2 unchanged sentences
Risks Related to Our Business and Industry
−Removed: • We face business disruption and related risks resulting from the outbreak of the novel coronavirus 2019 (COVID-19), including significant restrictions in the ability of our field commercial and medical teams to interact with third parties, delays in the enrollment of ongoing clinical trials and the initiation of planned clinical trials and other operational impacts, each of which could have a material adverse effect on our business.
−Removed: • We depend heavily on the commercial success of XERMELO.
−Removed: If we do not achieve commercial success with XERMELO, our business will suffer and our stock price will likely decline.
−Removed: • We depend heavily on our ability to obtain regulatory approval in the United States for sotagliflozin in type 1 diabetes.
+Added: • We face business disruption and related risks resulting from the outbreak of the novel coronavirus, or COVID-19, including delays in the enrollment of ongoing clinical trials and the initiation of planned clinical trials and other operational impacts, each of which could have a material adverse effect on our business.
+Added: • We depend on our ability to obtain regulatory approval in the United States for sotagliflozin in type 1 diabetes.
If we fail to obtain such regulatory approval or fail to successfully commercialize sotagliflozin for type 1 diabetes in the United States upon regulatory approval, our business will suffer and our stock price will likely decline.
−Removed: • We depend heavily on our ability to effectively close out the clinical trials included in the Phase 3 clinical development program for sotagliflozin in type 2 diabetes, heart failure and chronic kidney disease in a timely manner.
−Removed: If we fail to effectively close out such program on the anticipated timelines, our cash position will suffer and our stock price will likely decline.
+Added: • We depend on our ability to effectively close out two outcomes studies evaluating the effect of sotagliflozin on cardiovascular death and heart failure and involving approximately 10,500 and 1,200 patients, respectively.
+Added: If we fail to effectively close out such clinical trials on the anticipated timelines, our cash position will suffer and our stock price will likely decline.
+Added: • We depend on TerSera’s ability to successfully develop and commercialize XERMELO for biliary tract cancer and our receipt of milestone payments and royalties from such efforts.
+Added: If TerSera does not successfully complete such development and commercialization activities, we will not receive milestone payment and royalties relating to such efforts, our cash position will suffer and our stock price will likely decline.
• Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or prevention of regulatory approval.
1 unchanged sentence
• The commercial success of any products that we or our collaborators may develop will depend upon the degree of market acceptance among physicians, patients, health care payers and the medical community.
−Removed: • If we are unable to maintain an effective and specialized sales force, marketing infrastructure and distribution capabilities, we will not be able to successfully commercialize any products that we or our collaborators may develop.
+Added: • If we are unable to establish an effective and specialized sales force, marketing infrastructure and distribution capabilities, we will not be able to successfully commercialize any products that we or our collaborators may develop.
• If we are unable to obtain adequate coverage and reimbursement from third-party payers for any products that we or our collaborators may develop, our revenues and prospects for profitability will suffer.
8 unchanged sentences
Risks Related to Our Capital Requirements and Financial Results
−Removed: • We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our commercialization efforts or product development programs.
+Added: • We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our research and development programs.
If additional capital is not available on reasonable terms, we will be forced to obtain funds, if at all, by entering into financing agreements on unattractive terms.
1 unchanged sentence
• Our operating results have been and likely will continue to fluctuate, and we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.
−Removed: • We have substantial indebtedness that may limit cash flow available to invest in the ongoing needs of our business.
−Removed: • If we do not effectively manage our affirmative and restrictive covenants under the BioPharma Term Loan, our financial condition and results of operations could be adversely affected.
Risks Related to Our Relationships with Third Parties
−Removed: • We are significantly dependent upon our collaborations with Ipsen and other pharmaceutical and biotechnology companies.
−Removed: If pharmaceutical products are not successfully and timely developed and commercialized under our collaborations, our opportunities to generate revenues from milestones and royalties will be greatly reduced.
+Added: • We are significantly dependent upon our ability to establish collaborations with pharmaceutical and biotechnology companies for the development and commercialization of pharmaceutical products.
+Added: If we are unable to establish such collaborations or if pharmaceutical products are not successfully and timely developed and commercialized under such collaborations, our opportunities to generate revenues from pharmaceutical products we develop will be greatly reduced.
• Conflicts with our collaborators could jeopardize the success of our collaborative agreements and harm our product development efforts.
−Removed: • We depend on third-party manufacturers, including sole source suppliers, to manufacture commercial quantities of XERMELO.
−Removed: We may not be able to maintain these relationships and could experience supply disruptions outside of our control.
−Removed: • We rely on a single third-party logistics provider and a limited distribution network of specialty pharmacies and specialty distributors for distribution of XERMELO in fulfillment of prescriptions in the United States, and their failure to distribute XERMELO effectively would adversely affect sales of XERMELO.
−Removed: • We rely on third parties to carry out drug development activities.
−Removed: • We lack the capability to manufacture materials for nonclinical studies, clinical trials or commercial sales and rely on third parties to manufacture our drug candidates, which may harm or delay our product development and commercialization efforts.
+Added: • We rely on third parties to carry out our nonclinical studies and clinical trials, which may harm or delay our research and development efforts.
+Added: • We lack the capability to manufacture materials for nonclinical studies and clinical trials and rely on third parties to manufacture our drug candidates, which may harm or delay our research and development efforts.
Risks Related to Our Intellectual Property
• If we are unable to adequately protect our intellectual property, third parties may be able to use our products and technologies, which could adversely affect our ability to compete in the market.
−Removed: • We may be involved in patent litigation and other disputes regarding intellectual property rights and may require licenses from third parties for our planned nonclinical and clinical development and commercialization activities.
+Added: • We may be involved in patent litigation and other disputes regarding intellectual property rights and may require licenses from third parties for our planned nonclinical and clinical development activities.
We may not prevail in any such litigation or other dispute or be able to obtain required licenses.
2 unchanged sentences
Risks Related to Employees and Facilities Operations
−Removed: • If we are unable to manage our growth, our business, financial condition, results of operations and prospects may be adversely affected.
+Added: • If we are unable to manage any future growth, our business, financial condition, results of operations and prospects may be adversely affected.
• The loss of key personnel or the inability to attract and retain additional personnel could impair our ability to operate and expand our operations.
13 unchanged sentences
• Future sales of our common stock, or the perception that such sales may occur, may depress our stock price.
−Removed: • Conversion of our 5.25% Convertible Senior Notes due 2021 may dilute the ownership interest of our existing stockholders, including holders who had previously converted their notes, or may otherwise depress the price of our common stock.
+Added: • Conversion of the Convertible Senior Notes may dilute the ownership interest of our existing stockholders, including holders who had previously converted their notes, or may otherwise depress the price of our common stock.
• If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
3 unchanged sentences
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.