Market Newsdesk

November 12, 2020 4:05 pm

Navidea Biopharmaceuticals Reports Third Quarter and Year-to-Date 2020 Financial Results

Navidea Biopharmaceuticals Reports Third Quarter and Year-to-Date 2020 Financial Results

Conference Call to be held Thursday, November 12, 2020 at 5:00 pm EST

DUBLIN, Ohio–(BUSINESS WIRE)–
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the third quarter and year-to-date for the period ended September 30, 2020.

“Navidea continues to build on its clinical momentum and this quarter fully shows our ability to execute during a very trying time globally,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “The due diligence continues with Jubilant and the Phase 2b is nearing its conclusion. We are very excited to move forward and present to the FDA in the near future.”

Third Quarter 2020 Highlights and Subsequent Events

Executed a binding memorandum of understanding (“MOU”) on August 9, 2020 with Jubilant Draximage Inc. dba Jubilant Radiopharma, Radiopharmaceuticals Division (“Jubilant”). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s Rheumatoid Arthritis Diagnostic in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.
Entered into a Stock Purchase Agreement with investors, pursuant to which the investors agreed to purchase up to $25.0 million in shares of the Company’s Common Stock.
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company agreed to issue to the investor 150,000 shares of newly-designated Series D Redeemable Convertible Preferred Stock (the “Series D Preferred Stock”) for an aggregate purchase price of $15.0 million. Pursuant to the Series D Preferred Stock Purchase Agreement, Keystone will purchase Series D Preferred Stock in amounts to be determined by Keystone in one or more closings during the nine-month period following the date on which the prospectus supplement to register the underlying Common Stock was filed with the SEC, provided that all of the Series D Preferred Stock must be purchased by such date. The Series D Preferred Stock will be convertible into a maximum of 5,147,000 shares of Common Stock.
Announced acceptance by the American College of Rheumatology (“ACR”) of the results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting (“ACR Convergence 2020”) under the title, “Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy.”
Continued longitudinal imaging and clinical assessments of Arm 3 subjects, who are beginning new anti-TNFα therapy, in the NAV3-31 trial.
Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Converted a provisional patent on blocking off-target organ uptake of Tilmanocept to improve on-target localization.
Received a one-year extension on its NIH phase 1 Small Business Technology Transfer grant (1R41HL147640-01A1) entitled Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques, due to COVID-19 related shutdown of the research facility at the University of Alabama Birmingham. The site has reopened and these preclinical studies are ongoing.
Won dismissal of Platinum-Montaur Life Sciences LLC’s lawsuit against the Company.

Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, “The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. The currently running Phase 2b trial in RA is proceeding well, with Arm 3 subjects having their later imaging and clinical assessments. Preparation of the package to discuss with the FDA in planning for the upcoming Phase 3 is nearing completion. We are also preparing for the start of our second Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients.”

Financial Results

Total revenues for the third quarter 2020 were $268,000, compared to $237,000 for the same period in 2019. Total revenues for the first nine months of 2020 were $696,000, compared to $539,000 for the same period in 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept™ development.
Research and development (“R&D”) expenses for the third quarter of 2020 were $1.4 million, compared to $1.8 million in the same period in 2019. The third quarter decrease was primarily due to net decreases in drug project expenses, including decreased Manocept diagnostic and Tc99m tilmanocept development costs, coupled with decreased employee compensation. R&D expenses for the first nine months of 2020 were $3.7 million, compared to $3.6 million in the same period in 2019. The year-to-date increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic development costs offset by decreased Manocept therapeutic and Tc99m tilmanocept development costs, coupled with increased employee compensation.
Selling, general and administrative (“SG&A”) expenses for the third quarter of 2020 were $1.8 million, compared to $1.5 million in the same period in 2019. The third quarter increase was primarily due to increased legal and professional services and employee compensation, offset by decreased travel, insurance, and depreciation costs. SG&A expenses for the first nine months of 2020 were $4.9 million, compared to $5.1 million in the same period in 2019. The year-to-date decrease was primarily due to decreased travel, legal and professional services, insurance, depreciation, and investor relations costs, offset by increased employee compensation and franchise taxes.
Navidea’s net loss attributable to common stockholders for the third quarter of 2020 was $3.3 million, or $0.13 per share, compared to $3.1 million, or $0.17 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the first nine months of 2020 was $8.4 million, or $0.37 per share, compared to $8.2 million, or $0.62 per share, for the same period in 2019.
Navidea ended the third quarter of 2020 with $3.7 million in cash and cash equivalents. Since September 30, 2020, the Company has received $700,000 of cash related to the August 2020 funding transactions.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.


Event:		Q3 2020 Earnings and Business Update Conference Call
Date:		Thursday, November 12, 2020
Time:		5:00 p.m. (EST)
U.S. & Canada Dial-in:		800-754-1336
International Dial-in:		+1 415-226-5358
Conference ID:		21971993
Webcast Link:		https://webcasts.eqs.com/navidbioph20201112/en

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.


NAVIDEA BIOPHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
	September 30,		December 31,
	2020		2019
	(unaudited)
Assets:
Cash and cash equivalents	$	3,722,852	$	1,047,159
Other current assets		1,070,099		1,868,624
Non-current assets		1,202,884		1,235,123
Total assets	$	5,995,835	$	4,150,906

Liabilities and stockholders’ equity (deficit):
Current liabilities	$	4,014,418	$	3,819,551
Deferred revenue, non-current		700,000		700,000
Other liabilities		380,236		512,344
Total liabilities		5,094,654		5,031,895
Navidea stockholders’ equity (deficit)		169,877		(1,612,292	)
Noncontrolling interest		731,304		731,303
Total stockholders’ equity (deficit)		901,181		(880,989	)
Total liabilities and stockholders’ equity (deficit)	$	5,995,835	$	4,150,906


CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

	Three Months Ended						Nine Months Ended
	September 30,			September 30,			September 30,			September 30,
	2020			2019			2020			2019
	(unaudited)			(unaudited)			(unaudited)			(unaudited)
Revenue:
Royalty revenue	$	2,047		$	4,895		$	26,188		$	13,985
License revenue		4,726			–			4,726			9,953
Grant and other revenue		261,616			231,916			664,848			514,589
Total revenue		268,389			236,811			695,762			538,527
Cost of revenue		82			195			1,048			6,559
Gross profit		268,307			236,616			694,714			531,968
Operating expenses:
Research and development		1,377,998			1,801,558			3,659,046			3,612,783
Selling, general and administrative		1,788,934			1,519,496			4,946,279			5,109,612
Total operating expenses		3,166,932			3,321,054			8,605,325			8,722,395
Loss from operations		(2,898,625	)		(3,084,438	)		(7,910,611	)		(8,190,427	)
Other income (expense):
Interest income (expense), net		(149	)		11,858			12,822			23,336
Other, net		(564	)		(1,524	)		(777	)		(5,880	)
Loss before income taxes		(2,899,338	)		(3,074,104	)		(7,898,566	)		(8,172,971	)
Provision for income taxes		–			–			–			(707	)
Loss from continuing operations		(2,899,338	)		(3,074,104	)		(7,898,566	)		(8,173,678	)
Loss from discontinued operations, net of tax effect		–			–			–			(2,665	)
Net loss		(2,899,338	)		(3,074,104	)		(7,898,566	)		(8,176,343	)
Loss (income) attributable to noncontrolling interest		–			2			(1	)		16
Deemed dividend on Series C and Series D
preferred stock beneficial conversion feature		(405,555	)		–			(483,333	)		–
Net loss attributable to common stockholders	$	(3,304,893	)	$	(3,074,102	)	$	(8,381,900	)	$	(8,176,327	)
Loss per common share (basic and diluted):
Continuing operations	$	(0.13	)	$	(0.17	)	$	(0.37	)	$	(0.62	)
Attributable to common stockholders	$	(0.13	)	$	(0.17	)	$	(0.37	)	$	(0.62	)
Weighted average shares outstanding (basic)		25,843,732			18,044,406			22,946,201			13,082,393

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006021/en/

Navidea Biopharmaceuticals, Inc.

Jed Latkin, CEO

614-973-7490

[email protected]

Joel Kaufman, CBO

614-822-2372

[email protected]

KEYWORDS: United States North America Ohio

INDUSTRY KEYWORDS: Health Managed Care Clinical Trials Research Science Pharmaceutical Biotechnology

MEDIA:

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November 12, 2020 4:05 pm

Splunk Appoints Four-Star U.S. Army General Dennis Via to its Board of Directors

Splunk Appoints Four-Star U.S. Army General Dennis Via to its Board of Directors

Seasoned Leader Brings 40+ Years of Military and Technology Leadership Expertise to Splunk

SAN FRANCISCO–(BUSINESS WIRE)–Splunk Inc. (NASDAQ: SPLK), provider of the Data-to-Everything Platform, today announced that retired Army General Dennis Via has joined Splunk’s Board of Directors, bringing more than 40 years of military, technology and public sector leadership experience to the role.

Currently, General Via serves as an Executive Vice President with Booz Allen Hamilton, a technology and management consulting firm headquartered in McLean, Virginia. As a senior leader in the Booz Allen Global Defense Group’s Joint Combatant Command business, General Via leads security cooperation with a focus on innovation, transformation and multi-year market growth strategies. He also serves as a Defense Fellow, helping defense, intelligence and homeland security clients manage today’s evolving threat and budgetary environments.

“All three branches of the U.S. government and all four branches of the U.S. military leverage Splunk’s Data-to-Everything Platform to solve their toughest IT, Security and Observability challenges. General Via is a technology luminary within the government, and knows this world inside and out,” said Doug Merritt, President and CEO of Splunk. “I am thrilled to welcome Dennis to Splunk’s Board of Directors and am confident his extensive experience will help accelerate Splunk’s impact on our public sector customers and broader customer base.”

During his 36-year military career, General Via held multiple command and senior leader positions across the Department of Defense (DoD) in the areas of information technology, network operations, cybersecurity and global supply chain. Via culminated his career as the Commanding General of the U.S. Army Materiel Command, the Army’s primary logistics and sustainment command, responsible for managing the global supply chain and synchronizing logistics and sustainment activities across the U.S. Army. He also held multiple commander, signal, and chief information officer roles, working on everything from communications infrastructure and cybersecurity to global logistics and engineering.

“I am honored to join the Splunk Board,” said General Via. “Splunk’s customer-first focus, along with the company’s exceptional reputation for delivering actions and outcomes that positively impact the world through data, is truly admirable. I look forward to the opportunity to support the company’s vision of creating lasting data outcomes for its customers.”

General Via holds a B.S. from Virginia State University and a Master of Education from Boston University. He serves on the boards of directors of Milliken & Company and the nonprofit Capital Partners for Education, and is a member of the Council on Foreign Relations, the Association of the United States Army, and the Armed Forces Communications Electronics Association (AFCEA).

About Splunk Inc.

Splunk Inc. (NASDAQ: SPLK) turns data into doing with the Data-to-Everything Platform. Splunk technology is designed to investigate, monitor, analyze and act on data at any scale.

Splunk, Splunk>, Data-to-Everything, D2E and Turn Data Into Doing are trademarks and registered trademarks of Splunk Inc. in the United States and other countries. All other brand names, product names, or trademarks belong to their respective owners. © 2020 Splunk Inc. All rights reserved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112006040/en/

Media Contact

Bill Bode

Splunk Inc.

[email protected]

Investor Contact

Ken Tinsley

Splunk Inc.

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Data Management Defense Security Technology Software Networks Other Defense

MEDIA:

November 12, 2020 4:05 pm

SemiLEDs Reports Fourth Quarter and Fiscal Year End 2020 Financial Results

SemiLEDs Reports Fourth Quarter and Fiscal Year End 2020 Financial Results

HSINCHU, Taiwan–(BUSINESS WIRE)–
SemiLEDs Corporation (NASDAQ: LEDS), “SemiLEDs” or the “Company,” a developer and manufacturer of LED chips and LED components, today announced its financial results for the fourth quarter and full year of fiscal year 2020, ended August 31, 2020.

Revenues for the fourth quarter of fiscal year 2020 were $1.4 million, a 12% decrease compared to $1.6 million in the third quarter of fiscal year 2020. GAAP net loss attributable to SemiLEDs stockholders for the fourth quarter of fiscal year 2020 was $62 thousand, compared to a loss of $513 thousand in the third quarter of fiscal year 2020, or a net loss of $0.02 per diluted share, compared to a net loss of $0.14 per diluted share for the third quarter of fiscal year 2020.

GAAP gross margin for the fourth quarter of fiscal year 2020 was 8%, compared with gross margin for the third quarter of fiscal year 2020 of 27%. Operating margin for the fourth quarter of fiscal year 2020 was negative 28%, compared with negative 47% in the third quarter of fiscal year 2020. The Company’s cash and cash equivalents, excluding restricted cash, was $2.8 million as of August 31, 2020, compared to $2.5 million at the end of the third quarter of fiscal year 2020.

We are unable to forecast revenue for the first quarter ending November 30, 2020 at this time given the uncertain impact of COVID-19 on the global economy and the Company.

Revenues for fiscal year 2020 were $6.1 million, a 3% increase compared to $5.9 million in fiscal year 2019. GAAP net loss attributable to SemiLEDs stockholders for fiscal year 2020 was $544 thousand, compared to a loss of $3.6 million in fiscal year 2019 or a net loss of $0.15 per diluted share, compared to a net loss of $1.00 per diluted share for fiscal year 2019.

GAAP gross margin for the fiscal year 2020 was 26%, compared with gross margin for the fiscal year 2019 of 8%. Operating margin for the fiscal year 2020 was negative 34%, compared with negative 62% in the fiscal year 2019. The Company’s cash and cash equivalents, excluding restricted cash, was $2.8 million as of August 31, 2020, compared to $1.4 million as of August 31, 2019.

About SemiLEDs

SemiLEDs develops and manufactures LED chips and LED components for general lighting applications, including street lights and commercial, industrial, system and residential lighting, along with specialty industrial applications such as ultraviolet (UV) curing, medical/cosmetic, counterfeit detection, horticulture, architectural lighting and entertainment lighting. SemiLEDs sells blue, white, green and UV LED chips.

Forward Looking Statements

This press release contains statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, any statements about historical results that may suggest trends for SemiLEDs’ business; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are based on current expectations, estimates, forecasts and projections of future SemiLEDs’ or industry performance based on management’s judgment, beliefs, current trends and market conditions and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. SemiLEDs’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) and other SemiLEDs filings with the SEC (which you may obtain for free at the SEC’s website at http://www.sec.gov) discuss some of the important risks and other factors that may affect SemiLEDs’ business, results of operations and financial condition. SemiLEDs undertakes no intent or obligation to publicly update or revise any of these forward looking statements, whether as a result of new information, future events or otherwise, except as required by law.

SEMILEDS CORPORATION AND SUBSIDIARIES Unaudited Condensed Consolidated Balance Sheets (In thousands of U.S. dollars)

	August 31, 2020			August 31, 2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	2,832		$	1,363
Restricted cash and cash equivalents		85			19
Accounts receivable (including related parties), net		1,331			703
Inventories		2,476			2,083
Prepaid expenses and other current assets		781			460
Total current assets		7,505			4,628
Property, plant and equipment, net		5,645			5,878
Operating lease right of use assets		203			—
Intangible assets, net		89			93
Investments in unconsolidated entities		952			894
Other assets		186			169
TOTAL ASSETS	$	14,580		$	11,662
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Current installments of long-term debt	$	4,750		$	398
Accounts payable		536			680
Advance receipt toward the convertible note		500			500
Accrued expenses and other current liabilities		2,654			2,342
Other payable to related parties		460			—
Operating lease liabilities, current portion		97			—
Total current liabilities		8,997			3,920
Long-term debt, excluding current installments		2,909			5,954
Operating lease liabilities, less current portion		106			—
Total liabilities		12,012			9,874
Commitments and contingencies
EQUITY:
SemiLEDs stockholders’ equity
Common stock		—			—
Additional paid-in capital		177,235			175,804
Accumulated other comprehensive income		3,647			3,753
Accumulated deficit		(178,360	)		(177,816	)
Total SemiLEDs stockholders’ equity		2,522			1,741
Noncontrolling interests		46			47
Total equity		2,568			1,788
TOTAL LIABILITIES AND EQUITY	$	14,580		$	11,662

SEMILEDS CORPORATION AND SUBSIDIARIES Unaudited Condensed Consolidated Statements of Operations (In thousands of U.S. dollars and shares, except per share data)

	Three Months Ended						Year Ended August 31,
	August 31, 2020			May 31, 2020			2020			2019
Revenues, net	$	1,399		$	1,569		$	6,068		$	5,902
Cost of revenues		1,291			1,153			4,478			5,450
Gross profit		108			416			1,590			452
Operating expenses:
Research and development		426			375			1,538			1,613
Selling, general and administrative		667			782			2,808			2,792
Gain on disposals of long-lived assets, net		(590	)		—			(669	)		(288	)
Total operating expenses		503			1,157			3,677			4,117
Loss from operations		(395	)		(741	)		(2,087	)		(3,665	)
Other income (expenses):
Gain on disposals of investment		—			—			634			—
Interest income (expenses), net		(85	)		(95	)		(358	)		(190	)
Other income (loss), net		318			270			912			250
Foreign currency transaction gain (loss), net		96			57			352			40
Total other expenses, net		329			232			1,540			100
Loss before income taxes		(66	)		(509	)		(547	)		(3,565	)
Income tax expense		—			—			—			—
Net loss		(66	)		(509	)		(547	)		(3,565	)
Less: Net loss attributable to noncontrolling interests		(4	)		4			(3	)		—
Net loss attributable to SemiLEDs stockholders	$	(62	)	$	(513	)	$	(544	)	$	(3,565	)
Net loss per share attributable to SemiLEDs stockholders:
Basic and diluted	$	(0.02	)	$	(0.14	)	$	(0.15	)	$	(1.00	)
Shares used in computing net loss per share attributable to SemiLEDs stockholders:
Basic and diluted		4,008			3,738			3,921			3,580

View source version on businesswire.com: https://www.businesswire.com/news/home/20201112005364/en/

Christopher Lee

Chief Financial Officer

SemiLEDs Corporation

+886-37-586788

[email protected]

KEYWORDS: Taiwan Asia Pacific

INDUSTRY KEYWORDS: Retail Technology Home Goods Other Technology Construction & Property Building Systems

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November 12, 2020 4:05 pm

Steven Mickelsen, MD, Joins Acutus Medical as Chief Translational Science Officer

CARLSBAD, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB) today announced the appointment of Steven Mickelsen, MD, as Chief Translational Science Officer. Dr. Mickelsen will help guide the company’s vision to deliver the most advanced electrophysiology therapeutic solutions on the market for physicians and their patients. Mickelsen’s impact will further advance the company’s commitment to innovation across its access, diagnostic and therapy product portfolio, including researching, developing and advancing gold-tip catheter technology for Pulsed Field Ablation (PFA) and Radiofrequency (RF) ablation technologies.

“Acutus is committed to creating game-changing solutions and establishing new standards of care for cardiac arrhythmia management,” said Vince Burgess, President and CEO of Acutus Medical. “Dr. Mickelsen’s clinical and technical expertise and unique history pioneering the development of breakthrough therapeutic medical devices is indispensable as we progress from research to commercialization of important technologies such as Pulsed Field Ablation.”

Dr. Mickelsen joins Acutus Medical following an esteemed career practicing as a cardiac electrophysiologist at the University of Iowa Hospitals and Clinics in Iowa City. He focuses on complex ablation procedures and serves on faculty as Assistant Professor of Cardiovascular Medicine and Internal Medicine, and will continue his tenure going forward. In 2012, Dr. Mickelsen founded Farapulse, a company devoted to the discovery of more effective treatments for atrial fibrillation through the utilization of a pulsed electric field system that he invented. He served as the company’s initial President and CEO, and later as its Chief Science Officer, before stepping down in 2016 to focus on clinical research.

“The field of arrhythmia science is evolving at a breakneck speed. Physicians want to provide the best possible care, but we’re often confined by the limitations of technology. Acutus is changing that, and this is an opportunity to play a critical role delivering advanced EP solutions to treat the entire spectrum of cardiac arrhythmias,” said Dr. Mickelsen. “Pulsed field ablation represents an exciting potential future for EP; I’m thrilled to join a team that is dedicated to creating new solutions and enhancing the possibilities for physicians and their patients.”

Dr. Mickelsen is a board-certified electrophysiologist. He received his medical degree from the University of New Mexico School of Medicine, was a Howard Hughes Research Scholar at the National Institutes of Health in Bethesda, MD, and completed his internal medicine residency and clinical research at the Mayo Clinic. He also completed fellowships in Cardiology and Cardiac Electrophysiology at the University of Iowa Hospitals and Clinics.

About Acutus Medical

Acutus Medical is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias in each of its geographic markets. Founded in 2011, Acutus is based in Carlsbad, California.

Acutus PFA Technology is not for sale in the United States

Follow Acutus Medical on:

Twitter: @AcutusMedical
LinkedIn: www.linkedin.com/company/acutus-medical-inc-/
Facebook: @AcutusMedical

US Media Contacts

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November 12, 2020 4:05 pm

Nkarta Announces Treatment of First Patient in First-in-Human Clinical Trial of Engineered NKG2D-Based NK Cell Cancer Immunotherapy NKX101

First Multi-Center Clinical Trial to Investigate an Engineered NK Cell Targeting NKG2D

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the first patient has been treated in the first-in-human Phase 1 clinical trial of NKX101 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS). The multi-center clinical trial is designed to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101.

NKX101 is the first investigational NK cell cancer immunotherapy engineered to express a chimeric activating receptor (CAR) targeting NKG2D. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely and specifically expressed on cancer cells. With NKX101, NKG2D expression is increased by 10-fold and cytotoxic activity increased by 4-fold compared to non-engineered NK cells in preclinical models. NKX101 is also designed to express membrane-bound IL-15, which in preclinical models enhances the activity and persistence of the engineered NK cells. Nkarta’s proprietary manufacturing processes enable the evaluation of cryopreserved NKX101, expanding trial access across multiple clinical centers.

“Despite recent treatment breakthroughs, AML patients who relapse after front-line therapy still have poor outcomes, underscoring the need for new treatment options for this aggressive and lethal blood cancer,” said Carlos Bachier, M.D., Director of Cellular Therapy Research, Sarah Cannon Research Institute and Program Director for Sarah Cannon Center for Blood Cancer at TriStar Centennial Medical Center in Nashville, Tennessee, where the first patient has been treated. “To date, the significant clinical benefit achieved with CAR T cell therapies in the treatment of B cell lymphomas and acute lymphocytic leukemia has not extended to AML or other myeloid malignant disorders. The investigation of NKG2D-targeting and the tumor-killing potential of an engineered innate immune cell type is a promising new approach.”

“An extensive body of academic research has already shown increased expression of NKG2D targets in AML and other cancers, and demonstrated clinical responses in relapsed/refractory AML patients who received non-engineered allogeneic NK cells in single center academic studies as treatment,” said Kanya Rajangam, M.D., Ph.D., Chief Medical Officer of Nkarta. “With its amplified NKG2D targeting and enhanced NK cell engineering, NKX101 has the potential to improve upon this earlier clinical experience with non-engineered NK cells and to activate a deep and robust immune response in AML patients.”

A poster on the design of the NKX101 clinical trial in progress has been accepted for presentation at the 2020 American Society of Hematology Annual Meeting and Exhibition, Abstract 1040, “A Phase 1 Study of NKX101, an Allogeneic CAR Natural Killer (NK) Cell Therapy, in Subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-Risk Myelodysplastic Syndrome (MDS),” Session 616, December 5, 2020.

About the
Phase 1 Clinical Trial of NKX101 in Participants with Relapsed/Refractory Acute Myeloid Leukemia
(AML)
or Higher Risk Myelodysplastic Syndromes
(MDS)

This First-in-Human Phase 1 study evaluates the safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101, administered in a cycle of three weekly infusions following lymphodepletion, in adult patients living with relapsed/refractory AML or higher risk MDS. This single-arm, open-label, multi-center study consists of sequential dose-finding and dose-expansion. The safety of participants will be monitored by assessment of vital signs, physical examinations and laboratory tests. The clinical trial is designed to identify a recommended Phase 2 dose, and will evaluate cellular kinetics, pharmacodynamics, and preliminary anti-tumor activity using standard response criteria. Additional information is available on ClinicalTrials.gov, identifier NCT04623944.

About AML and MDS

Acute Myeloid Leukemia (AML) is a rapidly progressing blood cancer caused by abnormalities of myeloid cells, a cell type in the bone marrow that would normally develop into different types of blood cells. AML usually worsens rapidly and can lead to death if not treated. Despite recent advancements, an unmet need for novel treatment options remains high. Only approximately one in four patients with AML survive longer than five years. Patients with AML have a high rate of disease relapse after a treatment response. Due to age and comorbidities, not all patients are eligible to receive intensive chemotherapy, leaving them with limited treatment options. Once relapsed or refractory to front-line therapy, patients have limited treatment options. The worldwide incidence of AML was estimated to be more than 119,500 cases in 2017.^* In the United States, there will be an estimated 19,940 new cases of AML in 2020, with an estimated 11,180 deaths resulting from the disease.^**

Myelodysplastic Syndromes (MDS) are a group of bone marrow disorders in which the blood-forming cells in the bone marrow do not produce enough healthy blood cells. Some patients with MDS have too many young, immature blood-making cells in the bone marrow. The median overall survival rate of higher risk MDS patients is 0.8 to 3.0 years. There is currently no curative treatment for patients who relapse after front-line therapy or do not respond to front-line therapy. MDS can progress to AML in about one-third of patients.

^*Ming Yi et al, J Hematol Oncol. 2020; 13: 72; ^**National Institutes of Health, Cancer Stat Facts, accessed 11 Nov 2020.

About NKX101

NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

About
Nkarta’s
NK Cell Technologies

Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells, and builds upon the important advances in cellular immunotherapy and chimeric antigen receptor (CAR) biology. To enhance the intrinsic activity of NK cells, Nkarta genetically engineers the cells with a CAR that consists of a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta’s NK cell therapy candidates are engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

Nkarta’s manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.

About Nkarta

Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off the shelf natural killer (NK) cell therapies for cancer. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company’s website at www.nkartatx.com.

Cautionary Note on Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” “projects,” “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Nkarta’s expectations regarding: Nkarta’s growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101; the mechanism of action and activity of Nkarta’s product candidates, including the activity of NKX101 in AML patients; NKX101’s potential as a treatment for AML; the size of the AML market; the efficiency and cost of Nkarta’s manufacturing processes; the number of doses generated from a manufacturing run; and the proprietary nature of Nkarta’s technology. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

These and other risks are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Nkarta’s final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, and our other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Nkarta Media/Investor Contact:

Greg Mann
Nkarta, Inc.
[email protected]

November 12, 2020 4:05 pm

Diffusion Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Business Updates

Initiated and Advanced
C
linical Trial Evaluating Lead Product Candidate in COVID-19 Patients

Announces Next Steps in Development Program for Lead Product Candidate

Ended Quarter with $21.9 million in Cash and Cash Equivalents

CHARLOTTESVILLE, Va., Nov. 12, 2020 (GLOBE NEWSWIRE) — Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) (“Diffusion” or the “Company”) today reported financial results for the three and nine months ended September 30, 2020 and provided certain updates on its development program for its lead product candidate, trans sodium crocetinate (“TSC”), which is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions.

Third quarter results, recent developments, and anticipated next steps in the TSC development program include:

Third Quarter Results & Recent Developments

	•	Strengthened leadership team with additions and appointments to key management positions, including pharmaceutical industry veterans Jane Hollingsworth, as director, Robert Cobuzzi, Ph.D., as president and chief executive officer, and Chris Galloway, M.D., as chief medical officer, as well as Bill Elder, J.D., as general counsel.

	•	Ended quarter with $21.9 million in cash and cash equivalents.

	•	Announced dosing of first two patients in Phase 1b clinical trial evaluating TSC in hospitalized COVID-19 patients (the “100-303 COVID Trial”) with primary endpoint of evaluating safety and tolerability of TSC administered every six hours for up to 15 days, a more frequent dosing regimen than has been used in the Company’s previous clinical studies.

	•	As of November 11, 2020, patient enrollment continues, and no dose-limiting toxicities have been observed.

Near-Term Strategy

•	Ongoing review of existing TSC development program with plans to modify the program and accomplish two principal strategic objectives:

		•	Optimize the clinical dose and dosing frequency for TSC.

		•	Evaluate TSC in clinical models designed to establish proof of concept for improvement in oxygenation following administration of TSC.

•	Designing and initiating additional studies in effort to accomplish strategic objectives:

		•	Evaluating possibility of expanding 100-303 COVID Trial to include additional doses administered on the same regimen, assuming successful and timely completion of currently planned doses and final regulatory approval of pending protocol amendment to effect change.

		•	Designing additional clinical studies intended to evaluate (i) the effects of TSC using short-term experimental models of oxygenation with the expected primary objective of establishing proof of concept for improvement of tissue oxygen levels and certain other clinical parameters and (ii) depending on whether or not the Company decides to implement the expansion of the 100-303 COVID Trial, additional doses of TSC on a more frequent dosing regimen.

•	Diffusion expects to fully fund these studies with cash-on-hand.

•	Diffusion intends to provide certain additional details regarding the design of these new studies in January 2021 and to initiate the studies during the first quarter of 2021. The Company also now expects the 100-303 COVID Trial, whether or not the Company decides to implement the expansion described above, to be completed with topline data available by the end of first quarter of 2021.

Other Events

	•	Diffusion currently intends to participate in two virtual, biopharmaceutical and biotechnology industry conferences in mid-January 2021 – Biotech Showcase and the H.C. Wainwright 2021 Bioconnect Conference – and to provide its next update regarding its development program for TSC at that time.

	•	Launched new website design at www.diffusionpharma.com.

“Hypoxia can be a serious complication of a multitude of acute and chronic disease processes in patients of all ages and represents a continued area of unmet need that spans multiple therapeutic areas. I am excited about our development plans, which we believe will clarify TSC’s mechanism of action in controlled human studies of oxygenation. We intend to use these data to inform and evaluate our further development opportunities for TSC, as well as potential patient populations and indications,” said Chris Galloway, M.D., Chief Medical Officer of Diffusion.

“Diffusion has experienced a lot of changes over the past few months. While we continue to refine our vision for the Company, we are pleased with the progress we made during the third quarter and we are excited to begin implementing our plans during the coming months,” said Robert Cobuzzi, Ph.D., Chief Executive Officer of Diffusion. “We believe our near-term strategy will significantly improve the probability of development success for TSC by providing the opportunity to optimize dosing and obtain a clear clinical signal supporting the potential value of TSC’s mechanism of action across a broad range of conditions in which hypoxia remains a significant obstacle to effective treatment.”

Third
Quarter
Financial Results

Research and development (“R&D”) expenses were $3.1 million during the third quarter of 2020, compared with $1.7 million during the third quarter of 2019. A significant portion of the increase, $1.4 million, was attributable to expenses related to the initiation of the Company’s ongoing clinical trial evaluating TSC in COVID-19 patients. In addition, R&D expenses included $0.1 million related to winding down the Company’s Phase 2 stroke trial.

General and administrative (“G&A”) expenses were $2.1 million during the third quarter of 2020, compared with $1.3 million during the third quarter of 2019. The increase was primarily due to a $0.2 million increase in professional fees and a $0.6 million increase in salaries, wages and stock-based compensation expenses, including non-recurring expenses related to the retirement, resignation and separation of the Company’s former Chief Executive Officer in September 2020.

The Company recognized income tax benefits of $0.8 million and $0.2 million during the third quarters of 2020 and 2019, respectively. In both periods, the recognized benefit reflects the Company’s utilization of indefinite deferred tax liabilities as a source of income against indefinite lived portions of its deferred tax assets.

Diffusion had cash and cash equivalents of $21.9 million as of September 30, 2020, compared with $14.2 million as of December 31, 2019, and believes its cash and cash equivalents are sufficient to fund operating expenses and capital expenditures into the fourth quarter of 2022.

About Diffusion Pharmaceuticals Inc.

Diffusion Pharmaceuticals Inc. is an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to the areas where it is needed most. The Company’s lead product candidate, TSC, is being developed to enhance the diffusion of oxygen to tissues with low oxygen levels, also known as hypoxia, a serious complication of many of medicine’s most intractable and difficult-to-treat conditions. For more information please visit us on the web at www.diffusionpharma.com.

Forward-Looking Statements

This press release includes express and implied forward-looking statements including, without limitation, statements regarding the Company’s ongoing clinical trials and development plans for its product candidates and the Company’s financial condition, liquidity, and capital resources. By their nature, forward-looking statements involve risks and uncertainties because they relate to and depend on, among other things, events, competitive dynamics, and industry change. The Company may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although the Company believes that it has a reasonable basis for each forward-looking statement contained herein, as a result of certain risks and uncertainties, known and unknown, the Company’s actual results could differ materially from any intentions, beliefs, projections, outlook, analyses, or expectations expressed herein. Particular risk and uncertainties include, among other things, those related to: the Company’s ability to design, initiate, execute, and complete its ongoing and planned studies evaluating TSC; the Company’s ability to achieve its near-term strategic objectives, in the near-term or at all; the Company’s ability to obtain additional financing; the success and timing of the Company’s clinical trials and preclinical studies, including its ability to enroll subjects in such trials and studies at anticipated rates; the Company’s ability to develop and commercialize TSC or any other product candidate; the ongoing COVID-19 pandemic; general economic, political, business, industry, and market conditions, including the recent United States (“U.S.”) presidential election; and the other factors discussed under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”). Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified) and, except as required by applicable law, rule or regulation, the Company undertakes no obligation to update any such statements after the date hereof. Comparisons of current and any prior period results are not intended to express any ongoing or future trends or indications of future performance, unless explicitly expressed as such, and should only be viewed as historical data. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contact:

LHA Investor Relations
Kim Sutton Golodetz
(212) 838-3777
[email protected]

Media Contact:

Jeffrey Freedman
RooneyPartners
(646) 432-0191
[email protected]

(Tables to follow)


Diffusion Pharmaceuticals Inc.
Consolidated Balance Sheet
(unaudited)

	September 30, 2020			December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	21,910,183		$	14,177,349
Prepaid expenses, deposits and other current assets		766,932			472,464
Total current assets		22,677,115			14,649,813
Property and equipment, net		174,133			252,366
Intangible asset		8,639,000			8,639,000
Right of use asset		174,668			247,043
Other assets		252,057			322,301
Total assets	$	31,916,973		$	24,110,523
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,411,717		$	1,251,412
Accrued expenses and other current liabilities		1,162,278			358,532
Current operating lease liability		112,953			111,477
Total current liabilities		2,686,948			1,721,421
Deferred income taxes		443,893			2,119,274
Noncurrent operating lease liability		61,715			135,566
Total liabilities		3,192,556			3,976,261
Stockholders’ Equity:
Common stock, $0.001 par value:
1,000,000,000 shares authorized; 64,015,441 and 33,480,365 issued and outstanding at September 30, 2020 and December 31, 2019, respectively		64,016			33,481
Additional paid-in capital		130,507,728			111,824,859
Accumulated deficit		(101,847,327	)		(91,724,078	)
Total stockholders’ equity		28,724,417			20,134,262
Total liabilities and stockholders’ equity	$	31,916,973		$	24,110,523

Diffusion Pharmaceuticals Inc.
Consolidated Statement of Operations
(unaudited)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Operating expenses:
Research and development	$	3,137,553		$	1,743,494		$	6,845,203		$	4,961,720
General and administrative		2,112,375			1,290,371			4,964,440			3,559,551
Depreciation		24,192			18,178			78,233			70,840
Loss from operations		(5,274,120	)		(3,052,043	)		(11,887,876	)		(8,592,111	)
Other income:
Interest income		29,233			21,991			89,246			59,596
Loss from operations before income tax benefit		(5,244,887	)		(3,030,052	)		(11,798,630	)		(8,532,515	)
Income tax benefit		805,676			225,960			1,675,381			485,216
Net loss	$	(4,439,211	)	$	(2,804,092	)	$	(10,123,249	)	$	(8,047,299	)
Deemed dividend arising from warrant exchange		—			—			(1,950,378	)		—
Net loss attributable to common stockholders	$	(4,439,211	)	$	(2,804,092	)	$	(12,073,627	)	$	(8,047,299	)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.07	)	$	(0.60	)	$	(0.24	)	$	(2.01	)
Weighted average shares outstanding, basic and diluted		64,011,342			4,693,290			50,216,239			4,005,919

November 12, 2020 4:04 pm

Enbridge Line 3 Replacement Project Receives MPCA Approvals and Remaining DNR Permits

PR Newswire

CALGARY, AB and DULUTH, MN, Nov 12, 2020 /PRNewswire/ – Today Minnesota Pollution Control Agency announced approvals for Enbridge’s Line 3 project, including the 401 Water Quality Certification. Also, today the Minnesota Department of Natural Resources released the final eight permits for the project.

“Clearly this is a big day for Line 3 in Minnesota,” said Leo Golden Vice President of Line 3 Execution. “These authorizations and approvals are an important step towards construction for this safety and maintenance focused replacement project which comes at an important time for Minnesota.”

This decision from the Minnesota Pollution Control Agency, including the project’s 401 Water Quality Certification clears the way for a determination from the US Army Corps of Engineers regarding federal permits.

The Line 3 project has been designed to avoid and minimize impacts to sensitive streams and wetlands. Enbridge pipelines have coexisted with the nation’s most productive wild rice waters for 70 years.

The authorizations and permits approved today by the Minnesota DNR range from a license for utility crossing of state land and public water, to water appropriation for dust control, hydrostatic testing and horizontal directional drilling. Enbridge has now received all ten of the DNR permits and authorizations for the safety and maintenance focused Line 3 Replacement Project. The project still needs final permits and authorizations before construction can begin.

The thorough, robust, science-based review of the project over the past six years has led to evidence-based approvals. Enbridge recognizes that the permit conditions required by the PCA and DNR are essential for protecting Minnesota’s sensitive streams and wild rice waters during construction and planning for post-construction restoration and enhancement.

At Enbridge safety is our top priority. Enbridge implemented an effective COVID-19 testing and screening program that has proven effective during our recent Line 3 construction in North Dakota. We will continue to follow the latest guidance provided by local, federal and international public-health and government authorities to protect workers and communities.

The project will provide significant economic benefits for counties, small businesses, Native American communities, and union members. Line 3 is a shovel-ready, $2.6-billion private investment that will bring 4,200 family-sustaining construction jobs, millions of dollars in local spending and tax revenues at a time when Northern Minnesota needs it most.

Forward Looking Information

Forward-looking information, or forward-looking statements, have been included in this news release to provide information about Enbridge Inc. (“Enbridge” or the “Company”) and its subsidiaries and affiliates, including management’s assessment of Enbridge and its subsidiaries’ future plans and operations. This information may not be appropriate for other purposes. Forward-looking statements are typically identified by words such as ”anticipate”, ”expect”, ”project”, ”estimate”, ”forecast”, ”plan”, ”intend”, ”target”, ”believe”, “likely” and similar words suggesting future outcomes or statements regarding an outlook. Forward-looking information or statements in this news release include statements with respect to the Line 3 Replacement Project and expected regulatory and permitting actions and decisions, capital expenditures, construction schedules and anticipated economic benefits.

Although Enbridge believes these forward-looking statements are reasonable based on the information available on the date such statements are made and processes used to prepare the information, such statements are not guarantees of future performance and readers are cautioned against placing undue reliance on forward-looking statements. By their nature, these statements involve a variety of assumptions, known and unknown risks and uncertainties and other factors, which may cause actual results, levels of activity and achievements to differ materially from those expressed or implied by such statements. Assumptions regarding the expected supply of and demand for crude oil, natural gas, NGL and renewable energy, and the prices of these commodities, are material to and underlie all forward-looking statements, as they may impact current and future levels of demand for the Company’s services. Similarly, the COVID-19 pandemic, exchange rates, inflation and interest rates impact the economies and business environments in which the Company operates and may impact levels of demand for the Company’s services and cost of inputs and are therefore inherent in all forward-looking statements. Due to the interdependencies and correlation of these macroeconomic factors, the impact of any one assumption on a forward-looking statement cannot be determined with certainty. The most relevant assumptions associated with forward-looking statements on announced projects and projects under construction such as the Line 3 Replacement Project, including estimated completion dates and expected capital expenditures, include the following: the COVID-19 pandemic and the duration and impact thereof; the impact of customer, government and regulatory approvals on construction and in-service schedules and cost recovery regimes; the availability and price of labour and construction materials; the effects of inflation and foreign exchange rates on labour and material costs; the effects of interest rates on borrowing costs; and the impact of weather.

Enbridge’s forward-looking statements are subject to risks and uncertainties, including, but not limited to those risks and uncertainties discussed in this news release and in the Company’s other filings with Canadian and United States securities regulators. The impact of any one risk, uncertainty or factor on a particular forward-looking statement is not determinable with certainty as these are interdependent and Enbridge’s future course of action depends on management’s assessment of all information available at the relevant time. Except to the extent required by applicable law, Enbridge assumes no obligation to publicly update or revise any forward-looking statements made in this news release or otherwise, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements, whether written or oral, attributable to Enbridge or persons acting on the Company’s behalf, are expressly qualified in their entirety by these cautionary statements.

About Enbridge Inc.

Enbridge Inc. is a leading North American energy infrastructure company. We safely and reliably deliver the energy people need and want to fuel quality of life. Our core businesses include Liquids Pipelines, which transports approximately 25 percent of the crude oil produced in North America; Gas Transmission and Midstream, which transports approximately 20 percent of the natural gas consumed in the U.S.; and Utilities and Power Operations, which serves approximately 3.7 million retail customers in Ontario and Quebec, and generates approximately 1,750 MW of net renewable power in North America and Europe. The Company’s common shares trade on and stock exchanges under the symbol ENB. For more information, visit the Toronto and New York stock exchanges under the symbol ENB. For more information, visit www.enbridge.com

FOR FURTHER INFORMATION PLEASE CONTACT:

Media

Juli Kellner Toll Free: (888) 992-0997
Email: [email protected]

Investment Community

Jonathan Morgan Toll Free: (800) 481-2804
Email: [email protected]

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SOURCE Enbridge Inc.

November 12, 2020 4:04 pm

AGNC Investment Corp. Declares Monthly Common Stock Dividend of $0.12 per Common Share for November 2020 and Announces Estimated Tangible Net Book Value of $16.31 per Common Share as of October 31, 2020

PR Newswire

BETHESDA, Md., Nov. 12, 2020 /PRNewswire/ — AGNC Investment Corp. (Nasdaq: AGNC) (“AGNC” or the “Company”) announced today that its Board of Directors has declared a cash dividend of $0.12 per share of common stock for November 2020. The dividend is payable on December 9, 2020 to common stockholders of record as of November 30, 2020.

The Company also announced today its estimated tangible net book value of $16.31 per common share as of October 31, 2020. The estimate of tangible net book value includes deductions for the Company’s October 2020 dividend of $0.12 per common share, which was declared on October 8, 2020 with an October 30, 2020 record date.

The estimated tangible net book value is unaudited and has not been verified or reviewed by any third party. The Company’s current estimate may also be materially different from its estimate as of October 31, 2020. The Company undertakes no obligation to update or revise its estimate of tangible net book value.

For further information or questions, please contact Investor Relations at (301) 968-9300 or [email protected].

ABOUT AGNC INVESTMENT CORP.
AGNC Investment Corp. is an internally-managed real estate investment trust that invests primarily in residential mortgage-backed securities for which the principal and interest payments are guaranteed by a U.S. Government-sponsored enterprise or a U.S. Government agency. For further information, please refer to www.AGNC.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. Forward-looking statements are based on estimates, projections, beliefs and assumptions of management of the Company at the time of such statements and are not guarantees of future performance. Forward-looking statements involve risks and uncertainties in predicting future results and conditions. Actual results could differ materially from those projected in these forward-looking statements due to a variety of important factors, including, without limitation, changes in interest rates, changes in the yield curve, changes in prepayment rates, the availability and terms of financing, changes in the market value of the Company’s assets, general economic conditions, market conditions, conditions in the market for agency securities, and legislative and regulatory changes that could adversely affect the business of the Company. Certain factors that could cause actual results to differ materially from those contained in the forward-looking statements, are included in the Company’s periodic reports filed with the Securities and Exchange Commission (“SEC”). Copies are available on the SEC’s website, www.sec.gov. The Company disclaims any obligation to update or revise any forward-looking statements based on the occurrence of future events, the receipt of new information, or otherwise.

CONTACT:
Investor Relations – (301) 968-9300

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SOURCE AGNC Investment Corp.

November 12, 2020 4:04 pm

STAG Industrial Announces New Solar Systems In Illinois And Massachusetts

PR Newswire

BOSTON, Nov. 12, 2020 /PRNewswire/ — STAG Industrial, Inc. (the “Company”) (NYSE: STAG) today announced the groundbreaking of its first onsite solar installation in Illinois, and its fifth solar installation in Massachusetts. The projects are part of community solar programs and will provide low-cost renewable energy to local homes and businesses. Facilitated by Black Bear Energy in partnership with STAG, and developed by Green Street Power Partners (“GSPP”), these systems have an aggregate capacity of 3.5 MW and will generate over 4.4 million kWh of electricity annually – the equivalent of powering nearly 361 homes with solar. With the addition of these sites, STAG now hosts over 13.5 MW of solar nationally.

“We have a large presence in Illinois, and the passing of the Future Energy Jobs Act of 2017 gave us an opportunity to incorporate solar into another asset’s roof. We are honored to be one of the first rooftop community solar projects in Illinois, and to be a part of Illinois’ transition to a clean energy economy, enabling job creation and new clean energy resources.” said Brian LaMont, Senior Vice President of Construction at STAG.

Construction on the assets commenced in July and the systems are expected to come online as early as the fourth quarter of 2020.

“The Illinois Community solar market and the Massachusetts SMART Program provide fantastic opportunities to install solar on industrial rooftops. Community solar programs allow projects to be built on large roofs in areas with high demand for electricity and are a great solution for utility customers who may prefer solar electricity but are unable to host it on their own homes and buildings. It is a win for commercial real estate owners, the local utility and its customers,” commented Drew Torbin, Black Bear Energy’s Chief Executive Officer.

“Illinois’ goal of 4,300 MW by 2030 has led to a rapid expansion of its solar presence across the state. Our team at GSPP is excited to contribute to this solar energy growth with our first project in the state of Illinois, made possible through our partnership with STAG Industrial and Black Bear Energy. We look forward to increasing renewable energy access across the state with this rooftop community solar project, and hopefully more to come” commented Scott Kerner, Green Street’s Chief Executive Officer.

About STAG Industrial, Inc.

STAG Industrial, Inc. is a real estate investment trust focused on the acquisition, ownership and operation of single-tenant, industrial properties throughout the United States. As of September 30, 2020, the Company’s portfolio consists of 462 buildings in 38 states with approximately 92.3 million rentable square feet.

For additional information, please visit the Company’s website at www.stagindustrial.com.

About Green Street Power Partners

Headquartered in Stamford, CT, Green Street Power Partners (GSPP) is a national developer, financier, owner, and operator of solar energy systems benefiting businesses and communities across the country. GSPP specializes in structured finance for solar assets, securing sponsor and tax equity alongside project-level debt financing to realize the highest value for its clients.

GSPP’s proven dependability, experience within the industry, and established portfolio of over 90 MW, underpin its success as one of the leading solar developers and owners in the country.

About Black Bear Energy

Black Bear Energy is a technology-enabled, commercial buyer’s representative specializing in onsite renewable energy and cleantech services. In the past five years, Black Bear has helped its clients bid out over 1,000 clean technology projects in more than 20 states through its data driven process. For more information about Black Bear Energy, visit BlackBearEnergy.com. For press inquiries, contact [email protected].

Forward-Looking Statements

This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe the Company’s future plans, strategies and expectations, are generally identifiable by use of the words “believe,” “will,” “expect,” “intend,” “anticipate,” “estimate,” “should,” “project” or similar expressions. You should not rely on forward-looking statements since they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond the Company’s control and which could materially affect actual results, performances or achievements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, the risk factors discussed in the Company’s annual report on Form 10-K for the year ended December 31, 2019 as updated by the Company’s quarterly reports on Form 10-Q. Accordingly, there is no assurance that the Company’s expectations will be realized. Except as otherwise required by the federal securities laws, the Company disclaims any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

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SOURCE STAG Industrial, Inc.

November 12, 2020 4:04 pm

Applied Materials Announces Fourth Quarter and Fiscal Year 2020 Results

Record quarterly revenue of $4.69 billion, up 25 percent year over year
Record quarterly GAAP EPS of $1.23 and non-GAAP EPS of $1.25, up 64 percent and 56 percent year over year, respectively
Generated record annual cash from operations of $3.80 billion

SANTA CLARA, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Applied Materials, Inc. (NASDAQ: AMAT) today reported results for its fourth quarter and fiscal year ended Oct. 25, 2020.

Fourth Quarter Results

Applied generated revenue of $4.69 billion. On a GAAP basis, the company recorded gross margin of 45.4 percent, operating income of $1.28 billion or 27.4 percent of net sales, and earnings per share (EPS) of $1.23.

On a non-GAAP adjusted basis, the company reported gross margin of 45.7 percent, operating income of $1.33 billion or 28.3 percent of net sales, and EPS of $1.25.

The company generated $1.32 billion in cash from operations and returned $250 million to shareholders including $200 million in dividends and $50 million in share repurchases.

Full Year Results

In fiscal 2020, Applied generated revenue of $17.20 billion. On a GAAP basis, the company recorded gross margin of 44.7 percent, operating income of $4.37 billion or 25.4 percent of net sales, and EPS of $3.92.

On a non-GAAP adjusted basis, the company reported gross margin of 45.1 percent, operating income of $4.53 billion or 26.3 percent of net sales, and EPS of $4.17.

The company generated a record $3.80 billion in cash from operations, paid dividends of $787 million and used $649 million to repurchase 12 million shares of common stock.

“Applied Materials closed fiscal 2020 with record quarterly performance as demand for our semiconductor systems and services remains very strong,” said Gary Dickerson, president and CEO. “Our future opportunities have never looked better and, as powerful technology trends take shape, we are uniquely positioned to accelerate our customers’ roadmaps and outperform our markets.”

Results Summary

													Change
	Q4 FY2020			Q4 FY2019			FY2020			FY2019			Q4 FY2020 vs. Q4 FY2019		FY2020 vs. FY2019
	(In millions, except per share amounts and percentages)
Net sales	$	4,688		$	3,754		$	17,202		$	14,608		25	%	18	%
Gross margin	45.4		%	43.5		%	44.7		%	43.7		%	1.9 points		1.0 points
Operating margin	27.4		%	23.0		%	25.4		%	22.9		%	4.4 points		2.5 points
Net income	$	1,131		$	698		$	3,619		$	2,706		62	%	34	%
Diluted earnings per share	$	1.23		$	0.75		$	3.92		$	2.86		64	%	37	%
Non-GAAP Adjusted Results
Non-GAAP adjusted gross margin	45.7		%	43.8		%	45.1		%	44.0		%	1.9 points		1.1 points
Non-GAAP adjusted operating margin	28.3		%	23.7		%	26.3		%	23.5		%	4.6 points		2.8 points
Non-GAAP adjusted net income	$	1,148		$	744		$	3,845		$	2,875		54	%	34	%
Non-GAAP adjusted diluted EPS	$	1.25		$	0.80		$	4.17		$	3.04		56	%	37	%

A reconciliation of the GAAP and non-GAAP adjusted results is provided in the financial tables included in this release. See also “Use of Non-GAAP Adjusted Financial Measures” section.

Business Outlook

In the first quarter of fiscal 2021, Applied expects net sales to be approximately $4.95 billion, plus or minus $200 million. Non-GAAP adjusted diluted EPS is expected to be in the range of $1.20 to $1.32.

This outlook for non-GAAP adjusted diluted EPS excludes known charges related to completed acquisitions of $0.01 per share and includes a net income tax benefit related to intra-entity intangible asset transfers of $0.03 per share, but does not reflect any items that are unknown at this time, such as any additional charges related to acquisitions or other non-operational or unusual items, as well as other tax related items, which we are not able to predict without unreasonable efforts due to their inherent uncertainty.

Fourth Quarter and Fiscal Year Reportable Segment Information

*Semiconductor Systems*	Q4 FY2020			Q4 FY2019			FY2020			FY2019

	(In millions, except percentages)
Net sales	$	3,070		$	2,302		$	11,367		$	9,027
Foundry, logic and other	58		%	58		%	59		%	52		%
DRAM	21		%	21		%	20		%	22		%
Flash memory	21		%	21		%	21		%	26		%
Operating income	1,059			641			3,714			2,464
Operating margin	34.5		%	27.8		%	32.7		%	27.3		%
Non-GAAP Adjusted Results
Non-GAAP adjusted operating income	$	1,073		$	652		$	3,778		$	2,507
Non-GAAP adjusted operating margin	35.0		%	28.3		%	33.2		%	27.8		%

*Applied Global Services*	Q4 FY2020			Q4 FY2019			FY2020			FY2019

	(In millions, except percentages)
Net sales	$	1,106		$	977		$	4,155		$	3,854
Operating income	320			274			1,127			1,101
Operating margin	28.9		%	28.0		%	27.1		%	28.6		%
Non-GAAP Adjusted Results
Non-GAAP adjusted operating income	$	320		$	274		$	1,135		$	1,101
Non-GAAP adjusted operating margin	28.9		%	28.0		%	27.3		%	28.6		%

*Display and Adjacent Markets*	Q4 FY2020			Q4 FY2019			FY2020			FY2019

	(In millions, except percentages)
Net sales	$	485		$	457		$	1,607		$	1,651
Operating income	95			96			291			294
Operating margin	19.6		%	21.0		%	18.1		%	17.8		%
Non-GAAP Adjusted Results
Non-GAAP adjusted operating income	$	98		$	99		$	304		$	307
Non-GAAP adjusted operating margin	20.2		%	21.7		%	18.9		%	18.6		%

Use of Non-GAAP Adjusted Financial Measures

Applied provides investors with certain non-GAAP adjusted financial measures, which are adjusted for the impact of certain costs, expenses, gains and losses, including certain items related to mergers and acquisitions; restructuring charges and any associated adjustments; certain incremental expenses related to COVID-19; impairments of assets, or investments; gain or loss on sale of strategic investments; loss on early extinguishment of debt; certain income tax items and other discrete adjustments. On a non-GAAP basis, the tax effect related to share-based compensation is recognized ratably over the fiscal year. Additionally, non-GAAP results exclude estimated discrete income tax expense items associated with U.S. tax legislation. Reconciliations of these non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP are provided in the financial tables included in this release.

Management uses these non-GAAP adjusted financial measures to evaluate the company’s operating and financial performance and for planning purposes, and as performance measures in its executive compensation program. Applied believes these measures enhance an overall understanding of its performance and investors’ ability to review the company’s business from the same perspective as the company’s management, and facilitate comparisons of this period’s results with prior periods on a consistent basis by excluding items that management does not believe are indicative of Applied’s ongoing operating performance. There are limitations in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with generally accepted accounting principles, may be different from non-GAAP financial measures used by other companies, and may exclude certain items that may have a material impact upon our reported financial results. The presentation of this additional information is not meant to be considered in isolation or as a substitute for the directly comparable financial measures prepared in accordance with GAAP.

Webcast Information

Applied Materials will discuss these results during an earnings call that begins at 1:30 p.m. Pacific Time today. A live webcast and related slide presentation will be available at www.appliedmaterials.com. A replay will be available on the website beginning at 5:00 p.m. Pacific Time today.

Forward-Looking Statements

This press release contains forward-looking statements, including those regarding anticipated growth and trends in our businesses and markets, industry outlooks and demand drivers, technology transitions, our business and financial performance and market share positions, our capital allocation and cash deployment strategies, our investment and growth strategies, our development of new products and technologies, our business outlook for the first quarter of fiscal 2021 and beyond, the impact of the ongoing COVID-19 pandemic and responses thereto on our operations and financial results, strategic acquisitions and investments, including the proposed acquisition of Kokusai Electric Corporation, and other statements that are not historical facts. These statements and their underlying assumptions are subject to risks and uncertainties and are not guarantees of future performance. Factors that could cause actual results to differ materially from those expressed or implied by such statements include, without limitation: the level of demand for our products; global economic and industry conditions; the effects of regional or global health epidemics, including the severity and duration of the ongoing COVID-19 pandemic; global trade issues and changes in trade and export license policies, including the impact of the implementation and interpretation of the rules published by the U.S. Department of Commerce on April 28, 2020 and August 17, 2020 relating to certain export license requirements; consumer demand for electronic products; the demand for semiconductors; customers’ technology and capacity requirements; the introduction of new and innovative technologies, and the timing of technology transitions; our ability to develop, deliver and support new products and technologies; the concentrated nature of our customer base; acquisitions, investments and divestitures; changes in income tax laws; our ability to expand our current markets, increase market share and develop new markets; market acceptance of existing and newly developed products; our ability to obtain and protect intellectual property rights in key technologies; our ability to achieve the objectives of operational and strategic initiatives, align our resources and cost structure with business conditions, and attract, motivate and retain key employees; the variability of operating expenses and results among products and segments, and our ability to accurately forecast future results, market conditions, customer requirements and business needs; and other risks and uncertainties described in our SEC filings, including our recent Forms 10-Q and 8-K. All forward-looking statements are based on management’s current estimates, projections and assumptions, and we assume no obligation to update them.

About Applied Materials

Applied Materials, Inc. (Nasdaq: AMAT) is the leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. Our expertise in modifying materials at atomic levels and on an industrial scale enables customers to transform possibilities into reality. At Applied Materials, our innovations make possible the technology shaping the future. Learn more at www.appliedmaterials.com.

Contact:

Ricky Gradwohl (editorial/media) 408.235.4676
Michael Sullivan (financial community) 408.986.7977

APPLIED MATERIALS, INC.
UNAUDITED CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

	Three Months Ended				Twelve Months Ended
(In millions, except per share amounts)	October 25, 2020		October 27, 2019		October 25, 2020		October 27, 2019
Net sales	$	4,688	$	3,754	$	17,202	$	14,608
Cost of products sold	2,558		2,120		9,510		8,222
Gross profit	2,130		1,634		7,692		6,386
Operating expenses:
Research, development and engineering	560		515		2,234		2,054
Marketing and selling	131		129		526		521
General and administrative	156		126		567		461
Total operating expenses	847		770		3,327		3,036
Income from operations	1,283		864		4,365		3,350
Interest expense	59		59		240		237
Interest and other income (loss), net	19		35		41		156
Income before income taxes	1,243		840		4,166		3,269
Provision for income taxes	112		142		547		563
Net income	$	1,131	$	698	$	3,619	$	2,706
Earnings per share:
Basic	$	1.24	$	0.76	$	3.95	$	2.89
Diluted	$	1.23	$	0.75	$	3.92	$	2.86
Weighted average number of shares:
Basic	914		920		916		937
Diluted	921		931		923		945

APPLIED MATERIALS, INC.
UNAUDITED CONSOLIDATED CONDENSED BALANCE SHEETS

(In millions)	October 25, 2020		October 27, 2019
ASSETS
Current assets:
Cash and cash equivalents	$	5,351	$	3,129
Short-term investments	387		489
Accounts receivable, net	2,963		2,533
Inventories	3,904		3,474
Other current assets	764		581
Total current assets	13,369		10,206
Long-term investments	1,538		1,703
Property, plant and equipment, net	1,604		1,529
Goodwill	3,466		3,399
Purchased technology and other intangible assets, net	153		156
Deferred income taxes and other assets	2,223		2,031
Total assets	$	22,353	$	19,024
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current portion of long-term debt	$	—	$	600
Accounts payable and accrued expenses	3,138		2,511
Contract liabilities	1,321		1,336
Total current liabilities	4,459		4,447
Long-term debt, net of current portion	5,448		4,713
Income taxes payable	1,206		1,275
Other liabilities	662		375
Total liabilities	11,775		10,810
Total stockholders’ equity	10,578		8,214
Total liabilities and stockholders’ equity	$	22,353	$	19,024

APPLIED MATERIALS, INC.
UNAUDITED CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(In millions)	Three Months Ended						Twelve Months Ended
(In millions)	October 25, 2020			October 27, 2019			October 25, 2020			October 27, 2019
Cash flows from operating activities:
Net income	$	1,131		$	698		$	3,619		$	2,706
Adjustments required to reconcile net income to cash provided by operating activities:
Depreciation and amortization	97			92			376			363
Share-based compensation	73			66			307			263
Deferred income taxes	(18		)	(8		)	80			49
Other	5			—			60			(19		)
Net change in operating assets and liabilities	27			(22		)	(638		)	(115		)
Cash provided by operating activities	1,315			826			3,804			3,247
Cash flows from investing activities:
Capital expenditures	(162		)	(97		)	(422		)	(441		)
Cash paid for acquisitions, net of cash acquired	—			—			(107		)	(28		)
Proceeds from sales and maturities of investments	366			555			1,754			1,940
Purchases of investments	(345		)	(544		)	(1,355		)	(1,914		)
Cash used in investing activities	(141		)	(86		)	(130		)	(443		)
Cash flows from financing activities:
Debt borrowings, net of issuance costs	—			—			2,979			—
Debt repayments	—			—			(2,882		)	—
Proceeds from common stock issuances	83			72			174			145
Common stock repurchases	(50		)	(500		)	(649		)	(2,403		)
Tax withholding payments for vested equity awards	(6		)	(3		)	(172		)	(86		)
Payments of dividends to stockholders	(200		)	(194		)	(787		)	(771		)
Cash used in financing activities	(173		)	(625		)	(1,337		)	(3,115		)
Increase (decrease) in cash, cash equivalents and restricted cash equivalents	1,001			115			2,337			(311		)
Cash, cash equivalents and restricted cash equivalents—beginning of period	4,465			3,014			3,129			3,440
Cash, cash equivalents and restricted cash equivalents — end of period	$	5,466		$	3,129		$	5,466		$	3,129

Reconciliation of cash, cash equivalents, and restricted cash equivalents
Cash and cash equivalents	$	5,351		$	3,129		$	5,351		$	3,129
Restricted cash equivalents included in deferred income taxes and other assets	115			—			115			—
Total cash, cash equivalents, and restricted cash equivalents	$	5,466		$	3,129		$	5,466		$	3,129

Supplemental cash flow information:
Cash payments for income taxes	$	23		$	69		$	542		$	522
Cash refunds from income taxes	$	63		$	2		$	68		$	22
Cash payments for interest	$	68		$	76		$	219		$	219

APPLIED MATERIALS, INC.
UNAUDITED SUPPLEMENTAL INFORMATION

Corporate and Other

(In millions)	Q4 FY2020			Q4 FY2019			FY2020			FY2019
Unallocated net sales	$	27		$	18		$	73		$	76
Unallocated cost of products sold and expenses	(145		)	(99		)	(533		)	(322		)
Share-based compensation	(73		)	(66		)	(307		)	(263		)
Total	$	(191	)	$	(147	)	$	(767	)	$	(509	)

Additional Information

	Q4 FY2020		Q4 FY2019		FY2020		FY2019
Net Sales by Geography (In millions)
United States	448		412		1,619		1,871
% of Total	10	%	11	%	10	%	13	%
Europe	206		147		736		820
% of Total	4	%	4	%	4	%	6	%
Japan	706		471		1,996		2,198
% of Total	15	%	13	%	11	%	15	%
Korea	719		471		3,031		1,929
% of Total	15	%	13	%	18	%	13	%
Taiwan	872		919		3,953		2,965
% of Total	19	%	24	%	23	%	20	%
Southeast Asia	161		135		411		548
% of Total	3	%	3	%	2	%	4	%
China	1,576		1,199		5,456		4,277
% of Total	34	%	32	%	32	%	29	%

Employees (In thousands)
Regular Full Time	24.0		22.0

APPLIED MATERIALS, INC.
UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED RESULTS

	Three Months Ended						Twelve Months Ended
(In millions, except percentages)	October 25, 2020			October 27, 2019			October 25, 2020			October 27, 2019
Non-GAAP Adjusted Gross Profit
Reported gross profit – GAAP basis	$	2,130		$	1,634		$	7,692		$	6,386
Certain items associated with acquisitions¹	12			9			37			37
Certain incremental expenses related to COVID-19⁵	—			—			23			—
Non-GAAP adjusted gross profit	$	2,142		$	1,643		$	7,752		$	6,423
Non-GAAP adjusted gross margin	45.7		%	43.8		%	45.1		%	44.0		%
Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	1,283		$	864		$	4,365		$	3,350
Certain items associated with acquisitions¹	16			14			54			55
Acquisition integration and deal costs	26			10			80			22
Certain incremental expenses related to COVID-19⁵	—			—			30			—
Non-GAAP adjusted operating income	$	1,325		$	888		$	4,529		$	3,427
Non-GAAP adjusted operating margin	28.3		%	23.7		%	26.3		%	23.5		%
Non-GAAP Adjusted Net Income
Reported net income – GAAP basis	$	1,131		$	698		$	3,619		$	2,706
Certain items associated with acquisitions¹	16			14			54			55
Acquisition integration and deal costs	26			10			80			22
Certain incremental expenses related to COVID-19⁵	—			—			30			—
Realized loss (gain) on strategic investments, net	—			—			(1		)	(6		)
Unrealized loss (gain) on strategic investments, net	(7		)	(5		)	(8		)	(30		)
Loss on early extinguishment of debt	—			—			33			—
Income tax effect of share-based compensation²	13			4			—			—
Income tax effect of changes in applicable U.S. tax laws³	—			—			—			(24		)
Income tax effects related to intra-entity intangible asset transfers	10			6			114			62
Resolution of prior years’ income tax filings and other tax items	(36		)	20			(41		)	95
Income tax effect of non-GAAP adjustments⁴	(5		)	(3		)	(35		)	(5		)
Non-GAAP adjusted net income	$	1,148		$	744		$	3,845		$	2,875

1	These items are incremental charges attributable to completed acquisitions, consisting of amortization of purchased intangible assets.

2	GAAP basis tax benefit related to share-based compensation is recognized ratably over the fiscal year on a non-GAAP basis.

3	Charges to income tax provision related to a one-time transition tax as a result of U.S. tax legislation.

4	Adjustment to provision for income taxes related to non-GAAP adjustments reflected in income before income taxes.

5	Temporary incremental employee compensation during the COVID-19 pandemic.

APPLIED MATERIALS, INC.
UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED RESULTS

	Three Months Ended					Twelve Months Ended
(In millions, except per share amounts)	October 25, 2020			October 27, 2019		October 25, 2020			October 27, 2019
Non-GAAP Adjusted Earnings Per Diluted Share
Reported earnings per diluted share – GAAP basis	$	1.23		$	0.75	$	3.92		$	2.86
Certain items associated with acquisitions	0.02			0.01		0.05			0.05
Acquisition integration and deal costs	0.02			0.01		0.07			0.02
Certain incremental expenses related to COVID-19	—			—		0.03			—
Loss on early extinguishment of debt	—			—		0.03			—
Unrealized loss (gain) on strategic investments, net	(0.01		)	—		(0.01		)	(0.03		)
Income tax effect of share-based compensation	0.02			—		—			—
Income tax effect of changes in applicable U.S. tax laws	—			—		—			(0.03		)
Income tax effects related to intra-entity intangible asset transfers	0.01			0.01		0.12			0.07
Resolution of prior years’ income tax filings and other tax items	(0.04		)	0.02		(0.04		)	0.10
Non-GAAP adjusted earnings per diluted share	$	1.25		$	0.80	$	4.17		$	3.04
Weighted average number of diluted shares	921			931		923			945

APPLIED MATERIALS, INC.
UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED RESULTS

	Three Months Ended						Twelve Months Ended
(In millions, except percentages)	October 25, 2020			October 27, 2019			October 25, 2020			October 27, 2019
Semiconductor Systems Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	1,059		$	641		$	3,714		$	2,464
Certain items associated with acquisitions¹	12			11			41			43
Acquisition integration costs	2			—			3			—
Certain incremental expenses related to COVID-19²	—			—			20			—
Non-GAAP adjusted operating income	$	1,073		$	652		$	3,778		$	2,507
Non-GAAP adjusted operating margin	35.0		%	28.3		%	33.2		%	27.8		%
AGS Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	320		$	274		$	1,127		$	1,101
Certain incremental expenses related to COVID-19²	—			—			8			—
Non-GAAP adjusted operating income	$	320		$	274		$	1,135		$	1,101
Non-GAAP adjusted operating margin	28.9		%	28.0		%	27.3		%	28.6		%
Display and Adjacent Markets Non-GAAP Adjusted Operating Income
Reported operating income – GAAP basis	$	95		$	96		$	291		$	294
Certain items associated with acquisitions¹	3			3			12			12
Acquisition integration costs	—			—			—			1
Certain incremental expenses related to COVID-19²	—			—			1			—
Non-GAAP adjusted operating income	$	98		$	99		$	304		$	307
Non-GAAP adjusted operating margin	20.2		%	21.7		%	18.9		%	18.6		%

1	These items are incremental charges attributable to completed acquisitions, consisting of amortization of purchased intangible assets.
2	Temporary incremental employee compensation during the COVID-19 pandemic.

Note: The reconciliation of GAAP and non-GAAP adjusted segment results above does not include certain revenues, costs of products sold and operating expenses that are reported within corporate and other and included in consolidated operating income.

UNAUDITED RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED EFFECTIVE INCOME TAX RATE

	Three Months Ended
(In millions, except percentages)	October 25, 2020

Provision for income taxes – GAAP basis (a)	$	112
Income tax effect of share-based compensation	(13		)
Income tax effects related to intra-entity intangible asset transfers	(10		)
Resolutions of prior years’ income tax filings and other tax items	36
Income tax effect of non-GAAP adjustments	5
Non-GAAP adjusted provision for income taxes (b)	$	130

Income before income taxes – GAAP basis (c)	$	1,243
Certain items associated with acquisitions	16
Acquisition integration and deal costs	26
Unrealized loss (gain) on strategic investments, net	(7		)
Non-GAAP adjusted income before income taxes (d)	$	1,278

Effective income tax rate – GAAP basis (a/c)	9.0		%

Non-GAAP adjusted effective income tax rate (b/d)	10.2		%