Coherus BioSciences Inc
For the period ended Mar 31, 2025. Filed May 12, 2025.
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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.
Mar 31, 2025 · Filed May 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-06.
0001558370-24-014648
Item 2. Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001558370-25-007418
Item 2. Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 88 previous paragraphs and 56 current paragraphs.
21 unchanged; 24 reworded; 9 added; 39 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 41 previous and 39 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (9)
Current report
We expect net revenue from continuing operations in 2025 to be higher than in 2024 because of continued growth of LOQTORZI.
Current report
We expect cost of goods sold from continuing operations for 2025 to be higher than 2024 because of continued growth of LOQTORZI.
Current report
Interest expense from discontinued operations was $3.0 million and $8.0 million in the three months ended March 31, 2025 and 2024, respectively, and related to the 2026 Convertible Notes, the UDENYCA portion of the Revenue Purchase and Sale Agreement, and $175.0 million of the $250.0 million principal amount due under the 2027 Term Loans.
Current report
Net Income (Loss) from Discontinued Operations, net of tax
Current report
Net income (loss) from discontinued operations, net of tax in the three months ended March 31, 2025 changed unfavorably compared to the same period in the prior year primarily due to the $153.6 million gain on sale of the CIMERLI ophthalmology franchise in March 2024, as well as $42.6 million lower net revenue driven by 2024 divestitures and wholesaler allocations related to the supply interruption in fourth quarter of 2024, which were not lifted until the end of February 2025.
Current report
As of March 31, 2025, we had cash and cash equivalents of $82.4 million and an accumulated deficit of $1.6 billion. We have generated significant operating losses in all years since our inception with the exceptions of net income of $28.5 million in 2024, primarily due to the CIMERLI Sale in March 2024 and YUSIMRY Sale in June 2024, $132.2 million net income in 2020, and $89.8 million net income in 2019.
Current report
Net provided by (used in) investing activities
Current report
Cash flows from continuing operations and discontinued operations are presented together in the condensed consolidated statement of cash flows. During the three months ended March 31, 2025, changes in operating assets and liabilities of discontinued operations were primarily due to an increase in inventory of $22.9 million. During the three months ended March 31, 2024, changes in operating assets and liabilities of discontinued operations resulted in a net cash inflow primarily due to a decrease in prepaid manufacturing of $10.0 million and a decrease in inventory of $2.4 million.
Removed paragraphs (39)
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.”
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
On September 8, 2023, we obtained $28.8 million of cash, cash equivalents and marketable securities as part of the Surface Acquisition.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Reworded paragraphs (24)
Previous wording
Comparison of Three and Nine Months Ended September 30, 2024 and 2023
Current wording
Comparison of Three Months Ended March 31, 2025 and 2024
Previous wording
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.
Current wording
The increase in net revenue for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to higher volume of LOQTORZI, which launched in December 2023.
Previous wording
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
Current wording
The increase in cost of goods sold from continuing operations for the three months ended March 31, 2025 compared to the same period in the prior year was primarily due to higher demand of LOQTORZI, which launched in December 2023.
Previous wording
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:
Current wording
The decrease in research and development expense from continuing operations in the three months ended March 31, 2025 compared to the prior period was primarily due to the following:
Previous wording
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.
Current wording
We expect our research and development expense in 2025 to be higher than 2024 due to continued investments in our immuno-oncology pipeline.
Previous wording
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.
Current wording
The decrease in selling, general and administrative expense from continuing operations in the three months ended March 31, 2025 was primarily due to the $6.8 million net impairment charge in the first quarter of 2024 relating to the write-off of the net carrying value of the out-license 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, lower professional fees of $3.1 million, a lower average headcount which resulted in reductions of $2.2 million in employee-related costs and $1.2 million in stock-based compensation.
Previous wording
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.
Current wording
We expect our selling, general and administrative expense from continuing operations for the full year 2025 to be lower than the full year 2024 primarily as a result of decreased operating costs and headcount due to divestitures.
Previous wording
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.
Current wording
The decrease in interest expense from continuing operations in the three months ended March 31, 2025 was primarily due to prepaying the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by new interest on the $38.7 million 2029 Term Loan and the LOQTORZI portion of the Revenue Purchase and Sale Agreement, each commencing May 8, 2024.
Previous wording
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.
Current wording
We expect interest expense from continuing operations to be lower in 2025 than 2024, primarily as a result of repaying the remaining $75.0 million principal amount of the 2027 Term Loans during the second quarter of 2024.
Previous wording
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.
Current wording
Other income (expense), net from continuing operations in the three months ended March 31, 2025 changed unfavorably compared to the same period in the prior year primarily due to the decrease in foreign exchange gains of $1.0 million, the change in fair value of the LOQTORZI Royalty Fee Derivative Liability of $0.8 million, and the reduction in investment and interest income of $0.5 million.
Previous wording
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.
Current wording
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. The following is a summary of recent liquidity events and financing transactions:
Previous wording
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.
Current wording
We may utilize our ATM Offering from time to time in order to sell our common stock. As of March 31, 2025, we had approximately $64.9 million of our common stock remaining available for sales under the ATM Offering.
Previous wording
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.
Current wording
We believe that our available cash and cash equivalents, cash collected from divestitures, product sales, and ATM 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.
Previous wording
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.
Current wording
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 Biologics License Application (“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 March 31, 2025, such contingencies were not recorded in our financial statements.
Previous wording
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.
Current wording
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 March 31, 2025.
Previous wording
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
Current wording
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 March 31, 2025 were $59.0 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, and subsequent to March 31, 2025, $49.1 million of these purchase commitments was transferred to Intas in conjunction with the UDENYCA Sale.
Previous wording
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.
Current wording
There have been no significant changes to our leases during the three months ended March 31, 2025, as compared to the discussion in our 2024 Form 10-K.
Previous wording
The following table summarizes our cash flows for the periods presented**:**
Current wording
The following table summarizes our cash flows for discontinued and continuing operations on a combined basis as follows:** **
Previous wording
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.
Current wording
Cash used in operating activities of $25.8 million for the three months ended March 31, 2025 was primarily due to net loss of $56.6 million adjusted for non-cash items including change in fair value of derivatives of $12.6 million, stock-based compensation expense of $5.4 million, other non-cash adjustments of $1.9 million, and changes in our operating assets and liabilities of $10.9 million.
Previous wording
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.
Current wording
Cash used in operating activities of $46.8 million for the three months ended March 31, 2024 was primarily due to the net income of $102.9 million adjusted for non-cash items including stock-based compensation expense of $7.3 million, impairment of out-license asset net of CVR liability remeasurement of $6.8 million, and other non-cash adjustments of $1.3 million, partially offset by the net gain on Sale Transactions of $153.6 million and the changes in our operating assets and liabilities of $11.4 million.
Previous wording
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.
Current wording
Cash provided by investing activities of $202.8 million for the three months ended March 31, 2024 was primarily due tocash proceeds of $187.8 million from the CIMERLI 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.
Previous wording
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
Current wording
Cash used in financing activities of $0.3 million for the three months ended March 31, 2025 was due to tax payments related to net share settlement of RSUs.
Previous wording
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.
Current wording
Cash provided by financing activities of $0.9 million for the three months ended March 31, 2024 was primarily due to proceeds of $1.5 million proceeds from the ATM Offering, net of issuance costs, partially offset by $0.7 million in tax payments related to net share settlement of RSUs.
Previous wording
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.
Current wording
There have been no significant changes to our critical accounting estimates during the three months ended March 31, 2025, as compared to the critical accounting estimates described in our 2024 Form 10-K. We believe that the critical accounting estimates discussed in the 2024 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.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Cash used in investing activities of $17.5 million for the three months ended March 31, 2025 was primarily due to a $12.5 million milestone payment in connection with the 2 nd Amendment with Junshi Biosciences and $4.7 million in retention bonus payments in connection with the CIMERLI Sale.
Current report — wording carried from elsewhere
Net cash provided by (used in) financing activities
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
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:
Previous report — wording carried elsewhere
The decrease was partially offset by the following:
Previous report — wording carried elsewhere
Net cash provided by investing activities
Previous report — wording carried elsewhere
Net cash (used in) provided by financing activities