What changed in RIGEL PHARMACEUTICALS INC's 10-K — 2023 vs 2024
vs
Paragraph-level year-over-year comparison of RIGEL PHARMACEUTICALS INC's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.
+647 added−613 removedSource: 10-K (2025-03-04) vs 10-K (2024-03-05)
Top changes in RIGEL PHARMACEUTICALS INC's 2024 10-K
647 paragraphs added · 613 removed · 468 edited across 1 sections
- Item 1A. Risk Factors+647 / −613 · 468 edited
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
468 edited+179 added−145 removed633 unchanged
Item 1A. Risk Factors
Risk Factors — what could go wrong, per management
468 edited+179 added−145 removed633 unchanged
2023 filing
2024 filing
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.
Biggest changeSTATEMENTS OF CASH FLOWS (In thousands) Year Ended December 31, 2024 2023 2022 Operating activities Net income (loss) $ 17,485 $ (25,091) $ (58,573) Adjustments to reconcile net income (loss) to net cash provided by operating activities: Stock-based compensation expense 12,393 8,806 12,385 (Gain) loss on sale and disposal of fixed assets (79) 266 (138) Depreciation and amortization 2,228 1,238 998 Non-cash interest expense — — 682 Net amortization of discount on short-term investments and term loans (709) (479) (63) Changes in assets and liabilities: Accounts receivable, net (11,065) 9,770 (24,848) Inventories 764 1,172 (2,377) Prepaid and other current and non-current assets (3,440) 2,054 (513) Right-of-use assets 615 1,069 7,773 Accounts payable (3,803) (366) 3,788 Accrued compensation 1,463 (190) (1,824) Accrued research and development 560 (4,195) (2,676) Revenue reserves and refund liability 10,756 3,539 4,230 Other accrued liabilities 4,995 (1,151) 1,709 Lease liability (692) (1,128) (8,546) Deferred revenue — (14) (1,227) Other current and long-term liabilities — (1,043) (4,538) Net cash provided by (used in) operating activities 31,471 (5,743) (73,758) Investing activities Maturities of short-term investments 39,700 41,650 101,228 Purchases of short-term investments (35,272) (31,206) (28,894) Capital expenditures (36) — (450) Payments for acquisition of intangible assets (360) (15,000) — Proceeds from sale of property and equipment 98 259 893 Net cash provided by (used in) investing activities 4,130 (4,297) 72,777 Financing activities Net proceeds from term loan financing — 19,950 19,542 Net proceeds from issuance of common stock from equity plans 1,964 1,049 2,124 Closing purchase price payment related to asset acquisition (10,000) — — Cost share payments to a collaboration partner (3,605) (2,632) (15,116) Net cash (used in) provided by financing activities (11,641) 18,367 6,550 Net increase in cash and cash equivalents 23,960 8,327 5,569 Cash and cash equivalents at beginning of period 32,786 24,459 18,890 Cash and cash equivalents at end of period $ 56,746 $ 32,786 $ 24,459 Supplemental disclosure of cash flow information Interest paid $ 7,039 $ 5,848 $ 2,495 Income taxes paid 331 — — Purchases of intangible asset included within accounts payable — — 15,000 Acquisition-related liabilities 5,000 — — See Accompanying Notes to Financial Statements. 111 Table of Contents RIGEL PHARMACEUTICALS, INC.
These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any product for which we have obtained regulatory approval, or for which we obtain regulatory approval in the future.
These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any product for which we have obtained regulatory approval, or for which we may obtain regulatory approval in the future.
The GDPR has direct effect where an entity is established in the European Economic Area (EEA) or the UK (as applicable) and has extraterritorial effect, including where an entity established outside of the EEA or the UK processes personal data in relation to offering goods or services to individuals in the EEA and/or the UK or monitoring their behavior.
The GDPR has direct effect where an entity is established in the European Economic Area (EEA) or the UK (as applicable) and has extraterritorial effect, including where an entity established outside of the EEA or the UK processes personal data in relation to the offering of goods or services to individuals in the EEA and/or the UK or the monitoring of their behavior.
We participate in the Medicaid Drug Rebate Program, as administered by the CMS, the 340B Drug Pricing Program, as administered by the Health Resources and Services Administration, and other federal and state government drug pricing programs in the US, and we may participate in additional government pricing programs in the future.
We participate in the Medicaid Drug Rebate Program, as administered by CMS, the 340B Drug Pricing Program, as administered by the Health Resources and Services Administration, and other federal and state government drug pricing programs in the US, and we may participate in additional government pricing programs in the future.
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.
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; 76 Table of Contents ● 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.
Market acceptance of our products will depend on a number of factors, including: ● the timing of market introduction of the product as well as competitive products; ● the clinical indications for which the product is approved; ● acceptance by physicians, the medical community and patients of the product as a safe and effective treatment; ● potential future impacts, if any, due to the effects of a global pandemic and the global tensions arising from the Russian-Ukrainian war and Hamas-Israel war; ● the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies, if any; 81 Table of Contents ● the convenience of prescribing, administrating and initiating patients on the product and the length of time the patient is on the product; ● the potential and perceived value and advantages of the product over alternative treatments; ● the cost of treatment in relation to alternative treatments, including any similar generic treatments; ● pricing and the availability of coverage and adequate reimbursement by third-party payors and government authorities; ● a positive HTA concluding that the product is cost-effective and the HTA bodies issuing a positive recommendation for the use of the product as a first or second line of treatment for the granted therapeutic indication; ● the prevalence and severity of adverse side effects; and ● the effectiveness of sales and marketing efforts.
Market acceptance of our products will depend on a number of factors, including: ● the timing of market introduction of the product as well as competitive products; ● the clinical indications for which the product is approved; ● acceptance by physicians, the medical community and patients of the product as a safe and effective treatment; ● potential future impacts, if any, due to the effects of a global pandemic and the global tensions arising from 81 Table of Contents the Russian-Ukrainian war and Hamas-Israel war; ● the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies, if any; ● the convenience of prescribing, administrating and initiating patients on the product and the length of time the patient is on the product; ● the potential and perceived value and advantages of the product over alternative treatments; ● the cost of treatment in relation to alternative treatments, including any similar generic treatments; ● pricing and the availability of coverage and adequate reimbursement by third-party payors and government authorities; ● a positive HTA concluding that the product is cost-effective and the HTA bodies issuing a positive recommendation for the use of the product as a first or second line of treatment for the granted therapeutic indication; ● the prevalence and severity of adverse side effects; and ● the effectiveness of sales and marketing efforts.
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.
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 our 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.
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.
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 continue to maintain investment portfolios primarily in money market funds, US treasury bills, government-sponsored enterprise securities, and corporate bonds and commercial paper. Cash in excess of immediate requirements is invested with regard to liquidity and capital preservation. We view our investments portfolio as available-for-sale and are available for use in current operations.
We continue to maintain investment portfolios primarily in money market funds, US treasury bills, government-sponsored enterprise securities, corporate bonds and commercial paper. Cash in excess of immediate requirements is invested with regard to liquidity and capital preservation. We view our investments portfolio as available-for-sale and are available for use in current operations.
GAVRETO is also approved under accelerated approval based on overall response rate and duration response rate, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
GAVRETO is also approved under accelerated approval based on overall response rate and duration response rate, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
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.
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.
An allowance for credit losses for the excess of amortized cost over the expected cash flows is recorded in other income (expense), net on the statements of operations. Impairment losses that are not credit-related are included in accumulated other comprehensive income (loss) in stockholders’ (deficit) equity.
An allowance for credit losses for the excess of amortized cost over the expected cash flows is recorded in other income (expense), net on the statements of operations. Impairment losses that are not credit-related are included in accumulated other comprehensive income (loss) in stockholders’ equity (deficit).
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.
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.
Our future funding requirements will depend upon many factors, including, but not limited to: ● the ongoing costs to commercialize our products, or any other future product candidates, if any such candidate receives regulatory approval for commercial sale; ● our ability to generate expected revenue from our commercialization efforts; ● the progress and success of our clinical trials and preclinical activities (including studies and manufacture of materials) of our product candidates conducted by us; ● our ability to secure and maintain our patent protection and regulatory rights; ● our ability to meet operating covenants under our current and future credit facilities, if any; ● our ability to enter into partnering opportunities across our pipeline within and outside the US; ● the costs and timing of regulatory filings and approvals by us and our collaborators; ● the progress of research and development programs carried out by us and our collaborative partners; ● any changes in the breadth of our research and development programs; ● the ability to achieve the events identified in our collaborative agreements that may trigger payments to us from our collaboration partners; ● our ability to acquire or license other technologies or compounds that we may seek to pursue; ● our ability to manage our growth; ● competing technological and market developments; 102 Table of Contents ● the costs and timing of obtaining, enforcing and defending our patent and other intellectual property rights, including regulatory rights such as regulatory data exclusivities; and ● expenses associated with any unforeseen litigation, including any arbitration and securities class action lawsuits.
Our future funding requirements will depend upon many factors, including, but not limited to: ● the ongoing costs to commercialize our products, or any other future product candidates, if any such candidate receives regulatory approval for commercial sale; ● our ability to generate expected revenue from our commercialization efforts; ● the progress and success of our clinical trials and preclinical activities (including studies and manufacture of materials) of our product candidates conducted by us; ● our ability to secure and maintain our patent protection and regulatory rights; ● our ability to meet operating covenants under our current and future credit facilities, if any; ● our ability to enter into partnering opportunities across our pipeline within and outside the US; ● the costs and timing of regulatory filings and approvals by us and our collaborators; ● the progress of research and development programs carried out by us and our collaborative partners; ● any changes in the breadth of our research and development programs; ● the ability to achieve the events identified in our collaborative agreements that may trigger payments to us from our collaboration partners; ● our ability to acquire or license other technologies or compounds that we may seek to pursue; ● our ability to manage our growth; 101 Table of Contents ● competing technological and market developments; ● the costs and timing of obtaining, enforcing and defending our patent and other intellectual property rights, including regulatory rights such as regulatory data exclusivities; and ● expenses associated with any unforeseen litigation, including any arbitration and securities class action lawsuits.
Our future funding requirements will depend upon many factors, many of which are beyond our control, including, but not limited to: ● the costs to commercialize our products in the US, or any other future product candidates, if any such candidate receives regulatory approval for commercial sale; ● the progress and success of our clinical trials and preclinical activities (including studies and manufacture of materials) of our product candidates conducted by us; ● our ability to secure patent and regulatory protection; ● our ability to secure a favorable price or a positive HTA assessment; ● potential future impacts, if any, of a global pandemic; ● the costs and timing of regulatory filings and approvals by us and our collaborators; ● the progress of research and development programs carried out by us and our collaborative partners; ● any changes in the breadth of our research and development programs; ● the ability to achieve the events identified in our collaborative agreements that may trigger payments to us from our collaboration partners; ● our ability to acquire or license other technologies or compounds that we may seek to pursue; ● our ability to manage our growth; ● competing technological and market developments; ● the costs and timing of obtaining, enforcing and defending our patent and other intellectual property rights; and 58 Table of Contents ● expenses associated with any unforeseen litigation, including any arbitration and securities class action lawsuits.
Our future funding requirements will depend upon many factors, many of which are beyond our control, including, but not limited to: ● the costs to commercialize our products in the US, or any other future product candidates, if any such candidate receives regulatory approval for commercial sale; ● the progress and success of our clinical trials and preclinical activities (including studies and manufacture of materials) of our product candidates conducted by us; ● our ability to secure patent and regulatory protection; ● our ability to secure a favorable price or a positive HTA assessment; ● potential future impacts, if any, of a global pandemic; 57 Table of Contents ● the costs and timing of regulatory filings and approvals by us and our collaborators; ● the progress of research and development programs carried out by us and our collaborative partners; ● any changes in the breadth of our research and development programs; ● the ability to achieve the events identified in our collaborative agreements that may trigger payments to us from our collaboration partners; ● our ability to acquire or license other technologies or compounds that we may seek to pursue; ● our ability to manage our growth; ● competing technological and market developments; ● the costs and timing of obtaining, enforcing and defending our patent and other intellectual property rights; and ● expenses associated with any unforeseen litigation, including any arbitration and securities class action lawsuits.
Further, in February 2024, we entered into an Asset Purchase Agreement with Blueprint to purchase certain assets comprising the right to research, develop, manufacture and commercialize GAVRETO (pralsetinib), Blueprint’s proprietary RET inhibitor of tyrosine kinase for the treatment of metastatic RET fusion-positive NSCLC and advanced thyroid cancer, in the US.
Further, in February 2024, we entered into an Asset Purchase Agreement with Blueprint to purchase certain assets comprising the right to research, develop, manufacture and commercialize GAVRETO, Blueprint’s proprietary RET inhibitor of tyrosine kinase for the treatment of metastatic RET fusion-positive NSCLC and advanced thyroid cancer, in the US.
A separate marketing authorization will be required to market drugs in Great Britain. The MHRA has launched the Innovative Licensing and Access Pathway, or ILAP, a new accelerated assessment procedure for marketing authorization applications facilitating the interaction with pricing authorities and HTA bodies and aiming to enable companies to enter the UK market faster.
A separate marketing authorization will be required to market drugs in Great Britain. The MHRA has launched the Innovative Licensing and Access Pathway (ILAP), a new accelerated assessment procedure for marketing authorization applications facilitating the interaction with pricing authorities and HTA bodies and aiming to enable companies to enter the UK market faster.
If we decide to exercise our opt-in right, we will be required to continue to share in global development costs, and if we later exercise our second opt-out right (no later than April 1, 2025), our share in global development costs will be up to a specified cap through December 31, 2025, as provided for in the Lilly Agreement.
If we decide to exercise our opt-in right, we will be required to continue to share in the global development costs with Lilly, and if we later exercise our second opt-out right (no later than April 1, 2025), our share in global development costs will be up to a specified cap through December 31, 2025, as provided for in the Lilly Agreement.
Although we have regained compliance, the Nasdaq may in the future initiate the delisting process with a notification letter if we were to again fall out of compliance. If we were to receive such a notification, we would be afforded a grace period of 180 calendar days to regain compliance with the Bid Price Requirement.
Although we regained compliance with the Nasdaq Bid Price Requirement, in the future, Nasdaq may initiate a delisting process with a notification letter if we were to again fall out of compliance. If we were to receive such a notification, we would be afforded a grace period of 180 calendar days to regain compliance with the Bid Price Requirement.
IRA extended this increased tax credit assistance and removal of the 400% federal poverty limit through 2025. Additionally, beginning in April 2013, the Budget Control Act of 2011 created an automatic reduction of Medicare payments to providers of up to 2%.
The Inflation Reduction Act (IRA) extended this increased tax credit assistance and removal of the 400% federal poverty limit through 2025. Additionally, beginning in April 2013, the Budget Control Act of 2011 created an automatic reduction of Medicare payments to providers of up to 2%.
Inventories sold for the periods presented include inventory quantities acquired or produced prior to the FDA approval of the product, and do not reflect the full cost of the inventories sold, since such costs incurred prior to FDA approval were previously expensed and charged to research and development expense.
Certain inventories sold for the periods presented include inventory quantities acquired or produced prior to the FDA approval of the product, and do not reflect the full cost of the inventories sold, since such costs incurred prior to FDA approval were previously expensed and charged to research and development expense.
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.
TAVALISSE (fostamatinib disodium hexahydrate) is our first product approved by the FDA. TAVALISSE is 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 failure to accomplish any of these goals, including as a result of business or other interruptions resulting from a potential pandemic or global economic slowdown, could adversely affect our business and operations. 41 Table of Contents Our strategy to expand our hematology and oncology pipeline on our own, or through acquisitions or in-licensing of early or late-stage products or companies, or through partnerships with pharmaceutical and biotechnology companies, as well as academic institutions and government organizations, may not be successful.
Our failure to accomplish any of these goals, including as a result of business or other interruptions resulting from a potential pandemic or global economic slowdown, could adversely affect our business and operations. 39 Table of Contents Our strategy to expand our hematology and oncology pipeline on our own, or through acquisitions or in-licensing of early or late-stage products or companies, or through partnerships with pharmaceutical and biotechnology companies, as well as academic institutions and government organizations, may not be successful.
While we conducted an in-depth analysis of these data to better understand differences in patient characteristics and outcomes and submitted these findings to the FDA, in October 2022, we announced that we received guidance from the FDA’s of these findings.
While we conducted an in-depth analysis of these data to better understand differences in patient characteristics and outcomes and submitted these findings to the FDA, in October 2022, we announced that we received guidance from the FDA of these findings.
Other Informatio n Securities Trading Plans of Directors and Executive Officers During the three months ended December 31, 2023, none of our directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement” as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended.
Other Informatio n Securities Trading Plans of Directors and Executive Officers During the three months ended December 31, 2024, none of our directors or executive officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement” as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended.
As a result of the COVID-19 pandemic, this reduction was temporarily suspended from May 1, 2020 through March 31, 2022, with subsequent reductions to 1% from April 1, 2022 until June 30, 2022.
As a result of the COVID-19 pandemic, this reduction was temporarily suspended from May 1, 2020 through March 31, 2022, with subsequent reductions to 1% from April 1, 2022 through June 30, 2022.
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.
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 78 Table of Contents ● imposition of civil or criminal penalties.
The UK Information Commissioner’s Office has also published its version of the TIA and guidance on international transfers, although entities may choose to adopt either the EU or UK style TIA.
The UK Information Commissioner’s Office (ICO) has also published its version of the TIA and guidance on international transfers, although entities may choose to adopt either the EU or UK style TIA.
Moreover, on June 16, 2022, the Federal Trade Commission issued a policy statement stating its intent to increase enforcement scrutiny of “exclusionary rebates” to PBMs and other intermediaries that “foreclose competition.” On August 16, 2022, President Biden signed into law the IRA, which, among other reforms, allows Medicare to: beginning in 2026, establish a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation with CMS; beginning in 2023, penalize drug companies that raise prices for products covered under Medicare Parts B and D faster than inflation; and beginning in 2025, impose new discount obligations on pharmaceutical and biological manufacturers for products covered under Medicare Part D.
Moreover, on June 16, 2022, the Federal Trade Commission issued a policy statement stating its intent to increase enforcement scrutiny of “exclusionary rebates” to PBMs and other intermediaries that “foreclose competition.” On August 16, 2022, the IRA was signed into law, which, among other reforms, allows Medicare to: beginning in 2026, establish a “maximum fair price” for a fixed number of pharmaceutical and biological products covered under Medicare Parts B and D following a price negotiation with CMS; beginning in 2023, penalize drug companies that raise prices for products covered under Medicare Parts B and D faster than inflation; and beginning in 2025, impose new discount obligations on pharmaceutical and biological manufacturers for products covered under Medicare Part D.
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.
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 60 Table of Contents 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.
On September 28, 2023, we entered into an amendment to the Lilly Agreement which provided, among others that if we exercise our first opt-out right, we have the right to opt-in to the co-funding of R552 development, upon us providing notice to Lilly within 30 days of certain events as specified in the Lilly Agreement, and as a result receive greater royalties from sales.
On September 28, 2023, we entered into an amendment to the Lilly Agreement which provided, among others that if we exercise our first opt-out right, we have the right to opt-in to the co-funding of ocadusertib development, upon us providing notice to Lilly within 30 days of certain events as specified in the Lilly Agreement, and as a result receive greater royalties from sales.
In future clinical trials, we or our partners may discover additional side effects and/or a higher frequency of side effects than those observed in previously completed clinical trials.
In future clinical trials, we, our partners or others may discover additional side effects and/or a higher frequency of side effects than those observed in previously completed clinical trials.
Our ability to compete successfully will depend, in part, on our ability to: ● identify and validate targets; ● discover candidate drug compounds that interact with the targets we identify in a safe and efficacious way; ● attract and retain scientific and product development personnel; 65 Table of Contents ● recruit subjects into our clinical trials; ● obtain and maintain required regulatory approvals; ● obtain patent or other proprietary protection for our new drug compounds and technologies; ● obtain access to manufacturing resources of the sufficient standard and scale; ● enter commercialization agreements for our new drug compounds; and ● obtain and maintain appropriate reimbursement price and positive recommendations by HTA bodies.
Our ability to compete successfully will depend, in part, on our ability to: ● identify and validate targets; ● discover candidate drug compounds that interact with the targets we identify in a safe and efficacious way; ● attract and retain scientific and product development personnel; ● recruit subjects into our clinical trials; ● obtain and maintain required regulatory approvals; ● obtain patent or other proprietary protection for our new drug compounds and technologies; ● obtain access to manufacturing resources of the sufficient standard and scale; ● enter commercialization agreements for our new drug compounds; and ● obtain and maintain appropriate reimbursement price and positive recommendations by HTA bodies.
Institutional investors, in particular, use these ratings to compare companies, and any perceived lag in our ESG efforts might prompt voting decisions or other actions to hold our board accountable. Furthermore, evolving assessment criteria for corporate responsibility practices may raise expectations, compelling us to undertake costly initiatives to meet new standards.
Institutional investors, in particular, use these ratings to compare companies, and any perceived lag in our ESG efforts might prompt voting decisions or other actions to hold our Board of Directors accountable. Furthermore, evolving assessment criteria for corporate responsibility practices may raise expectations, compelling us to undertake costly initiatives to meet new standards.
Advertising costs for the years ended December 31, 2023, 2022 and 2021 amounted to $3.1 million, $2.7 million, and $2.3 million, respectively. Leases We account for leases in accordance with ASU No. 2016-02 , Leases (Topic 842) . Topic 842 requires a lessee to determine if an arrangement is a lease or contains a lease at contract inception.
Advertising costs for the years ended December 31, 2024, 2023 and 2022 amounted to $2.1 million, $3.1 million, and $2.7 million, respectively. Leases We account for leases in accordance with ASU No. 2016-02 , Leases (Topic 842) . Topic 842 requires a lessee to determine if an arrangement is a lease or contains a lease at contract inception.
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.
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; 56 Table of Contents ● the rate of adoption in the particular market, including fluctuations in demand for various reasons; ● potential future impacts, if any, including 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.
Lilly is responsible for funding the remainder of all development activities for R552 and other non-CNS disease development candidates. Pursuant to the terms of the Lilly Agreement, we have the right to opt-out of co-funding the R552 development activities in the US, Europe and Japan at two different specified times and as a result receive lesser royalties from sales.
Lilly is responsible for funding the remainder of all development activities for ocadusertib and other non-CNS disease development candidates. Pursuant to the terms of the Lilly Agreement, we have the right to opt-out of co-funding the ocadusertib development activities in the US, Europe and Japan at two different specified times and as a result receive lesser royalties from sales.
Knight Commercial License and Supply Agreement We have commercial license and supply agreements with Knight entered in May 2022 for the commercialization of fostamatinib for approved indications in Knight territory.
Knight Commercial License and Supply Agreement We have commercial license and supply agreements with Knight entered in May 2022 for the exclusive commercialization of fostamatinib for approved indications in Knight territory.
We did not have federal income taxes due to the sufficient NOL carryforwards that were generated prior to the enactment of the Tax Act, as well as significant research and development credit carryforwards. We continue to record a full valuation allowance on our deferred tax assets considering our cumulative losses in prior years and forecasted losses in the future.
We have not recorded federal income taxes due to the sufficient NOL carryforwards that were generated prior to the enactment of the Tax Act, as well as significant research and development credit carryforwards. We continue to record a full valuation allowance on our deferred tax assets considering our cumulative losses in prior years and forecasted losses in the future.
Despite our efforts to monitor evolving social media communication guidelines and comply with applicable laws, regulations and national and EU codes of conduct, there is risk that the unauthorized use of social media by us or our employees to communicate about our products or business, sharing of publications in unintended audiences in other jurisdictions, or any inadvertent promotional activity or disclosure of material, nonpublic information through these means, may cause us to be found in violation of applicable laws and regulations, which may give rise to liability and result in harm to our business.
Despite our efforts to monitor evolving social media communication guidelines and comply with applicable laws, regulations and national and EU codes of conduct, there is risk that the unauthorized use of social media by us or our employees to communicate about our products or business, sharing of publications in unintended audiences 88 Table of Contents in other jurisdictions, or any inadvertent promotional activity or disclosure of material, nonpublic information through these means, may cause us to be found in violation of applicable laws and regulations, which may give rise to liability and result in harm to our business.
We could also experience disruptions in our supply chain or limits our ability to obtain sufficient materials for our drug products in certain regions. Public perception of the risk-benefit balance for our COVID-19 product candidates may be affected by adverse events in clinical trials involving our product candidate or other COVID-19 treatments.
We could also experience disruptions in our supply chain or limits our ability to obtain sufficient materials for our drug products in certain regions. Public perception of the risk-benefit balance for our product candidates may be affected by adverse events in clinical trials involving our product candidate or other treatments.
In addition, depending on the extent of our co-funding of R552 development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets.
In addition, depending on the extent of our co-funding of ocadusertib development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets.
If our future drug candidates fail or do not gain regulatory approval, or if our drugs do not achieve sustainable market acceptance, we may not be profitable. As of December 31, 2023, we had an accumulated deficit of approximately $1.4 billion. The extent of our future losses or profitability, if any, is highly uncertain.
If our future drug candidates fail or do not gain regulatory approval, or if our drugs do not achieve sustainable market acceptance, we may not be profitable. As of December 31, 2024, we had an accumulated deficit of approximately $1.4 billion. The extent of our future losses or profitability, if any, is highly uncertain.
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.
This section does not discuss 2022 items and 2023 to 2022 year-to-year comparisons. Discussions of 2022 items and 2023 to 2022 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, 2023.
NET LOSS PER SHARE Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period.
NET INCOME (LOSS) PER SHARE Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period.
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.
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, in conformity with U.S. generally accepted accounting principles.
If neither of these conditions are met, we determine whether the impairment is due to credit losses by comparing the present value of the expected cash flows of the security with its amortized cost basis. The 118 Table of Contents amount of impairment recognized is limited to the excess of the amortized cost over the fair value of the security.
If neither of these conditions are met, we determine whether the impairment is due to credit losses by comparing the present value of the expected cash flows of the security with its amortized cost basis. The 117 Table of Contents amount of impairment recognized is limited to the excess of the amortized cost over the fair value of the security.
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.
These provisions: ● establish that members of our 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 our Board of Directors or for proposing matters that can be acted upon at stockholder meetings; ● provide for staggered terms for our Board of Directors; and ● provide that the authorized number of directors may be changed only by a resolution of our Board of Directors.
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.
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.
Because of the uncertainty of whether the accumulated preclinical evidence (PK, pharmacodynamic, safety and/or other factors) or early clinical results will be observed in later clinical trials, we can make no assurances regarding the likely results from our future clinical trials or the impact of those results on our business.
Because of the uncertainty of whether the accumulated preclinical evidence (pharmacokinetic, pharmacodynamic, safety and/or other factors) or early clinical results will be observed in later clinical trials, we can make no assurances regarding the likely results from our future clinical trials or the impact of those results on our business.
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.
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 2024 and 2023 items and 2024 and 2023 year-to-year comparisons.
In addition, exclusive marketing rights in the US for fostamatinib for the treatment of ITP, wAIHA or any future product candidate may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
In addition, exclusive marketing rights in the US for fostamatinib for the treatment of ITP, wAIHA or any future product candidate may be limited if we seek 80 Table of Contents approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.
It is also possible that we could experience delays in the timing of our interactions with regulatory authorities due to absenteeism by governmental employees or the diversion of regulatory authority efforts and attention to approval of other therapeutics, or other public health emergencies including a global pandemic, which could delay or limit our 84 Table of Contents ability to make planned regulatory submissions or develop and commercialize our product candidates on anticipated timelines.
It is also possible that we could experience delays in the timing of our interactions with regulatory authorities due to absenteeism by governmental employees or the diversion of regulatory authority efforts and attention to approval of other therapeutics, or other public health emergencies including a global pandemic, which could delay or limit our ability to make planned regulatory submissions or develop and commercialize our product candidates on anticipated timelines.
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 served an answer to Annora’s counterclaims in October 2022. Annora served invalidity and non-infringement contentions in December 2022. We served an answer to Annora’s invalidity and non-infringement contentions in March 2023.
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 served an answer to Annora’s counterclaims in October 2022. Annora served invalidity and non-infringement contentions in December 2022.
Opinion on Internal Control over Financial Reporting We have audited Rigel Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Rigel Pharmaceuticals, Inc.
Opinion on Internal Control Over Financial Reporting We have audited Rigel Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Rigel Pharmaceuticals, Inc.
Forma became a wholly owned subsidiary of Novo Nordisk following the closing of its acquisition by Novo Nordisk in October 2022.
Forma became a wholly owned subsidiary of Novo Nordisk following the closing of its acquisition in October 2022.
Following candidate selection, Lilly will be responsible for performing and funding all future development and commercialization of the CNS disease development candidates. We are responsible for 20% of development costs for R552 in the US, Europe, and Japan, up to a specified cap.
Following candidate selection, Lilly will be responsible for performing and funding all future development and commercialization of the CNS disease development candidates. We are responsible for 20% of development costs for ocadusertib in the US, Europe, and Japan, up to a specified cap.
Our ability to raise additional capital, including our ability to secure new collaborations and continue to support existing collaboration efforts with our partners, may also be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the US and worldwide resulting from the COVID-19 pandemic and the global tensions arising from the Russia-Ukraine war and the Hamas-Israel war.
Our ability to raise additional capital, including our ability to secure new collaborations and continue to support existing collaboration efforts with our partners, may also be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the US and worldwide resulting from a global pandemic and the global tensions arising from the Russia-Ukraine war and the Hamas-Israel war.
Our entities may be in scope of the NISD2 where they qualify as a MSP, cloud provider, R&D entity and/or medical device manufacturer within the meaning of NISD2 and offer those services in the EU. 48 Table of Contents The NISD2 empowers the EU Member States to define all rules regarding penalties applicable to infringements, provided that they are effective, proportionate, and dissuasive.
Our entities may be in scope of the NISD2 where they qualify as a MSP, cloud provider, R&D entity and/or medical device manufacturer within the meaning of NISD2 and offer those services in the EU. The NISD2 empowers the EU Member States to define all rules regarding penalties applicable to infringements, provided that they are effective, proportionate, and dissuasive.
The fair value of the RSU grant is based on the market price of our common stock on the date of grant. 117 Table of Contents Accounts Receivable Accounts receivable are recorded net of customer allowances for prompt payment discounts and any allowance for doubtful accounts.
The fair value of the RSU grant is based on the market price of our common stock on the date of grant. 116 Table of Contents Accounts Receivable Accounts receivable are recorded net of customer allowances for prompt payment discounts and any allowance for doubtful accounts.
The aggregate intrinsic values of stock options outstanding, vested and expected to vest, and exercisable represents the difference between the exercise price of the underlying awards and the quoted price of our common stock for the options that were in-the-money as of December 31, 2023.
The aggregate intrinsic values of stock options outstanding, vested and expected to vest, and exercisable represents the difference between the exercise price of the underlying awards and the quoted price of our common stock for the options that were in-the-money as of December 31, 2024.
We do not know if we will be able to maintain such consulting agreements or that such scientific advisors will not enter into consulting arrangements with competing pharmaceutical or biotechnology companies, any of which may have a detrimental impact on our research objectives and could have an adverse effect on our business, financial condition and results of operations.
We do not know if we will be able to maintain such consulting agreements or that such scientific advisors will not enter 68 Table of Contents into consulting arrangements with competing pharmaceutical or biotechnology companies, any of which may have a detrimental impact on our research objectives and could have an adverse effect on our business, financial condition and results of operations.
This feature is called a “reset.” Participants are automatically enrolled in the new offering period. Our previous 24-month offering period under our Purchase Plan ended on June 30, 2022, and a new 24-month offering period started on July 1, 2022.
This feature is called a “reset.” Participants are automatically enrolled in the new offering period. Our previous 24-month offering period under our Purchase Plan ended on June 30, 2024, and a new 24-month offering period started on July 1, 2024.
In addition, the unique nature of our research activities and of much of our equipment could make it difficult for us to recover from a disaster. The insurance we maintain may not be adequate to cover our losses resulting from disasters or other business interruptions. Item 1B. Unresolved Staff Comment s None. Item 1C.
In addition, the unique nature of our research activities and of much of our equipment could make it difficult for us to recover from a disaster. The insurance we maintain may not be adequate to cover our losses resulting from disasters or other business interruptions. 89 Table of Contents Item 1B. Unresolved Staff Comment s None. Item 1C.
We believe that this leased facility is in good operating condition and is adequate for all our present and near term uses. 90 Table of Contents Item 3. Legal Proceeding s From time to time, we may be a party or subject to legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business.
We believe that this leased facility is in good operating condition and is adequate for all our present and near term uses. Item 3. Legal Proceeding s From time to time, we may be a party or subject to legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business.
We entered into a Credit Agreement with MidCap on September 27, 2019, amended on March 29, 2021, February 11, 2022, and July 27, 2022. The Credit Agreement provides for a $60.0 million term loan credit facility.
We entered into a Credit Agreement with MidCap on September 27, 2019, amended on March 29, 2021, February 11, 2022, July 27, 2022, and April 11, 2024. The Credit Agreement provides for a $60.0 million term loan credit facility.
Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations and may result in tax obligations in excess of amounts accrued in our financial statements. 62 Table of Contents Our ability to use net operating losses (NOLs) and certain other tax attributes is uncertain and may be limited.
Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations and may result in tax obligations in excess of amounts accrued in our financial statements. Our ability to use net operating losses (NOLs) and certain other tax attributes is uncertain and may be limited.
The following table presents the future minimum principal payments of the outstanding loan as of December 31, 2023 (in thousands): For the year ending December 31, 2024 $ 7,500 2025 30,000 2026 22,500 Principal amount (Tranches 1, 2, 3 and 4) $ 60,000 The amended Credit Agreement contains certain covenants which, among others, require us to deliver financial reports at designated times of the year and maintain minimum unrestricted cash and trailing net revenues.
The following table presents the future minimum principal payments of the outstanding loan as of December 31, 2024 (in thousands): For the year ending December 31, 2025 $ 7,500 2026 30,000 2027 22,500 Principal amount (Tranches 1, 2, 3 and 4) $ 60,000 136 Table of Contents The amended Credit Agreement contains certain covenants which, among others, require us to deliver financial reports at designated times of the year and maintain minimum unrestricted cash and trailing net revenues.
Any such adjustments are recorded on a cumulative catch-up basis, and are recorded as part of contract revenues from collaborations during the period of adjustment. Product Supply Services: Arrangements that include a promise for future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options.
Any such adjustments are recorded on a cumulative catch-up basis, and recorded as part of contract revenues from collaborations during the period of adjustment. 115 Table of Contents Product Supply Services: Arrangements that include a promise for future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options.
We have updated our NOL carryforwards to reflect the results of the Section 382 owner shift analysis as of December 31, 2023. We did not experience any significant changes in ownership in the periods presented.
We have updated our NOL carryforwards to reflect the results of the Section 382 owner shift analysis as of December 31, 2024. We did not experience any significant changes in ownership in the periods presented.
For example, in September 2018, BerGenBio served us with a notice of arbitration seeking declaratory relief related to the interpretation of provisions 59 Table of Contents under our June 2011 license agreement, particularly as they relate to the rights and obligations of the parties in the event of the license or sale of a product in the program by BerGenBio and/or the sale of BerGenBio to a third party.
For example, in September 2018, BerGenBio served us with a notice of arbitration seeking declaratory relief related to the interpretation of provisions under our June 2011 license agreement, particularly as they relate to the rights and obligations of the parties in the event of the license or sale of a product in the program by BerGenBio and/or the sale of BerGenBio to a third party.
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.
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. 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.
Any product for which we have obtained regulatory approval, or for which we obtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, product labeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, the EMA and other comparable international regulatory authorities.
Any product for which we have obtained regulatory approval, or 77 Table of Contents for which we obtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, product labeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, the EMA and other comparable international regulatory authorities.
Changes in Internal Controls over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the fourth quarter of 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Changes in Internal Controls over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the fourth quarter of 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
For example, we conducted our Phase 3 clinical trial to evaluate safety and efficacy of fostamatinib in hospitalized COVID-19 patients, which we launched in November 2020 and completed the enrollment on this trial in July 2022. We previously announced in November 2022 the top-line results did not meet statistical significance in the primary efficacy endpoint.
For example, we conducted our Phase 3 clinical trial to evaluate safety and efficacy of fostamatinib in hospitalized COVID-19 patients launched in November 2020 and completed enrollment in July 2022. We previously announced in November 2022 the top-line results did not meet statistical significance in the primary efficacy endpoint.
In addition, we cannot be sure that our existing insurance coverage will continue to be available on acceptable terms or that our insurers will not deny coverage as to any future claim. Future equity issuances or a sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
In addition, we cannot be sure that our existing insurance coverage will continue to be available on acceptable terms or that our insurers will not deny coverage as to any future claim. 70 Table of Contents Future equity issuances or a sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
We routinely conduct employee trainings on important information security procedures and test and measure compliance with these security measures. In addition, we maintain cyber insurance policies that mitigate the financial risk of any potential incident. 89 Table of Contents We engage consultants, auditors, and other third parties in connection with such processes.
We routinely conduct employee trainings on important information security procedures and test and measure compliance with these security measures. In addition, we maintain cyber insurance policies that mitigate the financial risk of any potential incident. We engage consultants, auditors, and other third parties in connection with such processes.
Revenue from product sales is recorded net of certain variable consideration which includes estimated government-mandated rebates and chargebacks, distribution fees, estimated product returns and other deductions. 114 Table of Contents Provisions for returns and other adjustments are provided for in the period the related revenue is recorded. Actual amounts of consideration ultimately received may differ from our estimates.
Revenue from product sales is recorded net of certain variable consideration which includes estimated government-mandated rebates and chargebacks, distribution fees, estimated product returns and other deductions. Provisions for returns and other adjustments are provided for in the period the related revenue is recorded. Actual amounts of consideration ultimately received may differ from our estimates.
We use the straight-line attribution method over the requisite employee service period for the entire award in recognizing stock-based compensation expense. We account for forfeitures as they occur. 116 Table of Contents The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model.
We use the straight-line attribution method over the requisite employee service period for the entire award in recognizing stock-based compensation expense. We account for forfeitures as they occur. The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model.
Changes in these estimates that result in material changes to our accruals could materially affect our financial condition and results of operations. Research and development expenses also include milestone payment obligations incurred prior to r egulatory approval of the product, which are accrued when the event requiring payment of the milestone occurs.
Changes in these estimates that result in material changes to our accruals could materially affect our financial condition and results of operations. 119 Table of Contents Research and development expenses also include milestone payment obligations incurred prior to r egulatory approval of the product, which are accrued when the event requiring payment of the milestone occurs.
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