Market Newsdesk

Community Health Systems, Inc. Announces Early Tender Results of, and Amendment to, Previously Announced Tender Offers

FRANKLIN, Tenn.–(BUSINESS WIRE)–
Community Health Systems, Inc. (the “Company”) (NYSE: CYH) announced today the early tender results of the previously announced tender offers (the “Tender Offers”) by its wholly owned subsidiary, CHS/Community Health Systems, Inc. (the “Issuer”), to purchase for cash the Issuer’s outstanding (i) 6.875% Senior Notes due 2022 (the “2022 Notes”), (ii) 8.125% Junior-Priority Secured Notes due 2024 (the “Junior-Priority 2024 Notes”), (iii) Junior-Priority Secured Notes due 2023 (the “Junior-Priority 2023 Notes”) and (iv) 6.875% Senior Unsecured Notes due 2028 (the “2028 Notes” and, together with the 2022 Notes, Junior-Priority 2024 Notes and Junior-Priority 2023 Notes, the “Notes”) up to an aggregate principal amount that will not result in a maximum aggregate purchase price (excluding accrued and unpaid interest) that exceeds $400 million (the “Maximum Aggregate Purchase Price”), subject to the order of priority and proration provisions as set forth in the Offer to Purchase and Consent Solicitation Statement, dated October 30, 2020 (the “Offer to Purchase”). According to Global Bondholder Services Corporation, the tender agent and information agent for the Tender Offers and Consent Solicitation (as defined below), as of 5:00 p.m., New York City time, on November 13, 2020 (the “Early Tender Deadline”), approximately $86,089,000 aggregate principal amount of the Notes were validly tendered and not validly withdrawn.

The table below identifies the principal amount of each series of Notes validly tendered and not validly withdrawn as of the Early Tender Deadline, and the aggregate principal amount of each series of Notes accepted for purchase by the Issuer.

Because the principal amount of Notes validly tendered and not validly withdrawn at or prior to the Early Tender Deadline has not exceeded the Maximum Aggregate Purchase Price, the Issuer will accept all such Notes for purchase. In addition, because the principal amount of Notes validly tendered and not validly withdrawn at or prior to the Early Tender Deadline has not exceeded the Maximum Aggregate Purchase Price, the Issuer will continue to accept Notes tendered after the Early Tender Deadline subject to the Acceptance Priority Level set forth in the table above and the proration provisions set forth in the Offer to Purchase. The settlement date for Notes accepted for purchase as of the Early Tender Deadline is expected to occur on November 17, 2020 (the “Early Settlement Date”).

The withdrawal deadline for the Tender Offers was 5:00 p.m., New York City time, on November 13, 2020 and has not been extended (the “Withdrawal Deadline”). Accordingly, previously tendered Notes may not be withdrawn, subject to applicable law.

As part of the Tender Offer relating to the 2022 Notes (the “2022 Tender Offer”), the Issuer also solicited consents (the “Consent Solicitation”) from the holders of the 2022 Notes for certain proposed amendments (the “Proposed Amendments”) as set forth in the Offer to Purchase that would, among other things, eliminate substantially all restrictive covenants, certain events of default and certain other provisions contained in the indenture governing the 2022 Notes (the “2022 Notes Indenture”). Adoption of the Proposed Amendments with respect to the 2022 Notes requires the consent from at least a majority of the outstanding principal amount of 2022 Notes (the “Requisite Consent”). The Issuer did not receive the Requisite Consent from the holders of the 2022 Notes to adopt the Proposed Amendments and therefore the 2022 Notes will continue to be subject to the terms of the 2022 Notes Indenture without giving effect to the Proposed Amendments, unless and until the Requisite Consent is received as a result of additional 2022 Notes being validly tendered (and not validly withdrawn) after the Early Tender Deadline and prior 11:59 p.m., New York City time, on November 30, 2020 (such date and time, as it may be extended, the “Expiration Time”).

In addition, the Issuer has amended the terms and conditions of the Tender Offers so that registered holders of Notes that are validly tendered (and not validly withdrawn) at or prior to the Expiration Time and accepted for purchase pursuant to the Tender Offers will also receive the $50.00 early tender payment for each $1,000 in aggregate principal amount of Notes so validly tendered (and not validly withdrawn) and accepted for purchase. The Tender Offers are being made upon the terms and conditions described in the Offer to Purchase, as amended by this press release.

The Tender Offers and the Consent Solicitation are subject to the satisfaction or waiver of certain conditions as described in the Offer to Purchase.

The complete terms and conditions of the Tender Offers and the Consent Solicitation are set forth in the Offer to Purchase and remain unchanged except for the amendments set forth in this press release.

The Issuer has retained Credit Suisse Securities (USA) LLC to act as the dealer manager in connection with the Tender Offers and as the solicitation agent in connection with the Consent Solicitation. Questions about the Tender Offers or the Consent Solicitation may be directed to Credit Suisse Securities (USA) LLC at (800) 820-1653 (toll free) or (212) 538-2147 (collect). Copies of the Offer to Purchase and other related documents may be obtained from Global Bondholder Services Corporation, the tender agent and the information agent for the Tender Offers and the Consent Solicitation, at (866) 470-3800 (toll free) or (212) 430-3774 (collect), or by email at contact@gbsc‑usa.com.

This press release shall not constitute an offer to buy or sell, or the solicitation of any offer to buy or sell, any securities. Any offer or solicitation with respect to the Tender Offers and the Consent Solicitation will be made only by means of the Offer to Purchase, and the information in this press release is qualified by reference to the Offer to Purchase. The Tender Offers and the Consent Solicitation are not being made to holders of Notes in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction. Holders must make their own decision as to whether to tender any of their Notes, and, if so, the principal amount of Notes to tender.

Forward-Looking Statements

This press release may include information that could constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve risk and uncertainties. The Company undertakes no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005331/en/

Investor Contacts:

Kevin J. Hammons, 615-465-7000

Executive Vice President and Chief Financial Officer

or

Ross W. Comeaux, 615-465-7012

Vice President – Investor Relations

Media Contact:

Tomi Galin, 615-628-6607

Senior Vice President, Corporate

Communications, Marketing and Public Affairs

KEYWORDS: United States North America Tennessee

INDUSTRY KEYWORDS: Health Hospitals

MEDIA:

Logo

Mastercard Advances Multi-Rail Strategy to Modernize Business Payments

Adding Account-to-Account and Global Card Payments Functionality to Mastercard Track™ Business Payment Service

PURCHASE, N.Y.–(BUSINESS WIRE)–
Mastercard continues to deliver on its multi-rail strategy with the addition of Account-to-Account (A2A) payments functionality to Mastercard Track™ Business Payment Service.

This launch represents the next phase in Mastercard’s journey to modernize business payments by solving persistent pain points that Buyers and Suppliers experience today. Building on the success of card payments within Mastercard Track Business Payment Service, businesses can now have a similar experience for A2A payments – exchanging data with greater efficiency and facilitating payments across multiple payment rails including Real Time Payments (RTP) and the Automated Clearing House (ACH) in the United States.

The Account-to-Account payments functionality in Track Business Payment Service is now available in the U.S. and will be available in all regions by the end of 2021. Cross-border payments are also on the roadmap for next year.

Track Business Payment Service gives businesses greater control of their payments and supports rich data exchanges and the ability to automate payments without the need to share sensitive bank account information. About 80% of mid-size and large Suppliers view the sharing of bank account data as a business risk, according to Mastercard research.¹ The risk of bank account data being compromised is reduced because Suppliers no longer need to share their confidential bank account details with Buyers, nor do Buyers need to store those details.

“Today, the vast majority of B2B payments are made through bank account transfers. Extending Mastercard Track Business Payment Service to support these transfers is a step on our way to building out the best and most secure B2B payment network in the world,” said James Anderson, Executive Vice President of Global Commercial and B2B Solutions at Mastercard. “Our commitment to supporting multiple payment rails has always been about helping customers operate more efficiently and effectively leveraging all the capabilities available in the market with as little change as possible. This milestone is another step in the journey away from paper-based frustration, incomplete data and manual reconciliation work and toward a fully digitized business payments process.”

Modernizing B2B Payments Across New Geographies and Partners

In May 2020, Mastercard announced the commercial launch of Track Business Payment Service for U.S. card payments. Today, businesses of all sizes can use this service to pay and get paid with card through new distribution partners around the world including: bzPay, Gardenia Technologies, Girasol Payment Solutions, Network International, Pendo Technologies Corp., Plastiq, Today Payments, Inc., Transcard, Ukheshe, and Yak Pay.

Now, through Track Business Payment Service, commercial businesses have access to more control and greater simplicity in how they pay and get paid across multiple payment types.

What Our Partners are Saying

“B2B payments terms and delays can create debilitating negative cashflow dilemmas for business. bzPay helps with a practical way to reduce debt, accelerate payments and optimize cashflow through a single payments platform. Mastercard’s Track Business Payment Service multi-rail solution provides a New Payment Platform enablement and a scalable payment solution for our customers. By enabling payment flexibility options, Mastercard paves the way for a globally connected eCommerce solution.” – Aleks Kostadinovic, CEO bzPay Pty Ltd.

“Our company is focused on delivering data-driven working capital solutions including advanced analytics and finance to corporates. Mastercard Track Business Payment Service offers much-improved visibility into the source-to-pay and order-to-cash processes, as well as critical insights into payments for financial products and transactional reporting.” – Rupert Schneider, Co-Founder, Gardenia Technologies

“Payment behavior in the B2B market space is a crucial pain point in the Caribbean, mainly due to complex processes from different business cultures. As our company focuses on facilitating the business payment ecosystem with innovative technologies, it is our mission to add value to the way business payments are made. Mastercard Track Business Payment Service solution allows us to adopt global payment standards and add value by increasing transparency and providing rich reconciliation/remittance data in a secure trusted environment on both cards and A2A payment rails.” – Marwan Rozier, Chief Operating Officer, Girasol Payment Solutions

“We are delighted to be among the first partners in the Middle East and Africa to launch the Mastercard Track Business Payment Service solution that will address long-standing pain points in the B2B payment sector by creating an innovative service that responds to the industry’s urgent need for seamless and automated collection and reconciliation. We anticipate that Track Business Payment Service will act as a game changer, providing the scale and capability that will support our clients’ business needs.” – Samer Soliman, Managing Director – Middle East, Network International

“Pendo focuses on disruptive technologies and innovation leveraging business and technology trends to develop innovative solutions that alleviate many payments process pain points that both big corporations and small- and medium-sized enterprises encounter every day. We are delighted to partner with Mastercard Track Business Payment Service to help businesses reduce costs, increase speed, improve efficiencies and create healthier cash flow.” – Oscar Uribe, Co-Founder & Chief Commercial Officer, Pendo Technologies Corp.

“Businesses are in constant need to access new forms of working capital and streamline their payments. Plastiq’s ability to help businesses do more with their commercial cards is very aligned with Mastercard Track Business Payment Service’s global vision for making B2B payments frictionless. We’re excited to partner with Mastercard to help offer businesses more optimized payment solutions.” – Sameer Gulati, President & COO of Plastiq

“Suppliers/Billers need rich data exchanges, including itemized revenue transaction data, not just batch deposit summaries afforded them via direct connect banking. Track Business Payment Service magnificently delivers this expanded data. Our Today Payments API, an award-winning software innovation, automates the process of recording the rich, complex data efficiently. We are thrilled to provide this cutting-edge solution for all B2B transactions in what I consider to be the most real-world, revolutionary enhancement to business payments with the Track Business Payments Service.” – Leigh Cook, CEO, Today Payments, Inc.

“Traditional approaches to making and receiving B2B payments are inefficient, unnecessarily complex and risky. The combination of the Mastercard Track Business Payment Service and Transcard’s integration platform eliminates friction in B2B payments by digitally connecting buyers and sellers and facilitating touch-free real-time payments and the exchange of rich remittance information directly between trading partner ERPs and banks.” – Greg Bloh, CEO of Transcard

“Ukheshe, a digital banking platform focused on addressing financial inclusion in Africa, demands world-class partners and solutions that can address real customer concerns. With Mastercard Track Business Payment Service, we are able to ensure the secure transmission of payment details to multiple bill presenters, giving peace of mind to all parties involved.” – Mike Smits, Co-Founder, Ukheshe

“After seven years of processing B2B payments for thousands of our small business clients, we are on a mission to make their payments easier, faster and more secure. Yak Pay is delighted to be working with Mastercard to help achieve this, and Mastercard Track Business Payment Service is an excellent example of innovation helping small businesses operate more efficiently, profitably and securely.” – Sam Plowman, CEO of Payment Logic and Yak Pay

Notes to Editors

[1] Based on 404 survey responses, effective sample size of ~800, from an even split of small (>$50Mn), mid-size ($50Mn – $250Mn), and large ($250Mn+) companies. ​Source: Supplier survey; A.T. Kearney analysis (2019).

About Mastercard (NYSE:MA):

Mastercard is a global technology company in the payments industry. Our mission is to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our decency quotient, or DQ, drives our culture and everything we do inside and outside of our company. With connections across more than 210 countries and territories, we are building a sustainable world that unlocks priceless possibilities for all.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005324/en/

Katie Priebe, Global Communications

+1 (914) 707-9822 |[email protected]

Sandra Benjamin, North America Communications

+1 (416) 365-5567|[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Networks Finance Banking Professional Services Technology

MEDIA:

Logo

Exicure to Participate in Upcoming Conferences

CHICAGO & CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) constructs, today announced participation in the following conferences during the month of November:

• 2020 Virtual Guggenheim Healthcare Talks | Idea Forum | Neuro/Immunology Day
  
  One-on-one meetings
  
  Monday, November 16, 2020

• Virtual Fall Investor Summit
  
  Presentation
  
  Time: 4:00 PM Eastern Time
  
  Location: Virtual Webcast, Available for Live Streaming
  
  Monday, November 16, 2020

Replays of the webcast will be available on Exicure’s website for 30 days following the event.

About Exicure, Inc.

Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for neurology, immuno-oncology, inflammatory diseases and other genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure is in preclinical development of XCUR-FXN an SNA–based therapeutic candidate, for the treatment of Friedreich’s ataxia (FA). Exicure’s drug candidate AST-008 is currently in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Exicure is in Chicago, IL and has an office in Cambridge, MA.

For more information, visit Exicure’s website at www.exicuretx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005308/en/

Media Contact:

MacDougall

Karen Sharma

781-235-3060

[email protected]

KEYWORDS: United States North America Illinois Massachusetts

INDUSTRY KEYWORDS: Oncology Health Genetics Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo

Kala Pharmaceuticals Provides Update on Launch Plans for EYSUVIS^TM for the Treatment of Dry Eye Disease

— Poster presentation and promotional activities highlighted at the American Academy of Ophthalmology 2020 Virtual Annual Meeting —

— On-track to begin shipping EYSUVIS to wholesalers in mid-December —

— Wholesale Acquisition Cost announced —

WATERTOWN, Mass.–(BUSINESS WIRE)–
Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today provided an update on its plans to launch EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

“We continue to make significant progress on our plans to launch EYSUVIS and establish it as the preferred, first-line prescription therapy for dry eye disease,” said Todd Bazemore, Chief Operating Officer of Kala Pharmaceuticals. “We have nearly completed the hiring and onboarding of the first wave of our planned sales force expansion ahead of the virtual launch meeting in early December. We have also established a wholesale acquisition cost for EYSUVIS, which will allow us to begin submitting payer contract bids to pharmacy benefit managers (PBMs), commercial and Medicare Part D plans. We have expanded on our educational and marketing activities, including data presentations and promotional events at the recent American Academy of Ophthalmology 2020 Virtual Annual Meeting. We expect to begin shipping EYSUVIS to wholesalers in mid-December and look forward to delivering EYSUVIS to eye care professionals and patients by the end of the year.”

Kala continues to make significant progress in launch preparations for EYSUVIS since its approval by the U.S. Food and Drug Administration (FDA) on October 26, 2020. Educational activities were initiated at the American Academy of Ophthalmology (AAO) 2020 Virtual Meeting, held from November 13-15, 2020. Aggregate data from four clinical trials evaluating EYSUVIS for the treatment of dry eye disease, including three Phase 3 trials and one Phase 2 trial, were presented in a poster presentation by Edward Holland, M.D., Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. Promotional activities at AAO also included a virtual booth highlighting the product’s approval and upcoming availability, daily sponsored educational programs in the Industry Showcase, and a sponsored webinar hosted by the AAO Foundation.

Kala has nearly completed the hiring and onboarding of an expanded team of sales professionals who have on average more than seven years of ophthalmic sales experience and more than 14 years of pharmaceutical sales experience. At launch, Kala will have approximately 90 sales professionals and it plans to grow the sales force to approximately 125 sales representatives in 2021, pending the status of the COVID-19 pandemic. Over 90 percent of the sales force has eyecare experience, and more than half have experience in dry eye disease. A virtual launch meeting is planned for early December 2020 with promotional activities set to begin by year end. The Company expects to begin shipping EYSUVIS to wholesalers by mid-December.

The Wholesale Acquisition Cost (WAC or “list price”) for a 10 mL bottle of EYSUVIS has been set at $465. The list price is not inclusive of discounts to payers, providers, distributors and other purchasing organizations. The out-of-pocket cost to a patient will depend upon insurance coverage, copay, and eligibility for participation in the patient assistance program.

As of September 30, 2020, Kala had cash, cash equivalents and short-term investments of $159.1 million. Kala anticipates that its existing cash, cash equivalents and short-term investments, along with anticipated sales of INVELTYS^®, will enable it to fund its operations into at least the third quarter of 2022. Kala expects revenue anticipated to be generated from sales of EYSUVIS will provide additional cash runway.

About EYSUVIS:

EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS utilizes Kala’s AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the ocular surface. EYSUVIS was approved by the FDA on October 26, 2020. Kala believes that EYSUVIS’ broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, offer a differentiated product profile for the short-term treatment of dry eye disease, including the management of dry eye flares.

EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. The initial prescription and each renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP. Use of corticosteroids may result in posterior subcapsular cataract formation. Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients.

Please see full Prescribing Information at www.eysuvis.com

About Kala Pharmaceuticals, Inc.

Kala is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFY^® mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the October 2020 approval of EYSUVIS^TM (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and the January 2019 launch of INVELTYS^® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties, including statements regarding the Company’s expectation to begin shipping EYSUVIS to wholesalers by mid-December 2020 and delivering EYSUVIS to eye care professionals and patients by the end of the year, the Company’s plan to grow to 125 sales representatives in 2021, pending the status of the COVID-19 pandemic, and the Company’s expectations regarding its use of cash, cash runway and projected revenues. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of various risks and uncertainties including, but not limited to: the impact of extraordinary external events, such as the current pandemic health event resulting from the novel coronavirus (COVID-19), and their collateral consequences, including disruption of the activities of our sales force and the market for EYSUVIS and INVELTYS; whether the Company will be able to successfully implement its commercialization plans for EYSUVIS and INVELTYS; whether the market opportunity for EYSUVIS and INVELTYS is consistent with the Company’s expectations and market research; the Company’s ability execute on the commercial launch of EYSUVIS on the timeline expected, or at all; whether the Company will be able to generate its projected net product revenue on the timeline expected, or at all; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company’s expected timeline; other matters that could affect the availability or commercial potential of EYSUVIS, INVELTYS and the Company’s product candidates; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings the Company makes with the Securities and Exchange Commission. These forward-looking statements represent the Company’s views as of the date of this release and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005304/en/

Investor Contacts:

Loraine Spreen

[email protected]

857-277-4842

Hannah Deresiewicz

[email protected]

212-362-1200

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Optical Health FDA Clinical Trials

MEDIA:

Posted on November 16, 2020 7:03 am

Legend Biotech Reports Third Quarter 2020 Financial Results

Legend Biotech Reports Third Quarter 2020 Financial Results

SOMERSET, N.J.–(BUSINESS WIRE)–
Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech” or the “Company”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported financial results for the quarter ended September 30, 2020.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005237/en/

Legend Biotech’s Development Pipeline (Graphic: Business Wire)

“Legend Biotech continues to execute on our corporate strategy, advancing the development of our lead product candidate, ciltacabtagene autoleucel (cilta-cel), in collaboration with Janssen Biotech, Inc. as well as our other pipeline programs,” said Dr. Ying Huang, Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) of Legend Biotech. “We look forward to initiation of the Biologics License Application (“BLA”) filing for cilta-cel by Janssen Biotech, Inc.”

Third Quarter 2020 & Recent Highlights

• On November 9, 2020, Legend Biotech announced that Ms. Ye (Sally) Wang was appointed, effective November 6, 2020, as Chairwoman of the Board of Directors of Legend Biotech. The Board of Directors also named Dr. Ying Huang as CEO of Legend Biotech, effective November 6, 2020. Dr. Huang had been serving as interim CEO since September 21, 2020. Dr. Huang will continue to hold his position as CFO until such time as a successor CFO is identified.
• On November 5, 2020, Legend Biotech announced that the Company will present new and updated data from its CARTITUDE-1 and LEGEND-2 studies at the 62^nd American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.
• On September 21, 2020, Legend Biotech announced that the Customs Anti-Smuggling Department of the People’s Republic of China (“PRC”) had inspected places of business in China of Legend Biotech and GenScript Biotech Corporation, Legend Biotech’s majority shareholder, in connection with what Legend Biotech understands to be an investigation relating to suspected violations of import and export regulations under the laws of the PRC (the “Investigation”) and that Dr. Fangliang Zhang, the Chairman of the Board of Directors and CEO of Legend at that time, had been placed under “residential surveillance” in the PRC. No charges have been filed against Legend Biotech, Dr. Zhang, or any of its other officers or directors, and the Company does not believe that Legend Biotech is a subject of the investigation.
• On August 5, 2020, Legend Biotech announced that the China Center for Drug Evaluation (“CDE”) of National Medical Products Administration (“NMPA”) recommended Breakthrough Therapy Designation (“BTD”) for cilta-cel for the treatment of adults with relapsed/refractory multiple myeloma. The designation was granted on August 13, 2020, making cilta-cel the first investigational product to obtain BTD in China.

Key Upcoming Milestones

• On Saturday, December 5, 2020, during the Myeloma session at ASH entitled: Myeloma/Amyloidosis: Therapy, excluding Transplantation: Novel Therapies Targeting B Cell Maturation Antigen in Relapsed/Refractory Multiple Myeloma, the Phase 1b/2 clinical efficacy and safety data from the CARTITUDE-1 study will be presented.
• During the ASH Annual Meeting and Exposition, LEGEND-2 data in patients with relapsed or refractory multiple myeloma and extramedullary disease will be presented as a poster.
• Legend Biotech’s collaboration partner Janssen Biotech, Inc. anticipates initiating the BLA submission for cilta-cel to the U.S. Food and Drug Administration (“FDA”) by the end of 2020 and submitting a marketing authorization application to the European Medicines Agency (“EMA”) in early 2021.
• Legend Biotech expects to use data from CARTIFAN-1 study to file a regulatory submission in China in 2021.
• Please see Legend Biotech’s comprehensive development pipeline as shown below.

Development Pipeline

The extent to which the COVID-19 pandemic may impact our business and clinical trials is highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak and social distancing regulations, travel restrictions, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Financial Results for the Three-month and Nine-month Periods Ended September 30, 2020

Cash and Cash Equivalents:

As of September 30, 2020, Legend Biotech had approximately $449.4 million of cash and cash equivalents and approximately $125.6 million in time deposits.

Revenue

Revenue for the three months ended September 30, 2020 was $11.7 million compared to $17.7 million for the three months ended September 30, 2019. The decrease of $6.0 million was primarily due to milestone achieved in July 2019 under the agreement with Janssen Biotech, Inc., which resulted in additional consideration being allocated to the licensing of intellectual property and the steering committee service for the three months ended September 30, 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the three months ended September 30, 2020. Revenue for the nine months ended September 30, 2020 was $34.9 million compared to $37.8 million for the nine months ended September 30, 2019. Similarly, the decrease of the nine months period in 2020 was primarily driven by additional milestone payment received from Janssen Biotech, Inc. that was achieved in July 2019, net-off by additional milestone that was achieved in December 2019, which resulted in additional consideration being allocated to the steering committee service for the nine month ended September 30, 2020. Legend Biotech has not generated any revenue from product sales to date.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2020 were $63.7 million compared to $41.9 million for the three months ended September 30, 2019. This increase of $21.8 million was primarily due to a higher number of clinical trials, a higher number of patients enrolled in those trials and a higher number of research and development product candidates in the three months ended September 30, 2020. Consistently, research and development expenses for the nine months ended September 30, 2020 was $165.2 million compared to $95.8 million for the nine months ended September 30, 2019 with a $69.4 million increase.

Administrative Expenses

Administrative expenses for the three months ended September 30, 2020 were $6.0 million compared to $2.0 million for the three months ended September 30, 2019. The increase of $4.0 million was primarily due to Legend Biotech’s expansion of supporting administrative functions to aid continued research and development activities. Due to the consistent business expansion, administrative expenses for the nine months ended September 30, 2020 increased by $9.3 million, which was $14.0 million compared to $4.7 million for the nine months ended September 30, 2019.

Selling and Distribution Expenses

Selling and distribution expenses for the three months ended September 30, 2020 were $9.3 million compared to $4.5 million for the three months ended September 30, 2019. This increase of $4.8 million was primarily due to increased costs associated with commercial preparation activities for cilta-cel. Driven by the same commercial preparation activities, selling and distribution expenses for the nine months ended September 30, 2020 was $25.4 million compared to $12.2 million for the nine months ended September 30, 2019.

Other Income and Gains

Other income and gains for the three months ended September 30, 2020 was $1.5 million compared to $3.0 million for the three months ended September 30, 2019. The decrease was primarily driven by net foreign exchange loss incurred, net of an increase in government grant received. Other income and gains for the nine months ended September 30, 2020 was $5.3 million compared to $6.6 million for the nine months ended September 30, 2019. The decrease of the nine months period was primarily driven by reduced average interest rate for holding of time deposits that generate interest income.

Other Expenses

Other expenses for the three months ended September 30, 2020 was $1.2 million compared to $0.002 million for the three months ended September 30, 2019. Other expenses for the nine months ended September 30, 2020 was $1.3 million compared to $0.2 million for the nine months ended September 30, 2019. The increase was primarily due to foreign exchange loss.

Loss for the Period

For the three months ended September 30, 2020, net loss was $66.5 million, or $0.25 per share, compared to a net loss of $27.8 million, or $0.14 per share, for the three months ended September 30, 2019. Net loss was $245.7 million for the nine months ended September 30, 2020 compared to $69.0 million for the nine months ended September 30, 2019.

Grant of restricted share units and share options

On September 1, 2020, we granted a total number of 777,382 restricted share units (each representing the right to receive one ordinary share) to grantees with a grant date fair market value of $16.335 per share. On September 1, 2020, we granted share options, representing the right to acquire a total number of 569,000 shares to grantees with an exercise price of $16.335 per share.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of over 800 employees across the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, provide us with the strong potential to discover, develop, and manufacture cutting edge cell therapies for patients in need.

We are engaged in a strategic collaboration with Janssen Biotech, Inc. to develop and commercialize our lead product candidate, ciltacabtagene autoleucel, an investigational BCMA-targeted CAR-T cell therapy for patients living with multiple myeloma. This candidate is currently being studied in registrational clinical trials.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; the anticipated timing of, and ability to progress, clinical trials; the ability to make, and the timing of, regulatory submissions globally, including the BLA for cilta-cel to the U.S. FDA, the marketing authorization application (MAA) for cilta-cel to the EMA, regulatory submission filing for CARTIFAN-1 in China and the Investigational New Drug Application (IND) of LB1901, a CAR T product under development for the treatment of relapsed or refractory T-cell lymphoma (TCL), to the U.S. FDA; the ability to generate, analyze and present data from clinical trials; patient enrollment; the potential benefits of our product candidates, the status and outcome of the Investigation and its impact on the Company’s operations. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the factors discussed in the “Risk Factors” section of the prospectus filed with the Securities and Exchange Commission on June 8, 2020. Any forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005237/en/

Media and Investor Relations:

Jessie Yeung, Head of Corporate Finance and Investor

Relations, Legend Biotech [email protected] or

[email protected]

Surabhi Verma, Manager of Investor

Relations and Corporate Communications, Legend Biotech [email protected] or

[email protected]

For Medical Affairs inquiries, please contact:

Tonia Nesheiwat, Executive Director, Medical Affairs, Legend Biotech USA Inc.

[email protected] or [email protected]

KEYWORDS: United States North America New Jersey

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health

MEDIA:

Logo

Photo

Legend Biotech’s Development Pipeline (Graphic: Business Wire)

Can-Fite Presented NASH Phase II Namodenoson Data at a Late Breaking Session of the American Association for the Study of Liver Diseases (AASLD) Conference

Dr. Safadi, the study’s Principal Investigator: “Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety.”

PETACH TIKVA, Israel–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that Dr. Rifaat Safadi, Principal Investigator of the Company’s Phase II study of Namodenoson in the treatment of NAFLD/NASH delivered a late-breaking oral presentation at the AASLD conference, The Liver Meeting Digital Experience™ 2020.

Titled “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study Of The Efficacy And Safety Of Namodenoson (CF102), An A3 Adenosine Receptor (A3AR) Agonist, In Treating Non-Alcoholic Fatty Liver Disease (NAFLD) And Non-Alcoholic Steatohepatitis (NASH)” the oral presentation was given on Sunday, November 15 by Dr. Safadi, Head of the Liver Unit, Gastroenterology and Liver Diseases, Division of Medicine at Hadassah Medical Center, Professor of Internal Medicine, Bowel, Liver Disease, and Metabolic Syndrome at Hebrew University in Israel.

The double-blind, placebo-controlled, dose-finding efficacy and safety study enrolled 60 patients with NAFLD with or without NASH. Patients with evidence of an active inflammation were treated twice daily with 12.5 mg (n=21) or 25 mg (n=19) of oral Namodenoson vs. placebo (n=20). The patients were treated for 12 weeks and followed-up until week 16. As a result of the study, 25 mg was determined to be the optimal dose.

Data presented during the oral presentation included:

• Anti-Inflammatory effect – a significant decrease in the liver enzymes ALT and AST and significant improvement in the positive cytokine adiponectin was recorded in the Namodenoson 25 mg treated group
• Reduced liver fat content – manifested by a significant reduction in % of liver fat volume assessed by MRI-PDFF and a decrease in the Controlled Attenuation Parameter (CAP – score ≥ 331) measured by FibroScan in the Namodenoson 25 mg group
• Decrease in FIB-4 and FAST – non-invasive tests showed anti-fibrosis effect in Namodenoson 25 mg group
• Decrease in body weight – a linear decrease in body weight was recorded in the 25 mg and 12.5 mg Namodenoson groups with a better effect in the higher dose
• Safety – Namodenoson continued to have a safe profile and was very well tolerated with no drug emergent severe adverse effects and no hepatotoxicity

“We were very pleased that the AASLD accepted our late breaking abstract for an oral presentation, a prominent platform through which we shared these important study results with the leading scientists and health care professionals committed to preventing and curing liver diseases. We thank Dr. Safadi for delivering the presentation,” stated Can-Fite CEO Dr. Pnina Fishman.

Dr. Safadi added, “Namodenoson’s very impressive study data may result in a promising drug for the treatment of NAFLD/NASH due to the combination of good efficacy and favorable safety.”

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis/psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201116005022/en/

Can-Fite BioPharma

Motti Farbstein

[email protected]

+972-3-9241114

KEYWORDS: United States North America Israel Middle East New York

INDUSTRY KEYWORDS: Professional Services Health Finance General Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo