Novo Nordisk A/S – Share repurchase programme

On August 3, 2022 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, AUG 3, 2022, View Source [SID1234617338]). This programme is part of the overall share repurchase programme of up to DKK 24 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 3 May 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 4 May 2022 to 2 August 2022. The programme is now concluded.

Since the announcement 25 July 2022, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 17,647,425 B shares of DKK 0.20 as treasury shares, corresponding to 0.8% of the share capital. The total amount of A and B shares in the company is 2,280,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 24 billion during a 12-month period beginning 2 February 2022. As of 2 August 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 15,907,432 B shares at an average share price of DKK 767.05 per B share equal to a transaction value of DKK 12,201,768,861.

Corcept Therapeutics Announces Second Quarter Financial Results and Provides Corporate Update

On August 3, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended June 30, 2022 (Press release, Corcept Therapeutics, AUG 3, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-0 [SID1234617368]).

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Financial Results

Revenue of $103.4 million, compared to $91.6 million in second quarter 2021
Reiterated 2022 revenue guidance of $400 – $430 million
Diluted net income per common share of $0.24, compared to $0.21 in second quarter 2021
Cash and investments of $382.0 million, compared to $368.1 million at March 31, 2022
Corcept’s second quarter 2022 revenue was $103.4 million, compared to $91.6 million in the second quarter of 2021. Second quarter operating expenses were $72.0 million, compared to $59.6 million in the second quarter of 2021, due to increased clinical trial activity, expenses to support the expansion of our clinical development and commercial teams and legal fees. Net income was $27.4 million in the second quarter of 2022, compared to $26.5 million in the second quarter of 2021.

Cash and investments increased $13.9 million in the second quarter, to $382.0 million at June 30, 2022.

"Our revenue growth reflects the continued increase in our base of Korlym prescribers," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are reiterating our 2022 revenue guidance of $400 – $430 million."

Clinical Development

"Data generated by our clinical development programs have provided increasing evidence of cortisol modulation’s potential to treat many serious diseases," added Dr. Belanoff. "Positive results from our Phase 2 trial of selective cortisol modulator relacorilant in women with platinum-resistant ovarian cancer led to the recent initiation of our Phase 3 ROSELLA trial. Later this year, we expect important data from our programs in antipsychotic-induced weight gain and non-alcoholic steatohepatitis."

Solid Tumors

ROSELLA initiated – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus
pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer to begin in collaboration with the University of Chicago
"Opening our ROSELLA study is an important step forward," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "The 40,000 women in the United States and Europe with platinum-resistant ovarian cancer have few good treatment options. Our Phase 2 study demonstrated improvements in progression-free survival, duration of response and overall survival without increased side effect burden. Simply replicating these positive results in ROSELLA would be of unprecedented benefit to women with platinum-resistant ovarian cancer, for whom relacorilant plus nab-paclitaxel has the potential to become a new standard."

"We are also pleased to collaborate with investigators at the University of Chicago in initiating a placebo-controlled, Phase 2 trial of relacorilant, combined with enzalutamide, in patients with prostate cancer, pre-prostatectomy," said Dr. Guyer. "There is a large patient population at this stage of disease and we hope to be able to offer them substantial benefit."

Metabolic Diseases

Enrollment completed in GRATITUDE and GRATITUDE II – two double-blind, placebo-controlled Phase 2 trials of miricorilant to reverse recent and long-standing antipsychotic-induced weight gain (AIWG); data from both trials expected in fourth quarter 2022
Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients
with presumed non-alcoholic steatohepatitis (NASH); data expected in fourth quarter 2022
"Weight gain and other adverse metabolic effects caused by antipsychotic medications reduce the life expectancy of millions of patients. These side effects also dissuade many patients from adhering to their treatment regimen," said Dr. Guyer. "We expect our double-blind, placebo-controlled GRATITUDE and GRATITUDE II trials to build on the positive data from our Phase 1 studies in healthy volunteers."

Cushing’s Syndrome

Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome; new drug application (NDA) submission expected
in second half 2023
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients
with Cushing’s syndrome caused by adrenal adenomas
"We advanced relacorilant to Phase 3 in Cushing’s syndrome based on its extremely promising Phase 2 efficacy and safety data. We expect our GRACE trial to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the second half of 2023," said Dr. Guyer. "The Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that has not been subject to rigorous, controlled study, but affects many patients."

Amyotrophic Lateral Sclerosis (ALS)

DAZALS, a 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS, planned to start this quarter
"ALS, commonly known as Lou Gehrig’s disease, is a devastating illness with a significant need for better treatment," said Dr. Guyer. "Dazucorilant, a selective cortisol modulator that crosses the blood-brain barrier, showed outstanding promise in animal models of ALS. We plan to initiate a large, controlled Phase 2 trial, which we have named DAZALS, this quarter, at sites in Europe and the United States."

Conference Call

We will hold a conference call on August 3, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number, and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

Morphic Announces Corporate Highlights and Financial Results for the Second Quarter 2022

On August 3, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the second quarter of 2022 (Press release, Morphic Therapeutic, AUG 3, 2022, View Source [SID1234617384]).

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Second Quarter 2022 and Recent Corporate Highlights

Continued enrollment of EMERALD-1 (MORF-057-201) phase 2a study
EMERALD-1, an open-label multi-center study of MORF-057 enrolling up to 35 patients with moderate to severe ulcerative colitis (UC), who will receive 100 mg BID (twice daily), continues to progress as planned
EMERALD-2 (MORF-057-202), a global phase 2b double-blind randomized placebo-controlled trial of MORF-057, is now expected to begin in the fourth quarter of 2022 and top line results are expected in the first half of 2025
Announced several key leadership appointments and promotions
Appointed Joanne Gibbons as Senior Vice President of Regulatory Affairs
Ms. Gibbons has nearly 25 years of experience in Regulatory Affairs and Clinical Development, both in the development of novel drugs and the expansion of marketed products
Named Dr. Bruce Rogers as President of Morphic Therapeutic
Dr. Rogers previously served as Morphic’s Chief Scientific Officer from 2016
Dr. Rogers has over 25 years of biopharmaceutical experience, including 18 years of experience in roles of increasing responsibility at Pfizer
Named Dr. Blaise Lippa as Chief Scientific Officer of Morphic
Dr. Lippa previously served as Morphic’s Senior Vice President of Molecular Discovery and was part of the founding team at Morphic
Dr. Lippa has over 20 years of experience in the biopharmaceutical industry, including time at Pfizer and Cubist, prior to its acquisition by Merck
Advanced the Company’s research and development collaboration with Janssen, focused on an antibody activator of a high potential integrin target
Concluded the Company’s research and development collaboration efforts with AbbVie
Morphic successfully delivered on the terms of the AVB6 collaboration and Morphic and AbbVie are in the process of drafting a joint publication for the AVB6 program
"Morphic is confidently climbing through a vital period in our development as the EMERALD clinical trials of MORF-057 in UC move forward flat out," commented Praveen Tipirneni, MD, Chief Executive Officer of Morphic Therapeutic. "The EMERALD-1 phase 2a study is progressing according to plan and our esprit de corps continues to strengthen through several senior appointments. Most notably, we announced the promotion of two key longstanding and high performing executives, Bruce Rogers and Blaise Lippa, and the addition of our new SVP of Regulatory Affairs, Joanne Gibbons. With the additional capital raised in the second quarter and refined operating plans, we have bolstered our financial position and extended our cash-runway into 2025, well after the primary endpoint readout of the EMERALD-2 phase 2b study."

Financial Results for the Second Quarter 2022

Net income for the quarter ended June 30, 2022 was $26.8 million or $0.68 per share compared to a net loss of $27.8 million or $0.77 per share for the same quarter last year
Revenue was $60.2 million for the quarter ended June 30, 2022, compared to $3.8 million for the same quarter last year. The increase was primarily due to the forthcoming conclusion of the collaboration with AbbVie which resulted in $57.7 million recognition of collaboration revenue in the quarter ended June 30, 2022
Research and development expenses were $25.7 million for the quarter ended June 30, 2022, as compared to $24.6 million for the same quarter last year. The increase was primarily attributable to higher clinical and development costs along with higher pre-clinical and phase 2 clinical trial costs to support our lead product candidate MORF-057
General and administrative expenses were $8.2 million for the quarter ended June 30, 2022, compared to $7.1 million for the same quarter last year. The increase was due to increased non-cash stock-based compensation expense and higher payroll costs
As of June 30, 2022, Morphic had cash, cash equivalents and marketable securities of $397.6 million, compared to $380.7 million as of March 31, 2022. We have updated our current operating plan with the receipt of $39.2 million in net proceeds raised under our ATM; the focusing and reduction in the scope of our partnered programs; a proactive pipeline prioritization and the implementation of increased operational efficiencies. Morphic believes its cash, cash equivalents and marketable securities as of June 30, 2022, will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2025.

MorphoSys AG Reports Second Quarter and First Half 2022 Financial Results

On August 3, 2022 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that results for the second quarter and first half year of 2022 (Press release, MorphoSys, AUG 3, 2022, View Source [SID1234617421]).

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"In the second quarter of 2022 we made important progress in advancing patient enrollment across our pivotal phase 3 studies and commercializing Monjuvi, where we observed a bounce back in sales following a challenging first quarter", said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "Despite the reduced guidance update, we anticipate Monjuvi growth to continue into the second half of the year and beyond. We remain well capitalized to get through important clinical milestones, potentially bringing new effective blood cancer medicines to patients and generating significant value for our shareholders."

Tafasitamab Highlights:

Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 23.3 million (€ 21.7 million) for the second quarter 2022 (Q2 2021: US$ 18.0 million (€ 14.9 million)) and US$ 41.9 million (€ 38.3 million) for the first half of 2022.

Minjuvi royalty revenue of € 0.7 million for sales outside of the U.S. in the second quarter 2022 and € 1.4 million for the first half of 2022.

Pfizer, Incyte and MorphoSys signed a clinical trial collaboration and supply agreement on June 13, 2022, to investigate the immunotherapeutic combination of Pfizer’s TTI-622, a novel SIRPα-Fc fusion protein, and Monjuvi plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).

Other highlights:

Pelabresib data presented at EHA (Free EHA Whitepaper) Congress 2022: Efficacy and safety data from the ongoing phase 2 MANIFEST trial of pelabresib in myelofibrosis and translational research findings suggesting the potential disease-modifying effect of pelabresib in patients with myelofibrosis were presented in oral presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 (EHA 2022) Hybrid Congress.

Agreement with HIBio on felzartamab and MOR210: Human Immunology Biosciences, Inc. (HIBio) signed an equity participation agreement and license agreements with MorphoSys to allow HIBio to develop and commercialize MorphoSys’ felzartamab, an anti-CD38 antibody, and MOR210, an anti-C5aR1 antibody across all indications worldwide, with the exception of Greater China for felzartamab and Greater China and South Korea for MOR210. As part of the agreements, MorphoSys will receive a 15% equity stake in HIBio, along with certain equity earn-in provisions and standard investment rights. On achievement of development, regulatory and commercial milestones, MorphoSys will be eligible to receive payments from HIBio of up to US$ 1 billion across both programs, in addition to tiered, single- to low double-digit royalties on net sales of felzartamab and MOR210. Upon signing, MorphoSys also received an upfront payment of US$ 15 million for MOR210. HIBio has full responsibility for future development and commercialization of felzartamab and MorphoSys will transfer the development candidate and the clinical studies over to HIBio in the next months. MorphoSys will be compensated for ongoing program expenses for felzartamab during this program transition period by HIBio.

Significant Events After the End of the Second Quarter of 2022:

On July 26, 2022, MorphoSys notified Royalty Pharma that it intends to draw US$ 300.0 million (€ 296.3 million) of the development funding bond. The proceeds are anticipated to be delivered to MorphoSys in September 2022 and will be used primarily to fund development activities.

Financial Results for the Second Quarter of 2022 (IFRS):

Revenues for the second quarter 2022 were € 59.4 million compared to € 38.2 million for the same period in 2021. The year-over-year growth in Monjuvi product sales was driven by higher demand.

Cost of Sales: In the second quarter 2022, cost of sales were € 17.2 million compared to € 10.1 million for the comparable period in 2021.

Research and Development (R&D) Expenses: In the second quarter 2022, R&D expenses were € 60.9 million compared to € 40.5 million in the second quarter 2021. The increase in R&D expenses is primarily due to the first-time inclusion of Research and Development expenses from Constellation from July 2021 on and higher investment to support the advancement of clinical programs.

Selling, General and Administrative (SG&A) Expenses: Selling expenses in the second quarter 2022 were € 24.0 million compared to € 28.5 million in the second quarter 2021. The decrease was driven by higher investments in 2021 made into the commercial organization, the first full year after the Monjuvi launch. General and administrative (G&A) expenses in the second quarter 2022 amounted to € 12.4 million compared to € 30.5 million in the second quarter 2021. The decrease was driven by the transaction costs for the Constellation acquisition and Royalty Pharma agreements executed in the second quarter 2021.

Operating Loss: Operating loss amounted to € 55.1 million in the second quarter 2022 (Q2 2021: operating loss of € 71.4 million).

Consolidated Net Loss: For the second quarter 2022, consolidated net loss was € 235.0 million (Q2 2021: consolidated net profit of € 20.9 million).

Financial Results for the first six months 2022 (IFRS):

Revenues for the first six months of 2022 were € 100.9 million (H1 2021: € 85.4 million). Revenues include € 38.3 million from the recognition of Monjuvi product sales in the U.S. Royalties in H1 2022 included € 1.4 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 39.7 million from Tremfya sales which is fully passed onto Royalty Pharma.

Cost of Sales: For the first six months of 2022, cost of sales were € 25.1 million (H1 2021: € 15.2 million). The year-over-year increase was primarily driven by higher sales of Monjuvi in the U.S. and Minjuvi outside of the U.S.

R&D Expenses: In the first six months of 2022, R&D expenses were € 126.0 million compared to € 73.8 million for the same period in 2021. The R&D expenses increased due to inclusion of expenses from Constellation and higher investments to support the advancement of clinical programs.

SG&A Expenses: Selling expenses decreased in the first six months of 2022 to € 45.9 million compared to € 56.6 million for the same period in 2021. The year-over-year decrease was primarily driven by higher investments made in the commercial organization in 2021, the first full year after the Monjuvi launch. G&A expenses amounted to € 27.0 million in the first six months of 2022 compared to € 40.8 million for the same period in 2021. The year-over-year decrease was driven primarily by the transaction costs for the Constellation acquisition and Royalty Pharma agreements executed in the second quarter of 2021.

Operating Loss: Operating loss amounted to € 123.1 million in the first six months of 2022 (H1 2021: operating loss of € 101.0 million).

Consolidated Net Profit / Loss: For the first six months of 2022, consolidated net loss was € 357.6 million (H1 2021: consolidated net loss of € 20.7 million).

Cash and Other Financial Assets: As of June 30, 2022, the Company had cash and other financial assets of € 754.3 million compared to € 976.9 million on December 31, 2021. The Company anticipates proceeds of US$ 300.0 million in September 2022 from the development funding bond provided by Royalty Pharma.

Number of shares: The number of shares issued totaled 34,231,943 on June 30, 2022, remained unchanged since December 31, 2021.

Updated Full Year 2022 Financial Guidance:

The updated financial guidance was issued on July 26, 2022.

Amounts in million

Updated 2022
Financial Guidance

Previous* 2022
Financial Guidance

2022 Guidance Insights

Monjuvi U.S. Net Product Sales

US$ 90m to 110m

US$ 110m to 135m

100% of Monjuvi U.S. product sales are recorded on MorphoSys’ income
statement and related profit/loss is split 50/50 between MorphoSys and Incyte.

Gross Margin for Monjuvi U.S. Net Product Sales

75% to 80%

75% to 80%

100% of Monjuvi U.S. product cost of sales are recorded on MorphoSys’ income
statement and related profit/loss is split 50/50 between MorphoSys and Incyte.

R&D expenses

€ 275m to 300m

€ 300m to 325m

Reduction in guidance range driven primarily by license agreement for
felzartamab to HIBio executed on June 14, 2022.

SG&A expenses

€ 150m to 165m

€ 155m to 170m

53% to 58% of mid-point of SG&A expenses represent Monjuvi U.S. selling
costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses
MorphoSys for half of these selling expenses.

*The Previous 2022 Financial Guidance was initially provided on January 7 and reiterated on March 16 and on May 4, 2022.

Additional information related to 2022 Financial Guidance:

Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S. Guidance for these royalties is not being provided as MorphoSys does not receive any sales forecasts from its partner Incyte.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2022. Milestones for otilimab are passed on to Royalty Pharma. Milestones from all other programs remain with MorphoSys at 100%.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales.
While R&D expense is anticipated to grow year-over-year due to investments in three pivotal studies, the growth is partially being offset by the consolidation of research/discovery activities.
SG&A expense guidance range reflects savings from synergies following the acquisition of Constellation and streamlined commercialization efforts.
Operational Outlook for 2022:

MorphoSys anticipates the following key development milestones in 2022:

First proof-of-concept data from the ongoing clinical phase 2 study of CPI-0209 in solid tumors and blood cancer;
MorphoSys’ partner Roche expects a pivotal data readout of the GRADUATE 1 and GRADUATE 2 trials with gantenerumab in the second half of 2022. Roche initiated these phase 3 development programs for patients with Alzheimer’s disease in 2018;
MorphoSys’ partner GSK expects a pivotal data readout of the phase 3 ContRAst program investigating otilimab for rheumatoid arthritis by the end of 2022.

*Value as of December 31, 2021

MorphoSys will hold its conference call and webcast on August 4, 2022, to present the results of the second quarter and first half of 2022 and the outlook for 2022.

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at the Investors section under "Upcoming Events & Conferences" on MorphoSys’ website, View Source and after the call, a slide-synchronized audio replay of the conference will be available at the same location.

The statement for the second quarter/first half year of 2022 (IFRS) are available for download at: View Source

McKesson Corporation Reports Fiscal 2023 First-Quarter Results

On August 3, 2022 McKesson Corporation (NYSE:MCK) reported results for the first-quarter ended June 30, 2022 (Press release, McKesson, AUG 3, 2022, View Source [SID1234617444]).

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"McKesson had a solid start to fiscal 2023. Our results this quarter demonstrate the strength of our streamlined portfolio and successful execution as a diversified healthcare services company," said Brian Tyler, chief executive officer. "Our talented associates continue to deliver exceptional performance, and we remain confident that our strategy positions McKesson for long-term growth and value creation. As a result of our first-quarter operating performance and the continuation of COVID-19 response efforts, we are raising our guidance for fiscal 2023 Adjusted Earnings per Diluted Share to $23.95 to $24.65."

First-quarter revenues were $67.2 billion, an increase of 7% from a year ago, driven by growth in the U.S. Pharmaceutical segment, resulting from increased specialty product volumes, including retail national account customers, and market growth, partially offset by lower revenues in the International segment as a result of the planned progress with McKesson’s divestiture of its European businesses.

First-quarter earnings per diluted share from continuing operations was $5.25 compared to $3.09 a year ago, an increase of $2.16.

First-quarter Adjusted Earnings per Diluted Share was $5.83 compared to $5.56 a year ago, an increase of 5%, driven by growth across the North American businesses and a lower share count, partially offset by a higher tax rate and lower contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government. First-quarter Adjusted Earnings per Diluted Share also included pre-tax net losses of approximately $22 million associated with McKesson Ventures’ equity investments, compared to pre-tax net gains of approximately $7 million in the first-quarter of fiscal 2022.

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 $71 million of dividend payments. During the first three months of the fiscal year, McKesson used cash from operations of $941 million, and invested $100 million in capital expenditures, resulting in negative Free Cash Flow of $1.0 billion.

Capital Deployment Updates

McKesson maintains a disciplined approach to capital allocation, centered on delivering sustainable growth and long-term shareholder value. McKesson’s capital allocation framework consists of three pillars:

Prioritizing growth by investing internally and making acquisitions that support our strategic priorities.
Returning capital to shareholders through share repurchases and McKesson’s commitment to a growing dividend. Share repurchases are principally used to return cash to shareholders in absence of growth investment opportunities.
Maintaining a strong balance sheet, including strong Free Cash Flow generation, which provides ample liquidity and financial flexibility.
On July 22, 2022, McKesson’s Board of Directors declared a 15% increase to its quarterly dividend from $0.47 per share to $0.54 per share.

On July 22, 2022, McKesson’s Board of Directors authorized the company to repurchase up to an additional $4.0 billion of its common shares in a manner deemed in the best interest of the company and its stockholders, considering other growth opportunities and prevailing business and market conditions. Fiscal 2023 Adjusted Earnings per Diluted Share guidance continues to assume approximately $3.5 billion of share repurchases.

Business Highlights

Oncology: On June 23, 2022, McKesson announced an agreement to form a joint venture combining McKesson’s U.S. Oncology Research and HCA Healthcare’s Sarah Cannon Research Institute. Together, the joint venture will create a fully integrated oncology research organization aimed at expanding clinical research, accelerating drug development, and increasing availability and access to clinical trials for community oncology providers and patients, including those in underserved communities. The transaction is anticipated to close in 2022.
Europe: McKesson progressed in its planned exit of business operations within the European region and has completed divestitures or entered into agreements to sell 11 of the 12 countries.
After entering into an agreement in June 2022 to sell its Denmark business to Erhvervsinvest, McKesson closed the transaction on July 29, 2022.
After entering into an agreement in November 2021 to sell its UK business to AURELIUS, McKesson closed the transaction on April 6, 2022.
In July 2021, McKesson announced an agreement to sell certain McKesson Europe businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group. The transaction is expected to close in the second half of fiscal 2023.
Norway remains the only country that McKesson has not entered into an agreement to sell.
COVID-19: McKesson continues to play a leading role in the fight against COVID-19. McKesson renewed its partnership with the U.S. government to support the COVID-19 response efforts. The vaccine distribution contract has been extended through July 2023; and the kitting, storage, and distribution of ancillary supplies contract has been extended through January 2023.
U.S. Pharmaceutical Segment

First-quarter revenues were $56.9 billion, an increase of 14%, resulting from increased specialty product volumes, including retail national account customers, and market growth, partially offset by branded to generic conversions.
First-quarter Segment Operating Profit was $696 million. Adjusted Segment Operating Profit was $711 million, an increase of 4%, driven by growth in distribution of specialty products to providers and health systems, partially offset by lower demand of COVID-19 vaccine distribution. Excluding the impact of COVID-19 vaccine distribution, the U.S. Pharmaceutical segment delivered Adjusted Segment Operating Profit growth of 9%.
Prescription Technology Solutions Segment

First-quarter revenues were $1.1 billion, an increase of 21%, driven by our biopharma services programs due to prescription volume growth, and third-party logistics and technology service revenues.
First-quarter Segment Operating Profit was $144 million. Adjusted Segment Operating Profit was $165 million, an increase of 19%, driven by growth from access, affordability, and adherence solutions.
Medical-Surgical Solutions Segment

First-quarter revenues were $2.6 billion, an increase of 3%, driven by growth in the primary care business, partially offset by lower sales of COVID-19 tests and lower contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
First-quarter Segment Operating Profit was $256 million. Adjusted Segment Operating Profit was $268 million, an increase of 4%, driven by organic business performance as well as growth and improvements in the primary care business.
International Segment

First-quarter revenues were $6.5 billion. On an FX-Adjusted basis, revenues were $7.1 billion, a decrease of 23%, driven by the divestitures of McKesson’s UK and Austrian businesses.
First-quarter Segment Operating Loss was $6 million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $152 million, a decrease of 11%, driven by the divestitures of McKesson’s Austrian and UK businesses, partially offset by the reduction of depreciation and amortization on European assets under agreements to sell.
Opioid-Related Litigation

McKesson has settled, or reached agreements to settle, the opioid-related claims of all 50 states, as well as the District of Columbia and all eligible territories.
On May 3, 2022, McKesson reached an agreement in principle with the State of Washington.
On June 27, 2022, McKesson reached an agreement in principle with the State of Oklahoma.
On July 4, 2022, after a full trial, a federal judge ruled that McKesson along with two other distributors could not be held liable to two West Virginia subdivisions for contributing to the opioid crisis.
Corporate Responsibility Updates

McKesson was recognized by Forbes as one of the "Best Employers for Women," achieving an industry-leading ranking and demonstrating its outstanding progress in promoting gender equity and diversity in the workplace.
For the seventh consecutive year, McKesson was named a "Best Place to Work for Disability Inclusion." McKesson earned a top-ranking score of 100 on the 2022 Disability Equality Index, a joint initiative of the American Association of People with Disabilities and Disability:IN.
Fiscal 2023 Outlook

McKesson raised fiscal 2023 Adjusted Earnings per Diluted Share guidance to $23.95 to $24.65 from the previous range of $22.90 to $23.60 to reflect first-quarter operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs and COVID-19 tests.

Fiscal 2023 Adjusted Earnings per Diluted Share guidance includes approximately $0.99 to $1.29 of impacts attributable to the following:

Fiscal 2023 Adjusted Earnings per Diluted Share guidance, excluding the impacts of the above items from both fiscal 2023 guidance and fiscal 2022 results, indicates 10% to 15% forecasted growth compared to prior year.

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

Conference Call Details

McKesson has scheduled a conference call for today, Wednesday, August 3rd at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

Upcoming Investor Events

McKesson management will be participating in the following investor conference:

Morgan Stanley Healthcare Conference, September 13, 2022
Audio webcast, and a complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted 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.