What changed in this filing

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Item 2. Management’s Discussion and Analysis

2020-08-06 compared with 2020-05-05 · 101 added, 55 removed, 127 unchanged (55% of the section changed)

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

The management’s discussion and analysis of financial condition as of March 31, 2020 and results of operations for the three months ended March 31, 2020, should be read in conjunction with management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2019 which was filed with the Securities and Exchange Commission, or SEC, on February 25, 2020.

The management’s discussion and analysis of financial condition as of June 30, 2020 and results of operations for the three and six months ended June 30, 2020, should be read in conjunction with management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2019 which was filed with the Securities and Exchange Commission, or SEC, on February 25, 2020.

Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions.

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This multicenter pivotal trial enrolled patients with melanoma whose disease has progressed following treatment with at least one systemic therapy, including a PD-1 inhibitor and if BRAF mutated, a BRAF inhibitor, or a combination of BRAF and MEK inhibitors.

Cohort 4 of the C-144-01 clinical trial is a single-arm cohort intended to be used for the registration of lifileucel.

Cohort 4 of the C-144-01 clinical trial is a single-arm cohort intended to support a biologics license application, or BLA, submission for lifileucel.

The C-144-01 trial uses our proprietary Gen 2 manufacturing process.

We completed and closed enrollment of patients into Cohort 2 of the C-144-01 trial in 2018.

We announced that the last patient was dosed in pivotal Cohort 4 of this trial in January 2020.

Cohort 4 was enrolled with a prospective definition of objective response rate, or ORR, read out by an Independent Review Committee, or IRC, as the primary endpoint based on our interpretation of discussions with the U.S.

Food and Drug Administration, or FDA.

In October 2018, we announced that lifileucel had received a Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA.

Updated results from Cohort 2 of the C-144-01 clinical trial were initially reported at the American Society of Clinical Oncology, or ASCO, annual meeting on June 1, 2019 and subsequently updated at the Society for Immunotherapy of Cancer, or SITC, annual meeting in November 2019.

In 66 patients with metastatic melanoma, treatment with lifileucel resulted in an ORR of 36%, as assessed by investigator, with 2 complete responses and 22 partial responses.

Results from Cohort 2 of the C-144-01 clinical trial were initially reported at the American Society of Clinical Oncology, or ASCO, annual meeting on June 1, 2019 and subsequently updated at the ASCO annual meeting on May 29, 2020, or ASCO 2020.

In 66 patients with metastatic melanoma, treatment with lifileucel resulted in an objective response rate, or ORR, of 36%, as assessed by investigator, with 2 complete responses and 22 partial responses.

The disease control rate, or DCR, was 80.3%.

Patients were heavily pretreated and had a mean of 3.3 prior therapies.

For both the ASCO and SITC updates, the median duration of response, or DOR, had not been reached.

In January 2020, with a median follow up of 15.5 months for Cohort 2 patients, the median DOR has not been reached per investigator assessment.

The data released at ASCO 2020 disclosed that after a median study follow up of 18.7 months for Cohort 2 patients, the median duration of response, or DOR, has not been reached per investigator assessment.

Furthermore, durable responses have been observed across a wide age range of metastatic melanoma patients, and among those who have received prior anti-CTLA-4 and BRAF targeted treatments, regardless of BRAF mutation status, and equally in patients with PD-L1 high and low status.

The adverse event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.

Cohort 4 of in the C-144-01 trial was enrolled to evaluate ORR as read out by an Independent Review Committee, or IRC, as the primary endpoint based on our interpretation of discussions with the U.S.

Food and Drug Administration, or FDA, as part of an End of Phase 2, or EOP2, meeting held with the FDA in the third quarter of 2018.

In October 2018 and based on the data provided to the FDA during the EOP2 meeting, we announced that lifileucel had received a Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA.

Enrollment in pivotal Cohort 4 in the C-144-01 trial commenced in March 2019 and patient dosing was completed in January 2020.

A total of 89 patients were dosed in Cohort 4.

Initial results from the pivotal Cohort 4 are available for 68 patients with two radiological assessments, as determined by investigator.

Lifileucel shows a 32.4% ORR, including 1 complete response and 21 partial responses, 2 of which are yet to be confirmed with follow up visits, and a DCR of 72.1% as of the data cut off of March 16, 2020,

corresponding to 5.3 months of median study follow up.

This data is highly consistent with the Cohort 2 data read out at a similar median duration of study follow up.

The ORR of Cohort 2 at a median study follow up of 6 months was 33%.

We are also conducting a Phase 2 clinical trial, C-145-04, which is a multicenter pivotal trial that will assess the safety and efficacy of LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical cancer.

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The DOR had not been reached.

The adverse event profile was generally consistent with the underlying advanced disease

and the profile of the lymphodepletion and IL-2 regimens.

Based on an End of Phase 2 meeting held with the FDA in June 2019, the FDA has acknowledged that results from the C-145-04 clinical trial may be sufficient to support registration of LN-145 for the treatment of patients with metastatic cervical cancer.

The adverse event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.

Based on an EOP2 meeting held with the FDA in June 2019, we believe that results from the C-145-04 clinical trial may be sufficient to support registration of LN-145 for the treatment of patients with metastatic cervical cancer.

In accordance with the FDA’s recommendations, the protocol was amended to further define the patient population.

In November 2019, in order to position LN-145 for potential future use in broader lines of therapy in cervical cancer, we have further amended the C-145-04 trial to collect additional data on early-line patients as well as late-line patients by adding additional cohorts, in anticipation of a changing landscape in this indication, including Cohort 2 for patients that had previously received anti-PD-1 therapy.

These additional cohorts also allow access to TIL therapy when the pivotal Cohort 1 is completed and also may support a request from FDA to provide expanded access to LN-145.

These additional cohorts also allow access to TIL therapy when the pivotal Cohort 1 is completed and we believe may support expanded access to LN-145.

Cohort 2 of the C-145-04 trial continues and is expected to complete enrollment during the second half of 2020.

We intend to initiate a dialog with the FDA subsequent to such completion to discuss BLA submission plans.

C-145-03 is our ongoing Phase 2, multicenter trial that we are conducting to assess the safety and efficacy of LN-145 for the treatment of patients with recurrent metastatic squamous cell carcinoma of the head and neck.

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In addition to its ongoing enrollment in the U.S., the IOV-COM-202 trial has also received regulatory approval in Canada and in certain European countries.

In November 2019, we announced that our investigational new drug application, or IND, for our PBL therapy, IOV-2001, was approved by the FDA and our sponsored clinical trial using this therapy, IOV-CLL-01, was cleared to proceed.

In November 2019, we announced that our investigational new drug application, or IND, for our PBL therapy, IOV-2001, was authorized by the FDA and our sponsored clinical trial using this therapy, IOV-CLL-01, was cleared to proceed.

IOV-2001 is a non-genetically modified, polyclonal T cell product that is manufactured using a nine-day process from 50 mL of patient’s blood.

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Both trials are sponsored by MDACC.

The first trial, NCT03449108, is intended to allow for investigation of LN-145 manufactured by Iovance using our manufacturing processes to treat patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer.

The first trial, NCT03449108, is intended to allow for investigation of LN-145

manufactured by Iovance using our manufacturing processes to treat patients with soft tissue sarcoma, osteosarcoma and platinum resistant ovarian cancer.

A second trial under the collaboration with MDACC, NCT03610490, is active as well.

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Components of Operating Results

We have not yet generated any revenues since our formation, and we currently do not anticipate that we will generate any revenues during 2020 from the sale or licensing of our product candidates.

We have not yet generated any revenues since our formation, and we currently do not anticipate that we will generate any significant revenues from the sale or licensing of our product candidates during the 12 months from the date these financial statements are issued.

Our ability to generate revenues in the future will depend on our ability to complete the development of our product candidates and to obtain regulatory approval for them.

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The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow.

We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites.

We accrue and expense costs for clinical trial activities performed by third parties based upon

estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites.

We determine our estimates through discussions with internal clinical personnel and outside service providers as to the progress or stage of completion of trials or services and the agreed upon fee to be paid for such services.

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Results of Operations

Comparison of the Three Months Ended March 31, 2020 and 2019

We did not generate any revenues during the three months ended March 31, 2020 or March 31, 2019.

Comparison of the Three and Six Months Ended June 30, 2020 and 2019

We did not generate any revenues during the three and six months ended June 30, 2020 or June 30, 2019.

Research and Development expenses (in thousands)

Three Months Ended

Research and development expenses

Six Months Ended

Research and development

Stock-based compensation expense included in research and development expense

Research and development expense for the three months ended March 31, 2020 increased by $26.0 million, or 84%, compared to the same period in 2019.

The increase was primarily attributable to (i) a $10.0 million for the license to further develop IOV-3001 obtained from Novartis, (ii) a $5.2 million increase in clinical trial costs due to an increase in enrollment across all the trials, (iii) a $5.3 million increase in payroll and related expenses driven by a higher number of full-time research and development employees, (iv) a $4.4 million increase in manufacturing costs due to increased production runs for patients and additional manufacturing capacity costs to support the ongoing clinical trials, and (v) a $1.6 million increase in stock-based compensation expenses.

Research and development expense for the three months ended June 30, 2020 increased by $10.0 million, or 25%, compared to the same period in 2019.

The increase was attributable to (i) a $6.9 million increase in clinical trial costs due primarily to higher costs for the purchase of drugs used in the clinical trials, specifically IL-2, (ii) a $4.6 million increase in payroll and related expenses driven by a higher number of full-time research and development employees, and (iii) a $2.7 million increase in stock-based compensation expenses.

These increases were partially offset by a $3.1 million decrease in manufacturing costs due to decreased production runs during the three months ended June 30, 2020.

Research and development expense for the six months ended June 30, 2020 increased by $36.0 million, or 51%, compared to the same period in 2019.

The increase was primarily attributable to (i) a $12.0 million increase in clinical trial costs due to an increase in enrollment across all the trials, (ii) a $10.0 million increase for the license to further develop IOV-3001 obtained from Novartis, (iii) a $9.9 million increase in payroll and related expenses driven by a higher number of full-time research and development employees, and (iv) a $4.4 million increase in stock-based compensation expenses.

General and Administrative expenses (in thousands)

Three Months Ended

General and administrative expenses

Stock-based compensation expense included in general and administrative expense

General and administrative expenses for the three months ended March 31, 2020 increased by $4.8 million, or 53%, compared to the same period in 2019.

The increase was primarily attributable to (i) a $1.9 million increase in stock-based compensation expenses driven by a higher number of full-time general and administrative employees and a higher average stock price, (ii) a $1.4 million increase in payroll and related expenses, and (iii) a $0.7 million increase in legal costs.

Six Months Ended

General and administrative

Stock-based compensation expense included in general and administrative

General and administrative expenses for the three months ended June 30, 2020 increased by $3.5 million, or 32%, compared to the same period in 2019.

The increase was primarily attributable to a $2.1 million increase in payroll and related expenses and a $1.4 million increase in stock-based compensation expenses driven by a higher number of full-time general and administrative employees and a higher average stock price.

General and administrative expenses for the six months ended June 30, 2020 increased by $8.3 million, or 41%, compared to the same period in 2019.

The increase was primarily attributable to (i) a $3.5 million increase in payroll and related expenses driven by a higher number of full-time general and administrative employees and a higher average stock price, (ii) a $3.3 million increase in stock-based compensation expenses, and (iii) a $1.2 million increase in director’s and officer’s insurance premiums.

Interest Income (in thousands)

Three Months Ended

Interest income, net

Net interest income decreased by $1.8 million or 60% due to interest income earned on the lower cash balance, and a decrease in interest rates for the three months ended March 31, 2020 as compared to the same period in 2019.

As our cash, cash equivalents and short term investment balance decrease, we anticipate interest income to decrease.

Six Months Ended

Net interest income

Net interest income for the three and six months ended June 30, 2020 and 2019 decreased by $2.0 million or 77% and $3.8 million or 68% respectively, due to interest income earned on the lower cash balance, and a decrease in interest rates for the three and six months period ended June 30, 2020 as compared to the same period in 2019.

Interest income earned on the net proceeds received from the public offering in June 2020 was minimal during the three months ended June 30, 2020 due to the timing of investment.

Net Loss (in thousands)

Three Months Ended

Net loss for the three months ended March 31, 2020 increased by $32.6 million or 88%, compared to the same period in 2019.

Six Months Ended

Net loss for the three and six months ended June 30, 2020 increased by $15.5 million or 33% and $48.1 million or 57% compared to the same periods in 2019.

The increase in our net loss was due to the continued expansion of our research and development activities, increased clinical trials and manufacturing activities, and the overall growth of our corporate infrastructure.

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We expect to continue to incur significant losses in 2020 and may incur significant losses and negative cash flows from operations for the foreseeable future.

We have funded our operations from various public and private offerings of our equity securities (both common stock and preferred stock), from option and warrant exercises, and from interest income.

On December 28, 2017, we filed a shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $250 million, which we refer to as the 2017 Shelf Registration Statement.

Historically, we have funded our operations from various public and private offerings of our equity securities (both common stock and preferred stock), from option and warrant exercises, and from interest income.

Since 2017, our primary source of funds has been from the public sale of our common stock.

On December 28, 2017, we filed a shelf registration statement, or the 2017 Shelf Registration Statement, with the SEC, for the issuance of common stock, preferred stock, warrants, rights, debt securities and units, which we refer to collectively as Shelf Securities, up to an aggregate amount of $250 million.

The 2017 Shelf Registration Statement was declared effective on January 19, 2018.

On January 29, 2018, we sold 15,000,000 shares of our common stock at a public offering price of $11.50 per share pursuant to the 2017 Shelf Registration Statement.

On January 29, 2018, we sold 15,000,000 shares of our common stock at a public offering price of $11.50 per share pursuant to

the 2017 Shelf Registration Statement.

We received gross proceeds of approximately $172.5 million and net proceeds of approximately $162.0 million, after deducting underwriting discounts and offering expenses.

The 2017 Shelf Registration Statement was terminated upon effectiveness of the 2018 Shelf Registration Statement (as discussed below).

On September 7, 2018, we filed a shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $250 million, which we refer to as the 2018 Shelf Registration Statement.

The 2018 Shelf Registration Statement was declared effective on October 3, 2018 and the aggregate amount of securities we could issue thereunder was subsequently increased by $50 million through a post-effective amendment that we filed on October 11, 2018, pursuant to Rule 462(b) of the Securities Act.

On September 7, 2018, we filed a shelf registration statement with the SEC for the issuance of up to an aggregate amount of $250 million of Shelf Securities, which we refer to as the 2018 Shelf Registration Statement.

On October 17, 2018, we sold 25,300,000 shares of our common stock at a public offering price of $9.97 per share pursuant to the 2018 Shelf Registration Statement.

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The 2018 Shelf Registration Statement is no longer available for future offerings.

On September 17, 2019, we filed a shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $400 million, which we refer to as the 2019 Shelf Registration Statement.

On September 17, 2019, we filed a shelf registration statement with the SEC for the issuance of up to an aggregate amount of $400 million of Shelf Securities, which we refer to as the 2019 Shelf Registration Statement.

The 2019 Shelf Registration Statement was declared effective on September 24, 2019.

We have not yet sold any securities pursuant to the 2019 Shelf Registration Statement.

In the future, we may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered.

If any of the securities covered by the 2019 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of such offering at that time.

The 2019 Shelf Registration Statement was terminated upon effectiveness of the 2020 Automatic Shelf Registration Statement (as discussed below).

No shares were sold under the 2019 Shelf Registration Statement prior to its termination.

On May 27, 2020, we filed an automatic shelf registration statement with the SEC for the issuance of an indeterminate amount of Shelf Securities, which we refer to as the 2020 Automatic Shelf Registration Statement.

The 2020 Automatic Shelf Registration Statement was immediately effective upon filing with the SEC, and the 2019 Shelf Registration Statement was simultaneously terminated.

On June 2, 2020, we sold 19,475,806 shares of our common stock at a public offering price of $31.0 per share pursuant to the 2020 Automatic Shelf Registration Statement.

We received gross proceeds of $603.7 million and net proceeds of approximately $567.0 million, after deducting underwriting discounts and offering expenses.

Following the public offering, the 2020 Automatic Shelf Registration Statement remains available for the future issuance of an indeterminate amount of Shelf Securities.

In the future, we may periodically offer one or more of the Shelf Securities in amounts, prices and terms to be announced when and if the securities are offered.

If any of the Shelf Securities covered by the 2020 Automatic Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of such offering at that time.

We are currently engaged in the development of therapeutics to fight cancer.

We do not have any commercial products and have not yet generated any revenues from our biopharmaceutical business.

We currently do not anticipate that we will generate any revenues during 2020 from the sale or licensing of any products.

We have incurred a net loss of $69.6 million for the three months ended March 31, 2020 and used $65.3 million of cash in our operating activities for the three months ended March 31, 2020.

As of March 31, 2020, we had $52.5 million of cash and cash equivalents, $193.1 million of short-term investments, $5.5 million of restricted cash, $243.3 million of stockholders’ equity and had working capital of $216.8 million.

We currently do not anticipate that we will generate any significant revenues from the sale or licensing of any products during the 12 months from the date these financial statements are issued.

We have incurred a net loss of $132.6 million for the six months ended June 30, 2020 and used $101.9 million of cash in our operating activities for the six months ended June 30, 2020.

As of June 30, 2020, we had $160.6 million of cash and cash equivalents, $611.3 million of short-term investments, $5.5 million of restricted cash, $758.3 million of stockholders’ equity and had working capital of $727.7 million.

We expect to continue our research and development activities, initiate pre-commercial activities and to begin construction on our tenant improvements to our new production facility, which will increase the amount of cash we will use during 2020 and beyond.

Specifically, we expect continued spending on clinical trials, research and development activities, higher payroll expenses as we increase our professional, commercial and scientific staff and continue our expansion of manufacturing activities including building our own facility.

Based on the funds we have available as of the date of filing of this Quarterly Report on Form 10-Q, and after consideration of the possible impacts of the COVID-19 Pandemic, we believe that we have sufficient capital to fund our anticipated operating expenses and capital expenditure for at least 12 months from the date of filing this report.

We have latitude as to the timing and amount of expenditures for our commercial-scale production facility under construction in Philadelphia, Pennsylvania.

The following table summarizes our cash flows for the periods presented from Operating, Investing and Financing Activities (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Net cash (used in) provided by:

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Financing activities

Net increase (decrease) in cash, cash equivalents and restricted cash

Net increase in cash, cash equivalents and restricted cash

Operating Activities

Net cash used in operating activities for the three months ended March 31, 2020 was $65.3 million compared to $29.1 million for the same period in 2019.

Net cash used in operating activities for the six months ended June 30, 2020 was $101.9 million compared to $62.9 million for the same period in 2019.

The increase of $38.8 million was primarily due to increased costs in research and development activities.

Included in $65.3 million used in 2020 was the $10.0 million upfront payment we paid for IOV-3001.

Included in $38.8 million was the $10.0 million upfront payment we paid for IOV-3001.

Investing Activities

Net cash provided by investing activities for the three months ended March 31, 2020 was $100.1 million compared to $1.0 million for the same period in 2019.

The increase of $99.1 million was primarily due to the timing of maturities and purchases of short-term investments.

Net cash used in investing activities for the six months ended June 30, 2020 was $323.7 million compared to net cash used provided by investing activities of $59.7 million for the same period in 2019.

The increase in cash used in investing activities of $383.2 million was primarily due to the purchase of short-term investments to invest the net proceeds from our June 2020 public offering.

Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2020 was $3.8 million.

Net cash used for the same period in 2019 was nil.

The increase of $3.8 million was primarily due to cash proceeds received from the exercise of stock options.

Net cash provided by financing activities for the six months ended June 30, 2020 was $572.3 million compared to $3.4 million for the same period in 2019.

The increase of $568.5 million was primarily due to net proceeds of $567.4 million from our June 2020 public offering.

Impact of the CARES Act

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We are currently evaluating the impact of the CARES Act, however, at present we do not expect that any provision of the CARES Act would result in a material cash benefit to us or have a material impact on our financial statements or internal controls over financial reporting.

Impact of COVID-19 on our Business

In December 2019, a novel coronavirus known as SARS-CoV-2 was first detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease, known as COVID-19, that has now spread globally.

On January 30, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic, which we refer to herein as the COVID-19 Pandemic.

The Secretary of Health and Human Services declared a public health emergency on January 31, 2020, under section 319 of the Public Health Service Act (42 U.S.C.

247d), in response to the COVID-19 Pandemic.

Operations and Liquidity

The full impact of the COVID-19 Pandemic is unknown and rapidly evolving.

While the potential economic impact brought by and over the duration of the COVID-19 Pandemic may be difficult to assess or predict, the COVID-19 Pandemic has resulted in significant disruption of global financial markets, which could in the future negatively affect our liquidity.

In addition, a recession or market volatility resulting from the COVID-19 Pandemic could affect our business.

We have taken proactive, aggressive action throughout the COVID-19 Pandemic to protect the health and safety of our employees, and expect to continue to implement these measures until we determine that the COVID-19 Pandemic is adequately contained for purposes of our business.

We may take further actions as government authorities require or recommend or as we determine to be in the best interests of our employees.

To date, the COVID-19 Pandemic has not had significant effects on our clinical trial enrollment.

Given the nature and type of our short-term

investments in U.S.

government securities, we do not believe that the COVID-19 Pandemic will have a material impact on our current investment liquidity.

Although there is uncertainty related to the anticipated impact of the recent COVID-19 Pandemic on our future results, we believe our current cash reserves leave us well-positioned to manage our business through this crisis as it continues to unfold.

However, the impacts of the COVID-19 Pandemic are broad-reaching and continuing and the financial impacts associated with the COVID-19 Pandemic are still uncertain.

The COVID-19 Pandemic is ongoing, and its dynamic nature, including uncertainties relating to the ultimate geographic spread of the virus, the severity of the disease, the duration of the pandemic, and actions that would be taken by governmental authorities to contain the pandemic or to treat its impact, makes it difficult to forecast any effects on our results for the fiscal year ending December 31, 2020.

Despite the economic uncertainty resulting from the COVID-19 Pandemic, we intend to continue to focus on the development of our product candidates.

We continue to monitor the rapidly evolving situation and guidance from international and domestic authorities, including federal, state and local public health authorities and may take additional actions based on their recommendations.

In these circumstances, there may be developments outside our control requiring us to adjust our operating plan.

As such, given the dynamic nature of this situation, we cannot reasonably estimate the impacts of COVID-19 on our financial condition, results of operations or cash flows in the future.

Off-Balance Sheet Arrangements

At March 31, 2020, we had no obligations that would require disclosure as off-balance sheet arrangements.

At June 30, 2020, we had no obligations that would require disclosure as off-balance sheet arrangements.

Significant Accounting Policies and Recent Accounting Standards

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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