What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-01 compared with 2024-05-07 · 96 added, 50 removed, 264 unchanged (36% of the section changed)

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Ou r late and mid-stage clinic al programs are as follows:

• Tividenofusp alfa (DNL310, ETV:IDS), our lead enzyme replacement therapy ("ERT") program enabled by our Enzyme Transport Vehicle ("ETV"), is designed to cross the BBB and restore duronate 2-sulfatase ("IDS") and reduce glycosaminoglycans ("GAGs"), both peripherally and in the brain, in individuals with mucopolysaccharidosis II ("MPS II" or "Hunter syndrome");

• Tividenofusp alfa (DNL310, ETV:IDS), our lead enzyme replacement therapy ("ERT") program enabled by our Enzyme Transport Vehicle ("ETV"), is designed to cross the BBB and restore Iduronate 2-sulfatase ("IDS") and reduce glycosaminoglycans ("GAGs"), both peripherally and in the brain, in individuals with mucopolysaccharidosis II ("MPS II" or "Hunter syndrome");

• DNL343, our eukaryotic initiation factor 2 B ("eIF2B") activator program to address diseases such as amyotrophic lateral sclerosis ("ALS") and frontotemporal dementia ("FTD");

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• DNL126 (ETV:SGSH), our second most advanced ETV enabled program, which is designed to restore lysosomal activity of N-sulfoglucosamine sulfohydrolase ("SGSH"), an enzyme responsible for degrading heparan sulfates in the lysosome, in individuals with MPS IIIA (Sanfilippo syndrome Type A);

• TAK-594/DNL593 (PTV:PGRN), our recombinant progranulin ("PGRN") biotherapeutic enabled by our Protein Transport Vehicle ("PTV:PGRN"), being developed in collaboration with Takeda, to address frontotemporal dementia-granulin ("FTD-GRN") caused by PGRN deficiency.

• TAK-594/DNL593 (PTV:PGRN), our recombinant progranulin ("PGRN") biotherapeutic enabled by our Protein Transport Vehicle ("PTV"), being developed in collaboration with Takeda, to address frontotemporal dementia-granulin ("FTD-GRN"), or frontotemporal dementia due to loss of function mutations in the GRN gene.

The following table summarizes key information about our clinical stage programs:

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Sanfilippo syndrome Type A (MPS IIIA) Denali

TAK-594/DNL593 Ph 1/2 (paused) 1

TAK-594/DNL593 Ph 1/2

Joint with Takeda

__________________________________________________

(1) Study has been voluntarily paused in order to implement protocol modifications and is expected to resume later this year.

Since we commenced operations, we have devoted substantially all of our resources to discovering, acquiring and developing product candidates, building our BBB platform technology and assembling our core capabilities in understanding key neurodegenerative disease pathways.

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Also in February, we participated in the Reagan-Udall Foundation for the FDA workshop on CSF HS as a potential surrogate biomarker to support accelerated approval in MPS.

Based on continued dialogue with the Center for Drug Evaluation and Research (CDER) division of the FDA in April, we believe the division may be open to discussing an accelerated path for tividenofusp alfa.

We look forward to continuing the productive dialogue with CDER and, in parallel, conducting the global Phase 2/3 COMPASS study;

• In January 2024, we announced that Part B in the TAK-594/DNL593 Phase 1/2 study in participants with FTD-GRN had been voluntarily paused to implement protocol modifications and is expected to resume this year;

In April, we completed enrollment of 47 participants with MPS II in the Phase 1/2 open-label study.

Following the Reagan-Udall Foundation workshop, we received written communication from the Center for Drug Evaluation and Research ("CDER") division of the FDA indicating openness to discussing an accelerated approval pathway for tividenofusp alfa in MPS II with cerebrospinal fluid heparan sulfate (CSF HS) as a surrogate biomarker.

We look forward to continued engagement with CDER regarding our intention to file for approval of tividenofusp alfa using the accelerated approval pathway.

We will provide an update in 2H 2024;

• In January 2024, we announced that Part B in the TAK-594/DNL593 Phase 1/2 study in participants with FTD-GRN had been voluntarily paused to implement protocol modifications.

In the second quarter of 2024, we finalized the protocol amendment for the Phase 1/2 study and prescreening of participants for Cohort B2 is ongoing ;

• In January 2024, we announced our intention to divest our preclinical small molecule portfolio, which was completed effective March 1, 2024.

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• In February 2024, we announced that the Phase 2 HIMALAYA study evaluating SAR443820/DNL788 in participants with ALS did not meet the primary endpoint of change in ALS Functional Rating Scale-Revised (ALSFRS-R).

Sanofi intends to present the detailed efficacy and safety results of the ALS Phase 2 HIMALAYA study at a future scientific forum.

Sanofi is evaluating SAR443820/DNL788 in another Phase 2 clinical trial in participants with MS which is fully enrolled, and the outcome of HIMALAYA study has no impact on the ongoing MS study;

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• In February 2024, we announced that we executed a Collaboration and Development Funding Agreement in January 2024 with a third party related to a global Phase 2a study of BIIB122/DNL151, which we plan to solely operationalize to evaluate safety and biomarkers associated with BIIB122 in participants with Parkinson’s disease and confirmed pathogenic variants of LRRK2.

This agreement includes committed funding of $75.0 million, of which $12.5 million was received in January 2024, and the remainder will be triggered based on time and operational milestones in the study.

This agreement includes committed funding of $75.0 million, of which $12.5 million was received in January 2024 and $12.5 million was received in July 2024, with the remainder to be triggered based on operational milestones in the study.

The third party will be eligible to receive low single-digit royalties from Denali on annual worldwide net sales of LRRK2 inhibitors for the treatment of Parkinson’s disease, with royalty amounts varying based on the scope of the label.

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Healey & AMG Center for ALS at Massachusetts General Hospital (MGH) in collaboration with the Northeast ALS Consortium (NEALS) announced that enrollment is complete in Regimen G (DNL343) of the Phase 2/3 HEALEY ALS Platform Trial;

• In June 2024, we announced that the CDER has selected DNL126 (ETV:SGSH) for participation in the FDA's Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program to further accelerate the development of novel drug and biological products for rare diseases.

Participation in START is expected to facilitate and accelerate development of DNL126;

• In July 2024, Biogen terminated its license to the ATV:Abeta program enabled by our TfR-targeting technology against amyloid beta for the potential treatment of Alzheimer's disease and granted us rights to data generated during the collaboration.

As a result of the termination, all rights to develop, manufacture, perform medical affairs activities, and commercialize new TfR-targeting ATV:Abeta therapeutics reverted to us.

Biogen licensed our TfR-targeting ATV:Abeta program in April 2023 having exercised an option that was part of the 2020 collaboration agreement between the two companies.

Biogen’s decision was not related to any efficacy or safety concerns with the TV platform.

We do not have any products approved for sale and have not generated any product revenue since our inception.

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We have incurred significant operating losses to date and expect to continue to incur operating losses for the foreseeable future.

We had net losses of $101.8 million and $109.8 million for the three months ended March 31, 2024 and 2023, respectively .

As of March 31, 2024, we had an accumulated deficit o f $1.22 billion.

We had net losses of $99.0 million and $200.8 million for the three and six months ended June 30, 2024, respectively .

Due to revenue recognized from our collaboration arrangement with Biogen, we had net income of $183.4 million and $73.6 million for the three and six months ended June 30, 2023, respectively.

As of June 30, 2024, we had an accumulated deficit o f $1.32 billion.

Our ability to generate product revenue will depend on the successful development and eventual commercialization of one or more of our product candida tes.

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Where we share costs with our collaboration partners, such as in our Biogen Collaboration Agreement and Takeda Collaboration Agreement , research and development expenses may include cost sharing reimbursements from, or payments to, our collaboration partners.

Further, where we receive R&D funding from third parties, this may be recognized as a reduction to research and development expenses.

It is challenging to predict the nature, timing and estimated long-range costs of the efforts that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates.

This is made more challenging by events outside of our control, such as the COVID-19 pandemic and increased geopolitical uncertainty.

This is made more challenging by events outside of our control, such as global pandemics and increased geopolitical uncertainty.

We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product candidates.

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Results of Operations

Comparison of the three months ended March 31, 2024 and 2023

Comparison of the three and six months ended June 30, 2024 and 2023

The following table sets forth the significant components of our results of operations (in thousands):

Three Months Ended March 31, Change

Three Months Ended June 30, Change

2024 2023 $ %

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116,593 123,640 (7,047) (6)

Income (loss) from operations (116,593) 170,483 (287,076) *

Interest and other income, net

17,567 12,900 4,667 36

Net income (loss) $ (99,026) $ 183,383 $ (282,409) * %

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* Percentage is not meaningful.

Six Months Ended June 30,

2024 2023 $ %

Collaboration revenue:

Collaboration revenue from customers

$ — $ 329,264 $ (329,264) * %

Total collaboration revenue

— 329,264 (329,264) *

Operating expenses:

Research and development

198,415 226,336 (27,921) (12)

General and administrative

50,430 53,260 (2,830) (5)

Total operating expenses

248,845 279,596 (30,751) (11)

Gain from divestiture of small molecule programs 14,537 — 14,537 *

Loss from operations (117,715) (120,815) 3,100 (3)

Income (loss) from operations (234,308) 49,668 (283,976) *

Interest and other income, net

33,480 23,934 9,546 40

Net loss $ (101,802) $ (109,781) $ 7,979 (7) %

Net income (loss) $ (200,828) $ 73,602 $ (274,430) * %

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Collaboration revenue.

There was no collaboration revenue for three months ended March 31, 2024 and collaboration revenue of $35.1 million for three months ended March 31, 2023.

The decrease in revenue was primarily due to a decrease of revenue earned under the Sanofi Collaboration of $25.0 million and Takeda Collaboration of $10.0 million.

There was no collaboration revenue for three and six months ended June 30, 2024, respectively, and $294.1 million and $329.3 million for three and six months ended June 30, 2023, respectively.

The decrease for the three months ended June 30, 2024 compared to June 30, 2023 was primarily due to $293.9 million in revenue recognized in April 2023 under the Biogen Collaboration Agreement as a result of Biogen exercising its option to license our ATV:Abeta program.

The decrease for the six months ended June 30, 2024 compared to June 30, 2023 was primarily due to the decrease in Biogen revenue described above, as well as decreases of revenue earned under the Takeda and Sanofi Collaboration Agreements of $10.0 million and $25.0 million, respectively.

Research and development expen ses.

Research and development expenses were $107.0 million and $128.8 million for the three months ended March 31, 2024 and 2023, respectively.

Research and development expenses were $91.4 million and $198.4 million for the three and six months ended June 30, 2024, compared to $97.5 million and $226.3 million for the three and six months ended June 30, 2023, respectively.

The following table summarizes our research and development expenses by program and category (in thousands):

Three Months Ended March 31,

Three Months Ended June 30, Six Months Ended June 30,

2024 2023 2024 2023

ETV:IDS program external expenses $ 21,079 $ 20,642 $ 50,799 $ 67,286

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TV platform and other program external expenses

4,410 4,471 7,882 9,850

LRRK2 program external expenses 1,465 913 2,082 2,818

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Other external research and development expenses

3,781 5,673 9,643 13,388

Personnel related expenses (1)

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10,509 11,024 20,532 27,762

Net cost sharing payments (2)

Net cost sharing and research funding payments (2)

819 3,507 3,895 4,522

Total research and development expenses

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__________________________________________________

(1) Personnel related expenses include stock-based compensation expense of $16.3 million and $16.8 million for the three months ended March 31, 2024 and 2023, respectively.

(2) Net cost sharing payments details are broken down as shown in the table below.

The underlying costs for reimbursements are included with the specified external expenses line and personnel related expenses in the table above.

(1) Personnel related expenses include stock-based compensation expense of $14.4 million and $30.7 million for the three and six months ended June 30, 2024, respectively, and $15.2 million and $32.0 million for the three and six months ended June 30, 2023, respectively, reflecting decreases of $0.8 million and $1.3 million, respectively.

(2) The breakdown of net cost sharing and research funding payments is shown in the table below.

The underlying costs for reimbursements and research funding are included with the specified external expenses line and personnel related expenses in the table above.

ATV:TREM2 program external expenses are presented within the TV platform and other program external expenses line.

Three Months Ended March 31,

net reimbursements for ATV:TREM2 program

Three Months Ended June 30, Six Months Ended June 30,

2024 2023 2024 2023

net reimbursements for PTV:PGRN program $ (1,138) $ (1,864) $ (2,338) $ (3,342)

net reimbursements for ATV:TREM2 program

(215) (1,605) (728) (3,262)

net payments for LRRK2 program

Net cost sharing payments (reimbursements)

4,440 6,976 9,229 11,126

The decrease in research and development expenses of approximately $21.8 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023, was primarily attributable to the following:

LRRK2 research funding

(2,268) — (2,268) —

Net cost sharing payments and research funding payments

$ 819 $ 3,507 $ 3,895 $ 4,522

The decrease in research and development expenses of approximately $6.1 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, was primarily attributable to the following:

• a decrease of $4.9 million in personnel related expenses due to decreases in salary and stock based compensation expenses due to decreased headcount, primarily as a result of the divestiture of our preclinical small molecule programs in March 2024;

• a decrease in net cost sharing and research funding payments, primarily due to the recognition of $2.3 million of research funding for the LRRK2 program from the Collaboration and Development Funding Agreement executed in January 2024;

• decreases of $0.1 million and $1.4 million in TV platform and other program external expenses including ATV:TREM2 expenses, and PTV:PGRN program external expenses, respectively, due to the discontinuation of clinical development of TAK-920/DNL919 (ATV:TREM2) in Alzheimer’s disease and voluntary pause of Part B in the TAK-594/DNL593 (PTV:PGRN) Phase 1/2 study, respectively;

• a decrease of $1.9 million in other external research and development expenses associated with the divestiture of our preclinical small molecule programs.

These decreases were partially offset by increases in costs in various clinical stage programs, including of eIF2B ($3.7 million), ETV:SGSH ($0.7 million) and ETV:IDS ($0.4 million) reflecting the continued progress of these programs in clinical trials.

Further, there was an increase of $0.6 million in LRRK2 program external expenses due to activities related to our planned Phase 2a study in Parkinson's Disease patients.

The decrease in research and development expenses of approximately $27.9 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, was primarily attributable to the following:

• a decrease of $16.5 million in ETV:IDS program external expenses because the first quarter of 2023 included expense for a contingent consideration payment of $30.0 million related to the acquisition of F-star Gamma, which was triggered in March 2023 upon the achievement of a specified clinical milestone in the ETV:IDS program.

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• decreases of $2.0 million and $2.6 million in TV platform and other program external expenses including ATV:TREM2 expenses, and PTV:PGRN program external expenses, respectively, due to the discontinuation of clinical development of TAK-920/DNL919 (ATV:TREM2) in Alzheimer’s disease and voluntary pause of Part B in the TAK-594/DNL593 (PTV:PGRN) Phase 1/2 study, respectively;

• a decrease of $1.3 million in LRRK2 program external expenses due to the transition of LRRK2 clinical activities to Biogen;

• a decrease of $1.9 million in other external research and development expenses.

These decreases were partially offset by increases of $2.9 million and $1.8 million in eIF2B and ETV:SGSH program external expenses, respectively, reflecting the continued progress of these programs in clinical trials during 2024, and an increase of $2.1 million in net cost sharing payments due to increased payments due to Biogen as a result of increased LRRK2 clinical trial costs incurred by Biogen, offset by decreased reimbursements from Takeda as a result of the discontinuation of TREM2 DNL919 phase 1 trial and temporary pause of TAK-594/DNL593.

• a decrease of $3.7 million in personnel related expenses due to decreases in salary and stock based compensation expenses due to decreased headcount, primarily as a result of the divestiture of our preclinical small molecule programs in March 2024;

• a decrease of $3.7 million in other external research and development expenses primarily due to elevated facility costs in the six months ended June 30, 2023 as a result of accelerated depreciation on leasehold improvements associated with the termination of the former SLC Lease;

• the recognition of $2.3 million of research funding or the LRRK2 program from the Collaboration and Development Funding Agreement executed in January 2024.

These decreases were partially offset by increases of $6.6 million and $2.5 million in eIF2B and ETV:SGSH program external expenses, respectively, reflecting the continued progress of these programs in clinical trials.

General and administrative expenses.

General and administrative expenses were $25.2 million for the three months ended March 31, 2024 compared to $27.1 million for the three months ended March 31, 2023.

The decrease of $1.9 million was primarily attributable to $2.4 million of combined decreases in professional services, facilities and other corporate costs, partially offset by $0.5 million of increased personnel-related expenses consisting of employee compensation and stock-based compensation expense.

General and administrative expenses were $25.2 million for the three months ended June 30, 2024 compared to $26.1 million for the three months ended June 30, 2023.

The decrease of $0.9 million was primarily attributable to a decrease of $1.1 million in personnel-related expenses consisting of employee compensation and stock-based compensation expense, partially offset by combined increases of $0.2 million in professional services, facilities and other corporate costs.

General and administrative expenses were $50.4 million for the six months ended June 30, 2024 compared to $53.3 million for the six months ended June 30, 2023.

The decrease of $2.9 million was primarily attributable to $2.2 million of combined decreases in professional services, facilities and other corporate costs and $0.7 million of decreased personnel-related expenses consisting of employee compensation and stock-based compensation expense.

Gain from divestiture of small molecule programs.

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Sources of Liquidity

As of March 31, 2024, we had cash, cash equivalents and marketable securities in the amount of $1.43 billion.

As of June 30, 2024, we had cash, cash equivalents and marketable securities in the amount of $1.35 billion.

We fund our operations primarily with the proceeds from the sale of common stock and payments received from our collaboration partners, including those received under agreements with Takeda, Sanofi, and Biogen.

We have sold common stock and other securities in public offerings, a private placement, and stock purchase agreements with Takeda and Biogen.

Through March 31, 2024 we have obtained aggregate net proceeds of approximately $754.4 million from public offerings of our common stock, including $296.2 million obtained through the sale of 11.9 million shares of common stock in October 2022.

Under stock purchase agreements with collaboration partners we have received a further $575.0 million through March 31, 2024 .

Through June 30, 2024 we have obtained aggregate net proceeds of approximately $754.4 million from public offerings of our common stock, including $296.2 million obtained through the sale of 11.9 million shares of common stock in October 2022.

Under stock purchase agreements with collaboration partners we have received a further $575.0 million through June 30, 2024 .

Further, in February 2024 we received net proceeds of approximately $499.3 million from our private placement through the sale of approximately 3.2 million shares of common stock and pre-funded warrants to purchase a pproximately 26.0 million shares of our common stock .

In February 2022, we established a registered “at-the-market” facility for the sale of up to $400.0 million of shares of common stock from time to time by entering into an equity distribution agreement with Goldman Sachs & Co.

LLC, SVB Securities LLC and Cantor Fitzgerald & Co.

LLC, Leerink Partners LLC (formerly SVB Securities LLC) and Cantor Fitzgerald & Co.

as sales agents.

To date, no shares have been sold under the equity distribution agreement.

Pursuant to our collaboration and research funding agreements with Takeda, Sanofi, Biogen and an unrelated third party, through March 31, 2024 we have received upfront, option and milestone payments of $115.0 million , $225.0 million, $565.0 million and $12.5 million, respectively, and have also received $43.9 million and $16.2 million of gross cost sharing reimbursements from Takeda and Biogen, respectively, and received $13.7 million in specified reimbursements from Sanofi.

Pursuant to our collaboration and research funding agreements with Takeda, Sanofi, Biogen and an unrelated third party, through June 30, 2024 we have received upfront, option and milestone payments of $115.0 million , $225.0 million, $565.0 million and $12.5 million, respectively, and have also received $45.8 million and $16.2 million of gross cost sharing reimbursements from Takeda and Biogen, respectively, and received $13.7 million in specified reimbursements from Sanofi.

Future Funding Requirements and Commitments

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Since our inception, we have incurred significant losses and negative cash flows from operations.

We have an accumulated deficit of $1.22 billion through March 31, 2024.

We have an accumulated deficit of $1.32 billion through June 30, 2024.

We expect to incur substantial additional losses in the future as we conduct and expand our research and development activities.

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Our existing commitments primarily relate to our obligations under existing lease agreements, and certain clinical and manufacturing agreements, including the DMSA with Lonza Sales AG ("Lonza") for the development and manufacture of biologic products.

As of March 31, 2024, operating lease liabilities were $50.5 million.

As of June 30, 2024, operating lease liabilities were $48.8 million.

Under the SLC lease which was executed in April 2023, we have future undiscounted lease payments totaling approximately $13.4 million.

Under the DMSA with Lonza, and certain other clinical and manufacturing agreements, we had total non-refundable purchase commitments as of March 31, 2024 of $67.6 million, with certain amounts subject to cost sharing with Takeda.

Under the DMSA with Lonza, and certain other clinical and manufacturing agreements, we had total non-refundable purchase commitments as of June 30, 2024 of $56.5 million, with certain amounts subject to cost sharing with Takeda.

While the lease obligations span multiple years, the majority of the purchase commitments with Lonza and other clinical and manufacturing agreements are due within twelve months, with some spanning several years.

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The following table sets forth a summary of the primary sources and uses of cash for each of the periods presented below (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Net cash used in operating activities $ (204,840) $ (171,971)

Net cash used in investing activities (453,187) (92,715)

Net cash (used in) provided by investing activities (354,618) 75,352

Net cash provided by financing activities 507,031 10,623

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Net Cash Used In Operating Activities

During the three months ended March 31, 2024, net cash used in operating activities was $113.6 million, which consisted of a net loss of $101.8 million, adjusted by non-cash items primarily related to stock-based compensation expense, depreciation and amortization, net amortization of premiums and (discounts) on marketable securities, non-cash rent expenses, and the non-cash gain on divestiture of small molecule programs.

Cash used in operating activities was also driven by changes in our operating assets and liabilities, the most significant of which was an increase in other non-current assets related to costs associated with the new Salt Lake City manufacturing facility during the three months ended March 31, 2024.

During the six months ended June 30, 2024, net cash used in operating activities was $204.8 million, which consisted of a net loss of $200.8 million, adjusted by non-cash items primarily related to stock-based compensation expense, depreciation and amortization, net accretion of discounts on marketable securities, non-cash rent expenses, and the non-cash gain on divestiture of small molecule programs.

Net Cash Used In Investing Activities

During the three months ended March 31, 2024, net cash used in investing activities was $453.2 million, which consisted of $834.2 million of purchases of marketable securities, partially offset by $383.1 million in proceeds from maturities and sales of marketable securities, and $2.2 million of capital expenditures to purchase property and equipment.

During the six months ended June 30, 2024, net cash used in investing activities was $354.6 million, which consisted of $955.8 million of purchases of marketable securities and $6.9 million of capital expenditures to purchase property and equipment, partially offset by $608.1 million in proceeds from maturities and sales of marketable securities.

Net Cash Provided By Financing Activities

During the three months ended March 31, 2024, cash provided by financing activities was $500.3 million which consisted of $499.3 million of net proceeds from the sale of common stock and pre-funded warrants in a private placement in February 2024, as well as proceeds from the exercise of options to purchase common stock.

During the six months ended June 30, 2024, cash provided by financing activities was $507.0 million which consisted of $499.3 million of net proceeds from the sale of common stock and pre-funded warrants in a private placement in February 2024, as well as proceeds from the exercise of options to purchase common stock and purchases of ESPP shares.

Critical Accounting Estimates

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In our “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, 2023, as filed with the SEC on February 28, 2024, we described the accounting estimates that we believe involve a significant level of estimation uncertainty which could have a material impact on our financial condition or results of operations.

There have been no material changes to these critical accounting estimates during the three months ended March 31, 2024.

There have been no material changes to these critical accounting estimates during the six months ended June 30, 2024.

Recent Accounting Pronouncements

There have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2024 , as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 28, 2024, that are of significance or potential significance to us.

There have been no new accounting pronouncements or changes to accounting pronouncements during the six months ended June 30, 2024 , as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on February 28, 2024, that are of significance or potential significance to us.

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