On February 3, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2021 and forecasts for the fiscal year ending December 31, 2022 (Press release, Chugai, FEB 3, 2022, View Source [SID1234607681]).

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"2021 marked a successful first year of Chugai’s growth strategy TOP I 2030. We achieved record-high revenues and profits for the fifth consecutive year, and strategies in each business area made steady progress. In terms of financial performance, mainstay products such as Hemlibra, Tecentriq, and a new product Enspryng drove revenue growth in addition to the contribution of four newly launched products, including antibody cocktail Ronapreve for COVID-19. In R&D, the first project in mid-size molecules, a top priority for Chugai, entered the clinical development phase, enhancing our substantial pipeline of approximately 70 projects in a variety of modalities. In 2022, revenues are forecasted to exceed one trillion yen for the first time. Also, we’re aiming to make a full-scale entry into the ophthalmology field with faricimab, for which a regulatory application was filed last year. Moreover, the construction of our new core research laboratory, Chugai Life Science Park Yokohama, will finally be completed in October. We will continue pursuing innovation in order to provide better value to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported financial results for 2021 (Core-basis) with revenues of ¥999.8 billion (+¥212.9 billion, +27.1%). Sales and royalties and other operating income both increased by less than 30%. Domestic sales were ¥518.9 billion (+¥109.8 billion, +26.8%), driven by strong sales of mainstay products such as Tecentriq and Kadcyla in the oncology field, and Hemlibra and Actemra in the primary field. Penetration of new products, Enspryng, Polivy and Evrysdi, and the supply of Ronapreve to the government also contributed as well as an increase in comprehensive genomic profiling tests including the blood-based FoundationOne Liquid CDx cancer genomic profile. Overseas sales were ¥283.9 billion (+¥59.7 billion, +26.6%). In addition to the foreign exchange impact of a depreciation of the yen compared to the previous year, significant growth of Hemlibra due to full-scale export at regular shipment price and the strong sales of Alecensa outweighed the significant decline in Actemra (which is owing to the previous year’s significant increase in sales for reasons including clinical trials for COVID-19 pneumonia). Royalties and other operating income increased by less than 30%, mainly due to a significant increase in Hemlibra’s royalty and profit-sharing income, despite a decrease in one-time income.
The cost to sales ratio improved by 1.2% points year-on-year to 41.8%, mainly due to changes in the product mix. Marketing and distribution, research and development, and general and administration expenses have increased, resulting in an overall increase of operating expenses by approximately 10%. Marketing and distribution expenses increased due to promotion of digital marketing. Research and development expenses increased due to progress of projects. General and administration expenses increased due to the enterprise tax and various expenses. As a result, Core operating profit totaled ¥434.1 billion (+¥126.2 billion, +41.0%).

Reflecting the favorable results and based on our dividend policy, Chugai plans to pay year-end dividends of ¥46 per share. As a result, the annual dividend will be ¥76 per share, and the Core dividend payout ratio is 42.9% on a five-year average basis (40.1% on a single fiscal year basis).

Regarding research and development, the Company made good progress in both early and late-stage development toward achieving the two goals stated in TOP I 2030 – "Double R&D output" and "Launch in-house global products every year." As for in-house projects, which will be the foundation for future growth, an anti-cancer agent LUNA18 entered the clinical development phase as the first mid-size molecule project, which Chugai has been focusing on as its third modality following antibodies and small molecule drugs. There was also progress in projects applying Chugai’s proprietary antibody engineering technologies. Global phase III clinical trials started for Enspryng in generalized myasthenia gravis (gMG) and crovalimab in atypical hemolytic uremic syndrome (aHUS). A new investigational anti-cancer agent SOF10 entered the clinical development phase. In addition, Chugai filed a regulatory application for its mainstay product Hemlibra, for an additional indication of acquired hemophilia A. As for in-licensed projects, Chugai submitted a regulatory application for faricimab for two indications (diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD)), aiming full-scale entry in the ophthalmology field. Chugai in-licensed a project with a new modality from Roche, an investigational gene therapy SRP-9001, which is under development for Duchenne muscular dystrophy (DMD) by Sarepta Therapeutics. Furthermore, regulatory applications were filed for line extensions of Polivy and Tecentriq, respectively, both in the oncology field.

In the efforts to develop treatments for COVID-19, Chugai’s anti-IL-6 receptor monoclonal antibody Actemra was authorized for emergency use in the United States and approved in Europe for severe COVID-19 in 2021. In Japan, the drug was approved for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention) in January 2022. As for Ronapreve, the antibody cocktail in-licensed from Roche, Chugai received special approval in July and additional approval for prophylaxis and subcutaneous injection in November 2021.

In 2022, the Company expects revenues and profits to mark a record high for the sixth consecutive year. Revenues, Core operating profit, and Core net income are expected to be ¥1,150.0 billion (+¥150.2 billion, +15.0%), ¥440.0 billion (+¥5.9 billion, +1.4%), and ¥312.5 billion (+¥1.0 billion, +0.3%), respectively. Sales are expected to increase both in Japan and overseas, totaling ¥1,031.5 billion (+¥228.7 billion, +28.5%). New products (such as Ronapreve, Enspryng, Polivy, and Evrysdi) and mainstay products including Hemlibra are expected to drive the growth of domestic sales despite impacts from biosimilars and generics as well as NHI drug price revisions. Overseas sales of Hemlibra are expected to increase by approximately 60% as exports at regular shipment price started in the previous year. Likewise, overseas sales of Actemra are expected to increase by approximately 40% due to increased demand for COVID-19. Royalties and other operating income are expected to decrease significantly to ¥118.5 billion (-¥78.4 billion, -39.8%) due to decreases in royalty related to the stock of initial shipment of Hemlibra and one-time income.

For the fiscal year 2022, Chugai expects the annual dividends per share of ¥76 with the Core dividend payout ratio of 41.9% on a five-year average basis (40.0% on a single fiscal year basis).

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On February 3, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Quest Diagnostics, FEB 3, 2022, View Source [SID1234607697]).

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"In another unprecedented year, Quest provided critical COVID-19 testing to our country and delivered record revenues, earnings and cash from operations for full year 2021," said Steve Rusckowski, Chairman, CEO and President. "At the same time, our base business revenues grew more than 19 percent year over year, achieving record levels.

"Quest is well positioned in 2022 to deliver on our commitments. Our guidance for 2022 reflects lower demand for COVID-19 testing services; growth in the base business; and the impact of the previously announced one-year delay of PAMA cuts; partially offset by investments to accelerate growth.

"I am proud of the incredible accomplishments of our 50,000 Quest employees throughout the pandemic. They have risen to the challenge of bringing COVID-19 testing to millions of patients – all the while innovating, persevering, and remaining committed to our vision of empowering better health. Our team is strong, the business has momentum, and Quest’s future is bright."

(a) Excludes COVID-19 testing.

(b) For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

(c) The sum of reported and adjusted diluted EPS for the four quarters of 2021 did not equal the total for the year ended December 31, 2021 due to both quarterly fluctuations in our earnings and in the weighted average common shares outstanding throughout the year as a result of the impact of accelerated share repurchase agreements ("ASR") that we entered into during April 2021.

Dividend Increased

Quest Diagnostics’ Board of Directors authorized a 6.5% increase in its quarterly dividend from $0.62 to $0.66 per share, or $2.64 per share annually, starting with the dividend payable on April 20, 2022 to shareholders of record of Quest Diagnostics common stock on April 6, 2022. This dividend increase is the company’s eleventh since 2011.

Guidance for Full Year 2022

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, a gain on remeasurement of an equity interest, costs associated with donations, contributions, and other financial support through Quest for Health Equity, our initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on sale of an ownership interest in a joint venture, gains associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on February 3, 2022 until midnight Eastern Time on February 17, 2022, by phone at 800-839-9317 for domestic callers and 203-369-3605 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On February 3, 2022 Kriya Therapeutics, Inc., a fully integrated company pioneering novel technologies and therapeutics in gene therapy, reported that it has appointed Ma’an Muhsin, M.D., as President and Chief Medical Officer of Kriya Oncology, the company’s oncology therapeutic area division (Press release, Kriya Therapeutics, FEB 3, 2022, View Source [SID1234607717]). Dr. Muhsin will lead overall strategic, development, and partnership activities to accelerate and expand Kriya’s portfolio of transformative gene therapies for cancers of high unmet need.

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"Ma’an brings a wealth of experience in the development of novel oncology therapies across a number of modalities," said Shankar Ramaswamy, M.D., Co-Founder and Chief Executive Officer of Kriya. "He is uniquely positioned to accelerate the expansion and clinical translation of our growing pipeline of gene therapies that can be combined with existing and emerging standards of care in oncology. We are keen to bring forward in vivo gene therapy as a new modality to treat cancer, and Ma’an is a leader with an exceptional track record that will help us achieve this goal."

Dr. Muhsin previously served as Chief Medical Officer at Medicenna Therapeutics where he designed and executed clinical trials of the company’s solid tumor programs. Prior to joining Medicenna, he served as Medical Lead, Oncology Clinical Development for Nektar Therapeutics where he oversaw the progression of the PIVOT-12 and REVEAL clinical studies for metastatic melanoma and advanced and local solid tumors, respectively. Dr. Muhsin has held roles of increasing responsibility at HUYA Bioscience International where he served as the Senior Vice President, Oncology Clinical Development, and at Halozyme Therapeutics where he served as Senior Medical Director, Oncology Clinical Development. He also worked in the U.S. Army Combat Support Hospitals (CSH) and held other positions within the Medical Brigade and the Medical Command under the United States Department of Defense (DoD). Dr. Muhsin completed his medical education at the Baghdad University School of Medicine and completed postgraduate education in oncology drug development at Tufts University Center for the Study of Drug Development (CSDD).

"I am excited to join Kriya and look forward to advancing its promising portfolio of gene therapies in oncology," said Dr. Muhsin. "While the management of cancer has come a long way in the last decade, I believe in the potential to further enhance the treatment of patients with the incorporation of rationally engineered gene therapies that can transform treatment paradigms for a wide array of cancers. I look forward to leveraging Kriya’s fully-integrated gene therapy engine to deliver a pipeline of novel medicines with the potential to significantly impact the lives of cancer patients."

On February 3, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2021 and forecasts for the fiscal year ending December 31, 2022 (Press release, Chugai, FEB 3, 2022, View Source [SID1234607681]).

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"2021 marked a successful first year of Chugai’s growth strategy TOP I 2030. We achieved record-high revenues and profits for the fifth consecutive year, and strategies in each business area made steady progress. In terms of financial performance, mainstay products such as Hemlibra, Tecentriq, and a new product Enspryng drove revenue growth in addition to the contribution of four newly launched products, including antibody cocktail Ronapreve for COVID-19. In R&D, the first project in mid-size molecules, a top priority for Chugai, entered the clinical development phase, enhancing our substantial pipeline of approximately 70 projects in a variety of modalities. In 2022, revenues are forecasted to exceed one trillion yen for the first time. Also, we’re aiming to make a full-scale entry into the ophthalmology field with faricimab, for which a regulatory application was filed last year. Moreover, the construction of our new core research laboratory, Chugai Life Science Park Yokohama, will finally be completed in October. We will continue pursuing innovation in order to provide better value to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported financial results for 2021 (Core-basis) with revenues of ¥999.8 billion (+¥212.9 billion, +27.1%). Sales and royalties and other operating income both increased by less than 30%. Domestic sales were ¥518.9 billion (+¥109.8 billion, +26.8%), driven by strong sales of mainstay products such as Tecentriq and Kadcyla in the oncology field, and Hemlibra and Actemra in the primary field. Penetration of new products, Enspryng, Polivy and Evrysdi, and the supply of Ronapreve to the government also contributed as well as an increase in comprehensive genomic profiling tests including the blood-based FoundationOne Liquid CDx cancer genomic profile. Overseas sales were ¥283.9 billion (+¥59.7 billion, +26.6%). In addition to the foreign exchange impact of a depreciation of the yen compared to the previous year, significant growth of Hemlibra due to full-scale export at regular shipment price and the strong sales of Alecensa outweighed the significant decline in Actemra (which is owing to the previous year’s significant increase in sales for reasons including clinical trials for COVID-19 pneumonia). Royalties and other operating income increased by less than 30%, mainly due to a significant increase in Hemlibra’s royalty and profit-sharing income, despite a decrease in one-time income.
The cost to sales ratio improved by 1.2% points year-on-year to 41.8%, mainly due to changes in the product mix. Marketing and distribution, research and development, and general and administration expenses have increased, resulting in an overall increase of operating expenses by approximately 10%. Marketing and distribution expenses increased due to promotion of digital marketing. Research and development expenses increased due to progress of projects. General and administration expenses increased due to the enterprise tax and various expenses. As a result, Core operating profit totaled ¥434.1 billion (+¥126.2 billion, +41.0%).

Reflecting the favorable results and based on our dividend policy, Chugai plans to pay year-end dividends of ¥46 per share. As a result, the annual dividend will be ¥76 per share, and the Core dividend payout ratio is 42.9% on a five-year average basis (40.1% on a single fiscal year basis).

Regarding research and development, the Company made good progress in both early and late-stage development toward achieving the two goals stated in TOP I 2030 – "Double R&D output" and "Launch in-house global products every year." As for in-house projects, which will be the foundation for future growth, an anti-cancer agent LUNA18 entered the clinical development phase as the first mid-size molecule project, which Chugai has been focusing on as its third modality following antibodies and small molecule drugs. There was also progress in projects applying Chugai’s proprietary antibody engineering technologies. Global phase III clinical trials started for Enspryng in generalized myasthenia gravis (gMG) and crovalimab in atypical hemolytic uremic syndrome (aHUS). A new investigational anti-cancer agent SOF10 entered the clinical development phase. In addition, Chugai filed a regulatory application for its mainstay product Hemlibra, for an additional indication of acquired hemophilia A. As for in-licensed projects, Chugai submitted a regulatory application for faricimab for two indications (diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD)), aiming full-scale entry in the ophthalmology field. Chugai in-licensed a project with a new modality from Roche, an investigational gene therapy SRP-9001, which is under development for Duchenne muscular dystrophy (DMD) by Sarepta Therapeutics. Furthermore, regulatory applications were filed for line extensions of Polivy and Tecentriq, respectively, both in the oncology field.

In the efforts to develop treatments for COVID-19, Chugai’s anti-IL-6 receptor monoclonal antibody Actemra was authorized for emergency use in the United States and approved in Europe for severe COVID-19 in 2021. In Japan, the drug was approved for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention) in January 2022. As for Ronapreve, the antibody cocktail in-licensed from Roche, Chugai received special approval in July and additional approval for prophylaxis and subcutaneous injection in November 2021.

In 2022, the Company expects revenues and profits to mark a record high for the sixth consecutive year. Revenues, Core operating profit, and Core net income are expected to be ¥1,150.0 billion (+¥150.2 billion, +15.0%), ¥440.0 billion (+¥5.9 billion, +1.4%), and ¥312.5 billion (+¥1.0 billion, +0.3%), respectively. Sales are expected to increase both in Japan and overseas, totaling ¥1,031.5 billion (+¥228.7 billion, +28.5%). New products (such as Ronapreve, Enspryng, Polivy, and Evrysdi) and mainstay products including Hemlibra are expected to drive the growth of domestic sales despite impacts from biosimilars and generics as well as NHI drug price revisions. Overseas sales of Hemlibra are expected to increase by approximately 60% as exports at regular shipment price started in the previous year. Likewise, overseas sales of Actemra are expected to increase by approximately 40% due to increased demand for COVID-19. Royalties and other operating income are expected to decrease significantly to ¥118.5 billion (-¥78.4 billion, -39.8%) due to decreases in royalty related to the stock of initial shipment of Hemlibra and one-time income.

For the fiscal year 2022, Chugai expects the annual dividends per share of ¥76 with the Core dividend payout ratio of 41.9% on a five-year average basis (40.0% on a single fiscal year basis).

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results, and are consistent with the Core concept disclosed by Roche. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On February 3, 2022 Cardinal Health (NYSE: CAH) reported second quarter fiscal year 2022 revenues of $45.5 billion, an increase of 9% from the second quarter of last year. Second quarter GAAP operating loss was $950 million due to a non-cash, pre-tax goodwill impairment of $1.3 billion related to the Medical segment (Press release, Cardinal Health, FEB 3, 2022, View Source [SID1234607698]). GAAP diluted earnings per share (EPS) were $0.17, primarily due to this impairment, net of tax effects. Second quarter non-GAAP operating earnings decreased 26% to $467 million and non-GAAP diluted earnings per share (EPS) decreased 27% to $1.27, primarily due to inflationary impacts and global supply chain constraints in the Medical segment.

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Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. (PRNewsfoto/Cardinal Health)

"Consistent with our January update, we continue to experience significant inflationary impacts and global supply chain constraints in our US Medical Products and Distribution business. We’re taking action to drive performance in the Medical segment, including evolving our commercial contracting strategies and driving mix, simplifying our operating model, and investing in our growth businesses," said Mike Kaufmann, chief executive officer of Cardinal Health. "Our second quarter results demonstrate continued performance in other areas, including: growth in the Pharma segment, progress towards our $750 million enterprise cost savings target, strong cash flow generation, and efficient capital deployment."

Second-quarter revenue for the Pharmaceutical segment increased 11% to $41.4 billion, driven primarily by branded pharmaceutical sales growth from large Pharmaceutical Distribution and Specialty customers.

Pharmaceutical segment profit increased 3% to $426 million in the second quarter driven by generics program performance. This was partially offset by investments in technology enhancements and higher operations expenses.

Second-quarter revenue for the Medical segment decreased 5% to $4.1 billion, primarily due to the divestiture of the Cordis business.

Medical segment profit decreased 79% to $50 million in the second quarter, primarily due to inflationary impacts and global supply chain constraints in products and distribution. This also reflects the timing of selling higher cost PPE, including the net positive impact in the prior year, and to a lesser extent, the divestiture of the Cordis business.

Fiscal year 2022 outlook1
The company updated its fiscal year 2022 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.15 to $5.50, from $5.60 to $5.90.

This guidance reflects the previously announced additional $150 million to $175 million impact from increased inflation and global supply chain constraints, and a lower-than-expected offset from pricing actions. Accordingly, the company announced updated Medical segment profit outlook of thirty to forty-five percent decline, from mid-single to low-double digit percentage decline.

Additionally, the company updated expectations for its fiscal year 2022 non-GAAP effective tax rate to 23% to 24.5%, from 23% to 25%, and its Interest and Other to $140 million to $160 million, from $150 million to $180 million.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health recently announced a partnership with Ember Technologies to deliver a cold chain solution that ensures product integrity and security throughout the supply chain, while significantly reducing shipping waste in the transport of temperature-sensitive medicines.
Cardinal Health participated as a strategic investor in a new round of funding for Medically Home, a technology company that enables health systems to safely care for their patients at home, across the care continuum, including hospital-level care.
For the 14th consecutive year, Cardinal Health was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100% on the HRC’s 2021 Corporate Equality Index (CEI).
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until February 3, 2023.