidates;
our ability to benefit from established data of clinically validated parent drugs or pathways to which we apply our TransCon technologies;
our expectations with regard to our current and future collaboration partners to pursue the development of our product candidates and submit INDs or similar for such product candidates;
our development plans with respect to our products and product candidates;
our pursuit of additional indications for TransCon hGH;
our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials;
the implementation of our business model and strategic plans for our business, our products and product candidates and technologies, including global commercialization strategies;
the scope of protection we are able to establish and maintain for intellectual property rights covering our products and product candidates;
our expectations regarding our ability to apply our technology platform and algorithm for product innovation to develop highly differentiated product candidates to address unmet medical needs;
our ability to apply our TransCon Technology platform to build a leading, fully integrated, global biopharmaceutical company;
our use of our TransCon technologies to create new and potentially best-in-class therapies;
estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital;
our financial performance;
our ability to attract and hire qualified personnel;
developments and projections relating to our market conditions, competitors and industry;
our expectations with respect to ongoing and potential litigation;
the impact of international economic, political, legal, compliance, social and business factors, including inflation, tariffs, geopolitical conflicts and energy shortages; and
the effects on our business of the worldwide pandemics and the ongoing conflict in the region surrounding Ukraine and Russia and the conflict between Israel and Hamas.
These forward-looking statements are based on senior management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this annual report may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section of this annual report titled “Item 3.D—Key Information—Risk Factors” and elsewhere in this annual report. You are urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this annual report. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Given these risks and uncertainties, you are cautioned not to rely on such forward-looking statements as predictions of future events.
You should read this annual report and the documents that we reference in this annual report and have filed as exhibits to this annual report completely and with the understanding that our actual future results may be materially different from what we expect. You should also review the factors and risks we describe in the reports we will file or submit from time to time with the U.S. Securities and Exchange Commission (“SEC”) after the date of this annual report. We qualify all of our forward-looking statements by these cautionary statements.
Additionally, certain information included herein or elsewhere (such as our website) is informed by various stakeholder expectations or third-party frameworks, and therefore should not necessarily be interpreted as rising to the level of materiality as defined under U.S. federal securities laws and regulations, even if we use the language “material” or “materiality.” Particularly in the ESG context, materiality is subject to varying definitions that are often different (and more expansive) than the concept for U.S. federal securities laws purposes.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.