PTC Therapeutics Reports First Quarter 2020 Financial Results and Provides a Corporate Update

On April 30, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the first quarter ending March 31, 2020 (Press release, PTC Therapeutics, APR 30, 2020, View Source [SID1234556875]).

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"PTC continued to execute on our strategic priorities including the development and commercial fronts in the first quarter highlighted by DMD franchise revenue growth and strong risdiplam results," said Stuart Peltz, Ph.D., CEO of PTC Therapeutics. "The breadth of positive clinical risdiplam data reinforces the global commercial competitive profile of this therapy, which has the potential to be the first and only at-home SMA treatment, a critical advantage in the COVID-19 environment. We look forward to a number of potential value-creating catalysts including the risdiplam PDUFA date, and multiple clinical milestones in the upcoming months."

Key First Quarter and Other Corporate Updates:

Total net product revenues were $68.2 million across our commercial portfolio in the first quarter of 2020 representing 28% year over year growth. Translarna (ataluren) net product revenues were $40.5 million for the first quarter of 2020 and Emflaza (deflazacort) net product revenues were $27.5 million for the first quarter of 2020.
PTC announced the appointments of Matthew Klein, M.D., to Chief Development Officer and Eric Pauwels to Chief Business Officer.
Due to the uncertainty of the duration and severity of the COVID-19 impact, PTC is withdrawing financial guidance for the 2020 fiscal year.
Compelling Data Across Patients with Type 1, 2 & 3 SMA

The FIREFISH Part 2 data in type 1 Spinal muscular atrophy (SMA) patients demonstrated achievement of motor milestones and motor function improvements not observed in natural history. The study met its primary endpoint (p<0.0001), with 12 of 41 patients sitting, and all of its key secondary endpoints. Safety data was consistent with the known safety profile. There were no new safety signals and risdiplam was generally well tolerated.
The clinical data from Part 2 of the pivotal SUNFISH study evaluating risdiplam in people aged 2-25 years with non-ambulatory type 2 and type 3 SMA demonstrated statistically significant results in primary and key secondary endpoints. Safety for risdiplam was consistent with its known safety profile and no new safety signals were identified.
Risdiplam clinical studies are ongoing, including RAINBOWFISH and JEWELFISH. When necessary, patients are receiving drug through contactless home delivery to ensure study compliance.
Earlier this year, Roche opened early access programs in the United States (U.S.) and European countries for type 1 SMA patients. Recently, Roche announced that the program will be expanded to include patients with type 2 SMA in countries where applicable, at the moment of filing of the regulatory application for risdiplam. In addition, in response to requests received as well as to the unique pressures of the COVID-19 pandemic, Roche has decided to amend the programs for type 1 and type 2 patients whose current treatment have been interrupted as a direct consequence of the COVID-19 pandemic. The Prescription Drug User Fee Act (PDUFA) date for risdiplam is now August 24, 2020, following the submission of additional data including SUNFISH Part 2.
Advancing Gene Therapy Platform

PTC now expects to file the biologics license application (BLA) submission with the U.S. Food and Drug Administration (FDA) in the second half of 2020 for its gene therapy program for Aromatic L-amino acid decarboxylase (AADC) deficiency. The study of the use of the commercial cannula in young patients has been delayed due to COVID-19.
The Marketing Authorization Application (MAA) process in the European Union (EU) for the AADC deficiency program is ongoing and PTC expects to receive the Committee for Medicinal Products for Human Use (CHMP) final opinion by the end of 2020.
For our Friedreich ataxia (FA) and Angelman syndrome gene therapy programs, COVID-19 has impacted multiple investigational new drug application (IND) enabling activities. Therefore, we now anticipate the IND filings will be delayed by at least one quarter and we will provide an update on timing as we better understand the impact of COVID-19.
Due to COVID-19, PTC has deferred certain capital expenditures related to our leased biologics facility in Hopewell Township, New Jersey and now anticipates that GMP manufacturing of clinical material at this facility will begin in early 2021.
Updates in PTC’s Diverse Product Pipeline

PTC now anticipates results from the U.S. Translarna dystrophin study in the third quarter of 2020. Due to COVID-19, the study site is currently closed to elective procedures, which includes those required to complete the dystrophin study.
The Huntington disease program remains on track to be in healthy volunteers prior to the end of 2020. A development candidate has been chosen and IND toxicology studies are ongoing.
PTC now expects to initiate potential registrational trials in its Bio-e platform with PTC743 in refractory mitochondrial epilepsy in the third quarter of 2020 and in Friedreich ataxia in the fourth quarter of 2020. The initiation of these studies has been delayed due to COVID-19.
The Phase 1 trial of PTC857, which is being developed for GBA Parkinson’s disease, remains on track to start in the third quarter, with no current delays due to COVID-19.
In the interest of the health and safety of employees and guests, PTC has postponed the Analyst Day previously scheduled for mid-June. We plan to host virtual deep dives on our platforms throughout the year.
Financial Highlights:

Total revenues were $68.3 million for the first quarter of 2020, compared to total revenues of $53.6 million for the first quarter of 2019.
Translarna net product revenues were $40.5 million for the first quarter of 2020, compared to $35.3 million for the first quarter of 2019. These results reflect an increase in net product sales in existing markets as well as continued geographic expansion into new territories.
Emflaza net product revenues were $27.5 million for the first quarter of 2020, compared to $17.8 million for the first quarter of 2019. These results reflect new patient growth driven in part by diagnostic and educational efforts as well as ongoing operational improvements.
Generally accepted accounting principles in the United States (GAAP) research and development (R&D) expenses were $90.1 million for the first quarter of 2020, compared to $52.6 million for the first quarter of 2019. The increase in R&D expenses reflects costs associated with advancing the gene therapy and Bio-e platforms and increased investment in research programs as well as advancements of the clinical pipeline.
Non-GAAP R&D expenses were $81.9 million for the first quarter of 2020, excluding $8.2 million in non-cash stock-based compensation expense, compared to $47.9 million for the first quarter of 2019, excluding $4.7 million in non-cash stock-based compensation expense.
GAAP selling, general and administrative (SG&A) expenses were $58.2 million for the first quarter of 2020, compared to $40.6 million for the first quarter of 2019, reflecting continued investment to support our commercial activities including our expanding commercial portfolio.
Non-GAAP SG&A expenses were $51.2 million for the first quarter of 2020, excluding $7.0 million in non-cash stock-based compensation expense, compared to $36.0 million for the first quarter of 2019, excluding $4.6 million in non-cash stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $0.9 million for the first quarter of 2020, compared to $21.2 million for the first quarter of 2019. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
In discussions with certain former shareholders of Agilis, PTC has agreed to exchange their pro rata share of specific future cash milestone payments in the aggregate amount of $225 million for a mixture of cash and equity. Under this agreement, which the former shareholders and PTC entered into on April 29th, PTC has pre-paid 94% of time-based cash milestones due in August 2020, and has agreed to issue 2,821,176 shares of common stock in exchange for 94% of future cash milestones for the AADCd BLA approval by the FDA and the receipt of a Priority Review Voucher in connection with that approval.
Net loss was $112.7 million for the first quarter of 2020, compared to net loss of $72.1 million for the first quarter of 2019.
Cash, cash equivalents and marketable securities totaled $595.9 million at March 31, 2020, compared to $686.6 million at December 31, 2019.
Shares issued and outstanding as of March 31, 2020 were 62,758,520.
Due to the uncertainty with respect to the duration, nature and extent of impacts of the COVID-19 pandemic and responsive measures relating thereto, we cannot be certain that the pandemic will not cause us to experience further delays to the timelines set forth above or other negative additional impacts.

Today’s Conference Call and Webcast Reminder:
Today’s conference call will take place at 4:30 pm (ET) and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 8267466. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

CryoLife Reports First Quarter 2020 Financial Results

On April 30, 2020 CryoLife Reported that First Quarter 2020 Financial Results (Press release, CryoLife, APR 30, 2020, View Source [SID1234556874])

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First Quarter and Recent Business Highlights:

Achieved total revenues of $66.4 million in the first quarter 2020 versus preliminary first quarter 2020 revenues of $65.5 million
Total revenues decreased 2% and decreased 1% on a constant currency basis versus first quarter 2019
Excluding TMR, total revenues increased 1% and increased 2% on a constant currency basis versus first quarter of 2019
Received CE Mark for our Frozen Elephant Trunk E-vita OPEN NEO
Received renewed CE Mark status for our AAP Ascending Aortic Prosthesis
Secured Credit Facility Covenant Modification to Enhance Liquidity
CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the first quarter ended March 31, 2020.

"During these challenging times, we are focused on protecting our employees’ health and safety while continuing to supply our customers and patients who depend on our life saving and life sustaining products," commented Pat Mackin, Chairman, President, and Chief Executive Officer. "Our business is well suited to weather the impact of this global pandemic given the nature of the procedures in which our products are used. Our manufacturing facilities have been running at near capacity and our supply chain remained largely intact. We have continued to fund R&D programs related to products that could deliver revenue in 2021 and 2022, including our U.S. PerClot PMA, BioGlue China and PROACT Mitral. Further, we renegotiated our Credit Facility covenant to have greater financial flexibility, if necessary. Given our recent device approvals, and the ongoing progress made on our key growth initiatives, we expect 2021 to be a strong year for CryoLife."

First Quarter 2020 Financial Results
Total revenues for the first quarter of 2020 were $66.4 million, reflecting a decrease of (2%), and (1%) on a non-GAAP constant currency basis, both compared to the first quarter of 2019. Growth in tissue processing and On-X revenues was offset by decreases in BioGlue and JOTEC revenues.

Net loss for the first quarter of 2020 was ($6.7) million, or ($0.18) per fully diluted common share, compared to a net loss of ($297,000), or ($0.01) per fully diluted common share for the first quarter of 2019. Non-GAAP net loss for the first quarter of 2020 was ($3.0) million, or ($0.08) per fully diluted common share, compared to non-GAAP net income of $1.5 million, or $0.04 per fully diluted common share for the first quarter of 2019. Net loss on both a GAAP and non-GAAP basis reflects a $3.7 million pretax loss primarily related to non-cash unrealized foreign currency losses on intercompany payable balances.

2020 Financial Outlook
As previously reported on April 1, 2020, the Company has withdrawn its 2020 financial guidance due to uncertainties resulting from the COVID-19 pandemic.

All numbers are presented on a GAAP basis except where expressly referenced as non-GAAP. The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.

The Company’s financial performance for 2020 is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP. In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies. The Company’s non-GAAP net income and non-GAAP EBITDA results exclude (as applicable) business development and integration expenses, amortization expense, inventory basis step-up expense, loss on foreign currency revaluation, stock-based compensation expense, and corporate rebranding expenses. The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions; the operating expense structure of the Company’s existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense. The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations or can vary significantly between periods as a result of factors such as acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has excluded the impact of changes in currency exchange from certain revenues to evaluate growth rates on a constant currency basis. The Company does, however, expect to incur similar types of expenses and currency exchange impacts in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, April 30, 2020 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through May 7, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13702193.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

Viking Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Update

On April 30, 2020 Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, reported its financial results for the first quarter ended March 31, 2020, and provided an update on its clinical pipeline and other corporate developments (Press release, Viking Global Investors, APR 30, 2020, View Source [SID1234556873]).

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Highlights from the Quarter Ended March 31, 2020:

"During the first quarter, we made continued progress on our Phase 2b VOYAGE clinical trial evaluating VK2809 in patients with biopsy-confirmed NASH and fibrosis," stated Brian Lian, Ph.D., chief executive officer of Viking Therapeutics. "We have been proactive in implementing steps to mitigate the potential impact of the coronavirus pandemic, and are closely monitoring this evolving challenge. We are encouraged that enrolled patients continue to receive treatment, new patients continue to enroll, and clinical site activations remain ongoing. That said, the pandemic has disrupted each of these activities on some level. We currently anticipate completion of enrollment in VOYAGE in the first half of 2021. In the first quarter, we also made progress with our second thyroid hormone receptor beta agonist, VK0214, for the treatment of X-linked adrenoleukodystrophy. We currently expect to submit an IND for VK0214 this summer and initiate clinical studies with this candidate in the third quarter. Finally, we remain vigilant in managing our balance sheet and ended the quarter with $269 million in cash and cash equivalents, which we believe provides sufficient runway to accomplish multiple development milestones."

Pipeline and Corporate Highlights

Enrollment continues in Phase 2b VOYAGE study evaluating VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, and has demonstrated promising therapeutic potential in a range of lipid disorders, including NASH. In September 2018, the company announced positive results from a 12-week Phase 2 trial of VK2809 in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD). Patients receiving VK2809 in this study demonstrated potent reductions in liver fat content and plasma lipids compared with patients receiving placebo.

In 2019, the company initiated the Phase 2b VOYAGE trial. This trial is a randomized, double-blind, placebo-controlled, multicenter study designed to assess the efficacy, safety and tolerability of VK2809 in patients with biopsy-confirmed NASH and fibrosis ranging from stages F1 to F3. The study is targeting enrollment of approximately 340 patients across five treatment arms: 1.0 mg daily; 2.5 mg daily; 5.0 mg every other day; 10.0 mg every other day; and placebo.

The primary endpoint of the study will evaluate the relative change in liver fat content, as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) from baseline to Week 12 in subjects treated with VK2809, as compared to placebo. Secondary objectives include evaluation of histologic changes assessed by hepatic biopsy after 52 weeks of dosing. Enrollment is continuing at U.S. sites, with ex-U.S. sites expected to open later this year.

Additional data from VK2809 Phase 2 trial to be highlighted in podium presentation at EASL. An abstract describing additional data from the company’s completed 12-week Phase 2 trial of VK2809 in patients with NAFLD and hypercholesterolemia has been selected for oral presentation at the 2020 International Liver Congress, hosted by the European Association for the Study of the Liver (EASL). Due to the COVID-19 pandemic, this event has been postponed until August 25-28, 2020.

IND-enabling work near completion for VK0214 for the treatment of X-ALD – IND filing expected mid-year. VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy (X-ALD), a devastating disease for which there is currently no therapeutic treatment. X-ALD is caused by a defect in the ABCD1 peroxisomal transporter. This defect can result in an accumulation of very long chain fatty acids in plasma and tissue, which is believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease.

To date, findings from in vitro and in vivo studies have demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue, potentially leading to a therapeutic benefit. These promising results were achieved through the company’s ongoing collaboration with the Kennedy Krieger Institute – one of the world’s leading X-ALD research centers. The company plans to file an IND in mid-2020 and initiate clinical studies in the third quarter.

Balance sheet remains strong with approximately $270 million in cash. Viking completed the first quarter of 2020 with $269.2 million in cash, cash equivalents and short-term investments.

Upcoming investor events. Viking management will participate in the following upcoming investor events:
6th Annual SunTrust Robinson Humphrey Life Science Summit
Date: May 5- 6, 2020
Virtual Format

UBS Global Healthcare Conference
Dates: May 18 – 20, 2020
Virtual Format

Jefferies Global Healthcare Conference
Dates: June 2 –4, 2020
Virtual Format

Raymond James Healthcare Conference
Dates: June 16 – 17, 2020
Virtual Format

Q1 2020 Financial Highlights

Research and development expenses for the three months ended March 31, 2020 were $8.0 million compared to $4.5 million for the same period in 2019. The increase was primarily due to increased expenses related to our clinical studies, with the initiation of the Phase 2b VOYAGE study in November 2019, pre-clinical studies, and manufacturing for our drug candidates, partially offset by decreased expenses related to services provided by third-party consultants.

General and administrative expenses for the three months ended March 31, 2020 were $3.0 million compared to $2.3 million for the same period in 2019. The increase was primarily due to increased expenses related to stock-based compensation, legal expenses, and salaries and benefits, partially offset by decreased expenses related to services provided by third-party consultants and professional fees.

For the three months ended March 31, 2020, Viking reported a net loss of $9.7 million, or $0.13 per share, compared to a net loss of $4.9 million, or $0.07 per share, in the corresponding period in 2019. The increase in net loss and net loss per share for the three months ended March 31, 2020 was primarily due to increased research and development and general and administrative expenses noted previously, as well as decreased interest income due to the decline in interest rates throughout the first quarter of 2020 as compared to prevailing interest rates during the first quarter of 2019.

Balance Sheet as of March 31, 2020

At March 31, 2020, Viking held cash, cash equivalents and short-term investments totaling $269.2 million and had 72,562,863 shares of common stock outstanding.

Conference Call

Management will host a conference call to discuss the company’s first quarter 2020 financial results today at 4:30 pm Eastern. To participate in the conference call, please dial (844) 850-0543 from the U.S. or (412) 317-5199 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until May 7, 2020 by dialing (877) 344-7529 from the U.S. or (412) 317-0088 from outside the U.S. and entering conference ID # 10141875. Those interested in listening to the conference call live via the internet may do so by visiting the Investor Relations section of Viking’s website at www.vikingtherapeutics.com. An archive of the webcast will be available for 30 days on the company’s website at www.vikingtherapeutics.com.

Select Medical Holdings Corporation Announces Results For Its First Quarter Ended March 31, 2020

On April 30, 2020 Select Medical Holdings Corporation reported results for its first quarter ended March 31, 2020 (Press release, Select Medical, APR 30, 2020, View Source [SID1234556872]).

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For the first quarter ended March 31, 2020, net operating revenues increased 6.8% to $1,414.6 million, compared to $1,324.6 million for the same quarter, prior year. Income from operations increased 15.2% to $128.7 million for the first quarter ended March 31, 2020, compared to $111.7 million for the same quarter, prior year. Net income increased 32.1% to $70.4 million for the first quarter ended March 31, 2020, compared to $53.3 million for the same quarter, prior year. For both the first quarters ended March 31, 2020 and 2019, net income included pre-tax gains on sales of businesses of $7.2 million and $6.5 million, respectively. Adjusted EBITDA increased 10.1% to $187.3 million for the first quarter ended March 31, 2020, compared to $170.1 million for the same quarter, prior year. Earnings per common share increased to $0.40 on a fully diluted basis for the first quarter ended March 31, 2020, compared to $0.30 for the same quarter, prior year. Adjusted earnings per common share was $0.37 on a fully diluted basis for the first quarter ended March 31, 2020, compared to $0.27 for the same quarter, prior year. Adjusted earnings per common share excludes the gains on sales of businesses and their related tax effects for both of the quarters ended March 31, 2020 and 2019. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table VI of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table VII of this release.

Please refer to "Effects of the COVID-19 Pandemic on Select Medical’s Results of Operations" for further discussion regarding the impact of the coronavirus disease 2019 ("COVID-19") pandemic on Select Medical’s operating results for the first quarter ended March 31, 2020.

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 March 31, 2020, Select Medical operated 101 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,753 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. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At March 31, 2020, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Critical Illness Recovery Hospital Segment

For the first quarter ended March 31, 2020, net operating revenues for the critical illness recovery hospital segment increased 9.4% to $500.5 million, compared to $457.5 million for the same quarter, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 21.3% to $88.6 million for the first quarter ended March 31, 2020, compared to $73.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 17.7% for the first quarter ended March 31, 2020, compared to 16.0% for the same quarter, prior year. Certain critical illness recovery hospital key statistics are presented in table V of this release for both the first quarters ended March 31, 2020 and 2019.

Rehabilitation Hospital Segment

For the first quarter ended March 31, 2020, net operating revenues for the rehabilitation hospital segment increased 17.8% to $182.0 million, compared to $154.6 million for the same quarter, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 49.5% to $38.6 million for the first quarter ended March 31, 2020, compared to $25.8 million for the same quarter, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 21.2% for the first quarter ended March 31, 2020, compared to 16.7% for the same quarter, prior year. For the first quarter ended March 31, 2019, the Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $2.8 million. Certain rehabilitation hospital key statistics are presented in table V of this release for both the first quarters ended March 31, 2020 and 2019.

Outpatient Rehabilitation Segment

For the first quarter ended March 31, 2020, net operating revenues for the outpatient rehabilitation segment increased 3.4% to $255.2 million, compared to $246.9 million for the same quarter, prior year. Adjusted EBITDA for the outpatient rehabilitation segment was $27.1 million for the first quarter ended March 31, 2020, compared to $29.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 10.6% for the first quarter ended March 31, 2020, compared to 11.7% for the same quarter, prior year. Certain outpatient rehabilitation key statistics are presented in table V of this release for both the first quarters ended March 31, 2020 and 2019.

Concentra Segment

For the first quarter ended March 31, 2020, net operating revenues for the Concentra segment increased 0.6% to $398.5 million, compared to $396.3 million for the same quarter, prior year. Adjusted EBITDA for the Concentra segment was $61.5 million for the first quarter ended March 31, 2020, compared to $66.3 million for the same quarter, prior year. The Adjusted EBITDA margin for the Concentra segment was 15.4% for the first quarter ended March 31, 2020, compared to 16.7% for the same quarter, prior year. Certain Concentra key statistics are presented in table V of this release for both the first quarters ended March 31, 2020 and 2019.

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

The broader implications of the COVID-19 pandemic on Select Medical’s results of operations and overall financial performance remain uncertain. Select Medical is a healthcare service provider that provides patient care services in both inpatient and outpatient settings. Select Medical has provided certain additional performance metrics to assist readers in understanding how the COVID-19 pandemic impacted each of its segments during the one month ended March 31, 2020, including its (i) net operating revenues and Adjusted EBITDA for the two months ended February 29, 2020 and February 28, 2019, (ii) net operating revenues and Adjusted EBITDA for the one month ended March 31, 2020 and 2019, (iii) net operating revenues and Adjusted EBITDA for the quarters ended March 31, 2020 and 2019, and (iv) certain operating statistics for each of the aforementioned periods.

Critical Illness Recovery Hospital Segment. Select Medical’s critical illness recovery hospitals are a key part 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 impact 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. As COVID-19 has spread in the general acute care hospitals in many markets where it operates, Select Medical has admitted patients with COVID-19 and has faced the challenging task of treating them while attempting to protect its patients and staff members who do not have COVID-19. The hospitals have followed CDC guidelines, directives and recommendations with regard to the use of personal protective equipment and the isolation and treatment of patients with COVID-19. The pandemic has caused, and will 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.

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 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. As COVID-19 has spread in the general acute care hospitals in many markets where it operates, Select Medical has admitted patients with COVID-19 and has faced the challenging task of treating them while attempting to protect its patients and staff members who do not have COVID-19. The hospitals have followed CDC guidelines, directives and recommendations with regard to the use of personal protective equipment and the isolation and treatment of patients with 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. Additionally, elective surgeries at hospitals and other facilities have been suspended which is reducing the need for inpatient rehabilitation services.

Outpatient Rehabilitation Segment. Beginning in mid-March, hospitals and other facilities began to suspend elective surgeries. Additionally, state governments in the areas experiencing the most significant growth of COVID-19 infections began implementing mandatory closures of non-essential or non-life sustaining businesses, restrictions on individual activities outside of the home, restrictions on travel, and closures of schools. These actions continued to expand throughout March and by the end of March, most states implemented significant restrictions on businesses and individuals. The suspension of elective surgeries at hospitals and other facilities and the reduction of physician office visits combined with recommendations of social distancing and the other items noted above have had significant effects on patient visit volumes. As a result, Select Medical has temporarily consolidated the operations of some of its clinics by transferring staff and patients.

Concentra Segment. Beginning in mid-March, state governments in the areas experiencing the most significant growth of COVID-19 infections began implementing mandatory closures of non-essential or non-life sustaining businesses. These actions have continued to expand throughout March. By the end of March, most states implemented significant restrictions on businesses. These actions have had significant effects on patient visit volumes as employers have furloughed workforces and temporarily ceased operations or have significantly reduced their operations. As a result, Select Medical has temporarily consolidated the operations of some of its centers by transferring staff and patients.

Select Medical provided below certain performance measures and operating statistics used by management to help illustrate the impact of the COVID-19 pandemic on its operating results. For the quarter ended March 31, 2020, Select Medical defined the pre-COVID-19 outbreak period as the two months ended February 29, 2020, and the post-COVID-19 outbreak period as the one month ended March 31, 2020. Select Medical provided prior year comparative data for the pre-COVID-19 and post-COVID-19 outbreak periods presented. The following performance measures and operating statistics should be considered in conjunction with the operating results for the full quarter ended March 31, 2020. The performance measures and operating statistics presented for the two months ended February 29, 2020 and the one month ended March 31, 2020 are, when combined, equal to the performance measures and operating statistics presented for the full quarter ended March 31, 2020. The same is true for the prior year comparative data.

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, 2020, 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.

During the quarter ended March 31, 2020, Select Medical repurchased 491,559 shares at a cost of approximately $8.7 million, an average cost per share of $17.68, which includes transaction costs. Since the inception of the program through March 31, 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.

Conference Call

Select Medical will host a conference call regarding its first quarter results, as well as its business outlook and the impact of the COVID-19 pandemic on each of its reportable segments, on Friday, May 1, 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 2296334. 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 12:00pm ET, May 8, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 2296334. 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.

II. Earnings per Share
For the Three Months Ended March 31, 2019 and 2020
(In thousands, except per share amounts, unaudited)

Select Medical’s capital structure includes common stock and unvested restricted stock awards. To compute earnings per share ("EPS"), Select Medical applies the two-class method because its unvested restricted stock awards are participating securities which are entitled to participate equally with its common stock in undistributed earnings.

III. Condensed Consolidated Balance Sheets

IV. Condensed Consolidated Statements of Cash Flows
For the Three Months Ended March 31, 2019 and 2020
(In thousands, unaudited)

V. Key Statistics
For the Three Months Ended March 31, 2019 and 2020

VI. Net Income to Adjusted EBITDA Reconciliation
For the Three Months Ended March 31, 2019 and 2020
(In thousands, unaudited)

The presentation of Adjusted EBITDA is important to investors because Adjusted EBITDA is commonly used as an analytical indicator of performance by investors within the healthcare industry. Adjusted EBITDA is used to evaluate financial performance and determine resource allocation for each of Select Medical’s operating segments. Adjusted EBITDA is not a measure of financial performance under generally accepted accounting principles ("GAAP"). Items excluded from Adjusted EBITDA are significant components in understanding and assessing financial performance. Adjusted EBITDA should not be considered in isolation or as an alternative to, or substitute for, net income, income from operations, cash flows generated by operations, investing or financing activities, or other financial statement data presented in the consolidated financial statements as indicators of financial performance or liquidity. Because Adjusted EBITDA is not a measurement determined in accordance with GAAP and is thus susceptible to varying definitions, Adjusted EBITDA as presented may not be comparable to other similarly titled measures of other companies.

VII. Reconciliation of Earnings per Common Share to Adjusted Earnings per Common Share
For the Three Months Ended March 31, 2019 and 2020
(In thousands, except per share amounts, unaudited)

Adjusted net income attributable to common shares and adjusted earnings per common share are not measures of financial performance under GAAP. Items excluded from adjusted net income attributable to common shares and adjusted earnings per common share are significant components in understanding and assessing financial performance. Select Medical believes that the presentation of adjusted net income attributable to common shares and adjusted earnings per common share are important to investors because they are reflective of the financial performance of Select Medical’s ongoing operations and provide better comparability of its results of operations between periods. Adjusted net income attributable to common shares and adjusted earnings per common share should not be considered in isolation or as alternatives to, or substitutes for, net income, cash flows generated by operations, investing or financing activities, or other financial statement data presented in the consolidated financial statements as indicators of financial performance or liquidity. Because adjusted net income attributable to common shares and adjusted earnings per common share are not measurements determined in accordance with GAAP and are thus susceptible to varying calculations, adjusted net income attributable to common shares and adjusted earnings per common share as presented may not be comparable to other similarly titled measures of other companies.

ESSA Pharma Announces FDA Allowance of the Clinical Investigation of EPI-7386 in Prostate Cancer

On April 30, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (Nasdaq: EPIX, TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported that the U.S. Food and Drug Administration ("FDA") has notified the Company that it may proceed with its proposed clinical investigation of EPI-7386 for the treatment of metastatic castration-resistant prostate cancer ("mCRPC") (Press release, ESSA, APR 30, 2020, View Source [SID1234556871]). ESSA previously announced on March 30th, 2020 that it had filed an Investigational New Drug ("IND") application for EPI-7386 with the FDA. EPI-7386 is a first-in-class N-terminal domain inhibitor of the androgen receptor.

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"This is an important milestone for ESSA and we look forward to commencing our clinical trial with EPI-7386 as a potential new therapy for the treatment of prostrate cancer," commented David R. Parkinson, MD, CEO of ESSA. "The timing of this IND acceptance keeps us on track with our initial clinical development timeline. We are working with our initial clinical sites to ensure compliance with COVID-19 risk management guidance as provided by the FDA as well as site emergency plan policies to minimize any potential impact COVID-19 may have on site activation and patient enrollment."

ESSA expects the Phase 1 clinical trial to enroll approximately 18 mCRPC patients who are progressing on standard of care at selected clinical sites, with up to 10 additional patients enrolled in a dose expansion cohort. The study will evaluate safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy. A clinical trial application ("CTA") has been submitted to Health Canada and is pending authorization.