Theravance Biopharma Inc

Previous wording

You should read the following discussion in conjunction with our condensed consolidated financial statements (unaudited) and related notes included elsewhere in this report. This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements involve risks, uncertainties, and assumptions. All statements in this report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, designs, expectations, and objectives are forward-looking statements. The words “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “designed,” “developed,” “drive,” “estimate,” “expect,” “forecast,” “goal,” “indicate,” “intend,” “may,” “mission,” “opportunities,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “represent,” “seek,” “suggest,” “should,” “target,” “will,” “would,” and similar expressions (including the negatives thereof) are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward-looking statements and the assumptions underlying our forward-looking statements may prove incorrect. Therefore, you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and objectives disclosed in the forward-looking statements that we make. Factors that we believe could cause actual results or events to differ materially from our forward-looking statements include, but are not limited to, those discussed in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report and in our Annual Report on Form 10-K for the year ended December 31, 2023. Our forward-looking statements in this report are based on current expectations, and we do not assume any obligation to update any forward-looking statements for any reason, even if new information becomes available in the future. When used in this report, all references to “Theravance Biopharma”, the “Company”, or “we” and other similar pronouns refer to Theravance Biopharma, Inc. collectively with its subsidiaries.

Current wording

You should read the following discussion in conjunction with our condensed consolidated financial statements (unaudited) and related notes included elsewhere in this report. This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements involve risks, uncertainties, and assumptions. All statements in this report, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, designs, expectations, and objectives are forward-looking statements. The words “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “designed,” “developed,” “drive,” “estimate,” “expect,” “forecast,” “goal,” “indicate,” “intend,” “may,” “mission,” “opportunities,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “represent,” “seek,” “suggest,” “should,” “target,” “will,” “would,” and similar expressions (including the negatives thereof) are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements reflect our current views with respect to future events or our future financial performance, are based on assumptions, and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward-looking statements and the assumptions underlying our forward-looking statements may prove incorrect. Therefore, you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and objectives disclosed in the forward-looking statements that we make. Factors that we believe could cause actual results or events to differ materially from our forward-looking statements include, but are

Previous wording

In pursuit of our purpose, we leverage decades of expertise, which has led to the development of the United States (“US”) Food and Drug Administration (the “FDA”) approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”). Ampreloxetine, our late-stage investigational once-daily norepinephrine reuptake inhibitor in development for the

Current wording

In pursuit of our purpose, we leverage decades of expertise, which has led to the development of the United States (“US”) Food and Drug Administration (the “FDA”) approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”). Ampreloxetine, our late-stage investigational once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (“nOH”) in patients with Multiple System Atrophy (“MSA”) has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients.

Previous wording

We co-developed YUPELRI with our collaboration partner, Viatris Inc. Under the terms of the Viatris Development and Commercialization Agreement (the “Viatris Agreement”), we led the US Phase 3 development program for YUPELRI in COPD, and Viatris was responsible for reimbursement of our costs related to the registrational program up until the approval of the first new drug application, after which costs were shared. YUPELRI was approved by the FDA for the maintenance treatment of patients with COPD in November 2018. In the US, Viatris is leading the commercialization of YUPELRI, and we co-promote the product under a profit and loss sharing arrangement (65% to Viatris; 35% to us). Outside the US (excluding China and adjacent territories), Viatris is responsible for development and commercialization and will pay us a tiered royalty on net sales at percentage royalty rates ranging from low double-digits to mid-teens. We retain worldwide rights to revefenacin delivered through other dosage forms, such as a MDI/DPI.

Current wording

We co-developed YUPELRI with our collaboration partner, Viatris Inc. Under the terms of the Viatris Development and Commercialization Agreement (the “Viatris Agreement”), we led the US Phase 3 development program for YUPELRI in COPD, and Viatris was responsible for reimbursement of our costs related to the registrational program up until the approval of the first new drug application, after which costs were shared. YUPELRI was approved by the FDA for the maintenance treatment of patients with COPD in November 2018. In the US, Viatris is leading the commercialization of YUPELRI, and we co-promote the product under a profit and loss sharing arrangement (65% to Viatris; 35% to us). Outside the US (excluding China and adjacent territories), Viatris is responsible for development and commercialization and will pay us a tiered royalty on net sales at percentage royalty rates ranging from low double-

Previous wording

Under the terms of the Viatris Agreement, as amended, as of June 30, 2024, we were eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding the China Region) of up to $205.0 million in the aggregate with $160.0 million associated with YUPELRI monotherapy and $45.0 million associated with future potential combination products. Of the $160.0 million associated with monotherapy, $10.0 million relates to regulatory actions in the EU and $150.0 million relates to sales milestones based on achieving certain levels of annual US net sales as follows:

Current wording

Under the terms of the Viatris Agreement, as amended, as of September 30, 2024, we were eligible to receive from Viatris potential global development, regulatory and sales milestone payments (excluding the China Region) of up to $205.0 million in the aggregate with $160.0 million associated with YUPELRI monotherapy and $45.0 million associated with future potential combination products. Of the $160.0 million associated with monotherapy, $10.0 million relates to regulatory actions in the EU and $150.0 million relates to sales milestones based on achieving certain levels of annual aggregate US net sales as follows:

Previous wording

In August 2021, we announced that in collaboration with our partner Viatris, we were initiating a Phase 4 study comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment with either revefenacin (YUPELRI) delivered via standard jet nebulizer or tiotropium delivered via a dry powder inhaler (Spiriva® HandiHaler®). This study was aimed at helping to better inform decisions when physicians are designing a personalized COPD treatment plan with patients. In January 2024, we announced that the Phase 4 study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV 1) at day 85. While the primary endpoint in the Phase 4 study was not met, YUPELRI demonstrated an efficacy and safety profile consistent with its performance in other clinical studies.

Current wording

tiotropium delivered via a dry powder inhaler (Spiriva® HandiHaler®). This study was aimed at helping to better inform decisions when physicians are designing a personalized COPD treatment plan with patients. In January 2024, we announced that the Phase 4 study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV 1) at day 85. While the primary endpoint in the Phase 4 study was not met, YUPELRI demonstrated an efficacy and safety profile consistent with its performance in other clinical studies.

Previous wording

In April 2022, we reported that the REDWOOD Phase 3 clinical study did not meet its primary endpoint as the results were not statistically significant for the overall population of patients which included patients with PD, PAF, and MSA. The pre-specified subgroup analysis by disease type suggested that the average benefit seen in patients receiving ampreloxetine was largely driven by a benefit to MSA patients. The benefit to MSA patients in the study was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment Scale (“OHSA”) composite, Orthostatic Hypotension Daily Activities Scale (“OHDAS”) composite, Orthostatic Hypotension Questionnaire (“OHQ”) composite and OHSA #1. Throughout the study, there was no indication of worsening of supine hypertension among any of the patient sub-groups. Data suggest that ampreloxetine was well-tolerated and no new safety signals were identified among any of the patient sub-groups.

Current wording

In April 2022, we reported that the REDWOOD Phase 3 clinical study did not meet its primary endpoint as the results were not statistically significant for the overall population of patients which included patients with PD, PAF, and MSA. The pre-specified subgroup analysis by disease type suggested that the average benefit seen in patients receiving ampreloxetine was largely driven by a benefit to MSA patients. The benefit to MSA patients in the study was observed in multiple endpoints including Orthostatic Hypotension Symptom Assessment Scale (“OHSA”) composite, Orthostatic Hypotension Daily Activities Scale (“OHDAS”) composite, Orthostatic Hypotension Questionnaire (“OHQ”) composite

Previous wording

In June 2022, we held a Type C meeting with the FDA. From this meeting, we aligned on a path to a New Drug Application (“NDA”) filing with one additional Phase 3 clinical study (CYPRESS) in MSA patients with symptomatic nOH, using the OHSA composite score as the primary endpoint. This Phase 3 study was initiated in the first quarter of 2023, and we currently anticipate that the final patient will be enrolled in the open label period of the study in mid-2025 and top-line data will be available approximately 6 months thereafter. In May 2023, we announced that the FDA granted Orphan Drug Designation status to ampreloxetine for the treatment of symptomatic nOH in patients with MSA.

Current wording

In June 2022, we held a Type C meeting with the FDA. From this meeting, we aligned on a path to a New Drug Application (“NDA”) filing with one additional Phase 3 clinical study (CYPRESS) in MSA patients with symptomatic nOH, using the OHSA composite score as the primary endpoint. This Phase 3 study was initiated in the first quarter of 2023, and we currently anticipate that the final patient will be enrolled in the open label period of the study in mid-2025 and top-line data will be available approximately six months thereafter. In May 2023, we announced that the FDA granted Orphan Drug Designation status to ampreloxetine for the treatment of symptomatic nOH in patients with MSA.

Previous wording

From and after January 1, 2023, for any calendar year starting with the year ended December 31, 2023 and ending with the year December 31, 2026, upon certain milestone minimum royalty amounts for TRELEGY being met, Royalty Pharma is obligated to make certain cash payments to us (the “Milestone Payment(s)”). As of June 30, 2024, a total of $200.0 million in potential Milestone Payments remain available to us. For the next potential Milestone Payment, we are eligible to receive either (i) $25.0 million if Royalty Pharma receives $240.0 million or more in royalty payments from GSK with respect to 2024 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales are approximately $2.86 billion; or (ii) $50.0 million if Royalty Pharma receives $275.0 million or more in royalty payments from GSK with respect to 2024 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales exceed approximately $3.21 billion.

Current wording

From and after January 1, 2023, for any calendar year starting with the year ended December 31, 2023 and ending with the year December 31, 2026, upon certain milestone minimum royalty amounts for TRELEGY being met, Royalty Pharma is obligated to make certain cash payments to us (the “Milestone Payments(s)”). As of September 30, 2024, a total of $200.0 million in potential Milestone Payments remain available to us. For the next potential Milestone Payment, we are eligible to receive either (i) $25.0 million if Royalty Pharma receives $240.0 million or more in royalty payments from GSK with respect to 2024 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales are approximately $2.86 billion; or (ii) $50.0 million if Royalty Pharma receives $275.0 million or more in royalty payments from GSK with respect to 2024 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales exceed approximately $3.21 billion. The $2.86 billion and $3.21 billion global net sales thresholds would represent increases of approximately 4% and 17%, respectively, compared to 2023 global net sales.

Previous wording

TRELEGY global net sales for the three and six months ended June 30, 2024 were $1.07 billion and $1.81 billion, respectively, which represented a 40% and 37% year-over-year growth, respectively. TRELEGY is expected to generate global peak sales of $4.0 billion in 2027 according to Bloomberg consensus estimates as of early August 2024. Total 2023 TRELEGY global net sales were $2.74 billion which represented a 28% year-over-year growth.

Current wording

TRELEGY global net sales for the three and nine months ended September 30, 2024 were $789 million and $2.60 billion, respectively, which represented 17% and 30% year-over-year growth, respectively. TRELEGY is expected to generate global peak sales of $4.0 billion in 2026 according to Bloomberg consensus estimates as of late October 2024. Total 2023 TRELEGY global net sales were $2.74 billion which represented a 28% year-over-year growth.

Previous wording

Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with US Generally Accepted Accounting Principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities, and other related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies and estimates discussed in our Annual Report on Form 10-K for the year ended December 31, 2023 are essential to understanding our operating results and financial condition, as these policies and estimates relate to the more significant areas involving management’s judgments. There have been no material changes to the critical accounting policies and estimates discussed in our Annual Report on Form 10-K for the year ended December 31, 2023.

Current wording

Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with US Generally Accepted Accounting Principles (“GAAP”). The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities, and other related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

For the three and six months ended June 30, 2024, we recognized $14.3 million and $28.8 million, respectively, in revenue from the Viatris collaboration agreement which represented increases of 4% and 19%, respectively, compared to the prior year periods. The increase for the three months ended June 30, 2024 was primarily due to lower costs

Current wording

For the three and nine months ended September 30, 2024, we recognized $16.9 million and $45.6 million, respectively, in revenue from the Viatris collaboration agreement which represented increases of 8% and 15%, respectively, compared to the prior year periods. The increase in Viatris collaboration revenue for the third quarter of 2024 was primarily due to an increase in net sales. The increase for the nine months ended September 30, 2024 was primarily due to an increase in net sales, as well as lower costs incurred by Viatris. During the third quarter of 2024, customer demand increased by 14% and market share increased to nearly 19% in the hospital setting and reached 32% in the community setting.

Previous wording

R&D expenses increased by $0.5 million for the three months ended June 30, 2024 compared to the prior year period. The $0.5 million increase was attributed to a $0.5 million increase in employee-related expenses and a $1.2 million increase in external-related expense. These increases were primarily driven by the continued progression of the ampreloxetine Phase 3 clinical study (CYPRESS) for MSA patients with symptomatic nOH. These clinical development-related increases were partially offset by a $0.7 million decrease in share-based compensation and a $0.4 million decrease in allocated expenses primarily driven by our 2023 strategic actions announced in February 2023 (“2023 Strategic Actions”) which included the discontinuation of investment in our research activities.

Current wording

R&D expenses increased by $1.0 million for the three months ended September 30, 2024 compared to the prior year period. The $1.0 million increase was attributed to a $1.9 million increase in external-related expenses and partially offset by a $0.9 million decrease in share-based compensation expense. The increase in external-related expenses was primarily driven by the continued progression of the ampreloxetine Phase 3 clinical study (CYPRESS) for MSA patients with symptomatic nOH and was partially offset by the previously announced close-out of certain research programs. The decrease in share-based compensation expense was primarily driven by employee departures.

Previous wording

R&D expenses decreased by $5.1 million for six months ended June 30, 2024 compared to the prior year period. The $5.1 million decrease was attributed to all of our R&D categories and was primarily driven by our 2023 Strategic Actions. The $0.6 million and $0.8 million decreases in employee-related expenses and external-related expenses, respectively, were partially offset by increases in expenses related to the CYPRESS study as discussed above.

Current wording

R&D expenses decreased by $4.1 million for nine months ended September 30, 2024 compared to the prior year period. The $4.1 million decrease was attributed to nearly all of our R&D categories and was primarily driven by our 2023 Strategic Actions which included the discontinuation of investment in our research activities. External-related expenses did increase by $1.1 million primarily driven by the continued progression of our CYPRESS study.

Previous wording

Total SG&A expenses were $17.1 million for the three months ended June 30, 2024. Excluding share-based compensation expense (“SBC”), total SG&A expenses were $12.8 million for the second quarter of 2024 and were comprised of $6.8 million of general and administrative (“G&A”) expenses and $6.0 million of selling, marketing & medical affairs (“SM&M”) expenses. Total SG&A expenses (excluding SBC) was $14.9 million for the second quarter of 2023 and were comprised of $8.8 million of G&A expenses and $6.1 million of SM&M expenses. The $2.0 million decrease in G&A expenses (excluding SBC) in the second quarter of 2024 compared to the prior year period represented a 23% reduction and was primarily due to our company-wide cost savings initiative that began in the second half of 2023 and included reductions in various areas such as, finance-related expenses, information & technology, and facility-related expenses. SM&M expenses (excluding SBC) was relatively unchanged in the second quarter of 2024 compared to the prior year period.

Current wording

Total SG&A expenses were $16.9 million for the three months ended September 30, 2024. Excluding share-based compensation expense (“SBC”), total SG&A expenses were $13.0 million for the third quarter of 2024 and were comprised of $6.6 million of general and administrative (“G&A”) expenses and $6.4 million of selling, marketing & medical affairs (“SM&M”) expenses. Total SG&A expenses (excluding SBC) was $11.9 million for the third quarter of 2023 and were comprised of $7.1 million of G&A expenses and $4.8 million of SM&M expenses. The $0.5 million decrease in G&A expenses (excluding SBC) in the third quarter of 2024 compared to the prior year period represented a 9% reduction and was primarily due to our company-wide cost savings initiative that began in the second half of 2023 and included reductions in various areas such as, finance-related expenses, information & technology, and facility-related expenses. SM&M expenses (excluding SBC) increased by $1.6 million in the third quarter of 2024 compared to the prior year period and was primarily due to pre-launch medical affairs and commercialization expenses associated with ampreloxetine and an increase in employee-related expenses.

Previous wording

Total SG&A expenses were $33.8 million for the six months ended June 30, 2024. Excluding SBC, total SG&A expenses were $25.8 million for the current period and were comprised of $13.7 million of G&A expenses and $12.1 million of SM&M expenses. Total SG&A expenses (excluding SBC) was $29.8 million for the prior year period and were comprised of $18.4 million of G&A expenses and $11.4 million of SM&M expenses. The $4.7 million decrease in G&A expenses (excluding SBC) in the current period compared to the prior year period represented a 26% reduction and was primarily due to our company-wide cost savings initiative as discussed above. SM&M expenses (excluding SBC) increased slightly by $0.7 million in the current period compared to the prior year period and was primarily due to an increase in employee-related expenses.

Current wording

SM&M expenses. Total SG&A expenses (excluding SBC) was $41.7 million for the prior year period and were comprised of $25.5 million of G&A expenses and $16.2 million of SM&M expenses. The $5.2 million decrease in G&A expenses (excluding SBC) compared to the prior year period represented a 20% reduction and was primarily due to our company-wide cost savings initiative as discussed above. SM&M expenses (excluding SBC) increased by $2.3 million in the third quarter of 2024 compared to the prior year period and was primarily due pre-launch medical affairs and commercialization expenses associated with ampreloxetine and an increase in employee-related expenses.

Previous wording

Total SBC related to SG&A expenses was $4.2 million and $8.0 million for the three and six months ended June 30, 2024, respectively. Total SBC related to SG&A expenses was $4.4 million and $8.6 million for the three and six months ended June 30, 2023, respectively.

Current wording

Total SBC related to SG&A expenses was $3.9 million and $11.8 million for the three and nine months ended September 30, 2024, respectively. Total SBC related to SG&A expenses was $4.3 million and $12.9 million for the three and nine months ended September 30, 2023, respectively.

Previous wording

There were no restructuring and related expenses recognized for the three and six months ended June 30, 2024. The restructuring and related expenses recognized for the prior year comparable periods were a result of our 2023 Strategic Actions as discussed above.

Current wording

There were no restructuring and related expenses recognized for the three and nine months ended September 30, 2024. The restructuring and related expenses recognized for the prior year comparable periods were a result of our 2023 Strategic Actions that included the discontinuation of our research activities and a 17% reduction in headcount.

Previous wording

Interest expense was $0.6 million and $1.3 million for the three and six months ended June 30, 2024, respectively, and represented non-cash interest expense associated with $25.0 million received from Royalty Pharma in July 2022 to fund the CYPRESS study. The increase in interest expense was primarily due to the compounding of non-cash interest due to Royalty Pharma. We do not anticipate having any cash interest expense in the foreseeable future.

Current wording

Interest expense was $0.6 million and $1.9 million for the three and nine months ended September 30, 2024, respectively, and represented non-cash interest expense associated with $25.0 million received from Royalty Pharma in July 2022 to partially fund the CYPRESS study. The increase in interest expense was primarily due to the compounding of non-cash interest due to Royalty Pharma. We do not anticipate having any cash interest expense in the foreseeable future.

Previous wording

Interest income and other income (expense), net, decreased by $1.4 million and $2.9 million for the three and six months ended June 30, 2024, respectively, compared to the prior year periods. The decreases were primarily due to a reduction in interest income earned on our cash, cash equivalents, and marketable securities driven by a significant reduction in such balances over the past year. Our cash, cash equivalents, and marketable securities balances were lower in the current year, compared to the prior year, due to the completion of our previously announced capital return program that began in September 2022 and was completed in early January 2024.

Current wording

Interest and other income, net, decreased by $0.4 million and $3.3 million for the three and nine months ended September 30, 2024, respectively, compared to the prior year periods. The decreases were primarily due to a reduction in interest income earned on our cash, cash equivalents, and marketable securities driven by a significant reduction in such balances over the past year. Our cash, cash equivalents, and marketable securities balances were lower in the current year, compared to the prior year, due to the completion of our previously announced capital return program that began in September 2022 and was completed in early January 2024.

Previous wording

For the six months ended June 30, 2024, we recognized an income tax expense of $2.6 million compared to $1.1 million for the same period in 2023. For the six months ended June 30, 2024, our income tax expense was related to the uncertain tax positions, as well as interest expense on our uncertain tax position liability which we began to accrue in the fourth quarter of 2023. For the 2023 comparable period, the income tax expense was primarily due to uncertain tax positions related to our transfer pricing position.

Current wording

For the nine months ended September 30, 2024, we recognized an income tax expense of $5.2 million compared to $2.4 million for the same period in 2023. For the nine months ended September 30, 2024, our income tax expense was primarily related to uncertain tax positions, as well as interest expense on our uncertain tax position liability which we began to accrue in the fourth quarter of 2023. For the 2023 comparable period, the income tax expense was also primarily due to uncertain tax positions.

Previous wording

As of June 30, 2024, we had approximately $96.1 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash) and no long-term debt.

Current wording

As of September 30, 2024, we had approximately $91.4 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash) and no long-term debt.

Previous wording

Net cash used in operating activities was $5.4 million for the six months ended June 30, 2024, consisting of a net loss of $28.2 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $15.9 million and a net increase in cash resulting from changes in operating assets and liabilities of $6.8 million.

Current wording

Net cash used in operating activities was $10.6 million for the nine months ended September 30, 2024, consisting of a net loss of $40.9 million, a net increase in cash resulting from adjustments to net loss for non-cash and other reconciling items of $23.8 million and a net increase in cash resulting from cash movements related to changes in operating assets and liabilities of $6.5 million.

Previous wording

Net cash used in operating activities was $23.7 million for the six months ended June 30, 2023, consisting of a net loss of $37.7 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $17.7 million and a net decrease in cash resulting from changes in operating assets and liabilities of $3.6 million.

Current wording

Net cash used in operating activities was $26.1 million for the nine months ended September 30, 2023, consisting of a net loss of $46.7 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $25.5 million and a net decrease in cash resulting from changes in operating assets and liabilities of $4.9 million.

Previous wording

Net cash provided by investing activities was $14.0 million for the six months ended June 30, 2024, consisting of cash inflows from the net purchase and maturities of marketable securities of $14.1 million and cash outflows from the purchase of property and equipment of $0.1 million.

Current wording

Net cash used in investing activities was $3.4 million for the nine months ended September 30, 2024, consisting of cash outflows from the net purchase and maturities of marketable securities of $3.3 million and cash outflows from the purchase of property and equipment of $0.1 million.

Previous wording

Net cash used in investing activities was $32.0 million for the six months ended June 30, 2023, consisting primarily of cash outflows from the net purchase and maturities of marketable securities of $31.7 million and cash outflows from the net purchase and sale of property and equipment of $0.3 million.

Current wording

Net cash used in investing activities was $32.0 million for the nine months ended September 30, 2023, consisting primarily of cash outflows from the net purchase and maturities of marketable securities of $31.7 million and cash outflows from the net purchase and sale of property and equipment of $0.3 million.

Previous wording

Net cash used in financing activities was $1.8 million for the six months ended June 30, 2024, consisting primarily of $0.4 million of cash outflows related to the repurchase of ordinary shares as part of completion of our capital return program, $0.4 million of cash inflows related to the sale of shares through our employee share purchase program (“ESPP”) and $1.7 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.

Current wording

Net cash used in financing activities was $2.1 million for the nine months ended September 30, 2024, consisting primarily of $0.4 million of cash outflows related to the repurchase of ordinary shares as part of completion of our capital return program, $0.4 million of cash inflows related to the sale of shares through our employee share purchase program (“ESPP”) and $2.1 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.

Previous wording

Net cash used in financing activities was $136.9 million for the six months ended June 30, 2023, consisting of $135.9 million of cash outflows related to the repurchase of ordinary shares as part of our capital return program, $1.5 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations, and $0.5 million of cash inflows related to the sale of shares through our ESPP.

Current wording

Net cash used in financing activities was $168.3 million for the nine months ended September 30, 2023, consisting primarily of $166.8 million of cash outflows related to the repurchase of ordinary shares as part of our capital return program.