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IGM Biosciences Announces First Quarter 2021 Financial Results and Provides Corporate Update

On May 6, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the first quarter ended March 31, 2021 and provided an update on recent developments (Press release, IGM Biosciences, MAY 6, 2021, View Source [SID1234579357]).

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Pipeline Updates

IGM-2323

Recommended Phase 2 dose expected in 2021. IGM continues to advance the clinical development of IGM-2323, the Company’s IgM-based CD20 x CD3 bispecific antibody, for the treatment of non-Hodgkin’s lymphoma (NHL) and potentially other CD20-expressing hematologic malignancies, including chronic lymphocytic leukemia (CLL). IGM has cleared the titration dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs in the ongoing Phase 1 clinical trial of IGM-2323, and is currently enrolling patients in what is expected to be its top titration dose cohort, 50/1000 mgs. IGM is also currently enrolling patients in the expansion dose cohorts of 50/100 mgs, 50/300 mgs and 50/600 mgs. IGM expects to complete enrollment in the dose escalation portion of the Phase 1 clinical trial and select a recommended Phase 2 dose in 2021.
IGM-8444

Phase 1 data expected in the second half of 2021. IGM also continues to advance the clinical development of IGM-8444, the Company’s IgM Death Receptor 5 (DR5) agonist, for the treatment of a potentially broad range of solid tumors and hematologic malignancies. IGM has cleared its second dose escalation dose cohort, 1 mg/kg, in the ongoing Phase 1 trial, and is currently dosing patients in its third dose escalation cohort, 3 mg/kg, with every two week dosing. IGM has also begun dosing patients in its first combination with FOLFIRI dose cohort and its first weekly dosing cohort. IGM expects to report initial data from the dose escalation portion of the Phase 1 trial in the second half of 2021.
Clinical testing of birinapant in combination with IGM-8444 expected to begin this year. As previously announced, during the first quarter of 2021, IGM entered into an exclusive license agreement with Medivir AB, by which IGM received global, exclusive development and commercialization rights for birinapant. IGM remains on track to begin clinical testing of birinapant in combination with IGM-8444 this year.
IGM-7354

Investigational New Drug (IND) application expected to be filed this year. IGM also plans to file an IND application with the U.S. Food and Drug Administration (FDA) for IGM-7354, the Company’s IL‑15 x PD‑L1 bispecific IgM antibody, before the end of 2021 in order to begin clinical testing initially in solid tumors, followed by hematologic malignancies.
Corporate Updates

George Gauthier appointed to the newly created position of Chief Commercial Officer. Gauthier brings twenty years of experience in global commercial strategy, marketing and product development. Most recently, Mr. Gauthier was Vice President of Global Product Strategy for Breast and Gynecological Cancers at Genentech, where he led a global team in the creation and execution of commercial and product development strategies.
First Quarter 2021 Financial Results

Cash and Investments: Cash and investments as of March 31, 2021 were $331.7 million, compared to $366.3 million as of December 31, 2020.
Research and Development (R&D) Expenses: For the first quarter of 2021, R&D expenses were $23.6 million, compared to $14.6 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the first quarter of 2021, G&A expenses were $8.1 million, compared to $4.0 million for the same period in 2020.
Net Loss: For the first quarter of 2021, net loss was $31.6 million, or a loss of $0.95 per share, compared to a net loss of $17.6 million, or a loss of $0.58 per share, for the same period in 2020.
2021 Financial Guidance

IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses to be between $175 million and $185 million including estimated non-cash stock-based compensation expense of approximately $25 million. IGM expects to end 2021 with a balance of over $200 million in cash and investments.

Codiak BioSciences Reports First Quarter 2021 Financial Results and Operational Progress

On May 6, 2021 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported first quarter 2021 financial results and operational progress (Press release, Codiak Biosciences, MAY 6, 2021, View Source [SID1234579356]).

"We are making excellent progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx exosome engineering and manufacturing platform can harness exosomes as delivery vehicles for potent and selective therapeutics, not only in immuno-oncology, but potentially in vaccines, gene therapy and neuro-oncology/neurology as well," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "We remain on track to deliver safety, biomarker and preliminary efficacy data from our exoIL-12 and exoSTING clinical programs in oncology and file an IND for our third program, exoASO-STAT6, later this year."

First Quarter 2021 and Recent Highlights

Reported positive Phase 1 results for exoIL-12 confirming local pharmacology and dose selection for safety and efficacy trial in patients with early-stage cutaneous T cell lymphoma (CTCL)
Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors
Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies
Detailed versatility of Codiak’s engEx Platform in manuscript published in Molecular Therapeutics, a Cell partner journal
Presented pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and preclinical data from the exoASO-STAT6 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 10-15
Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication
Anticipated Milestones and Events

Four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting on May 11, including new preclinical data on exoAAV, exoVACC, exoASO-STAT6, and the ability of engineered exosomes to direct tropism to neuronal cells of interest
Safety, biomarker and preliminary pharmacodynamics and efficacy data from the exoSTING Phase 1/2 clinical trial in patients with solid tumors continue to be expected mid-2021, within the third quarter
Investigational New Drug (IND) application filing for exoASO-STAT6 anticipated during the second half of 2021 to enable initiation of clinical trials
Safety, biomarker and preliminary pharmacodynamics and efficacy data in CTCL patients from the exoIL-12 Phase 1 trial expected by year-end 2021
First Quarter 2021 Financial Results

Total revenues for the quarter ended March 31, 2021 were $13.2 million, compared to $0.1 million for the same period in 2020. This increase was primarily due to the mutual agreement between the Company and Jazz Pharmaceuticals to discontinue their work on exoASO-STAT3, one of five oncogene targets subject to the Collaboration and License Agreement by and between Codiak and Jazz Pharmaceuticals. The Company recognized the remaining $10.9 million in deferred revenue allocated to this target as revenue during the three months ended March 31, 2021.

Net loss for the quarter ended March 31, 2021 was $10.3 million, compared to a net loss of $22.5 million for the same period in 2020. Net loss for the quarter was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform, offset in part by the $10.9 million in deferred revenue described above.

Research and development expenses were $16.6 million for the quarter ended March 31, 2021 compared to $18.4 million for the same period in 2020. The decrease in research and development expenses was driven primarily by lower manufacturing and preclinical costs as our lead assets progressed into the clinic during the second half of 2020.

General and administrative expenses were $6.6 million for the quarter ended March 31, 2021 compared to $4.2 million for the same period in 2020. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

As of March 31, 2021, Codiak had cash, cash equivalents, and marketable securities of approximately $130.3 million.

Corcept Therapeutics Provides Clinical Update and Announces First Quarter 2021 Financial Results

On May 6, 2021 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended March 31, 2021 (Press release, Corcept Therapeutics, MAY 6, 2021, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-provides-clinical-update-and-announces [SID1234579355]).

First quarter 2021 revenue was $79.4 million, compared to $93.2 million in the first quarter of 2020. The decrease in revenue in the first quarter was primarily due to the effects of the COVID-19 pandemic on our business.

First quarter operating expenses were $59.8 million, compared to $55.5 million in the first quarter of 2020, due to increased spending on clinical trials in Cushing’s syndrome and metabolic diseases and the formulation and manufacture of the company’s proprietary selective cortisol modulators.

First quarter 2021 GAAP net income was $23.5 million, compared to $30.1 million in the first quarter of 2020. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the first quarter was $25.8 million, compared to $41.2 million in the first quarter of 2020. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments were $454.8 million at March 31, 2021, compared to $476.9 million at December 31, 2020. The company repurchased 2.1 million shares of its common stock in the first quarter – 1.3 million shares for $33.5 million pursuant to the company’s stock repurchase program and 0.8 million shares for $16.4 million in connection with the net exercise of stock options – at a total cost of $50.0 million. Under the stock repurchase program’s currently authorized terms, $156.8 million remains available for the purchase of shares.

Corcept modified its 2021 revenue guidance to $355 – $385 million. Corcept anticipates positive cash flow for the foreseeable future.

"The lingering effects of the spike in COVID-19 in the fourth quarter of last year extended further into the first quarter than we anticipated, coloring our commercial results," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "Many physicians are still not able to see their patients often enough to optimally diagnose and treat a complex disease such as Cushing’s syndrome. Further, many patients introduced to Korlym during the pandemic have so far not reached their ideal dose, as many physicians are seeing their patients less frequently, particularly in person, and testing them less frequently, slowing optimal titration.

"We expect these effects to diminish as COVID restrictions and fears diminish. The best treatment for Cushing’s syndrome involves substantial and frequent engagement between patients and physicians," said Dr. Belanoff. "Our modified 2021 revenue guidance assumes that pandemic-related obstacles will ease substantially in the third quarter – about two quarters later than we had originally thought. Leading physicians increasingly believe that the number of patients with hypercortisolism is substantially greater than once assumed. Korlym is an excellent treatment for hypercortisolism. Relacorilant, if approved, will be even better. We expect significant revenue growth and profits in the years ahead."

Clinical Development Highlights

"Despite having to contend with pandemic-related headwinds," said Dr. Belanoff, "our clinical development efforts, particularly in the United States, gained momentum in the first quarter. Today we announced positive data related to two of our proprietary, selective cortisol modulators as possible treatments for platinum-resistant ovarian cancer and NASH. These are important advances for the potential treatment of these diseases, which have a high unmet need. In addition, we are encouraged that these results provide further clinical validation of our cortisol modulation platform as a treatment for a broad range of diseases. In contrast to the past when sometimes a year would pass between releases of clinical results, we now expect important information to emerge every quarter."

Solid Tumors

In a 178-patient, controlled, Phase 2 trial, women with platinum-resistant ovarian cancer who received relacorilant plus nab-paclitaxel experienced improved progression free survival (PFS) compared to women who received nab-paclitaxel alone, with comparable safety and tolerability *
Planning underway for a Phase 3 pivotal trial in ovarian cancer
Preliminary results in the first 40 patients enrolled in open-label Phase 3 RELIANT trial of relacorilant
plus nab-paclitaxel in patients with metastatic pancreatic cancer expected this quarter
Selection of the optimum dose of exicorilant plus enzalutamide in patients with castration-resistant prostate cancer ("CRPC") expected by third quarter 2021
Enrollment continues in a 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"We are extremely pleased with the results of our trial of relacorilant as a possible treatment for platinum-resistant ovarian cancer," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Delaying disease progression in these women, without causing additional side effects, is heartening. We are planning a Phase 3 pivotal trial which we hope will replicate these positive data."

Participants in the trial were randomized 1:1:1 to receive either (i) nab-paclitaxel plus a daily dose of relacorilant (100 mg), (ii) nab-paclitaxel plus relacorilant (150mg) given "intermittently" (i.e., the day before, the day after, and the day of each weekly nab-paclitaxel infusion) or (iii) nab-paclitaxel alone.

Women who received the higher dose of relacorilant intermittently exhibited a statistically significant improvement in median progression free survival compared to those who received nab-paclitaxel alone (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: 0.038). Women who received the lower, daily, dose of relacorilant experienced longer progression free survival, but the improvement did not reach statistical significance (5.3 months versus 3.8 months, hazard ratio: 0.83). Full results of the trial, including overall survival, will be available later this year.

"Our trials in other solid tumors continue to progress," added Dr. Grauer. "We expect to have interim data from our RELIANT trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer at the end of this quarter. Our trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess continues to enroll patients. And by the end of the third quarter, we expect to select an optimal dose of our selective cortisol modulator exicorilant combined with enzalutamide in patients with castration-resistant prostate cancer."

Metabolic Diseases

In Phase 2 trial, patients with presumed NASH administered miricorilant experienced large, rapid reductions in liver fat *
Enrollment continues in GRATITUDE, a 100-patient double-blind, placebo-controlled, Phase 2 trial of miricorilant to reverse recent anti-psychotic-induced weight gain ("AIWG")
Enrollment continues in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing AIWG
"Four of the first five patients who received miricorilant for four weeks in our Phase 2 trial of patients with presumed NASH experienced sharply elevated levels of the liver enzymes ALT and AST, which resolved after miricorilant was withdrawn" said Dr. Grauer. "They also exhibited large reductions in liver fat (see Table 1).

Patient Miricorilant
(per day) Days
on Drug % Liver Fat
at Baseline % Liver Fat
at Follow up Days Between
Last Dose
and Follow-up Relative
Reduction in
% Liver Fat
Patient 1 900 mg 30 17.6 6.1 19 -65.3 %
Patient 2 900 mg 31 27.8 17.1 64 -38.5 %
Patient 3 900 mg 44 28.3 15.0 16 -47.0 %
Patient 4 600 mg 34 12.6 3.3 21 -73.8 %
Table 1: Reduction in liver fat content measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)
"The improvement in liver fat in these patients was greater and occurred much more rapidly than we had expected. We powered our trial with a planned enrollment of 120 patients to detect a 30 percent reduction in liver fat after twelve weeks’ dosing," said Dr. Grauer. "These results are especially notable given that they were measured many days after miricorilant was stopped. We are gathering more information, consulting with experts in liver disease and formulating our plans to advance miricorilant in NASH."

"In the meantime, our Phase 2 trials evaluating miricorilant as treatment for patients with AIWG – GRATITUDE and GRATITUDE II – continue to add patients," added Dr. Grauer. "We expect to complete enrollment in GRATITUDE II by year-end and GRATITUDE in mid-2022."

Cushing’s Syndrome

Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with any etiology of Cushing’s syndrome at sites in the United States, Canada, Europe and Israel; NDA submission expected by second quarter 2023

Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome of adrenal origin at sites in the United States, Europe and Israel
"Relacorilant’s Phase 2 efficacy and safety data were extremely promising. We expect GRACE to serve as the basis for our NDA in Cushing’s syndrome. GRACE is accruing patients and generating data and we have observed an improved enrollment rate at our sites in the United States over the last few months. While the pandemic continues to suppress enrollment in GRACE and GRADIENT, particularly in Europe, where the pace of recovery from COVID has lagged, we remain on track for NDA submission by the second quarter of 2023," said Dr. Grauer. "GRADIENT will produce valuable data about the role of cortisol modulation in an etiology of Cushing’s syndrome that has not previously been subject to a rigorous, controlled study."

Conference Call

We will hold a conference call on May 6, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, Click this link (listen-only mode) or dial 1-888-204-4368 from the United States or 1-313-209-4906 internationally approximately 15 minutes before the start of the call. The passcode will be 8720277. A replay will be available on the Investors / Past Events tab of our website.

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 in the body and can be lethal if not treated effectively. Corcept holds patents covering the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism

McKESSON REPORTS FISCAL 2021 FOURTH-QUARTER AND FULL-YEAR RESULTS

On May 6, 2021 McKesson Corporation (NYSE:MCK) reported results for the fourth quarter and fiscal year ended March 31, 2021 (Press release, McKesson, MAY 6, 2021, View Source [SID1234579354]).

"Our notable performance in fiscal 2021 reflects the continued momentum in our businesses and is a testament to the leadership role McKesson plays in the healthcare supply chain. McKesson’s differentiated capabilities make us the partner of choice for our customers and government entities in their COVID-19 response efforts. I am proud of our employees and what we have accomplished together," said Brian Tyler, chief executive officer. "Despite the dynamic macro environment, the business demonstrated strong execution as we grew Adjusted Earnings per diluted share by 15%. These results allowed us to generate $3.9 billion of Free Cash Flow."

"As we enter fiscal 2022, our top priorities remain the safety of our employees, the success of our customers, and fulfilling our leadership responsibility as the centralized distributor of COVID-19 vaccines and ancillary supplies in the U.S.," Mr. Tyler continued. "We have positioned the business for long-term growth through strategic investments in the areas of oncology and biopharma services and successful transformation of our operating model. Our accomplishments in fiscal 2021 are the foundation for the future and we remain confident in our ability to create long-term value for our shareholders."

Fourth-quarter revenues were $59.1 billion, up 1% from a year ago, driven by market growth and higher volumes from retail national account customers in the U.S. Pharmaceutical segment, partially offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic. Full-year revenues were $238.2 billion, up 3% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to market growth and higher specialty volumes, partially offset by branded to generic conversions.

Fourth-quarter earnings per diluted share from continuing operations was $4.15 compared to $5.82 a year ago, a decrease of 29%. Full-year loss per diluted share from continuing operations of ($28.26) included a pre-tax $8.1 billion expense accrual related to the estimated liability for opioid-related claims. This charge was taken in the company’s third-quarter and is not included in full-year Adjusted Earnings per diluted share.

Fourth-quarter Adjusted Earnings per diluted share was $5.05 compared to $4.27 a year ago, an increase of 18%, primarily driven by the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government and a lower share count, partially offset by a higher tax rate and the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"). Fourth-quarter Adjusted Earnings per diluted share included pre-tax net gains of approximately $44 million, or $0.21 per diluted share, associated with McKesson Ventures’ equity investments.

Full-year Adjusted Earnings per diluted share was $17.21 compared to $14.95 a year ago, an increase of 15%, primarily driven by a lower share count and the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government, partially offset by the prior year contribution from the company’s now separated investment in Change Healthcare. Full-year Adjusted Earnings per diluted share included pre-tax net gains of approximately $133 million, or $0.60 per diluted share, associated with McKesson Ventures’ equity investments.

For the full year, McKesson returned $1.0 billion of cash to shareholders, which included $770 million of common stock repurchases and $276 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.5 billion, and invested $641 million in capital expenditures, resulting in Free Cash Flow of $3.9 billion.

Business Highlights

U.S. Pharmaceutical’s operational excellence and scaled distribution network was highlighted by the successful distribution of over 150 million COVID-19 vaccines through April 30, 2021.
McKesson continued to invest in Ontada, the company’s differentiated oncology technology and insights business and also joined MYLUNG, a collaborative real-world research consortium designed to advance precision medicine for non-small cell lung cancer patients.
Prescription Technology Solutions finished fiscal 2021 with positive momentum and Access for More Patients (AMP) contributed to profit growth in the fourth quarter.
Medical-Surgical Solutions played a central role in the COVID-19 response efforts, assembling and distributing the ancillary supply kits needed for COVID-19 vaccinations and distributing COVID-19 tests to healthcare provider customers.
Segment Financials

U.S. Pharmaceutical Segment

Fourth-Quarter:

Revenues were $47.0 billion, an increase of 3%, driven by market growth and higher volumes from retail national account customers, partially offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and branded to generic conversions.
Segment Operating Profit was $892 million. Adjusted Segment Operating Profit was $813 million, an increase of 7% from a year ago, driven by the contribution from COVID-19 vaccine distribution, offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and higher operating costs to support oncology growth initiatives.
Full-Year:

Revenues were $189.3 billion, an increase of 4%, driven by market growth and higher specialty volumes, partially offset by branded to generic conversions.
Segment Operating Profit was $2.8 billion. Adjusted Segment Operating Profit was $2.7 billion, an increase of 3% from a year ago, driven by growth in distribution of specialty products to providers and the contribution from COVID-19 vaccine distribution, offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and higher operating costs to support oncology growth initiatives.
Prescription Technology Solutions Segment

Fourth-Quarter:

Revenues were $789 million, an increase of 7%, driven by higher volumes of technology and service offerings to support biopharma customers.
Segment Operating Profit was $125 million. Adjusted Segment Operating Profit was $146 million, an increase of 11%, driven by organic growth from access and adherence solutions including the contribution from AMP.
Full-Year:

Revenues were $2.9 billion, an increase of 7%, driven by higher volumes of technology and service offerings to support biopharma customers.
Segment Operating Profit was $395 million. Adjusted Segment Operating Profit was $467 million, flat to prior year. Organic growth from access and adherence solutions was offset by higher operating costs to support biopharma services growth initiatives.
Medical-Surgical Solutions Segment

Fourth-Quarter:

Revenues were $2.7 billion, an increase of 23%, driven by demand for COVID-19 tests.
Segment Operating Profit was $171 million. Adjusted Segment Operating Profit was $192 million, an increase of 13%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by inventory charges on certain personal protective equipment (PPE) incurred to support customers through the extraordinary demand related to the COVID-19 pandemic.
Full-Year:

Revenues were $10.1 billion, an increase of 22%, driven by demand for COVID-19 tests and personal protective equipment in the Primary Care and Extended Care businesses.
Segment Operating Profit was $707 million. Adjusted Segment Operating Profit was $805 million, an increase of 19%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by inventory charges on certain PPE and related products.
International Segment

Fourth-Quarter:

Revenues were $8.6 billion. On an FX-adjusted basis, revenues were $7.9 billion, a decline of 18%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Segment Operating Profit was $76 million. On an FX-adjusted basis, Adjusted Segment Operating Profit was $126 million, a decline of 8%.
Full-Year:

Revenues were $36.0 billion. On an FX-adjusted basis, revenues were $34.9 billion, a decline of 9%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Segment Operating Loss was ($37) million, primarily driven by a GAAP-only pre-tax long-lived asset impairment charge of $115 million. On an FX-adjusted basis, Adjusted Segment Operating Profit was $466 million, an increase of 1%.
Company Updates

McKesson’s commitment to transform its operating model resulted in annual pre-tax cost savings in excess of $400 million, achieving the company’s three-year target of $400 million to $500 million by the end of Fiscal 2021.
Susan Shiff joined McKesson as president of Ontada, the company’s oncology technology and insights business within the U.S. Pharmaceutical segment.
As part of the company’s strategy and actions towards better health for people and the planet, McKesson committed to set science-based targets to reduce the company’s greenhouse gas emissions.
Fiscal 2022 Outlook

McKesson expects full-year fiscal 2022 Adjusted Earnings per diluted share of $18.85 to $19.45, which reflects Adjusted Operating Profit growth in all segments coupled with disciplined, efficient capital deployment, including approximately $2 billion of share repurchases. Fiscal 2022 Adjusted Earnings per diluted share guidance assumes $0.40 to $0.50 related to U.S. government COVID-19 vaccine distribution and $0.10 to $0.20 related to the kitting and distribution of ancillary supplies.

The fiscal 2022 outlook is based on the following key assumptions and expectations and is subject to risks and uncertainties such as those described in the Cautionary Statements below:

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

Other remaining businesses

Other reflects equity earnings and charges for retrospective periods for the company’s previous investment in Change Healthcare, which was separated from the company during the fourth quarter of fiscal 2020.

Conference Call Details

The company has scheduled a conference call for today, Thursday, May 6th 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:

BofA Securities Virtual 2021 Healthcare Conference, May 13, 2021
Goldman Sachs 42nd Annual Global Healthcare Conference, June 8, 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 Equity Income from Change Healthcare, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

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

Caladrius Biosciences Reports First Quarter 2021 Financial Results and Provides Business Update

On May 6, 2021 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, reported financial results for the three months ended March 31, 2021 (Press release, Caladrius Biosciences, MAY 6, 2021, View Source [SID1234579353]).

"We are at a truly exciting point in our evolution with tremendous opportunities ahead of us. While the pandemic has impacted many companies, during the first quarter of 2021 we were able to both markedly strengthen our financial position and advance and expand our clinical pipeline," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. To date, we are seeing good progress with site activation for our Phase 2b clinical trial of CLBS16 in the U.S., known as the FREEDOM Trial, for the treatment of coronary microvascular dysfunction as we continue to accelerate enrollment. Additionally, we remain optimistic that we soon will complete enrollment in our registration-eligible study of HONEDRA in critical limb ischemia and Buerger’s disease in Japan. However, enrollment for this program has been greatly impacted by the Japanese government-issued states of emergency tied to the pandemic. Lastly, we are working with the U.S. Food and Drug Administration ("FDA") to finalize the protocol design for our CLBS201 proof-of-concept study in diabetic kidney disease and have targeted initiation of that Phase 2 study in the third quarter of 2021."

Product Development and Financing Highlights

CLBS16 for the treatment of coronary microvascular dysfunction

Caladrius reported in May 2020 the compelling positive results of its ESCaPE-CMD Phase 2a study of CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that continues to be underdiagnosed and potentially afflicts millions annually – a vast majority of whom are female – with no current treatment options. The Company is committed to raising awareness of this growing women’s health crisis and finding an effective treatment. Caladrius recently initiated, and is currently treating patients in, a rigorous 105-subject Phase 2b clinical trial (the FREEDOM Trial), which to our knowledge, is the first controlled regenerative medicine trial in CMD. The trial is targeted to complete enrollment by the end of 2021 with top line data anticipated for the third quarter of 2022. This double-blind, randomized, placebo-controlled Phase 2b trial will evaluate the efficacy and safety of delivering autologous CD34+ cells to the hearts of subjects with CMD.

HONEDRA (CLBS12) for the treatment of critical limb ischemia

The Company’s open-label, registration-eligible study of SAKIGAKE-designated HONEDRA in Japan for the treatment of critical limb ischemia ("CLI") and Buerger’s disease (an orphan-sized subset of CLI) has shown strong results to date. The initial responses observed in the subjects who have reached an endpoint in this study are consistent with a therapeutic effect and safety profile reported by previously published clinical trials in Japan and the U.S. The study’s enrollment continues to be slowed by the pandemic’s impact in Japan, however, the Company is encouraged by the patient pre-screening pipeline and continues to make progress towards study completion, the exact date of which is impossible to predict given the continuing impact of COVID-19 on clinical trials in Japan. While the final outcome of the trial will depend on all data from all subjects, the data to date is very encouraging (~60% of subjects in the completed Buerger’s disease cohort have reached a positive "CLI-free" endpoint despite a natural history of such patients that predicts continuing disease progression to amputation). In the U.S., the Company was pleased to report that the FDA granted orphan designation to CLBS12 as a treatment for Buerger’s disease.

CLBS201 for the treatment of diabetic kidney disease

The Company’s most recently proposed development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease in patients not yet requiring dialysis. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression of the disease or even reverse the course of diabetic kidney disease. A Phase 2 proof of concept, randomized, placebo-controlled study is planned for initiation in the second half of 2021.

OLOGOTM for the treatment of no option refractory disabling angina ("NORDA")

Caladrius acquired the rights to data and regulatory filings for a CD34+ cell therapy program for NORDA that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies that a single administration of OLOGOTM reduces mortality, improves angina and increases exercise capacity in patients with otherwise untreatable angina, this product received Regenerative Medicine Advanced Therapy ("RMAT") designation from the FDA. Caladrius remains in ongoing discussions with the FDA regarding the size and scope of an appropriate and practical Phase 3 trial, which in combination with previously filed Phase 1, 2 and 3 data, will be considered for the registration of OLOGOTM. Notably, the RMAT designation affords the product a 6-month review time for a biologics license application ("BLA"), once submitted.

Sufficient capital to fund operations beyond multiple key data readouts (>2023)

As previously disclosed, in January 2021, Caladrius raised $25.0 million in a private placement priced at-the-market under Nasdaq rules. In February 2021, the Company announced that it closed a $65.0 million capital raise through the sale of its common stock to several institutional and accredited investors in two registered direct offerings priced at-the-market under Nasdaq rules.

First Quarter 2021 Financial Summary

Research and development expenses for the three months ended March 31, 2021 were $5.1 million, compared to $1.5 million for the three months ended March 31, 2020. Research and development in the current year period focused on the advancement of our ischemic repair platform and related to:

•Ongoing expenses for HONEDRA in critical limb ischemia and Buerger’s disease in Japan for which we continue to focus spending on patient enrollment and Japanese NDA preparation; and

•Expenses associated with efforts to advance the FREEDOM Trial where the first patient was dosed in the first quarter of 2021; and

•Expenses associated with the planning and preparation of an IND and proof-of-concept protocol for CLBS201 as a treatment for diabetic kidney disease.

General and administrative expenses, which focus on general corporate related activities, were $3.0 million for the three months ended March 31, 2021 compared to $2.6 million for the three months ended March 31, 2020, representing an increase of 18%.

Overall, net losses were $8.1 million and $4.0 million for the years ended March 31, 2021 and 2020, respectively.
Balance Sheet Highlights

As of March 31, 2021, Caladrius had cash, cash equivalents and marketable securities of approximately $111.5 million. Based on existing programs and projections, the Company remains confident that its current cash balances will fund its operations for the next several years, notably through study completion for the FREEDOM Trial, through the registration-eligible study completion for HONEDRA and through the Phase 2 proof-of-concept study for CLBS201, while still providing capital to explore additional pipeline expansion opportunities.

Conference Call
Caladrius will hold a live conference call today, May 6, 2021, at 4:30 p.m. (ET) to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below. A live webcast of the call will also be available under "Events" in the Investors section of the Caladrius website, View Source, and will be available for replay for 90 days after the conclusion of the call.