Protalix BioTherapeutics (PLX) risk factors, FY2024 10-K

Risks Related to the Commercialization and Continued Approval of our Products

1. 01We currently depend heavily on the generation of revenues from the sales of Elfabrio and Elelyso. Any failure to successfully commercialize Elfabrio will have a material adverse effect on our business, results of operations and financial condition
2. 02Any failure to commercialize Elfabrio or Elelyso globally or the experience of significant delays in doing so will have a material adverse effect on our business, results of operations and financial condition
3. 03includes risk minimization measures in connection with risks associated with hypersensitivity reactions and possible medication errors in the home infusion setting
4. 04If physicians, patients, third party payors and others in the medical community do not accept and use Elfabrio, Elelyso or any other future products, our ability to generate revenue from product sales will be materially impaired
5. 05If the market opportunities for Elfabrio, Elelyso or any other future products are smaller than we believe they are, our revenues may be adversely affected and our business may suffer
6. 06Coverage and reimbursement may not be available for Elfabrio, Elelyso or any other future products in all territories, which could diminish sales of our products or adversely affect the profitably of such sales
7. 07available only to limited levels, the sales of Elfabrio, Elelyso or other future products, if any, may be diminished or we may not be able to sell such products profitably
8. 08Fiocruz is not complying, and we expect they will continue to not comply, with the terms and conditions of the Brazil Agreement
9. 09We and our collaborating partners may be subject, directly or indirectly, to federal and state healthcare fraud and abuse and false claims laws and regulations. If we or our collaborating partners are unable to comply, or have not fully complied, with such laws, we could face substantial penalties

Risks Related to Our Business

1. 10We have a limited commercial operating history which may limit the ability of investors to make an informed investment decision
2. 11Any failure by us to supply drug substance to Chiesi or Pfizer may have a material adverse effect on our business, results of operations and financial condition
3. 12If we are unable to enhance our portfolio of product candidates, our business may be adversely affected
4. 13The manufacture of our products is an exacting and complex process, and any manufacturing problems encountered by us or certain of our providers may have a material adverse effect on our business, results of operations and financial condition
5. 14We rely on third parties for final processing of Elfabrio, Elelyso and our other product candidates, which exposes us to a number of risks that may delay development, regulatory approval and commercialization of Elfabrio, Elelyso or our other product candidates or result in higher product costs
6. 15We have limited experience in selling, marketing or distributing products and limited internal capability to do so
7. 16Developments by competitors may render our products or technologies obsolete or non-competitive which would have a material adverse effect on our business, results of operations and financial condition
8. 17If we in-license drug candidates, we may delay or otherwise adversely affect the development of our existing drug candidates, which may negatively impact our business, results of operations and financial condition
9. 18If we acquire companies, products or technologies, we may face integration risks and costs associated with those acquisitions that could potentially negatively impact our business, results of operations and financial condition
10. 19We depend upon key employees and consultants in a competitive market for skilled personnel. If we are unable to attract and retain key personnel, it could adversely affect our ability to develop and market our products
11. 20Under current U.S. and Israeli laws, we may not be able to enforce employees’ covenants not to compete and therefore may be unable to prevent our competitors from benefiting from the expertise of some of our former employees
12. 21We could be subject to securities class action litigation
13. 22If product liability claims are brought against us, it may result in reduced demand for our products and product candidates or damages that exceed our insurance coverage
14. 23Our ability to utilize net operating loss carryforwards may be limited
15. 24Our corporate structure may create U.S. federal income tax inefficiencies
16. 25We are a holding company with no operations of our own
17. 26Outbreaks of contagious disease or similar public health threats could materially and adversely affect our business, results of operations and financial condition
18. 27Our operating costs and business operations could be adversely affected by climate-related events and increasing regulatory requirements and security

Risks Related to Clinical Trials and Regulatory Matters

1. 28We may not obtain the necessary U.S., EMA or other worldwide regulatory approvals to commercialize our drug candidates in a timely manner, if at all, which would have a material adverse effect on our business, results of operations and financial condition
2. 29We are subject to extensive governmental regulation including the requirements of the FDA and other comparable regulatory authorities before our drug candidates may be marketed
3. 30Delays in obtaining regulatory approvals with respect to any drug candidate will materially and adversely affect our prospects, business, results of operations and financial condition
4. 31Preclinical and clinical trials are very expensive, time-consuming and difficult to design and implement and may result in unforeseen costs, which may have a material adverse effect on our business, results of operations and financial condition
5. 32Interim, top-line or preliminary data from clinical trials that we announce or publish may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data
6. 33Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions
7. 34Our clinical trials depend upon third-party service providers and, accordingly, the results of our clinical trials and such research activities are subject to delays and other risks which are, to a certain extent, beyond our control, which could impair our clinical development programs and our competitive position
8. 35We have only limited experience in regulatory affairs, and some of our drug candidates may be based on new technologies. These factors may affect our ability or the time we require to obtain necessary regulatory approvals
9. 36We may seek orphan drug designation for some or all of our product candidates across various indications, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced

Risks Related to our Financial Condition and Capital Requirements

1. 37We may fail to meet the continued market capitalization-based listing requirement or other continued listing requirements of the NYSE American
2. 38We may need to raise additional capital to operate our business, which may not be available on favorable terms, or at all, and which will have a dilutive effect on our stockholders

Risks Related to Intellectual Property Matters

1. 39If we fail to adequately protect or enforce our intellectual property rights or secure rights to third party patents, the value of our intellectual property rights would diminish and our business, competitive position and results of operations would suffer
2. 40We rely on confidentiality agreements that could be breached and may be difficult to enforce which could have a material adverse effect on our business and competitive position
3. 41If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages and required to defend against litigation which could result in substantial costs and may have a material adverse effect on our business, results of operations and financial condition
4. 42If we cannot meet requirements under our license agreements, we could lose the rights to our products, which could have a material adverse effect on our business

Risks Relating to our Operations in Israel

1. 43Significant parts of our operations are located in Israel and, therefore, our results may be adversely affected by political, economic and military conditions in Israel
2. 44Our operations may be disrupted by the obligations of our personnel to perform military service which could have a material adverse effect on our business
3. 45A certain portion of our expenses is incurred in New Israeli Shekels and, accordingly, our results of operations may be seriously harmed by currency fluctuations and inflation
4. 46The tax benefits available to us require that we meet several conditions and may be terminated or reduced in the future, which would increase our taxes

Risks Related to Investing in our Common Stock

1. 47The market price of our common stock may fluctuate significantly
2. 48The market price of our common stock has experienced significant volatility. The securities of life sciences companies often experience significant volatility in connection with clinical trial and regulatory announcements
3. 49Future sales of our common stock could reduce our stock price
4. 50If securities analysts stop publishing research or reports about us or our business or if they downgrade our common stock, the market price of our common stock could decline
5. 51Compliance with changing regulation of corporate governance and public disclosure may result in additional expenses, divert management’s attention from operating our business which could have a material adverse effect on our business
6. 52Delaware law and our organizational documents contain certain provisions, including anti-takeover provisions that limit the ability of our stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable
7. 53Any provision of our organizational documents or the DGCL that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a related premium for their common stock and could also affect the price that some investors are willing to pay for our common stock
8. 54asserting a claim arising pursuant to the DGCL or our Certificate of Incorporation, as amended, or our Bylaws, or (iv) any action asserting a claim governed by the internal affairs doctrine