What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-01 compared with 2024-05-03 · 82 added, 74 removed, 175 unchanged (47% of the section changed)

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and its consolidated subsidiaries.

We are an immunology company focused on combining cutting-edge technologies to treat and prevent serious infectious diseases and other serious conditions, including viral-associated diseases.

We are a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer.

At Vir, we have a bold vision – powering the immune system to transform lives.

We aim to achieve this in two fundamental ways – first through developing powerful antibody therapeutics and second by generating unique T cell responses in vivo through our T cell-based viral vector platform.

Our growth and pursuit of scientific innovation is fueled by our world-class leading monoclonal antibody (mAb) platform that has a proven track record and is further strengthened by our artificial intelligence-led mAb optimization and engineering capabilities.

Our current clinical development pipeline consists of product candidates targeting hepatitis delta virus (HDV), hepatitis B virus (HBV), and human immunodeficiency virus (HIV).

The most advanced preclinical candidates in our pipeline include those targeting influenza A and B, coronavirus disease 2019 (COVID-19), respiratory syncytial virus (RSV) and human metapneumovirus (MPV), and human papillomavirus (HPV).

We have assembled two technology platforms that modulate the immune system by exploiting critical observations of natural immune processes— a mAb discovery platform and a T cell-based viral vector platform.

Our current clinical development pipeline consists of product candidates targeting hepatitis delta virus (HDV) and hepatitis B virus (HBV).

The most advanced preclinical candidate in our pipeline includes respiratory syncytial virus (RSV) and human metapneumovirus (MPV).

Additionally, Vir is evaluating a small interfering RNA (siRNA) through a collaboration with Alnylam in our hepatitis clinical trials.

We have established our own internal process development, analytical development, manufacturing, supply chain and quality capabilities and work with contract development and manufacturing organizations (CDMOs) to develop, manufacture, test and supply our early- and late-stage product candidates.

We have established our own internal process development, analytical development, manufacturing, supply chain and quality capabilities and worked with contract development and manufacturing organizations (CDMOs) to develop, manufacture, test and supply our early- and late-stage product candidates.

We have an industry-leading management team and board of directors with significant immunology and infectious diseases experience, including a proven track record of progressing product candidates from early-stage research through clinical development, and worldwide regulatory approval and commercialization experience.

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Significant Developments

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Annual Report on Form 10-K for the year ended December 31, 2023 .

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the period ended March 31, 2024.

For additional developments or for a more comprehensive discussion of certain developments below, see our Annual Report on Form 10-K for the year ended December 31, 2023 and our Quarterly Report on Form 10-Q for the period March 31, 2024.

Pipeline Programs

Chronic Hepatitis Delta (CHD)

• On March 5, 2024, we announced our Phase 2 chronic hepatitis delta SOLSTICE trial completed enrollment of its current cohorts one month ahead of schedule with over 60 participants enrolled in two additional cohorts.

◦ The trial is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta.

◦ One cohort is evaluating the combination of tobevibart and elebsiran given every 4 weeks with a second cohort evaluating tobevibart monotherapy given every 2 weeks.

◦ Approximately 50% of participants have compensated cirrhosis.

• We will report data on a subset of SOLSTICE participants in a late breaker poster presentation at the European Association for the Study of the Liver (EASL) Congress 2024.

This includes additional 12-week treatment data on approximately 30 participants (~15 per regimen) and 24-week treatment data on approximately 20 participants (~10 per regimen).

• Additional follow-up data for the initial six SOLSTICE trial participants will also be shared at the EASL Congress 2024.

• Complete 24-week treatment data is expected in the fourth quarter of 2024.

• We presented positive preliminary Phase 2 chronic hepatitis delta SOLSTICE study data at the European Association for the Study of the Liver, EASL™ Congress 2024.

◦ Tobevibart monotherapy and combination therapy with elebsiran achieved high virologic response and ALT normalization in people living with the hepatitis delta virus after 12 and 24 weeks of treatment.

◦ Complete 24-week treatment data on the approximately 60 participants is on track to be reported in the fourth quarter of 2024.

• On June 26, the U.S.

Food and Drug Administration (FDA) cleared our investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection.

Chronic Hepatitis B (CHB)

• Two abstracts have been accepted for poster presentation at the EASL Congress 2024.

• The Phase 2 MARCH Part B trial is fully enrolled with 48-week end of treatment data expected in the fourth quarter of 2024.

The trial is evaluating the safety, tolerability and antiviral activity of the combination of tobevibart and elebsiran with and without peginterferon alpha.

• Initial data from the Phase 2 PREVAIL platform trial and its THRIVE/STRIVE sub-protocols is expected in the first half of 2025.

These trials are evaluating combinations of tobevibart, elebsiran and/or peginterferon alpha in two patient populations:

• The Phase 2 MARCH Part B study is fully enrolled with 48-week end of treatment data expected in the fourth quarter of 2024.

The study is evaluating the safety, tolerability and antiviral activity of the combination of tobevibart and elebsiran with and without peginterferon alpha.

• Initial data from the Phase 2 PREVAIL platform study and its THRIVE/STRIVE sub-protocols is expected in the first half of 2025.

These studies are evaluating combinations of tobevibart, elebsiran and/or peginterferon alpha in two patient populations:

immune-active but treatment-naïve and inactive carriers.

Human Immunodeficiency Virus (HIV)

• Part A of the Phase 1 trial of VIR-1388, an investigational novel T cell vaccine for the prevention of HIV, is fully enrolled with initial immunogenicity data expected in the second half of 2024.

◦ The trial is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Bill & Melinda Gates Foundation, and is being conducted by the HIV Vaccine Trials Network.

• On April 4, 2024, we published the full data analysis from the Phase 2 PENINSULA trial evaluating VIR-2482 on medRxiv.

Preclinical Pipeline Candidates

• We are continuing to advance next-generation antibodies using our proprietary platform, which leverages dAIsY™ ( d ata AI s tructure and antibod y ), our proprietary AI engine, enabling us to bring high-quality drug candidates to the clinic more efficiently.

• We expect the filing of multiple investigational new drug applications within the next 18 months, including:

◦ VIR-1949, an investigational therapeutic T cell vaccine based on our human cytomegalovirus (HCMV) vector platform that is designed to treat precancerous lesions caused by the human papillomavirus.

◦ VIR-7229, a next-generation COVID monoclonal antibody candidate that has been AI-engineered to have increased potency, breadth and resistance to viral escape.

The development of VIR-7229 has been supported in part with federal funds from the Department of Health and Human Services (HHS);

Administration for Strategic Preparedness and Response (ASPR);

Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number:

75A50122C00081.

◦ VIR-2981, an investigational neuraminidase-targeting monoclonal antibody against both influenza A and B viruses.

◦ VIR-8190 and other investigational monoclonal antibodies against respiratory syncytial virus and/or metapneumovirus as part of the collaboration established with GSK in May of 2021.

Corporate Update

• Effective May 3, 2024, Sung Lee, Executive Vice President and Chief Financial Officer will be stepping down from his role to pursue another career opportunity.

We have initiated a search for a successor.

• As announced on August 1, 2024, we signed an exclusive worldwide license agreement with Sanofi for multiple potential best-in-class clinical-stage T-cell engagers and exclusive use of the protease-cleavable masking platform, acquired by Sanofi from Amunix Pharmaceuticals.

This license agreement is subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Act Antitrust Improvements Act of 1976, as amended (HSR).

• We initiated a strategic restructuring to advance the development of our hepatitis programs and focus on the highest near-term value opportunities.

The organizational realignment and optimization include phasing out programs in influenza, COVID-19, and our T cell-based viral vector platform, as well as a workforce reduction of approximately 25% or approximately 140 employees.

We expect to end 2024 with approximately 435 employees, a decrease of approximately 200 from our peak headcount in the second quarter of 2023.

This includes the Sanofi employees who are expected to join us following receipt of HSR clearance.

As a result of this strategic restructuring and prioritization we anticipate:

• Approximately $50 million of annual workforce cost savings starting in 2025.

Combined with the strategic actions taken in December 2023, we lowered our cost structure by approximately $90 million since its peak in 2023, part of which will be redeployed to the newly anticipated key personnel from Sanofi.

• Cost savings of $50 million through the end of 2025 due to the phasing out of certain programs.

These savings will substantially be reinvested in the newly licensed programs from Sanofi following closing of the transaction.

• Restructuring expenses estimated at $11 million to $13 million, primarily related to employee severance cash payouts.

We expect to recognize most of these expenses in the second half of 2024.

• On May 29, 2024, we announced the appointment of Mark D.

Eisner, M.D., M.P.H.

as Executive Vice President and Chief Medical Officer, effective June 3, 2024.

Eisner brings extensive late-stage clinical development expertise and deep knowledge in the fields of immunology and infectious disease.

• On April 18, 2024, we announced that founding board members Phillip Sharp, Ph.D.

and Robert Perez would not stand for reelection.

Effective May 29, 2024, two new independent directors were elected in their place, including Norbert Bischofberger, Ph.D., who brings close to 40 years of biotech leadership experience and Ramy Farid, Ph.D., whose pioneering work applying advanced computational methods to drug discovery has enabled high-quality, novel molecules for drug development and materials applications.

Our Collaboration, License and Grant Agreements

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Although we have previously recognized revenue from our profit-share related to sotrovimab under our definitive collaboration agreement with GSK executed in June 2020, or the 2020 GSK Agreement, we may continue to incur net operating losses for at least the next several years as the extent of future revenue from the sale of sotrovimab remains uncertain.

While we have an EUA from the U.S.

Food and Drug Administration, or FDA, for sotrovimab, the FDA has excluded the use of sotrovimab in all U.S.

regions due to the continued proportion of COVID-19 cases caused by certain Omicron subvariants.

While we have an EUA from the FDA for sotrovimab, the FDA has excluded the use of sotrovimab in all U.S.

regions due to the continued proportion of COVID-19 cases caused by certain variants.

With this EUA revision, sotrovimab is not currently authorized for use in any U.S.

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In April 2022, the FDA excluded the use of sotrovimab in all U.S.

regions due to the continued proportion of COVID-19 cases caused by certain Omicron subvariants.

regions due to the continued proportion of COVID-19 cases caused by certain variants.

As the lead party for all manufacturing and commercialization activities, GSK incurs all of the manufacturing, sales and marketing expenses and is the principal on sales transactions with third parties.

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We expect our selling, general and administrative expenses to increase in absolute dollars over time as we continue to support our research and development activities, and commercialization activities for any of our product candidates, if approved, and to grow our business.

Restructuring, long-lived asset impairment and related charges

Restructuring, long-lives asset impairment and related charges consist primarily of charges incurred in connection with our cost saving initiatives implemented during the second half of 2023, including severance and other employee-related expenses and long-lived assets impairment charges and disposal losses.

Change in Fair Value of Equity Investments

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Other expense, net consists of gains and losses from foreign currency transactions and the remeasurement of our contingent consideration obligation.

(Provision for) Benefit from Income Taxes

(Provision for) benefit from income taxes consists primarily of income taxes on our domestic and foreign operations.

Benefit from Income Taxes

Benefit from income taxes consists primarily of income taxes on our domestic and foreign operations.

Net Loss Attributable to Noncontrolling Interest

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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 summarizes our results of operations for the periods presented (in thousands):

Three Months Ended

2024 2023 Change

June 30, Six Months Ended

2024 2023 Change 2024 2023 Change

Collaboration revenue $ 55 $ (13,779) $ 13,834 $ (932) $ 32,795 $ (33,727)

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Selling, general and administrative 30,265 45,512 (15,247) 66,586 92,290 (25,704)

Restructuring, long-lived assets impairment and related charges 26,275 5,366 20,909 26,227 5,366 20,861

Total operating expenses 161,705 218,983 (57,278) 298,162 425,311 (127,149)

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Total other income 18,740 17,563 1,177 33,821 17,746 16,075

Loss before (provision for) benefit from income taxes (65,000) (143,188) 78,188

(Provision for) benefit from income taxes (276) 2,232 (2,508)

Loss before benefit from income taxes (139,890) (197,623) 57,733 (204,890) (340,811) 135,921

Benefit from income taxes 1,512 2,848 (1,336) 1,236 5,080 (3,844)

Net loss (138,378) (194,775) 56,397 (203,654) (335,731) 132,077

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Net loss attributable to Vir $ (138,378) $ (194,775) $ 56,397 $ (203,654) $ (335,675) $ 132,021

The decrease in collaboration revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to lower revenues from the release of profit-sharing amount previously constrained and from the sales of sotrovimab under the 2020 GSK Agreement.

The negative collaboration revenue for the three months ended March 31, 2024 consisted of $0.3 million profit-sharing loss from the sale of sotrovimab and $0.7 million profit-sharing amount constrained.

The increase in contract revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to $51.7 million of deferred revenue recognized during the three months ended March 31, 2024 as GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024.

The decrease in grant revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to lower revenue recognized in accordance with our agreement with BARDA.

The increase in collaboration revenue for the three months ended June 30, 2024 compared to the same period in 2023 was primarily due to lower loss from the sales of sotrovimab and lower profit-sharing amount constrained under the 2020 GSK Agreement.

The decrease in collaboration revenue for the six months ended June 30, 2024 compared to the same period in 2023 was primarily due to lower revenues from the release of profit-sharing amount previously constrained.

The decrease in contract revenue for the three months ended June 30, 2024 compared to the same period in 2023 was not material.

The increase in contract revenue for the six months ended June 30, 2024 compared to the same period in 2023 was primarily due to $51.7 million of deferred revenue recognized during the first quarter of 2024 as GSK’s rights to select up to two additional non-influenza target pathogens under the 2021 GSK Agreement expired on March 25, 2024.

The decrease in grant revenue for the three and six months ended June 30, 2024 compared to the same periods in 2023 was primarily due to lower revenue recognized in accordance with our agreement with BARDA.

Cost of Revenue

The decrease in cost of revenue for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to lower third-party royalties owed based on the sales of sotrovimab under the 2020 GSK Agreement.

The increase in cost of revenue for the three months ended June 30, 2024 compared to the same period in 2023 was not material.

The decrease in cost of revenue for the six months ended June 30, 2024 compared to the same period in 2023 was primarily due to lower third-party royalties owed based on the sales of sotrovimab under the 2020 GSK Agreement.

Research and Development Expenses

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Three Months Ended

2024 2023 Change

June 30, Six Months Ended

2024 2023 Change 2024 2023 Change

Licenses, collaborations and contingent consideration $ 5,182 $ 7,551 $ (2,369) $ 10,878 $ 15,297 $ (4,419)

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Total research and development expenses $ 105,113 $ 168,083 $ (62,970) $ 205,238 $ 325,726 $ (120,488)

The decrease in research and development expenses for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to lower clinical costs and contract manufacturing costs associated with the wind down of the Company’s Phase 2 PENINSULA trial evaluating VIR-2482.

The decrease in research and development expenses for the three and six months ended June 30, 2024 compared to the same periods in 2023 was primarily due to lower clinical costs and contract manufacturing costs associated with the wind down of the Company’s Phase 2 PENINSULA trial evaluating VIR-2482, lower contract manufacturing costs associated with tobevibart and elebsiran used in the Company's CHD and CHB clinical trials, and lower personnel costs associated with the reduction in the headcount resulting from the cost saving initiatives implemented during the second half of 2023.

Selling, General and Administrative Expenses

The decrease in selling, general and administrative expenses for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to cost saving initiatives implemented during the second half of 2023.

The decrease in selling, general and administrative expenses for the three and six months ended June 30, 2024 compared to the same periods in 2023 was primarily due to cost saving initiatives implemented during the second half of 2023.

Restructuring, long-lived assets impairment and related charges

The increase in restructuring, long-lived assets impairment and related charges for the three and six months ended June 30, 2024 compared to the same periods in 2023 was primarily due to right-of-use asset and leasehold improvement impairment charges related to closing our St.

Louis, Missouri facility, which was previously announced on December 13, 2023.

Change in Fair Value of Equity Investments

Our investment consisted solely of shares of Brii Bio Parent is a marketable equity investment and remeasured to fair value at each reporting period.

For the three months ended March 31, 2024, we recognized an unrealized loss of $5.9 million due to the change in fair value, compared to an unrealized loss of $13.1 million for the same period in 2023.

Our investment consisted solely of shares of Brii Bio Parent, which is a marketable equity investment and remeasured to fair value at each reporting period.

For the three and six months ended June 30, 2024, we recognized an unrealized gain of $0.4 million and an unrealized loss $5.5 million due to the change in fair value, respectively, compared to an unrealized loss of $5.1 million and $18.2 million for the same periods in 2023, respectively.

Interest Income

The decrease in interest income for the three months ended March 31, 2024 compared to the same period in 2023 was not material.

The decrease in interest income for the three and six months ended June 30, 2024 compared to the same periods in 2023 was primarily due to lower balances of cash, cash equivalents, and investments.

Other Expense, Net

The decrease in other expense, net for the three months ended March 31, 2024 compared to the same period in 2023 was primarily due to a decrease in foreign exchange measurement loss related to the accrued liability recognized in connection with the profit-sharing amount constrained under the 2020 GSK Agreement.

(Provision for) Benefit from Income Taxes

The provision for income taxes for the three months ended March 31, 2024 was not material.

The benefit from income taxes for the three months ended March 31, 2023 was primarily due to a pre-tax loss and the Company’s ability to carry back the research and development credit to 2022.

The increase in other expense, net for the three months ended June 30, 2024 compared to the same period in 2023 was not material.

The decrease in other expense, net for the six months ended June 30, 2024 compared to the same period in 2023 was primarily due to a decrease in foreign exchange measurement loss related to the accrued liability recognized in connection with the profit-sharing amount constrained under the 2020 GSK Agreement.

Benefit from Income Taxes

The benefit for income taxes for the three and six months ended June 30, 2024 was primarily due to favorable adjustments in estimated tax payable.

The benefit from income taxes for the three and six months ended June 30, 2023 was primarily due to a pre-tax loss and the Company’s ability to carry back the research and development credit to 2022.

Liquidity, Capital Resources and Capital Requirements

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To date, we have financed our operations primarily through sales of our common stock from our initial public offering and subsequent follow-on offering, sales of our convertible preferred securities, and payments received under our grant and collaboration agreements.

As of March 31, 2024, we had $1.51 billion in cash, cash equivalents, and investments.

As of March 31, 2024, we had accumulated deficit of $303.1 million.

As of June 30, 2024, we had $1.43 billion in cash, cash equivalents, and investments.

As of June 30, 2024, we had accumulated deficit of $441.5 million.

We entered into a sales agreement, or the Sales Agreement, with Cowen and Company, LLC, or TD Cowen, in November 2023 pursuant to which we may from time to time offer and sell shares of our common stock for an aggregate offering price of up to $300.0 million, through or to TD Cowen, acting as sales agent or principal.

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We will pay TD Cowen a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide TD Cowen with customary indemnification and contribution rights.

As of March 31, 2024, no shares have been sold under the Sales Agreement.

As of June 30, 2024, no shares have been sold under the Sales Agreement.

Funding Requirements and Conditions

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We may continue to incur net losses for the foreseeable future.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of March 31, 2024 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

Based upon our current operating plan, we believe that our existing cash, cash equivalents and investments as of June 30, 2024 as noted above will enable us to fund our operations for at least the next 12 months from the filing date of this Quarterly Report on Form 10-Q.

However, our operating plan may change as a result of many factors currently unknown to us, and we may need to raise additional capital to complete the development and commercialization of our product candidates and fund certain of our existing manufacturing and other commitments.

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We have various operating lease arrangements for office and laboratory spaces located in California, Oregon, Missouri and Switzerland with contractual lease periods expiring between 2024 and 2035.

As of March 31, 2024, we expect to make total lease payments of $152.1 million through 2034.

As of June 30, 2024, we expect to make total lease payments of $143.5 million through 2034.

To date, we have entered into collaboration, license and acquisition agreements where the payment obligations are contingent upon future events such as our achievement of specified development, regulatory and commercial milestones, and we are required to make royalty payments in connection with the sale of products developed under those agreements.

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In the first quarter of 2024, the Company and a third-party contract development manufacturing organization entered into various scopes of work with respect to the manufacturing of tobevibart (the "Tobevibart Agreements").

As of March 31, 2024, the Company had a balance of unpaid commitments of approximately $20 million under the Tobevibart Agreements.

As of June 30, 2024, the Company had a balance of unaccrued unpaid commitments of approximately $19 million under the Tobevibart Agreements.

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements.

The following table summarizes our cash flows for the periods indicated (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Net cash (used in) provided by:

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Financing activities 3,094 5,523

Net decrease in cash, cash equivalents and restricted cash and cash equivalents $ (80,818) $ (25,359)

Net increase (decrease) in cash, cash equivalents and restricted cash and cash equivalents $ 55,884 $ (181,112)

Operating Activities

Cash used in operating activities is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities.

Cash used in operating activities during the three months ended March 31, 2024 decreased compared to the same period in 2023 primarily due to lower clinical development and contract manufacturing activities related to the wind down of the Phase 2 PENINSULA trial evaluating VIR-2482, lower payments for third-party royalties based on the sales of sotrovimab under the 2020 GSK Agreement, and higher interest receipts, partially offset by lower receipts for grant and collaboration revenues.

Cash used in operating activities during the six months ended June 30, 2024 decreased compared to the same period in 2023 primarily due to lower payments to GSK related to profit-sharing amount constrained under the 2020 GSK Agreement, and lower clinical development and contract manufacturing activities related to the wind down of the Phase 2 PENINSULA trial evaluating VIR-2482, partially offset by lower receipts for grant and collaboration revenues.

Investing Activities

Cash provided by investing activities during the three months ended March 31, 2024 decreased compared to the same period in 2023 primarily due to lower proceeds from investments maturities and sales net of investments purchases.

Cash provided by investing activities during the six months ended June 30, 2024 decreased compared to the same period in 2023 primarily due to higher cash used in investment purchases, net of investment maturities and sales.

Financing Activities

Cash provided by financing activities during the three months ended March 31, 2024 decreased compared to the same period in 2023 primarily due to lower proceeds from the exercises of stock options.

Cash provided by financing activities during the six months ended June 30, 2024 decreased compared to the same period in 2023 primarily due to lower proceeds from the exercises of stock options.

Critical Accounting Policies and Estimates

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Actual results may differ from these estimates.

There have been no significant changes in our critical accounting policies during the three months ended March 31, 2024, as compared with those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 26, 2024.

There have been no significant changes in our critical accounting policies during the six months ended June 30, 2024, as compared with those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on February 26, 2024.

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