Item 1. Business.
OVERVIEW
We are a team of scientists, engineers, and business professionals focused on discovering and developing first-in-class and best-in-class antibody-based medicines for indications with high unmet medical need. To address the barriers of conventional antibody drug development, we have built the capabilities to advance innovative, differentiated antibody drug programs, from target to the clinic. To maximize the value and impact of our work, we are advancing a pipeline of internal programs and strategically partnering with companies that have novel science, innovative technology, or a strong track record of bringing programs through clinical development. Our first two internal programs, ABCL635 and ABCL575, are currently in late-preclinical studies. ABCL635 is a potential first-in-class antibody drug candidate for metabolic and endocrine conditions, and ABCL575 is a potential best-in-class antibody drug candidate with broad potential in inflammatory conditions and autoimmune diseases and an initial indication in atopic dermatitis. We intend to submit Clinical Trial Applications (CTAs), the Canadian equivalent to an Investigational New Drug (IND) submission, for both programs in Q2 2025. In addition to ABCL635 and ABCL575, we are advancing a pipeline of more than 20 internal discovery programs across multiple modalities and indications.
Our strategy is to build a competitive advantage in the creation of antibody medicines and use that advantage to bring innovative and impactful medicines to patients.
We have several core beliefs that impact how we think about our business:
1.Investments in technology will improve the quality, speed, and success of antibody drug development.
2.Long-term value-creation begins with building a company that can create multiple products repeatedly and successfully.
3.People are the foundation of success.
4.Building a great company takes time. We define our strategy and allocate resources to optimize long-term value.
After more than a decade of building our Company and working on over 100 drug discovery programs, we have grown from six entrepreneurial founders in a laboratory, to a high-performing team of approximately 600 people. We are focused on the development of antibody-based drugs and are committed to improving the way these drugs are discovered, developed, and brought to patients. As business operators, we think deeply about capital allocation and strive to maximize long-term value by advancing a portfolio of antibody therapeutics both in our internal pipeline and with our strategic partners.
Our strategy is to:
•Build integrated and differentiated antibody discovery and development capabilities that bring next generation antibody therapeutics to the clinic;
•Use those capabilities to bring a portfolio of potential first-in-class and best-in-class programs in areas of high unmet medical need to the clinic for ourselves and for our partners; and
•Capture value through our ownership of a portfolio of programs, varying from royalty positions to outright ownership of potential future antibody therapeutics.
Our Business Model
We build and apply our capabilities to solve long-standing problems in drug discovery and development. As we do, we convert investments in talent and technology into intellectual capital: intellectual property, know-how, optimized workflows, expertise, data, and ultimately drugs. We believe this continued accumulation of intellectual capital makes our internal capabilities increasingly effective at discovering and developing future antibody drugs. Our teams and technology get stronger as we solve each new problem. Improved capabilities enable and attract new program opportunities.
Our integrated capabilities were built through over 10 years of drug discovery partnerships with some of the industry’s most innovative groups. Historically, a significant part of our business has been based on partnering. Partners seeking a competitive advantage approach us with ideas for new antibody drugs and specific problems that need to be solved. We deliver optimized antibody drug candidates for further preclinical development. We structure each partner-initiated
program to reflect the needs of the program and the contributions from each partner. These can take the form of partner-initiated discovery agreements, which include near-term payments, clinical and commercial milestones, and royalties on net sales. Increasingly, we are entering into co-development agreements where both partners contribute to and co-lead drug discovery and development. In the future we would anticipate some outlicensing activities of our internal portfolio if we believe that a future partner would be a better sponsor of the prospective drug to the benefit of patients. The majority of the value of every deal is associated with downstream stakes in the success of a program that accrue in our portfolio. This is complemented by upfront payments, research fees, and milestones that help manage nearer-term cash requirements of AbCellera. All together, we believe that these dynamics allow us to deploy capital efficiently across our company.
As of December 31, 2024, we have started 96 partner-initiated programs with downstream participation. At the portfolio level, we reduce risk through diversification across discovery programs, therapeutic areas, and partners, making our portfolio risk significantly lower than the risk that is typical of single drug development programs. We strategically select partners and programs to include in our portfolio based on our assessment of their unique insights or capabilities and their likelihood of success, thereby creating a slice of the market that we believe is enriched for its best parts.
We have also deployed capital to expand and apply our capabilities in drug development areas of high value. These self-initiated technology-development efforts seek to overcome technical barriers in industry and are now producing wholly owned assets. We evaluate each internal program on a program-by-program basis to determine if we will advance resulting molecules into preclinical and clinical development ourselves, co-develop them with partners, or out-license them to maximize their clinical and commercial opportunities. We have developed specific technologies to generate potential first-in-class and best-in-class antibody medicines for well-validated targets in the areas of G-protein-coupled receptors (GPCRs) and ion channels, and T-cell engagers (TCEs). These capabilities allow us to increasingly initiate drug discovery and development efforts ourselves, giving rise to our internal program pipeline.
We are well-positioned to execute on our business strategy
We believe that companies in our space should be evaluated not on the promise of their technology, but on the output of their platforms. We believe evidence of a successful platform includes:
•Success in solving discovery problems that are recognized as difficult across the biotechnology industry;
•A growing list of new and expanding partnerships with top-tier drug-developers; and
•A growing number of drug candidates discovered on the platform advancing towards and through the clinic – in our own hands or those of our partners.
Since our incorporation in 2012, we have accumulated over 10 years of experience discovering therapeutic antibody candidates and have built substantial capabilities, scale, and expertise. We estimate that we have invested over $600 million in our internal capabilities and – with over 40 partnerships, and approximately 600 employees – we believe we have earned a significant competitive advantage in the maturity of our technology and the scale of our operations. We have worked on more than 100 different programs and have succeeded in discovering antibodies against recognized difficult targets. We have also validated our capabilities both clinically and commercially. Since 2012, we have generated over $100 million in cumulative earnings and have approximately $840 million in available liquidity as of December 31, 2024 to continue executing on our strategy.
We expect to generate losses and negative operating cash flow in the near-to-medium term ahead of revenues generated from outlicensing- and milestone payments and royalties in the longer term.
OUR STRATEGY
The development of antibody-based drugs comes with unique challenges
Antibodies are specialized proteins, adept at binding biological and non-biological targets with high specificity and potency. This gives antibodies potential tolerability advantages relative to small-molecule-based drugs and makes therapeutic antibodies central to the precision-medicine toolkit. In addition, the success rates of antibodies in the clinic are driving drug developers of all sizes to invest in antibody drug development. Together, these factors contribute to the rapid growth of the therapeutic antibody market.
As proteins, antibodies are larger and more complex than small-molecule drugs. This creates unique challenges for drug developers. For example, antibodies and other protein-based drugs are more costly and time-consuming to manufacture compared to small molecules. Similarly, obtaining the right antibody for a particular program requires highly specialized capabilities relating to immunization, screening, high-throughput analytics, functional and biophysical characterization, protein engineering, and optimization. Efficient development of antibody therapies involves the integration of highly
specialized skills, technology, and infrastructure – something that few firms can do successfully. For this reason, we believe there is a serious structural challenge in the biotechnology industry that makes it difficult to turn biological insights into drugs that are ready for clinical testing.
These problems, inherent in developing new drugs, are hard to solve. As the biotechnology industry matures and becomes increasingly competitive, the issues are getting more complex. Solving these problems will open new areas of drug development and has the potential to unlock additional value.
Our founding idea and insight
Our Company was founded to deliberately re-think the optimal approach to discovery and development of new antibody drugs. This idea originated from deep insights into the structure of our industry and the three essential steps of drug development, which are:
1.Product ideation. This step includes basic science and biomedical research to identify disease targets and define the properties of an optimal antibody therapy.
2.Product creation. Once ideation is complete, the next step is to create the therapeutic product candidate. This step is arguably one of the most complex, regulated, and technologically intensive in any sector, yet this is also the step that is most critical to get right.
3.Product testing. Once the drug developer has committed to a therapeutic product, it must be thoroughly tested in patients to demonstrate safety and efficacy. This is the step that incurs most of the product development spend. It is also the step that represents the most frequent, and most expensive, point of failure.
We believe there has been chronic underinvestment in developing product-creation capabilities for antibody drug development. We also believe this step represents significant opportunities for learning and the development of capabilities that are transferable between different drug development projects. Finally, we believe this is where technology investments can most effectively drive value.
Our integrated capabilities for accelerated drug discovery
Our founders aspired to create a seamless platform for antibody discovery and development, grounded in sound biology, process engineering, and design principles. Functionally, the goal of these efforts is to systematically produce therapeutic antibodies that meet the many requirements for proceeding into clinical testing. Over the past decade, we have worked to achieve this vision to break the barriers of conventional antibody discovery and development to advance optimal antibody drug candidates into the clinic.
We discover antibodies from natural immune responses, which are pre-enriched for antibodies with higher target-binding specificity and developability than those generated by synthetic methods. We maximize the search space through proprietary immunization strategies and single-cell screening to generate a wide range of diverse antibodies. We downselect these antibodies to optimal clinical candidates using robust characterization and developability assessments.
AbCellera integrates expert teams, technology, and facilities with data science and automation to support the optimized workflows that are necessary to move therapeutic programs from concept through to the clinic. Today, our capabilities allow us to take discovery and development programs through to the delivery of optimal clinical candidates. To vertically expand, we are integrating process development, manufacturing, and regulatory capabilities into our capabilities. When complete, we will be able to advance programs from targets to delivery of investigational drug products, complete with data and the regulatory documents necessary to start clinical testing. We expect these multi-year investments to be completed in 2025, with the first run of our clinical manufacturing facility.
AbCellera brings together data and computational tools
A key pillar of AbCellera is integrating modern software and data science infrastructure. Across many sectors, data science has revolutionized business performance, but biotechnology has yet to exploit many of its most promising applications.
Our data science efforts primarily aim to make our business more efficient and scalable. We achieve this by integrating software and data architectures with our experimental work into a much larger engine.
AbCellera integrates data collection, standardization, and storage with a suite of computational tools and an interactive interface that allows our scientists to explore and interpret complex antibody data sets quickly. Data from every experiment is securely stored in a central database designed to maintain the relationships that exist between different measurement types, samples, protocols, metadata, and antibodies. Because we do not rely on third-party data, we are able to maintain strict data quality assurance and standardization.
We believe this approach provides an advantage that increases the value of the data resulting from discovery programs, as we can extract informative insights by uncovering hidden relationships within the data. We believe that managing data and leveraging the proprietary datasets in this way allows us to continually refine our approach to antibody drug development and leverage the benefits of artificial intelligence and machine learning methods.
Our data science infrastructure allows us to make use of artificial intelligence and machine learning methods
Artificial intelligence (“AI”) generally refers to advanced computational methods and algorithms that enable the discovery of data features, patterns, or associations within large and complex data sets that can be used to classify data sets, make predictions, and solve problems.
We currently use AI and machine learning methods extensively emphasizing the automation and scaling of data operations associated with our experimental workflows. While we believe AI has tremendous potential to accelerate antibody discovery through the prediction, engineering, and potentially even de novo design of antibodies with improved therapeutic properties, we believe many of the claims associated with AI drug discovery are ahead of current capabilities. What we believe is missing, in most cases, is the data and the experimental capabilities needed to iterate and learn. Ultimately, we believe it is only through the accumulation of large, complex, and high-quality data sets that the full promise of AI in drug discovery will be realized.
We believe a strong foundation that integrates large-scale experimentation with software and data infrastructure will be required to successfully apply AI and machine learning methods to biological data sets. We believe this is the only way the necessary data sets can be captured and standardized, while also maintaining the integrity of relationships between different data types. We also believe the importance and difficulty of developing the necessary robust software and data infrastructure is widely underestimated.
We invest significant resources to build the necessary foundations for successfully using AI and machine learning methods. We generate large amounts of data throughout each program. We can capture these large data sets because we (i) prioritize investing in the experimental capabilities and their necessary integrations with software and data science and (ii) use these capabilities frequently in real drug discovery and development programs. We believe these features of our business will position us to be a leader in applying advanced computation to antibody drug development.
We are building a competitive advantage in going from target to clinic
Already, we find that seamless data capture along an integrated end-to-end workflow allows us to improve our efficiency and ability to predict early in the discovery process how antibodies will behave later in development and manufacturing (Figure 1). Today, we integrate data from the start of a program to comprehensive characterization of antibody candidates. We are also investing to connect program data from program launch to manufacturing and clinical testing. We believe that the additional insights from these data may also allow us to select and advance antibody candidates that are more potent or more easily manufactured.
Figure 1: Our integrated capabilities create a virtuous cycle.
We are completing construction projects that will expand our access to lab, office and manufacturing facilities to support the operation of AbCellera into the foreseeable future. These facilities allow us to support cell-line development, process development, and GMP manufacturing of antibody therapeutics all with an integrated team. In May 2020, in support of this effort, we received a commitment for CAD $175.6 million ($125.6 million) in financing from the Government of Canada.
Upon completion of our facilities, we expect to support drug development programs from initiation to fill-finish. We believe that integrating an optimized manufacturing process with our discovery and protein-engineering capabilities will create synergies in speed and efficiency and will allow us to more rapidly test and validate new antibody therapeutic formats, including bispecific antibodies and antibody conjugates. We expect to complete this facility and to have GMP manufacturing capabilities in use in 2025.
Using this approach to workflow optimization, we can meaningfully accelerate the speed of antibody drug discovery and development.
To date, we have invested over $600 million in building our infrastructure and expanding our capabilities. We have also successfully used our capabilities to overcome some of the hardest problems in the biotechnology industry. As an example, we discovered two antibody therapies for patients with COVID-19 (under emergency use authorization in 2020 and 2022), which we believe was one of the most competitive and time-sensitive drug development efforts in history. Even as the focus of our company turns to using our capabilities to focus on program development, we continue to invest to refine and enhance our capabilities, with approximately 40% of our total research and development spend in 2024 applied to platform development.
In May 2023 we secured CAD $300 million ($222.3 million) in non-dilutive financing from the Governments of Canada and British Columbia toward an eight-year project to build new capabilities in Canada to develop, manufacture, and deliver antibody medicines to patients through Phase 1 clinical trials and build expertise in translational science, technical operations, and clinical operations and research. We expect to use the proceeds from the financing to:
1.Complete the build of our facilities;
2.Establish and validate fully integrated capabilities to take programs from concept to the clinic; and
3.Support the development of up to 17 internal programs up to and through Phase 1 clinical trials.
We have developed specific platform technologies to unlock high-value drug targets, modalities, and classes
As we further build the capabilities, we pursue technology development projects that we believe will open up new market segments in antibody therapeutics by unlocking new drug targets, modalities, and classes. To date, we have developed two specific technology platforms that we are leveraging to advance both internal and partner-initiated programs.
1.T-cell engager platform
Our T-cell engager platform leverages hundreds of diverse CD3-binding antibodies to create bispecific antibodies that achieve potent tumor-cell killing with reduced cytokine release, which can help address dose-limiting toxicities.
2. GPCR and ion channel platform
We are using our platform to develop first-in-class antibody medicines for well-validated complex transmembrane protein targets that have been intractable using traditional approaches.
OUR PIPELINE
We are leveraging our capabilities and technology platforms to develop internal programs and advance a pipeline of AbCellera programs with first-in-class and/or best-in-class potential. We evaluate these programs individually to determine the advisability of entering into preclinical and clinical development ourselves, entering into collaborations with partners, or out-licensing programs to optimize their development and clinical and commercial potential. In 2023, we advanced two drug programs, ABCL635 and ABCL575, into IND/CTA-enabling studies and announced in 2024 that we would seek clinical trial authorizations for both programs in 2025.
ABCL635: A potential first-in-class medicine for metabolic and endocrine conditions
ABCL635 is an antibody-drug candidate against an undisclosed target with an indication in metabolic and endocrine conditions. It can potentially be a first-in-class therapy in an addressable market estimated at more than $2 billion in annual sales. ABCL635 is the first AbCellera-led asset derived from our GPCR- and ion-channel platform. We anticipate submission of a CTA for ABCL635 in Q2 2025.
ABCL575: A potential best-in-class medicine for atopic dermatitis
ABCL575 is a fully human, half-life extended monoclonal antibody targeting OX40 ligand that is being developed as a potential best-in-class therapy for treating T-cell-mediated autoimmune conditions, such as atopic dermatitis. Antibody-mediated blockade of OX40L is a clinically validated, non-T cell depleting mechanism to modulate inflammation. Targeting OX40L has the potential to address a broad range of inflammatory conditions and autoimmune diseases, some of which include colitis/inflammatory bowel disease (IBD), asthma/atopy, and diabetes. OX40L blocking is under investigation for atopic dermatitis, asthma, alopecia areata, hidradenitis suppurativa (HS).
We discovered ABCL575 during our collaboration with EQRx Inc. (“EQRx”) as part of a co-development program that began in 2021. We took control of the program in September 2023 and have advanced ABCL575 into IND/CTA-enabling studies. ABCL575 has been designed with potency, pharmacokinetics, and developability to support a Q12W or longer dosing schedule, which provides differentiation potential. We anticipate submission of a CTA for ABCL575 in Q2 2025.
Table 1: Our Pipeline
Molecule Status Target Method of Action (MOA) Indication Therapeutic Area
ABCL635 IND/CTA-enabling studies (Preclinical) Undisclosed - GPCR or ion channel Antagonist Undisclosed Metabolic endocrine conditions
ABCL575 IND/CTA-enabling studies (Preclinical) OX40 ligand (OX40L) Blocking and non-depleting ◦Atopic dermatitis◦Other indications in autoimmunity and inflammation Immunology & inflammation
OUR PEOPLE
Our people are critical to our success
We believe that great and enduring companies are built by strong teams of exceptional people. For this reason, team-building is a top priority in our business. We see talent and team-development as an opportunity to build a competitive advantage that amplifies every dimension of our business. We see investments in our people as investments that are necessary for the success of our Company.
We build systems to support our people
We believe a strong corporate culture is essential for the recruitment, development, and retention of exceptional employees and teams. Although leaders must model corporate values and desired behaviors, we do not believe culture can be invented or enforced from the top of an organization. Instead, we see the responsibility for building and stewarding our culture as shared across our entire organization. We believe culture starts from individuals with shared core values and a common sense of purpose, and that culture emerges and is strengthened through a network of interactions and relationships built on mutual trust and appreciation.
Building a winning culture requires investment and continuous diligent effort. Our Company and our Talent Development team work to develop and deliver the necessary processes, training programs, and events that we believe are essential for our culture to thrive. These are designed to:
•Encourage relationship-building across interdisciplinary teams;
•Share information broadly, to promote mutual appreciation and to ensure our employees see how their work and the work of others connects to our overall strategy;
•Craft mentorship networks and leadership-training systems that help our employees develop strong leadership skills;
•Promote our corporate values and engage in conversations with our teams to understand how our values apply across the organization;
•Develop and deliver a curriculum of learning and development programs to accelerate career progression; and
•Offer events that help build strong relationships and a shared sense of purpose and community.
Through these and related activities we believe our Talent Development team plays a critical role in creating an effective organization that our teams are proud to be a part of.
Our philosophy for hiring and recruitment
Our philosophy for hiring is based on insights gained over a decade of building and managing interdisciplinary teams. First, we recognize that the success of a large and complex organization depends on the contributions of people with broad and complementary sets of technical expertise and aptitudes. Second, we prioritize the long-term potential of candidates and invest in our team’s continued development. We believe this framework has allowed us to build an exceptional team at all levels and develop strong leaders that drive our business's continued long-term growth.
How we structure our pay and compensation packages
We believe our long-term success depends on our ability to compete for top talent. To attract and retain top talent, we aim to offer competitive compensation for any given role, as determined by market data on local, regional, or global conditions, as appropriate. In addition to competitive salaries, equity awards, and performance bonuses, our compensation includes comprehensive healthcare benefits, fitness and active-lifestyle benefits, and retirement-savings contributions.
We grant equity awards, comprising of share options and restricted share units, to all employees. We do this because we believe that shared ownership promotes employee retention, creates alignment, and promotes a sense of shared ownership in the long-term success of our Company.
As discussed above, we recognize that our ability to compete effectively for talent also depends on us maintaining a strong corporate culture, that our programs for training and development remain strong, and that we can continue to offer attractive working conditions. We further stress the importance of guidelines and cultural norms that encourage each team-member to find their optimal work-life synergy, aiming for productivity and constant improvement that is sustained over time. Finally, we believe that our strategy of using technology to impact the lives of patients positively is attractive to top talent who want to spend their days well and who value challenging work with a clear sense of purpose.
Our discovery and development capabilities require interdisciplinary talent
Interdisciplinarity is a core feature of our business. The nature of our work in technology and drug development requires an exceptionally interdisciplinary workforce in its scientific, engineering, and professional skills. After more than a decade of technology development at the nexus of science, engineering, and computation, we believe we effectively assemble and integrate strong cross-functional teams. As of December 31, 2024, our team comprised approximately 62% scientists, 14% engineers and data scientists, and 24% business professionals. Over 54% of our team members have either a Master’s degree and/or a Ph.D.
Our geographic locations give us an advantage in recruitment
Attracting and retaining large teams of highly trained scientists and engineers is one of the most critical challenges in executing on our strategy. We believe that we have a significant recruitment advantage by virtue of our largest research facilities being in Vancouver, Canada, and Sydney, Australia. Both the Vancouver and Sydney regions are consistently ranked amongst the most liveable cities in the world. Both also have world-class universities that train large pools of talent in fields relevant to our work, including computer science, biochemistry, genomics, engineering, cell biology, and immunology. We believe the combination of (i) these regions providing access to large talent pools and less-developed biotechnology sectors, and (ii) our willingness to hire for potential and invest in employee training and development are key factors contributing to our success in discovering, attracting, and retaining top talent.
We foster and enjoy high levels of employee engagement
We see employee engagement and retention as two important measures of the health of a company. We measure our employee engagement and ability to retain professional talent regularly. In 2024, we had a voluntary turnover rate of 4.7%.
As of December 31, 2024, we had 596 full-time employees in Canada, the United States, and Australia, representing over 45 nationalities.
OUR MARKET OPPORTUNITY
We believe the biotechnology sector will be one of the most important opportunities for growth and investment over the next 30 years. The large size and rapid growth of the market for therapeutic antibodies combined with our capabilities represents a large opportunity for our business to make a difference for patients and partners by catalyzing a change in how antibody drugs are discovered and developed.
Therapeutic antibodies are one of the largest and fastest growing classes of drugs
Antibodies are one of the largest and fastest growing classes of drugs and are used across multiple therapeutic areas, such as oncology, inflammation, infectious disease, ophthalmology, cardiovascular disease, autoimmunity, and neurodegeneration.
In 2023, global therapeutic antibody sales approached $300 billion. This market is expected to grow to well over $450 billion by 2028, representing a five-year compound annual growth rate, or CAGR, of over 10%. In 2023, around 50 antibody therapeutics achieved blockbuster status, defined as achieving annual sales in excess of $1 billion. In 2024, therapeutic antibodies also represented 5 out of the world’s 10 top-selling pharmaceutical products.
The mean peak-year sales for currently marketed monoclonal antibody drugs and monoclonal conjugate antibody drugs are estimated at over $3 billion. In 2024, there were approximately 200 approved antibody therapeutics, with more than 170 in Phase 3 clinical trials worldwide.
Historically, the time for antibody discovery projects to reach Phase 1 clinical trials from target selection has been estimated at approximately 5.5 years. On average, antibody drugs have taken between seven and ten years to reach market-authorization from the start of Phase 1 clinical trials. Each year, well over 200 antibody therapeutics enter Phase 1 clinical trials.
Our approach to expanding markets and creating value
We seek to advance a pipeline of first-in-class and/or best-in-class antibody medicines and strategically partner with companies with novel technology or science to advance programs to the clinic. We believe that we create differentiated value in three main ways:
•Unlock new markets: Opening new target space and enabling new modalities has the potential to unlock new market segments. We believe that many of these segments could represent multi-billion-dollar commercial opportunities for our partners.
•Improve discovery speed: Bringing antibody treatments to market faster than the current industry standard would make a difference for those in need. We estimate that accelerating the path to market by one year could improve the value of an average approved treatment by more than $100 million in net present value, considering only the impact of bringing cash flows forward. If we can help a new drug to be first to market, the drug may capture greater market share with the potential to generate billions of dollars in additional therapy sales over the patent life of the product.
•Level the playing field: With our centralized integrated capabilities, we have removed the need to build discrete discovery and development infrastructure or piece together CROs and CDMOs. We believe this lowers the barriers to entry in our industry for ourselves and our partners. For example, we estimate that our capabilities could save innovative biotechnology companies more than a year and tens of millions of dollars in discovery and development efforts at the earliest stages.
OUR PARTNERS
We have extensive experience partnering with emerging biotechnology companies, leading pharmaceutical companies, and non-profit and government organizations. Our partners are specialist scientific ideators and skilled clinical testers that are predominantly based in the United States and Europe. They seek increased speed and probability of success of their drug development programs.
Our partnership agreements to date have commonly included: (i) near-term payments for access, research, and intellectual property rights; (ii) downstream payments in the form of clinical and commercial milestones; and (iii) royalties on net sales of therapeutics. We also structure agreements with additional approaches to capture value, including through equity in our business partners and various options for deeper investment in moving therapeutic candidates forward. We believe the long-term value of our business will be driven by downstream milestone payments and royalties on the net sales of a resulting therapeutic.
As we have grown and developed, we have strategically emphasized agreements where we add more value for partners beyond the initial discovery work. These programs include more-valuable downstream terms and help maximize the value of our portfolio.
Our partners are specialists who come to us for help to develop clinical candidates
Our partners are specialists with deep knowledge and understanding of their targets. They seek to use this understanding of target and disease biology to develop therapeutic products for the ultimate benefit of patients. Biotechnology companies that do not have internal antibody discovery capabilities partner with us to help discover and develop clinical candidates at greater speed, with higher quality, and with a fraction of the capital outlay that has historically been associated with internal discovery efforts. Leading biopharmaceutical companies with well-developed internal discovery capabilities partner with us to help solve discovery problems that have proven intractable using their platforms.
Our capabilities have made us a strategic partner in the biotechnology industry
We believe we have become a strategic partner in the biotechnology industry, as our integrated discovery and development technology aims to improve the speed and probability of success of antibody drug development. We leverage our partners’ specialist insights into target biology and use our technology to generate what we believe are optimal clinical candidates for downstream development. Our investments in full integration also allow us to take a big-picture perspective on antibody drug discovery, starting with the end in mind and optimizing for the final developability of antibodies from the start. This approach is intended to increase our partners’ probabilities of success in developing an antibody candidate, with a commensurate improvement in their return on investment.
We are strategic in the selection of our partners
We take a deliberate and strategic approach to selecting partners. We believe successful antibody drugs are developed in collaboration with partners who have insights, technology, skills or experience complementary to our own. We look for partners with innovative and impactful ideas, strong leadership teams, and the continued ability to raise the capital needed to fund the development of a product candidate. Being a strategic partner in our industry also allows us to work on the programs that mean the most to partners.
We also seek to work with companies that have the potential to be optimal partners for the final development and commercialization of our pipeline assets. Supporting such partners on their discovery challenges allows us to demonstrate our capabilities and earn trust for future partnerships.
Our agreements emphasize participation in the success of antibody therapeutics
Our agreements emphasize participation in the success and upside of the future antibody therapeutics we help to discover and develop. Typical partnership agreements for partner-initiated discovery programs include (i) near-term payments for access, research, and intellectual property rights; (ii) downstream payments in the form of clinical and commercial milestones; and (iii) royalties on net sales of therapeutics. Agreements may include alternative approaches to capture value, including equity in our business partner and various options for deeper investment in moving drug candidates forward.
As of December 31, 2024, we have started 96 partner-initiated programs that have the potential for milestone and royalty payments. Our partnership agreements are typically terminable at will with 90 days’ notice prior to identification of a target, after which point they may only be terminated for cause. A summary of publicly disclosed partnerships is included in the table below.
Table 2: Summary Partnership Agreements with Pharmaceutical & Biotechnology Companies that include downstream participation from 2016 to December 31, 2024
Partner # of Targets & Duration Therapeutic Indication or Modality Date Announced
Eli Lilly and Company Multi-target, multi-year Immunology, cardiovascular disease, and neuroscience July 31, 2024
Viking Global Investors & ArrowMark Partners Multi-target, multi-year Immunology May 1, 2024
Biogen Inc. Single target Neuroscience March 11, 2024
Undisclosed Multi-target, multi-year Undisclosed December 28, 2023
Undisclosed biotechnology company Multi-target, multi-year Undisclosed December 20, 2023 *
Undisclosed biotechnology company Multi-target, multi-year Undisclosed December 4, 2023 *
Prelude Therapeutics Up to 5 targets, multi-year Oncology November 1, 2023
Regeneron Pharmaceuticals, Inc. Up to 4 targets, multi-year Undisclosed September 20, 2023
Incyte Corporation Undisclosed Oncology September 13, 2023
RQ Biotechnology Ltd. Up to 3 targets, multi-year Infectious disease March 22, 2023
AbbVie Inc. Up to 5 targets, multi-year Undisclosed December 15, 2022
Rallybio Corporation Up to 5 targets, multi-year Rare metabolic disorder and undisclosed December 1, 2022
Atlas' stealth stage company Up to 3 targets, multi-year Undisclosed August 3, 2022
Undisclosed biotechnology company Up to 3 targets, multi-year Undisclosed June 29, 2022 *
Empirico Inc. 2 additional targets Undisclosed May 3, 2022
Everest Medicines Ltd. Up to 10 targets, multi-year Oncology and undisclosed September 22, 2021
Moderna, Inc. Up to 6 targets, multi-year RNA-encoded antibodies September 15, 2021
EQRx, Inc. Multi-target, multi-year Oncology and immunology (initially) August 4, 2021
Tachyon Inc. Single target Oncology August 3, 2021
Undisclosed biotechnology company Up to 4 targets, multi-year Undisclosed June 30, 2021 *
Angios Multi-target, multi-year Ophthalmology May 6, 2021
Undisclosed biotechnology company Multi-target, multi-year Oncology May 6, 2021 *
Empirico Inc. 5 targets, multi-year Undisclosed April 14, 2021
Gilead Sciences, Inc. 8 targets, multi-year Undisclosed April 1, 2021
Abdera Therapeutics Inc. 9 targets, multi-year Oncology January 14, 2021
Invetx, Inc. Multi-target, multi-year Animal Health November 19, 2020
Kodiak Sciences Inc. Multi-target, multi-year Ophthalmology October 29, 2020
IGM Biosciences, Inc. Multi-target, multi-year Oncology and immunology September 24, 2020
Undisclosed Single target Bispecific June 3, 2020 *
Eli Lilly and Company Up to 9 targets, multi-year COVID-19 program and additional indications May 22, 2020 *
Regeneron Pharmaceuticals, Inc. 4 targets, multi-year Multiple undisclosed March 16, 2020 *
Invetx, Inc. Multi-target, multi-year Animal health February 23, 2020
Undisclosed Multi-target, multi-year Cell therapy September 25, 2019 *
Gilead Sciences, Inc. Single target Infectious disease June 13, 2019
Denali Therapeutics, Inc. 8 targets, multi-year Neurological diseases February 28, 2019
Novartis AG Up to 10 targets, multi-year Undisclosed February 14, 2019
Autolus Therapeutics plc Single target Cell therapy (CAR-T) November 29, 2018
Denali Therapeutics, Inc. Single target Neurological diseases June 12, 2018
Undisclosed mid-cap biopharmaceutical company Undisclosed Undisclosed January 25, 2018
Teva Pharmaceutical Industries Ltd. Single target Membrane protein June 13, 2017
Pfizer Inc. Multi-target, multi-year Membrane protein January 5, 2017
Undisclosed global biotechnology company Multi-target, multi-year Undisclosed November 4, 2016
Kodiak Sciences Inc. Single target Ophthalmology August 24, 2016
Teva Pharmaceutical Industries Ltd. Undisclosed Undisclosed February 2, 2016
* Effective date of agreement
Most of the programs with our partners will generate milestone payments to us if our partners reach certain preclinical, clinical, regulatory, and commercial milestones. In addition, programs that create drug candidates which become commercial products may generate royalty payments to us on the net sales of those products. We also have other forms of downstream economic participation, including equity and equity-like positions, and options to co-invest. The following table represents the range of royalty (and equivalent) rates and the hypothetical maximum value of the milestone payments included in our partnership agreements as of December 31, 2024:
Table 3: Downstream Participation
Milestones (in billions) Royalty on net sales, 5th to 95th percentile range
Preclinical $0.10 2015-2019 contracts 0-4.0%
Clinical $1.11 2020-2023 contracts 1.5-9.0%
Regulatory $1.97
Commercial $5.51 Other downstream participation
Total $8.69 Equity/equity-like positions
Options to co-invest
All programs with downstream participation not probability adjusted
Includes range of royalty (and equivalent) rates of each contract, considering step-downs, if any
OUR INDUSTRY STRUCTURE
Ideas for new antibody drugs can come from anywhere
We believe that sound biological insights and new ideas for new antibody drugs are a key input of our work. As product creators, we compete with other companies for access to ideas. The complexity and vastness of disease biology means there is no universal approach to generating ideas for new drugs. Good ideas can come from anywhere. Academic institutions, venture capital groups, non-government organizations, small biotechnology companies, and large biopharmaceutical companies all have a role to play in driving ideation in our industry.
The standard model for turning ideas into antibody drugs is inefficient
The conventional model for turning ideas into drugs requires biotechnology companies to independently recruit the teams, build the infrastructure, and acquire the technologies needed for product creation. If these companies end up building such capabilities internally, we estimate that up to $50 million could be spent per company in pursuit of such efforts. Because these companies would build these capabilities separate from their core area of focus, and because such businesses have limited time to develop these capabilities, we believe that such decentralized capabilities are unable to approach the state of the art in our industry.
Ideation is dominated by innovative biotechnology companies
Small biotechnology companies dominate industry-wide ideation. Between 2011 and 2021, over 50% of new-drug approvals in the United States originated with smaller biotechnology companies with annual revenues below $500 million. For blockbuster therapeutics, the probability of the idea originating with a smaller biotechnology company increases to over 60%. These early-stage companies are often rich in ideas but low on capital and lack the necessary capabilities to efficiently pursue their ideas. These companies are forced to develop and to use suboptimal technology, or to piece together fragmented point solutions and contract services. Spread across a number of smaller biotechnology companies, we believe that the costs to advance their ideas – both in capital and in opportunity – can create serious economic barriers and inefficiencies that artificially restrict innovation and damage productivity in our industry.
Our integrated capabilities level the playing field and enables new therapies
We believe our capabilities and business model improves efficiencies in our industry in three main ways:
1.We prioritize integration over the accumulation of stand-alone tools
We believe that drug development cannot be broken down into a series of independent steps and see the development of new antibody drugs as a single process with one end goal – the rapid delivery of successful medicines to patients. We prioritize the outcome of an integrated end-to-end workflow over the accumulation of stand-alone tools. Where other providers in our industry may offer partial solutions or stand-alone instruments, our integrated capabilities offer the creation of new antibody drugs. By delivering complete and optimized solutions to our partners, we think this perspective gives us a competitive advantage relative to providers of modular solutions.
2.We empower a more diverse set of innovators
As our centralized infrastructure for antibody drug discovery lowers the barriers to entry in our industry, we create the conditions for smaller biotechnology companies to focus on what is unique and valuable in their businesses,
and to compete on the merits of their ideas. We believe this dynamic has the potential to catalyze a structural change in how antibody drugs are developed. We create opportunities for a more-diverse set of innovators and believe that our capabilities have the potential to expand the ecosystem and make our industry more efficient.
3.We enable new types of antibody therapies
The differentiated capabilities of our capabilities make more and new kinds of antibody discovery possible. For instance, we believe our technology gives us a unique advantage in the discovery of antibodies that modulate the function of difficult transmembrane protein targets, such as G-protein-coupled receptors (“GPCRs”) and ion channels. These are two large and well-validated families of drug targets for which antibody discovery using traditional techniques has been extremely difficult. By unlocking access to these and other types of targets with antibodies, we believe that our capabilities have the potential to grow the market for antibody therapies. We believe that our platform investments can unlock the technical challenges that are limiting drug discovery in such areas and provide a strong basis for successful internal program development.
COMPETITION
The biopharmaceutical industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While we believe we have built a competitive advantage in the discovery of antibody-based therapeutics, we face potential competition from many different sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions, governmental agencies and public and private research institutions.
There are several companies developing and marketing treatments that may be approved for the same indications and/or diseases as our programs. For example, with respect to our ABCL575 candidate:
•Atopic Dermatitis: Treatments currently approved in some geographies for atopic dermatitis from, amongst others, Regeneron Pharmaceuticals/Sanofi, Lilly, AbbVie Inc., and Pfizer Inc.. Additionally, therapeutics for atopic dermatitis currently in clinical testing are being developed by large pharmaceutical and biotechnology companies including Amgen Inc., Apogee Enterprises Inc. and Bristol Myers Squibb Co..
We do not yet have clinical data for any of our programs and there can be no assurance that our programs will have similar or comparable results.
In addition, we operate in the global market for solutions that enable the discovery and development of therapeutic antibodies. The solutions and applications offered by companies operating in this market vary in size, breadth, and scope. Significant intellectual property barriers restrict these solutions.
Given the broad promise of antibody therapeutics, we face competition from a number of sources, including companies that provide antibody discovery services such as contract research organizations (“CROs”) and companies that provide specialized solutions to antibody discovery using proprietary technologies or platforms.
•Examples of companies that provide antibody discovery and development services include fully integrated CROs that offer contract research, development, and/or manufacturing services include WuXi Biologics Inc., Evotec SE, and Charles River Laboratories International, Inc. These CROs operate on a large scale and earn fees on research work, but often lack differentiated capabilities at critical steps of antibody discovery and development.
•Examples of companies that use proprietary platforms or technologies to discover antibodies include Adimab LLC, Twist Bioscience Corporation (“Twist Bioscience”), and OmniAb, Inc. These and similar antibody discovery specialists engage in discovery activities with partners and earn downstream payments based on the value added by their proprietary technology platforms.
Many emerging and established life sciences companies have also been built around technologies that focus on one or a limited number of steps in antibody discovery and development. These companies provide technological point-solutions that can be integrated into antibody discovery workflows within our partners’ laboratories or at CROs.
An example of a company that provides a technological point-solution that is integrated into antibody discovery workflows is Bruker Cellular Analysis ("Bruker") (on October 3, 2023, PhenomeX, the successor to Berkeley Lights was acquired by Bruker). They and similar tool-providers place instruments with our potential customers and with CROs that compete directly with our antibody discovery platform. Such point-solution companies commonly earn revenues on the sale of machines and proprietary reagents, and in some cases also perform discovery services with fees and royalties on downstream products. For example, Twist Bioscience markets and provides antibody discovery services using the Bruker Beacon platform to its customers.
OUR APPROACH TO CAPITAL ALLOCATION
We think like owners when making investments
Our founders, leadership team, and employees own a significant portion of the equity in our Company. Our teams think like owners when deciding to allocate time and capital across our business activities. Cognizant of the specific challenges that characterize biotechnology as a sector, we specialize in addressing hard but tractable engineering problems and avoid staking our fortunes on high-risk science projects. We believe this is the best way for us to create value, and to do so reliably. We quickly grew our business and completed the build of our infrastructure and capabilities in a capital-efficient way. We are now anticipating a period of continued investments in our pipeline with corresponding losses and negative operating cash flow in the near-to-medium term, ahead of revenues generated from out-licensing, milestone payments and royalties in the longer term.
We invest with a long-term perspective
We allocate capital with a long-term perspective and our largest investments have been in the intellectual capital, infrastructure, and capabilities that we have built over the years. Using these assets, we make capital-efficient investments in the discovery and development of new antibody drugs, with the largest value tied to their long-term success. In many cases, this results in cash flows that are further in the future. We do this because we believe that the real value from drug development is realized when drugs deliver value to patients. This drives our emphasis on sharing in the economics of successful drugs, developed both with our partners and internally. In the long run, we believe this approach has the potential to yield exceptional rates of return.
Consistent with the long timelines for drug product development and testing, we expect the most meaningful additional revenues from our pipeline and portfolio to begin after 2030. As our economic stakes in drug candidates mature, we believe that the contributions from programs in our portfolio will result in a long-lived stream of strong cash flows and a high rate of return on invested capital. We accept that cash flows from drug sales will only result when we have created value for patients, i.e. when the drug candidates that compose our pipeline and portfolio reach the market as successfully commercialized antibody drugs. This fundamental dynamic applies to our internal, co-development, and partner-led programs.
Our capabilities help us build a valuable portfolio with capital efficiency
Building our integrated capabilities and infrastructure has been a focal point of our capital-allocation strategy. These capabilities now generate our growing pipeline of programs and portfolio of valuable stakes in drug candidates in a capital-efficient manner.
By using our differentiated capabilities to attract business from strategic partners across the biotechnology industry, we believe that discovery partnerships can be used to grow our portfolio without significant capital outlay apart from capability investments.
Increasingly, we are leveraging our capabilities internally to develop a pipeline of assets, at a low marginal cost, against well-validated targets, particularly using our T-cell engager and GPCR & ion-channel platforms. We believe that our differentiated capabilities in these areas uniquely position us to create first in class assets against these challenging targets.
We select opportunities and partners to maximize the value of our portfolio
As business operators, we understand the value of active portfolio management and how it can be used to enhance value in an industry where not all ideas are equally likely to succeed. With our dedication to discovery and development, we focus our efforts on developing internal programs where we can leverage our competitive advantage in technology and connecting with strong partners whom we believe have compelling ideas for therapeutics and the capabilities to clinically and commercially develop the drug candidates that we discover either in partnership or through our internal programs.
The largest risk to our portfolio is not wasted effort, but rather the opportunity cost of missing out on potential future blockbuster therapeutics. To maximize our chances of investing in the most promising opportunities in our industry, we have made substantial investments that we believe will enable us to generate potential first-in-class and best-in-class antibody drugs repeatedly.
Thinking like investors, we believe active management is most impactful when used to screen out weak opportunities. When partnering, we look for companies with what we believe are innovative and impactful ideas, strong leadership teams, and the continued ability to raise the capital needed to support a drug candidate on its way to and through the clinic. Being a strategic partner in our industry also allows us to collaborate on the programs that mean the most to partners, where
quality and the speed to the clinic really matter. We believe this strategy allows us to enrich our portfolio for programs with above-average potential to deliver commercially successful therapeutics.
When launching internal programs, we look for opportunities we believe have the highest potential to generate attractive returns, without adding a constraint of a specific therapeutic area. In general, we seek to develop medicines that:
•target validated biology;
•pursue a significant commercial opportunity, resulting from addressing an unmet medical need;
•possess potential for differentiation; and
•offer a clear development path.
We seek to maximize the net present value of our pipeline and portfolio
Contractual rights to royalties, profit shares, and commercial milestones are financial stakes in the commercial success of the drug candidates that we help develop. We negotiate these stakes as part of our agreements with partners at the outset for partner-initiated programs and when we outlicense pipeline programs.
We believe the near-term and clinical milestone payments we earn from programs are only a small proportion of the expected total value that we ascribe to an individual program. Instead, for a given program that undergoes clinical development, obtains marketing approval, and is successfully commercialized, we expect the bulk of the revenues to result to be associated with our downstream royalty or profit-share rights and commercial milestone payments.
Our approach is to maximize the expected net present value of our stakes in future antibody drugs. We believe this approach will maximize free cash flow in the long term and the value of our business overall.
Partnering opens multiple value-creation opportunities
By partnering, we generate opportunities to leverage our differentiated capabilities to contribute value to drug discovery efforts. The economics we earn on partnered programs scale with the value we bring to each program. Typically, these economics take the form of near-term payments, clinical and commercial milestone payments, and royalties on or share of the profits from the net sales of a resulting therapeutic.
We increase the value of our portfolio and our business in three ways – by partnering on additional drug development programs; by contributing more value to the drug development programs we work on; and by capturing more of the value we contribute to a program. In addition to the partner-initiated discovery program model which we have entered since the founding of our Company, we have introduced additional program structures. These aim to unlock additional partnering opportunities, to allow us to develop and deploy additional value-creating capabilities, and to enhance the potential economics in programs where the value we add is particularly large.
Our programs broadly fall into two initiation categories:
Partner-Initiated Programs
In partner-initiated programs, partners come to us with a target in mind and work with us to turn their idea into an antibody drug product. This is our first category of program, dating back to 2014.
The volume of programs in this category has been high. As of December 31, 2024, we started 96 partner-initiated programs that include downstream milestones, royalty stakes, or co-ownership. Through selectively entering into new and expanded strategic partnerships, we continue to add programs to this portfolio.
We work closely with our partners on these programs, leveraging their insight and expertise into target and disease biology and modality while using our discovery and development capabilities to create value. Depending on the terms of the program, we may perform work from target specification as far as the delivery of a final drug candidate. For some large or well-enabled partners, we will hand our work off at an earlier stage, allowing our partner to work with our panel of characterized antibodies while leveraging their proprietary data.
Discovery agreements
To date, the most common structure for partner-initiated programs has been that of a discovery agreement. Royalties on net sales in our typical discovery agreement are in the low-to-mid-single-digit-percentage-point range. Because the research fees we earn on the work under such agreements generally more than cover our marginal costs of running these programs, the potential return on our incremental investment in these programs is high. In the long term, as our portfolio matures and
results in approved therapies, we believe our aggregate economic position from these programs has the potential to produce large revenues at near-100% margin.
Co-development agreements
Another structure for partner-initiated programs is a co-development agreement. These represent a further amplification of our business model, as they enhance the potential economics in our portfolio by giving us and our partner the option – but not the obligation – to co-invest in developing drug candidates. We each begin discovery with a 50% stake in the program and can invest to retain our ownership position on a stage-by-stage basis. Some programs in this category also include equity investments in partner companies.
The investments we make under this type of program are in the form of cost-sharing, where we initially contribute to discovery and development costs in proportion to our level of program ownership. After completing the initial work phases (typically to identify a development candidate), we and our partner have the option – but not the obligation – to continue co-funding further development of the drug candidate in return for a maintained ownership share.
As a co-owner of these programs, we have complete visibility on data and progress. We believe this preferential insight into program potential and viability puts us in an attractive position to decide on exercising our option to continue to invest. If we exercise our option to continue co-development in a program, we invest at cost and at what we believe to be at a discount to the intrinsic value of the incremental stake.
In cases where we do not exercise our option to continue to invest, our stake typically converts to a royalty-and-milestones position, with royalty rates reflecting the value of our contributions to that point. Our effective royalty position is increased for each staged investment we make in a co-development program. The royalty rates for these programs are generally higher than for our partner-initiated discovery programs.
The potential for us to assume deeper ownership stakes through a co-development agreement allows us to capture more value from programs to which our capabilities can make an outsized contribution and from programs in which we have a particularly high level of conviction.
One notable effort that started under a partner-initiated co-development agreement is the program to develop antibodies against OX40L. After our partner EQRx. Inc. was acquired in 2023 by Revolution Medicines, Inc., AbCellera took control of the program and advanced the resulting molecule, ABCL575, into IND/CTA-enabling studies.
AbCellera-initiated Programs
In our technology development work, we prioritize areas where we believe there are multiple high-value therapeutic opportunities to explore. This allows us to start internal programs to solve widely recognized real-world problems with large economic potential. Today, we focus on two such technology development efforts that have yielded over 20 AbCellera-initiated programs:
•T-cell engagers: We have developed our T-cell-engager platform and started internal programs to develop therapeutic antibody candidates against eight important tumor targets.
•GPCR and ion channels: We have started 10 internal programs associated with our platform investments to unlock difficult target classes like GPCRs and ion channels.
Assets that potentially result from our technology development-associated internal programs are wholly owned by us. AbCellera may elect to out-license these molecules to partners for final clinical development and commercialization. Given the high technical barriers these programs need to overcome, we anticipate that any such deals could achieve significant economics in the form of large near-term payments and above-average downstream participation through milestones and royalties.
Precedent suggests that the important assets that we target with our internal programs can be partnered on attractive economic terms. For example, in 2020, we partnered with Lilly to develop and commercialize COVID-19 antibody assets resulting from our previous internal work on pandemic-response. From 2020 to 2022, we earned over $950 million in combined royalties from commercial sales of bamlanivimab and bebtelovimab, commercialized by Lilly.
We are leading drug development programs
AbCellera leads the development for all AbCellera-initiated programs that have not been outlicensed and select partner-initiated co-development programs, as in the case of ABCL575 discussed above. We have invested in the capabilities to successfully conduct late-stage preclinical development of drug candidates as well as the ability to initiate and carry out clinical trials for these internal programs.
While the majority of internal programs are still at an early stage, we anticipate submitting our first two CTAs for ABCL635 and ABCL575 in Q2 2025 and commencing their clinical development thereafter. We also anticipate progressing additional internal programs into selection of therapeutic antibody candidates for IND/CTA-enabling studies within the near-to-medium term.
As our internal pipeline grows and matures, we expect to direct increasing efforts and resources towards advancing internal programs in clinical development. The selection, prioritization, and direction of internal programs is supported by an ongoing evaluation of the expected net present value of the program in light of its risks, commercial prospects, development costs, and timelines.
Figure 2: Progress of partner-initiated program starts with downstream participation*.
* Excludes AbCellera-initiated and Trianni-license program. As of December 31, 2024. Historical results are not necessarily indicative of future results.
Of the 96 partner-initiated programs with downstream participation that we had started as of December 31, 2024, we were still actively leading or co-leading the work on 14 of these programs. For 76 programs, we have successfully completed the agreed scope of work and transferred the resulting antibody sequences and data to our partners for evaluation and further development under their leadership. For a historical total of six programs – less than 10% – we did not succeed in finding antibodies that met the partner’s target specifications.
To the best of our knowledge, our partners are actively progressing 37 of the 76 programs and have decided not to progress the other 39 programs.
Of the 51 programs that are actively progressing, we believe that 42 are in late-stage discovery, five in preclinical development, and four have reached clinical development.
Overall, we view the progress of the molecules we have discovered in our and our partners’ hands positively. Over half of all programs with downstream participation that we have started are currently still progressing.
Our portfolio and pipeline are well-diversified
We believe an optimal portfolio is diversified, long-term, and robust. Diversification reduces the risk associated with individual drug development programs. Because our capabilities are broadly applicable to antibody-based drug development, we can access the full depth and breadth of programs in the biotechnology industry. Our resulting portfolio of partner-initiated programs and internal pipeline are well-diversified across therapeutic areas (Figure 3), modalities, and partner types. We believe the current distribution of programs in our portfolio broadly reflects the overall distribution of programs in our industry.
Figure 3: Our large, diversified portfolio of stakes in next-generation antibody therapies.
* As of December 31, 2024
Drivers of value in our portfolio and pipeline
The value of our portfolio and pipeline is driven by several factors, which we believe include:
•Our number of downstream stakes in drug discovery programs (our “program starts”);
•The probability of success of a drug discovery program;
•The expected timeline for a program to proceed through development and to commercial sales;
•The potential for upfront payments from out-licensing or partnering pipeline assets;
•The expected resulting commercial sales if a program is successful;
•Our economic stake in a program’s commercial success (with most of the value being defined by the royalty rates associated with each program); and
•The value of other downstream stakes which we may obtain as part of our agreements.
We invest in and operate our business with the belief that we can favorably impact each driver of value in our portfolio:
Program starts. Each program that we start has the potential to turn an idea into a new marketed therapy. The investments we have made in our capabilities and capacity for business development allow us to connect with, and credibly pursue, an increasing number of therapeutic ideas in our industry. We believe that our ability to connect with and pursue such ideas is reflected in the growth in our cumulative number of program starts.
We believe our ability to accelerate drug development timelines and to unlock new types of targets puts us in a position to continue driving business development growth. In pursuing the growth of our portfolio, we are mindful of the strong connection between commercial success of our programs and our largest payouts, as well as of opportunity costs. We do not aim to maximize our number of program starts. Instead, we choose to engage with partners and on programs that we believe have the potential to deliver first-in-class and best-in-class antibody therapeutics with strong commercial prospects, be they initiated by a partner or by AbCellera.
Probability of success. For a drug development program to ultimately achieve commercial success, several conditions generally need to be met: the therapeutic hypothesis must be valid; the drug candidate must be optimal-for-purpose (e.g. effective, safe, manufacturable); the clinical trials must be designed and run appropriately; a significant medical need must be met; regulatory, logistical, and commercial matters must be handled well; and good organizational and financial support must be established and maintained throughout. Failure on any one factor often leads to program-failure overall. Historically, such failures have resulted in success rates for drug development programs estimated to be in the mid-single-digit percentage range.
Through our investments and capabilities, we aim to raise the probability of success of the programs in our portfolio and pipeline. The investments we have made are primarily driven by our goal of finding and developing optimal drug candidates and enhancing the likelihood that a program will succeed on this critical factor. Our investments include the technology development efforts we have made to repeatedly deliver successful drug candidates in areas where particularly high technical challenges and high unmet medical needs exist, such as those associated with T-cell engagers, GPCRs, and ion channels.
Information on the other success factors may be uncertain and limited (or unavailable to us) at the time of program inception. However, our approach to partner selection and program selection includes evaluating all available information to steer our work toward programs that do not raise concerns on these factors. As a result, we believe that we are enriching our portfolio for programs with an above-industry-average probability of success.
Timelines. Development of a commercialized drug from program start is estimated to commonly take from eight to fourteen years, followed by approximately over a decade of patent-protected potential sales. Within this overall time frame, drug discovery and preclinical development is estimated to typically take three to five years with the remainder taken up largely by clinical development.
With our ongoing investments in our integrated target-to-clinic capabilities, we are aiming to substantially reduce the time required for discovery and development, with a stated goal of – in the future – repeatedly moving from target nomination to an IND (or equivalent) filing in two years or less.
Accelerating drug development – beyond the obvious benefit for patients – positively impacts the value of an ultimately successful drug in two ways. First, it increases the therapeutic’s chance of being first (or next) to market with a large and lasting impact on market share. Second, it brings forward all positive cash flows from a program with a corresponding impact on their net present value.
Notably, some programs in our portfolio may progress faster than average for reasons beyond the speed of our discovery and development capabilities. This can be the case for therapeutics against rare disease; those with breakthrough designation; drugs that are best-in-class and following a well-understood development path; in a pandemic response situation (as demonstrated by bamlanivimab and bebtelovimab); and in animal therapeutics.
Upfront payments from out-licensing or partnering pipeline assets. When a drug developer licenses or partners a drug or drug-candidate molecule to another party for further clinical or commercial development, the original owner commonly negotiates an upfront payment. Such payments reflect a portion of the expected value of the molecule. As such, the size of such payments typically scales with the drivers of drug- or drug-candidate-value, being importantly expected peak sales if approved, remaining risk to achieve marketed status, and expected additional development and commercialization costs. Upfront payments are typically negotiated in combination with milestone payments and royalties in an out-licensing or partnering agreement.
AbCellera has the potential to earn significant upfront payments from out-licensing or partnering pipeline assets from both, internal as well as co-development programs. Market transactions between other drug developers have been reported with upfront payment amounts for T-cell engager molecules in the double-digit-million dollar range while those for potentially more valuable GPCR-targeting drug candidates have shown triple-digit-million dollar amounts, depending on the stage of their pre-clinical or clinical development.
Commercial sales. Today’s antibody therapeutics generate average peak sales of approximately $3 billion, following several years of ramping sales after commercialization. Substantial annual sales typically continue until the therapeutic patents expire. The average sales of therapeutics are derived from a long-tailed distribution of peak sales. This distribution
includes some therapeutics with sustained annual sales of tens of billions of dollars and many with annual sales over $1 billion (so-called “blockbusters”), as well as many that have more-limited commercial success.
We aim to position our portfolio with particular exposure to therapeutics with high and very high commercial potential. We believe that we can achieve this in three ways:
1.By achieving the technical breakthroughs that allow us to develop first-in-class or best-in-class drug candidates in high-value therapeutic applications where others have struggled or failed (e.g. based on T-cell engagers, GPCRs, ion channels);
2.By accelerating antibody discovery and preclinical development to increase chances of the resulting therapeutic being first- or next-to-market, with correspondingly large market share (as discussed above); and
3.By following an approach to partner selection and program selection that avoids programs with apparently low commercial potential and clinical development risk.
Royalty rates. Royalties are the economic expression of our win-win approach to partnering, tying our financial success in a program to that of our partner and to the benefit that the commercialized drug brings to patients. Royalties on net sales are nearly 100%-margin revenue to the recipient, less volatile than a share of profits, and inherently protected against inflation.
The level of royalties to us which our partners agree to directionally depends on:
•The value we add to the program;
•Our partner’s appreciation of the value we add to the program;
•Our investment in the program; and
•The degree to which we emphasize near-term and milestone payments in the agreement structure.
We add more value to a program when we overcome challenging obstacles, accelerate the program, avoid costs for our partner, and improve the program’s chances of success, e.g. by providing superior drug candidates. The investments in our technology and capabilities – including forward integration along the value chain – all enhance the opportunity and ability to add more value to programs.
A partner’s recognition of the value we add to their program grows with each successful demonstration of our capabilities, either when we can show results from our work, particularly from internal programs, or during the inaugural programs we complete with them. Our investments in programs depend on the program type. Investments are minimal in the case of partner-initiated discovery programs, where we typically cover the marginal cost of our work with near-term payments. For internal programs, our investments in the form of our initial technology development (and the subsequent advancement of development work for a particular program) are more substantial. When we enter into a partner-initiated co-development program, our initial investment during discovery and development is limited. However, the option to keep investing at cost in consecutive stages of development allows us to achieve a deeper royalty (or equivalent) position. All else equal, a greater investment by us generally translates into a higher royalty rate or equivalent for a program.
For commercial reasons, we do not disclose the specific economic terms of each partnership agreement, which are generally bespoke. Instead, we report on the average and distribution of royalty rates in our portfolio.
Our average royalty rates reflect the increasing value we create for our industry
The range and progression of our royalty (and equivalent) positions reflect the value that we create and our ability to capture that value.
As of December 31, 2024, we started 96 partner-initiated programs with downstream participation. These 96 programs have a mean royalty rate of 3.2%. The average negotiated rate for such programs has increased over time, reflecting the dynamics discussed above. Between 2015 and 2019, we agreed to a mean royalty rate of 2.4% across 37 partner-initiated programs with downstream participation contracted in the period; we note that contracts often include multiple program slots that represent potential future program starts. Between 2020 and 2024, we negotiated an increased mean royalty rate of 4.2% across our programs with downstream participation signed in the period and our agreement to partner our COVID-19 antibody asset to Lilly. A quarter of these programs signed in the 2020 to 2024 period can achieve royalty rates above 5.0%.
Our position in a partner-initiated co-development program generally reflects our proportionate contribution to the program. The royalty (or equivalent) rates that apply at each point where we can continue our co-investments depend on
our cumulative contribution to the program's funding. Even at an early point, the rates we stand to earn from such a program generally exceed the agreed-to royalty rates of our partner-initiated discovery programs.
Other downstream economic stakes. In addition to royalty positions, we have included and expect to continue to include other downstream stakes in our agreements for programs.
As is customary in our industry, because drug development and testing spans many years, we typically negotiate clinical and commercial milestone payments as deferred compensation to recognize future value inflection points arising from our work. For our portfolio of programs under contract and not adjusted for the probability of success, as of December 31, 2024, the total hypothetical value of our clinical and commercial milestone payments was $8.7 billion.
On a case-by-case basis, we may negotiate additional means of capturing value in addition to a reasonable royalty or equivalent position, including equity or equity-like positions, options for deeper investment, or larger near-term payments.
OTHER MATTERS
Intellectual Property
We strive to protect the proprietary technologies that we believe are important to our business, including seeking and maintaining patent protection intended to cover the compositions of matter of our product candidates, their methods of use, related technology, and other inventions that are important to our business.
Our success depends in part on our ability to obtain and maintain intellectual property protection for the components of our discovery and development capabilities and products arising from the same; to defend and enforce our patents, to preserve the confidentiality of our trade secrets, and to operate without infringing valid and enforceable patents and other proprietary rights of third parties; and to identify new opportunities for intellectual property protection.
As of December 31, 2024, we owned or exclusively licensed over 100 issued or allowed patents and over 70 pending patent applications worldwide, which includes over 30 issued U.S. patents and over 10 pending U.S. patent applications. We own registered trademarks and trademark applications for AbCellera, Celium, Orthomab, TetraGenetics, TetraExpress, Trianni, and the Trianni Mouse in the U.S., Canada, Australia and/or Europe.
Obtaining patent protection is not the only method that we employ to protect our proprietary rights. We also utilize other forms of intellectual property protection, including trademark, copyright, internal know-how and trade secrets, when those other forms are better suited to protect a particular aspect of our intellectual property. Our belief is that our comprehensive approach to intellectual property protection strengthens our proprietary rights. It is our policy to require our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to execute confidentiality and invention assignment agreements upon accepting employment or consulting relationships with us. These agreements provide that all confidential information concerning our business or financial affairs developed or made known to the individual during the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees, the agreements provide that all inventions conceived by the individual, related to our current or planned business or research and development or made during normal working hours, on our premises or using our equipment or proprietary information, are our exclusive property. We are diligent in taking precautions that our proprietary information is not released to third parties through the use of security measures. Our trade secrets encompass certain reagent compositions and concentrations, nucleic acid vector sequences and immunization protocols.
Data Rights
Our product to partners is data on the composition of matter of antibodies and their properties. We enter into contracts that allow us rights to use the data that we generate for the purpose of improving our discovery and development capabilities and fueling machine-learning algorithms. We maintain strict firewall protocols so target-specific data derived from a partner cannot be used to inform the discovery on another project by a different partner.
Patent Portfolio
We have developed an expansive patent portfolio with claims related to multiple aspects of our discovery and development capabilities, beginning with our first patent applications exclusively licensed from UBC, in 2013. We continuously assess new ways to improve our technology platform through license or acquisition of third-party patent portfolios, as was the case with our acquisitions of Lineage in 2017 and the OrthoMab platform from Dualogics LLC, or Dualogics, in 2020, our acquisition of Trianni, Inc., or Trianni, in 2020, our acquisition of TetraGenetics, Inc. in 2021, and our license agreements with Alloy Therapeutics LLC, or Alloy Therapeutics.
Our patent prosecution strategy encompasses the pursuit of protection for our discovery and development capabilities and tangentially related methods.
UBC License
In December 2013, we executed a license agreement with UBC, or the UBC License, to gain a worldwide, exclusive license to certain patents, or the UBC Patents, patented at UBC by Dr. Hansen and his team for the later of 20 years from the start date of the UBC License, or the expiry date of the last patent licensed under the UBC License. Under the terms of the UBC License, we have the right to sublicense a subset of the UBC Patents and a worldwide, exclusive license to UBC Improvements and/or Joint Improvements on these Patents solely in the antibody field of use. In addition, for a second subset of the UBC Patents, we have a worldwide, exclusive license to use and sublicense solely within the antibody field of use.
Under the terms of the UBC License, we paid a CAD $0.1 million initial license fee and pay annual license fees to UBC during the term of the UBC License. We also pay UBC a low single-digit royalty on our revenue related solely to the use of the technology during antibody screening and a low double digit royalty of our sublicensing revenue during the term of the UBC License. UBC was also granted a single-digit percent equity position in our company as further consideration for the exclusive license.
Under the terms of the UBC License, in consultation with UBC we manage the filing, maintenance and prosecution of the licensed patents and we pay all costs associated with the same while we control all litigation associated with the licensed patents.
UBC may terminate the license under certain circumstances, including in the case of our insolvency, winding up or liquidation, if a court or similar process is levied on the rights under the agreement or on money due to UBC that is not released, if the subject technology becomes subject to a security interest that is not released, if we or any of our directors or officers have materially breached or failed to comply with securities laws, or in the event of certain breaches of, or failure to perform, our obligations under the license or other agreements between us and UBC. Either party may terminate the license for any breach not remedied within specific time periods.
The UBC Core Patents
The UBC Core Patent license includes a patent family directed toward certain systems, devices and methods for microfluidic cell culture. This patent family includes five issued U.S. patents. Issued patents from this family are expected to expire as early as July 2031, absent any disclaimers or extensions available.
The UBC Core Patent license also includes a patent family directed toward systems and methods for assaying binding interactions between a protein produced by a single cell, e.g., an antibody produced by a single B cell, and a second biomolecule (e.g., antigen) in microfluidic chambers and devices. This patent family includes thirteen issued U.S. patents and one pending U.S. non-provisional patent application. Issued patents from this family are expected to expire in July 2031, absent any disclaimers or extensions available.
A patent family directed toward methods for assaying functional properties exhibited by a protein produced by a single cell, e.g., an antibody produced by a single B cell, and a second biomolecule (e.g., antigen) in microfluidic chambers and devices is also included in the UBC Core Patent license. This patent family includes patents issued in the U.S. and Australia and granted in Europe, Japan, and Korea, as well as one pending U.S. non-provisional patent application and four pending foreign counterpart patent applications. Issued patents from this patent family are expected to expire in March 2034, absent any disclaimers or extensions available.
Lastly, the UBC Core Patent license includes a patent family directed toward methods for determining lymphocyte receptor chain pairs, for example, antibody heavy and light chain pairs. This patent family includes two issued U.S. patents, two granted patents in Europe, and one granted patent in Canada, as well as one pending U.S. non-provisional patent application. Issued patents from this patent family are expected to expire in May 2035, absent any disclaimers or extensions available.
Lineage
The Lineage patent portfolio complements our single-cell microfluidic intellectual property with downstream methods of sequencing reaction preparation, immune RepSeq and analysis. The immune repertoire patents and applications that we obtained from Lineage form the basis for the sequencing technologies that we currently use in our discovery and development capabilities.
The acquisition of Lineage included a patent portfolio comprising four patent families. One patent family is directed toward methods of determining the immune repertoire of a subject. This patent family includes three granted patents in Europe, one issued patent in China, one issued patent in Canada, and one issued patent in Hong Kong. This patent family also includes one pending foreign counterpart patent application. Issued patents from this patent family are expected to expire in March 2034, absent any disclaimers or extensions available.
Another patent family is directed toward tagging target oligonucleotides. This patent family includes three issued U.S. patents, one issued patent in China, and two granted patents in Europe. This patent family also includes one pending U.S. non-provisional patent application and one pending foreign counterpart patent application. Issued patents from this patent family are expected to expire in March 2034, absent any disclaimers or extensions available.
An additional patent family is directed toward methods for detection of isotype profiles as signatures for disease. This patent family includes one patent issued in each of Japan, China, Europe, and Canada. This patent family also includes one pending foreign counterpart patent application. Issued patents from this patent family are expected to expire in September 2032, absent any disclaimers or extensions available.
Lastly, the Lineage patent portfolio includes a patent family directed toward compositions and methods for analyzing heterogeneous samples. This patent family includes a granted patent in Europe and an issued patent in Hong Kong. Issued patents from this patent family are expected to expire in September 2032, absent any disclaimers or extensions available.
OrthoMab
As part of our agreement to purchase certain assets from Dualogics related to its OrthoMab bispecific antibody platform, we were assigned Dualogics’ interests and rights to that certain Exclusive License Agreement between Dualogics and the University of North Carolina at Chapel Hill, effective February 22, 2019, or the UNC Agreement. Under the UNC Agreement, we have an exclusive license to UNC’s rights under three patent families.
One patent family is directed toward methods of producing an antigen-binding fragment, or Fab. This patent family includes three issued U.S. patents, and one patent granted in Europe. Issued patents from this patent family are expected to expire in March 2034, absent any disclaimers or extensions available.
Another patent family is directed toward IgG bispecific antibodies and processes for preparation. This patent family includes two issued U.S. patents and one foreign counterpart patent application. Any patents that issue from this patent family are expected to expire in January 2036, absent any disclaimers or extensions available.
The last patent family is directed toward methods for producing Fabs and IgG bispecific antibodies. This patent family includes one granted U.S. patent, one pending U.S. non-provisional patent application, and one pending foreign counterpart patent application. Any patents that issue from this patent family are expected to expire in December 2037, absent any disclaimers or extensions available.
Under the terms of the OrthoMab asset purchase, we granted Dualogics a sublicense under the three patent families to develop, market, sell and otherwise commercialize its existing programs related to the OrthoMab technology.
Under the terms of the UNC Agreement, we are required to pay UNC an annual license maintenance fee, low single-digit royalties on net sales of clinically approved and other products as well as sublicense fees. The term of the license and our obligation to pay royalties runs until the last licensed patent expires. UNC may terminate the agreement governing the license if there is a material breach by us of the agreement and we fail to cure such breach, which breaches include but are not limited to our failure to deliver payment to UNC when due, to provide progress reports, to meet or achieve performance milestones or to possess and maintain insurance, or the execution of a sublicense that complies with the terms of the agreement. We may terminate the agreement at any time upon at least 60 days’ notice to UNC.
Trianni
Through our acquisition of Trianni, we acquired all existing intellectual property including issued patents and pending applications worldwide relating to the flagship Trianni mouse and new platforms in development. We also acquired Trianni’s trademarks including the terms “Trianni” and “Trianni Mouse”, that have been issued in the United States and various other jurisdictions worldwide.
The Trianni intellectual property portfolio includes issued patents and pending applications in the U.S. and certain jurisdictions around the world.
In one patent family, the patents are directed to transgenic animals and methods of use. This patent family includes fourteen issued patents including in the U.S., Australia, the Russian Federation, Europe, India, Israel, Canada, China and Japan. Patents issuing from this family are expected to expire in July 2031, absent any disclaimers or extensions available.
Another patent family is directed to enhanced production of immunoglobulins. This patent family includes six issued patents including in the U.S., Israel, Australia, Europe, and Japan. There are four pending applications including one in the U.S. and three in pending foreign counterparts, including Canada, Europe, and Korea. Any patents that issue from this family are expected to expire in February 2037, absent any disclaimers or extensions available.
Another patent family is also directed to enhanced production of immunoglobulins. This patent family includes two issued patents in Australia and Israel and four pending applications, including in Canada, Europe, China, and Korea. Any patents that issue from this family are expected to expire in August 2036, absent any disclaimers or extensions available.
Another patent family is directed to enhanced immunoglobulin diversity. This patent family includes two issued patents in the U.S. and two pending applications, including one in the U.S. and one in Europe. Issued patents from this family are expected to expire in November 2036, absent any disclaimers or extensions available.
Another patent family is directed to transgenic mammals that express canine-based immunoglobulins. This patent family contains two issued U.S. patents. Issued patents from this family are expected to expire in July 2031, absent any disclaimers or extensions available.
Another patent family is directed to transgenic mammals that express bovine-based immunoglobulins. This patent family contains one issued U.S. patent. Issued patents from this family are expected to expire in July 2031, absent any disclaimers or extensions available.
Another patent family is directed to transgenic mammals that express canine-based immunoglobulins. This patent family contains eight pending applications, including in the U.S., Australia, Canada, China, Europe, Israel, Japan, and Korea. Issued patents from this family are expected to expire in July 2039, absent any disclaimers or extensions available.
Another patent family is directed to transgenic mammals that express bovine-based immunoglobulins. This patent family contains seven pending applications, including in Australia, Canada, China, Europe, Israel, Japan, and Korea. Issued patents from this family are expected to expire in July 2039, absent any disclaimers or extensions available.
Another patent family is directed to single chain VH and heavy chain antibodies. This patent family includes six issued patents including in the U.S., Canada, Australia, Europe, Israel, and Japan. There are two pending applications, including in the U.S. and China. Issued patents from this family are expected to expire in July 2038, absent any disclaimers or extensions available.
Another patent family is directed to long germline DH gene and long HCDR3 antibodies. This patent family contains two issued patents, one in Europe and the second in the U.S., and one pending application in the U.S. Issued patents from this family are expected to expire in October 2037, absent any disclaimers or extensions available.
Another patent family is directed to transgenic rodents expressing chimeric equine-rodent antibodies. This patent family contains eight pending applications including in the U.S., China, Australia, Korea, Japan, Israel, Canada, and Europe. Issued patents from this family are expected to expire in May 2042, absent any disclaimers or extensions available.
Another patent family is directed to Adam6 knock-in mice. This patent family contains one issued patent in Europe. Issued patent is expected to expire in August 2039, absent any disclaimers or extensions available.
Another patent family is directed to heavy chain-only antibodies. This patent family contains eight pending applications, including in Australia, Canada, China, Korea, Israel, Japan, and Europe. Issued patents from this family are expected to expire in September 2040, absent any disclaimers or extensions available.
CD3 T-Cell Engagers
Our discovery and development capabilities have directly led to our discovery of novel CD3 T-cell engagers. Our CD3 T-cell engager portfolio consists of a patent family that is directed to novel CD3-binding antibodies (including bispecific antibodies capable of binding both CD3 and a tumor antigen), and methods of using the CD3-binding antibodies in treating hyperproliferative disorders or autoimmune disorders. This patent family has one pending application in the U.S. Issued patents from this family are expected to expire in March 2043, absent any disclaimers or extensions available.
Anti-OX40L Antibodies
Our discovery and development capabilities have also directly led to our discovery of novel anti-OX40L antibodies. Our OX40L portfolio consists of a patent family that is directed to novel anti-OX40L antibodies, and methods of using the anti-OX40L antibodies to treat atopic dermatitis. This patent family has one pending International (PCT) patent application. Issued patents from this family are expected to expire in October 2044, absent any disclaimers or extensions available.
ABCL635
Our discovery and development capabilities have also directly led to our discovery of novel antibodies to a still undisclosed target. This portfolio consists of a patent family that is directed to the novel antibodies, and methods of using the antibodies to treat a still undisclosed indication. This patent family has one pending International (PCT) patent application. Issued patents from this family are expected to expire in October 2044, absent any disclaimers or extensions available.
AbCellera
We also aim to continue developing our product portfolio. We currently own several recently filed pending U.S. non-provisional patent applications directed toward methods for high throughput screening of multispecific antibody libraries and anti-coronavirus antibodies and methods of use.
The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In the countries in which we file, the patent term is 20 years from the earliest non-provisional filing date, subject to any disclaimers or extensions. The term of a patent in the United States can be adjusted due to any failure of the United States Patent and Trademark Office following certain statutory and regulation deadlines for issuing a patent.
In the United States, the patent term of a patent that covers an FDA-approved drug may also be eligible for patent term extension, which permits patent term restoration as compensation for a portion of the patent term lost during the FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the original expiration of the patent. The protection provided by a patent varies from country to country, and is dependent on the type of patent granted, the scope of the patent claims, and the legal remedies available in a given country.
For a discussion of the risks we face relating to intellectual property, see “Risk Factors—Risks Related to our Intellectual Property—If we are unable to obtain and maintain sufficient intellectual property protection for our technology, including our platform and Celium, our proprietary antibody visualization software, or if the scope of the 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 data packages may be impaired.”
Government Regulation
Our focus is on the discovery and development of antibodies for ourselves and for our partners to improve patients' lives. We are involved in the discovery, development, manufacturing, and clinical trials activities of these prospective future medicines. As such, we are subject to many regulations, such as those governing our laboratory facilities, drug manufacturing, clinical trials, as well as regulations that apply to businesses in the private sector generally. In 2025, we will start our own first clinical trial and will be subject to many of the regulations that ordinarily apply to companies in the life sciences, biotechnology and pharmaceutical sectors and industries. However, we believe that the long-term success of our business depends, in part, on our and our partners’ ability to successfully develop and sell therapeutic products using the antibodies we discover. The regulations that govern our pharmaceutical and biotechnology partners are those we therefore believe have the most significant impact on our business.
Government authorities in the United States, at the federal, state and local level, and in the European Union, or E.U., and other countries and jurisdictions, extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of pharmaceutical products, including biological products such as those that our partners develop. The processes for obtaining marketing approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.
We and our partners will be subject to various regulations in applicable jurisdictions governing, among other things, clinical studies and any commercial sales and distribution of their products. Whether or not our partners obtain approval from the U.S. Food and Drug Administration, or FDA, or the European Commission for the E.U. for a product, they must obtain the requisite approvals from regulatory authorities in foreign countries before the commencement of clinical studies or marketing of the product in those countries. The requirements and process governing the conduct of clinical studies, product licensing, coverage, pricing and reimbursement vary from country to country.
Additional Regulation
In addition to the foregoing, provincial, state and federal U.S. and Canadian laws regarding environmental protection and hazardous substances affect our business. These and other laws govern our use, handling and disposal of various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations contaminate the environment or expose individuals to hazardous substances, we could be liable for damages and governmental fines. We
believe that we are in material compliance with applicable environmental laws and that continued compliance therewith will not adversely affect our business. We cannot predict, however, how changes in these laws may affect our future operations.
Anti-Corruption Laws
We are subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, the Canadian Corruption of Foreign Public Officials Act and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities, such as the UK Bribery Act 2010 and the UK Proceeds of Crime Act 2002, or collectively, Anti-Corruption Laws. Among other matters, such Anti-Corruption Laws prohibit corporations and individuals from directly or indirectly paying, offering to pay or authorizing the payment of money or anything of value to any foreign government official, government staff member, political party or political candidate, or certain other persons, to obtain, retain or direct business, regulatory approvals or some other advantage in an improper manner. We can also be held liable for the acts of our third-party agents under the FCPA, the Canadian Corruption of Foreign Public Officials Act, the UK Bribery Act 2010 and possibly other Anti-Corruption Laws. In the healthcare sector, anti-corruption risk can also arise in the context of improper interactions with doctors, key opinion leaders and other healthcare professionals who work for state-affiliated hospitals, research institutions or other organizations.
Available Information
Our website address is www.abcellera.com. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, including exhibits, proxy and information statements and amendments to those reports filed or furnished according to Sections 13(a), 14, and 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available through the “Investors” portion of our website free of charge as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Information on our website is not part of this Annual Report on Form 10-K or any of our other filings with the SEC unless specifically incorporated herein by reference. In addition, our filings with the SEC may be accessed through the SEC’s website at www.sec.gov. All statements made in any of our filings with the SEC or documents available on our website, including all forward-looking statements or information, are made as of the date of the document in which the statement is included, and we do not assume or undertake any obligation to update any of those statements or documents unless we are required to do so by law.
Our code of conduct, corporate governance guidelines and the charters of our Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee are available through the “Investors” portion of our website.