Xeris Biopharma Holdings (XERS) risk factors, FY2024 10-K

Risks Related to Our Operating History

1. 01We have a limited operating history and limited experience commercializing pharmaceutical products and have incurred significant losses since inception
2. 02continue to operate as a public company
3. 03We may never be profitable or be able to sustain revenues or, if achieved, sustain profitability in the future and we may not be able to continue operations without additional fundings
4. 04launch and commercialize our products utilizing our own sales force or by entering into partnership or co-promotion arrangements with third parties

Risks Related to Future Financial Condition

1. 05We may require additional capital to sustain our business, and this capital may cause dilution to our stockholders and might not be available on terms favorable to us, or at all, which could force us to delay, reduce or eliminate our product development programs or commercialization efforts
2. 06Our PPP Loan, which we repaid in full in June 2020, was subject to the terms and conditions applicable to loans administered by the SBA under the CARES Act, and we may be subject to an audit or enforcement action related to the PPP Loan
3. 07Greater than expected product returns may exceed our reserve for returns
4. 08competitive products and introductions of generic products. Any significant increase in returns that exceeds our reserves could adversely affect our revenue and operating results

Risks Related to Commercialization and Marketing

1. 09Our business depends entirely on the commercial success of our products and product candidates. Even if approved, our product candidates may not be accepted in the marketplace and our business may be materially harmed
2. 10neither experimental nor investigational
3. 11our reputation may suffer

Risks Related to Third-Parties Actions and Market Acceptance

1. 12< the possibility of breach or termination of a manufacturing agreement or purchase order by the third party
2. 13In addition, we could be forced to secure new materials or develop alternative third-party suppliers, which can be difficult given our product complexity, long development lead-times and global regulatory review processes
3. 14We are party to a number of material agreements which contain complex commercial terms that could result in litigation or liability that could adversely affect our business, results of operations and financial condition
4. 15indemnity obligations for third-party intellectual property infringement, product liability and certain other claims
5. 16Government and other third-party payors are also challenging the prices charged for healthcare products and increasingly limiting, and attempting to limit, both coverage and level of reimbursement for prescription drugs
6. 17to what extent a new medicine will be covered and reimbursed under Medicare, and private payors tend to follow CMS to a substantial degree
7. 18The success of Recorlev, Gvoke, Keveyis and our product candidates will be dependent on their proper use by patients, healthcare practitioners and caregivers. Additionally, individual devices may fail
8. 19A small number of major customers account for a high percentage of our revenue, thus, the loss of any of these customers and our inability to enter into new customer relationships could negatively impact our business
9. 20< indemnity obligations for third-party intellectual property infringement, product liability and certain other claims

Risk Related to our Dependence on Third Parties for Clinical Trials

1. 21We depend on third parties to conduct the clinical trials for our product candidates, and any failure of those parties to fulfill their obligations could harm our development and commercialization plans

Risks Related to Regulatory Approval

1. 22We cannot be certain that our product candidates will receive marketing approval. Without marketing approval, we will not be able to commercialize our product candidates
2. 23We have devoted significant financial resources and business efforts to the development of our product candidates. We cannot be certain that any of our product candidates will receive marketing approval
3. 24may not approve the labeling claims that we believe are necessary or desirable for the successful commercialization of our product candidates
4. 25Additional time may be required to obtain regulatory approval for certain of our product candidates because they are combination products
5. 26Recorlev, Gvoke, Keveyis and our product candidates may have undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to include safety warnings, require them to be taken off the market or otherwise limit their sales
6. 27Any of these events could also prevent us from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from the sale of our products
7. 28Even with the FDA approval of Recorlev, Gvoke and Keveyis in the United States, and the EMA and MHRA approval of Ogluo in the European Union ("EU") and the United Kingdom ("UK"), we may not be able to obtain or maintain foreign regulatory approvals to market our products in other countries
8. 29with numerous and varying regulatory requirements. The approval procedures vary among countries and may involve requirements for additional testing, and the time required to obtain approval may differ from country to country and from that required to obtain clearance or approval in the United States
9. 30Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and product candidates and affect the prices we may obtain
10. 31< the availability of capital

Risks Related to Ongoing Regulatory Obligations

1. 32< seize or detain products or recommend or require a product recall
2. 33Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain product candidates outside the United States and require us to develop and implement costly compliance programs
3. 34Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any

Risks Related to Industry Competition

1. 35If the FDA or other applicable regulatory authorities approve generic products that compete with any of our products or product candidates, the sales of our products and product candidates, if approved, could be adversely affected

Risks Related to Product Development

1. 36Our failure to successfully identify, develop and market additional product candidates, or acquire additional product candidates or enter into collaborations or other commercial agreements could impair our ability to grow
2. 37< inability to motivate or retain key employees of any acquired businesses

Risks Related to Protecting Our Intellectual Property

1. 38Our success depends on our ability to protect our intellectual property and proprietary formulation science, as well as the ability of our collaborators to protect their intellectual property and proprietary formulation science
2. 39We, or any future partners, collaborators, or licensees, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, we may miss potential opportunities to strengthen our patent position
3. 40countries other than the United States may have patent laws less favorable to patentees than those upheld by United States courts, allowing foreign competitors a better opportunity to create, develop and market competing product candidates in such countries
4. 41Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
5. 42< if issued, the patents under which we hold rights may not be valid or enforceable
6. 43Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time
7. 44Our unpatented trade secrets, know-how, confidential and proprietary information, and technology may be inadequately protected
8. 45Thus, there is a risk that our trade secrets and other confidential and proprietary information could have been, or could, in the future, be shared by any of our former employees with, and be used to the benefit of, any company that competes with us
9. 46If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected

Risks Related to Intellectual Property Litigation

1. 47The pharmaceutical industry is characterized by frequent patent litigation, and we could become subject to litigation that could be costly, result in the diversion of management’s time and efforts, require us to pay damages or prevent us from marketing our existing or future products
2. 48expand and more patents are issued, the risk increases that our products and product candidates may be subject to claims of infringement of the intellectual property rights of third parties
3. 49Others may challenge inventorship or claim an ownership interest in our intellectual property, which could expose it to litigation and have a significant adverse effect on its prospects
4. 50< attempt to obtain a license to the relevant intellectual property from third parties, which may not be available on reasonable terms or at all
5. 51We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
6. 52An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our product candidates
7. 53However, an NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our product candidates
8. 54We may not be able to enforce our intellectual property rights throughout the world

Risk Related to Intellectual Property Laws

1. 55Changes to the patent law in the United States and other jurisdictions could diminish the value of our patents in general, thereby impairing our ability to protect our products

Risk Related to Employment Matters

1. 56Our business could suffer if we lose the services of key members of our senior management or if we are not able to attract and retain other key employees and consultants

Risks Related to Investment in Securities

1. 57Our stock price has been and will likely continue to be volatile, and you may lose part or all of your investment
2. 58< events that affect or have the potential to affect, general economic conditions, including but not limited to political unrest, trade disputes and tariffs, natural disasters, acts of war or terrorism, or any public health crisis
3. 59We have a number of convertible securities outstanding, including Contingent Value Rights ("CVRs"), Convertible Notes and warrants, and the conversion of such securities into shares of our common stock could have a material dilutive effect that could cause our share price to decline
4. 60We do not anticipate paying any cash dividends in the foreseeable future, and accordingly, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock

Risks Related to Tax

1. 61We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards
2. 62Changes in tax law may adversely affect us or our investors

Risks Related to our Indentures for our Convertible Notes, Charter and Bylaws

1. 63Provisions in the Indentures for our Convertible Notes and corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us
2. 64establish a Delaware Forum Provision (as defined below) or a Federal Forum Provision (as defined below)
3. 65If we experience significant disruptions in our information technology systems, our business may be adversely affected
4. 66If products liability lawsuits are brought against us, our business may be harmed, and we may be required to pay damages that exceed our insurance coverage
5. 67As a result of being a public company, we will continue to incur significant additional costs which may adversely affect our operating results and financial condition
6. 68Securities analysts may publish inaccurate or unfavorable research or reports about our business or may publish no information at all, which could cause our stock price or trading volume to decline
7. 69Our data collection and processing activities are governed by restrictive regulations governing the use, processing and, in certain jurisdictions, cross-border transfer of personal information
8. 70Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data
9. 71Our employees, independent contractors, consultants, collaborators and CROs may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm to our reputation
10. 72Global economic uncertainty and weakening product demand caused by political instability, changes in trade agreements and conflicts, such as the conflicts between Russia and Ukraine and Israel and Hamas, or other events could adversely affect our business and financial performance
11. 73Our operations are subject to the effects of fluctuating inflation
12. 74Our business could be negatively impacted by environmental, social and corporate governance matters or our reporting of such matters