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Theravance Biopharma Inc

For the period ended Jun 30, 2024. Filed Aug 8, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2024 · Filed Aug 8, 2024

TBPH$17.030.0%Stored close · as of Sep 23, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-03-31; filed 2024-05-15.

0001558370-24-008201

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

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

0001558370-24-011636

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 90 previous paragraphs and 90 current paragraphs.

48 unchanged; 32 reworded; 9 added; 6 removed; 4 previous and 1 current paragraphs rearranged.

Tables are not compared: 18 previous and 19 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (9)

Current report

The 1% decrease in aggregate net sales during the second quarter of 2024 compared to the prior year period was primarily due to headwinds from an evolved channel mix and a lower realized net price, offset by a 13% increase in customer demand. We are only expecting the lower net price in the second quarter to improve slightly during the second half of the year. For 2025 and beyond, we anticipate a more stable pricing environment and continued YUPELRI demand growth across all patient fulfillment channels. COPD market share growth continued in the second quarter of 2024 with the hospitals surpassing 18% market share and the community setting reaching 32% market share. For the three and six months ended June 30, 2024, YUPELRI continued to be profitable on a brand basis.

Current report

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 report

incurred by Viatris, and the increase for the six months ended June 30, 2024 was primarily due to an increase in net sales during the first three months of the year, as well as lower costs incurred by Viatris.

Current report

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 report

Impairment of long-lived assets, as compared to the prior year comparable periods, was as follows:

Current report

For each of the three and six months ended June 30, 2024,we recognized a non-cash impairment charge of $3.0 million related to our vacant laboratory spaces and related leasehold improvements in South San Francisco, California, which are currently on the market for sublease. There was no charge for impairment of long-lived assets recognized inthe prior year comparable periods.

Current report

The provision for income tax expense, as compared to the prior year comparable periods, was as follows:
Removed paragraphs (6)

Previous report

For the three months ended March 31, 2024, we recognized $14.5 million in revenue from the Viatris collaboration agreement which represented a 39% increase compared to the prior year comparable period. The increase was driven primarily by (i) year-over-year net sales growth as the brand achieved year-over-year market share increases in both the hospital and community segments; and (ii) lower costs incurred by Viatris. We traditionally experience seasonal dips in net sales for the year's first quarter as we transition from the fourth quarter to the first quarter of the following year. We believe this may be partially due to ordering patterns at the end of the fourth quarter of the prior year.

Previous report

Under certain of our collaborative arrangements, we receive partial reimbursement of external costs, which have been reflected as a reduction of R&D expenses of $0.2 million and $1.8 million for three months ended March 31, 2024 and 2023, respectively.

Previous report

The provision for income tax expense (benefit), as compared to the prior year comparable period, was as follows:
Reworded paragraphs (32)

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 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.

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

Previous wording

YUPELRI (revefenacin) inhalation solution is a once-daily, nebulized long-acting muscarinic antagonist (“LAMA”) approved for the maintenance treatment of COPD in the US. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD, regardless of severity of disease. Our market research indicates there is an enduring population of COPD patients in the US that either need or prefer nebulized delivery for maintenance therapy. The stability of revefenacin in both metered dose inhaler and dry powder inhaler

Current wording

YUPELRI (revefenacin) inhalation solution is a once-daily, nebulized long-acting muscarinic antagonist (“LAMA”) approved for the maintenance treatment of COPD in the US. LAMAs are recognized by international COPD treatment guidelines as a cornerstone of maintenance therapy for COPD, regardless of severity of disease. Our market research indicates there is an enduring population of COPD patients in the US that either need or prefer nebulized delivery for maintenance therapy. The stability of revefenacin in both metered dose inhaler and dry powder inhaler (“MDI/DPI”) formulations suggests that revefenacin could also serve as a foundation for novel handheld combination products.

Previous wording

In November 2023, we learned that Viatris’ Phase 3 study of YUPELRI in China was positive, and the data were consistent with previous findings of YUPELRI’s strong efficacy. Viatris plans to move forward with a registrational filing for YUPELRI in China in mid-2024.

Current wording

In November 2023, we learned that Viatris’ Phase 3 study of YUPELRI in China was positive, and the data were consistent with previous findings of YUPELRI’s strong efficacy. In June 2024, Viatris completed a registrational filing for YUPELRI in China which may lead us to receive (i) a $7.5 million milestone upon regulatory approval in the China Region; and (ii) a 14% - 20% royalty on net sales generated in the China Region, as shown above.

Previous wording

Based on positive results from a small exploratory Phase 2 study in nOH and discussions with the FDA, we advanced ampreloxetine into a Phase 3 program. We announced the initiation of patient dosing in study in early 2019. The Phase 3 program consisted of two pivotal studies and one non-pivotal study. The first pivotal study (SEQUOIA), a four-week, randomized double-blind, placebo-controlled study, was designed to evaluate the efficacy and safety of ampreloxetine in Parkinson’s disease (“PD”), pure autonomic failure (“PAF”) and MSA patients with symptomatic nOH. The second pivotal study (REDWOOD), a four-month open label study followed by a six-week randomized withdrawal phase was designed to evaluate the durability of the same patient group’s response to ampreloxetine. The protocol for the pivotal studies stipulated an enrollment threshold of 40% MSA patients based on the hypothesis ampreloxetine would work the best in patients with MSA because they have more intact nerves on which ampreloxetine can exert its effect, relative to the other patient types in the study. The third, non-pivotal study (OAK), was a three and a half year long-term extension study.

Current wording

Based on positive results from a small exploratory Phase 2 study in nOH and discussions with the FDA, we advanced ampreloxetine into a Phase 3 program. We announced the initiation of patient dosing in the study in early 2019. The Phase 3 program consisted of two pivotal studies and one non-pivotal study. The first pivotal study (SEQUOIA), a four-week, randomized double-blind, placebo-controlled study, was designed to evaluate the efficacy and safety of ampreloxetine in Parkinson’s disease (“PD”), pure autonomic failure (“PAF”) and MSA patients with symptomatic nOH. The second pivotal study (REDWOOD), a four-month open label study followed by a six-week randomized withdrawal phase was designed to evaluate the durability of the same patient group’s response to ampreloxetine. The protocol for the pivotal studies stipulated an enrollment threshold of 40% MSA patients based on the hypothesis ampreloxetine would work the best in patients with MSA because they have more intact nerves on which ampreloxetine can exert its effect, relative to the other patient types in the study. The third, non-pivotal study (OAK), was a three and a half year long-term extension study.

Previous wording

In September 2021, we reported that the SEQUOIA Phase 3 clinical study did not meet its primary endpoint. Most treatment-related adverse events were mild or moderate in severity. Serious adverse events occurred in two patients

Current wording

In September 2021, we reported that the SEQUOIA Phase 3 clinical study did not meet its primary endpoint. Most treatment-related adverse events were mild or moderate in severity. Serious adverse events occurred in two patients on placebo and four on ampreloxetine, none of which were considered related to the study drug. No deaths were reported, and there was no signal for supine hypertension.

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 the study is currently open to recruitment with the expectation of enrolling the final patient into the open label period of the study in the second half of 2024. 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 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.

Previous wording

Total 2023 TRELEGY global net sales were $2.74 billion which represented a 28% year-over-year growth, and TRELEGY’s annual growth rate was 28% and 58% in 2022 and 2021, respectively. TRELEGY global net sales for the first quarter of 2024 were $749 million which represented a 32% year-over-year growth. TRELEGY is expected to generate global peak sales of $3.80 billion in 2027 according to Bloomberg consensus estimates as of early May 2024.

Current 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.

Previous wording

TRELEGY in the US, and (b) sales or other activities occurring on and after July 1, 2029 related to TRELEGY outside of the US. US TRELEGY royalties payable to us by Royalty Pharma are expected to end in late 2032, and ex-US royalties are expected to end in the mid-2030s and are country specific. Royalty rates are upward tiering from 6.5% to 10% and based on total annual global net sales as follows:

Current wording

In addition to potential Milestone Payments, we will receive from Royalty Pharma 85% of the royalty payments on TRELEGY due from GSK for (a) sales or other activities occurring on and after January 1, 2031 related to TRELEGY in the US, and (b) sales or other activities occurring on and after July 1, 2029 related to TRELEGY outside of the US. US TRELEGY royalties payable to us by Royalty Pharma are expected to end in late 2032, and ex-US royalties are expected to end in the mid-2030s and are country specific. Royalty rates are upward tiering from 6.5% to 10% and based on total annual global net sales as follows:

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 below 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. 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.

Previous wording

While Viatris records the total net sales of YUPELRI within its own financial statements, our implied 35% YUPELRI revenue, as compared to the prior year comparable period, was as follows:

Current wording

While Viatris records the total net sales of YUPELRI within its own financial statements, our implied 35% YUPELRI revenue, as compared to the prior year comparable periods, was as follows:

Previous wording

Our recognized revenue, as compared to the prior year comparable period, was as follows:

Current wording

Our recognized revenue, as compared to the prior year comparable periods, was as follows:

Previous wording

We are entitled to a share of US profits and losses (65% to Viatris; 35% to Theravance Biopharma) received in connection with YUPELRI net sales. In accordance with the applicable accounting guidance, amounts receivable from Viatris in connection with the commercialization of YUPELRI are recorded within the condensed consolidated statements of operations as revenue from “Viatris collaboration agreement”. Any reimbursement from Viatris attributed to the 65% cost-sharing of our R&D expenses is characterized as a reduction of R&D expense, as we do not consider performing R&D services for reimbursement to be a part of our ordinary operations.

Current wording

We are entitled to a share of US profits and losses (65% to Viatris; 35% to Theravance Biopharma) received in connection with YUPELRI net sales. In accordance with the applicable accounting guidance, amounts receivable from Viatris in connection with the commercialization of YUPELRI are recorded within the condensed consolidated statements of operations as revenue from “Viatris collaboration agreement”. Any reimbursement from Viatris attributed to the 65% cost-sharing of our research and development (“R&D”) expenses is characterized as a reduction of R&D expense, as we do not consider performing R&D services for reimbursement to be a part of our ordinary operations.

Previous wording

The following table summarizes our R&D expenses incurred, net of any reimbursements from collaboration partners, as compared to the prior year comparable period:

Current wording

The following table summarizes our R&D expenses incurred, net of any reimbursements from collaboration partners, as compared to the prior year comparable periods:

Previous wording

strategic actions announced in February 2023 (“2023 Strategic Actions”) which included the discontinuation of investment in our research activities. The $2.0 million decrease in external-related expenses was net of an $0.8 million increase related to the progression of the ampreloxetine Phase 3 clinical study (CYPRESS) for MSA patients with symptomatic nOH.

Current 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.

Previous wording

R&D expenses decreased by $5.6 million for the three months ended March 31, 2024 compared to the prior year comparable period. The decrease was across all of our R&D categories and was primarily driven by our 2023

Current 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.

Previous wording

SG&A expenses, as compared to the prior year comparable period, were as follows:

Current wording

SG&A expenses, as compared to the prior year comparable periods, were as follows:

Previous wording

Total SG&A expenses were $16.7 million for the three months ended March 31, 2024. Total SG&A expenses (excluding share-based compensation expense, or “SBC”) were $13.0 million and were comprised of $6.9 million of general and administrative (“G&A”) expenses and $6.1 million of selling, marketing & medical affairs (“SM&M”) expenses. Total SG&A expenses (excluding SBC) was $15.0 million for the comparable prior year period and was comprised of $9.7 million of G&A expenses and $5.3 million of SM&M expenses.

Current 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.

Previous wording

Total SBC related to SG&A expenses was $3.8 million and $4.2 million for the three months ended March 31, 2024 and 2023, respectively.

Current 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.

Previous wording

Restructuringand related expenses, as compared to the prior year comparable period, were as follows:

Current wording

Restructuringand related expenses, as compared to the prior year comparable periods, were as follows:

Previous wording

There were no restructuring and related expenses recognized for the three months ended March 31, 2024. The restructuring and related expenses recognized for the prior year comparable period 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 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.

Previous wording

Interest expense, as compared to the prior year comparable period, was as follows:

Current wording

Interest expense, as compared to the prior year comparable periods, was as follows:

Previous wording

Interest expense was $0.6 million for the three months ended March 31, 2024 and represented non-cash interest expense associated with $25.0 million received from Royalty Pharma in July 2022 to fund the ampreloxetine Phase 3 clinical study (CYPRESS). 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 $1.3 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.

Previous wording

Interest income and other income (expense), net, as compared to the prior year comparable period, was as follows:

Current wording

Interest income and other income (expense), net, as compared to the prior year comparable periods, was as follows:

Previous wording

Interest income and other income (expense), net, decreased by $1.5 million for the three months ended March 31, 2024 compared to the prior year period. The decrease was 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 three months ended March 31, 2024, compared to the prior year period, 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 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.

Previous wording

For the three months ended March 31, 2024, the provision for income tax expense was $1.3 million compared to a $0.4 million benefit for the prior year period. In 2023, the benefit was due to R&D tax credits generated and losses in the US which we expect to be realizable. The income tax expense in the first quarter of 2024 was primarily due to interest expense recorded on uncertain tax positions which we began to accrue in the fourth quarter of 2023.

Current 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.

Previous wording

As of March 31, 2024, we had approximately $100.0 million in cash, cash equivalents, and investments in marketable securities (excluding restricted cash) and no long-term debt.

Current 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.

Previous wording

Net cash used in operating activities was $1.0 million for the three months ended March 31, 2024, consisting of a net loss of $11.7 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $6.5 million and a net increase in cash resulting from changes in operating assets and liabilities of $4.1 million.

Current 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.

Previous wording

Net cash used in operating activities was $11.2 million for the three months ended March 31, 2023, consisting of a net loss of $22.1 million, a net increase in cash resulting from adjustments for non-cash and other reconciling items of $8.6 million and a net increase in cash resulting from changes in operating assets and liabilities of $2.3 million.

Current 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.

Previous wording

Net cash provided by investing activities was $17.0 million for the three months ended March 31, 2024, consisting of cash inflows from the net purchase and maturities of marketable securities of $17.1 million and cash outflows from the net purchase and sale of property and equipment of $0.1 million.

Current 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.

Previous wording

Net cash used in investing activities was $43.0 million for the three months ended March 31, 2023, consisting of cash outflows from the net purchase and maturities of marketable securities of $42.3 million and cash outflows from the net purchase and sale of property and equipment of $0.7 million.

Current 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.

Previous wording

Net cash used in financing activities was $1.7 million for the three months ended March 31, 2024, consisting of $0.4 million of cash outflows related to the repurchase of ordinary shares as part of completion of our capital return program and $1.3 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.

Current 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.

Previous wording

Net cash used in financing activities was $56.2 million for the three months ended March 31, 2023, consisting of $55.3 million of cash outflows related to the repurchase of ordinary shares as part of our capital return program and $0.9 million of cash outflows related to the repurchase of shares to satisfy tax withholding obligations.

Current 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.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

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.
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

(“MDI/DPI”) formulations suggests that revefenacin could also serve as a foundation for novel handheld combination products.

Previous report — wording carried elsewhere

on placebo and four on ampreloxetine, none of which were considered related to the study drug. No deaths were reported, and there was no signal for supine hypertension.

Previous report — wording carried elsewhere

In addition to potential Milestone Payments, we will receive from Royalty Pharma 85% of the royalty payments on TRELEGY due from GSK for (a) sales or other activities occurring on and after January 1, 2031 related to

Previous report — wording carried elsewhere

The $2.8 million decrease in G&A expenses (excluding SBC) compared to the prior year comparable period represented a 29% 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. The $0.8 million increase in SM&M expenses (excluding SBC) was primarily due to an increase in employee-related expenses.