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Sun Sep 6 · markets closed2 signals today321 insider buys this week · $404MCIRO short report next: Sep 15The week ahead

ABCL

AbCellera Biologics Inc.
NASDAQ · HEALTH CARE · PHARMACEUTICAL PREPARATIONS
11.43
−0.14 −1.21%
USD · close Sep 4

How ABCL rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
51%
of sentences unchanged
Added
380
new sentences
Dropped
412
sentences removed
Length
−1,187
words, now 43,910

New in FY2025

  • Risks 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.
  • We cannot accurately predict the timing or amount of our increased expenses, or when, if at all, we may achieve profitability.
  • Our net loss for the years ended December 31, 2025 and 2024 was $146.4 million and $162.9 million, respectively.
  • Our accumulated losses at December 31, 2025 and accumulated earnings at 2024 was $29.5 million and $116.9 million, respectively.
  • 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.
  • Developing a drug on our own will require us to succeed in a range of challenging activities that are still in the preliminary stages, including developing drug candidates, obtaining regulatory approval, manufacturing, and commercializing approved drugs.
  • We may never succeed in these activities and generate revenue from drug sales from our internal pipeline that are significant enough to achieve profitability.
  • Our failure to become or remain profitable would depress our market value and impair our ability to raise capital, expand our pipeline, develop drug candidates, or continue our operations.
  • We have, and continue to receive, revenue from our partnership contracts and are eligible to receive future milestones and royalties related to potential future success of antibodies that we have discovered under past and existing agreements.
  • These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to: • interest income from our cash management strategy, which is subject to variability due to cash, cash equivalents and marketable securities balances and market interest yields available to the Company; • the timing and cost of, and level of investment in, research, clinical development and commercialization activities relating to our discovery and development capabilities and initiation and advancement of internal programs, which may change from time to time; • the cost of maintaining and running our GMP facility, activities which are new to us; • our ability to generate viable development candidates; • the relative reliability and robustness of our discovery and development capabilities, including our data generation and computational tools; • the introduction of new technologies, platform features or software, by us or others in our industry; • costs that we may incur to acquire, develop or commercialize additional technologies; • costs and fees occurring in litigation that we may be involved in; • the degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among our competitors or future partners; • natural disasters, pandemics, outbreaks of disease or public health crises; • the timing and nature of any future acquisitions or partnerships; • future accounting pronouncements or changes in our accounting policies; and • general social, political and economic conditions and other factors, including inflationary pressures and factors unrelated to our operating performance or the operating performance of our competitors.
  • We may need to raise additional capital to fund our existing operations, improve our discovery and development capabilities, advance internal programs through the clinic, or expand our operations.
  • If we are unable to raise additional capital on terms acceptable to us or at all or generate cash flows necessary to maintain or expand our operations and pipeline investments, we may not be able to compete successfully, which would harm our business, operations, and financial condition.
  • Based on our current business plan, we believe our available liquidity from existing cash and cash equivalents, marketable securities, and anticipated cash flows from operations and government contributions, will be sufficient to meet our working capital and capital expenditure needs.
  • If our available cash resources together with our anticipated cash flow from operations are insufficient to satisfy our liquidity requirements including because of the realization of other risks described in this report, we may be required to raise additional capital prior to such time through issuances of equity or convertible debt securities, entrance into a credit facility or another form of third-party funding or seek other debt financing, including real estate and asset backed financing on the significant investments we have funded towards our corporate headquarters and GMP facility.
  • Such additional future financing may not be available on terms acceptable to us or at all.
  • For example, this may include reasons such as to: • fund development and marketing efforts of our current and future internal and partner programs; • expand our discovery, development, clinical and regulatory capabilities; • advance our current and future drug candidates through clinical trials; • acquire, license or invest in technologies; • acquire or invest in complementary businesses or assets; and • finance capital expenditures and general and administrative expenses.
  • Our present and future funding requirements will depend on many factors, including: • our ability to achieve revenue growth; • the cost of expanding our operations, including our GMP activities; • the initiation and advancement of internal programs and marketing activities associated therewith; • our rate of progress in, and cost of research and development activities associated with, antibody discovery and development for our internal pipeline; • the receipt of potential future payments from partners related to milestones, royalties, and licensing; • the effect of competing technological and market developments; • costs and fees occurring in litigation that we may be involved in; and • costs related to any business and operations expansion.
  • Debt financing and preferred equity financing, if available, may also involve agreements that include covenants restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our assets, making acquisitions, making capital expenditures, or declaring dividends.
  • For example, in December 2025, we obtained financing secured against our office building held in our Dayhu joint venture.
  • This financing, along with our agreement with the Strategic Response Fund (SRF), previously Strategic Innovation Fund (SIF), subjects us to certain restrictive covenants.
  • Our agreement with the SRF requires that we obtain prior consent for specific corporate actions, such as when an entity acquires 20% or more of our voting securities.
  • Similarly, our December 2025 financing includes covenants that restrict our ability to sell or transfer the secured property without lender consent and change of control provisions when any person or group acquires beneficial ownership of more than 25% of our voting shares.
  • If we fail to comply with these covenants or obtain necessary consents, we could be obligated to repay all or a portion of the contribution amounts from SRF and the outstanding principal under our financing, which would have a material adverse effect on our business, financial condition, and results of operations.
  • In addition, failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our strategy, financial performance, and share price.
  • Risks 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.
  • As a result, the quality and sophistication of our discovery and development capabilities is critical to our ability to conduct our research discovery activities and to deliver promising drug candidates.
  • In particular, our business depends, among other things, on: • our discovery and development capabilities to successfully identify drug candidates on the desired timeframes that can ultimately be used as medicines to prevent and treat diseases; • our capabilities to successfully advance our current and future drug candidates through clinical trials; • our ability to successful employ our newly constructed GMP facility to advance our pipeline; • our ability to utilize our discovery and development capabilities to build a robust pipeline of potential development candidates; • our ability to partner drug candidates from our internally developed pipeline; • the rate at which partners continue to develop molecules in which we hold an economic stake; • the timing and scope of any approval that may be required by regulatory bodies for drugs that are developed based on antibodies discovered by us; • the impact of our investments in innovation and commercial growth.
  • There can be no assurance that we will successfully address any of these or other factors that may affect the ability of our discovery and development capabilities to create viable molecules that ultimately lead to commercially viable drugs.
  • If we cannot create commercially viable drugs, our business, financial condition, results of operations, and prospects could be adversely affected.
  • Furthermore, our strategic pivot from a primarily partnership-focused business to one focused on developing our own internal pipeline of antibody medicines requires different capital allocation, operational expertise, and risk management compared to our historical partnership model.
  • As we direct substantial resources toward our internal programs, we may experience reduced near-term revenue from partnerships, increased cash costs, and greater exposure to the often binary risks of clinical trial outcomes.
  • If we fail to successfully manage this strategic transition, or if our internal pipeline fails to generate value that outweighs the reduction in partnership focus, our business and valuation may suffer.
  • Business” included in our Annual Report on Form 10-K for the year ended December 31, 2025.
  • 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.
  • We allocate our resources to certain research programs and drug candidates.
  • As a result, we may forgo or delay pursuit of opportunities with other drug candidates or for our current development candidates in other indications that later prove to have greater commercial potential.
  • Our spend on current and future research and development programs and ongoing clinical development of drug candidates for specific indications may not yield commercially viable medicines.
  • Development of a biological molecule or other drug is inherently uncertain, and it is possible that none of the drug candidates discovered using our discovery and development capabilities that are further developed by us or our partners will receive marketing approval or become viable commercial drugs, on a timely basis, or at all.
  • These partners include pharmaceutical companies, biotechnology companies, and non-profit and government organizations.

and 340 more.

Gone since FY2024

  • Risks Related to Our Financial Position and Need for Additional Capital 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.
  • We cannot accurately predict the timing or amount of our increased expenses, or when and if we may be able to achieve profitability.
  • Our net loss for the years ended December 31, 2024 and 2023 was $162.9 million and $146.4 million, respectively.
  • Our accumulated earnings at December 31, 2024 and 2023 was $116.9 million and $279.8 million.
  • 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.
  • Developing a therapeutic on our own will require us to be successful in a range of challenging activities for which we are only in the preliminary stages, including developing product candidates, obtaining regulatory approval, manufacturing, and commercializing approved products.
  • We may never succeed in these activities and generate revenue from product sales from our internal pipeline that is significant enough to achieve profitability.
  • Our failure to become or remain profitable would depress our market value and impair our ability to raise capital, expand our business, develop other product candidates, or continue our operations.
  • During the years ended December 31, 2020, 2021 and 2022 we generated revenue related to royalty payments upon net sales of antibodies that we discovered.
  • In 2021 and 2022, these royalty payments related to our partnership with Lilly upon sales of bamlanivimab and bebtelovimab, antibodies designed to treat and prevent COVID-19.
  • Since November 2022, when the FDA announced that bamlanivimab and bebtelovimab, respectively were no longer authorized for emergency use and, as a result, we have not, and we do not expect to, generate revenue from royalties associated with Lilly's sales of our COVID-19 antibodies going forward.
  • We have, and continue to receive, other forms of revenue from our partnership contracts and are eligible to receive future milestones and royalties related to potential future success of antibodies that we have discovered under past and existing agreements.
  • These fluctuations may occur due to a variety of factors, many of which are outside of our control, including, but not limited to: • interest income from our cash management strategy, which is subject to variability due to cash, cash equivalents and marketable securities balances and market interest yields available to the Company; • the timing and cost of, and level of investment in, research, development and commercialization activities relating to our discovery and development capabilities and initiation and advancement of internal programs, which may change from time to time; • the cost of maintaining and running our GMP facility, activities which are new to us; • our ability to generate viable development candidates; • the relative reliability and robustness of our discovery and development capabilities, including our data generation and computational tools; • the introduction of new technologies, platform features or software, by us or others in our industry; • costs that we may incur to acquire, develop or commercialize additional technologies; • costs and fees occurring in litigation that we may be involved in; • the degree of competition in our industry and any change in the competitive landscape of our industry, including consolidation among our competitors or future partners; • natural disasters, pandemics, outbreaks of disease or public health crises; • the timing and nature of any future acquisitions or strategic partnerships; • future accounting pronouncements or changes in our accounting policies; and • general social, political and economic conditions and other factors, including inflationary pressures and factors unrelated to our operating performance or the operating performance of our competitors.
  • We may need to raise additional capital to fund our existing operations, improve our discovery and development capabilities, advance internal programs, or expand our operations.
  • If we are unable to raise additional capital on terms acceptable to us or at all or generate cash flows necessary to maintain or expand our operations, we may not be able to compete successfully, which would harm our business, operations, and financial condition.
  • Based on our current business plan, we believe our available liquidity from existing cash and cash equivalents, marketable securities, and anticipated cash flows from operations and government contributions, will be sufficient to meet our working capital and capital expenditure needs and expenditure required for later stage development of our internal pipeline.
  • If our available cash resources together with our anticipated cash flow from operations are insufficient to satisfy our liquidity requirements including because of the realization of other risks described in this annual report, we may be required to raise additional capital prior to such time through issuances of equity or convertible debt securities, entrance into a credit facility or another form of third-party funding or seek other debt financing, including real estate and asset backed financing on the significant investments we have funded towards our corporate headquarters and GMP facility which are currently under construction.
  • Such additional financing may not be available on terms acceptable to us or at all.
  • For example, this may include reasons such as to: • fund development and marketing efforts of our current and future internal and partner programs; • expand our discovery and development capabilities; • acquire, license or invest in technologies; • acquire or invest in complementary businesses or assets; and • finance capital expenditures and general and administrative expenses.
  • Our present and future funding requirements will depend on many factors, including: • our ability to achieve revenue growth; • the cost of expanding our operations, including our planned GMP activities; • our rate of progress in selling access to our discovery and development capabilities, the initiation and advancement of internal programs and marketing activities associated therewith; • our rate of progress in, and cost of research and development activities associated with, antibody discovery and development for our internal pipeline; • the effect of competing technological and market developments; • costs and fees occurring in litigation that we may be involved in; and • costs related to any business and operations expansion.
  • Debt financing and preferred equity financing, if available, may also involve agreements that include covenants restricting our ability to take specific actions, such as incurring additional debt, selling or licensing our assets, making product acquisitions, making capital expenditures, or declaring dividends.
  • For example, our agreement with the Strategic Innovation Fund, or SIF, requires that we obtain consent in the event that an individual or company (or two or more of them acting in concert) acquires the direct or indirect beneficial ownership of 20% or more of our voting securities.
  • In the event consent is not obtained, the agreement may be terminated and we will be obligated to repay all or a portion of the contribution amounts from SIF.
  • In addition, failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and share price.
  • Risks Related to our Business and the Development and Commercialization of Our Product 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.
  • As a result, the quality and sophistication of our discovery and development capabilities is critical to our ability to conduct our research discovery activities and to deliver more promising molecules and to accelerate and lower the costs of discovery as compared to traditional methods for our partnerships.
  • In particular, our business depends, among other things, on: • our discovery and development capabilities to successfully identify therapeutic antibodies on the desired timeframes that can ultimately be used to prevent and treat diseases; • our ability to successful employ our newly constructed GMP facility to advance our pipeline; • our ability to utilize our discovery and development capabilities to build a robust pipeline of potential development candidates; • our ability to partner our internally developed pipeline; • our ability to increase awareness of the capabilities of our technology and solutions; • our partners’ and potential partners’ willingness to adopt new technologies; • whether our discovery and development capabilities reliably provide advantages over legacy and other alternative technologies and is perceived by customers to be cost effective; • the rate of adoption of our solutions by pharmaceutical companies, biotechnology companies of all sizes, government organizations and non-profit organizations and others; • the relative reliability and robustness of our discovery and development capabilities; • the timing and scope of any approval that may be required by regulatory bodies for therapeutics that are developed based on antibodies discovered by us; • the impact of our investments in innovation and commercial growth; • negative publicity regarding our or our competitors’ technologies resulting from defects or errors; and • our ability to further validate our technology through research and accompanying publications.
  • There can be no assurance that we will successfully address any of these or other factors that may affect the ability of our discovery and development capabilities to create viable molecules that ultimately lead to commercially viable therapeutics.
  • If we cannot create commercially viable therapeutics, our business, financial condition, results of operations and prospects could be adversely affected.
  • Business” included in our Annual Report on Form 10-K for the year ended December 31, 2024.
  • 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.
  • We allocate our resources to certain research programs and development candidates.
  • As a result, we may forgo or delay pursuit of opportunities with other development candidates or for our current development candidates in other indications that later prove to have greater commercial potential.
  • Our spend on current and future research and development programs and development candidates for specific indications may not yield commercially viable therapeutics.
  • If we do not accurately evaluate the commercial potential or target market for a particular development candidate, we may relinquish valuable rights to that candidate through collaboration, licensing or other commercialization opportunities.
  • Development of a biological molecule is inherently uncertain, and it is possible that none of the antibody-drug candidates discovered using our antibody discovery and development capabilities that are further developed by us or our partners will receive marketing approval or become viable commercial products, on a timely basis, or at all.
  • These partners include large cap pharmaceutical companies, biotechnology companies of all sizes and non-profit and government organizations.
  • While we receive upfront payments from our partners generated through technology access and discovery research fees, we estimate that the vast majority of the economic value of the contracts that we enter with our partners is in the downstream payments that are payable if certain milestones are met or approved products are sold.
  • Due to our reliance on our partners, the risks relating to product development, regulatory clearance, authorization or approval and commercialization apply to us derivatively through the activities of our partners.

and 372 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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