AbCellera Biologics (ABCL) FY2025 10-K Risk Factors: 11 New, 12 Dropped

What the changes say

AbCellera reports continued net losses of $146.4 million in 2025 and $162.9 million in 2024.
The filing highlights increased focus on platform scalability, partner reliance, and AI-related security risks.

What changed since the prior 10-K

New

NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if these markets achieve the forecasted growth, our drug candidates may fail to achieve sufficient market acceptance or adoption
Our market opportunity estimates may be inaccurate, and our drug candidates may fail to achieve sufficient market acceptance or adoption.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
application, approval of our drug candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our drug candidates
We rely on third parties like CROs and academic institutions to conduct clinical trials, which may cause significant delays or added costs.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
prevent new or modified drug candidates from being developed, or approved or commercialized in a timely manner or at all, which could negatively impact our business
Government funding fluctuations, regulatory backlogs, and global health concerns could delay the review and approval of our drug candidates.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Our drug candidates may have undesirable side effects that may delay or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales
Undesirable side effects in clinical trials could delay approval or require us to take our approved drugs off the market.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
consuming and costly process that will require us to provide scientific and clinical support for the use of a drug candidate that receives regulatory approval to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained
We must secure separate reimbursement coverage from payors for approved drugs under regulations like the Medicare Modernization Act of 2003.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We may not be successful in our efforts to use our drug discovery and development platform to build a pipeline of drug candidates
We may fail to successfully use our drug discovery platform to build a safe and effective pipeline of drug candidates.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Our management uses certain data to evaluate the advancement of our internal pipeline to make strategic decisions and such data may not accurately reflect all of the aspects of our business needed to make such evaluations and decisions, in particular as our business continues to grow
Management's internal data used to evaluate pipeline advancement and strategic decisions may not accurately reflect all aspects of our growing business.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data
Adopting generative artificial intelligence tools poses security risks to our confidential, proprietary, and personal data.
NewRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
liability claim, or series of claims, in which judgments exceed our insurance coverage could adversely affect our business, financial condition, results of operations, and prospects, including preventing or limiting the use of our discovery and development capabilities to discover antibodies
Higher director and officer liability insurance costs and reduced coverage limits could make it difficult to attract and retain qualified leadership.
NewRisks Related to Our Intellectual Property
protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies or a platform similar or identical to ours, and our ability to successfully sell our drug candidates, drugs, or services may be impaired
Inadequate patent protection could allow competitors to develop similar platforms and impair our ability to sell drug candidates or services.
NewRisks Related to Our Intellectual Property
required to file new applications and/or seek other forms of protection for any such alterations to our technology. There can be no assurance that we would be able to secure patent protection that would adequately cover an alternative to our technology
Uncertain patent positions and shifting court opinions in the life sciences sector could prevent us from securing adequate protection for our technology.

Dropped

DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
be no assurance that our partnerships will successfully develop, secure marketing approvals for and commercialize any therapeutics based on the antibodies that we discover. As a result, we may not realize the intended benefits of our partnerships
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
clinical testing and receive approval of any regulatory filing for our product candidates, the regulatory authority may approve our product candidates for a more limited indication or a narrower patient population than we originally requested
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
If clinical trials for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
later-stage clinical trials, particularly because early trials have smaller numbers of subjects tested. In addition, it is not uncommon for product candidates to exhibit unforeseen safety or efficacy issues, such as immunogenicity, when tested in humans despite promising results in preclinical animal models
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
Any failure or significant delay in commencing or completing clinical trials for our product candidates would adversely affect our ability to obtain regulatory approval, and our commercial prospects and ability to generate product revenue will be diminished
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
The design or our execution of clinical trials may not support regulatory approval
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
We may not be successful in our efforts to use our therapeutic platforms to build a pipeline of product candidates
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
sensitive data, conduct data protection assessments, transfer personal data to affiliates, and respond to consumer rights requests
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
Our restructuring and reorganization activities may be disruptive to our operations or ineffective
Partnership risks regarding development and commercialization of discovered antibodies.
DroppedRisks Related to our Business and the Development and Commercialization of Our Product Candidates
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation
DroppedRisks Related to Our Intellectual Property
issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects
DroppedRisks Related to Our Intellectual Property
The outcome of our litigation with Bruker Cellular Analysis may adversely affect our business, financial condition, results of operations and prospects

Reworded

88% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We have a limited number of drug candidates. If we do not obtain regulatory approval of one or more of our drug candidates, or experience significant delays in doing so, our business will be materially adversely affected
Updated to state that the majority of drug candidates are in preclinical development as of December 31, 2024.
Was: We have a limited number of product candidates, all which are still in preclinical development. If we do not obtain regulatory approval of one or more of our product candidates, or experience significant delays in doing so, our business will be materially adversely affected
77% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our drugs, it is less likely that our drugs will be widely used
Changed references from product to drug for regulatory and pricing approval processes.
Was: Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that our products will be widely used
76% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Successful development of our current and future drug candidates is uncertain and we may discontinue or reprioritize the development of any of our drug candidates at any time, at our discretion
Added a sentence noting that pipeline updates may highlight preclinical data supporting first-in-class or best-in-class profiles.
Was: Successful development of our current and future product candidates is uncertain and we may discontinue or reprioritize the development of any of our product candidates at any time, at our discretion
75% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We allocate our resources to pursue a particular drug candidate or indication and, as a result, may fail to capitalize on other drug candidates or indications that may be more profitable or for which there is a greater likelihood of success
Updated terminology from development candidates to drug candidates and commercial medicines.
Was: We allocate our resources to pursue a particular development candidate or indication and, as a result, may fail to capitalize on other development candidates or indications that may be more profitable or for which there is a greater likelihood of success
71% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We do not carry insurance for all categories of risk that our business may encounter and our policies have limits and significant deductibles. Some of the policies we currently maintain include general liability, property, umbrella and directors’ and officers’ insurance
Truncated the discussion on potential uninsured liability claims impacting discovery capabilities.
70% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
In addition, we expect to compete with biosimilar versions of already approved drugs, and even if our drug candidates achieve marketing approval, they may be challenged to achieve a price premium over competitive biosimilar drugs and will compete for market share with them
Replaced the word product with drug when discussing biosimilar competition under the BPCIA.
Was: In addition, we expect to compete with biosimilar versions of already approved products, and even if our product candidates achieve marketing approval, they may be challenged to achieve a price premium over competitive biosimilar products and will compete for market share with them
68% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
We have incurred losses in certain years since inception, including in 2025, and we may not be able to generate sufficient revenue to achieve profitability
Updated 2025 net loss to $146.4 million, 2024 net loss to $162.9 million, and added accumulated losses of $29.5 million.
Was: We have incurred losses in certain years since inception, including in 2024, and we may not be able to generate sufficient revenue to achieve profitability
63% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or protected health information or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation
Added four specific data protection risk categories: loss of access, inappropriate disclosure, inappropriate modification, and monitoring controls.
61% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Our commercial success depends on the quality of our antibody discovery and development capabilities, technological capabilities, the advancement of internal programs, and their acceptance by new and existing partners in our industry
57% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We may not be able to file applications or amendments to commence additional clinical trials on the timelines we expect, and even if we are able to file as expected, the regulatory body may not permit us to proceed
Was: We may not be able to file applications or amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the regulatory body may not permit us to proceed
55% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Interim, preliminary or top-line data from our clinical trials that we may announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
54% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our success depends on our ability to develop and monetize a drug, either independently or through significant economic participation. Unless and until either of those events occur, we do not anticipate being able to generate sufficient revenue to achieve profitability
Was: Our success depends on our ability to develop and monetize a therapeutic, either on our own or where we have significant participation. If or until either of those events occur, we do not anticipate being able to generate sufficient revenue to achieve profitability
49% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Failure to execute our business strategy could adversely impact our growth and profitability
48% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our revenue has fluctuated from period to period, and our revenue for any historical period may not be indicative of results that may be expected for any future period
48% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Upgrading and integrating our business systems could result in implementation issues and business disruptions
47% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
If any of our drug candidates receive regulatory approval, the approved drugs may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited
Was: If any of our product candidates receive regulatory approval, the approved products may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited
47% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Although we expect business acquisitions will result in synergies and other benefits to us, we may not realize those benefits because of uncertainties related to certain assets acquired as a result of the acquisitions
37% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
The failure of our partners to meet their contractual obligations to us could adversely affect our business
36% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Growth of our international business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of Canada and the United States
35% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Our billing and collections processing activities are time-consuming, and any delay in transmitting invoices or failure to comply with applicable billing requirements, could have an adverse effect on our future revenue
33% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Our long-term prospects depend in part upon discovering, developing and commercializing additional drug candidates, which may fail in development or suffer delays that adversely affect their commercial viability
Was: Our long-term prospects depend in part upon discovering, developing and commercializing additional product candidates, which may fail in development or suffer delays that adversely affect their commercial viability
31% rewrittenRisks Related to Ownership of Our Common Shares
The total purchase price pertaining to our acquisitions in recent years have been allocated to net tangible assets, identifiable intangible assets, in-process research and development and goodwill
30% rewrittenRisks Related to Our Financial Position and Need for Additional Capital
Our quarterly and annual operating results have fluctuated significantly in the past and may fluctuate significantly in the future, making it difficult to predict our future operating results and could cause our operating results to fall below expectations
28% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
If any product liability lawsuits are successfully brought against us or any of our partners, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates
Was: If any product liability lawsuits are successfully brought against us or any of our strategic partners, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
26% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
If we, or any of our partners, are unable to enroll patients in clinical trials, we will be unable to complete these trials on a timely basis or at all
26% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We face significant competition, and if our competitors develop and market therapies that are more effective, safer or less expensive than our drug candidates, our commercial opportunities will be negatively impacted
Was: We face significant competition, and if our competitors develop and market products that are more effective, safer or less expensive than our product candidates, our commercial opportunities will be negatively impacted
25% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
The loss of any member of our senior management team or our ability to attract and retain talent across the Company, including senior management, could adversely affect our business
24% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
If we do not achieve one or more of these requirements in a timely manner, we could experience significant delays or an inability to successfully commercialize our drug candidates, which would materially harm our business
Was: If we do not achieve one or more of these requirements in a timely manner, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business
24% rewrittenRisks Related to Our Intellectual Property
Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our technology
24% rewrittenRisks Related to Ownership of Our Common Shares
The market price of our common shares may be volatile, and you could lose all or part of your investment
23% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Material modifications in method of drug product manufacturing or formulating, and price controls imposed by governments may adversely affect our future profitability
Was: Material modifications in method of product candidate manufacturing or formulating, and price controls imposed by governments may adversely affect our future profitability
23% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We rely on a limited number of suppliers for laboratory equipment and materials and may not be able to find replacements or immediately transition to alternative suppliers
22% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
If our operating facilities become damaged or inoperable or we are required to vacate a facility, our ability to conduct and pursue our research and development efforts may be jeopardized
22% rewrittenRisks Related to Our Intellectual Property
We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business
21% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
If we or any of our third-party manufacturers encounter manufacturing difficulties, our ability to provide supply of drug product for clinical trials or our drug candidates for patients, if approved, could be delayed or prevented
Was: If we or any of our third-party manufacturers encounter manufacturing difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented
21% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
Even if we obtain FDA approval of any of our drug candidates, we may never obtain approval or commercialize such drugs outside of the United States, which would limit our ability to realize their full market potential
Was: Even if we obtain FDA approval of any of our product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential
21% rewrittenRisks Related to our Business and the Development and Commercialization of Our Drug Candidates
We have no marketed proprietary drugs and have not yet independently started late-stage clinical development, which makes it difficult to assess our ability to independently develop future drug candidates and monetize any resulting drugs
Was: We have no marketed proprietary products and have not yet independently started clinical development, which makes it difficult to assess our ability to independently develop future product candidates and monetize any resulting products

All 97 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Position and Need for Additional Capital

01We have incurred losses in certain years since inception, including in 2025, and we may not be able to generate sufficient revenue to achieve profitability68% rewritten
02Our success depends on our ability to develop and monetize a drug, either independently or through significant economic participation. Unless and until either of those events occur, we do not anticipate being able to generate sufficient revenue to achieve profitability54% rewritten
03Our revenue has fluctuated from period to period, and our revenue for any historical period may not be indicative of results that may be expected for any future period48% rewritten
04Our quarterly and annual operating results have fluctuated significantly in the past and may fluctuate significantly in the future, making it difficult to predict our future operating results and could cause our operating results to fall below expectations30% rewritten
05Unstable market and economic conditions may have serious adverse consequences on our business, financial condition, and share price

Risks Related to our Business and the Development and Commercialization of Our Drug Candidates

06Our commercial success depends on the quality of our antibody discovery and development capabilities, technological capabilities, the advancement of internal programs, and their acceptance by new and existing partners in our industry61% rewritten
07Failure to execute our business strategy could adversely impact our growth and profitability49% rewritten
08We allocate our resources to pursue a particular drug candidate or indication and, as a result, may fail to capitalize on other drug candidates or indications that may be more profitable or for which there is a greater likelihood of success75% rewritten
09Our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if these markets achieve the forecasted growth, our drug candidates may fail to achieve sufficient market acceptance or adoptionNew
10The failure of our partners to meet their contractual obligations to us could adversely affect our business37% rewritten
11Any of these factors could adversely impact their financial condition and results of operations, which could impair their ability to meet their contractual obligations to us, which may have a material adverse effect on our business, financial condition, and results of operations
12Our partners may not achieve projected discovery and development milestones and other anticipated key events in the expected timelines or at all, which could have an adverse impact on our business and could cause the price of our common shares to decline
13We may not be able to file applications or amendments to commence additional clinical trials on the timelines we expect, and even if we are able to file as expected, the regulatory body may not permit us to proceed57% rewritten
14We have no marketed proprietary drugs and have not yet independently started late-stage clinical development, which makes it difficult to assess our ability to independently develop future drug candidates and monetize any resulting drugs21% rewritten
15We have a limited number of drug candidates. If we do not obtain regulatory approval of one or more of our drug candidates, or experience significant delays in doing so, our business will be materially adversely affected88% rewritten
16application, approval of our drug candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional trials in support of potential approval of our drug candidatesNew
17Our long-term prospects depend in part upon discovering, developing and commercializing additional drug candidates, which may fail in development or suffer delays that adversely affect their commercial viability33% rewritten
18If we, or any of our partners, are unable to enroll patients in clinical trials, we will be unable to complete these trials on a timely basis or at all26% rewritten
19Interim, preliminary or top-line data from our clinical trials that we may announce or publish may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data55% rewritten
20prevent new or modified drug candidates from being developed, or approved or commercialized in a timely manner or at all, which could negatively impact our businessNew
21Successful development of our current and future drug candidates is uncertain and we may discontinue or reprioritize the development of any of our drug candidates at any time, at our discretion76% rewritten
22Our drug candidates may have undesirable side effects that may delay or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their salesNew
23If any of our drug candidates receive regulatory approval, the approved drugs may not achieve broad market acceptance among physicians, patients, the medical community and third-party payors, in which case revenue generated from their sales would be limited47% rewritten
24Even if we obtain FDA approval of any of our drug candidates, we may never obtain approval or commercialize such drugs outside of the United States, which would limit our ability to realize their full market potential21% rewritten
25If we do not achieve one or more of these requirements in a timely manner, we could experience significant delays or an inability to successfully commercialize our drug candidates, which would materially harm our business24% rewritten
26Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our drugs, it is less likely that our drugs will be widely used77% rewritten
27consuming and costly process that will require us to provide scientific and clinical support for the use of a drug candidate that receives regulatory approval to each payor separately, with no assurance that coverage and adequate reimbursement will be obtainedNew
28We may not be successful in our efforts to use our drug discovery and development platform to build a pipeline of drug candidatesNew
29Even if we receive regulatory approval to commercialize any of the drug candidates that we develop, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense
30If any product liability lawsuits are successfully brought against us or any of our partners, we may incur substantial liabilities and may be required to limit commercialization of our drug candidates28% rewritten
31If we or any of our third-party manufacturers encounter manufacturing difficulties, our ability to provide supply of drug product for clinical trials or our drug candidates for patients, if approved, could be delayed or prevented21% rewritten
32Material modifications in method of drug product manufacturing or formulating, and price controls imposed by governments may adversely affect our future profitability23% rewritten
33Current and future legislation may increase the difficulty and cost for us to commercialize any drug that we or our partners develop and affect the prices we may obtain
34Our business may be adversely affected by public health outbreaks and pandemics
35Healthcare providers, physicians, and third-party payors in the countries in which we operate and elsewhere play a primary role in the recommendation and prescription of any drug candidates for which we obtain marketing approval
36Because of the breadth of these laws and the narrowness of any available statutory exceptions and safe harbors, it is possible that some of our current and future business activities could be subject to challenge under one or more of such laws
37We face significant competition, and if our competitors develop and market therapies that are more effective, safer or less expensive than our drug candidates, our commercial opportunities will be negatively impacted26% rewritten
38In addition, we expect to compete with biosimilar versions of already approved drugs, and even if our drug candidates achieve marketing approval, they may be challenged to achieve a price premium over competitive biosimilar drugs and will compete for market share with them70% rewritten
39Our management uses certain data to evaluate the advancement of our internal pipeline to make strategic decisions and such data may not accurately reflect all of the aspects of our business needed to make such evaluations and decisions, in particular as our business continues to growNew
40We depend on our information technology systems, and any failure of these systems could harm our business
41Upgrading and integrating our business systems could result in implementation issues and business disruptions48% rewritten
42Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or protected health information or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation63% rewritten
43We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure
44Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal dataNew
45The loss of any member of our senior management team or our ability to attract and retain talent across the Company, including senior management, could adversely affect our business25% rewritten
46We have made technology acquisitions and may acquire businesses or assets or make investments in other companies or technologies, any of which could negatively affect our operating results, dilute our shareholders’ ownership, increase our debt or cause us to incur significant expense
47Our billing and collections processing activities are time-consuming, and any delay in transmitting invoices or failure to comply with applicable billing requirements, could have an adverse effect on our future revenue35% rewritten
48If our operating facilities become damaged or inoperable or we are required to vacate a facility, our ability to conduct and pursue our research and development efforts may be jeopardized22% rewritten
49We do not carry insurance for all categories of risk that our business may encounter and our policies have limits and significant deductibles. Some of the policies we currently maintain include general liability, property, umbrella and directors’ and officers’ insurance71% rewritten
50liability claim, or series of claims, in which judgments exceed our insurance coverage could adversely affect our business, financial condition, results of operations, and prospects, including preventing or limiting the use of our discovery and development capabilities to discover antibodiesNew
51Growth of our international business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of Canada and the United States36% rewritten
52Our business is subject to risks relating to foreign currency exchange rates
53We rely on a limited number of suppliers for laboratory equipment and materials and may not be able to find replacements or immediately transition to alternative suppliers23% rewritten
54Unexpected shortages in raw materials or other materials and other unanticipated events could adversely affect our business, prospects, financial condition, and results of operation
55We use biological and hazardous materials that require considerable expertise and expense for handling, storage and disposal and may result in claims against us
56Our discovery and development capabilities, and internal programs, utilize various species of animals that could contract disease or die and could otherwise subject us to controversy and adverse publicity, which may interrupt our business operations or harm our reputation
57Our manufacturing operations will be dependent upon third-party suppliers, including single-source suppliers, making us vulnerable to supply shortages and price fluctuations, which could harm our business
58Although we expect business acquisitions will result in synergies and other benefits to us, we may not realize those benefits because of uncertainties related to certain assets acquired as a result of the acquisitions47% rewritten

Risks Related to Our Intellectual Property

59protection obtained is not sufficiently broad, our competitors could develop and commercialize technologies or a platform similar or identical to ours, and our ability to successfully sell our drug candidates, drugs, or services may be impairedNew
60required to file new applications and/or seek other forms of protection for any such alterations to our technology. There can be no assurance that we would be able to secure patent protection that would adequately cover an alternative to our technologyNew
61Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our technology24% rewritten
62Issued patents covering our discovery and development capabilities could be found invalid or unenforceable if challenged
63If we cannot acquire or license rights to use technologies on reasonable terms or if we fail to comply with our obligations under such agreements, we may not be able to commercialize new technologies or services in the future and our business could be harmed
64While we still face all of the risks described herein with respect to those agreements, we cannot prevent third parties from also accessing those technologies. In addition, our licenses may place restrictions on our future business opportunities
65We may not be able to protect our intellectual property rights throughout the world
66Intellectual property rights do not necessarily address all potential threats to our competitive advantage
67If we are unable to protect the confidentiality of our information and our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed
68We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
69We may not be able to protect and enforce our trademarks and trade names, or build name recognition in our markets of interest thereby harming our competitive position
70We may be subject to claims challenging the inventorship of our patents and other intellectual property
71We are currently, and in the future may be, involved in litigation and other proceedings related to intellectual property, which could be time-intensive and costly and may adversely affect our business, financial condition, results of operations, and prospects
72The outcome of our civil litigation with Schrader may adversely affect our business, financial condition, results of operations, and prospects
73Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
74We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business22% rewritten
75Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
76Patent terms may be inadequate to protect our competitive position on our technology for an adequate amount of time
77Our use of open source software could compromise our ability to offer our products and services and subject us to possible litigation

Risks Related to Ownership of Our Common Shares

78If we fail to maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed
79Future sales and issuances of our common shares or rights to purchase common shares, including pursuant to our Employee Share Option and Incentive Plan, or ESOIP, could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall
80Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our technologies
81We do not intend to pay dividends on our common shares, so any returns will be limited to the value of our common shares
82Our principal shareholders and management own a significant percentage of our shares and will be able to exert significant influence over matters subject to shareholder approval
83We have filed registration statements on Form S-3 and on Form S-8 to register our common shares that are issuable pursuant to our equity incentive plans. Shares registered under Form S-8 will be available for sale in the public market subject to vesting arrangements and exercise of options
84We are governed by the corporate laws of Canada which in some cases have a different effect on shareholders than the corporate laws of the United States
85Our articles and certain Canadian legislation contain provisions that may have the effect of delaying, preventing or making undesirable an acquisition of all or a significant portion of our shares or assets or preventing a change in control
86Our articles designate specific courts in Canada and the United States as the exclusive forum for certain litigation that may be initiated by our shareholders, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us
87Because we are a Canadian company, it may be difficult to serve legal process or enforce judgments against us
88If our estimates or judgments relating to our critical accounting policies prove to be incorrect or financial reporting standards or interpretations change, our results of operations could be adversely affected
89Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
90Our U.S. shareholders may suffer adverse tax consequences if we are characterized as a PFIC
91Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits
92Changes in tax law could adversely affect our business and financial condition
93The total purchase price pertaining to our acquisitions in recent years have been allocated to net tangible assets, identifiable intangible assets, in-process research and development and goodwill31% rewritten
94Our employees, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading
95The market price of our common shares may be volatile, and you could lose all or part of your investment24% rewritten
96Requirements associated with being a public company could increase our costs significantly, as well as divert significant company resources and management attention
97If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline

Other AbCellera Biologics 10-Ks

FY2024 10-K risk factors
98 risks
AbCellera relies heavily on unproven antibody discovery platforms and early-stage therapeutics pipelines with no commercial products yet.
Filed Feb 27, 2025

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.