KNSA 10-K & 10-Q changes, risk factors and insider trading

Since our commercial launch of ARCALYST, we have focused on establishing and expanding our internal capabilities, including but not limited to, sales, marketing, distribution, access and payor and patient support services capabilities as well as contracting with third parties to perform certain services. Each aspect of commercialization on its own can be complex, expensive and time consuming, and, collectively, the required effort for coordination is intensive. While we have realized revenues from such efforts, there is no guarantee that we will be able to maintain the trajectory of growth or significant and sustained revenues in the long-term.future.

●any delays in our ability to produce sufficient quantities of ARCALYST, or any of our future products, at an acceptable cost or quality, including such delays arising out of quality assurance concerns or changes in regulatory guidance, or those caused by our reliance on our third party manufacturers;

●our inability to recruit, train and retain adequate numbers of effective sales, marketing, access,access and payor and patient support personnel;

●unforeseen costs and expenses associated with creating and maintaining a sales, marketing,marketing and access organization.

We rely on a select network of third party specialty pharmacies to distribute ARCALYST andin the United States, which is the only country where it is currently approved for sale. We expect to use a similar strategy forto sell and distribute our current and future product candidates, if approved. We rely on such specialty pharmacies to effectively distribute products in a timely manner, provide certain patient support services, manage prescription intake, collect accurate patient and inventory data and collect payments from payors. While we have entered into agreements with each of these specialty pharmacies, they may not perform as agreed, our strategic priorities may change or they may terminate their agreements with us. Further, an inability of our specialty pharmacies to meet our patients’ needs may lead to reputational harm or patient loss. In the event that such network fails to properly meet our or our patients’ needs, we may need to partner with other specialty pharmacies to replace or supplement our current network and there is no guarantee that we will be able to do so on commercially reasonable terms or at all. In addition, there is a risk that patients may discontinue or suspend their ARCALYST treatment in the process of transitioning between specialty pharmacies, and it may take time to re-integrate such patients into our network, if at all. In such an eventevent, our business, results of operations, financial condition and prospects may be materially affected.

Our ability to continue to commercialize ARCALYST in its approved indications or any of our future products, if any, particularly in orphan or rare disease indications, will depend in part on the availability of favorable coverage,coverage theand adequacy ofadequate reimbursement (including affordability of patient cost-sharing obligations) for ARCALYST or the future product and alternativeassociated treatments from third party payors (e.g., governmental authorities, private health insurers and other organizations). We currently enjoy largely favorable coverage and reimbursement from third party payors for ARCALYST in the approved recurrent pericarditis indication and seek to maintain such favorable coverage and reimbursement. We cannot be certain we will continue to effectively execute our coverage and reimbursement strategy in the markets we pursue, which could limit the future commercial potential of ARCALYST in the approved recurrent pericarditis indication or any of our product candidates, if approved.

Governmental authorities, private health insurers and other third party payors have attempted to control costs through a number of efforts, including by delaying the time to reimbursement, byreimbursement; restricting the breadth of coverage,coverage; implementing utilization management controls such as requiring prior authorization,authorization; limiting the amount of reimbursement for a particular product; restricting the prices that manufacturers may charge for their products and increasing the proportion of the cost for which the patient is responsible. Additional future government action to control costs is likely. There may be significant delays in obtaining reimbursement for newly approved products or product indications,indications; coverage may be limited to a subset of the patient population for which the treatment is approved by the FDA or by similar regulatory authorities outside the United States including health technology assessment bodies in the European Union (the “EU”) and Unitedthe Kingdom,UK; and reimbursement rates may vary according to the use of the product and the clinical setting in which it is used. Coverage and reimbursement barriers by payors may materially impact the demand for, or the price at which we can sell, ARCALYST and any product candidate for which we obtain marketing approval, if any. If coverage and reimbursement are not available, or available only at limited levels, or if such coverage will require patient out-of-pocket costs that are unacceptably high, our ability to successfully commercialize ARCALYST or any of the product candidates for which we obtain marketing approval may be adversely affected. Moreover, any coverage or reimbursement that may be obtained may be decreased or eliminated in the future. For example, in January 2023, one of the large private health insurers that currently covers ARCALYST placed ARCALYST on its exclusion list for the CAPS indication, which could create hurdles for new patients seeking coverage for their prescriptions in all indications. In addition, obtaining and maintaining favorable coverage and adequate reimbursement may require us to offer pricing concessions to third party payors.

We have and may continue to periodically increase the price of ARCALYST and may implement similar pricing practices for future products, if approved, and may be unable to realize commercial benefits from such price increases due to unfavorable actions that third party payors (including governmental authorities and private health insurers) may take in response. Even if price increases lie below contractual price protection clauses, payors may request price concessions in exchange for covering our products or may opt to change coverage or reimbursement policies with respect to such products. If we cannot successfully negotiate with such payors, we may be forced to provide significant price concessions or, if we fail to arrive at a satisfactory resolution, lose favorable coverage or reimbursement for patients served by such payor. We are also required to provide discounts or rebates under government healthcare programs or to certain government and private purchases in order to obtain coverage under federal healthcare programs. In suchaddition, anprice event,increases patientsthat outpace inflation may havealso difficultytrigger obtainingadditional accessrebate to,obligations, orincluding affording,under suchthe productsMedicaid andDrug weRebate may see materially negative impacts on our business operations.Program.

Any price concessions will reduce our overall revenue generation and may impair the benefit of any price increases we may take. Even comparatively small discounts, if aggregated across payors, may cause materially lower revenue generation in the long-term, which may offset the increased revenue we hoped to realize through a price increase. In the event that we cannot successfully negotiate with payors requesting price concessions in connection with a price increase or otherwise, such payors may choose to notend cover our current and future products at allcoverage or may impose onerous reimbursement policies that limit patient access.policies. We cannot assure you that current payor coverage and reimbursement policies for ARCALYST will continue. The loss of any payor, especially a large payor, or limitations on access to our drugs affecting a sizeable number of patients may materially harm our ability to generate revenue and execute on our commercial strategy. Further, as a company targeting patients with significant unmet medical need, the loss of access to our products may materially harm our targeted patient populations who cannot source adequate alternative therapies.

The incidence and prevalence for target patient populations of our products or product candidates have not been established with precision. If the market opportunities for our products and product candidates are smaller than we estimate, or if any approval that we obtain is based on a narrower definition of our targeted patient population, our revenue and ability to achievesustain profitability may be materially adversely affected.

The total addressable market for ARCALYST and any other of our current or future product candidates, if approved, will ultimately depend upon, among other things, the diagnostic criteria and applicable patient population included in the final label for the product or product candidate approved for sale for its indication; the efficacy, safety and tolerability demonstrated by the product candidate in our clinical trials; acceptance by the medical community; and patients, pricing, access and reimbursement. The number of addressable patients in the United StatesStates, the country where substantially all ARCALYST sales occur, and other major markets outside of the United States may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business. Further, even if we obtain significant market share for our product candidates, because the potential target populations are small for many of our approved and targeted indications, we may never achieve significant and sustained profitability.

●decreased demand for any approved products we commercialize;

●regulatory investigations that could require costly recalls or product modifications (or withdrawal of the product from the market);

We are currently only authorized to market ARCALYST, our sole product, for the treatment of recurrent pericarditis in the United States, where we derive substantially all of our revenue. Our future growth may depend, in part, on our ability to commercialize our current and future products in markets outside of the United States either on our own or through collaborations with third parties.

We continue to evaluate the opportunities for the development and commercialization of our product candidates in certain markets outside of the United States, including through our Named Patient Program, Managed Access Program and collaborations with third parties, including Huadong. We and our collaborators are not permitted to market or promote any of our product candidates before we receive regulatory approval from the applicable regulatory authority in that market, and we may never receive such regulatory approval for any of our product candidates. To obtain separate regulatory approval in many other countries, we, or our collaborators, must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials, manufacturing and commercial sales, pricing and distribution of our product candidates, and we cannot predict success in these jurisdictions. If we obtain approval, and ultimately commercialize, our product candidates in markets outside of the United States, we would be subject to additional risks and uncertainties, including:

●exposure to increased regulatory risk, including those arising under the FCPAUnited States Foreign Corrupt Practices Act (asthe defined“FCPA”), below)the UK Economic Crime and Corporate Transparency Act 2023 or similar foreign regulations;

The policies of the FDA and other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates.candidates or require significant changes to the manufacturing, sales and distribution of any of our products. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States, Europe or in other jurisdictions. In addition, ifIf we or third parties acting on our behalf are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, we may be subject to potentially significant enforcement actions.

The development and marketing of pharmaceutical products and related arrangements with healthcare professionals, third party payors, patients and other third parties in the healthcare industry are subject to a wide range of healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our current and future products. Given the broad scope andscope, evolving government interpretation and unpredictable enforcement of these laws, our business activities could be subject to challenge underin onethe or more of such laws. We have entered into consulting and advisory board agreements with physicians and other healthcare professionals and could be adversely affected if regulatory authorities determine our financial relationships with such prescribers violate applicable laws or create a conflict of interest.future. For example, investigators for our clinical trials may serve as scientific advisorsadvisors, speakers, advisory board members or consultants to us from time to time and receive compensation in connection with such services. Regulatory authorities may conclude that a financial relationship between us and a principal investigator or a clinical trial site has created a conflict of interest or otherwise affected interpretation of a study. Regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized, which could result in a delay in approval, or rejection, of our marketing applications by regulatory authorities and may ultimately lead to the denial of marketing approval of our product candidates. Furthermore, investigators for our clinical trials may become debarred by regulatory authorities, which may impact the integrity of our studies and the utility of the clinical trial itself may be jeopardized.

We cannot be certain that any of our product candidates will be successful in their clinical trials.trials We also cannot be certain that theyor will receive regulatory approval,approval. evenFurther, after completing a successful pivotal clinical trial. Wewe may also choose to cease development of a product candidate prior to conducting a pivotal trial for any reason, including capital conservation purposes. We may also choose not to commercialize a product candidate that has completed a pivotal trial or received regulatory approval,approval for a number of reasons, including commercial viability. Such decisions may be for a particular indication or be for the product candidate entirely. In the event that a product candidate is unsuccessful in its clinical trials, fails to receive regulatory approvalapproval, is deprioritized for strategic reasons or is unviablenon-viable for another reason, our business may be materially harmed by limiting our ability to recoup our development expenses through a successful commercial launch.

●submission to and authorization to proceed with clinical trials by the FDA under INDs and CTAs to applicable authorities outside of the United States for our product candidates to commence planned clinical trials or future clinical trials;

●successful completion of required nonclinical studies, including toxicology studies, pharmacological,pharmacological and biodistribution studies, as conducted, where applicable, under GLP;

●successful site activation for, enrollment in,in and completion of clinical trials, including the ability of our CROs to successfully conduct such trials within our planned budget and timing parameters without adversely impacting our trials, and our ability to successfully oversee CRO activities;

ARCALYST is an IL-1α and IL-1β cytokine trap. In 2017, we licensed ARCALYST from Regeneron, which discovered and initially developed the drug. Our exclusive license to ARCALYST from Regeneron includes worldwide rights, excluding the Middle East and North Africa, for all applications other than those in oncology and local administration to the eye or ear. We received FDA approval of ARCALYST for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older in March 2021. Recurrent pericarditis is a painful inflammatory cardiovascular disease with an estimated United States prevalent population of approximately 40,000 patients seeking and receiving medical treatment. ARCALYST is also approved in the United States for the treatment of CAPS, including FCAS and Muckle-Wells Syndrome in adults and children 12 years and older, and the maintenance of remission in DIRA in adults and children weighing 10 kg or more. ARCALYST is commercially available across the United States through a select network of specialty pharmacies. We are responsible for sales and distribution of ARCALYST in all approved indications in the United States, and evenly split profits on sales as well as third party proceeds with Regeneron. In 2022, we granted Huadong exclusive rights to develop and commercialize ARCALYST in the Huadong Territory. In 2023, Regeneron initiated a technology transfer of the manufacturing process for ARCALYST drug substance, and we are working to qualify Samsung as our replacement CDMO. In December 2024, we initiated a collaborative study agreement with The Mayo Clinic (together with Johns Hopkins University) to investigate the effects of ARCALYST in the treatment of cardiac sarcoidosis.

KPL-387 is an investigational, fully human immunoglobulin G2 monoclonal antibody that binds IL1-R1, inhibiting IL-1α and IL-1β mediated signaling. KPL-387 is an independently developed asset that we believe hasmay expand the recurrent pericarditis market and provide an additional treatment option for patients, with the potential to further advance recurrent pericarditis treatment options for patients by providingadd the added convenience of monthly subcutaneous dosingself-administration with a liquid formulation. In June 2024, we initiated a Phase 1 clinical trial of KPL-387 in normal healthy volunteers. In FebruaryJuly 2025, we announced ourthat planthe toPhase initiate2 adose-focusing portion of the Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis inhad mid-2025.begun recruiting. We expect data from the Phase 2 portion of the trial in the second half of 2026.2026 and plan to use the totality of the data to determine further development strategy. In September 2025, we announced plans to conduct a supplemental Phase 2 transition to KPL-387 monotherapy dosing and administration study to evaluate the efficacy and safety of dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy. In October 2025, the FDA granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis.

KPL-1161 is an independently developed, pre-clinical, Fc-modified immunoglobulin G2 monoclonal antibody that binds IL-1R1, inhibiting IL-1α- and IL-1β-mediated signaling. KPL-1161 is a modified version of KPL-387 designed to have an increased drug half-life that we believe could support quarterly subcutaneous dosing. We are currently conducting preclinical activities with respect to this asset, with an expectation to initiate a Phase 1 first-in-human clinical trial by the end of 2026.

Abiprubart is an investigational monoclonal antibody inhibitor of CD40-CD154 costimulatory interaction, which we believe to be an attractive approach to address multiple autoimmune disease pathologies. We hold an exclusive worldwide license to abiprubart from BIDMC. We previously announced a Phase 2b clinical trial of abiprubart in Sjögren’s Disease. In February 2025, we announced our plans to discontinue development of abiprubart in the indication and to explore strategic alternatives for the asset.

We have been generating product revenue from sales of ARCALYST since April 2021. ARCALYST is sold through a third party logistics provider that distributes primarily through a select network of specialty pharmacies (collectively, “customers”), which deliver the medication to patients by mail. ARCALYST is currently only approved for sale in the United States, and, therefore, we expect to derive substantially all of our product revenue from the United States for the foreseeable future.

In February 2022, we entered into the Huadong Collaboration Agreements,Agreements with Huadong, pursuant to which we granted Huadong exclusive rights to develop and commercialize theARCALYST Huadongand Licensed Productsmavrilimumab, in the Huadong Territory. In FebruaryApril 2025, we providedentered writteninto noticea mutual termination agreement with Huadong pursuant to Huadongwhich thatwe Huadong has not conducted material development activity with respectagreed to mavrilimumab in the People’s Republic of China for a continuous period in excess of six months as required under the mavrilimumab Huadong Collaboration Agreement. Unless Huadong conducts material development activity within 60 days of the notice,terminate the mavrilimumab Huadong Collaboration Agreement willand terminaterelease onall Aprilclaims 25,related 2025.thereto. WeThe otherwise retain our current rights to theARCALYST Huadong LicensedCollaboration ProductsAgreement outsideremains thein Huadong Territory.effect. For more information, see “Business –License and Acquisition Agreements—Out-Licensing Agreements—Huadong Collaboration Agreements”.

Under the Genentech License Agreement, we received an upfront payment of $80.0 million for the license. Additionally, in 2023, we received a total of $35.0 million in additional payments from Genentech related to delivery of certain drug material to Genentech and Genentech’s achievement of a development milestone. In the fourth quarter of 2023, following the achievement of a development milestone related to a second indication under the Genentech License Agreement, Genentech became obligated to make an additional cash payment of $10.0 million, which was received in the first quarter of 2024. In the second quarter of 2024, we received $5.0 million following the achievement of a development milestone related to a third indication under the Genentech License Agreement. We will be eligible to receive up to a total of approximately $600.0 million in contingent payments, including specified development, regulatory and sales-based milestones, of which approximately $570.0 million remains as of December 31, 2024.2025. We will also be eligible to receive tiered percentage royalties on a Genentech Licensed Product-by-Genentech Licensed Product basis ranging from low-double digits to mid-teens on annual net sales of each Genentech Licensed Product, subject to certain customary reductions, with an aggregate minimum floor, before fulfilling our upstream financial obligations. Royalties will be payable on a Genentech Licensed Product-by-Genentech Licensed Product and country-by-country basis until the latest to occur of the expiration of certain patents that cover a Genentech Licensed Product, the expiration of regulatory exclusivity for such Genentech Licensed Product, or the tenth anniversary of first commercial sale of such Genentech Licensed Product in such country. As of December 31,In 2024, we havecompleted recognizedour theremaining $130.0 million received from Genentechobligations under the Genentech License Agreement and we have recognized as revenue.revenue all of the consideration received.

Cost of goods sold includes production and distribution costs of ARCALYST, amortization of the $20.0 million payment we made to Regeneron in the first quarter of 2021 upon achievement of a regulatory milestone and other miscellaneous product costs associated with ARCALYST. Cost of goods sold also includes labor and overhead costs associated with the production of ARCALYST associated with supply chain, quality, and regulatory activities, and the technology transfer of the manufacturing process for the ARCALYST drug substance.ARCALYST.

Other income consists of interest income recognized from investments in money market funds, United States Treasury notessecurities and other miscellaneous income offset by expenses related to investments.

Prior to the Redomiciliation, our principal holding company was incorporated and principally subject to taxation in Bermuda. Following the Redomiciliation, our principal holding company is incorporated and principally subject to taxation in the United Kingdom. Under the currentprevious laws of Bermuda, there is no corporate income tax levied on an exempted company’s income, resulting in an effective zero percent tax rate. As a result, we have not recorded any income tax benefits from our losses incurred in Bermuda during each of the reporting periods in which it was incorporated there, and no net operating loss carryforwards are currently available to us for those losses. Following the Redomiciliation, our income is subject to the enacted United Kingdom statutory corporate tax rate and net operating losses incurred have an indefinite carryforward. Our wholly owned Unitedsubsidiaries States(including subsidiaries,any Kiniksa US, and Primatope Therapeutics, Inc. are subject to federal and state income taxes in the United States. Our wholly owned subsidiary Kiniksa UK, its Swissforeign branch office,offices and Kiniksa UK’s wholly owned subsidiaries, Kiniksa Pharmaceuticals (Germany) GmbH, Kiniksa Pharmaceuticals (France) SARL, and Kiniksa Pharmaceuticals, GmbH (“Kiniksa Switzerland”thereof) are subject to taxation in their respective countries.

In the first quarter of 2022, Kiniksa Bermuda transferred exclusive rights to develop and commercialize mavrilimumab in the Asia Pacific region, excluding Japan, to Kiniksa UK. In the third quarter of 2022, Kiniksa Pharmaceuticals, Ltd. (“Kiniksa Bermuda”) transferred exclusive worldwide rights to develop and commercialize vixarelimab to Kiniksa UK.Pharmaceuticals (UK), Ltd. (“Kiniksa UK”). In the fourth quarter of 2023, all rights, title and interest in, among other things, certain contracts, intellectual property rights, product filings and approvals and other information, plans and inventory owned insofar as they related exclusively or primarily to ARCALYST were allocated by Kiniksa UK to its Swiss branch office. In the first quarter of 2024, Kiniksa Bermuda transferred to Kiniksa Pharmaceuticals, GmbH (“Kiniksa Switzerland”) all rights, title and interest in, among other things, certain contracts, intellectual property rights, product filings and approvals and other information, plans and materials owned insofar as they related exclusively or primarily to abiprubart, mavrilimumab, KPL-387, KPL-1161 and other preclinical assets, with such exceptions as necessary to allow the completion of Cohort 4 of our Phase 2 clinical trial of abiprubart in rheumatoid arthritis (“RA”).assets. In connection with each of the foregoing transfers and /or allocations, we recognized a step-up in basis and did not incur any material tax liabilities.

In the second quarter of 2024, Kiniksa UK terminated its exclusive rights to develop and commercialize mavrilimumab in the Huadong Territory, with such rights reverting to Kiniksa Switzerland. Thereafter, Kiniksa Switzerland held worldwide rights to develop and commercialize mavrilimumab. In the fourth quarter of 2024, Kiniksa UK contributed all of its rights, title and interest in, among other things, certain contracts, intellectual property rights, product filings and approvals and other information, plans and materials owned or controlled by Kiniksa UK insofar as they related exclusively or primarily to vixarelimab to Kiniksa Switzerland. In connection with the termination of Kiniksa UK rights and the contribution, we revalued the assets at fair market value and did not incur any material tax liabilities.

We did not recognize any license and collaboration revenue for the year ended December 31, 2025. We reported $6.2 million of license and collaboration revenue for the year ended December 31, 2024, primarily driven by the achievement of a $5.0 million development milestone related to a third indication under the Genentech License Agreement,Agreement and $0.7 million of products sold under the ARCALYST Huadong Collaboration Agreements, and $0.2 million of deferred revenue recognized related to the delivery of such materials.Agreements. We reported $37.1 million of license and collaboration revenue for the year ended December 31, 2023, related to the Genentech License Agreement primarily driven by the achievement of $25.0 million in development milestones related to two new indications, materials delivered and our ongoing recognition of the transaction price related to the in-progress Phase 2b clinical trial of vixarelimab in prurigo nodularis. We reported $97.7 million of license and collaboration revenue for the year ended December 31, 2022, which primarily consisted of $87.7 million for revenue related to the Genentech License Agreement and $10.0 million in revenue recognized upon the signing of the mavrilimumab Huadong Collaboration Agreement in February of 2022. We expect to recognize $31.8 million of deferred revenue related to the ARCALYST Huadong Collaboration Agreement over the life of the agreement as materials are delivered.

We recognized cost of goods sold of $60.9$77.7 million, $33.4$60.9 million, and $22.9$33.4 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. The increase of $16.8 million in 2025 from 2024 related primarily to the increase in sales of ARCALYST. The increase of $27.5 million in 2024 from 2023 related primarily to the increase in sales of ARCALYST and a $12.6 million increase related to the technology transfer of the manufacturing process offset by a decrease in average cost per unit resulting from favorable production variances. The increase of $10.5 million in 2023 from 2022 related primarily to the increase in sales of ARCALYST and $3.3 million related to the initiation of the technology transfer of the manufacturing process offset by a decrease in average cost per unit resulting from favorable production variances.

We recognized collaboration expenses of $128.3$229.5 million, $56.5$128.3 million and $24.1$56.5 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. The increase of $101.2 million in 2025 from 2024 relates primarily to increased revenue from sales of ARCALYST. The increase of $71.8 million in 2024 from 2023 relates primarily to increasedan increase in revenue from the sales of ARCALYST driving higher profits under the Regeneron agreement and to a $10.0 million payment due to Regeneron related to a regulatory milestone achieved under the ARCALYST Huadong Collaboration Agreement. The increase of $32.5 million in 2023 from 2022 relates primarily to an increase in revenue from the sales of ARCALYST and improved profitability under the Regeneron agreement.

Direct costs for our KPL-387 program were $11.2$47.3 million, $2.5$11.2 million and less than $0.1$2.5 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. During the year ended December 31, 2025, expenses primarily related to the start-up of our Phase 2/3 clinical trial in recurrent pericarditis and manufacturing of clinical supply. During the year ended December 31, 2024, expenses primarily related to our Phase 1 study in normal healthy volunteers and manufacturing of clinical supply. During the year ended December 31, 2023, expenses primarily related to manufacturing of clinical supply.

Direct costs for our KPL-1161 program were $4.2 million and $0.6 million for the yearyears ended December 31, 2024.2025 and 2024, respectively. We did not incur any expenses related to KPL-1161 for the year ended December 31, 2023. For the years ended December 31, 20232025 and 2022. For the year ended December 31, 2024 expenses incurred primarily related to pre-clinical development.

Direct costs for our abiprubart program were $59.5$6.1 million, $28.4$59.5 million and $11.6$28.4 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. During the year ended December 31, 2025 expenses incurred primarily related to the close-out of our Phase 2b clinical trial in Sjögren’s Disease. During the year ended December 31, 2024 expenses incurred primarily related to a $18.5 million write-off of prepayments for future manufacturing we no longer expect to utilize, manufacturing of clinical material, continuation of cohort four and study wind-down activities of our Phase 2 clinical trial in RA and start-up costs of our Phase 2b clinical trial in Sjögren’s Disease. During the year ended December 31, 2023, expenses incurred primarily related to the manufacturing of clinical material, the continuation of the first two cohorts of the Phase 2 clinical trial of abiprubart in RA and Cohorts 3 and 4 of such trial. During the year ended December 31, 2022, expenses incurred primarily related to the first two cohorts of our Phase 2 clinical trial of abiprubart in RA, which was initiated in December 2021.

Direct costs for our vixarelimab program were $1.5less than $0.1 million, $7.7$1.5 million and $12.8$7.7 million for the yearyears ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. During the year ended December 31, 2024, expenses incurred were primarily related to the wind-down activities of our Phase 2b clinical trial in prurigo nodularis. During the yearsyear ended December 31, 2023 and 2022, expenses incurred primarily related primarily to our ongoing Phase 2b clinical trial of vixarelimab in prurigo nodularis. The decrease of $5.1 million in 2023 from 2022 was primarily related to a decrease in active participants in our ongoing Phase 2b clinical trial of vixarelimab in prurigo nodularis.

Unallocated research and development expenses were $37.7$38.2 million, $34.1$37.8 million and $33.9$34.8 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. The increase of $3.6$0.8 million in unallocated research and development expenses in 2025 from 2024 was primarily due to an increase in pre-clinical development. The increase of $3.0 million in unallocated research and development expenses in 2024 from 2023 was primarily due to an increase in personnel to support our clinical trials. The increase of $0.2 million in unallocated research and development expenses in 2023 from 2022 was primarily due to timing of raw material purchases to support internal development. Personnel-related costs for the years ended December 31, 2024,2025, 20232024 and 20222023 included share-based compensation of $6.1$6.6 million, $5.5$6.1 million and $6.8$5.5 million, respectively.

Selling, general and administrative expenses were $168.0$196.3 million, $129.4$168.0 million and $98.0$129.4 million for the years ended December 31, 2024,2025, 2023 and 2022, respectively. In 20222024 and 2023, werespectively. expandedThe ourincrease ARCALYSTof salesforce$28.3 million in 2025 from 2024 was primarily due to helpan driveincrease furtherof prescriber$23.1 adoptionmillion in personnel-related costs largely attributable to an increase in headcount and patientan enrollments.increase in sales and marketing expenses of $5.5 million. The increase of $38.6 million in 2024 from 2023 was primarily due to an increase of $18.9 million in personnel-related costs and an increase in sales and marketing expenses of $13.5 million, largely attributable to a full year of expenses associated with the expansion of our salesforce in 2023 and an increase in professional fees of $2.8 million largely attributable to the Redomiciliation. The increase of $31.5 million in 2023 from 2022 was primarily due to an increase of $18.9 million in personnel-related costs and an increase in sales and marketing of $6.0 million largely attributable to the expansion of our salesforce. Personnel-related costs for the years ended December 31, 2024,2025, 20232024 and 20222023 included share-based compensation of $22.9$28.2 million, $19.8$22.9 million and $17.7$19.8 million, respectively.

For the year ended December 31, 2024,2025, we recorded an income tax provision of $7.0$29.9 million relating primarily to income earned in SwitzerlandSwitzerland, the United States, and the U.S.,UK; netvaluation allowance on Swiss losses and revaluation of Foreign-DerivedSwiss Intangibledeferred Incometax (“FDII”)assets deductionfor enacted rate changes; offset by benefits related to share-based compensation, and U.S.United States federal and state R&D Credits utilized.Credits.

For the year ended December 31, 2023, we recorded an income tax benefit of $30.7 million relating to a non-cash deferred tax benefit of $33.8 million primarily associated with Kiniksa UK’s allocation of its ARCALYST assets to its Swiss branch office and the release of the valuation allowance on U.S.United States deferred tax assets offset by the establishment of a partial valuation allowance on our UK deferred tax assets. The net benefit in the net deferred tax asset was offset by current income tax expense of $3.1 million primarily associated with income earned in the UK and the United States.

As of December 31, 2024,2025, our principal source of liquidity was cash, cash equivalents and short-term investments, which totaled $243.6$414.1 million. Our net income (losses) were $59.0 million, ($43.2) million, $14.1 million and $183.4$14.1 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. We expect our cash balance and our expected cash inflows from operations to allow us to meet our current operating plan.

Under various agreements with third parties, we have agreed to make milestone payments, pay royalties, pay annual maintenance fees and to meet due diligence requirements, each based upon specified events. Pursuant to the Regeneron Agreement, we have entered into a supply agreement with Regeneron to purchase both clinical and commercial product. We have committed to minimum payments to Regeneron of $40.7$24.6 million, all of which are due within one year. We have entered into lease agreements for office and laboratory space, and vehicles, with total future lease payments of $11.3$10.5 million, $2.7$3.5 million of which are due within one year. In connection with our ongoing technology transfer of ARCALYST drug substance manufacturing, we have entered into a manufacturingMaster commitmentServices Agreement and a Product Specific Agreement with SamsungSamsung. toOur establishcommitments aunder newsuch manufacturing site for ARCALYST drug substance. Such commitment,agreements, which includes the purchase of raw materials and related service fees, obligates us to minimum payments of $151.0$147.7 million, $15.2$18.9 million of which are due within one year. As December 31, 2025, we have capitalized $20.9 million of production cost into inventory as semi-finished goods related to drug substance manufactured at Samsung. We have additionally entered into agreements with several CDMOs to provide us with preclinical and clinical trial materials for our non-ARCALYST assets, which obligate us to minimum payments of $40.8$3.4 million, $39.0 millionall of which are due within one year. InWe Februaryhave 2025long-term weincentive issuedplans terminationfor noticesour employees that may result in cash award payments of $23.1 million, based upon the achievement of certain regulatory milestones, none of which are expected to severalbe ofachieved these CDMOs to terminate clinical supply agreements forin the productionnext of abiprubart. The terminations will be effective in March 2025, and we are currently performing an analysis of the financial impact of the terminations. As of the date of this report, we expect to pay between $14.0 million and $17.0 million in termination cost.year.

Under various agreements with third parties, we are entitled to receive upfront payments, milestone payments, and royalties, each based upon specified milestones. DuringIn the year ended December 31, 20242024, we received $10.0$15.0 million,million following Genentech’s achievement of ain development milestone inpayments thefrom fourth quarter of 2023Genentech related to a second indication under the Genentech License Agreement and $5.0 million following Genentech’s achievement of a development milestone related to a third indication under the Genentech License Agreement. In the2025, fourthwe quarterreceived ofa 2024,$20.0 followingmillion milestone payment related to Huadong’s achievement of a regulatory milestone under the ARCALYST Huadong Collaboration Agreement, Huadong became obligated to pay a $20.0$10.0 million milestone,of which was receivedpaid to Regeneron in the2025 firstas quarterpart of 2025.the Regeneron Agreement.

We expect to incur significant expenses in connection with our ongoing and planned activities as we continue to commercialize ARCALYST and advance our current and future product candidates through preclinical and clinical development, seek regulatory approval and commercialize one or more of our current or future product candidates, if approved. We may also incur expenses in connection with thecollaboration, in-licensinglicensing or acquisitionother ofstrategic additionaltransactions. product candidates. As a result,Further, we expect tomay incur additional expenses related to milestone, royalty and other payments payable to third parties with whom we have entered into license, acquisition and other similar agreements to acquire the rights to our product candidates. For more information on our near and long-term funding requirements, see “Risk Factors – General Risk Factors – We expecthave toa incurhistory expensesof asoperating we:losses and may require substantial additional financing in the future.”

We believe that our existing cash, cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. The future viability of our company is dependent on our ability to fund our operations through sales of ARCALYST and/or raise additional capital, such as through debt or equity offerings, as needed. We anticipate that we may require additional capital if we choose to pursue in-licensescollaboration, licensing or acquisitions of other productstrategic candidates and technologies or their related businesses.transactions. We expect to continue to incur significant expenses related to product manufacturing, including technology transfer costs, sales, marketing and distribution of ARCALYST. In addition, if we obtain regulatory approval for any of our current or future product candidates, pursue additional indications or additional territories for our products or any of our current or future product candidates, we expect to incur significant expenses related to product development and manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

In addition to the information discussed elsewhere in this Quarterly Report, you should carefully review and consider the risk factors disclosed in Part I, Item 1A of the Annual Report, as updated by any information appearing in Part II, Item 1A of any of our subsequent Quarterly Reports on Form 10-Q. These risks could materially and adversely affect our business, results of operations, financial condition and prospects. The risks and uncertainties described therein are not the only ones we face. Additional risks and uncertainties not currently known to us or that we deem immaterial also may impair our businessbusiness, operations.results of operations, financial condition and prospects.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report, and our audited consolidated financial statements and related notes for the year ended December 31, 2025 included in the Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the risks identified in Part I, Item 1A of the Annual Report, as updated by any information appearing in Part II, Item 1A of any of our subsequent Quarterly Reports on Form 10-Q,10-Q (including this Quarterly Report), and our other filings with the Securities and Exchange Commission (the “SEC”) our actual results could differ materially from the results, performance or achievements expressed in or implied by these forward-looking statements.

ARCALYST is an interleukin-1α (“IL-1α”) and interleukin-1β (“IL-1β”) cytokine trap. In 2017, we licensed ARCALYST from Regeneron, which discovered and initially developed the drug. Our exclusive license to ARCALYST from Regeneron includes worldwide rights, excluding the Middle East and North Africa, for all applications other than those in oncology and local administration to the eye or ear. We received FDA approval of ARCALYST for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older in March 2021. Recurrent pericarditis is a painful inflammatory cardiovascular disease with an estimated United States prevalent population of approximately 40,000 patients seeking and receiving medical treatment. ARCALYST is also approved in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (“CAPS”), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome in adults and children 12 years and older, and the maintenance of remission in Deficiency of Interleukin-1 Receptor Antagonist (“DIRA”) in adults and children weighing 10 kg or more. ARCALYST is commercially available across the United States through a select network of specialty pharmacies. We are responsible for sales and distribution of ARCALYST in all approved indications in the United States, and evenly split profits on sales, as well as third party proceeds, with Regeneron. In 2022, we granted Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (“Huadong”) exclusive rights to develop and commercialize ARCALYST in the Huadong Territory (as defined below). In 2023, Regeneron initiated a technology transfer of the manufacturing process for ARCALYST drug substance.substance, Sinceand thenin weJune have2026 workedthe toFDA qualifyapproved Samsung Biologics Co., Ltd. (“Samsung”) as our replacement contract development and manufacturing organization (“CDMO”) and, in April 2026, the FDA accepted the supplemental biologics license application related to such technology transfer and assigned a Prescription Drug User Fee Act target action date of June 19, 2026.. In December 2024, we initiated a collaborative study agreement with The Mayo Clinic (together with Johns Hopkins University) to investigate the effects of ARCALYST in the treatment of cardiac sarcoidosis.

KPL-387 is an investigational, fully human immunoglobulin G2 monoclonal antibody that binds human interleukin-1 receptor 1 (“IL-1R1”), inhibiting IL-1α- and IL-1β-mediated signaling. KPL-387 is an independently developed asset that we believe may expand the recurrent pericarditis market and provide an additional treatment option for patients, with the potential to add the convenience of monthly subcutaneous self-administration with a liquid formulation. In July 2025,2026, we announced that the Phase 2 dose-focusing portion of thepivotal Phase 2/3 clinical trial of KPL-387 in recurrent pericarditispericarditis, PASTORALE, had begun recruiting.enrolling Weand expectdosing datapatients, fromsupported theby Phase 2 portiondata ofat the trial300 inmg thesubcutaneous secondmonthly halfdose of 2026 and plan to use the totality of the data to determine further development strategy.level. In September 2025,addition, we announced plansthat we expect to conductbegin commercializing KPL-387 in 2028 or 2029. We are also conducting a supplemental Phase 2 transition to KPL-387 monotherapy dosing and administration study to evaluate the efficacy and safety of dosing regimens used to transition patients from standard therapies to KPL-387 monotherapy. In April 2026, we announced our expectation to initiate a pivotal Phase 3 clinical trial of KPL-387 in recurrent pericarditis by the end of 2026. In October 2025, theThe FDA previously granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis.

Under the Huadong Collaboration Agreement, we received a total upfront cash payment of $12.0 million for the Huadong Territory license of ARCALYST. In the fourth quarter of 2024, following the achievement of a regulatory milestone under the Huadong Collaboration Agreement, Huadong became obligated to make an additional cash payment of $20.0 million, which was received in the first quarter of 2025. In addition, we will be eligible to receive additional contingent sales-based milestones payments related to ARCALYST. Huadong will also be obligated to pay us tiered percentage royalties on ARCALYST ranging from the low-to-mid teens on annual net sales in the Huadong Territory, subject to certain reductions tied to ARCALYST manufacturing costs and certain other customary reductions, with an aggregate minimum floor. Royalties will be payable on a country-by-country or region-by-region basis until the later of (i) 12 years after the first commercial sale of ARCALYST in such country or region in the Huadong Territory, (ii) the date of expiration of the last valid patent claim of our patent rights or any joint collaboration patent rights that covers ARCALYST in such country or region in the Huadong Territory, and (iii) the expiration of the last regulatory exclusivity for ARCALYST in such country or region in the Huadong Territory. We have recognized $0.2 million of revenue of the $32.0 million transaction price under the Huadong Collaboration Agreement as of MarchJune 31,30, 2026, and will recognize the remaining revenue as materials are shipped.

Under the Genentech License Agreement, we will be eligible to receive up to a total of approximately $600.0 million in contingent payments, including specified development, regulatory and sales-based milestones, of which approximately $570.0 million remains as of MarchJune 31,30, 2026. We will also be eligible to receive tiered percentage royalties on a Genentech Licensed Product-by-Genentech Licensed Product basis ranging from low-double digits to mid-teens on annual net sales of each Genentech Licensed Product, subject to certain customary reductions, with an aggregate minimum floor, before fulfilling our upstream financial obligations. Royalties will be payable on a Genentech Licensed Product-by-Genentech Licensed Product and country-by-country basis until the latest to occur of the expiration of certain patents that cover a Genentech Licensed Product, the expiration of regulatory exclusivity for such Genentech Licensed Product, or the tenth anniversary of first commercial sale of such Genentech Licensed Product in such country.

Our income is subject to the enacted United Kingdom statutory corporate tax rate. Our wholly owned United States subsidiaries, including Kiniksa Pharmaceuticals,Pharmaceuticals Inc.Corp. (“Kiniksa US”), are subject to federal and state income taxes in the United States. Our wholly owned subsidiary Kiniksa Pharmaceuticals (UK), Ltd. (“Kiniksa UK”), its Swiss branch office, and Kiniksa UK’s wholly owned subsidiaries, including Kiniksa Pharmaceuticals, GmbH (“Kiniksa Switzerland”) are subject to taxation in their respective countries.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

We recognized net revenue from the sale of ARCALYST of $214.3$243.6 million for the three months ended MarchJune 31,30, 2026, compared to $137.8$156.8 million for the three months ended MarchJune 31,30, 2025, an increase of $76.5$86.8 million. The increase in product revenue was driven primarily by an increase in patientpatients enrollment.on therapy.

We recognized cost of goods sold of $20.8$23.6 million for the three months ended MarchJune 31,30, 2026, compared to $17.9$18.6 million for the three months ended MarchJune 31,30, 2025, an increase of $2.9$5.0 million. The increase in cost of goods sold relates primarily to the increase in sales of ARCALYST partially offset by favorable production variances.

Collaboration expenses were $75.6$88.1 million for the three months ended MarchJune 31,30, 2026, compared to $43.8$52.4 million for the three months ended MarchJune 31,30, 2025, an increase of $31.8$35.7 million. The increase ofin $31.8collaboration millionexpenses relates primarily to increased revenue from sales of ARCALYST.

Research and development expenses were $27.5$40.9 million for the three months ended MarchJune 31,30, 2026, compared to $19.3$18.8 million for the three months ended MarchJune 31,30, 2025, an increase of $8.2$22.1 million.

Direct costs for our KPL-387 program were $16.2$21.4 million during the three months ended MarchJune 31,30, 2026, compared to $5.2$8.5 million during the three months ended MarchJune 31,30, 2025. The increase in expenses incurred primarily related to the enrollment and continuation of our Phase 2/3 clinical trial in recurrent pericarditis and the start of the supplemental Phase 2 transition to KPL-387 monotherapy dosing and administration study during the three months ended MarchJune 31,30, 2026, as compared to the Phase 1 clinical trial in normal healthy volunteers and the start-up of our Phase 2/3 clinical trial during the three months ended MarchJune 31,30, 2025.

Direct costs for our KPL-1161 program were $1.0$0.8 million for the three months ended MarchJune 31,30, 2026, compared to $0.1$0.4 million during the three months ended MarchJune 31,30, 2025. For the three months ended MarchJune 31,30, 2026 and 2025, expenses incurred primarily related to pre-clinical development.

Unallocated research and development expenses were $10.0$18.2 million and $9.3$9.1 million for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, respectively. The increase was primarily related to an increase in pre-clinical development expenses of $6.7 million during the three months ended June 30, 2026. Personnel-related costs for the three months ended MarchJune 31,30, 2026 and 2025 included share-based compensation of $1.6$2.5 million and $1.2$1.7 million, respectively.

Selling, general and administrative expenses were $61.2$63.9 million for the three months ended MarchJune 31,30, 2026, compared to $43.5$46.9 million for the three months ended MarchJune 31,30, 2025. The increase of $17.6$17.0 million was primarily due to an increase of $10.8$9.6 million in personnel-related costs largely attributable to an increase in headcount and an increase in sales and marketing expenses of $5.2$4.8 million largely attributable to increased promotional activitiesactivities, andincluding theour timingdirect-to-consumer ofadvertising free goods designation.campaign. Personnel-related costs for the three months ended MarchJune 31,30, 2026 and 2025 included share-based compensation of $7.9$8.5 million and $5.8$6.6 million, respectively.

Other income, net was $3.4$4.0 million and $2.3$2.7 million for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, respectively. The year-over-year increase was driven primarily by higher interest income generated by increased average holdings of cash, cash equivalents, and short-term investments.

We recorded an income tax provision of $10.1$5.7 million and $7.0$5.0 million for the three months ended MarchJune 31,30, 2026 and MarchJune 31,30, 2025, respectively. The provision for income taxes was driven primarily by income earned in Switzerland, UK and the United States as well as uncertain tax positions offset in part by tax benefits related to share-based compensation, United States federal and state research and development credits (“R&D Credits”) and Foreign Derived Intangible Income (“FDII”) deduction. The increase in the provision for income taxes was driven primarily by an increase in taxable income partially offset by an increase in the tax benefits related to share-based compensation.

As of MarchJune 31,30, 2026, our principal source of liquidity was cash, cash equivalents and short-term investments, which totaled $468.1$525.9 million. Net income was $22.6$48.0 million and $8.5$26.4 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We expect our cash balance and our expected cash inflows from operations to allow us to meet our current operating plan.

Under various agreements with third parties, we have agreed to make milestone payments, pay royalties, pay annual maintenance fees and to meet due diligence requirements, each based upon specified events. Pursuant to the Regeneron Agreement, we have entered into a supply agreement with Regeneron to purchase both clinical and commercial product. We have committed to minimum payments to Regeneron of $51.0 million, all of which are due within one year. We have entered into lease agreements for office and laboratory space, and vehicles, with total future lease payments of $9.9$9.6 million, $3.6$4.4 million of which are due within one year. InWe connectionare withalso ourparty ongoing technology transfer of ARCALYST drug substance manufacturing, we have entered intoto a Master Services Agreement and a Product Specific Agreement with Samsung.Samsung related to the manufacture of ARCALYST drug substance. Our commitments under such agreements, which includes the purchase of raw materials and related service fees, obligates us to minimum payments of $147.1$140.4 million, $59.8$53.1 million of which are due within one year. As of March 31, 2026, we have capitalized $21.1 million of production cost into inventory as semi-finished goods related to drug substance manufactured at Samsung. We have additionally entered into agreements with several CDMOs to provide us with preclinical and clinical trial materials for our non-ARCALYST assets, which obligate us to minimum payments of $10.2$14.5 million all of which are due within one year. We have long-term incentive plans for our employees that may result in cash award payments of $23.1$24.9 million, based upon the achievement of certain regulatory milestones, none of which are expected to be achieved in the next year.

Net cash provided by operations was $50.2$97.4 million and $22.3$50.4 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The increase in cash provided by operating activities is primarily due to an increase in net contribution from higher ARCALYST sales offset by a decrease in net cash received from licensing agreements of $20.0 million.sales.

Net cash used in investing activities was $31.9$105.5 million and $51.5$55.4 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. The increase in net cash used in investing activities was driven by managing our cash and short-term investment portfolio mix as we deployed higher levels of cash into Treasury Securities with longer-terms.

During the threesix months ended MarchJune 31,30, 2026 and 2025, net cash provided by financing activities was $6.1$18.2 million and $2.8$13.5 million, respectively, consisting of proceeds from the exercise of share options offset by payments in connection with ordinary shares tendered for employee tax obligations.

We expect to incur significant expenses in connection with our ongoing and planned activities as we continue to commercialize ARCALYST and advance our current and future product candidates through preclinical and clinical development, seek regulatory approval and commercialize one or more of our current or future product candidates, if approved. We may also incur expenses in connection with collaboration, licensing or other strategic transactions. Further, we may incur expenses related to milestone, royalty and other payments payable to third parties with whom we have entered into license, acquisition and other similar agreements to acquire the rights to our product candidates We believe that our existing cash, cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. The future viability of our company is dependent on our ability to fund our operations through sales of ARCALYST and/or raise additional capital, such as through debt or equity offerings, as needed. We anticipate that we may require additional capital if we choose to pursue collaboration, licensing or other strategic transactions. We expect to continue to incur significant expenses related to product manufacturing, including technology transfer costs, sales, marketing and distribution of ARCALYST. In addition, if we obtain regulatory approval for any of our current or future product candidates, pursue additional indications or additional territories for our products or any of our current or future product candidates, we expect to incur significant expenses related to product development and manufacturing, sales, marketing and distribution, depending on where we choose to commercialize.

Because of the numerous risks and uncertainties associated with research, development and commercialization of biologic products, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements may be impacted by a number of factors, including those described in Part I, Item 1A of the Annual Report, as updated by any information appearing in Part II, Item 1A of any of our subsequent Quarterly Reports on Form 10-Q.10-Q, including this Quarterly Report.