NextCure Provides Business Update and Reports First Quarter 2022 Financial Results

On May 5, 2022 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported first quarter 2022 financial results and provided a business update (Press release, NextCure, MAY 5, 2022, View Source [SID1234613819]).

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"In the first quarter, we continued to advance our pipeline of four product candidates towards key clinical milestones," said Michael Richman, NextCure’s President and Chief Executive Officer. "In the second half of 2022, we anticipate clinical trial updates for NC318, NC410, and NC762, as well as an IND filing for NC525. We also expect our quarter-end cash position of $201.3 million will fund our operations into the first quarter of 2024."

Expected Milestones

We believe we are on track to meet the following milestones during the second half of 2022:

NC318 Phase 2 update: fourth quarter of 2022 (Amended Phase 2 with patient selection and increased dosing).
NC318 anti-PD-1 combo initial data second half of 2022 (Yale University Investigator-Initiated trial).
NC410 Phase 1 update: second half of 2022.
NC762 Phase 1 initial data: second half of 2022.
NC525 Investigational New Drug Application (IND) filing: fourth quarter of 2022.
Financial Guidance

Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into the first quarter of 2024.

Financial Results for First Quarter March 31, 2022

Cash, cash equivalents, and marketable securities, excluding restricted cash, as of March 31, 2022, were $201.3 million as compared with $219.6 million as of December 31, 2021. The decrease of $18.3 million primarily reflects cash used to fund operations.
Research and development expenses were $15.0 million for the quarter ended March 31, 2022 as compared to $12.4 million for the quarter ended March 31, 2021. The increase of $2.6 million was driven primarily by additional clinical and lab-related costs.
General and administrative expenses were $5.8 million for the quarter ended March 31, 2022 as compared with $4.9 million for the quarter ended March 31, 2021. The increase of $0.9 million was primarily related to additional personnel-related costs.
Net loss was $20.6 million for the quarter ended March 31, 2022 as compared with $16.5 million for the quarter ended March 31, 2021. The changes in net loss from the previous year’s quarter were primarily due to increased research and development expenses.

NGM Bio Provides Business Highlights and Reports First Quarter 2022 Financial Results

On May 5, 2022 NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a biotechnology company focused on discovering and developing transformative therapeutics for patients, reported financial results for the quarterly period ended March 31, 2022 (Press release, NGM Biopharmaceuticals, MAY 5, 2022, View Source [SID1234613844]).

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"We are pleased with the progress that we have made to date in 2022, in particular with our oncology portfolio, including the advancement of our second myeloid checkpoint inhibitor program, NGM831, into the clinic," said David J. Woodhouse, Ph.D., Chief Executive Officer at NGM Bio. "We plan to deliver several program updates in the second half of the year with multiple milestones expected, including topline Phase 2 data from the CATALINA trial for NGM621, a monoclonal antibody product candidate engineered to potently inhibit complement C3 for patients with geographic atrophy, as well as initial interim monotherapy data from the NGM707 Phase 1 trial and updated data from the Phase 1a/1b trial of NGM120, an antagonist antibody product candidate that binds GFRAL and is designed to inhibit GDF15 signaling, both of which we are developing for the treatment of cancer."

Key First Quarter and Recent Highlights

Oncology

Initiated the Phase 1/1b clinical trial of NGM831 as a monotherapy and in combination with KEYTRUDA for the treatment of patients with advanced solid tumors.
Delivered an oral presentation at the 2022 AACR (Free AACR Whitepaper) annual meeting to showcase in vitro and in vivo research demonstrating potential advantages of dual ILT2/ILT4 inhibition with NGM707 and late-breaking poster presentations to highlight preclinical research supporting development of NGM831 and NGM438.
Retinal Disease

The U.S. Food and Drug Administration granted Fast Track designation to NGM621 for the treatment of patients with geographic atrophy, or GA, secondary to age-related macular degeneration.
Liver and Metabolic Diseases

Completed enrollment in ALPINE 4, the Phase 2b trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated NASH cirrhosis (F4 NASH), in January 2022. A topline data readout for ALPINE 4 is expected in the first half of 2023.
Corporate Highlights

Hosted the first two sessions of a four-part virtual R&D overview event titled the "Explorer Series" showcasing NGM Bio’s discovery engine and NGM Bio’s myeloid reprogramming programs, NGM831 and NGM438, both targeting tumor stromal checkpoints.
First Quarter 2022 Financial Results

NGM reported a net loss of $32.5 million for the quarter ended March 31, 2022, compared to a net loss of $27.5 million for the same period in 2021.
Related party revenue from our collaboration with Merck was $20.9 million for the quarter ended March 31, 2022, compared to $21.6 million for the same period in 2021.
R&D expenses were $42.8 million for the quarter ended March 31, 2022, compared to $40.7 million for the same period in 2021. R&D expenses increased $2.1 million in the quarter as compared to the same period in 2021, primarily due to our ongoing clinical trials of NGM621, NGM707, NGM831 and NGM120, our preclinical study of NGM438, and personnel-related expenses partially offset by decreased expenses for our manufacturing activities and our clinical trials of aldafermin.
General and administrative expenses were $10.7 million for the quarter ended March 31, 2022, compared to $8.7 million for the same period in 2021. The $2.0 million increase in general and administrative expenses in the quarter as compared to the same period in 2021 was primarily attributable to compensation-related expenses driven by higher headcount and an increase in expenses associated with being a public company.
Cash, cash equivalents and short-term marketable securities were $329.8 million as of March 31, 2022, compared to $366.3 million as of December 31, 2021.

Relay Therapeutics Reports First Quarter 2022 Financial Results and Corporate Highlights

On May 5, 2022 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, reported first quarter 2022 financial results and corporate highlights (Press release, Relay Therapeutics, MAY 5, 2022, View Source [SID1234613843]).

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"We have continued our execution focus into 2022, as we advance our portfolio of precision medicines towards patients," said Sanjiv Patel, M.D., Relay Therapeutics’ president and chief executive officer. "With three programs in the clinic, we believe our platform and approach have the potential to address some of the hardest-to-treat diseases. We look forward to disclosing another innovative target next month as we continue on our journey of bringing life-changing therapies to patients."

Recent Corporate Highlights

▪Continued to enroll patients in the first arm of the dose escalation part of the first-in-human trial for RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, assessing it as a single agent for patients with unresectable or metastatic solid tumors with PI3Kα mutation
▪Initiated the second arm of the dose escalation part of the first-in-human trial for RLY-2608, evaluating RLY-2608 in combination with fulvestrant for patients with HR+, HER2–, PI3Kα-mutated, locally advanced or metastatic breast cancer
▪Anticipate disclosing initial clinical data of RLY-2608 in the first half of 2023
▪Received orphan drug designation from the FDA for RLY-4008 for the treatment of cholangiocarcinoma in January 2022 and continued to enroll patients in expansion cohorts
▪Presented poster at AACR (Free AACR Whitepaper) in April 2022 summarizing RLY-1971/GDC-1971 preclinical data including newly disclosed preclinical combination data with GDC-6036, Genentech’s KRAS G12C inhibitor
▪Aligned with current guidance of disclosing a new target in the first half of 2022, announced a virtual analyst and investor event on June 27, 2022

First Quarter 2022 Financial Results

Cash, Cash Equivalents and Investments: As of March 31, 2022, cash, cash equivalents and investments totaled approximately $898 million compared to $958 million as of December 31, 2021. Relay Therapeutics expects its current cash, cash equivalents and investments will be sufficient to fund its current operating plan into at least 2025.

R&D Expenses: Research and development expenses were $51.7 million for the first quarter of 2022, as compared to $30.6 million for the first quarter of 2021. The increase of $21.0 million was primarily due to $9.4 million of additional employee related costs, including an increase in stock-based compensation of $3.0 million, $6.0 million related to clinical trial expenses and $4.6 million related to pre-clinical development candidates.

G&A Expenses: General and administrative expenses were $16.1 million for first quarter of 2022, as compared to $12.7 million for the first quarter of 2021. The increase of $3.3 million was primarily due to $3.0 million of additional employee related costs, including an increase in stock-based compensation of $0.8 million.

Net Loss: Net loss was $62.0 million for the first quarter of 2022, or a net loss per share of $0.57, as compared to a net loss of $42.2 million for the first quarter of 2021, or a net loss per share of $0.47.

Codiak BioSciences Reports First Quarter 2022 Financial Results and Operational Progress

On May 5, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported first quarter 2022 financial results and operational progress (Press release, Codiak Biosciences, MAY 5, 2022, View Source [SID1234613842]).

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"We are making exciting progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx Platform can harness exosomes for potent and selective delivery of therapeutics, not only in immuno-oncology, but in vaccines and gene therapy as well," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "We remain on track to deliver on several key milestones by the end of this quarter, including results from all five dose cohorts in our exoSTING trial, initial CTCL patient data from the exoIL-12 program, and commencement of dosing in the Phase 1 study of our third candidate to enter the clinic, exoASO-STAT6."

First Quarter 2022 and Recent Highlights

Completed enrollment and dose escalation in cohorts 4 and 5 in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors; patient follow-up continues in all dose cohorts, as well as enrollment of enrichment cohorts
Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003); implemented plans for protocol amendment to include a broader range of CTCL patients, and developed plans to enroll patients with additional cutaneous malignancies responsive to rIL-12
Activated sites for Phase 1 trial of exoASO-STAT6 (CDK-004) for the intravenous treatment of hepatocellular carcinoma in preparation for patient dosing
Presented new preclinical data from the exoVACC pan-beta coronavirus vaccine program, as part of Codiak’s collaboration with the Ragon Institute, at the World Vaccine Congress 2022
Presented preclinical data for exoASO-C/EBPb, a proprietary engineered exosome loaded with antisense oligonucleotides targeting C/EBPβ, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Published a manuscript describing the full exoASO-STAT6 preclinical program in the American Association for the Advancement of Science’s journal, Science Advances
Named industry veteran oncology drug developer David Mauro, M.D., Ph.D. as Chief Medical Officer
Anticipated Milestones and Events

First patients dosed in exoASO-STAT6 Phase 1 clinical trial in hepatocellular carcinomas anticipated during 1H 2022
Safety, PK, PD, objective response rate (ORR), and efficacy data in injected and non-injected tumors from dose escalation cohorts 1-5 in the Phase 1/2 trial of exoSTING and recommended Phase 2 dose expected in late 1H 2022
Initial safety, PK/PD and efficacy data from at least the first cohort of CTCL patients in the Phase 1 clinical trial of exoIL-12 anticipated in late 1H 2022
Presentation of new data from engEx-AAV discovery program describing the generation of potent and high-yield exosome-associated AAV constructs as a strategy for improving gene therapy delivery at the American Society of Gene and Cell Therapy Annual Meeting to be held May 16-19, 2022
Dr. Williams added, "As we have noted in prior quarters, enrollment in the exoIL-12 study at trial sites in the UK has been challenging, and we have worked to pursue options for expediting enrollment. We’re looking forward to the positive impact of protocol enhancements for this trial to include a broader CTCL population (stage IIIa) and the potential to enroll patients with cutaneous malignancies responsive to rIL-12 in past studies – including Kaposi’s sarcoma, Merkel cell carcinoma, and Squamous cell carcinoma – each orphan cutaneous diseases treated by the same physicians, where local treatment is common."

First Quarter 2022 Financial Results

Total revenues for the quarter ended March 31, 2022, were $12.7 million, compared to $13.2 million for the same period in 2021. These results reflect deferred revenue recognized under the Company’s collaboration with Jazz Pharmaceuticals.

Net loss for the quarter ended March 31, 2022, was $8.0 million, compared to a net loss of $10.3 million for the same period in 2021. The decrease in net loss for the quarter was driven primarily by a reduction in research and development expenses, some of which were in connection with the Company’s agreement with Lonza.

Research and development expenses were $14.2 million for the quarter ended March 31, 2022, compared to $16.6 million for the same period in 2021. The decrease in research and development expenses was driven primarily by decreases in lab expenses and personnel-related costs in connection with our agreement with Lonza.

General and administrative expenses were $6.7 million for the quarter ended March 31, 2022, compared to $6.6 million for the same period in 2021. The increase was driven primarily by an increase in personnel expenses.

As of March 31, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $56.5 million.

McKesson Reports Fiscal 2022 Fourth Quarter and Full-Year Results

On May 5, 2022 McKesson Corporation (NYSE:MCK) reported results for the fourth-quarter and fiscal year ended March 31, 2022 (Press release, McKesson, MAY 5, 2022, View Source [SID1234613841]).

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Fiscal 2022 Fourth-Quarter and Full-Year Result Summary

"McKesson delivered strong financial performance in fiscal 2022," said Brian Tyler, chief executive officer. "Our transformation to a diversified healthcare services company is underway and our strategy is working."

"We are encouraged by the growth in our strategic pillars of oncology and biopharma services, and the strength in our core North American distribution businesses," Mr. Tyler continued. "Our results reflect the unwavering commitment of our employees and their resilience to deliver for our customers, patients, our communities, and our shareholders. We are excited about the opportunities ahead of us to advance healthcare outcomes for all in fiscal 2023 and beyond."

Fourth-quarter revenues were $66.1 billion, an increase of 12% from a year ago, and full-year revenues were $264.0 billion, an increase of 11%, primarily driven by growth in the U.S. Pharmaceutical segment, due to increased volumes of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.

Fourth-quarter earnings per diluted share from continuing operations was $2.48 compared to $4.15 a year ago, a decrease of $1.67. Full-year earnings per diluted share from continuing operations was $7.26 compared to a loss per diluted share of ($28.26) a year ago, an increase of $35.52, due to a prior year pre-tax charge of $8.1 billion expense accrual related to the opioid litigation.

Fourth-quarter Adjusted Earnings per Diluted Share was $5.83 compared to $5.05 a year ago, an increase of 15%, driven by growth across the business and a lower share count. Full-year Adjusted Earnings per Diluted Share was $23.69 compared to $17.21 a year ago, an increase of 38%, driven by strong operating performance across the segments, the contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government, and a lower share count.

For the full-year, McKesson returned $3.8 billion of cash to shareholders, which included $3.5 billion of common stock repurchases and $277 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.4 billion, and invested $535 million in capital expenditures, resulting in Free Cash Flow of $3.9 billion.

Business Highlights

In fiscal 2022, McKesson announced a planned exit from the European market, exemplifying its commitment to streamline the business and prioritizing investments in areas that are central to the long-term growth strategy.
On July 7, 2021, McKesson announced an agreement to sell certain McKesson Europe businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group. The transaction is expected to close in the second half of fiscal 2023.
On November 1, 2021, McKesson announced an agreement to sell its UK businesses to AURELIUS. The transaction closed on April 6, 2022.
On November 30, 2021, McKesson announced an agreement to sell the remaining share of its German joint venture to Walgreens Boots Alliance. The transaction closed on January 31, 2022.
On December 20, 2021, McKesson announced an agreement to sell its Austrian business to Quadrifolia Management GmbH. The transaction closed on January 31, 2022.
Norway and Denmark remain the only countries that McKesson has not entered into agreements to sell.
McKesson continued to expand its differentiated Oncology and Biopharma ecosystems, further demonstrating the significant progress against its company priorities.
McKesson’s proprietary oncology-focused software suite has documented approximately 10 million patient visits in the last year, helping to advance cancer care within the Oncology ecosystem.
Within the Biopharma ecosystem, McKesson helped patients save more than $6 billion on brand and specialty medications.
McKesson played a leading role in the fight against COVID-19. Through March 31, 2022:
U.S. Pharmaceutical successfully shipped over 380 million COVID-19 vaccines to administration sites across the U.S. and in support of the U.S. government’s international donation mission.
Medical-Surgical Solutions assembled enough kits to support the administration of more than 1.2 billion doses of COVID-19 vaccines.
Medical-Surgical Solutions distributed more than 135 million COVID-19 tests to physicians’ offices and other alternate healthcare sites.
U.S. Pharmaceutical Segment
Fourth-Quarter

Revenues were $53.7 billion, an increase of 14%, driven by increased volume of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.
Segment Operating Profit was $693 million. Adjusted Segment Operating Profit was $780 million, a decrease of 4%, driven by lower demand of COVID-19 vaccine distribution, partially offset by growth in distribution of specialty products to providers and health systems. Excluding the impact of COVID-19 vaccine distribution, the U.S. Pharmaceutical segment delivered Adjusted Segment Operating Profit growth of 2%.
Full-Year

Revenues were $212.1 billion, an increase of 12%, driven by increased volumes of specialty products, including higher volumes from retail national account customers, and market growth, partially offset by branded to generic conversions.
Segment Operating Profit was $2.9 billion. Adjusted Segment Operating Profit was $2.9 billion, an increase of 8%, driven by growth in distribution of specialty products to providers and health systems and contribution from COVID-19 vaccine distribution.
Prescription Technology Solutions Segment
Fourth-Quarter

Revenues were $1.0 billion, an increase of 29%, driven by volume growth related to biopharma services, including third-party logistics services and increased technology service revenue, partially resulting from the growth of prescription volumes.
Segment Operating Profit was $139 million. Adjusted Segment Operating Profit was $162 million, an increase of 11%, driven by growth from access and adherence solutions.
Full-Year

Revenues were $3.9 billion, an increase of 34%, driven by volume growth related to biopharma services, including third-party logistics services and increased technology service revenue.
Segment Operating Profit was $500 million. Adjusted Segment Operating Profit was $590 million, an increase of 26%, driven by growth from access and adherence solutions.
Medical-Surgical Solutions Segment
Fourth-Quarter

Revenues were $2.9 billion, an increase of 6%, driven by growth and improvements in the primary care business.
Segment Operating Profit was $280 million. Adjusted Segment Operating Profit was $298 million, an increase of 55%, driven by prior year inventory charges on PPE and related products as well as growth and improvements in the primary care business.
Full-Year

Revenues were $11.6 billion, an increase of 15%, driven by growth and improvements in the primary care business and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
Segment Operating Profit was $959 million. Adjusted Segment Operating Profit was $1.2 billion, an increase of 50%, driven by growth and improvements in the primary care business, prior year inventory charges on PPE and related products, and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by increased labor expenses.
International Segment
Fourth-Quarter

Revenues were $8.5 billion. On an FX-Adjusted basis, revenues were $8.8 billion, an increase of 3%, driven by the sales to new customers in the Canadian business and year-over-year volume recovery from COVID-19, partially offset by the divestiture of McKesson’s Austrian business, which was closed during the fourth quarter of fiscal 2022.
Segment Operating Loss was $207 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $152 million, an increase of 10%, driven by the reduction of depreciation and amortization on European assets under agreements to sell and increased volumes in the pharmaceutical distribution business, including COVID-19 vaccines, tests, and PPE.
Full-Year

Revenues were $36.3 billion. On an FX-Adjusted basis, revenues were $35.4 billion, a decrease of 2%, driven by the contribution of McKesson’s German pharmaceutical wholesale business to a joint venture with Walgreens Boots Alliance, partially offset by year-over-year volume recovery from COVID-19 and sales to new customers in the Canadian business.
Segment Operating Loss was $968 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $681 million, an increase of 40%, driven by increased volumes in the pharmaceutical distribution business, including COVID-19 vaccines, tests, and PPE, and the reduction of depreciation and amortization on European assets under agreements to sell.
Corporate Responsibility Updates

On February 25, 2022, McKesson announced the approval of the proposed opioid settlement agreement with 46 of 49 eligible states, as well as the District of Columbia and all eligible territories.
McKesson accomplished a significant refresh of the Board of Directors in fiscal 2022:
McKesson completed a smooth transition as Donald R. Knauss became independent chair of McKesson’s Board of Directors on April 1, 2022.
W. Roy Dunbar joined McKesson’s Board of Directors as a new director and member of the Audit and Governance Committees effective April 1, 2022.
James H. Hinton joined McKesson’s Board of Directors as a new director and member of the Compliance and Governance Committees effective January 13, 2022.
Kathleen Wilson-Thompson joined McKesson’s Board of Directors as a new director and member of the Compensation and Governance Committees effective January 13, 2022.
Dr. Richard H. Carmona joined McKesson’s Board of Directors as an independent director and member of the Compensation and Compliance Committees effective September 6, 2021.
McKesson received multiple awards and acknowledgements for its diversity, equity, and inclusion achievements. McKesson continues to build a diverse workplace by expanding representation of women and people of color in leadership roles.
McKesson submitted science-based targets to the Science Based Targets initiative (SBTi) for official validation in fourth quarter fiscal 2022. McKesson remains committed to establishing science-based greenhouse gas emissions reduction targets that are intended to meet SBTi’s standards.
Fiscal 2023 Outlook
McKesson continues its focused execution on company priorities including its planned exit from the European market. For fiscal 2023, McKesson expects Adjusted Earnings per Diluted Share of $22.90 to $23.60 to reflect continued operating momentum and a balanced approach to capital deployment.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance includes approximately $0.20 to $0.60 of impacts attributable to the following:

$0.05 to $0.25 related to the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs; and $0.15 to $0.35 related to COVID-19 tests.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance excluding the impacts of the above items from both fiscal 2023 guidance and fiscal 2022 results and $0.47 related to net gains associated with McKesson Ventures’ equity investments in fiscal 2022, indicates 9% to 14% forecasted growth compared to prior year.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details
McKesson has scheduled a conference call for today, Thursday, May 5th at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

Upcoming Investor Events
McKesson management will be participating in the following investor conference:

Bank of America Healthcare Conference, May 12, 2022
Audio webcast, and a complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures
GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Loss on Debt Extinguishment, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.