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TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2020 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board (DSMB). The DSMB’s recommendation is based on an unblinded analysis of safety data from the first 70 patients treated for 14 days.

“With each review of unblinded safety data, by independent reviewers, as part of our development program, our confidence in the safety profile of opaganib increases further,” said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. “We are fast compiling a robust and extensive safety data set with opaganib, giving us good reason to look forward to the rapid conclusion of this study which, if positive, is expected to provide the necessary efficacy data to support the next step of emergency use applications in the first quarter of 2020.”

Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is more than 50% complete. The study, approved in six countries and rapidly enrolling across 22 study sites, is on track to deliver top line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation. A prescheduled, unblinded futility interim analysis will be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.

The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed enrollment of all 40 subjects, with topline data expected in the coming weeks. This study is not powered for efficacy and is focused on safety evaluation and identification of efficacy signals.

Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on the cause and effect of COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing likelihood of resistance due to viral mutations.

About Opaganib (ABC294640, Yeliva^®)

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood for resistance due to viral mutations. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19. Opaganib also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

Under a compassionate use program, patients with severe COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published[3]. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

About RedHill Biopharma    

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik^® for opioid-induced constipation in adults with non-cancer pain^[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults^[5], and Aemcolo^® for the treatment of travelers’ diarrhea in adults^[6]. RedHill’s key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva^®), a first–in–class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (iv) RHB-102 (Bekinda^®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB–106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words and include statements regarding the timing of the reporting of data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications of opaganib and reporting of topline data, safety analysis and of unblinded futility interim analysis for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company’s Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment, reporting of topline data, safety analysis and/or unblinded futility interim analysis will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia^®; (v) the Company’s ability to successfully commercialize and promote Movantik^®, Talicia^® and Aemcolo^®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

 

 

 

[1] Opaganib is an investigational new drug, not available for commercial distribution.

[2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

[3] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010

[4] Full prescribing information for Movantik^® (naloxegol) is available at: www.Movantik.com.  

[5] Full prescribing information for Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

[6] Full prescribing information for Aemcolo^® (rifamycin) is available at: www.Aemcolo.com.

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SOURCE RedHill Biopharma Ltd.

AUSTIN, Nov. 19, 2020 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases, has announced that Dr. Mark Eccleston, a founding scientist and Business Development Director at Volition, will today present preliminary results from its proof of concept clinical studies focused on monitoring disease progression of COVID-19 as part of the “Innovative COVID-19 Diagnostics” session at the virtual MEDICA LABMED FORUM.

Volition’s initial studies demonstrated that symptomatic COVID-19 patients have elevated circulating nucleosomes and, as a result, Volition has filed a novel patent for monitoring disease progression of COVID-19 and other NETosis associated infections. Preliminary results from ongoing longitudinal COVID-19 studies are expected to be released before the end of 2020. The Company plans to utilise the results of these current trials and other ongoing studies to further its aim of developing a clinically useful product to help in the COVID-19 pandemic, and potentially in other infections with dangerous complications caused by NETosis including influenza and sepsis.

The presentation, “Circulating nucleosomes as potential prognostic markers for COVID-19 disease severity” will outline the data compiled so far to support the Company’s use of its Nu.Q™ Nucleosomics™ technology to identify cell free circulating nucleosomes associated with elevated NETosis – the body’s immune response to an infection – in “at risk” individuals with COVID-19.

Data from two independent cohorts of COVID-19 positive patients with quantitative nucleosome immunoassays showed that nucleosomes were highly elevated in the plasma of patients with severe COVID-19, relative to healthy control subjects. The data showed that the levels of both histone 3.1 variant and citrullinated nucleosomes increased with disease severity.

The highest levels of nucleosomes were found in patients requiring artificial ventilation or extracorporeal oxygenation. Volition believes that it is possible, therefore, that nucleosomes could be used to monitor disease progression in COVID-19 positive patients and potentially other diseases such as influenza and sepsis.

Nu.Q H3.1 increased with disease severity.

Early identification and triaging of at-risk COVID-19 patients to determine those most likely to deteriorate and require critical care would enable both improved outcomes for patients and a more efficient use of critical care resources for healthcare providers.

Dr. Eccleston said: “We are very pleased to be invited to present data at the MEDICA LABMED FORUM on the work we are doing to use circulating nucleosomes to monitor COVID-19. As we see the number of cases rise again worldwide, we believe more than ever that the ability to understand disease progression and to manage resources accordingly is an important and still unmet need. We look forward to announcing further data soon.”

You can view the presentation here: https://volition.com/resources/downloads/Volition-Medica-COVID-presentation.pdf

About Volition

Volition is a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. The tests are based on the science of Nucleosomics^TM, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present. Volition is primarily focused on human diagnostics but also has a subsidiary focused on animal diagnostics.

Volition’s research and development activities are centered in Belgium, with a small laboratory in California and additional offices in Texas, London and Singapore, as the company focuses on bringing its diagnostic products to market.

For more information about Volition, visit Volition’s website volition.com or connect with us via:

Twitter: https://twitter.com/volitionrx
LinkedIn: https://www.linkedin.com/company/volitionrx
Facebook: https://www.facebook.com/VolitionRx/
YouTube: https://www.youtube.com/user/VolitionRx

The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document.  The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.

Media / Investor Contacts

Safe Harbor Statement

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the timing, completion and delivery of data from clinical studies, the effectiveness of Volition’s blood-based diagnostic and prognostic tests, and Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases as well as serving as a diagnostic or prognostic tool for COVID-19. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests. For instance, if Volition fails to develop and commercialize diagnostic or prognostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic or prognostic products Volition might develop; Volition’s failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; downturns in domestic and foreign economies; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics™ and Nu.Q™ and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.

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SOURCE VolitionRx Ltd

QUEBEC CITY, Nov. 19, 2020 /CNW/ – OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today reported its results for the fourth quarter and fiscal year 2020 ended August 31, 2020.

Financial Highlights

• Sales of product at $29.5 million in FY 2020 compared to prior FY 2019;
• Delivered Q4 2020 a $2.2 million improvement in profitability compared with Q4 2019;
• The Company ended fourth quarter with a cash balance of $10.9 million compared to $10.0 million as of May 31, 2020.

Recent Developments

• Awarded 3-year contract with major American group purchasing organization (“GPO”) to provide access to the OptoWire to their members across the United States;
• Progress in the development of a guidewire for transcatheter aortic valve replacement (TAVI or TAVR) procedures.

Management Commentary

“I am pleased with the way the company is successfully navigating the COVID-19 pandemic,” said Louis Laflamme, President and CEO of OpSens. “Despite the temporary closure of several cardiology laboratories, we continued to  achieve progress  in our commercial activities, including the signing of our first GPO contract to further increase our U.S. coronary artery stenosis measurement business.”

“As we look ahead to fiscal 2021, we are cautiously optimistic about continued improvement in access to our commercial customers as hospital protocols for managing the pandemic are being implemented. In addition to continued traction in our currently commercialized products, we are accelerating the development of our new guidewire for TAVR procedures, a $4 billion global market  which is growing in excess of 40% per year.”

“Our continued progress over the past few years to create, manufacture and deliver world-class products, that contribute to health through our expertise in innovative medical products was highlighted during the last quarter. I congratulate the OpSens team for their determination to provide customers with continued access to our technology under these unusual circumstances,” concluded Mr. Laflamme. 

Financial Results – Year Ended August 31, 2020

Sales of product were stable at $29.5 million in fiscal 2020 compared with fiscal 2019.

Sales of products for the measurement of coronary artery stenosis (Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”)) were $18.7 million in FY 2020 compared with $20.0 million in FY 2019. The $1.3 million decrease in OptoWire sales was primarily related to the temporary closure of several cardiology laboratories brought on by COVID-19.

Sales of optical medical systems, including the Company’s partnership for ventricular assist device sensors, were $8.3 million in FY 2020 compared with $7.0 million in FY 2019.

Operating expenses in fiscal 2020 were $19.3 million compared with $20.5 million in fiscal 2019. The improvement in operating expenses is attributable to savings on sales and marketing expenses offset by continued investment in research and development.

Net loss was $2.6 million during fiscal 2020 compared with a net loss of $2.0 million in fiscal 2019. This variation is mainly explained by a decrease of $3.3 million in non-recurring licensing revenue offset by a decrease in sales and marketing expenses and by a grant of $1.7 M from the Canadian government.

EBITDAO¹ (see table B) was $0.1 million in fiscal 2020 compared with $(0.4) million in fiscal 2019.

OpSens had a cash position of $10.9 million as of August 31, 2020.

Financial Results – Three-Month Period Ended August 31, 2020

Total revenue was $7.6 million in the fourth quarter of 2020 compared with $7.9 million in the fourth quarter of 2019.

Sales of products for the measurement of coronary artery stenosis (FFR and dPR) were $4.8 million in Q4 2020 compared with $5.3 million in Q4 2019. The $0.5 million decrease in OptoWire sales was primarily related to the temporary closure of several cardiology laboratories brought on by COVID-19.

Sales of optical medical systems including the Company’s partnership for ventricular assist device sensors were $2.2 million in Q4 2020 compared with $1.8 million in Q4 2019.

Operating expenses in the fourth quarter of 2020 were $3.8 million compared with $5.5 million in the fourth quarter of 2019. The improvement in operating expenses is attributable to savings on sales and marketing expenses.

Net income was $0.6 million during the fourth quarter of 2020 compared with a net loss of $1.6 million in the fourth quarter of 2019. The $2.2 million improvement in net earnings is the result of a reduction in sales and marketing expenses and the recognition of a grant of $0.9 M from the Canadian government.

EBITDAO¹  (see table B) was $1.4 million in the fourth quarter of 2020 compared with $(1.1) million in the fourth quarter of 2019.

Table A

Table B

Reconciliation of net earnings (loss) to EBITDAO

The Earnings Before Interest, Taxes, Depreciation, Amortisation and Stock-based compensation costs (EBITDAO) has no normalized sense prescribed by IFRS. It is not very probable that this measure is comparable with measures of the same type presented by other issuers. EBITDAO is defined by the Company as the addition of net loss, financial expenses (income), depreciation and amortisation and stock-based compensation costs. The Company uses EBITDAO for the purposes of evaluating its historical and prospective financial performance. This measure also helps the Company to plan and forecast for future periods as well as to make operational and strategic decisions. The Company believes that providing this information to investors, in addition to IFRS measures, allows them to see the Company’s results through the eyes of management, and to better understand its historical and future financial performance.

 

Table C

About OpSens Inc. (www.OpSens.com or www.OpSensmedical.com)

OpSens focuses mainly on coronary physiology products in interventional cardiology. OpSens offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of over 100,000 patients in more than 30 countries. It is approved for sale in the United States, European Union, Japan, and Canada.

OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, and achievements of OpSens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

SOURCE OPSENS Inc.

LOS ANGELES, Nov. 19, 2020 /PRNewswire/ — LiveXLive Media (NASDAQ: LIVX) (“LiveXLive”), a global platform for livestream and on-demand audio, video and podcast content in music, comedy, and pop culture, and owner of PodcastOne, Slacker Radio and React Presents, announced today that it will be forming a new division, LiveXLive Music Publishing. The new business vertical will be headed by music industry veteran David Schulhof as President and expands publishing into LiveXLive’s artists first platform now offering live events, audio, livestreaming, pay-per-view, podcasts and merchandising.

Like all facets of LiveXLive, LiveXLive Music Publishing will be added to LiveXLive’s Artist Ambassador Program providing revenue sharing to artists for all activations within the company’s business construct, thus providing a one stop end-to-end music platform for artists. In addition LiveXLive will be distributing music and collecting publishing royalties from multiple demand side platform (DSP) destinations, such as Amazon Music, Pandora, SoundCloud, Spotify, Tidal, Tencent, TikTok, United Media Agency and more.

Schulhof joined LiveXLive last year in the role of Chief Development Officer. David was the co-founder and CEO of Evergreen Copyright Acquisitions, a global music publishing entity backed by private equity. There, he built one of the largest independent music companies in the world which was sold to KKR/BMG for $80 million which had a catalog of 65,000 songs, including tracks recorded by Tupac Shakur, MC Hammer, JJ Cale, Eric Clapton, Joe Cocker, Bill Monroe, Teddy Riley, Michael Jackson and many others. Before Evergreen David was VP of Motion Picture Music, Music Publishing and Soundtracks at Miramax and Dimension Films.

“LiveXLive Music Publishing is a natural extension of our brand and our artists first company ethos. Our platform is perfectly designed to maximize and monetize music publishing assets and generate incremental synch and performance revenue for writers, artists, and producers,” said Robert Ellin, CEO and Chairman of LiveXLive. “As we launch linear channels, build original programming and continue to livestream music content around the world, this is a win for global songwriters. David is a perfect fit for our vision for growth.”

Schulhof’s career highlights include President of AGC Studios and prior to that he held the post of President of IM Global Music where he produced the award-winning music documentary The ‘Soundtrack of Our Lives’ highlighting the music industry icon Clive Davis, which is a worldwide hit, available on Netflix.

“I am thrilled about this new and extraordinary chapter in my career”, stated Schulhof. “We are well positioned and capitalized to be strategic in acquiring music publishing assets, sign writers and producers, all supporting our artists first philosophy, a tentpole of the LiveXLive flywheel. The ability to build a new publishing entity within the context of a company that is so focused on the successes of artists in all facets of the music industry is a challenge I am ready to conquer. I am confident my 20+ years in publishing and venture capital will support the growth of LiveXLive and the new publishing division will bring us closer to artists, producers and the songwriting community allowing full service deals to be done within the music industry.”

LiveXLive has the first talent-centric platform focused on superfans and building long-term franchises in on-demand audio and video, podcasting, vodcasting, OTT linear channels, pay-per-view (“PPV”), and livestreaming. Its model includes multiple monetization paths including subscription, advertising, sponsorship, merchandise sales, licensing, and ticketing. So far in calendar year 2020, LiveXLive content has been viewed over 90 million times. From emerging to established artists, LiveXLive has streamed a variety of artists and celebrities in 2020 alone, including Billie Eilish, Kygo, Billy Joel, Bon Jovi, Chris Rock, Idina Menzel, Jennifer Lopez, Jimmy Buffett, OneRepublic, Zac Brown Band, Sofi Tukker, and Darius Rucker.

About LiveXLive Media, Inc.

Headquartered in Los Angeles, California, LiveXLive Media, Inc. (NASDAQ: LIVX) (the “Company”) (pronounced Live “by” Live) is a global platform for livestream and on-demand audio, video and podcast content in music, comedy, and pop culture. LiveXLive, which has streamed over 1,400 artists since January 2020, has become a go-to partner for the world’s top artists and celebrity voices as well as music festivals concerts, including Rock in Rio, EDC Las Vegas, and many others. In April 2020, LiveXLive produced its first 48-hour music festival called “Music Lives” with tremendous success as it earned over 50 million views and over 5 billion views for #musiclives on TikTok on 100+ performances. LiveXLive’s library of global events, video-audio podcasts and original shows are also available on Amazon, Apple TV, Roku and Samsung TVs in addition to its own app, destination site and social channels. The Company’s wholly-owned subsidiary, PodcastOne, generates more than 2.1 billion downloads annually across more than 300 podcasts. For more information, visit www.livexlive.com and follow us on Facebook, Instagram, TikTok, Twitter at @livexlive, and YouTube.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including: the Company’s reliance on one key customer for a substantial percentage of its revenue; the Company’s ability to consummate any proposed financing or acquisition and the timing of the closing of such proposed transactions, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of any proposed transaction will not occur; the Company’s ability to continue as a going concern; the Company’s ability to attract, maintain and increase the number of its users and paid subscribers; the Company identifying, acquiring, securing and developing content; the Company’s ability to maintain compliance with certain financial and other covenants; the Company successfully implementing its growth strategy, including relating to its technology platforms and applications; management’s relationships with industry stakeholders; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; risks and uncertainties applicable to the businesses of the Company’s subsidiaries; and other risks, uncertainties and factors including, but not limited to, those described in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2020, filed with the U.S. Securities and Exchange Commission (the “SEC”) on June 26, 2020, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 16, 2020, and in the Company’s other filings and submissions with the SEC. These forward-looking statements speak only as of the date hereof and the Company disclaims any obligations to update these statements, except as may be required by law. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Press Contact:

The Rose Group
[email protected]
[email protected]

LiveXLive IR Contact:

310.529.2500
[email protected]

 

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SOURCE LiveXLive Media, Inc.

Big expectations: 84% of Canadians say they will take their business elsewhere if they have a poor digital experience, while 81% say they have adjusted to a new normal because of COVID-19 restrictions and they expect businesses to do the same

TORONTO, Nov. 19, 2020 /CNW/ – According to the TD New Digital CustomerStudy, released today, Canadians’ digital expectations of the companies that they engage with are on the rise: 84% of Canadians surveyed say they will take their business elsewhere if they have a poor digital experience, and 81% say they have adjusted to a new normal and expect businesses to do the same. Another 80% now expect organizations to enhance their digital tools more often to ensure better customer experiences.

“We saw our customer engagement and expectations surge with the onset of the COVID-19 pandemic,” says Rizwan Khalfan, Chief Digital and Payments Officer, TD Bank Group. “Now, the majority of our customers are regularly using our digital platforms to manage their day-to-day banking and learn more about their spending and saving. We know our customers are expecting experiences that reflect how they have adapted during the pandemic and we’re working to deliver personalized experiences in new and innovative ways, across all our channels.”

Building customer trust and loyalty, virtually
According to the study, in the year ahead, almost three-quarters (72%) of Canadians surveyed believe they will spend more time online, engaging with companies digitally and making purchases. But the data from survey respondents reveals that pressure is on companies to ensure that they are meeting customer expectations.

Financial services are at the top of the list when it comes to the types of products and services Canadians are most likely to purchase or access digitally: 87% of Canadians surveyed say they are most likely to make financial transactions online, like e-transfers and bill payments, with 44% saying they are using digital services for financial advice. Clothing, remote learning and household items round out the top five types of products and services Canadians are most likely to purchase or access digitally:

While the trend is towards digital adoption, these Canadians are still looking for the same level of service that they would expect from an in-person experience, with the majority, 74%, saying they want companies to prioritize virtual customer service as they introduce new digital offerings.

Canadians less forgiving than you’d think
The study also investigated the different perspectives of Canadians and Americans in their digital expectations and priorities. Canadians turned out to be more likely to walk away from a company over a bad digital experience (84% of Canadians surveyed vs 75% of Americans surveyed), and felt more strongly that companies should be upping their game and adapting to meet their needs (81% of Canadians surveyed vs 75% of Americans surveyed).

Canadians and Americans remain united in their plans to engage more with companies digitally and order items electronically in the year ahead (72% for both), and with COVID-19, they have both made digital purchases more frequently than ever before (63% for both).

The evolution of digital engagement
With the onset of COVID-19 restrictions, the study reveals that the Canadians surveyed have increasingly turned to digital for experiences beyond commerce, exploring new online services like virtual therapy sessions and consultations with a family physician (37%), virtual exercise programs (32%) and adult learning classes (26%).

The study also shows that Canadians are supporting small businesses and have changed their shopping habits to do so:

• With the onset of COVD-19, 47% of Canadians surveyed say they have shifted their shopping habits and now purchase more from small, local businesses than they did before the pandemic.
• A majority of Canadians surveyed, (57%) say that local businesses in their communities now offer more digital shopping/service options than they did before the onset of COVID-19; the same percentage also say they plan to continue to purchase goods and services from small, local businesses through their digital shopping options beyond the pandemic.

The uptick in digital engagement isn’t going anywhere – 68% of Canadians surveyed say they plan to continue accessing digital platforms more than they did before the pandemic.

Delivering for the new digital customer
Now more than ever, it is critical for businesses to deliver seamless and connected experiences for all of their customers.

“For TD, this means remaining focused on truly understanding our customers’ evolving needs and expectations,” says Frank Psoras, Senior Vice President, Customer Strategy and Innovation at TD. “As we continue to focus on delivering positive customer experiences, we are also committing to meeting and exceeding customer expectations across all the platforms where we engage and connect with them.”

Since the onset of the pandemic, teams from across TD have collaborated to create new, connected experiences, including:

• The TD Ready Advice Hub through which appointments can be made with an advisor and financial information and tools are available to help customers manage their changing financial needs.
• Offering customers a convenient way to access financial advice from the comfort of their home using digital tools like online conferencing and an interactive wealth planning platform.
• The new TD Global Transfer marketplace, which allows customers to securely send money to more than 200 countries and territories, right from their TD account, through EasyWeb and mobile.
• TD GoalAssist as a way to help Canadians set financial goals, invest for their futures, and most significantly, save on fees.

“Knowing that Canadians are relying on digital more heavily than ever before, we know that we will need to continue to innovate in order to exceed their expectations. Using technologies like artificial intelligence, voice, chat, and video will be key to creating stronger connections with our customers,” adds Khalfan.

About the Survey These are some of the findings of a Leger poll conducted between October 9 and 19, 2020, on behalf of TD. For this survey, a sample of 1508 Canadians and 1594 Americans aged 18+ were interviewed using Leger’s online panel. The margin of error for each of these samples was +/- 2.5%, 19 times out of 20.  

About TD Bank Group The Toronto-Dominion Bank and its subsidiaries are collectively known as TD Bank Group (“TD” or the “Bank”). TD is the sixth largest bank in North America by branches and serves over 26 million customers in three key businesses operating in a number of locations in financial centres around the globe: Canadian Retail, including TD Canada Trust, TD Auto Finance Canada, TD Wealth (Canada), TD Direct Investing, and TD Insurance; U.S. Retail, including TD Bank, America’s Most Convenient Bank^®, TD Auto Finance U.S., TD Wealth (U.S.), and an investment in The Charles Schwab Corporation; and Wholesale Banking, including TD Securities. TD also ranks among the world’s leading online financial services firms, with more than 14 million active online and mobile customers. TD had CDN$1.7 trillion in assets on July 31, 2020. The Toronto-Dominion Bank trades under the symbol “TD” on the Toronto and New York Stock Exchanges.

SOURCE TD Bank Group

TORONTO, Nov. 19, 2020 /PRNewswire/ – Magna Gold Corp. (TSXV: MGR) (OTCQB: MGLQF) (“Magna” or the “Company“) is pleased to announce that the Company and Molimentales del Noroeste, S.A. de C.V. (the “Purchaser“), a subsidiary of the Company, have closed the acquisition (the “Acquisition“) of the option (the “Option“) to acquire a 100% undivided interest in the mining concessions comprising the Margarita Silver Project (the “Property“) pursuant to a definitive option acquisition agreement (the “Agreement“) with Sable Resources Ltd. (“Sable“) and Exploraciones Sable, S. de R.L. de C.V. (the “Vendor“), a wholly-owned subsidiary of Sable. Immediately following the Acquisition, the Purchaser exercised the Option to acquire the Property (the “Option Exercise“). The Property is comprised of two mining concessions, covering 125.625 hectares, located within the prolific Sierra Madre Gold Belt, which hosts numerous multimillion-ounce gold-silver deposits, 88 kilometers south of the state capital of Chihuahua in the Municipality of Satevo, State of Chihuahua, Mexico. The Property lies 15 kilometres northwest on strike with Sunshine Silver Corp.’s Los Gatos Mine.

Pursuant to the terms of the Agreement, the Purchaser acquired the Option in exchange for: (i) CAD$1,500,000 in cash, plus an additional CAD$800,000 in cash representing Mexican VAT; and (ii) CAD$3,500,000 in common shares in the capital of Magna (“Magna Shares“), being 3,219,278 Magna Shares at a deemed price of $1.0872 per Magna Share (the “Issue Price“), representing the volume weighted average price of the Magna Shares on the TSX Venture Exchange for the fifteen trading days prior to the date of the Agreement. Immediately following the Acquisition, the Purchaser exercised the Option to acquire the Property by payment to the titleholders of the Property (the “Titleholders“) of: (i) CAD$500,000 in cash, plus an additional $368,000 in cash representing Mexican VAT; and (ii) CAD$1,800,000 in Magna Shares, being 1,655,629 Magna Shares at the Issue Price.

The Magna Shares issued in connection with the Acquisition and the Option Exercise are subject to a four-month hold period in accordance with applicable Canadian securities laws which will expire on March 18, 2021.

Concurrent with the Option Exercise, in accordance with the terms of an amended and restated royalty purchase agreement dated October 13, 2020 between Osisko Gold Royalties Ltd (“Osisko“), Sable, the Vendor and certain affiliates of Sable and the Vendor, the Company and the Purchaser have entered into a royalty agreement with Osisko, pursuant to which the Purchaser will pay Osisko a 2% net smelter returns royalty on all products mined and produced from the Property.

For more information about the Property, please refer to the Company’s news release dated November 10, 2020.

About Magna Gold Corp.

Magna Gold Corp. is a Canadian gold company engaged in operations, development, exploration and acquisitions in Mexico. Its primary asset is the producing San Francisco gold mine in Sonora, Mexico and exploration stage projects include San Judas, La Pima and Mercedes.

The Company’s shares trade on the TSXV under the trading symbol “MGR” and OTCQB under the trading symbol “MGLQF”. Magna is well integrated into its nearby communities, employs local residents, and uses local services when possible.

This news release includes certain “forward-looking statements” which are not comprised of historical facts. Forward-looking statements include estimates and statements that describe the Company’s future plans, objectives or goals, including words to the effect that the Company or management expects a stated condition or result to occur. Forward-looking statements may be identified by such terms as “believes”, “anticipates”, “expects”, “estimates”, “may”, “could”, “would”, “will” or “plan”. Since forward-looking statements are based on assumptions and address future events and conditions, by their very nature they involve inherent risks and uncertainties. Although these statements are based on information currently available to the Company, the Company provides no assurance that actual results will meet management’s expectations. Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. Forward looking information in this news release includes, but is not limited to, the Company’s objectives, goals or future plans, exploration results, potential mineralization, the estimation of mineral reserves and resources, exploration and mine development plans, timing of the commencement of operations and estimates of market conditions. Factors that could cause actual results to differ materially from such forward-looking information include, but are not limited to, failure to identify mineral resources, failure to convert estimated mineral resources to reserves, the inability to complete a feasibility study which recommends a production decision, the preliminary nature of metallurgical test results, delays in obtaining or failures to obtain required governmental, environmental or other project approvals, political risks, inability to fulfill the duty to accommodate First Nations and other indigenous peoples, uncertainties relating to the availability and costs of financing needed in the future, changes in equity markets, inflation, changes in exchange rates, fluctuations in commodity prices, delays in the development of projects, capital and operating costs varying significantly from estimates and the other risks involved in the mineral exploration and development industry, and those risks set out in the Company’s public documents filed on SEDAR. Although the Company believes that the assumptions and factors used in preparing the forward-looking information in this news release are reasonable, undue reliance should not be placed on such information, which only applies as of the date of this news release, and no assurance can be given that such events will occur in the disclosed time frames or at all. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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SOURCE Magna Gold Corp.

ST. LOUIS, Nov. 19, 2020 /PRNewswire/ — Centene Corporation (NYSE: CNC) today announced its support for National Rural Health Day to bring awareness to the unique healthcare challenges faced by providers and individuals who live in rural communities.  Rural residents exhibit higher mortality rates and higher incidences of preventable inpatient and emergency room admissions than their counterparts in urban areas, and the COVID-19 pandemic has only intensified these issues.

As part of its support, Centene has partnered with the National Organization of State Offices of Rural Health for National Rural Health Day (NHRD) to take the “Power of Rural Pledge” to help bring awareness to specific healthcare issues facing rural communities across the United States.

“Centene is committed to ensuring our members and providers in rural communities have access to the care and support they need,” said Michael F. Neidorff, Chairman, President and Chief Executive Officer for Centene. “We are proud to help bring a collective focus to issues facing rural communities, and we will continue to support innovative programs that create critical healthcare access for the most vulnerable populations.”

Centene recognizes that in order to ensure people in rural communities have access to high-quality care, it must support rural providers and the broader communities they serve. One way the Company is accomplishing this is through telehealth solutions, which significantly improve access to care for members, especially during the COVID-19 pandemic.

Through various partnerships, Centene has expanded access to telehealth by supplying providers with smartphones to distribute to their patients; streamlining access to affordable, high-speed wireless broadband services for primary care providers in rural and underserved communities; and extending grants to assist providers with the upfront investment costs of new devices, equipment, and training. These efforts can help practices expand their reach and access by removing financial barriers that may prevent them from expanding telehealth services during COVID-19.

In addition, Centene has worked closely with FQHCs to increase COVID-19 testing capabilities and PPE  (personal protective equipment) distribution for our target populations, including rural populations.

Improving rural healthcare serves as a crucial aspect of Centene’s purpose of transforming the health of our communities, one person at a time. Centene is committed to working with local community partners around the country to address rural health challenges and ensure these communities have access to quality healthcare.

About Centene Corporation

Centene Corporation, a Fortune 50 company, is a leading multi-national healthcare enterprise that is committed to helping people live healthier lives. The Company takes a local approach – with local brands and local teams – to provide fully integrated, high-quality, and cost-effective services to government-sponsored and commercial healthcare programs, focusing on under-insured and uninsured individuals. Centene offers affordable and high-quality products to nearly 1 in 15 individuals across the nation, including Medicaid and Medicare members (including Medicare Prescription Drug Plans) as well as individuals and families served by the Health Insurance Marketplace, the TRICARE program, and individuals in correctional facilities. The Company also serves several international markets, and contracts with other healthcare and commercial organizations to provide a variety of specialty services focused on treating the whole person. Centene focuses on long-term growth and the development of its people, systems and capabilities so that it can better serve its members, providers, local communities, and government partners.

Centene uses its investor relations website to publish important information about the company, including information that may be deemed material to investors. Financial and other information about Centene is routinely posted and is accessible on Centene’s investor relations website, http://investors.centene.com/.

Forward-Looking Statements

All statements, other than statements of current or historical fact, contained in this press release are forward-looking statements. Without limiting the foregoing, forward-looking statements often use words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “seek,” “target,” “goal,” “may,” “will,” “would,” “could,” “should,” “can,” “continue” and other similar words or expressions (and the negative thereof). Centene (the Company, our, or we) intends such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and we are including this statement for purposes of complying with these safe-harbor provisions. In particular, these statements include, without limitation, statements about our future operating or financial performance, market opportunity, growth strategy, competition, expected activities in completed and future acquisitions, including statements about the impact of our recently completed acquisition (the WellCare Acquisition) of WellCare Health Plans, Inc. (WellCare), other recent and future acquisitions, investments and the adequacy of our available cash resources. These forward-looking statements reflect our current views with respect to future events and are based on numerous assumptions and assessments made by us in light of our experience and perception of historical trends, current conditions, business strategies, operating environments, future developments and other factors we believe appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties and are subject to change because they relate to events and depend on circumstances that will occur in the future, including economic, regulatory, competitive and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions. All forward-looking statements included in this press release are based on information available to us on the date hereof. Except as may be otherwise required by law, we undertake no obligation to update or revise the forward-looking statements included in this press release, whether as a result of new information, future events or otherwise, after the date hereof. You should not place undue reliance on any forward-looking statements, as actual results may differ materially from projections, estimates, or other forward-looking statements due to a variety of important factors, variables and events including but not limited to: the impact of COVID-19 on global markets, economic conditions, the healthcare industry and our results of operations, which is unknown, and the response by governments and other third parties; uncertainty as to our expected financial performance during the period of integration of the WellCare Acquisition; the possibility that the expected synergies and value creation from the WellCare Acquisition will not be realized, or will not be realized within the expected time period; the risk that unexpected costs will be incurred in connection with the integration of the WellCare Acquisition or that the integration of WellCare will be more difficult or time consuming than expected; unexpected costs, charges or expenses resulting from the WellCare Acquisition; the inability to retain key personnel; disruption from the integration of the WellCare Acquisition, including potential adverse reactions or changes to business relationships with customers, employees, suppliers or regulators, making it more difficult to maintain business and operational relationships; the risk that we may not be able to effectively manage our expanded operations; our ability to accurately predict and effectively manage health benefits and other operating expenses and reserves, including fluctuations in medical utilization rates due to the impact of COVID-19; competition; membership and revenue declines or unexpected trends; changes in healthcare practices, new technologies, and advances in medicine; increased healthcare costs; changes in economic, political or market conditions; changes in federal or state laws or regulations, including changes with respect to income tax reform or government healthcare programs as well as changes with respect to the Patient Protection and Affordable Care Act (ACA) and the Health Care and Education Affordability Reconciliation Act, collectively referred to as the ACA and any regulations enacted thereunder that may result from changing political conditions or judicial actions, including the ultimate outcome in “Texas v. United States of America” regarding the constitutionality of the ACA; rate cuts or other payment reductions or delays by governmental payors and other risks and uncertainties affecting our government businesses; our ability to adequately price products on the Health Insurance Marketplaces and other commercial and Medicare products; tax matters; disasters or major epidemics; the outcome of legal and regulatory proceedings; changes in expected contract start dates; provider, state, federal, foreign and other contract changes and timing of regulatory approval of contracts; the expiration, suspension, or termination of our contracts with federal or state governments (including but not limited to Medicaid, Medicare, TRICARE or other customers); the difficulty of predicting the timing or outcome of pending or future litigation or government investigations; challenges to our contract awards; cyber-attacks or other privacy or data security incidents; the possibility that the expected synergies and value creation from acquired businesses, including businesses we may acquire in the future, will not be realized, or will not be realized within the expected time period; the exertion of management’s time and our resources, and other expenses incurred and business changes required in connection with complying with the undertakings in connection with any regulatory, governmental or third party consents or approvals for acquisitions; disruption caused by significant completed and pending acquisitions, including, among others, the WellCare Acquisition, making it more difficult to maintain business and operational relationships; the risk that unexpected costs will be incurred in connection with the completion and/or integration of acquisition transactions; changes in expected closing dates, estimated purchase price and accretion for acquisitions; the risk that acquired businesses will not be integrated successfully; restrictions and limitations in connection with our indebtedness; our ability to maintain or achieve improvement in the Centers for Medicare and Medicaid Services (CMS) Star ratings and maintain or achieve improvement in other quality scores in each case that can impact revenue and future growth; availability of debt and equity financing, on terms that are favorable to us; inflation; foreign currency fluctuations and risks and uncertainties discussed in the reports that Centene has filed with the Securities and Exchange Commission. This list of important factors is not intended to be exhaustive. We discuss certain of these matters more fully, as well as certain other factors that may affect our business operations, financial condition and results of operations, in our filings with the Securities and Exchange Commission (SEC), including our annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Due to these important factors and risks, we cannot give assurances with respect to our future performance, including without limitation our ability to maintain adequate premium levels or our ability to control our future medical and selling, general and administrative costs.

 

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SOURCE Centene Corporation

— Net sales increased 90% year-over-year to $51 million

— Adjusted EBITDA
¹
 margin increased to 35% from 24% in Q2

— 2020 full year guidance increased to at least $196 million in net sales from $192 million and at least $54 million of adjusted EBITDA
¹
 from $45 million

— 2021 full year guidance initiated at $360-380 million in net sales and $140-160 million of adjusted EBITDA
¹

NEW YORK and TORONTO, Nov. 19, 2020 /CNW/ – TerrAscend Corp. (“TerrAscend” or the “Company”) (CSE: TER) (OTCQX: TRSSF), a leading North American cannabis operator, today reported financial results for its third quarter ending September 30, 2020.  

Third Quarter 2020 Financial Highlights
(Unless otherwise stated, results are in Canadian dollars)

• Net sales of $51 million in Q3 2020 compared to $47 million in Q2 2020 and $35 million in Q1 2020.
• Gross margin increased to 59% in Q3 2020 compared to 56% in Q2 2020 and 45% in Q1 2020 (before gain on fair value of biological assets).
• Adjusted EBITDA
  ¹ increased to $17.8 million in Q3 2020 compared to $11.4 million in Q2 2020 and $4.9 million in Q1 2020.
• Adjusted EBITDA margin increased to 35% in Q3 2020 compared to 24% in Q2 2020 and 14% in Q1 2020.

Management Commentary

“We’re driving strong revenue growth and continued margin expansion by focusing on operational excellence, controlled SG&A spending, and strategically allocating our capital.” said Jason Ackerman, CEO and Executive Chairman of TerrAscend.  “Leveraging the skills of our of best-in-class operating team, we are focused on rapidly building scale in growing limited license markets.”

Mr. Ackerman added, “We continued to build out our footprint in the northeast, including completion of an additional 25% cultivation expansion at our Pennsylvania facility in Q3, which began selling into the market in November. In New Jersey, where I believe we will be a major player, sales from our newly operational cultivation facility and our first retail location in Phillipsburg are expected to begin in the coming days.  I look forward to realizing the full benefit of our substantially larger cultivation and manufacturing capacities across our system, including our recently announced Maryland acquisition, to further accelerate our revenue and adjusted EBITDA growth in Q4 and beyond.”

Third Quarter 2020 Operational Highlights

• Completed additional 25% cultivation expansion in Pennsylvania
• TerrAscend Canada achieved breakeven adjusted EBITDA
• 
  Opened third Pennsylvania Apothecarium dispensary in Thorndale
  
• 
  Opened fourth California Apothecarium dispensary in Berkeley
  
• 
  Received approval for and commenced cultivation in its 37,000 square foot New Jersey greenhouse, the first approved for medical cannabis cultivation in the state
  
• 
  Named Jason Marks as new Chief Legal Officer
  

Subsequent Events

• 
  Commenced sales from newly expanded State Flower cultivation facility in California
  
• 
  Appointed Ed Schutter to its Board of Directors
  
• 
  Expanded U.S. footprint via acquisition of Maryland Based Grower Processor
  
• 
  Opened fifth California Apothecarium dispensary in Capitola
   

Financial Summary of Q3 2020 and Comparative Periods

Net sales increased 90% to $51 million in the third quarter of 2020, as compared to $26.8 million in the third quarter of 2019.  Net sales increased 8% sequentially.  The Company continued to expand organically through an increase in cultivation capacity in Pennsylvania and store expansions in Pennsylvania and California.

Gross margin, before gain on fair value of biological assets, was 59% in Q3 2020, compared to 18% in Q3 2019 and 56% in Q2 2020. The sequential increase in gross margin is the result of higher mix as well as improved yields and lower cost per pound from the Pennsylvania operations.  Additionally, the turnaround of the Canadian operations has contributed to this sequential improvement. 

Q3 2020 G&A expense was $13.7 million, representing 27% of Net Sales, a reduction from 33% of Net Sales in Q2 2020 and 45% of Net Sales in Q3 2019.  This strong leverage is a result of tight control of costs combined with continued robust revenue growth. 

Adjusted EBITDA¹ was $17.8 million in Q3 2020, compared to $11.4 million in Q2 2020 and a loss of $(6.6) million in Q3 2019.  Adjusted EBITDA margins expanded sequentially to 35% in Q3 2020 from 24% in Q2 2020, driven by the growing contribution of Ilera combined with an adjusted EBITDA breakeven result for TerrAscend Canada. 

Net loss for Q3 2020 was $17.6 million, largely impacted by a net increase in fair value of warrant and derivative liability of $22.2 million and a revaluation of contingent consideration of $8.1 million. 

Adjusted net income² for Q3 2020 was $12.7 million, a positive result for the first time in company history.

Cash and cash equivalents, including restricted cash, were $45 million as of September 30, 2020, compared to $6.9 million as of September 30, 2019, and $75 million as of June 30, 2020.  

As of September 30, 2020, there were 291 million shares outstanding on a fully diluted basis.  Fully diluted shares outstanding include 77 million common shares, 76 million common share equivalent proportionate voting shares, 15 million preferred shares, 39 million exchangeable non-voting shares, and 84 million warrants and options.  The warrants and options having a weighted average strike price of $4.48. 

2020 and 2021 Outlook

TerrAscend is increasing full year 2020 guidance to at least $196 million in net sales and at least $54 million of adjusted EBITDA. TerrAscend is also providing first time guidance for 2021.  The Company expects full year 2021 net sales of $360-380 million and adjusted EBITDA of $140-160 million.

TerrAscend’s outlook is driven by the Company’s emphasis on organic growth through expansion in high-quality, limited license markets while continuing to maintain tight control on costs. TerrAscend’s sales and profits in Pennsylvania are expected to continue to scale following its recently completed 25% cultivation expansion. In New Jersey, sales from the Company’s greenhouse and indoor cultivation facilities are expected to commence this month and ramp throughout 2021. TerrAscend’s Phillipsburg, New Jersey dispensary is expected to open in the coming days, with plans to open two additional dispensaries in the state in the first half of 2021.

In California, the Company recently completed an expansion of its State Flower cultivation facility which enables a 500% increase in annual production capacity of super-premium craft flower. The Company’s California retail footprint continued to expand with the opening of two new Apothecarium locations in Berkeley and Capitola.

In Canada, with a newly streamlined and targeted product portfolio and an optimized cost structure, TerrAscend expects to see positive contributions to sales and profit growth in 2021.

Lastly, upon completion of TerrAscend’s previously announced grower/processor acquisition in Maryland, the Company expects to scale its operations in the state, leveraging both its strong portfolio of brands and existing talent to gain market share.

Conference Call

TerrAscend will host a conference call today, November 19, 2020, to discuss these results. Jason Ackerman, Executive Chairman and Chief Executive Officer, Keith Stauffer, Chief Financial Officer, and Jason Wild, Chairman, will host the call starting at 8:30 a.m. Eastern time. A question and answer session will follow management’s presentation.

Financial results and analyses are available on the Company’s website (www.terrascend.com) and SEDAR (www.sedar.com).

The Canadian Securities Exchange (“CSE”) has neither approved nor disapproved the contents of this news release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

About TerrAscend
TerrAscend is a leading North American cannabis operator with vertically integrated operations in Pennsylvania, New Jersey, and California in addition to operating as a licensed producer in Canada. TerrAscend operates an award-winning chain of Apothecarium dispensary retail locations as well as scaled cultivation, processing and manufacturing facilities on both the East and West coasts. TerrAscend’s best-in-class cultivation and manufacturing practices yield consistent, high-quality cannabis, providing industry-leading product selection to both the medical and legal adult-use market. The Company owns a number of synergistic businesses and brands, including The Apothecarium, Ilera Healthcare, State Flower, Valhalla Confections, and Arise Bioscience Inc. For more information, visit www.terrascend.com.

Non-IFRS Measures, Reconciliation and Discussion
Certain financial measures in this news release are non-IFRS measures, including EBITDA, Adjusted EBITDA, and Adjusted Net Income. These terms are not defined by IFRS and, therefore, may not be comparable to similar measures provided by other companies. These metrics have no direct comparable IFRS financial measure. Such information is intended to provide additional information and should not be considered in isolation or as a substitute for measures of performance prepared in accordance with IFRS. For more information, please see “Non-IFRS Financial Measures” in the Company’s Interim MD&A available on www.sedar.com.

EBITDA is a non-IFRS measure which management uses to evaluate the performance of the Company’s business as it reflects its ongoing profitability. EBITDA is calculated as earnings before interest, tax, depreciation and amortization.

Adjusted EBITDA is a non-IFRS measure which management uses to evaluate the performance of the Company’s business as it reflects its ongoing profitability. The Company believes that certain investors and analysts use this measure to evaluate a company’s ability to service debt and to meet other payment obligations or as a common measurement to value companies in certain industries. The Company measures Adjusted EBITDA as EBITDA less unrealized gain on changes in fair value of biological assets and other income plus fair value changes in biological assets included in inventory sold, impairments, restructuring costs, purchase accounting adjustments, transaction costs, share based compensation, revaluation of warrants and derivatives liabilities, and unrealized loss on investments.

Adjusted net income is a non-IFRS measure which management uses to evaluate the performance of the Company’s business as it reflects its ongoing profitability. The Company believes that certain investors and analysts use this measure to evaluate a company’s ability to service debt and to meet other payment obligations or as a common measurement to value companies in certain industries. The Company measures Adjusted net income as Net Income / (loss) plus revaluation of contingent consideration plus net increase in fair value of warrant and derivative liabilities.  The company considers these two specific items to be non-cash and non-recurring in nature. 

Caution Regarding Cannabis Operations in the United States
Investors should note that there are significant legal restrictions and regulations that govern the cannabis industry in the United States. Cannabis remains a Schedule I drug under the US Controlled Substances Act, making it illegal under federal law in the United States to, among other things, cultivate, distribute or possess cannabis in the United States. Financial transactions involving proceeds generated by, or intended to promote, cannabis-related business activities in the United States may form the basis for prosecution under applicable US federal money laundering legislation.

While the approach to enforcement of such laws by the federal government in the United States has trended toward non-enforcement against individuals and businesses that comply with medical or adult-use cannabis programs in states where such programs are legal, strict compliance with state laws with respect to cannabis will neither absolve TerrAscend of liability under US federal law, nor will it provide a defense to any federal proceeding which may be brought against TerrAscend. The enforcement of federal laws in the United States is a significant risk to the business of TerrAscend and any proceedings brought against TerrAscend thereunder may adversely affect TerrAscend’s operations and financial performance.

Forward Looking Information
This news release contains “forward-looking information” within the meaning of applicable securities laws. Forward-looking information contained in this press release may be identified by the use of words such as, “may”, “would”, “could”, “will”, “likely”, “expect”, “anticipate”, “believe, “intend”, “plan”, “forecast”, “project”, “estimate”, “outlook” and other similar expressions, and include statements with respect to future revenue and profits. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, current and future market conditions; risks related to federal, state, provincial, territorial, local and foreign government laws, rules and regulations, including federal and state laws in the United States relating to cannabis operations in the United States; and the risk factors set out in the Company’s most recently filed MD&A, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com.

The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

Financial Outlook
This press release contains a financial outlook within the meaning of applicable Canadian securities laws. The financial outlook has been prepared by management of TerrAscend to provide an outlook for full years 2020 and 2021 and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions including the assumptions discussed under the heading “Forward Looking Information” above and assumptions with respect to production, pricing, and demand, The actual results of TerrAscend’s operations for any period will likely vary from the amounts set forth in these projections and such variations may be material. TerrAscend and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward Looking Information” above, it should not be relied on as necessarily indicative of future results. Except as required by applicable Canadian securities laws, TerrAscend undertakes no obligation to update the financial outlook.

TerrAscend undertakes no obligation to comment on analyses, expectations or statements made by third parties in respect of TerrAscend, its securities, or financial or operating results (as applicable).

1 See “Non-IFRS Financial Measures” at the end of this press release for more information regarding the Company’s use of non-IFRS financial measures.

SOURCE TerrAscend

NEW YORK, Nov. 19, 2020 /PRNewswire/ — Shutterstock, Inc. (NYSE: SSTK), today announced the official launch of the highly anticipated Shutterstock Studios along with the hire of their new Head of Global Production, Aiden Darné. This new creative division extends Shutterstock’s offering by providing custom, high-quality content matched with production tools and services at scale. Shutterstock Studios delivers end-to-end custom creative services providing data-driven content strategy, full scale production, brand storytelling and amplification for today’s most influential brands.

Shutterstock Studios offers a unique blend of solutions paired with the human touch of dedicated, world-class photographers, cinematographers, producers, directors providing partnership services including brand storytelling, full production services, creative ideation, storyboarding, script writing, talent booking, influencer management and post-production––each exceptionally delivered and tailored to each clients’ needs. Utilizing our network of over 1 million contributors across the world in over 100 countries, the studio specializes in capturing cultural nuances and aesthetics that speak to respective markets with artistry and authenticity. 

“The launch of Shutterstock Studios is a milestone moment for our company. Through our talented global network of photographers, cinematographers, and contributors who provide an unending catalog of premium content, we’re able to build this global production studio and expand our services,” said Shutterstock CRO, Jamie Elden. “Under the helm of our new Head of Global Production, Aiden Darné, we’re looking forward to creating innovative content to all of our valued partners, brands, agencies and entertainment industry.”

As Head of Global Production, Aiden will oversee global production and strategy of Shutterstock Studios. Most recently Aiden held Senior Vice President of Production at Vice Media Group, where he ran the studio for commercial and editorial production across North America.  Aiden launched the internal brand production studio at VICE Media and was part of the leadership group that launched the TV Network, VICELAND. Prior to VICE, Aiden was Vice President of Production at Viacom, where he ran the East Coast production team for Viacom Digital Studios, a studio responsible for producing digital originals for MTV, Comedy Central, Nickelodeon, BET and Paramount Network.  Aiden brings a wealth of experience in creating compelling content for some of today’s leading programs, brands and more.

“I’m thrilled to join Shutterstock at such an exciting time for the company, since now more than ever, there is huge demand for a global production infrastructure that’s underpinned by a hyper local point of view,” said Shutterstock Studios Head of Global Production, Aiden Darné. “Shutterstock Studios is uniquely positioned to succeed within this marketplace with it’s vast and varying global network of contributors and creatives. It has a bright future and I’m honored to have been brought on to build out Shutterstock’s best in class production offering.”

Shutterstock Studios is proud to share its ever-expanding access to over 1M+ creators from film makers, SFX, commercial directors, producers and musicians.

To learn more about Shutterstock Studios visit: https://www.shutterstock.com/business/studios

About Shutterstock

Shutterstock, Inc. (NYSE: SSTK), directly and through its group subsidiaries, is a leading global provider of high-quality licensed photographs, vectors, illustrations, videos and music to businesses, marketing agencies and media organizations around the world. Working with its growing community of over 1 million contributors, Shutterstock adds hundreds of thousands of images each week, and currently has more than 350 million images and more than 20 million video clips available.

Headquartered in New York City, Shutterstock has offices around the world and customers in more than 150 countries. The company’s brands also include Bigstock, a value-oriented stock media offering; Shutterstock Custom, a custom content creation platform; Offset, a high-end image collection; PremiumBeat, a curated royalty-free music library; and Shutterstock Editorial, a premier source of editorial images and videos for the world’s media.

For more information, please visit www.shutterstock.com and follow Shutterstock on Twitter and on Facebook.

 

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SOURCE Shutterstock, Inc.

KING OF PRUSSIA, Pa., Nov. 19, 2020 /PRNewswire/ — CSL Behring, a global biotherapeutics leader, today announced survey results showing that a vast majority of HAE patients (94%) say it’s important their preventive therapy specifically corrects C1 esterase inhibitor (C1-INH) deficiency. Both people living with Hereditary Angioedema (HAE) (94%) and the physicians who treat them (91%) agree that a reduction in the number of attacks is the leading factor when evaluating prophylactic therapy, followed closely by the importance of safety. The survey was conducted online by The Harris Poll and was sponsored by CSL Behring.

HAE is a rare, genetic and potentially life-threatening condition that causes painful, potentially debilitating and unpredictable episodes of swelling of the abdomen, larynx, face and extremities, among other areas of the body. HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control swelling.

“This data shows that those living with HAE and their physicians place importance on preventing more attacks, with most people living with HAE preferring a prophylactic treatment that is effective in reducing the number of attacks rather than a treatment that offers less frequent administration,” said Jonathan A. Bernstein, M.D., Professor of Medicine, Department of Internal Medicine, Division of Immunology and Allergy Section, University of Cincinnati College of Medicine. “A treatment that may offer less frequent administration may seem appealing, but these findings suggest that many people living with HAE live with daily fear, stress and anxiety related to having an attack. These substantial burdens should be important points of consideration when discussing and developing treatment plans.”  

According to the survey findings, physicians do recognize the negative impact of HAE on virtually every aspect of their patients’ lives, but the survey results also show that people living with HAE view the disease as having a more significant impact on their daily activities. For example, 43% of people living with HAE say the disease has a major negative impact on their work or studies, but only 9% of physicians say the same about their patients.

“HAE affects my life daily; with the concerns and stress of not only maintaining my own health as a patient, but also that of my children, both of whom also have HAE,” said Cheryl French, a person living with HAE.

The survey findings demonstrate physicians and people living with HAE are generally aligned when it comes to making treatment decisions, but results also show that physicians and people living with HAE could benefit from improved dialogue on the factors that are most important in selecting a therapy.

Other key findings include the following:

Treatment

• More than 95% of people living with HAE say they are determined to do whatever it takes to avoid HAE attacks and most physicians (82%) agree
• People living with HAE (97%) and physicians (99%) almost universally agree that the best way to manage HAE is to take measures to prevent attacks

Impact of HAE on Lifestyle

• 76% of people living with HAE say they worry about having another attack on a daily basis
• Over 8 in 10 people living with HAE consider managing and recovering from an HAE attack to be disruptive to their overall quality of life
• 70% of people living with HAE rate their HAE attacks as severe/very severe
• 68% of people living with HAE say having HAE has a major or moderate negative impact on their work/studies

For more information about HAE, please visit www.beyondhae.com.   

About Hereditary Angioedema
A rare, genetic and potentially life-threatening condition, HAE causes painful, potentially debilitating and unpredictable episodes of swelling of the abdomen, larynx, face and extremities, among other areas of the body. HAE is one of two forms of bradykinin-mediated angioedema, the other being nonhereditary or acquired angioedema. HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control swelling. The defect with C1-INH lies within a person’s genetic code, which is why HAE runs in families. HAE is classified as either type I, type II or n1-C1-INH (previously known as type III), which is HAE with normal C1-INH levels.

About the Survey
The survey was conducted online by The Harris Poll on behalf of CSL Behring between June 3 and July 7, 2020 among 100 U.S. adults ages 18+ who have been diagnosed by a healthcare professional with HAE (“people living with HAE“); and 150 licensed Allergists/Immunologists in the U.S. who have treated/managed at least two people living with HAE in the past 12 months (“physicians“). 

People living with HAE were identified and recruited directly by treating physicians. Pre-screened participants were provided a custom, password protected link and were invited to a secure website to be fully screened, and if qualified, to complete an online self-administered questionnaire via a personal device. Results were not weighted and are only representative of those who participated in the research.

Physicians were sampled from the online physician panel and invited to a secure website to be fully screened, and if qualified, to complete an online self-administered questionnaire via a personal device. Raw data for physicians were weighted by years in practice, gender and geographic region.

About CSL Behring


CSL Behring
 is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, the company develops and delivers innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people worldwide, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.

Media Contact:

Jennifer Purdue, External Communications Manager
[email protected] 
(610) 306-9355

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SOURCE CSL Behring