On October 29, 2020 Universal Health Services, Inc. (NYSE: UHS) reported that its reported net income attributable to UHS was $241.3 million, or $2.82 per diluted share, during the third quarter of 2020, as compared to $97.2 million, or $1.10 per diluted share, during the comparable quarter of 2019 (Press release, Universal Health Services, OCT 29, 2020, View Source [SID1234569421]). Net revenues increased 3.2% to $2.913 billion during the third quarter of 2020 as compared to $2.822 billion during the third quarter of 2019.

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As reflected on the Schedule of Non-GAAP Supplemental Information ("Supplemental Schedule"), our adjusted net income attributable to UHS during the third quarter of 2020 was $246.5 million, or $2.88 per diluted share, as compared to $176.3 million, or $1.99 per diluted share, during the third quarter of 2019.

Included in our reported and adjusted net income attributable to UHS during the three-month period ended September 30, 2020 were the following:

A favorable impact of approximately $21.4 million, or $0.25 per diluted share, resulting from $28 million of net revenues recorded in connection with the California Medicaid supplemental payment program related to our acute care hospitals. Approximately $11 million of these supplemental revenues were attributable to the first nine months of 2020 and $17 million were attributable to prior years, and;
An unfavorable impact of approximately $4.7 million, or $0.06 per diluted share, resulting from a reversal of previously recorded grant income revenues of approximately $5 million, as provided for by the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"), as discussed below in CARES Act and Other Governmental Grants and Medicare Accelerated Payments.
As reflected on the Supplemental Schedule, included in our reported results during the third quarter of 2020, was a net aggregate unfavorable after-tax impact of $5.2 million, or $.06 per diluted share, consisting of the following: (i) an after-tax unrealized loss of $2.1 million, or $.02 per diluted share, ($2.7 million pre-tax which is included in "Other (income) expense, net"), resulting from a decrease in the market value of shares of certain marketable securities held for investment and classified as available for sale, and; (ii) a unfavorable after-tax impact of $3.1 million, or $.04 per diluted share, resulting from our adoption of ASU 2016-09, "Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting" ("ASU 2016-09").

As reflected on the Supplemental Schedule, included in our reported results during the third quarter of 2019, is an aggregate net unfavorable after-tax impact of $79.1 million, or $.89 per diluted share, resulting from: (i) an unfavorable after-tax impact of $74.6 million, or $.84 per diluted share, resulting from a $97.6 million provision for asset impairment recorded in connection with Foundations Recovery Network, L.L.C.; (ii) an unfavorable after-tax impact of $6.2 million, or $.07 per diluted share, resulting from the non-deductible portion of the net federal and state income taxes due on the settlement finalized in July, 2020 with the Department of Justice, Civil Division, and; (iii) a favorable after-tax impact of $1.7 million, or $.02 per diluted share, resulting from our adoption of ASU 2016-09.

Included in our reported and our adjusted net income attributable to UHS during the third quarter of 2019 is a pre-tax unrealized loss of $15.2 million, or $.13 per diluted share (included in "Other (income) expense, net"), resulting from a decrease in the market value of shares of certain marketable securities held for investment and classified as available for sale.

As calculated on the attached Supplemental Schedule, our earnings before interest, taxes, depreciation & amortization ("EBITDA net of NCI", NCI is net income attributable to noncontrolling interests), was $471.0 million during the third quarter of 2020, as compared to $297.4 million during the third quarter of 2019. Our adjusted earnings before interest, taxes, depreciation & amortization ("Adjusted EBITDA net of NCI"), which excludes the impact of other (income) expense, net, and the above-mentioned provision for asset impairment recorded during the third quarter of 2019, was $472.8 million during the third quarter of 2020 as compared to $404.4 million during the third quarter of 2019.

COVID-19

The impact of the COVID-19 pandemic, which began during the second half of March, 2020, has had a material unfavorable effect on our operations and financial results since that time, before giving effect to the revenues recorded in connection with the CARES Act and other governmental grants as discussed below in CARES Act and Other Governmental Grants and Medicare Accelerated Payments. Patient volumes at both our acute care and behavioral health care facilities were most significantly reduced in March and April. Our acute care and behavioral health facilities began experiencing gradual and continued improvement in patient volumes since May as various states eased stay-at-home restrictions and acute care hospitals were permitted to resume elective surgeries and procedures. Although many of our acute care and behavioral health facilities are located in states that have continued to experience intermittent increases in COVID-19 infections, non-COVID-19 patient volumes at our hospitals have not been as dramatically impacted in recent months by increases experienced from time-to-time in COVID-19 patient volumes. We believe that the adverse impact that COVID-19 will have on our future operations and financial results will depend upon many factors, most of which are beyond our capability to control or predict.

Consolidated Results of Operations, As Reported and As Adjusted – Nine-month periods ended September 30, 2020 and 2019:

Reported net income attributable to UHS was $635.2 million, or $7.40 per diluted share, during the nine-month period ended September 30, 2020, as compared to $569.7 million, or $6.35 per diluted share, during the first nine months of 2019. Net revenues decreased slightly to $8.472 billion during the first nine months of 2020 as compared to $8.482 billion during the comparable period of 2019.

As reflected on the Supplemental Schedule, our adjusted net income attributable to UHS during the nine-month period ended September 30, 2020 was $646.9 million, or $7.53 per diluted share, as compared to $646.7 million, or $7.21 per diluted share, during the first nine months of 2019.

Our reported and adjusted net income attributable to UHS during the nine-month period ended September 30, 2020 included the following:

A favorable impact of $157.2 million, or $1.84 per diluted share, resulting from the recording of approximately $213 million of grant income revenues, as discussed below in CARES Act and Other Governmental Grants and Medicare Accelerated Payments, and;
A favorable impact of $21.4 million, or $0.25 per diluted share, resulting from the above-mentioned $28 million of net revenues recorded during the third quarter of 2020 in connection with the California Medicaid supplemental payment program.
As reflected on the Supplemental Schedule, included in our reported results during the nine-month period ended September 30, 2020, was a net aggregate unfavorable after-tax impact of $11.6 million, or $.13 per diluted share, consisting of the following: (i) an after-tax unrealized loss of $7.2 million, or $.08 per diluted share, ($9.4 million pre-tax which is included in "Other (income) expense, net"), resulting from a decrease in the market value of shares of certain marketable securities held for investment and classified as available for sale, and; (ii) an unfavorable after-tax impact of $4.4 million, or $.05 per diluted share, resulting from our adoption of ASU 2016-09.

As reflected on the Supplemental Schedule, included in our reported results during the nine-month period ended September 30, 2019, is an aggregate net unfavorable after-tax impact of $77.0 million, or $.86 per diluted share, resulting from: (i) an unfavorable after-tax impact of $74.6 million, or $.84 per diluted share, resulting from a $97.6 million provision for asset impairment recorded in connection with Foundations Recovery Network, L.L.C.; (ii) an unfavorable after-tax impact of $14.6 million, or $.16 per diluted share, resulting from the non-deductible portion of the net federal and state income taxes due on the settlement finalized in July, 2020 with the Department of Justice, Civil Division, and; (iii) a favorable after-tax impact of $12.1 million, or $.14 per diluted share, resulting from our adoption of ASU 2016-09.

Included in our reported and our adjusted net income attributable to UHS during the nine-month period ended September 30, 2019 is a pre-tax unrealized loss of $12.5 million, or $.11 per diluted share (included in "Other (income) expense, net"), resulting from a decrease in the market value of shares of certain marketable securities held for investment and classified as available for sale.

As calculated on the attached Supplemental Schedule, our EBITDA net of NCI was $1.303 billion during the first nine months of 2020, as compared to $1.222 billion during the first nine months of 2019. Our Adjusted EBITDA net of NCI, which excludes the impact of other (income) expense, net, and the increase in the Department of Justice settlement reserve and the provision for asset impairment, both of which were recorded during the first nine months of 2019, was $1.311 billion during the nine-month period ended September 30, 2020 and $1.336 billion during the comparable period of 2019.

Acute Care Services – Three and nine-month periods ended September 30, 2020 and 2019:

During the third quarter of 2020, at our acute care hospitals owned during both periods ("same facility basis"), adjusted admissions (adjusted for outpatient activity) decreased 17.3% and adjusted patient days decreased 1.6%, as compared to the third quarter of 2019. At these facilities, excluding the CARES Act and other grant income revenues of approximately $4 million recorded during the third quarter of 2020, net revenue per adjusted admission increased 26.2% while net revenue per adjusted patient day increased 6.0% during the third quarter of 2020 as compared to the third quarter of 2019. During the third quarter of 2020, as compared to the third quarter of 2019, net revenues generated from our acute care services on a same facility basis increased 5.5% including the impact of the CARES Act and other grant income revenues, and increased 5.2% excluding the impact of the CARES Act and other grant income revenues.

During the nine-month period ended September 30, 2020, at our acute care hospitals on a same facility basis, adjusted admissions decreased 15.4% and adjusted patient days decreased 6.6%, as compared to the first nine months of 2019. At these facilities, excluding the CARES Act and other grant income revenues of approximately $161 million recorded during the first nine months of 2020, net revenue per adjusted admission increased 13.8% while net revenue per adjusted patient day increased 3.0% during the nine-month period ended September 30, 2020 as compared to the comparable nine-month period of 2019. During the first nine months of 2020, as compared to the comparable period of 2019, net revenues generated from our acute care services on a same facility basis increased 0.8% including the CARES Act and other grant income revenues, and decreased 2.8% excluding the CARES Act and other grant income revenues.

Behavioral Health Care Services – Three and nine-month periods ended September 30, 2020 and 2019:

During the third quarter of 2020, at our behavioral health care facilities on a same facility basis, adjusted admissions decreased 5.6% while adjusted patient days decreased 3.6% as compared to the third quarter of 2019. At these facilities, excluding the impact of the CARES Act and other grant income revenue reversal of approximately $9 million recorded during the third quarter of 2020, net revenue per adjusted admission increased 8.0% while net revenue per adjusted patient day increased 5.7% during the third quarter of 2020 as compared to the comparable quarter in 2019. During the third quarter of 2020, as compared to the third quarter of 2019, net revenues generated from our behavioral health care services on a same facility basis increased 1.2% including the impact of the CARES Act and other grant income revenue reversal, and increased 1.9% excluding the impact of the CARES Act and other grant income revenue reversal.

During the nine-month period ended September 30, 2020, at our behavioral health care facilities on a same facility basis, adjusted admissions decreased 7.6% and adjusted patient days decreased 5.1%, as compared to the first nine months of 2019. At these facilities, excluding the CARES Act and other grant income revenues of approximately $52 million recorded during the first nine months of 2020, net revenue per adjusted admission increased 6.6% while net revenue per adjusted patient day increased 3.8% during the first nine months of 2020 as compared to the comparable period of 2019. During the first nine months of 2020, as compared to the comparable period of 2019, net revenues generated from our behavioral health care services on a same facility basis decreased 0.2% including the CARES Act and other grant income revenues, and decreased 1.5% excluding the CARES Act and other grant income revenues.

Net Cash Provided by Operating Activities and Liquidity:

Net Cash Provided by Operating Activities:

For the nine months ended September 30, 2020, our net cash provided by operating activities increased to $2.218 billion as compared to $1.105 billion generated during the first nine months of 2019.

The $1.113 billion net increase was due to: (i) a favorable change of $878 million resulting from the Medicare accelerated payments and deferred CARES Act and other grants; (ii) a favorable change of $111 million due to the payment deferral of the employer’s share of Social Security taxes, as provided for by the CARES Act; (iii) a favorable change of $52 million in accrued and deferred income taxes; (iv) a favorable change of $49 million in accounts receivable; (v) a favorable change $30 million in other working capital accounts due primarily to the timing of accounts payable disbursements, and; (vi) $7 million of other combined net unfavorable changes.

Liquidity:

As of September 30, 2020, there were no borrowings outstanding pursuant to our $1 billion revolving credit facility or our $450 million accounts receivable securitization program. As of that date, we had $1.447 billion of aggregate available borrowing capacity pursuant to the terms of these debt facilities, net of outstanding letters of credit.

In addition, as of September 30, 2020, we had approximately $1.101 billion of cash and cash equivalents.

CARES Act and Other Governmental Grants and Medicare Accelerated Payments:

As of September 30, 2020, we have received an aggregate of $1.091 billion as follows:

Approximately $396 million of funds received from various governmental stimulus programs, most notably the Public Health and Social Services Emergency Fund, as provided for by the CARES Act.
Included in our reported and adjusted net income attributable to UHS for the three-month period ended September 30, 2020, was an unfavorable impact of $4.7 million, or $0.06 per diluted share, resulting from a reversal of previously recorded CARES Act and other grant income revenues of approximately $5 million. During the third quarter of 2020, approximately $4 million of grant income revenues were recorded by our acute care services, while our behavioral health services reversed approximately $9 million of previously recorded CARES Act and other grant income revenues.
Included in our reported and adjusted net income attributable to UHS for the nine-month period ended September 30, 2020, was the favorable impact of $157.2 million, or $1.84 per diluted share, resulting from the recording of approximately $213 million of CARES Act and other grant income revenues. Approximately $161 million of the grant income revenues were attributable to our acute care services and approximately $52 million were attributable to our behavioral health care services.
As of September 30, 2020, approximately $183 million of these funds remain in the Medicare accelerated payments and deferred CARES Act and other grants liability account in our condensed consolidated balance sheet.
Approximately $695 million of Medicare accelerated payments received. Pursuant to legislation enacted on October 1, 2020, these funds are required to be repaid to the government beginning in the second quarter of 2021 through the third quarter of 2022 through withholding of future Medicare revenues earned during those periods. There was no impact on our earnings during the three and nine-month periods ended September 30, 2020 in connection with receipt of these funds. As of September 30, 2020, the funds are included in the Medicare accelerated payments and deferred CARES Act and other grants liability account in our condensed balance sheet.
We recognized grant income net revenues related to the CARES Act and other governmental grant funding based on information available at September 30, 2020 based upon laws and regulations governing the funding as well as interpretations issued by the Department of Health and Human Services ("HHS"). In October 2020, HHS issued new reporting requirements for the CARES Act funding. Due to these new reporting requirements and various interpretations, there is at least a reasonable possibility that amounts recorded under CARES Act funding will change in future periods.

Update on Previously Disclosed Information Technology Incident:

As previously disclosed on September 29, 2020, we experienced an information technology security incident in the early morning hours of September 27, 2020. As a result of this cyberattack, we suspended user access to our information technology applications related to operations located in the United States. While our information technology applications were offline, patient care was delivered safely and effectively at our facilities across the country utilizing established back-up processes, including offline documentation methods.

Since that time, our information technology applications have been restored at our acute care and behavioral health hospitals, as well as at the corporate level, thereby re-establishing connections to all major systems and applications, including electronic medical records, laboratory and pharmacy systems. With the back-loading of data substantially complete at this point, our hospitals are resuming normal operations.

We have worked diligently with our information technology security partners to restore our information technology infrastructure and business operations as quickly as possible. In parallel, we immediately began investigating the nature and potential impact of the security incident and engaged third-party information technology and forensic vendors to assist. Although the investigation remains ongoing, no evidence of unauthorized access, copying or misuse of any patient or employee data has been identified to date.

Conference call information:

We will hold a conference call for investors and analysts at 10:00 a.m. eastern time on October 30, 2020. The dial-in number is 1-877-648-7971.

A live broadcast of the conference call will be available on our website at www.uhsinc.com. Also, a replay of the call will be available following the conclusion of the live call and will be available for one full year.

General Information, Forward-Looking Statements and Risk Factors and Non-GAAP Financial Measures:

One of the nation’s largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. has built an impressive record of achievement and performance. Growing steadily since our inception into an esteemed Fortune 500 corporation, our annual revenues were approximately $11.4 billion during 2019. In 2020, UHS was again recognized as one of the World’s Most Admired Companies by Fortune; ranked #281 on the Fortune 500; and listed #330 in Forbes ranking of U.S.’ Largest Public Companies.

Our operating philosophy is as effective today as it was 40 years ago, enabling us to provide compassionate care to our patients and their loved ones. Our strategy includes building or acquiring high quality hospitals in rapidly growing markets, investing in the people and equipment needed to allow each facility to thrive, and becoming the leading healthcare provider in each community we serve.

Headquartered in King of Prussia, PA, UHS has more than 90,000 employees and through its subsidiaries operates 26 acute care hospitals, 330 behavioral health facilities, 41 outpatient facilities and ambulatory care access points, an insurance offering, a physician network and various related services located in 37 U.S. states, Washington, D.C., Puerto Rico and the United Kingdom. It acts as the advisor to Universal Health Realty Income Trust, a real estate investment trust (NYSE:UHT). For additional information on the Company, visit our web site: View Source

This press release contains forward-looking statements based on current management expectations. Numerous factors, including those disclosed herein, those related to the anticipated impact of COVID-19 on our operations and financial results, those related to healthcare industry trends and those detailed in our filings with the Securities and Exchange Commission (as set forth in Item 1A-Risk Factors and in Item 7-Forward-Looking Statements and Risk Factors in our Form 10-Q for the quarterly period ended June 30, 2020), may cause the results to differ materially from those anticipated in the forward-looking statements. These statements are subject to risks and uncertainties and therefore actual results may differ materially. Readers should not place undue reliance on such forward-looking statements which reflect management’s view only as of the date hereof. We undertake no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. Many of the factors that could affect our future results are beyond our control or ability to predict, including the impact of the COVID-19 pandemic. Our future operations and financial results will likely be materially impacted by developments related to COVID-19 including, but not limited to, the length of time and severity of the spread of the pandemic; the volume of cancelled or rescheduled elective procedures and the volume of COVID-19 patients treated at our hospitals and other healthcare facilities; measures we are taking to respond to the COVID-19 pandemic; the impact of government and administrative regulation and stimulus on the hospital industry and potential retrospective adjustment in future periods of CARES Act and other grant income revenues recorded as revenues in prior periods; declining patient volumes and unfavorable changes in payer mix caused by deteriorating macroeconomic conditions (including increases in uninsured and underinsured patients as the result of business closings and layoffs); potential disruptions to our clinical staffing and shortages and disruptions related to supplies required for our employees and patients; and potential increases to expenses related to staffing, supply chain or other expenditures; the impact of our substantial indebtedness and the ability to refinance such indebtedness on acceptable terms, as well as risks associated with disruptions in the financial markets and the business of financial institutions as the result of the COVID-19 pandemic which could impact us from a financing perspective; and changes in general economic conditions nationally and regionally in our markets resulting from the COVID-19 pandemic. We are not able to fully quantify the impact that these factors will have on our future financial results, but expect developments related to the COVID-19 pandemic to materially affect our financial performance in 2020. In addition, although we are unable to quantify the ultimate impact of the above-mentioned information technology security incident that we experienced in late September, 2020, the incident could have an adverse effect on our future results of operations.

We believe that adjusted net income attributable to UHS, adjusted net income attributable to UHS per diluted share, EBITDA net of NCI and Adjusted EBITDA net of NCI, which are non-GAAP financial measures ("GAAP" is Generally Accepted Accounting Principles in the United States of America), are helpful to our investors as measures of our operating performance. In addition, we believe that, when applicable, comparing and discussing our financial results based on these measures, as calculated, is helpful to our investors since it neutralizes the effect of material items impacting our net income attributable to UHS, such as, our adoption of ASU 2016-09, unrealized gains/losses resulting from changes in the market value of shares of certain marketable securities held for investment and classified as available for sale, and other potential material items that are nonrecurring or non-operational in nature including, but not limited to, impairments of long-lived and intangible assets, changes in the reserve established in connection with our discussions with the Department of Justice, reserves for various matters including settlements, legal judgments and lawsuits, costs related to extinguishment of debt, gains/losses on sales of assets and businesses, and other amounts that may be reflected in the current or prior year financial statements that relate to prior periods. To obtain a complete understanding of our financial performance these measures should be examined in connection with net income attributable to UHS, as determined in accordance with GAAP, and as presented in the condensed consolidated financial statements and notes thereto in this report or in our other filings with the Securities and Exchange Commission including our Reports on Form 10-K for the year ended December 31, 2019 and Form 10-Q for the quarterly period ended June 30, 2020. Since the items included or excluded from these measures are significant components in understanding and assessing financial performance under GAAP, these measures should not be considered to be alternatives to net income as a measure of our operating performance or profitability. Since these measures, as presented, are not determined in accordance with GAAP and are thus susceptible to varying calculations, they may not be comparable to other similarly titled measures of other companies. Investors are encouraged to use GAAP measures when evaluating our financial performance.

On October 29, 2020 Rafael Holdings, Inc., (NYSE: RFL), reported revenue of $4.9 million and a loss per share of $0.66 for the fiscal year ended July 31, 2020 (Press release, Rafael Holdings, OCT 29, 2020, View Source [SID1234569420]). Fourth quarter revenue was $1.2 million with a loss per share of $0.34.

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Q4 FY 2020 Consolidated Highlights

Revenue of $1.2 million in Q4 FY2020, generated by Rafael Holdings’ real estate portfolio, was unchanged from the year-ago quarter. The loss per share of $0.34 increased from $0.16 in the year ago quarter largely due to additional investment in the Company’s wholly owned pharmaceutical research venture, the Barer Institute.
In August after the quarter close, the company sold its commercial real estate property in Piscataway, New Jersey for $3.9 million
Rafael Pharmaceuticals

At July 31, 2020, the Company and its subsidiaries collectively owned securities representing 51% of the outstanding capital stock of Rafael Pharmaceuticals and approximately 37% on a fully diluted basis.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for Rafael Pharma’s lead compound, CPI-613 (devimistat), for the treatment of soft tissue sarcoma. Rafael’s clinical trial will focus on the treatment of relapsed or refractory clear cell sarcoma.
Ono Pharmaceutical Co., has begun a multicenter, open-label Phase 1 study in Japan for patients with pancreatic cancer. The study is evaluating the efficacy and safety of CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX).
Rafael Pharma reached its target enrollment of 500 patients in its pivotal Phase 3 clinical trial for metastatic pancreatic cancer (AVENGER 500). The trial is evaluating the efficacy and safety of CPI-613️ (devimistat) in combination with modified FOLFIRINOX (mFFX) as first-line therapy. Efficacy data for this trial could be available for analysis as early as the second quarter of calendar year 2021.
Rafael Pharma has crossed the midpoint to its first interim analysis in enrollment for its pivotal Phase 3 clinical trial (ARMADA 2000) of CPI-613 (devimistat) for relapsed or refractory acute myeloid leukemia (AML). The multicenter, open-label, randomized pivotal trial is evaluating the efficacy and safety of its lead compound devimistat in combination with high dose cytarabine and mitoxantrone (CHAM) in older patients. The efficacy data for this trial couuld be available for interim analysis as early as the second quarter of calendar year 2021.
Rafael Pharma expanded its Phase 2 clinical trial of CPI-613 (devimistat) for patients with relapsed or refractory Burkitt’s lymphoma/leukemia.
Rafael Pharma entered into a research collaboration with Roswell Park Comprehensive Cancer Center to evaluate the effects of CPI-613 (devimistat) with or without chemotherapy agents, including oxaliplatin/cisplatin/5-FU/carboplatin/taxol, on esophageal cancer cells.
LipoMedix
At July 31, 2020, Rafael Holdings held 67% of the issued and outstanding ordinary shares of LipoMedix, a development-stage Israeli company focused on the development of an innovative, safe and effective cancer therapy based on liposome delivery. This stake is inclusive of 4 million shares of LipoMedix purchased in May 2020 for $1 million including conversion of outstanding bridge notes.

Barer Institute
The Barer Institute has identified and begun to evaluate new therapeutic compounds, including compounds to regulate cancer metabolism, through internal development and in-licensing. It is working to validate newly discovered biomarkers for resistance and sensitivity within its portfolio compounds and to identify certain novel targetable mechanisms of action. In addition, the Barer Institute has identified several potential lead compounds for clinical development and found combinations that may meaningfully increase the efficacy of certain clinical compounds.

Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings
"Rafael Holdings’ continued to execute on our strategic vision in the fourth quarter, selling our Piscataway property and further increasing our majority stake in LipoMedix. In August, Rafael Pharma announced a major milestone – fully enrolling its pivotal Phase 3 Avenger 500 study for patients with metastatic pancreatic cancer. Results could be available as early as the second quarter of 2021. The Barer Institute has multiple compounds under development and collaboration programs in process with some of the premier academic centers in the country."

On October 29, 2020 Select Medical Holdings Corporation ("Select Medical," "we," "us," or "our") (NYSE: SEM) reported results for its third quarter ended September 30, 2020 (Press release, Select Medical, OCT 29, 2020, View Source [SID1234569419]).

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For the third quarter ended September 30, 2020, net operating revenues increased 2.2% to $1,423.9 million, compared to $1,393.3 million for the same quarter, prior year. Income from operations increased 27.0% to $156.1 million for the third quarter ended September 30, 2020, compared to $122.9 million for the same quarter, prior year. Income from operations included a net reduction of $1.2 million related to payments received under the Provider Relief Fund, as described below. Net income increased 137.2% to $104.5 million for the third quarter ended September 30, 2020, compared to $44.0 million for the same quarter, prior year. Net income included pre-tax gains on sales of businesses of $5.1 million for the third quarter ended September 30, 2020. Net income included pre-tax losses on early retirement of debt of $18.6 million for the third quarter ended September 30, 2019. Adjusted EBITDA increased 16.7% to $213.2 million for the third quarter ended September 30, 2020, compared to $182.7 million for the same quarter, prior year. Earnings per common share was $0.57 on a fully diluted basis for the third quarter ended September 30, 2020, compared to $0.23 for the same quarter, prior year. Adjusted earnings per common share was $0.56 on a fully diluted basis for the third quarter ended September 30, 2020, compared to $0.33 for the same quarter, prior year. Adjusted earnings per common share excludes the gains on sales of businesses and related tax effects for the third quarter ended September 30, 2020. Adjusted earnings per common share excludes the losses on early retirement of debt and related costs, and their related tax effects, for the third quarter ended September 30, 2019. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

For the nine months ended September 30, 2020, net operating revenues were $4,071.2 million, compared to $4,079.3 million for the same period, prior year. Income from operations increased 12.5% to $404.3 million for the nine months ended September 30, 2020, compared to $359.5 million for the same period, prior year. For the nine months ended September 30, 2020, income from operations included other operating income of $53.8 million related to the recognition of payments received under the Provider Relief Fund, as described below, for loss of revenue and health care related expenses attributable to coronavirus disease 2019 ("COVID-19"). Net income increased 54.0% to $242.4 million for the nine months ended September 30, 2020, compared to $157.4 million for the same period, prior year. Net income included pre-tax gains on sales of businesses of $12.7 million for the nine months ended September 30, 2020. Net income included pre-tax losses on early retirement of debt of $18.6 million and a pre-tax gain on sale of businesses of $6.5 million for the nine months ended September 30, 2019. Adjusted EBITDA increased 7.5% to $579.3 million for the nine months ended September 30, 2020, compared to $539.0 million for the same period, prior year. Earnings per common share was $1.35 on a fully diluted basis for the nine months ended September 30, 2020, compared to $0.86 for the same period, prior year. Adjusted earnings per common share was $1.31 on a fully diluted basis for the nine months ended September 30, 2020, compared to $0.93 for the same period, prior year. Adjusted earnings per common share excludes the gains on sales of businesses and related tax effects for the nine months ended September 30, 2020. Adjusted earnings per common share excludes the losses on early retirement of debt and related costs, gain on sale of businesses, and their related tax effects for the nine months ended September 30, 2019. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

Please refer to "Effects of the COVID-19 Pandemic on Select Medical’s Results of Operations" below for further discussion.

Company Overview

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on number of facilities. Select Medical’s reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of September 30, 2020, Select Medical operated 100 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,777 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 523 occupational health centers in 41 states. At September 30, 2020, Select Medical had operations in 46 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

CARES Act Provider Relief Fund

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act") was enacted. The CARES Act provided additional waivers, reimbursement, grants and other funds to assist health care providers during the COVID-19 pandemic, including $100.0 billion in appropriations for the Public Health and Social Services Emergency Fund, also referred to as the Provider Relief Fund, to be used for preventing, preparing, and responding to the coronavirus, and for reimbursing eligible health care providers for lost revenues and health care related expenses that are attributable to COVID-19.

For the three and nine months ended September 30, 2020, Select Medical recognized payments received under the Provider Relief Fund for loss of revenue and health care related expenses attributable to COVID-19 as other operating income. For the three months ended September 30, 2020, other operating income of $0.4 million is included within the operating results of our Select Medical’s Concentra segment, and a reduction to other operating income of $1.5 million is included within the operating results of its other activities. The reduction in other operating income resulted from changes in the terms and conditions associated with the acceptance of the Provider Relief Fund payments; these terms and conditions have changed from those which existed upon receipt of the payments. For the nine months ended September 30, 2020, $52.7 million and $1.1 million of other operating income is included within the operating results of Select Medical’s other activities and its Concentra segment, respectively.

Critical Illness Recovery Hospital Segment

For the third quarter ended September 30, 2020, net operating revenues for the critical illness recovery hospital segment increased 12.2% to $519.5 million, compared to $462.9 million for the same quarter, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 55.2% to $88.8 million for the third quarter ended September 30, 2020, compared to $57.2 million for the same quarter, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 17.1% for the third quarter ended September 30, 2020, compared to 12.4% for the same quarter, prior year. Certain critical illness recovery hospital key statistics are presented in table VII of this release for both the third quarters ended September 30, 2020 and 2019.

For the nine months ended September 30, 2020, net operating revenues for the critical illness recovery hospital segment increased 11.4% to $1,539.6 million, compared to $1,381.6 million for the same period, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 37.4% to $267.1 million for the nine months ended September 30, 2020, compared to $194.4 million for the same period, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 17.4% for the nine months ended September 30, 2020, compared to 14.1% for the same period, prior year. Certain critical illness recovery hospital key statistics are presented in table VIII of this release for both the nine months ended September 30, 2020 and 2019.

Rehabilitation Hospital Segment

For the third quarter ended September 30, 2020, net operating revenues for the rehabilitation hospital segment increased 8.5% to $188.1 million, compared to $173.4 million for the same quarter, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 21.4% to $44.6 million for the third quarter ended September 30, 2020, compared to $36.8 million for the same quarter, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 23.7% for the third quarter ended September 30, 2020, compared to 21.2% for the same quarter, prior year. Certain rehabilitation hospital key statistics are presented in table VII of this release for both the third quarters ended September 30, 2020 and 2019.

For the nine months ended September 30, 2020, net operating revenues for the rehabilitation hospital segment increased 10.3% to $538.8 million, compared to $488.3 million for the same period, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 19.7% to $110.8 million for the nine months ended September 30, 2020, compared to $92.5 million for the same period, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 20.6% for the nine months ended September 30, 2020, compared to 19.0% for the same period, prior year. For the nine months ended September 30, 2019, the Adjusted EBITDA results for the rehabilitation hospital segment included start-up losses of approximately $8.8 million. Certain rehabilitation hospital key statistics are presented in table VIII of this release for both the nine months ended September 30, 2020 and 2019.

Outpatient Rehabilitation Segment

For the third quarter ended September 30, 2020, net operating revenues for the outpatient rehabilitation segment were $240.0 million, compared to $265.3 million for the same quarter, prior year. Adjusted EBITDA for the outpatient rehabilitation segment was $30.6 million for the third quarter ended September 30, 2020, compared to Adjusted EBITDA of $40.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 12.8% for the third quarter ended September 30, 2020, compared to 15.1% for the same quarter, prior year. Certain outpatient rehabilitation key statistics are presented in table VII of this release for both the third quarters ended September 30, 2020 and 2019.

For the nine months ended September 30, 2020, net operating revenues for the outpatient rehabilitation segment were $662.4 million, compared to $774.1 million for the same period, prior year. Adjusted EBITDA for the outpatient rehabilitation segment was $51.5 million for the nine months ended September 30, 2020, compared to $111.6 million for the same period, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 7.8% for the nine months ended September 30, 2020, compared to 14.4% for the same period, prior year. Certain outpatient rehabilitation key statistics are presented in table VIII of this release for both the nine months ended September 30, 2020 and 2019.

Concentra Segment

For the third quarter ended September 30, 2020, net operating revenues for the Concentra segment were $391.9 million, compared to $421.9 million for the same quarter, prior year. Adjusted EBITDA for the Concentra segment increased 3.7% to $80.5 million for the third quarter ended September 30, 2020, compared to $77.7 million for the same quarter, prior year. The Adjusted EBITDA margin for the Concentra segment was 20.6% for the third quarter ended September 30, 2020, compared to 18.4% for the same quarter, prior year. Certain Concentra key statistics are presented in table VII of this release for both the third quarters ended September 30, 2020 and 2019.

For the nine months ended September 30, 2020, net operating revenues for the Concentra segment were $1,102.7 million, compared to $1,231.7 million for the same period, prior year. Adjusted EBITDA for the Concentra segment was $183.5 million for the nine months ended September 30, 2020, compared to $220.0 million for the same period, prior year. The Adjusted EBITDA margin for the Concentra segment was 16.6% for the nine months ended September 30, 2020, compared to 17.9% for the same period, prior year. Certain Concentra key statistics are presented in table VIII of this release for both the nine months ended September 30, 2020 and 2019.

Effects of the COVID-19 Pandemic on Select Medical’s Results of Operations

The continuing implications of the COVID-19 pandemic on Select Medical’s results of operations and overall financial performance remain uncertain. Select Medical has provided net operating revenues and certain operating statistics to assist readers in understanding how the COVID-19 pandemic impacted each of its segments during the three and nine months ended September 30, 2020.

Critical Illness Recovery Hospital Segment. Select Medical’s critical illness recovery hospitals are a key component of the inpatient hospital continuum of care. Both the Centers for Medicare & Medicaid Services ("CMS") and Congress acted to temporarily suspend certain regulations concerning length of stay requirements, which apply to Select Medical’s critical illness recovery hospitals, in order to facilitate the transfer of patients from general acute care hospitals. This was done in order to expand hospital bed capacity to care for COVID-19 patients. COVID-19 has been prevalent in certain markets that Select Medical serves; as a result, Select Medical’s critical illness recovery hospitals have admitted patients with COVID-19 and have faced the challenging task of treating those patients while also taking measures to protect their patients and staff members who do not have COVID-19. The pandemic has caused, and may continue to cause, disruptions in Select Medical’s critical illness recovery hospitals, which include, in some cases, the addition or reduction of beds, the creation of isolated units and spaces, temporary increases or restrictions on admissions, the incurrence of additional costs, staff illnesses, and the increased use of contract clinical labor.

The following table shows the trend in net operating revenues, patient day volume, and occupancy rates for each of the periods presented, as well as the number of critical illness recovery hospitals Select Medical owned at the end of each period.

Rehabilitation Hospital Segment. Select Medical’s rehabilitation hospitals receive most of their admissions from general acute care hospitals. Both CMS and Congress acted to temporarily suspend certain regulations that govern admissions into rehabilitation hospitals in order to facilitate the transfer of patients from general acute care hospitals and critical illness recovery hospitals. This was done in order to expand hospital bed capacity to care for COVID-19 patients. COVID-19 has been prevalent in certain markets that Select Medical serves; as a result, Select Medical’s rehabilitation hospitals have admitted patients with COVID-19 and have faced the challenging task of treating those patients while also taking measures to protect their patients and staff members who do not have COVID-19. The pandemic has caused, and will continue to cause, disruptions in Select Medical’s rehabilitation hospitals, which include, in some cases, the addition or reduction of beds, the creation of isolated units and spaces, temporary restrictions on admissions, the incurrence of additional costs, staff illnesses, and the increased use of contract clinical labor. At the beginning of the pandemic, elective surgeries at hospitals and other facilities were suspended, which reduced the need for inpatient rehabilitation services. Beginning in May, state governments and health departments began to ease these restrictions and hospitals began to perform elective surgeries again, which has since increased the need for the services provided by Select Medical’s rehabilitation hospitals.

The following table shows the trend in net operating revenues, patient day volume, and occupancy rates for each of the periods presented, as well as the number of rehabilitation hospitals Select Medical owned at the end of each period.

Outpatient Rehabilitation Segment. Beginning in mid-March, state governments began implementing mandatory closures of non-essential or non-life sustaining businesses, restricting travel and individual activities outside of the home, closing schools, and mandating other social distancing measures. Additionally, hospitals and other facilities began to suspend elective surgeries. As a result, Select Medical’s outpatient rehabilitation clinics experienced significantly less patient visit volume due to a decline in patient referrals from physicians, a reduction in workers’ compensation injury visits resulting from the temporary closure of businesses, and the suspension of elective surgeries which would have required outpatient rehabilitation services. Beginning in May, state governments began to ease restrictions imposed on individuals and businesses. Further, most physician offices have reopened for routine office visits and hospitals and other facilities have begun to perform elective surgeries again, which has since increased the need for services provided by Select Medical’s outpatient rehabilitation clinics.

The following table shows the trend in net operating revenues and patient visit volume for each of the periods presented, as well as the number of working days for each period.

Concentra Segment. Beginning in mid-March, state governments began placing significant restrictions on businesses and mandating closures of non-essential or non-life sustaining businesses, causing many employers to furlough their workforce and temporarily cease or significantly reduce their operations. These actions have had significant effects on Select Medical’s patient visit volumes. Beginning in May, state governments began to ease restrictions imposed on businesses and employers began to increase their workforce, which has since resulted in an increased need for occupational health services.

The following table shows the trend in net operating revenues and patient visit volume for each of the periods presented, as well as the number of working days for each period.

Stock Repurchase Program

The board of directors of Select Medical has authorized a common stock repurchase program to repurchase up to $500.0 million worth of shares of its common stock. The program has been extended until December 31, 2021, and will remain in effect until then, unless further extended or earlier terminated by the board of directors. Stock repurchases under this program may be made in the open market or through privately negotiated transactions, and at times and in such amounts as Select Medical deems appropriate. Select Medical funds this program with cash on hand and borrowings under its revolving credit facility.

Select Medical did not repurchase shares during the quarter ended September 30, 2020. Since the inception of the program through September 30, 2020, Select Medical has repurchased 38,580,908 shares at a cost of approximately $356.6 million, or $9.24 per share, which includes transaction costs.

Business Outlook

Select Medical is issuing an updated business outlook following the reporting of its third quarter 2020 results. Select Medical now expects for the full year of 2020 consolidated net operating revenues to be in the range of $5.44 billion to $5.50 billion and Adjusted EBITDA for the full year of 2020 to be in the range of $745.0 million to $765.0 million. Select Medical now expects fully diluted earnings per common share for the full year 2020 to be in the range of $1.65 to $1.75 and adjusted earnings per common share for the full year 2020 to be in the range of $1.61 to $1.71. Adjusted earnings per common share excludes the gains on sales of businesses and their related tax effects. Reconciliations of net income to Adjusted EBITDA and diluted earnings per common share to adjusted earnings per common share for the full year of 2020 are presented in table XI of this release.

Conference Call

Select Medical will host a conference call regarding its third quarter results, as well as its business outlook and the impact of the COVID-19 pandemic on each of its reporting segments, on Friday, October 30, 2020, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 6297066. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 11:00am ET, November 6, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 6297066. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Certain statements contained herein that are not descriptions of historical facts are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to factors including the following:

developments related to the COVID-19 pandemic including, but not limited to, the duration and severity of the pandemic, additional measures taken by government authorities and the private sector to limit the spread of COVID-19, and further legislative and regulatory actions which impact healthcare providers, including actions that may impact the Medicare program;
changes in government reimbursement for our services and/or new payment policies may result in a reduction in net operating revenues, an increase in costs, and a reduction in profitability;
the failure of our Medicare-certified long term care hospitals or inpatient rehabilitation facilities to maintain their Medicare certifications may cause our net operating revenues and profitability to decline;
the failure of our Medicare-certified long term care hospitals and inpatient rehabilitation facilities operated as "hospitals within hospitals" to qualify as hospitals separate from their host hospitals may cause our net operating revenues and profitability to decline;
a government investigation or assertion that we have violated applicable regulations may result in sanctions or reputational harm and increased costs;
acquisitions or joint ventures may prove difficult or unsuccessful, use significant resources or expose us to unforeseen liabilities;
our plans and expectations related to our acquisitions and our ability to realize anticipated synergies;
private third-party payors for our services may adopt payment policies that could limit our future net operating revenues and profitability;
the failure to maintain established relationships with the physicians in the areas we serve could reduce our net operating revenues and profitability;
shortages in qualified nurses, therapists, physicians, or other licensed providers, or the inability to attract or retain healthcare professionals due to the heightened risk of infection related to the COVID-19 pandemic, could increase our operating costs significantly or limit our ability to staff our facilities;
competition may limit our ability to grow and result in a decrease in our net operating revenues and profitability;
the loss of key members of our management team could significantly disrupt our operations;
the effect of claims asserted against us could subject us to substantial uninsured liabilities;
a security breach of our or our third-party vendors’ information technology systems may subject us to potential legal and reputational harm and may result in a violation of the Health Insurance Portability and Accountability Act of 1996 or the Health Information Technology for Economic and Clinical Health Act; and
other factors discussed from time to time in our filings with the Securities and Exchange Commission (the "SEC"), including factors discussed under the heading "Risk Factors" of the quarterly reports on Form 10-Q and of the annual report on Form 10-K for the year ended December 31, 2019.
Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, or otherwise. You should not place undue reliance on our forward-looking statements. Although we believe that the expectations reflected in forward-looking statements are reasonable, we cannot guarantee future results or performance.

On October 29, 2020 Novocure (NASDAQ: NVCR) reported it has entered into a strategic alliance with the NYU Grossman School of Medicine’s Department of Radiation Oncology that provides a framework for preclinical and clinical development projects studying Tumor Treating Fields (Press release, NovoCure, OCT 29, 2020, View Source [SID1234569414]). Novocure’s Tumor Treating Fields are electric fields that disrupt cancer cell division.

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"It is our goal to establish NYU as a center for Tumor Treating Fields research and development based on the academic interests of the Department of Radiation Oncology and its collaborators," said Dr. Erik Sulman, co-director of the Brain and Spine Tumor Center at NYU Langone’s Perlmutter Cancer Center. "This partnership will help bring us closer to our goal through the development of preclinical and clinical shared platforms, and facilitate rapid clinical trial development."

Research to be conducted is designed to further the understanding of the interaction between Tumor Treating Fields and radiation therapy, to study Tumor Treating Fields in combination with various pharmacological agents, and to identify new indications for use. This translational research is intended to deepen the understanding of Tumor Treating Fields’ effects on cancer and to fuel development of new treatment strategies.

"We are excited to partner with a leading U.S. academic institution and look forward to working with NYU’s top researchers," said William Doyle, Novocure’s Executive Chairman. "We believe that collaborations with leading academic research centers signify growing interest in Tumor Treating Fields across the scientific community and advance our mission to extend survival in some of the most aggressive forms of cancers."

On October 29, 2020 Elpis Biopharmaceuticals reported the closing of a $30 million Series A financing to propel solid tumor and hematological disease therapeutics through pre-clinical studies, which brings the company to a total of $40 million raised including seed funding (Press release, Elpis Biopharmaceuticals, OCT 29, 2020, View Source [SID1234569412]). The investment is part of a new strategic partnership with a global pharmaceutical company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Elpis Biopharmaceuticals also welcomes seasoned translational and clinical research investigator to the Scientific Advisory Board – Michael Atkins MD, Deputy Director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC and Professor of Oncology and Medicine (Hematology/Oncology) at Georgetown University School of Medicine.

"We are excited to have this financial support as we continue to advance our pre-clinical assets," said Yan Chen, President and Chief Executive Officer at Elpis Biopharmaceuticals. "We believe our biologics platforms enable us to discover and engineer better treatment options for cancer patients and look forward to continuing to grow and advance our pipeline into the clinic. Michael brings significant expertise in cancer immunotherapy from his distinguished tenure at leading medical institutions. We are looking forward to leveraging his expertise, as well as other scientific experts, to guide us as we bring effective treatment options to patients as soon as possible."

Dr. Atkins is a leader in translational and clinical research. He began his career at Tufts Medical Center before moving to Beth Israel Deaconess Medical Center and being appointed Professor at Harvard Medical School where he served as Deputy Chief of the Division of Hematology/Oncology and leader of the Biologic Therapy and Cutaneous Oncology Programs, as well as Co-PI of the Harvard Skin Cancer SPORE, leader of the Dana Farber Harvard Cancer Center Kidney Cancer Program and Director of the DF/HCC Kidney Cancer SPORE. In 2012, he became the Deputy Director of the Georgetown Lombardi Comprehensive Cancer Center and William M. Scholl Professor and Vice Chair of the Department of Oncology. He is the former president of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and currently co-Chair of the Melanoma Research Foundation Scientific Advisory Council. His current research focuses on immunotherapy for melanoma, renal cell carcinoma, and predictive biomarkers for biologic therapy response.

"I am excited to join the Elpis Scientific Advisory Board and provide guidance as they propel their pre-clinical candidates forward," said Michael Atkins. "The Elpis platforms use unique approaches to address cancer resistance and have the potential to bring about the next generation of transformative cancer immunotherapeutic candidates."

Elpis’ proprietary mRNADisTM antibody discovery and mSCAFold rational protein engineering platforms enable rapid and robust discovery of novel bi-specific antibodies, dual targeting and armored CAR-T, and mechanism re-directed immunomodulator proteins.

Elpis has a broad preclinical pipeline aimed at overcoming tumor resistance by synergizing multiple mechanisms ranging from tumor targeting to immune cell activation. The Company’s lead immuno-oncology product candidates EPIM-001, a bispecific and engineered dual functional IL-2Rβ agonist with minimal IL-2Rα activation to treat solid tumor indications, and EPC-001, a CD19/CD22 dual targeting CAR-T to treat B Cell malignancies, are being advanced to enter clinical studies.