Coherus BioSciences Inc
For the period ended Sep 30, 2024. Filed Nov 6, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 6, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
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Item 2. Results of Operations
Comparison of Three and Nine Months Ended September 30, 2024 and 2023
Revenue
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Net revenue | | $70,774 | | $74,568 | | $(3,794) | | $212,816 | | $165,720 | | $47,096 |
The decrease in net revenue for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 was primarily due to the sale of the YUSIMRY immunology franchise and the CIMERLI ophthalmology franchise which contributed a combined $41.4 million of net revenue in the third quarter of 2023 and were disposed of prior to the third quarter 2024, partially offset by an increase in UDENYCA net revenue of $33.1 million compared to the same period in 2023 due to the launch of additional presentations and increased market share, and $5.8 million in net sales of LOQTORZI, which launched in December 2023.
The increase in net revenue for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily driven by an increase in UDENYCA net revenue of $68.8 million due to additional presentations and increased market share, partially offset by a decline in UDENYCA’s average net selling price per unit. Additionally, sales of LOQTORZI, which launched in December 2023, and YUSIMRY, which launched in July 2023, contributed $11.6 million and $6.1 million of additional net revenue, respectively, during the nine months ended September 30, 2024 compared to the same period in the prior year. The nine months ended September 30, 2024 also included $6.3 million for the sale of rights to commercialize toripalimab within Canada on June 27, 2024. These favorable factors were partially offset by the sale of the CIMERLI ophthalmology franchise which contributed $46.0 million less net revenue during the nine months ended September 30, 2024 compared to the same period in 2023. Our net revenue and market penetration may continue to be adversely impacted by pricing trends and competitive dynamics in the overall pegfilgrastim market.
We expect net revenue in the fourth quarter of 2024 to be significantly less than the third quarter of 2024 because of the impact of the temporary UDENYCA supply interruption driven by over-commitments and capacity constraints at our third-party CMO for packaging and labeling leading to channel supply of UDENYCA becoming substantially depleted after our announcement about the temporary UDENYCA supply interruption on September 13, 2024 and sales not becoming able to commence until we resume shipping UDENYCA, which we expect to do as final product lots are completed.
Cost of Goods Sold
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| · · Three Months Ended September 30, · · · · Nine Months Ended September 30, | |||||||||||||||
| (in thousands) · 2024 · 2023 · Change · · · 2024 · 2023 · Change | |||||||||||||||
| Cost of goods sold | | $20,741 | | $32,703 | | $(11,962) | | | | $83,695 | | $74,425 | | $9,270 | |
| Gross margin | | 71% | 56% | | | | | 61% | 55% | | |||||
The decrease in cost of goods sold for the three months ended September 30, 2024 compared to the same period in the prior year was primarily due to $24.1 million of costs in the third quarter of 2023 related to CIMERLI and YUSIMRY
which were divested during the first half of 2024 and a $1.6 million reduction in the royalty payable to Amgen on UDENYCA net product revenue that expired on July 1, 2024. These decreases were partially offset by a $9.7 million increase in product costs driven primarily by increased UDENYCA volume, a $1.1 million increase in LOQTORZI royalties, and due to the sale in the third quarter of 2023 of certain UDENYCA units having no carrying value following our third quarter of 2022 write-down and a total original cost of $2.4 million.
The increase in cost of goods sold for the nine months ended September 30, 2024 compared to the same period in the prior year was primarily due to a $27.8 million increase related to volumes driven by UDENYCA and LOQTORZI, $4.5 million in connection with a CMO contract change, and $2.5 million in LOQTORZI royalties. These increases were partially offset by non-recurring costs of $24.1 million related to products divested during the first half of 2024 mentioned above and $3.0 million in contract modification fees in the first quarter of 2023 with one of our manufacturers for reducing the number of UDENYCA batches to be produced.
We expect COGS for the fourth quarter of 2024 to be significantly less than the third quarter of 2024 because of the impact of the temporary UDENYCA supply interruption driven by over-commitments and capacity constraints at our third-party CMO for packaging and labeling to channel supply of UDENYCA becoming substantially depleted after our announcement about the temporary UDENYCA supply interruption on September 13, 2024 and sales not becoming able to commence until we resume shipping UDENYCA, which we expect to do as final product lots are completed.
Research and Development Expense
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Research and development | | $21,676 | | $25,647 | | $(3,971) | | $72,101 | | $83,068 | | $(10,967) |
The decrease in research and development expense in the three months ended September 30, 2024 compared to the prior period was primarily due to the following:
| ● | a decrease of $5.8 million in co-development costs for toripalimab and CHS-006 resulting from reducing the scope of the development plan for toripalimab in the United States beginning in 2023 and the termination of the TIGIT Program announced in January 2024; |
| ● | a decrease of $2.7 million for fewer expenditures during the quarter for the development of CHS-1000; |
| ● | a decrease of $1.2 million in costs related to YUSIMRY; and |
| ● | a decrease of $1.1 million in personnel and stock-based compensation expense primarily due to fewer employees. |
The decrease was partially offset by the following:
| ● | an increase of $4.7 million for the development of casdozokitug; and |
| ● | an increase of $1.5 million for the development of CHS-114. |
The decrease in research and development expense in the nine months ended September 30, 2024 compared to the prior period was primarily due to the following:
| ● | a decrease of $13.1 million in personnel and stock-based compensation expense primarily due to a decrease in headcount, inclusive of $3.6 million in restructuring charges from our reduction in force in the first quarter of 2023; |
| ● | a decrease of $6.4 million in YUSIMRY costs primarily due to discontinuation of a study in the first quarter of 2023 and overall lower spend related to YUSIMRY; |
| ● | a decrease of $3.8 million for fewer expenditures during the period for the development of CHS-1000; and |
| ● | a decrease of $2.7 million in co-development costs for toripalimab and CHS-006 resulting from reducing the scope of the development plan for toripalimab in the United States beginning in 2023 and the termination of the TIGIT Program announced in January 2024. |
The decrease was partially offset by the following:
| ● | an increase of $10.7 million for the development of casdozokitug; and |
| ● | an increase of $5.0 million for the development of CHS-114. |
We expect our research and development expense in 2024 to be lower than 2023 due to the estimated impacts of our cost containment initiatives and the termination of the TIGIT Program in January 2024. We expect these decreases to be partially offset by expenditures on our pipeline.
Selling, General and Administrative Expense
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Selling, general and administrative | | $34,744 | | $48,224 | | $(13,480) | | $126,441 | | $142,521 | | $(16,080) |
The decrease in selling, general and administrative expense in the three months ended September 30, 2024 was primarily due to a reduction of $5.2 million in professional service fees; a lower average headcount, including reductions of $4.5 million in employee and consultant costs and $2.4 million in stock-based compensation; and a reduction of $1.2 million in facilities, supplies and materials and other infrastructure related expenses to support our commercial infrastructure for our products.
The decrease in selling, general and administrative expense in the nine months ended September 30, 2024 was primarily due to a lower average headcount, including reductions of $12.6 million in employee and consultant costs and $6.0 million in stock-based compensation; a $4.5 million decrease related to the non-recurring Surface acquisition costs incurred during the nine months ended September 2023; and a reduction of $1.2 million in travel costs. These decreases were partially offset by the $6.8 million net impairment charge relating to the write-off of the net carrying value of the intangible asset of $10.6 million and the final remeasurement of the CVR liability of $3.8 million related to NZV930 to its fair value of zero.
Excluding the potential impact of any acquisitions or business development transactions that have not been consummated, we expect our selling, general and administrative expense for 2024 to be lower than 2023 primarily as a result of the Sale Transactions, reduced headcount and decreased commercial costs.
Interest Expense
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Interest expense | | $5,362 | | $10,268 | | $(4,906) | | $21,812 | | $29,923 | | $(8,111) |
The decrease in interest expense in the three and nine months ended September 30, 2024 was primarily due to prepaying $175.0 million of the principal amount due under the 2027 Term Loans on April 1, 2024 and prepaying the remaining $75.0 million principal amount on May 8, 2024, partially offset by interest on the $38.7 million 2029 Term Loan and the Revenue Purchase and Sale Agreement, both commencing May 8, 2024.
Primarily, as a result of fully repaying the $250.0 million principal amount of the 2027 Term Loans during the second quarter of 2024, we expect interest expense to be lower in 2024 compared to 2023.
Gain (loss) on Sale Transactions, net
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Gain (loss) on Sale Transactions, net | | $(1,086) | | $— | | $(1,086) | | $176,646 | | $— | | $176,646 |
The Gain (loss) on Sale Transactions, net for the nine months ended September 30, 2024 includes the first quarter CIMERLI Sale and second quarter YUSIMRY Sale. The net gain of $153.8 million on the CIMERLI Sale 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. The net gain of $22.9 million on the YUSIMRY Sale to HFK includes the cash receipts of $40.0 million less assets transferred to HKF, assets and liabilities derecognized, and transaction costs of $1.0 million.
Loss on Debt Extinguishment
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Loss on debt extinguishment | | $— | | $— | | $— | | $12,630 | | $— | | $12,630 |
The$12.6 million loss on debt extinguishment in the nine months ended September 30, 2024 resulted from the payoff of the 2027 Term Loans in May 2024, and the charge includedthe write-off of theremaining debt discount and debt issuance costs, theprepayment premium fee, themake-whole interest payment, and lender fees.
Other Income (Expense), Net
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| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| (in thousands) · 2024 · 2023 · Change · 2024 · 2023 · Change | ||||||||||||
| Other income (expense), net | | $2,084 | | $2,253 | | $(169) | | $6,420 | | $5,598 | | $822 |
Other income (expense), net in the three months ended September 30, 2024 was comparable to the three months ended September 30, 2023. Other income (expense), net in the nine months ended September 30, 2024 changed favorably compared to the same period in the prior year primarily due to an increase in TSA income of $2.1 million and an increase in foreign exchange gains of $1.1 million, partially offset by a reduction of $1.3 million in investment and interest income.
Liquidity and Capital Resources
Certain relevant measures of our liquidity and capital resources are summarized as follows:
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| · · September 30, · · · December 31, | |||||||
| (in thousands) · 2024 · 2023 | |||||||
| Financial assets | | | | | | | |
| Total Cash, cash equivalents and marketable securities | | $97,690 | | | $117,748 | ||
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| Financial liabilities: | | | | | | ||
| 2029 Term Loan | | $36,618 | | | $— | ||
| Revenue Purchase and Sale Agreement | | | 29,607 | | | | — |
| 2027 Term Loans | | | — | | | | 246,481 |
| 2026 Convertible Notes | | 227,891 | | | 226,888 | ||
| Total Financial liabilities | | $294,116 | | | $473,369 | ||
We have generated significant operating losses in all years since our inception other than $79.2 million of net income in the nine months ended September 30, 2024, primarily due to the Sale Transactions in March 2024 and June 2024, $132.2 million in 2020, and $89.8 million in 2019. We have funded our operations primarily through sales of our common stock, issuance and incurrence of convertible and term debt, the Revenue Purchase and Sale Agreement, the Sale Transactions and sales of our products.
On September 13, 2024, we announced that our third-party labeling and packaging CMO for UDENYCA delayed production of UDENYCA due to over-commitments and capacity constraints. These delays caused a temporary UDENYCA supply interruption. The CMO recently informed us that production will resume later in the week of November 4, 2024. Based on the production schedule, a significant number of units are projected to be completed without further interruption or delay by the end of 2024. We expect to restock the distribution channels as fast as possible, as we expect to ship final product lots as they are completed, making sure they get to customers in an expedited fashion. We have also made significant progress in our efforts to diversify our labeling and packaging resources. An additional final packaging and labeling CMO has already started production testing and is expected to start manufacturing saleable product by the end of 2024. Commercial supply from that CMO is expected to commence in the first quarter of 2025, subject to FDA authorization. Although we currently believe that our estimates for the timing of UDENYCA commercial supply availability from our two labeling and packaging CMOs are reasonable, any delays from third parties would result in delays to UDENYCA commercial supply availability. For a discussion of risks related to manufacturing our products and our reliance on third parties, please see “Risk Factors— Risks Related to Manufacturing and Supply Chain” and “Risk Factors—Risks Related to Reliance on Third Parties.”
On June 27, 2024, we entered into the Canada License Agreement pursuant to which, we granted to Apotex an exclusive license under our rights to toripalimab to commercialize toripalimab within Canada. Pursuant to the Canada License Agreement, Apotex paid us $6.3 million USD. In addition, Apotex agreed to pay us the USD equivalent of up to an aggregate of $51.5 million CAD in milestone payments in connection with the achievement of certain regulatory and sales milestones with respect to toripalimab in Canada. Finally, Apotex agreed to pay us a low double-digit percentage of any future net sales of toripalimab in Canada that we will subsequently pay to Junshi Biosciences pursuant to the Collaboration Agreement.
On June 26, 2024, we entered into the YUSIMRY Purchase Agreement by and between us and HKF. Pursuant to the terms and subject to the conditions set forth in the YUSIMRY Purchase Agreement, we sold our YUSIMRY immunology franchise through the sale of certain assets, including YUSIMRY, intellectual property exclusively related to YUSIMRY, certain contracts related to YUSIMRY, YUSIMRY inventory, and all activities related to research and development of YUSIMRY to HKF for upfront, cash consideration of $40.0 million and the assumption of $17.0 million of inventory purchase commitments by HKF. We retained the rights to certain patents that were licensed to Pfizer under the Pfizer License Agreement.
On May 8, 2024, we entered into the 2029 Term Loan providing for a secured loan facility in the principal amount of $38.7 million, with proceeds of $37.5 million after the original issue discount which were used as part of the full repayment of all outstanding indebtedness and terminated all commitments under the 2027 Term Loans.
On May 8, 2024, we entered into the Revenue Purchase and Sale Agreement. We received proceeds of $37.5 million by selling to the Purchaser Group a right to receive payment in full of 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, commencing May 8, 2024. The proceeds were used by us as part of the full repayment of all outstanding indebtedness and terminated all commitments under the 2027 Term Loans.
On April 1, 2024, $175.0 million of the cash and cash equivalents was used to repay $175.0 million of the total principal balance of $250.0 million of the 2027 Term Loans, as further described below.
On January 19, 2024, we entered into the CIMERLI Purchase Agreement by and between us and Sandoz. Pursuant to the terms and subject to the conditions set forth in the CIMERLI Purchase Agreement, on March 1, 2024, we completed the CIMERLI Sale for our CIMERLI ophthalmology franchise through the sale of our 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.
On February 5, 2024, we entered into the Consent and Amendment, that among other things: (1) provided consent to consummation of the transactions contemplated by the CIMERLI Purchase Agreement, and released certain of our subsidiary from our obligation and certain assets subject to the transactions contemplated thereby, (2) required us to make a partial prepayment of $175.0 million of the principal of the 2027 Term Loans outstanding upon consummation of the transactions contemplated by the CIMERLI Purchase Agreement, subject to certain conditions and (3) adjusted the minimum net sales covenant level under the 2027 Term Loans. Upon the closing of the CIMERLI Sale, we became obligated to repay $175.0 million of the total principal balance of $250.0 million of the loans outstanding as well as $6.8 million in prepayment premium and make-whole payments under the 2027 Term Loans, of which we paid on April 1, 2024.
On September 8, 2023, we obtained $28.8 million of cash, cash equivalents and marketable securities as part of the Surface Acquisition.
On May 16, 2023, we entered into the Underwriting Agreement with the Underwriters, pursuant to which we sold an aggregate of 11,764,706 Firm Shares to the Underwriters. Additionally, under the terms of the Underwriting Agreement, we granted the Underwriters an option, for 30 days from the date of the Underwriting Agreement, to purchase up to an additional 1,764,705 Option 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 us pursuant to the Underwriting Agreement at a price of $3.995 per share.
On May 18, 2023, we completed the sale and issuance of an aggregate of 13,529,411 Shares in the Public Offering, including the exercise in full of the Underwriters’ option to purchase the Option Shares. We received net proceeds of approximately $53.6 million, after deducting the Underwriters’ discounts and commissions and offering expenses payable by us.
On November 8, 2022, we entered into the Sales Agreement related to the ATM Offering pursuant to which we may issue and sell from time to time up to $150.0 million of our common stock. On May 15, 2023, pursuant to an Amendment No. 1 to Sales Agreement and in connection with the Public Offering, we 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 Agreement from $150.0 million to $63.8 million. On September 11, 2023, pursuant to an Amendment No. 2 to Sales Agreement, we 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. No shares were sold during the three months ended September 30, 2024. During the nine months ended September 30, 2024, we sold 650,005 shares of common stock pursuant to the ATM Offering, at a weighted-average price per share of $2.44 for gross proceeds of $1.6 million and received net proceeds of $1.5 million, net of $0.1 million of commissions and fees. For the ATM Offering program to date as of September 30, 2024, we sold 5,126,650 shares of common stock at a weighted-average price per share of $5.39 for gross proceeds of $27.6 million and received net proceeds of $26.9 million, net of $0.7 million of commissions and fees. As of September 30, 2024, we had approximately $64.9 million of our common stock remaining available for sales under the ATM Offering. The ability to elect to sell shares of our common stock in the ATM Offering from time to time adds to our financial flexibility.
As of September 30, 2024, we had an accumulated deficit of $1.5 billion and cash and cash equivalents of $97.7 million. We believe that our available cash and cash equivalents, cash collected from product sales, divestitures, ATM Offering and Public Offering proceeds received to date will be sufficient to fund our planned expenditures and meet our obligations for at least the twelve months following our financial statement issuance date.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates and the extent to which we may enter into additional agreements with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated research and development activities, and on-going and future licensing and collaboration obligations. We may need to raise additional funds in the future; however, there can be no assurance that such efforts will be successful or that, if they are successful, the terms and conditions of such financing will be favorable. Our future funding requirements will depend on many factors, including the following:
| ● | cash proceeds from product sales; |
| ● | the payment of interest, principal and royalties related to our financial liabilities; |
| ● | the costs of manufacturing, distributing and marketing our products; |
| ● | the cost of manufacturing clinical drug supplies and establishing commercial supplies of our product candidates and products; |
| ● | the timing for our packaging and labeling CMO to resume manufacturing and to make UDENYCA products available in a sufficient quantity to meet the demand from our customers; |
| ● | the timing for us to receive FDA authorization to produce UDENYCA product at our additional packaging and labeling CMO’s facility and the timing for our additional packaging and labeling CMO to make UDENYCA products available in a sufficient quantity to meet the demand from our customers; |
| ● | the percentage of customers that continue to purchase our products and that do not switch to products made by our competitors; |
| ● | the terms and timing of any other collaborative, licensing and other arrangements that we have established or may establish; |
| ● | the timing, receipt and amount of sales, profit sharing or royalties, if any, from any product candidates that are approved in the future; |
| ● | the number and characteristics of product candidates that we pursue; |
| ● | the scope, rate of progress, results and cost of our clinical trials, preclinical testing and other related activities; |
| ● | the costs of acquiring originator comparator materials and manufacturing preclinical study and clinical trial supplies and other materials from CMOs and related costs associated with release and stability testing; |
| ● | the cost, timing and outcomes of regulatory approvals; |
| ● | the cost of preparing, filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
| ● | the extent to which we divest, acquire or invest in businesses, products or technologies; |
| ● | the impact of general economic conditions on our business, including but not limited to increased interest rates and high inflation; and |
| ● | the costs of the impact from any future outbreaks of the COVID-19 pandemic or future pandemics. |
For further discussion of risks related to our financial condition and capital requirements, please see “Risk Factors— Risks Related to Our Financial Condition and Capital Requirements.”
Financing arrangements
2027 Term Loans
During the second quarter of 2024, we fully repaid and terminated all commitments under the 2027 Term Loans. Proceeds from the divestiture of our CIMERLI ophthalmology franchise received in March 2024 were used to pay down $175.0 million of outstanding principal, and a prepayment premium and make-whole amount totaling $6.8 million on April 1, 2024. On May 8, 2024, we used the proceeds from the 2029 Term Loan and Revenue Purchase and Sale Agreement to repay the remaining $75.0 million principal balance outstanding on the 2027 Term Loans and a prepayment premium and make-whole amount totaling $3.5 million.
2029 Term Loan
Concurrent with the payoff of the 2027 Term Loans, on May 8, 2024, we entered into the 2029 Term Loan providing for a secured loan facility in the principal amount of $38.7 million, with proceeds of $37.5 million after the original issue discount. The 2029 Term Loan will mature on May 8, 2029, accrues interest equal to 8.0% per annum, plus a three-month SOFR rate and provides for interest-only payments on a quarterly basis until maturity.
The 2029 Term Loan is secured by a lien on substantially all of our assets, 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 us to maintain certain levels of cash and cash equivalents. The 2029 Loan Agreement also contains other customary provisions, such as expense reimbursement, as well as indemnification rights for the benefit of the Agent and the 2029 Lenders. For further details, see Note 8. Financial Liabilities in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Revenue Purchase and Sale Agreement
On May 8, 2024, we entered into the Revenue Purchase and Sale Agreement. Under the terms of the Revenue Purchase and Sale Agreement, in exchange for the Purchaser Group’s payment to us of $37.5 million, we sold to the Purchaser Group a right to receive payment in full of 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, commencing on May 8, 2024. The Purchaser Group’s right to receive the Revenue Payment terminates and we no longer have the obligation to pay the Purchaser Group Revenue Payments once the Purchaser Group receives the amount equal to 2.25 times the Purchase Price. We 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 us 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.
2026 Convertible Notes
As of September 30, 2024, the carrying amount of our $230.0 million aggregate principal amount convertible senior subordinated notes due 2026 was $227.9 million. 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, and will mature on April 15, 2026, unless earlier repurchased or converted at the option of holders. 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 our 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. The 2026 Convertible Notes are not redeemable at our election before maturity. 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 our closing stock price of $1.04 as of September 30, 2024.
In connection with the pricing of the 2026 Convertible Notes, we entered into privately negotiated capped call transactions with certain of the initial purchasers of the 2026 Convertible Notes and other financial institutions. 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 our 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.
Contingent Milestones
We have obligations to make future payments to third parties that become due and payable upon the achievement of certain development, regulatory and commercial milestones (such as clinical trial achievements, the filing of a BLA, approval by the FDA or product launch). These milestone payments and other similar fees are contingent upon future events and therefore are only recorded when it becomes probable that a milestone will be achieved or other applicable criteria will be met. Because the achievement of these milestones had not reached the threshold for recognition as of September 30, 2024, such contingencies were not recorded in our financial statements.
The following presents a summary of our active partnerships and collaborations that have contingent regulatory and sales milestones as of September 30, 2024:
| | | | | |
|---|---|---|---|---|
| Counterparty | | Description | | Potential Aggregate Milestone Amount |
| Junshi Biosciences | | LOQTORZI | | $355.0 million (1) |
| Adimab | | Casdozokitug | | $13.0 million |
| Vaccinex | | CHS-114 | | $15.0 million |
| (1) | $290.0 million relates to sales milestones and $65.0 million relates to regulatory milestones for indications that are not currently the subject of our clinical trials, excluding the $25.0 million milestone payment to Junshi Biosciences, of which we paid $12.5 million in the second quarter of 2024 and expect to pay $12.5 million in the first quarter of 2025. |
Contingent Value Rights
We have recorded a contingent consideration liability for the fair value of the potential payments under the CVR Agreement in connection with the Surface Acquisition. These potential payments during the 10-year period following September 8, 2023 are only due if wefirst receive milestone- or royalty-based payments under certain license agreements or upfront payments pursuant to ex-U.S. licensing agreements. Payments can be in the form of cash, stock or a combination of cash and stock. The CVR liability associated with GSK and contingent consideration are recorded in other liabilities, non-current on the condensed consolidated balance sheets at September 30, 2024. For further details, see Note 6. Acquisition and Dispositions in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
Other Commitments
We enter into contracts in the normal course of business with CROs for preclinical research studies and clinical trials, research supplies and other services and products for operating purposes. We have also entered into agreements with several CMOs for the manufacture and clinical drug supply of our commercial and product candidates. Our non-cancelable purchase commitments as of September 30, 2024 were $67.0 million, as outlined in Note 9. Commitments
and Contingencies in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q. 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, we could become liable to pay any unpaid portion of these purchase commitments.
There have been no significant changes to our leases during the nine months ended September 30, 2024, as compared to the discussion in the 2023 Form 10-K.
Summary Statement of Cash Flows
The following table summarizes our cash flows for the periods presented**:**
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Nine Months Ended | ||||||
| · · September 30, | ||||||
| (in thousands) · 2024 · 2023 | ||||||
| Net cash used in operating activities | | $(49,048) | | $(161,947) | ||
| Net cash provided by investing activities | | 230,863 | | 109,437 | ||
| Net cash (used in) provided by financing activities | | | (187,205) | | | 69,234 |
| Net (decrease) increase in cash, cash equivalents and restricted cash | | $(5,390) | | $16,724 | ||
Net cash used in operating activities
Cash used in operating activities of $49.0 million for the nine months ended September 30, 2024 was primarily due to net income of $79.2 million adjusted for non-cash items including stock-based compensation expense of $21.4 million, loss on debt extinguishment of $12.6 million, impairment of out-license asset net of CVR liability remeasurement of $6.8 million, other non-cash adjustments of $6.2 million, and changes in our operating assets and liabilities of $1.4 million, partially offset by the net gain on Sale Transactions of $176.6 million.
Cash used in operating activities of $161.9 million for the nine months ended September 30, 2023 was primarily due to the net loss of $158.2 million adjusted for non-cash items including stock-based compensation expense of $32.3 million and other non-cash adjustments of $7.2 million, partially offset by the changes in our operating assets and liabilities of $43.2 million.
Net cash provided by investing activities
Cash provided by investing activities of $230.9 million for the nine months ended September 30, 2024 was primarily due to cash proceeds of $187.8 million from the CIMERLI Sale, cash proceeds of $40.0 million from the YUSIMRY Sale, proceeds from sale of investments in marketable securities of $8.7 million, and proceeds from maturities of investments in marketable securities of $6.2 million, partially offset by a $12.5 million milestone payment in connection with the 2 nd Amendment with Junshi Biosciences.
Cash provided by investing activities of $109.4 million for the nine months ended September 30, 2023 was primarily due to proceeds from maturities of investments in marketable securities of $108.1 million, proceeds from sale of investments in marketable securities of $13.3 million, and $7.0 million of cash acquired from the Surface Acquisition, partially offset by purchases of investments in marketable securities of $19.5 million.
Net cash (used in) provided by financing activities
Cash used in financing activities of $187.2 million for the nine months ended September 30, 2024 was primarily due to $260.4 million in payments to fully repay the 2027 Term Loans (excluding interest which is presented as an operating activity) and $2.5 million in tax payments related to net share settlement of RSUs. These payments were
partially offset by $37.0 million of proceeds on the 2029 Term Loan, net of debt discount and issuance costs, $36.5 million of proceeds from the Revenue Purchase and Sale Agreement, net of issuance costs, and $1.5 million in proceeds from the ATM Offering, net of issuance costs.
Cash provided by financing activities of $69.2 million for the nine months ended September 30, 2023 was primarily due to proceeds of $53.6 million from the Public Offering, net of issuance costs, $18.2 million proceeds from the ATM Offering, net of issuance costs, and $1.3 million proceeds from purchase under the ESPP. These were partially offset by $3.3 million in tax payments related to net share settlement.
Critical Accounting Policies and Significant Judgments and Estimates
The preparation of our condensed consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue generated and expense incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe to be reasonable under the circumstances. These estimates form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
There have been no significant changes to our critical accounting estimates during the nine months ended September 30, 2024, as compared to the critical accounting estimates described in our 2023 Form 10-K, except for the Revenue Purchase and Sale Agreement described below. We believe that the critical accounting estimates discussed in the 2023 Form 10-K are meaningful to understanding our historical and future performance, as these estimates relate to the more significant areas involving management’s judgments and assumptions.
Revenue Purchase and Sale Agreement
The Revenue Purchase and Sale Agreement 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 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 a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded derivative and then valuing the Revenue Purchase and Sale Agreement without the embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative is the fair value of the Royalty Fee Derivative. We use 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.
Recent Accounting Pronouncements
For a description of the impact of recent accounting pronouncements, see Note 1. Organization and Summary of Significant Accounting Policies in the Notes to Condensed Consolidated Financial Statements contained in Part I, Item 1 of this Quarterly Report on Form 10-Q.
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