On February 2, 2021 Genomic Testing Cooperative, LCA (GTC) reported that they are establishing a program offering comprehensive molecular profiling (DNA+RNA) testing to patients with cancer who are affected by cancer disparity and unable to pay due to lack of insurance or lack of coverage of this type of testing (Press release, Genomic Testing Cooperative, FEB 2, 2021, View Source [SID1234574506]). Ethnic and racial minorities, impoverished people, sexual and gender minorities (LGBTQ) are typically affected more negatively with cancer. One of the reasons for this disparity is poor access to precision medicine and exclusion from clinical trials or studies evaluating the potential differences in the biology of their cancer.

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GTC molecular profiling will provide the treating physicians and patients with proper diagnosis and classification of the tumor, help in determining prognosis, selecting therapy and in developing a strategy for treatment that is specific for the patient. The molecular profiling report provides information regarding potential clinical trials that will help the patients evaluate their options to participate and be treated in these clinical trials. Participation in this program will increase access of underserved patients and reduce disparity within community-based cancer care. In addition, the data generated from this program will be de-identified and made available to appropriate academic and scientific groups for the purpose of developing more personalized cancer treatment for minority groups of patients.

GTC is committed to donating 5% of its annual testing volume to this program. GTC is also establishing a donation fund allowing others to support this program and to increase the number of patients benefiting from this program. Individual donors and organizations can contribute to this program with 100% of the raised funds being used to pay for the actual cost of testing.

Patients must be nominated for this program by their physicians. Patients with solid tumors or hematologic neoplasms are eligible for testing. Hematologists/Oncologists can download a simple nomination form from the GTC website, fill in the required information and fax or e-mail to GTC. Patients can mention this program to their hematologists/oncologists and request nomination for this program.

Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer, stated "GTC is committed to making cancer molecular profiling available to all patients with cancer. We all know that patients seen in academic centers are different from real-world patients. Minority patients are not adequately represented in the process for developing innovative medicine nor in the implementation of state-of-the-art medicine. As a diagnostic company, we are doing our part by defining the precise molecular abnormalities that can be targeted but having access to the expensive targeted therapy is a different struggle. We are hoping that pharmaceutical companies will join our effort and do their part in providing the appropriate drugs to these patients and will develop a mechanism to recruit them in their clinical trials."

A recent study reported that one-third of disparities in survival between white and black patients with stage IV colorectal cancer is a product of treatment gaps (HemOnctoday, January 21/2021).

On February 2, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that a preclinical study in animals demonstrated a potentially significant therapeutic benefit of Annamycin against metastatic osteosarcoma (Press release, Moleculin, FEB 2, 2021, View Source [SID1234574505]). This appears to be the result of the high cytotoxic potential of Annamycin previously demonstrated in vitro against sarcoma cells in combination with its high uptake by the lungs where the tumors in this study are localized. Computerized tomography (CT) scans demonstrated that animals treated with Annamycin exhibited significant suppression of tumor growth and not a single death was observed in the treated animals, whereas significant tumor burden contributed to the rapid death of 90% of untreated animals. While the study continues, as of day 130, the survival rate for animals treated with Annamycin was 100%, compared with only 10% for untreated animals.

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

Osteosarcoma is among a class of tumors that initiate in the bone of patients, with bone-related sarcomas representing the second most common form of sarcoma after soft tissue sarcoma. While many bone sarcomas can be addressed through surgical removal, it is estimated that as many as 40% of bone sarcomas will eventually metastasize to the lungs, where treatment can become more problematic. Researchers have more recently referred to the lungs and certain other vital organs as "sanctuary sites" for cancer where tumors can develop out of reach from conventional chemotherapies.

Once metastasized to the lungs, if tumors cannot be surgically removed, the primary chemotherapy regimen is the anthracycline doxorubicin (also known as Adriamycin). While 10% to 30% of patients with sarcoma lung metastases may initially respond to doxorubicin, most will relapse leaving the majority of these patients without an alternative chemotherapy. Moleculin recently announced findings from its sponsored research showing that doxorubicin has a limited ability to accumulate in the lungs of animals, which may help explain its limited efficacy in this sanctuary site. Treatment options are further limited because of the inherent cardiotoxicity of currently approved anthracyclines, including doxorubicin, which limits the amount of anthracycline that can be given to patients.

Annamycin is a "next generation" anthracycline that has recently been shown in animal models to accumulate in the lungs at up to 34 times the level of doxorubicin, which may account for the 100% survival rate attained in this most recent osteosarcoma lung metastases study. Importantly, Annamycin has also demonstrated a lack of cardiotoxicity in recently conducted human clinical trials of Annamycin for the treatment of acute myeloid leukemia, so the use of Annamycin may not face the same dose limitations imposed on doxorubicin.

Moleculin recently announced that the FDA has allowed the Company’s request for investigational new drug (IND) status in order to study Annamycin for the treatment of soft tissue sarcoma metastasized to the lungs. In addition, the FDA granted Orphan Drug Designation for Annamycin for the treatment of soft tissue sarcomas.

"Our ongoing sponsored research continues to expand the potential uses for Annamycin," commented Walter Klemp, Chairman and CEO of Moleculin. "We expect that one, and potentially two, clinical trials in sarcoma lung metastases should be up and running this year."

On February 2, 2021 Bio-Techne Corporation (NASDAQ:TECH)reported its financial results for the second quarter ended December 31, 2020 (Press release, Bio-Techne, FEB 2, 2021, View Source [SID1234574504]).

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Second Quarter FY2021 Snapshot

Second quarter organic revenue increased by 19% (21% reported) to $224.3 million and 15% (16% reported) in the first half of fiscal 2021 to $428.5 million.
GAAP EPS was $1.15 versus $3.02 one year ago primarily relating to a non-recurring gain of approximately $121 million in our ChemoCentryx investment in the second quarter of fiscal 2020. Delivered record adjusted earnings per share (EPS) of $1.62 versus $1.08 one year ago.
Adjusted Operating Margin increased to 38.7% in the second quarter of fiscal 2021 compared to 33.4% in the second quarter of fiscal 2020.
Excellent commercial execution in both the Protein Sciences and Diagnostics and Genomics segments, with each delivering record organic growth of 19%.
Delivered record operating cash flows in the first half of fiscal 2021 while paying down approximately $125 million in outstanding debt.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"I would like to thank the entire global Bio-Techne team for delivering such a stellar quarter," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "To achieve 19% organic growth, with only 3% attributed to Covid tailwinds, attests to the strong execution of our strategy we have implemented in recent years. It’s great to see this planning succeed in virtually all areas of our business. We delivered this organic growth with a continued focus on profitability, as our adjusted operating margin improved over 500 basis points year over year to 38.7%."

Kummeth added, "The continued ramp of our high-growth platforms including Exosome Dx, Cell and Gene Therapy, GMP Proteins, proteomics instrumentation and genomics will be exciting to watch as we strive for continued double-digit organic growth. Our expanded digital platform, increased global brand presence, and world class customer relationships has brought our renowned protein and antibody products (as well as our new platforms) to the forefront of the life science tools and diagnostics industry."

Second Quarter Fiscal 2021

Revenue

Net sales for the second quarter increased 21% to $224.3 million. Organic growth was 19% compared to the prior year, with foreign currency exchange having a favorable impact of 2% and acquisitions contributing an immaterial amount to revenue growth.

GAAP Earnings Results

GAAP EPS decreased to $1.15 per diluted share, versus $3.02 in the same quarter last year. GAAP EPS was favorably impacted by a non-recurring gain of approximately $121 million on our ChemoCentryx investment in the second quarter of fiscal 2020. GAAP operating income for the second quarter of fiscal 2021 increased 37.9% to $51.0 million, compared to $37.0 million in the second quarter of fiscal 2020. GAAP operating margin was 22.7%, compared to 20.0% in the second quarter of fiscal 2020. GAAP operating margin compared to prior year was positively impacted by volume leverage and cost management.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.62 per diluted share, versus $1.08 in the same quarter last year, an increase of 50%. Adjusted EPS increased due to revenue growth and operating margin expansion. Adjusted operating income for the second quarter of fiscal 2021 increased 40% compared to the second quarter of fiscal 2020. Adjusted operating margin was 38.7%, compared to 33.4% in the second quarter of fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage and cost management.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s second quarter fiscal 2021 net sales were $172.2 million, an increase of 22% from $141.5 million for the second quarter of fiscal 2020. Organic growth for the segment was 19%, with foreign currency exchange having a favorable impact of 3% on revenue growth and acquisitions contributing an immaterial amount to revenue growth. Protein Sciences segment’s operating margin was 46.6% in the second quarter of fiscal 2021 compared to 43.0% in the second quarter of fiscal 2020. The segment’s operating margin compared to the prior year was positively impacted by volume leverage and cost management.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s second quarter fiscal 2021 net sales were $52.5 million, an increase of 20% from $43.8 million for the second quarter of fiscal 2020. Organic growth for the segment was 19% with foreign currency exchange having a 1% impact on revenue. The Diagnostics and Genomics segment’s operating margin was 15.5% in the second quarter of fiscal 2021 compared to 2.2% in the second quarter of fiscal 2020. The segment’s operating margin was favorably impacted by volume leverage and cost management.

Conference Call

Bio-Techne will host an earnings conference call today, February 2, 2021 at 8:00 a.m. CST. To listen, please dial 1-877-407-9208 or 1-201-493-6784 for international callers, and reference conference ID 13715028. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13715028. The replay will be available from 11:00 a.m. CST on Tuesday, February 2, 2021 until 11:00 p.m. CST on Tuesday, March 2, 2021.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs and gains. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. For the Eminence acquisition, amortization expense and costs of acquired inventory were adjusted in the net earnings calculation based on the Company’s ownership percentage to calculate the adjusted net earnings per share attributable to Bio-Techne. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

On February 2, 2021 EORTC reported 1945 OligoRARE trial in stereotactic body radiotherapy in addition to standard of care treatment in patients with oligometastatic rare cancers, receives significant financial contribution by the Anticancer Fund and the Rising Tide Foundation for Clinical Cancer Research (Press release, EORTC, FEB 2, 2021, View Source [SID1234574503]).

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Metastatic cancer can range from a single metastasis to widely disseminated metastases, making it the leading cause of cancer death. Today, the concept of oligometastases is generally considered an intermediate state between locoregional cancer and widespread metastases with a limited number of lesions and organs involved. By nature of its limited spread, it has been shown through mostly retrospective studies that aggressive metastasis-directed therapy (surgery or radiation) added to standard of care systemic therapy achieved long-term survival or even cure in about one quarter of the patients. Two thirds of these patients had lung, prostate, breast or colorectal cancer.

In a joint grant call, the Anticancer Fund and the Rising Tide Foundation for Clinical Cancer Research have selected to award the EORTC 1945 OligoRARE clinical trial, which aims at improving overall survival in patients with oligometastatic rare cancers, including all solid cancer types except lung, breast, colon, prostate cancer.

The total cost of the EORTC OligoRARE study amounts to approximately €1.9M, of which the Anticancer Fund and Rising Tide Foundation will jointly contribute €800,000 while the remaining €1.1M has been secured by the EORTC.

"We are very happy to count both the Anticancer Fund and Rising Tide Foundation as partners in tackling unmet patient-centred needs in cancer clinical research. Their funding will contribute to an important international randomised clinical trial, evaluating oligometastatic treatment in underrepresented cancer types", commented Dr Denis Lacombe, EORTC’s Director General.

"The Anticancer Fund believes in the power of partnerships to develop cancer treatments that are outside the scope of the pharma industry. Cancer care is multidisciplinary but clinical research in radiotherapy, and in surgery, is badly underserved, while contributing substantially to patients’ benefit", explained Lydie Meheus, Managing Director of the Anticancer Fund. ‘We are also delighted we can join hands with EORTC and Rising Tide Foundation to make this trial happen. This is the second time we support an EORTC led trial and we believe this partnership is meant to last. Because together, we can do so much more.’

The CEO of Rising Tide GmbH, Wendelin Zellmayer stated, "Oligometastatic rare cancers are an under-served area in research. In collaboration with the Anticancer Fund, the Rising Tide Foundation for Clinical Cancer Research has granted the European Organization for Research and Treatment of Cancer ("EORTC") a joint award to conduct a clinical trial in 6 countries with Matthias Guckenberger from University Hospital Zurich as the Study Coordinator, to change the standard of treatment and improve patient outcome."

The study

OligoRARE builds on the experience and network of the partnership between the EORTC and ESTRO (European Society for Therapeutic Radiology and Oncology). EORTC’s OligoRARE, a European based study (six countries) with a transatlantic collaboration with British Columbia Cancer Agency in Canada, will be the first to be done using an identical stereotactic body radiotherapy (SBRT) approach in cancers where the oligometastatic state is uncommon, thus where data is severely lacking. The study will target patients with oligometastatic cancer, including all solid cancer types except lung, breast, colon and prostate cancer.

The primary objective of this clinical trial is to assess if the addition of SBRT improves overall survival (OS) compared to standard of care treatment alone, in patients with ‘oligometastatic rare’ cancers. Patients with a maximum of 5 oligometastatic lesions will be treated as per standard of care with or without the addition of targeted radiation therapy to sites of known disease. Standard of care in both arms may include chemotherapy, targeted therapy, hormonal therapy, immunotherapy or observation. Patients will be followed every 3 months for the first 2 years then every 6 months for the next 3 years.

A total of 200 patients will be recruited over a period of 5.5 years. Additional follow-up of 28 months is expected to provide the targeted number of events for analysis. The study is coordinated by Dr Matthias Guckenberger (Zurich, Switzerland) and Dr Piet Ost (Gent, Belgium).

On the study’s importance, Dr Mattias Guckenberger commented: "Today, we have a strong rational that adding local treatment, mostly radiotherapy or surgery, to systemic therapy improves survival of oligometastatic patients, meaning patients with only limited metastatic disease. Evidence is mostly based on the common cancer sites: lung cancer, colorectal cancer and prostate cancer. There is consequently a strong need to test this hypothesis of a curative approach in oligometastatic disease also in patients with less common cancer sites. Such a trial in rare oligometastatic cancer patients does require a large and strong network to enroll sufficiently large numbers of patients, which is the rational for the OligoCare trial in the European EORTC network."

On February 2, 2021 McKesson Corporation (NYSE:MCK) reported results for the third quarter ended December 31, 2020 (Press release, McKesson, FEB 2, 2021, View Source [SID1234574502]).

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"McKesson continued to demonstrate its operational excellence and extensive healthcare supply chain expertise, as we began the distribution of COVID-19 vaccine doses to the entire U.S. in the third quarter," said Brian Tyler, chief executive officer. "McKesson’s long history of serving as the centralized distributor for the Vaccines for Children program for the Centers for Disease Control and Prevention, including during the H1N1 public health crisis, positions us well to distribute hundreds of millions of COVID-19 vaccines safely and efficiently to the right location, in the right quantity, and in the right condition. Our COVID-19 vaccine distribution has been highly successful, achieving all volume and timing requirements by the government, and I want to thank our 80,000 employees around the world for their tremendous efforts and dedication."

"While the overall environment remains challenging due to the sustained impact of the COVID-19 pandemic, we are pleased to report third-quarter adjusted earnings results ahead of our expectations. McKesson’s performance reflects strong execution and the benefits from our ongoing strategic investments in the growth areas of oncology and biopharma services. Based on our year-to-date progress and the successful execution of distributing COVID-19 vaccines and ancillary supplies in the U.S., we are raising and narrowing our guidance range for fiscal 2021 and now expect Adjusted Earnings per diluted share of $16.95 to $17.25."

Third-quarter revenues were $62.6 billion, up 6% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to market growth and higher specialty volumes, partially offset by branded to generic conversions.

Third-quarter Loss per diluted share of ($39.03) included a pre-tax $8.1 billion expense accrual related to opioid litigation and a pre-tax long-lived asset impairment charge of $115 million primarily related to McKesson’s retail pharmacy businesses in the International segment. Third-quarter Adjusted Earnings per diluted share does not include these charges.

Third-quarter Adjusted Earnings per diluted share was $4.60 compared to $3.81 a year ago, an increase of 21%, driven by a lower share count and growth in the Medical-Surgical Solutions segment, partially offset by a higher tax rate and the lapping of the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"). Third-quarter Adjusted Earnings per diluted share also included pre-tax net gains of approximately $30 million, or $0.14 per diluted share, associated with McKesson Ventures’ equity investments.

For the first nine months of the fiscal year, McKesson returned $709 million of cash to shareholders via $500 million of common stock repurchases and $209 million of dividend payments. During the first nine months of the fiscal year, McKesson generated cash from operations of $1.2 billion, and invested $427 million internally, resulting in Free Cash Flow of $745 million.

Opioid-related charges

In the third quarter of fiscal 2021, McKesson recorded a GAAP-only pre-tax charge of $8.1 billion, $6.7 billion post-tax, related to the estimated liability for opioid-related claims of governmental entities. The Company is in ongoing, advanced discussions with state attorneys general and plaintiffs’ attorneys regarding a settlement framework under which the Company would pay its portion of a broad settlement over a period of 18 years. A loss in this amount has now been deemed probable and reasonably estimable.
U.S. Pharmaceutical Segment

Third-quarter revenues were $49.5 billion, up 7%, driven by market growth and higher specialty volumes, partially offset by branded to generic conversions.
Third-quarter Segment Operating Profit was $635 million and operating margin was 1.28%. Adjusted Segment Operating Profit was $656 million, up 2% from a year ago, driven by growth in specialty, partially offset by higher operating expenses in support of the company’s strategic growth initiatives. Adjusted operating margin was 1.33%, down 5 basis points.
International Segment

Third-quarter revenues were $9.3 billion, down 6% on a reported basis and down 10% on an FX-Adjusted basis, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Third-quarter Segment Operating Loss was ($71) million and operating margin was (0.77%), driven by a GAAP-only pre-tax long-lived asset impairment charge of $115 million primarily related to McKesson’s retail pharmacy businesses in Canada and Europe. Adjusted Segment Operating Profit was $158 million, up 9%. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $150 million, up 3%. Adjusted operating margin was 1.70%, up 23 basis points. On an FX-Adjusted basis, adjusted operating margin was 1.69%, up 22 basis points.
Medical-Surgical Solutions Segment

Third-quarter revenues were $3.1 billion, up 43%, primarily driven by demand for COVID-19 tests in the Primary Care and Extended Care businesses.
Third-quarter Segment Operating Profit was $260 million and operating margin was 8.51%. Adjusted Segment Operating Profit was $279 million, up 52%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for COVID-19 vaccines, partially offset by inventory charges. Adjusted operating margin was 9.14%, up 55 basis points.
Prescription Technology Solutions Segment

Third-quarter revenues were $777 million, up 9%, driven by new brand support programs and higher volumes of existing brand support programs.
Third-quarter Segment Operating Profit was $114 million and operating margin was 14.67%. Adjusted Segment Operating Profit was $131 million, up 27%, reflecting organic growth in the segment. Adjusted operating margin was 16.86%, up from 14.43% in the prior year.
Company Updates

McKesson launched Ontada, an oncology technology and insights business within the U.S. Pharmaceutical Segment, designed to support innovation, acceleration and evidence generation to drive better outcomes for cancer patients.
McKesson’s Board of Directors authorized an additional $2.0 billion share repurchase program, demonstrating confidence in McKesson’s diversified capital allocation strategy.
Recent Sustainability and ESG Highlights

Dr. Kelvin A. Baggett joined McKesson in the newly created role of chief impact officer effective November 30, 2020.
McKesson issued its FY20 Corporate Responsibility report highlighting its strategy and action towards better health for people and the planet and has joined the United Nations Global Compact initiative, a voluntary leadership platform for the development, implementation and disclosure of responsible business practices.
For the eighth consecutive year, McKesson was recognized as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100 percent on the HRC’s 2021 Corporate Equality Index.
Fiscal 2021 Outlook

McKesson raised and narrowed fiscal 2021 Adjusted Earnings per diluted share guidance to $16.95 to $17.25 from the previous range of $16.00 to $16.50 to primarily reflect improved growth in the business and the contribution from McKesson’s successful distribution of COVID-19 vaccines and ancillary supplies. Fiscal 2021 Adjusted Earnings per diluted share guidance assumes $0.25 to $0.35 related to COVID-19 vaccine distribution and $0.20 to $0.30 related to the kitting and distribution of ancillary supplies for COVID-19 vaccines.

Fiscal 2021 guidance continues to assume that a full recovery of pharmaceutical prescription volumes and patient visits will not occur this fiscal year.

Other remaining businesses

As a result of the segment realignment effective in the second quarter of fiscal 2021, Other reflects equity earnings and charges for retrospective periods for the company’s previous investment in Change Healthcare, which was separated from the company during the fourth quarter of fiscal 2020.

Conference Call Details

The company has scheduled a conference call for today, Tuesday, February 2nd at 8:00 AM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

Cowen 41st Annual Health Care Conference, March 1, 2021
Webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’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 Equity Income from Change Healthcare, 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, gains from antitrust legal settlements, 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.