Coherus BioSciences Inc
For the period ended Sep 30, 2024. Filed Nov 6, 2024.
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Sep 30, 2024 · Filed Nov 6, 2024
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Notes to Condensed Consolidated Financial Statements
- Organization and Summary of Significant Accounting Policies
Organization
Coherus BioSciences, Inc. (the “Company” or “Coherus”) is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. The Company is developing an innovative immuno-oncology pipeline that it believes will be synergistic with its proven commercial capabilities in oncology. The Company’s headquarters and laboratories are located in Redwood City, California and in Camarillo, California, respectively.
On January 2, 2024, the Company announced the launch in the U.S. of LOQTORZI® in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (“NPC”), and as monotherapy for the treatment of adults with recurrent unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. LOQTORZI is a novel PD-1 inhibitor that the Company developed in collaboration with Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”). The Company also sells UDENYCA® (pegfilgrastim-cbqv), a biosimilar to Neulasta, a long-acting granulocyte-colony stimulating factor, in the United States.
The Company launched YUSIMRY (adalimumab-aqvh), a biosimilar to Humira (adalimumab), in the United States in July 2023. On June 26, 2024, the Company entered into an Asset Purchase Agreement (the “YUSIMRY Purchase Agreement”) with Hong Kong King-Friend Industrial Company Ltd. (“HKF”). Pursuant to the YUSIMRY Purchase Agreement, the Company completed the sale of its YUSIMRY (adalimumab-aqvh) franchise (the “YUSIMRY Sale”) for upfront, cash consideration of $40.0 million and the assumption of $17.0 million of inventory purchase commitments by HKF. The Company launched CIMERLI (ranibizumab-eqrn), a biosimilar to Lucentis, in the United States in October 2022. On January 19, 2024, the Company entered into a Purchase and Sale Agreement (the “CIMERLI Purchase Agreement”) with Sandoz Inc. (“Sandoz”). Pursuant to the terms and subject to the conditions set forth in the CIMERLI Purchase Agreement, on March 1, 2024, the Company completed the sale of its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology LLC (“Coherus Ophthalmology”), to Sandoz for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets (the “CIMERLI Sale” and, together with the YUSIMRY Sale, the “Sale Transactions”). Proceeds from the CIMERLI Sale received in March were used in April 2024 to pay down $175.0 million of the total principal balance of $250.0 million on the Company’s senior secured term loan facility that was entered into January 5, 2022 (as amended on April 7, 2022, February 6, 2023, and February 5, 2024, the “2027 Term Loans”). During the second quarter of 2024, the Company repaid in full all the remaining outstanding indebtedness and terminated all commitments under the 2027 Term Loans, resulting in a $12.6 million loss on debt extinguishment from the 2027 Term Loans (see Note 8. Financial Liabilities).
The Company’s product pipeline comprises the following three product candidates: CHS-1000, an antibody targeting ILT4; casdozokitug (CHS-388, formerly SRF388), an antibody targeting interleukin 27 (“IL-27”); and CHS-114 (formerly SRF114), a highly specific afucosylated immunoglobulin isotype G1 (“IgG1”) antibody targeting CCR8. In addition to the Company’s internally developed portfolio of product candidates, the Company has a product candidate, GSK4381562, which has been exclusively licensed to GlaxoSmithKline Intellectual Property No. 4 Limited (“GSK”).
Basis of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of Coherus and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated upon consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with
United States generally accepted accounting principles (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements reflect all adjustments, including normal recurring accruals that the Company believes are necessary to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with U.S. GAAP. Interim-period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period.
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”) filed with the SEC.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying values of assets and liabilities when these values are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information, such as, the estimated effects and uncertainty surrounding the temporary supply interruption relating to the Company’s third-party labeling and packaging CMO for UDENYCA. Accounting estimates and judgments are inherently uncertain and therefore actual results could differ from these estimates.
Cash, Cash Equivalents and Restricted Cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets, which, in aggregate, represent the amount reported in the condensed consolidated statements of cash flows:
| | | | | | | |
|---|---|---|---|---|---|---|
| (in thousands) · · January 1, | ||||||
| At beginning of period: · 2024 · 2023 | ||||||
| Cash and cash equivalents | | $102,891 | | $63,547 | ||
| Restricted cash | | | 452 | | | 440 |
| Total cash, cash equivalents and restricted cash | | $103,343 | | $63,987 | ||
| | | | | | | |
| | | September 30, | ||||
| At end of period: | | 2024 | 2023 | |||
| Cash and cash equivalents | | $97,690 | | $80,259 | ||
| Restricted cash | | 263 | | 452 | ||
| Total cash, cash equivalents and restricted cash | | $97,953 | | $80,711 | ||
Restricted cash consists of deposits for letters of credit that the Company has provided to secure its obligations under certain leases and is included in other assets, non-current on the condensed consolidated balance sheets.
Trade Receivables
Trade receivables are recorded net of allowances for chargebacks, cash discounts for prompt payment and credit losses. The Company estimates an allowance for expected credit losses by considering factors such as historical experience, credit quality, the age of the accounts receivable balances, and current economic conditions that may affect
a customer’s ability to pay. The corresponding expense for the credit loss allowance is reflected in selling, general and administrative expenses. The credit loss allowance was immaterial as of September 30, 2024 and December 31, 2023.
Revenue Purchase and Sale Agreement
The Revenue Purchase and Sale Agreement (see Note 8. Financial Liabilities) contains an embedded derivative that meets the criteria to be bifurcated and accounted for separately from the Revenue Purchase and Sale Agreement (the "Royalty Fee Derivative Liability"). The Royalty Fee Derivative Liability was recorded at fair value upon entering into the Revenue Purchase and Sale Agreement and is subsequently remeasured to fair value at each reporting period with the corresponding change in fair value recognized in other income (expense), net in the condensed consolidated statements of operations. The Revenue Purchase and Sale Agreement was initially valued and is remeasured using Monte Carlo simulation models to perform the “with-and-without” method, which involves valuing the Revenue Purchase and Sale Agreement with the embedded derivative and then valuing it without the embedded derivative. The difference between values is determined to be the estimated fair value of the Royalty Fee Derivative. Refer to Note 3. Fair Value Measurements for details regarding the fair value.
The Revenue Purchase and Sale Agreement is accounted for as a liability net of a discount comprising issuance costs and the fair value of the embedded derivative requiring bifurcation. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the liability to be repaid in full over the anticipated life of the arrangement. Interest expense is recognized over the estimated term on the condensed consolidated statement of operations. The interest rate on this revenue participation liability may vary during the term of the agreement depending on a number of factors, including the level of actual and forecasted net sales. The Company evaluates the interest rate quarterly based on actual and forecasted net sales utilizing the prospective method. A significant increase or decrease in actual or forecasted net sales could materially impact the revenue participation liability, interest expense, and the time period for repayment.
Contingent Consideration
Contingent consideration relates to the potential payments to holders of Contingent Value Rights (“CVRs”)that are contingent upon the achievement of the Company and certain third parties meeting product development or financial performance milestones. For transactions accounted for as business combinations, the Company records contingent consideration at fair value at the date of the acquisition based on the consideration expected to be transferred. Liabilities for contingent consideration are remeasured each reporting period and subsequent changes in fair value are recognized within selling, general and administrative expense in the condensed consolidated statements of operations. The assumptions utilized in the calculation of the fair values include probability of success and the discount rates. Contingent consideration involves certain assumptions requiring significant judgment and actual results may differ from estimated amounts.
Stock-Based Compensation
The Company’s compensation programs include stock-based awards. For awards other than condition-based performance stock options, the fair values are recognized as compensation expense on a straight-line basis over the vesting period. For condition-based performance stock options, expense is recognized only when performance conditions are considered probable of being achieved and is recognized over the period from the grant date through the time the milestone is expected to be achieved. The related costs are recorded in cost of goods sold, research and development, and selling, general and administrative expense, as appropriate. The Company accounts for forfeitures as they occur. The Company accounts for stock issued in connection with business combinations based on the fair value of the Company’s common stock on the date of issuance.
Recent Accounting Pronouncements
The following are recent accounting pronouncements that the Company has not yet adopted:
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures. The amendments in this update expand annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. The new standard is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this update should be applied retrospectively to all periods presented. The Company is currently evaluating the impact this ASU may have on its financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which provides qualitative and quantitative updates to the rate reconciliation and income taxes paid disclosures, among others, in order to enhance the transparency of income tax disclosures, including consistent categories and greater disaggregation of information in the rate reconciliation and disaggregation by jurisdiction of income taxes paid. The new standard is effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted. The amendments in this ASU should be applied prospectively; however, retrospective application is also permitted. The Company is currently evaluating the impact this ASU may have on its financial statement disclosures.
The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the condensed consolidated financial statements as a result of future adoption.
- Revenue
The Company launched LOQTORZI in December 2023, YUSIMRY in July 2023 and CIMERLI in October 2022. Net revenue for sales of YUSIMRY and CIMERLI effectively ceased to be recognized in the Company’s condensed consolidated statements of operations on June 26, 2024 and March 1, 2024, respectively (see Note 6. Acquisition and Dispositions). All net product revenue was generated in the United States, and the Company’s net revenue was as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| (in thousands) | 2024 | | 2023 | | 2024 | 2023 | ||||||
| Products | | | | | | | | | | | | |
| UDENYCA | | $66,089 | | $32,967 | | $159,673 | | $90,875 | ||||
| CIMERLI | | | (1,215) | | | 40,037 | | | 26,979 | | | 72,939 |
| YUSIMRY | | | (152) | | | 1,360 | | | 7,508 | | | 1,360 |
| LOQTORZI | | | 5,832 | | | — | | | 11,609 | | | — |
| Total net product revenue | | | 70,554 | | | 74,364 | | | 205,769 | | | 165,174 |
| Other revenue | | 220 | | 204 | | 7,047 | | 546 | ||||
| Total net revenue | | $70,774 | | $74,568 | | $212,816 | | $165,720 | ||||
Gross product revenues by significant customer as a percentage of total gross product revenues were as follows:
| · · · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · Three Months Ended · · Nine Months Ended | |||||||
| · · September 30, · · September 30, · | |||||||
| · · 2024 · · 2023 · · · 2024 · · 2023 | |||||||
| McKesson Corporation | 45% | | 44% | | 41% | | 38% |
| Cencora (previously known as AmeriSource-Bergen Corporation) | 33% | | 41% | | 39% | | 45% |
| Cardinal Health, Inc. | 21% | | 13% | | 18% | | 15% |
Product Sales Discounts and Allowances
The total provision related to sales made in the prior period was $0.3 million and $1.1 million for the three months ended September 30, 2024 and 2023, respectively. Chargebacks and discounts for prompt payment are recorded as a reduction in trade receivables, and the remaining reserve balances are classified as current liabilities and other liabilities, non-current on the accompanying unaudited condensed consolidated balance sheets.
In connection with the Sale Transactions, the Company retained and will continue to be responsible for sales discounts and allowance liabilities incurred prior to March 1, 2024 for CIMERLI and June 26, 2024 for YUSIMRY. Sales discounts and allowances incurred on behalf of the respective counterparties following the close of the Sale Transactions in accordance with the Company’s Transition Services Agreement with Sandoz (the “CIMERLI TSA”) in March 2024 for CIMERLI and the Company’s Transition Services Agreement with HKF (the “YUSIMRY TSA” and, together with the CIMERLI TSA, collectively the “TSA”) in June 2024 for YUSIMRY are reflected within TSA receivables, net and TSA payables and other accrued liabilitiesin the unaudited condensed consolidated balance sheets and are excluded from the below table (see Note 6. Acquisition and Dispositions).
The activities and ending reserve balances for each significant category of discounts and allowances that constitute variable consideration were as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Nine Months Ended September 30, 2024 | ||||||||||||
| · Chargebacks · · · Other Fees, · · | ||||||||||||
| · · and Discounts · · · · · Co-pay · · · | ||||||||||||
| · · for Prompt · · · · · Assistance · · · | ||||||||||||
| (in thousands) · · Payment · · Rebates · · and Returns · · Total | ||||||||||||
| Balances at December 31, 2023 | | $73,953 | | $121,137 | | $49,795 | | $244,885 | ||||
| Provision related to sales made in: | | | | | | | | | | | | |
| Current period | | | 727,028 | | | 150,820 | | | 117,299 | | | 995,147 |
| Prior period - increase (decrease) | | | (969) | | | 6,343 | | | (1,010) | | | 4,364 |
| Payments and customer credits issued | | (747,070) | | | (159,737) | | | (121,332) | | | (1,028,139) | |
| Balances at September 30, 2024 | | $52,942 | | $118,563 | | $44,752 | | $216,257 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Nine Months Ended September 30, 2023 | ||||||||||||
| · Chargebacks · · · Other Fees, · · | ||||||||||||
| · · and Discounts · · · · · Co-pay · · · | ||||||||||||
| · · for Prompt · · · · · Assistance · · · | ||||||||||||
| (in thousands) · · Payment · · Rebates · · and Returns · · Total | ||||||||||||
| Balances at December 31, 2022 | | $42,677 | | $38,713 | | $19,113 | | $100,503 | ||||
| Provision related to sales made in: | | | | | | | | | | | | |
| Current period | | 387,238 | | | 83,009 | | | 69,362 | | | 539,609 | |
| Prior period - increase (decrease) | | | (1,375) | | | 1,540 | | | 4,469 | | | 4,634 |
| Payments and customer credits issued | | (379,076) | | (42,097) | | (55,681) | | (476,854) | ||||
| Balances at September 30, 2023 | | $49,464 | | $81,165 | | $37,263 | | $167,892 |
|---|
- Fair Value Measurements
The fair values of financial instruments are classified into one of the following categories based upon the lowest level of input that is significant to the fair value measurement:
| ● | Level 1 — Quoted prices in active markets for identical assets or liabilities. |
| ● | Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
| ● | Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The fair values of cash equivalents approximate their carrying values due to the short-term nature of such financial instruments.
Unrealized gains and losses on available-for-sale debt securities are reported as a component of accumulated comprehensive income (loss), with the exception of unrealized losses believed to be related to credit losses, if any, which are recognized in earnings in the period the impairment occurs. Impairment assessments are made at the individual security level each reporting period. When the fair value of an available-for-sale debt investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is related to a credit loss and, if it is, the portion of the impairment relating to credit loss is recorded as an allowance through net income. Realized gains and losses, if any, on available-for-sale securities are included in other income (expense), net, in the condensed consolidated statements of operations based on the specific identification method.
In connection with the acquisition (the “Surface Acquisition”) of Surface Oncology, Inc. (“Surface”) on September 8, 2023 (see Note 6. Acquisition and Dispositions), the Company recorded contingent consideration liabilities related to CVRs. The fair value of the CVR liabilities were determined using a Monte Carlo simulation-based model discounted to present value and represents a Level 3 measurement within the fair value hierarchy. Assumptions used in this calculation include estimated revenue, discount rate and various probability factors. If different assumptions were used for the various inputs, the estimated fair value could be significantly higher or lower than the fair value the Company determined. For example, increases in discount rates and the time to payment may result in lower fair value measurements. There is no assurance that any of the conditions for payment of the CVR liabilities will be met. During the three months ended March 31, 2024, the Company impaired its historical out-licensed partnership program with Novartis Institutes for Biomedical Research, Inc. (“Novartis Institutes”) (NZV930), which resulted in a net impairment charge of$6.8 million inselling, general and administrative expenses in the condensed consolidated statements of operations relating to the write-off of the net carrying value of the Novartis Institutes out-license intangible asset of$10.6 million and the final remeasurement of the CVR liability related to NZV930 of$3.8 million to its fair value ofzero. The remaining CVR liability associated with GSK of$0.5 million and other contingent consideration are recorded in other liabilities, non-current on the condensed consolidated balance sheets at September 30, 2024.
On May 8, 2024, the Company recognized the Royalty Fee Derivative Liability which was estimated to be $9.2 million in connection with the Revenue Purchase and Sale Agreement (see Note 8. Financial Liabilities), which is recorded in accrued and other current liabilities on the condensed consolidated balance sheets. To estimate the fair value, the Company uses Monte Carlo simulation models that require the use of Level 3 unobservable inputs, primarily the amount and timing of our expected future revenue, the estimated volatility of these revenues, the discount rate corresponding
to the risk of revenue, and the probability of certain events. At September 30, 2024, the estimated fair value of the Royalty Fee Derivative Liability remained unchanged at $9.2 million.
Financial liabilities related to long-term debt obligations are summarized in Note 8. Financial Liabilities. Other financial liabilities and financial assets measured at fair value on a recurring basis are summarized as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurements | ||||||||||||
| · · September 30, 2024 | ||||||||||||
| (in thousands) · Level 1 · Level 2 · Level 3 · Total | ||||||||||||
| Financial Assets: · · · · · | ||||||||||||
| Cash equivalents(1) | | $69,070 | $— | $— | $69,070 | |||||||
| Total | | $69,070 | | $— | | $— | | $69,070 | ||||
| Financial Liabilities: | | | | | | |||||||
| Royalty Fee Derivative Liability | | $— | | $— | | $9,202 | | $9,202 | ||||
| Contingent consideration | | | — | | | — | | | 632 | | | 632 |
| Total | | $— | | $— | | $9,834 | | $9,834 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Fair Value Measurements | ||||||||||||
| · · December 31, 2023 | ||||||||||||
| (in thousands) · Level 1 · Level 2 · Level 3 · Total | ||||||||||||
| Financial Assets: · · · · · | ||||||||||||
| Cash equivalents(1) | | $88,460 | | $998 | | $— | | $89,458 | ||||
| Marketable debt securities: | | | | | | | | | ||||
| U.S. government agency securities | | | 5,195 | | | — | | | — | | | 5,195 |
| U.S. treasury securities | | | 2,993 | | | — | | | — | | | 2,993 |
| Commercial paper and corporate notes | | | — | | | 6,669 | | | — | | | 6,669 |
| Prepaid financial instrument in Prepaid manufacturing(2) | | | — | | | — | | | 625 | | | 625 |
| Total | | $96,648 | | $7,667 | | $625 | | $104,940 | ||||
| Financial Liabilities: | | | | | | | | | | | | |
| Contingent consideration | | $— | | $— | | $4,472 | | $4,472 | ||||
| (1) | Cash equivalents consist of money market funds, U.S treasury securities and commercial paper and corporate notes with original maturities of 90 days or less. |
The cost, unrealized gains or losses, and fair value by investment type are summarized as follows:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · September 30, 2024 | ||||||||
| (in thousands) · Cost · Unrealized Gain · Unrealized (Loss) · Fair Value | ||||||||
| Money market funds | | $69,070 | | $— | | $— | | $69,070 |
| Total | | $69,070 | $— | | $— | | $69,070 | |
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | ||||||||||||
| (in thousands) · Cost · Unrealized Gain · Unrealized (Loss) · Fair Value | ||||||||||||
| Money market funds | | $79,484 | | $— | | $— | | $79,484 | ||||
| U.S. government agency securities | | | 5,200 | | — | | | (5) | | | 5,195 | |
| U.S. treasury securities | | | 11,967 | | | 2 | | | — | | | 11,969 |
| Commercial paper and corporate notes | | | 7,673 | | | — | | | (6) | | | 7,667 |
| Total | | $104,324 | $2 | | $(11) | | $104,315 | |||||
- Inventory
Inventory consisted of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · September 30, · · December 31, | ||||
| (in thousands) | | 2024 | | 2023 |
| Raw materials | | $13,735 | | $12,975 |
| Work in process | | 102,989 | | 82,588 |
| Finished goods | | 2,291 | | 34,537 |
| Total | | $119,015 | | $130,100 |
Inventory as of December 31, 2023 included $16.4 million related to the CIMERLI ophthalmology franchise and $17.0 million related to the YUSIMRY immunology franchise (see Note 6. Acquisition and Dispositions). Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. The determination of excess or obsolete inventory requires judgment including consideration of many factors, such as estimates of future product demand, current and future market conditions, product expiration information, and potential product obsolescence, among others. During the year ended December 31, 2023, the Company recorded a $47.0 million charge for the write-down of slow moving YUSIMRY inventory, which included the recognition of $20.5 million in certain firm purchase commitments. Of this charge, $11.5 million was reflected in accrued and other current liabilities and $9.0 million in other liabilities, non-current as of December 31, 2023. Liabilities for firm inventory purchase commitments related to YUSIMRY were derecognized upon the YUSIMRY Sale.
Inventory expected to be sold more than twelve months from the balance sheet date is classified as inventory, non-current on the condensed consolidated balance sheets. As of September 30, 2024 and December 31, 2023, the non-current portion of inventory consisted of raw materials and work in process, as well as a portion of finished goods at December 31, 2023. The following table presents the inventory balance sheet classifications:
| · · · · · · | ||||
|---|---|---|---|---|
| · September 30, · · December 31, | ||||
| (in thousands) | | 2024 | | 2023 |
| Inventory | | $47,640 | | $62,605 |
| Inventory, non-current | | 71,375 | | 67,495 |
| Total | | $119,015 | | $130,100 |
Prepaid manufacturing of $10.7 million as of September 30, 2024 includes prepayments of $6.5 million to CMOs for manufacturing services, which the Company expects to be converted into inventory within the next twelve months, and prepayments of $4.2 million to various CMOs for research and development pipeline programs. Prepaid manufacturing of $23.7 million as of December 31, 2023 included prepayments of $11.1 million to various CMOs for research and development pipeline programs and $12.6 million to CMOs for manufacturing services, of which $6.4 million related to the CIMERLI ophthalmology franchise and $0.5 million related to the YUSIMRY immunology franchise (see Note 6. Acquisition and Dispositions).
- Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · September 30, · · December 31, | ||||||
| (in thousands) · · 2024 · 2023 | ||||||
| Machinery and equipment | | $13,161 | | $13,124 | ||
| Computer equipment and software | | 3,566 | | 3,546 | ||
| Furniture and fixtures | | 1,055 | | 1,055 | ||
| Leasehold improvements | | 5,751 | | 5,751 | ||
| Finance lease right of use assets | | | — | | | 2,294 |
| Total property and equipment | | 23,533 | | 25,770 | ||
| Accumulated depreciation and amortization | | (20,622) | | (20,651) | ||
| Property and equipment, net | | $2,911 | | $5,119 | ||
Depreciation and amortization expense related to property and equipment, net was $0.4 million and $1.5 million for the three and nine months ended September 30, 2024, respectively, and $0.8 million and $2.5 million for the three and nine months ended September 30, 2023, respectively.
As of September 30, 2024 and December 31, 2023, the net book value of software implementation costs related to hosting arrangements was$2.3 million and$3.2 million, respectively, and the amortization expense was immaterial for all periods presented.
Intangible Assets, Net
Intangible assets, net consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · September 30, · · December 31, | ||||||
| (in thousands) · · 2024 · 2023 | ||||||
| Finite-lived assets, net of accumulated amortization of $2,052 and $639, as of September 30, 2024 and December 31, 2023, respectively | | $25,454 | | $41,871 | ||
| Indefinite-lived assets - in-process research and development | | | 28,859 | | | 28,859 |
| Goodwill | | — | | 943 | ||
| Total Intangible assets, net | | $54,313 | | $71,673 | ||
Amortization expense related to finite-lived intangible assets was $1.2 million and $2.8 million in the three and nine months ended September 30, 2024, respectively, and immaterial for the three and nine months ended September 30, 2023. In connection with the CIMERLI Sale on March 1, 2024, a finite-lived asset, net of $2.1 million and goodwill of $0.9 million were derecognized. In connection with the YUSIMRY Sale on June 26, 2024, a finite-lived asset with a net value of $0.9 million was derecognized.
The exclusive license of NZV930 to Novartis Institutes, acquired as part of the Surface Acquisition, was terminated by Novartis Institutes with an effective date of October 2, 2024. As a result, the Company recognized an impairment charge of $10.6 million for the carrying value of the Novartis Institutes out-license during the three months ended March 31, 2024, which was classified within selling, general and administrative expense in the condensed consolidated statements of operations.
Amortization expense for the remaining finite-lived assets for each of the five succeeding fiscal years is expected to be $2.7 million.
Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · September 30, · December 31, | ||||||
| (in thousands) · · 2024 · · 2023 | ||||||
| Accrued commercial and research and development manufacturing | | $19,729 | | $23,470 | ||
| Accrued co-development costs and milestone payments | | | 12,500 | | | 26,812 |
| Accrued royalties | | | 1,199 | | | 42,031 |
| Royalty Fee Derivative Liability (Note 8) | | | 9,202 | | | — |
| Revenue participation liability, current (Note 8) | | | 2,180 | | | — |
| Accrued other | | 14,526 | | 7,628 | ||
| Lease liabilities, current | | | 1,629 | | | 2,145 |
| Contingent consideration, current | | | — | | | 3,300 |
| Total Accrued and other current liabilities | | $60,965 | | $105,386 | ||
Other Liabilities, Non-current
Other liabilities, non-current consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · September 30, · December 31, | ||||||
| (in thousands) · · 2024 · · 2023 | ||||||
| Contingent consideration, non-current | | $632 | | $1,172 | ||
| Deferred tax liability | | | 1,102 | | | 1,102 |
| Revenue participation liability, non-current (Note 8) | | | 27,427 | | | — |
| Other | | | — | | | 10,287 |
| Total Other liabilities, non-current | | $29,161 | | $12,561 | ||
- Acquisition and Dispositions
2024 Dispositions
YUSIMRY Sale
On June 26, 2024, the Company completed the sale of its YUSIMRY immunology franchise which comprised certain assets, including certain YUSIMRY intellectual property, contracts, YUSIMRY inventory, and all activities related to research and development of YUSIMRY. In exchange, HKF paid upfront cash consideration of $40.0 million and assumed certain liabilities, including $17.0 million of inventory purchase commitments. During the second quarter of 2024, the Company recognized a net gain on the YUSIMRY Sale of $22.9 million, which included the cash receipts of $40.0 million less net assets transferred to HKF or otherwise derecognized and transaction costs of $1.0 million. At September 30, 2024, unpaid transaction costs totaled $0.8 million. The pretax profit (loss) related to the YUSIMRY immunology franchise prior to the YUSIMRY Sale, which excludes any corporate overhead allocations, was $(0.2) million and $1.3 million during the three and nine months ended September 30, 2024, respectively, and $(2.0) million and $(12.1) million during the three and nine months ended September 30, 2023, respectively.
In connection with the YUSIMRY Sale, the Company and HKF entered into the YUSIMRY TSA, pursuant to which the Company is providing certain business support services on behalf of HKF including billings, collections, and the remittance of rebates, to ensure business continuity for patients and customers for a period not expected to extend beyond December 31, 2024. Under the YUSIMRY TSA, the Company is entitled to be reimbursed for its costs which were $0.5 million for thethree and nine months ended September 30, 2024. As of September 30, 2024, assets of $3.4 million and liabilities of $3.2 million related to transactions entered into on behalf of HKF in accordance with the YUSIMRY TSA were presented in TSA receivables, net and TSA payables and other accrued liabilities, respectively, in the condensed consolidated balance sheets.
CIMERLI Sale
On March 1, 2024, the Company completed the sale of its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology, to Sandoz for upfront, all-cash consideration of$170.0 million plus an additional$17.8 million for CIMERLI product inventory and prepaid manufacturing assets. During the first quarter of 2024, the Company recognized a net gain on the CIMERLI Sale of$153.6 million, which includes the cash receipts of$187.8 million less assets transferred to Sandoz, assets derecognized, transaction costs of$7.2 million, and other related employee transition expenses. As of September 30, 2024, unpaid commitments for retention bonuses totaled$4.7 million. The pretax profit (loss) related to the CIMERLI ophthalmology franchise prior to the CIMERLI Sale, which excludes any corporate overhead allocations, was$(1.2) million and$6.2 million during the three and nine months ended September 30, 2024, respectively, and$6.9 million and$5.7 million during the three and nine months ended September 30, 2023, respectively.
In connection with the CIMERLI Sale, the Company and Sandoz entered into the CIMERLI TSA, pursuant to which the Company is providing certain business support services on behalf of Sandoz including billings, collections, and the remittance of rebates, to ensure business continuity for patients and customers for a period not expected to extend beyond December 31, 2024. Under the CIMERLI TSA, the Company is entitled to be reimbursed for its costs and has recorded income of$0.5 million and$1.6 million for the three and nine months ended September 30, 2024 in other income (expense), net in the condensed consolidated statements of operations. As of September 30, 2024, assets related to transactions entered into on behalf of Sandoz in accordance with the CIMERLI TSA of $27.8 million were presented in TSA receivables, net and liabilities related to transactions entered into on behalf of Sandoz in accordance with the CIMERLI TSA of $30.4 million were presented in TSA payables and other accrued liabilities in the condensed consolidated balance sheet.
2023 Acquisition
Surface Acquisition
On September 8, 2023 (the “Acquisition Date”), in accordance with an Agreement and Plan of Merger dated June 15, 2023 (the “Merger Agreement”) by and among the Company, Crimson Merger Sub I, Inc. (“Merger Sub I”), Crimson Merger Sub II, LLC (“Merger Sub II,” and together with Merger Sub I, the “Merger Subs”), and Surface, the Company completed the Surface Acquisition. The Surface Acquisition expanded the Company’s I-O pipeline with the following: casdozokitug (CHS-388, formerly SRF388), an investigational, novel IL-27-targeted antibody currently being evaluated in a Phase 2 clinical trial in HCC, and CHS-114 (formerly SRF114), an investigational, CCR8-targeted antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors and head and neck squamous cell carcinoma (“HSNSCC”).
On the Acquisition Date, and in accordance with the Merger Agreement, the Company issued to the holders of all outstanding Surface common stock (subject to certain exceptions)0.1960 shares of Coherus common stock in exchange for each share of outstanding Surface common stock and certain outstanding Surface employee equity awards. The exchange ratio was calculated pursuant to the terms of the Merger Agreement and was based on a$5.2831 per share price of Coherus common stock and a nominal total amount of cash in lieu of fractional shares. Surface shareholders also
receivedone CVR for each share of Surface common stock and employee equity award converted. Each CVR entitles the holder to receive quarterly contingent payments in the form of cash, stock or a combination of cash and stock at the Company’s discretion during the 10-year period following September 8, 2023, for the sum of the following, less any permitted deductions (in accordance with the Contingent Value Rights Agreement, dated September 8, 2023, by and among the Company and Computershare Inc. and its affiliate Computershare Trust Company, N.A., together, as the rights agent thereunder (the “CVR Agreement”)):
| ● | 70% of all milestone- and royalty-based payments actually received by the Company or its affiliates from GSK under a license agreement with GSK, dated December 16, 2020, which was subsequently amended in August 2021 (as amended, the “GSK Agreement”) related to the existing program (GSK4381562); |
| ● | 25% of any upfront payment actually received by the Company or its affiliates pursuant to potential ex-U.S. licensing agreements for CHS-114; and |
| ● | 50% of any upfront payment actually received by the Company or its affiliates pursuant to potential ex-U.S. licensing agreements for casdozokitug. |
The Company has recorded a contingent consideration liability for the fair value of the potential payments under the CVR Agreement described above. The Company is unable to estimate a range of outcomes for potential royalty and milestone payments for CHS-114 and casdozokitug.
The following table below sets forth the purchase price allocation to the estimated fair value of the net assets acquired:
| | | | |
|---|---|---|---|
| (in thousands) · · Amounts Recognized at Acquisition Date | |||
| Assets Acquired | | | |
| Cash and cash equivalents | | $6,997 | |
| Investments in marketable securities | | | 21,791 |
| Prepaids and other assets | | | 5,260 |
| In-process research and development | | | 26,239 |
| Out-licenses | | | 13,530 |
| Total assets | | $73,817 | |
| Liabilities Assumed | | | |
| Accrued and other current liabilities | | $7,722 | |
| Deferred tax liability | | | 1,499 |
| Total liabilities | | | 9,221 |
| Total net assets acquired | | $64,596 | |
The Company believes that, even after reassessing its identification of all assets acquired and liabilities assumed, it was able to acquire Surface for a price that was completely allocable to identifiable assets acquired and liabilities assumed withno residual attributable to goodwill primarily due to Surface’s need to raise additional capital to finance its operations, the challenging biotech funding environment at the time the transaction was initially announced, and the value of the acquired net assets.
The amounts allocated to identifiable intangible assets was as follows:
| | | | | | |
|---|---|---|---|---|---|
| (in thousands) · · Useful lives · · Fair Value at Acquisition Date | |||||
| In-process research and development - casdozokitug | | n/a | | $25,899 | |
| In-process research and development - CHS-114 | | n/a | | | 340 |
| Out-license - GSK | | 15 years | | | 2,506 |
| Out-license - Novartis Institutes | | 15 years | | | 11,024 |
| Total identifiable intangible assets | | | | $39,769 | |
The out-license intangible assets represent potential milestone and royalty-based payments to be received undertwo out-licensed partnership programs to advance certain next-generation cancer therapies, Novartis Institutes (NZV930) and GSK (GSK4381562). Surface shareholders received CVRs for certain percentages of these milestone and royalty-based payments, as further explained above. The exclusive license of NZV930 to Novartis Institutes was terminated by Novartis Institutes with an effective date of October 2, 2024. As a result, during the first quarter of 2024, the Company recognized a net impairment charge of $6.8 million inselling, general and administrative expenses in the condensed consolidated statements of operations relating to the write-off of the net carrying value of the Novartis Institutes out-license intangible asset of $10.6 million and the final remeasurement of the CVR liability related to NZV930 of $3.8 million to its fair value ofzero.
Unaudited Pro Forma Summary of Operations
The following table shows the unaudited pro forma summary of operations for the three and nine months ended September 30, 2023, as if the Surface Acquisition had occurred on January 1, 2022. This pro forma information does not purport to represent what the Company’s actual results would have been if the acquisition had occurred as of January 1, 2022, and it is not indicative of what such results would be expected for any future period:
| · · · · · · | ||||
|---|---|---|---|---|
| | | Three Months Ended | | Nine Months Ended |
| (in thousands) | | September 30, 2023 | | September 30, 2023 |
| Total revenues | | $74,568 | | $165,720 |
| Net loss | | $(49,984) | | $(204,922) |
Acquisition-related costs of$2.6 million and$4.5 million were recorded inselling, general and administrative expense in the condensed consolidated statement of operations during the three and nine months ended September 30, 2023, respectively.
- Collaborations and Other Arrangements
In-Licensing Agreements
Junshi Biosciences
On February 1, 2021, the Company entered into an Exclusive License and Commercialization Agreement (the “Collaboration Agreement”) with Junshi Biosciences for the co-development and commercialization of LOQTORZI, Junshi Biosciences’ anti-PD-1 antibody, in the United States and Canada.
Under the terms of the Collaboration Agreement, the Company paid $150.0 million upfront for exclusive rights to LOQTORZI in the United States and Canada, an option in these territories to Junshi Biosciences’ anti-TIGIT antibody CHS-006, an option in these territories to a next-generation engineered IL-2 cytokine, and certain negotiation rights totwo
undisclosed preclinical immuno-oncology drug candidates. The Company is obligated to pay Junshi Biosciences a 20% royalty on net sales of LOQTORZI and up to an aggregate $380.0 million in one-time payments for the achievement of various regulatory and sales milestones.
In March 2022, the Company paid $35.0 million for the exercise of its option to license CHS-006. Subsequent joint development consistent with the Collaboration Agreement commenced. On January 10, 2024, the Company announced that it had delivered a notice of termination of the TIGIT program CHS-006 described in the Collaboration Agreement (the “TIGIT Program”) to Junshi Biosciences. The Company plans to continue to wind down work with Junshi Biosciences on the TIGIT Program pursuant to the termination. If the Company exercises its remaining option for the IL-2 cytokine, it will be obligated to pay an additional option exercise fee of $35.0 million and an 18% royalty on net sales, up to $85.0 million for the achievement of certain regulatory approvals, and up to $170.0 million for the attainment of certain sales thresholds. Under the Collaboration Agreement, the Company retains the right to collaborate in the development of LOQTORZI and the other licensed compounds, and will pay for a portion of these co-development activities up to a maximum of $25.0 million per licensed compound per year. Additionally, the Company is responsible for certain associated regulatory and technology transfer costs for LOQTORZI and other licensed compounds and will reimburse Junshi Biosciences for such costs.
In March 2024, the Company entered into an Amendment No. 2 to the Collaboration Agreement (the “2 nd Amendment”) with Junshi Biosciences to revise the timing of the$25.0 million milestone payment to Junshi Biosciences that became due in connection with the approval by the FDA of toripalimab for the treatment of patients with NPC in the first quarter of 2024. Under the terms of the 2 nd Amendment, the$25.0 million milestone payment was split into two installments of$12.5 million each, one that was paid in the second quarter of 2024 and one due in the first quarter of 2025.
The licensing transaction and the exercise of the option were accounted for as asset acquisitions under the relevant accounting rules. There wasno material research and development expense recognized for obligations to Junshi Biosciences for the three months ended September 30, 2024. During the nine months ended September 30, 2024, the Company recognized a reduction in research and development expenses for the release of certain liabilities of $4.8 million pursuant to the 2 nd Amendment with Junshi Biosciences. Research and development expenses were $3.1 million and $7.7 million for the three and nine months ended September 30, 2023, respectively. In the condensed consolidated balance sheets as of September 30, 2024, the Company has classified $12.5 million in accrued and other current liabilities related to a milestone payment in connection with the 2 nd Amendment and $0.4 million in accounts payable related to the co-development, regulatory and technology transfer costs related to these programs.
The accrued royalty obligation to Junshi Biosciences was$1.1 million as of September 30, 2024 and immaterial at December 31, 2023. The additional milestone payments, option fee for the IL-2 cytokine and royalties are contingent upon future events and, therefore, will be recorded if and when it becomes probable that a milestone will be achieved, or when an option fee or royalties are incurred.
Apotex
On June 27, 2024, the Company entered into an exclusive license and distribution agreement (the “Canada License Agreement”) with Apotex, Inc. (“Apotex”), pursuant to which, the Company granted to Apotex an exclusive license under the Company’s rights to toripalimab to commercialize toripalimab within Canada. Pursuant to the Canada License Agreement, Apotex paid the Company an upfront payment of$6.3 million United States Dollars (“USD”) which has been classified as net revenue in the condensed consolidated statements of operations for the nine months ended September 30, 2024. In addition, Apotex agreed to pay the Company up to an aggregate of$51.5 million Canadian Dollars (“CAD”) in milestone payments in connection with the achievement of certain regulatory and sales milestones with respect to toripalimab in Canada. Lastly, Apotex agreed to pay the Company a low double-digit percentage of any future net sales of toripalimab in Canada that the Company will subsequently pay to Junshi Biosciences pursuant to the Collaboration Agreement.
The Canada License Agreement term continues until the tenth year after the first commercial sales of toripalimab in Canada, subject to an extension for a subsequentten-year term at the option of Apotex. Apotex may terminate the License Agreement for any reason after a specified notice period. The License Agreement will terminate automatically if the rights granted to the Company by the Collaboration Agreement are terminated, if there is material breach that is not cured, if there are certain challenges to licensed patents by Apotex and in the case of certain insolvency events.
Bioeq
On November 4, 2019, the Company entered into a license agreement (the “Bioeq License Agreement”) with Bioeq AG (“Bioeq”) for the commercialization of CIMERLI, a biosimilar version of Lucentis (ranibizumab), in certain dosage forms in both a vial and pre-filled syringe presentation (the “Bioeq Licensed Products”). Under the Bioeq License Agreement, Bioeq granted to the Company an exclusive, royalty-bearing license to commercialize the Bioeq Licensed Products in the field of ophthalmology (and any other approved labelled indication) in the United States.
Royalties due to Bioeq were $38.4 million as of December 31, 2023.
On January 19, 2024 the Company entered into the CIMERLI Purchase Agreement with Sandoz. Pursuant to the CIMERLI Purchase Agreement, on March 1, 2024, the Company completed the divestiture of its CIMERLI ophthalmology franchise through the sale of its subsidiary, Coherus Ophthalmology, for upfront, all-cash consideration of $170.0 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets. Refer to Note 6. Acquisition and Dispositions for additional information. Upon closing of the CIMERLI Sale, the Bioeq License Agreement was assumed by Sandoz. Refer to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed on March 15, 2024 for additional information related to the Bioeq License Agreement.
Adimab Development and Option Agreement
In October 2018, Surface and Adimab LLC (“Adimab”), entered into an amended and restated development and option agreement, (as amended by the amendments dated as of December 16, 2020, June 1, 2022 and July 18, 2022, the “A&R Adimab Agreement”), which amended and restated the development and option agreement with Adimab dated July 2014, as amended, (“the Original Adimab Agreement”), for the discovery and optimization of proprietary antibodies as potential therapeutic product candidates. Under the A&R Adimab Agreement, the Company will select biological targets against which Adimab will use its proprietary platform technology to research and develop antibody proteins using a mutually agreed upon research plan.
Adimab granted the Company an exclusive option to obtain a non-exclusive, worldwide, fully paid-up, sublicensable license under Adimab’s platform patents and other Adimab technology solely to research up toten antibodies, chosen by the Company against a specific biological target for a specified period of time (the “Research Option”). In addition, Adimab granted the Company an exclusive option to obtain a worldwide, royalty-bearing, sublicensable license under Adimab platform patents and other Adimab technology to exploit, including commercially,20 or more antibodies against specific biological targets (the “Commercialization Option”). Upon the exercise of a Commercialization Option, and payment of the applicable option fee to Adimab, Adimab will assign the Company the patents that cover the antibodies selected by such Commercialization Option. The Company will be required to use commercially reasonable efforts to develop, seek market approval of, and commercialize at leastone antibody against the target covered by the Commercialization Option in specified markets upon the exercise of a Commercialization Option.
Under the A&R Adimab Agreement, the Company is obligated to make milestone payments and to pay specified fees upon the exercise of the Research Option or Commercialization Option. During the discovery term, the Company may be obligated to pay Adimab up to $0.3 million for technical milestones achieved against each biological target. Upon exercise of a Research Option, the Company is obligated to pay a nominal research maintenance fee on each of the next four anniversaries of the exercise. Upon the exercise of each Commercialization Option, the Company will be required
to pay an option exercise fee of a low seven-digit dollar amount, and the Company may be responsible for milestone payments of up to an aggregate of $13.0 million for each licensed product that receives marketing approval. For any licensed product that is commercialized, the Company is obligated to pay Adimab tiered royalties of a low to mid single-digit percentage on worldwide net sales of such product. The Company may also partially exercise a Commercialization Option with respect toten antibodies against a biological target by paying 65% of the option fee and later either (i) paying the balance and choosing additional antibodies for commercialization, up to the maximum number under the Commercialization Option, or (ii) foregoing the Commercialization Option entirely. For any Adimab diagnostic product that is used with or in connection with any compound or product other than a licensed antibody or licensed product, the Company is obligated to pay Adimab up to a low seven digits in regulatory milestone payments and low single-digit royalties on net sales.
Vaccinex License Agreement
On March 23, 2021, Surface and Vaccinex, Inc. (“Vaccinex”) entered into an exclusive product license agreement (the ”Vaccinex License Agreement”) which provides the Company a worldwide, exclusive, sublicensable license to make, have made, use, sell, offer to sell, have sold, import, and otherwise exploit licensed products that incorporate certain Vaccinex intellectual property which covers certain antibodies (each, a “Vaccinex Licensed Products”), including the antibody CHS-114 targeting CCR8. Under the Vaccinex License Agreement, the Company is obligated to use commercially reasonable efforts to develop, clinically test, achieve regulatory approval, manufacture, market and commercialize at least one Vaccinex Licensed Product.
The Company is responsible for all costs and expenses of such development, manufacturing and commercialization. Vaccinex is eligible to receive up to an aggregate of $3.5 million based on achievement of certain clinical milestones, up to an aggregate of $11.5 million based on achievement of certain regulatory milestones per Vaccinex Licensed Product, and low single digit royalties on global net sales of any approved licensed products.
The Company may terminate the Vaccinex License Agreement for convenience upon the notice period specified in the Vaccinex License Agreement. Either party may terminate the agreement for an uncured material breach by the other party. Vaccinex may terminate the Vaccinex License Agreement if we default on any payments owed to Vaccinex under the agreement, if the Company is in material breach of, and fails to cure, its development obligations, or institute certain actions related to the licensed patents. In the event of termination, all rights in the licensed intellectual property would revert to Vaccinex.
Out-Licensing Agreements Acquired as part of the Surface Acquisition
On September 8, 2023, at the closing of the Surface Acquisition, all the assets, liabilities, rights and obligations of Surface were assumed by the Company’s direct, wholly-owned subsidiary, Surface Oncology, LLC. See further details in Note 6. Acquisition and Dispositions.
GSK Agreement
In December 2020, Surface entered into the GSK Agreement. Pursuant to the GSK Agreement, Surface granted GSK a worldwide exclusive, sublicensable license to develop, manufacture and commercialize antibodies that target CD112R, also known as PVRIG, including the antibody GSK4381562 (the “Licensed Antibodies”). GSK is responsible for the development, manufacturing and commercialization of the Licensed Antibodies and a joint development committee was formed to facilitate information sharing. GSK is responsible for all costs and expenses of such development, manufacturing and commercialization and is obligated to provide the Company with updates on its development, manufacturing and commercialization activities through the joint development committee. In March 2022, Surface earned a$30.0 million milestone payment from GSK upon the dosing of the first patient in the Phase 1 trial of GSK4381562. The Company is eligible to receive up to$60.0 million in additional clinical milestones and$155.0 million in regulatory milestones. In addition, the Company may receive up to$485.0 million in sales milestone payments. The Company is also eligible to receive royalties on global net sales of any approved products based on the Licensed
Antibodies, ranging in percentages from high single digits to mid-teens. Due to the uncertainty of pharmaceutical development and the historical failure rates generally associated with drug development, the Company may not receive any milestone payments or any royalty payments under the GSK Agreement. The Company did not recognize license-related revenue under the GSK Agreement during the three and nine months ended September 30, 2024.
Unless terminated earlier, the GSK Agreement expires on a licensed product-by-licensed product and country-by-country basis on the later often years from the date of first commercial sale or when there is no longer a valid patent claim or regulatory exclusivity covering such licensed product in such country. Either party may terminate the GSK Agreement for an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. GSK may terminate the GSK Agreement for its convenience. The Company may terminate the GSK Agreement if GSK institutes certain actions related to the licensed patents or if GSK ceases development activities, other than for certain specified technical or safety reasons. In the event of termination, the Company would regain worldwide rights to the terminated program.
- Financial Liabilities
A summary of the Company’s debt obligations, including level within the fair value hierarchy (see Note 3. Fair Value Measurements), is as follows:
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | At September 30, 2024 | ||||||||||||
| (in thousands) · PrincipalAmount · · · Unamortized Debt Discount and Debt Issuance Costs · · NetCarrying Value · · EstimatedFair Value · Level | |||||||||||||
| Financial Liabilities: · · · · · · · · | |||||||||||||
| 2029 Term Loan | $38,660 | | $(2,042) | | $36,618 | | $36,618 | | Level 2* | ||||
| 2026 Convertible Notes | $230,000 | | $(2,109) | | $227,891 | | $180,550 | | Level 2** | ||||
| | | | | | | | | | | | | | |
| | At December 31, 2023 | ||||||||||||
| Financial Liabilities: | | | | | | | | ||||||
| 2027 Term Loans | $250,000 | | $(3,519) | | $246,481 | | $246,481 | | Level 2* | ||||
| 2026 Convertible Notes | $230,000 | | $(3,112) | | $226,888 | | $150,155 | | Level 2** | ||||
| * | The principal amounts outstanding are subject to variable interest rates based on three-month SOFR plus fixed percentages. Therefore, the Company believes the carrying amount of these obligations approximate their fair values. |
|---|
| ** | The fair value is influenced by interest rates, the Company’s stock price and stock price volatility and is determined by prices observed in market trading. Since the market for trading of the 2026 Convertible Notes is not considered to be an active market, the estimated fair value is based on Level 2 inputs. |
|---|
2029 Term Loan
On May 8, 2024 (the “2029 Term Loan Effective Date”), the Company entered into a senior secured term loan facility of up to $38.7 million (the “2029 Term Loan”) that was fully funded on the 2029 Term Loan Effective Date with Ankura Trust Company, LLC, as administrative agent (in such capacity, the “Agent”), and the lenders signatory thereto (collectively, the “2029 Lenders”). The net proceeds of$37.5 million, net of the original issuance discount, were used by the Company to help repay in full the existing outstanding indebtedness owed by the Company to BioPharma Credit, PLC (“BioPharma”), BPCR Limited Partnership (as a “2027 Lender”), and Biopharma Credit Investments V (Master) LP, acting by its general partner, BioPharma Credit Investments V GP LLC (as a “2027 Lender”) pursuant to the 2027 Term Loans.
The 2029 Term Loan is governed by a loan agreement, dated as of the 2029 Term Loan Effective Date, by and among the Company, the Agent and the 2029 Lenders (the “2029 Loan Agreement”). The 2029 Term Loan will mature
on May 8, 2029. The amount borrowed under the 2029 Term Loan accrues interest equal to 8.0% per annum, plus a three-month SOFR rate (the “Interest Rate”). The 2029 Term Loan provides for interest-only payments on a quarterly basis until maturity. The Company may prepay the 2029 Term Loan in full or in part provided the Company(i) provides at least three (3) business days’ prior written notice to the Agent, (ii) pays on the date of such prepayment (A) all outstanding principal to be prepaid plus accrued and unpaid interest, (B) a prepayment fee of (x)10.0% of the 2029 Term Loans so prepaid if paid on or after the first anniversary of the 2029 Term Loan Effective Date and before the second anniversary of the 2029 Term Loan Effective Date; (y)5.0% of the 2029 Term Loan so prepaid if paid after the second anniversary of the 2029 Term Loan Effective Date and on or before the third anniversary of the 2029 Term Loan Effective Date; and (z)0% of the 2029 Term Loan so prepaid if paid after the third anniversary of the 2029 Term Loan Effective Date, (C) if paid before the first anniversary of the 2029 Term Loan Effective Date, a make-whole amount equal to the interest that would have accrued from the date of prepayment through the first anniversary of the 2029 Term Loan Effective Date, and (D) all other sums, if any, that shall become due and payable under the 2029 Loan Agreement, including interest at the default rate with respect to any past due amounts. Amounts outstanding during an event of default shall accrue interest at an additional rate of 4.0% per annum, which interest shall be payable on demand in cash.
The 2029 Term Loan is secured by a lien on substantially all the assets of the Company, including intellectual property, subject to customary exclusions and exceptions. The 2029 Loan Agreement contains customary representations and warranties, covenants and events of default, including a financial covenant commencing on the 2029 Term Loan Effective Date, which requires the Company to maintain certain levels of cash and cash equivalents. As of September 30, 2024, the Company was in full compliance with these covenants, and there wereno events of default under the 2029 Term Loan.
The Company incurred $2.2 million of debt discount and issuance costs relating to the issuance of the 2029 Term Loan, which were recorded as a reduction to the carrying value of the 2029 Term Loan on the condensed consolidated balance sheets. The debt issuance costs are being amortized and recognized as additional interest expense over thefive-year contractual term of the 2029 Term Loan using the effective interest rate method.
The Company adopted the prospective method to account for future cash payments. Under the prospective method, the effective interest rate is not constant, and any change in the expected cash flows is recognized prospectively as an adjustment to the effective yield.
The following table presents the components of interest expense related to the 2029 Term Loan:
| | | | | | | |
|---|---|---|---|---|---|---|
| · Three Months Ended · · Nine Months Ended | ||||||
| · · September 30, 2024 · · September 30, 2024 | ||||||
| Contractual interest | | $1,316 | | $2,074 | ||
| Amortization of debt discount and debt issuance costs | | | 77 | | | 120 |
| Total interest expense | | $1,393 | | $2,194 | ||
As of September 30, 2024, the total remaining unamortized debt discount and debt offering costs of $2.0 million will be amortized using the effective interest rate over the remaining term of 4.6 years.
Assuming the third quarter of 2024 interest rate of 13.3%, future payments on the 2029 Term Loan as of September 30, 2024 are as follows:
| | | | |
|---|---|---|---|
| Year ending December 31, (in thousands) | | | |
| Remainder of 2024 - interest only | | $1,316 | |
| 2025 - interest only | | 5,221 | |
| 2026 - interest only | | 5,222 | |
| 2027 - interest only | | | 5,222 |
| 2028 and thereafter - principal and interest | | | 45,712 |
| Total minimum payments | | | 62,693 |
| Less amount representing interest | | (24,033) | |
| 2029 Term Loan, gross | | 38,660 | |
| Less unamortized debt discount and debt issuance costs | | (2,042) | |
| Net carrying amount of 2029 Term Loan | | $36,618 |
Revenue Purchase and Sale Agreement** **
On May 8, 2024, concurrent with the 2029 Term Loan, the Company entered into a revenue participation right purchase and sale agreement (the “Revenue Purchase and Sale Agreement”) with Coduet Royalty Holdings, LLC, as administrative agent and each buyer named in an annex thereto (collectively, the “Purchaser Group”). Under the terms of the Revenue Purchase and Sale Agreement, the Purchaser Group paid the Company$37.5 million, subject to certain conditions at closing (the “Purchase Price”). In exchange, the Company sold to the Purchaser Group a right to receive 5.0% of U.S. net sales of UDENYCA and LOQTORZI with respect to a specified threshold applicable to UDENYCA net sales and a specified threshold applicable to LOQTORZI net sales during an applicable year and 0.5% of U.S. net sales of UDENYCA and LOQTORZI that exceeded the specified threshold during that year (the “Revenue Payment”) for each calendar quarter commencing May 8, 2024. The Purchaser Group’s right to receive the Revenue Payment terminates and the Company no longer has the obligation to pay Revenue Payments once the Purchaser Group receives the amount equal to 2.25 times the Purchase Price allocated to each product. The Company may also buy-out the Purchaser Group’s rights to receive the Revenue Payments by triggering certain conditions and paying the Purchaser Group the unpaid portion of the 2.25 multiple on the Purchase Price. The proceeds from the Purchase Price were used by the Company as part of the full repayment of the 2027 Term Loans.
The Revenue Purchase and Sale Agreement contains various representations and warranties, including with respect to organization, authorization, and certain other matters, certain covenants with respect to payment, reporting, intellectual property, in-licenses, out-licenses, and certain other actions, indemnification obligations and other provisions customary for transactions of this nature.
The Revenue Purchase and Sale Agreement contains an embedded derivative that meets the criteria to be bifurcated and accountedfor as a freestanding derivative instrument subject to derivative accounting. The allocation of the Purchase Price to the embedded derivative resulted in a$9.2 million discount on the revenue participation liability. Additionally, there was$1.4 million in issuance costs. The Company is amortizing the discount and issuance costs to interest expense over the estimated term of the Revenue Purchase and Sale Agreement using the effective interest method. For the three and nine months ended September 30, 2024, interest expense was$2.7 million and$4.4 million, respectively, inclusive of the amortization of discount and issuance costs of$0.5 million and$0.8 million, respectively. For details on the Royalty Fee Derivative Liability, see Note 3. Fair Value Measurements.
A summary of the revenue participation liability is as follows:
| · · · | ||
|---|---|---|
| | September 30, | |
| (in thousands) | | 2024 |
| Revenue participation liability | | $39,382 |
| Less unamortized discount and issuance costs | | (9,775) |
| Total | | $29,607 |
Classification on the condensed consolidated balance sheets is as follows:
| | | | | |
|---|---|---|---|---|
| · · September 30, | ||||
| (in thousands) · Balance Sheet Classification · · 2024 | ||||
| Revenue participation liability, current | Accrued and other current liabilities | | $2,180 | |
| Revenue participation liability, non-current | Other liabilities, non-current | | | 27,427 |
| Total | | | $29,607 | |
2027 Term Loans
The Company entered into a loan agreement in January 2022 (as amended, the “2027 Loan Agreement”) with BioPharma and the 2027 Lenders that provided for a senior secured term loan facility of up to$300.0 million, of which $250.0 million was funded. The 2027 Term Loans accrued interest at 8.25% plus the sum (the “Adjusted Term SOFR”) of three-month SOFR and 0.26161% per annum, with a floor on Adjusted Term SOFR of 1.0%.
On February 5, 2024, the Company entered into a Consent, Partial Release and Third Amendment to the 2027 Term Loans (the “Consent and Amendment”) with the Collateral Agent and the 2027 Lenders. Pursuant to and subject to terms and conditions in the Consent and Amendment, among other things: (1) the 2027 Lenders and the Collateral Agent provided consent to consummation of the transactions contemplated by the CIMERLI Purchase Agreement, and released certain subsidiary of the Company from its obligation and certain assets subject to the transactions contemplated thereby, (2) the 2027 Lenders and the Collateral Agent required the Company to make a partial prepayment of the principal of the loans outstanding under the 2027 Loan Agreement in the amount of $175.0 million upon consummation of the transactions contemplated by the CIMERLI Purchase Agreement, subject to certain conditions and (3) the parties thereto agreed to adjust the minimum net trailing twelve month net sales covenant level to be $125.0 million under the 2027 Loan Agreement.
As a result of the CIMERLI Sale closing, the Company made a partial prepayment of $175.0 million of the total principal balance of $250.0 million of the 2027 Term Loans on April 1, 2024. On May 8, 2024, in connection with entering into the 2029 Term Loan and the Revenue Purchase and Sale Agreement, the Company repaid in full all outstanding indebtedness and terminated all commitments under the 2027 Term Loans. The May 8, 2024 payoff amount of $79.6 million included principal repayment in full, accrued interest, a 3.0% prepayment premium fee of the principal amount, a make-whole interest payment and lender fees. During the nine months ended September 30, 2024, the Company recorded a $12.6 million loss on debt extinguishment in the condensed consolidated statements of operations for the payoff of the 2027 Term Loans, and the charge included the write-off of the remaining debt discount and debt issuance costs, the prepayment premium fee, the make-whole interest payment, and lender fees.
The following table presents the components of interest expense related to the 2027 Term Loans:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · September 30, | ||||||||||||
| (in thousands) · · 2024 · · 2023 · · 2024 · · 2023 | ||||||||||||
| Contractual interest | | $— | | $8,790 | | $9,916 | | $25,404 | ||||
| Amortization of debt discount and debt issuance costs | | | — | | | 255 | | | 1,277 | | | 830 |
| Total interest expense | | $— | | $9,045 | | $11,193 | | $26,234 | ||||
1.5%** Convertible Senior Subordinated Notes due 2026**
In April 2020, the Company issued and sold $230.0 million aggregate principal amount of its 1.5% Convertible Senior Subordinated notes due 2026 (the “2026 Convertible Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The net proceeds from the offering were $222.2 million after deducting initial purchasers’ fees and offering expenses. The 2026 Convertible Notes are general unsecured obligations and will be subordinated to the Company’s designated senior indebtedness (as defined in the indenture for the 2026 Convertible Notes) andstructurally subordinated to all existing and future indebtedness and other liabilities, including trade payables. The 2026 Convertible Notes accrue interest at a rate of 1.5% per annum, payable semi-annually in arrears on April 15 and October 15 of each year, since October 15, 2020, and will mature on April 15, 2026, unless earlier repurchased or converted.
At any time before the close of business on the second scheduled trading day immediately before the maturity date, noteholders may convert their 2026 Convertible Notes at their option into shares of the Company’s common stock, together, if applicable, with cash in lieu of any fractional share, at the then-applicable conversion rate. Since inception, the conversion price has been 51.9224 shares of common stock per $1,000 principal amount of the 2026 Convertible Notes, which represents a conversion price of approximately $19.26 per share of common stock. The initial conversion price represents a premium of approximately 30.0% over the last reported sale of $14.82 per share of the Company’s common stock on the Nasdaq Global Market on April 14, 2020, the date the 2026 Convertible Notes were issued. The conversion rate and conversion price will be subject to customary adjustments upon the occurrence of certain events. If a “make-whole fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, the Company will, in certain circumstances, increase the conversion rate for a specified period of time for noteholders who convert their 2026 Convertible Notes in connection with that make-whole fundamental change. The 2026 Convertible Notes are not redeemable at the Company’s election before maturity. If a “fundamental change” (as defined in the indenture for the 2026 Convertible Notes) occurs, then, subject to a limited exception, noteholders may require the Company to repurchase their 2026 Convertible Notes for cash. The repurchase price will be equal to the principal amount of the 2026 Convertible Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.
The 2026 Convertible Notes have customary provisions relating to the occurrence of “events of default” (as defined in the Indenture for the 2026 Convertible Notes). The occurrence of such events of default could result in the acceleration of all amounts due under the 2026 Convertible Notes.
As of September 30, 2024, the Company was in full compliance with these covenants and there wereno events of default under the 2026 Convertible Notes.
The Company evaluated the features embedded in the 2026 Convertible Notes under the relevant accounting rules and concluded that the embedded features do not meet the requirements for bifurcation, and therefore do not need to be separately accounted for as equity components.
Capped Call Transactions
In connection with the pricing of the 2026 Convertible Notes, the Company paid $18.2 million to enter into privately negotiated capped call transactions with one or a combination of the initial purchasers, their respective affiliates and other financial institutions. The capped call transactions are generally expected to reduce the potential dilution upon conversion of the 2026 Convertible Notes in the event that the market price per share of the Company’s common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the 2026 Convertible Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the 2026 Convertible Notes. Since inception, the cap price has been $25.93 per share, which represents a premium of approximately 75.0% over the last reported sale price of the Company’s common stock of $14.82 per share on April 14, 2020, and is subject to certain adjustments under the terms of the capped call transactions.
The capped call transactions are accounted for as separate transactions from the 2026 Convertible Notes and classified as equity instruments; thus, they are recorded as a reduction to additional paid-in capital on the condensed consolidated balance sheets. The capped calls are not re-measured as long as the conditions for equity classification continue to be met.
The Company incurred $0.9 million of debt issuance costs relating to the issuance of the 2026 Convertible Notes, which were recorded as a reduction to the carrying value of the notes on the condensed consolidated balance sheets. The debt issuance costs are being amortized and recognized as additional interest expense over thesix-year contractual term of the notes using the effective interest rate method.
If the 2026 Convertible Notes were converted on September 30, 2024, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $12.4 million based on the Company’s closing stock price of $1.04 as of September 30, 2024.
The following table presents the components of interest expense related to the 2026 Convertible Notes:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||
| · · September 30, · · September 30, | ||||||||
| (in thousands) · 2024 · · 2023 · · 2024 · 2023 | ||||||||
| Stated coupon interest | | $863 | | $863 | | $2,588 | | $2,588 |
| Amortization of debt discount and debt issuance costs | | 336 | | 329 | | 1,003 | | 982 |
| Total interest expense | | $1,199 | | $1,192 | | $3,591 | | $3,570 |
The remaining unamortized debt discount and debt offering costs related to the 2026 Convertible Notes of $2.1 million as of September 30, 2024 will be amortized using the effective interest rate over the remaining term of the 2026 Convertible Notes. The annual effective interest rate is 2.1% for the 2026 Convertible Notes.
Future payments on the 2026 Convertible Notes as of September 30, 2024 are as follows:
| · · · | ||
|---|---|---|
| Year ending December 31, (in thousands) | | |
| Remainder of 2024 - interest only | | $1,725 |
| 2025 - interest only | | 3,450 |
| 2026 - principal and interest | | 231,725 |
| Total minimum payments | | 236,900 |
| Less amount representing interest | | (6,900) |
| 2026 Convertible Notes, principal amount | | 230,000 |
| Less unamortized debt discount and debt issuance costs | | (2,109) |
| Net carrying amount of 2026 Convertible Notes | | $227,891 |
- Commitments and Contingencies
Purchase Commitments
The Company entered into agreements with certain vendors to secure raw materials and certain CMOs to manufacture its supply of products. As of September 30, 2024, the Company’s non-cancelable purchase commitments under the terms of its agreements are as follows:
| | | | |
|---|---|---|---|
| Year ending December 31, (in thousands) · · | |||
| 2024 | | $7,293 | |
| 2025 | | | 57,606 |
| 2026 | | | 1,654 |
| 2027 | | | 450 |
| Total obligations | | $67,003 | |
The Company enters into contracts in the normal course of business with contract research organizations for preclinical studies and clinical trials and CMOs for the manufacture of clinical trial materials. The contracts are generally cancellable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would generally only be obligated for products or services that the Company had received as of the effective date of the termination and any applicable cancellation fees. In connection with the YUSIMRY Sale, HKF assumed $17.0 million in YUSIMRY inventory purchase commitments, of which $17.0 million remained as of September 30, 2024. If HKF were to default on its obligations under the YUSIMRY Purchase Agreement, the Company could become liable to pay any unpaid portion of these purchase commitments.
Guarantees and Indemnifications
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company assesses the likelihood of any adverse judgments or related claims, as well as ranges of probable losses. In the cases where the Company believes that a reasonably possible or probable loss exists, it will disclose the facts and circumstances of the claims, including an estimate range, if possible.
Legal Proceedings and Other Claims
The Company is a party to various legal proceedings and claims that arise in the ordinary, routine course of business and that have not been fully resolved. The outcome of such legal proceedings and claims is inherently uncertain. Accruals are recognized for such legal proceedings and claims to the extent that a loss is both probable and reasonably estimable. The best estimate of a loss within a range is accrued; however, if no estimate in the range is better than any other, then the minimum amount in the range is accrued. If it is determined that a material loss is reasonably possible and the loss or range of loss can be estimated, the possible loss is disclosed. Sometimes it is not possible to determine the outcome of these matters or, unless otherwise noted, the outcome (including in excess of any accrual) is not expected to be material, and the maximum potential exposure or the range of possible loss cannot be reasonably estimated. As of September 30, 2024 and December 31, 2023, the Company had an accrual of $6.4 million related to such matters that was included in accrued rebates, fees and reserves on the condensed consolidated balance sheets.
In late April of 2022, the Company received a demand letter from Zinc Health Services, LLC (“Zinc”) asserting that Zinc was entitled to approximately $14.0 million from the Company for claims related to certain sales of UDENYCA from October 2020 through December 2021. No legal proceeding has been filed in connection with the claims in the letter and based on currently available information the final resolution of the matter is uncertain. The Company intends to defend any legal proceeding that may be filed. The Company has an accrual established as of September 30, 2024 that represented its estimated liability to resolve the matter. Loss contingencies are inherently unpredictable, the assessment is highly subjective and requires judgments about future events and unfavorable developments or resolutions can occur. The Company regularly reviews litigation matters to determine whether its accrual is adequate. The amount of ultimate loss may differ materially from the amount accrued to date.
Other than the matter in connection with the demand letter described in this Note 9. Commitments and Contingencies, there are no pending legal proceedings, other than ordinary routine litigation incidental to the business, to which the Company or any of its subsidiaries is a party, or that any of the Company or its subsidiaries' property is subject.
- Stockholders’ Deficit
Public Offering
On May 16, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC and Citigroup Global Markets Inc., as representatives of the several underwriters named therein (collectively, the “Underwriters”), pursuant to which the Company issued and sold an aggregate of 11,764,706 shares (the “Firm Shares”) of its common stock, par value $0.0001 per share, to the Underwriters (the “Public Offering”). Additionally, under the terms of the Underwriting Agreement, the Company granted the Underwriters an option, for 30 days from the date of the Underwriting Agreement, to purchase up to an additional 1,764,705 shares of common stock (the “Option Shares,” and together with the Firm Shares, the “Shares”), which the Underwriters elected to exercise in full. The price to the public in the Public Offering was $4.25 per share. The Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $3.995 per share.
The Offering was made pursuant to a prospectus supplement and related prospectus filed with the SEC pursuant to the Company’s shelf registration statement on Form S-3 that was declared effective on November 17, 2022 (the “Registration Statement”) under which the Company may offer and sell up to $150.0 million in the aggregate of its common stock, preferred stock, debt securities, warrants and units from time to time in one or more offerings.
On May 18, 2023, the Company completed the sale and issuance of an aggregate of 13,529,411 Shares, including the exercise in full of the Underwriters’ option to purchase the Option Shares. The Company received net proceeds of approximately $53.6 million, after deducting the Underwriters’ discounts and commissions and offering expenses payable by the Company.
ATM Offering
On November 8, 2022, the Company filed the Registration Statement. Also on November 8, 2022, the Company entered into a sales agreement (“Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”), pursuant to which the Company may issue and sell from time to time up to $150.0 million of its common stock through or to TD Cowen as the Company’s sales agent or principal in an at-the-market offering (“ATM Offering”).
On May 15, 2023, pursuant to an Amendment No. 1 to Sales Agreement and in connection with the Public Offering, the Company reduced the amount of shares that could be issued and sold pursuant to its ATM Offering with TD Cowen by $86.2 million, lowering the aggregate offering price under the Sales Agreement from $150.0 million to $63.8 million.
On September 11, 2023, pursuant to an Amendment No. 2 to Sales Agreement, the Company increased the amount of shares that could be issued and sold pursuant to its ATM Offering with TD Cowen by $28.7 million, increasing the aggregate offering price under the Sales Agreement from $63.8 million to $92.5 million.
The following table summarizes information regarding settlements under the ATM Offering for the three and nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands, except share and per share data) · · 2024 · · 2023 · 2024 · · 2023 | ||||||||||||
| Number of common stock shares sold during the period | | | — | | | 2,428,311 | | | 650,005 | | | 3,559,761 |
| Weighted-average price per share | | $— | | $4.92 | | $2.44 | | $5.43 | ||||
| Gross proceeds | | $— | | $11,938 | | $1,589 | | $19,339 | ||||
| Less commissions and fees | | — | | (298) | | (40) | | (483) | ||||
| Net proceeds after commissions and fees | | $— | | $11,640 | | $1,549 | | $18,856 | ||||
As of September 30, 2024, the Company had approximately $64.9 million of its common stock remaining available for sales under the ATM Offering.
- Stock-Based Compensation
In April 2024 and May 2024, the Company granted performance-based stock options to purchase 1,982,500 and 640,000 shares of Company common stock (“PSOs”), respectively, to its Chief Executive Officer and certain other senior executives with performance-based vesting conditions under the 2014 Equity Incentive Award Plan and the Amended and Restated 2014 Equity Incentive Award Plan that have a term often years. Vesting is based on the achievement of various commercial, clinical, strategic and total shareholder return performance milestones during specified periods. The fair value of each PSO was estimated on the grant date, using the Black-Scholes model for PSOs tied to commercial, clinical and strategic milestones (the “Performance Condition PSOs”) and a Monte Carlo simulation model for PSOs with total shareholder return vesting criteria (the “Market Condition PSOs”). Expense for the Performance Condition PSOs is recognized over the requisite service period only when the performance condition is considered probable of being achieved and is recognized over the period from the grant date through the time the milestone is expected to be achieved. Expense for the Market Condition PSOs is recognized over the requisite service period. Expense related to PSOs was $0.2 million and $1.0 million during the three and nine months ended September 30, 2024, respectively.
The following table summarizes the classification of stock-based compensation expense in the Company’s condensed consolidated statements of operations related to options, including PSOs, and restricted stock units granted to employees and nonemployees:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||
| · · September 30, · · September 30, | ||||||||
| (in thousands) · 2024 · 2023 · 2024 · 2023 | ||||||||
| Cost of goods sold (1) | | $282 | | $174 | | $834 | | $535 |
| Research and development | | 2,092 | | 2,929 | | 6,552 | | 11,760 |
| Selling, general and administrative | | 4,494 | | 6,850 | | 14,032 | | 20,017 |
| Stock-based compensation expense | | $6,868 | | $9,953 | | $21,418 | | $32,312 |
| | | | | | | | | |
| Stock-based compensation expense capitalized into inventory | | $313 | | $373 | | $1,107 | | $697 |
(1)
(1) Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold.
- Net Income (Loss) Per Share
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive common shares. Diluted net income per share is computed by dividing the net income by the weighted average number of common shares outstanding for the period plus any diluted potential common shares outstanding for the period determined using the treasury stock method for options, PSOs, RSUs and ESPP and using the if-converted method for the convertible notes. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for any potential dilutive common share equivalents as their effect would be antidilutive.
The following table sets forth the computation of the basic and diluted net income (loss) per share:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||||||
| · · September 30, · · · September 30, | ||||||||||||
| (in thousands, except share and per share data) · 2024 · 2023 · 2024 · 2023 | ||||||||||||
| Basic net income (loss) per share · · · · · | ||||||||||||
| Numerator: · · · · · | ||||||||||||
| Net income (loss) | | $(10,751) | | $(39,641) | | $79,203 | | $(158,239) | ||||
| Denominator: | | | | | | | | | ||||
| Weighted-average common shares outstanding | | 115,210,091 | | 97,738,509 | | 114,263,256 | | 88,277,936 | ||||
| Basic net income (loss) per share | | $(0.09) | | $(0.41) | | $0.69 | | $(1.79) | ||||
| | | | | | | | | | | | | |
| Diluted net income (loss) per share | | | | | ||||||||
| Numerator: | | | | | ||||||||
| Net income (loss) | | $(10,751) | | $(39,641) | | $79,203 | | $(158,239) | ||||
| Add interest expense on convertible notes, net of tax | | | — | | | — | | | 3,591 | | | — |
| Numerator for diluted net income (loss) per share | | $(10,751) | | $(39,641) | | $82,794 | | $(158,239) | ||||
| Denominator: | | | | | | | | | ||||
| Denominator for basic net income (loss) per share | | 115,210,091 | | 97,738,509 | | 114,263,256 | | 88,277,936 | ||||
| Add effect of potential dilutive securities: | | | | | | | | | ||||
| Stock options, including shares subject to ESPP | | — | | — | | 213,872 | | — | ||||
| Restricted stock units | | — | | — | | 144,271 | | — | ||||
| Shares issuable upon conversion of convertible notes | | | — | | | — | | | 11,942,152 | | | — |
| Denominator for diluted net income (loss) income per share | | 115,210,091 | | 97,738,509 | | 126,563,551 | | 88,277,936 | ||||
| Diluted net income (loss) per share | | $(0.09) | | $(0.41) | | $0.65 | | $(1.79) | ||||
The following outstanding dilutive potential shares were excluded from the calculation of diluted net income (loss) per share due to their anti-dilutive effect:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Nine Months Ended | ||||||||
| · · September 30, · · September 30, | ||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||
| Stock options, PSOs, including shares subject to ESPP | 30,104,147 | 24,558,893 | | 28,103,519 | 24,003,706 | |||
| Restricted stock units | 831,401 | 2,141,403 | | 930,737 | 2,354,166 | |||
| Shares issuable upon conversion of 2026 Convertible Notes | | 11,942,152 | | 11,942,152 | | — | | 11,942,152 |
| Total | 42,877,700 | 38,642,448 | | 29,034,256 | 38,300,024 | |||
The amounts in the table above exclude any shares contingently issuable pursuant to the CVR Agreement because the conditions that could result in a payment becoming due were not met.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.