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Coherus BioSciences Inc

For the period ended Sep 30, 2024. Filed Nov 6, 2024.

View on SEC.gov

About this filing

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

CHRS$0.77+2.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-06-30; filed 2024-08-08.

0001558370-24-011629

Item 2. Results of Operations

Current report: 10-Q

Period ended 2024-09-30; filed 2024-11-06.

0001558370-24-014648

Item 2. Results of Operations

The 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 84 previous paragraphs and 88 current paragraphs.

48 unchanged; 28 reworded; 8 added; 6 removed; 2 previous and 4 current paragraphs rearranged.

Tables are not compared: 40 previous and 41 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 (8)

Current 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.

Current 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.

Current report

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 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.

Current 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.

Current report

Gain (loss) on Sale Transactions, net

Current 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.”

Current report

Net cash used in operating activities
Removed paragraphs (6)

Previous report

The increase in net revenue for the three months ended June 30, 2024 compared to the three months ended June 30, 2023 was primarily due to an increase in UDENYCA net revenue of $19.2 million due to additional presentations launched and overall higher demand, partially offset by a decline in UDENYCA’s average net selling price per unit. Additionally, our launches of YUSIMRY in July 2023 and LOQTORZI in December 2023 each contributed $3.8 million of net revenue during the three months ended June 30, 2024, and the sale ofrights to commercialize toripalimab within Canada on June 27, 2024 contributed $6.3 million. These positive factors were partially offset by no longer receiving product revenue for CIMERLI after the CIMERLI Sale, which contributed $26.7 million of net revenue in the second quarter of 2023.

Previous report

We expect our net revenue in 2024 to be higher than in 2023 driven by growth in UDENYCA and LOQTORZI sales, partially offset by the divestiture of CIMERLI which occurred on March 1, 2024 and YUSIMRY which occurred on June 26, 2024.

Previous report

The increase in cost of goods sold for the three months ended June 30, 2024 compared to the same period in the prior year was primarily due to a $7.4 million increase in product costs driven primarily by increased volume and the launch of new products and $4.5 million in connection with a CMO contract change. These increases were partially offset by a $9.7 million reduction in royalty costs, primarily from no CIMERLI sales in the second quarter of 2024.

Previous report

We expect our gross margin in 2024 to be greater than 2023, primarily because the 2023 results included a $47.0 million charge for the write-down of slow moving YUSIMRY inventory, and cost of goods sold ceased being incurred for profit share expenditures following the CIMERLI Sale, royalties following the YUSIMRY Sale and the mid-single digit royalty on UDENYCA net product revenue due to Amgen, which expired on July 1, 2024.

Previous report

Gain on Sale Transactions, net

Previous report

Net cash provided by (used in) operating activities
Reworded paragraphs (28)

Previous wording

Comparison of Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

The increase in net revenue for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was primarily driven by an increase in UDENYCA net revenue of $35.7 million due to additional presentations and overall higher demand, partially offset by a decline in UDENYCA’s average net selling price per unit. Additionally, our launches of YUSIMRY in July 2023 and LOQTORZI in December 2023 contributed $7.7 million and $5.8 million of net revenue during the six months ended June 30, 2024, respectively, and the sale ofrights to commercialize toripalimab within Canada on June 27, 2024 contributed $6.3 million. These positive factors were partially offset by no longer receiving product revenue for CIMERLI after the CIMERLI Sale, which contributed $4.8 million of additional net revenue in the first half of 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 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.

Previous wording

The increase in cost of goods sold for the six months ended June 30, 2024 compared to the same period in the prior year was primarily due to a $20.8 million increase in product costs driven primarily by increased volume and the launch of new products and $4.5 million in connection with a CMO contract change. These increases were partially offset by the sale of certain UDENYCA units having no carrying value following our third quarter of 2022 write-down and a total original cost of $2.6 million, as well as $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.

Current wording

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 wording

The decrease in research and development expense in the six months ended June 30, 2024 compared to the prior period was primarily due to the following:

Current wording

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 wording

The decrease in selling, general and administrative expense in the three months ended June 30, 2024 was primarily due to a lower average headcount, including reductions of $5.2 million in employee and consultant costs and $1.8 million in stock-based compensation, and a reduction of $1.9 million related to the non-recurring acquisition costs incurred in the second quarter of 2023.

Current wording

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 wording

The decrease in selling, general and administrative expense in the six months ended June 30, 2024 was primarily driven by an $8.2 million decrease in employee and consultant costs and $3.6 million decrease in stock-based compensation due to a lower average headcount. These increases 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 and an increase of $3.8 million in professional service fees.

Current 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.

Previous wording

The decrease in interest expense in the three and six months ended June 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, as well as an average higher variable rate in the first half of 2024 than first half of 2023.

Current 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.

Previous wording

Primarily, as a result of decreasing our total indebtedness by fully repaying the $250.0 million principal amount due under the 2027 Term Loans during the second quarter of 2024, we expect interest expense to be lower in 2024 compared to 2023.

Current 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.

Previous wording

The Gain on Sale Transactions, net for the three months ended June 30, 2024 primarily relates to the YUSIMRY Sale to HKF on June 26, 2024, which includes cash receipts of $40.0 million less assets transferred to HKF, assets and liabilities derecognized, and transaction costs of $0.9 million. The Gain on Sale Transactions, net for the six months ended June 30, 2024 includes the second quarter gain of $22.9 million related to the YUSIMRY Sale and first quarter CIMERLI Sale, 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.

Current wording

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 wording

The$12.6 million loss on debt extinguishment in the three and six months ended June 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.

Current wording

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 wording

Other income (expense), net in the three months ended June 30, 2024 was comparable to the three months ended June 30, 2023. Other income (expense), net in the six months ended June 30, 2024 changed favorably compared to the same period in the prior year primarily due to foreign exchange gains and TSA income.

Current 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.

Previous wording

In the six months ended June 30, 2024, we generated net income primarily due to the Sale Transactions and we were profitable in 2020 and 2019. Otherwise, we have generated significant operating losses in all other years since our inception, including in 2021 through 2023, primarily due to our research and development expenditures and a shortfall in revenue beginning in 2021. We have funded our operations primarily through sales of our common stock, issuance and incurrence of convertible and term debt, and sales of our products.

Current 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.

Previous wording

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.

Current wording

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 wording

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 a mid-single digit percentage of U.S. net sales of UDENYCA and LOQTORZI 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.

Current wording

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 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 June 30, 2024. During the six months ended June 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 June 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 June 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

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.

Previous wording

As of June 30, 2024, we had an accumulated deficit of $1.5 billion and cash and cash equivalents of $159.2 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

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.

Previous wording

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 a mid-single digit percentage of U.S. net sales of UDENYCA and LOQTORZI for each calendar quarter 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.

Current wording

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 wording

As of June 30, 2024, the carrying amount of our $230.0 million aggregate principal amount convertible senior subordinated notes due 2026 was $227.6 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 June 30, 2024, the holders of the 2026 Convertible Notes would have received common shares with an aggregate value of $20.7 million based on our closing stock price of $1.73 as of June 28, 2024.

Current wording

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 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 exclusive license of NZV930 to Novartis Institutes was terminated by Novartis Institutes with an effective date of October 2, 2024. As a result, we recognized a net impairment charge of $6.8 million in selling, 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 of zero. The remaining CVR liability associated with GSK and contingent consideration are recorded in other liabilities, non-current on the condensed consolidated balance sheets at June 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 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.

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 June 30, 2024 were $53.6 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. 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.

Current wording

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 wording

There have been no significant changes to our leases during the six months ended June 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 nine months ended September 30, 2024, as compared to the discussion in the 2023 Form 10-K.

Previous wording

Cash provided by operating activities of $13.0 million for the six months ended June 30, 2024 was primarily due to net income of $90.0 million adjusted for changes in our operating assets and liabilities of $62.9 million, non-cash items including stock-based compensation expense of $14.6 million, loss on debt extinguishment of $12.6 million, impairment of out-license asset net of CVR liability remeasurement of $6.8 million, and other non-cash adjustments of $3.9 million, partially offset by the net gain on Sale Transactions of $177.7 million.

Current 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.

Previous wording

Cash used in operating activities of $107.6 million for the six months ended June 30, 2023 was primarily due to the net loss of $118.6 million adjusted for non-cash items including stock-based compensation expense of $22.4 million and other non-cash adjustments of $4.2 million, partially offset by the changes in our operating assets and liabilities of $15.6 million. Accounts receivable, net as of June 30, 2023 included invoices totaling $20.1 million with due dates falling after the second quarter of 2023 due to extended payment terms offered to certain customers with the majority related to the launch of CIMERLI.

Current 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.

Previous wording

Cash provided by investing activities of $230.4 million for the six months ended June 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 $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.

Previous wording

Cash provided by investing activities of $58.9 million for the six months ended June 30, 2023 was primarily due to proceeds from maturities of investments in marketable securities of $64.8 million and proceeds from sale of investments in marketable securities of $13.3 million, partially offset by purchases of investments in marketable securities of $19.5 million.

Current wording

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 wording

Cash used in financing activities of $187.0 million for the six months ended June 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 $37.1 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.

Current 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

Previous wording

Cash provided by financing activities of $58.1 million for the six months ended June 30, 2023 was primarily due to proceeds of $53.6 million from the Public Offering, net of issuance costs, $6.8 million proceeds from the ATM Offering, net of issuance costs, and $1.3 million proceeds from purchase under the ESPP. These proceeds were partially offset by $3.1 million in tax payments related to net share settlement of RSUs.

Current 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.

Previous wording

There have been no significant changes to our critical accounting estimates during the six months ended June 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 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.
Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

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

Current report — wording carried from elsewhere

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 report — wording carried from elsewhere

Net cash (used in) provided by financing activities

Current report — wording carried from elsewhere

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.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

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

Previous report — wording carried elsewhere

Net cash provided by (used in) financing activities