2 unchanged sentences
Risks Related to our Business, Financial Condition and Capital Requirements
−Removed: We will incur significant losses during development of our current pipeline over the foreseeable future.
+Added: We will incur significant losses during the development of our current pipeline in the foreseeable future.
We currently have limited opportunities to generate revenue and may never sustain profitability.
Our future success may be dependent on the regulatory approval and commercialization of our product candidates.
−Removed: New laws or regulations could impact our ability to receive the necessary approvals to successfully market and commercialize our product candidates.
+Added: New laws or regulations could impact on our ability to receive the necessary approvals to successfully market and commercialize our product candidates.
Product candidates we advance into clinical trials may not have favorable results in clinical trials or receive regulatory approval.
52 unchanged sentences
In addition, we completed a modified Dutch auction tender offer for our common shares in February 2020 and June 2023, which consumed $420 million and $14 thousand of our cash resources, respectively.
−Removed: We also distributed $75 million cash dividend to our investors in July 2021.
+Added: We also distributed a $75 million cash dividend to our investors in July 2021.
Accordingly, we may require substantial additional capital to continue our clinical development and potential commercialization activities.
334 unchanged sentences
Further, any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our business, results of operations, financial condition and cash flows from future prospects.
+Added: The transition to a new presidential administration in the United States, including the potential use and effects of tariffs to address the administration ’ s policy goals, could materially impact the macroeconomic framework in which we operate.
+Added: The transition to a new presidential administration in the United States could impact the macroeconomic framework in which we operate, and we are unable to precisely predict what actions the new administration will take.
+Added: For example, on February 1, 2025, the current U.S.
+Added: presidential administration announced the implementation of a 25% additional tariff on imports from Canada.
+Added: It is possible there could be further modifications of tariff policy and other U.S.
+Added: governmental policies that could impact our financial performance.
+Added: Any trade wars, through the implementation of tariffs or otherwise, has the potential to adversely affect us, including by impacting (a) the supply chains for our operations as well as the third parties with whom we engage, and (b) the macroeconomic markets at large.
Risks Related to Intellectual Property
34 unchanged sentences
The asserted claims and/or litigation could include claims against us, our licensors or our suppliers alleging infringement of intellectual property rights with respect to our products or components of those products.
−Removed: Regardless of the merit of the claims, they could be time consuming, result in costly litigation and diversion of technical and management personnel, or require us to develop a non-infringing technology or enter into license agreements.
+Added: Regardless of the merit of the claims, they could be time consuming, resulting in costly litigation and diversion of technical and management personnel, or require us to develop a non-infringing technology or enter into license agreements.
We cannot assure you that licenses will be available on acceptable terms, if at all.
60 unchanged sentences
For example, in February 2020, we completed a cash tender offer in which we repurchased $420 million of our common shares.
−Removed: In July 2021, we distributed $75 million cash dividend to our shareholders.
+Added: In July 2021, we distributed a $75 million cash dividend to our shareholders.
Our shareholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds.
19 unchanged sentences
We believe that to suggest that such bank account interest makes us a PFIC is absurd;
−Removed: this would suggest that we cannot keep our cash in a bank account and that interest on the Company’s funds supersedes any other consideration in defining the the actual operations and essential nature of the Company.
+Added: this would suggest that we cannot keep our cash in a bank account and that interest on the Company’s funds supersedes any other consideration in defining the actual operations and essential nature of the Company.
XBiotech will never accept an arbitrary and erroneous definition that could potentially penalize the Company and its shareholders and will oppose any effort to do so by the tax authorities.
42 unchanged sentences
An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not.
−Removed: UNRESOLVED STAFF COMMENTS
−Removed: Not applicable.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.