Select Medical Holdings Corporation Announces Business Outlook for 2020 and Release Date for Fourth Quarter and Full Year 2019 Financial Results

On January 27, 2020 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM), reported its business outlook for calendar year 2020 (Press release, Select Medical, JAN 27, 2020, View Source [SID1234553600]).

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Select Medical expects consolidated net operating revenues for the full year 2020 to be in the range of $5.575 billion to $5.675 billion. Select Medical expects net income before interest, income taxes, depreciation and amortization, stock compensation expense, other income/(expense), and equity in earnings/(losses), or Adjusted EBITDA for the full year 2020 to be in the range of $725 million to $760 million. Select Medical expects fully diluted income per common share for the full year 2020 to be in the range of $1.27 to $1.46.

Select Medical assumed total shares outstanding of 134.5 million when preparing the above business outlook for 2020. This share count includes unvested restricted shares, which have participation rights and are allocated an equitable portion of earnings under the two-class method for calculating income per common share.

The following is a reconciliation of full year 2020 Adjusted EBITDA expectations as computed to the low and high points of the range to the closet comparable GAAP financial measure. Refer to Select Medical’s most recent Form 10-Q filing for a discussion of Select Medical’s use of Adjusted EBITDA in evaluating financial performance and determining resource allocation. Each item presented in the table below is an estimation of full year 2020 expectations (dollars in millions).

Select Medical will release the financial results for its fourth quarter and full year ended December 31, 2019 on Thursday, February 20, 2020 after the market closes.

Select Medical will host a conference call regarding its fourth quarter and full year ending December 31, 2019 results on Friday, February 21, 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 8644656. 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, February 28, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 8644656. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

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 the number of facilities. Our reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of December 31, 2019, Select Medical operated 101 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,740 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 521 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At December 31, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.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:

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 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, 2018.
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.

Ningbo NewBay Medical Technology Co., Ltd. Announces a License Agreement with Genentech

On January 27, 2020 NewBay Medical Technology Co., Ltd., a subsidiary of Ningbo Tai Kang Medical Technology Co., Ltd. reported that it has entered into a licensing agreement with Genentech, a member of the Roche Group, under which it has been granted the exclusive global rights to further develop and commercialize GDC-0570, a small molecule Pan-PIM inhibitor that is active against multiple myeloma and prostate cancer in preclinical models (Press release, NewBay Medical Technology, JAN 27, 2020, View Source [SID1234553563]). PIM kinases regulate cell metabolism, growth and survival.

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"We are very pleased to enter this global exclusive license agreement with Genentech. We look forward to working with medical experts and global regulatory agents to accelerate clinical development of this promising investigational medicine," commented Dr. Zhenhai Shen, CEO of Ningbo NewBay Medical Technology Co., Ltd.

Under the agreement, Genentech will receive an upfront payment and will be eligible to receive milestone payments linked to clinical, regulatory and commercial successes, as well as royalty payments.

About GDC-0570

GDC-0570 is a small molecule Pan-PIM inhibitor discovered and developed by Genentech. PIM-1/2/3 are Serine/Threonine kinases which play an essential role in the regulation of signal transduction cascades. GDC-0570 is a potential first-in-class drug candidate.

Bavarian Nordic Announces Closing of Sale of Priority Review Voucher

On January 27, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the completion of the sale of its Priority Review Voucher (PRV) to an undisclosed buyer (Press release, Bavarian Nordic, JAN 27, 2020, View Source [SID1234553586]). Upon completion, the company received a cash consideration of USD 95 million.

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Arix Co-founds Quench Bio With Series A Financing

On January 27, 2020 Arix Bioscience plc ("Arix", LSE: ARIX) a global venture capital company focused on investing in and building breakthrough biotech companies, reported that its discovery portfolio company Quench Bio has emerged from stealth mode with the completion of a Series A financing (Press release, Arix Bioscience, JAN 27, 2020, View Source [SID1234553601]). This follows a period of company creation, with seed investment and close involvement by Arix.

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Led by a team of drug developers and scientists with deep experience in inflammation and small molecule drug discovery, Quench Bio’s lead therapeutic approach centres on inhibiting the protein Gasdermin D, which has recently been discovered as a key target at the core of multiple inflammatory cell death pathways, including pyroptosis and NETosis. This is at the cutting edge of contemporary drug development and a field of significant commercial interest by big pharma.

The company has built a highly experienced leadership team, led by Chief Executive Officer Samantha Truex, the former Chief Business Officer of Padlock Therapeutics, which was acquired by Bristol Myers Squibb in 2016.

Arix and Atlas Venture co-founded and seeded the company in 2018 along with co-founders Mark Tebbe, Ph.D., Chief Technology Officer, and Mike Nolan, Ph.D., Head of Biology, together with Arturo Zychlinsky and Herbert Waldmann, both Directors at The Max Planck Institute who collaborated with the Lead Discovery Center on inhibitors of NETosis and gasdermin.

In addition to Arix and its co-founding investor Atlas Venture, RA Capital led the Series A and were joined by AbbVie Ventures. Josh Resnick, Managing Director and co-head of Ventures at RA Capital and Adam Houghton, Head of AbbVie Ventures will join the board, alongside existing directors Jonathan Tobin of Arix Bioscience and Bruce Booth of Atlas Venture. Additionally, Arix’s John Cassidy will continue his role as Board Observer.

Jonathan Tobin, Investment Director at Arix and Board Director of Quench Bio, commented: "We are excited and privileged to work alongside such a distinguished team of entrepreneurs and co-investors to develop first-in-class medicines that could make a major difference to patients suffering from chronic inflammatory and auto-immune diseases. The genesis of Quench originated from our long-standing relationship with the Lead Discovery Center in Germany and its close connections with the Max Planck Society. It exemplifies the advantage of Arix’s transatlantic approach, combining the best of European and US science and talent."

Samantha Truex, Chief Executive Officer of Quench Bio, commented: "The successful financing underscores the potential of our innovative approach. We are delighted by the strong support from Arix as well as our existing and new investors and I look forward to leveraging their extensive experience as we develop multiple programs to target severe inflammatory diseases."

TILT Biotherapeutics Signs a Licensing Deal with Biotheus, Inc for Cancer Therapy with Oncolytic Virus TILT-123

On January 27, 2020 TILT Biotherapeutics ("TILT"), a privately held biopharmaceutical company based in Helsinki, Finland, reported that they have signed a license agreement with Biotheus Inc. ("Biotheus"), a privately held Chinese company based in Zhuhai, Guangdong, China (Press release, TILT Biotherapeutics, JAN 27, 2020, View Source [SID1234553564]). Under the agreement TILT has granted Biotheus rights for development and commercialization of TILT’s proprietary oncolytic virus TILT-123 in Greater China (including Mainland China, Hongkong, Taiwan and Macau).

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The license agreement includes an upfront payment as well as milestone payments linked to finishing of various phases of clinical development and obtaining marketing approvals. Under the agreement TILT is eligible to receive upfront and milestone payments as well as significant royalties on future sales.

"We are very happy to give our flagship product TILT-123 into the expert hands of Biotheus. TILT-123 is a unique product developed for activation of T-cells, and currently under clinical development in Europe and soon in the US. Biotheus has an interesting portfolio of synergic compounds and valuable development expertise in immuno-oncology. We believe that this collaboration greatly supports the global development and commercialization of TILT-123 while making the product also available to Chinese cancer patients." says Akseli Hemminki, MD, PhD, eMBA, Founder and CEO of TILT Biotherapeutics Ltd.

The patented TILT technology is based on novel oncolytic viruses coding for cytokines. The constructs are unique in structure, sequence and function. TILT-123 is a human 5/3 chimeric adenovirus capable of replicating only in cells defective in retinoblastoma/p16 pathway, found in most human tumors. TILT-123 was further modified to insert expression sequences for two cytokines: human Tumor Necrosis Factor alpha (hTNFα) and human Interleukin 2 (hIL-2).