4 unchanged sentences
The trading price of our common stock could decline due to any of these risks and you may lose all or part of your investment.
−Removed: The risk factors set forth below update, and should be read together with, the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2019.
−Removed: Our ability to continue as a going concern and achieve profitability is highly dependent on the commercial success of OMIDRIA, and to the extent OMIDRIA is not successful, our business, financial condition and results of operations would be materially adversely affected, and the price of our common stock may decline.
−Removed: OMIDRIA is currently our only product that has been approved by the FDA for commercial sale in the U.S.
−Removed: For the three months ended September 30, 2020, we recorded net sales of OMIDRIA of $26.1 million.
−Removed: Revenues from sales of OMIDRIA have not been sufficient to fund our operations fully in prior periods and we cannot provide assurance that revenues from OMIDRIA sales will be sufficient to fund our operations fully in the future.
−Removed: In prior periods, when OMIDRIA was not reimbursed separately under Medicare Part B, our revenues decreased significantly.
−Removed: In the absence of other revenue sources, we will need to generate substantially more product revenue from OMIDRIA to achieve and sustain profitability.
−Removed: We may be unable to sustain or increase revenues generated from OMIDRIA product sales for a number of reasons, including:
−Removed: ● the significant reduction in the volume of ophthalmic surgical procedures and corresponding reduction in demand for OMIDRIA as a result of the COVID-19 pandemic;
−Removed: ● the expiration of pass-through reimbursement on October 1, 2020 and uncertainty regarding the extent of coverage and reimbursement for OMIDRIA when used in Medicare patients;
−Removed: ● pricing, coverage and reimbursement policies of government and private payers such as Medicare, Medicaid, the U.S.
−Removed: Department of Veterans Affairs, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;
−Removed: ● a lack of acceptance by physicians, patients and other members of the healthcare community;
−Removed: ● the availability, relative price and efficacy of the product as compared to alternative treatment options or branded, compounded or generic competing products;
−Removed: ● an unknown safety risk;
−Removed: ● the failure to enter into and maintain acceptable partnering arrangements for marketing and distribution of OMIDRIA outside of the U.S.;
−Removed: ● changed or increased regulatory restrictions in the U.S., EU or other foreign territories.
−Removed: Pass-through reimbursement for OMIDRIA under Medicare Part B expired on October 1, 2020.
−Removed: In the event that we are not able to secure separate payment or similar reimbursement for OMIDRIA, or if there is a delay in securing separate payment or similar reimbursement for OMIDRIA, our revenue from OMIDRIA could decrease significantly as was the case during the period from January 1, 2018 to September 30, 2018, when OMIDRIA was not reimbursed separately when used for procedures involving patients covered by Medicare Part B.
−Removed: Any decline in sales from OMIDRIA also would impact our ability to borrow under the Loan Agreement since the amount we can borrow is dependent on our eligible receivables.
−Removed: If legislative and/or administrative means to secure separate payment for OMIDRIA are not successful, we would need to pursue an alternative sales strategy, and our revenues and financial condition could be adversely and significantly affected.
−Removed: Pass-through reimbursement status allows for separate payment (i.e., outside the packaged payment rate for the surgical procedure) under Medicare Part B.
−Removed: In March 2018, Congress extended pass-through reimbursement status for a small number of drugs, including OMIDRIA, used during procedures performed on Medicare Part B fee-for-service patients through September 30, 2020.
−Removed: In its 2021 OPPS final rule, CMS confirmed the October 1, 2020 expiration of pass-through reimbursement for OMIDRIA and indicated an intention to package payment for OMIDRIA within the ambulatory payment classification for the associated surgical procedure in both the hospital outpatient department and ASC settings.
−Removed: We are continuing to pursue separate payment for OMIDRIA and have submitted to CMS a comment letter and a legal memorandum outlining our position that OMIDRIA meets all of the regulatory criteria established by CMS for separate payment in the ASC setting.
−Removed: However, we can provide no assurances that separate reimbursement for OMIDRIA will be available for the remainder of 2020 and beyond or, if available, that the reimbursement rate will be adequate.
−Removed: If the future reimbursement status of OMIDRIA continues to be uncertain, then demand for OMIDRIA from ASCs and hospitals may be reduced substantially.
−Removed: In such event, sales to our wholesalers may decrease correspondingly, as they adjust on-hand inventory in anticipation of reduced demand from end users.
−Removed: If we are unable to obtain separate payment for OMIDRIA, we expect to pursue an alternative sales strategy.
−Removed: We may face difficulties or delays in implementing an alternative sales strategy and, even if successfully implemented, we cannot predict how quickly, or if, our customers would increase their OMIDRIA utilization, and the net revenues we receive from sales of OMIDRIA could be reduced, potentially by a significant amount.
−Removed: Additionally, private payers often follow CMS with respect to reimbursement for new drugs, and they may cease or decrease coverage or reimbursement for OMIDRIA if we are unable to obtain separate payment for OMIDRIA from CMS.
−Removed: A reduction in OMIDRIA revenues for these or any other reasons may also impair our ability to borrow under our line of credit facility with Silicon Valley Bank.
−Removed: Any of these risks, if realized, would adversely affect our ability to generate revenue and attain profitability, and there would be a material adverse effect on our business, financial condition, results of operations and growth prospects and the trading price of our stock could decline.
−Removed: The spread of COVID-19 and efforts to reduce its transmission may negatively impact our business, operations and financial results.
−Removed: The COVID-19 pandemic has significantly affected the global economy and has adversely affected our sales of OMIDRIA due to a reduction in the overall volume of cataract surgery and intraocular lens replacement procedures.
−Removed: In March 2020, ASCs and hospitals using OMIDRIA postponed nearly all cataract procedures in response to recommendations from government and medical organizations.
−Removed: As a result, we did not record any sales of OMIDRIA to our wholesalers from March 25 to May 19, 2020.
−Removed: Beginning in the second half of May 2020, cataract surgeries resumed to varying degrees in locations throughout the country.
−Removed: If the number of cataract procedures becomes or continues to be limited, either by necessity for time-consuming safety protocols, reduction in patient demand, or the imposition of prohibitions on elective surgeries in some localities, then we would expect there to be a corresponding reduction in demand for OMIDRIA.
−Removed: We may also experience disruptions to our operations due to COVID-19, such as delays or disruptions with respect to manufacturing of clinical or commercial drug substance or drug product and delays in our clinical trials or in the submission or review of regulatory applications.
−Removed: Such delays or disruptions could negatively affect our commercial
−Removed: operations, clinical programs, and research and development.
−Removed: The health of our employees, contractors and other persons on whom we rely may be adversely affected by COVID-19.
−Removed: Although we are taking precautionary measures intended to help minimize the risk of the virus to our employees, these measures may be ineffective or may otherwise adversely affect our productivity.
−Removed: In addition, the conditions created by the pandemic may intensify other risks inherent in our business.
−Removed: Due to the unknown magnitude, duration and outcome of the COVID-19 pandemic, it is not possible to estimate precisely its impact on our business, operations or financial results;
−Removed: however, the impact could be material.
−Removed: To the extent COVID-19 adversely affects our business, financial condition, and results of operations and global economic conditions more generally, it may also have the effect of heightening many of the other risk factors set forth herein as well as those described in “Item 1A.
−Removed: Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019.
−Removed: We may be unable to further evaluate narsoplimab in COVID-19 patients and there can be no guarantee that the results of any such evaluations will be favorable.
−Removed: In response to the COVID-19 pandemic, we initiated a compassionate use program for narsoplimab to treat COVID-19 patients with ARDS.
−Removed: While all six COVID-19 patients initially treated with narsoplimab survived, recovered, and were discharged from the hospital, and we believe the results observed following narsoplimab treatment in severe COVID-19 cases demonstrate the similarity in pathophysiology between COVID-19 and HSCT-TMA, we cannot provide assurance that the results observed in the compassionate use program will be observed in any future study of narsoplimab for this indication or that we will receive regulatory authorization or approval for narsoplimab in the treatment of hospitalized patients with COVID-19.
−Removed: We may be unable to design and conduct a large-scale clinical trial evaluating narsoplimab in COVID-19, secure the large-scale manufacturing capacity from third parties necessary to manufacture narsoplimab in sufficient quantities to enable broader availability of narsoplimab for COVID-19 patients, or secure funding and other resources necessary for us to conduct these activities from government or other sources.
−Removed: In addition, another party may be successful in producing a vaccine or an alternative therapy for COVID-19 or ARDS associated with COVID-19, which may also lead to the diversion of governmental and other potential sources of funding away from us and toward other companies and limit the viability of any approved or authorized product candidate for the treatment of COVID-19.
−Removed: Any therapeutic candidate that we may develop to address COVID-19 will be subject to risks in addition to those normally associated with pharmaceutical research, development, and commercialization, such as higher risk of technical failure, lower and transient opportunities for revenue, higher manufacturing costs, product safety or efficacy risks related to an expedited research and development timeline, and novel liability theories.
−Removed: Relatedly, FDA may require that we conduct a large-scale trial of narsoplimab in COVID-19 patients in order to grant any approval or authorization.
−Removed: These risks may affect our ability to develop or commercialize a therapeutic for COVID-19 or any other current or future indication.
−Removed: If our clinical trials or clinical protocols are delayed, suspended or terminated, we may be unable to develop our product candidates on a timely basis, which would adversely affect our ability to obtain regulatory approvals, increase our development costs and delay or prevent commercialization of approved products.
−Removed: We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials or clinical data collection protocols that will cause regulatory agencies, institutional review boards or ethics committees, or us to delay our clinical trials or suspend or delay the analysis of the data from those trials.
−Removed: Clinical trials and clinical data protocols can be delayed for a variety of reasons, including:
−Removed: ● discussions with the FDA, the EMA or other foreign authorities regarding the scope or design of our clinical trials or clinical data collection protocols;
−Removed: ● delays or the inability to obtain required approvals from institutional review boards, ethics committees or other responsible entities at clinical sites selected for participation in our clinical trials;
−Removed: ● delays in enrolling patients into clinical trials, collecting data from enrolled patients, adequately monitoring patients before or after treatment, or collecting historical control data for any reason including disease severity, trial or data collection protocol design, study eligibility criteria, patient population size (e.g., for orphan diseases or for some pediatric indications), proximity or availability of clinical trial sites for prospective patients, availability of competing therapies and clinical trials, regional differences in diagnosis and treatment, perceived
−Removed: risks and benefits of the product or product candidate, physician patient referral practices, disruptions due to external events, including an outbreak of pandemic or contagious disease such as the COVID-19 coronavirus, which has slowed enrollment in our clinical trials of narsoplimab in patients with IgA nephropathy;
−Removed: ● lower than anticipated retention rates of patients in clinical trials;
−Removed: ● the need to repeat or conduct additional clinical trials as a result of inconclusive or negative results, failure to replicate positive early clinical data in subsequent clinical trials, failure to deliver an efficacious dose of a product candidate, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol, an unacceptable study design or other problems;
−Removed: ● adverse findings in clinical or nonclinical studies related to the safety of our product candidates in humans;
−Removed: ● an insufficient supply of product candidate materials or other materials necessary to conduct our clinical trials;
−Removed: ● the need to qualify new suppliers of product candidate materials for FDA and foreign regulatory approval;
−Removed: ● an unfavorable inspection or review by the FDA or other regulatory authority of a clinical trial site or records of any clinical investigation;
−Removed: ● the occurrence of unacceptable drug-related side effects or adverse events experienced by participants in our clinical trials;
−Removed: ● the suspension by a regulatory agency of a trial by imposing a clinical hold;
−Removed: ● the amendment of clinical trial or data collection protocols to reflect changes in regulatory requirements and guidance or other reasons as well as subsequent re-examination of amendments to clinical trial or data collection protocols by institutional review boards or ethics committees.
−Removed: ● In addition, our clinical trial or development programs have been, and in the future may be, suspended or terminated by us, the FDA or other regulatory authorities, or institutional review boards or ethics committees due to a number of factors, including:
−Removed: ● failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
−Removed: ● inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
−Removed: ● the failure to remove a clinical hold in a timely manner, if at all;
−Removed: ● unforeseen safety issues or any determination that a trial presents unacceptable health risks;
−Removed: ● inability to deliver an efficacious dose of a product candidate;
−Removed: ● lack of adequate funding to continue the clinical trial or development program, including as a result of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies or increased expenses associated with the services of our contract research organizations, or other third parties.
−Removed: If the results of our clinical trials are not available when we expect or if we encounter any delay in the analysis of data from our clinical trials, we may be unable to file for regulatory approval or conduct additional clinical trials on the schedule we currently anticipate.
−Removed: Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.
−Removed: Any delays in completing our clinical trials could increase our development costs, could slow down our product development and
−Removed: regulatory submission process, could delay our receipt of product revenue and could make it difficult to raise additional capital.
−Removed: In addition, significant clinical trial delays also could allow our competitors to bring products to market before we do and impair our ability to commercialize our future products, potentially harming our business.
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.