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• 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
	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		%

SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (NASDAQ: BNGO), a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business, today reported its financial results for the third quarter ended September 30, 2020 and provided a business update.

“We believe key events this quarter have set us up for continued growth and success,” said Erik Holmlin, Ph.D., CEO of Bionano. “Yesterday, in the largest Saphyr study on leukemia to date, cytogenetic thought leaders from leading U.S. institutions recommended that optical genome mapping using Saphyr be considered as a first-line diagnostic tool in leukemias. We saw continued adoption by cytogenomic labs around the world and for COVID host genome research, publication of several major studies on cancer genomics, genetic diseases and reference genome assembly, and made significant improvements to the Saphyr system. We enhanced our management team with the addition of our Chief Financial Officer and our first Chief Medical Officer. In addition, we completed the strategic acquisition of Lineagen, which adds to our revenue and outlines a potential path to reimbursement of laboratory developed tests performed on Saphyr.”

Recent Business Highlights

The Company continued building scientific momentum and driving utilization of its Saphyr System at key institutions across the globe, with the following notable announcements:

• Multi-Center Evaluation of Bionano Optical Genome Mapping by Cytogenetics Thought Leaders in the US Led to Recommendation for Bionano’s Saphyr to Replace Karyotyping as First-Line Test for Detection and Identification of Structural and Copy Number Variants in Leukemia Patients
   
• Saphyr played essential role in identifying three previously unknown genetic mutation types in cancer in study from Weill Cornell
   
• Saphyr showed to be key to understanding cancer genome structures that make tumors grow aggressively
   
• Boston Children’s Hospital used Saphyr to study children with severe COVID-19 form MIS-C, and Rockefeller University used animal species susceptible and resistant to COVID-19 in Saphyr-based comparative genomics study to identify genome variants that predispose to infection
   
• Saphyr data provided insight and understanding of repeat expansion disorders causing muscular dystrophy and ALS, and was shown to be indispensable for analysis of microdeletion syndromes
   
• Vertebrate Genome Project ruled Bionano optical genome mapping technology as essential part of assembling reference quality genomes
   
• Expanded European business with adoption of Saphyr at three of Europe’s largest pediatric hospitals in Spain, Italy and France.
   
• Expanded Global business with adoption of Saphyr for Next-Generation Cytogenomics in Eastern Europe, Australia and Canada
   
• Saphyr received German accreditation of Laboratory Developed Test for genetic disease testing

Enhanced Saphyr System

• Released fast and simple DNA isolation protocol to process solid tumor samples
   
• Released largest ever update to its suite of software tools that simplifies clinical analysis, reduces time to actionable results and makes adoption by clinical labs easier
   
• Saphyr services offered in CLIA Certified Lab Expanded Bionano Genomics’ clinical applications

Corporate

• Acquired Diagnostics Services Provider Lineagen to Accelerate Clinical Adoption of Saphyr for Digital Cytogenetics, Expanded Diagnostic Testing Menu with Launch of Lineagen’s EpiPanelDx PLUS Gene Panel Test that Identifies Genetic Conditions Related to Epilepsy
   
• Announced positive outcome from a special shareholder meeting where stockholders voted in favor of the company’s proposal to increase the number of authorized shares of common stock
   
• Enhanced senior management team with the appointments of Christopher Stewart as Chief Financial Officer and Dr. Alka Chaubey as Chief Medical Officer

Third Quarter Ended 2020 Financial Results

Total Revenue. Total revenue was $2.2 million for the three months ended September 30, 2019, up 86% sequentially from $1.2M in the prior quarter. Third quarter revenue was down 33.7% compared to $3.3 million for the same period in 2019. The decrease was driven by a change in the mix of revenue between instrument sales and our reagent rental program. Revenue for the three months ended September 30, 2020 includes service revenue of $0.4 million from our recently acquired subsidiary, Lineagen, from the date of the acquisition of August 21, 2020 to September 30, 2020.

Cost of Revenue. Total cost of revenue decreased by $0.9 million, or 38.5%, to $1.5 million for the three months ended September 30, 2020 compared to $2.4 million for the same period in 2019. The decrease was driven by a change in the mix of revenue between instrument sales and our reagent rental program. The decrease in cost was  partially offset by an increase in in cost of our consumables as the number of units sold increased 34%.  In addition, cost of service revenue increased by $0.2 million attributed to revenue generated by our recently acquired subsidiary, Lineagen, from the date of the acquisition of August 21, 2020 to September 30, 2020.

Operating Expenses. Operating expenses were $11.0 million for the three months ended September 30, 2020, compared to $6.6 million for the same period in 2019. The change is primarily due to increased legal and accounting fees to support business operations and its international presence, including approximately $1.5 million in transaction costs associated with the Lineagen acquisition, and an increase in wage expenses as a result of the addition of the 33 employees from the Lineagen acquisition and increased headcount in the Company’s global sales and marketing teams and back-office support teams to assist with the growth of its world-wide product distribution. Reduced travel and trade show expenses, in response to COVID travel protocols, have partially offset the increases in wages and professional services.

Cash and cash equivalents. At September 30, 2020, the Company had cash and cash equivalents of $18.9 million compared to cash and cash equivalents of $17.3 million at December 31, 2019.

Nine Months Ended 2020 Financial Results

Total Revenue.  Total revenue was $4.5 million for the nine months ended September 30, 2020 compared to $7.3 million for the same period in 2019. The decrease is largely driven by customers temporarily shutting down their lab operations in response to the COVID-19 pandemic. In addition, the decrease was driven by a change in the mix of revenue between instrument sales and our reagent rental program.

Cost of Revenue.  Total cost of revenue decreased by $2.2 million, or 42.5%, to $2.9 million for the nine months ended September 30, 2020 compared to $5.1 million for the same period in 2019. The decrease was driven by the reduction in revenue largely driven by customers temporarily shutting down their lab operations in response to the COVID-19 pandemic as well as a change in the mix of revenue between instrument sales and our reagent rental program. The cost reduction was  partially offset by an increase in consumable units sold of 70%.

Operating Expenses.  Operating expenses were $29.0 million for the nine months ended September 30, 2020, compared to $21.0 million for the same period in 2019. Research and development expenses increased $0.7 million, or 10.4%, to $7.4 million for the nine months ended September 30, 2020 compared to $6.7 million for the same period in 2019. This is due to headcount additions to the Company’s development teams but partially offset by the salary reductions implemented in April 2020. In addition, the Company’s materials and supply expense increased during the nine months ended September 30, 2020 due to continued efforts to innovate on Saphyr. Selling and general administrative expenses increased by $7.3 million, or 51.4%, to $21.6 million for the nine months ended September 30, 2020 compared to $14.3 million for the same period in 2019. This is primarily due to an increase in overall wage expenses due to increased headcount. In addition to the 33 employees added from the Lineagen acquisition, the Company increased headcount to its global sales and marketing teams and back-office support teams to assist with the growth of its world-wide product distribution. Also, the Company incurred increased legal and accounting fees to support business operations and its international presence, including approximately $1.5 million in transaction costs associated with the Lineagen acquisition. Lastly, the Company recognized bad debt expense of $1.3 million during the nine months ended September 30, 2020.

Conference Call & Webcast Details

Date:	Thursday November 12th
Time:	4:30 p.m. Eastern Time
Toll Free:	877-407-0784
International:	201-689-8560
Conference ID:	13712129
Webcast:	http://public.viavid.com/index.php?id=142056

To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay in the Investors section of the Bionano website.

About Bionano Genomics
Bionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing, and providing diagnostic testing for those with autism spectrum disorder (ASD) and other neurodevelopmental disabilities through its Lineagen business. Bionano’s Saphyr system is a platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. For more information, visit www.bionanogenomics.com or www.lineagen.com. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the contribution of our OGM technology to the improved detection of diagnostic information in the patients with leukemia and other genetic diseases, current and future utilization or adoption of Saphyr by researchers, scientists and leading medical institutions; our contributions to and the outcomes of studies discussed in this press release; our integration of Lineagen into our combined business, including any benefits or synergies from such integration; our future operating and our financial performance; potential reimbursement of laboratory developed tests performed on Saphyr; and the advancement of our strategic plans. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the ability of medical and research institutions to obtain funding to support adoption or continued use of our technologies; the loss of key members of management and our commercial team; our inability to achieve the anticipated benefits from our acquisition of Lineagen; and the risks and uncertainties associated with our business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

CONTACTS

Company Contact:

Erik Holmlin, CEO
Bionano Genomics, Inc.
+1 (858) 888-7610
[email protected]

Investor Relations Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
+1 (617) 430-7577
[email protected]

Media Contact:

Darren Opland, PhD
LifeSci Communications
+1 (617) 733-7668
[email protected]

Bionano Genomics, Inc.
Consolidated Balance Sheets
	(Unaudited)
	September 30, 2020				December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	18,867,000			$	17,311,000
Accounts receivable, net	3,860,000				6,334,000
Inventory, net	4,593,000				3,444,000
Prepaid expenses and other current assets	1,920,000				1,169,000
Total current assets	29,240,000				28,258,000
Property and equipment, net	3,635,000				1,950,000
Intangible assets, net	1,580,000				—
Goodwill	6,941,000				—
Total assets	$	41,396,000			$	30,208,000
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	5,665,000			$	2,699,000
Accrued expenses	4,466,000				3,225,000
Contract liabilities	412,000				358,000
Current portion of long-term debt	14,239,000				20,085,000
Total current liabilities	24,782,000				26,367,000
Long-term debt, net of current portion	1,775,000				—
Long-term contract liabilities	88,000				183,000
Other non-current liabilities	75,000				44,000
Total liabilities	26,720,000				26,594,000
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.0001 par value, 200,000,000 and 200,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 148,348,000 and 34,274,000 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	15,000				3,000
Additional paid-in capital	146,613,000				106,188,000
Accumulated deficit	(131,952,000		)		(102,577,000		)
Total stockholders’ equity	14,676,000				3,614,000
Total liabilities and stockholders’ equity	$	41,396,000			$	30,208,000

Bionano Genomics, Inc.
Consolidated Statements of Operations
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Revenue:
Product revenue	$	1,580,000			$	3,162,000			$	3,503,000			$	6,870,000
Service and other revenue	616,000				151,000				1,010,000				470,000
Total revenue	2,196,000				3,313,000				4,513,000				7,340,000
Cost of revenue:
Cost of product revenue	1,137,000				2,238,000				2,427,000				4,883,000
Cost of service and other revenue	324,000				137,000				493,000				194,000
Total cost of revenue	1,461,000				2,375,000				2,920,000				5,077,000
Operating expenses:
Research and development	2,304,000				2,174,000				7,379,000				6,682,000
Selling, general and administrative	8,659,000				4,449,000				21,640,000				14,295,000
Total operating expenses	10,963,000				6,623,000				29,019,000				20,977,000
Loss from operations	(10,228,000		)		(5,685,000		)		(27,426,000		)		(18,714,000		)
Other expenses:
Interest expense	(589,000		)		(578,000		)		(1,911,000		)		(1,613,000		)
Loss on debt extinguishment	—				—				—				(1,333,000		)
Other expenses	55,000				(131,000		)		—				(241,000		)
Total other expenses	(534,000		)		(709,000		)		(1,911,000		)		(3,187,000		)
Loss before income taxes	(10,762,000		)		(6,394,000		)		(29,337,000		)		(21,901,000		)
Provision for income taxes	(30,000		)		(4,000		)		(40,000		)		(13,000		)
Net loss	$	(10,792,000	)		$	(6,398,000	)		$	(29,377,000	)		$	(21,914,000	)

–  Nine Month Revenue Grew 84% to $3.8 Million During Covid-19 Economy; Exceeds Full Year 2019 Total Revenue of $2.8 Million

–  668 EV charging stations were sold, deployed, or acquired across 25 states

–  Acquired BlueLA Carsharing, Significantly Expanding Presence in California

Miami Beach, FL, Nov. 12, 2020 (GLOBE NEWSWIRE) — Blink Charging Co. (Nasdaq: BLNK, BLNKW) (“Blink” or the “Company”), a leading owner, operator, and provider of electric vehicle (EV) charging equipment and services, today announced financial results for the third quarter and nine months ended September 30, 2020. The Company reported strong quarterly earnings, notwithstanding business shutdowns during the third quarter due to the ongoing global pandemic.

Selected Highlights:

• Total revenue for the first nine months of 2020 grew 84% to $3.8 million, during Covid-19 economy; exceeds full year 2019 total revenue of $2.8 million
• Total revenue for Q3 increased by 18% to $0.9 million compared to Q3 2019 despite business interruptions due to the COVID-19 pandemic
• 668 EV charging stations were sold, deployed, or acquired across 25 states
• Product sales in Q3 2020 grew 74% to $0.6 million as compared to the prior year quarter, related primarily to increased demand for the Company’s commercial and residential products
• Company made significant progress with its owner/operator strategy; Blink owned chargers deployed during the quarter increased 87% compared to 3Q 2019
• Net loss was $3.9 million or $(0.12) per basic and diluted share in Q3 2020 compared to net loss of $2.6 million or $(0.10) in the third quarter of 2019
• During Q3 2020, the Company completed its acquisition of BlueLA Carsharing, the EV carsharing contractor for the city of Los Angeles
• From April 17, 2020 through September 30, 2020, the Company sold 3,521,971 shares of common stock for aggregate gross proceeds of $19 million
• Cash was $14.9 million on September 30, 2020

“The accelerating adoption of electric vehicles represents an enormous opportunity for EV infrastructure providers, and Blink in particular, as more and more drivers seek fast, convenient and reliable charging options. One of the key differentiators of our model is that we are the owner and operator of many of our chargers and realize an economic benefit each time a vehicle is charged at one of our owned units. We are confident that as EV adoption grows and utilization of chargers increases, we will see substantial economic returns from our owned chargers. As a leader in the EV charging space, we have been systematically expanding our footprint and growing our brand recognition by capturing premium locations and establishing strategic partnerships that promote the adoption of EV use. Importantly, these initiatives position Blink for continued growth as the EV revolution takes hold,” commented Michael D. Farkas, Founder and Chief Executive Officer of Blink.

“Our momentum continued during the third quarter of 2020 despite the ongoing pandemic, which included challenges with logistics, shipping delays, and a decrease in driving patterns impacting utilization. Our continued growth was demonstrated by increased revenue driven by significant increases in product sales. However, the quarter’s revenue was impacted by the timing of certain orders that we now expect to be completed in the fourth quarter of 2020. We sold, deployed, or acquired 668 EV charging stations across 25 states during the quarter. Eighty-nine of these deployments were upgrades as part of our aggressive initiative to replace first-generation equipment with our state-of-the-art IQ 200 chargers, 88 of which are Blink-owned. While upgrades are optional in our host-owned model, where we can control it, we want to ensure that our best equipment is made available to drivers.”

“In a key development during the quarter, we announced our acquisition of BlueLA Carsharing, the EV carsharing contractor serving the City of Los Angeles. With the acquisition, we doubled the number of Blink stations in Los Angeles, a city widely acknowledged as the epicenter for EV adoption. Not only does this acquisition position us to help drive the buildout of LA’s EV infrastructure, but the BlueLA carsharing program is also groundbreaking in its focus on making EV use attainable in low-income neighborhoods, and we look forward to advancing that mission. There is a significant market opportunity for this type of solution as urban centers throughout the U.S. transition to more sustainable transportation models. We believe LA can serve as our prototype for replicating EV carsharing and infrastructure programs in other cities.”

“We are energized by the fast-developing worldwide EV infrastructure market and by the opportunities we’re seeing for our portfolio of charging solutions. We continued to make solid progress during the third quarter, expanding and upgrading our network, developing innovative technology, and growing our customer base and partnerships. With our visibility today, we believe Blink is well positioned to grow our global position as a leading provider of charging stations as worldwide demand continues to increase for effective and convenient EV infrastructure.”

Business Updates and Highlights

During the third quarter of 2020, the Company:

• Acquired BlueLA Carsharing with 200 EV charging stations centrally located in downtown Los Angeles, CA
• Signed agreement with Cushman & Wakefield for marketing of Blink EV charging stations to that firm’s U.S. clients
• Announced interoperability agreement with SemaConnect, allowing customers of both companies to roam between charging networks without needing additional accounts or cards, establishing more accessible nationwide charging options
• Launched an upgrade program for existing host-owned Blink EV charging stations to transition from their first-generation equipment to Blink’s fast level 2 IQ 200 charging stations
• Announced a follow-on order from InterEnergy of 150 fast-charging stations, including its IQ 200 and DCFC units, for deployment in the Dominican Republic
• 668 EV charging stations were sold, deployed, or acquired across 25 states
• Joined with Sustainable Westchester in a partnership to promote EV charging infrastructure in the suburbs of New York

Subsequent to the close of the third quarter ended September 30, 2020, the Company:

• Announced the deployment of 14 IQ 200 charging stations in five locations in the city of Richmond, CA
• Announced an agreement with The Elysian residential building in downtown Los Angeles for the deployment of 44 level 2 EV charging stations in support of the building’s all-electric parking areas
• Entered into a strategic master development and production agreement with SG Blocks, a leading designer, innovator and fabricator of container-based structures, to bring solar, off-grid, modular EV charging solutions to market
• Installed six Level 2 IQ 200 EV charging stations at the Trail’s Bend and Cambium Apartments in Springfield, MO

Earnings Conference Call:

The Company will host a conference call and webcast to discuss the third quarter 2020 results today, November 12, 2020 at 4:30 P.M., Eastern Time.

To access the live webcast, log onto the Blink Charging website at www.blinkcharging.com, and click on the News/Events section of the Investor Relations page. Investors may also access the webcast via the following link: https://www.webcaster4.com/Webcast/Page/2468/38458.

To participate in the call by phone, dial (877) 876-9173 approximately five minutes prior to the scheduled start time. International callers please dial (785) 424-1667.

A replay of the teleconference will be available until December 12, 2020 and may be accessed by dialing (877) 481-4010. International callers may dial (919) 882-2331. Callers should use conference ID: 38458.

###

About Blink Charging

Blink Charging Co. (Nasdaq: BLNK, BLNKW) is a leader in electric vehicle (EV) charging equipment and has deployed over 23,000 charging stations, many of which are networked EV charging stations, enabling EV drivers to easily charge at any of the Company’s charging locations worldwide. Blink Charging’s principal line of products and services include its Blink EV charging network (“Blink Network”), EV charging equipment, and EV charging services. The Blink Network uses proprietary, cloud-based software that operates, maintains, and tracks the EV charging stations connected to the network and the associated charging data. With global EV purchases forecasted to rise to 10 million vehicles by 2025 from approximately 2 million in 2019, the Company has established key strategic partnerships for rolling out adoption across numerous location types, including parking facilities, multifamily residences and condos, workplace locations, health care/medical facilities, schools and universities, airports, auto dealers, hotels, mixed-use municipal locations, parks and recreation areas, religious institutions, restaurants, retailers, stadiums, supermarkets, and transportation hubs. For more information, please visit https://www.blinkcharging.com/.

 Forward-Looking Statements

This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements, and terms such as “anticipate,” “expect,” “intend,” “may,” “will,” “should” or other comparable terms, involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of Blink Charging and members of its management, as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those described in Blink Charging’s periodic reports filed with the SEC, and that actual results may differ materially from those contemplated by such forward-looking statements. Except as required by federal securities law, Blink Charging undertakes no obligation to update or revise forward-looking statements to reflect changed conditions.

Blink Media Contact 


[email protected]

Blink Investor Relations Contact 


[email protected]


855-313-8187

IRVINE, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today reported financial results for its third quarter ended September 30, 2020.

Third
Quarter Highlights
:

• Record procedure volume in Q3, treated over 3,700 patients
• Reported revenue of $38.7 million in the third quarter of 2020, a 172% increase over the same quarter last year and 52% sequentially compared to Q2
• Presented the first 230 patients from our FLASH database as a late breaking clinical trial at TCT
• Ended the quarter with $168.0M in cash and equivalents

“In the third quarter we made significant progress in our mission to treat and transform the lives of patients with venous disease,” said Bill Hoffman, Chief Executive Officer of Inari Medical. “We presented ground-breaking FLASH data at TCT, expanded our Clot Warrior Academy training and education series, introduced meaningful new technology and aggressively expanded our commercial footprint. Most importantly, we treated a record number of patients. We are pleased that our team has responded so effectively to the challenges created by the pandemic, and we are grateful that our hospital customers and physicians have also adapted and established a constructive operating environment for patient treatments. In these uncertain times, we remain thankful for the opportunity and privilege to serve our patients.”

Third
Quarter 2020 Financial Results

Revenue was $38.7 million for the third quarter of 2020, compared to $25.4 million for the prior quarter and $14.2 million for the third quarter of 2019. The increase from last year was driven by continued US commercial expansion and increased product adoption.

Gross profit for the third quarter of 2020 was $35.5 million compared to $12.7 million for the third quarter of 2019. Gross margin increased slightly to 91.7% for the third quarter of 2020, compared with 89.4% in the same quarter last year.

Operating expenses were $28.3 million for the third quarter of 2020, compared with $11.8 million in the same quarter last year. The increase was driven primarily by personnel-related expenses to fund expansion of the commercial, research and development, clinical and support organizations, as well as expenses related to being a public company.

Net income was $6.5 million for the third quarter of 2020 and net income per share was $0.13 on a weighted-average basic share count of 48.3 million and $0.12 on a diluted share count of 55.4 million, compared to net income of $0.4 million and an income per share of $0.06 on a weighted-average basic share count of 6.0 million and $0.01 on a diluted share count of 43.9 million in the same period of the prior year.

Cash and cash equivalents were $168.0 million as of September 30, 2020, which reflects a $30.3 million payoff of our long-term debt during the third quarter of 2020.

Outlook and COVID-19

Due to uncertainty surrounding the COVID-19 pandemic, Inari Medical will not provide financial guidance for the remainder of 2020 at this time.  

Webcast and Conference Call Information

Inari Medical will host a conference call to discuss the third quarter financial results after market close on Thursday, November 12, 2020 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 519-1265 for U.S. callers or (914) 800-3838 for international callers, using conference ID: 6551049. The live webinar can be accessed at https://ir.inarimedical.com.

About Inari Medical, Inc.

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

Inari is focused on treating venous thromboembolism and improving the quality of life of patients suffering from this disease by safely and effectively removing blood clots. Inari has developed two minimally invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The ClotTriever system is 510(k)-cleared by the FDA for the treatment of deep vein thrombosis. The FlowTriever system is 510(k)-cleared by the FDA for the treatment of pulmonary embolism.

Forward Looking Statements

Statements in this press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements include assumptions about the impact of COVID-19, and are based on Inari’s current expectations, forecasts and assumptions, are subject to inherent uncertainties, risks and assumptions that are difficult to predict and actual outcomes and results could differ materially due to a number of factors. These and other risks and uncertainties include those described more fully in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Quarterly Report on Form 10-Q for the period ended September 30, 2020 and in its other reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are based on information available to Inari as of the date hereof and are made only as of the date of this release. Inari undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing Inari’s views as of any date subsequent to the date of this press release. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Inari.

Investor Contact:

Westwicke Partners
Caroline Corner
Phone +1-415-202-5678
[email protected]

INARI MEDICAL, INC.

Condensed Consolidated Statemen
ts of Operations and Comprehensive Income (Loss)

(in thousands, except share and per share data)

(unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Revenue		$	38,715			$	14,225			$	91,059			$	31,242
Cost of goods sold			3,228				1,510				9,420				3,772
Gross profit			35,487				12,715				81,639				27,470
Operating expenses
Research and development			5,217				1,722				11,863				4,511
Selling, general and administrative			23,080				10,100				58,353				23,328
Total operating expenses			28,297				11,822				70,216				27,839
Income (loss) from operations			7,190				893				11,423				(369	)
Other income (expense)
Interest income			208				19				409				66
Interest expense			(251	)			(226	)			(1,060	)			(682	)
Change in fair value of warrant liabilities			—				(320	)			(3,317	)			(562	)
Other expenses			(651	)			—				(651	)			—
Total other expenses			(694	)			(527	)			(4,619	)			(1,178	)
Net income (loss) and comprehensive income (loss)		$	6,496			$	366			$	6,804			$	(1,547	)
Net income (loss) per share
Basic		$	0.13			$	0.06			$	0.26			$	(0.27	)
Diluted		$	0.12			$	0.01			$	0.14			$	(0.27	)
Weighted average common shares used to compute net income (loss) per share,
Basic			48,335,443				5,962,665				26,423,681				5,773,263
Diluted			55,355,846				43,911,252				49,940,409				5,773,263

INARI MEDICAL, INC.

Condensed Consolidated Bal
ance Sheets

(in thousands, except share data)

(unaudited)

		September 30, 2020				December 31, 2019
Assets
Current assets
Cash and cash equivalents		$	167,988			$	23,639
Restricted cash			50				50
Accounts receivable, net			20,837				11,302
Inventories, net			7,195				3,953
Prepaid expenses and other current assets			3,391				464
Total current assets			199,461				39,408
Property and equipment, net			5,476				3,331
Restricted cash			338				338
Deposits and other assets			536				1,469
Total assets		$	205,811			$	44,546
Liabilities, Mezzanine Equity and Stockholders’ Equity (Deficit)
Current liabilities
Accounts payable		$	3,533			$	2,549
Payroll-related accruals			8,596				5,225
Accrued expenses and other current liabilities			2,198				1,096
Total current liabilities			14,327				8,870
Notes payable, net			—				19,481
Warrant liabilities			—				1,169
Total liabilities			14,327				29,520
Commitments and contingencies (Note 6)
Mezzanine equity
Redeemable convertible preferred stock, par value $0.001, no shares authorized, issued, and outstanding as of September 30, 2020; 32,225,227 shares authorized, 31,968,570 shares issued and outstanding as of December 31, 2019; aggregate liquidation preference of zero as of September 30, 2020 and $54,415 as of December 31, 2019			—				54,170
Stockholders’ equity (deficit)
Preferred stock, $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding as of September 30, 2020; no shares authorized, issued, and outstanding as of December 31, 2019			—				—
Common stock, $0.001 par value, 300,000,000 and 49,019,607 shares authorized as of September 30, 2020 and December 31, 2019, respectively; 48,658,271 and 6,720,767 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively			49				7
Additional paid in capital			225,843				2,061
Accumulated deficit			(34,408	)			(41,212	)
Total stockholders’ equity (deficit)			191,484				(39,144	)
Total liabilities, mezzanine equity and stockholders’ equity (deficit)		$	205,811			$	44,546

 

ORLANDO, Fla., Nov. 12, 2020 (GLOBE NEWSWIRE) — IZEA Worldwide, Inc. (NASDAQ: IZEA), the premier provider of influencer marketing technology, data, and services for the world’s leading brands, reported its financial and operational results for the third quarter ended September 30, 2020.

Q3 2020 Financial Summary Compared to Q3 2019

• Total revenue down 9% to $4.0 million, compared to $4.4 million.
• Managed Services unit revenue decreased 1% to $3.5 million, compared to $3.6 million.
• SaaS Services unit revenue decreased 39% to $522,000, compared to $853,000.
• Total costs and expenses decreased to $5.3 million, compared to $5.6 million.
• Net loss was $1.3 million, compared to a net loss of $1.2 million.
• Adjusted EBITDA* improved to $(0.7) million, compared to $(1.3) million.

Q3 2020 Operational Highlights

• Raised gross proceeds of $10.3 million from sale of securities through an at-the-market offering. In total, we have raised $25.7 million at an average price of $1.94 per share.
• Opened pre-registration for the Shake Marketplace.
• Announced launch of BrandGraph Pulse with Slack and Microsoft Teams Integration.
• Formed Influence+United and onboarded multiple global influencer marketing partners.

* Adjusted EBITDA is a non-GAAP financial measure. Refer to the definition and reconciliation of this measure under “Use of Key Metrics and Non-GAAP Financial Measures”.

Management Commentary

“While revenue was down year over year in Q3, we saw a material improvement in both revenue and Adjusted EBITDA quarter over quarter. Revenue increased 29% and Adjusted EBITDA improved 43% compared to the second quarter ended in June 2020,” said Ted Murphy, IZEA’s Chairman and CEO. “Managed Services revenue in Q3 was close to flat year over year, despite the large gaps in new business we saw in March and April and the ongoing challenges associated with COVID-19 and the political environment. There was no way for IZEA to completely avoid the impacts that COVID-19 has had on the marketing budgets of some of our existing clients, but I believe our team has done a fantastic job adjusting our sales approach and finding new opportunities to bridge the gap.”

“There was a bigger impact in our SaaS Services unit, as we expected,” continued Murphy. “We were already in the midst of a change in pricing model for enterprise customers from last year which would impact 2020 revenue even without the events that have unfolded since the pandemic was declared. The acquisition of new enterprise customers has been slow since March, and many of our existing customers have reduced their marketplace spend. We expect to see challenges with enterprise SaaS until such time that the macro environment stabilizes, and marketers feel more comfort in making long term commitments.”

“Despite the decreases in overall SaaS revenue, our count of active SaaS customers is growing and hit an all-time high again this quarter,” said Murphy. “We continue to see growth with IZEAx Discovery, our $149/mo self-service offering. New customer signups for IZEAx Discovery hit an all-time high in October and were up 2.6x from October of last year. Monthly revenue for IZEAx Discovery also hit an all-time high in October and was up more than 25% from September of this year, which was the previous record. We are beginning to invest much more aggressively in our marketing efforts to broaden our customer base and drive more of this self-service growth. Early indications are that our marketing efforts are working, and we believe there are ongoing performance optimizations to make each dollar we spend more effective as we gather more data.”

“IZEA ended the quarter with $30.6 million in cash, the strongest our balance sheet has ever been,” said Murphy. “Our team has been working to prudently make strategic investments in technology, marketing, and people to best position ourselves for 2021 and beyond. Our primary focus for the year ahead is returning to revenue growth by broadening our customer base with emphasis on self-service revenue streams.”

Q3 2020 Financial Results

Total revenue in the third quarter of 2020 was down 9% to $4.0 million, compared to $4.4 million in the third quarter of 2019, with revenue from Managed Services decreasing by $44,000 or 1% to $3.5 million in the third quarter of 2020 compared to the third quarter of 2019 and revenue from SaaS Services decreasing by $331,000 or 39% in the third quarter of 2020 compared to the third quarter of 2019.

Revenue from Managed Services decreased slightly due to marketers canceling or pausing planned advertising campaigns or events in March and throughout the third quarter of 2020 as a result of uncertainty or inability to offer their products for sale as a result of business or event shutdowns due to COVID-19. Despite the delay in the execution of existing orders from our customers, we experienced a slight increase in net sales orders in the third quarter of 2020 compared to the second quarter of 2020, as marketers who were still advertising shifted more of their spend to influencer marketing campaigns.

Revenue from SaaS Services decreased primarily as a result of lower marketplace spend levels (“gross billings,” a key metric as further defined below) from our SaaS marketers and, as a result of competitive pricing efforts, our margins on those spends were reduced. Our gross billings for SaaS Services decreased 35% to $2.0 million in Q3 2020, compared to $3.1 million in Q3 2019. Our SaaS marketers decreased their spend levels as they transitioned from the TapInfluence platform to IZEAx and curtailed spending in March 2020 and throughout Q3 2020. The reduction in these gross billings resulted in the $331,000 decrease in SaaS Services Revenue in the third quarter of 2020 compared to the third quarter of 2019.

Total costs and expenses decreased 5% in the third quarter of 2020 to $5.3 million compared to $5.6 million in the corresponding quarter of 2019. This decrease was due to a $203,000 reduction in cost of revenue as a result of the lower sales, a $61,000 reduction in amortization costs as assets were fully amortized in the quarter, and cost reduction efforts affecting personnel, software subscriptions, hosting costs, rent, travel and marketing expenditures. The improvement between periods is more than $1 million after removing the effect of a $794,000 gain on the final settlement of our acquisition cost liabilities recorded in the prior year quarter. The gain resulted due to the actual closing market price of our common stock on the date of settlement being lower than the 30-day volume weighted average price used to calculate the number of shares used to pay for the acquisition liability pursuant to the terms of the purchase agreements.

Net loss in the third quarter of 2020 was $1.3 million or $(0.03) per share, as compared to a net loss of $1.2 million or $(0.04) per share in the third quarter of 2019, based on 45.8 million and 32.4 million shares outstanding, respectively.

Adjusted EBITDA (a non-GAAP measure management uses as a proxy for operating cash flow, as defined below) improved 42% or $531,000 to $(0.7) million compared to $(1.3) million in the third quarter of 2020 and 2019, respectively. Adjusted EBITDA as a percentage of revenue in the third quarter of 2020 was negative eighteen percent (18)% compared to negative twenty-eight percent (28)% in the third quarter of 2019. Despite the decline in revenue, we were able to improve Adjusted EBITDA through the steps taken to curb spending during these months of uncertainty.

We raised $10.3 million from sale of securities through our at-the-market offering (the “ATM”) in Q3 2020. To date, we have raised total gross proceeds through the ATM of $25.7 million between June and August 2020. Our cash balance as of September 30, 2020 was $30.6 million.

Conference Call

IZEA will hold a conference call to discuss its third quarter 2020 results on Thursday, November 12th at 5:00 p.m. Eastern time. Management will host the call, followed by a question and answer period.

Date: Thursday, November 12, 2020
Time: 5:00 p.m. Eastern time
Toll-free dial-in number: 1-855-327-6837
International dial-in number: 1-631-891-4304

The conference call will be webcast live and available for replay via the investors section of our website at https://izea.com/. Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. A replay of the call will be available after 8:00 p.m. Eastern time on the same day through November 19, 2020.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 10011744

About IZEA Worldwide, Inc.

IZEA Worldwide, Inc. (“IZEA”) operates online platforms that connect marketers with content creators. IZEA platforms automate influencer marketing and custom content development, allowing brands and agencies to identify social trends and scale their marketing programs. IZEA influencers include everyday creators, as well as celebrities and accredited journalists. Creators are compensated for producing unique content such as long and short form text, videos, photos, status updates and illustrations for marketers or distributing such content on behalf of marketers through their personal websites, blogs and social media channels. Marketers receive influential content and engaging, shareable stories that drive awareness. For more information about IZEA, visit https://izea.com/.

Use of Key Metrics and Non-GAAP Financial Measures

We define gross billings, a key metric, as the total dollar value of the amounts earned from our customers for the services we performed, or the amounts billed to our customers for their self-service purchase of goods and services on our platforms. Gross billings for Legacy Workflow and Marketplace Spend (which are included in SaaS Services) differs from revenue for these services reported in our consolidated statements of operations. These services are presented net of the amounts we pay to the third-party creators providing the content or sponsorship services. Gross billings for all other revenue types equal the revenue reported in our consolidated statements of operations.

We consider this metric to be an important indicator of our performance as it measures the total dollar volume of transactions generated through our marketplaces. Tracking gross billings allows us to evaluate our transaction totals on an equal basis in order for us to see our contribution margins by revenue stream so that we can better understand where we should be allocating our resources.  Additionally, because we invoice our customers on a gross basis based on our services or their transactions plus a fee, tracking gross billings is critical as it pertains to our credit risk and cash flow.

“Adjusted EBITDA” is a non-GAAP financial measure under the rules of the Securities and Exchange Commission. EBITDA is commonly defined as “earnings before interest, taxes, depreciation and amortization.” IZEA defines “Adjusted EBITDA,” also a non-GAAP financial measure, as earnings or loss before interest, taxes, depreciation and amortization, non-cash stock related compensation, gain or loss on asset disposals or impairment, changes in acquisition cost estimates, and certain other unusual or non-cash income and expense items such as gains or losses on settlement of liabilities and exchanges, and changes in the fair value of derivatives, if applicable. 

We believe that Adjusted EBITDA provides useful information to investors as it excludes transactions not related to our core cash-generating operating business activities, and it provides consistency to facilitate period-to-period comparisons. We believe that excluding these transactions allows investors to meaningfully trend and analyze the performance of our core cash-generating operations.

All companies do not calculate gross billings and Adjusted EBITDA in the same manner. These metrics as presented by IZEA may not be comparable to those presented by other companies. Moreover, these metrics have limitations as analytical tools, and you should not consider them in isolation or as a substitute for an analysis of our results of operations as reported under GAAP. A reconciliation of GAAP to non-GAAP results is included in the financial tables included in this press release.

Safe Harbor Statement

All statements in this release that are not based on historical fact are “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “may,” “will,” “would,” “could,” “should,” “expects,” “anticipates,” “estimates,” “believes,” “intends,” “likely,” “projects,” “plans,” “pursue,” “strategy” or “future,” or the negative of these words or other words or expressions of similar meaning. Examples of forward-looking statements include, among others, statements we make regarding expectations regarding future results and the realization of revenue from bookings, expectations with respect to operational efficiency, and expectations concerning IZEA’s business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to raise additional funding needed to fund our business operation in the future, uncertainty relating to the effects of COVID-19, competitive conditions in the content and social sponsorship segment in which IZEA operates; failure to popularize the IZEAx marketplace platform; our ability to satisfy the requirements for continued listing of our common stock on the Nasdaq Capital Market; changing economic conditions that are less favorable than expected; and other risks and uncertainties described in IZEA’s periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and IZEA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

Press Contact

Martin Smith
IZEA Worldwide, Inc.
Phone: 407-674-6911
Email: [email protected]

IZEA Worldwide, Inc. Unaudited Consolidated Balance Sheets
	September 30, 2020				December 31, 2019
Assets
Current assets:
Cash and cash equivalents	$	30,617,921			$	5,884,629
Accounts receivable, net	3,981,132				5,596,719
Prepaid expenses	385,128				400,181
Other current assets	140,291				153,031
Total current assets	35,124,472				12,034,560
Property and equipment, net	260,994				309,780
Goodwill	4,016,722				8,316,722
Intangible assets, net	768,879				1,611,516
Software development costs, net	1,480,288				1,519,980
Security deposits	—				151,803
Total assets	$	41,651,355			$	23,944,361
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,333,281			$	2,252,536
Accrued expenses	1,267,553				1,377,556
Contract liabilities	7,028,687				6,466,766
Current portion of notes payable	1,157,103				—
Right-of-use liability	—				83,807
Total current liabilities	10,786,624				10,180,665
Finance obligation, less current portion	65,604				45,673
Notes payable, less current portion	778,092				—
Total liabilities	11,630,320				10,226,338
Commitments and Contingencies	—				—
Stockholders’ equity:
Preferred stock; $.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding	—				—
Common stock; $.0001 par value; 200,000,000 shares authorized; 48,331,379 and 34,634,172, respectively, issued and outstanding	4,833				3,464
Additional paid-in capital	99,610,374				74,099,328
Accumulated deficit	(69,594,172		)		(60,384,769		)
Total stockholders’ equity	30,021,035				13,718,023
Total liabilities and stockholders’ equity	$	41,651,355			$	23,944,361

IZEA Worldwide, Inc. Unaudited Consolidated Statements of Operations
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Revenue	$	4,036,120			$	4,411,086			$	11,934,827			$	13,128,706
Costs and expenses:
Cost of revenue (exclusive of amortization)	1,701,770				1,904,287				5,256,536				5,821,237
Sales and marketing	1,403,037				1,518,165				4,154,871				4,238,074
General and administrative	1,827,267				1,752,126				6,165,597				6,596,485
Impairment of goodwill	—				—				4,300,000				—
Depreciation and amortization	372,483				433,094				1,250,859				1,317,423
Total costs and expenses	5,304,557				5,607,672				21,127,863				17,973,219
Loss from operations	(1,268,437		)		(1,196,586		)		(9,193,036		)		(4,844,513		)
Other income (expense):
Interest expense	(16,448		)		(27,734		)		(42,542		)		(242,935		)
Other income, net	30,085				51,285				26,175				91,447
Total other income (expense), net	13,637				23,551				(16,367		)		(151,488		)
Net loss	$	(1,254,800	)		$	(1,173,035	)		$	(9,209,403	)		$	(4,996,001	)
Weighted average common shares outstanding – basic and diluted	45,772,638				32,421,043				38,879,218				22,506,929
Basic and diluted loss per common share	$	(0.03	)		$	(0.04	)		$	(0.24	)		$	(0.22	)

Revenue Details:

	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Managed Services Revenue	$	3,513,806			$	3,558,109			$	10,129,210			$	10,416,912
Legacy Workflow Fees	—				44,170				—				135,791
Marketplace Spend Fees	120,630				266,037				482,817				955,328
License Fees	358,879				505,634				1,184,423				1,545,222
Other Fees	42,805				37,136				138,377				75,453
SaaS Services Revenue	522,314				852,977				1,805,617				2,711,794
Total Revenue	$	4,036,120			$	4,411,086			$	11,934,827			$	13,128,706

IZEA Worldwide, Inc. Reconciliation of GAAP Net loss to Non-GAAP Adjusted EBITDA (Unaudited)
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Net loss	$	(1,254,800	)		$	(1,173,035	)		$	(9,209,403	)		$	(4,996,001	)
Non-cash stock-based compensation		108,568				179,866				356,846				498,071
Non-cash stock issued for payment of services		31,250				37,509				93,749				112,504
Gain on settlement of acquisition costs payable		—				(793,849	)			—				(602,410	)
Increase in value of acquisition costs payable		—				889				—				6,222
Interest expense		16,448				27,734				42,542				242,935
Depreciation and amortization		372,483				433,094				1,250,859				1,317,423
Impairment of goodwill		—				—				4,300,000				—
Other non-cash items		1,283				31,998				(22,423	)			23,903
Adjusted EBITDA	$	(724,768	)		$	(1,255,794	)		$	(3,187,830	)		$	(3,397,353	)
Revenue	$	4,036,120			$	4,411,086			$	11,934,827			$	13,128,706
Adjusted EBITDA as a % of Revenue		(18	)%			(28	)%			(27	)%			(26	)%

IZEA Worldwide, Inc. Gross Billings (Unaudited)
Gross billings by revenue type:
	Three Months Ended September 30,								Nine Months Ended September 30,
	2020				2019				2020				2019
Managed Services Gross Billings	$	3,513,806			$	3,558,109			$	10,129,210			$	10,416,912
Legacy Workflow Fees	—				609,375				—				1,871,056
Marketplace Spend Fees	1,605,729				1,942,995				4,702,383				7,199,141
License Fees	358,879				505,634				1,184,423				1,545,222
Other Fees	42,805				37,136				138,377				75,453
SaaS Services Gross Billings	2,007,413				3,095,140				6,025,183				10,690,872
Total Gross Billings	$	5,521,219			$	6,653,249			$	16,154,393			$	21,107,784

R
evenue growth of
44
%
over the second quarter of 2020
and
58
% over the third quarter of 2019

R
eturn to
sequential revenue
growth across all channels

Further strengthened balance sheet

Reduced
quarterly cash burn

Company to host conference call and webcast today,
November 12
, 2020 at 4:30 pm ET

BASKING RIDGE, N.J., Nov. 12, 2020 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced third quarter 2020 financial results and provided an operational update.

Third
Quarter 2020 and Recent Highlights

• Generated revenue of approximately $1.1 million, representing an increase of 44% sequentially and 58% over the third quarter of 2019.
• Net cash used was approximately $4.1 million.
• Announced receipt of Emergency Use Authorization for the use of gammaCore Sapphire™ CV at home or in a healthcare setting to acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief.
• Secured a six-month extension for reimbursement of gammaCore by NHS England’s Innovation and Technology Payment Program (ITP) for adult patients suffering from cluster headache. The extension runs through March 31, 2021 and includes an option for up to an additional three years. Total contract value assuming exercise of the three-year extension option would be approximately £3.6 million based on recent exchange rates.
• Announced that the Veterans Administration (VA) is sponsoring a clinical trial evaluating non-invasive vagal nerve stimulation (nVNS) in mild traumatic brain injury (mTBI) and Post-Traumatic Stress Disorder (PTSD).
• Announced a publication in the journal Brain Stimulation highlighting a double-blind sham-controlled study of nineteen participants who had experienced trauma but did not have the diagnosis of PTSD and that highlights the ability of nVNS to decrease the fear associated with emotional stress.
• Appointed business development executive and U.S. Navy veteran Commander Sylvester “Sly” Steele as Vice President of Government Channels Business Unit.

Dan Goldberger, Chief Executive Officer of electroCore, commented: “During the third quarter, we demonstrated progress in key operating metrics across all of our revenue channels, most notably the VA and U.S. Department of Defense (DOD), and the U.K., as our team continues to successfully adapt to an evolving business environment. We believe gammaCore fits well with the rapid growth in telehealth consults driven by the ongoing pandemic, and in the VA in particular, we were able to generate a 59% sequential increase in paid months of therapy by leveraging the agency’s advanced telehealth capabilities. Similarly, in COVID-19, our recently announced partnership with Upscript, LLC facilitates access to gammaCore Sapphire CV from the comfort of one’s home without having to visit a physician or pharmacy.

“With $26 million of cash and marketable securities as of September 30, our financial condition remains strong. Our net cash used in operations of $4.1million during the third quarter reflects our relentless drive to be efficient and nimble, and capable of responding quickly to emerging opportunities and challenges. I am proud of our accomplishments thus far and believe we have built a solid foundation for growth in 2021,” Mr. Goldberger concluded.

Third
Quarter 2020 Financial Results

For the quarter ended September 30, 2020, electroCore reported net sales of approximately $1.1 million compared to $683,000 in the same period of 2019, and consistent with the guidance provided in the company’s October 13, 2020 business update.

Revenue from the VA and DOD increased 56% sequentially to $646,000 during the third quarter of 2020 from $415,000 in the second quarter of 2020 and $279,000 in the third quarter of 2019. Paid months of therapy shipped to the VA and DOD increased 59% sequentially to 1,571 in the third quarter of 2020 from 988 during the second quarter of 2020 and increased 184% as compared to 553 in the third quarter of 2019.

Revenue from outside the U.S. increased sequentially to $278,000 from $247,000 in the second quarter of 2020 and $188,000 in the third quarter of 2019. Paid months of therapy shipped outside the U.S. increased 9% sequentially to 1,020 in the third quarter of 2020 from 938 in the second quarter of 2020 and increased 23% as compared to 828 in the third quarter of 2019.

Total operating expenses in the third quarter of 2020 were approximately $5.2 million, a reduction of approximately $6.0 million from $11.2 million in the third quarter of 2019.

SG&A expense declined approximately $3.5 million to $4.6 million in the third quarter of 2020 from approximately $8.1 million in the third quarter of 2019. This decrease was primarily due to the company’s reduction in sales and marketing activities, consistent with its cost reduction plan which commenced in 2019.

Research and development expense decreased by approximately $1.7 million to $0.6 million in the third quarter of 2020 from $2.3 million in the third quarter of 2019. This reduction is consistent with the company’s strategy of reducing its near-term investment in research and development.

GAAP net loss in the third quarter of 2020 was $4.5 million as compared to a GAAP net loss of $10.7 million in the third quarter of 2019.

Adjusted EBITDA net loss in the third quarter of 2020 was a loss of $3.3 million as compared to a loss of $8.7 million in the third quarter of 2019.

The company defines adjusted EBITDA net loss as GAAP net loss, excluding income tax expense/benefit, stock-compensation expense, restructuring and other severance related charges, legal fees associated with stockholders’ litigation and total other income/expense. A reconciliation of GAAP net loss to Non-GAAP adjusted EBITDA net loss has been provided in the financial statement tables included in this press release.

Net cash used in the quarter ended September 30, 2020 was approximately $4.1 million, excluding $11.2 million of proceeds received from sales of stock to Lincoln Park Capital, as compared to $5.2 million in the second quarter of 2020, which excludes the tax benefit received for the sale of New Jersey NOL’s and financing activities, and $7.6 million in the third quarter of 2019.

Cash and cash equivalents and marketable securities at September 30, 2020 totaled approximately $26.0 million, as compared to approximately $24.1 million at December 31, 2019.

Webcast and Conference Call Information

electroCore’s management team will host a conference call today November 12, 2020 beginning at 4:30 p.m. ET. Investors interested in listening to the conference call, or webcast may do so by dialing 877-407-4018 for domestic callers or 201-689-8471 for international callers, using Conference ID: 13711577, or by connecting to the Web: http://public.viavid.com/index.php?id=141806

An archived webcast of the event will be available on the “Investors” section of the company’s website at: www.electrocore.com.

About electroCore, Inc.

electroCore, Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore

<sup>e

TM</sup>

gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients. 

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

	•	Safety and efficacy of gammaCore have not been evaluated in the following patients:
			º	Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
			º	Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
			º	Pediatric patients
			º	Pregnant women
			º	Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
	•	Patients should not use gammaCore if they:
			º	Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
			º	Have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck
			º	Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)

In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

gammaCore SapphireTM CV has received Emergency Use Authorization (EUA) from the FDA for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus Nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic.

gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic

gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked.

Please refer to gammaCore Sapphire CV (nVNS) Instructions for Use for Use for all of the important warnings and precautions before using or prescribing gammaCore Sapphire CV (nVNA).

Forward-Looking Statement

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans, its pipeline or potential markets for its technologies, the timing, outcome and impact of regulatory, clinical and commercial developments including commercialization of, and potential reimbursement for, gammaCore Sapphire CV, the business, operating or financial impact of such studies, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Investors:

Hans Vitzthum
LifeSci Advisors
617-430-7578
[email protected]

or
Media Contact:
Jackie Dorsky
electroCore
973-290-0097
[email protected]

electroCore, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except per share data)

	For the three months ended September 30,								For the nine months ended September 30,
		2020				2019				2020				2019
	(in thousands)
Net sales	$	1,080.8			$	683.0			$	2,567.6			$	1,715.3
Cost of goods sold		347.5				353.9				918.6				766.2
Gross profit		733.3				329.1				1,649.0				949.2
Operating expenses
Research and development		629.0				2,274.9				3,182.6				8,279.4
Selling, general and administrative		4,592.9				8,143.4				16,427.0				28,155.6
Restructuring and other related charges		—				804.6				464.6				1,997.3
Total operating expenses		5,221.9				11,222.9				20,074.2				38,432.3
Loss from operations		(4,488.6	)			(10,893.8	)			(18,425.3	)			(37,483.2	)
Other (income)/expense
Interest and other income		(5.7	)			(206.1	)			(80.5	)			(850.1	)
Other expense		3.5				—				13.4				16.7
Total other (income)/expense		(2.2	)			(206.1	)			(67.1	)			(833.4	)
Loss before income taxes		(4,486.4	)			(10,687.7	)			(18,358.2	)			(36,649.8	)
Benefit from income taxes		—				—				1,170.9				—
Net loss	$	(4,486.4	)		$	(10,687.7	)		$	(17,187.3	)		$	(36,649.8	)
Net loss per share of common stock – Basic and Diluted	$	(0.10	)		$	(0.36	)		$	(0.47	)		$	(1.25	)
Weighted average common shares outstanding – Basic and Diluted		44,030,685				29,352,026				36,847,548				29,399,384

electroCore, Inc.

Condensed Consolidated Balance Sheet Information

(in thousands)

	As of			As of
	September 30, 2020			December 31, 2019
	(unaudited)			(audited)
Cash and cash equivalents	$	3,832.5		$	13,563.8
Marketable securities	$	22,135.2		$	10,495.4
Total assets	$	37,075.3		$	35,461.7
Current liabilities	$	5,811.6		$	9,144.7
Total liabilities	$	8,179.3		$	10,564.6
Total equity	$	28,896.0		$	24,897.1

(Unaudited)
Use of Non-GAAP Financial Measure

The company is presenting adjusted EBIDTA net loss because it believes this measure is a useful indicator of its operating performance. electroCore management uses this non-GAAP measure principally as a measure of the company’s core operating performance and believes that this measure is useful to investors because it is frequently used by the financial community, investors, and other interested parties to evaluate companies in the company’s industry. The company also believes that this measure is useful to its management and investors as a measure of comparative operating performance from period to period. Additionally, the company believes its use of non-GAAP adjusted EBITDA net loss from operations facilitates management’s internal comparisons to historical operating results by factoring out potential differences caused by charges not related to its regular, ongoing business, including, without limitation, non-cash charges and certain large and unpredictable charges such as restructuring expenses.

The company has presented adjusted EBITDA net loss as a non-GAAP financial measure in this press release. The company defines adjusted EBITDA net loss as its reported GAAP net loss excluding income tax expense/benefit, depreciation and amortization, stock-based compensation, restructuring and other severance related charges, legal fees associated with stockholders litigation and total other income /expense and other income and expense.

	For the three months ended September 30,								For the nine months ended September 30,
		2020				2019				2020				2019
GAAP net loss	$	(4,486.4	)		$	(10,687.7	)		$	(17,187.3	)		$	(36,649.8	)
Depreciation/amortization	$	94.9			$	98.6			$	288.6			$	152.3
Stock-based compensation	$	742.9			$	1,219.6			$	2,490.6			$	2,690.4
Restructuring and other related charges	$	—			$	804.6			$	464.6			$	1,997.3
Legal fees associated with stockholders litigation	$	371.0			$	76.6			$	1,104.7			$	76.6
Total other (income)/expense	$	(2.2	)		$	(206.1	)		$	(67.1	)		$	(833.4	)
Benefit from income taxes	$	—			$	—			$	(1,170.9	)		$	—
Adjusted EBIDTA net loss from operations	$	(3,279.8	)		$	(8,694.3	)		$	(14,076.8	)		$	(32,566.6	)

The company’s use of a non-GAAP measure has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of its results as reported under GAAP. Some of these limitations are: the non-GAAP measure does not reflect interest or tax payments that may represent a reduction in cash available; although depreciation and amortization are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and the non-GAAP measure does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements; the non-GAAP measure does not reflect the potentially dilutive impact of equity-based compensation; and the non-GAAP measure does not reflect changes in, or cash requirements for, working capital needs; other companies, including companies in electroCore’s industry, may calculate adjusted EBITDA net loss differently, which reduces its usefulness as a comparative measure.

Because of these and other limitations, you should consider the non-GAAP measure together with other GAAP-based financial performance measures, including various cash flow metrics, net loss, and other GAAP results. A reconciliation of GAAP net loss to non-GAAP adjusted EBITDA net loss has been provided in the preceding financial statements table of this press release.

AUSTIN, Texas, Nov. 12, 2020 (GLOBE NEWSWIRE) — Aspira Women’s Health Inc. (“ASPIRA”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on gynecologic disease, today reported its financial results for the third quarter ended September 30, 2020.

“Our test volume and revenue have rebounded in Q3 to nearly pre-pandemic levels coupled with price expansion due to the CIGNA contract starting in Q2.  We also added a key payer to help further drive adoption and price. We remain on track with our product launches and lastly we are very excited about our board and senior leadership team announcements. Aspira is now a Company majority led by women, for women, and these additions will significantly help to propel our growth.” stated Valerie Palmieri, President and CEO.

Recent Corporate Highlights 

Strengthened executive and medical advisory leadership team: Expanded the leadership team with the appointment and promotion of five new corporate executives: Kaile Zagger, Chief Operating Officer; Lesley Northrop M.D., Chief Scientific Officer; Elena Ratner, M.D., Global Chief Medical Advisor, Clinical and Translational Medicine; Gary Altwerger, M.D., BS, Global Deputy Chief Medical Advisor, Clinical and Translational Medicine; and Diane Powis, Chief Spokeswoman           

Board Expansion: Aspira announced the appointment to our Board of Dr Sandra Brooks M.D., Senior Vice President and Chief Medical Officer of Thomas Jefferson University Hospitals. The majority of our board is now female. 

Volume Recovery: Aspira ended the third quarter at 95% of pre-covid levels comparing February 2020, the last full calendar month before COVID-19 significantly impacted the United States, to September 2020. Our OVA1 test volume increased 46% sequentially from the second quarter test volume levels and was approximately at the same level as third quarter of 2019. Our average unit price of OVA1 Plus increased sequentially 15%  compared with the second quarter of 2020.  2,450 physicians ordered OVA1 with 84 percent of the customers being repeat customers. The number of ordering physicians increased 37% from the second quarter.  The number of tests ordered by practice is up 32% compared to the prior year third quarter. 

Expanded Payer Coverage: Aspira is a participating provider with Anthem BlueCross BlueShield of Georgia, for an estimated additional 3.3 million members across the state. Aspira now has approximately 72% of the covered lives in Georgia.  As of November 1, 2020, Aspira has approximately 173 million covered lives in the US.

State of Connecticut Financing: The Company previously announced a $4M loan from the State of Connecticut Department of Economic and Community Development, $2M of which we received in 2016. We expect to receive the additional $2M of funding under the DECD loan in the fourth quarter of 2020.

Publications: In October 2020, we published a paper in Current Medical Research and Opinion, titled “Low-risk Multivariate Index Assay Scores, Physician Referral and Surgical Choices in Women with Adnexal Masses”.  A total of 282 independent patient charts were reviewed of which 146 were Low Risk results. Surgery was performed on 56% patients with low risk scores. The other 44% had no surgery and were followed clinically.  There were no invasive cancers in the patients who had surgery. Clinicians were comfortable with expectant management of pelvic masses when OVA1 is low risk. These results demonstrated to us that there is an immediate need to assessing the status of a pelvic mass even though surgery is not performed. 

Third Quarter Highlights:

• Product revenue was $1.2 million for the third quarter 2020, compared to $726,000 in the second quarter of 2020 and $1.2 million in the third quarter of 2019. Revenue increased 68% over second quarter of 2020 and was flat over the third quarter of 2019.  This reflects a strong volume and price recovery from the second quarter level as a result of the impact of COVID.
• The number of OVA1plus tests performed was 3596 for the third quarter 2020, compared to 2,458 in the second quarter of 2020 and 3,602 in the third quarter of 2019. Volume increased 46% over the second quarter of 2020 and was relatively flat over the third quarter of 2019.  This reflects a strong volume recovery from the second quarter level as a result of the impact of COVID.
• Revenue on a per test performed basis for OVA1 revenue was $338 in the third quarter of 2020 compared to $295 in the second quarter of 2020.   The sequential  increase was driven by realization of a full quarter of our new contract price from CIGNA as of April 1, 2020 as well as the absence of one time items recorded in the second quarter.
• Gross profit on OVA1^® product revenue was $547 thousand (a 45% profit margin) for the third quarter 2020 compared to $268 thousand for the second quarter of 2020 (a 37% profit margin).
• Research and development expenses for the third quarter 2020 were $595 thousand an increase of $255 thousand compared to the same period in 2019. This increase was primarily due to launching clinical studies as well as bioinformatics investments.
• Sales and marketing expenses for the third quarter 2020 were $2.1M compared to $2.4M the same period in 2019. This decrease was primarily due to reduced travel due to the COVID-19 pandemic.
• General and administrative expenses for the third quarter 2020 were $1.9M compared to $1.4M for the same period in 2019. This increase was primarily due to an increase in headcount and personnel-related expenses as well as legal expenses.
• The cash balance at September 30, 2020 was approximately $19 million. Cash utilization in the third quarter of 2020 was $3.1M compared to $3.3M in the second quarter and $3.6M in the prior year third quarter.  The sequential reduction in cash utilization was driven primarily by stronger revenue and gross margin while the year on year decrease was primarily reduced spending on sales and marketing.

Conference Call and Webcast

ASPIRA will host a call today at 4:30 p.m. Eastern Time to discuss results followed by a question and answer period.

Thursday, November 12th @ 4:30pmET

Investors Dial-in:	877-407-4018
International Dial-in:	201-689-8471
Conference ID:	1372253
Webcast:	http://public.viavid.com/index.php?id=142095

About Aspira Women’s Health Inc.

ASPIRA is transforming women’s health with the discovery, development and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management and improve gynecologic health outcomes for women. OVA1^®plus combines our FDA-cleared products OVA1^® and OVERA^® to detect risk of ovarian malignancy in women with adnexal masses. ASPiRA GenetiX^SM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus.  With over 10 years of expertise in ovarian cancer risk assessment ASPIRA has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans.

Visit our website for more information about our products at www.aspirawh.com.

Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995 including statements regarding expected timing and receipt of proceeds from the State of Connecticut Department of Economic Development loan. These statements involve a number of risks and uncertainties.  All statements other than statements of historical facts contained in this press release are forward-looking statements. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled “Risk Factors” in ASPIRA’s Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by the section entitled “Risk Factors” in ASPIRA’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and June 30, 2020. The events and circumstances reflected in ASPIRA’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.  ASPIRA expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.

Investor Relations Contact:


Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-535-7742
[email protected]

	September 30,				December 31,
	2020				2019
Assets
Current assets:
Cash and cash equivalents	$	18,836			$	11,703
Accounts receivable		848				924
Prepaid expenses and other current assets		522				758
Inventories		45				25
Total current assets		20,251				13,410
Property and equipment, net		593				353
Right-of-use asset		421				52
Other assets		–				13
Total assets	$	21,265			$	13,828
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,315			$	1,158
Accrued liabilities		2,815				2,588
Short-term debt		476				193
Lease liability		9				39
Total current liabilities		4,615				3,978
Non-current liabilities:
Long-term debt		1,678				1,099
Lease liability		422				13
Total liabilities		6,715				5,090
Commitments and contingencies
Stockholders’ equity:
Common stock, par value $0.001 per share, 150,000,000 shares authorized at September 30, 2020 and December 31, 2019; 104,041,493 and 97,286,157 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		104				97
Additional paid-in capital		448,431				430,802
Accumulated deficit		(433,985	)			(422,161	)
Total stockholders’ equity		14,550				8,738
Total liabilities and stockholders’ equity	$	21,265			$	13,828

 

	Three Months Ended									Nine Months Ended
	September 30,								September 30,
	2020				2019				2020				2019
Revenue:
Product	$	1,239			$	1,241			$	3,192			$	3,120
Service		–				44				13				110
Total revenue		1,239				1,285				3,205				3,230
Cost of revenue(1):
Product		803				736				2,187				1,950
Service		4				213				13				601
Total cost of revenue		807				949				2,200				2,551
Gross profit		432				336				1,005				679
Operating expenses:
Research and development(2)		595				340				1,370				774
Sales and marketing(3)		2,152				2,425				6,000				7,569
General and administrative(4)		1,966				1,421				5,542				4,210
Total operating expenses		4,713				4,186				12,912				12,553
Loss from operations		(4,281	)			(3,850	)			(11,907	)			(11,874	)
Interest income, net		5				34				14				39
Other income (expense), net		(11	)			(4	)			69				(15	)
Net loss	$	(4,287	)		$	(3,820	)		$	(11,824	)		$	(11,850	)
Net loss per share – basic and diluted	$	(0.04	)		$	(0.04	)		$	(0.12	)		$	(0.14	)
Weighted average common shares used to compute basic and diluted net loss per common share		103,200,612				97,144,586				99,555,194				83,017,019
Non-cash stock-based compensation expense included in cost of revenue and operating expenses:
(1)  Cost of revenue	$	20			$	20			$	73			$	57
(2)  Research and development		16				–				17				4
(3)  Sales and marketing		31				32				116				93
(4)  General and administrative		343				243				915				738

CARLSBAD, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported results for the third quarter of 2020.

Recent
Highlights:

• Reported revenue of $3.2 million in the third quarter ended September 30, 2020, a 180% increase sequentially and a 391% increase over the same quarter last year.
• Increased worldwide installed base of second generation AcQMap consoles to 37 as of September 30, 2020, up from 21 at the end of the prior quarter – bringing the total installed base of AcQMap consoles to 49 as of September 30, 2020.
• Filled a key role with the addition of Dr. Steve Mickelson as our Chief Translational Science Officer. Dr. Mickelsen is a prominent figure in the emerging area of Pulsed Field Ablation.

Vince Burgess, President & CEO of Acutus, said, “In the third quarter we saw strong execution by our commercial team and made considerable progress on key development and operational fronts. Despite headwinds from COVID-19, we continued to add new customers and aggressively upgraded existing customers to our groundbreaking second-generation electrophysiology mapping system, AcQMap. Bringing on a new customer in our business requires extensive cross-functional collaboration with our customers and many members of our internal team. The growth of our installed base achieved this quarter demonstrates enthusiastic demand for our technology and terrific execution from our entire team during uniquely challenging times.   As we look to the future, we are highly confident that Acutus is well positioned for continued growth in the years ahead.”

Third
Quarter 2020 Financial Results

Revenue was $3.2 million for the third quarter of 2020, compared to $1.1 million for the prior quarter and $0.6 million in the third quarter last year. The improvement over the same quarter last year was driven by increased direct sales of Acutus disposables, sales of our AcQMap consoles, and distributor sales through our partner Biotronik as we continue to operationalize this foundational relationship.

Gross margin was negative 62% for the third quarter of 2020, compared with negative 251% in the same quarter last year. The improvement was driven by greater production volumes and efficiencies in labor and manufacturing overhead absorption when compared to the same period last year. Also affecting margins in the quarter were our first ever console sales that are paid for via long-term disposables commitment deals. These types of sales, which will be common at Acutus going forward, allocate a portion of the future disposables’ revenue stream and all of the console COGS at the time of the placement. It is typical for these transactions to result in unfavorable gross margins on the up-front placement of the console that is more than offset by a committed, predictable annuity stream of disposables sales in future quarters. We continue to make significant investments in our manufacturing infrastructure to support our aggressive launch expectations and position us to scale in-house production as our business grows. As volumes increase over time, and the benefit of console sales accrues, we expect to see continuous improvements to our margin profile.

Operating expenses were $24.3 million for the third quarter of 2020, compared with $29.5 million in the same quarter last year. The decrease was driven by a $15.0 million payment for the acquisition and in-licensing of the force sensing product line from Biotronik made during the third quarter of 2019. This decrease was partially offset by the expansion of our commercial team in conjunction with our full commercial launch, various R&D projects related to console enhancements and catheter development programs, and increased G&A costs incurred associated with our initial public offering and becoming a public company.

Net loss on a GAAP basis was $31.3 million for the third quarter of 2020 and net loss per share was $1.95 on a weighted average basic and diluted outstanding share count of 16.1 million, compared to $32.1 million and a net loss per share of $47.21 on a weighted average basic and diluted outstanding share count of 0.7 million in the same period of the prior year. Excluding non-cash stock-based compensation expense, remeasurement of our warrant liability, and changes in the fair value of contingent consideration, our non-GAAP net loss for the third quarter of 2020 was $21.1 million, or $0.91 per share, compared to $30.6 million, or $1.86 per share, after giving effect to the pro forma conversion of our convertible preferred stock for the third quarter of 2019.

Cash, cash equivalents, marketable securities and restricted cash were $167.0 million as of September 30, 2020, which includes the $166.3 million net proceeds from our IPO, which closed on August 10, 2020.

Outlook and COVID-19

Due to uncertainty surrounding the COVID-19 pandemic, Acutus Medical will not provide financial guidance for the remainder of 2020 at this time. Management will continue to evaluate its guidance policies and anticipates providing an update at the time of its fourth quarter earnings announcement, to the extent practicable, based on available information at that time.

Non-GAAP Financial Measures

This press release includes references to non-GAAP net loss and non-GAAP net loss per share, which are non-GAAP financial measures, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. We believe these non-GAAP financial measures are important indicators of our operating performance because they exclude items that are non-cash accounting line items unrelated to, and may not be indicative of, our core operating results. These non-GAAP financial measures, as we calculate them, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. To the extent we utilize such non-GAAP financial measures in the future, we expect to calculate them using a consistent method from period to period. A reconciliation of each of the most directly comparable GAAP financial measures to the non-GAAP financial measures has been provided under the heading “Reconciliation of GAAP results to Non-GAAP Results” in the financial statement tables attached to this press release.

Webcast and Conference Call Information

Acutus Medical will host a conference call to discuss the third quarter financial results after market close on Thursday, November 12, 2020 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone (833) 570-1131 for U.S. callers or (914) 987-7078 for international callers, using conference ID: 6990208. The live webinar can be accessed at https://ir.acutusmedical.com.

About
Acutus
Medical, Inc.

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. Acutus Medical’s goal is to 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.

Caution Regarding Forward-Looking Statements

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States, including changes in government reimbursement of procedures, dependence upon third-party vendors and distributors, timing of regulatory approvals, the impact of the coronavirus (COVID-19) pandemic and our response to it, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Investor Contact:

Caroline Corner
Westwicke ICR
D: 415-314-1725
[email protected]

Holly Windler
M: 619-929-1275
[email protected]

Acutus Medical, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands)

	September 30,				December 31,
	2020				2019
	(unaudited)
ASSETS:
Current assets:
Cash and cash equivalents	$	58,302			$	9,452
Marketable securities, short-term		99,742				62,351
Restricted cash		150				150
Accounts receivable		1,893				263
Inventory		10,932				8,424
Prepaid expenses and other current assets		4,635				1,816
Total current assets		175,654				82,456
Marketable securities, long-term		8,789				–
Property and equipment, net		9,940				4,427
Right-of-use asset, net		1,838				2,341
Intangible assets, net		3,780				4,110
Goodwill		12,026				12,026
Other assets		482				95
Total assets	$	212,509			$	105,455
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	4,723			$	3,882
Accrued liabilities		6,500				10,076
Contingent consideration, short-term		4,000				8,200
Operating lease liabilities, short-term		907				833
Common and preferred stock warrant liability		–				8,919
Total current liabilities		16,130				31,910
Operating lease liabilities, long-term		1,365				2,054
Long-term debt		38,762				38,244
Contingent consideration, long-term		3,600				5,700
Other long-term liabilities		8				–
Total liabilities		59,865				77,908
Commitments and contingencies
Convertible preferred stock
Series A convertible preferred stock		–				3,059
Series B convertible preferred stock		–				40,685
Series C convertible preferred stock		–				74,575
Series D convertible preferred stock		–				135,039
Stockholders’ equity (deficit)
Preferred stock		–				–
Common stock		28				1
Additional paid-in capital		484,162				33,252
Accumulated deficit		(331,613	)			(259,034	)
Accumulated other comprehensive income (loss)		67				(30	)
Total stockholders’ equity (deficit)		152,644				(225,811	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)	$	212,509			$	105,455

Acutus Medical, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)
(Unaudited)

			Three Months Ended September 30,								Nine Months Ended September 30,
			2020				2019				2020				2019
	Revenue		$	3,173			$	646			$	5,890			$	2,167
	Costs and operating expenses:
	Cost of products sold			5,141				2,267				10,998				6,878
	Research and development			8,343				5,865				24,492				15,489
	Research and development – license acquired			–				15,000				–				15,000
	Selling, general and administrative			15,833				7,978				35,193				18,998
	Change in fair value of contingent consideration			118				700				(1,466	)			700
	Total costs and operating expenses			29,435				31,810				69,217				57,065
	Loss from operations			(26,262	)			(31,164	)			(63,327	)			(54,898	)
	Other income (expense):
	Change in fair value of warrant liability and embedded derivative			(3,683	)			(3	)			(5,555	)			(608	)
	Loss on debt extinguishment			–				(49	)			–				(1,447	)
	Interest income			23				525				393				733
	Interest expense			(1,366	)			(1,394	)			(4,090	)			(20,905	)
	Total other expense, net			(5,026	)			(921	)			(9,252	)			(22,227	)
	Net loss		$	(31,288	)		$	(32,085	)		$	(72,579	)		$	(77,125	)
	Other comprehensive income (loss)
	Unrealized (loss) gain on marketable securities			(9	)			40				(50	)			47
	Foreign currency translation adjustment			78				(45	)			147				(57	)
	Comprehensive loss		$	(31,219	)		$	(32,090	)		$	(72,482	)		$	(77,135	)
	Net loss per common share, basic and diluted		$	(1.95	)		$	(47.21	)		$	(12.36	)		$	(115.66	)
	Weighted average shares outstanding, basic and diluted			16,080,467				679,591				5,870,861				666,823

Acutus Medical, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(in thousands)
(Unaudited)

			Nine Months Ended September 30,
			2020				2019
	Cash flows from operating activities
	Net loss		$	(72,579	)		$	(77,125	)
	Adjustments to reconcile net loss to net cash used in operating activities:
	Depreciation expense			1,754				1,676
	Amortization of intangible assets			330				125
	Stock-based compensation expense			9,272				2,174
	Amortization of premiums/(accretion of discounts) on marketable securities, net			113				(100	)
	Amortization of debt issuance costs			518				17,438
	Amortization of right-of-use assets			507				470
	Research and development – license acquired			–				15,000
	Gain on disposal of property and equipment			–				(1	)
	Loss on debt extinguishment			–				1,447
	Change in fair value of warrant liability and embedded derivative			5,555				608
	Change in fair value of contingent consideration			(1,466	)			700
	Changes in operating assets and liabilities, net of effect from business combination:
	Accounts receivable			(1,630	)			(697	)
	Inventory			(1,865	)			(3,829	)
	Prepaid expenses and other current assets			(2,729	)			(306	)
	Other assets			(387	)			(8	)
	Accounts payable			753				2,873
	Accrued liabilities			1,423				9,268
	Operating lease liabilities			(615	)			(536	)
	Other long-term liabilities			8				–
	Net cash used in operating activities			(61,038	)			(30,823	)
	Cash flows from investing activities
	Purchases of available-for-sale marketable securities			(108,528	)			(68,735	)
	Sales of available-for-sale marketable securities			17,095				–
	Maturities of available-for-sale marketable securities			45,000				11,550
	Purchases of property and equipment			(7,822	)			(683	)
	Purchase of research and development license			–				(10,000	)
	Cash paid, net of cash acquired for the Rhythm Xience Acquisition			–				(3,000	)
	Net cash used in investing activities			(54,255	)			(70,868	)
	Cash flows from financing activities
	Proceeds from issuance of debt and warrants			–				77,000
	Repayment of debt			–				(15,000	)
	Payment of issuance and extinguishment costs related to debt			–				(2,332	)
	Payment of contingent consideration			(2,636	)			–
	Proceeds from issuance of convertible preferred stock, net of issuance costs			–				66,567
	Proceeds from issuance of common stock upon IPO, net of issuance costs			166,286				–
	Proceeds from stock options exercises			350				76
	Net cash provided by financing activities			164,000				126,311
	Effect of exchange rate changes on cash, cash equivalents and restricted cash			143				(50	)
	Net change in cash, cash equivalents and restricted cash			48,850				24,570
	Cash, cash equivalents and restricted cash, at the beginning of the period			9,602				9,775
	Cash, cash equivalents and restricted cash, at the end of the period		$	58,452			$	34,345

 

Acutus Medical, Inc. and Subsidiaries

Reconciliation of GAAP Results to Non-GAAP Results

(in thousands, except share and per share data)
(Unaudited)

			Three Months Ended September 30,								Nine Months Ended September 30,
			2020				2019				2020				2019
	GAAP net loss		$	(31,288	)		$	(32,085	)		$	(72,579	)		$	(77,125	)
	Stock-based compensation			6,374				812				9,272				2,174
	Change in fair value of contingent consideration			118				700				(1,466	)			700
	Change in fair value of warrant liability and embedded derivative			3,683				3				5,555				608
	Non-GAAP net loss		$	(21,113	)		$	(30,569	)		$	(59,218	)		$	(73,643	)
	Denominator
	Weighted average shares of common stock outstanding used in GAAP per share calculations			16,080,467				679,591				5,870,861				666,823
	Adjustments to reflect the assumed conversion of convertible preferred stock (1)			7,205,624				15,712,489				13,373,360				11,290,142
	Shares used in non-GAAP per share calculations			23,286,091				16,392,080				19,244,221				11,956,965
	GAAP net loss per share		$	(1.95	)		$	(47.21	)		$	(12.36	)		$	(115.66	)
	Non-GAAP net loss per share		$	(0.91	)		$	(1.86	)		$	(3.08	)		$	(6.16	)
	(1) Assumes the conversion of outstanding shares of convertible preferred stock into shares of common stock as if such conversion had occurred at the beginning of the period or their issuance dates, if later.