Market Newsdesk

ROCKVILLE, Md., Dec. 10, 2020 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV^® Technology Platform, today announced that the first patient has been dosed in ALTITUDE, a Phase II trial to evaluate the suprachoroidal delivery of RGX-314 using the SCS Microinjector for the treatment of diabetic retinopathy (DR).

“We are pleased to announce the first patient dosed in our ALTITUDE trial, an important milestone as we continue to evaluate the overall clinical profile of RGX-314 for the treatment of chronic retinal conditions. This is our second Phase II trial using the in-office suprachoroidal delivery approach, which may allow physicians to treat patients with diseases like DR earlier in the disease course,” said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. “Long-term treatment with anti-VEGF injections has been shown to significantly reduce disease progression and severity of DR, even in patients who are asymptomatic, as well as prevent vision threatening complications. We believe that one-time treatment with anti-VEGF gene therapy can have a meaningful impact for patients with DR, and we look forward to providing additional updates from this trial next year.”

“The SCS Microinjector is designed to provide targeted delivery of the gene therapy to the suprachoroidal space, with broad distribution to the back of the eye and into the retina through a one-time, in-office procedure, which could be an important alternative to current standard of care,” said Charles Wykoff, M.D., Ph.D., trial investigator, Retina Specialist and Director of Research with Retina Consultants of Houston.

“DR is the most common cause of vision loss among patients with diabetes, with an average age of disease onset between 45-50 years old. Anti-VEGF injections have been approved by the FDA for diabetic retinopathy, but treatment with anti-VEGF agents requires frequent clinic visits and injections. RGX-314 may provide sustainable, long-term anti-VEGF protein production in the eye, which could be a one-time treatment option for working-age adults,” said Arshad M. Khanani M.D., M.A., trial investigator and director of clinical research at Sierra Eye Associates.

ALTITUDE is a multi-center, open label, randomized, controlled dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314. The trial is expected to enroll approximately 40 patients with DR across two cohorts. Patients will be randomized to receive RGX-314 versus observational control at a 3:1 ratio, and two dose levels of RGX-314 will be evaluated: 2.5×10¹¹ GC/eye and 5.0×10¹¹ GC/eye. Patients will not receive prophylactic immune suppressive corticosteroid therapy before or after administration of RGX-314.

The primary endpoint of the trial is the proportion of patients that improve in DR severity based on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at 48 weeks. Other endpoints include safety and development of DR-related ocular complications.

The Company expects to report initial data from this trial in 2021.

About RGX-314

RGX-314 is being developed as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.

REGENXBIO is advancing two separate routes of administration of RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector® from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.

About Diabetic Retinopathy

Diabetic retinopathy (DR) is the leading cause of vision loss in adults between 24 and 75 years of age worldwide. DR affects approximately eight million people in the United States alone. The spectrum of DR severity ranges from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) and as DR progresses, a large proportion of patients develop vision threatening complications, including diabetic macular edema (DME) and neovascularization that can lead to blindness.  Current treatment options for patients with DR include “watchful waiting”, anti-VEGF treatment, retinal laser or surgical treatment. Anti-VEGF treatments have been shown to reduce the severity of DR and prevent vision threatening complications by at least 75% in patients with moderately severe to severe NPDR.

About REGENXBIO Inc.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Forward-Looking Statements

This press release includes “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. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO’s future operations and clinical trials. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO’s expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, the impact of the COVID-19 pandemic or similar public health crises on REGENXBIO’s business, and other factors, many of which are beyond the control of REGENXBIO. Refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2019, and comparable “risk factors” sections of REGENXBIO’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC’s website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SCS Microinjector® is a trademark of Clearside Biomedical, Inc. All other trademarks referenced herein are registered trademarks of REGENXBIO.

Contacts:

Tricia Truehart

Investor Relations and Corporate Communications
347-926-7709

Investors:
Eleanor Barisser, 212-600-1902
[email protected]

Media:
David Rosen, 212-600-1902
[email protected]

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SOURCE REGENXBIO Inc.

PITTSBURGH, Dec. 10, 2020 /PRNewswire/ —

Key Highlights

• XRby is using Ansys’ cutting-edge optical design simulation software to innovate métiers d’art limited edition luxury wristwatches that are engineered with tremendous speed and affordability   
• With Ansys, XRby is radically simplifying the development and enhancing the aesthetics of wristwatches by eliminating physical prototype testing

XRby is leveraging Ansys’ (NASDAQ: ANSS) cutting-edge optical design simulation software to innovate métiers d’art limited edition luxury wristwatches that are engineered with tremendous speed and affordability. Using Ansys software, XRby is radically simplifying the development and enhancing the aesthetics of the wristwatches by eliminating physical prototype testing.  

Jura Mountains watchmaker XRby is producing a limited edition of high-end métiers d’art mechanical wristwatches, which will incorporate costly materials such as organic fibers and precious stones. Historically, these customized watches would require at least one physical prototype to attract customers. Facing extremely high production costs and stringent sustainability goals, XRby pivoted to produce virtual protypes using Ansys^® SPEOS^™, through the Ansys Startup Program. Adopting this Industry 4.0 vision equipped engineers with a numerical optical simulation approach, helping them innovate watch concepts, analyze light reflection and rapidly test numerous aesthetic options to achieve their optimum design.

Using Ansys SPEOS, XRby selected sapphire thickness and edge angles to improve watch aesthetics, tested several watch assemblies and evaluated more than 100 materials and elements. Additionally, SPEOS generated physics-based, true-to-life images of digital prototypes throughout the development process. This empowered XRby to not only understand how watch designs would appear in real-world lighting and usage conditions, but also make design choices more quickly — substantially reducing development time and cost.

“Adopting an Industry 4.0 approach and using SPEOS helped our engineers design a beautiful canvas less than two inches wide, conserve natural resources and introduce a new luxury brand to targeted elite clientele in a purely virtual manner,” said Xavier Rousset, founder at XRby. “With SPEOS, our engineers selected the optimal materials, shapes and decorations for the watch’s designs in mere hours, compared to traditional simulations, which may require days to deliver the same results.”

XRby utilizes SPEOS texture mapping early in the development cycle to forecast how watch materials will behave in different lighting conditions.

“SPEOS helps XRby perform accurate texture mapping to create next-generation optical simulations that demonstrate how their material choices will behave across numerous environments,” said Yvain Ballini, CEO at CADFEM France, XRby’s dedicated Ansys channel partner. “This helps them perfect the physical appearance of their extremely unique watch under practically any possible lighting scenario.”

Prospective customers are able to view SPEOS’ high-definition simulations of the watch design and place orders on XRby’s website.

“Using SPEOS through the Ansys Startup Program equips XRby with a state-of-the-art, Industry 4.0 method for simulating photons’ path across physical matter and creating an image just as it would be perceived by the human eye,” said Shane Emswiler, senior vice president at Ansys. “This helps slash development time, drives enhanced decision-making during the design phase and delivers unique product customizations for a highly discerning market.”  

/ About Ansys

If you’ve ever seen a rocket launch, flown on an airplane, driven a car, used a computer, touched a mobile device, crossed a bridge or put on wearable technology, chances are you’ve used a product where Ansys software played a critical role in its creation. Ansys is the global leader in engineering simulation. Through our strategy of Pervasive Engineering Simulation, we help the world’s most innovative companies deliver radically better products to their customers. By offering the best and broadest portfolio of engineering simulation software, we help them solve the most complex design challenges and create products limited only by imagination. Founded in 1970, Ansys is headquartered south of Pittsburgh, Pennsylvania, U.S.A. Visit www.ansys.com for more information.

Ansys and any and all ANSYS, Inc. brand, product, service and feature names, logos and slogans are registered trademarks or trademarks of ANSYS, Inc. or its subsidiaries in the United States or other countries. All other brand, product, service and feature names or trademarks are the property of their respective owners.

ANSS–C

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SOURCE Ansys

VANCOUVER, BC, Dec. 10, 2020 /PRNewswire/ – Hollister Biosciences Inc. (CSE: HOLL) (OTCPK: HSTRF) (FRANKFURT: HOB) (the “Company“, “Hollister Cannabis Co.” or “Hollister“) a diversified cannabis branding company with products in over 230 dispensaries throughout California, and over 80 dispensaries throughout Arizona, is pleased to announce that further to the news release dated March 30^th, 2020, its 100% owned subsidiary, Venom Extracts (“Venom“) has achieved its second of two revenue milestones in accordance with the terms of the definitive agreement that was entered in connection with the acquisition of Venom by the Company (the “Transaction“).

On December 9^th, 2020, Venom achieved the second and final revenue milestone by generating in excess of CDN$40,000,000 of revenue calculated from January 1^st, 2020. Hollister also reports that Venom generated CDN$ 4.8 million in adjusted EBITDA over the same period.  As a result, the Company will issue 9,870,018 common shares (the “Earn-Out Shares“) to certain former Venom shareholders at a deemed price of $0.20 per Earn-Out Share. The Earn-Out Shares will not be subject to any hold period under applicable securities laws.

On November 4^th the state of Arizona passed Prop 207 authorizing the Adult Use of Cannabis. Arizona is a mature, limited license medical market with 123 Operational Dispensaries as of 10/31/20, and 287,715 patients reported as of September 2020.  “The victory also puts Arizona on pace to create one of the biggest new marijuana markets in the country. The Arizona recreational market could generate as much as USD $375 million–$400 million in its first year and $700 million–$760 million by 2024, according to projections by Marijuana Business Daily.”

Venom Extracts is a leading concentrate brand in Arizona, accounting for between 25-30% of category sales. Venom has 8 sku’s with varying product forms including; Shatter, Crystals, Nectar Sauce, Sugar Wax, Live Resin, Diamond Sauce, THC-A, and Vape Cartridges.  Venom products can be found in over 80 retail locations including Arizona’s market leader; Harvest Health and Recreation (CSE:HARV, OTCMKTS: HRVSF), leading multi-state cannabis operator Curaleaf  (CSE:CURA, OTCMKTS: CURLF), MUV by Atlmed and other leading dispensaries.

“We are very proud of the Arizona team and their ability to achieve this final revenue milestone and market leadership position.  We look forward to continuing the growth of our Arizona platform as it transitions to an adult use market.” shared Carl Saling, CEO of Hollister.

None of the securities to be issued pursuant to the Transaction have been or will be registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state securities laws, and any securities issued pursuant to the Transaction are anticipated to be issued in reliance upon available exemptions from such registration requirements pursuant to Rule 506(b) of Regulation D and/or Section 4(a)(2) of the U.S. Securities Act and applicable exemptions under state securities laws. In addition, the securities issued under an exemption from the registration requirements of the U.S. Securities Act will be “restricted securities” as defined under Rule 144(a)(3) of the U.S. Securities Act and will contain the appropriate restrictive legend as required under the U.S. Securities Act.

About Hollister Biosciences Inc.

Hollister Biosciences Inc. is a multi-state cannabis company with a vision to be the sought-after premium brand portfolio of innovative, high-quality cannabis & hemp products. Hollister uses a high margin model, controlling the whole process from manufacture to sales to distribution or seed to shelf. Products from Hollister Biosciences Inc. include HashBone, the brand’s premier artisanal hash-infused pre-roll, along with concentrates (shatter, budder, crumble), distillates, solvent-free bubble hash, pre-packaged flower, pre-rolls, tinctures, vape products, and full-spectrum high CBD pet tinctures. Hollister Cannabis Co. additionally offers white-labeling manufacturing of cannabis products.  Our wholly-owned California subsidiary Hollister Cannabis Co is the 1st state and locally licensed cannabis company in the city of Hollister, CA birthplace of the “American Biker”.

Website: www.hollistercannabisco.com

The CSE, nor its regulation services provider, does not accept responsibility for the adequacy or accuracy of this release.

Non-IFRS Financial Measures: This news release makes reference to certain non
–
IFRS financial measures. These measures are not recognized measures under IFRS, do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. These measures are provided as additional information to complement the IFRS financial measures by providing further metrics to understand the Company’s results of operations from management’s perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of our financial information reported under IFRS. We use non
–
IFRS financial measures, including segmented revenue and adjusted EBITDA, to provide investors with supplemental measures of our operating performance and thus highlight trends in our core business that may not otherwise be apparent when relying solely on IFRS financial measures.

Forward-Looking Information: This news release includes certain statements that may be deemed “forward-looking statements”. The use of any of the words “anticipate”, “continue”, “estimate”, “expect”, “may”, “will”, “would”, “project”, “should”, “believe” and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this News Release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company’s disclosure documents which can be found under the Company’s profile on www.sedar.com

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SOURCE Hollister Biosciences Inc.

The company sold US$348+ million of equipment in Fort Worth this year; its Edmonton site sold US$437+ million in 2020

FORT WORTH, Texas, Dec. 10, 2020 /PRNewswire/ – This week Ritchie Bros. held its final auctions of the year at two of its largest auction sites: Edmonton, AB and Fort Worth, TX. Over three days the Edmonton team sold 5,500+ equipment items for US$41 million (CA$53 million), while Ritchie Bros.’ Fort Worth team sold US$69+ million of equipment in just two days. Both auctions were conducted 100% online due to COVID-19.

“Online demand continues to be strong, resulting in record bidder registrations and solid pricing across most equipment categories,” said Kari Taylor, President, North America Sales, Ritchie Bros. “We would like to thank the thousands of buyers and sellers who have participated in Fort Worth and Edmonton auctions in 2020. A lot has changed, but thanks to our investments in technology, we continue to deliver certainty in uncertain times. Just this year we registered more than 54,000 bidders for our Fort Worth auctions, which is up 64 percent year over year.”

The final Fort Worth auction, on December 8 – 9, attracted 11,700+ bidders, which is up 40 percent from the same auction last year. In total, the Fort Worth site attracted 54,000+ bidders over five auctions in 2020, up 63 percent from 2019. Approximately 39 percent of the equipment sold this week in Fort Worth was purchased by Texas buyers, while out-of-state and international buyers from as far away as Australia, Egypt, and the United Kingdom purchased the remaining 61 percent.

In its final auction of 2020, Ritchie Bros.’ Edmonton site registered 14,500+ bidders from 60 countries. Approximately 94 percent of the equipment sold in this week’s Edmonton auction was sold to Canadians, with 56 percent purchased by Albertans, while international buyers from as far away as India, Peru, and Poland purchased six percent of the equipment.

“Our Alberta and Texas markets are major sources of equipment and trucks across North America and the globe,” said Doug Olive, Senior Vice President, Pricing. “More than 70 percent of all dozers sold in Canada were sold in Alberta. In 2020 alone, Edmonton sold 540 excavators for $52 million! Meanwhile, Fort Worth sells an unbelievable amount of trucks auction after auction. This year, we sold close to 2,700 truck tractors for $71 million in Fort Worth.”

With both auctions 100% online, traffic to Ritchie Bros. websites was also impressive. The Edmonton webpage received 496,000+ unique pageviews, with 59,000+ additions to customer equipment watchlists, and 11,000+ PriorityBids. The Fort Worth webpage saw 650,000+ unique pageviews, with 66,000+ watchlist adds, and 23,000+ PriorityBids.

Ritchie Bros. has 18 auction events left in 2020. For more information about these events and available equipment, visit RitchieBros.com. 

About Ritchie Bros.:

Established in 1958, Ritchie Bros. (NYSE and TSX: RBA) is a global asset management and disposition company, offering customers end-to-end solutions for buying and selling used heavy equipment, trucks and other assets. Operating in a number of sectors, including construction, transportation, agriculture, energy, oil and gas, mining, and forestry, the company’s selling channels include: Ritchie Bros. Auctioneers, the world’s largest industrial auctioneer offers live auction events with online bidding; IronPlanet, an online marketplace with featured weekly auctions and providing the exclusive IronClad Assurance® equipment condition certification; Marketplace-E, acontrolled marketplace offering multiple price and timing options; Mascus, a leading European online equipment listing service; and Ritchie Bros. Private Treaty, offering privately negotiated sales. The company’s suite of multichannel sales solutions also includes RB Asset Solutions, a complete end-to-end asset management and disposition system. Ritchie Bros. also offers sector-specific solutions including GovPlanet, TruckPlanet, and Kruse Energy, plus equipment financing and leasing through Ritchie Bros. Financial Services. For more information about Ritchie Bros., visit RitchieBros.com.

Photos and video for embedding in media stories are available at rbauction.com/media. 

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SOURCE Ritchie Bros.

REHOVOT, Israel and VANCOUVER, BC, Dec. 10, 2020 /PRNewswire/ — CollPlant (NASDAQ: CLGN), a regenerative medicine company, and STEMCELL Technologies, Canada’s largest privately owned biotechnology company, which develops cell culture media, cell separation systems, instruments, and other reagents for life sciences research, today jointly announced they have entered into a product manufacturing and supply agreement. CollPlant will sell its proprietary recombinant human Type I collagen (rhCollagen), the world’s first plant-based rhCollagen, to STEMCELL Technologies, which will incorporate CollPlant’s product into cell culture media kits.

The recently signed agreement follows the companies’ established business relationship, which started in 2014 when STEMCELL began purchasing and incorporating CollPlant’s rhCollagen into some of its cell culture expansion and differentiation media kits. To date, hundreds of companies, as well as research and academic institutes, have used these kits for research and development projects. STEMCELL will distribute the kits globally for use in the regenerative medicine research market.

“Incorporation of rhCollagen into STEMCELL’s cell culture applications sold to researchers worldwide is designed to help advance the science in a broad range of dynamic fields including stem cells, immunology, cancer, regenerative medicine, and cellular therapy. We are happy to have entered into this agreement with STEMCELL, which, as Canada’s largest biotechnology company, is very well positioned to make rhCollagen-containing cell culture kits widely available in the market,” stated Yehiel Tal, Chief Executive Officer of CollPlant. “The cell culture market is just one example of the vast potential of our rhCollagen platform technology in life science applications. We continuously evaluate new fields in which CollPlant’s products and technologies have the potential to enable breakthroughs that improve patients’ lives.”

Dr. Sharon Louis, STEMCELL’s Senior Vice President of Research and Development noted that “STEMCELL is pleased to utilize CollPlant’s animal component free rhCollagen to promote cell attachment in several products that support the culture of diverse human progenitor cell types. The quality and animal component-free composition of CollPlant’s rhCollagen is what first brought this product to STEMCELL’s attention, and the robust performance rhCollagen provides with a variety of STEMCELL media is what we want to be able to provide to our customers. Upon entering into this agreement, STEMCELL and CollPlant will together provide high-quality reagents that will be used to further our understanding in life sciences and potentiate regenerative medicine research.”

About STEMCELL Technologies
 

STEMCELL Technologies is Canada’s largest biotechnology company. Based in Vancouver, STEMCELL supports life sciences research around the world with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, and educational resources that are used by scientists advancing the stem cell, immunology, cancer, regenerative medicine, microbiology, and cellular therapy fields.

Find more information at www.stemcell.com 

About CollPlant Biotechnologies

CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant’s proprietary plant based genetic engineering technology.

Our products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing, and, we believe, are ushering in a new era in regenerative and aesthetic medicine.

Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. In October 2018, we entered into a licensing agreement with United Therapeutics, whereby United Therapeutics is using CollPlant’s BioInks in the manufacture of 3D bioprinted lungs for transplant in humans. Recently, the parties announced the expansion of the collaboration with the exercise by United Therapeutics of its option to cover a second lifesaving organ, human kidneys.

Safe Harbor for Forward-Looking Statements 

This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant’s objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant’s actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the CollPlant’s history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; CollPlant’s expectations regarding the timing and cost of commencing clinical trials; regulatory action with respect to rhCollagen-based products, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the CollPlant’s rhCollagen-based BioInk; CollPlant’s ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third-party distributors and resellers; CollPlant’s reliance on third parties to conduct some aspects of its product manufacturing; the scope of protection CollPlant is able to establish and maintain for intellectual property rights and the company’s ability to operate its business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the company operates; projected capital expenditures and liquidity; changes in the company’s strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading “Risk Factors” included in CollPlant’s most recent annual report on Form 20-F, filed with the SEC, and in other filings that CollPlant has made. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant’s current views with respect to future events, and CollPlant does not undertake, and specifically disclaims, any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact at
 CollPlant:

Eran Rotem

Deputy CEO & CFO
Tel: + 972-73-2325600
[email protected]

Contact at STEMCELL:
Luba Metlitskaia
Vice President, Business Development & Licensing
[email protected]

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SOURCE CollPlant

DUBLIN, Dec. 10, 2020 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced a Value Enhancement Plan, or the Plan, designed to drive growth, improve operational and financial performance and enhance shareholder value, as the company continues to advance its mission of developing new medicines designed to have a real-world impact in the treatment of serious mental illness, addiction and cancer. The Plan includes a commitment to multi-year profitability targets, a review and optimization of the company’s cost structure, potential monetization of non-core assets, and continued governance enhancements, including the addition of two new independent directors with substantial financial and operational expertise to the company’s board of directors (the “Board”).

The Value Enhancement Plan is the result of an intensive process initiated over the last several months and is intended to position the company to efficiently execute on its business strategy, support the continued growth of its commercial products, including the potential approval and launch of ALKS 3831, and further the advancement of its pipeline of development programs. The Plan builds upon the company’s implementation of a restructuring and addition of two new independent directors to the Board in the fall of 2019 and the company’s board refreshment efforts announced in July 2020. These initiatives also follow constructive dialogue with the company’s shareholders, including funds advised by Elliott Advisors (UK) Limited (“Elliott”), and entry into an associated cooperation agreement between Alkermes and affiliates of Elliott.

“Alkermes’ Board and management are committed to engaging with shareholders and understanding their perspective and have been working on initiatives to drive greater operational efficiency, with a focus on shareholder value creation. These new initiatives also support our strong growth trajectory, which has come more clearly into focus over the past few months, with the positive advisory committee meeting and constructive regulatory interactions for ALKS 3831 for schizophrenia and bipolar I disorder, and with new clinical data emerging in our ALKS 4230 immuno-oncology program,” said Richard Pops, Chairman and Chief Executive Officer of Alkermes. “We believe these actions, alongside our focus on commercial execution, the potential approval and commercial launch of ALKS 3831, and the continued development of our pipeline candidates, position the company well for long-term value creation.”

A spokesperson for Elliott said, “Elliott is highly supportive of the initiatives announced today and commends the Board and management of Alkermes on taking these steps. From our dialogue with management we are confident that the Company is committed to creating shareholder value. Further, both David Daglio and Brian McKeon will add significant value to Alkermes’ Board and the newly formed board committee. Alkermes is significantly undervalued given its attractive assets and growth potential, and we are confident that these new initiatives will yield meaningful share price upside. We thank Richard and the rest of the team for their constructive dialogue and look forward to an ongoing engagement with the Company.”

Profitability Targets & Cost Structure Optimization Efforts

As part of the Value Enhancement Plan, the company today announced its commitment to achieving:

• FY 2023 non-GAAP net income equal to 25% of the company’s total revenues and EBITDA margin¹ of 20% of total revenues
• FY 2024 non-GAAP net income equal to 30% of the company’s total revenues and EBITDA margin of 25% of total revenues

The company plans to achieve these margins through disciplined management of the company’s cost structure combined with revenue growth, and is committed to meeting these targets in a range of scenarios. To underline Alkermes’ commitment to strong profitability, the compensation committee of the Board will consider these targets in its design of this year’s long-term incentive plan for senior management.

Alkermes has already undertaken several important initiatives to support these targets, including a reorganization of the company’s commercial infrastructure, which was implemented in November 2020. As part of the reorganization, several functional areas within the company’s commercial organization were consolidated to improve efficiencies and approximately 80 full-time positions were reallocated to support the anticipated launch of ALKS 3831, reducing the need for previously planned new hires. Additionally, the company has commenced an extensive review of its operations and structure both internally and with external advisors to identify potential areas for improved efficiencies. This review is ongoing, and the company plans to provide an update on the findings and planned initiatives resulting from the review following its conclusion, expected in the first quarter of 2021.

Evaluation of Strategic Opportunities

A newly set-up committee of the board will evaluate a broad range of potential strategic options related to Alkermes’ non-core assets, including monetization and divestiture opportunities.

In addition, the company underscored its prior commitment to exploring a strategic collaboration for ALKS 4230, the company’s immuno-oncology pipeline candidate, as an important element of the company’s focus on realizing the full potential of ALKS 4230 across a broad spectrum of possible treatment combinations, tumor types and lines of therapy. Alkermes believes that accumulating objective response data and subcutaneous administration data from its ARTISTRY development program for ALKS 4230 will serve as the basis for potential collaboration discussions.     

Board Refreshment and Governance Update

The company today announced that it is taking a series of actions as part of its ongoing commitment to strong corporate governance and regular Board refreshment. These efforts build upon the refreshment process that began in 2019 with the engagement of a leading recruitment firm and the subsequent appointment of two highly-qualified independent directors: Andy Wilson and Richard Gaynor, M.D. 

• Following the company’s July 2020 announcement of its continuing Board refreshment efforts, the Alkermes Board has appointed two new independent directors – David Daglio and Brian McKeon – who bring investor perspectives and strong financial and operational expertise to the Board.
• Two long-serving directors, Robert Breyer and Paul Mitchell, plan to retire and step down from the Board at the close of the company’s 2021 Annual General Meeting of Shareholders.
• The Board plans to identify at least one additional independent director to be appointed in the first half of 2021.

“Our board refreshment efforts during the past two years reflect our continued commitment to a strong, independent board with expertise that aligns with and directly supports Alkermes’ strategic priorities,” said Lead Independent Director David W. Anstice. “I am pleased to welcome David and Brian to the Board and believe that Alkermes will benefit greatly from their distinct combination of financial and operational expertise. We are confident that the Board is well positioned to provide robust guidance and oversight as the company continues its efforts to positively impact the lives of patients living with serious mental illness, addiction and cancer, while driving shareholder value creation.”

“On behalf of the Board, I would also like to express our most sincere appreciation to Paul Mitchell and Bob Breyer for their long and distinguished tenure on the Board and their invaluable contributions to Alkermes,” Mr. Anstice added.

In addition to the appointment of new directors, the company will also undertake the following corporate governance actions:

• The Board plans to form a committee to oversee achievement of the Profitability Targets and the potential monetization of the company’s non-core assets. The committee will initially be comprised of the Chief Executive Officer and three independent directors, including two of the newly appointed directors.
• The Board also intends to recommend that the company’s shareholders approve, at the company’s 2021 Annual General Meeting of Shareholders, an amendment to the company’s Articles of Association to declassify the Board.

Investor Day

The company plans to host an investor day in the first quarter of 2021 to provide an update on the implementation of the Value Enhancement Plan and highlight some of the new research and development programs in the company’s portfolio.

New Director Biographies

About David Daglio


As former Executive Vice President and Chief Investment Officer of Mellon Investments, Mr. Daglio brings a seasoned institutional investment management perspective to the Board. Over his 21-year career at Mellon, Mr. Daglio oversaw active equity portfolio management teams, served as the head of Opportunistic Value strategies and on Mellon’s board of directors, and helped architect and manage the merger of three unique companies to create the 12^th largest U.S. asset manager. In his roles at Mellon, Mr. Daglio worked with institutional clients and boards around the world and grew portfolio assets by more than five-fold. Mr. Daglio currently serves as a director of Total Brain Ltd.

About Brian McKeon
Mr. McKeon brings strong financial and management expertise as well as public company executive and director experience to the Board. He has served as Executive Vice President and Chief Financial Officer of IDEXX Laboratories since 2014, leading its finance, corporate development and strategy, and investor relations functions, and, since June 2019, has overseen IDEXX’s livestock, water and human diagnostics businesses. Mr. McKeon previously served as a director of IDEXX from 2003 through 2013, and as a director of athenahealth, Inc. from September 2017 to February 2019. Prior to IDEXX, Mr. McKeon held executive leadership roles at Iron Mountain, The Timberland Company and PepsiCo.

About Alkermes

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

About Elliott

Elliott Management Corporation manages approximately $41 billion of assets. Its flagship fund, Elliott Associates, L.P., was founded in 1977, making it one of the oldest funds of its kind under continuous management. The Elliott funds’ investors include pension plans, sovereign wealth funds, endowments, foundations, funds-of-funds, and employees of the firm. Elliott Advisors (UK) Limited is an affiliate of Elliott Management Corporation.

Non-GAAP Financial Measures

Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from U.S. generally accepted accounting principles (“GAAP”) results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; changes in the fair value of the contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items.

Note Regarding Forward-Looking Statements

Certain statements set forth in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company’s expectations concerning future financial and operating performance, business plans or prospects, including expected revenue growth, the company’s commitment to, and ability to achieve, specified profitability targets, including non-GAAP net income and EBITDA margin targets as a percentage of total revenues, oversight of the achievement of such targets by a newly formed Board committee, and the company’s ability to create share price upside and long-term value for shareholders through expense management, cost structure optimization and potential monetization or divestiture of non-core assets; the company’s expectations regarding the timing and results of the review of the company’s operations and cost structure; the potential therapeutic and commercial value of the company’s marketed and development products; the company’s expectations concerning future development activities for the company’s development products, including expectations regarding the potential for future ALKS 4230 data to serve as a basis for a potential collaboration; expectations concerning the company’s regulatory interactions and commercial activities, including those relating to the potential approval and commercial launch of ALKS 3831; and the company’s plans for additional Board-related changes, including the expected appointment of at least one additional director and its plans to recommend declassification of the Board. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the cost structure review and optimization activities being undertaken by the company may not yield the intended results; the company may not be able to achieve its targeted profitability metrics, including non-GAAP net income and EBITDA margin targets as a percentage of total revenues, in a timely manner or at all; the unfavorable outcome of litigation, including so-called “Paragraph IV” litigation and other patent litigation, related to any of the company’s products or products using the company’s proprietary technologies, which may lead to competition from generic drug manufacturers; clinical development activities may not be completed on time or at all; the results of the company’s clinical development activities may not be positive, or predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products, such as decisions not to approve the company’s NDAs, including the NDA for ALKS 3831; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to governmental payers; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and the impacts of the ongoing COVID-19 pandemic and continued efforts to mitigate its spread on the company’s business, results of operations or financial condition; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended Dec. 31, 2019, the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.

¹Calculated as earnings before interest, taxation, depreciation, amortization and one-time items, includes share-based compensation expenses

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SOURCE Alkermes plc

KATY, Texas, Dec. 10, 2020 /PRNewswire/ — Academy Sports and Outdoors, Inc. (NASDAQ: ASO) today reported financial results for the third quarter ended October 31, 2020.

Third Quarter Summary for the Period Ending October 31, 2020

Net sales for the third quarter 2020 were $1.35 billion, a 17.8% increase over $1.15 billion in the third quarter 2019.  Comparable sales for the third quarter 2020 increased 16.5% over the third quarter 2019.

Academy reported net income for the third quarter 2020 of $59.6 million, or $0.74 per diluted share, a 109% net income increase over $28.6 million, or $0.38 per diluted share, in the third quarter 2019.  Pro Forma Adjusted Net Income, which excludes the impact of certain non-cash and extraordinary items, was $73.7 million or $0.91 per diluted share, a 188% increase in Pro Forma Adjusted Net Income over $25.6 million or $0.34 per diluted share, in the third quarter 2019.

The Company’s gross margin rate for the third quarter 2020 was 32.7% of net sales, a 110 basis point increase over 31.6% in the third quarter of 2019, while the selling, general, and administrative (“SG&A”) expense rate was 26.6% of net sales on $359.0 million of SG&A expenses, a 40 basis point improvement over 27.0% on $309.2 million of SG&A expenses in the third quarter 2019.  Excluding nonrecurring expenses associated with the Company’s October initial public offering (“IPO”), consisting of $19.9 million in additional stock compensation expense and $12.3 million for the settlement of the Company’s private equity sponsor’s monitoring agreement, SG&A expenses for third quarter 2020 would have been $326.8 million or 24.2% of net sales, a 280 basis point improvement over the third quarter 2019.

The Company reported eCommerce sales growth of 95.9% over the third quarter 2019 and that stores facilitated over 95% of the Company’s total sales, including ship-from-store, buy-online-pick-up-in-store, and in-store retail sales.

Ken Hicks, Chairman, President and Chief Executive Officer, said, “I am proud to report record-breaking quarterly sales and net income and our fifth consecutive quarter with a comparable sales increase.  This was a significant accomplishment that our entire team delivered in a challenging quarter filled with many important achievements.  We continue to work on our key strategic initiatives, including power merchandising, omnichannel, and customer focus, which we believe will position us well for the future.”

Year-to-date 2020 Summary

Net sales for the 39 weeks ended October 31, 2020 (“year-to-date 2020”) was $4.1 billion, an 18.3% increase over the 39 weeks ended November 2, 2019 (“year-to-date 2019”).  Comparable sales for the year-to-date 2020 increased 16.1% over the year-to-date 2019.

The Company reported net income for the year-to-date 2020 of $217.2 million, a 112.3% increase over the year-to-date 2019.  This resulted in earnings per diluted share of $2.82 compared to $1.37 per diluted share for the year-to-date 2019.  Pro Forma Adjusted Net Income for the year-to-date 2020 was $208.6 million, a 257.6% improvement over the year-to-date 2019.  This resulted in Pro Forma Adjusted Earnings per diluted share of $2.70 compared to $0.78 per diluted share for the year-to-date 2019.

The Company reported net cash provided by operating activities of $857.2 million for the year-to-date 2020, a $762.4 million increase over $94.8 million for the year-to-date 2019.  Adjusted Free Cash Flow for the year-to-date 2020 was $843.4 million compared to $42.2 million for the year-to-date 2019.

Michael Mullican, Executive Vice President and Chief Financial Officer, said, “We are proud of our extraordinary team members for delivering strong year-to-date sales and earnings results.  Based on our comparable sales growth before and during the ongoing pandemic, we believe our diversified product categories and resilient business model resonate well with our growing customer base.  Despite challenges during the year to maintain in-stock levels in certain very productive categories, we believe that our inventory is now at an acceptable level in most categories and that we are in a good position to support our current and planned sales velocity and continue to improve even more in the near future.”

Capital Structure

The Company’s cash and cash equivalents totaled $869.7 million with no borrowings under its $1 billion ABL credit facility as of the end of the third quarter 2020.  Subsequent to the third quarter, on November 6, 2020, the Company issued $400 million of senior secured notes and entered into a new $400 million term loan facility, both of which mature in 2027.  The net proceeds from the notes and the new term loan, as well as cash on hand, were utilized to repay in full outstanding borrowings under the Company’s existing term loan facility in the amount of $1.4 billion, reducing the Company’s debt by $631 million.  In addition, on November 6, 2020, the Company extended its $1 billion ABL facility through 2025.

Conference Call Info

The Company will host a live conference call today at 11:00 a.m. Eastern Time to discuss its financial results.  Participants interested in accessing the live call can dial 1-800-289-0438 from the U.S. or 1-323-794-2423 from international locations.  The conference passcode is 4060996.  An audio webcast of the live call can be accessed on the Investor Relations section of the Company’s website at investors.academy.com.  To listen to the live call, please dial in or go to the website at least 10 minutes prior to the start of the call.

A telephonic replay of the conference call will be available shortly after its broadcast for approximately 30 days, by dialing 1-844-512-2921 from the U.S. or 1-412-317-6671 from international locations, and entering conference passcode 4060996.  A replay of the audio webcast will be archived on the Investor Relations section of the Company’s website for approximately 30 days.

About Academy

Academy is a leading full-line sporting goods and outdoor recreation retailer in the United States.  Originally founded in 1938 as a family business in Texas, Academy has grown to 259 stores across 16 contiguous states.  Academy’s mission is to provide “Fun for All” and Academy fulfills this mission with a localized merchandising strategy and value proposition that strongly connects with a broad range of consumers.  Academy’s product assortment focuses on key categories of outdoor, apparel, footwear and sports & recreation through both leading national brands and a portfolio of 17 private label brands, which go well beyond traditional sporting goods and apparel offerings.

All references to “Academy,” “Academy Sports + Outdoors,” “we,” “us,” “our” or the “Company” in this press release refer to (1) prior to October 1, 2020 (the “IPO pricing date”), New Academy Holding Company, LLC, a Delaware limited liability company (“NAHC”) and the prior parent holding company for our operations, and its consolidated subsidiaries; and (2) on and after the IPO pricing date, Academy Sports and Outdoors, Inc., a Delaware corporation (“ASO, Inc.”) and the current parent holding company of our operations, and its consolidated subsidiaries.

On the IPO pricing date, we completed a series of reorganization transactions (the “Reorganization Transactions”) that resulted in NAHC being contributed to ASO, Inc. by its members and becoming a wholly owned subsidiary of ASO, Inc. and one share of common stock of ASO, Inc. issued to then-existing members of NAHC for every 3.15 membership units of NAHC contributed to ASO, Inc. (the “Contribution Ratio”).  Unless indicated otherwise, the information in this press release has been adjusted to give retrospective effect to the Contribution Ratio.

Non-GAAP Measures

Adjusted EBITDA, Adjusted Net Income (Loss), Pro Forma Adjusted Net Income (Loss), Pro Forma Adjusted Earnings Per Share, and Adjusted Free Cash Flow have been presented in this press release as supplemental measures of financial performance that are not required by, or presented in accordance with, generally accepted accounting principles (“GAAP”). 

These non-GAAP measures have limitations as analytical tools.  For information on these limitations, as well as information on why management believes these non-GAAP measures are useful, please see our final prospectus dated October 1, 2020 (the “Prospectus”), as filed with the Securities and Exchange Commission (“SEC”) on October 2, 2020 pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Securities Act”), as such factors may be updated from time to time in our periodic filings with the SEC including our quarterly report on Form 10-Q for the third quarter ended October 31, 2020  (the “Quarterly Report”), which is expected to be filed on or about the date of this press release.  We compensate for these limitations by primarily relying on our GAAP results in addition to using these non-GAAP measures supplementally.

See “Reconciliations of Non-GAAP to GAAP Financial Measures” below for reconciliations of non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures.

Comparable Sales

We define comparable sales as the percentage of period-over-period net sales increase or decrease, in the aggregate, for stores open after thirteen full fiscal months, as well as for all e-commerce sales.  There may be variations in the way in which some of our competitors and other retailers calculate comparable sales.  As a result, data in this press release regarding our comparable sales may not be comparable to similar data made available by other retailers.  For additional information on comparable sales, please see the Prospectus and the Quarterly Report.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements include, but are not limited to, statements related to our current beliefs and expectations regarding the performance of our industry, our strategic direction, market position, prospects and future results.  You can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “projects,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Caution should be taken not to place undue reliance on any forward-looking statement as such statements speak only as of the date when made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  Forward-looking statements are not guarantees and are subject to various risk factors and uncertainties, which may cause actual results to differ materially from those implied in the forward-looking statements.  Such factors include, but are not limited to, overall decline in the health of the economy and consumer discretionary spending; our ability to predict or effectively react to changes in consumer tastes and preferences, to acquire and sell brand name merchandise at competitive prices and/or to manage our inventory balances; intense competition in the sporting goods and outdoor recreation retail industries; the impact of COVID-19 on our business and financial results; our ability to safeguard sensitive or confidential data relating to us and our customers, team members and vendors;  risks associated with our reliance on internationally manufactured merchandise;  our ability to comply with laws and regulations affecting our business, including those relating to the sale, manufacture and import of consumer products;  claims, demands and lawsuits to which we are, and may in the future, be subject and the risk that our insurance or indemnities coverage may not be sufficient; harm to our reputation; our ability to operate, update or implement our information technology systems; risks associated with disruptions in our supply chain and losses of merchandise purchasing incentives; any failure of our third-party vendors of outsourced business services and solutions; our ability to successfully continue our store growth plans or manage our growth effectively, or any failure of our new stores to generate sales and/or achieve profitability; risks associated with our e-commerce business; risks related to our owned brand merchandise; any disruption in the operation of our distribution centers; quarterly and seasonal fluctuations in our operating results; the occurrence of severe weather events, catastrophic health events, natural or man-made disasters, social and political conditions or civil unrest; our ability to protect our intellectual property and avoid the infringement of third-party intellectual property rights;  our dependence on our ability to meet our labor needs; the geographic concentration of our stores; fluctuations in merchandise costs and availability; our ability to manage the growth of our business; our ability to retain key executives; our ability to successfully pursue strategic acquisitions and integrate acquired businesses; payment-related risks; the effectiveness of our marketing and advertising programs; our substantial indebtedness; and our sponsor controls us and their interests may conflict with ours or yours in the future.  Additional factors that could cause our results to differ materially from those described in the forward-looking statements can be found under the heading entitled “Risk Factors” in our Prospectus, and Quarterly Report as such factors may be further updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and in our filings with the SEC. 

ACADEMY SPORTS AND OUTDOORS, INC.

RECONCILIATIONS OF NON-GAAP TO GAAP FINANCIAL MEASURES

(Unaudited)

(Dollar amounts in thousands)

Adjusted EBITDA

We define “Adjusted EBITDA” as net income (loss) before interest expense, net, income tax expense and depreciation, amortization and impairment, further adjusted to exclude consulting fees, private equity sponsor monitoring fees, stock based compensation expense, gain on early extinguishment of debt, net, severance and executive transition costs, costs related to the COVID-19 pandemic, inventory write-down adjustments associated with strategic merchandising initiatives and other adjustments. We describe these adjustments reconciling net income (loss) to Adjusted EBITDA in the following table.

Adjusted Net Income, Pro Forma Adjusted Net Income and Pro Forma Adjusted Earnings Per Share

We define “Adjusted Net Income (Loss)” as net income (loss), plus consulting fees, private equity sponsor monitoring fees, stock based compensation expense, gain on early extinguishment of debt, net, severance and executive transition costs, costs related to the COVID-19 pandemic, inventory write-down adjustments associated with strategic merchandising initiatives and other adjustments, less the tax effect of these adjustments. We define “Pro Forma Adjusted Net Income (Loss)” as Adjusted Net Income (Loss) less the retroactive tax effect of Adjusted Net Income at our estimated effective tax rate of approximately 25% for periods prior to October 1, 2020, the effective date of our conversion to a C-Corporation. We define “Pro Forma Adjusted Earnings per Common Share, Basic” as Pro Forma Adjusted Net Income divided by the basic weighted average common shares outstanding during the period and “Pro Forma Adjusted Earnings per Common Share, Diluted” as Pro Forma Adjusted Net Income divided by the diluted weighted average common shares outstanding during the period. We describe these adjustments reconciling net income (loss) to Adjusted Net Income (Loss), Pro Forma Adjusted Net Income (Loss), and Pro Forma Adjusted Earnings Per Share in the following table. 

Adjusted Free Cash Flow

We define “Adjusted Free Cash Flow” as net cash provided by (used in) operating activities less net cash used in investing activities. We describe these adjustments reconciling net cash provided by operating activities to Adjusted Free Cash Flow in the following table.

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SOURCE Academy Sports + Outdoors

MONMOUTH JUNCTION, N.J., Dec. 10, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces it has closed on the Third Amendment (the “Amendment”) of its Amended Loan and Security Agreement with Bridge Bank.  Under the terms of the Amendment, which closed on December 4, 2020 (the “Closing Date”), the Company repaid the outstanding principal balance of its existing $15 million term loans and simultaneously received a commitment from Bridge Bank to provide a new term loan of $15 million (the “New Term Loan”), if needed. 

“As a result of the $57.5 million equity raise that the Company completed in July 2020, the Company has enough cash to meet our needs for the foreseeable future.  Following a thorough review of different options, we concluded it was prudent to repay our outstanding term loan to avoid the payment of interest expense.  Bridge Bank was simultaneously able to provide us with an additional $15 million term loan commitment, which is exercisable at our sole discretion over the next 12 months, should we need additional funding for expansion.” stated Ms. Kathleen P. Bloch, CPA, MBA, Chief Financial Officer of CytoSorbents.  “We are pleased to continue to build on our excellent relationship with Bridge Bank, a premier lending institution with a broad scope of financial services.”

“We have been working with CytoSorbents for the past five years and are excited to continue our partnership with this rapidly growing and dynamic company that is helping to save lives,” said Ms. Lindsay Fouty, Vice President of Portfolio Management in Bridge Bank’s Life Sciences Group.  “We are pleased to be a part of the success and evolution of the Company by providing attractive growth capital and flexible payment terms.”

Under the terms of the Amendment, the Company may, at its sole discretion, draw down the New Term Loan at any time over the next twelve months. The New Term Loan, if drawn, shall bear interest at the Index Rate (defined in the Amendment as the greater of 3.25% or the Prime Rate as published by the Wall Street Journal on the last business date of the month the immediately preceding the month in which the interest will accrue) plus 1.25%.  In addition, the Company would be required to make payments of interest-only commencing on the first day of the month after the New Term Loan was made until January 2023.  The interest-only period may be further extended through July 2023 if the Company maintains compliance certain conditions as outlined in the Amendment.  Following the interest-only period, the Company will be required to make equal monthly payments of principal and interest until maturity of the New Term Loan.  The maturity date of the New Term Loan is December 1, 2024.

About Bridge Bank

Bridge Bank, a division of Western Alliance Bank, Member FDIC, helps business clients realize their ambitions. Founded in 2001 in Silicon Valley, Bridge Bank offers a better way to bank for small-market and middle-market businesses across many industries, as well as emerging technology companies and the private equity community. Geared to serving both venture-backed and non-venture-backed companies, Bridge Bank delivers a broad scope of financial solutions including capital, equipment and working capital credit facilities, venture debt, treasury management, asset-based lending, SBA and commercial real estate loans, ESOP finance and a full line of international products and services. Based in San Jose, Bridge Bank has 16 offices in major markets across the country along with Western Alliance Bank’s powerful array of specialized financial services. Western Alliance Bank is the primary subsidiary of Phoenix-based Western Alliance Bancorporation. One of the country’s top-performing banking companies, Western Alliance has ranked in the top 10 on the Forbes “Best Banks in America” list for five consecutive years, 2016-2020, and was named #1 best-performing of the 50 largest public U.S. banks for 2019 by S&P Global Market Intelligence. For more information, visit bridgebank.com.

About CytoSorbents Corporation (

NASDAQ: CTSO

)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 66 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 110,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K⁺ontrol™, ContrastSorb, DrugSorb, and others.    For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions, including statements regarding our expectations about our cash runway, the advancement of our trials, our plans to initiate new trials, our goals to develop and commercialize CytoSorb and the timing thereof, the potential impact of COVID-19 on our operations and milestones,  and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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Cytosorbents Contact:

Amy Vogel

Investor Relations
732-398-5394
[email protected]

Investor Relations Contact:

Jeremy Feffer

LifeSci Advisors
917-749-1494
[email protected]

Public Relations Contact:

Eric Kim

Rubenstein Public Relations
212-805-3055
[email protected]

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SOURCE CytoSorbents Corporation

NEW YORK, Dec. 10, 2020 /PRNewswire/ — Broadridge Financial Solutions, Inc. (NYSE: BR), a global Fintech leader, is hosting its virtual 2020 Investor Day at 8:00 AM EST today.

“We are excited to highlight the Broadridge growth story at our 2020 Investor Day,” said Tim Gokey, Broadridge’s Chief Executive Officer. “Broadridge is continuing to scale its position as a leading global Fintech for governance and investing.  We intend to build on our leadership across governance, capital markets and wealth management to drive more value for our clients and deliver top quartile shareholder returns to our owners.”

As part of its 2020 Investor Day, Broadridge announced its new three-year growth objectives for the period ending Fiscal Year 2023. The growth objectives are shown as compound annual growth rates (“CAGRs”) for the fiscal years 2020-2023.

Broadridge also reaffirmed its Fiscal Year 2021 guidance provided on its fiscal first quarter 2021 conference call on October 30, 2020, including for Recurring revenue growth of 3-6% and Adjusted EPS growth of 6-10%.

To view the virtual event and access the slide presentation, visit Broadridge’s Investor Relations website at www.broadridge-ir.com prior to the start of the event.

Forward-Looking Statements
This press release and other written or oral statements made from time to time by representatives of Broadridge may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not historical in nature, and which may be identified by the use of words such as “expects,” “assumes,” “projects,” “anticipates,” “estimates,” “we believe,” “could be” and other words of similar meaning, are forward-looking statements. These statements are based on management’s expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed. These risks and uncertainties include those risk factors described and discussed in Part I, “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended June 30, 2020 (the “2020 Annual Report”), as they may be updated in any future reports filed with the Securities and Exchange Commission. All forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by reference to the factors discussed in the 2020 Annual Report. Broadridge disclaims any obligation to update or revise forward-looking statements that may be made to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events, other than as required by law.

Explanation and Reconciliation of the Company’s Use of Non-GAAP Financial Measures 
The Company’s results in this press release and related materials are presented in accordance with U.S. generally accepted accounting principles (“GAAP”) except where otherwise noted. In certain circumstances, results have been presented that are not generally accepted accounting principles measures (“Non-GAAP”). These Non-GAAP measures are Adjusted Operating income, Adjusted Operating income margin, Adjusted Net earnings, Adjusted earnings per share, and Free cash flow. These Non-GAAP financial measures should be viewed in addition to, and not as a substitute for, the Company’s reported results.

The Company believes our Non-GAAP financial measures help investors understand how management plans, measures and evaluates the Company’s business performance. Management believes that Non-GAAP measures provide consistency in its financial reporting and facilitates investors’ understanding of the Company’s operating results and trends by providing an additional basis for comparison. Management uses these Non-GAAP financial measures to, among other things, evaluate our ongoing operations, and for internal planning and forecasting purposes. In addition, and as a consequence of the importance of these Non-GAAP financial measures in managing our business, the Company’s Compensation Committee of the Board of Directors incorporates Non-GAAP financial measures in the evaluation process for determining management compensation.

For additional information regarding the Company’s use of Non-GAAP financial measures and the reconciliation of the Company’s Non-GAAP measures to the most directly comparable financial measures presented in accordance with GAAP, please see the tables that are part of the Company’s Investor Day presentations posted on Broadridge’s Investor Relations website at www.broadridge-ir.comand are also included as Exhibit 99.2 to the Company’s Form 8-K dated December 10, 2020.

About Broadridge
Broadridge Financial Solutions, Inc. (NYSE: BR), a $4.5 billion global Fintech leader, is a leading provider of investor communications and technology-driven solutions to banks, broker-dealers, asset and wealth managers and corporate issuers. Broadridge’s infrastructure underpins proxy voting services for over 50 percent of public companies and mutual funds globally, and processes on average U.S. $10 trillion in fixed income and equity securities trades per day. Broadridge is part of the S&P 500® Index and employs over 12,000 associates in 17 countries. For more information about Broadridge, please visit www.broadridge.com.

Investors:
W. Edings Thibault
Investor Relations
+1 516-472-5129

Media:
Gregg Rosenberg
Corporate Communications
+1 212-918-6966

View original content:http://www.prnewswire.com/news-releases/broadridge-highlights-market-leadership-and-growth-objectives-at-2020-investor-day-301189986.html

SOURCE Broadridge Financial Solutions, Inc.