What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-08-08 compared with 2022-05-05 · 103 added, 52 removed, 246 unchanged (39% of the section changed)

24 unchanged sentences

• our ability to attract and retain key managerial, scientific and medical personnel;

• the impact of increasing geopolitical uncertainty, rising inflation and increased labor market competition;

• the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

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• Engineering Brain Delivery :

We engineer our product candidates to cross the BBB and act directly in the brain;

We engineer our product candidates to cross the blood-brain barrier ("BBB") and act directly in the brain;

• Biomarker-Driven Development :

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By executing this strategy with a team of experienced and passionately dedicated scientists and drug developers, we believe we can succeed in a field that has seen limited progress over the past several decades.

We have a focused yet diversified portfolio with six clinical programs and more than fifteen programs in the preclinical development stage.

We have a focused yet diversified portfolio with seven clinical programs and more than fifteen programs in the preclinical development stage.

We have also developed a proprietary BBB platform technology, our transport vehicle ("TV"), which enables multiple modality-based platforms to deliver a wide range of large-molecule therapeutics across the BBB, including enzymes, antibodies, proteins and oligonucleotides.

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• our recombinant progranulin ("PGRN") biotherapeutic enabled by our protein transport vehicle ("PTV:PGRN"), to be developed in collaboration with Takeda, to address certain types of FTD, especially FTD-GRN caused by PGRN deficiency;

• our novel, selective, high affinity triggering receptors expressed on myeloid cells 2 ("TREM2") antibody, enabled by our antibody transport vehicle ("ATV"), to be developed in collaboration with Takeda for the potential treatment of Alzheimer's disease.

The following table summarizes key information about our planned and ongoing clinical studies:

Program Product Candidate Clinical Study(ies) Indication Operational Control

LRRK2 BIIB122/DNL151 Ph 2b (planned)

LRRK2 BIIB122/DNL151 Ph 2b

PD Joint with Biogen

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Joint with Takeda

ATV:TREM2 TAK-920/DNL919 Ph 1 Alzheimer's disease Joint with Takeda

To complement our internal capabilities, we have entered into arrangements with biopharmaceutical companies, patient-focused data companies, numerous leading academic institutions and foundations to gain access to new product candidates, enable and accelerate the development of our existing programs and deepen our scientific understanding of certain areas of biology.

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• In January 2022, we announced that Sanofi plans to initiate a Phase 2 trial of SAR443820/ DNL788 in MS, and a Phase 2 trial of SAR443122/ DNL758 in patients with UC;

• In January 2022, we announced that the DNL919 (ATV:TREM2) IND application had been placed on clinical hold by the FDA.

We received a formal clinical hold letter and are moving forward to address the FDA’s observations related to the preclinical toxicology assessment and to provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure.

We expect a delay of at least 3 months to our plans to begin dosing in a first-in-human clinical trial of DNL919.

We intend to provide an update in the second half of 2022 once a clear path forward is established;

• In January 2022, the clinical trial application ("CTA") for TAK-594/DNL593 (PTV:PGRN) was approved by the MHRA, triggering a $12.0 million milestone from Takeda which was received in February 2022;

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• In March 2022, we announced the initiation of a Phase 1/2 Clinical Trial of TAK-594/DNL593 for Frontotemporal Dementia-Granulin (FTD-GRN).

Pending initial clinical data from the Phase 1 healthy volunteer portion of the clinical trial, we expect to begin dosing individuals with FTD-GRN in the second half of 2022;

Pending initial clinical data from healthy volunteers, we expect to begin dosing participants with FTD-GRN in the second half of 2022;

• In March 2022, we mutually agreed under the Takeda Collaboration Agreement to terminate activity on the ATV:Tau program over which Takeda had an option to develop and commercialize jointly with the Company;

• In April 2022, our collaboration partner Sanofi commenced dosing in the HIMALAYA Phase 2 study of SAR3820/DNL788 expected to enroll approximately 260 participants with ALS , triggering a $40.0 million milestone which is due in May 2022;

• In April 2022, our collaboration partner Sanofi commenced dosing in the HIMALAYA Phase 2 study of SAR443820/DNL788 expected to enroll approximately 260 participants with ALS , triggering a $40.0 million milestone which was received in May 2022;

• Effective May 1, 2022, Steve Krognes transitioned from his role as Chief Financial Officer to join the Company’s Board of Directors, and Alexander Schuth, M.D., former Chief Operating Officer and Secretary of the Company, added the Chief Financial Officer role to his responsibilities, becoming Denali’s Chief Operating and Financial Officer;

• In May 2022, we announced that our collaboration partner Biogen commenced dosing in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122/DNL151, as compared to placebo in approximately 640 participants with early-stage Parkinson’s disease, which triggered a clinical milestone payment of $7.5 million owed to Genentech.

In August 2022 we announced that t he Phase 3 LIGHTHOUSE study in approximately 400 participants with Parkinson's disease with a confirmed LRRK2 pathogenic variant is expected to begin in the second half of 2022;

• In August 2022, we announced that dosing has commenced in the Phase 1 single ascending dose study in healthy volunteers in the Netherlands.

In June 2022, the CTA for TAK-920/DNL919 (ATV:TREM2) was approved, triggering a $12.0 million milestone payment from Takeda which was received in July 2022.

In January 2022, we announced that the TAK-920/DNL919 Investigational New Drug ("IND") application had been placed on clinical hold by the U.S.

Food and Drug Administration ("FDA").

Denali plans to continue to engage with the FDA and regulatory authorities in Europe to define the path forward for the TAK-920/DNL919 clinical program;

• In August 2022, we announced that new longer-term interim data from the ongoing Phase 1/2 study for DNL310 (ETV:IDS) continues to show sustained normalization to healthy levels of CSF heparan sulfate and improvements in markers of lysosomal function consistent with durable CNS activity, and the safety profile with up to 85 weeks of dosing remains comparable with standard of care therapy.

In addition, 49-week open label data on global impression of change continues to suggest stabilization and/or improvement in MPS II symptoms.

We also announced that we have initiated recruitment of the Phase 2/3 COMPASS study for DNL310 (ETV:IDS).

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

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

Our net losses wer e $65.2 million and $70.0 million for the three months ended March 31, 2022 and 2021 , respectively.

As of March 31, 2022, we had an accumulated deficit o f $710.2 million.

We e xpect to continue to incur significant expenses and operating losses as we advance our current clinical stage programs through healthy volunteer and patient trials;

Our net losses wer e $58.8 million and $124.0 million for the three and six months ended June 30, 2022, respectively, and $60.7 million and $130.7 million for three and six months ended June 30, 2021 , respectively.

As of June 30, 2022, we had an accumulated deficit o f $769.0 million.

We e xpect to continue to incur signi ficant expenses and operating losses as we advance our current clinical stage programs through healthy volunteer and patient trials;

broaden and improve our BBB platform technology;

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Results of Operations

Comparison of the three months ended March 31, 2022 and 2021

Comparison of the three and six months ended June 30, 2022 and 2021

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

2022 2021 $ %

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2,649 1,126 1,523 *

Loss before income taxes (58,767) (60,691) 1,924 3

Income tax expense (27) — (27) *

Net loss $ (58,794) $ (60,691) $ 1,897 3 %

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* Percentage is not meaningful.

Six Months Ended June 30, Change

2022 2021 $ %

Collaboration revenue:

Collaboration revenue was $42.1 million and $7.9 million for the three months ended March 31, 2022 and 2021, respectively.

The increase in collaboration revenue of $34.2 million for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 was primarily due to an increase in revenue from our collaborations with Takeda and Biogen of $32.9 million and $1.3 million, respectively.

Takeda revenue for the three months ended March 31, 2022 is composed of $27.9 million recognized due to the performance obligation satisfaction associated with termination of the Tau program, and $12.0 million related to the milestone earned for approval of the CTA for TAK-594/DNL593 (PTV:PGRN).

Collaboration revenue from customers

$ 94,621 $ 30,858 $ 63,763 * %

Other collaboration revenue

— 4 (4) (100)

Total collaboration revenue

94,621 30,862 63,759 *

Operating expenses:

Research and development

178,835 125,918 52,917 42

General and administrative

43,700 37,981 5,719 15

Total operating expenses

222,535 163,899 58,636 36

Loss from operations (127,914) (133,037) 5,123 4

Interest and other income, net

3,927 2,305 1,622 70

Loss before income taxes (123,987) (130,732) 6,745 5

Income tax expense (27) — (27) *

Net loss $ (124,014) $ (130,732) $ 6,718 5 %

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* Percentage is not meaningful.

Collaboration revenue.

Collaboration revenue was $52.5 million and $94.6 million for the three and six months ended June 30, 2022, respectively, and $22.9 million and $30.9 million for the three and six months ended June 30, 2021.

The increases in collaboration revenue of $29.6 million and $63.7 million for the three and six months ended June 30, 2022, respectively, compared to the comparative period in the prior year were primarily due to an increase in revenue from our collaborations with Takeda and Sanofi.

Takeda revenue increased for the three months ended June 30, 2022 due to the $12.0 million preclinical milestone earned for approval of the CTA for TAK-920/DNL919 ("ATV:TREM2"), and further increased for the six months ended June 30, 2022 due to the $12.0 million preclinical milestone earned for approval of the CTA for TAK-594/DNL593 ("PTV:PGRN"), and revenue recognized for the performance obligation satisfaction associated with termination of the Tau program.

Sanofi revenue increased for the three and six months ended June 30, 2022 due to a $40.0 million milestone earned in April 2022 upon dosing the first patient in a Phase 2 study of SAR443820/DNL788 in individuals with ALS, compared with a $15.0 million milestone recognized in the comparable period related to the initiation of a Phase 2 study of SAR443122/DNL758.

Research and development expen ses.

Research and development expenses were $86.1 million and $60.2 million for the three months ended March 31, 2022 and 2021, respectively.

Research and development expenses were $92.7 million and $178.8 million for the three and six months ended June 30, 2022, compared to $65.7 million and $125.9 million for the three and six months ended June 30, 2021, 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,

2022 2021 2022 2021

LRRK2 program external expenses

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TV platform and other program external expenses

9,362 3,509 17,851 8,384

Other external research and development expenses

10,362 7,755 17,868 13,234

Personnel related expenses (1)

1 unchanged sentence

Other unallocated research and development expenses

8,848 9,117 17,996 17,504

Net cost sharing payments (reimbursements) (2)

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__________________________________________________

(1) Personnel related expenses include stock-based compensation expense of $15.6 million and $12.3 million for the three months ended March 31, 2022 and 2021, respectively, reflecting an increase of $3.3 million.

(2) There were $2.3 million and $2.5 million in net cost sharing reimbursements during the three months ended March 31, 2022 and 2021, respectively.

For the three months ended March 31, 2022, net cost sharing reimbursements includes $2.9 million of reimbursements from Takeda for the PTV:PGRN program (included within PTV program external program expenses and Personnel related expenses) and $2.1 million of reimbursements from Takeda for the ATV:TREM2 program (included within TV platform and other program external expenses and Personnel related expenses).

These cost sharing reimbursements were partially offset by cost sharing payments of $2.7 million to Biogen for LRRK2 program external expenses and program internal expenses (included within Personnel related expenses).

For the three months ended March 31, 2021, the entire amount represents cost sharing reimbursements from Biogen.

The increase in research and development expenses of approximately $25.9 million for the three months ended March 31, 2022 compared to the three months ended March 31, 2021, was primarily attributable to the following:

• An increase of $11.0 million in ETV:IDS program external expenses reflecting the continued progress of this program in clinical trials during 2022;

• An increase of $8.4 million in personnel related expenses, consisting of a $3.3 million increase in stock-based compensation expense primarily attributable to additional equity award grants, and a $5.1 million increase in salaries and related expenses attributable to an increase in our research and development headcount;

• Increases of $1.5 million, $3.6 million and $2.0 million in PTV program external expenses, TV platform and other program external expenses, and other external research and development expenses, respectively, reflecting the progress in our PTV:PGRN and ATV:TREM2 programs as well as our continued investment in developing a robust pipeline;

• An increase of $0.8 million in other unallocated research and development expenses, primarily due to an increase of $0.4 million in lab consumable expenses, an increase in facilities-related expenses of $0.2 million including depreciation expense, both due to our increased research and development headcount, and $0.2 million in other research costs;

• A decrease of $0.2 million in cost sharing reimbursements, as discussed above.

These increases were partially offset by a decrease in external expenses related to the LRRK2 program of $1.2 million primarily due to the transition of clinical activities to Biogen, and a decrease of $0.4 million in eIF2B program external expenses.

(1) Personnel related expenses include stock-based compensation expense of $14.9 million and $30.4 million for the three and six months ended June 30, 2022, respectively, and $12.5 million and $24.8 million for the three and six months ended June 30, 2021, respectively, reflecting an increase of $2.4 million and $5.6 million, respectively.

(2) For the three and six months ended June 30, 2022, net cost sharing reimbursements includes $2.8 million and $5.7 million of reimbursements from Takeda for the PTV:PGRN program (included within PTV program external program expenses and Personnel related expenses), respectively, and $1.5 million and $3.6 million of reimbursements from Takeda for the ATV:TREM2 program (included within TV platform and other program external expenses and Personnel related expenses), respectively.

For the three months ended June 30, 2022, cost sharing reimbursements includes $0.4 million of reimbursements from Biogen for LRRK2 program external expenses and program internal expenses (included within Personnel related expenses).

For the six months ended June 30, 2022, cost sharing reimbursements were partially offset by cost sharing payments of $2.4 million to Biogen.

For the three and six months ended June 30, 2021, the entire amount represents cost sharing reimbursements from Biogen.

The increase in research and development expenses of approximately $27.0 million for the three months ended June 30, 2022 compared to the three months ended June 30, 2021, was primarily attributable to the following:

• An increase of $10.4 million in ETV:IDS program external expenses reflecting the continued progress of this program in clinical trials during 2022, including costs incurred to prepare for our planned potentially registrational Phase 2/3 study;

• An increase of $6.8 million in personnel related expenses, consisting of increases of $2.4 million and $4.4 million in stock-based compensation expense pertaining to additional equity award grants and salaries and related expenses, as a result of an increase in our research and development headcount, respectively;

• An increase in external expenses related to the LRRK2 program of $6.3 million primarily due to a $7.5 million clinical milestone payment to Genentech triggered upon the commencement of dosing in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122/DNL151 by our collaboration partner Biogen, partially offset by decreases in costs due to the transition of clinical activities to Biogen;

• Increases of $5.8 million, $2.6 million, and $0.5 million in TV platform and other program external expenses, other external research and development expenses, and PTV program external expenses, respectively, reflecting the progress in our ATV:TREM2 and PTV:PGRN programs as well as our continued investment in developing a robust pipeline.

These increases were partially offset by a decrease of $1.9 million in eIF2B program external expenses due to the timing of significant clinical activities year over year, a decrease of $0.3 million in other unallocated research and development expenses, and an increase of $3.2 million in cost sharing reimbursements due to the commencement of cost sharing in the Takeda collaboration and Biogen's share of the $7.5 million milestone to Genentech, as discussed above.

The increase in research and development expenses of approximately $52.9 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021, was primarily attributable to the following:

• An increase of $21.4 million in ETV:IDS program external expenses reflecting the continued progress of this program in clinical trials during 2022, including costs incurred to prepare for our planned potentially registrational Phase 2/3 study;

• An increase of $15.0 million in personnel related expenses, consisting of increases of $5.6 million and $9.4 million in stock-based compensation expense primarily attributable to additional equity award grants, and salaries and related expenses attributable to an increase in our research and development headcount, respectively;

• An increase in external expenses related to the LRRK2 program of $5.1 million primarily due to a $7.5 million clinical milestone payment to Genentech triggered upon the commencement of dosing in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122/DNL151 by our collaboration partner Biogen, partially offset by decreases in costs due to the transition of clinical activities to Biogen;

• Increases of $9.5 million, $4.6 million and $2.0 million, in TV platform and other program external expenses, other external research and development expenses, and PTV program external expenses, respectively, reflecting the progress in our ATV:TREM2 and PTV:PGRN programs as well as our continued investment in developing a robust pipeline;

• An increase of $0.5 million in other unallocated research and development expenses.

These increases were partially offset by a decrease of $2.3 million in eIF2B program external expenses due to the timing of significant clinical activities year over year, and an increase of $2.9 million in cost sharing reimbursements due to the commencement of cost sharing in the Takeda collaboration, as discussed above.

General and administrative expenses.

General and administrative expenses were $22.5 million for the three months ended March 31, 2022 compared to $18.9 million for the three months ended March 31, 2021.

General and administrative expenses were $21.2 million for the three months ended June 30, 2022 compared to $19.0 million for the three months ended June 30, 2021.

The increase of $2.2 million was primarily attributable to the following:

• $3.4 million of increased personnel related expenses, driven by higher general and administrative headcount and stock-based compensation expense associated with additional equity award grants;

• $0.4 million of increased other general costs, including software subscriptions, insurance, and travel related expenses;

• $0.1 million of increased facilities related expenses, including depreciation expense.

These increases were partially offset by a decrease of $0.3 million in legal and other professional services expenses due to accounting and tax fees incurred in 2021 associated with assessment of the Biogen Collaboration Agreement.

• $1.5 million of increased personnel related expenses and stock-based compensation expense associated with additional salary expenses and equity award grants driven by higher general and administrative headcount;

• $1.0 million of increased other general costs, including general corporate services, IT services and subscriptions, taxes, insurance, and travel related expenses.

These increases were partially offset by a decrease of $0.3 million in consulting and legal professional services expenses.

General and administrative expenses.

General and administrative expenses were $43.7 million for the six months ended June 30, 2022 compared to $38.0 million for the six months ended June 30, 2021.

The increase of $5.7 million was primarily attributable to the following:

• $4.9 million of increased personnel related expenses and stock-based compensation expense associated with additional salary expenses and equity award grants driven by higher general and administrative headcount;

• $1.5 million of increased other general costs, including general corporate services, IT services and subscriptions, taxes, insurance, and travel related expenses.

These increases were partially offset by a decrease of $0.7 million in consulting and legal professional services expenses.

Liquidity and Capital Resources

6 unchanged sentences

We have not yet issued any shares under the facility.

Pursuant to our collaboration agreements with Takeda, Sanofi and Biogen, through March 31, 2022 we have received upfront, option and milestone payments of $93.0 million , $150.0 million, and $560.0 million, respectively, and have also received $13.7 million and $15.8 million of cost sharing reimbursements from Takeda and Biogen, respectively, and have received $13.7 million of reimbursement from Sanofi for the Phase 1b trial for DNL747 for ALS and associated activities.

Further, under associated stock purchase agreements with Takeda and Biogen, through March 31, 2022 we have received $110.0 million and $465.0 million, respectively, for the sale and issuance of shares of our common stock to collaboration partners.

As of March 31, 2022, we had cash, cash equivalents and marketable securities in the amount of $1.2 billion.

Pursuant to our collaboration agreements with Takeda, Sanofi and Biogen, through June 30, 2022 we have received upfront, option and milestone payments of $93.0 million , $190.0 million, and $560.0 million, respectively, and have also received $18.7 million and $15.8 million of gross cost sharing reimbursements from Takeda and Biogen, respectively, and have received $13.7 million of reimbursement from Sanofi for the Phase 1b trial for DNL747 for ALS and associated activities.

Further, under associated stock purchase agreements with Takeda and Biogen, through June 30, 2022 we have received $110.0 million and $465.0 million, respectively, for the sale and issuance of shares of our common stock to collaboration partners.

As of June 30, 2022, we had cash, cash equivalents and marketable securities in the amount of $1.16 billion.

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 $710.2 million through March 31, 2022.

We have an accumulated deficit of $769.0 million through June 30, 2022.

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 the DMSA with Lonza Sales AG ("Lonza") for the development and manufacture of biologic products.

As of March 31, 2022, operating lease liabilities were $62.7 million.

Under the SLC lease which has not yet commenced, we have future undiscounted lease payments totaling approximately $12.5 million.

Under the DMSA with Lonza, we had total non-refundable purchase commitments of $35.2 million as of March 31, 2022, with certain amounts subject to cost sharing with Takeda.

As of June 30, 2022, operating lease liabilities were $61.4 million.

Under other leases which have not yet commenced, including the SLC lease, we have future undiscounted lease payments totaling approximately $22.4 million.

Under the DMSA with Lonza, we had total non-refundable purchase commitments of $25.2 million as of June 30, 2022, with certain amounts subject to cost sharing with Takeda.

Further, in the normal course of business, we enter into various firm purchase commitments primarily related to research and development activities.

1 unchanged sentence

These commitments are more fully described in Note 9, "Commitments and Contingencies" to the consolidated financial statements included in Item 1.

of our Annual Report on Form 10-K and have not materially changed during the three months ended March 31, 2022.

of our Annual Report on Form 10-K and have not materially changed during the six months ended June 30, 2022.

Our future funding requirements, including changes to and new commitments, will depend on many factors, including:

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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 $ (115,007) $ (104,461)

Net cash used in investing activities (117,878) (25,405)

Net cash (used in) provided by investing activities (29,247) 72,132

Net cash provided by financing activities 5,865 10,865

1 unchanged sentence

Net Cash Used In Operating Activities

During the three months ended March 31, 2022, cash used in operating activities was $72.1 million, which consisted of a net loss of $65.2 million, adjusted by non-cash items primarily related to stock-based compensation and depreciation, net amortization of discounts on marketable securities and non-cash rent expenses.

During the six months ended June 30, 2022, cash used in operating activities was $115.0 million, which consisted of a net loss of $124.0 million, adjusted by non-cash items primarily related to stock-based compensation and depreciation, net amortization of discounts on marketable securities and non-cash rent expenses.

Cash used in operating activities was also driven by changes in our operating assets and liabilities.

Net Cash Used In Investing Activities

During the three months ended March 31, 2022, cash used in investing activities was $117.9 million, which consisted of $364.3 million of purchases of marketable securities and $4.1 million of capital expenditures to purchase property and equipment, partially offset by $250.5 million in proceeds from maturities of marketable securities.

Net Cash (Used In) Provided By Investing Activities

During the six months ended June 30, 2022, cash used in investing activities was $29.2 million, which consisted of $505.5 million of purchases of marketable securities and $6.9 million of capital expenditures to purchase property and equipment, partially offset by $483.1 million in proceeds from maturities of marketable securities.

Net Cash Provided By Financing Activities

During the three months ended March 31, 2022, cash provided by financing activities was $1.5 million in proceeds from the exercise of options to purchase common stock.

During the six months ended June 30, 2022, cash provided by financing activities was $5.9 million in proceeds from the exercise of options to purchase common stock as well as the purchase 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, 2021, as filed with the SEC on February 28, 2022, 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, 2022.

There have been no material changes to these critical accounting estimates during the six months ended June 30, 2022.

Recent Accounting Pronouncements

There have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2022 , as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on February 28, 2022, 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, 2022 , as compared to the recent accounting pronouncements described in our Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC on February 28, 2022, 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