What changed in RIGEL PHARMACEUTICALS INC's 2023 10-K compared to 2022?

Across the narrative sections we track, RIGEL PHARMACEUTICALS INC (RIGL) added 717 paragraphs, removed 694, and edited 494 between the 2022 and 2023 10-K filings. The biggest movers are Item 1A. Risk Factors (+717/−694).

Did RIGEL PHARMACEUTICALS INC add new Risk Factors in the 2023 10-K?

Yes — Item 1A Risk Factors shows 717 new/edited paragraphs and 694 removed paragraphs versus the 2022 10-K.

Where does this RIGL 10-K diff come from?

The source filings are RIGEL PHARMACEUTICALS INC's official 2022 and 2023 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

RIGL 10-K Diff 2022 vs 2023 — RIGEL PHARMACEUTICALS INC Risk Factors & MD&A Changes

Biggest changeSTATEMENTS OF CASH FLOWS (In thousands) Year Ended December 31, 2022 2021 2020 Operating activities Net loss $ (58,573) $ (17,914) $ (29,744) Adjustments to reconcile net loss to net cash (used in) provided by operating activities: Stock-based compensation expense 12,385 9,486 7,297 Net gain on sale and write-down of property and equipment (138) — — Depreciation and amortization 998 1,162 706 Non-cash interest expense 682 3,139 — Net amortization and accretion of discount on short-term investments and term loan (63) 287 (122) Changes in assets and liabilities: Accounts receivable, net (24,848) 501 (5,862) Inventories (2,377) (4,875) (126) Prepaid and other current assets (847) 6,633 (4,583) Other assets 334 (150) (128) Right-of-use assets 7,773 8,192 7,814 Accounts payable 3,788 41 (331) Accrued compensation (1,824) 1,098 773 Accrued research and development (2,676) 5,495 (1,071) Revenue reserves and refund liability 4,230 1,850 2,733 Other accrued liabilities 1,709 (24) 1,318 Lease liability (8,546) (8,621) (7,230) Deferred revenue (1,227) (422) (23,629) Other current and long-term liabilities (4,538) — — Net cash (used in) provided by operating activities (73,758) 5,878 (52,185) Investing activities Purchases of short-term investments (28,894) (141,459) (81,706) Maturities of short-term investments 101,228 62,050 130,434 Proceeds from sale of property and equipment 893 — — Purchases of property and equipment (450) (627) (1,262) Net cash provided by (used in) investing activities 72,777 (80,036) 47,466 Financing activities Cost share advance from a collaboration partner — 57,900 — Cost share payments to a collaboration partner (15,116) — — Net proceeds from issuances of common stock upon exercise of options and participation in Purchase Plan 2,124 4,775 2,596 Net proceeds from term loan financing 19,542 — 9,975 Net cash provided by financing activities 6,550 62,675 12,571 Net increase (decrease) in cash and cash equivalents 5,569 (11,483) 7,852 Cash and cash equivalents at beginning of period 18,890 30,373 22,521 Cash and cash equivalents at end of period $ 24,459 $ 18,890 $ 30,373 Supplemental disclosure of cash flow information Interest paid $ 2,495 $ 1,500 $ 1,180 Purchases of intangible asset included within accounts payable $ 15,000 $ — $ — See Accompanying Notes to Financial Statements. 109 Table of Contents RIGEL PHARMACEUTICALS, INC.

Biggest changeSTATEMENTS OF CASH FLOWS (In thousands) Year Ended December 31, 2023 2022 2021 Operating activities Net loss $ (25,091) $ (58,573) $ (17,914) Adjustments to reconcile net loss to net cash (used in) provided by operating activities: Stock-based compensation expense 8,806 12,385 9,486 Loss (gain) on sale and disposal of fixed assets 266 (138) — Depreciation and amortization 1,238 998 1,162 Non-cash interest expense — 682 3,139 Net amortization and accretion of discount on short-term investments and term loan (479) (63) 287 Changes in assets and liabilities: Accounts receivable, net 9,770 (24,848) 501 Inventories 1,172 (2,377) (4,875) Prepaid and other current assets 1,998 (847) 6,633 Other assets 56 334 (150) Right-of-use assets 1,069 7,773 8,192 Accounts payable (366) 3,788 41 Accrued compensation (190) (1,824) 1,098 Accrued research and development (4,195) (2,676) 5,495 Revenue reserves and refund liability 3,539 4,230 1,850 Other accrued liabilities (1,151) 1,709 (24) Lease liability (1,128) (8,546) (8,621) Deferred revenue (14) (1,227) (422) Other current and long-term liabilities (1,043) (4,538) — Net cash (used in) provided by operating activities (5,743) (73,758) 5,878 Investing activities Maturities of short-term investments 41,650 101,228 62,050 Purchases of short-term investments (31,206) (28,894) (141,459) Purchases of intangible asset (15,000) — Proceeds from sale of property and equipment 259 893 — Purchases of property and equipment — (450) (627) Net cash (used in) provided by investing activities (4,297) 72,777 (80,036) Financing activities Net proceeds from term loan financing 19,950 19,542 — Net proceeds from issuances of common stock upon exercise of options and participation in Purchase Plan 1,049 2,124 4,775 Cost share advance from a collaboration partner — — 57,900 Cost share payments to a collaboration partner (2,632) (15,116) — Net cash provided by financing activities 18,367 6,550 62,675 Net increase (decrease) in cash and cash equivalents 8,327 5,569 (11,483) Cash and cash equivalents at beginning of period 24,459 18,890 30,373 Cash and cash equivalents at end of period $ 32,786 $ 24,459 $ 18,890 Supplemental disclosure of cash flow information Interest paid $ 5,848 $ 2,495 $ 1,500 Purchases of intangible asset included within accounts payable $ — $ 15,000 $ — See Accompanying Notes to Financial Statements. 112 Table of Contents RIGEL PHARMACEUTICALS, INC.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, including promoting off-label uses of our products, commission compensation, certain customer incentive programs, certain patient support offerings, and other business arrangements generally.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, including promoting off-label uses of our products, certain commission compensation, certain customer incentive programs, certain patient support offerings, and other business arrangements generally.

These pressures can arise from rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and healthcare reform, pharmaceutical reimbursement policies and pricing in general. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

These pressures can arise from rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid, healthcare reform, pharmaceutical reimbursement policies and pricing in general. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

On July 25, 2022, we filed a lawsuit in the US District Court for the District of New Jersey against Annora and its affiliates, Hetero Labs Ltd., and Hetero USA, Inc., for infringement of our US patents identified in Annora’s Paragraph IV certification.

We began our commercialization of REZLIDHIA (olutasidenib) in December 2022. W e in-licensed olutasidenib from Forma with exclusive, worldwide rights for its development, manufacturing and commercialization.

We began our commercialization of REZLIDHIA in December 2022. W e in-licensed olutasidenib from Forma, with exclusive, worldwide rights for its development, manufacturing and commercialization.

In August 2020, we entered into an Open Market Sale Agreement with Jefferies, as a sole agent, pursuant to which we may sell from time to time, through Jefferies, shares of our common stock in sales deemed to be “at-the-market offerings” as defined in Rule 415 under the Securities Act, subject to conditions specified in the Open Market Sale Agreement, including maintaining an effective registration statement covering the sale of shares under the Open Market Sale Agreement.

Open Market Sale Agreement In August 2020, we entered into an Open Market Sale Agreement with Jefferies, as a sole agent, pursuant to which we may sell from time to time, through Jefferies, shares of our common stock in sales deemed to be “at-the-market offerings” as defined in Rule 415 under the Securities Act, subject to conditions specified in the Open Market Sale Agreement, including maintaining an effective registration statement covering the sale of shares under the Open Market Sale Agreement.

Our first product approved by the FDA is TAVALISSE (fostamatinib disodium hexahydrate) tablets, the only approved oral SYK inhibitor, for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment.

Our first product approved by the FDA is TAVALISSE (fostamatinib disodium hexahydrate) tablets, the only approved oral SYK inhibitor for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment.

We began our commercialization of REZLIDHIA (olutasidenib) in December 2022. W e in-licensed olutasidenib from Forma with exclusive, worldwide rights for its development, manufacturing and commercialization.

We began our commercialization of REZLIDHIA in December 2022. W e in-licensed olutasidenib from Forma, with exclusive, worldwide rights for its development, manufacturing and commercialization.

The terms of these arrangements typically include payment to us for a combination of one or more of the following: upfront license fees; development, regulatory and commercial milestone payments; product supply services; and royalties on net sales of licensed products.

Upfront License Fees: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenues from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license.

For licenses that are bundled with other promises, we determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, we use judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees.

If such share in the development costs is payable beyond 12 months from the delivery of the corresponding license, a significant financing component is deemed to exist.

If a significant financing component is identified, we adjust the transaction price by reducing the upfront fee by the net present value of our share in future development costs over the expected commitment period.

If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until uncertainty associated with the approvals has been resolved.

The transaction price is then allocated to each performance obligation, on a relative standalone selling price basis, for which we recognize revenue as or when the performance obligations under the contract are satisfied.

Sales-based Milestone Payments and Royalties: For arrangements that include sales-based royalties, including milestone payments based on the volume of sales, we determine whether the license is deemed to be the predominant item to which the royalties or sales-based milestones relate to and if such is the case, we recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Unrealized gains (losses) are reported within the statements of stockholders’ equity (deficit) and comprehensive income (loss). The cost of securities sold is based on the specific identification method. We periodically evaluate our available-for-sale marketable debt securities for impairment.

Unrealized gains (losses) are reported within the statements of stockholders’ (deficit) equity and comprehensive income (loss). The cost of securities sold is based on the specific identification method. We periodically evaluate our available-for-sale marketable debt securities for impairment.

Expenses related to other research and development contracts, such as research contracts, toxicology study contracts and manufacturing contracts are estimated to be incurred generally on a straight-line basis over the duration of the contracts.

This estimated future contingent amount does not include any estimated royalties that could be due to us if the partners successfully commercialize any of the licensed products. Future events that may trigger payments to us under the agreements are based solely on our partners’ future efforts and achievements of specified development, regulatory and/or commercial events.

Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow will be diminished, and the capital necessary to fund our operations will be increased.

Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA, MHRA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow will be diminished, and the capital necessary to fund our operations will be increased.

In addition, we cannot predict what additional ANDAs could be filed by Annora or other potential generic competitors requesting approval to market generic forms of fostamatinib, which would require us to incur significant additional expense and result in distraction for our management team, and if approved, result in significant decreases in the revenue derived from sales of our marketed products and thereby materially harm our business and financial condition.

In addition, we cannot predict what additional ANDAs could be filed by Annora or other potential generic competitors requesting approval to market generic forms of our products, which would require us to incur significant additional expense and result in distraction for our management team, and if approved, result in significant decreases in the revenue derived from sales of our marketed products and thereby materially harm our business and financial condition.

Such supply disruptions would adversely impact our ability to generate sales of and revenues from our products and our business, financial condition, results of operations and growth prospects could be adversely affected. Pandemics may affect our collaboration and licensing partners for the commercialization of fostamatinib globally, as well as our ability to advance our various clinical stage programs.

Such supply disruptions would adversely impact our ability to generate sales of and revenues from our products and our business, financial condition, results of operations and growth prospects could be adversely affected. Pandemics may affect our collaboration and licensing partners for the commercialization of our products globally, as well as our ability to advance our various clinical stage programs.

Development, Regulatory or Commercial Milestone Payments: At the inception of each arrangement that includes payments based the achievement of certain development, regulatory and commercial or launch events, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method.

Development, Regulatory or Commercial Milestone Payments: At the inception of each arrangement that includes payments based on the achievement of certain development, regulatory and commercial or launch events, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method.

We will continue to need additional capital and the amount of future capital needed will depend largely on the success of our commercialization of our products, and the success of our internally developed programs as they proceed in later and more expensive clinical trials, including any additional clinical trials that we may decide to conduct with respect to fostamatinib.

We will continue to need additional capital and the amount of future capital needed will depend largely on the success of our commercialization of our products, and the success of our internally developed programs as they proceed in later and more expensive clinical trials, including any additional clinical trials that we may decide to conduct with respect to our products.

The product is also commercially available in Europe and UK (as TAVLESSE), and in Canada and Israel (as TAVALISSE) for the treatment of chronic ITP in adult patients. Our second FDA approved product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test.

The product is also commercially available in Europe and the UK (as TAVLESSE), and in Canada, Israel and Japan (as TAVALISSE) for the treatment of chronic ITP in adult patients. Our second FDA-approved product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test.

The product is also commercially available in Europe and UK (as TAVLESSE), and in Canada and Israel (as TAVALISSE) for the treatment of chronic ITP in adult patients. Our second FDA approved product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test.

The product is also commercially available in Europe and the UK (as TAVLESSE), and in Canada, Israel and Japan (as TAVALISSE) for the treatment of chronic ITP in adult patients. Our second FDA-approved product is REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test.

These provisions: ● establish that members of the board of directors may be removed only for cause upon the affirmative vote of stockholders owning a majority of our capital stock; ● authorize the issuance of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and thwart a takeover attempt; ● limit who may call a special meeting of stockholders; ● prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; 83 Table of Contents ● establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; ● provide for a board of directors with staggered terms; and ● provide that the authorized number of directors may be changed only by a resolution of our board of directors.

These provisions: ● establish that members of the board of directors may be removed only for cause upon the affirmative vote of stockholders owning a majority of our capital stock; ● authorize the issuance of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and thwart a takeover attempt; ● limit who may call a special meeting of stockholders; ● prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; ● establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; 87 Table of Contents ● provide for a board of directors with staggered terms; and ● provide that the authorized number of directors may be changed only by a resolution of our board of directors.

In the US, there have been several recent Congressional inquiries and federal legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer-sponsored patient assistance programs, and reform government program reimbursement methodologies for drugs .

In the US, there have been several Congressional inquiries and federal legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer-sponsored patient assistance programs, and reform government program reimbursement methodologies for drugs .

On September 21, 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of the ’458, ’122, ’492, ’648, and ’504 patents. We filed an answer to Annora’s counterclaims on October 12, 2022. Annora served invalidity and non-infringment contentions on December 31, 2022.

On September 21, 2022, Annora and its affiliates answered and counterclaimed for declaratory judgment of non-infringement and invalidity of the ’458, ’122, ’492, ’648, and ’504 patents. We filed an answer to Annora’s counterclaims on October 12, 2022. Annora served invalidity and non-infringement contentions on December 31, 2022.

We expect we will continue to enter into contracts in the normal course of business with various third parties who support our clinical trials, support our preclinical research studies, and provide other services related to our operating purposes as well as our commercialization of our products.

We expect that we will continue to enter into contracts in the normal course of business with various third parties who support our clinical trials, support our preclinical research studies, and provide other services related to our operating purposes as well as our commercialization of our products.

We currently rely on third parties to, among other things, manufacture and ship our commercial product, raw materials and product supply for our clinical trials, perform quality testing and supply other goods and services to help manage our commercial activities, our clinical trials and our operations in the ordinary course of business.

We rely on third parties to, among other things, manufacture and ship our commercial product, raw materials and product supply for our clinical trials, perform quality testing and supply other goods and services to help manage our commercial activities, our clinical trials and our operations in the ordinary course of business.

As of December 31, 2022, we are a party to collaboration agreements with Lilly to develop and commercialize R552, a RIPK1 inhibitor, for the treatment of non-CNS diseases and collaboration aimed at developing additional RIPK1 inhibitors for the treatment of CNS diseases; with Grifols to commercialize fostamatinib for human diseases in all indications, including chronic ITP and AIHA, in Grifols territory which includes Europe, the UK, Turkey, the Middle East, North Africa and Russia (including Commonwealth of Independent States); with Kissei to develop and commercialize fostamatinib in Kissei territory which includes Japan, China, Taiwan and the Republic of Korea; with Medison to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Medison territory which includes Canada and Israel; and with Knight to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Knight territory which includes Latin America, consisting of Mexico, Central and South America, and the Caribbean.

As of December 31, 2023, we are a party to collaboration agreements with Lilly to develop and commercialize R552, a RIPK1 inhibitor, for the treatment of non-CNS diseases and collaboration aimed at developing additional RIPK1 inhibitors for the treatment of CNS diseases; with Grifols to commercialize fostamatinib for human diseases in all indications, including chronic ITP and AIHA, in Grifols territory which includes Europe, the UK, Turkey, the Middle East, North Africa and Russia (including Commonwealth of Independent States); with Kissei to develop and commercialize fostamatinib in Kissei territory which includes Japan, China, Taiwan and the Republic of Korea; with Medison to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Medison territory which includes Canada and Israel; and with Knight to commercialize fostamatinib in all indications, including chronic ITP and AIHA, in Knight territory which includes Latin America, consisting of Mexico, Central and South America, and the Caribbean.

At this time, we do not have nor will we seek to apply for orphan drug designation in the EU or the UK in the foreseeable future. We cannot assure you that any future application for orphan drug designation with respect to any other product candidate will be granted.

At this time, we do not have nor will we seek to apply for orphan drug designation in the EU or the UK in the foreseeable future. We cannot assure that any future application for orphan drug designation with respect to any other product candidate will be granted.

Pursuant to the terms of the license and transition services agreement, we paid Forma an upfront fee of $2.0 million, with the potential to pay up to $67.5 million of additional payments upon achievement of specified development and regulatory milestones and up to $165.5 million of additional payments upon achievement of certain commercial milestones.

Pursuant to the terms of the license and transition services agreement, we paid an upfront fee of $2.0 million, with the potential to pay up to $67.5 million of additional payments upon achievement of specified development and regulatory milestones and up to $165.5 million of additional payments upon achievement of certain commercial milestones.

We cannot assure you that any compound developed by us, alone or with others, will prove to be safe and efficacious in clinical trials and will meet all of the applicable regulatory requirements needed to receive marketing approval.

We cannot assure that any compound developed by us, alone or with others, will prove to be safe and efficacious in clinical trials and will meet all of the applicable regulatory requirements needed to receive marketing approval.

To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability, incur significant remediation or litigation costs, result in product development delays, disrupt key business operations, cause loss of revenue and divert attention of management and key information technology resources. 64 Table of Contents Hackers and data thieves are increasingly sophisticated and operate large-scale and complex automated attacks, including on companies within the healthcare industry.

To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability, incur significant remediation or litigation costs, result in product development delays, disrupt key business operations, cause loss of revenue and divert attention of management and key information technology resources. 69 Table of Contents Hackers and data thieves are increasingly sophisticated and operate large-scale and complex automated attacks, including on companies within the healthcare industry.

We have established our distribution, sales, marketing and market access capabilities, all of which will be necessary to successfully commercialize our products. As a result, we will be required to expend significant time and resources to market, sell, and distribute our products to hematologists and hematologists-oncologists.

We have established our distribution, sales, marketing and market access capabilities, all of which will be necessary to successfully commercialize our products. As a result, we will be required to expend significant time and resources to market, sell, and distribute our products to hematologists and hematologist-oncologists.

Such discounted amount will be reported as a liability in the balance sheet, with a corresponding interest expense being accreted based on a discount rate applied over the expected commitment period. 112 Table of Contents Development, Regulatory or Commercial Milestone Payments: At the inception of each arrangement that includes payments based on the achievement of certain development, regulatory and commercial or launch events, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method.

Such discounted amount will be reported as a liability in the balance sheet, with a corresponding interest expense being accreted based on a discount rate applied over the expected commitment period. 94 Table of Contents Development, Regulatory or Commercial Milestone Payments: At the inception of each arrangement that includes payments based the achievement of certain development, regulatory and commercial or launch events, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method.

See “Note 9 – Debt” to our “Notes to Financial Statements” contained in “Part II, Item 8, Financial Statements and Supplementary Data” of this Annual Report on Form 10-K for additional details of the Credit Agreement.

See “Note 10 – Debt” to our “Notes to Financial Statements” contained in “Part II, Item 8, Financial Statements and Supplementary Data” of this Annual Report on Form 10-K for additional details of the Credit Agreement.

We also rely heavily on our clinical trial investigators to inform us of the best course of action with respect to resuming enrollment/screening, considering the ability of sites to ensure patient safety or data integrity.

We may also rely heavily on our clinical trial investigators to inform us of the best course of action with respect to resuming enrollment/screening, considering the ability of sites to ensure patient safety or data integrity.

Any of these existing suppliers or manufacturers may: ● fail to supply us with product on a timely basis or in the requested amount due to unexpected damage to or destruction of facilities or equipment or otherwise; ● fail to increase manufacturing capacity and produce drug product and components in larger quantities and at higher yields in a timely or cost-effective manner, or at all, to sufficiently meet our commercial needs; ● be unable to meet our production demands due to issues related to their reliance on sole-source suppliers and manufacturers; ● supply us with product that fails to meet regulatory requirements; ● become unavailable through business interruption or financial insolvency; ● lose regulatory status as an approved source; ● be unable or unwilling to renew current supply agreements when such agreements expire on a timely basis, on acceptable terms or at all; or ● discontinue production or manufacturing of necessary drug substances or products.

Any of these existing suppliers or manufacturers may: ● fail to supply us with product on a timely basis or in the requested amount due to unexpected damage to or destruction of facilities or equipment or otherwise; ● fail to increase manufacturing capacity and produce drug product and components in larger quantities and at higher yields in a timely or cost-effective manner, or at all, to sufficiently meet our commercial needs; ● be unable to meet our production demands due to issues related to their reliance on sole-source suppliers and manufacturers; ● supply us with product that fails to meet regulatory requirements; ● become unavailable through business interruption or financial insolvency; ● lose regulatory status as an approved source; ● be unable or unwilling to renew current supply agreements when such agreements expire on a timely basis, 76 Table of Contents on acceptable terms or at all; or ● discontinue production or manufacturing of necessary drug substances or products.

If we or our suppliers encounter manufacturing, quality or compliance difficulties with respect to our products or any of our product candidates, when and if approved, whether due to the impacts of the COVID-19 pandemic (including as a result of disruptions of global shipping and the transport of products) or otherwise, we may be unable to obtain or maintain regulatory approval or meet commercial demand for such products, which could adversely affect our business, financial conditions, results of operations and growth prospects.

If we or our suppliers encounter manufacturing, quality or compliance difficulties with respect to our products or any of our product candidates, when and if approved, whether due to the impacts of a global pandemic (including as a result of disruptions of global shipping and the transport of products) or otherwise, we may be unable to obtain or maintain regulatory approval or meet commercial demand for such products, which could adversely affect our business, financial conditions, results of operations and growth prospects.

The obligations under the amended Credit Agreement are secured by a perfected security interest in all of our assets including our intellectual property. The amendment to the Credit Agreement was accounted for as debt modification.

The obligations under the amended Credit Agreement are secured by a perfected security interest in all of our assets including our intellectual property. The amendment to the Credit Agreement in 2022 was accounted for as debt modification.

For example, our clinical trial programs and research collaborations outside the US may implicate foreign data protection laws, including in the European Economic Area, Switzerland, and/or the UK (collectively, Europe).

For example, our clinical trial programs and research collaborations outside the US may implicate foreign data protection laws, including those in the European Economic Area, Switzerland, and/or the UK (collectively, Europe).

If we encounter difficulties with any of our distribution facilities, whether due to the potential future impacts of the COVID-19 pandemic (including as a result of disruptions of global shipping and the transport of products) or otherwise, or other problems or disasters arise, we cannot ensure that critical systems and operations will be restored in a timely manner or at all, and this would have an adverse effect on our business.

If we encounter difficulties with any of our distribution facilities, whether due to the potential future impacts of a global pandemic (including as a result of disruptions of global shipping and the transport of products) or otherwise, or other problems or disasters arise, we cannot ensure that critical systems and operations will be restored in a timely manner or at all, and this would have an adverse effect on our business.

Discovery after approval of previously unknown problems with any of our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in actions such as: ● restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; ● restrictions on product manufacturing processes; ● restrictions on the marketing of a product; ● restrictions on product distribution; 74 Table of Contents ● requirements to conduct post-marketing clinical trials; ● untitled or warning letters or other adverse publicity; ● withdrawal of products from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of products; ● refusal to permit the import or export of our products; ● product seizure; ● fines, restitution or disgorgement of profits or revenue; ● refusal to allow us to enter into supply contracts, including government contracts; ● injunctions; or ● imposition of civil or criminal penalties.

Discovery after approval of previously unknown problems with any of our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in actions such as: ● restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; ● restrictions on product manufacturing processes; ● restrictions on the marketing of a product; ● restrictions on product distribution; ● requirements to conduct post-marketing clinical trials; ● untitled or warning letters or other adverse publicity; ● withdrawal of products from the market; ● refusal to approve pending applications or supplements to approved applications that we submit; ● recall of products; ● refusal to permit the import or export of our products; ● product seizure; ● fines, restitution or disgorgement of profits or revenue; ● refusal to allow us to enter into supply contracts, including government contracts; ● injunctions; or ● imposition of civil or criminal penalties.

Our bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of us under Delaware law, (ii) any action asserting a claim of breach of a fiduciary duty owed by any current or former director, officer, or other employee of the Company to us or our stockholders, (iii) any action asserting a claim against us or any of our directors, officers, or other employees arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation and bylaws (as either may be amended from time to time), (iv) any action asserting a claim against us governed by the internal affairs doctrine, or (v) any other action asserting an “internal corporate claim,” as defined under Section 115 of the DGCL.

Our bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of us under Delaware law, (ii) any action asserting a claim of breach of a fiduciary duty by any current or former director, officer, or other employee of ours that is owed to us or our stockholders, (iii) any action asserting a claim against us or any of our directors, officers, or other employees arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation and bylaws (as either may be amended from time to time), (iv) any action asserting a claim against us governed by the internal affairs doctrine, or (v) any other action asserting an “internal corporate claim,” as defined under Section 115 of the DGCL.

We have various contracts with third parties related to our research and development activities. Costs that are incurred but not billed to us as of the end of the period are accrued.

Research and Development Accruals We have various contracts with third parties related to our research and development activities. Costs that are incurred but not billed to us as of the end of the period are accrued.

For the year ended December 31, 2021, we recorded provision for income tax of $0.6 million. This provision for income tax was related to the state tax liability primarily due to revenue recognized for the Lilly Agreement.

For the year ended December 31, 2021, we recognized provision for income tax of $0.6 million. This provision for income tax was related to the state tax liability primarily due to revenue recognized for the Lilly Agreement.

Because the degree of future protection for our proprietary rights is uncertain, we cannot assure you that: ● we were the first to make the inventions covered by each of our pending patent applications; ● we were the first to file patent applications for these inventions; ● others will not independently develop similar or alternative technologies or duplicate any of our technologies; ● any of our pending patent applications will result in issued patents; ● any patents issued to us or our collaborators will provide a basis for commercially viable products or will provide us with any competitive advantages or will not be challenged by third parties; ● we will develop additional proprietary technologies that are patentable; ● we will obtain a supplemental protection certificate that will extend the protection afforded by the patent to the product with a marketing authorization; or ● the patents of others will not have a negative effect on our ability to do business.

Because the degree of future protection for our proprietary rights is uncertain, we cannot assure that: ● we were the first to make the inventions covered by each of our pending patent applications; ● we were the first to file patent applications for these inventions; ● others will not independently develop similar or alternative technologies or duplicate any of our technologies; ● any of our pending patent applications will result in issued patents; ● any patents issued to us or our collaborators will provide a basis for commercially viable products or will provide us with any competitive advantages or will not be challenged by third parties; ● we will develop additional proprietary technologies that are patentable; ● we will obtain a supplementary protection certificate that will extend the protection afforded by the patent to the product with a marketing authorization; or ● the patents of others will not have a negative effect on our ability to do business.

We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. We entered into a Commercial Supply Agreement with Grifols in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols shall order from us pursuant to and in accordance with the agreement.

We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. We have a Commercial Supply Agreement with Grifols entered in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols shall order from us pursuant to and in accordance with the agreement.

We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. Grifols License Agreement In January 2019, we entered into a commercialization license agreement with Grifols with exclusive rights to commercialize fostamatinib for human diseases, including chronic ITP and AIHA, and non-exclusive rights to develop, fostamatinib in Grifols territory.

We will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. Grifols License Agreement We have a commercialization license agreement with Grifols entered in January 2019 with exclusive rights to commercialize fostamatinib for human diseases, including chronic ITP and AIHA, and non-exclusive rights to develop, fostamatinib in Grifols territory.

Kissei is responsible for performing and funding all development activities for fostamatinib in the above-mentioned territories. We received an upfront cash payment of $33.0 million, with the potential for up to an additional $147.0 million in development, regulatory and commercial milestone payments, and will receive mid- to upper twenty percent, tiered, escalated net sales-based payments for the supply of fostamatinib.

Kissei is responsible for performing and funding all development activities for fostamatinib in Kissei territories. We received an upfront cash payment of $33.0 million, with the potential for up to an additional $147.0 million in development, regulatory and commercial milestone payments, and will receive mid- to upper twenty percent, tiered, escalated net sales-based payments for the supply of fostamatinib.

While under various circumstances we are entitled to be indemnified against losses by our corporate collaborators, indemnification may not be available or adequate should any claim arise. 63 Table of Contents We depend on various scientific consultants and advisors for the success and continuation of our research and development efforts. We work extensively with various scientific consultants and advisors.

While under various circumstances we are entitled to be indemnified against losses by our corporate collaborators, indemnification may not be available or adequate should any claim arise. 68 Table of Contents We depend on various scientific consultants and advisors for the success and continuation of our research and development efforts. We work extensively with various scientific consultants and advisors.

There is a significant trend in the health care industry by public and private payers to contain or reduce their costs, including by taking the following steps, among others: decreasing the portion of costs payers will cover, ceasing to provide full payment for certain products depending on outcomes, and/or not covering certain products at all.

There is a significant trend in the health care industry by public and private payors to contain or reduce their costs, including by taking the following steps, among others: decreasing the portion of costs payors will cover, ceasing to provide full payment for certain products depending on outcomes, and/or not covering certain products at all.

Actual results may differ materially from projected results for various reasons, including the following, as well as risks identified in other risk factors: ● the efficacy and safety of any of our product candidates, including as relative to marketed products and product candidates in development by third parties; ● pricing (including discounting or other promotions), reimbursement, product returns or recalls, competition, labeling, adverse events and other items that impact commercialization; ● the rate of adoption in the particular market, including fluctuations in demand for various reasons; ● potential future impacts, if any, due to the COVID-19 pandemic; ● lack of patient and physician familiarity with the drug; ● lack of patient use and physician prescribing history; ● lack of commercialization experience with the drug; ● actual sales to patients may significantly differ from expectations based on sales to wholesalers; and ● uncertainty relating to when the drug may become commercially available to patients and rate of adoption in other territories.

Actual results may differ materially from projected results for various reasons, including the following, as well as risks identified in other risk factors: ● the efficacy and safety of any of our product candidates, including as relative to marketed products and product candidates in development by third parties; ● pricing (including discounting or other promotions), reimbursement, product returns or recalls, competition, labeling, adverse events and other items that impact commercialization; ● the rate of adoption in the particular market, including fluctuations in demand for various reasons; ● potential future impacts, if any, due to a global pandemic; ● lack of patient and physician familiarity with the drug; ● lack of patient use and physician prescribing history; ● lack of commercialization experience with the drug; ● actual sales to patients may significantly differ from expectations based on sales to wholesalers; and ● uncertainty relating to when the drug may become commercially available to patients and rate of adoption in other territories.

In the US and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay regulatory approval of our product candidates, restrict or regulate post-approval activities and affect our ability to successfully sell fostamatinib or any product candidates for which we obtain regulatory approval in the future.

In the US and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay regulatory approval of our product candidates, restrict or regulate post-approval activities and affect our ability to successfully sell our products, or any product candidates for which we obtain regulatory approval in the future.

In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs. 138 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Rigel Pharmaceuticals, Inc.

In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs. 142 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Rigel Pharmaceuticals, Inc.

If payers implement any of the foregoing with respect to our products, it would have an adverse impact on our revenue and results of operations. If coverage is not available, or reimbursement is limited, we, or any of our collaborative partners, may not be able to successfully commercialize our products or any of our product candidates in some jurisdictions.

If payors implement any of the foregoing with respect to our products, it would have an adverse impact on our revenue and results of operations. If coverage is not available, or reimbursement is limited, we, or any of our collaborative partners, may not be able to successfully commercialize our products or any of our product candidates in some jurisdictions.

With this FDA approval and first commercial sale of the product, Forma was entitled to receive a total of $15.0 million milestone payments. Since such milestone payment obligations were incurred upon and after regulatory approval of the product, we recorded such amount as intangible asset on the balance sheet.

With this FDA approval and first commercial sale of the product, Forma was entitled to receive a total of $15.0 million in milestone payments. Since such milestone payment obligations were incurred upon and after regulatory approval of the product, we recorded such amount as intangible asset on our balance sheet.

If any of our product candidates are approved, if at all, but do not achieve an adequate level of acceptance, we may not generate significant product revenue and we may not become profitable on a sustained basis. We will need additional capital in the future to sufficiently fund our operations and research.

If any of our product candidates are approved, but do not achieve an adequate level of acceptance, we may not generate significant product revenue and we may not become profitable on a sustained basis. We will need additional capital in the future to sufficiently fund our operations and research.

This section does not discuss 2020 items and 2021 to 2020 year-to-year comparisons. Discussions of 2020 items and 2021 to 2020 year-to-year comparisons can be found in the “Part II, Item 7 Management’s Discussion and Analysis of Financial Condition and Result of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2021.

This section does not discuss 2021 items and 2022 to 2021 year-to-year comparisons. Discussions of 2021 items and 2022 to 2021 year-to-year comparisons can be found in the “Part II, Item 7 Management’s Discussion and Analysis of Financial Condition and Result of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2022.

Our short-term investments are classified as available-for-sale securities. Accordingly, we have classified certain securities as short-term investments on our balance sheets as they are available for use in the current operations. As of December 31, 2022, we had no investments that had been in a continuous unrealized loss position for more than 12 months.

Our short-term investments are classified as available-for-sale securities. Accordingly, we have classified certain securities as short-term investments on our balance sheets as they are available for use in the current operations. As of December 31, 2023, we had no investments that had been in a continuous unrealized loss position for more than 12 months.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce the costs of healthcare and/or impose price controls may adversely affect, for example: 66 Table of Contents ● the demand for fostamatinib or our product candidates, if we obtain regulatory approval; ● our ability to set a price that we believe is fair for our products; ● our ability to generate revenue and achieve or maintain profitability; ● the level of taxes that we are required to pay; and ● the availability of capital.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce the costs of healthcare and/or impose price controls may adversely affect, for example: ● the demand for our products, or our product candidates, if we obtain regulatory approval; 71 Table of Contents ● our ability to set a price that we believe is fair for our products; ● our ability to generate revenue and achieve or maintain profitability; ● the level of taxes that we are required to pay; and ● the availability of capital.

If our estimates of the prevalence or number of patients potentially on therapy prove to be inaccurate, the market opportunities for fostamatinib and our other product candidates may be smaller than what we believe they are, our prospects for generating expected revenue may be adversely affected and our business may suffer.

If our estimates of the prevalence or number of patients potentially on therapy prove to be inaccurate, the market opportunities for our products and our other product candidates may be smaller than what we believe they are, our prospects for generating expected revenue may be adversely affected and our business may suffer.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payers and customers, may expose us to broadly applicable federal, state and foreign fraud and abuse and other healthcare laws and regulations including anti-kickback and false claims laws, data privacy and security laws, and transparency reporting laws.

Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors and customers, may expose us to broadly applicable federal, state and foreign fraud and abuse and other healthcare laws and regulations including anti-kickback and false claims laws, data privacy and security laws, and transparency reporting laws.

We are liable for errors associated with our submission of pricing data and for any overcharging of government payers. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the federal False Claims Act and other laws and regulations.

We are liable for errors associated with our submission of pricing data and for any overcharging of government payors. Failure to make necessary disclosures and/or to identify overpayments could result in allegations against us under the federal False Claims Act and other laws and regulations.

Also, many of our competitors are large pharmaceutical companies that will have a greater ability to reduce prices for their competing drugs in an effort to gain market share and undermine the value proposition that we might otherwise be able to offer to payers.

Also, many of our competitors are large pharmaceutical companies that will have a greater ability to reduce prices for their competing drugs in an effort to gain market share and undermine the value proposition that we might otherwise be able to offer to payors.

Risks Related to Clinical Development and Regulatory Approval Enacted or future legislation, and/or potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain regulatory approval of our product candidates and/or commercialize fostamatinib or our product candidates, once approved, and affect the prices we may set or obtain.

Risks Related to Clinical Development and Regulatory Approval Enacted or future legislation, and/or potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain regulatory approval of our product candidates and/or commercialize our products or our product candidates, once approved, and affect the prices we may set or obtain.

The activities associated with the research, development and commercialization of fostamatinib and other product candidates in our pipeline must undergo extensive clinical trials, which can take many years and require substantial expenditures, subject to extensive regulation by the FDA and other regulatory agencies in the US and by comparable authorities in other countries.

The activities associated with the research, development and commercialization of our products and other product candidates in our pipeline must undergo extensive clinical trials, which can take many years and require substantial expenditures, subject to extensive regulation by the FDA and other regulatory agencies in the US and by comparable authorities in other countries.

The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods. The table below summarizes the weighted-average assumptions related to our Purchase Plan for periods presented.

The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods. 132 Table of Contents The table below summarizes the weighted-average assumptions related to our Purchase Plan for periods presented.

Should Annora or any other third parties receive FDA approval of an ANDA for a generic version of fostamatinib or a 505(b)(2) NDA with respect to fostamatinib, and if our patents covering fostamatinib were held to be invalid (or if such competing generic versions of fostamatinib were found to not infringe our patents), then they could introduce generic versions of 56 Table of Contents fostamatinib or other such 505(b)(2) products before our patents expire, and the resulting competition would negatively affect our business, financial condition and results of operations.

Should Annora or any other third parties receive FDA approval of an ANDA for a generic version of fostamatinib or a 505(b)(2) NDA with respect to fostamatinib, and if our patents covering fostamatinib were held to be invalid (or if such competing generic versions of fostamatinib were found to not infringe our patents), then they could introduce generic versions of fostamatinib or other such 505(b)(2) products before our patents expire, and the resulting competition would negatively affect our business, financial condition and results of operations.

In addition to reviewing the three categories of research and development expenses described in the preceding paragraph, we principally consider qualitative factors in making decisions regarding our research and development programs, which include enrollment in clinical trials and the results thereof, the clinical and commercial potential for our drug candidates and competitive dynamics.

In addition to reviewing the three categories of research and development expense described in the preceding paragraph, we principally consider qualitative factors in making decisions regarding our research and development programs, which include enrollment in clinical trials and the results thereof, the clinical and commercial potential for our drug candidates and competitive dynamics.

Because of the numerous risks and uncertainties associated with commercializing a product, the development of our product candidates and other research and development activities, we are unable to estimate with certainty our future product revenues, our revenues from our current and future collaborative partners, the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials and other research and development activities.

Because of the numerous risks and uncertainties associated with commercializing our products, the development of our product candidates and other research and development activities, we are unable to estimate with certainty our future product revenues, our revenues from our current and future collaborative partners, the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials and other research and development activities.

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, in conformity with U.S. generally accepted accounting principles.

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.

We also face significant competition from organizations that are pursuing the same or similar technologies, including the discovery of targets that are useful in compound screening, as the technologies used by us in our drug discovery efforts. Competition may also arise from: ● new or better methods of target identification or validation; ● generic versions of our products or of products with which we compete; ● other drug development technologies and methods of preventing or reducing the incidence of disease; ● new small molecules; or ● other classes of therapeutic agents.

We also face significant competition from organizations that are pursuing the same or similar technologies, including the discovery of targets that are useful in compound screening, as the technologies used by us in our drug discovery efforts. Competition may also arise from: ● new or better methods of target identification or validation; ● generic versions of our products or of products with which we compete; 64 Table of Contents ● other drug development technologies and methods of preventing or reducing the incidence of disease; ● new small molecules; or ● other classes of therapeutic agents.

Management’s Discussion and Analysi s of Financial Condition and Results of Operations The following discussion should be read in conjunction with our “Notes to Financial Statements” contained in Part II, Item 8 of this Form 10-K. This section of this Form 10-K discusses 2022 and 2021 items and 2022 and 2021 year-to-year comparisons.

Management’s Discussion and Analysi s of Financial Condition and Results of Operations The following discussion should be read in conjunction with our “Notes to Financial Statements” contained in Part II, Item 8 of this Form 10-K. This section of this Form 10-K discusses 2023 and 2022 items and 2023 and 2022 year-to-year comparisons.

Milestone payment obligations incurred upon and after a regulatory approval of an indication associated with the acquired licensed asset, and at the commercial stage, will be recorded as intangible asset when the event requiring payment of the milestones occurs. The amount recorded as an intangible asset is amortized over the estimated useful life of the acquired licensed asset.

Milestone payment obligations incurred upon and after a regulatory approval of an indication associated with the acquired licensed asset, and at the commercial stage, is recorded as intangible asset when the event requiring payment of the milestones occurs. The amount recorded as an intangible asset is amortized over the estimated useful life of the acquired licensed asset.

On December 1, 2022, the FDA approved REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with R/R AML with susceptible IDH1 mutations as detected by an FDA-approved test. Following the FDA approval, we launched REZLIDHIA and made first shipments of the product to our customers.

On December 1, 2022, the FDA approved REZLIDHIA capsules for the treatment of adult patients with R/R AML with susceptible IDH1 mutations as detected by an FDA-approved test. Following the FDA approval, we launched REZLIDHIA and made first shipments of the product to our customers in December 2022.

Further, we recognized $0.2 million of revenue related to the delivery of CNS compound to Lilly during the year ended December 31, 2022. The remaining future variable consideration related to future milestone payments as discussed above were fully constrained because we cannot conclude that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones.

Further, we recognized additional $0.2 million of revenue relative to a separate delivery of CNS compound to Lilly during the year ended December 31, 2022. The remaining future variable consideration related to future milestone payments as discussed above were fully constrained because we cannot conclude that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur, given the inherent uncertainty of success with these future milestones.

What changed in RIGEL PHARMACEUTICALS INC's 10-K — 2022 vs 2023

Top changes in RIGEL PHARMACEUTICALS INC's 2023 10-K

Item 1A. Risk Factors

Other RIGL 10-K year-over-year comparisons