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Risks Related to Our Business and Industry
−Removed: • We depend heavily on the commercial success of INPEFA in heart failure.
−Removed: If we do not achieve commercial success with INPEFA, our business will suffer significant adverse consequences.
−Removed: • We depend heavily on our ability to obtain regulatory approval in the United States for ZYNQUISTA in patients with type 1 diabetes and CKD.
−Removed: If we fail to obtain such regulatory approval, our business will suffer significant adverse consequences.
−Removed: • We depend heavily on our ability to successfully complete and obtain positive results from our ongoing PROGRESS Phase 2b clinical trial of LX9211 in DPNP.
−Removed: If we fail to successfully complete and obtain positive results from such clinical trial, or if the progress of such clinical trial is delayed beyond our expected timelines, our business will suffer significant adverse consequences.
−Removed: • We depend heavily on our ability to successfully complete and obtain positive results from our ongoing SONATA Phase 3 clinical trial of sotagliflozin in HCM.
−Removed: If we fail to successfully complete and obtain positive results from such clinical trial, or if the progress of such clinical trial is delayed beyond our expected timelines, our business will suffer significant adverse consequences.
+Added: • We depend heavily on our ability to successfully complete the ongoing research and development of our drug programs.
+Added: If we fail to successfully complete and gain positive results from such research and development efforts, our business 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.
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• 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 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 effectiv e sales force, m arketing 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 establish 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.
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• Our competitors may develop products that impair the value of any products that we or our collaborators may develop.
−Removed: • The outbreak of the novel coronavirus, or COVID-19, had an adverse impact historically on our business operations and clinical trials and another global health pandemic could adversely affect our business in the future.
+Added: • The outbreak of the novel coronavirus, or COVID-19, had an adverse impact on our business operations and clinical trials and another novel coronavirus could adversely affect our business in the future.
+Added: • Changes in government trade policies could disrupt our supply chain or increase the costs of our clinical and commercial supply, negatively impacting our ability to conduct our clinical and commercial operations, price our commercial product competitively and conduct clinical development in a cost effective manner.
Risks Related to Our Capital Requirements and Financial Results
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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.
−Removed: • We may not have sufficient capital to support Phase 3 development of LX9211 in DPNP and do not have sufficient capital to support Phase 3 development of LX9211 in neuropathic pain broadly.
−Removed: If we are unable to establish a strategic collaboration or other arrangement for that purpose, our capital needs will be substantially higher and we may be unable to obtain financing sufficient to fund Phase 3 development of LX9211 on acceptable terms, or at all, and may be required to forego or reduce the scope of any such Phase 3 development program.
+Added: • We may not have sufficient capital to support Phase 3 development of pilavapadin in DPNP and do not have sufficient capital to support Phase 3 development of pilavapadin in neuropathic pain broadly.
+Added: If we are unable to establish a strategic collaboration or other arrangement for that purpose, our capital needs will be substantially higher and we may be unable to obtain financing sufficient to fund Phase 3 development of pilavapadin on acceptable terms, or at all, and may be required to forego or reduce the scope of any such Phase 3 development program.
• We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.
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Risks Related to Our Relationships with Third Parties
−Removed: • We depend on our ability to establish collaborations with pharmaceutical and biotechnology companies for the development and commercialization of our other drug candidates.
−Removed: 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 our other drug candidates will be greatly reduced.
+Added: • We depend on our ability to establish collabora tions or other arrangements with phar maceutical and biotechnology companies for the development and commercialization of our drug candidates.
+Added: If we are unable to establish such collaborations or arrangements, or if pharmaceutical products are not successfully and timely developed and commercialized under such collaborations or arrangements, our opportunities to generate revenues from milestones and royalties or our other drug candidates will be greatly reduced.
• Conflicts with our collaborators could jeopardize the success of our collaborative agreements and harm our product development efforts.
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Risks Related to Our Employees and Facilities
−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 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.
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• 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.
+Added: • If we are unable to meet Nasdaq continued listing requirements, including minimum trading price, Nasdaq may take action to delist our common stock.
For additional discussion of the risks and uncertainties that affect our business, see “Item 1A.
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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.