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Avenue Therapeutics Provides Regulatory Update for IV Tramadol

Company Anticipates NDA Resubmission in February 2021

NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (NASDAQ: ATXI) (Avenue), a company focused on the development of intravenous (IV) tramadol for the U.S. market, today provided a regulatory update following receipt of the official meeting minutes from a November 2020 Type A meeting with the U.S. Food and Drug Administration (FDA) relating to a path forward for IV tramadol.

Avenue had requested this Type A meeting to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV tramadol. Avenue intends to resubmit the NDA in February 2021, barring any Covid-19 related or other setbacks. The NDA resubmission will incorporate revised language relating to the proposed product label and a report relating to terminal sterilization validation.

About Avenue Therapeutics
Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.avenuetx.com.

About Fortress Biotech

Fortress Biotech, Inc. (Fortress) is an innovative biopharmaceutical company that was ranked in Deloitte’s 2019 and 2020 Technology Fast 500™, annual rankings of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing high-potential marketed and development-stage pharmaceutical products and product candidates. The company has five marketed prescription pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca, City of Hope, Fred Hutchinson Cancer Research Center, InvaGen Pharmaceuticals Inc. (a subsidiary of Cipla Limited), St. Jude Children’s Research Hospital and Nationwide Children’s Hospital. For more information, visit www.fortressbiotech.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to us obtaining regulatory approval from the FDA for our product candidate, risks relating to the Covid-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner, risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts:

Jaclyn Jaffe and William Begien
Avenue Therapeutics, Inc.
(781) 652-4500
[email protected]



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Neovasc Announces Publication of Peer-Reviewed Article in EuroIntervention

REDUCER I Study Shows Improvement in Chest Pain Symptoms

VANCOUVER and MINNEAPOLIS, Dec. 17, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that EuroIntervention, the official journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI), has published online a peer-reviewed study announcing the outcomes of patients undergoing Neovasc Reducer™ (“Reducer”) implantation in the Company’s REDUCER-I trial. The article, entitled “Coronary Sinus Narrowing for the Treatment of Refractory Angina A Multi-center Prospective Open-label Clinical Study (The REDUCER-I Study)”, is the latest of numerous publications supporting the safety and effectiveness of the Reducer. The trial examined the safety and efficacy of the coronary sinus (CS) Reducer in improving angina severity and quality of life in patients suffering from angina pectoris, refractory to medical and interventional therapies.

The ongoing REDUCER-I trial is the largest-to-date cohort of patients undergoing Reducer implantation for the treatment of refractory angina. Presented in the peer-reviewed article are the outcomes of the first 228 patients enrolled to this observational study with up to 2-year follow up. The study reported procedural success of 99%. Canadian Cardiovascular Society (CCS) Angina Class, a measure of chest pain severity, improved following the procedure, together with other measured parameters of functional class and quality of life.

Prof. Maayan Konigstein, MD, Department of Cardiology, Tel-Aviv Medical Center, said, “Millions of people around the world suffer from the debilitating condition of refractory angina. The evidence from the REDUCER-I Study further supports the European Society of Cardiology Guidelines that state Reducer may be a safe and effective treatment option for patients suffering from refractory angina. These interim analyses provide further evidence supporting Reducer therapy for patients that are suffering and have no other treatment options.”

Patients included in the trial were experiencing chest pain, or angina, despite taking medications or having invasive procedures to treat their symptoms. Over half of the population had previously experienced a heart attack, 78% had previously undergone coronary artery bypass graft surgical procedures, and 70% had coronary stenting procedures in the past. Despite all of the previous efforts to control their symptoms, the patients still experienced chest pain.

Following implantation of the Reducer device, the mean CCS class improved from 2.8±0.6 to 1.8±0.7 at two years follow-up. 82% of patients experienced improvement of at least 1 CCS class, and 31% achieved at least a 2 CCS class improvement, representing a substantial reduction in symptoms. At baseline, 70% of patients had CCS class III or IV angina (representing severe disability with anginal chest pain at rest or at minimal effort). At 6-months, 1-year and two-year follow-up, only 15% of patients remained at Class III or IV.

Prof. Stefan Verheye, MD, PhD, Antwerp Cardiovascular Center Middelheim, Antwerp, Belgium, added, “It’s gratifying to see the interim results of the REDUCER-I Study reinforce the outstanding results from the COSIRA randomized sham-controlled trial previously published in The New England Journal of Medicine. I want to thank the patients and the investigators for their participation in the trial, and I look forward to completing the enrollment in this important real-world study.”

The Reducer device is CE marked and commercially available in Europe.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the safety and effectiveness of the Reducer and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F and in the Management’s Discussion and Analysis for the three and nine months ended September 30, 2020 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company’s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Citation. Verheye S, Agostoni P, Giannini F, Hill J, Jensen C, Lindsay S, Stella P, Redwood S, Banai S, Konigstein M. Coronary Sinus Narrowing for the Treatment of Refractory Angina A Multi-Center Prospective Open-Label Clinical Study (The REDUCER-I Study). EuroIntervention 2020; Jaa-872 2020, doi: 10.4244/EIJ-D-20-00873


Investors

Mike Cavanaugh

Westwicke/ICR

Phone: +1.646.877.9641

[email protected]


Media

Sean Leous

Westwicke/ICR

Phone: +1.646.866.4012

[email protected]



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Aberdeen International Looks to Expand Into Hydrogen Renewable Energy

TORONTO, Dec. 17, 2020 (GLOBE NEWSWIRE) — Aberdeen International Inc. (“Aberdeen” or the “Company”) (TSX: AAB) is pleased to announce its intention to augment its investment strategy with a larger focus on renewable energies, particularly the hydrogen sector.

The Company believes that the hydrogen sector is on the verge of a breakthrough due to the clean tech revolution and its economic advantages over incumbent fueling technologies. Hydrogen’s high energy to mass ratio makes it particularly suitable for heavy-duty, long-distance road freight, maritime and aviation applications. Industry analysts forecast demand for hydrogen to grow to 575 million tonnes per year by 2050 in a market worth more than US$1 trillion.

  1. Hydrogen powered vehicles have major advantages over battery electric, gas, and diesel vehicles (driving range, fueling time and cost per mile).
  2. Billions of dollars’ worth of hydrogen long haul trucks and cars are expected on the market in next 2-4 years from incumbents and upstarts in the next 36 months.
  3. Over 20 countries, collectively representing around 70% of global GDP, are proposing hydrogen strategies or roadmaps as key elements of their decarbonizations plans.

Established vehicle manufacturers (Toyota, Hyundai, Daimler and Volvo) have announced that they are ramping up their delivery schedules of hydrogen powered cars and long-haul trucks and many other applications in the industrial and energy markets are growing at a substantial rate.

In order to strengthen our capabilities in the hydrogen space, the Company is pleased to announce the appointment of Mr. Martin Schuermann and Mr. Halady Prabhu as strategic advisors.

Martin Schuermann has been a serial entrepreneur throughout different industries and has been involved in the clean energy sector since 2009, becoming the CEO of Vision Motor Corp and Vision Industries where they were focused on developing zero emission transportation solutions, using hydrogen as the dominant energy storage medium. 

Mr. Prabhu has more than a decade of experience in the renewable energy industry having worked with EDF Énergies Nouvelles Canada (EDF EN), one of the leading renewable energy companies in the world and other leading solar PV developers globally. Mr. Prabhu is involved in transactions in the renewable energy and clean tech sector and is constantly identifying new opportunities in the energy storage and hydrogen economy sector. He is actively involved in identifying new technologies and opportunities in the fast-growing hydrogen sector in both the mobility and industrial verticals. Mr. Prabhu has an extensive network of companies and individuals playing key roles in the hydrogen economy from which the company will leverage to gain exposure to this rapidly growing sector.

The Company believes by investing, financing, and helping lead the development of hydrogen as an alternative energy fuel source, we will drive significant shareholder value going forward. We seek to partner with leading-edge researchers, government agencies and forward-looking energy entities to advance the technology, attract end-market users and position hydrogen, as the main alternative energy fuel source.

ABOUT ABERDEEN INTERNATIONAL

Aberdeen International is a global resource investment company and merchant bank focused on small capitalization companies in the mining and metals and renewable energy sectors.

For additional information, please visit our website at www.aberdeeninternational.ca.

For further information, please contact:

Ryan Ptolemy
Chief Financial Officer
Aberdeen International Inc.
[email protected]
+1 416-861-5882

Cautionary Notes

This press release contains “forward-looking information” within the meaning of applicable Canadian securities legislation. Forward-looking information includes, without limitation, statements regarding the renewable energy sectors, including hydrogen, the impact of appointees as strategic advisors and the Company’s future plans. Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information, including risks inherent in the mining industry and risks described in the public disclosure of the Company which is available under the profile of the Company on SEDAR at www.sedar.com and on the Company’s website at www.aberdeeninternational.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. The Company does not undertake to update any forward-looking information, except in accordance with applicable securities laws.



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Guardian Capital Announces December 2020 Distributions for Guardian Capital ETFs

TORONTO, Dec. 17, 2020 (GLOBE NEWSWIRE) — Guardian Capital LP announces the following regular cash distributions for the period ending December 31, 2020, in respect of the Guardian Capital ETFs listed below. In each case, the distribution will be paid on December 31, 2020 to unitholders of record on December 24, 2020. The ex-dividend date in each case is December 23, 2020.  

Exchange Traded Fund Class of
Units 		Distribution

Frequency 		Trading

Symbol 		Distribution Amount

(per Unit)
Guardian Directed Equity Path ETF Hedged Monthly GDEP $0.0667
Guardian Directed Equity Path ETF Unhedged Monthly GDEP.B $0.0667
Guardian Directed Premium Yield ETF Hedged Monthly GDPY $0.10
Guardian Directed Premium Yield ETF Unhedged Monthly GDPY.B $0.10
Guardian i3 Global Quality Growth ETF Hedged Quarterly GIQG $01
Guardian i3 Global Quality Growth ETF Unhedged Quarterly GIQG.B $01
Guardian i3 US Quality Growth ETF Hedged Quarterly GIQU $01
Guardian i3 US Quality Growth ETF Unhedged Quarterly GIQU.B $01
Guardian i3 Global REIT ETF Hedged Quarterly GIGR $0.0215
Guardian i3 Global REIT ETF Unhedged Quarterly GIGR.B $0.0207

About Guardian Capital LP

Guardian Capital LP is the manager and portfolio manager of the Guardian Capital Funds and each of the Guardian ETFs. Additionally, Guardian Capital manages portfolios for defined benefit and defined contribution pension plans, insurance companies, foundations, endowments and third-party mutual funds. Guardian Capital is a wholly-owned subsidiary of Guardian Capital Group Limited. For further information on Guardian Capital, please call 416-350-8899 or visit www.guardiancapitallp.com.

About Guardian Capital Group Limited

Guardian Capital Group Limited is a diversified financial services company founded in 1962. Guardian operates in two main business areas, Asset Management and Financial Advisory.  As of September 30, 2020, Guardian had C$32.7 billion of assets under management and C$20.8 billion of assets under administration. Guardian offers institutional and private wealth investment management services; financial services to international investors; services to financial advisors in its national mutual fund dealer, securities dealer, and insurance distribution network; and maintains and manages a proprietary investment portfolio, which had a fair market value of C$552 million at September 30, 2020.  Its Common and Class A shares are listed on the Toronto Stock Exchange; in 2019, Guardian celebrated 50 years as a listed company. To learn more about Guardian, visit www.guardiancapital.com.

This communication is intended for informational purposes only and does not constitute an offer to sell or the solicitation of an offer to purchase Guardian Capital ETFs and is not, and should not be construed as, investment, tax, legal or accounting advice, and should not be relied upon in that regard. Commissions, management fees and expenses all may be associated with investments in exchange-traded funds (ETFs). Please read the prospectus before investing. ETFs are not guaranteed, their values change frequently and past performance may not be repeated. You will usually pay brokerage fees to your dealer if you purchase or sell units of an ETF on the TSX. If the units are purchased or sold on the TSX, investors may pay more than the current net asset value when buying units of the ETF and may receive less than the current net asset value when selling them.

1 There is no quarterly distribution for this ETF unit class, in respect of the period ending December 31, 2020.

 



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Skylight Health to Provide a Discount Drug Card Program to its Expanding Subscription Offering for Uninsured Americans

  • There are over 40 million Americans who are either uninsured or underinsured1
  • Over 58 million Americans cannot afford prescription drugs2
  • Skylight will provide a discount drug card program to save up to 80% of the cost of generic drugs
  • This program will be a strong value driver for its low-cost fixed urgent care telemedicine offering
  • The total addressable market is $8 billion for its subscription service offering
  • The Company expects to commence this program in Q1 2021

TORONTO, Dec. 17, 2020 (GLOBE NEWSWIRE) — Skylight Health Group Inc (CSE:SHG; OTCQX:SHGFF) (“SHG” or the “Company”), one of the largest multi-specialty healthcare systems in the United States, is pleased to announce that it has partnered with United Networks of America (“UNA”) to provide its subscription members access to a discounted drug card program. This service will establish a unique value proposition for Skylight to expand on its subscription base, while providing a much-needed benefit for un/under insured Americans.

Skylight Health operates, in addition to insurable services, a disruptive low-cost subscription offering to urgent care telemedicine services for patients across the US. The subscription, which costs $199/year or $24.99/month, offers patients who are un/under insured access to a Skylight Health provider at a fixed cost without the fear of additional fees or co-pays. The program designed to provide Americans access to healthcare, has been launched in a pilot phase within select US states. The Company expects that over 40 million Americans can benefit from this low-cost offering.

The discount drug program offered in partnership with UNA will provide a value-add to the subscription program. Members will receive a free drug discount card virtually using a QR code that they can use at over 72,000 participating pharmacies across the US. Members can save up to 80% off the cost of generic prescription drugs as well as discounts on brand name medication. The QR codes, which will be linked to the patient profile on the Company’s proprietary patient record system, provides safe and secure access on any device.

Prad Sekar, CEO of Skylight Health, said, “While we are doing our part to ensure that healthcare becomes a basic human right in a market that has traditionally seen a major disparity in access to care, we recognize that access to care goes beyond just the patient and physician relationship. It is about how patients can access much needed medication, tests and other services. As we expand with UNA, we look forward to bringing more solutions to help our members access the care they need, no matter what their financial situation looks like. We are excited for the value this is going to bring our members nationally.”

The Company expects to begin rolling out digital cards in Q1 2021 following further integrations within the technology of both organizations. The Company continues to see strong validation for its subscription model as it pilots the program directly to patients and is working on a number of employer and sponsor-based initiatives.

About Skylight Health Group

Skylight Health Group (CSE:SHG OTCQX:SHGFF) is a healthcare services and technology company, working to positively impact patient health outcomes. The Company operates a US multi-state health network that comprises of physical multi-disciplinary medical clinics providing a range of services from primary care, sub-specialty, allied health and laboratory/diagnostic testing. The Company owns and operates a proprietary electronic health record system that supports the delivery of care to patients via telemedicine and other remote monitoring system integrations. With a patient roster of over 120,000 patients, the Company’s operations servicing 14 states and continues to expand in services and locations both organically and by way of strategic acquisitions.

The Company primarily operates a traditional insurable fee-for-service model contracting with Medicare, Medicaid and other Commercial Payors. The Company also offers a disruptive subscription-based telemedicine service for the un/under-insured population who have limited access to urgent care due to cost.

About United Networks of America

United Networks of America is one of the largest providers of value-added managed care products and services in the United States. UNA has more than 72,000 participating pharmacies serving more than 120.1 million members. To date, UNA has saved members an estimated $4.9 billion. The UNA family of networks includes prescription drug, cosmetic surgery, ProSmile UNA, dental, vision, hearing and wellness benefits. Visit UNA at www.unitednetworksofamerica.com.

For more information, please visit www.skylighthealthgroup.com or contact:

Investor Relations
Jonathan L. Robinson CFA
Oak Hill Financial
[email protected]
416-669-1001

Cautionary and Forward-Looking Statements

Statements in this news release that are forward-looking statements are subject to various risks and uncertainties concerning the specific factors disclosed here and elsewhere in Skylight Health’s filings with Canadian securities regulators. When used in this news release, words such as “will, could, plan, estimate, expect, intend, may, potential, believe, should,” and similar expressions, are forward-looking statements.

Forward-looking statements may include, without limitation, statements regarding the Company’s unaudited financial results and projected growth.

Although Skylight Health has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those contained in the forward-looking statements, there can be other factors that cause results, performance or achievements not to be as anticipated, estimated or intended, including, but not limited to: the ability of Skylight Health to execute on its business strategy, continued revenue growth in accordance with management’s expectations, operating expenses continuing in accordance with management expectations, dependence on obtaining regulatory approvals; Skylight Health being able to find, complete and effectively integrate target acquisitions; change in laws relating to health care regulation; reliance on management; requirements for additional financing; competition; hindering market growth or other factors that may not currently be known by the Company.

There can be no assurance that such information will prove to be accurate or that management’s expectations or estimates of future developments, circumstances or results will materialize. As a result of these risks and uncertainties, the results or events predicted in these forward-looking statements may differ materially from actual results or events.

Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date of this release. Skylight Health disclaims any intention or obligation to update or revise such information, except as required by applicable law, and Skylight Health does not assume any liability for disclosure relating to any other company mentioned herein.


Third Party Information

This press release includes market and industry data that has been obtained from third party sources, including industry publications. The Company believes that the industry data is accurate and that its estimates and assumptions are reasonable, but there is no assurance as to the accuracy or completeness of this data. Third party sources generally state that the information contained therein has been obtained from sources believed to be reliable, but there is no assurance as to the accuracy or completeness of included information. Although the data is believed to be reliable, the Company has not independently verified any of the data from third party sources referred to in this press release or ascertained the underlying economic assumptions relied upon by such sources.

No securities regulator or exchange has reviewed, approved, disapproved, or accepts responsibility for the content of this news release.

1 Source: PBS – Healthcare Crisis: The Uninsured Link: https://www.pbs.org/healthcarecrisis/uninsured.html
2 Source: Gallup – Millions in the US Lost Someone Who Couldn’t Afford Prescriptions. November 12, 2019. Link: Millions in U.S. Lost Someone Who Couldn’t Afford Treatment (gallup.com)



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Baudax Bio Announces $12 Million Offering Priced at a Premium to Market

MALVERN, Pa., Dec. 17, 2020 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on therapeutics for acute care settings, (“Baudax Bio” or the “Company”) today announced that it has entered into a definitive agreement with a healthcare-focused institutional investor for the purchase and sale of an aggregate of 10,300,430 shares of common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to an aggregate of 10,300,430 shares of common stock at a purchase price of $1.165 per share (or $1.155 per prefunded warrant) and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.18 per share, are exercisable immediately, and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about December 21, 2020, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Baudax Bio from the offering are expected to be approximately $12 million. In addition, in the event the warrants are exercised in full for cash, Baudax Bio expects to receive approximately $12.15 million in additional gross proceeds. However, there is no assurance that all or any portion of the warrants will be exercised prior to their expiration. Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.

The securities described above are being offered by Baudax Bio pursuant to a “shelf” registration statement on Form S-3 (File No. 333-243488) filed with the Securities and Exchange Commission (SEC) on August 10, 2020 and declared effective on October 2, 2020. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC.  Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (646) 975-6996, or email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About ANJESO®

ANJESO (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis. ANJESO was launched in the U.S. in June 2020 following its approval by the Food and Drug Administration in February 2020. ANJESO is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics. Because of the delayed onset of analgesia, ANJESO alone is not recommended for use when rapid onset of analgesia is required. ANJESO is supported by two pivotal Phase III clinical efficacy trials, a large double-blind, placebo-controlled Phase III safety trial and four Phase II clinical efficacy trials, as well as other safety studies. As a non-opioid, Baudax Bio believes ANJESO has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics, including respiratory depression, constipation, excessive nausea and vomiting, as well as having no addictive potential, while maintaining meaningful analgesic effects for relief of pain. ANJESO was designed using the NanoCrystal® platform, a technology that enables enhanced bioavailability of poorly water-soluble drug compounds. NanoCrystal® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on therapeutics for acute care settings. The launch of Baudax Bio’s first commercial product ANJESO® began in June 2020 following its approval by the U.S. Food and Drug Administration in February 2020. ANJESO is a once daily IV NSAID with preferential Cox-2 activity, which has successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and other studies for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other pharmaceutical assets including two novel neuromuscular blocking agents (NMBAs) and a proprietary chemical reversal agent specific to these NMBAs which is currently in preclinical studies, and intranasal dexmedetomidine which is being developed for possible uses in pain or sedation. For more information please visit www.baudaxbio.com.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend,” and “expect,” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These forward-looking statements are subject to risks and uncertainties including, among other things, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of proceeds from the registered direct offering, the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the commercial launch of ANJESO® or disruption in supply chain, Baudax Bio’s ability to maintain regulatory approval for ANJESO, Baudax Bio’s ability to successfully commercialize ANJESO; the acceptance of ANJESO by the medical community, including physicians, patients, health care providers and hospital formularies; Baudax Bio’s ability and that of Baudax Bio’s third party manufacturers to successfully scale-up our commercial manufacturing process for ANJESO, Baudax Bio’s ability to produce commercial supply in quantities and quality sufficient to satisfy market demand for ANJESO, Baudax Bio’s ability to raise future financing for continued product development, payment of milestones and ANJESO commercialization, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on our operational and budget plans, the accuracy of Baudax Bio’s estimates of the potential market for ANJESO, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results included in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

CONTACT:   

Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected]
[email protected]   

Baudax Bio, Inc.
Ryan D. Lake
(484) 395-2436
[email protected]

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected] 



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C4 Therapeutics to be Added to the Russell 2000® and Russell 3000® Indexes

WATERTOWN, Mass., Dec. 17, 2020 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a biopharmaceutical company pioneering a new class of small-molecule drugs that selectively destroys disease-causing proteins through degradation, today announced that the Company will be added to the Russell 2000® and Russell 3000® Indexes as part of the Russell quarterly update, effective December 21, 2020.

The Russell 2000® Index measures the performance of the small cap segment of the U.S. equity market. Membership in the Russell 2000® provides automatic inclusion in the appropriate growth and value style indexes. The Russell 2000® Index is a constituent part of the Russell 3000® Index, which measures the performance of the 3,000 largest publicly traded U.S. companies based on market capitalization.

“We are pleased to be added to the Russell Indexes only two months after our IPO,” said Andrew Hirsch, President and Chief Executive Officer at C4 Therapeutics. “C4T’s inclusion will broaden our exposure to the investment community, as we prepare to enter the clinic with our lead candidate, CFT7455 for hematologic malignancies, and advance our mission to discover and develop medicines that destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases.”

The Russell U.S. Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell U.S. Indexes. Russell U.S. Indexes are part of FTSE Russell, a leading global index provider.

For more information about the Russell® U.S. Indexes and the Russell Indexes reconstitution, visit the FTSE Russell website.

About C4 Therapeutics

C4 Therapeutics (C4T) is a biopharmaceutical company focused on harnessing the body’s natural regulation of protein levels to develop novel therapeutic candidates to target and destroy disease-causing proteins for the treatment of cancer, neurodegenerative conditions and other diseases. This targeted protein degradation approach offers advantages over traditional therapies, including the potential to treat a wider range of diseases, reduce drug resistance, achieve higher potency, and decrease side effects through greater selectivity. To learn more about C4 Therapeutics, visit www.C4Therapeutics.com.

Forward-Looking Statements

This press release contains “forward-looking statements” of C4 Therapeutics, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, express or implied statements regarding our ability to develop potential therapies for patients; the design and potential efficacy of our therapeutic approaches; the predictive capability of our TORPEDO™ platform in the development of novel, selective, orally bioavailable degraders; the potential timing and advancement of our preclinical studies and clinical trials; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials; our ability to replicate results achieved in our preclinical studies or clinical trials in any future studies or trials; our current resources and cash runway; and regulatory developments in the United States and foreign countries. Any forward-looking statements in this press release are based on management’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties related to the initiation, timing and conduct of studies and other development requirements for our product candidates; the risk that any one or more of our product candidates will not be successfully developed and commercialized; and the risk that the results of preclinical studies and clinical trials will be predictive of future results in connection with future studies or trials. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause C4T’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in C4 Therapeutics’ Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and C4T undertakes no duty to update this information unless required by law.



Investor & Media Contact:
Kendra Adams
SVP, Communications & Investor Relations
[email protected]

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Atlas Announces Pricing of Seaspan’s $175 Million 3.75% Exchangeable Senior Notes Offering

PR Newswire

LONDON, Dec. 17, 2020 /PRNewswire/ – Atlas Corp. (“Atlas”) (NYSE: ATCO) announced that its wholly-owned subsidiary, Seaspan Corporation (“Seaspan”), priced an offering (the “Offering”) of $175.0 million aggregate principal amount of 3.75% exchangeable senior notes due 2025 in a private placement to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Seaspan also granted the initial purchasers of the notes an option to purchase up to an additional $26.25 million aggregate principal amount of notes. The sale of the notes is expected to close on December 21, 2020, subject to customary closing conditions. The notes will be exchangeable under certain circumstances at the option of the holders into Atlas common shares, par value $0.01 per share (“Atlas shares”), cash, or a combination of Atlas shares and cash, at Seaspan’s election, unless the notes have been previously repurchased or redeemed by Seaspan. The exchange rate will initially equal 76.8935 Atlas shares per $1,000 principal amount of notes (equivalent to an initial exchange price of approximately $13.01 per Atlas share). The exchange rate will be subject to adjustment upon the occurrence of certain events, but will not be adjusted for any accrued and unpaid interest. After giving effect to the cap price established in the capped call transactions described in more detail below entered into by Seaspan concurrently with the pricing of the notes, the initial effective exchange price on the notes of $17.85 per Atlas share will represent a premium of approximately 75% over the last reported sale price of the Atlas shares of $10.20 per share on the New York Stock Exchange on December 16, 2020.

The notes will be Seaspan’s senior unsecured obligations and will accrue interest payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2021, at a rate of 3.75% per year. The notes will not be guaranteed by Atlas or any of its or Seaspan’s respective subsidiaries. The notes will mature on December 15, 2025, unless earlier exchanged, repurchased or redeemed. The effective interest cost to the company over the term of the notes, after giving effect to the net cost of the capped call transactions described below, will be approximately 5.5% per year.

Seaspan may redeem the notes, at its option, in whole or in part, on any business day on or after December 20, 2023 and prior to September 15, 2025, if the last reported sale price of Atlas shares has been at least 130% of the exchange price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period ending within three trading days immediately preceding the date on which Seaspan provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date.

In connection with the pricing of the notes, Seaspan entered into privately negotiated capped call transactions with one or more of the initial purchasers of the notes or their respective affiliates and/or other financial institutions having an expiration date that is the same as the maturity date of the notes. The capped call transactions would cover, subject to anti-dilution adjustments substantially similar to those applicable to the notes, the number of Atlas shares underlying the notes and are expected generally to reduce the potential dilution to Atlas shares upon any exchange of notes and/or offset any cash payments Seaspan is required to make upon exchange of the notes in excess of the principal amount thereof in the event that the market value per Atlas share, as measured under the capped call transactions, is greater than the strike price of the capped call transactions, with such reduction and/or offset being subject to a cap. The cap price of the capped call transactions will initially be $17.85 per share, which represents a premium of approximately 75% over the last reported sale price of the Atlas shares of $10.20 per share on the New York Stock Exchange on December 16, 2020. If the initial purchasers of the notes exercise their option to purchase additional notes, Seaspan expects to enter into additional capped call transactions with the option counterparties.

Seaspan expects that, in connection with establishing its initial hedges of the capped call transactions, the counterparties to the capped call transactions or their respective affiliates will enter into various derivative transactions with respect to the Atlas shares and/or purchase Atlas shares concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of the Atlas shares or the notes at that time. In addition, Seaspan expects that the counterparties to the capped call transactions or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to the Atlas shares and/or by purchasing or selling Atlas shares or other securities of Atlas in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to an exchange of the notes). This activity could also cause or avoid an increase or a decrease in the market price of the Atlas shares or the notes, which could affect the ability of holders to exchange their notes and, to the extent the activity occurs during any observation period related to an exchange of the notes, it could affect the amount of cash that holders will receive upon exchange of their notes.

Seaspan estimates that the net proceeds from the Offering will be approximately $170.4 million (or approximately $196.0 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ commission and Seaspan’s estimated offering expenses. Seaspan intends to use a portion of the net proceeds from the Offering to pay the net cost of the capped call transactions and for general corporate purposes, which may include funding acquisitions, repayment of debt, capital expenditures, potential acquisitions and partially financing the pre-delivery of payments for Seaspan’s recently announced newbuilding vessels.

Neither the notes nor the Atlas shares issuable upon exchange of the notes have been registered under the Securities Act or any state securities laws, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers (as defined in Rule 144A under the Securities Act). Atlas has agreed to file a registration statement covering resales of the Atlas shares issuable upon exchange of the notes with the Securities and Exchange Commission.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of, the notes in any jurisdiction in which the offer, solicitation or sale of the notes would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

About Atlas

Atlas is a leading global asset management company, differentiated by its position as a best-in-class owner and operator with a focus on deploying capital to create sustainable shareholder value. Atlas brings together an experienced asset management team with deep operational and capital allocation experience. We target long-term, risk adjusted returns across high-quality infrastructure assets in the maritime sector, energy sector and other infrastructure verticals. Our two portfolio companies, Seaspan Corporation and APR Energy are unique, industry-leading operating platforms in the global maritime and energy spaces, respectively.

About Seaspan

Seaspan is a leading independent owner and operator of containerships with industry leading ship management services. We charter our vessels primarily pursuant to long-term, fixed-rate, time charters to the world’s largest container shipping liners. As of today, Seaspan’s fleet consists of 127 containerships, representing total capacity of approximately 1,073,000 TEU with $4.0 billion of contracted revenue as of September 30, 2020. Seaspan’s operating fleet of vessels has an average age of approximately 7 years and an average remaining lease period of approximately 4 years, on a TEU-weighted basis.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains certain “forward-looking statements” (as such term is defined in Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, including statements regarding the Offering and capped call transactions, the potential terms thereof, and the use of any proceeds if the Offering is successful. Statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “estimates”, “projects”, “forecasts”, “will”, “may”, “potential”, “should”, and similar expressions are forward-looking statements. These forward-looking statements reflect management’s current expectations only as of the date of this release. As a result, you are cautioned not to rely on any forward-looking statements. Although these statements are based upon assumptions we believe to be reasonable based upon available information, they are subject to risks and uncertainties. With respect to the Offering, such uncertainties and circumstances include whether Seaspan will consummate the Offering, the terms of the capped call transactions and the use of the net proceeds from the Offering. Various factors could also adversely affect Seaspan’s operations, business or financial results in the future and cause Seaspan’s actual results to differ materially from those contained in the forward-looking statements, including those factors detailed from time to time in Atlas’s periodic reports and filings with the Securities and Exchange Commission, including Atlas’s Annual Report on Form 20-F for the year ended December 31, 2019 and Atlas’s Reports on Form 6-K furnished on November 10, 2020 and December 16, 2020. We expressly disclaim any obligation to update or revise any of these forward-looking statements, whether because of future events, new information, a change in our views or expectations, or otherwise. We make no prediction or statement about the performance of any of our securities. 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/atlas-announces-pricing-of-seaspans-175-million-3-75-exchangeable-senior-notes-offering-301194856.html

SOURCE Atlas Corp.

Posted on

Surface Oncology Announces Exclusive License Agreement with GSK for Novel Immunotherapy Program

GSK will have exclusive rights to develop and commercialize SRF813, a novel antibody targeting PVRIG

Surface Oncology to receive $85 million upfront payment

CAMBRIDGE, Mass., Dec. 17, 2020 (GLOBE NEWSWIRE) — Surface Oncology (Nasdaq: SURF) today announced an agreement for GSK to exclusively license worldwide development and commercial rights to Surface Oncology’s preclinical program SRF813, a fully human IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells.

Under the terms of the agreement, GSK will make an $85 million upfront payment. In addition, Surface Oncology may receive up to an additional $730 million in future milestone payments, as well as be eligible to receive tiered royalties on global net sales.

“We are extremely pleased to be entering into this agreement with GSK given the strong strategic fit for SRF813 within GSK’s oncology portfolio, including the possibility of pursuing compelling novel clinical combinations. Furthermore, the economics of the transaction position us well to continue to drive the development of our wholly-owned clinical programs, SRF617 and SRF388, while also advancing SRF114, our CCR8 targeted program,” said Jeff Goater, chief executive officer at Surface Oncology. “We believe this transaction is further validation of our strong immuno-oncology drug discovery capabilities.”

“GSK’s R&D approach focuses on the science of the immune system and I am excited to add a natural killer cell approach, such as SRF813, as it complements our existing programs focused on T cell/adaptive immunity,” said Dr. Axel Hoos, senior vice president and head of oncology R&D at GSK. “We’re making great progress to build an exciting pipeline of new oncology therapies with transformational potential for patients. I strongly believe that we are uniquely positioned to maximize the potential of SRF813 for patients, both as monotherapy and in potential combinations with our investigational anti-CD96 and anti-PD1 assets.”

Goodwin Procter is serving as legal counsel to Surface Oncology.

Financial Outlook:

Following the close of the GSK license agreement, together with current cash and cash equivalents, Surface Oncology projects cash runway sufficient to fund its operations through 2023.

About SRF813:

SRF813 is a fully human, IgG1 antibody targeting PVRIG (also known as CD112R), an inhibitory protein expressed on natural killer cells (NK cells) and T cells. SRF813 binds to a distinct epitope on PVRIG and blocks the interaction of PVRIG with CD112, its binding partner that is overexpressed on tumor cells. Preclinically, SRF813 promotes the activation of both NK cells and T cells, with the potential to elicit a strong anti-tumor response and promote immunological memory. SRF813 is currently in IND-enabling studies with an IND planned for 2021.

About Surface Oncology:

Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment. Its pipeline includes two wholly-owned lead programs targeting CD39 (SRF617) and IL-27 (SRF388), a clinical-stage collaboration with Novartis targeting CD73 (NZV930), a preclinical program licensed to GlaxoSmithKline targeting PVRIG (also known as CD112R (SRF813)), and a preclinical program focused on depleting regulatory T cells (via targeting CCR8 (SRF114)). Surface’s novel cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. For more information, please visit www.surfaceoncology.com.

Cautionary 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. Forward-looking statements can be identified by terms such as “believes,” “expects,” “plans,” “potential,” “would,” or similar expressions, and the negative of those terms. These forward-looking statements are based on Surface Oncology’s management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Surface Oncology’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to Surface Oncology’s ability to successfully develop SRF388, SRF617 and SRF114 through current and future milestones or regulatory filings on the anticipated timeline, if at all, the therapeutic potential of Surface Oncology’s product candidates, the risk that results from preclinical studies or early clinical trials may not be representative of larger clinical trials, the risk that Surface Oncology’s product candidates, including SRF388, SRF617 and SRF114, will not be successfully developed or commercialized, the risks related to Surface Oncology’s dependence on third-parties in connection with its manufacturing, clinical trials and preclinical studies, and the potential impact of COVID-19 on our clinical and preclinical development timelines and results of operations. Additional risks and uncertainties that could affect Surface Oncology’s future results are included in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ending March 31, 2020, both of which are available on the Security and Exchange Commission’s website at www.sec.gov and Surface Oncology’s website at www.surfaceoncology.com.

Additional information on potential risks will be made available in other filings that Surface Oncology makes from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements contained in this press release are based on assumptions that Surface Oncology believes to be reasonable as of this date. Except as required by law, Surface Oncology assumes no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

Contacts:

Investors
Matt Lane
[email protected]
617-901-7698

Media
Matthew Corcoran
[email protected]
617-866-7350



Posted on

Navistar Reports Fourth Quarter And Full-Year 2020 Results

– Reports fourth quarter net loss of $236 million, or $2.36 per diluted share, which reflects $297 million of tax-affected significant items; adjusted net income of $61 million on revenues of $2.1 billion

– Reports a full-year net loss of $347 million, or $3.48 per diluted share, and adjusted net income of $10 million on revenues of $7.5 billion

– Generates adjusted EBITDA of $169 million in the fourth quarter and $420 million in full-year 2020

– Ends the fiscal year with $1.8 billion in consolidated cash and cash equivalents

– Announced definitive merger agreement with TRATON SE

PR Newswire

LISLE, Ill., Dec. 17, 2020 /PRNewswire/ — Navistar International Corporation (NYSE: NAV) today announced a fourth quarter 2020 net loss of $236 million, or $2.36 per diluted share, compared to fourth quarter 2019 net income of $102 million, or $1.02 per diluted share. Navistar reported a net loss of $347 million, or $3.48 per diluted share for fiscal year 2020, versus net income of $221 million, or $2.22 per diluted share, for fiscal year 2019.

Revenues in the quarter were $2.1 billion versus $2.8 billion a year ago. Fourth quarter 2020 Core (Class 6-8 trucks and buses in the United States and Canada) charge outs were 13,200 versus 20,200 in fourth quarter 2019. Revenue for fiscal year 2020 was $7.5 billion versus $11.25 billion in 2019. Fiscal 2020 Core charge outs were 50,400 versus 87,200 in fiscal 2019. The decrease in revenue and charge outs was primarily driven by the impact of COVID-19 on the trucking industry.

Fourth quarter 2020 results were impacted by $297 million of tax-affected significant items. Included in this amount is a $289 million accrual related to a profit sharing dispute, a $58 million settlement with the Department of Justice related to Navistar Defense and a $14 million charge related to pre-existing warranties.

Adjusted net income for the fourth quarter was $61 million versus $114 million in the fourth quarter of last year. Adjusted net income for fiscal year 2020 was $10 million versus $423 million in 2019.

Fourth quarter 2020 adjusted EBITDA was $169 million versus $219 million one year ago. Fiscal year 2020 adjusted EBITDA was $420 million versus $882 million in 2019.

Navistar finished fourth quarter 2020 with $1.8 billion in consolidated cash and cash equivalents.

“While our results were affected by the pandemic and the impact of certain legal matters, we have experienced consistent sequential improvement in our business since April, which reflects broader improvement in the economy and trucking industry as well as our business performance from the implementation of our Navistar 4.0 strategy,” said Persio Lisboa, chief executive officer. “I believe that the actions and investments we have made in the business during 2020 position us to emerge from the pandemic a much stronger company.”

The company continued to make progress on Navistar 4.0, its multi-year strategic plan. Navistar 4.0 is focused on achieving sustained success through putting the customer at the core of the company’s decision-making process, while increasing the company’s EBITDA margins by four percentage points by 2025. The company launched a new version of its International HX Series severe service truck, the first new product developed under Project Compass. Navistar also continued to make progress on emerging technologies, announcing that it will deliver a full electrification solution, including charging, route planning and infrastructure, to a school bus customer in British Columbia. The company also conducted a successful West Coast tour of its electric school bus.

In connectivity, Navistar launched Intelligent Fleet Care, the industry’s most comprehensive standard suite of connected vehicle solutions, which is standard for Navistar’s new on-highway vehicles. In addition to its Gateway Integrations partnerships now in place with seven leading telematics providers that enable customers to avoid hardware installation costs by using Navistar’s own factory-installed device, Intelligent Fleet Care adds additional solutions driven by vehicle performance and telematics data.

Navistar continues to make progress on capital investments that will help transform the company’s manufacturing and supply footprint, including the Huntsville, Ala., plant, where the company will produce its next generation of big-bore powertrains, and its new manufacturing facility in San Antonio, Texas.

The most significant announcement during the fourth quarter was Navistar’s planned merger with TRATON SE. The merger will accelerate Navistar’s growth, providing it with access to new technologies, products and services while taking advantage of TRATON’s global scale.

“Despite the challenges of 2020, the company pressed ahead with new steps that position Navistar well for the future, including sustained investments in our business and products and important strategic partnerships in emerging technologies,” said Lisboa. “Looking forward, our exciting opportunity with TRATON will build further on this foundation, accelerating our progress and delivering long-term, sustainable benefits for our stakeholders.”

 


SEGMENT REVIEW


Summary of Financial Results:


Quarters Ended
October 31,


Years Ended October
31,


(in millions, except per share data)


2020


2019


2020


2019

Sales and revenues, net………………………………………………………………………………………………………………………….


$


2,065

$

2,780


$


7,503

$

11,251


Segment Results:…………………………………………………………………………………………………………………………………

Truck………………………………………………………………………………………………………………………………………………


$


(10)

$

86


$


(141)

$

269

Parts………………………………………………………………………………………………………………………………………………


129

161


448

598

Global Operations…………………………………………………………………………………………………………………………….


12

(10)


—


—


—

Financial Services…………………………………………………………………………………………………………………………….


14

30


65

123

Income (loss) from continuing operations, net of tax(A)………………………………………………………………………………..


$


(236)

$

102


$


(347)

$

221

Net income (loss)(A)………………………………………………………………………………………………………………………………..


(236)

102


(347)

221

Diluted earnings (loss) per share(A)……………………………………………………………………………………………………………


(2.36)

1.02


(3.48)

2.22

________________

(A)

Amounts attributable to Navistar International Corporation.

 

Truck Segment – In fourth quarter 2020, the Truck segment net sales were $1.5 billion, a 30 percent decrease compared to fourth quarter last year. In fiscal year 2020, the Truck segment net sales decreased by $3.3 billion, or 38 percent, to $5.3 billion. The decrease was primarily due to lower volumes in Core markets due to the pandemic.

The Truck segment incurred a net loss of $10 million in fourth quarter 2020, compared to a profit of $86 million in fourth quarter 2019. For fiscal year 2020, the Truck segment incurred a net loss of $141 million, compared to profit of $269 million in full-year 2019. The decrease was a result of lower revenues and reflects the impact of legal settlements and the sale of Navistar Defense in 2019.

Parts Segment – For fourth quarter 2020, the Parts segment net sales were $496 million, a nine percent decrease from fourth quarter 2019. In fiscal year 2020, the Parts segment net sales decreased by $399 million, or 18 percent, to $1.85 billion. The decrease was primarily due to lower volumes in the U.S. and Canada due to the pandemic.

The Parts segments saw a fourth quarter profit of $129 million, compared to $161 million in fourth quarter 2019. In fiscal year 2020, the Parts segment profit decreased by $150 million, or 25 percent, to $448 million. The decrease was due to the impact of lower revenues.

Global Operations Segment – In fourth quarter 2020, the Global Operations segment net sales decreased six percent versus fourth quarter 2019 to $87 million. In fiscal year 2020, the Global Operations segment net sales decreased by $90 million, or 26 percent, to $253 million. The decrease was primarily driven by lower volumes in South American operations triggered by temporary production stoppages related to the pandemic as well as unfavorable foreign currency impact.

The Global Operation segment recorded a profit of $12 million in the fourth quarter of 2020 versus a loss of $10 million in fourth quarter 2019 that included a restructuring charge. In fiscal year 2020, the Global Operations segment recorded breakeven results comparable to 2019.

Financial Services Segment – In fourth quarter 2020, the Financial Services segment net revenues decreased to $47 million, a 34 percent decrease from fourth quarter 2019. In fiscal year 2020, Financial Services segment net revenues were $217 million, a 27 percent decrease versus 2019. Revenues were lower in 2020 due to lower average yields from lower interest rates and lower average finance receivables on lower volumes.

The Financial Services segment recorded a profit of $14 million in the quarter, compared to $30 million in fourth quarter 2019. The Financial Services segment recorded a profit of $65 million in fiscal year 2020, a 47 percent decrease from 2019. The decrease was due to lower revenues, partially offset by lower interest expense resulting from lower borrowing requirements and rates.

About Navistar
Navistar International Corporation (NYSE: NAV) is a holding company whose subsidiaries and affiliates produce International® brand commercial trucks, proprietary diesel engines, and IC Bus® brand school and commercial buses. An affiliate also provides truck and diesel engine service parts. Another affiliate offers financing services. Additional information is available at www.Navistar.com.

Forward-Looking Statement

Information provided and statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements only speak as of the date of this report and Navistar International Corporation assumes no obligation to update the information included in this report. Such forward-looking statements include information concerning our possible or assumed future results of operations, including descriptions of our business strategy. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” or similar expressions. These statements are not guarantees of performance or results and they involve risks, uncertainties, and assumptions. For a further description of these factors, see the risk factors set forth in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K for the fiscal year ended October 31,2020. Although we believe that these forward-looking statements are based on reasonable assumptions, there are many factors that could affect our actual financial results or results of operations and could cause actual results to differ materially from those in the forward-looking statements. All future written and oral forward-looking statements by us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to above. Except for our ongoing obligations to disclose material information as required by the federal securities laws, we do not have any obligations or intention to release publicly any revisions to any forward-looking statements to reflect events or circumstances in the future or to reflect the occurrence of unanticipated events.

 


Navistar International Corporation and Subsidiaries

Consolidated Statements of Operations


Quarters Ended
October 31,


Years Ended October
31,


(in millions, except per share data)


2020


2019


2020


2019


Sales and revenues

Sales of manufactured products, net……………………………………………………………………………………………………………


$


2,025

$

2,731


$


7,335

$

11,061

Finance revenues……………………………………………………………………………………………………………………………………..


40

49


168

190

Sales and revenues, net……………………………………………………………………………………………………………………..


2,065

2,780


7,503

11,251


Costs and expenses……………………………………………………………………………………………………………………………………..

Costs of products sold……………………………………………………………………………………………………………………………….


1,680

2,272


6,221

9,245

Restructuring charges……………………………………………………………………………………………………………………………….


(3)

11


2

12

Asset impairment charges………………………………………………………………………………………………………………………….


3

1


28

7

Selling, general and administrative expenses……………………………………………………………………………………………….


528

208


1,021

934

Engineering and product development costs………………………………………………………………………………………………..


84

77


321

319

Interest expense………………………………………………………………………………………………………………………………………


69

69


268

312

Other expense, net…………………………………………………………………………………………………………………………………..


5

24


32

164

Total costs and expenses…………………………………………………………………………………………………………………..


2,366

2,662


7,893

10,993

Equity in income of non-consolidated affiliates…………………………………………………………………………………………………..


2

—


2

4

Income (loss) before income taxes………………………………………………………………………………………………………………….


(299)

118


(388)

262

Income tax expense………………………………………………………………………………………………………………………………………


69

(10)


59

(19)

Net income (loss)………………………………………………………………………………………………………………………………………….


(230)

108


(329)

243

Less: Net income attributable to non-controlling interests…………………………………………………………………………………..


6

6


18

22


Net income (loss) attributable to Navistar International Corporation……………………………………………………………..


$


(236)

$

102


$


(347)

$

221

Net income (loss) per share attributable to Navistar International Corporate………………………………………………………….

Basic:…………………………………………………………………………………………………………………………………………………….


$


(2.36)

$

1.03


$


(3.48)

$

2.23

Diluted:…………………………………………………………………………………………………………………………………………………..


(2.36)

1.02


(3.48)

2.22

Weighted average shares outstanding:…………………………………………………………………………………………………………….

Basic…………………………………………………………………………………………………………………………………………………


99.8

99.4


99.7

99.3

Diluted……………………………………………………………………………………………………………………………………………….


99.8

99.6


99.7

99.5

 

 

 


Navistar International Corporation and Subsidiaries

Consolidated Balance Sheets


As of October 31,


(in millions, except per share data)


2020


2019


ASSETS

Current assets

Cash and cash equivalents………………………………………………………………………………………………………………………………………………………………………….


$


1,843

$

1,370

Restricted cash and cash equivalents……………………………………………………………………………………………………………………………………………………………


64

133

Trade and other receivables, net………………………………………………………………………………………………………………………………………………………………….


273

338

Finance receivables, net…………………………………………………………………………………………………………………………………………………………………………….


1,371

1,923

Inventories, net…………………………………………………………………………………………………………………………………………………………………………………………


763

911

Other current assets………………………………………………………………………………………………………………………………………………………………………………….


263

277

Total current assets…………………………………………………………………………………………………………………………………………………………………………….


4,577

4,952

Restricted cash…………………………………………………………………………………………………………………………………………………………………………………………………


66

54

Trade and other receivables, net…………………………………………………………………………………………………………………………………………………………………………


7

10

Finance receivables, net……………………………………………………………………………………………………………………………………………………………………………………


251

274

Investments in non-consolidated affiliates…………………………………………………………………………………………………………………………………………………………….


31

31

Property and equipment, net………………………………………………………………………………………………………………………………………………………………………………


1,298

1,309

Operating lease right of use assets……………………………………………………………………………………………………………………………………………………………………..


119

—

Goodwill…………………………………………………………………………………………………………………………………………………………………………………………………………..


38

38

Intangible assets, net………………………………………………………………………………………………………………………………………………………………………………………..


18

25

Deferred taxes, net…………………………………………………………………………………………………………………………………………………………………………………………..


117

117

Other noncurrent assets……………………………………………………………………………………………………………………………………………………………………………………


115

107


Total assets……………………………………………………………………………………………………………………………………………………………………………………..


$


6,637

$

6,917


LIABILITIES and STOCKHOLDERS’ DEFICIT


Liabilities

Current liabilities

Notes payable and current maturities of long-term debt…………………………………………………………………………………………………………………………………..


$


640

$

871

Accounts payable………………………………………………………………………………………………………………………………………………………………………………………


1,278

1,341

Other current liabilities………………………………………………………………………………………………………………………………………………………………………………..


1,453

1,363

Total current liabilities………………………………………………………………………………………………………………………………………………………………………….


3,371

3,575

Long-term debt…………………………………………………………………………………………………………………………………………………………………………………………………


4,690

4,317

Postretirement benefits liabilities…………………………………………………………………………………………………………………………………………………………………………


1,705

2,103

Other noncurrent liabilities………………………………………………………………………………………………………………………………………………………………………………….


693

645


Total liabilities……………………………………………………………………………………………………………………………………………………………………………………….


10,459

10,640


Stockholders’ deficit

Series D convertible junior preference stock…………………………………………………………………………………………………………………………………………………………


2

2

Common stock, $0.10 par value per share (103.1 shares issued and 220 shares authorized at
both dates)……………………………………………………………………………………………………………………………………………………………………………………………………….


10

10

Additional paid-in capital…………………………………………………………………………………………………………………………………………………………………………………….


2,726

2,730

Accumulated deficit……………………………………………………………………………………………………………………………………………………………………………………………


(4,566)

(4,409)

Accumulated other comprehensive loss……………………………………………………………………………………………………………………………………………………………….


(1,865)

(1,912)

Common stock held in treasury, at cost (3.5 and 3.9 shares, respectively)………………………………………………………………………………………………………………..


(133)

(147)

Total stockholders’ deficit attributable to Navistar International Corporation……………………………………………………………………………………………………….


(3,826)

(3,726)

Stockholders’ equity attributable to non-controlling interests……………………………………………………………………………………………………………………………………


4

3


Total stockholders’ deficit………………………………………………………………………………………………………………………………………………………………………


(3,822)

(3,723)


Total liabilities and stockholders’ deficit…………………………………………………………………………………………………………………………………………….


$


6,637

$

6,917

 

 

 


Navistar International Corporation and Subsidiaries

Condensed Consolidated Statements of Cash Flows


For the Years Ended October 31,


(in millions)


2020


2019


Cash flows from operating activities

Net income (loss)……………………………………………………………………………………………………………………………………………………………………………………………………


$


(329)

$

243

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

Depreciation and amortization…………………………………………………………………………………………………………………………………………………………………………..


136

132

Depreciation of equipment leased to others………………………………………………………………………………………………………………………………………………………..


63

61

Deferred taxes, including change in valuation allowance………………………………………………………………………………………………………………………………………


(80)

(31)

Asset impairment charges…………………………………………………………………………………………………………………………………………………………………………………


28

7

Gain on sales of investments and businesses, net………………………………………………………………………………………………………………………………………………..


—

(56)

Amortization of debt issuance costs and discount………………………………………………………………………………………………………………………………………………..


14

19

Stock-based compensation……………………………………………………………………………………………………………………………………………………………………………….


25

23

Provision for doubtful accounts, net of recoveries………………………………………………………………………………………………………………………………………………..


16

4

Equity in income of non-consolidated affiliates, net of dividends…………………………………………………………………………………………………………………………….


(2)

(2)

Write-off of debt issuance cost and discount………………………………………………………………………………………………………………………………………………………


5

6

Other non-cash operating activities……………………………………………………………………………………………………………………………………………………………………


(5)

(9)

Changes in other assets and liabilities, exclusive of the effects of businesses disposed:

Trade and other receivables……………………………………………………………………………………………………………………………………………………………….


36

141

Finance receivables…………………………………………………………………………………………………………………………………………………………………………..


490

(42)

Inventories……………………………………………………………………………………………………………………………………………………………………………………….


136

103

Accounts payable…………………………………………………………………………………………………………………………………………………………………………….


(77)

(250)

Other assets and liabilities…………………………………………………………………………………………………………………………………………………………………


18

101


Net cash provided by operating activities……………………………………………………………………………………………………………………………………………………..


474

450


Cash flows from investing activities

Maturities of marketable securities………………………………………………………………………………………………………………………………………………………………………….


—

102

Capital expenditures……………………………………………………………………………………………………………………………………………………………………………………………..


(148)

(134)

Purchases of equipment leased to others………………………………………………………………………………………………………………………………………………………………..


(97)

(152)

Proceeds from sales of property and equipment……………………………………………………………………………………………………………………………………………………….


13

14

Investments in non-consolidated affiliates………………………………………………………………………………………………………………………………………………………………..


(5)

—

Proceeds from (payments for) sales of affiliates………………………………………………………………………………………………………………………………………………………..


19

100

Other investing activities………………………………………………………………………………………………………………………………………………………………………………………..


1

2


Net cash used in investing activities…………………………………………………………………………………………………………………………………………………………….


(217)

(68)


Cash flows from financing activities

Proceeds from issuance of securitized debt…………………………………………………………………………………………………………………………………………………………….


389

363

Principal payments on securitized debt……………………………………………………………………………………………………………………………………………………………………


(352)

(316)

Net change in secured revolving credit facilities………………………………………………………………………………………………………………………………………………………


(255)

12

Proceeds from issuance of non-securitized debt……………………………………………………………………………………………………………………………………………………..


847

209

Principal payments on non-securitized debt……………………………………………………………………………………………………………………………………………………………


(341)

(1,044)

Net change in notes and debt outstanding under revolving credit facilities…………………………………………………………………………………………………………………


(74)

527

Debt issuance costs……………………………………………………………………………………………………………………………………………………………………………………………


(18)

(9)

Proceeds from financed lease obligations………………………………………………………………………………………………………………………………………………………………


—

22

Proceeds from exercise of stock options………………………………………………………………………………………………………………………………………………………………..


4

4

Dividends paid by subsidiaries to non-controlling interest…………………………………………………………………………………………………………………………………………


(17)

(24)

Other financing activities………………………………………………………………………………………………………………………………………………………………………………………


(2)

(2)


Net cash provided by (used in) financing activities………………………………………………………………………………………………………………………………………


181

(258)


Effect of exchange rate changes on cash, cash equivalents and restricted cash……………………………………………………………………………………………………….


(22)

(12)


Increase in cash, cash equivalents and restricted cash…………………………………………………………………………………………………………………………………………….


416

112


Cash, cash equivalents and restricted cash at beginning of the year…………………………………………………………………………………………………………………………


1,557

1,445


Cash, cash equivalents and restricted cash at end of the year………………………………………………………………………………………………………………………………….


$


1,973

$

1,557

 

 


Navistar International Corporation and Subsidiaries

Segment Reporting

We define segment profit (loss) as net income (loss) attributable to Navistar International Corporation, excluding income tax
expense. The following tables present selected financial information for our reporting segments:


(in millions)


Truck


Parts


Global Operations


Financial
Services(A)


Corporate
and
Eliminations


Total


Quarter Ended October 31, 2020

External sales and revenues, net………………………………………………………………………….


$


1,440


$


495


$


89


$


42


$


(1)


$


2,065

Intersegment sales and revenues………………………………………………………………………….


38


1


(2)


5


(42)


—

Total sales and revenues, net……………………………………………………………………….


$


1,478


$


496


$


87


$


47


$


(43)


$


2,065

Net income (loss) attributable to NIC……………………………………………………………………..


$


(10)


$


129


$


12


$


14


$


(381)


$


(236)

Income tax expense……………………………………………………………………………………………


—


—


—


—


69


69

Segment profit (loss)…………………………………………………………………………………..


$


(10)


$


129


$


12


$


14


$


(450)


$


(305)

Depreciation and amortization………………………………………………………………………………


$


31


$


—


$


1


$


17


$


1


$


50

Interest expense…………………………………………………………………………………………………


—


—


—


14


55


69

Equity in income of non-consolidated affiliates……………………………………………………….


2


—


—


—


—


2

Capital expenditures(B)……………………………………………………………………………………….


31


2


—


—


—


33

 


(in millions)


Truck


Parts


Global Operations


Financial
Services(A)


Corporate
and
Eliminations


Total


Quarter Ended October 31, 2019

External sales and revenues, net…………………………………………………………………………

$

2,096

$

546

$

86

$

52

$

—

$

2,780

Intersegment sales and revenues………………………………………………………………………..

9

1

7

19

(36)

—

Total sales and revenues, net………………………………………………………………………

$

2,105

$

547

$

93

$

71

$

(36)

$

2,780

Net income (loss) attributable NIC……………………………………………………………………….

$

86

$

161

$

(10)

$

30

$

(165)

$

102

Income tax expense…………………………………………………………………………………………..

—

—

—

—

(10)

(10)

Segment profit (loss)………………………………………………………………………………….

$

86

$

161

$

(10)

$

30

$

(155)

$

112

Depreciation and amortization…………………………………………………………………………….

$

26

$

1

$

4

$

16

$

2

$

49

Interest expense……………………………………………………………………………………………….

—

—

—

22

47

69

Equity in income of non-consolidated affiliates………………………………………………………

(1)

1

—

—

—

—

       Capital expenditures(B)………………………………………………………………………………………

32

4

—

—

8

44

 


          (in millions)


Truck


Parts


Global Operations


Financial
Services(A)


Corporate
and
Eliminations


Total


          Year Ended October 31, 2020

External sales and revenues, net…………………………………………………………..


$


5,240


$


1,841


$


242


$


177


$


3


$


7,503

Intersegment sales and revenues………………………………………………………….


72


5


11


40


(128)


—

Total sales and revenues, net………………………………………………………..


$


5,312


$


1,846


$


253


$


217


$


(125)


$


7,503

Income (loss) from continuing operations
attributable to NIC, net of tax………………………………………………………………..


$


(141)


$


448


$


—


$


65


$


(719)


$


(347)

Income tax expense…………………………………………………………………………….


—


—


—


—


59


59

Segment profit (loss)…………………………………………………………………..


$


(141)


$


448


$


—


$


65


$


(778)


$


(406)

Depreciation and amortization………………………………………………………………


$


116


$


6


$


6


$


65


$


6


$


199

Interest expense…………………………………………………………………………………


—


—


—


69


199


268

Equity in income (loss) of non-consolidated affiliates…………………………………………………………………………………………….


1


1


—


—


—


2

Capital expenditures(B)………………………………………………………………………..


124


8


3


—


13


148


(in millions)


Truck


Parts


Global Operations


Financial
Services(A)


Corporate
and
Eliminations


Total


Year Ended October 31, 2019

External sales and revenues, net……………………………………………………………..

$

8,501

$

2,239

$

309

$

193

$

9

$

11,251

Intersegment sales and revenues……………………………………………………………..

84

6

34

104

(228)

—

Total sales and revenues, net……………………………………………………………

$

8,585

$

2,245

$

343

$

297

$

(219)

$

11,251

Income (loss) from continuing operations
attributable to NIC, net of tax…………………………………………………………………..

$

269

$

598

$

—

$

123

$

(769)

$

221

Income tax expense………………………………………………………………………………

—

—

—

—

(19)

(19)

Segment profit (loss)……………………………………………………………………..

$

269

$

598

$

—

$

123

$

(750)

$

240

Depreciation and amortization…………………………………………………………………

$

104

$

5

$

11

$

64

$

9

$

193

Interest expense……………………………………………………………………………………

—

—

—

105

207

312

Equity in income (loss) of non-consolidated affiliates………………………………………………………………………………………………..

2

3

(1)

—

—

4

       Capital expenditures(B)…………………………………………………………………………..

101

7

2

2

22

134

_________________________

(A) 

Total sales and revenues in the Financial Services segment include interest revenues of $130 million and $208 million for the years ended October 31, 2020, and 2019 respectively.

(B) 

Exclusive of purchases of equipment leased to others and liabilities related to capital expenditures.

 


(in millions)


Truck


Parts


Global Operations


Financial


Services


Corporate


and


Eliminations


Total


Segment assets, as of:


October 31, 2020……………………………………………………………………..


$


1,619


$


663


$


216


$


2,191


$


1,948


$


6,637

October 31, 2019………………………………………………………………………

1,705

688

296

2,774

1,454

6,917

 


SEC Regulation G Non-GAAP Reconciliation


The financial measures presented below are unaudited and not in accordance with, or an alternative for, financial measures presented in accordance with U.S. generally accepted accounting principles (“GAAP”). The non-GAAP financial information presented herein should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP and are reconciled to the most appropriate GAAP number below.


Earnings (loss) Before Interest, Income Taxes, Depreciation, and Amortization (“EBITDA”):


We define EBITDA as our consolidated net income (loss) attributable to Navistar International Corporation, net of tax, plus manufacturing interest expense, income taxes, and depreciation and amortization. We believe EBITDA provides meaningful information to the performance of our business and therefore we use it to supplement our GAAP reporting. We have chosen to provide this supplemental information to investors, analysts and other interested parties to enable them to perform additional analyses of operating results.


Adjusted EBITDA and Adjusted Net Income (loss):


We believe that adjusted EBITDA and Adjusted Net Income (loss), which excludes certain identified items that we do not consider to be part of our ongoing business, improves the comparability of year to year results, and is representative of our underlying performance. Management uses this information to assess and measure the performance of our operating segments. We have chosen to provide this supplemental information to investors, analysts and other interested parties to enable them to perform additional analyses of operating results, to illustrate the results of operations giving effect to the non-GAAP adjustments shown in the below reconciliations, and to provide an additional measure of performance.


Manufacturing Cash and Cash Equivalents:


Manufacturing cash and cash equivalents represent the Company’s consolidated cash and cash equivalents excluding cash and cash equivalents of our financial services operations. We have chosen to provide this supplemental information to investors, analysts and other interested parties to enable them to perform additional analyses of our ability to meet our operating requirements, capital expenditures, equity investments, and financial obligations.


Structural costs

consist of Selling, general and administrative expenses and Engineering and product development costs.

 


EBITDA reconciliation:


Quarters Ended
October 31,


Years Ended October
31,


(in millions)


2020


2019


2020


2019

Net loss attributable to NIC……………………………………………………………………………………………………………..


$


(236)

$

102


$


(347)

$

221


Plus:…………………………………………………………………………………………………………………………………………….

Depreciation and amortization expense………………………………………………………………………………………


53

49


199

193

Manufacturing interest expense(A)……………………………………………………………………………………………..


55

47


199

207


Less:…………………………………………………………………………………………………………………………………………..

Income tax (expense) benefit…………………………………………………………………………………………………..


69

(10)


59

(19)

EBITDA………………………………………………………………………………………………………………………………………


$


(197)

$

208


$


(8)

$

640

______________________

(A) 

Manufacturing interest expense is the net interest expense primarily generated for borrowings that support the manufacturing and corporate operations,
adjusted to eliminate intercompany interest expense with our Financial Services segment. The following table reconciles Manufacturing interest expense
to the consolidated interest expense.

 


Quarters Ended
October 31,


Years Ended October
31,


(in millions)


2020


2019


2020


2019

Interest expense………………………………………………………………………………………………………………………..


$


69

$

69


$


268

$

312

Less:  Financial services interest expense…………………………………………………………………………………….


14

22


69

105

Manufacturing interest expense……………………………………………………………………………………………………


$


55

$

47


$


199

$


207

 

 



Adjusted EBITDA Reconciliation:


Quarters Ended
October 31,


Years Ended October
31,


(in millions)


2020


2019


2020


2019


EBITDA (reconciled above)……………………………………………………………………………………………………………….


$


(197)

$

208


$


(8)

$

640



Adjusted for significant items of:
………………………………………………………………………………………………………

Adjustments to pre-existing warranties(A)…………………………………………………………………………………………..


14

(4)


40

3

Asset impairment charges(B)……………………………………………………………………………………………………………


3

1


28

7

Restructuring of manufacturing operations(C)…………………………………………………………………………………….


(3)

13


2

14

MaxxForce Advanced EGR engine lawsuits(D)…………………………………………………………………………………..


—


—

1


—

129

Legal settlement (E)


58


—


58


—

Shy profit-sharing accrual(F)


289


—


289


—

Gain (loss) on sales(G)……………………………………………………………………………………………………………………


—


—


—

(56)

Debt refinancing charges(H)…………………………………………………………………………………………………………….


5


—


5

6

Pension settlement(I)………………………………………………………………………………………………………………………


—

—


7

142

Settlement gain(J)…………………………………………………………………………………………………………………………..


—


—


(1)

(3)

Total adjustments………………………………………………………………………………………………………………………………


366

11


428

242


Adjusted EBITDA…………………………………………………………………………………………………………………………….


$


169

$

219


$


420

$

882

 

 



Adjusted Net Income (Loss) attributable to NIC:


Quarters Ended
October 31,


Years Ended October
31,


(in millions)…………………………………………………………………………………………………………………………………………………


2020


2019


2020


2019



Net loss attributable to NIC
………………………………………………………………………………………………………………………….


$


(236)

$

102


$


(347)

$

221



Adjusted for significant items of:
…………………………………………………………………………………………………………………

Adjustments to pre-existing warranties(A)………………………………………………………………………………………………………


14

(4)


40

3

Asset impairment charges(B)……………………………………………………………………………………………………………………….


3

1


28

7

Restructuring of manufacturing operations(C)…………………………………………………………………………………………………


(3)

13


2

14

MaxxForce Advanced EGR engine lawsuits(D)………………………………………………………………………………………………


—


—

1


—

129

Legal settlement(E)


58


—


58


—

Shy profit-sharing accrual(F)


289


—


289


—

Gain on sales(G)……………………………………………………………………………………………………………………………………….


—


—


—

(56)

Debt refinancing charges(H)……………………………………………………………………………………………………………………….


5


—


5

6

Pension settlement(I)………………………………………………………………………………………………………………………………..


—

—


7

142

Settlement gain(J)……………………………………………………………………………………………………………………………………..


—


—


(1)

(3)

Total adjustments…………………………………………………………………………………………………………………………………………


366

11


428

242

Tax effect (K)………………………………………………………………………………………………………………………………………………..


(69)

1


(71)

(40)


Adjusted net income (loss) attributable to NIC……………………………………………………………………………………………..


$


61

$

114


$


10

$

423

_____________________

(A) 

Adjustments to pre-existing warranties reflect changes in our estimate of warranty costs for products sold in prior periods. Such adjustments typically
occur when claims experience deviates from historical and expected trends. Our warranty liability is generally affected by component failure rates, repair
costs, and the timing of failures. Future events and circumstances related to these factors could materially change our estimates and require adjustments to
our liability. In addition, new product launches require a greater use of judgment in developing estimates until historical experience becomes available.

(B) 

During 2020, we recorded $28 million of asset impairment charges, comprised of $16 million of asset impairment charges related to certain assets under
operating leases and certain other long-lived assets in our Truck segment and $12 million of asset impairment charges related to long-lived assets in our
Brazil asset group in our Global Operations segment. During 2019, we recorded $7 million of asset impairment charges relating to certain assets under
operating leases in our Truck segment. During 2018, we recorded $14 million of impairment charges related to the exit of our railcar business in
Cherokee, Alabama, certain long-lived assets and certain assets under operating leases in our Truck and Financial Services segments.

(C) 

During 2020, we recorded net restructuring charges of $2 million due to restructuring activity throughout the organization. During 2019, we recorded
charges of $14 million primarily related to cost reduction actions recorded in Costs of product sold and Restructuring charges in our Global Operations
segment. During 2018, we recognized a benefit of $1 million related to adjustments for restructuring charges in our Truck, Global Operations and
Corporate segments.

(D)

During 2019, we recognized a net charge of $129 million related to the MaxxForce Advanced EGR engine class action settlement and related litigation in
our Truck segment. During 2018, we recognized a charge of $1 million for a jury verdict related to the MaxxForce Advanced EGR engine lawsuits in our
Truck segment.

(E) 

During 2020, we recorded a charge of $58 million, including $8 million of legal and other fees, related to a proposed legal settlement with the Department
of Justice, related to Navistar Defense. 

(F) 

During 2020, we recorded a charge of $289 million related to the Shy profit-sharing accrual.

(G) 

During 2019, we recognized a gain of $51 million related to the sale of a majority interest in the Navistar Defense business in our Truck segment, and a
gain of $5 million related to the sale of our joint venture in China with JAC in our Global Operations segment.

(H)

During 2020 we recorded a charge of $5 million for the write-off of debt issuance costs and discounts associated with the 6.75% Tax Exempt Bonds.
During 2019, we recorded a charge of $6 million for the write-off of debt issuance costs and discounts associated with the NFC Term Loan. During 2018,
we recorded a charge of $46 million for the write off of debt issuance costs and discounts associated with the repurchase of our 8.25% Senior Notes and
the refinancing of our previously existing Term Loan.

(I) 

During 2020, 2019 and 2018, we purchased group annuity contracts for certain retired pension plan participants resulting in plan remeasurements. As a
result, we recorded pension settlement charges of $7 million, $142 million and $9 million, respectively, in Other expense, net in Corporate.

(J) 

During 2020 and 2019, we recorded interest income of $1 million and $3 million, respectively, in Other expense, net derived from the prior year
settlement of a business economic loss claim. During 2018, we settled a business economic loss claim relating to our Alabama engine manufacturing
facility from the Deepwater Horizon Settlement Program. As a result, we recorded the net present value of the settlement of $70 million and related
interest income of $2 million in Other expense, net.

(K) 

Tax effect is calculated by excluding the tax impact of the non-GAAP adjustments from the tax provision calculations. 

 

 


Manufacturing segment cash and cash equivalents reconciliation:


As of October 31, 2020


(in millions)


Manufacturing Operations


Financial Services Operations


Consolidated Balance Sheet


Total cash and cash equivalents……………………………………………….


$


1,749


$


94


$


1,843

               

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SOURCE Navistar International Corporation