On August 4, 2021 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter ended June 30, 2021, and provided an update on the progress of its clinical programs (Press release, vTv Therapeutics, AUG 4, 2021, View Source [SID1234585720]).

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"We held our first, highly-productive meeting with the FDA following the designation of Breakthrough Therapy for TTP399 as a potential adjunct treatment for type 1 diabetes," said Steve Holcombe, president and CEO, vTv Therapeutics. "Based upon the outcome of this meeting, we are planning to conduct two pivotal studies of TTP399 starting in the first half of 2022. We are appreciative of the ongoing dialogue that the Breakthrough Designation affords us and look forward to continuing to work closely with the agency as we refine the design of these studies in the coming weeks."

Recent Achievements and Outlook

Type 1 Diabetes

Breakthrough Therapy Designation Type B Meeting. As announced in April, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for TTP399 as an adjunctive therapy to insulin for the treatment of type 1 diabetes. The Company held its first Type B meeting with the FDA pursuant to the Breakthrough Therapy designation to discuss the development of TTP399.

Mechanistic Study of Ketoacidosis with TTP399. The Company completed enrollment in the mechanistic study of TTP399 in people with type 1 diabetes. This phase 1 study is designed to assess the impact of TTP399 on ketone body formation, and therefore the risk of diabetic ketoacidosis, during a period of acute insulin withdrawal. vTv expects to report topline results from this mechanistic study in late third quarter or early fourth quarter of 2021.

Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects with type 1 diabetes that are expected to begin in the first half of 2022.
Psoriasis

Multiple Ascending Dose Study with HPP737. The Company completed dosing healthy subjects in a phase 1 multiple ascending dose study to assess the safety, tolerability, and pharmacokinetic profile of HPP737, an oral PDE4 inhibitor. We expect to report the results from this study in the third quarter.

Phase 2 Study Planning. The Company is planning a phase 2 clinical trial of HPP737 in patients with psoriasis. We are discussing the proposed study design with the FDA during the third quarter and expect to begin the study late in the fourth quarter of 2021 or early in the first quarter of 2022.
License Partner Updates

vTv and Cantex Entered into a Strategic Licensing Agreement for Azeliragon. In June, the Company announced a new strategic collaboration with Cantex Pharmaceuticals under which Cantex will continue the development of azeliragon for the treatment of the complications associated with cancer, including cachexia and pain from bone metastasis. Cantex will be responsible for the development and commercialization of azeliragon and the companies will allocate profits under a tiered arrangement.

Reneo Dosed the First Patient in Phase 2b STRIDE Study. In July, Reneo Pharmaceuticals dosed the first patient in the phase 2b STRIDE Study, designed to assess the efficacy and safety of REN001 for the treatment of patients with primary mitochondrial myopathies.
Funding Updates

$50 Million ATM Program. The Company added an additional $50 million of capacity to its at-the-market equity program with Cantor Fitzgerald to fund the ongoing and planned development of TTP399 and HPP737.

Registration of Additional Shares to Support Equity Line. The Company registered an additional 9.4 million shares of Class A Common Stock to provide the continued flexibility to raise capital with share sales to Lincoln Park Capital under the Purchase Agreement entered into in November of 2020.
First Quarter 2021 Financial Results

Cash Position: The Company’s cash position as of June 30, 2021, was $10.8 million compared to $8.4 million as of March 31, 2021.

Revenue: Revenue for the second quarter of 2021 was an insignificant amount. For the first quarter of 2021 revenue was $1.0 million. The revenue for the first quarter was non-cash and related to the recognition of revenue pertaining to the Huadong license agreement.

R&D Expenses: Research and development expenses were $2.4 million and $3.1 million for the three months ended June 30, 2021 and March 31, 2021, respectively. This decrease of $0.7 million was driven primarily by the decreases in spending for the Elevage study as the analysis and close out of this study largely occurred in the first quarter as well as a decrease in spending for our study of HPP737 in psoriasis.

G&A Expenses: General and administrative expenses were consistent between periods at $2.2 million for each of the three months ended June 30, 2021 and March 31, 2021.

Other Income/(Expense): Other income for the three months ended June 30, 2021 was $3.8 million and was attributable to the changes in the fair value of our investment in Reneo Pharmaceuticals, Inc. which completed its initial public offering in the second quarter of 2021 as well as gains related to a reduction in fair value of the warrants to purchase shares of our own stock issued to a related party (the "Related Party Warrants"). Other expense for the three months ended March 31, 2021 was driven by losses related to an increase in the fair value of the Related Party Warrants.

Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $0.8 million for the second quarter of 2021 compared to net loss of $5.9 million for the first quarter of 2021.

Net Loss Per Share: Diluted net loss per share was ($0.01) for the three months ended June 30, 2021 compared to diluted net loss per share of ($0.08) for the three months ended March 31, 2021, based on weighted-average diluted shares of 58.6 million and 56.5 million for the three-month periods ended June 30, 2021 and March 31, 2021, respectively.

On August 4, 2021 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the quarter ended June 30, 2021 (Press release, Adaptive Biotechnologies, AUG 4, 2021, View Source [SID1234585719]).

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"We had another strong quarter with 83% revenue growth over prior year," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "I am encouraged by our performance across the business and excited about the emerging data from our immune medicine platform, which we expect to monetize for multiple opportunities in research, diagnostics and drug discovery."

Recent Highlights

Revenue of $38.5 million for the second quarter 2021, representing an 83% increase from the second quarter 2020
clonoSEQ clinical sequencing volume in the second quarter 2021 grew 75% versus prior year and 15% over the first quarter of 2021
Signed a license agreement with Vaccibody to leverage Adaptive Biotechnologies’ T-cell data to inform the development of a T-cell based SARS-CoV-2 vaccine
Signed an agreement with Moderna to use immunoSEQ T-MAP COVID to measure the T-cell response to their second generation COVID vaccine and their Zika vaccine
Published case control data in Lyme disease and completing enrollment in ImmuneSense study to enable T-Detect Lyme offering in our CLIA certified lab around year end
Advanced T-Detect pipeline in autoimmune diseases including Crohn’s and Ulcerative Colitis for IBD differential diagnosis, and generated new early signal in Multiple Sclerosis
Second Quarter 2021 Financial Results

Revenue was $38.5 million for the quarter ended June 30, 2021, representing an 83% increase from the second quarter in the prior year. Sequencing revenue was $18.6 million for the quarter, representing a 132% increase from the second quarter in the prior year. Development revenue was $20.0 million for the quarter, representing a 53% increase from the second quarter in the prior year.

Operating expenses were $88.3 million for the second quarter of 2021, compared to $57.9 million in the second quarter of the prior year, representing an increase of 53%.

Net loss was $49.3 million for the second quarter of 2021, compared to $33.5 million for the same period in 2020.

Adjusted EBITDA (non-GAAP) was a loss of $35.6 million for the second quarter of 2021, compared to a loss of $28.5 million for the second quarter of the prior year.

Cash, cash equivalents and marketable securities was $689.5 million as of June 30, 2021.

2021 Financial Guidance

Adaptive Biotechnologies expects full year 2021 revenue to be in the range of $148 million to $155 million, representing 54% growth at the mid-point of the range over full year 2020 revenue. This compares to Adaptive Biotechnologies’ previous outlook of $145 million to $155 million.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its second quarter 2021 financial results after market close on Wednesday, August 4, 2021 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On August 4, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the second quarter ended June 30, 2021 (Press release, Zymeworks, AUG 4, 2021, View Source [SID1234585718]).

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"The second half of 2021 is an exciting time at Zymeworks as we prepare to present important data readouts at upcoming medical conferences in support of the planned launch of our pivotal trial for zanidatamab in first-line HER2-positive gastric cancer," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "The first data presentation will be at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in September and highlights results from our Phase 2 clinical trial evaluating zanidatamab plus chemotherapy in first-line gastric cancer, a setting where the current standard of care is Herceptin plus chemotherapy. These results will be integral to our goal of establishing zanidatamab as the new foundational HER2-targeted therapy and bring us one step closer to realizing our mission of enabling patients to return home to their loved ones, disease free."

Second Quarter 2021 Business Highlights and Recent Developments

Zanidatamab in First-Line Gastroesophageal Adenocarcinoma (GEA) to be Presented at ESMO (Free ESMO Whitepaper) Annual Meeting
The presentation will feature new clinical data for our lead product candidate, zanidatamab, in combination with chemotherapy, as a first-line treatment for patients with HER2-positive GEA. The presentation will be available on Thursday, September 16 at 8:30 AM CEST (Central European Summer Time) on both the ESMO (Free ESMO Whitepaper) and Zymeworks websites.
Enrollment Initiated for First-Line Biliary Tract Cancer and Colorectal Cancer Cohorts in Zanidatamab Phase 2 Clinical Trial
The ongoing Phase 2 study is evaluating zanidatamab in combination with standard of care chemotherapy as a first-line treatment for patients with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastrointestinal cancers including biliary tract cancer, colorectal cancer, and GEA. Results from this study are expected to inform future potential pivotal trials.
First Patient Dosed with Zanidatamab in Combination with Tukysa (Tucatinib) and Chemotherapy in Advanced HER2-Positive Breast Cancer
The first patient has been dosed in a new cohort of a Phase 1 trial investigating the safety, tolerability, and efficacy of zanidatamab in combination with tucatinib and capecitabine. This new cohort will evaluate HER2-positive breast cancer patients with locally advanced (unresectable) and/or metastatic disease that have received prior therapy with trastuzumab, pertuzumab and T-DM1.
First Patient Dosed for Janssen-Developed Bispecific Antibody Utilizing Zymeworks’ Azymetric and EFECT Therapeutic Platforms
The new bispecific antibody developed by Janssen, JNJ-78278343, represents Zymeworks’ fourth pharmaceutical partnership with programs reaching clinical development. Zymeworks will receive a payment in connection with this milestone under Zymeworks’ 2017 licensing agreement with Janssen.
ZW49 Cohort Expansion Study Opens New Sites in South Korea and Australia
Zymeworks has opened new sites in South Korea and Australia to accelerate the cohort expansion portion of the Phase 1 clinical trial for ZW49. This will support Zymeworks’ goal of identifying the recommended Phase 2 dose and schedule by the end of this year. Dose escalation continues in weekly and once every three week schedules while three indication-specific expansion cohorts utilizing the 2.5 mg/kg once every three week regimen are ongoing.
Financial Results for the Quarter Ended June 30, 2021

Zymeworks’ revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as research support and other payments. Revenue for the three months ended June 30, 2021 was $1.8 million compared to $12.4 million for the same period of 2020. Revenue for the second quarter of 2021 related to research support and other payments from our partners. Revenue for the same period in 2020 included recognition of a $12.0 million expansion fee resulting from an amendment to our collaboration agreement with BMS, as well as $0.4 million in research support and other payments from our partners.

For the three months ended June 30, 2021, research and development expenses were $50.7 million compared to $39.8 million for the same period of 2020. The increase was primarily due to higher salaries and benefits expense from additional headcount as well as higher stock-based compensation expense and third-party research and development program expenses. For the three months ended June 30, 2021, research and development expenses included non-cash stock-based compensation expense of $5.8 million from equity-classified equity awards and $0.2 million from the non-cash mark-to-market revaluation of certain historical liability classified equity awards. Excluding stock-based compensation expense, research and development expenses increased by $8.1 million for the three months ended June 30, 2021 compared to the same period in 2020.

For the three months ended June 30, 2021, general and administrative expenses were $19.9 million compared to $12.9 million for the same period in 2020. The increase was primarily due to higher salaries and benefits due to additional headcount, stock-based compensation expense and professional fees. For the three months ended June 30, 2021, general and administrative expenses included non-cash stock-based compensation expense of $5.3 million from equity-classified equity awards and $1.5 million from the non-cash mark-to-market revaluation of certain historical liability-classified equity awards. Excluding stock-based compensation expense, general and administrative expenses increased by $3.9 million for the three months ended June 30, 2021 compared to the same period in 2020.

Net loss for the three months ended June 30, 2021 was $67.5 million compared to $39.0 million for the same period of 2020. This was primarily due to the decrease in revenue and interest income and increase in research and development and general and administrative expenses referred to above.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of June 30, 2021, Zymeworks had $359.8 million in cash resources consisting of cash, cash equivalents and short-term investments. We anticipate this will enable us to fund our planned operations into the second half of 2022 and potentially beyond.

On August 4, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King (Press release, GlycoMimetics, AUG 4, 2021, View Source [SID1234585717]). Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company’s pipeline.

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Tim Pearson, Chairman of the Board of Directors of GlycoMimetics, said, "On behalf of the entire Board, I offer sincere thanks to Rachel for her leadership of GlycoMimetics and for her commitment to the company’s employees and to patients who will hopefully benefit from GlycoMimetics’ technology. We look forward to her continued contributions as a board member."

Mr. Pearson continued, "Harout is ideally positioned to lead GlycoMimetics into the company’s next phase of growth as we anticipate the completion of our Phase 3 trial and potential commercialization of uproleselan. He possesses the right leadership and operational skills as well as tremendous know-how from his many years at Novartis overseeing several oncology and hematology product launches and from subsequent C-level positions he has held within the industry. I am confident Harout will be an effective leader for GlycoMimetics into the future."

Mrs. King, who has served as CEO for 18 years, has decided to retire for personal reasons and will continue her involvement with the company through her role on the Board of Directors and serving as an advisor during this transition. Mrs. King led GlycoMimetics’ evolution from an early venture-backed company through its initial public offering, strategic partnerships and the advancement of two late-stage clinical candidates. She also shepherded the company’s unique and productive glycochemistry platform to build a multi-faceted pipeline of drug candidates targeting key unmet needs in oncology, sickle cell disease and other indications.

"It has been a privilege and a pleasure to lead GlycoMimetics and to work with such an extraordinary team of colleagues," said Mrs. King. "I am extremely proud of what we have collectively accomplished in the 18 years since the company was founded. When I approached the Board to let them know that I was considering retirement, I committed to do all I can to ensure a smooth transition. I look forward to working with Harout and the team as a board member to continue to advance our programs. My decision to focus on spending more time with my family seems appropriately timed as we near an opportunity to commercialize our first product candidate."

Mr. Semerjian is a global biopharmaceutical veteran. Over the last 25 years, he acquired extensive US, European and international commercialization experience having led multiple successful hematology/oncology product launches, including preparation for the launch of midostaurin in AML. During his 16-year tenure at Novartis, Mr. Semerjian held both strategic and operational leadership roles including US Hematology franchise head. He then served as EVP, chief commercial officer at Ipsen where he was accountable for worldwide commercialization and portfolio strategy. Most recently, he briefly served as CEO of Immunomedics before its sale to Gilead Sciences, Inc.

"I believe GlycoMimetics has exciting opportunities ahead. Uproleselan is a differentiated drug candidate already recognized by both FDA and the Chinese regulatory authority with Breakthrough Therapy Designations and the potential for significant impact across the spectrum of AML. The enthusiasm of independent investigators as well as the clinicians participating in our registration trials provides a foundation for a successful commercialization plan, should the readout and regulatory interactions prove positive. While there are just a few glycobiology-based therapeutics on the market today, the field of glycobiology is rapidly advancing and ripe with opportunity. The expertise resident in GlycoMimetics underlies my confidence in its platform’s productivity. Across the pipeline, I’m seeing novel and potentially game-changing therapies," said Mr. Semerjian. "I look forward to working with the outstanding team at GlycoMimetics as we strive to make a difference in the lives of patients with cancer and other diseases."

On August 4, 2021 McKesson Corporation (NYSE:MCK) reported results for the first quarter ended June 30, 2021 (Press release, McKesson, AUG 4, 2021, View Source [SID1234585716]).

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Fiscal 2022 First-Quarter Result Summary

"McKesson delivered record first-quarter earnings, marking another quarter of solid performance across all four operating segments," said Brian Tyler, chief executive officer. "As we execute against our strategic priorities, we are evolving our portfolio to drive long-term growth and create shareholder value. We remain optimistic that the momentum we’ve generated will continue given the strength we see across our businesses. Based on our first-quarter operating performance and current trends, we are raising our previous guidance range for fiscal 2022 Adjusted Earnings per diluted share to $19.80 to $20.40."

First-quarter revenues were $62.7 billion, an increase of 13% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to higher volumes from retail national account customers and market growth, partially offset by branded to generic conversions.

During the first quarter of fiscal 2022, McKesson committed to donate certain personal protective equipment (PPE) to charitable organizations to assist in COVID-19 recovery efforts. First-quarter earnings per diluted share from continuing operations of $3.09 included $164 million of pre-tax inventory charges on certain PPE and related products. First-quarter Adjusted Earnings per diluted share excluded $155 million of these charges for inventory which the company no longer intends to sell and will instead direct to charitable organizations.

First-quarter Adjusted Earnings per diluted share was $5.56 compared to $2.77 a year ago, an increase of 101%, driven by the recovery of prescription volumes and primary care patient visits following the onset of the COVID-19 pandemic. Adjusted Earnings per diluted share growth was also driven by a lower tax rate and the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government.

For the first three months of the fiscal year, McKesson returned $1.1 billion of cash to shareholders, which included $1.0 billion of common stock repurchases and $69 million of dividend payments. During the first three months of the fiscal year, McKesson used cash from operations of $1.6 billion, and invested $159 million in capital expenditures, resulting in negative Free Cash Flow of $1.8 billion. McKesson also used $1.0 billion of cash for payments related to the exercises of a put right option available to non-controlling shareholders of McKesson Europe that expired in June 2021.

Business Highlights

McKesson is playing a central role in the COVID-19 response efforts in the U.S. and abroad through the distribution of COVID-19 vaccines, ancillary supply kits, and COVID-19 tests.
McKesson’s partnership with the U.S. government was expanded to support the U.S. government’s international COVID-19 vaccine donation mission. Including vaccine distribution in the U.S. and related to the U.S. government’s international donation mission, McKesson has successfully shipped over 250 million COVID-19 vaccines on behalf of the U.S. government through July 31, 2021.
On July 7, 2021, McKesson announced that it has entered into an agreement to sell its European businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX group for approximately $1.5 billion, subject to certain adjustments under the agreement. The transaction is subject to customary closing conditions, including regulatory review, and is expected to close in fiscal 2023. McKesson is committed to exploring strategic alternatives for all remaining European businesses.
U.S. Pharmaceutical Segment

First-quarter revenues were $50.0 billion, an increase of 12%, driven by higher volumes from retail national account customers and market growth, partially offset by branded to generic conversions.
First-quarter Segment Operating Profit was $682 million. Adjusted Segment Operating Profit was $682 million, an increase of 16%, driven by the contribution from COVID-19 vaccine distribution and growth in distribution of specialty products to providers and health systems.
Prescription Technology Solutions Segment

First-quarter revenues were $881 million, an increase of 34%, driven by higher volumes of technology and service offerings to support biopharma customers and the recovery of prescription volumes.
First-quarter Segment Operating Profit was $104 million. Adjusted Segment Operating Profit was $139 million, an increase of 62%, driven by organic growth from access and adherence solutions and the recovery of prescription volumes.
Medical-Surgical Solutions Segment

First-quarter revenues were $2.5 billion, an increase of 40%, driven by improvements in primary care patient visits and increased sales of COVID-19 tests.
First-quarter Segment Operating Profit was $75 million and included $164 million of pre-tax inventory charges on certain PPE and related products. During the first quarter of fiscal 2022, McKesson committed to donate certain PPE to charitable organizations to assist in COVID-19 recovery efforts. First-quarter Adjusted Segment Operating Profit excluded $155 million of these charges for inventory which the company no longer intends to sell and will instead direct to charitable organizations.
Adjusted Segment Operating Profit was $257 million, an increase of 107%, driven by improvements in primary care patient visits and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
International Segment

First-quarter revenues were $9.2 billion. On an FX-Adjusted basis, revenues were $8.3 billion, a decline of 3%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance which was completed during the third quarter of fiscal 2021, partially offset by volume recovery in the pharmaceutical distribution and retail pharmacy businesses.
First-quarter Segment Operating Profit was $53 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $151 million, an increase of 107%, driven by volume recovery in the pharmaceutical distribution and retail pharmacy businesses and distribution of COVID-19 tests and vaccines.
Company Updates

On July 21, 2021, McKesson announced that it negotiated a comprehensive proposed settlement agreement which, if all conditions are satisfied, would result in the settlement of a substantial majority of opioid lawsuits filed by state and local governmental entities.
McKesson’s Board of Directors declared an increase in the regular quarterly dividend to $0.47 per share of common stock, demonstrating McKesson’s commitment to returning cash to shareholders and confidence in its outlook.
For the sixth consecutive year, McKesson was named a "Best Place to Work for Disability Inclusion." McKesson earned a top-ranking score of 100 on the 2021 Disability Equality Index, a joint initiative of the American Association of People with Disabilities and Disabilities:IN.
Fiscal 2022 Outlook

McKesson raised fiscal 2022 Adjusted Earnings per diluted share guidance to $19.80 to $20.40 from the previous range of $18.85 to $19.45 to reflect strong first-quarter operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution and kitting programs. Fiscal 2022 Adjusted Earnings per diluted share guidance assumes $0.45 to $0.55 related to U.S. government COVID-19 vaccine distribution and does not assume any contribution from COVID-19 vaccines designated for pediatric patients or booster shots. Guidance also assumes $0.35 to $0.45 related to the kitting and distribution of ancillary supplies. Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

The company has scheduled a conference call for today, Wednesday, August 4th at 4:30 PM 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:

Morgan Stanley 19th Annual Healthcare Conference, September 13, 2021
Audio 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 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.