ADC Therapeutics SA
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout 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 7, 2024
ADCT$1.58-3.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0001628280-24-034999
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001628280-24-046050
Item 2. Management’s Discussion and Analysis of Financial Condition and 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 172 previous paragraphs and 136 current paragraphs.
73 unchanged; 47 reworded; 15 added; 49 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 15 previous and 13 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 (15)
Current report
Royalties were $448 thousand for the three months ended September 30, 2024 as compared to $226 thousand for the three months ended September 30, 2023.
Current report
(1) Beginning in September 30, 2024, Cami, ADCT-901 and ADCT-212 were included in Discontinued programs. Prior to September 30, 2024 these programs were separately presented as major development programs. Prior periods have been recast to conform to the current period presentation.
Current report
Research and development expenses for ZYNLONTA were $18.2 million for the three months ended September 30, 2024 as compared to $17.1 million for the three months ended September 30, 2023, an increase of $1.1 million. The increase was primarily due to higher chemistry, manufacturing and controls (“CMC”) expense of $1.8 million for LOTIS 5 and LOTIS
Current report
Discontinued programs
Current report
Spending on our discontinued programs have decreased from $2.5 million for the three months ended September 30, 2023 to $0.7 million for three months ended September 30, 2024, a decrease of $1.8 million. The decrease was attributable to decreased spending on ADCT-901 of $1.2 million, Cami of $0.3 million and ADCT-212 of $0.3 million.
Current report
Share-based compensation expense was $1.0 million for the three months ended September 30, 2024 as compared to $0.2 million for the three months ended September 30, 2023, an increase of $0.8 million. The increase was primarily driven by fluctuations in our share price and forfeitures of awards in connection with employee terminations during the three months ended September 30, 2023.
Current report
Cumulative catch-up adjustment income, deferred royalty obligation
Current report
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of $0.3 million and $1.4 million for the three months ended September 30, 2024 and 2023, respectively. For the three months ended September 30, 2024 we recorded our share of Overland ADCT Biopharma’s net loss up until the point at which our share of losses exceeded our interest in Overland ADCT BioPharma. Losses were not recognized in excess of our total investment, as we have not incurred legal or constructive obligations or committed to additional funding on behalf of the joint venture.
Current report
Nine Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023
Current report
Product revenues, net, was $52.9 million for the nine months ended September 30, 2024 as compared to $52.4 million for the nine months ended September 30, 2023, an increase of $0.5 million, or 0.9%. The increase is primarily attributable to a higher price, partially offset by lower sales volume.
Current report
Royalties were $1.0 million for the nine months ended September 30, 2024 as compared to $0.4 million for the nine months ended September 30, 2023.
Current report
(1) Beginning in September 30, 2024, Cami, ADCT-901 and ADCT-212 were included in Discontinued programs. Prior to September 30, 2024 these programs were separately presented as major development programs. Prior periods have been recast to conform to the current period presentation.
Current report
Discontinued programs
Current report
Spending on our discontinued programs including Cami, ADCT-901 and ADCT-212 have decreased from $19.4 million for the three months ended September 30, 2023 to $3.4 million for three months ended September 30, 2024, a decrease of $16.1 million. The decrease was attributable to decreased spending on Cami of $8.4 million, ADCT-212 of $4.4 million and ADCT-901 of $3.3 million.
Current report
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of $1.5 million and $3.5 million for the nine months ended September 30, 2024 and 2023, respectively. For the nine months ended September 30, 2024 we recorded our share of Overland ADCT BioPharma’s net loss up until the point at which our share of losses exceeded our interest in Overland ADCT BioPharma. Losses were not recognized in excess of our total investment, as we have not incurred legal or constructive obligations or committed to additional funding on behalf of the joint venture.
Removed paragraphs (49)
Previous report
Recent Developments
Previous report
Hematology
Previous report
In April 2024, the Company provided an update on the progress of the LOTIS-7 trial in hematology and on its technology platform capabilities, research and development activities and pipeline in the solid tumor space. In addition, in May 2024, IIT data was presented on ZYNLONTA in MZL.
Previous report
LOTIS-7
Previous report
On April 4, 2024, The Company announced the completion of dose escalation in LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with bispecific antibodies glofitamab or mosunetuzumab in heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).
Previous report
In the dose escalation portion (Part 1) of LOTIS-7, no dose-limiting toxicities (“DLTs”), no or low-grade cytokine release syndrome (“CRS”) and no immune effector cell-associated neurotoxicity syndrome (“ICANS”) were observed across all patients when ZYNLONTA was administered in combination with glofitamab or mosunetuzumab. Additionally, after the first investigator assessment, evidence of anti-tumor activity (complete response or partial response) was observed among the majority of patients, with mixed histologies including DLBCL, follicular lymphoma (“FL”) and marginal zone lymphoma (“MZL”). In addition, as of April 19, 2024, initial safety findings showed that the majority of CRS events seen were grade 1 (6 out of 18 patients) or grade 2 (2 of 18 patients), with no CRS greater than grade 2 observed in either combination arm. Furthermore, all grade 2 events responded to Tocilizumab/corticosteroids with no requirement for pressors or ICU management. Based on the data from Part 1, all three dose levels (90, 120 and 150 µg/kg) have now been cleared and enrollment in Part 2 dose expansion is ongoing with ZYNLONTA administered in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels in 2L+ DLBCL.
Previous report
The early data from Part 1 of the LOTIS-7 trial highlight the potential combinability of ZYNLONTA with bispecifics in lymphoma patients and continued progression of this trial in 2L+ DLBCL patients. The Company believes LOTIS-7 demonstrates the potential for ZYNLONTA plus bispecifics to enable broader accessibility in community settings, and based upon the current data and coupled with the potential for additive or synergistic efficacy with this combination, we are encouraged about the potential opportunity to expand the use of ZYNLONTA in DLBCL in the future where there remains high unmet need.
Previous report
LOTIS-7 is a Phase 1b global multicenter, multi-arm study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma including Part 1 (dose escalation) and Part 2 (dose expansion). The three dosing arms include ZYNLONTA plus polatuzumab vedotin, ZYNLONTA plus glofitamab, and ZYNLONTA plus mosunetuzumab T-cell-engaging bispecific monoclonal antibodies (“BsAbs”). Enrollment in LOTIS-7 includes Part 1 of the study with a 3+3 dose escalation in 3L/3L+ heavily pre-treated patients with ZYNLONTA doses starting at 90 µg/kg and then proceeding to 120 µg/kg and 150 µg/kg. The dose-limiting toxicity period has now been cleared across all three dose levels.
Previous report
The following table sets forth the Grade 3 and Grade 4 adverse events (AE), regardless of relatedness, for the LOTIS-7 Part 1 dose escalation as of April 19, 2024:
Previous report
*A patient may have more than one adverse event.
Previous report
The following table summarizes serious adverse events (SAE), regardless of relatedness, for the LOTIS-7 Part 1 dose escalation as of April 19, 2024:
Previous report
*CRS expressed as number of patients with at least 1 CRS event. 2 patients experienced multiple Grade 1 CRS events. 5 of 8 patients experiencing CRS coded SAE based on whether hospitalization required and/or prolonged.
Previous report
MZL
Previous report
Initial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) for the treatment of relapsed/refractory (r/r) MZL were presented on May 4, 2024, at the Lymphoma Research Foundation’s 2024 Marginal Zone Lymphoma Scientific Workshop by the trial’s lead investigator, Izidore Lossos, MD, Professor, Director, Lymphoma Program at the Sylvester Comprehensive Cancer Center, University of Miami. The 50-patient single-arm, open-label Phase 2 multicenter study is currently being conducted at the Sylvester Comprehensive Cancer Center at University of Miami and City of Hope, and led by Izidore Lossos. This study is evaluating the safety and efficacy of 6 cycles of ZYNLONTA across 18 weeks in patients with r/r MZL previously treated with ≥1 line of systemic therapy (www.clinicaltrials.gov identifier NCT05296070). As of the data cutoff date of March 30, 2024, 15 patients were evaluable. Of these 15 patients evaluated, 13 achieved a complete response (“CR”) and one patient achieved a partial response (“PR”). All patients who achieved responses had maintained them at the time of the data cutoff with the longest responder reaching approximately 20 months.
Previous report
In this study, according to the lead investigator, ZYNLONTA was generally well tolerated and safety was consistent with the known profile with two patient discontinuations. One patient discontinued after cycle 2 and a second patient discontinued after cycle 4 due to a toxicity which fully resolved upon discontinuation of treatment. Both of these patients remain in CR at 10 and 6 months respectively.
Previous report
MZL is a rare, indolent non-Hodgkin lymphoma (“NHL”) and the third most common NHL subtype. In the United States, there are an estimated 3,000 - 4,000 r/r MZL patients treated with systemic anti-cancer regimens annually. There are few FDA-approved therapies for MZL. With existing treatment options, despite patients achieving durable responses, high unmet medical need remains with <30% CR for 2L+ NCCN preferred treatments. Achievement of complete response to treatment represents the strongest predictor of positive outcomes in MZL. As this investigator-initiated trial progresses, with the expected number of sites expanding to 5 to help accelerate trial enrollment, assuming the results continue to be positive, the Company plans to potentially pursue a regulatory pathway and compendia strategy in parallel as soon as sufficient data are available. We believe the total addressable 2L+ MZL patient population has a potential peak market value of approximately $500 million, which assumes a total addressable population and average net price for ZYNLONTA in 2030 with a CAGR ~2% and ~3% respectively, and average cycles expected in MZL. The potential expansion in MZL contributes to the overall ZYNLONTA growth strategy in NHL.
Previous report
Solid Tumors
Previous report
Research Strategy, Platform and Pipeline
Previous report
Our solid tumor research strategy is focused on three key elements. First, we have identified areas of high unmet need that currently feature high use of chemotherapy. Second, we are pursuing targets within these tumor types that are amenable to an ADC approach. And third, we are utilizing our deep knowledge and broad toolkit to optimize the design of ADCs that fit with our first two criteria.
Previous report
On April 9, 2024, the Company hosted a virtual Research Investor Event featuring presentations from Ameet Mallik, Chief Executive Officer, and Patrick van Berkel, PhD, Chief Scientific Officer, sharing details on this strategy and highlighting recent updates and the Company’s novel exatecan-based antibody drug conjugate platform.
Previous report
As shared during this event, our four lead candidates have a differentiated profile based on a novel, proprietary linker approach to tracelessly release exatecan and a high therapeutic index, which reflects the proprietary design of our ADCs.
Previous report
Our Napi2b and Claudin-6 targeting ADCs are in IND-enabling studies and our PSMA and ASCT2 targeting ADCs are in drug candidate selection stage which we expect to complete this year. The Company expects to select and sponsor one targeted drug candidate for advancement toward IND enabling activity.
Previous report
Details include:
Previous report
•Claudin-6 and NaPI2b: As recently presented at the American Association for Cancer Research (“AACR”) Annual Meeting from preclinical studies supporting the future clinical development two of our lead candidates GB01-VA-PL2202 targeting Claudin-6 and NaPi2b-PL2202 targeting NaPi2b. These preclinical studies demonstrated the Company’s novel, exatecan-based ADCs, targeting Claudin-6 and NaPi2b, were well tolerated with potent and specific in vitro and in vivo anti-tumor activity. Based on these results, we believe a Claudin-6 directed ADC and a NaPi2b directed ADC have the potential for high impact in platinum-resistant ovarian cancer and non-small cell lung cancer.
Previous report
•PSMA: With PSMA-PL2202, we are developing an optimized ADC directed against a validated target with high potential impact in metastatic castrate resistant prostate cancer.
Previous report
•ASCT2: And with ASCT2-PL2202, we are designing an optimized ADC directed against a novel target with high potential impact in many indications including - but not limited to - colorectal cancer and non-small cell lung cancer.
Previous report
Beyond this, we are further diversifying our toolbox with drugs with other Mode of Actions, including other DNA damaging agents and immunomodulators and focus on conjugation technology to develop dual conjugate ADCs based on two different drugs with orthogonal modes of action.
Previous report
2024 Equity Offering
Previous report
In May 2024, the Company completed an underwritten offering of equity securities in which 13,411,912 of the Company’s common shares were sold to public investors at a price of $4.90 per share and pre-funded warrants (the “2024 Pre-Funded Warrants”) to purchase 8,163,265 of the Company’s common shares were sold to public investors at a price of $4.81 per pre-funded warrant, which equals the per share 2024 Equity Offering price, less the CHF 0.08 exercise price for each pre-funded warrant (collectively, the “2024 Equity Offering”). Gross proceeds from the 2024 Equity Offering were approximately $105.0 million, and, after giving effect to $7.6 million of transaction costs related to the offering, net proceeds were approximately $97.4 million.
Previous report
The 2024 Pre-Funded Warrants are exercisable, on a cash basis (or, if there is no registration statement and current prospectus covering the issuance of the shares upon exercise, then on a cashless basis), at the option of the holder after the date of issuance until the tenth anniversary of their original issuance. At any time during the last 90 days of the term, the holder may exchange the Pre-Funded Warrant for, and we will issue, a new pre-funded warrant for the number of common shares then remaining under the Pre-Funded Warrant. The Pre-Funded Warrants have certain limitations on exercise, including (i) any exercise must be for at least 50,000 common shares (or, if less, the remaining common shares available for purchase under the Pre-Funded Warrants), (ii) a holder cannot exercise for any amount that would cause such holder’s beneficial ownership of our common shares to exceed 9.99% (or 19.99% with 61-days’ notice to us), and (iii) cashless exercise is not available in certain circumstances as specified in the Pre-Funded Warrants. The Pre-Funded Warrants contain customary anti-dilution adjustments and will entitle holders to receive any dividends or other distributions paid on the underlying common shares prior to their expiration on an as-exercised basis. For additional information, see our Current Report on Form 8-K filed with the SEC on May 8, 2024.
Previous report
Product revenues, net, was $17.0 million for the three months ended June 30, 2024 as compared to $19.2 million for the three months ended June 30, 2023, a decrease of $2.2 million, or 11.3%. The decrease is primarily driven by lower sales volume, partially offset by a higher selling price.
Previous report
Royalties were $380 thousand for the three months ended June 30, 2024 as compared to $86 thousand for the three months ended June 30, 2023.
Previous report
Cami
Previous report
Research and development expenses for Cami were $0.3 million for the three months ended June 30, 2024 as compared to $3.2 million for the three months ended June 30, 2023, a decrease of $3.0 million. The decrease was primarily due to our evaluation of FDA feedback and decision to stop the program.
Previous report
ADCT-901
Previous report
Research and development expenses for ADCT-901 were $0.7 million for the three months ended June 30, 2024 as compared to $2.3 million for the three months ended June 30, 2023, a decrease of $1.6 million. The decrease is primarily attributable to lower clinical trial costs. We have re-prioritized the R&D pipeline to focus resources on the most advanced, lower risk value-generating programs and have therefore stopped investing on this preclinical program.
Previous report
ADCT-212
Previous report
Research and development expenses for ADCT-212 were nil for the three months ended June 30, 2024 as compared to $1.8 million for the three months ended June 30, 2023, a decrease of $1.8 million. The decrease is primarily attributable to a decrease in expenses related to IND enabling analytical work. We have re-prioritized the R&D pipeline to focus resources on the most advanced, lower risk value-generating programs and have therefore stopped investing on this preclinical program.
Previous report
Share-based compensation expense was $0.4 million for the three months ended June 30, 2024 as compared to an expense reversal of $0.1 million for the three months ended June 30, 2023, an increase of $0.5 million. The increase was primarily driven by the expense reversal associated with forfeitures of awards recognized during the three months ended June 30, 2023 in connection with employee terminations and the workforce reduction announced and put into effect during the second quarter of 2023.
Previous report
We recorded our proportionate share of Overland ADCT BioPharma’s net loss of $0.6 million and $0.8 million for the three months ended June 30, 2024 and 2023, respectively. The decrease in Overland ADCT BioPharma's net loss for thesix months ended June 30, 2024 as compared to thesix months ended June 30, 2023 was primarily attributable tolower R&D costs as the BLA submitted by Overland ADCT BioPharma has been accepted and granted priority review by the NMPA.
Showing the first 40 of 49 passages. Open the source sections for the rest.
Reworded paragraphs (47)
Previous wording
In the hematology space, our flagship product, ZYNLONTA, a CD19-directed ADC, received accelerated approval from the U.S. Food and Drug Administration (“FDA”) and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) after two or more lines of systemic therapy. We have a direct commercialization model in the US to help drive growth of ZYNLONTA. Outside the US, we continue to advance the development and commercialization of ZYNLONTA through strategic partnerships. We are seeking to continue expanding ZYNLONTA internationally, and into earlier lines of DLBCL and other indolent lymphomas, including follicular lymphoma (“FL”) and marginal zone lymphoma (“MZL”) as a single and combination agent of choice through our LOTIS-5 confirmatory Phase 3 clinical trial and LOTIS-7 Phase1b clinical trial as well as through investigator-initiated trials (“IITs”) at leading institutions. In addition, we are investigating a CD-22 targeted compound, ADCT-602, in a Phase 1/2 investigator-initiated study in relapsed or refractory B-cell acute lymphoblastic leukemia.
Current wording
In our hematology program, our flagship product, ZYNLONTA, a CD19-directed ADC, received accelerated approval from the U.S. Food and Drug Administration (“FDA”) and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”) after two or more lines of systemic therapy. We have a direct commercialization model in the U.S. to help drive growth of ZYNLONTA. Outside the U.S., we continue to advance the development and commercialization of ZYNLONTA through strategic partnerships. We are seeking to continue expanding ZYNLONTA internationally, and into earlier lines of DLBCL and other indolent lymphomas, including follicular lymphoma (“FL”) and marginal zone lymphoma (“MZL”) as a single and combination agent of choice through our LOTIS-5 confirmatory Phase 3 clinical trial and LOTIS-7 Phase1b clinical trial as well as through investigator-initiated trials (“IITs”) at leading institutions. In addition, we are investigating a CD-22 targeted compound, ADCT-602, in collaboration with MD Anderson Cancer Center in a Phase 1/2 investigator-initiated study in relapsed or refractory B-cell acute lymphoblastic leukemia.
Previous wording
In the solid tumor space, our clinical-stage pipeline consists of ADCT-601 (mipasetamab uzoptirine) targeting AXL as a single agent and/or in combination in sarcoma, pancreatic, and NSCLC. Our pre-clinical stage pipeline includes a portfolio of next generation investigational ADCs targeting Claudin-6, NaPi2b, PSMA and ASCT2. Investigational New Drug (IND) enabling studies are in progress for ADC targeting NaPi2b and Claudin-6 programs while PSMA and ASCT2 targeting ADCs are in drug candidate selection stage and are expected to be completed this year. In addition, we are advancing research with a range of payloads, linkers and conjugation technologies against undisclosed targets.
Current wording
In our solid tumor program, we have a pipeline of early stage pre-clinical research programs, and our clinical-stage program ADCT-601 (mipasetamab uzoptirine) targeting AXL as a single agent and/or in combination in sarcoma, pancreatic, and non-small cell lung cancer (“NSCLC”). Based on the available clinical data and capital requirements for continued development, we have made the decision to discontinue the phase 1b ADCT-601 program. Although early signs of antitumor activity were observed during the dose escalation phase, we were unable to demonstrate a favorable benefit-risk profile during the dose optimization/expansion phase. Our pre-clinical stage pipeline includes a portfolio of next generation investigational ADCs targeting Claudin-6, PSMA, NaPi2b and ASCT2. Investigational New Drug (IND) enabling studies are in progress for ADC targeting Claudin-6, PSMA and NaPi2b programs while ASCT2 targeting ADC is in drug candidate selection stage and is expected to be completed this year. In addition, we are advancing research with a range of payloads, linkers and conjugation technologies against undisclosed targets.
Previous wording
Product revenues, net, was $34.9 million for the six months ended June 30, 2024 as compared to $38.2 million for the six months ended June 30, 2023, a decrease of $3.3 million, or 8.6%. The decrease is primarily attributable to lower sales volume, partially offset by a higher price. The decrease in product revenues is also attributable to higher GTN deductions primarily due to a higher discarded drug rebate accrual for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. We expect to continue experiencing these higher level of GTN sales adjustments as a percentage of gross sales, and may also experience variability in GTN sales adjustments due to additional information and actual experience such as actual rebate and return rates.
Current wording
Product revenues, net, were $18.0 million for the three months ended September 30, 2024 as compared to $14.3 million for the three months ended September 30, 2023, an increase of $3.7 million, or 26.3%. The increase is primarily driven by higher sales volume and a higher selling price. The increase in product revenues is also attributable to lower GTN deductions primarily due to a lower discarded drug rebate accrual for the three months ended September 30, 2024 compared to the three months ended September 30, 2023.
Previous wording
Cost of product sales primarily includes direct and indirect costs relating to the third-party manufacture and distribution of ZYNLONTA, royalties payable to a collaboration partner based on net product sales of ZYNLONTA and inventory write-downs. We expect that cost of product sales will increase on an absolute basis as product revenue increases and as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation may also increase our cost of product sales as a percentage of product revenue if we are not able to increase the price at which we sell ZYNLONTA to offset such increases in our cost of product sales.
Current wording
Cost of product sales primarily includes direct and indirect costs relating to the third-party manufacture and distribution of ZYNLONTA, royalties payable to a collaboration partner based on net product sales of ZYNLONTA and inventory write-downs. We expect that cost of product sales will increase over time as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation may also increase our cost of product sales as a percentage of product revenue if we are not able to increase the price at which we sell ZYNLONTA to offset such increases in our cost of product sales.
Previous wording
Cost of product sales were $1.2 million for the three months ended June 30, 2024 as compared to cost of product sales of $1.1 million for the three months ended June 30, 2023 an increase of $0.1 million, or 7.5%. While product sales decreased, the increase in cost of product sales was primarily driven by higher commercial shipping and storage costs during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.
Current wording
Cost of product sales were $0.9 million for the three months ended September 30, 2024 as compared to cost of product sales of $0.2 million for the three months ended September 30, 2023 an increase of $0.6 million, or 309.1%. The increase in cost of product sales was primarily driven by higher commercial shipping, storage and stability costs during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023.
Previous wording
(1)Includes third-party contracting and employee expenses, as well as expense for preclinical research, storage, shipping and lab consumables that span multiple programs.
Current wording
(2)Includes third-party contracting and employee expenses, as well as expense for preclinical research, storage, shipping and lab consumables that span multiple programs.
Previous wording
Our R&D expenses were $24.3 million for the three months ended June 30, 2024 as compared to $31.3 million for the three months ended June 30, 2023, a decrease of $7.0 million, or 22.5%, primarily due to lower spend on ZYNLONTA R&D as discussed in more detail below, a reduction of costs associated with Cami development as the program was discontinued, other productivity and cost savings initiatives and focused investment toward prioritized development programs.
Current wording
Our R&D expenses were $32.5 million for the three months ended September 30, 2024 as compared to $27.1 million for the three months ended September 30, 2023, an increase of $5.4 million, or 20.0%, primarily due to higher spend on ZYNLONTA, ADCT-601 and other R&D research strategy, platform and pipeline initiatives, partially offset by other productivity and cost savings initiatives and decreased spending on discontinued programs, as discussed below.
Previous wording
Research and development expenses for ADCT-601 were $4.5 million for the three months ended June 30, 2024 as compared to $2.5 million for the three months ended June 30, 2023, an increase of $2.0 million. The increase is primarily attributable to higher patient enrollment and progress towards the completion of the study.
Current wording
Research and development expenses for ADCT-601 were $5.6 million for the three months ended September 30, 2024 as compared to $2.2 million for the three months ended September 30, 2023, an increase of $3.4 million. The increase is primarily attributable to higher patient enrollment and progress towards the completion of the study. The ADCT-601 program will be discontinued and is no longer enrolling patients.
Previous wording
Research and development expenses associated with our preclinical product candidates and research pipeline were $3.7 million for the three months ended June 30, 2024 as compared to $2.5 million for the three months ended June 30, 2023, an increase of $1.2 million. The increase is primarily attributable to increased spending on our research strategy, platform and pipeline initiatives including Claudin-6, Napi2b, PSMA and ASCT2.
Current wording
Research and development expenses associated with our preclinical product candidates and research pipeline were $4.6 million for the three months ended September 30, 2024 as compared to $2.8 million for the three months ended September 30, 2023. The increase is primarily attributable to increased spending on our research strategy, platform and pipeline initiatives including Claudin-6, PSMA and ASCT2.
Previous wording
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment). We expect our S&M expenses to decrease as a percentage of revenue over time as we have transitioned to being a commercial-stage public organization and implemented a new go-to-market model in 2023 to help drive growth and optimize local area influence.
Current wording
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment).
Previous wording
Selling and marketing expenses were $10.7 million for the three months ended June 30, 2024 as compared to $14.5 million for the three months ended June 30, 2023, a decrease of $3.8 million or 26.0%. The decrease in external costs and overhead was primarily attributable to $3.8 million in lower spend on marketing and advertising expenses as a result of reduced spending initiatives within the US, partially offset by $0.3 million in higher travel and IT expenses. The decrease in employee expenses was primarily due to lower wages and benefits of $0.8 million primarily due to decreased headcount, as well as lower recruitment costs of $0.3 million. The increase in share-based compensation expense of $0.8 million was primarily driven by the expense reversal associated with forfeitures of awards recognized during the three months ended June 30, 2023 in connection with employee terminations and the workforce reduction announced and put into effect during the second quarter of 2023.
Current wording
Selling and marketing expenses were $10.7 million for the three months ended September 30, 2024 as compared to $13.7 million for the three months ended September 30, 2023, a decrease of $3.1 million or 22.3%. The decrease in external costs and overhead was primarily attributable to $3.1 million in lower spend on marketing and advertising expenses as a result of reduced spending initiatives within the U.S. The decrease in employee expenses was primarily due to lower wages and benefits of $0.3 million. The increase in share-based compensation expense was primarily due to fluctuations in our share price, as well as lower forfeitures of awards in connection with employee terminations.
Previous wording
General and administrative expenses were $10.2 million for the three months ended June 30, 2024 as compared to $12.0 million for the three months ended June 30, 2023, a decrease of $1.8 million, or 14.7%. The decrease in external costs and overhead was primarily related to lower legal and audit fees of $1.2 million, insurance costs of $0.3 million and IT expenses of $0.2 million. The increase in employee expenses was primarily due to higher wages and benefits and recruitment costs. The decrease in share-based compensation expense was primarily due to fluctuations in our share price, as well as forfeitures of awards in connection with employee terminations.
Current wording
General and administrative expenses were $10.0 million for the three months ended September 30, 2024 as compared to $9.6 million for the three months ended September 30, 2023, an increase of $0.4 million, or 3.9%. External costs and overhead costs decreased primarily as a result of lower insurance costs of $0.4 million. The increase in employee expenses was primarily due to higher wages, benefits and recruitment costs of $1.0 million. The decrease in share-based compensation expense was primarily due to fluctuations in our share price.
Previous wording
Interest income was $3.3 million for the three months ended June 30, 2024 as compared to $2.4 million for the three months ended June 30, 2023, an increase of $0.9 million. The increase was due to higher average cash balances.
Current wording
Interest income was $3.4 million for the three months ended September 30, 2024 as compared to $2.7 million for the three months ended September 30, 2023, an increase of $0.7 million. The increase was due to higher average cash balances and higher yields received on cash deposits.
Previous wording
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $12.7 million for the three months ended June 30, 2024 as compared to $10.3 million for the three months ended June 30, 2023, an increase of $2.4 million, or 23.0%. The increase was related to higher accretion of our deferred royalty obligation with HCR as a result of the $73.1 million, net of transaction costs, received in
Current wording
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $13.1 million for the three months ended September 30, 2024 as compared to $12.8 million for the three months ended September 30, 2023, an increase of $0.3 million, or 2.3%. The increase was related to higher accretion of our deferred royalty obligation with HCR.
Previous wording
Pursuant to an Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to Deerfield to purchase an aggregate of 4,412,840 common shares. The Deerfield warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on August 15, 2022 and is remeasured to fair value at the end of each reporting period. The income of $2.2 million and nil as a result of changes in the warrant obligation for the three months ended June 30, 2024 and 2023, respectively, was primarily due to the decrease in fair value of the underlying shares during the respective periods.
Current wording
Pursuant to an Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to Deerfield to purchase an aggregate of 4,412,840 common shares. The Deerfield warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on August 15, 2022 and is remeasured to fair value at the end of each reporting period. The income of $1.1 million for the three months ended September 30, 2024 was primarily due to a decrease in projected volatility of the underlying shares during the period while the income of $0.1 million for the three months ended September 30, 2023 was primarily due to the decrease in fair value of the underlying shares during the respective period.
Previous wording
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income (expense) was $0.5 million for the six months ended June 30, 2024 as compared to $(5.3) million for the six months ended June 30, 2023, a change of $5.7 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2023, which revisions were primarily attributable to the Company’s updated strategic and development plans.
Current wording
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income of $0.2 million and $0.4 million as a result of changes in the deferred royalty obligation for the three months ended September 30, 2024 and 2023, respectively, was primarily due to the quarterly revenue results incorporated into the valuation model during the respective periods.
Previous wording
We are subject to corporate taxation in Switzerland. We are also subject to taxation in other jurisdictions in which we operate, in particular, the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. We recorded an income tax (expense) benefit of $(0.2) million for the three months ended June 30, 2024 as compared to $4.5 million for the three months ended June 30, 2023, primarily driven by our US operations and transfer pricing model which was implemented in the fourth quarter of 2023.
Current wording
We are subject to corporate taxation in Switzerland. We are also subject to taxation in other jurisdictions in which we operate, in particular, the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. We recorded an income tax (expense) benefit of $(0.1) million for the three months ended September 30, 2024 as compared to $0.1 million for the three months ended September 30, 2023. The change is primarily driven by the new transfer pricing model which was implemented in the fourth quarter of 2023.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:
Previous wording
We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. In the long term, we expect that our product revenue will increase as we execute our business strategy, although our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration, of patient therapy and customers’ buying patterns and gross-to-net deductions.
Current wording
We generate product revenue through the sale of ZYNLONTA in the United States. Revenue is recognized when control is transferred to the customer at the net selling price, which includes reductions for gross-to-net (“GTN”) sales adjustments such as government rebates, chargebacks, distributor service fees, other rebates and administrative fees, sales returns and allowances and sales discounts. In the long term, we expect that our product revenue will increase as we execute our business strategy, although our product revenue may fluctuate from period to period based on a number of factors, including patient demand, as well as the timing, dose and duration, of patient therapy and customers’ buying patterns and GTN deductions. We expect a similar level of GTN sales adjustments as a percentage of gross sales, and may also experience variability in GTN sales adjustments due to additional information and actual experience such as actual rebate and return rates.
Previous wording
Cost of product sales primarily includes direct and indirect costs relating to the third-party manufacture and distribution of ZYNLONTA, royalties payable to a collaboration partner based on net product sales of ZYNLONTA and inventory write-downs. We expect that cost of product sales will increase on an absolute basis as product revenue increases and as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation may also increase our cost of product sales as a percentage of product revenue if we are not able to increase the price at which we sell ZYNLONTA to offset such increases in our cost of product sales.
Current wording
Cost of product sales primarily includes direct and indirect costs relating to the third-party manufacture and distribution of ZYNLONTA, royalties payable to a collaboration partner based on net product sales of ZYNLONTA and inventory write-downs. We expect that cost of product sales will increase over time as we sell through pre-approval inventory that was previously expensed prior to commercialization under U.S. GAAP. Factors such as inflation may also increase our cost of product sales as a percentage of product revenue if we are not able to increase the price at which we sell ZYNLONTA to offset such increases in our cost of product sales.
Previous wording
Cost of product sales were $3.7 million for the six months ended June 30, 2024 as compared to cost of product sales of $1.1 million for the six months ended June 30, 2023. The increase is primarily attributable to a $1.1 million batch cancellation fee, a $0.6 million increase in our excess inventory reserve and higher stability, shipping and storage costs of $0.6 million recognized during the six months ended June 30, 2024, as well as a $0.3 million manufacturing credit received from a contract manufacturer which was recorded as a reduction to cost of product sales for the three months ended June 30, 2023.
Current wording
Cost of product sales were $4.6 million for the nine months ended September 30, 2024 as compared to cost of product sales of $1.3 million for the nine months ended September 30, 2023. The increase is primarily attributable to a $1.1 million batch cancellation fee, higher stability, shipping and storage costs of $1.2 million recognized during the nine months ended September 30, 2024, a $0.6 million increase in our excess inventory reserve, and a $0.3 million manufacturing credit received from a contract manufacturer which was recorded as a reduction to cost of product sales for the nine months ended September 30, 2023.
Previous wording
The following table summarizes our research and development expenses for our major development programs for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our research and development expenses for our major development programs for the nine months ended September 30, 2024 and 2023:
Previous wording
(1)Includes third-party contracting and employee expenses, as well as expense for preclinical research, storage, shipping and lab consumables that span multiple programs.
Current wording
(2)Includes third-party contracting and employee expenses, as well as expense for preclinical research, storage, shipping and lab consumables that span multiple programs.
Previous wording
Our R&D expenses were $50.0 million for the six months ended June 30, 2024 as compared to $69.7 million for the six months ended June 30, 2023, a decrease of $19.7 million, or 28.2%, primarily due to lower spending on ZYNLONTA and Cami programs, as discussed below and focused investment toward prioritized development programs.
Current wording
Our R&D expenses were $82.5 million for the nine months ended September 30, 2024 as compared to $96.8 million for the nine months ended September 30, 2023, a decrease of $14.3 million, or 14.7%, primarily due to lower spending on ZYNLONTA and focused investment toward prioritized development programs, as discussed below.
Previous wording
Research and development expenses for ZYNLONTA were $12.2 million for the three months ended June 30, 2024 as compared to $16.5 million for the three months ended June 30, 2023, a decrease of $4.4 million. The decrease was primarily due to lower clinical trial costs for LOTIS 3, LOTIS 5, LOTIS 6 and LOTIS 7, as well as lower professional fees related to ZYNLONTA for the three months ended June 30, 2024 as a result of productivity initiatives and portfolio prioritization.
Current wording
Research and development expenses for ZYNLONTA were $45.4 million for the nine months ended September 30, 2024 as compared to $52.8 million for the nine months ended September 30, 2023, a decrease of $7.5 million. The decrease was primarily due to lower clinical trial costs for LOTIS 3, LOTIS 5, LOTIS 6 and LOTIS 7 of $2.6 million, as well as lower professional fees of $1.9 million related to ZYNLONTA for the nine months ended September 30, 2024 as a result of productivity initiatives and portfolio prioritization.
Previous wording
Research and development expenses for ADCT-601 were $7.8 million for the six months ended June 30, 2024 as compared to $4.5 million for the six months ended June 30, 2023, an increase of $3.3 million. The increase is primarily attributable to higher patient enrollment and progress towards the completion of the study.
Current wording
Research and development expenses for ADCT-601 were $13.5 million for the nine months ended September 30, 2024 as compared to $6.7 million for the nine months ended September 30, 2023, an increase of $6.7 million. The increase is primarily attributable to higher patient enrollment and progress towards the completion of the study. The ADCT-601 program will be discontinued and is no longer enrolling patients.
Previous wording
Research and development expenses associated with our preclinical product candidates and research pipeline were $7.4 million for the six months ended June 30, 2024 as compared to $4.9 million for the six months ended June 30, 2023, an increase of $2.5 million. The increase is primarily attributable to increased spending on our research strategy, platform and pipeline initiatives including Claudin-6, Napi2b, PSMA and ASCT2.
Current wording
Research and development expenses associated with our preclinical product candidates and research pipeline were $12.0 million for the nine months ended September 30, 2024 as compared to $7.7 million for the nine months ended September 30, 2023, a decrease of $4.3 million. The increase is primarily attributable to increased spending on our research strategy, platform and pipeline initiatives including Claudin-6, Napi2b, PSMA and ASCT2.
Previous wording
Share-based compensation expense reversals were $0.1 million for the six months ended June 30, 2024 as compared to expense of $3.0 million for the six months ended June 30, 2023, a decrease of $3.2 million. The decrease was primarily driven by fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Current wording
Share-based compensation expense was $0.8 million for the nine months ended September 30, 2024 as compared to $3.2 million for the nine months ended September 30, 2023, a decrease of $2.3 million. The decrease was primarily driven by fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Previous wording
The following table summarizes our selling and marketing expenses for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our selling and marketing expenses for the nine months ended September 30, 2024 and 2023:
Previous wording
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment). We expect our S&M expenses to decrease as a percentage of revenue over time as we have transitioned to being a commercial-stage public organization and implemented a new go-to-market model in 2023 to help drive growth and optimize local area influence.
Current wording
Selling and marketing costs (“S&M”) are expensed as incurred and are primarily attributable to commercialization of ZYNLONTA in the United States. S&M includes employee costs and share-based compensation expense for commercial employees and external costs related to commercialization (including professional fees, communication costs and IT costs, travel expenses and depreciation of property and equipment).
Previous wording
Selling and marketing expenses were $22.1 million for the six months ended June 30, 2024 as compared to $29.8 million for the six months ended June 30, 2023, a decrease of $7.7 million or 25.9%. The decrease in external costs and overhead was primarily attributable to $5.3 million in lower spend on marketing and advertising expenses as a result of reduced spending initiatives within the US, partially offset by higher travel and IT expenses of $0.3 million. The decrease in employee expenses was primarily due to lower wages and benefits of $1.9 million primarily due to decreased headcount, as well as lower recruitment costs of $0.2 million. The decrease in share-based compensation expense of $0.5 million was primarily due to fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Current wording
Selling and marketing expenses were $32.8 million for the nine months ended September 30, 2024 as compared to $43.5 million for the nine months ended September 30, 2023, a decrease of $10.8 million or 24.7%. The decrease in external costs and overhead was primarily attributable to $8.4 million in lower spend on marketing and advertising expenses as a result of reduced spending initiatives within the U.S., partially offset by higher travel and IT expenses of $0.4 million. The decrease in employee expenses was primarily due to lower wages and benefits of $2.2 million primarily due to decreased headcount, as well as lower recruitment costs of $0.2 million. The decrease in share-based compensation expense of $0.3 million was primarily due to fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Previous wording
The following table summarizes our general and administrative expenses for the six months ended June 30, 2024 and 2023:
Current wording
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2024 and 2023:
Previous wording
General and administrative expenses were $22.3 million for the six months ended June 30, 2024 as compared to $27.5 million for the six months ended June 30, 2023, a decrease of $5.2 million, or 19.0%. The decrease in external costs and overhead was primarily related to lower insurance and IT costs of $1.0 million, partially offset by higher legal and audit fees of $0.3 million. The decrease in employee expenses was primarily due to lower wages and benefits of $1.4 million partially offset by higher recruitment costs of $0.3 million. The decrease in share-based compensation expense was primarily due to fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Current wording
General and administrative expenses were $32.3 million for the nine months ended September 30, 2024 as compared to $37.1 million for the nine months ended September 30, 2023, a decrease of $4.9 million, or 13.1%. The decrease in external costs and overhead was primarily related to lower insurance and IT costs of $1.1 million. The decrease in employee expenses was primarily due to lower wages and benefits of $0.4 million partially offset by higher recruitment costs of $0.2 million. The decrease in share-based compensation expense was primarily due to fluctuations in our share price as well as forfeitures of awards in connection with employee terminations.
Previous wording
Interest income was $6.2 million for the six months ended June 30, 2024 as compared to $4.5 million for the six months ended June 30, 2023, an increase of $1.7 million or 36.4%. The increase was due to higher yields received on our cash deposits during the six months ended June 30, 2024 and higher average cash balances.
Current wording
Interest income was $9.6 million for the nine months ended September 30, 2024 as compared to $7.3 million for the nine months ended September 30, 2023, an increase of $2.4 million or 33.0%. The increase was due to higher average cash balances and higher yields received on cash deposits.
Previous wording
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $25.2 million for the six months ended June 30, 2024 as compared to $20.6 million for the six months ended June 30, 2023, an increase of $4.6 million, or 22.2%. The increase was related to higher accretion of our deferred royalty obligation with HCR as a result of the $73.1 million, net of transaction costs, received in June 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country, which increased the liability.
Current wording
Interest expense is primarily related to the accretion of our deferred royalty obligation with HCR and the senior secured term loan facility. Interest expense was $38.3 million for the nine months ended September 30, 2024 as compared to $33.4 million for the nine months ended September 30, 2023, an increase of $4.9 million, or 14.6%. The increase was related to higher accretion of our deferred royalty obligation with HCR as a result of the $73.1 million, net of transaction costs, received in June 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country, which increased the liability.
Previous wording
Other, net for the six months ended June 30, 2024 and 2023 included the following:
Current wording
Other, net for the nine months ended September 30, 2024 and 2023 included the following:
Previous wording
Deerfield Warrant Obligation, Change in Fair Value (Expense) Income
Current wording
Deerfield Warrant Obligation, Change in Fair Value Income
Previous wording
Pursuant to an Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to Deerfield to purchase an aggregate of 4,412,840 common shares. The Deerfield warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on August 15, 2022 and is remeasured to fair value at the end of each reporting period. The (expense) income of $(0.8) million and $0.6 million as a result of changes in the warrant obligation for the six months ended June 30, 2024 and 2023, respectively, was primarily due to the (increase) decrease in fair value of the underlying shares during the respective periods.
Current wording
Pursuant to an Exchange Agreement with Deerfield entered into on August 15, 2022, the Company issued warrants to Deerfield to purchase an aggregate of 4,412,840 common shares. The Deerfield warrant obligation has been recorded at its initial fair value at the time the agreement was entered into on August 15, 2022 and is remeasured to fair value at the end of each reporting period. The income of $0.3 million for the nine months ended September 30, 2024 was primarily due to a decrease in the projected volatility of the underlying shares partially offset by an increase in fair value of the underlying shares during the respective period while the income of $0.8 million during the nine months ended September 30, 2023 was primarily due to the decrease in fair value of the underlying shares during the respective period.
Previous wording
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income (expense) was $0.3 million for the three months ended June 30, 2024 as compared to $(5.4) million for the three months ended June 30, 2023, a change of $5.7 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2023, which revisions were primarily attributable to the Company’s updated strategic and development plans.
Current wording
We periodically assess the expected payments to HCR based on our underlying revenue projections and to the extent the amount or timing of such payments is materially different than our initial estimates we will record a cumulative catch-up adjustment to the deferred royalty obligation. The adjustment to the carrying amount is recognized in Other, net as an adjustment in the period in which the change in estimate occurred. The cumulative catch-up adjustment income (expense) was $0.7 million for the nine months ended September 30, 2024 as compared to $(4.9) million for the nine months ended September 30, 2023, a change of $5.6 million. The change was primarily due to revised revenue forecasts incorporated into the valuation model in 2023, which revisions were primarily attributable to the Company’s updated strategic and development plans.
Previous wording
We are subject to corporate taxation in Switzerland. We are also subject to taxation in other jurisdictions in which we operate, in particular, the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. We recorded an income tax (expense) benefit of $(0.4) million for the six months ended June 30, 2024 as compared to $4.0 million for the six months ended June 30, 2023, primarily driven by our US operations and transfer pricing model which was implemented in the fourth quarter of 2023.
Current wording
We are subject to corporate taxation in Switzerland. We are also subject to taxation in other jurisdictions in which we operate, in particular, the United States and the United Kingdom, where our two wholly-owned subsidiaries are incorporated. We recorded an income tax (expense) of $(0.5) million for the nine months ended September 30, 2024 as compared to an income tax benefit of $4.1 million for the nine months ended September 30, 2023, primarily driven by our U.S. and UK operations and transfer pricing model which was implemented in the fourth quarter of 2023.
Showing the first 40 of 47 pairs. Open the source sections for the rest.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
7, partially offset by lower professional fees of $0.5 million related to ZYNLONTA for the three months ended September 30, 2024 as a result of productivity initiatives and portfolio prioritization.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
June 2023 upon the first commercial sale of ZYNLONTA in the United Kingdom or any European Union country, which increased the liability.
Previous report — wording carried elsewhere
Research and development expenses for ZYNLONTA were $27.1 million for the six months ended June 30, 2024 as compared to $35.8 million for the six months ended June 30, 2023, a decrease of $8.6 million. The decrease was primarily due to lower clinical trial costs for LOTIS 3, LOTIS 5, LOTIS 6 and LOTIS 7, as well as lower professional fees related to ZYNLONTA for the six months ended June 30, 2024 as a result of productivity initiatives and portfolio prioritization.
Previous report — wording carried elsewhere
Cumulative catch-up adjustment income (expense), deferred royalty obligation