Market Newsdesk

• Q4 total revenues up 13.7% sequentially and 28.4% year-over-year to a record $834.5 million
• Q4 diluted net income per share of $2.00, Q4 non-GAAP diluted net income per share of $2.61
• Q4 operating margin of 25.5%, up 1.4 points sequentially and up 2.3 points year-over-year
• Q4 Clear Aligner revenues up 12.9% sequentially and 28.9% year-over-year to a record $700.7 million
• Q4 Clear Aligner volume up 14.5% sequentially and 37.3% year-over-year to 568.0 thousand cases
• Q4 Clear Aligner volume for teenage patients was 160.9 thousand cases, up 38.7% year-over-year
• Q4 Imaging Systems and CAD/CAM Services revenues were up 18.0% sequentially and 26.0% year-over-year to a record $133.8 million
• 2020 total revenues up 2.7% to a record $2.5 billion, Clear Aligner revenues a record $2.1 billion

TEMPE, Ariz., Feb. 03, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the fourth quarter (“Q4’20”) and year ended December 31, 2020. Q4’20 total revenues were $834.5 million, up 28.4% year-over-year. Q4’20 Clear Aligner revenues were $700.7 million, up 28.9% year-over-year and Q4’20 Imaging Systems and CAD/CAM Services revenues were $133.8 million, up 26.0% year-over-year. Q4’20 Clear Aligner volume was 568.0 thousand cases, up 37.3% year-over-year. For the Americas and International regions, Q4’20 Clear Aligner volume was up 34.1% and up 41.1% year-over-year, respectively. Q4’20 Clear Aligner volume for teenage patients was 160.9 thousand cases, up 38.7% year-over-year. Q4’20 operating income of $213.2 million was up 41.0% year-over-year, resulting in an operating margin of 25.5%. Q4’20 GAAP net income was $159.0 million, or $2.00 per diluted share. On a non-GAAP basis, Q4’20 net income was $207.7 million, or $2.61 per diluted share.

Commenting on Align’s Q4’20 and 2020 results, Align Technology President and CEO Joe Hogan said, “Our fourth quarter was a strong finish to the year — with record revenues and volumes from both Invisalign aligners and iTero scanners, as well as increased gross margins, operating margins, EPS, and cash flow. Our Q4 performance was driven by strong year-over-year growth across customer channels and regions and continued momentum sequentially. Q4 reflects increased Invisalign adoption from both adults and teenagers, which were up 36.7% and 38.7% year-over-year, respectively. Our Teen and Mom-focused consumer campaign generated a +77% year-over-year increase in unique visitors to our website and a 76% increase in leads generated. In addition, Invisalign social media influencers like Charli D’ Amelio, Marsai Martin, Christina Milian, Tisha Campbell-Martin, Rachel Zoe, Tiffany Ma, and Tahj Mowry continued to deliver exciting new content and increased engagement for the Invisalign brand with consumers and among their millions of followers.”

For 2020, total revenues were a record $2.5 billion, up 2.7% year-over-year. Record 2020 Clear Aligner revenues were $2.1 billion, up 3.7% year-over-year and record Clear Aligner volume was 1.6 million cases, up 7.0% year-over-year. 2020 Imaging Systems and CAD/CAM Services revenues were $370.5 million, down 2.8% year-over-year. 2020 Invisalign cases for teenage patients were 498.2 thousand, up 11.5% year-over-year. 2020 net income was $1,775.9 million, or $22.41 per diluted share. On a non-GAAP basis, 2020 net income was $415.9 million, or $5.25 per diluted share.

Continued Hogan, “2020 was a year unlike any other that we have experienced. The COVID-19 pandemic and its impact have been life-changing – marked by loss and separation, recovery and renewal, record highs and lows, and significant milestones and accomplishments even in a time of huge disruption. Despite the swift onset of the pandemic and uncertainty throughout 2020, we didn’t halt our plans or change our strategy for continued growth. We completed the acquisition and integration of exocad; accelerated our investments in marketing to create Invisalign brand awareness and drive consumer demand for our doctors’ offices; accelerated new technology to market with virtual tools that enabled our doctors to stay connected with their patients; provided PPE to those in need; and supported doctors and their teams with online education and digital forums that went beyond products to help them navigate the uncertainties of the pandemic. As a result of our continued strategic focus and investments, we exited the year stronger than we started and 2021 is off to a great start.”

Financial Summary – Fourth Quarter Fiscal 2020

	Q4’20		Q3’20		Q4’19
Invisalign Case Shipments 1		567,950		496,065		413,715
GAAP
Net Revenues	$834.5M		$734.1M		$649.8M
Clear Aligner 2	$700.7M		$620.8M		$543.6M
Imaging Systems & CAD/CAM Services	$133.8M		$113.4M		$106.2M
Net Income	$159.0M		$139.4M		$121.3M
Diluted EPS	$ 2.00		$1.76		$1.53
Non-GAAP
Net Income	$207.7M		$177.9M		$139.4M
Diluted EPS	$ 2.61		$2.25		$1.76

Financial Summary – Fiscal 2020

		2020		2019
Invisalign Case Shipments 1		1,645,335		1,525,415
GAAP
Net Revenues	$2,471.9M		$2,406.8M
Clear Aligner 2	$2,101.5M		$2,025.8M
Imaging Systems & CAD/CAM Services	$370.5M		$381.0M
Net Income	$1,775.9M		$442.8M
Diluted EPS	$ 22.41		$5.53
Non-GAAP
Net Income	$415.9M		$478.3M
Diluted EPS	$ 5.25		$5.97

¹

Invisalign shipments do not include SmileDirectClub (
“
SDC
“
) aligners.


² Clear Aligner revenues include Invisalign clear aligners and SDC aligners. The supply agreement with SDC terminated on December 31, 2019, and was not renewed.

As of December 31, 2020, Align had $960.8 million in cash and cash equivalents and marketable securities, short-term, compared to $868.6 million as of December 31, 2019. Additionally, we have $100.0 million remaining available for repurchase of our common stock under our May 2018 Repurchase Program.

2020 Announcement Highlights:

• Align achieved a major milestone in EMEA with the shipment to our 2 millionth Invisalign patient, that we will amplify with an EMEA-wide campaign that will launch next month. This milestone for EMEA reflects strong acceleration in Invisalign adoption and growth.
• Align established its new global corporate headquarters in Tempe, Arizona, effective January 1, 2021. The Company’s San Jose, California campus remains the hub for its global innovation, product, and marketing organization and will become home to its new Digital Innovation Center, currently under construction.
• Align closed the acquisition of privately held exocad, a global leader in the dental CAD/CAM software market that offers fully integrated workflows to dental labs and dental practices via a broad customer base of partners and resellers in over 150 countries. The acquisition of exocad broadens Align’s digital platform reach by adding technology that addresses restorative needs in an end-to-end digital platform workflow to facilitate ortho-restorative and comprehensive dentistry. The acquisition brings exocad’s expertise in restorative dentistry, implantology, guided surgery, and smile design to the Align technology portfolio.
• Align celebrated its 1 millionth Invisalign patient milestone in the Asia Pacific region. The 1 millionth Invisalign patient from the Asia Pacific region is Ayumu Saito, a 23-year-old aspiring Olympic athlete from Japan who is a modern pentathlon champion (2019), fencer, and fashion model. Ayumu is in treatment with Dr. Koji Yokoya, head director at Aoyama Gaien Orthodontics Dental Offices in Tokyo.
• Align announced an agreement with the National Football League (“NFL”) to make the Invisalign brand the Official Clear Aligner Sponsor of the NFL. Through this agreement, the Invisalign brand will connect doctors, patients, and consumers through an extended network of NFL sponsored channels and support a variety of community initiatives championed by NFL Clubs, including youth-focused programs. This agreement builds on Align’s previously announced Club sponsorship agreements with the New England Patriots and the San Francisco 49ers and expands the Invisalign brand’s “Official Smile” designation to 11 individual NFL Clubs with the Dallas Cowboys, New Orleans Saints, Green Bay Packers, New York Giants, Kansas City Chiefs, Houston Texans, Philadelphia Eagles, Tampa Bay Buccaneers, and the Chicago Bears. 
• Align announced a multi-year partnership with the New Orleans Saints, making the Invisalign brand the “Official Smile” partner of the Saints. The collaboration will focus on building awareness and generating demand for Invisalign treatment across social and digital platforms to engage consumers and highlight the benefits of in-office, doctor-delivered clear aligner treatment. Additionally, the Invisalign brand and the Saints have teamed up with defensive end Cam Jordan to bring more smiles to teens and young adults through the Youth Empowerment Project (“YEP”).
• Align announced the global launch of the Align Digital and Practice Transformation (“ADAPT”) service for Invisalign and iTero doctors. ADAPT is an expert and independent fee-based business consulting service offered by Align to optimize practices’ operational workflow and processes to enhance patients’ experiences and customer and staff satisfaction, which will, in turn, translate into higher growth and greater efficiencies for orthodontic practices. The goal of ADAPT is to support digital practice transformation for Invisalign doctors and their staff.
• Align awarded nine research grants totaling $225,000 under the Company’s eleventh Annual Research Award Program. The funded research studies cover a wide range of topics for projects seeking to better understand treatment in orthodontics and dentistry. The global interest in research of dental and orthodontic treatment continues to grow, as evidenced by the increasing number of applications Align receives each year from universities worldwide.
• Align announced the 2 millionth Invisalign teen patient, reflecting accelerating adoption in the largest segment of the orthodontic market. The 2 millionth teen Invisalign patient, Kaitlynn Ratliff, is a student and athlete who started her Invisalign treatment in January 2020. She’s being treated by Dr. Tom Hartsock of Hartsock and Sword Orthodontics in Pikeville, Kentucky. Dr. Hartsock is an Invisalign provider who specializes in teen treatment with Invisalign aligners and with the iTero scanner.
• Align announced our partnership with MedTech Innovator Asia Pacific, the premier nonprofit startup accelerator in the medical technology industry. MedTech Innovator matches healthcare industry leaders with innovative medtech startups for mentorship and support. Support for the program underscores Align’s commitment to advancing health solutions and improving the lives of patients in the Asia Pacific Region.
• Align announced the following contributions towards relief efforts in response to COVID-19:
  – Pledged RMB 1 million donation to the Chinese Red Cross Foundation to support its ongoing prevention and control efforts for the outbreak in China.
  – The Align Technology Foundation, Align’s donor-advised fund through Fidelity Charitable, pledged US $1 million donation to support relief efforts globally. In addition, Align donated personal protective equipment (PPE) such as N95 masks, working with partners to source supplies for any additional PPE to help hospitals and healthcare providers treating patients with COVID-19. As the world’s largest manufacturer of custom 3D-printed materials, Align also reached out to public and private sector organizations to offer its technology expertise and counsel on ways to reduce the scarcity of parts and materials for public health needs.

Product

• Align announced the launch of the iTero Element Plus Series next generation of scanners and imaging systems. The Series of new solutions feature advanced technology and capabilities designed to improve the scanning experience, increase practice productivity, and drive higher patient treatment conversion. The new iTero Element Plus Series of scanners and imaging systems builds on the success of the award-winning iTero Element family of scanners and offers all of the existing orthodontic and restorative digital capabilities doctors have come to rely on — plus faster processing time and advanced visualization capabilities for a seamless scanning experience in a new sleek, ergonomically designed package. Available in both cart and mobile configurations, the iTero Element Plus Series offers increased flexibility and mobility. The mobile configuration makes the power of the iTero Element Plus Series portable with a medical grade, compact mobile scanner solution that delivers the same high-quality images as the cart configuration.
• Align announced the launch and then the global commercial availability of Invisalign G8 with SmartForce^® Aligner Activation, the latest of the Company’s biomechanics innovations. Invisalign G8 with SmartForce Aligner Activation is informed by the Company’s foundational biomechanics for clear aligners and its database of more than 9 million Invisalign patients to optimize tooth movements and further improve predictability for frequently treated crowding, crossbite, and deep bite cases.
• Align announced the commercial availability of its previously announced ClinCheck™ Pro 6.0 proprietary treatment planning software, which was featured at the Align APAC Virtual Symposium on October 16, a fully digital event that showcased digital treatment techniques and featured practitioners from across the Asia Pacific region. ClinCheck Pro 6.0 software provides doctors with a 3D model of planned tooth movements throughout Invisalign treatment. ClinCheck Pro 6.0 software moves Invisalign digital treatment planning to the cloud, making its robust ClinCheck treatment planning tools and features available to doctors anytime, anywhere, on any laptop, personal computer, or tablet. The release includes the new ClinCheck “In-Face” Visualization tool, an enhanced doctor-facing digital clinical tool that combines a photo of the patient’s face with their 3D Invisalign treatment plan, creating a personalized view of how their new smile could look.
• Align introduced virtual solutions to connect doctors and existing Invisalign patients for continuity of care. Invisalign^® Virtual Appointment and Invisalign^® Virtual Care represent the next level in practice and care transformation, enabling doctors to manage a range of practice services even when they are not in the same physical location as their patients.
• Align announced the launch of Invisalign Stickables, innovative sticker accessories exclusively for use with the patented SmartTrack^® material in Invisalign clear aligners designed to personalize Invisalign clear aligners. Available in an array of designs, colors, shapes, and themes, Invisalign Stickables are a cool, engaging, and fun way for patients to show their personal flair during Invisalign treatment. Invisalign Stickables patent-pending accessories are available in the U.S. and Canada and are expected to be introduced in other countries in 2021. Invisalign providers can purchase Invisalign Stickables through the Webstore in Invisalign Doctor Site. Invisalign Stickables are also available to Invisalign patients at participating doctor offices or online through the Invisalign accessories site https://www.invisalignaccessories.com/.
• Align announced that the iTero Element 5D Imaging System was awarded “Best New Technology Solution for Dentistry” from MedTech Breakthrough, an independent market intelligence organization that recognizes the top technology product companies in the global health and medical technology market. The iTero Element 5D, the latest innovation in the iTero product portfolio, is the first integrated dental imaging system that simultaneously records 3D intra-oral optical impressions, 2D color images, and Near Infrared images (NIRI).
• Align launched ClinCheck^® “In-Face” visualization tool for the Invisalign Go system, Align’s innovative tooth movement system designed for general dentists. The ClinCheck In-Face Visualization tool enhances the digital treatment planning experience for doctors and their patients by incorporating a front-facing smile image of a patient’s face into their ClinCheck treatment plan.
• Received U.S. Food and Drug Administration (FDA) 510(K) clearance for the award-winning iTero Element 5D Imaging System for commercial availability in the United States. The iTero Element 5D Imaging System expands the suite of existing high-precision, full-color imaging and fast scan times of the iTero Element intraoral scanner portfolio with a new clinical approach, optimized orthodontic and restorative dental workflows, and an improved doctor experience.

Align Web Cast and Conference Call

Align will host a conference call today, February 3, 2021, at 4:30 p.m. ET, 2:30 p.m. MT, to review its fourth quarter and full-year 2020 results, discuss future operating trends and the business outlook. The conference call will also be webcast live via the Internet. To access the webcast, go to the “Events & Presentations” section under Company Information on Align’s Investor Relations web site at http://investor.aligntech.com. To access the conference call, please dial 201-689-8261. An archived audio webcast will be available beginning approximately one hour after the call’s conclusion and will remain available for approximately one month. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with conference number 13714292 followed by #. For international callers, please dial 201-612-7415 and use the same conference number referenced above. The telephonic replay will be available through 5:30 p.m. ET on February 17, 2021.

About Non-GAAP Financial Measures


To supplement our condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (“GAAP”), we may provide investors with certain non-GAAP financial measures for gross profit, gross margin, operating expenses, income from operations, operating margin, interest income and other income (expense), net, net income before provision for (benefit from) income taxes, effective tax rate, net income and diluted net income per share, which exclude certain items that may not be indicative of our fundamental operating performance including discrete cash and non-cash charges or gains that are included in the most directly comparable GAAP measure. Non-GAAP measures will exclude the effects of stock-based compensation, amortization of acquired intangibles, non-cash deferred tax assets and associated amortization related to the intra-entity transfer of non-inventory assets, acquisition-related costs, impairments and other (gains) charges, and litigation settlement gains, and, if applicable, any associated tax impacts.

We use non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our recurring core operating performance. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. These non-GAAP financial measures also facilitate management’s internal evaluation of period-to-period comparisons. We believe these non-GAAP financial measures are useful to investors both because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they will be provided to and used by our institutional investors and the analyst community to help them analyze the performance of our business.

There are limitations to using non-GAAP financial measures, though, because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. The non-GAAP financial measures are limited in value because they exclude certain items that may have a material impact upon our reported financial results. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management about which charges are excluded from the non-GAAP financial measures. We compensate for these limitations by analyzing current and future results on a GAAP as well as a non-GAAP basis and also by providing GAAP measures in our public disclosures. The presentation of non-GAAP financial information is meant to be considered in addition to, not as a substitute for or in isolation from, the directly comparable financial measures prepared in accordance with GAAP. We urge investors to review the reconciliation of our GAAP financial measures to the comparable Non-GAAP financial measures included in this presentation and not to rely on any single financial measure to evaluate our business. For more information on these non-GAAP financial measures, please see the table captioned “Unaudited GAAP to Non-GAAP Reconciliation.”

About Align Technology, Inc.

Align Technology designs and manufactures the Invisalign^® system, the most advanced clear aligner system in the world, iTero^® intraoral scanners and services, and exocad CAD/CAM software. Align has helped treat over 9.6 million patients with the Invisalign system and is driving the evolution in digital dentistry with the iTero intraoral scanner and exocad CAD/CAM software − modernizing today’s practices by enabling enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Forward-Looking Statements

This news release contains forward-looking statements, including quotations from management regarding business and product momentum, the COVID-19 pandemic and its impact on our business and results of operations, our expectations for digital adoption in dentistry and the potential impact of our products in the transition, our expectations for our marketing activities, and our expectations for our new products, features, and accessories and their availability. Forward-looking statements contained in this news release relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Factors that might cause such a difference include, but are not limited to:

• the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers, as well as the physical and economic impacts of the various recommendations, orders, and protocols issued by local and national governmental agencies in light of continual evolution of the pandemic, including any periodic reimplementation of preventative measures in various global locations;
• difficulties predicting customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages, and consumer confidence, particularly in light of the pandemic;
• unexpected or rapid changes in the growth or decline of our domestic and/or international markets;
• increasing competition from existing and new competitors;
• rapidly evolving and groundbreaking advances that fundamentally alter the dental industry or the way new and existing customers market and provide products and services to consumers;
• the ability to protect our intellectual property rights;
• continued compliance with regulatory requirements;
• declines in, or the slowing of the growth of, sales of our intra-oral scanners domestically and/or internationally and the impact either would have on the adoption of Invisalign products;
• the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers;
• the possibility that the development and release of new products or enhancements to existing products do not proceed in accordance with the anticipated timeline or may themselves contain bugs or errors requiring remediation and that the market for the sale of these new or enhanced products may not develop as expected;
• a tougher consumer demand environment in China generally, especially for manufacturers and service providers whose headquarters or primarily operations are not based in China;
• the risks relating to our ability to sustain or increase profitability or revenue growth in future periods (or minimize declines) while controlling expenses;
• the impact of excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel;
• the compromise of customer and/or patient data for any reason;
• the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case;
• foreign operational, political and other risks relating to our international manufacturing operations; and
• the loss of key personnel or work stoppages.

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission (SEC) on February 28, 2020, and its latest Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the SEC on October 30, 2020. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason. 

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
		Three Months Ended December 31,						Year Ended December 31,
		2020			2019				2020				2019
Net revenues		$	834,520		$	649,787		$	2,471,941			$	2,406,796
Cost of net revenues			224,057			177,829			708,706				662,899
Gross profit			610,463			471,958			1,763,235				1,743,897
Operating expenses:
Selling, general and administrative			348,392			279,481			1,200,757				1,072,053
Research and development			48,887			41,327			175,307				157,361
Impairments and other (gains) charges			–			–			–				22,990
Litigation settlement gain			–			–			–				(51,000	)
Total operating expenses			397,279			320,808			1,376,064				1,201,404
Income from operations			213,184			151,150			387,171				542,493
Interest income and other income (expense), net:
Interest income			337			2,906			3,125				12,482
Other income (expense), net			1,021			1,741			(11,347	)			7,676
Total interest income and other income (expense), net			1,358			4,647			(8,222	)			20,158
Net income before provision for (benefit from) income taxes and equity in losses of investee			214,542			155,797			378,949				562,651
Provision for (benefit from) income taxes			55,554			34,535			(1,396,939	)			112,347
Equity in losses of investee, net of tax			–			–			–				7,528
Net income		$	158,988		$	121,262		$	1,775,888			$	442,776
Net income per share:
Basic		$	2.02		$	1.54		$	22.55			$	5.57
Diluted		$	2.00		$	1.53		$	22.41			$	5.53
Shares used in computing net income per share:
Basic			78,853			78,578			78,760				79,424
Diluted			79,505			79,137			79,230				80,100

 

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
		December 31, 2020			December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents		$	960,843		$	550,425
Marketable securities, short-term			–			318,202
Accounts receivable, net			657,704			550,291
Inventories			139,237			112,051
Prepaid expenses and other current assets			91,754			102,450
Total current assets			1,849,538			1,633,419
Property, plant and equipment, net			734,721			631,730
Operating lease right-of-use assets, net			82,553			56,244
Goodwill			444,817			63,924
Intangible assets, net			130,072			11,768
Deferred tax assets			1,552,831			64,007
Other assets			35,151			39,610
Total assets		$	4,829,683		$	2,500,702
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	142,132		$	87,250
Accrued liabilities			405,582			319,958
Deferred revenues			777,887			563,762
Total current liabilities			1,325,601			970,970
Income tax payable			105,748			102,794
Operating lease liabilities			64,445			43,463
Other long-term liabilities			100,024			37,306
Total liabilities			1,595,818			1,154,533
Total stockholders’ equity			3,233,865			1,346,169
Total liabilities and stockholders’ equity		$	4,829,683		$	2,500,702

ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
		Year Ended December 31,
			2020				2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net cash provided by operating activities		$	662,174			$	747,270
CASH FLOWS FROM INVESTING ACTIVITIES
Net cash used in investing activities			(231,506	)			(350,444	)
CASH FLOWS FROM FINANCING ACTIVITIES
Net cash used in financing activities			(30,808	)			(485,540	)
Effect of foreign exchange rate changes on cash, cash equivalents, and restricted cash			10,480				2,282
Net increase (decrease) in cash, cash equivalents, and restricted cash			410,340				(86,432	)
Cash, cash equivalents, and restricted cash at beginning of the period			551,134				637,566
Cash, cash equivalents, and restricted cash at end of the period		$	961,474			$	551,134

ALIGN TECHNOLOGY, INC.
INVISALIGN BUSINESS METRICS*
			Q1				Q2				Q3				Q4				Fiscal				Q1				Q2				Q3				Q4				Fiscal
			2019				2019				2019				2019				2019				2020				2020				2020				2020				2020
Invisalign Average Selling Price (ASP):
	Worldwide ASP		$	1,245			$	1,230			$	1,260			$	1,240			$	1,245			$	1,255			$	1,255			$	1,180			$	1,165			$	1,200
	International ASP		$	1,330			$	1,305			$	1,330			$	1,300			$	1,315			$	1,340			$	1,285			$	1,240			$	1,255			$	1,270
Invisalign Cases Shipped by Geography:
	Americas			202,935				211,360				215,355				225,925				855,575				213,505				100,995				268,970				302,995				886,465
	International			146,260				165,785				170,005				187,790				669,840				145,935				120,885				227,095				264,955				758,870
	Total Cases Shipped			349,195				377,145				385,360				413,715				1,525,415				359,440				221,880				496,065				567,950				1,645,335
	YoY % growth			28.3 %				24.6 %				20.7 %				23.9 %				24.2 %				2.9 %				-41.2%				28.7 %				37.3 %				7.9 %
	QoQ % growth			4.6 %				8.0 %				2.2 %				7.4 %								-13.1%				-38.3%				123.6 %				14.5 %
Number of Invisalign Doctors Cases Were Shipped To:
	Americas			30,200				31,445				31,975				33,130				47,130				32,315				22,165				34,625				38,165				49,615
	International			26,510				28,970				30,980				33,720				48,650				28,535				25,945				35,380				38,585				52,445
	Total Doctors Cases Shipped To			56,710				60,415				62,955				66,850				95,780				60,850				48,110				70,005				76,750				102,060
Invisalign Doctor Utilization Rates**:
	North America			7.0				7.0				7.0				7.2				19.4				6.9				4.8				8.4				8.7				19.8
	North American Orthodontists			18.3				18.9				19.1				19.3				65.0				18.9				11.0				24.1				25.0				67.3
	North American GP Dentists			3.6				3.6				3.5				3.8				9.5				3.6				2.5				4.2				4.5				9.6
	International			5.5				5.7				5.5				5.6				13.8				5.1				4.7				6.4				6.9				14.5
	Total Utilization Rates			6.2				6.2				6.1				6.2				15.9				5.9				4.6				7.1				7.4				16.1
Number of Invisalign Doctors Trained:
	Americas			1,840				3,070				2,760				2,095				9,765				2,035				1,140				3,350				2,550				9,075
	International			2,410				3,520				3,135				3,445				12,510				2,600				2,350				3,175				3,900				12,025
	Total Doctors Trained Worldwide			4,250				6,590				5,895				5,540				22,275				4,635				3,490				6,525				6,450				21,100
	Total to Date Worldwide			156,205				162,795				168,690				174,230				174,230				178,865				182,355				188,880				195,330				195,330
* Invisalign business metrics exclude SmileDirectClub aligners.
** # of cases shipped / # of doctors to whom cases were shipped. LATAM utilization rate is not separately disclosed, but included in the total utilization rates.
ALIGN TECHNOLOGY, INC.
STOCK-BASED COMPENSATION
(in thousands)
			Q1				Q2				Q3				Q4				Fiscal				Q1				Q2				Q3				Q4				Fiscal
			2019				2019				2019				2019				2019				2020				2020				2020				2020				2020
Stock-based Compensation (SBC)
	SBC included in Gross Profit		$	1,112			$	1,278			$	1,354			$	1,410			$	5,154			$	1,347			$	891			$	1,247			$	1,234			$	4,719
	SBC included in Operating Expenses			19,932				21,189				22,822				19,087				83,030				21,580				24,116				23,982				24,030				93,708
	Total SBC		$	21,044			$	22,467			$	24,176			$	20,497			$	88,184			$	22,927			$	25,007			$	25,229			$	25,264			$	98,427

 

ALIGN TECHNOLOGY, INC.
UNAUDITED GAAP TO NON-GAAP RECONCILIATION
(in thousands except per share data)
			Three Months Ended December 31,								Year Ended December 31,
				2020				2019				2020				2019
GAAP gross profit			$	610,463			$	471,958			$	1,763,235			$	1,743,897
	Stock-based compensation			1,234				1,410				4,719				5,154
	Amortization of intangibles (1)			2,175				–				6,525				–
Non-GAAP gross profit			$	613,872			$	473,368			$	1,774,479			$	1,749,051
GAAP gross margin				73.2%				72.6%				71.3%				72.5%
Non-GAAP gross margin				73.6%				72.8%				71.8%				72.7%
GAAP operating expenses			$	397,279			$	320,808			$	1,376,064			$	1,201,404
	Stock-based compensation			(24,030	)			(19,087	)			(93,708	)			(83,030	)
	Amortization of intangibles (1)			(887	)			–				(3,062	)			–
	Acquisition related costs (2)			(62	)			–				(7,683	)			–
	Impairments and other (gains) charges (3)			–				–				–				(22,990	)
	Litigation settlement gain (4)			–				–				–				51,000
Non-GAAP operating expenses			$	372,300			$	301,721			$	1,271,611			$	1,146,384
GAAP income from operations			$	213,184			$	151,150			$	387,171			$	542,493
	Stock-based compensation			25,264				20,497				98,427				88,184
	Amortization of intangibles (1)			3,062				–				9,587				–
	Acquisition related costs (2)			62				–				7,683				–
	Impairments and other (gains) charges (3)			–				–				–				22,990
	Litigation settlement gain (4)			–				–				–				(51,000	)
Non-GAAP income from operations			$	241,572			$	171,647			$	502,868			$	602,667
GAAP operating margin				25.5%				23.3%				15.7%				22.5%
Non-GAAP operating margin				28.9%				26.4%				20.3%				25.0%
GAAP interest income and other income (expense), net			$	1,358			$	4,647			$	(8,222	)		$	20,158
	Acquisition related costs (2)			–				–				10,187				–
Non-GAAP interest income and other income (expense), net			$	1,358			$	4,647			$	1,965			$	20,158
GAAP net income before provision for (benefit from) income taxes and equity in losses of investee			$	214,542			$	155,797			$	378,949			$	562,651
	Stock-based compensation			25,264				20,497				98,427				88,184
	Amortization of intangibles (1)			3,062				–				9,587				–
	Acquisition related costs (2)			62				–				17,870				–
	Impairments and other (gains) charges (3)			–				–				–				22,990
	Litigation settlement gain (4)			–				–				–				(51,000	)
Non-GAAP net income before provision for (benefit from) income taxes and equity in losses of investee			$	242,930			$	176,294			$	504,833			$	622,825
GAAP provision for (benefit from) income taxes			$	55,554			$	34,535			$	(1,396,939	)		$	112,347
	Tax impact on non-GAAP adjustments			2,635				2,390				23,566				24,635
	Tax related non-GAAP items (5)			(22,984	)			–				1,462,302				–
Non-GAAP provision for (benefit from) income taxes			$	35,205			$	36,925			$	88,929			$	136,982
GAAP effective tax rate				25.9%				22.2%				(368.6	)%			20.0%
Non-GAAP effective tax rate				14.5%				20.9%				17.6%				22.0%
GAAP net income			$	158,988			$	121,262			$	1,775,888			$	442,776
	Stock-based compensation			25,264				20,497				98,427				88,184
	Amortization of intangibles (1)			3,062				–				9,587				–
	Acquisition related costs (2)			62				–				17,870				–
	Impairments and other (gains) charges (3)			–				–				–				22,990
	Litigation settlement gain (4)			–				–				–				(51,000	)
	Tax impact on non-GAAP adjustments			(2,635	)			(2,390	)			(23,566	)			(24,635	)
	Tax related non-GAAP items (5)			22,984				–				(1,462,302	)			–
Non-GAAP net income			$	207,725			$	139,369			$	415,904			$	478,315
GAAP diluted net income per share			$	2.00			$	1.53			$	22.41			$	5.53
Non-GAAP diluted net income per share			$	2.61			$	1.76			$	5.25			$	5.97
Shares used in computing diluted net income per share				79,505				79,137				79,230				80,100
Notes:
(1) During the three months and year ended December 31, 2020, we recorded amortization of intangible assets related to our Q2’20 exocad acquisition.
(2) During the year ended December 31, 2020, we recorded certain incremental expenses related to our Q2’20 exocad acquisition including third party advisory, legal, tax, accounting, banking, valuation, and other professional or consulting fees and foreign exchange losses related to a forward contract for the purchase commitment. Acquisition costs for the three months ended December 31, 2020 relate to professional fees.
(3) During the year ended December 31, 2019, we recorded a net impairment charge of $23.0 million consisting of impairments and other charges as a result of closing our Invisalign stores due to the arbitrator’s decision regarding SDC including operating lease right-of-use asset impairments, store leasehold improvement and fixed asset impairments and employee severance and other charges offset by a gain from the negotiation of early termination of our Invisalign store leases.
(4) During the year ended December 31, 2019, we recorded a $51.0 million gain from the settlement of the Straumann litigation.
(5) During the year ended December 31, 2020, we recorded a one-time net tax benefit for the deferred tax asset and certain costs associated with the intra-entity transfer in the three months ended March 31, 2020 of certain intellectual property rights and assets to our Swiss subsidiary and related tax impact from the amortization of the transferred intangibles assets. For the three months ended December 31, 2020, we recorded amortization of the benefit from the transferred intangibles assets.
Refer to “About Non-GAAP Financial Measures” section of press release.

Align Technology	Zeno Group
Madelyn Homick	Sarah Johnson
(408) 470-1180	(828) 551-4201
[email protected]	[email protected]

GREENSBORO, N.C., Feb. 03, 2021 (GLOBE NEWSWIRE) — Qorvo^® (Nasdaq:QRVO), a leading provider of innovative RF solutions that connect the world, today announced financial results for the Company’s fiscal 2021 third quarter, ended January 2, 2021.

On a GAAP basis, revenue for Qorvo’s fiscal 2021 third quarter was $1.1 billion, gross margin was 49.1%, operating income was $299 million and diluted earnings per share was $1.74. On a non-GAAP basis, gross margin was 54.4%, operating income was $401 million and diluted earnings per share was $3.08.

Bob Bruggeworth, president and chief executive officer of Qorvo, said, “Qorvo delivered an exceptional quarter helping our customers keep the world connected through the deployment of 5G, the roll-out of Wi-Fi 6 and 6E, and emerging technologies like precision location ultra-wideband. We are sustaining technology leadership in these markets and innovating in new ones including biotechnologies. In January, the National Institutes of Health selected Qorvo for its program to add COVID-19 testing capacity.”

Strategic Highlights

• Expanded shipments of complete main path solutions (LB, MHB and UHB) across leading 5G basebands and secured wins to supply next-generation complete main path solutions in 2021 Android® smartphones
• Commenced shipments of first MHB dual-connectivity modules (DCMs) to the leading Android OEM, leveraging Qorvo’s high-performance BAW filtering in the diversity path for receive and transmit
• Launched next-generation BAW process increasing bandwidth and reducing insertion loss in UHB and Wi-Fi 6E applications
• Began production shipments of Wi-Fi 6E solutions to top-tier Android customers, supporting increased capacity and lower latency in a range of smartphones and other mobile devices
• Increased UWB customer engagements in smartphones and a broadening range of consumer applications, including tracker tags, smart speakers, smart TVs and other smart home appliances
• Selected by the National Institutes of Health (NIH) for its Rapid Acceleration of Diagnostics initiative (RADx^SM) to add COVID-19 antigen testing capacity, utilizing Qorvo’s Omnia™ test platform, enabled by Qorvo’s high-frequency BAW
• Secured design wins with multiple base station OEMs to support U.S. 5G C-band deployments and received Best Comprehensive Performance Award from ZTE for support of their 2020 5G roll-out
• Achieved strong growth in defense business, driven by domestic airborne radar and communications applications and GaN products for international radar programs
• Commenced shipments of 5 GHz Wi-Fi 6 BAW filters and sampled 6 GHz Wi-Fi 6E FEMs for routers and gateways, maximizing throughput and range for high bandwidth applications
• Selected to supply 5G/LTE, C-V2X and Wi-Fi automotive-qualified products to multiple OEMs including Audi, BMW and Volvo
• Selected to supply the leading television manufacturer with low power multi-protocol SOC and custom software enabling solar-charging remote controls

Financial Commentary and Outlook

Mark Murphy, chief financial officer of Qorvo, said, “We expect robust end market demand to continue into the March quarter driving strong year-over-year revenue growth and operating margin expansion. For the full fiscal year, we now project free cash flow of approximately $1 billion.”

Qorvo currently believes the demand environment in its end markets supports the following expectations for the March 2021 quarter:

• Quarterly revenue of $1.025 billion to $1.055 billion
• Non-GAAP gross margin of 50.5% to 51%
• Non-GAAP diluted earnings per share of $2.42 at the midpoint of guidance

Qorvo’s actual quarterly results may differ from these expectations and projections, and such differences may be material.

Selected Financial Information

The following tables set forth selected GAAP and non-GAAP financial information for Qorvo for the periods indicated. See the more detailed financial information for Qorvo, including reconciliations of GAAP and non-GAAP financial information, attached.

 

		SELECTED GAAP RESULTS
		(Unaudited)
		(In millions, except for percentages and EPS)
		For the quarter ended January 2, 2021			For the quarter ended October 3, 2020			Change vs. Q2 FY 2021
Revenue	$	1,094.8		$	1,060.3		$	34.5
Gross profit	$	537.8		$	491.6		$	46.2
Gross margin		49.1	%		46.4	%		2.7		ppt
Operating expenses	$	238.5		$	269.9		$	(31.4	)
Operating income	$	299.2		$	221.6		$	77.6
Net income	$	201.0		$	136.9		$	64.1
Weighted average diluted shares		115.7			116.2			(0.5	)
Diluted EPS	$	1.74		$	1.18		$	0.56

		SELECTED NON-GAAP RESULTS 1
		(Unaudited)
		(In millions, except for percentages and EPS)
		For the quarter ended January 2, 2021			For the quarter ended October 3, 2020			Change vs. Q2 FY 2021
Revenue	$	1,094.8		$	1,060.3		$	34.5
Gross profit	$	595.6		$	547.9		$	47.7
Gross margin		54.4	%		51.7	%		2.7		ppt
Operating expenses	$	194.2		$	218.6		$	(24.4	)
Operating income	$	401.4		$	329.4		$	72.0
Net income	$	356.7		$	282.3		$	74.4
Weighted average diluted shares		115.7			116.2			(0.5	)
Diluted EPS	$	3.08		$	2.43		$	0.65

		SELECTED GAAP RESULTS
		(Unaudited)
		(In millions, except for percentages and EPS)
		For the quarter ended January 2, 2021			For the quarter ended December 28, 2019			Change vs. Q3 FY 2020
Revenue	$	1,094.8		$	869.1		$	225.7
Gross profit	$	537.8		$	368.1		$	169.7
Gross margin		49.1	%		42.4	%		6.7		ppt
Operating expenses	$	238.5		$	215.0		$	23.5
Operating income	$	299.2		$	153.1		$	146.1
Net income	$	201.0		$	161.4		$	39.6
Weighted average diluted shares		115.7			118.5			(2.8	)
Diluted EPS	$	1.74		$	1.36		$	0.38

		SELECTED NON-GAAP RESULTS 1
		(Unaudited)
		(In millions, except for percentages and EPS)
		For the quarter ended January 2, 2021			For the quarter ended December 28, 2019			Change vs. Q3 FY 2020
Revenue	$	1,094.8		$	869.1		$	225.7
Gross profit	$	595.6		$	428.1		$	167.5
Gross margin		54.4	%		49.3	%		5.1		ppt
Operating expenses	$	194.2		$	175.6		$	18.6
Operating income	$	401.4		$	252.4		$	149.0
Net income	$	356.7		$	220.8		$	135.9
Weighted average diluted shares		115.7			118.5			(2.8	)
Diluted EPS	$	3.08		$	1.86		$	1.22
1Excludes stock-based compensation expense, amortization of intangible assets, restructuring related charges, acquisition and integration related costs, accelerated depreciation, loss (gain) on assets, start-up costs, loss on debt extinguishment, loss on investments, gain on consolidation of investment, other income and an adjustment of income taxes.

Non-GAAP Financial Measures

In addition to disclosing financial results calculated in accordance with United States (U.S.) generally accepted accounting principles (GAAP), this earnings release contains some or all of the following non-GAAP financial measures: (i) non-GAAP gross profit and gross margin, (ii) non-GAAP operating income and operating margin, (iii) non-GAAP net income, (iv) non-GAAP net income per diluted share, (v) non-GAAP operating expenses (research and development; selling, general and administrative), (vi) free cash flow, (vii) EBITDA, (viii) non-GAAP return on invested capital (ROIC), and (ix) net debt or positive net cash. Each of these non-GAAP financial measures is either adjusted from GAAP results to exclude certain expenses or derived from multiple GAAP measures, which are outlined in the “Reconciliation of GAAP to Non-GAAP Financial Measures” tables, attached, and the “Additional Selected Non-GAAP Financial Measures and Reconciliations” tables, attached.

In managing Qorvo’s business on a consolidated basis, management develops an annual operating plan, which is approved by our Board of Directors, using non-GAAP financial measures. In developing and monitoring performance against this plan, management considers the actual or potential impacts on these non-GAAP financial measures from actions taken to reduce costs with the goal of increasing gross margin and operating margin. In addition, management relies upon these non-GAAP financial measures to assess whether research and development efforts are at an appropriate level, and when making decisions about product spending, administrative budgets, and other operating expenses. Also, we believe that non-GAAP financial measures provide useful supplemental information to investors and enable investors to analyze the results of operations in the same way as management. We have chosen to provide this supplemental information to enable investors to perform additional comparisons of our operating results, to assess our liquidity and capital position and to analyze financial performance excluding the effect of expenses unrelated to operations, certain non-cash expenses and stock-based compensation expense, which may obscure trends in Qorvo’s underlying performance.

We believe that these non-GAAP financial measures offer an additional view of Qorvo’s operations that, when coupled with the GAAP results and the reconciliations to corresponding GAAP financial measures, provide a more complete understanding of Qorvo’s results of operations and the factors and trends affecting Qorvo’s business. However, these non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP.

Our rationale for using these non-GAAP financial measures, as well as their impact on the presentation of Qorvo’s operations, are outlined below:

Non-GAAP gross profit and gross margin. Non-GAAP gross profit and gross margin exclude stock-based compensation expense, amortization of intangible assets, accelerated depreciation, restructuring related charges and certain non-cash expenses. We believe that exclusion of these costs in presenting non-GAAP gross profit and gross margin facilitates a useful evaluation of our historical performance and projected costs and the potential for realizing cost efficiencies. We view amortization of acquisition-related intangible assets, such as the amortization of the cost associated with an acquired company’s research and development efforts, trade names, and customer relationships, as items arising from pre-acquisition activities, determined at the time of an acquisition, rather than ongoing costs of operating Qorvo’s business. While these intangible assets are continually evaluated for impairment, amortization of the cost of purchased intangible assets is a static expense, which is not typically affected by operations during any particular period. Although we exclude the amortization of purchased intangible assets from these non-GAAP financial measures, management believes that it is important for investors to understand that such intangible assets were recorded as part of purchase price accounting and contribute to revenue generation.

We believe that presentation of non-GAAP gross profit and gross margin and other non-GAAP financial measures that exclude the impact of stock-based compensation expense assists management and investors in evaluating the period-over-period performance of Qorvo’s ongoing operations because (i) the expenses are non-cash in nature, and (ii) although the size of the grants is within our control, the amount of expense varies depending on factors such as short-term fluctuations in stock price volatility and prevailing interest rates, which can be unrelated to the operational performance of Qorvo during the period in which the expense is incurred and generally are outside the control of management. Moreover, we believe that the exclusion of stock-based compensation expense in presenting non-GAAP gross profit and gross margin and other non-GAAP financial measures is useful to investors to understand the impact of the expensing of stock-based compensation to Qorvo’s gross profit and gross margins and other financial measures in comparison to prior periods. We also believe that the adjustments to profit and margin related to accelerated depreciation, restructuring related charges and certain non-cash expenses do not constitute part of Qorvo’s ongoing operations and therefore the exclusion of these items provides management and investors with better visibility into the actual revenue and actual costs required to generate revenues over time and facilitates a useful evaluation of our historical and projected performance. We believe disclosure of non-GAAP gross profit and gross margin has economic substance because the excluded expenses do not represent continuing cash expenditures and, as described above, we have little control over the timing and amount of the expenses in question.

Non-GAAP operating income and operating margin. Non-GAAP operating income and operating margin exclude stock-based compensation expense, amortization of intangible assets, restructuring related charges, acquisition and integration related costs, accelerated depreciation, loss (gain) on assets, start-up costs and certain non-cash expenses. We believe that presentation of a measure of operating income and operating margin that excludes amortization of intangible assets and stock-based compensation expense is useful to both management and investors for the same reasons as described above with respect to our use of non-GAAP gross profit and gross margin. We believe that restructuring related charges, acquisition and integration related costs, accelerated depreciation, loss (gain) on assets, start-up costs and certain non-cash expenses do not constitute part of Qorvo’s ongoing operations and therefore, the exclusion of these costs provides management and investors with better visibility into the actual costs required to generate revenues over time and facilitates a useful evaluation of our historical and projected performance. We believe disclosure of non-GAAP operating income and operating margin has economic substance because the excluded expenses are either unrelated to ongoing operations or do not represent current cash expenditures.

Non-GAAP net income and non-GAAP net income per diluted share. Non-GAAP net income and non-GAAP net income per diluted share exclude the effects of stock-based compensation expense, amortization of intangible assets, restructuring related charges, acquisition and integration related costs, accelerated depreciation, loss (gain) on assets, start-up costs, certain non-cash expenses, loss on debt extinguishment, loss on investments, gain on consolidation of investment, other income and also reflect an adjustment of income taxes. The income tax adjustment primarily represents the use of research and development tax credit carryforwards, deferred tax expense (benefit) items not affecting taxes payable, adjustments related to the deemed and actual repatriation of historical foreign earnings, non-cash expense (benefit) related to uncertain tax positions and other items unrelated to the current fiscal year or that are not indicative of our ongoing business operations. We believe that presentation of measures of net income and net income per diluted share that exclude these items is useful to both management and investors for the reasons described above with respect to non-GAAP gross profit and gross margin and non-GAAP operating income and operating margin. We believe disclosure of non-GAAP net income and non-GAAP net income per diluted share has economic substance because the excluded expenses are either unrelated to ongoing operations or do not represent current cash expenditures.

Non-GAAP operating expenses (research and development and selling, general and administrative). Non-GAAP research and development and selling, general and administrative expenses exclude stock-based compensation expense, amortization of intangible assets and certain non-cash expenses (primarily acquisition and integration related costs). We believe that presentation of measures of these operating expenses that exclude amortization of intangible assets and stock-based compensation expense is useful to both management and investors for the same reasons as described above with respect to our use of non-GAAP gross profit and gross margin. We believe that acquisition and integration related costs and certain non-cash expenses do not constitute part of Qorvo’s ongoing operations and therefore, the exclusion of these costs provides management and investors with better visibility into the actual costs required to generate revenues over time and facilitates a useful evaluation of our historical and projected performance. We believe disclosure of these non-GAAP operating expenses has economic substance because the excluded expenses are either unrelated to ongoing operations or do not represent current cash expenditures.

Free cash flow. Qorvo defines free cash flow as net cash provided by operating activities during the period minus property and equipment expenditures made during the period, and free cash flow margin is calculated as free cash flow as a percentage of revenue. We use free cash flow as a supplemental financial measure in our evaluation of liquidity and financial strength. Management believes that this measure is useful as an indicator of our ability to service our debt, meet other payment obligations and make strategic investments. Free cash flow should be considered in addition to, rather than as a substitute for, net income as a measure of our performance and net cash provided by operating activities as a measure of our liquidity. Additionally, our definition of free cash flow is limited, in that it does not represent residual cash flows available for discretionary expenditures due to the fact that the measure does not deduct the payments required for debt service and other contractual obligations. Therefore, we believe it is important to view free cash flow as a measure that provides supplemental information to our entire statement of cash flows.

EBITDA. Qorvo defines EBITDA as earnings before interest expense and interest income, income tax expense (benefit), depreciation and intangible amortization. Management believes that this measure is useful to evaluate our ongoing operations and as a general indicator of our operating cash flow (in conjunction with a cash flow statement which also includes among other items, changes in working capital and the effect of non-cash charges).

Non-GAAP ROIC. Return on invested capital (ROIC) is a non-GAAP financial measure that management believes provides useful supplemental information for management and the investor by measuring the effectiveness of our operations’ use of invested capital to generate profits. We use ROIC to track how much value we are creating for our shareholders. Non-GAAP ROIC is calculated by dividing annualized non-GAAP operating income, net of an adjustment for income taxes (as described above), by average invested capital. Average invested capital is calculated by subtracting the average of the beginning balance and the ending balance of current liabilities (excluding the current portion of long-term debt and other short-term financings) from the average of the beginning balance and the ending balance of net accounts receivable, inventories, other current assets, net property and equipment and a cash amount equal to seven days of quarterly revenue.

Net debt or positive net cash. Net debt or positive net cash is defined as unrestricted cash, cash equivalents and short-term investments minus any borrowings under our credit facility and the principal balance of our senior unsecured notes. Management believes that net debt or positive net cash provides useful information regarding the level of Qorvo’s indebtedness by reflecting cash and investments that could be used to repay debt.

Forward-looking non-GAAP financial measures. Our earnings release contains forward-looking free cash flow, gross margin, income tax rate and diluted earnings per share. We provide these non-GAAP measures to investors on a prospective basis for the same reasons (set forth above) that we provide them to investors on a historical basis. We are unable to provide a reconciliation of the forward-looking non-GAAP financial measures to the most directly comparable forward-looking GAAP financial measures without unreasonable effort due to variability and difficulty in making accurate projections for items that would be required to be included in the GAAP measures, such as stock-based compensation, acquisition and integration related costs, restructuring related charges, asset impairments and the provision for income taxes. We believe such reconciliations would imply a degree of precision that would be confusing or misleading to investors.

Limitations of non-GAAP financial measures. The primary material limitations associated with the use of non-GAAP financial measures as an analytical tool compared to the most directly comparable GAAP financial measures are these non-GAAP financial measures (i) may not be comparable to similarly titled measures used by other companies in our industry, and (ii) exclude financial information that some may consider important in evaluating our performance, thus limiting their usefulness as a comparative tool. We compensate for these limitations by providing full disclosure of the differences between these non-GAAP financial measures and the corresponding GAAP financial measures, including a reconciliation of the non-GAAP financial measures to the corresponding GAAP financial measures, to enable investors to perform their own analysis of our gross profit and gross margin, operating expenses, operating income, net income, net income per diluted share and net cash provided by operating activities. We further compensate for the limitations of our use of non-GAAP financial measures by presenting the corresponding GAAP measures more prominently.

Qorvo will conduct a conference call at 5:00 p.m. ET today to discuss today’s press release. The conference call will be broadcast live over the Internet and can be accessed by any interested party at http://www.qorvo.com (under “Investors”). A telephone playback of the conference call will be available approximately two hours after the call’s completion and can be accessed by dialing 719-457-0820 and using the passcode 6596083. The playback will be available through the close of business February 10, 2021.

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.

Financial Tables to Follow

QORVO, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF INCOME (In thousands, except per share data) (Unaudited)
		Three Months Ended								Nine Months Ended
		January 2, 2021				December 28, 2019				January 2, 2021				December 28, 2019
Revenue		$	1,094,834			$	869,073			$	2,942,577			$	2,451,369
Costs and expenses:
Cost of goods sold		557,082				500,962				1,587,486				1,465,387
Research and development		136,697				122,851				423,110				357,385
Selling, general and administrative		93,139				81,205				289,115				258,458
Other operating expense		8,713				10,986				29,307				49,077
Total costs and expenses		795,631				716,004				2,329,018				2,130,307
Operating income		299,203				153,069				613,559				321,062
Interest expense		(17,453		)		(16,900		)		(59,788		)		(41,457		)
Other (expense) income, net		(58,234		)		47,022				(33,177		)		50,849
Income before income taxes		223,516				183,191				520,594				330,454
Income tax expense		(22,481		)		(21,835		)		(85,720		)		(46,519		)
Net income		$	201,035			$	161,356			$	434,874			$	283,935
Net income per share, diluted		$	1.74			$	1.36			$	3.74			$	2.37
Weighted average outstanding diluted shares		115,690				118,455				116,257				119,712

QORVO, INC. AND SUBSIDIARIES RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES (In thousands, except per share data) (Unaudited)
		Three Months Ended
		January 2, 2021				October 3, 2020				December 28, 2019
GAAP operating income		$	299,203			$	221,644			$	153,069
Stock-based compensation expense		19,247				30,048				16,381
Amortization of intangible assets		73,112				72,147				62,910
Restructuring related charges		546				609				5,956
Acquisition and integration related costs		5,261				7,259				7,226
Accelerated depreciation		—				—				4,324
Loss (gain) on assets, start-up costs and other non-cash expenses		3,990				(2,354		)		2,540
Non-GAAP operating income		$	401,359			$	329,353			$	252,406
GAAP net income		$	201,035			$	136,917			$	161,356
Stock-based compensation expense		19,247				30,048				16,381
Amortization of intangible assets		73,112				72,147				62,910
Restructuring related charges		546				609				5,956
Acquisition and integration related costs		5,261				7,259				7,226
Accelerated depreciation		—				—				4,324
Loss (gain) on assets, start-up costs and other non-cash expenses		3,990				(2,354		)		2,540
Loss on debt extinguishment		61,991				—				—
Loss on investments		388				450				—
Gain on consolidation of investment		—				—				(43,008		)
Other income		(2,850		)		(2,051		)		(1,560		)
Adjustment of income taxes		(6,033		)		39,262				4,712
Non-GAAP net income		$	356,687			$	282,287			$	220,837
GAAP weighted average outstanding diluted shares		115,690				116,177				118,455
Dilutive stock-based awards		—				—				—
Non-GAAP weighted average outstanding diluted shares		115,690				116,177				118,455
Non-GAAP net income per share, diluted		$	3.08			$	2.43			$	1.86

QORVO, INC. AND SUBSIDIARIES RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL MEASURES (Unaudited)
	Three Months Ended
(in thousands, except percentages)	January 2, 2021						October 3, 2020						December 28, 2019
GAAP gross profit/margin	$	537,752		49.1	%		$	491,550		46.4	%		$	368,111		42.4	%
Amortization of intangible assets	52,989			4.9	%		52,149			4.9	%		44,910			5.2	%
Restructuring related charges	—			—	%		—			—	%		3,438			0.4	%
Stock-based compensation expense	4,478			0.4	%		3,600			0.3	%		6,601			0.7	%
Accelerated depreciation	—			—	%		—			—	%		4,324			0.5	%
Other non-cash expenses	375			—	%		627			0.1	%		670			0.1	%
Non-GAAP gross profit/margin	$	595,594		54.4	%		$	547,926		51.7	%		$	428,054		49.3	%

	Three Months Ended
Non-GAAP Operating Income	January 2, 2021
(as a percentage of sales)
GAAP operating income	27.3	%
Stock-based compensation expense	1.8	%
Amortization of intangible assets	6.7	%
Restructuring related charges	0.1	%
Acquisition and integration related costs	0.5	%
Loss on assets, start-up costs and other non-cash expenses	0.3	%
Non-GAAP operating income	36.7	%

	Three Months Ended
Free Cash Flow (1)	January 2, 2021
(in millions)
Net cash provided by operating activities	$	403.7
Purchases of property and equipment	(36.1		)
Free cash flow	$	367.6
(1) Free Cash Flow is calculated as net cash provided by operating activities minus property and equipment expenditures.

QORVO, INC. AND SUBSIDIARIES ADDITIONAL SELECTED NON-GAAP FINANCIAL MEASURES AND RECONCILIATIONS (In thousands) (Unaudited)
	Three Months Ended
	January 2, 2021				October 3, 2020				December 28, 2019
GAAP research and development expense	$	136,697			$	156,342			$	122,851
Less:
Stock-based compensation expense	7,897				8,445				6,205
Other non-cash expenses	525				526				482
Non-GAAP research and development expense	$	128,275			$	147,371			$	116,164
	Three Months Ended
	January 2, 2021				October 3, 2020				December 28, 2019
GAAP selling, general and administrative expense	$	93,139			$	109,372			$	81,205
Less:
Stock-based compensation expense	6,872				18,001				3,540
Amortization of intangible assets	20,123				19,998				17,999
Other non-cash expenses	184				171				182
Non-GAAP selling, general and administrative expense	$	65,960			$	71,202			$	59,484

QORVO, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited)
	January 2, 2021				March 28, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	1,234,415			$	714,939
Accounts receivable, net	507,078				367,172
Inventories	479,340				517,198
Other current assets	101,424				91,193
Total current assets	2,322,257				1,690,502
Property and equipment, net	1,232,374				1,259,203
Goodwill	2,650,912				2,614,274
Intangible assets, net	656,239				808,892
Long-term investments	31,271				22,515
Other non-current assets	148,325				165,296
Total assets	$	7,041,378			$	6,560,682
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities	$	516,108			$	464,755
Other current liabilities	97,790				74,248
Total current liabilities	613,898				539,003
Long-term debt	1,743,794				1,567,231
Other long-term liabilities	179,985				161,783
Total liabilities	2,537,677				2,268,017
Stockholders’ equity	4,503,701				4,292,665
Total liabilities and stockholders’ equity	$	7,041,378			$	6,560,682

At Qorvo^®
Doug DeLieto
VP, Investor Relations
1-336-678-7968

Chicago, IL, Feb. 03, 2021 (GLOBE NEWSWIRE) — Mergers & Acquisitions’ magazine has released their list of the 25 Most Influential Women in Mid-Market M&A. Mary Josephs, Founder and CEO of Verit Advisors® was recognized on this list for the fifth straight year. The list honors consummate deal makers who are also champions of change and powerful advocates of diversity, equity, and inclusion.

“It is an honor to be recognized by Mergers & Acquisitions’ magazine. The women who are being honored and their accomplishments are very impressive. I truly enjoy working with middle market privately owned companies and watching them flourish.  I am inspired by new trends in middle market M&A including:

• Growing diversity in the corporate finance world inclusive of, as this list suggests, attorneys, advisors, and capital providers
• Fueled by KKR and others, increased use of employee ownership to improve culture and operating performance.  Just yesterday they announced an exciting new chapter for Harley Davidson 
• Continued softening of the historical divide between ESOPs and private equity 

Ms. Josephs has spent her career advising and structuring ownership options for privately held middle-market companies. She takes pride in providing unbiased options to business owners as they navigate the next chapter of their company. Josephs launched a national ESOP Advisory practice for ABN AMRO LaSalle Corporate Finance and led the ESOP Solutions Group for all of Bank of America-Merrill Lynch. In 2009, she founded Verit Advisors® to continue providing strategic alternatives to privately held business owners.

Ms. Josephs was awarded the U.S.A: Women Leaders & Top Dealmakers Award in 2020

and Private Board Directors magazine named Mary a Director to Watch in 2019. Ms. Josephs is a board member for Hisco Inc., Manson Construction and Performance Contracting Inc. and a member of Rutgers NJ/NY Center for Employee Ownership Advisory Board. Ms. Josephs is also a member of the International Women’s Forum, The Economic Club of Chicago, and the Chicago Network.

About Verit Advisors LLC

Verit Advisors unites sophisticated investment banking capabilities with a client centric boutique, fluent in ESOPs, debt capital markets, mergers and acquisitions, and valuation services. Integrity, teamwork, service, and innovation are at the heart of the organization, as Verit strives to provide unparalleled advice and custom solutions to its clients. Mary Josephs founded Verit Advisors in 2009.  Josephs and her team are considered to be one of the foremost experts in ESOP transactions and middle market strategic alternatives.

Attachment

• Josephs-Mary-contributor

Pat Eichten
Verit Advisors, LLC
[email protected]

San Diego, CA, Feb. 03, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Regrow (the “Company”), the premier supply chain management cloud platform designed specifically for the cannabis industry, announced today the establishment of an advisory board composed of renowned technology executives paired with cannabis industry experts to strategically advance the Company.

“We have assembled a board of thought leaders and experts who are on the front lines of innovations in the tech and cannabis space and are poised to bolster Regrow’s strategic focus and offer supportive guidance as we develop the brand into the industry standard,” said Regrow CEO Rob Woodbyrne. “Our board is not only made up of renowned experts with years of experience under their belt, but they are also great friends of the brand that want to see us succeed and have willfully dedicated their strongest efforts to make that happen.”

The strategic advisory board members include: 

BUSINESS DEVELOPMENT AND STRATEGIC GROWTH: 

Craig E. Harper

Board member and executive advisor to high-growth companies.

Craig E. Harper has led many of the fastest growing and most successful technology companies to tremendous achievement over his career spanning more than 30 years. He has served as CEO of Cherwell Software, and has run global sales at ServiceNow, BMC Software and ServiceMesh. Under his leadership these organizations have achieved remarkable growth, scale and value realization through either IPO or acquisition. Currently, Harper serves as board member and executive advisor for several high-growth technology companies.

Matthew Schvimmer

Matthew Schvimmer is a seasoned manager and product executive within the SaaS and Cloud Software industries and was instrumental in the meteoric success of digital workflow dynamo ServiceNow.

Jonathan Sparks

Jonathan Sparks brings to Regrow more than a decade of innovative product development experience through his work at ServiceNow. At ServiceNow, Sparks serves as Vice President of IoT and Operations Products.

Samantha Smith

Samantha Smith is a seasoned leader and innovator in creating and building customer success programs for some of the leading SaaS companies in the world with over two decades of experience. Her focus on positive customer engagements, customer satisfaction and customer retention has proven her ability to create some of the highest retention rates in the industry, transforming the way companies retain and grow customers. 

Joseph Rusty Bishop, Ph.D.

Dr. Bishop is a successful entrepreneur with expertise in go-to-market and fundraising strategy for start-up tech companies. He is currently SVP of Marketing for Bigtincan, a publicly traded SaaS company specializing in sales enablement automation.

Adam Duckett 

Adam Duckett is no stranger to the Cloud Services industry. Having climbed the ranks of Enterprise Cloud Company ServiceNow for the last decade, he now serves as Senior Director of GTM, Future Products and Innovation.

CANNABIS INDUSTRY EXPERTISE:

Rick Goff 

Rick Goff holds over 25 years of experience as an Information Systems professional, designing and implementing corporate business solutions. He is currently Director of Information Systems at cannabis-focused Indus Holdings.

Nick David 

Nick David has over 5 years of experience as a Director of Operations and in executive leadership roles within the cannabis industry. David currently serves as Executive GM for Dubbros Management, a MSO based out of Los Angeles. 

Damian Solomon 

Damian Solomon is a 20-year veteran in the high tech controlled environment agriculture industry. Solomon served as Director of Cultivation at MedMen until 2017 and serves as Chief Botanist at Harvest Health.

Jeff Thorne 

Jeff Thorne has worked within the rapidly growing cannabis industry for over 15 years with experience in production management for greenhouse operations to scale. He currently serves as Vice President of Sales at Terra Labs Inc.

TECHNOLOGY-FOCUSED EXPERTISE:

John Roberts 

John Roberts is a development and architectural guru with almost 15 years of experience in the space, including serving as Technical Alliance Architect at ServiceNow. Roberts is currently Co-Founder of growth mindset app Sevwins.

Bobby Edmonds 

Bobby Edmonds is a veteran of both the United States Air Force and the technology industry. He is a seasoned technical architect and is currently serving as the Senior Principal Product Manager at ServiceNow for Service Provider Product Strategy.

John Olsen 

John Olsen is an experienced leader working in the management consulting industry. He is a strong business development professional skilled in customer relationship management (CRM), management, start-ups, business intelligence and product development. 

Cameron J. Stone

Cameron J. Stone is a Principal Solution Consultant and an avid gardener who helps cannabis professionals understand the complex compliance environments that have been disrupting corporate IT shops for decades. Stone spent 20 years working in network security, software development and SaaS platform sales and delivery.

Designed by software engineers and experienced technology executives, the Regrow software service allows cultivators to analyze performance metrics of their strains, formulations, harvests, workforce, pest management tasks, vendors and monitor environmental measures to increase efficiency of their operation. This service allows cultivators to fully configure the metrics that matter most to their business, such as the cost per gram in production, time to market and overall increased yield and margins. The Regrow software eliminates the manual recording of tasks that contributes to costly human error, which allows for measurable profitability gains across an organization.

Regrow recently announced their first phase launch, offering the service to select cultivators in legalized markets in North America, and will soon expand globally to become available to any countries that will be federally legal in the near future. 

For more information on Regrow visit regrow.io or to be a part of Regrow’s limited phase one launch, please email us at [email protected].

About Regrow

Regrow is a first-of-its-kind cloud platform designed specifically to help cannabis operators increase their yields, maximize their canopy space, automate workflows, manage work forces and ensure documented compliance in all areas of the supply chain. Designed by software and process experts passionate about cannabis and helping scale the industry, Regrow’s platform helps companies automate manual tasks, reduce costs, avoid supply shortages, and create dynamic workflows that help to maximize yields and increase profitability. Driven by a core “continuous improvement” philosophy, Regrow’s platform is configurable to specific business needs and easily adaptable to a company’s scaling objectives, offering prescriptive solutions while conforming to unique business requirements. 

Public Relations Contact:

CMW Media

Cassandra Dowell, 858-264-6600

[email protected]

www.cmwmedia.com

Danville, KY, Feb. 03, 2021 (GLOBE NEWSWIRE) — Dr. Anjum Bux, a leading expert in pain management, was the first in the nation to successfully treat commercial patients using Transcutaneous Auricular Neurostimulation (tAN) for opioid withdrawal relief. This innovative approach to opioid withdrawal management is delivered using The Sparrow Therapy System™— an FDA cleared, drug-free wearable technology.

Dr. Anjum Bux stated, “We’re excited to be first in the nation to offer wearable neurostimulation to our patients using the Sparrow Therapy System. With the addition of tAN, we were able to taper our first patient off high-dose oral opioids in 7 days with no reported withdrawal symptoms in preparation for an intrathecal pump trial. The ability to safely taper patients’ opioid use over days instead of months while reliably managing withdrawal symptoms is a game-changer for my patients and practice. This is an important advancement in the fight against opioid use disorder.”

Daniel Powell, co-founder, and CEO of Spark Biomedical, Inc, stated, “We designed Sparrow because we saw an enormous unmet need for patients trying to reduce or eliminate opioids from daily use who are hindered by physical withdrawal. Developing the therapy is just the first step. Physicians like Dr. Bux are critical in discussing treatment options with their patients and delivering this new therapy to those in need.”

The Sparrow Therapy System is a wearable neurostimulation device that delivers personally tailored, mild electrical signals through the skin on and around the ear — known as Transcutaneous Auricular Neurostimulation (tAN)— targeting specific cranial nerve branches. Stimulation activates central brain structures to promote the release endogenous opioids (endorphins). Endorphins then fill the vacant opioid receptors to help alleviate opioid withdrawal symptoms.

The Sparrow Therapy System (tAN therapy) is supported by evidence from a double-blind, randomized controlled clinical trial targeting patients with opioid use disorder. In clinical trials, 89% of participants experienced mild to no withdrawal symptoms at 60 minutes of therapy; and one in three was symptom-free after the first day of treatment. By day two, 100% of participants sustained a clinically meaningful reduction in opioid withdrawal symptoms.

Indication for Use
The Sparrow Therapy System is a transcutaneous nerve field stimulator intended to be used in patients experiencing opioid withdrawal in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms under the supervision of trained clinical personnel.

About Bux Pain Management
Bux Pain Management offers patient-centered pain management treatments to those living in Lexington, Cynthiana, and Danville, Kentucky. Anjum Bux, MD, launched Bux Pain Management more than 20 years ago. The practice focuses on the nonsurgical, minimally invasive treatment of chronic pain.

As a board-certified anesthesiologist, Dr. Bux understands the effect that chronic pain can have on a patient’s life. While oral medications can provide short-term pain relief, many are addictive, and their effects temporary. Many patients feel that their only solution to pain is invasive surgery. That’s why Bux Pain Management is dedicated to cutting-edge technology.

About Spark Biomedical
Spark Biomedical, Inc. is a Texas-based medical device company and developer of the first drug-free, needle-free, wearable solution for opioid withdrawal relief backed by evidence from a double-blind, randomized controlled clinical trial targeting patients with opioid use disorder.

The Sparrow Therapy System uses Transcutaneous Auricular Neurostimulation (tAN) to treat withdrawal symptoms by stimulating nerves on and around the ear. The wearable earpiece is designed to be worn up to 24 hours a day throughout opioid reduction or as prescribed to aid in the reduction of withdrawal symptoms.

The company’s vision to ignite a brighter future for those struggling with opioid addiction and dependence is fueled by its unique blend of scientific expertise, technical innovation, and deep medical device industry experience. For more information, schedule a consultation at www.sparkbiomedical.com.

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Attachments

• SparkSparrow_03913B_Web
• DrAnjumBux

Jackie Powell
Spark Biomedical
832-792-0666
[email protected]