Market Newsdesk

May 12, 2021 4:04 pm

PLBY Group Reports First Quarter 2021 Financial Results

First Quarter 2021 Revenue Up 34% Year-Over-Year to $42.7 Million

LOS ANGELES, May 12, 2021 (GLOBE NEWSWIRE) — PLBY Group, Inc. (NASDAQ: PLBY) (“PLBY Group” or the “Company”), a leading pleasure and leisure lifestyle company and owner of Playboy, one of the most recognizable and iconic brands in the world, today provided financial results for the first quarter ended March 31, 2021.

Ben Kohn, Chief Executive Officer of PLBY Group, stated, “Our strong first quarter financial performance reflects the exciting growth potential of our direct-to-consumer business, which experienced triple digit revenue growth year-over-year as we successfully increased merchandising, cross-selling, and influencer marketing programs. I’m especially pleased with our results considering we continue to experience short-term, industry-wide supply chain disruptions leading to out-of-stocks on select items.”

Mr. Kohn continued, “We’re also thrilled by the recent performance of our first NFT art drop, a symbol of the infinite product experiences we can build off the back of our iconic flagship brand and rich archive. We are in the early innings of unlocking the tremendous potential of our intellectual property and global fan base and remain focused on investing today in opportunities to drive superior long-term growth and deliver substantial long-term value for our shareholders.”

First Quarter 2021 Financial Highlights

Revenue grew 34% year-over-year to $42.7 million, driven by 114% growth in direct-to-consumer revenue in the comparable period.
Net loss was $5.0 million, largely due to a $13.8 million year-over-year increase in selling and administrative expenses as the Company incurred $6.3 million of non-recurring items related to the closing of its recent business combination, including a $2.7 million increase in stock-based compensation expense. Additionally, the Company had increased costs related to M&A transaction expenses, ongoing costs attributable to acquired businesses, and expenses associated with being a newly public company.
Adjusted EBITDA was $6.7 million and was burdened by an additional $1.5 million of one-time expenses related to M&A transaction expenses, severance, and COVID testing at the Company’s fulfillment center, none of which were added back to arrive at adjusted EBITDA.

Webcast Details

The Company will host a webcast at 5:00 p.m. Eastern Time on May 12, 2021 to discuss first quarter 2021 results. Participants may access the live webcast on the PLBY Group, Inc. Investor Relations website at https://www.plbygroup.com/investors.

About PLBY Group, Inc.

PLBY Group connects consumers around the world with products, services, and experiences to help them look good, feel good, and have fun. PLBY Group serves consumers in four major categories: Sexual Wellness, Style & Apparel, Gaming & Lifestyle, and Beauty & Grooming. PLBY Group’s flagship consumer brand, Playboy, is one of the most recognizable, iconic brands in the world, driving billions of dollars in consumer spending annually across 180 countries. Learn more at http://www.plbygroup.com.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. The Company’s actual results may differ from their expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to future performance, growth plans and anticipated financial impacts of the business combination and the Lovers acquisition.

These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Factors that may cause such differences include, but are not limited to: (1) the impact of COVID-19 pandemic on the Company’s business; (2) the inability to maintain the listing of the Company’s shares of common stock on Nasdaq; (3) the risk that the business combination, recent acquisitions or any proposed transactions disrupt the Company’s current plans and operations, including the risk that the Company does not complete any such proposed transactions or achieve the expected benefit from them; (4) the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the Company to grow and manage growth profitably, and retain its key employees; (5) costs related to the business combination; (6) changes in applicable laws or regulations; (7) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (8) risks relating to the uncertainty of the projected financial information of the Company; (9) risks related to the organic and inorganic growth of the Company’s business and the timing of expected business milestones; and (10) other risks and uncertainties indicated from time to time in the Company’s annual report on Form 10-K, including those under “Risk Factors” therein, and in the Company’s other filings with the Securities and Exchange Commission. The Company cautions that the foregoing list of factors is not exclusive, and readers should not place undue reliance upon any forward-looking statements, which speak only as of the date which they were made. The Company does not undertake any obligation to update or revise any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.

Contact:

Investors: [email protected]
Media: [email protected]

PLBY Group, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands)

	Three Months Ended March 31,
	2021			2020
Net revenues	$	42,680		$	31,774
Costs and expenses
Cost of sales	(20,398		)	(16,279		)
Selling and administrative expenses	(26,571		)	(12,723		)
Related party expenses	(250		)	(250		)
Total costs and expenses	(47,219		)	(29,252		)
Operating (loss) income	(4,539		)	2,522
Nonoperating income (expense):
Interest expense	(3,297		)	(3,342		)
Other income (expense), net	745			(13		)
Total nonoperating expense	(2,552		)	(3,355		)
Loss before income taxes	(7,091		)	(833		)
Benefit (expense) from income taxes	2,094			(1,576		)
Net loss	(4,997		)	(2,409		)
Net loss attributable to redeemable noncontrolling interest	—			—
Net loss attributable to PLBY Group, Inc.	$	(4,997	)	$	(2,409	)

PLBY Group, Inc.
Condensed Consolidated Balance Sheets
*(in thousands, except share and per share amounts)*

	March 31, 2021			December 31, 2020
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	70,249		$	13,430
Restricted cash	2,130			2,130
Receivables, net of allowance for doubtful accounts of $233 and $233, respectively	7,303			6,601
Inventories, net	17,310			11,788
Stock receivable	—			4,445
Prepaid expenses and other current assets	16,057			8,822
Total current assets	113,049			47,216
Property and equipment, net	8,093			5,203
Trademarks and trade name	331,475			336,655
Goodwill	19,235			504
Other intangible assets, net	11,514			2,377
Contract assets, net of current portion	6,641			7,159
Other noncurrent assets	12,741			13,013
Total assets	$	502,748		$	412,127
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	11,199		$	8,678
Accrued salaries, wages, and employee benefits	2,649			4,870
Deferred revenues, current portion	20,085			11,159
Long-term debt, current portion	4,888			4,470
Convertible promissory notes	—			6,230
Other current liabilities and accrued expenses	18,720			18,556
Total current liabilities	57,541			53,963
Deferred revenues, net of current portion	34,329			43,792
Long-term debt, net of current portion	153,007			154,230
Deferred tax liabilities, net	74,897			74,909
Other noncurrent liabilities	4,077			2,422
Total liabilities	323,851			329,316
Commitments and contingencies (Note 13)
Redeemable noncontrolling interest	(208		)	(208		)
Stockholders’ equity:
Common stock, $0.0001 par value per share, 150,000,000 shares authorized, 34,260,980 shares issued and 33,560,980 shares outstanding as of March 31, 2021; 20,626,249 shares issued and outstanding as of December 31,2020	3			2

Treasury stock, at cost, 700,000 shares and 0 shares as of March 31, 2021 and December 31, 2020	(4,445		)	—
Additional paid-in capital	266,560			161,033
Accumulated deficit	(83,013		)	(78,016		)
Total stockholders’ equity	179,105			83,019
Total liabilities, redeemable noncontrolling interest, and stockholders’ equity	$	502,748		$	412,127

EBITDA Reconciliation

This release presents the financial measure earnings before interest, taxes, depreciation and amortization, or “EBITDA”, and Adjusted EBITDA, which are not financial measures under the accounting principles generally accepted in the United States of America (“GAAP”). “EBITDA” is defined as net income or loss before interest, income tax expense or benefit, and depreciation and amortization. “Adjusted EBITDA” is defined as EBITDA adjusted for stock-based compensation and other special items determined by Company management. Adjusted EBITDA is intended as a supplemental measure of the Company’s performance that is neither required by, nor presented in accordance with, GAAP. The Company believes that the use of EBITDA and Adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with those of comparable companies, which may present similar non-GAAP financial measures to investors. However, investors should be aware that when evaluating EBITDA and Adjusted EBITDA, the Company may incur future expenses similar to those excluded when calculating these measures. In addition, the Company’s presentation of these measures should not be construed as an inference that the Company’s future results will be unaffected by unusual or nonrecurring items. The Company’s computation of Adjusted EBITDA may not be comparable to other similarly titled measures computed by other companies, because all companies may not calculate Adjusted EBITDA in the same fashion.

In addition to adjusting for non-cash stock-based compensation, the Company typically adjusts for nonoperating expenses and income, such as management fees paid to its largest shareholder, merger related bonus payments, non-recurring special projects including the implementation of internal controls and the expense associated with reorganization and severance resulting in the elimination or right-sizing of specific business activities or operations as the Company transforms from a print and digital media business to a commerce centric business. The Company also adjusts for nonrecurring and nonoperating expenses.

Because of these limitations, EBITDA and Adjusted EBITDA should not be considered in isolation or as a substitute for performance measures calculated in accordance with GAAP. The Company compensates for these limitations by relying primarily on its GAAP results and using EBITDA and Adjusted EBITDA on a supplemental basis. Investors should review the reconciliation of net loss to EBITDA and Adjusted EBITDA below and not rely on any single financial measure to evaluate the Company’s business.

The following table reconciles the Company’s net loss to EBITDA and Adjusted EBITDA:

GAAP Net Income to Adjusted EBITDA Reconciliation
(Unaudited)
(in thousands)

	Three Months Ended March 31,
	2021			2020

	(in thousands)
Net loss	$	(4,997	)	$	(2,409	)
Adjusted for:
Interest expense	3,297			3,342
Provision for income taxes	(2,094		)	1,576
Depreciation and amortization	728			641
EBITDA	(3,066		)	3,150
Adjusted for:
Stock-based compensation	3,498			749
Reduction in force expenses	—			997
Nonrecurring items	6,040			1,615
Management fees and expenses	250			250
Nonoperating (income) expenses	—			59
Adjusted EBITDA	$	6,722		$	6,820

May 12, 2021 4:04 pm

NV5 Announces Strong First Quarter Results; Delivers Record Cash Flows and Issues Full-Year 2021 Guidance Exceeding Analyst Consensus

HOLLYWOOD, Fla., May 12, 2021 (GLOBE NEWSWIRE) — NV5 Global, Inc. (Nasdaq: NVEE) (“NV5” or the “Company”), a leading provider of compliance, technology, and engineering consulting solutions, today reported financial results for the first quarter ended April 3, 2021.

“We are pleased with our first quarter performance, which generated $48 million in cash flows from operations and delivered increases in net income, adjusted EBITDA margins, and earnings per share. These positive results were accomplished despite weather-related project delays that significantly postponed projects in the quarter. The COVID-19 pandemic also limited revenue generation for some of our services. Demand for our utility, infrastructure, and public sector services continues to be strong, driving a 5% increase in our backlog for the quarter. We anticipate increased growth opportunities as the economy continues to open throughout the year. In addition, the strength of our balance sheet allows us to invest in acquisitions that support our platform and expand our high-margin offerings,” said Dickerson Wright, PE, Chairman and CEO of NV5.

First Quarter 2021 Results

Resume full year 2021 guidance as follows:
- Increase gross revenues to $695 million to $720 million
- Increase GAAP EPS to $2.36 per share to $2.78 per share
- Increase Adjusted EPS to $4.05 per share to $4.45 per share
Gross revenues were $153.1 million compared to $165.5 million in the pre-pandemic first quarter of 2020.
Cash flows from operations for the first quarter of 2021 were $48.2 million, more than three times the cash flows from operations in the first quarter of 2020 of $13.6 million.
Completed a secondary offering for which the Company received $141.0 million in net proceeds.
Reduced debt by $135.2 million, bringing net leverage to 0.8x funded by strong cash flows from operations and secondary offering proceeds.
Net income grew by 31% in the first quarter of 2021 to $5.5 million compared to $4.2 million in the first quarter of 2020.
Adjusted EBITDA, which excludes stock-based compensation and acquisition-related costs, grew in the first quarter of 2021 to $24.2 million compared to $24.1 million in the first quarter of 2020.
GAAP EPS in the first quarter of 2021 was $0.41 per share compared to $0.33 per share in the first quarter of 2020, a 24% increase.
Adjusted EPS in the first quarter of 2021 was $0.88 per share compared to $0.84 per share in the first quarter of 2020, a 5% increase. Diluted weighted average shares were 13,429,102 in the first quarter of 2021 compared to 12,593,788 in the first quarter of 2020.

Use of Non-GAAP Financial Measures; Comparability of Certain Measures

Earnings before interest, taxes, depreciation, and amortization (“EBITDA”) is not a measure of financial performance under GAAP. Adjusted EBITDA reflects adjustments to EBITDA to eliminate stock-based compensation expense and acquisition-related costs. Management believes adjusted EBITDA, in addition to operating profit, Net Income, and other GAAP measures, is a useful indicator of our financial and operating performance and our ability to generate cash flows from operations that are available for taxes, capital expenditures, and debt service. A reconciliation of Net Income, as reported in accordance with GAAP, to adjusted EBITDA is provided at the end of this news release.

Adjusted earnings per diluted share (“Adjusted EPS”) is not a measure of financial performance under GAAP. Adjusted EPS reflects adjustments to reported diluted earnings per share (“GAAP EPS”) to eliminate amortization expense of intangible assets from acquisitions, net of tax benefits, and acquisition-related costs. As we continue our acquisition strategy, the growth in Adjusted EPS may increase at a greater rate than GAAP EPS. A reconciliation of GAAP EPS to Adjusted EPS is provided at the end of this news release.

Our definition of Adjusted EBITDA and Adjusted EPS may differ from other companies reporting similarly named measures. These measures should be considered in addition to, and not as a substitute for, or superior to, other measures of financial performance prepared in accordance with GAAP, such as Net Income, and Diluted Earnings per Share.

Conference Call

NV5 will host a conference call to discuss its first quarter 2021 financial results at 4:30 p.m. (Eastern Time) on May 12, 2021. The accompanying presentation for the call is available by visiting http://ir.nv5.com.

Date:	Wednesday, May 12, 2021
Time:	4:30 p.m. Eastern
Toll-free dial-in number:	+1 833-900-1538
International dial-in number:	+1 236-712-2278
Conference ID:	2088906
Webcast:	http://ir.nv5.com

Please dial-in at least 5-10 minutes prior to the start time to allow the operator to log your name and connect you to the conference.

The conference call will be webcast live and available for replay via the “Investors” section of the NV5 website.

About NV5

NV5 Global, Inc. (NASDAQ: NVEE) is a provider of compliance, technology, and engineering consulting solutions for public and private sector clients supporting infrastructure, utility, and building assets and systems. The Company primarily focuses on six business verticals: testing, inspection & consulting, infrastructure engineering, utility services, buildings & program management, environmental health sciences, and geospatial services. NV5 operates out of more than 106 offices nationwide and abroad. For additional information, please visit the Company’s website at www.NV5.com. Also visit the Company on Twitter, LinkedIn, Facebook, and Vimeo.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. The Company cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements contained in this news release and on the conference call. Such factors include: (a) changes in demand from the local and state government and private clients that we serve; (b) general economic conditions, nationally and globally, and their effect on the market for our services; (c) competitive pressures and trends in our industry and our ability to successfully compete with our competitors; (d) changes in laws, regulations, or policies; and (e) the “Risk Factors” set forth in the Company’s most recent SEC filings. All forward-looking statements are based on information available to the Company on the date hereof, and the Company assumes no obligation to update such statements, except as required by law.

Investor Relations Contact

NV5 Global, Inc.
Jack Cochran
Vice President, Marketing & Investor Relations
Tel: +1-954-637-8048
Email: [email protected]

Source: NV5 Global, Inc.


NV5 GLOBAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(in thousands, except share data)

	April 3, 2021		January 2, 2021
Assets
Current assets:
Cash and cash equivalents	$	92,925	$	64,909
Billed receivables, net	108,921		142,705
Unbilled receivables, net	72,967		74,458
Prepaid expenses and other current assets	8,085		6,804
Total current assets	282,898		288,876
Property and equipment, net	29,143		27,011
Right-of-use lease assets, net	42,419		43,607
Intangible assets, net	179,711		174,931
Goodwill	359,101		343,796
Other assets	3,059		2,954
Total Assets	$	896,331	$	881,175

Liabilities and Stockholders’ Equity

Current liabilities:
Accounts payable	$	34,014	$	39,989
Accrued liabilities	53,797		45,325
Billings in excess of costs and estimated earnings on uncompleted contracts	17,721		24,962
Client deposits	480		380
Current portion of contingent consideration	3,423		1,334
Current portion of notes payable and other obligations	26,896		24,196
Total current liabilities	136,331		136,186
Contingent consideration, less current portion	697		1,066
Other long-term liabilities	37,841		38,737
Notes payable and other obligations, less current portion	145,443		283,326
Deferred income tax liabilities, net	28,830		27,791
Total liabilities	349,142		487,106

Commitments and contingencies

Stockholders’ equity:
Preferred stock, $0.01 par value; 5,000,000 shares authorized, no shares issued and outstanding	—		—
Common stock, $0.01 par value; 45,000,000 shares authorized, 14,933,927 and 13,270,131 shares issued and outstanding as of April 3, 2021 and January 2, 2021, respectively	149		133
Additional paid-in capital	415,895		268,271
Retained earnings	131,145		125,665
Total stockholders’ equity	547,189		394,069
Total liabilities and stockholders’ equity	$	896,331	$	881,175


NV5 GLOBAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF NET INCOME AND COMPREHENSIVE INCOME
(UNAUDITED)
(in thousands, except share data)

	Three Months Ended
	April 3, 2021			March 28, 2020
Gross revenues	$	153,095		$	165,480

Direct costs:
Salaries and wages	41,459			45,034
Sub-consultant services	23,246			27,427
Other direct costs	9,798			8,487
Total direct costs	74,503			80,948

Gross profit	78,592			84,532

Operating expenses:
Salaries and wages, payroll taxes and benefits	42,951			45,556
General and administrative	11,549			13,157
Facilities and facilities related	5,097			5,397
Depreciation and amortization	9,440			11,040
Total operating expenses	69,037			75,150

Income from operations	9,555			9,382

Interest expense	(2,318		)	(3,788		)

Income before income tax expense	7,237			5,594
Income tax expense	(1,757		)	(1,406		)
Net income and comprehensive income	$	5,480		$	4,188

Earnings per share:
Basic	$	0.43		$	0.34
Diluted	$	0.41		$	0.33

Weighted average common shares outstanding:
Basic	12,876,822			12,233,477
Diluted	13,429,102			12,593,788


NV5 GLOBAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)

	Three Months Ended
	April 3, 2021			March 28, 2020
Cash flows from operating activities:
Net income	$	5,480		$	4,188
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	10,542			11,040
Non-cash lease expense	2,161			1,704
Provision for doubtful accounts	(536		)	215
Stock-based compensation	3,696			3,379
Change in fair value of contingent consideration	209			—
Gain on disposals of property and equipment	(530		)	(339		)
Deferred income taxes	(2,282		)	(1,614		)
Amortization of debt issuance costs	227			220
Changes in operating assets and liabilities, net of impact of acquisitions:
Billed receivables	36,037			6,053
Unbilled receivables	2,032			(7,764		)
Prepaid expenses and other assets	(1,114		)	1,962
Accounts payable	(6,332		)	44
Accrued liabilities	2,629			(8,061		)
Income taxes payable	3,085			1,365
Billings in excess of costs and estimated earnings on uncompleted contracts	(7,241		)	1,204
Deposits	92			7
Net cash provided by operating activities	48,155			13,603

Cash flows from investing activities:
Cash paid for acquisitions (net of cash received from acquisitions)	(15,007		)	—
Proceeds from sale of assets	460			425
Purchase of property and equipment	(1,470		)	(4,525		)
Net cash used in investing activities	(16,017		)	(4,100		)

Cash flows from financing activities:
Proceeds from common stock offering	150,000			—
Payments on notes payable	(1,669		)	(2,116		)
Payments of contingent consideration	(150		)	(650		)
Payments of borrowings from Senior Credit Facility	(143,207		)	—
Payments of common stock offering costs	(9,044		)	—
Purchases of common stock tendered by employees to satisfy the required withholding taxes related to stock-based compensation	(52		)	—
Payments of debt issuance costs	—			(236		)
Net cash used in financing activities	(4,122		)	(3,002		)

Net increase in cash and cash equivalents	28,016			6,501
Cash and cash equivalents – beginning of period	64,909			31,825
Cash and cash equivalents – end of period	$	92,925		$	38,326


NV5 GLOBAL, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
TO COMPARABLE GAAP FINANCIAL MEASURES
(UNAUDITED)
(in thousands)

RECONCILIATION OF GAAP NET INCOME TO ADJUSTED EBITDA

		Three Months Ended
		April 3, 2021			March 28, 2020
Net Income		$	5,480		$	4,188
Add:	Interest expense		2,318			3,788
	Income tax expense		1,757			1,406
	Depreciation and amortization		10,542			11,040
	Stock-based compensation		3,696			3,379
	Acquisition-related costs		449			340
Adjusted EBITDA		$	24,242		$	24,141

RECONCILIATION OF GAAP EPS TO ADJUSTED EPS

		Three Months Ended
		April 3, 2021			March 28, 2020
Net Income – per diluted share		$	0.41		$	0.33
Per diluted share adjustments:
Add:	Amortization expense of intangible assets and acquisition-related costs		0.63			0.69
	Income tax expense		(0.16	)		(0.18	)
Adjusted EPS		$	0.88		$	0.84

May 12, 2021 4:04 pm

mPhase Engages MZ Group to Lead Strategic Investor Relations and Shareholder Communication Program

Gaithersburg, MD, May 12, 2021 (GLOBE NEWSWIRE) — mPhase Technologies, Inc. (OTC: XDSL) (“mPhase” or the “Company”), a technology company specializing in EV charging, artificial intelligence, machine learning, software, and consumer engagement, has engaged international investor relations specialists MZ Group (MZ) to lead a comprehensive strategic investor relations and financial communications program across all key markets.

MZ Group will work closely with mPhase management to develop and implement a comprehensive capital markets strategy designed to increase the Company’s visibility throughout the investment community. The campaign will highlight how mPhase, an AI-focused technology company, is building a fabric of uncorrelated revenue streams based on synergistic technology platforms. The Company currently operates in five business segments including online training, consumer engagement, travel planning, data analysis and battery technology.

MZ has developed a distinguished reputation as a premier resource for institutional investors, brokers, analysts and private investors. The firm maintains offices worldwide and was recently ranked No. 7 in the world in business communication.

Brian M. Prenoveau, CFA, Managing Director at MZ North America, will advise mPhase in all facets of corporate and financial communications, including the coordination of roadshows and investment conferences across key cities and building brand awareness with financial and social media outlets.

Mr. Prenoveau commented on the opportunity, saying, “In 2019 new management for mPhase began building a team of global experts in artificial intelligence, machine learning and data analytics and seeking strategic acquisitions. During this time, the Company refocused its revenue strategy on Software as a Service (Saas). mPhase partnered with the fastest company in online training, iLearningEngines and acquired Learning Track, an India-based provider of real-time online training. Learning Track is a powerful yet simple cloud-based white label learning management system (LMS), designed to identify training needs and learning gaps, using analytical data and reporting with AI and Machine Learning as a backbone. mPhase quickly signed a $30 million annual contract to provide software, training, and support services to an IT solutions and services company.

“CloseComms was acquired in 2020 to pioneer technology to learn customer preferences and drive engagement. Its predictive algorithms help tailor promotions to maximize success targeting the quick service restaurant sector. After a successful pilot with Subway, the technology is now in the deployment phase. mPhase acquired Travel Buddhi, a technology platform designed to create, sell and fulfill personalized vacations. B2B subscription revenue and commissions from advertisements and bookings are driven through AI, blockchain, chatbot, dynamic itinerary, and location technologies. mPhase also restarted its battery development project which is now in the partnering stage targeting consumer, commercial, and government end markets. Potential partnerships under consideration are for transportation, specialty storage, and remote and critical-use applications,” concluded Prenoveau.

Anshu Bhatnagar, Chief Executive Officer of mPhase commented, “2020 was an important inflection point for mPhase with the acquisition of Learning Track and its immediately accretive artificial intelligence enabled technology platforms and services. Recurring service-related revenue from the acquisition has driven growth, reduced debt, and enabled the continued investment in new opportunities. We have a well thought out timeline that stresses rapid revenue generation and cross-division synergies. We have a catalyst-rich opportunity, with the potential to add corporate partners and customers in every division each quarter. CloseComms and Travel Buddhi are on the cusp of their revenue cycles, representing two open-ended growth drivers. We look forward to working with Brian and the entire team at MZ Group to communicate the multiple avenues to drive continued, sustained growth, building long-term value for our shareholders,” concluded Bhatnagar.

For more information on mPhase, please visit the Company’s investor relations website at www.mphasetech.com. To schedule a conference call with management, please email your request to [email protected] or call Brian Prenoveau at 561-489-5315.

About MZ Group

MZ North America is the US division of MZ Group, a global leader in investor relations and corporate communications. MZ North America was founded in 1996 and provides full scale Investor Relations to both private and public companies across all industries. Supported by our exclusive one‐stop‐shop approach, MZ works with top management to support the clients’ business strategy in six integrated product and service categories: 1) IR Consulting & Outreach – full service investor relations and roadshow services; 2) ESG iQ & Advisory – reporting technology platform and audit and reporting guidance; 3) SPAC Alpha IR+ & IPO Advisory – providing critical and timely guidance through business combinations and IPOs; 4) Financial & Social Media – lead generation and social media relations; 5) Market Intelligence – real time ownership monitoring; 6) Technology Solutions – webhosting, webcasting, conference calls, distribution services and board portals. MZ North America has a global footprint with offices located in New York, Chicago, San Diego, Aliso Viejo, Austin, Minneapolis, Taipei and São Paulo.

About
mPhase
Technologies

mPhase is a technology driven, innovative development company that creates and commercializes products and applications that impact everyday people. The Company is assembling industry-leading teams specializing in artificial intelligence, machine learning, software, consumer engagement, and other advanced technologies. Additional information can be found at the mPhase website, www.mphasetech.com. Please follow us on twitter: @mPhase_Tech for the latest updates.

Safe Harbor Statement

This press release contains certain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of the words “could,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “may,” “continue,” “predict,” “potential,” “project” and similar expressions that are intended to identify forward-looking statements. All forward-looking statements speak only as of the date of this press release. You should not place undue reliance on these forward-looking statements. Although we believe that our plans, objectives, expectations and intentions reflected in or suggested by the forward-looking statements are reasonable, we can give no assurance that these plans, objectives, expectations or intentions will be achieved. Forward-looking statements involve significant risks and uncertainties (some of which are beyond our control) and assumptions that could cause actual results to differ materially from historical experience and present expectations or projections. Actual results to differ materially from those in the forward-looking statements and the trading price for our common stock may fluctuate significantly. Forward-looking statements also are affected by the risk factors described in the Company’s filings with the U.S. Securities and Exchange Commission. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.

Company Contact

301-329-2700
[email protected]

Investor
Contact

Brian Prenoveau
MZ Group – MZ North America
561-489-5315
[email protected]
www.mzgroup.us

May 12, 2021 4:04 pm

Eargo Reports First Quarter 2021 Financial Results

Recent Highlights:

Net revenues of $22.0 million, up 74.0% year-over-year
Gross systems shipped of 11,704, up 66.5% year-over-year
Return accrual rate of 23.2%, a 4.4 percentage point improvement year-over-year
GAAP gross margin of 71.4%, up 8.2 percentage points year-over-year; non-GAAP gross margin of 72.2%, up 9.0 percentage points year-over-year
GAAP sales and marketing expense as a percent of net revenues of 76.4%, a 9.3 percentage point improvement year-over-year; non-GAAP sales and marketing expense as a percent of net revenues of 68.0%, a 16.7 percentage point improvement year-over-year

SAN JOSE, Calif., May 12, 2021 (GLOBE NEWSWIRE) — Eargo, Inc. (Nasdaq: EAR), a medical device company on a mission to improve the quality of life of people with hearing loss, today reported its financial results for the first quarter ended March 31, 2021.

Christian Gormsen, President and CEO, said, “We started 2021 with a great first quarter, as our digital and offline marketing programs continued to drive demand across multiple customer types, including both cash pay and insurance customers producing 74% year-over-year growth. Our first quarter growth was particularly impressive given we did not have a new product launch or related sales to repeat customers compared to the first quarter of 2020. Our mix shift towards insurance customers also resulted in a lower return accrual rate of 23.2%, which combined with higher average selling prices, drove non-GAAP gross margin to 72.2%. Our strong start to the year gives us increased confidence in our ability to deliver our full year revenue and gross margin guidance, while driving innovation across our value chain.”

Mr. Gormsen continued, “It is becoming more evident that telecare is here to stay, not just in hearing but across healthcare. As a pioneer in bringing a vertically integrated telecare experience to hearing care, we believe we are well positioned to lead the disruption of this large and underpenetrated market as more consumers realize there is simply a better, more efficient way to solve for hearing loss.”

First Quarter 2021 Financial Results

Net revenue was $22.0 million for the first quarter of 2021, compared to $12.7 million for the first quarter of 2020. The increase was driven by an increase in gross systems shipped and a decrease in the sales return accrual rate.

Gross profit for the first quarter of 2021 was $15.8 million compared to $8.0 million for the first quarter of 2020. Gross margin increased to 71.4% for the first quarter of 2021, compared with 63.2% for the first quarter of 2020. The increase was primarily due to a decrease in sales returns as a percentage of gross systems shipped, higher average selling prices, and lower cost of goods sold.

Total operating expenses were $29.1 million or 132.1% of net revenues, for the first quarter of 2021, compared with $19.7 million or 155.9% of net revenues, for the first quarter of 2020. The increase was primarily due to higher sales and marketing investments related to media investments, personnel investments to scale the organization for growth, stock-based compensation and expenses related to being a public company.

Sales and marketing expenses were $16.9 million or 76.4% of net revenues, for the first quarter of 2021, compared with $10.9 million or 85.7% of net revenues, for the first quarter of 2020.

Research and development expenses were $4.8 million or 21.7% of net revenues, for the first quarter of 2021, compared with $2.8 million or 22.2% of net revenues, for the first quarter of 2020.

General and administrative expenses were $7.5 million or 34.0% of net revenues for the first quarter of 2021, compared with $6.1 million or 48.0% of net revenues, for the first quarter of 2020.

Excluding stock-based compensation expense, non-GAAP operating expenses were $24.2 million, including research and development expenses of $3.7 million, sales and marketing expenses of $15.0 million, and general and administrative expenses of $5.5 million. Please refer to the section below titled “Use of Non-GAAP Financial Measures” and the non-GAAP reconciliation tables at the end of this press release.

Net loss attributable to common stockholders for the first quarter of 2021 was ($13.6) million, or ($0.36) per share, compared to a net loss of ($11.7) million, or ($43.76) per share, for the first quarter of 2020. Excluding stock-based compensation expense, non-GAAP net loss attributable to common stockholders for the first quarter of 2021 was ($8.5) million, or ($0.22) per share, compared to a non-GAAP net loss of ($11.2) million, or ($41.81) per share for the same period in 2020.

Cash and cash equivalents were $201.6 million as of March 31, 2021, compared to $212.2 million as of December 31, 2020.

Full Year 2021 Financial Guidance

Increasing net revenue guidance from between $87 million and $93 million to between $89 million and $93 million
Reiterating GAAP gross margin guidance of between 68% and 71%
Reiterating non-GAAP gross margin of between 70% and 72%

Conference Call and Web Cast Information

Eargo will host a conference call to discuss the first quarter financial results after market close on Wednesday, May 12, 2021 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live over the phone at (833) 649-1234 for U.S. callers or (914) 987-7293 for international callers, using conference ID: 3971939. The live webinar can be accessed at ir.eargo.com.

About Eargo

Eargo is a medical device company dedicated to improving the quality of life of people with hearing loss. Our innovative product and go-to-market approach address the major challenges of traditional hearing aid adoption, including social stigma, accessibility and cost. We believe our Eargo hearing aids are the first and only virtually invisible, rechargeable, completely-in-canal, FDA regulated, exempt Class I or Class II devices for the treatment of hearing loss. Our differentiated, consumer-first solution empowers consumers to take control of their hearing. Consumers can purchase online or over the phone and get personalized and convenient consultation and support from licensed hearing professionals via phone, text, email or video chat. The Eargo solution is offered to consumers at approximately half the cost of competing hearing aids purchased through traditional channels in the United States.

The company’s 4^th generation product, the Eargo Neo HiFi, was launched in January 2020 and features improved capabilities across audio fidelity and bandwidth. The Eargo Neo HiFi is available for purchase here.

Keros Therapeutics to Present at the Virtual 26th Annual Congress of the European Hematology Association

LEXINGTON, Mass., May 12, 2021 (GLOBE NEWSWIRE) — Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, today announced that four abstracts will be presented from the KER-050 and ALK2 hematology programs at the 26^th Annual Congress of the European Hematology Association (“EHA”), to be held as a virtual event from June 9-17, 2021.

“We are pleased to present additional mechanistic preclinical data for KER-050, which further demonstrate that KER-050 potentially promotes differentiation of both early- and terminal-stage progenitor cells, at this year’s virtual Congress. These data further support our belief that KER-050 can potentially treat diseases that exhibit defects in different stages of erythropoiesis, such as myelodysplastic syndromes and myelofibrosis. Additionally, new preclinical data from our ALK2 program provide further evidence of the effects of ALK2 inhibition on hepcidin and iron metabolism to potentially resolve anemias,” said Jasbir S. Seehra, Ph.D., Chief Executive Officer of Keros. “Separately, we remain on track to provide a program update on KER-050 with initial data from Part 1 of our Phase 2 clinical trial of KER-050 in patients with myelodysplastic syndromes to be announced by the end of June 2021.”

Details of the presentations are as follows:

“KER-050, an inhibitor of TGF-β superfamily signaling, observed to have a rapid, dynamic, and durable effect on erythropoiesis”

Abstract Number: EP758
Date and Time: Virtual poster presentation available June 11-17, 2021

“ALK2 is a potential therapeutic target in anemia resulting from chronic inflammation”

Abstract Number: EP839
Date and Time: Virtual poster presentation available June 11-17, 2021

“ALK2 inhibition, a novel therapeutic approach to iron overload”

Abstract Number: EP842
Date and Time: Virtual poster presentation available June 11-17, 2021

“Administration of ALK2 neutralizing antibodies to cynomolgus monkeys led to a sustained decrease in hepcidin, increase in circulating iron and increase in erythrocyte hemoglobin”

Abstract Number: EP840
Date and Time: Virtual poster presentation available June 11-17, 2021

About KER-050

Keros’ lead protein therapeutic product candidate, KER-050, is an engineered ligand trap comprised of a modified ligand-binding domain of the Transforming Growth Factor-Beta, or TGF-ß, receptor known as activin receptor type IIA that is fused to the portion of the human antibody known as the Fc domain. KER-050 is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes, or MDS, and in patients with myelofibrosis. In October 2020, Keros announced the dosing of the first two participants in its Phase 2 clinical trial evaluating KER-050 for the treatment of anemia and thrombocytopenia in very low-, low-, or intermediate-risk MDS. Keros expects to report initial data from Part 1 of this trial by the end of June 2021. Additionally, Keros plans to commence an open-label Phase 2 clinical trial evaluating KER-050 for the treatment of patients with myelofibrosis-associated cytopenias in the third quarter of 2021 and expects to report initial data from this trial in 2022.

About Keros Therapeutics, Inc.

Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the Transforming Growth Factor-Beta family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros’ lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros’ lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros’ third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

Cautionary Note Regarding Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “potential,” “projects,” “would” and “future” or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Keros’ expectations regarding its growth, strategy, progress and timing of its clinical trials for KER-050; the potential of KER-050 to treat diseases that exhibit defects in different stages of erythropoiesis; the potential of ALK2 inhibition to treat anemias; and Keros’ presentation plans for the upcoming EHA virtual annual meeting. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Keros’ limited operating history and historical losses; Keros’ ability to raise additional funding to complete the development and any commercialization of its product candidates; Keros’ dependence on the success of its lead product candidates, KER-050 and KER-047; that Keros may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Keros’ ability to obtain, maintain and protect its intellectual property; Keros’ dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

These and other risks are described more fully in Keros’ filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Quarterly Report on Form 10-Q, filed with the SEC on May 6, 2021, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Keros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Contact:

Julia Balanova

[email protected]

646-378-2936

May 12, 2021 4:04 pm

STRATA Skin Sciences Reports First Quarter 2021 Financial Results

HORSHAM, Pa., May 12, 2021 (GLOBE NEWSWIRE) — STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, today announced financial results for the quarter ended March 31, 2021.

Recent Highlights

Total revenue for the first quarter of 2021 was $5.8 million, a decrease of 13.4% as compared to the first quarter of 2020
- Recurring revenue for the first quarter of 2021 was $4.7 million, a 17.9% decrease over the first quarter of 2020
- Gross domestic recurring billings were $4.6 million, a 6.8% decrease over the first quarter 2020 (See Reconciliation of Non-GAAP measures below)
Total gross margins in the first quarter of 2021 were 63.7%, a 1.7% decrease over first quarter 2020
Cash, cash equivalents and restricted cash at March 31, 2021 were $17.5 million down from 18.1 million at December 31, 2020
Concluded the quarter with a global recurring revenue installed base of 871 XTRAC devices, an increase of 11 from December 31, 2020
Results of a study on patients with refractory vitiligo published in the Journal of the European Academy of Dermatology and Venerology demonstrated satisfactory regimentation in five treatments using the XTRAC excimer laser
Appointed William D. Humphries to the Company’s Board of Directors

“Our first quarter results reflected the continued impact of COVID-19 on dermatology offices, where staffing challenges persisted, patient access remained curtailed and patient willingness to return to offices for a full treatment regimen was weak. In addition, we had an unfavorable impact of deferred revenue. Internationally, certain sales and placements came in too late to ship in time to be recognized in the first quarter. As a result, the revenue and placements will be recognized in the second quarter,” said Robert J. Moccia, Chief Executive Officer of STRATA Skin Sciences.

“Since joining the Company in March, I have spent much of my time meeting and speaking with our territory managers and customers. These meetings have reinforced my belief that XTRAC delivers one of the safest, most effective treatments available in the market today for treating psoriasis, vitiligo and various other skin conditions. With the vaccine rollout well under way and states easing COVID-19 restrictions, I see an exciting opportunity to re-engage with dormant accounts and expand dermatology group placements,” continued Mr. Moccia. “Commercial execution and pursuing opportunities to drive recurring billing revenue is our primary focus in 2021. Currently, we are evaluating our operating profile to develop and promote key strategies that will enable us to capture the greatest market share and drive further utilization in our partner clinics.”

First Quarter 2021 Financial Results

Revenues for the first quarter of 2021 were $5.8 million, as compared to revenues of $6.7 million for the first quarter of 2020. Recurring revenues for the first quarter of 2021 were $4.7 million, as compared to recurring revenues of $5.7 million for the first quarter of 2020. Equipment revenues were $1.1 million for the first quarter of 2021, as compared to $1.0 million for the first quarter of 2020.

Gross profit for the first quarter of 2021 was $3.7 million, or 63.7% of revenues, as compared to $4.4 million, or 65.4% of revenues, for the first quarter of 2020. Gross profit on recurring revenues for the first quarter of 2021 was $3.2 million, or 67.9% of revenues, as compared to $3.9 million, or 68.4% of revenues, for the first quarter of 2020. The decrease in gross profit is the result of lower sales and the unfavorable impact of $0.8 million in deferred revenue, as compared to the first quarter of 2020, partially offset by lower depreciation expense.

Engineering and product development costs for the first quarter of 2021 were $0.4 million, as compared to $0.3 million for the first quarter of 2020 as a result of certain engineering projects. Selling and marketing costs for the first quarter of 2021 were $2.9 million, as compared to $3.0 million for the first quarter of 2020, primarily as a result of lower trade show costs and travel, partially offset by higher compensation and consulting costs. General and administrative costs for the first quarter of 2021 were $2.8 million, as compared to $2.1 million for the first quarter of 2020, as a result of the CEO transition in the first quarter of 2021 including accruals for severance, recruiting fees and stock compensation.

Net loss for first quarter 2021 was $2.4 million, or a loss of $0.07 per basic and diluted common share, as compared to the net loss for the first quarter of 2020 of $1.0 million, or a net loss of $0.03 per basic and diluted common share.

Webcast and Conference Call Information

STRATA management will host a conference call today, beginning at 4:30 p.m. Eastern. The conference call will be concurrently webcast. The link to the webcast is available on the company website (www.strataskinsciences.com) under the investor relations section and will be archived for future reference. To listen to the conference call, please dial +1 (877) 451-6152 (US/Canada) or +1 (201)-389-0879 (International) or +1 (809)-406-247 (Israel) and use the conference ID number 13719082.

Reconciliation of Non-GAAP Measures

To supplement the Company’s consolidated financial statements, prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), the Company provides certain non-GAAP measures of financial performance, including non-GAAP adjusted EBITDA and Gross Domestic Recurring Gross Billings.

The Company’s reference to these non-GAAP measures should be considered in addition to results prepared under current accounting standards, but is not a substitute for, nor superior to, GAAP results. These non-GAAP measures are provided to enhance investors’ overall understanding of our current financial performance and to provide further information for comparative purposes.

Specifically, the Company believes the non-GAAP measures provide useful information to both management and investors by isolating certain expenses, gains and losses that may not be indicative of the Company’s core operating results and business outlook. In addition, the Company believes non-GAAP measures enhance the comparability of results against prior periods. Reconciliation of the GAAP measures of net loss to non-GAAP measures included in this press release is as follows (in thousands):

Adjusted EBITDA

		For the Three Months Ended March 31,
			2021			2020

Net Loss		$(2,418		)	$(1,035		)
Adjustments:
	Depreciation/amortization		919			1,117
	Income taxes		4			88
	Interest expense (income), net		22			(1	)

Non-GAAP EBITDA			(1,473	)		169
	Stock compensation		662			430

Non-GAAP adjusted EBITDA		$(811		)	$599

Gross Domestic Recurring Billings

Gross domestic recurring billings represent the amount invoiced to partner clinics when treatment codes are sold to the physician. It does not include normal GAAP adjustments which are deferred revenue from prior quarters recorded as revenue in the current quarter, the deferral of revenue from the current quarter recorded as revenue in future quarters, adjustments for co-pay and other discounts. This excludes international recurring revenues.

The total gross domestic recurring billings for the first quarter of 2021 was $4.6 million, compared to $5.0 million for the first quarter of 2020.

The following is a reconciliation of non-GAAP gross domestic billings to recorded revenue for the first quarter of 2021 and 2020 (in thousands):

		2021			2020
Gross domestic recurring billings	$4,619			$4,955
Co-Pay adjustments		(157	)		(168	)
Other discounts		(32	)		(18	)
Deferred revenue from prior quarters		1,765			2,286
Deferral of revenue to future quarters		(1,769	)		(1,458	)
GAAP Recorded revenue	$4,426			$5,597

About STRATA Skin Sciences, Inc.

STRATA Skin Sciences is a medical technology company in dermatology dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions. Its products include the XTRAC® excimer laser and VTRAC® lamp systems utilized in the treatment of psoriasis, vitiligo and various other skin conditions.

The Company’s proprietary XTRAC excimer laser delivers a highly targeted therapeutic beam of UVB light to treat psoriasis, vitiligo, eczema, atopic dermatitis and leukoderma, diseases which impact over 31 million patients in the United States alone. The technology is covered by multiple patents.

STRATA’s unique business model leverages targeted Direct to Consumer (DTC) advertising to generate awareness and utilizes its in-house call center and insurance advocacy teams to increase volume for the Company’s partner dermatology clinics.

Safe Harbor

This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to the Company’s plans, objectives, expectations and intentions and may contain words such as “will,” “may,” “seeks,” and “expects,” that suggest future events or trends. These statements, the Company’s ability to generate the growth in its core business, the Company’s ability to develop social media marketing campaigns, and the Company’s ability to build a leading franchise in dermatology and aesthetics, are based on the Company’s current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from the Company’s expectations due to financial, economic, business, competitive, market, regulatory, adverse market conditions or supply chain interruptions resulting from the coronavirus and political factors or conditions affecting the Company and the medical device industry in general, future responses to and effects of COVID-19 pandemic including the distribution and effectiveness of the COVID-19 vaccines, as well as more specific risks and uncertainties set forth in the Company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all these forward-looking statements may prove to be incorrect or unreliable. The statements in this press release are made as of the date of this press release, even if subsequently made available by the Company on its website or otherwise. The Company does not undertake any obligation to update or revise these statements to reflect events or circumstances occurring after the date of this press release. The Company urges investors to carefully review its SEC disclosures available at www.sec.gov and www.strataskinsciences.com.

Investor Contact

Leigh Salvo
(415) 937-5404
[email protected]

STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)

	March 31, 2021			December 31, 2020
ASSETS	(unaudited)
Current assets:
Cash and cash equivalents	$10,043			$10,604
Restricted cash		7,482			7,508
Accounts receivable, net of allowance for doubtful accounts of $220 and $274, respectively		2,853			2,944
Inventories		3,312			3,444
Prepaid expenses and other current assets		413			331
Total current assets		24,103			24,831

Property and equipment, net		5,788			5,529
Operating lease right-of-use assets, net		902			988
Intangible assets, net		5,993			6,345
Goodwill		8,803			8,803
Other assets		265			282
Total assets	$45,854			$46,778

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Note payable	$7,275			$7,275
Current portion of long-term debt		1,811			1,478
Accounts payable		3,151			2,764
Other accrued liabilities		5,286			4,690
Current portion of operating lease liabilities		375			369
Deferred revenues		2,208			2,262
Total current liabilities		20,106			18,838

Long-term liabilities:
Long-term debt, net		717			1,050
Deferred tax liability		258			254
Long-term operating lease liabilities, net		613			710
Other liabilities		24			34
Total liabilities		21,718			20,886

Commitments and contingencies

Stockholders’ equity:
Series C Convertible Preferred Stock, $.10 par value, 10,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2021 and, December 31, 2020		–			–
Common Stock, $.001 par value, 150,000,000 shares authorized; 33,817,305 and 33,801,045 shares issued and outstanding at March 31, 2021 and, December 31, 2020, respectively		34			34
Additional paid-in capital		245,493			244,831
Accumulated deficit		(221,391	)		(218,973	)
Total stockholders’ equity		24,136			25,892
Total liabilities and stockholders’ equity	$45,854			$46,778

STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(unaudited)

	For the Three Months Ended March 31,
		2021			2020
Revenues, net	$5,827			$6,730

Cost of revenues		2,114			2,331

Gross profit		3,713			4,399

Operating expenses:
Engineering and product development		384			292
Selling and marketing		2,932			2,953
General and administrative		2,789			2,102
		6,105			5,347

Loss from operations		(2,392	)		(948	)

Other (expense) income, net:
Interest (expense) income, net		(22	)		1
		(22	)		1

Loss before income taxes		(2,414	)		(947	)
Income tax expense		(4	)		(88	)
Net loss	$(2,418		)	$(1,035		)

Loss attributable to common shares	$(2,418		)	$(1,018		)
Loss attributable to Preferred Series C shares		$-		$(17		)
Loss per common share:
Basic	$(0.07		)	$(0.03		)
Diluted	$(0.07		)	$(0.03		)
Shares used in computing loss per common share:
Basic		33,802,129			33,164,321
Diluted		33,802,129			33,164,321

Loss per Preferred Series C share – basic and diluted		$-		$(11.42		)
Shares used in computing loss per basic and diluted Preferred Series C Shares		–			1,480

STRATA SKIN SCIENCES, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands, unaudited)

	For the Three Months Ended March 31,
		2021			2020
Cash Flows From Operating Activities:
Net loss	$(2,418		)	$(1,035		)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization		833			1,038
Amortization of right-of-use asset		86			79
Provision for doubtful accounts		(54	)		2
Stock-based compensation		662			430
Deferred taxes		4			88
Changes in operating assets and liabilities:
Accounts receivable		145			1,176
Inventories		132			(444	)
Prepaid expenses and other assets		(65	)		43
Accounts payable		387			222
Other accrued liabilities		596			16
Other liabilities		(10	)		(59	)
Operating lease liabilities		(91	)		(60	)
Deferred revenues		(54	)		(898	)
Net cash provided by operating activities		153			598

Cash Flows From Investing Activities:
Lasers placed-in-service		(654	)		(596	)
Purchases of property and equipment		(86	)		–
Net cash used in investing activities		(740	)		(596	)

Net (decrease) increase in cash and cash equivalents and restricted cash		(587	)		2
Cash, cash equivalents and restricted cash, beginning of period		18,112			15,629

Cash, cash equivalents and restricted cash, end of period	$17,525			$15,631

May 12, 2021 4:04 pm

Qorvo® Appoints Judy Bruner to its Board of Directors

GREENSBORO, N.C., May 12, 2021 (GLOBE NEWSWIRE) — Qorvo® (Nasdaq: QRVO), a leading provider of innovative RF solutions that connect the world, today announced the election of Judy Bruner to its Board of Directors, effective immediately. Ms. Bruner will also join the Board’s Audit and Governance and Nominating Committees.

Ms. Bruner most recently served as Executive Vice President, Administration and Chief Financial Officer of SanDisk Corporation, a supplier of flash storage products, from June 2004 until its acquisition by Western Digital in May 2016. Previously, she was Senior Vice President and Chief Financial Officer of Palm, Inc., a provider of handheld computing and communications solutions, from September 1999 until June 2004. Prior to Palm, Inc., Ms. Bruner held financial management positions at 3Com Corporation, Ridge Computers and Hewlett-Packard Company. She currently serves as a member of the boards of directors of Applied Materials, Inc., Rapid7, Inc., and Seagate Technology plc.

Bob Bruggeworth, President and Chief Executive Officer of Qorvo, said, “I am delighted that Judy will be joining our Board of Directors. She brings semiconductor industry leadership and significant experience in financial management with a range of technology companies, and we look forward to her insights and contributions to our Board.”

“Qorvo is recognized globally for its product and technology leadership,” said Ms. Bruner. “I am excited to join Qorvo’s Board, and I look forward to working with Bob and my fellow directors in driving Qorvo’s growth strategy to create long-term value for its shareholders.”

About Qorvo

Qorvo (Nasdaq: QRVO) makes a better world possible by providing innovative Radio Frequency (RF) solutions at the center of connectivity. We combine product and technology leadership, systems-level expertise and global manufacturing scale to quickly solve our customers’ most complex technical challenges. Qorvo serves diverse high-growth segments of large global markets, including advanced wireless devices, wired and wireless networks and defense radar and communications. We also leverage unique competitive strengths to advance 5G networks, cloud computing, the Internet of Things, and other emerging applications that expand the global framework interconnecting people, places and things. Visit www.qorvo.com to learn how Qorvo connects the world.

Qorvo is a registered trademark of Qorvo, Inc. in the U.S. and in other countries. All other trademarks are the property of their respective owners.

This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions, and are not historical facts and typically are identified by use of terms such as “may,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements included herein represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those expressed or implied by forward-looking statements. We do not intend to update any of these forward-looking statements or publicly announce the results of any revisions to these forward-looking statements, other than as is required under U.S. federal securities laws. Our business is subject to numerous risks and uncertainties, including those relating to fluctuations in our operating results; our substantial dependence on developing new products and achieving design wins; our dependence on a few large customers for a substantial portion of our revenue; a loss of revenue if contracts with the United States government or defense and aerospace contractors are canceled or delayed or if defense spending is reduced; the COVID-19 pandemic, which has and will likely continue to negatively impact the global economy and disrupt normal business activities, and which may have an adverse effect on our results of operations; our dependence on third parties; risks related to sales through distributors; risks associated with the operation of our manufacturing facilities; business disruptions; poor manufacturing yields; increased inventory risks and costs due to timing of customer forecasts; our inability to effectively manage or maintain evolving relationships with platform providers; risks from international sales and operations; economic regulation in China; changes in government trade policies, including imposition of tariffs and export restrictions; our ability to implement innovative technologies; underutilization of manufacturing facilities as a result of industry overcapacity; we may not be able to borrow funds under our credit facility or secure future financing; we may not be able to generate sufficient cash to service all of our debt; restrictions imposed by the agreements governing our debt; volatility in the price of our common stock; damage to our reputation or brand; fluctuations in the amount and frequency of our stock repurchases; our recent and future acquisitions and other strategic investments could fail to achieve financial or strategic objectives; our ability to attract, retain and motivate key employees; our reliance on our intellectual property portfolio; claims of infringement of third-party intellectual property rights; security breaches and other similar disruptions compromising our information; theft, loss or misuse of personal data by or about our employees, customers or third parties; warranty claims, product recalls and product liability; and risks associated with environmental, health and safety regulations and climate change. Many of the foregoing risks and uncertainties are, and will continue to be, exacerbated by the COVID-19 pandemic and any worsening of the global business and economic environment as a result. These and other risks and uncertainties, which are described in more detail in Qorvo’s most recent Annual Report on Form 10-K and in other reports and statements filed with the Securities and Exchange Commission, could cause actual results and developments to be materially different from those expressed or implied by any of these forward-looking statements.

At Qorvo ^®
Doug DeLieto
VP, Investor Relations
336-678-7968

May 12, 2021 4:04 pm

Flexion Therapeutics Reports First-Quarter 2021 Financial Results and Recent Business Updates

Flexion
reported
ZILRETTA
^®
(triamcinolone acetonide extended-release injectable suspension)
net sales of $24.6 million
David Arkowitz, CFO, stepping down effective May 31,2021, and will be succeeded by Fred Driscoll
New data presented at ASGCT indicate the low dose of FX201 provided durable pain improvement for two patients with knee OA out to Week 52
Conference call scheduled for today at 4:30 p.m. ET

BURLINGTON, Mass., May 12, 2021 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial results and recent business highlights for the quarter ended March 31, 2021.

“The first quarter of 2021 was marked by solid ZILRETTA sales and important progress with both FX201 and FX301, our exciting investigational drug candidates,” said Michael Clayman, M.D., President and Chief Executive Officer. “While COVID-19 continues to weigh on the nation, broad availability of vaccines and dropping infection rates, combined with our laser-like focus on commercial execution, reinforce our confidence in our ability to deliver full-year net sales in the range of $120 million to $130 million.”

Dr. Clayman added, “Today we announced that David Arkowitz, CFO, will be leaving the company at the end of the month to pursue other opportunities. While David’s leadership will be missed, I am particularly pleased to report that Fred Driscoll will be returning as CFO. Fred is uniquely qualified for this important role having served as Flexion’s CFO from IPO through the approval and launch of ZILRETTA. It is a pleasure to welcome him back to Flexion.”

First-Quarter Results & Financial Highlights

The Company reported a net loss of $28.6 million for the first quarter of 2021, compared to a net loss of $36.8 million for the same period of 2020. Net sales of ZILRETTA were $24.6 million and $20.1 million for the three months ended March 31, 2021 and 2020, respectively. Cost of sales was $6.1 million and $2.3 million for the three months ended March 31, 2021 and 2020, respectively.

Research and development expenses were $14.0 million and $21.1 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in research and development expenses of $7.1 million was primarily due to a decrease of $3.6 million in development expenses for ZILRETTA due to a reduction in ZILRETTA lifecycle management activities, a decrease of $2.2 million related to FX201 program costs, which is largely due to the $2.5 million milestone payment related to dosing the first human patient in the Phase 1 clinical trial, which occurred in the first quarter of 2020, as well as a decrease of $3.4 million in salary and other employee-related costs and stock-based compensation expense related to lower headcount. Decreases were partially offset by an increase of $2.4 million in expenses related to FX301, due to the achievement of certain development milestones, including the clearing of the IND by the U.S. Food and Drug Administration (FDA) and the initiation of the Phase 1b clinical trial, both of which occurred in the first quarter of 2021.

Selling, general and administrative expenses were $27.6 million and $29.3 million for the three months ended March 31, 2021 and 2020, respectively. Selling expenses were $19.1 million and $20.5 million for the three months ended March 31, 2021 and 2020, respectively. The year-over-year decrease in selling expenses of $1.4 million was primarily due to the fact that the majority of industry conferences and physician speaker programs remained virtual due to COVID-19, and, although more physician offices are opening, business travel remains low compared to pre-pandemic levels. General and administrative expenses were $8.5 million and $8.8 million for the three months ended March 31, 2021 and 2020, respectively, which represents a decrease of $0.3 million.

Interest income was $0.3 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively. Interest expense was $5.2 million and $4.7 million for the three months ended March 31, 2021 and 2020, respectively.

The Company anticipates 2021 full-year ZILRETTA net sales in the range of $120 million to $130 million. In addition, total operating expenses, including cost of sales, research and development expenses, and selling, general and administrative expenses, are anticipated in the range of $195 million to $205 million. As of March 31, 2021, the Company had $154.3 million in cash, cash equivalents and marketable securities compared with $175.3 million as of December 31, 2020.

ZILRETTA Commercial Metrics

Today, Flexion introduced updated commercial metrics to provide increased visibility and insights into the commercial performance of ZILRETTA. In the first quarter of 2021:

2,044 accounts purchased ZILRETTA
90% of accounts that purchased ZILRETTA had purchased ZILRETTA in a prior quarter
Total account purchases grew by 6% over the fourth quarter of 2020
Approximately 38% of ZILRETTA purchases came from accounts purchasing more than 100 units

FX201 ASGCT Data and Clinical Trial Update

On May 11, Flexion presented preliminary FX201 data at the 2021 American Society of Gene & Cell Therapy (ASGCT) annual meeting (Abstract/Presentation #594). Key findings from the Phase 1 dose-escalation study evaluating the safety and tolerability of FX201 in patients with knee osteoarthritis (OA) pain include:

FX201 was generally well-tolerated in the initial low-dose cohort (1.4E10 genome copies of FX201), and all five patients remain in the study at 38 to 56 weeks post-treatment.
- Two patients had self-limited Grade 2 index-knee adverse events (pain, swelling, effusion) possibly related to treatment; these were managed conservatively.
No evidence of systemic biodistribution of FX201 in plasma or shedding in urine or in swab samples from the injection site was observed in any patient.
Improvement in WOMAC-A pain from baseline was observed in four of the five patients at Week 12 and 24 and in two of the three patients with Week 52 data.
In a responder analysis based on IMMPACT criteria, two out of the five patients demonstrated substantial improvement in knee OA pain at Weeks 8, 12 and 24 following treatment with FX201.
- One of the three patients with data available at Week 52 continued to demonstrate substantial improvement in pain.
Functional improvement from baseline assessed by the KOOS questionnaire was observed in four of the five patients at Week 24, and all three patients with Week 52 data reported an improved KOOS score compared to baseline at Week 52.

In May, one participant in the high-dose cohort experienced gastrointestinal bleeding and atrial fibrillation, which required hospitalization. An adverse event resulting in hospitalization is deemed serious; however, the investigator determined it to be unrelated to the study drug. As dictated by the protocol, any serious adverse event (SAE), regardless of relatedness, requires a pause in study enrollment, followed by a review of the event by the independent Data Monitoring Committee (DMC) for the study and FDA. Both the DMC and FDA agreed with the investigator’s assessment and endorsed the re-initiation of the trial, and enrollment has resumed.

Additional data readouts are expected by the end of 2021, including the interrogation of synovial fluid from patients to assess biological activity of FX201 locally in the joint and potential correlation with clinical endpoints over time.

Recent News & Business Updates

Today the company announced that David Arkowitz, CFO, will step down on May 31, 2021, and will be succeeded by Fred Driscoll. Mr. Driscoll brings vast financial management experience in both the biotechnology and medical device industries. He previously served as Flexion’s CFO from 2013 to 2017.
In March 2021, the Company announced the treatment of the first patient in a Phase 1b proof-of-concept trial evaluating the safety and tolerability of FX301 administered as a single-dose, popliteal fossa block (a commonly used nerve block in foot and ankle-related surgeries) in patients undergoing bunionectomy. Results from that trial could potentially be available in late 2021.

Conference Call

Flexion’s management will host a conference call today at 4:30 p.m. ET. A live webcast of the conference call can be accessed through the “Investors” tab on the Flexion Therapeutics website, and a replay will be available online after the call. For those planning to ask a question, the dial-in number for the conference call is 855-770-0022 for domestic participants and 908-982-4677 for international participants, with Conference ID # 9786283. Please dial in at least 15 minutes in advance to ensure a timely connection to the call.

Indication and Select Important Safety Information for ZILRETTA

Indication: ZILRETTA is indicated as an intra-articular injection for the management of osteoarthritis pain of the knee.

Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.

Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.

Warnings and Precautions:

Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and, if confirmed, institute appropriate antimicrobial treatment.

Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.

Please see

ZilrettaLabel.com

for full Prescribing Information.

About ZILRETTA

On October 6, 2017, ZILRETTA was approved by the U.S. FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.

About Osteoarthritis (OA) of the Knee

OA, also known as degenerative joint disease, is the most common form of arthritis, affecting more than 32.5 million adults living in the United States. In 2017, approximately 15 million Americans were diagnosed with OA of the knee, and the average age of physician-diagnosed knee OA has fallen by 16 years, from 72 in the 1990s to 56 in the 2010s. The prevalence of OA is expected to continue to increase as a result of aging, obesity, and sports injuries. Each year, approximately five million OA patients receive either a corticosteroid (immediate-release or extended-release) or hyaluronic acid intra-articular injection to manage their knee pain.

About FX201

FX201 is an investigational gene therapy that utilizes a helper-dependent adenovirus (HDAd) vector devoid of all viral genes that carries a coding sequence for an anti-inflammatory protein called interleukin-1 receptor antagonist (IL-1Ra) under the control of an inflammation-responsive promoter. FX201 is injected directly into the joint space (also termed the intra-articular space) and is intended to deliver as-needed anti-inflammatory activity to joint tissues, with the goal of providing at least 6 to 12 months of meaningful pain relief and functional improvement following a single injection with the possibility of slowing disease progression.

About FX301

FX301 is an investigational locally administered NaV1.7 inhibitor known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral analgesic nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief for at least three to five days while preserving motor function.

About Flexion Therapeutics

Flexion Therapeutics (Nasdaq:FLXN) is a biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, the most common form of arthritis. The company’s core values are focus, ingenuity, tenacity, transparency and fun. Please visit flexiontherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on the current expectations and beliefs of Flexion. Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; potential sales growth of ZILRETTA; expectations regarding full-year 2021 net sales and operating expenses; expected timing of clinical trials; expected increases in the rate of individuals with OA of the knee; the potential therapeutic and other benefits of ZILRETTA and Flexion’s product candidates; and expected changes in Flexion’s management, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risk that Flexion may not achieve net sales and operating expense expectations for 2021; the potential future impacts of the COVID-19 pandemic and actions taken in response to the pandemic; the risk that we may not achieve anticipated growth or advancements in our development programs; the risk that we may not be able to successfully maintain an effective sales force to commercialize ZILRETTA; competition from alternative therapies; risks associated with clinical trials, including potential delays in enrollment or negative results; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to ZILRETTA; the risk that ZILRETTA may not be successfully commercialized or adopted; risks regarding our ability to obtain adequate reimbursement from payers for ZILRETTA; risks related to the manufacture and distribution of ZILRETTA, including our reliance on sole sources of supply and distribution; risks related to key employees, markets, economic conditions, health care reform, prices, and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 10, 2021, and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

FLEXION THERAPEUTICS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited in thousands, except for per share information)

	Three Months Ended March 31,
			2021		2020
Revenue		$24,589		$20,127

Operating expenses:
Cost of sales			6,085		2,276
Research and development			14,047		21,134
Selling, general and administrative			27,598		29,299
Total operating expenses			47,730		52,709
Loss from operations			(23,141)		(32,582)
Interest income (expense), net			(4,889)		(4,294)
Other (expense) income			(526)		74
Net loss		$(28,556)		$(36,802)

Basic and diluted net loss per share		$(0.57)		$(0.95)
Basic and diluted weighted average number of common shares outstanding			49,841		38,553

FLEXION THERAPEUTICS CONDENSED CONSOLIDATED BALANCE SHEET DATA (Unaudited in thousands)
	March 31,		December 31,
		2021		2020

Cash and cash equivalents	$98,707		$107,704
Marketable securities		55,573		67,576
Total current assets		204,622		225,811
Working capital		146,640		170,543
Total assets		230,379		251,926
Total notes payable		58,091		60,920
Total convertible notes		165,271		162,786
Total stockholders’ deficit		(38,867)		(16,660)

Contact:

Scott Young
Vice President, Corporate Communications & Investor Relations
T: 781-305-7194
[email protected]

Julie Downs
Associate Director, Corporate Communications & Investor Relations
T: 781-305-7137
[email protected]

May 12, 2021 4:04 pm

Celyad Oncology to Present Data from Phase 1 IMMUNICY-1 Trial of Non-Gene Edited Allogeneic CAR T Candidate CYAD-211 in Relapsed/Refractory Multiple Myeloma at the European Hematology Association Virtual Congress

No Grade ≥ 3 treatment-related adverse events nor evidence of Graft-versus-Host disease reported from the completed first dose-level (DL1) cohort of Phase 1 dose-escalation IMMUNICY-1 trial evaluating the shRNA-based anti-BCMA CAR T candidate, CYAD-211, for relapsed/refractory (r/r) multiple myeloma
Initial clinical activity observed, with
one confirmed partial response (PR) observed in this low dose (
30×10
⁶
cells per infusion)

MONT-SAINT-GUIBERT, Belgium, May 12, 2021 (GLOBE NEWSWIRE) — Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T-cell (CAR T) therapies for cancer, today announced that an abstract highlighting initial clinical data from the Phase 1 IMMUNICY-1 trial of CYAD-211 has been accepted for e-poster presentation at the upcoming European Hematology Association (EHA) Virtual Congress 2021

Filippo Petti, Chief Executive Officer at Celyad Oncology, commented, “We are very pleased with the initial results from the low dose cohort of our first shRNA-based allogeneic candidate, CYAD-211, which has showed preliminary signs of clinical activity, including a confirmed partial response, with no evidence of Graft-versus-Host-Disease. We are encouraged by the observed clinical activity at such a low dose level and the overall steady progress of the trial to date. Our team is intently focused on further assessing whether shRNA-mediated knockdown can generate safe, functional and clinically relevant allogeneic CAR T-cells for the treatment of cancer while offering an alternative technology platform with key advantages over gene-editing. We are excited for the opportunity to present the latest safety, clinical activity and cell kinetic data for the program next month at EHA and look forward to future updates for the program throughout 2021 as we move towards our goal of establishing proof-of-concept for this dynamic platform.”

CYAD-211 is an investigational, non-gene edited allogeneic CAR T candidate engineered to co-express a single hairpin RNA (shRNA) and a BCMA-targeting chimeric antigen receptor in development for the treatment of relapsed/refractory multiple myeloma (r/r MM). This non-gene editing technology, which does not permanently alter the genome integrity, is intended to decrease the potential safety risk associated with “off-target” genome modifications. This “All-in-One” Vector approach with one single transduction step avoids multiple genetic modifications and cost associated with additional GMP grade materials.

EHA 2021 ePoster Presentation Details:

The following abstract published today is now available on the EHA 2021 website. Following the presentation at the meeting, the posters will be available in the Scientific Publications section of Celyad Oncology’s website.

Title: Objective response at low dose in the first-in-human IMMUNICY-1 trial evaluating non-gene edited allogeneic CYAD-211 anti-BCMA CAR T product in relapsed or refractory multiple myeloma
Presenter: Dr. Sébastien Anguille, Antwerp University Hospital (UZA), Edegem, Belgium
Topic: Gene therapy, cellular immunotherapy and vaccination – Clinical
Date and Time: e-Poster available starting Friday, June 11, 2021 at 9:00 a.m. CEST
Abstract Number: EP739

About CYAD-211

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate for the treatment of r/r MM. CYAD-211 is engineered to co-express an anti-BCMA targeting chimeric antigen receptor and a single shRNA to knockdown the CD3ζ component of the T cell receptor complex.

About IMMUNICY-1 Phase 1 trial

The open-label, dose-escalation trial will evaluate the safety and clinical activity of CYAD-211 following cyclophosphamide and fludarabine preconditioning chemotherapy in patients with relapsed or refractory multiple myeloma. The trial will evaluate multiple dose levels of CYAD-211: 30×10⁶, 100×10⁶ and 300×10⁶ cells per infusion. For more information, please visit www.clinicaltrials.gov, study identifier number NCT04613557.

About Celyad Oncology SA

Celyad Oncology SA is a clinical-stage biotechnology company focused on the discovery and development of CAR T therapies for cancer. The Company is developing a pipeline of allogeneic (off-the-shelf) and autologous (personalized) CAR T cell therapy candidates for the treatment of both hematological malignancies and solid tumors. Celyad Oncology was founded in 2007 and is based in Mont-Saint-Guibert, Belgium and New York, NY. The Company has received funding from the Walloon Region (Belgium) to support the advancement of its CAR T cell therapy programs. For more information, please visit www.celyad.com.

Forward-Looking Statement

This release may contain forward-looking statements, within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may include statements regarding: the safety and clinical activity of Celyad Oncology’s pipelines and financial condition, results of operation and business outlook. Forward-looking statements may involve known and unknown risks and uncertainties which might cause actual results, financial condition, performance or achievements of Celyad Oncology to differ materially from those expressed or implied by such forward-looking statements. Such risk and uncertainty includes outcomes of the Phase 1 IMMUNICY-1 trial of CYAD-211. A further list and description of these risks, uncertainties and other risks can be found in Celyad Oncology’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in its Annual Report on Form 20-F filed with the SEC on March 24, 2021 and subsequent filings and reports by Celyad Oncology. These forward-looking statements speak only as of the date of publication of this document and Celyad Oncology’s actual results may differ materially from those expressed or implied by these forward-looking statements. Celyad Oncology expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

Investor and Media Contacts:

Sara Zelkovic
Communications & Investor Relations Director
Celyad Oncology
[email protected]

Daniel Ferry
Managing Director
LifeSci Advisors, LLC
[email protected]

Source: Celyad Oncology SA

May 12, 2021 4:04 pm

Acutus Medical Reports First Quarter 2021 Financial Results

CARLSBAD, Calif., May 12, 2021 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported results for the first quarter of 2021.

Recent Highlights:

Reported revenue of $3.6 million in the first quarter of 2021, compared to $1.6 million in the same quarter last year.
Increased worldwide installed base of second generation AcQMap consoles to 57 as of March 31, 2021, up from 51 at the end of the prior quarter – bringing the total installed base of AcQMap consoles to 62 as of March 31, 2021.
Commenced US IDE trial for the AcQBlate Force-Sensing Ablation Catheter and System.
Advanced AcQBlate Force-Sensing Ablation Catheter and System from limited to full market release in CE Mark countries.
Received US 510K clearance for AcQCross, a full suite of universal transseptal crossing devices.

“We are pleased with the progress on several key strategic initiatives, including improved revenue performance and commercial execution, the initiation of our US ablation therapy IDE clinical trial, and new product introductions. In the face of regional COVID-19 headwinds, our commercial teams are driving accelerated uptake for our complete guided ablation solutions globally,” said Vince Burgess, President and CEO of Acutus. “Our Europe direct organization and Biotronik partnership led the Company’s first quarter performance, and we continue to see strong execution from these teams. In the US, we are encouraged to see this part of our business gaining momentum as end-markets improve.”

First Quarter 2021 Financial Results

Revenue was $3.6 million for the first quarter of 2021, compared to $1.6 million in the first quarter last year. The improvement over the same quarter last year was driven by increased direct sales of Acutus disposables, sales of the AcQMap consoles, and distributor sales through the Company’s partner, Biotronik.

Gross margin on a GAAP basis was negative 94% for the first quarter of 2021, compared with negative 102% in the same quarter last year. During the quarter, the Company incurred charges for the write-off of excess and obsolete inventory related to the transition to fully in-house manufacturing and product line transition for its transseptal access crossing device portfolio as well as for certain short shelf-life products currently in inventory. These charges had a significant impact on gross margin in the quarter, and this is not expected to recur in subsequent periods.

Operating expenses on a GAAP basis were $24.5 million for the first quarter of 2021, compared with $16.0 million in the same quarter last year. The increase was driven by the expansion of Acutus’ commercial team in conjunction with its full commercial launch, increased general and administrative costs incurred associated with being a public company, and change in fair value of the contingent consideration related to the acquisition of Rhythm Xience.

Net loss on a GAAP basis was $29.2 million for the first quarter of 2021 and net loss per share was $1.04 on a weighted average basic and diluted outstanding share count of 28.0 million, compared to $18.1 million and a net loss per share of $25.84 on a weighted average basic and diluted outstanding share count of 0.7 million in the same period of the prior year. Excluding amortization of acquired intangibles, non-cash stock-based compensation expense, remeasurement of the warrant liability, and changes in the fair value of contingent consideration, the Company’s non-GAAP net loss for the first quarter of 2021 was $27.3 million, or $0.97 per share, compared to $19.0 million, or $1.11 per share, after giving effect to the pro forma conversion of convertible preferred stock for the first quarter of 2020.

Cash, cash equivalents, marketable securities and restricted cash were $106.9 million as of March 31, 2021.

Outlook and COVID-19

COVID-19 continues to create significant uncertainty in several markets that the Company serves, most notably in Western Europe and the UK. Procedure volumes are stabilizing in the US, although some hospital access restrictions remain in effect. The impact of COVID-19 was more acutely negative earlier in 2021, and this dynamic is reflected in the Company’s first quarter financial results. Management anticipates continued regional headwinds in 2021, particularly in the first half of the year. For the full year 2021, management continues to expect revenue to range between $22.0 million and $30.0 million. With respect to the second quarter of 2021, management expects revenue to range between $3.8 million and $5.0 million.

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. The Company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are primarily non-cash accounting line items unrelated to, and may not be indicative of, the Company’s core operating results. These non-GAAP financial measures, as Acutus calculates 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. Non-GAAP net loss is defined as net loss before income taxes, adjusted for stock-based compensation, amortization of acquisition-related intangibles, acquisition related costs, discontinued operations, asset impairments, non-operating items, restructuring charges, stock repurchases, and other adjustments. To the extent such non-GAAP financial measures are used in the future, the Company expects to calculate them using a consistent method from period to period. A reconciliation of the most directly comparable GAAP financial measure to the non-GAAP financial measure 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 will host a conference call to discuss the first quarter 2021 financial results after market close on Wednesday, May 12, 2021 at 1:30 p.m. Pacific Time / 4:30 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: 9151567. The live webinar can be accessed at https://ir.acutusmedical.com.

About Acutus Medical, Inc.

Acutus is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. 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 its products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase the Company’s 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 Acutus’ 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, Acutus undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Investor Contact:	Media Contact:
Caroline Corner	Holly Windler
Westwicke ICR	M: 619-929-1275
D: 415-314-1725	[email protected]
[email protected]

Acutus Medical, Inc.

Consolidated Balance Sheets

	March 31,			December 31,
(in thousands, except per share amounts)	2021			2020
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	8,631		$	25,234
Marketable securities, short-term		86,888			105,839
Restricted cash		150			150
Accounts receivable		2,477			2,160
Inventory		13,837			12,958
Prepaid expenses and other current assets		4,124			5,047
Total current assets		116,107			151,388

Marketable securities, long-term		11,225			8,726
Property and equipment, net		14,648			12,356
Right-of-use assets, net		1,480			1,669
Intangible assets, net		5,493			5,653
Goodwill		12,026			12,026
Other assets		967			717
Total assets	$	161,946		$	192,535

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	6,108		$	8,266
Accrued liabilities		8,808			7,308
Contingent consideration, short-term		2,600			5,400
Operating lease liabilities, short-term		955			933
Total current liabilities		18,471			21,907

Operating lease liabilities, long-term		875			1,134
Long-term debt		39,339			39,011
Contingent consideration, long-term		3,000			3,900
Total liabilities		61,685			65,952

Stockholders’ equity
Preferred stock, $0.001 par value		—			—
Common stock, $0.001 par value		28			28
Additional paid-in capital		490,369			487,290
Accumulated deficit		(390,196	)		(361,015	)
Accumulated other comprehensive income		60			280
Total stockholders’ equity		100,261			126,583
Total liabilities and stockholders’ equity	$	161,946		$	192,535

Acutus Medical, Inc.

Consolidated Statements of Operations and Comprehensive Loss

	Three Months Ended March 31,
(in thousands, except share and per share amounts)	2021			2020
	(unaudited)
Revenue	$	3,591		$	1,583

Costs and operating expenses:
Cost of products sold		6,955			3,194
Research and development		9,370			7,973
Selling, general and administrative		16,252			10,235
Change in fair value of contingent consideration		(1,153	)		(2,219	)
Total costs and operating expenses		31,424			19,183
Loss from operations		(27,833	)		(17,600	)

Other income (expense):
Change in fair value of warrant liability		—			581
Interest income		40			275
Interest expense		(1,388	)		(1,354	)
Total other expense, net		(1,348	)		(498	)
Loss before income taxes		(29,181	)		(18,098	)
Income tax benefit		—			—
Net loss	$	(29,181	)	$	(18,098	)

Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities		6			(27	)
Foreign currency translation adjustment		(226	)		(27	)
Comprehensive loss	$	(29,401	)	$	(18,152	)

Net loss per common share, basic and diluted	$	(1.04	)	$	(25.84	)
Weighted average shares outstanding, basic and diluted		28,031,686			700,505

Acutus Medical, Inc.

Consolidated Statements of Cash Flows

	Three Months Ended March 31,
(in thousands)	2021			2020
	(unaudited)
Cash flows from operating activities
Net loss	$	(29,181	)	$	(18,098	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		1,241			429
Amortization of intangible assets		160			110
Stock-based compensation expense		2,910			1,741
Amortization of premiums/(accretion of discounts) on marketable securities, net		412			(5	)
Amortization of debt issuance costs		328			154
Amortization of right-of-use assets		180			169
Change in fair value of warrant liability		—			(581	)
Change in fair value of contingent consideration		(1,153	)		(2,219	)
Changes in operating assets and liabilities:
Accounts receivable		(317	)		(708	)
Inventory		(879	)		(1,809	)
Prepaid expenses and other current assets		1,104			214
Other assets		(250	)		(267	)
Accounts payable		(2,091	)		3,602
Accrued liabilities		1,500			(83	)
Operating lease liabilities		(237	)		(207	)
Net cash used in operating activities		(26,273	)		(17,558	)

Cash flows from investing activities
Purchases of available-for-sale marketable securities		(9,135	)		—
Sales of available-for-sale marketable securities		—			8,100
Maturities of available-for-sale marketable securities		25,000			25,300
Purchases of property and equipment		(3,693	)		(1,683	)
Net cash provided by investing activities		12,172			31,717

Cash flows from financing activities
Payment of contingent consideration		(2,547	)		(2,584	)
Proceeds from stock options exercises		169			—
Net cash used in financing activities		(2,378	)		(2,584	)
Effect of exchange rate changes on cash, cash equivalents and restricted cash		(124	)		(27	)
Net change in cash, cash equivalents and restricted cash		(16,603	)		11,548
Cash, cash equivalents and restricted cash, at the beginning of the period		25,384			9,602
Cash, cash equivalents and restricted cash, at the end of the period	$	8,781		$	21,150

Acutus Medical, Inc.

Reconciliation of GAAP Results to Non-GAAP Results

(Unaudited)

Three Months Ended March 31, 2021	Cost of products sold			Selling, general and administrative			Research and development			Loss from operations			Other expenses, net			Net loss			Diluted EPS
Reported	$	6,955		$	16,252		$	9,370		$	(27,833	)	$	(1,348	)	$	(29,181	)	$	(1.04	)
Amortization of acquired intangibles		—			(160	)		—			160			—			160			0.01
Stock-based compensation		(157	)		(2,311	)		(442	)		2,910			—			2,910			0.10
Change in fair value of contingent consideration		—			—			—			(1,153	)		—			(1,153	)		(0.04	)
Adjusted	$	6,798		$	13,781		$	8,928		$	(25,916	)	$	(1,348	)	$	(27,264	)	$	(0.97	)

Three Months Ended March 31, 2020	Cost of products sold			Selling, general and administrative			Research and development			Loss from operations			Other expenses, net			Net loss			Diluted EPS
Reported	$	3,194		$	10,235		$	7,973		$	(17,600	)	$	(498	)	$	(18,098	)	$	(25.84	)
Adjustment for assumed conversion of convertible preferred stock		—			—			—			—			—			—			24.78
Amortization of acquired intangibles		—			(110	)		—			110			—			110			0.01
Stock-based compensation		(108	)		(1,422	)		(211	)		1,741			—			1,741			0.10
Change in fair value of contingent consideration		—			—			—			(2,219	)		—			(2,219	)		(0.13	)
Change in fair value of warrant liability		—			—			—			—			(581	)		(581	)		(0.03	)
Adjusted	$	3,086		$	8,703		$	7,762		$	(17,968	)	$	(1,079	)	$	(19,047	)	$	(1.11	)

Three Months Ended June 30, 2020	Cost of products sold			Selling, general and administrative			Research and development			Loss from operations			Other expenses, net			Net loss			Diluted EPS
Reported	$	2,663		$	9,125		$	8,176		$	(19,465	)	$	(3,728	)	$	(23,193	)	$	(32.24	)
Adjustment for assumed conversion of convertible preferred stock		—			—			—			—			—			—			30.90
Amortization of acquired intangibles		—			(110	)		—			110			—			110			0.01
Stock-based compensation		(58	)		(981	)		(118	)		1,157			—			1,157			0.07
Change in fair value of contingent consideration		—			—			—			635			—			635			0.04
Change in fair value of warrant liability		—			—			—			—			2,453			2,453			0.14
Adjusted	$	2,605		$	8,034		$	8,058		$	(17,563	)	$	(1,275	)	$	(18,838	)	$	(1.08	)

Three Months Ended September 30, 2020	Cost of products sold			Selling, general and administrative			Research and development			Loss from operations			Other expenses, net			Net loss			Diluted EPS
Reported	$	5,141		$	15,833		$	8,343		$	(26,262	)	$	(5,026	)	$	(31,288	)	$	(1.95	)
Adjustment for assumed conversion of convertible preferred stock		—			—			—			—			—			—			0.61
Amortization of acquired intangibles		—			(110	)		—			110			—			110			—
Stock-based compensation		(127	)		(6,008	)		(239	)		6,374			—			6,374			0.27
Change in fair value of contingent consideration		—			—			—			118			—			118			0.01
Change in fair value of warrant liability		—			—			—			—			3,683			3,683			0.16
Adjusted	$	5,014		$	9,715		$	8,104		$	(19,660	)	$	(1,343	)	$	(21,003	)	$	(0.90	)

Three Months Ended December 31, 2020	Cost of products sold			Selling, general and administrative			Research and development			Loss from operations			Other expenses, net			Net loss			Diluted EPS
Reported	$	4,891		$	15,164		$	8,962		$	(28,006	)	$	(1,373	)	$	(29,402	)	$	(1.05	)
Income tax expense		—			—			—			—			23			23			—
Amortization of acquired intangibles		—			(127	)		—			127			—			127			—
Stock-based compensation		(147	)		(2,378	)		(305	)		2,831			—			2,831			0.10
Change in fair value of contingent consideration		—			—			—			1,563			—			1,563			0.06
Adjusted	$	4,744		$	12,659		$	8,657		$	(23,485	)	$	(1,350	)	$	(24,858	)	$	(0.89	)

	Three Months Ended
	March 31,				June 30,		September 30,		December 31,
	2021		2020		2020		2020		2020
Denominator
Weighted average shares of common stock outstanding used in GAAP per share calculations		28,031,686		700,505		719,421		16,080,467		27,897,224
Adjustments to reflect the assumed conversion of convertible preferred stock (1)		—		16,409,293		16,572,935		7,205,624		—
Shares used in non-GAAP per share calculations		28,031,686		17,109,798		17,292,356		23,286,091		27,897,224

(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.

Acutus Medical, Inc.

Key Business Metrics

Installed Base

The total installed base as of March 31, 2021 and 2020 is set forth in the table below:

	As of March 31,
	2021		2020
	(unaudited)
Acutus Direct
US		39		13
Europe		16		18
Total Acutus Direct		55		31
Biotronik		7		—
Total installed base		62		31

The net increase in installed base for the three months ended March 31, 2021 and 2020, exclusive of transfers between Acutus and Biotronik, is set forth in the table below:

	Three Months Ended March 31,
	2021		2020
	(unaudited)
Acutus Direct
US		2		3
Europe		2		1
Total Acutus Direct		4		4

Net systems to Biotronik		—		—
Total net system placements		4		4

Revenue

The following table sets forth the Company’s revenue for disposables, systems, and service/other for the three months ended March 31, 2021 and 2020 (in thousands):

	Three Month Ended March 31,
	2021		2020
	(unaudited)
Acutus Direct
Disposables	$	1,783	$	1,017
Systems		613		520
Service/Other		35		10
Total Acutus direct revenue		2,431		1,547
Distribution agreements		1,160		36
Total revenue	$	3,591	$	1,583

The following table provides revenue by geographic location for the three months ended March 31, 2021 and 2020 (in thousands):

	Three Months Ended March 31,
	2021		2020
	(unaudited)
Acutus Direct
United States	$	1,468	$	770
Europe		963		777
Total Acutus direct revenue		2,431		1,547
Distribution Agreements
United States		113		—
Europe		1,047		36
Total revenue through distribution		1,160		36
Total revenue	$	3,591	$	1,583



Eargo, Inc. Consolidated Balance Sheets *(Unaudited)* ( *In thousands, except share and per share amounts* )

	March 31,			December 31,
		2021			2020
ASSETS
Current assets:
Cash and cash equivalents	$	201,624		$	212,185
Accounts receivable, net		5,339			3,793
Inventories		2,463			2,739
Prepaid expenses and other current assets		3,175			3,740
Total current assets		212,601			222,457
Operating lease right-of-use assets		1,218			1,079
Property and equipment, net		8,924			8,034
Other assets		1,086			1,062
Total assets	$	223,829		$	232,632
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	6,604		$	6,020
Accrued expenses		10,992			13,909
Other current liabilities		3,950			2,448
Deferred revenue, current portion		173			311
Lease liability, current portion		1,050			1,030
Total current liabilities		22,769			23,718
Lease liability, noncurrent portion		263			166
Long-term debt, noncurrent portion		14,940			14,837
Total liabilities		37,972			38,721
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value per share; 5,000,000 shares authorized
as of March 31, 2021 and December 31, 2020, respectively; zero shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively		—			—
Common stock; $0.0001 par value; 110,000,000 shares authorized
as of March 31, 2021 and December 31, 2020, respectively; 38,298,068 and 38,246,601 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively		4			4
Additional paid in capital		398,532			392,965
Accumulated deficit		(212,679	)		(199,058	)
Total stockholders’ equity		185,857			193,911
Total liabilities and stockholders’ equity	$	223,829		$	232,632

Eargo, Inc. Consolidated Statements of Operations and Comprehensive Loss *(Unaudited)* ( *In thousands, except share and per share amounts* )

	Three months ended March 31,
		2021			2020
Revenue, net	$	22,048		$	12,669
Cost of revenue		6,297			4,656
Gross profit		15,751			8,013
Operating expenses:
Research and development		4,778			2,809
Sales and marketing		16,855			10,859
General and administrative		7,487			6,078
Total operating expenses		29,120			19,746
Loss from operations		(13,369	)		(11,733	)
Other income (expense), net:
Interest income		11			21
Interest expense		(263	)		(266	)
Other income (expense), net		—			240
Total other income (expense), net		(252	)		(5	)
Loss before income taxes		(13,621	)		(11,738	)
Income tax provision		—			—
Net loss and comprehensive loss	$	(13,621	)	$	(11,738	)
Net income (loss) attributable to common stockholders, basic and diluted	$	(13,621	)	$	(11,738	)
Net income (loss) per share attributable to common stockholders, basic and diluted	$	(0.36	)	$	(43.76	)
Weighted-average shares used in computing net income (loss) per
share attributable to common stockholders, basic and diluted		38,283,360			268,214

Eargo, Inc. Results of Operations – Reconciliation between GAAP and Non-GAAP *(Unaudited)* ( *In thousands, except per share amounts* )

Reconciliation between GAAP and non-GAAP net loss per share attributable to common stockholders:
	Three months ended March 31,
		2021			2020
GAAP net loss per share to common stockholders, basic and diluted	$	(0.36	)	$	(43.76	)
Stock-based compensation		0.14			1.95
Non-GAAP net loss per share to common stockholders, basic and diluted	$	(0.22	)	$	(41.81	)


Reconciliation between GAAP and non-GAAP net loss attributable to common stockholders:
	Three months ended March 31,
		2021			2020
GAAP net loss attributable to common stockholders, basic and diluted	$	(13,621	)	$	(11,738	)
Stock-based compensation		5,131			525
Non-GAAP net loss attributable to common stockholders, basic and diluted	$	(8,490	)	$	(11,213	)


Reconciliation between GAAP and non-GAAP gross profit and gross margin:
	Three months ended March 31,
		2021			2020
GAAP gross profit	$	15,751		$	8,013
Stock-based compensation		186			5
Non-GAAP gross profit	$	15,937		$	8,018

GAAP gross margin		71.4	%		63.2	%
Stock-based compensation		0.8	%		0.0	%
Non-GAAP gross margin		72.2	%		63.2	%


Reconciliation between GAAP and non-GAAP operating expenses and operating loss:

	Three months ended March 31,
		2021			2020
GAAP research and development expense	$	4,778		$	2,809
Stock-based compensation		(1,067	)		(164	)
Non-GAAP research and development expense	$	3,711		$	2,645

GAAP sales and marketing expense	$	16,855		$	10,859
Stock-based compensation		(1,856	)		(123	)
Non-GAAP sales and marketing expense	$	14,999		$	10,736

GAAP general and administrative expense	$	7,487		$	6,078
Stock-based compensation		(2,022	)		(233	)
Non-GAAP general and administrative expense	$	5,465		$	5,845

GAAP total operating expense	$	29,120		$	19,746
Stock-based compensation		(4,945	)		(520	)
Non-GAAP total operating expense	$	24,175		$	19,226

GAAP operating loss	$	(13,369	)	$	(11,733	)
Stock-based compensation		5,131			525
Non-GAAP operating loss	$	(8,238	)	$	(11,208	)

Reconciliation between GAAP and non-GAAP full year 2021 forecasted gross margin
	Low			High
Forecasted 2021 GAAP gross margin		68%			71%
Estimated impact of stock-based compensation		2.0%			1.0%
Forecasted 2021 non-GAAP gross margin		70%			72%