What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-07-25 compared with 2024-05-02 · 91 added, 73 removed, 220 unchanged (43% of the section changed)

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Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations.

We encourage you to read this MD&A in conjunction with our unaudited consolidated financial statements and the notes thereto for the period ended March 31, 2024 included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

We encourage you to read this MD&A in conjunction with our unaudited consolidated financial statements and the notes thereto for the period ended June 30, 2024 included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

This discussion contains forward-looking statements that involve risks and uncertainties.

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We have also received CE certification in the EU and approval or local registration to market Optune Lua in certain other countries.

We market Optune Gio and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany and Japan.

We market Optune Gio and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan.

We are actively evaluating opportunities to expand our international footprint.

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We have also filed applications for use to the necessary regulatory bodies in Europe and Japan.

In March 2024, we announced the topline results of the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with 1-10 brain metastases from NSCLC following stereotactic radiosurgery (“METIS”).

The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with Tumor Treating Fields (TTFields) therapy and supportive care compared to patients treated with supportive care alone.

In June 2024, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with 1-10 brain metastases from NSCLC following stereotactic radiosurgery (“METIS”) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting.

The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.

Patients treated with TTFields therapy and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone for brain metastasis (n=298;

hazard ratio=0.67;

Consistent with previous studies, TTFields therapy was well-tolerated with sustained quality of life and neurocognitive function.

Baseline characteristics were well balanced between arms.

Preliminary analyses of key secondary endpoints (time to neurocognitive failure, overall survival, and radiological response rate) did not demonstrate statistical significance.

We plan to share the full analysis of the METIS trial data at the upcoming American Society of Clinical Oncology scientific congress in June.

These data are expected to serve as the basis for regulatory submissions.

In June 2024, we also presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO annual meeting.

The TIGER study investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany.

Of the 710 patients enrolled in the study between August 2017 to November 2019, 429 patients received TTFields therapy, across 81 participating centers.

Median overall survival for patients treated with TTFields therapy was 19.6 months (95% CI, 17.9-22.4) and median progression-free survival was 10.2 months (95% CI, 9.4-11.4).

TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.

The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial.

In March 2024, an exploratory subgroup analysis of the phase 3 INNOVATE-3 clinical trial was presented at the European Society of Gynaecological Oncology 2024 Congress.

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Novocure and investigators will continue to analyze the data from the INNOVATE-3 trial.

We have several ongoing or planned trials which will further explore the use of TTFields therapy in the treatment of NSCLC, including the phase 3 LUNAR-2 trial, as well as the phase 2 KEYNOTE B36 and LUNAR-4 trials.

In addition to our trials in NSCLC, we have multiple ongoing trials in our brain and pancreatic cancer programs, including the phase 3 TRIDENT, and PANOVA-3 trials, and the phase 2 PANOVA-4 trial.

In March 2024, the FDA approved the Investigational New Drug application for the randomized, phase 3 KEYNOTE D58 clinical trial.

This trial will evaluate the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of newly diagnosed GBM.

We anticipate launching this trial in 2024.

We have several ongoing or planned trials which will further explore the use of TTFields therapy in the treatment of NSCLC, pancreatic cancer, and primary brain cancer.

In addition to the recently completed METIS trial, our NSCLC program includes the phase 3 LUNAR-2 trial, which explores the use of TTFields therapy together with pembrolizumab and platinum-based chemotherapy as first-line treatment for metastatic NSCLC and the phase 2 LUNAR-4 trial, which evaluates the use of TTFields therapy together with an immune checkpoint inhibitor (ICI) following prior ICI treatment as a second-line treatment for metastatic NSCLC.

Finally, our phase 2 KEYNOTE B36 trial is exploring the use of TTFields therapy together with pembrolizumab for front-line treatment of locally advanced or metastatic NSCLC.

We are evaluating appropriate next steps for this trial given its pace of enrollment and our focus on LUNAR-2.

Our pancreatic cancer program is comprised of the phase 3 PANOVA-3 trial and the phase 2 PANOVA-4 trial.

The PANOVA-3 trial is exploring the use of TTFields therapy together with nab-paclitaxel and gemcitabine as front-line treatment for unresectable locally advanced pancreatic cancer and is fully enrolled with top-line data anticipated in the fourth quarter of 2024.

The PANOVA-4 trial is exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer and is currently open and enrolling.

Our primary brain cancer clinical trial program includes the fully enrolled phase 3 TRIDENT trial and the planned KEYNOTE D58 trial.

The TRIDENT trial is exploring the use of TTFields therapy concomitant with radiation and chemotherapy for the treatment of newly diagnosed GBM and top-line data is anticipated in 2026.

The KEYNOTE D58 trial will evaluate the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of newly diagnosed GBM.

We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields therapy for additional solid tumor indications and combinations with other cancer treatment modalities.

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One of these initiatives is the launch of new arrays, which are thinner, lighter and more flexible.

We have obtained a CE Mark and have begun rolling out our new arrays in multiple European countries.

We have obtained a CE Mark and are rolling out our new arrays in multiple European countries.

We submitted the new arrays for regulatory approval in the U.S.

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We view our operations and manage our business in one operating segment.

For the three months ended March 31, 2024, our net revenues were $138.5 million.

Our net loss for the three months ended March 31, 2024 was $38.8 million.

As of March 31, 2024, we had an accumulated deficit of $1,024.3 million.

For the three and six months ended June 30, 2024, our net revenues were $150.4 million and $288.9 million, respectively.

Our net loss for the three and six months ended June 30, 2024 was $33.4 million and $72.1 million, respectively..

As of June 30, 2024, we had an accumulated deficit of $1,057.6 million.

Impact of Current Events

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As of the date of this filing, we believe that there is no immediate risk to our business facilities or operations.

Our supply chain teams are working to increase stock levels to mitigate distribution and service risks from our suppliers in Israel.

Our supply chain teams have increased stock levels to mitigate distribution and service risks from our suppliers in Israel.

Commentary on Results of Operations

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Results of Operations

The following discussion provides an analysis of our results of operations and reasons for material changes therein for the three months ended March 31, 2024 as compared to the three months ended March 31, 2023.

The following discussion provides an analysis of our results of operations and reasons for material changes therein for the three and six months ended June 30, 2024 as compared to the three and six months ended June 30, 2023.

The tables contained in this section report U.S.

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The following table sets forth our consolidated statements of operations data:

Three months ended March 31,

Three months ended June 30, Six months ended June 30,

2024 2023 2024 2023

Unaudited Unaudited

Net revenues $ 150,356 $ 126,051 $ 288,859 $ 248,233

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The following table details the share-based compensation expense included in costs and expenses:

Three months ended March 31,

Three months ended June 30, Six months ended June 30,

2024 2023 2024 2023

Unaudited Unaudited

Cost of revenues $ 1,698 $ 2,023 $ 3,446 $ 4,029

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Germany 538 499

France 369 70

Japan 403 352

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Total 3,963 3,571

Three months ended March 31,

Three months ended June 30, Six months ended June 30,

2024 2023 2024 2023

Prescriptions received in period

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Germany 206 204 412 412

France 176 132 362 152

Japan 108 92 199 164

Other international 187 147 357 292

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Total 1,634 1,556 3,277 3,052

Three months ended March 31, 2024 compared to three months ended March 31, 2023

Three months ended March 31,

2024 2023 % Change

Three and six months ended June 30, 2024 compared to three and six months ended June 30, 2023

Three months ended June 30, Six months ended June 30,

2024 2023 % Change 2024 2023 % Change

Net revenues $ 150,356 $ 126,051 19 % $ 288,859 $ 248,233 16 %

Net revenues.

Net revenues increased 13% to $138.5 million for the three months ending March 31, 2024 from $122.2 million for the same period in 2023.

For the three months ended March 31, 2024, the increase primarily resulted from $10.5 million of revenues from the successful launch in France and $5.3 million of revenues in the US due to improved approval rates.

Net revenues increased 19% to $150.4 million for the three months ending June 30, 2024 from $126.1 million for the same period in 2023.

For the three months and six months ended June 30, 2024, the increase primarily resulted from $14.3 million and $24.8 million of net revenues from the successful launch in France and $8.8 million and $14.1 million of net revenues in the U.S.

due to improved approval rates.

The improved approval rates in the U.S.

resulted in $4.2 million of increased revenue from prior period claims, primarily from 2023.

Three months ended March 31,

2024 2023 % Change

resulted in $5.0 million and $9.2 million of increased net revenue from prior period claims during the three- and six- month periods, primarily from 2023.

In addition, we received $2.6 million in net revenues in the second quarter from a private payer in the United Kingdom where payments are not routine.

Three months ended June 30, Six months ended June 30,

2024 2023 % Change 2024 2023 % Change

Cost of revenues $ 34,654 $ 34,018 2 % $ 68,343 $ 63,632 7 %

Cost of revenues.

Our cost of revenues for the three months ended March 31, 2024 was $33.7 million, an increase of 14% from $29.6 million for the same period in 2023.

For the three months ended March 31, 2024, the increase in cost of revenues was primarily due to 11% growth in active patients and increased costs related to the ongoing launch of our next generation array.

Excluding sales to Zai, cost of revenues per active patient per month was $2,715 for the three months ended March 31, 2024, an increase of 4% from $2,608 for the same period in 2023, primarily due to the ongoing launch of next generation arrays.

Our cost of revenues for the three months ended June 30, 2024 was $34.7 million, an increase of 2% from $34.0 million for the same period in 2023.

For the three and six months ended June 30, 2024, the increase in cost of revenues was primarily due to 11% growth in active patients, partially offset by lower support personnel costs in the amount of $0.9 million and $0.8 million, respectively.

Excluding sales to Zai, cost of revenues per active patient per month was $2,692 for the three months ended June 30, 2024, a decrease of 6% from $2,878 for the same period in 2023, primarily due to decreased support personnel costs.

Cost of revenues per active patient is calculated by dividing the cost of revenues for the quarter less equipment sales to Zai for the quarter by the average of the active patients at the end of the prior quarter and the ending active patients in the current quarter.

This quarterly figure is then divided by three to estimate the monthly cost of revenues per active patient.

Sales to Zai are deducted because they are sold at cost

and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population.

Product sales to Zai totaled $2.7 million for the three months ended March 31, 2024 compared to $2.6 million million for the three months ended March 31, 2023.

Gross margin was 76% for the three months ended March 31, 2024 compared to 76% for the three months ended March 31, 2023.

Sales to Zai are deducted because they are sold at cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population.

Product sales to Zai totaled $3.1 million and $5.9 million for the three and six months ended June 30, 2024 compared to $3.6 million and $6.3 million for the three and six months ended June 30, 2023.

Gross margin was 77% for the three months ended June 30, 2024 compared to 73% for the three months ended June 30, 2023.

We expect that our gross margins will continue to be impacted by current and future product enhancements, such as the ongoing launch of next generation arrays in the U.S.

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Operating Expenses.

Three months ended March 31,

2024 2023 % Change

Three months ended June 30, Six months ended June 30,

2024 2023 % Change 2024 2023 % Change

Research, development and clinical studies $ 54,955 $ 55,427 (1) % $ 106,553 $ 115,131 (7) %

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Research, development and clinical study expenses.

Research, development and clinical study expenses decreased 14% to $51.6 million for the three months ended March 31, 2024 from $59.7 million for the same period in 2023.

For the three months ended March 31, 2024, the change resulted primarily from $5.5 million in decreased personnel expenses and $1.0 million in reduced direct clinical trial expenses driven by the timing of activities within the ongoing clinical trial portfolio.

Research, development and clinical study expenses decreased 1% to $55.0 million for the three months ended June 30, 2024 from $55.4 million for the same period in 2023.

For the three months ended June 30, 2024, the change was de minimis.

For the six months ended June 30, 2024, the change resulted primarily from $5.6 million in decreased personnel expenses.

Total research and development expenses can fluctuate quarter-to-quarter dependent upon the amount of clinical research organization services delivered, clinical materials procured and the number of trials actively underway within a given quarter.

Sales and marketing expenses.

Sales and marketing expenses increased 8% to $55.2 million for the three months ended March 31, 2024 from $51.2 million for the same period in 2023.

For the three months ended March 31, 2024, these changes were primarily driven by $1.7 million in sales force expansion and $1.7 million in increased marketing activities in anticipation of a potential launch in NSCLC.

Sales and marketing expenses decreased 3% to $56.6 million for the three months ended June 30, 2024 from $58.5 million for the same period in 2023.

For the three months ended June 30, 2024, these changes were primarily driven by a $4.2 million reduction in marketing and health policy spend attributed to lower personnel costs and $1.2 million less in medical grants, partially offset by a $3.5 million increase in sales costs related to a sales force expansion in anticipation of a potential launch in NSCLC.

For the six months ended June 30, 2024, the increase was driven by a $5.2 million increase related to the sales force expansion for NSCLC, partially offset by $3.7 million reduction in other personnel expenses.

General and administrative expenses.

General and administrative expenses decreased 6% to $39.5 million for the three-month period ended March 31, 2024 from $41.9 million for the same period in 2023.

For the three months ended March 31, 2024, these changes were primarily due to lower personnel expenses.

Three months ended March 31,

2024 2023 % Change

General and administrative expenses decreased 8% to $37.7 million for the three-month period ended June 30, 2024 from $40.8 million for the same period in 2023.

For the three and six months ended June 30, 2024, these changes were primarily due to lower personnel expenses.

Three months ended June 30, Six months ended June 30,

2024 2023 % Change 2024 2023 % Change

Financial income (expenses), net $ 10,851 $ 8,756 24 % $ 20,729 $ 17,925 16 %

Financial income (expenses), net.

Financial income increased $0.7 million or 8%, to $9.9 million for the three months ended March 31, 2024 from $9.2 million in income for the same period in 2023.

For the three-month period ending March 31, 2024, the change from 2023 was primarily due to $2.1 million in increased interest income offset by a $1.3 million negative impact from foreign exchange.

Three months ended March 31,

2024 2023 % Change

For the three months ended June 30, 2024, financial income increased $2.1 million or 24% to $10.9 million from $8.8 million for the same period in 2023, primarily due to $2.2 million higher interest income offset by $2.0 million interest expenses related to the senior secured credit facility (see "Senior Secured Term Loan Credit Facility" below), $1.1 million in gain from redemptions of our 0% Convertible Senior Notes due 2025 (the “Notes”) and $0.9 million in favorable foreign exchange adjustments.

Financial income increased $2.8 million or 16%, to $20.7 million for the six months ended June 30, 2024 from $17.9 million in income for the same period in 2023, primarily due to $2.2 million in higher interest income.

Three months ended June 30, Six months ended June 30,

2024 2023 % Change 2024 2023 % Change

Income taxes $ 10,646 $ 3,514 203 % $ 17,764 $ 5,495 223 %

Income taxes .

Income taxes increased 259% to $7.1 million for the three months ended March 31, 2024 from $2.0 million for the same period in 2023.

Income taxes increased 203% to $10.6 million for the three months ended June 30, 2024 from $3.5 million for the same period in 2023, and increased 223% to $17.8 million for the six months ended June 30, 2024 from $5.5 million for the same period in 2023.

The change is driven by a decrease in tax benefits from share-based compensation and the utilization of tax credits in 2023 related to prior years.

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We also measure our performance using a non-GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation (“Adjusted EBITDA”).

We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

We believe Adjusted EBITDA is

useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

We calculate Adjusted EBITDA as operating income before financial expenses and income taxes, net of depreciation, amortization and share-based compensation.

The following table reconciles net income (loss), which is the most directly comparable GAAP operating performance measure, to Adjusted EBITDA.

Three months ended March 31,

2024 2023 % Change

Three months ended June 30, Six months ended June 30,

2024 2023 % Change 2024 2023 % Change

Net income (loss) $ (33,375) $ (57,418) (42) % $ (72,135) $ (110,479) (35) %

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Adjusted EBITDA $ 1,108 $ (27,199) (104) % $ (3,513) $ (45,642) (92) %

Adjusted EBITDA increased by $13.8 million to $(4.6) million for the three months ended March 31, 2024 from $(18.4) million for the same period in 2023.

This increase was primarily driven by revenue growth and an associated $12.2 million increase in gross margin.

Adjusted EBITDA increased by $28.3 million to $1.1 million for the three months ended June 30, 2024 from $(27.2) million for the same period in 2023.

This increase was primarily driven by revenue growth from improved approval rates in the U.S., a successful launch in France, and a benefit from prior period claims in the U.S.

The revenue increase resulted in a $23.7 million increase in gross margin.

Actions taken during the November 2023 restructuring and a heightened focus on driving operational efficiencies reduced total operating expenses, excluding share-based compensation, by $4.1 million year-over-year.

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We have incurred significant losses and cumulative negative cash flows from operations since our founding in 2000.

As of March 31, 2024, we had an accumulated deficit of $1,024.3 million.

As of June 30, 2024, we had an accumulated deficit of $1,057.6 million.

To date, we have primarily financed our operations through the issuance and sale of equity and the proceeds from long-term loans.

At March 31, 2024, we had $870.1 million in cash, cash equivalents and short-term investments, a decrease of $40.5 million compared to $910.6 million at December 31, 2023.

We believe our cash, cash equivalents and short-term investments as of March 31, 2024 are sufficient for our operations for at least the next 12 months based on our existing business plan and our ability to control the timing of significant expense commitments.

At June 30, 2024, we had $951.2 million in cash, cash equivalents and short-term investments, an increase of $40.6 million compared to $910.6 million at December 31, 2023, primarily as a result of the $100 million draw down of the first tranche of our senior secured credit facility in May 2024 (see "Senior Secured Term Loan Credit Facility" below), offset by net cash used in operations and used in investing activities.

We believe our cash, cash equivalents and short-term investments as of June 30, 2024 are sufficient for our operations for at least the next 12 months based on our existing business plan and our ability to control the timing of significant expense commitments.

We expect that our operating expenses will continue to increase over the next several years and may outpace our gross profit as we prepare to expand into additional indications beyond GBM.

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The following summary of our cash flows for the periods indicated has been derived from our unaudited consolidated financial statements, which are included elsewhere in this Quarterly Report:

Three months ended March 31,

Six months ended June 30,

2024 2023 Change % Change

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Operating cash flows are also impacted by changes in working capital.

Net cash used in operating activities increased by $14.8 million from $16.7 million net cash used in operating activities for the three months ended March 31, 2023 to $31.6 million net cash used in operating activities for the three months ended March 31, 2024.

This increase was a result of net loss decreasing by $14.3 million, offset by a $27.5 million increase in working capital, a decrease of $2.7 million in cash to non-cash based expenses primarily consisting of shared-based compensation, and an increase of $1.1 million in other long term assets and liabilities.

The $27.5 million increase in working capital includes a $17.8 million increase in accounts receivable, a decrease of $7.8 million in accounts payable and accrued expenses as well as an increase of $ 1.9 million in inventories.

Net cash used in operating activities decreased by $6.2 million from $39.5 million net cash used in operating activities for the six months ended June 30, 2023 to $33.3 million net cash used in operating activities for the six months ended June 30, 2024.

This was a result of a $38.3 million reduction in net loss, offset by a $32.9 million increase in working capital primarily driven by a $35.8 million increase in accounts receivable, a decrease of $7.1 million in cash to non-cash based expenses primarily consisting of shared-based compensation, and a decrease of $7.8 million in other long term assets and liabilities.

Investing activities.

Our investing activities consist primarily of investments in and redemptions of our short-term investments as well as investments in property and equipment.

Net cash provided by investing activities was $246.2 million for the three months ended March 31, 2024, compared to $82.3 million used in investing activities for the three months ended March 31, 2023.

The $246.2 million net cash provided by investing activities for the three months ended March 31, 2024 was primarily attributable to $258.0 million of net proceeds from the maturity of short-term investments and the purchase of $11.8 million of property and equipment.

The $82.3 million net cash provided by investing activities for the three months ended March 31, 2023 was primarily attributable to $88.4 million of net proceeds in short-term investments and by the purchase of $6.1 million of property and equipment.

Net cash used in investing activities was $128.2 million for the six months ended June 30, 2024, compared to $68.4 million provided by investing activities for the six months ended June 30, 2023.

The $128.2 million net cash used in investing activities for the six months ended June 30, 2024 was primarily attributable to $105.0 million of the net purchase of short term investments and the purchase of $23.2 million of property and equipment.

The $68.4 million net cash provided by investing activities for the six months ended June 30, 2023 was primarily attributable to $81.4 million of net proceeds from maturity of short term investments and by the purchase of $13.0 million of property and equipment.

Financing activities.

To date, our primary financing activities have been the sale of equity and the proceeds from long-term loans.

Net cash provided by financing activities was $0.2 million for the three months ended March 31, 2024, as compared to $5.2 million provided by financing activities for the three months ended March 31, 2023.

The net cash provided by financing activities for the three months ended March 31, 2024 and March 31, 2023 included proceeds from the exercise of options under the Company's stock option plan.

Net cash provided by financing activities was $87.5 million for the six months ended June 30, 2024, as compared to $12.7 million provided by financing activities for the six months ended June 30, 2023, primarily attributable to $96.9 million of net proceeds from the first tranche of our senior secured credit facility offset by $12.9 million used to partially repay Notes, In addition, the net cash provided by financing activities for the six months ended June 30, 2024 and June 30, 2023 included proceeds from the exercise of options under the Company's stock option plan.

Convertible Notes

On November 5, 2020, we issued $575.0 million aggregate principal amount of 0% Convertible Senior Notes due 2025 (the “Notes”).

On November 5, 2020, we issued $575.0 million aggregate principal amount of Notes.

The Notes are senior unsecured obligations.

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to the Consolidated Financial Statements in the 2023 10-K.

Term loan credit facility

Senior Secured Term Loan Credit Facility

On May 1, 2024 Novocure Luxembourg S.a.r.l.

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Not later than December 31, 2025, the Borrower has the option to draw an additional $100.0 million of the Facility (the "Tranche C Loan") if (i) (A) we have received positive results from our PANOVA-3 phase 3 clinical trial or (B) our trailing net revenues for the most recently completed four quarters as reported in our financial statements filed with the U.S.

Securities and Exchange Commission ("Trailing Four Quarters of Net Revenue") are greater than $575.0 million and (ii) our Convertible Notes due 2025 are extinguished in full and are no longer outstanding.

Securities and Exchange Commission ("Trailing Four Quarters of Net Revenue") are greater than $575.0 million and (ii) the Notes are extinguished in full and are no longer outstanding.

Not later than March 31, 2026, the Borrower has the option to draw an additional $100.0 million of the Facility (the "Tranche D Loan") if (i) we receive an approval or clearance from the U.S.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis