DJO Invests in Next-Generation Augmented Reality Technology Primed for ASC Market Growth

DJO Invests in Next-Generation Augmented Reality Technology Primed for ASC Market Growth

AUSTIN, Texas–(BUSINESS WIRE)–
DJO, a subsidiary of Colfax Corporation (NYSE:CFX), and a leading global provider of medical technologies to get and keep people moving, today announced a strategic investment in Insight Medical Systems (“Insight”), a technology company dedicated to wearable surgical navigation in orthopaedics. Insight’s flagship product, ARVIS® (Augmented Reality Visualization and Information System), will combine tracking cameras with both a 3D display and handsfree interface in an integrated eyepiece for total joint arthroplasty. Unlike other augmented reality (AR) platforms, ARVIS is the first system with proprietary hardware designed to assist arthroplasty surgeons in enhancing component positioning precision to improve joint arthroplasty outcomes.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210330005381/en/

ARVIS Next-Generation Augmented Reality System (Photo: Business Wire)

ARVIS Next-Generation Augmented Reality System (Photo: Business Wire)

The Computer Assisted Surgery (CAS) Technology market is growing at a compound annual growth rate (CAGR) of 32%1. Similarly, the shift in the site of care from hospitals to Ambulatory Surgery Centers (ASCs) is expanding rapidly. If half of routine total joint cases were done in the ASC, UnitedHealth Group quantified this shift as having the potential to help 500,000 patients avoid overnight hospital stays and save $3B annually2. As surgeons look to incorporate technology into their surgical workflows whether at the hospital or ASC, the discussion often focuses on balancing the clinical benefit of a technology with the added time and cost associated with it. The high acquisition cost of current CAS systems can include a capital-intensive investment as well as per-case disposables and service contracts. These costs, along with the large footprint of technologies like robotics, are particularly restricting for ASCs.

“DJO® has been partnering with the orthopaedic surgeon community to understand their technology needs across all anatomies and in all settings in which they operate,” said Louis Vogt, President and General Manager of DJO Surgical®. “The Insight team has developed an impressive 3D AR technology that tracks the surgeon’s viewpoint and delivers navigation and patient-specific information right at the surgical site in a highly efficient and seamless workflow. ARVIS complements DJO’s ASC 360™ solutions and adds to our full range of implant technologies, surgical tools and digital care solutions that uniquely span the continuum of care.”

“We’re thrilled to partner with a leading MedTech company that has an impressive growth trajectory,” said Nick van der Walt, CEO of Insight. “DJO and Insight have a shared vision of improving clinical outcomes with technology in a streamlined, cost-effective way. We will build on the current capabilities of ARVIS in knee and hip arthroplasty and expand to other indications in orthopaedics.”

For ease of use, the ARVIS system will be compatible with existing surgical helmets, and a single tray of trackable instruments eliminates the need for disposables. Insight will leverage DJO’s sales channel to launch ARVIS in the second half of this year. The EMPOWR™ Partial, Primary and Complex Primary Knee and Hip implant systems will be compatible. The EMPOWR portfolio is the culmination of research, clinical legacy and material technologies that have resulted in hip and knee products that help restore healthy kinematics and provide surgical efficiencies optimized for today’s health care environment. Driven by premium, intelligently designed single-tray instrumentation, these implant systems have up to a 50% reduction in storage and sterilization costs compared to similar products on the market3.

For more information about DJO’s EMPOWR brand and ASC 360 offering, visit djoglobal.com/empowr and djoglobal.com/asc360.

About DJO®

DJO, a subsidiary of Colfax Corporation (NYSE:CFX), is a leading developer and distributor of high-quality medical devices that provide proven solutions for musculoskeletal health, joint reconstruction, vascular health, and pain management. The Company’s extensive range of products and integrated technologies address the orthopedic continuum of care from performance and mobility to surgical intervention and post-operative rehabilitation, enabling people around the world to regain or maintain their natural motion. For additional information about DJO, please visit www.DJOGlobal.com.

About Insight Medical Systems

Insight Medical Systems is a medical device company with a focus on orthopedic surgical procedures. It is leveraging augmented reality technology to provide a highly cost effective and easy-to-use alternative to surgical navigation systems and robots. Insight is currently expanding their R&D and Marketing teams to accelerate product development and prepare for commercialization. Prospective candidates should email resumes to [email protected]. For additional information about Insight, please visit www.insightmedsys.com.

ARVIS is pending clearance by the FDA.

ARVIS is a registered trademark of Insight Medical Systems.

References

  1. SmartTrak Computer Assisted Surgery Revenue projections: https://www.smarttrak.com/
  2. https://www.unitedhealthgroup.com/newsroom/research-reports/posts/2020-12-10-research-ambulatory-surgery-centers-490916.html
  3. Based on calculation of no. of trays compared to DePuy Pinnacle and Zimmer Biomet G7. https://www.ajog.org/article/S0002-9378(16)30358-1/pdf for cost of sterilization https://www.corailpinnacle.net/sites/default/files/2018-10/DSEMJRC05181044%20PINNACLE%20Surgical%20Technique.pdf

    https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/hip/2336.2-GLBL-en_G7%20Surgical%20Technique.pdf

    Based on calculation of no. of trays compared to Oxford Uni Knee.

    https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/oxford-partial-knee-microplasty-instrumentation-surgical-technique.pdf

 

DJO Contact:

Ashley Brown

[email protected]

Insight Contact:

Nick van der Walt

[email protected]

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Surgery Medical Devices Hospitals Health Managed Care

MEDIA:

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ARVIS Next-Generation Augmented Reality System (Photo: Business Wire)

500 Chicago Area Black Churches to Launch Covid-19 Vaccine Video Campaign During Easter Weekend Services

500 Chicago Area Black Churches to Launch Covid-19 Vaccine Video Campaign During Easter Weekend Services

Chicago area faith leaders and Evolent Health will brief media April 1 on their community effort to inform up to 1 million Black and Latinx Chicagoans on vaccine safety and efficacy

CHICAGO–(BUSINESS WIRE)–
This Holy Thursday at Quinn Chapel AME in Chicago, clergy leaders from a wide range of black communitieswill launch a Covid-19 vaccine video education program expected to reach up to 1 million Black and Latinx congregants during Easter weekend worship. Leaders in the campaign will discuss their own journeys in learning about the vaccines, address myths and misinformation that have contributed to vaccine resistance in marginalized communities and encourage members to take their opportunities to be vaccinated.

“For many of our community members, this Sunday will be the first time in a year they are able to attend worship in person, and many more will worship with us on video,” said Apostle Carl White. “As we reflected on the meaning of this high holy day, we saw this as the perfect time to help our community learn more about the importance of vaccination and become comfortable with getting vaccinated for themselves, their families and their neighbors.”

Evolent Health, a health care managed services company supporting the care of more than 375,000 Medicaid beneficiaries in Cook County, convened the coalition and has been collaborating with them on Covid-19 initiatives. These initiatives include this video campaign (click here for an excerpt from one of the videos), as well as the donation in November of 10,000 masks by Evolent Health employees, many hand-sewn for children, that coincided with a return to in-person education for local elementary-age children.

Faith leaders from the following organizations each filmed video segments about their own experience becoming or preparing to be vaccinated and about vaccine safety. These will be shown during Easter services at their own churches, as well as others they are affiliated with, to reach about 500 faith communities and 1 million people this weekend.

  • Rainbow Push Coalition
  • The United Baptist State Convention of Illinois
  • United Covenant Churches
  • Southland Ministerial Healthcare Network
  • Midwest Region of the Churches of God In Christ
  • Fourth District of the African American Episcopal Church
  • Pilgrim Assembly Churches
  • Westside Ministers Coalition
  • Midwest Regional Full Gospel Baptist Churches

These faith leaders and Evolent Health will brief media on the initiative, preview the videos and answer questions at a press event Thursday, April 1, at 10:30 a.m. at Quinn Chapel, 2401 South Wabash Avenue in Chicago. The site has significant historical and cultural significance as the first African American congregation in the city of Chicago and a once-functioning stop on the Underground Railroad.

“We are honored and humbled to be extending hands with this community in support of such an important campaign. Throughout this pandemic, we have looked for opportunities where we could help to bridge the gaps in care exacerbated by COVID-19,” said Naprisha Taylor, Head of Diversity, Equity and Inclusion for Evolent Health. “We are very proud that we have been able to expand our efforts to convene this group to help reach these communities and work toward vaccine-readiness.”

Members of the news media are encouraged to attend the April 1 event, while observing social distancing and mask protocols.

About Evolent Health

Evolent Health (NYSE: EVH) delivers proven clinical and administrative solutions that improve whole-person health while making health care simpler and more affordable. Our solutions encompass total cost of care management, specialty care management, and administrative simplification. Evolent serves a national base of leading payers and providers, is the first company to receive the National Committee for Quality Assurance’s Population Health Program Accreditation, and is consistently recognized as a top place to work in health care nationally. Learn more about how Evolent is changing the way health care is delivered by visiting evolenthealth.com.

Local Chicago Media Contact:

Lindsey Artola

708-606-7647

[email protected]

Evolent Health Media Contact:

Liz DeForest

212-584-5477

[email protected]

KEYWORDS: United States North America Illinois

INDUSTRY KEYWORDS: Hispanic Health Family Insurance Consumer Other Health Pharmaceutical Professional Services Managed Care Infectious Diseases Hospitals Seniors Clinical Trials Religion

MEDIA:

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Prospect Capital Corporation Announces Results of Cash Tender Offer For Any and All of its Outstanding 5.875% Senior Notes due 2023

NEW YORK, March 30, 2021 (GLOBE NEWSWIRE) — Prospect Capital Corporation (the “Company”) today announced the results of its previously announced cash tender offer (the “Tender Offer”) to purchase any and all of the outstanding notes listed below. The Tender Offer was made pursuant to an Offer to Purchase dated March 23, 2021 (the “Offer to Purchase”), which set forth the terms and conditions of the Tender Offer.

As of the previously announced expiration time of 5:00 p.m., New York City time, on March 29, 2021 (the “Expiration Time”), according to information provided by D.F. King & Co., Inc., the information and tender agent for the Tender Offer, a total of $726,000 aggregate principal amount of Notes (defined below) had been validly tendered and not validly withdrawn in the Tender Offer. Withdrawal rights for the Notes expired at 5:00 p.m., New York City time, on March 29, 2021. The table below sets forth the aggregate principal amount and percentage of the Notes validly tendered and not validly withdrawn by the Expiration Time that will be accepted for purchase by the Company (the “Eligible Notes”).

Title of Security CUSIP / ISIN Nos. Outstanding Principal
Amount

Principal Amount
Tendered
5.875% Senior Notes due
2023 (the “Notes”)
74348TAJ1 /
US74348TAJ16
$ 285,781,000 $ 726,000


The consideration to be paid for the Eligible Notes is $1,042.00 for each $1,000 principal amount of Eligible Notes, plus accrued and unpaid interest on the Eligible Notes, if any, from the applicable last interest payment date up to, but not including, the settlement date, which date is expected to be March 11, 2021.

The Company has retained D.F. King & Co., Inc. to serve as the Information and Tender Agent for the Notes in the Tender Offer.

The Tender Offer is being made pursuant to the terms and conditions contained in the Offer to Purchase, a copy of which may be obtained from D.F. King & Co., Inc. at (212) 269-5550 (Banks and Brokers) or (866) 388-7452 (toll free), or via [email protected].

A copy of the Offer to Purchase is also available at the following web address:
https://dfking.com/psec/

This announcement is for informational purposes only and is not an offer to purchase or sell or a solicitation of an offer to purchase or sell, with respect to any securities. The solicitation of offers to buy the Notes is only being made pursuant to the terms of the Offer to Purchase, as it may be amended or supplemented. The Tender Offer is not being made in any state or jurisdiction in which such offer would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. None of the Company or the Information and Tender Agent are making any recommendation as to whether or not holders should tender their Notes in connection with the Tender Offer.

About Prospect Capital Corporation

Prospect Capital Corporation is a business development company that focuses on lending to and investing in private businesses. Prospect’s investment objective is to generate both current income and long-term capital appreciation through debt and equity investments.

Prospect has elected to be treated as a business development company under the Investment Company Act of 1940 (“1940 Act”). Prospect is required to comply with regulatory requirements under the 1940 Act as well as applicable NASDAQ, federal and state rules and regulations. We have elected to be treated as a regulated investment company under the Internal Revenue Code of 1986.

Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, whose safe harbor for forward-looking statements does not apply to business development companies. These forward-looking statements include statements regarding expectations as to the completion of the transactions contemplated by the Tender Offer. Any such statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that we may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements. Such statements speak only as of the time when made, and we undertake no obligation to update any such statement now or in the future.

For further information, contact:

Grier Eliasek, President and Chief Operating Officer
[email protected]
Telephone (212) 448-0702



Sanitas Brewing Company Named Colorado Ale Brewery of the Year

Boulder-Based Craft Brewer Claims Three Honors At New York International Beer Competition

BOULDER, CO, March 30, 2021 (GLOBE NEWSWIRE) — Sanitas Brewing Company, a mainstay on the competitive Colorado craft beer scene for more than half a decade, announced today that it has been named  Colorado Ale Brewery of the Year in the 10th Annual New York International Beer Competition, and that the brewery’s acclaimed Passion Fruit Sour and Black IPA beers also claimed prizes in the annual competition.

This year’s NYIBC  featured more than 800 entries from over 14 countries competing in nearly 40 categories, and the top beer buyers and trade professionals in the country served as judges in the competition. This marked the first time Sanitas Brewing Company entered the competition and it was rewarded not only with the prized Colorado Ale Brewery of the Year honor, but also with a silver medal for its Passion Fruit Sour and a bronze medal for its Black IPA.

Founded in 2013, the Sanitas Brewing Company currently offers four year-round beers and more than 25 unique beers throughout the year, all available in their taproom and patio, located in the shadow of the iconic Boulder Flatirons and Mount Sanitas, for which the brewery is named. 

“The New York International Beer Competition is one of the most legitimate competitions in the beer world, so to get two of our best selling beers to win awards and to be named Colorado Ale Brewery of the Year was awesome,” said Sanitas Brewing Company co-founder Michael Memsic. “It’s exciting that our beer is becoming more recognized, because it signifies to us that the changes and improvements we’ve made to our products are paying off.”

The NYIBC awards highlight an optimistic spring season for the Sanitas Brewing Company, following a silver medal at the Great American Beer Fest in the fall which continues to thrive in Boulder’s competitive craft brewery scene, despite challenges from the ongoing COVID-19 pandemic. 

Last year the Sanitas Brewing Company opened an expanded new patio space covering roughly 8,000 square feet that includes an outdoor bar with four taps of Sanitas microbrews, making it the largest outdoor seating space for any brewery in the City of Boulder. Sanitas has since added additional seating, lighting and shade to accommodate more guests this spring and summer and to help alleviate concerns about social distancing during the pandemic.

In addition,  Sanitas Brewing Company is on pace to have every staff member completely vaccinated against COVID-19 by May 1, and the brewery will continue to abide by all CDC guidelines throughout the pandemic to help limit the spread of the virus.

“I am extremely optimistic about the spring and summer and 2021 as a whole, and I can’t wait,” Memsic said. “I think our patio is going to explode this summer because of the improvements we’ve made, and we’re doing even more this year to make it the best patio in Boulder. We have a killer staff, great seating and a really cool environment overall.”

About Sanitas Brewing Company

Sanitas Brewing Company began with two brewers’ audacious passion for beer. Since then, they’ve built a team of bold, spirited and adventurous individuals working together to bring you a tasty beverage to enjoy in the company of our tap room, to accompany you to our neighboring Rocky Mountains or sip in the comfort of your own home. Our team strongly believes in beer bringing people together and taking pride in our tap room serving as a watering hole for your entrepreneurial collaborations, post-work decompressing and celebrations! Stop by and enjoy a taco and crisp brew, hike Mt. Sanitas and reward yourself with one of our famous lagers or sip a stout next to your fireplace; where your passion leads you, we’re confident in our beer you bring to compliment that journey.  https://www.sanitasbrewing.com

Attachments



Michael Eisenbrown
Sanitas Brewing Co.
4407250031
[email protected]

AngioDynamics Reports Fiscal 2021 Third Quarter Financial Results and Updates Guidance

AngioDynamics Reports Fiscal 2021 Third Quarter Financial Results and Updates Guidance

Fiscal 2021 Third Quarter Highlights

  • Net sales of $71.2 million increased 2.0% compared to the prior-year quarter
  • Gross margin of 54.1%, a decline of 370 basis points year over year
  • GAAP loss per share of $0.09 and adjusted earnings per share of $0.02
  • Cash and cash equivalents on February 28, 2021 were $54.5 million
  • The Company is raising its fiscal year 2021 guidance. The Company now expects net sales between $285 and $288 million and fiscal year 2021 adjusted earnings per share between $0.04 and $0.06

LATHAM, N.Y.–(BUSINESS WIRE)–
AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced financial results for the third quarter of fiscal year 2021, which ended February 28, 2021.

“I am pleased with our strong third quarter performance, driven by continued strength in our AngioVac and Auryon platforms. Our revenue grew 2% year over year despite continued COVID-19 headwinds, particularly in January and the first half of February. Further, we are encouraged by the recent improvements in our end markets and increasing availability of vaccines,” commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “We continue to execute on our strategy to drive revenue growth through our key technology platforms: Auryon, AngioVac, and NanoKnife. In addition, our balanced approach to cash and expense management continues to yield profitability on an adjusted basis while allowing us to invest in the development and progression of these key platforms. I am excited about the planned launch of our new mechanical thrombectomy device later in calendar 2021, as well as a number of other planned product improvements and clinical and regulatory pathway expansions that will open up opportunities for us in larger, higher-growth markets.”

Third Quarter 2021 Financial Results

Net sales for the third quarter of fiscal 2021 were $71.2 million, an increase of 2.0% compared to the prior-year quarter. Net sales in the third quarter continued to be impacted by the disruption to procedure volumes resulting from the COVID-19 global pandemic. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

  • Vascular Interventions and Therapies (“VIT”) net sales were $33.3 million, an increase of 8.8%, compared to $30.6 million a year ago. Growth was driven primarily by increased sales of the Company’s Auryon and AngioVac platforms compared to the previous year. This growth was partially offset by a decline in sales of Venous products resulting from a decline in elective procedure volumes due to the ongoing COVID-19 global pandemic. Auryon sales during the quarter were $3.3 million.
  • Oncology net sales were $13.1 million, a decrease of 10.1% from $14.6 million in the prior-year period. The year-over-year decline was primarily attributable to lower capital sales and ongoing procedure impacts of COVID-19, particularly in international markets, partially offset by continued growth in sales of NanoKnife disposables in the United States.
  • Vascular Access net sales were $24.8 million, compared to $24.6 million a year ago.

U.S. net sales in the third quarter of fiscal 2021 were $58.7 million, an increase of 6.9% from $54.9 million a year ago. International net sales were $12.5 million in the third quarter of fiscal 2021 compared to $14.9 million a year ago.

Gross margin for the third quarter of fiscal 2021 was 54.1%, a decline of 370 basis points compared to the third quarter of fiscal 2020. Consistent with the first half of the year, the year-over-year decline in gross margin was primarily due to Auryon start-up costs and the Company’s previously discussed COVID-related operating plan, including under-absorption of the Company’s manufacturing facilities attributable to additional operating protocols designed to secure the supply-chain and prioritize employee safety. In addition, gross margin was negatively impacted by staffing challenges in the Company’s upstate New York manufacturing facility. During the third quarter, inventory was reduced by $0.6 million when compared to inventory levels on November 30, 2020. During the fiscal year, inventory levels have been reduced by $10.9 million.

The Company recorded a net loss of $3.5 million, or loss per share of $0.09, in the third quarter of fiscal 2021. This compares to a net loss of $5.7 million, or loss per share of $0.15, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2021 was $0.7 million, and adjusted earnings per share was $0.02, compared to adjusted net income in the prior-year period of $0.4 million and adjusted earnings per share of $0.01. Adjusted net income and adjusted earnings per share in the third quarter of fiscal 2021 includes a $1.9 million, and $0.04 per share benefit, respectively, related to the reimbursement of certain expenses under the CARES Act.

Adjusted EBITDA in the third quarter of fiscal 2021, excluding the items shown in the reconciliation table below, was $5.4 million, compared to $3.8 million in the third quarter of fiscal 2020.

In the third quarter of fiscal 2021, the Company generated $5.9 million in operating cash and had capital expenditures of $1.4 million. As of February 28, 2021, the Company had $54.5 million in cash and cash equivalents compared to $58.0 million in cash and cash equivalents on November 30, 2020. The Company reduced its debt outstanding under its revolving credit facility at February 28, 2021, to $30.0 million compared to $40.0 million at November 30, 2020. Subsequent to the end of the third fiscal quarter, the Company further reduced debt outstanding under the revolving credit facility to $20 million. Management remains focused on cash preservation and expense management amid the current environment.

Nine Months Financial Results

For the nine months ended February 28, 2021:

  • Net sales were $214.2 million, an increase of 4.1%, compared to $205.8 million for the same period a year ago.
  • The Company’s net loss was $12.1 million, or a loss of $0.32 per share, compared to a net loss of $9.7 million, or a loss of $0.26 per share, a year ago.
  • Gross margin decreased 490 basis points to 53.4% from 58.3% a year ago due to the Company’s COVID-related operating plan and Auryon start-up costs.
  • Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $1.9 million, with adjusted earnings per share of $0.05, compared to adjusted net income and adjusted earnings per share of $5.7 million, and $0.15, respectively, a year ago.
  • Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $15.0 million, compared to $17.5 million for the same period a year ago.

Fiscal Year 2021 Financial Guidance

The Company is increasing its guidance for fiscal year 2021. Management now projects net sales between $285 and $288 million and fiscal year 2021 adjusted earnings per share between $0.04 and $0.06, compared to previous projections of net sales between $278 and $284 million and adjusted earnings per share between $0.00 and $0.05.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2021 third quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13717367.

This conference call will also be webcast and can be accessed from the “Investors” section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Tuesday, March 30, 2021, until 11:59 p.m. ET on Tuesday, April 6, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13717367.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDA, adjusted net income, adjusted earnings per share, and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

About AngioDynamics, Inc.

AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products. For more information, visit www.angiodynamics.com.

Safe Harbor

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects”, “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2020. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue and is similarly approved for commercialization in Canada, the European Union, and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.

ANGIODYNAMICS, INC. AND SUBSIDIARIES

CONSOLIDATED INCOME STATEMENTS

(in thousands, except per share data)

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28, 2021

 

Feb 29, 2020

 

Feb 28, 2021

 

Feb 29, 2020

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

Net sales

$

71,182

 

 

 

$

69,780

 

 

 

$

214,168

 

 

 

$

205,825

 

 

Cost of sales (exclusive of intangible amortization)

32,652

 

 

 

29,481

 

 

 

99,700

 

 

 

85,765

 

 

Gross profit

38,530

 

 

 

40,299

 

 

 

114,468

 

 

 

120,060

 

 

% of net sales

54.1

 

%

 

57.8

 

%

 

53.4

 

%

 

58.3

 

%

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

Research and development

8,565

 

 

 

8,395

 

 

 

27,286

 

 

 

22,450

 

 

Sales and marketing

19,607

 

 

 

20,934

 

 

 

57,486

 

 

 

60,427

 

 

General and administrative

9,011

 

 

 

10,203

 

 

 

26,787

 

 

 

29,651

 

 

Amortization of intangibles

4,292

 

 

 

5,019

 

 

 

13,838

 

 

 

13,417

 

 

Change in fair value of contingent consideration

183

 

 

 

419

 

 

 

(290

)

 

 

116

 

 

Acquisition, restructuring and other items, net

610

 

 

 

1,565

 

 

 

3,057

 

 

 

4,486

 

 

Total operating expenses

42,268

 

 

 

46,535

 

 

 

128,164

 

 

 

130,547

 

 

Operating loss

(3,738

)

 

 

(6,236

)

 

 

(13,696

)

 

 

(10,487

)

 

Interest expense, net

(226

)

 

 

(166

)

 

 

(676

)

 

 

(672

)

 

Other income (expense), net

(163

)

 

 

(131

)

 

 

259

 

 

 

(67

)

 

Total other expense, net

(389

)

 

 

(297

)

 

 

(417

)

 

 

(739

)

 

Loss before income tax benefit

(4,127

)

 

 

(6,533

)

 

 

(14,113

)

 

 

(11,226

)

 

Income tax benefit

(583

)

 

 

(824

)

 

 

(2,033

)

 

 

(1,506

)

 

Net loss

$

(3,544

)

 

 

$

(5,709

)

 

 

$

(12,080

)

 

 

$

(9,720

)

 

 

 

 

 

 

 

 

 

Loss per share

 

 

 

 

 

 

 

Basic

$

(0.09

)

 

 

$

(0.15

)

 

 

$

(0.32

)

 

 

$

(0.26

)

 

Diluted

$

(0.09

)

 

 

$

(0.15

)

 

 

$

(0.32

)

 

 

$

(0.26

)

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

 

 

 

 

 

Basic

38,360

 

 

 

37,999

 

 

 

38,281

 

 

 

37,924

 

 

Diluted

38,360

 

 

 

37,999

 

 

 

38,281

 

 

 

37,924

 

 

 
 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

(in thousands, except per share data)

 

Reconciliation of Net Loss to non-GAAP Adjusted Net Income:

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28, 2021

 

Feb 29, 2020

 

Feb 28, 2021

 

Feb 29, 2020

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

Net loss

$

(3,544

)

 

 

$

(5,709

)

 

 

$

(12,080

)

 

 

$

(9,720

)

 

 

 

 

 

 

 

 

 

Amortization of intangibles

4,292

 

 

 

5,019

 

 

 

13,838

 

 

 

13,417

 

 

Change in fair value of contingent consideration

183

 

 

 

419

 

 

 

(290

)

 

 

116

 

 

Acquisition, restructuring and other items, net (1)

610

 

 

 

1,565

 

 

 

3,057

 

 

 

4,486

 

 

Write-off of deferred financing fees (2)

 

 

 

 

 

 

 

 

 

593

 

 

Tax effect of non-GAAP items (3)

(803

)

 

 

(932

)

 

 

(2,606

)

 

 

(3,205

)

 

Adjusted net income

$

738

 

 

 

$

362

 

 

 

$

1,919

 

 

 

$

5,687

 

 

 

 

 

 

 

 

 

 

Reconciliation of Diluted Loss Per Share to non-GAAP Adjusted Diluted Earnings Per Share:

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28, 2021

 

Feb 29, 2020

 

Feb 28, 2021

 

Feb 29, 2020

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

Diluted loss per share

$

(0.09

)

 

 

$

(0.15

)

 

 

$

(0.32

)

 

 

$

(0.26

)

 

 

 

 

 

 

 

 

 

Amortization of intangibles

0.11

 

 

 

0.13

 

 

 

0.36

 

 

 

0.35

 

 

Change in fair value of contingent consideration

 

 

 

0.01

 

 

 

(0.01

)

 

 

 

 

Acquisition, restructuring and other items, net (1)

0.02

 

 

 

0.04

 

 

 

0.08

 

 

 

0.12

 

 

Write-off of deferred financing fees (2)

 

 

 

 

 

 

 

 

 

0.02

 

 

Tax effect of non-GAAP items (3)

(0.02

)

 

 

(0.02

)

 

 

(0.06

)

 

 

(0.08

)

 

Adjusted diluted earnings per share

$

0.02

 

 

 

$

0.01

 

 

 

$

0.05

 

 

 

$

0.15

 

 

 

 

 

 

 

 

 

 

Adjusted diluted sharecount (4)

39,271

 

 

38,094

 

 

38,770

 

 

38,111

 

(1) Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items.

(2) Deferred financing fees related to the old credit agreement were written off during the first quarter of fiscal year 2020.

(3) Adjustment to reflect the income tax provision on a non-GAAP basis has been calculated assuming no valuation allowance on the Company’s U.S. deferred tax assets and an effective tax rate of 23% for the periods ended February 28, 2021 and February 29, 2020.

(4) Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP loss.

 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION (Continued)

(in thousands, except per share data)

 

Reconciliation of Net Loss to Adjusted EBITDA:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28, 2021

 

Feb 29, 2020

 

Feb 28, 2021

 

Feb 29, 2020

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

Net loss

$

(3,544

)

 

 

$

(5,709

)

 

 

$

(12,080

)

 

 

$

(9,720

)

 

 

 

 

 

 

 

 

 

Income tax benefit

(583

)

 

 

(824

)

 

 

(2,033

)

 

 

(1,506

)

 

Interest expense, net

226

 

 

 

166

 

 

 

676

 

 

 

672

 

 

Depreciation and amortization

6,340

 

 

 

6,401

 

 

 

19,276

 

 

 

17,434

 

 

Change in fair value of contingent consideration

183

 

 

 

419

 

 

 

(290

)

 

 

116

 

 

Stock based compensation

2,147

 

 

 

1,772

 

 

 

6,398

 

 

 

5,998

 

 

Acquisition, restructuring and other items, net (1)

610

 

 

 

1,565

 

 

 

3,057

 

 

 

4,486

 

 

Adjusted EBITDA

$

5,379

 

 

 

$

3,790

 

 

 

$

15,004

 

 

 

$

17,480

 

 

 

 

 

 

 

 

 

 

Per diluted share:

 

 

 

 

 

 

 

Adjusted EBITDA

$

0.14

 

 

 

$

0.10

 

 

 

$

0.39

 

 

 

$

0.46

 

 

(1) Includes costs related to merger and acquisition activities, restructuring, and unusual items, including asset impairments and write-offs, certain litigation, and other items.

ANGIODYNAMICS, INC. AND SUBSIDIARIES

NET SALES BY PRODUCT CATEGORY AND BY GEOGRAPHY

(in thousands)

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28,

2021

 

Feb 29,

2020

 

%

Growth

 

Currency

Impact

 

Constant

Currency

Growth

 

Feb 28,

2021

 

Feb 29,

2020

 

%

Growth

 

Currency

Impact

 

Constant

Currency

Growth

 

 

 

 

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

 

(unaudited)

 

 

 

 

 

 

Net Sales by Product Category

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vascular Interventions & Therapies

$

33,251

 

 

$

30,552

 

 

8.8%

 

 

 

 

 

$

97,008

 

 

$

90,616

 

 

7.1%

 

 

 

 

Vascular Access

24,813

 

 

24,642

 

 

0.7%

 

 

 

 

 

76,848

 

 

70,585

 

 

8.9%

 

 

 

 

Oncology

13,118

 

 

14,586

 

 

(10.1)%

 

 

 

 

 

40,312

 

 

44,624

 

 

(9.7)%

 

 

 

 

 

$

71,182

 

 

$

69,780

 

 

2.0%

 

(0.4)%

 

1.6%

 

$

214,168

 

 

$

205,825

 

 

4.1%

 

(0.3)%

 

3.8%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Sales by Geography

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

$

58,654

 

 

$

54,889

 

 

6.9%

 

 

 

 

 

$

173,446

 

 

$

163,381

 

 

6.2%

 

 

 

 

International

12,528

 

 

14,891

 

 

(15.9)%

 

(2.1)%

 

(18.0)%

 

40,722

 

 

42,444

 

 

(4.1)%

 

(1.2)%

 

(5.3)%

 

$

71,182

 

 

$

69,780

 

 

2.0%

 

(0.4)%

 

1.6%

 

$

214,168

 

 

$

205,825

 

 

4.1%

 

(0.3)%

 

3.8%

 
 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

Feb 28, 2021

 

May 31, 2020

 

(unaudited)

 

(audited)

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

54,469

 

 

$

54,435

 

Accounts receivable, net

33,171

 

 

31,263

 

Inventories

49,006

 

 

59,905

 

Prepaid expenses and other

9,011

 

 

7,310

 

Total current assets

145,657

 

 

152,913

 

Property, plant and equipment, net

29,827

 

 

28,312

 

Other assets

19,443

 

 

15,338

 

Intangible assets, net

186,216

 

 

197,136

 

Goodwill

201,102

 

 

200,515

 

Total assets

$

582,245

 

 

$

594,214

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

17,067

 

 

$

19,096

 

Accrued liabilities

30,760

 

 

29,380

 

Current portion of contingent consideration

 

 

836

 

Other current liabilities

2,429

 

 

2,133

 

Total current liabilities

50,256

 

 

51,445

 

Long-term debt, net of current portion

30,000

 

 

40,000

 

Deferred income taxes

22,371

 

 

24,057

 

Contingent consideration, net of current portion

15,362

 

 

14,811

 

Other long-term liabilities

9,320

 

 

9,029

 

Total liabilities

127,309

 

 

139,342

 

Stockholders’ equity

454,936

 

 

454,872

 

Total Liabilities and Stockholders’ Equity

$

582,245

 

 

$

594,214

 

 
 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28, 2021

 

Feb 29, 2020

 

Feb 28, 2021

 

Feb 29, 2020

 

(unaudited)

 

(unaudited)

Cash flows from operating activities:

 

 

 

 

 

 

 

Net loss

$

(3,544

)

 

 

$

(5,709

)

 

 

$

(12,080

)

 

 

$

(9,720

)

 

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

 

 

 

 

 

 

 

Depreciation and amortization

6,379

 

 

 

6,440

 

 

 

19,392

 

 

 

17,550

 

 

Non-cash lease expense

595

 

 

 

663

 

 

 

1,860

 

 

 

1,567

 

 

Stock based compensation

2,147

 

 

 

1,772

 

 

 

6,398

 

 

 

5,998

 

 

Change in fair value of contingent consideration

183

 

 

 

419

 

 

 

(290

)

 

 

116

 

 

Deferred income taxes

(634

)

 

 

(872

)

 

 

(2,187

)

 

 

(1,606

)

 

Change in accounts receivable allowances

2

 

 

 

(13

)

 

 

31

 

 

 

186

 

 

Fixed and intangible asset impairments and disposals

10

 

 

 

26

 

 

 

190

 

 

 

395

 

 

Write-off of other assets

 

 

 

 

 

 

 

 

 

593

 

 

Other

81

 

 

 

97

 

 

 

(149

)

 

 

70

 

 

Changes in operating assets and liabilities, net of acquisitions:

 

 

 

 

 

 

 

Accounts receivable

458

 

 

 

(1,630

)

 

 

(1,823

)

 

 

7,834

 

 

Inventories

591

 

 

 

(4,027

)

 

 

11,119

 

 

 

(14,036

)

 

Prepaid expenses and other

(2,498

)

 

 

(5,834

)

 

 

(8,821

)

 

 

(9,378

)

 

Accounts payable, accrued and other liabilities

2,101

 

 

 

(9,169

)

 

 

(1,746

)

 

 

(18,003

)

 

Net cash provided by (used in) operating activities

5,871

 

 

 

(17,837

)

 

 

11,894

 

 

 

(18,434

)

 

Cash flows from investing activities:

 

 

 

 

 

 

 

Additions to property, plant and equipment

(1,382

)

 

 

(1,742

)

 

 

(4,567

)

 

 

(5,756

)

 

Acquisition of intangibles

 

 

 

 

 

 

 

 

 

(350

)

 

Cash paid in acquisition

 

 

 

(10,000

)

 

 

 

 

 

(55,760

)

 

Net cash used in investing activities

(1,382

)

 

 

(11,742

)

 

 

(4,567

)

 

 

(61,866

)

 

Cash flows from financing activities:

 

 

 

 

 

 

 

Proceeds from borrowings on long-term debt

 

 

 

15,000

 

 

 

 

 

 

15,000

 

 

Repayment of long-term debt

(10,000

)

 

 

 

 

 

(10,000

)

 

 

(132,500

)

 

Deferred financing costs on long-term debt

 

 

 

(34

)

 

 

 

 

 

(775

)

 

Payment of acquisition related contingent consideration

 

 

 

 

 

 

 

 

 

(1,208

)

 

Proceeds (outlays) from exercise of stock options and employee stock purchase plan

1,978

 

 

 

594

 

 

 

2,459

 

 

 

(706

)

 

Net cash provided by (used in) financing activities

(8,022

)

 

 

15,560

 

 

 

(7,541

)

 

 

(120,189

)

 

Effect of exchange rate changes on cash and cash equivalents

(23

)

 

 

(68

)

 

 

248

 

 

 

8

 

 

Increase (decrease) in cash and cash equivalents

(3,556

)

 

 

(14,087

)

 

 

34

 

 

 

(200,481

)

 

Cash and cash equivalents at beginning of period

58,025

 

 

 

41,247

 

 

 

54,435

 

 

 

227,641

 

 

Cash and cash equivalents at end of period

$

54,469

 

 

 

$

27,160

 

 

 

$

54,469

 

 

 

$

27,160

 

 

 
 

ANGIODYNAMICS, INC. AND SUBSIDIARIES

GAAP TO NON-GAAP RECONCILIATION

(in thousands)

 

Reconciliation of Free Cash Flows:

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

Feb 28, 2021

 

Feb 29, 2020

 

Feb 28, 2021

 

Feb 29, 2020

 

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

Net cash provided by (used in) operating activities

$

5,871

 

 

 

$

(17,837

)

 

 

$

11,894

 

 

 

$

(18,434

)

 

Additions to property, plant and equipment

(1,382

)

 

 

(1,742

)

 

 

(4,567

)

 

 

(5,756

)

 

Free Cash Flow

$

4,489

 

 

 

$

(19,579

)

 

 

$

7,327

 

 

 

$

(24,190

)

 

 

Investor Contact:

AngioDynamics, Inc.

Stephen Trowbridge, Executive Vice President & CFO

(518) 795-1408

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Surgery Medical Devices Health Cardiology Oncology

MEDIA:

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OraSure Technologies Submits COVID-19 Rapid Antigen Prescription Home Self-Test and Professional Test to FDA for Emergency Use Authorization

Tests designed to detect active COVID-19 infection with a simple, easy-to-use workflow

BETHLEHEM, Pa., March 30, 2021 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its COVID-19 rapid antigen test for both Prescription Home Use, and Professional Use in point of care (POC) settings.

These lateral flow, rapid diagnostic tests are designed to detect active COVID-19 infection with a simple, easy-to-use workflow, using samples self-collected from the lower nostrils. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution. No instrumentation, batteries, smart phone or laboratory analysis is needed to read the result, which appears on the test stick a short time later.

“We believe our rapid antigen tests will be well received in the market thanks to their simplicity and ease of use. We also have the proven experience and capabilities to manufacture at scale to meet demand. With the race between vaccines and variants ongoing, testing will continue to play a crucial role in reopening workplaces, schools and other places where people gather,” said Stephen Tang, Ph.D., President and CEO of OraSure Technologies. “I’m delighted that we were able to accelerate the submission of the Prescription Home Self-Test. At-home testing will make it easier for individuals to safely and quickly know if they are infectious, and self-isolate to minimize transmission.”

Subject to receipt of Emergency Use Authorization, the Company intends to market a COVID-19 Prescription Home Self-Test and a Professional Test for use in POC settings. With a simple design and straightforward workflow, OraSure’s tests are well suited for use by individuals at home, as well as by health care providers, employers, pharmacies, universities, and deployment into underserved communities when prescribed by a healthcare provider.

Manufacturing

OraSure has started manufacturing the COVID-19 rapid antigen test in parallel with EUA submission. The Company has well-established manufacturing capabilities, having produced over 80 million rapid HIV, HCV and Ebola tests. OraSure is in the midst of a manufacturing capacity expansion that will bring annual capacity for its rapid tests from 55 million tests at the end of the first quarter to 70 million tests beginning in the third quarter of 2021, and further to 120 million units per year by the second quarter of 2022. Included in these numbers are approximately 17 million of the Company’s existing tests for HIV, HCV and Ebola.

OraSure’s Response to the COVID-19 Pandemic

OraSure is leveraging its expertise in infectious disease testing and molecular sample collection to advance COVID-19 testing and sample collection solutions across three modalities: Molecular/PCR, Antibody and Antigen. The Company’s portfolio of COVID-19 tests and collection kits all feature convenient, pain-free self-collection, and help increase access to testing, alleviate the burden on the healthcare system, minimize exposure risks and conserve personal protective equipment (PPE).

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Important Information
This press release contains certain forward-looking statements, including with respect to expected revenues, products, product development activities, regulatory submissions and authorizations and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management’s attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; ability to market and sell products, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (“FDA”) or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on our business and our ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales; ability to identify, complete, integrate and realize the full benefits of future acquisitions; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention (“CDC”) or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; and general political, business and economic conditions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2020, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.   

Investor contact:

Sam Martin
Argot Partners
212-600-1902
[email protected]

Media contact:

Jeanne Mell
OraSure Technologies
484-353-1575
[email protected] 



Rover and Nebula Caravel Acquisition Corp. to Participate in SPACInsider Webinar on March 31, 2021 at 2pm ET

Rover and Nebula Caravel Acquisition Corp. to Participate in SPACInsider Webinar on March 31, 2021 at 2pm ET

SEATTLE–(BUSINESS WIRE)–
A Place for Rover, Inc. (“Rover” or the “Company”), the world’s largest network of five-star pet sitters and dog walkers, and Nebula Caravel Acquisition Corp. (“Caravel”) (Nasdaq: NEBC), a publicly traded special purpose acquisition company sponsored by True Wind Capital, today announced that the two companies will participate in a webinar hosted by SPACInsider on Wednesday, March 31, 2021 at 2:00 pm ET to discuss Rover and Caravel’s proposed business combination.

The webinar for this event can be accessed at: https://zoom.us/webinar/register/3216165207970/WN_XvkPNFiyR8iklUT0QpjPJQ.

Participants in the webinar will include:

  • Aaron Easterly, Co-Founder and Chief Executive Officer of Rover
  • Tracy Knox, Chief Financial Officer of Rover
  • Charlie Wickers, VP of Finance of Rover
  • Adam Clammer, Chief Executive Officer of Caravel and Co-CEO of True Wind Capital

Rover, the leading online marketplace for pet care, connects pet parents with local, high-quality pet care providers who offer a wide range of services, including boarding, in-home pet sitting, doggy daycare, dog walking, drop-in visits, and grooming. Since its inception through 2020, more than 2 million pet parents have booked services on Rover with more than 500,000 pet care providers across North America and Europe. Rover was created to provide a better pet care alternative for pets and their parents than the existing options of friends and family, neighbors, and kennels. Rover built a simple, easy-to-use platform and mobile app to enable pet parents to discover, book, pay, and review loving pet care providers online. Rover eliminates many of the barriers of pet ownership, enabling Rover’s mission to make it possible for everyone to experience the unconditional love of pets.

On February 11, 2021, Rover and Caravel entered into a definitive business combination. Upon closing of the transaction, which is expected to be completed in the first half of 2021, the combined company intends to trade on Nasdaq under the new ticker symbol, “ROVR”, with an anticipated implied enterprise value of approximately $1.35 billion. Institutional investors have committed to a private investment of $50 million in Class A common stock of the combined company that will close concurrently with the business combination. It is anticipated that the combined company will have an equity market capitalization at closing of approximately $1.63 billion and have over $300 million of unrestricted cash on the balance sheet, subject to any redemptions by Caravel stockholders.

About Rover

Founded in 2011 and based in Seattle, Rover is the world’s largest online marketplace for pet care. Rover connects pet parents with caring pet care providers who offer overnight services, including boarding and in-home pet sitting, as well as daytime services, including doggy daycare, dog walking, drop-in visits, and grooming. Millions of pet parents have booked a service on Rover, with more than 500,000 pet care providers across North America and Europe.

About Nebula Caravel Acquisition Corp.

Nebula Caravel Acquisition Corp (Nasdaq: NEBC) (“Caravel”) is a blank check company sponsored by True Wind Capital and led by Adam H. Clammer and James H. Greene, Jr., who serve as Chief Executive Officer and Chairman, respectively, formed for the purpose of partnering with one high-quality technology business. Caravel follows Nebula Acquisition Corporation’s successful merger with Open Lending in June 2020.

About True Wind Capital

True Wind Capital is a San Francisco-based private equity firm focused on investing in leading technology companies. True Wind has a broad investing mandate, with deep industry expertise across software, data analytics, tech-enabled services, internet, financial technology, and hardware. Rover will be True Wind’s 8th platform investment.

Important Information and Where to Find It

This press release relates to the proposed merger involving Nebula Caravel Acquisition Corp. (“Caravel”) and A Place for Rover, Inc. (“Rover”). Caravel intends to file a Registration Statement on Form S-4 with the SEC, which will include a proxy statement and prospectus of Caravel and an information statement of Rover, and each party will file other documents with the SEC regarding the proposed transaction. A definitive proxy statement/prospectus/information statement will also be sent to the stockholders of Caravel and Rover, seeking any required stockholder approvals. Before making any voting or investment decision, investors and securityholders of Caravel and Rover are urged to carefully read the entire registration statement and proxy statement/prospectus/information, when they become available, and any other relevant documents filed with the SEC, as well as any amendments or supplements to these documents, because they will contain important information about the proposed transaction. The documents filed by Caravel with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov. Alternatively, these documents, when available, can be obtained free of charge from Caravel upon written request to Nebula Caravel Acquisition Corp., Four Embarcadero Center, Suite 2100, San Francisco, California 94111.

Participants in the Solicitation

Caravel, Rover and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Caravel, in favor of the approval of the merger. Information regarding Caravel’s directors and executive officers is contained in the section of Caravel’s Form S-1 titled “Management”, which was filed with the SEC on November 20, 2020. Additional information regarding the interests of those participants and other persons who may be deemed participants in the transaction may be obtained by reading the registration statement and the proxy statement/prospectus/information statement and other relevant documents filed with the SEC when they become available. Free copies of these documents may be obtained as described in the preceding paragraph.

No Offer or Solicitation

This press release does not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This press release also does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor will there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such other jurisdiction. No offering of securities will be made except by means of a prospectus meeting the requirements of section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including, but not limited to, Caravel’s and Rover’s expectations or predictions of future financial or business performance or conditions. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events or results of operations, are forward-looking statements. These statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or similar expressions. Such forward-looking statements involve risks and uncertainties that may cause actual events, results or performance to differ materially from those indicated by such statements. Certain of these risks are identified and discussed in the section of Caravel’s Form S-1 titled “Risk Factors” which was filed with the SEC on November 20, 2020. These risk factors will be important to consider in determining future results and should be reviewed in their entirety. These forward-looking statements are based on Caravel’s or Rover’s management’s current expectations and beliefs, as well as a number of assumptions concerning future events. However, there can be no assurance that the events, results or trends identified in these forward-looking statements will occur or be achieved. Forward-looking statements speak only as of the date they are made, and neither Caravel nor Rover is under any obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Readers should carefully review the statements set forth in the reports, which Caravel has filed or will file from time to time with the SEC.

In addition to factors previously disclosed in Caravel’s reports filed with the SEC and those identified elsewhere in this press release, the following factors, among others, could cause actual results to differ materially from forward-looking statements or historical performance: risks and uncertainties related to the inability of the parties to successfully or timely consummate the merger, including the risk that any required regulatory approvals or stockholder approvals of Caravel or Rover are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the merger is not obtained, failure to realize the anticipated benefits of the merger, risks related to Rover’s ability to execute on its business strategy, attract and retain users, develop new offerings, enhance existing offerings, compete effectively, and manage growth and costs, the duration and global impact of COVID-19, the number of redemption requests made by Caravel’s public stockholders, the ability of the combined company to meet Nasdaq’s listing standards (or the standards of any other securities exchange on which securities of the public entity are listed) following the merger, the inability to complete the private placement of common stock of Caravel to certain institutional accredited investors, the risk that the announcement and consummation of the transactions disrupts Rover’s current plans and operations, costs related to the transactions, the outcome of any legal proceedings that may be instituted against Caravel, Rover, or any of their respective directors or officers, following the announcement of the transactions, the ability of Caravel’s or the combined company to issue equity or equity-linked securities in connection with the proposed business combination or in the future, the failure to realize anticipated pro forma results and underlying assumptions, including with respect to estimated stockholder redemptions and purchase price and other adjustments; and those factors discussed in documents of Caravel filed, or to be filed, with SEC.

Additional factors that could cause actual results to differ materially from those expressed or implied in forward-looking statements can be found in Caravel’s most recent reports on Form 8-K, which are available, free of charge, at the SEC’s website at www.sec.gov, and will also be provided in the Registration Statement on Form S-4 and Caravel’s proxy statement/prospectus/information statement when available. Any financial projections in this press release are forward-looking statements that are based on assumptions that are inherently subject to significant uncertainties and contingencies, many of which are beyond Caravel’s and Rover’s control. While all projections are necessarily speculative, Caravel and Rover believe that the preparation of prospective financial information involves increasingly higher levels of uncertainty the further out the projection extends from the date of preparation. The assumptions and estimates underlying the projected results are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the projections. The inclusion of projections in this press release should not be regarded as an indication that Caravel and Rover, or their representatives, considered or consider the projections to be a reliable prediction of future events.

Annualized, pro forma, projected and estimated numbers are used for illustrative purpose only, are not forecasts and may not reflect actual results.

This press release is not intended to be all-inclusive or to contain all the information that a person may desire in considering an investment in Caravel and is not intended to form the basis of an investment decision in Caravel. All subsequent written and oral forward-looking statements concerning Caravel and Rover, the proposed transaction or other matters and attributable to Caravel and Rover or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.

For Rover

Investors:

[email protected]

Brinlea Johnson

(415) 269-2645

Media:

[email protected]

Kristin Sandberg

(360) 510-6365

For Nebula Caravel

Stephanie Portillo

[email protected]

KEYWORDS: United States North America Washington

INDUSTRY KEYWORDS: Software Internet Pets Finance Professional Services Technology Consumer Other Consumer

MEDIA:

Logo
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PolarityTE Reports Fourth Quarter and Fiscal Year 2020 Results

PolarityTE Reports Fourth Quarter and Fiscal Year 2020 Results

Fourth Quarter Revenues of $3.59 million and Full Year 2020 Revenues of $10.13 million

PolarityTE to host conference call and webcast today, March 30, 2021 at 8:00 a.m. ET

SALT LAKE CITY–(BUSINESS WIRE)–PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, today reported financial results for the fourth quarter and fiscal year ended December 31, 2020.

David Seaburg, Chief Executive Officer, commented, “2020 was a transformational year for PolarityTE as we made the decision to pursue an IND and BLA for SkinTE. If we successfully obtain a BLA for SkinTE, we believe it will create a more valuable asset with a greater likelihood of achieving widespread commercial adoption bolstered by robust clinical data, which should have a positive effect on stockholder value. As a result of this change in direction, we reduced our commercial operations in May 2020 and have realized a substantial reduction in our operating expenses. This cost savings coupled with our recent capital raises means we have the resources to pursue the FDA regulatory process and fund our operations well into 2022. Our team weathered COVID-19’s headwinds to our SkinTE business and leveraged our internal resources to build out our testing business, allowing us to defray expenses and support the public health effort to combat the pandemic. We have also made great progress towards our planned IND submission, which we remain on track to file in the second half of 2021. I am proud of what we have accomplished over the past year, and look forward to what the future holds for PolarityTE and all of our stakeholders.”

Recent Business Highlights

  • Raised $25.67 million of capital (before offering costs) from a single healthcare-dedicated institutional investor in December 2020 and January 2021
  • Submitted a Type B Pre-IND meeting request to FDA for SkinTE and received written responses in October 2020
  • In February 2021, U.S. Patent No. 10,926,001 issued, and U.S. Application No. 16/165,169 was allowed. The granted and allowed claims pertain to methods of making compositions for regenerating functional skin tissue, and related methods of treatment. The Company’s total number of allowed and granted utility patents is currently ten—eight internationally and two in the U.S.
  • Final patient enrolled in our multicenter, randomized controlled trial evaluating SkinTE plus standard of care versus standard of care alone in treatment of diabetic foot ulcers in January 2021, with top-line results expected to be announced at the Symposium on Advanced Wound Care (SAWC) Spring Conference in May 2021

Operating Highlights for the Year Ended December 31, 2020

  • Total revenues were $10.13 million for FY:20 compared to $5.65 million for FY:19, representing a 79% increase year over year
  • SkinTE revenues were $3.73 million for FY:20 compared to $2.35 million for FY:19, representing a 59% increase year over year
  • Contract services revenues were $6.40 million for FY:20 compared to $3.30 million for FY:19, representing a 94% increase year over year

    • Contract services revenues for FY:20 includes $4.32 million from COVID-19 test processing that began in late May of 2020
  • Operational cash burn for FY:20 was $37.75 million which is a reduction of $18.89 million from FY:19, representing a 33% decrease year over year

Operating Highlights for the Quarter Ended December 31, 2020

  • Total revenues were $3.59 million in Q4:20 compared to $3.34 million in Q3:20, representing an 8% increase quarter over quarter
  • SkinTE revenues were $1.20 million in Q4:20 compared to $1.16 million in Q3:20, representing a 4% increase quarter over quarter
  • Contract services revenues were $2.39 million in Q4:20 compared to $2.18 million in Q3:20, representing a 9% increase quarter over quarter

    • Contract services revenues for Q4:20 includes $1.86 million from COVID-19 testing processing
  • Operational cash burn for Q4:20 was $4.82 million, excluding $0.76 million of offering and warrant repricing expenses, which represents a 70% reduction from Q4:19 and 29% reduction from Q3:20

Financial Results for the Year Ended December 31, 2020

Net revenues increased by 79% to $10.13 million in 2020. The increase in net revenues for sale of products was the result of a sales strategy adopted in May 2020 to focus on regions and facilities where we had repeat users of SkinTE. For 2020 the average wound size treated with SkinTE was 219 cm2 compared to 120 cm2 in 2019, which corresponds with the difference in revenue between those years. The increase in net revenues for services was the result of $4.32 million in new COVID-19 testing services we began to offer through Arches Research at the end of May 2020. In 2019 services net revenues was derived primarily from pre-clinical testing services provided through IBEX Preclinical Research, which were adversely impacted by COVID-19 in 2020.

Total operating costs and expenses decreased to $51.64 million in 2020 from $96.57 million in 2019, or 47%. This is the most significant change in our results of operations period over period and is attributable to the 46% reduction in personnel from the end of 2019 to the end of 2020. The reduction in personnel substantially reduced salary and benefit costs across the Company. Salary and benefits totaled $19.72 million in 2020 compared to $28.81 million in 2019. In addition, stock-based compensation decreased by 77% from $31.40 million in 2019 to $7.26 million in 2020. The decrease in salary and benefits in 2020 accounts for 20% of the decrease in total operating costs and expenses in 2020 compared to 2019. The decrease in stock-based compensation in 2020 accounts for 54% of the decrease in total operating costs and expenses in 2020 compared to 2019. The reduction in personnel also allows us to make incremental reductions in the cost of infrastructure required to support the activities of employees.

Research and development expenses decreased by 30% in 2020 to $11.53 million, which is attributable to the reduction in salary and benefits and stock compensation costs from 2019.

General and administrative expenses decreased by 56% in 2020 to $27.56 million. In addition to reductions in salary and benefits and stock compensation costs from 2019, travel and related costs decreased to $0.24 million in 2020 from $1.32 million in 2019. Expenses for our leased facilities were $2.09 million in 2020.

Sales and marketing expenses decreased by 49% in 2020 to $8.72 million. In addition to reductions in salary and benefits and stock compensation costs from 2019, promotional consulting and expense was reduced to $0.83 million in 2020 from $5.27 in 2019, and travel and related costs decreased to $0.44 million in 2020 from $1.44 million in 2019.

Net loss for the year ended December 31, 2020 was $42.85 million compared with a net loss of $92.49 million for the year ended December 31, 2019.

Cash and Liquidity as of December 31, 2020

As of December 31, 2020, we had $25.52 million in cash and cash equivalents. In January 2021, we raised an additional $17.67 million in gross proceeds before offering expenses in a registered direct offering and through a warrant exercise agreement. Based on currently available information as of the date we file this press release, we believe that our existing cash and cash equivalents will be sufficient to fund our activities through the end of 2021 and into the third quarter of 2022. However, our projections of future cash needs may differ from actual results.

Cash used in operating activities for the three-month period ended December 31, 2020 was approximately $5.58 million, which included $0.76 million of offering and repricing costs, or $4.82 million excluding offering and repricing costs or approximately $1.61 million per month on average, 70% lower than the $5.33 million monthly average in the three months ended December 31, 2019 and 29% lower than the $2.25 million monthly average in the three months ended September 30, 2020.

Conference Call and Webcast Details

The conference call can be accessed by calling 1-800-581-5838 (U.S. and Canada) or +44 (0)330 336 9104 (International), with confirmation code 363305 and referencing “PolarityTE Fiscal Year 2020 Earnings Call.” A webcast of the conference call can be accessed by using the link below.

Earnings Call Webcast – CLICK HERE

A replay of the earnings conference call will be available for 30 days, beginning approximately one hour after the conclusion of the call and can be found by visiting PolarityTE’s website at https://www.polarityte.com/news-media/events or by clicking on the link above.

About PolarityTE®

PolarityTE is focused on transforming the lives of patients by discovering, designing, and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures products from the patient’s own tissue and uses the patient’s own body to support the regenerative process. From a small piece of healthy autologous tissue, the company creates an easily deployable, dynamic, and self-propagating product designed to regenerate the target tissues. PolarityTE’s innovative methods are intended to promote and accelerate growth of the patient’s tissues to undergo a form of effective regenerative healing. Learn more at www.PolarityTE.com – Welcome to the Shift®.

Forward Looking Statements

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. They are generally identified by words such as “believes,” “may,” “expects,” “anticipates,” “intend,” “plan,” “will,” “would,” “should” and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company’s beliefs and assumptions as of the date of this release. The Company’s actual results could differ materially due to the impact of the COVID-19 pandemic and FDA regulatory matters, which cannot be predicted, and the risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law. Our actual results could differ materially due to risk factors and other items described in more detail in the “Risk Factors” section of the Company’s Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov).

POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are trademarks or registered trademarks of PolarityTE, Inc.

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

 

 

December 31,

2020

 

December 31,

2019

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

25,522

 

 

$

10,218

 

Short-term investments

 

 

 

 

 

19,022

 

Accounts receivable, net

 

 

3,819

 

 

 

1,731

 

Inventory

 

 

883

 

 

 

252

 

Prepaid expenses and other current assets

 

 

992

 

 

 

1,264

 

Total current assets

 

 

31,216

 

 

 

32,487

 

Property and equipment, net

 

 

10,550

 

 

 

14,911

 

Operating lease right-of-use assets

 

 

2,452

 

 

 

4,590

 

Intangible assets, net

 

 

542

 

 

 

731

 

Goodwill

 

 

278

 

 

 

278

 

Other assets

 

 

472

 

 

 

602

 

TOTAL ASSETS

 

$

45,510

 

 

$

53,599

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

4,148

 

 

$

7,095

 

Other current liabilities

 

 

2,106

 

 

 

2,338

 

Current portion of long-term note payable

 

 

2,059

 

 

 

528

 

Deferred revenue

 

 

168

 

 

 

98

 

Total current liabilities

 

 

8,481

 

 

 

10,059

 

Common stock warrant liability

 

 

5,975

 

 

 

 

Operating lease liabilities

 

 

1,476

 

 

 

2,994

 

Other long-term liabilities

 

 

723

 

 

 

1,630

 

Long-term notes payable

 

 

1,517

 

 

 

 

Total liabilities

 

 

18,172

 

 

 

14,683

 

 

 

 

 

 

 

 

Commitments and Contingencies (Note 17)

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred stock – 25,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2020 and 2019

 

 

 

 

 

 

Common stock – $.001 par value; 250,000,000 shares authorized; 54,857,099 and 27,374,653 shares issued and outstanding at December 31, 2020 and 2019, respectively

 

 

55

 

 

 

27

 

Additional paid-in capital

 

 

505,494

 

 

 

474,174

 

Accumulated other comprehensive income

 

 

 

 

 

72

 

Accumulated deficit

 

 

(478,211

)

 

 

(435,357

)

Total stockholders’ equity

 

 

27,338

 

 

 

38,916

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

45,510

 

 

$

53,599

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

 

 

For the Year Ended

December 31,

 

For the Year Ended

December 31,

 

 

2020

 

2019

Net revenues

 

 

 

 

 

 

Products

 

$

3,730

 

 

$

2,353

 

Services

 

 

6,396

 

 

 

3,299

 

Total net revenues

 

 

10,126

 

 

 

5,652

 

Cost of sales

 

 

 

 

 

 

Products

 

 

1,068

 

 

 

1,365

 

Services

 

 

3,356

 

 

 

1,114

 

Total costs of sales

 

 

4,424

 

 

 

2,479

 

Gross profit

 

 

5,702

 

 

 

3,173

 

Operating costs and expenses

 

 

 

 

 

 

Research and development

 

 

11,532

 

 

 

16,397

 

General and administrative

 

 

27,557

 

 

 

63,189

 

Sales and marketing

 

 

8,719

 

 

 

16,980

 

Restructuring and other charges

 

 

3,834

 

 

 

 

Total operating costs and expenses

 

 

51,642

 

 

 

96,566

 

Operating loss

 

 

(45,940

)

 

 

(93,393

)

 

 

 

 

 

 

 

Other income (expense), net

 

 

 

 

 

 

Change in fair value of common stock warrant liability

 

 

2,914

 

 

 

 

Interest (expense) income, net

 

 

(182

)

 

 

151

 

Other income, net

 

 

354

 

 

 

749

 

Net loss

 

$

(42,854

)

 

$

(92,493

)

 

 

 

 

 

 

 

Net loss per share attributable to common stockholders

 

 

 

 

 

 

Basic

 

$

(1.11

)

 

$

(3.70

)

Diluted

 

$

(1.16

)

 

$

(3.70

)

Weighted average shares outstanding

 

 

 

 

 

 

Basic

 

 

38,779,316

 

 

 

24,966,355

 

Diluted

 

 

39,367,390

 

 

 

24,966,355

 

POLARITYTE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

 

 

For the Year

Ended

December 31,

 

For the Year

Ended

December 31,

 

 

2020

 

2019

CASH FLOWS FROM OPERATING ACTIVITIES

 

 

 

 

 

 

Net loss

 

$

(42,854

)

 

$

(92,493

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

7,258

 

 

 

31,402

 

Depreciation and amortization

 

 

3,074

 

 

 

2,992

 

Change in allowance for doubtful accounts

 

 

148

 

 

 

26

 

Change in fair value of common stock warrant liability

 

 

(2,914

)

 

 

 

Amortization of intangible assets

 

 

189

 

 

 

193

 

Amortization of debt discount

 

 

19

 

 

 

49

 

Change in fair value of contingent consideration

 

 

 

 

 

(36

)

Loss on abandonment of property and equipment and ROU assets

 

 

2,806

 

 

 

914

 

Other non-cash adjustments

 

 

(21

)

 

 

20

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(2,236

)

 

 

(1,045

)

Inventory

 

 

(631

)

 

 

84

 

Prepaid expenses and other current assets

 

 

272

 

 

 

193

 

Operating lease right-of-use assets

 

 

1,700

 

 

 

1,651

 

Other assets/liabilities, net

 

 

(200

)

 

 

(249

)

Accounts payable and accrued expenses

 

 

(2,761

)

 

 

1,269

 

Other current liabilities

 

 

35

 

 

 

32

 

Deferred revenue

 

 

70

 

 

 

(72

)

Operating lease liabilities

 

 

(1,708

)

 

 

(1,578

)

Net cash used in operating activities

 

 

(37,754

)

 

 

(56,648

)

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

Purchase of property and equipment

 

 

(1,339

)

 

 

(2,773

)

Purchase of available-for-sale securities

 

 

(14,144

)

 

 

(40,072

)

Proceeds from maturities of available-for-sale securities

 

 

16,945

 

 

 

23,327

 

Proceeds from sale of available-for-sale securities

 

 

16,171

 

 

 

3,901

 

Net cash provided by/(used in) investing activities

 

 

17,633

 

 

 

(15,617

)

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

Proceeds from term note payable and financing arrangements

 

 

4,629

 

 

 

 

Principal payments on term note payable and financing arrangements

 

 

(1,675

)

 

 

(534

)

Payment of contingent consideration liability

 

 

 

 

 

(225

)

Principal payments on financing leases

 

 

(508

)

 

 

(453

)

Net proceeds from the sale of common stock, warrants and pre-funded warrants

 

 

32,020

 

 

 

28,073

 

Proceeds from warrants exercised

 

 

1,008

 

 

 

 

Cash paid for tax withholdings related to net share settlement

 

 

(155

)

 

 

(679

)

Proceeds from stock options exercised

 

 

31

 

 

 

529

 

Proceeds from ESPP purchase

 

 

75

 

 

 

99

 

Net cash provided by financing activities

 

 

35,425

 

 

 

26,810

 

 

 

 

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

 

15,304

 

 

 

(45,455

)

Cash and cash equivalents – beginning of period

 

 

10,218

 

 

 

55,673

 

Cash and cash equivalents – end of period

 

$

25,522

 

 

$

10,218

 

 

Investors:

Rich Haerle

VP, Investor Relations

PolarityTE, Inc.

[email protected]

(385) 315-0697

KEYWORDS: United States North America Utah

INDUSTRY KEYWORDS: Medical Devices FDA Health Stem Cells Clinical Trials Biotechnology

MEDIA:

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Lantronix Named to 2021 CRN Partner Program Guide

Lantronix met strict scoring for CRN partner program based on channel benefits that drive success

IRVINE, Calif., March 30, 2021 (GLOBE NEWSWIRE) — Lantronix Inc. (NASDAQ: LTRX), a global provider of Software as a Service (SaaS), connectivity services, engineering services, intelligent hardware and turnkey solutions for the Internet of Things (IoT) and Remote Environment Management (REM), today announced it has been named to the 2021 CRN Partner Program Guide published by CRN®, a brand of The Channel Company. This annual guide provides a conclusive list of the most distinguished partner programs from leading technology companies that provide products and services through the IT Channel. The 2021 Partner Program Guide will be featured in the April 2021 issue of CRN and online at www.CRN.com/PPG.

“Lantronix is pleased to be named to CRN’s Partner Program Guide as it is the definitive guide to the technology industry’s best channel partner programs,” said Roger Holliday, VP of Worldwide Sales at Lantronix. “Our Lantronix SmartEdge channel program met CRN’s strict criteria with scoring based on program offerings, partner profitability, training, education, support, marketing and other resources. We are delighted to be among an exclusive group of technology companies to be included in this year’s list.”

Lantronix’s SmartEdge™ Partner Program was designed to help Value-Added Resellers (VARs) and Systems Integrators (SIs) drive revenues by differentiating their offerings with Lantronix’s innovative Industrial Internet of Things (IoT), Remote Environment Management (REM), Out-of-Band Management (OOBM), engineering services and Mobility/Connectivity solutions.

Given the importance of IT vendor channel programs, each year CRN develops its Partner Program Guide to provide the channel community with a detailed look at the partner programs offered by IT manufacturers, software developers, service companies and distributors. Vendors are scored based on investments in program offerings, partner profitability, partner training, education and support, marketing programs and resources, sales support and communication.

“As innovation continues to fuel the speed and intricacy of technology, solution providers need partners that can keep up and support their developing business,” said Blaine Raddon, CEO of The Channel Company. “We are pleased to announce that Lantronix has been named to CRN’s 2021 Partner Program Guide, which gives insight into the strengths of each organization’s program to recognize those that continually support and push positive change inside the IT channel.”

About The Channel Company

The Channel Company enables breakthrough IT channel performance with our dominant media, engaging events, expert consulting and education, and innovative marketing services and platforms. As the channel catalyst, we connect and empower technology suppliers, solution providers and end users. Backed by nearly 40 years of unequalled channel experience, we draw from our deep knowledge to envision innovative new solutions for ever-evolving challenges in the technology marketplace. www.thechannelcompany.com  Follow The Channel Company:Twitter, LinkedIn, and Facebook.

About Lantronix

Lantronix Inc. is a global provider of Software as a Service (SaaS), connectivity services, engineering services, intelligent hardware and turnkey solutions for the Internet of Things (IoT) and Remote Environment Management (REM). Lantronix enables its customers to provide reliable and secure IoT Intelligent Edge and OOBM solutions while accelerating time to market. Lantronix’s products and services dramatically simplify the creation, development, deployment and management of IoT projects while providing quality, reliability and security across hardware, software and solutions.

With three decades of proven experience in creating robust IoT technologies and OOBM solutions, Lantronix is an innovator in enabling its customers to build new business models, leverage greater efficiencies and realize the possibilities of the Internet of Things. Lantronix’s solutions are deployed inside millions of machines at data centers, offices and remote sites serving a wide range of industries, including energy, agriculture, medical, security, manufacturing, distribution, transportation, retail, financial, environmental and government.

Lantronix is headquartered in Irvine, Calif. For more information, visit www.lantronix.com.

Learn more at the Lantronix blog, www.lantronix.com/blog, featuring industry discussion and updates. To follow Lantronix on Twitter, please visit www.twitter.com/Lantronix. View our video library on YouTube at www.youtube.com/user/LantronixInc or connect with us on LinkedIn at www.linkedin.com/company/lantronix.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Any statements set forth in this news release that are not entirely historical and factual in nature, including without limitation statements related to our solutions, technologies and products as well as being named to the 2021 CRN Partner Program Guide published by CRN®, are forward-looking statements. These forward-looking statements are based on our current expectations and are subject to substantial risks and uncertainties that could cause our actual results, future business, financial condition, or performance to differ materially from our historical results or those expressed or implied in any forward-looking statement contained in this news release. The potential risks and uncertainties include, but are not limited to, such factors as the effects of negative or worsening regional and worldwide economic conditions or market instability on our business, including effects on purchasing decisions by our customers; the impact of the COVID-19 outbreak on our employees, supply and distribution chains, and the global economy; cybersecurity risks; changes in applicable U.S. and foreign government laws, regulations, and tariffs; our ability to successfully implement our acquisitions strategy or integrate acquired companies; difficulties and costs of protecting patents and other proprietary rights; the level of our indebtedness, our ability to service our indebtedness and the restrictions in our debt agreements; and any additional factors included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed with the Securities and Exchange Commission (the “SEC”) on September 11, 2020, including in the section entitled “Risk Factors” in Item 1A of Part I of such report, as well as in our other public filings with the SEC. Additional risk factors may be identified from time to time in our future filings. The forward-looking statements included in this release speak only as of the date hereof, and we do not undertake any obligation to update these forward-looking statements to reflect subsequent events or circumstances.

© 2021 Lantronix, Inc. All rights reserved. Lantronix is a registered trademark, and EMG and ConsoleFlow are trademarks of Lantronix Inc. Other trademarks and trade names are those of their respective owners.

© 2021. CRN is a registered trademark of The Channel Company, LLC. All rights reserved.

Lantronix Media Contact:

Gail Kathryn Miller
Corporate Marketing &
Communications Manager
[email protected]
949-453-7158

Lantronix Analyst and Investor Contact:

Jeremy Whitaker
Chief Financial Officer
[email protected]
949-450-7241

Lantronix Sales:

[email protected]

Americas +1 (800) 422-7055 (US and Canada) or +1 949-453-3990
Europe, Middle East and Africa +31 (0)76 52 36 744
Asia Pacific + 852 3428-2338
China + 86 21-6237-8868
Japan +81 (0) 50-1354-6201
India +91 994-551-2488



Visa Expands Global Money Movement Capabilities Beyond the Card with Visa Direct Payouts

Visa Expands Global Money Movement Capabilities Beyond the Card with Visa Direct Payouts

Simplifies SMB and consumer payments for corporate banks, remitters and fintechs

SAN FRANCISCO–(BUSINESS WIRE)–
Visa (NYSE:V) today announced the expansion of Visa Direct, a real-time1 push payments platform, with the introduction of Visa Direct Payouts. The new solution allows Visa’s clients and partners around the world to use a single point of connection to push payments to eligible cards for domestic payouts, and eligible cards and/or accounts for cross-border payments.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210330005157/en/

Visa Expands Global Money Movement Capabilities Beyond the Card with Visa Direct Payouts (Graphic: Business Wire)

Visa Expands Global Money Movement Capabilities Beyond the Card with Visa Direct Payouts (Graphic: Business Wire)

“As digital commerce accelerates, Visa is innovating to give financial institutions, governments, individuals and businesses new ways to pay and get paid beyond the card,” said Bill Sheley, SVP, Global Head, Visa Direct, Visa. “The launch of Visa Direct Payouts marks an important milestone in Visa’s expansion of its account-to-account capabilities to now reach an additional 2 billion bank accounts around the world. Backed by the operating scale and performance of VisaNet, the solution integrates Visa’s acquisition of Earthport to transform how Visa’s clients deploy and optimize global money movement programs.”

Flexible Visa Direct Payouts APIs reduce complexities often associated with managing and sending money across multiple networks and intermediaries worldwide. The solution provides operational simplicity to move money globally through a single connection to VisaNet, enabling financial institutions, fintechs, remittance providers and corporate banks to capture new payment flows for growth and value creation. Visa Direct Payouts supports real-time2 domestic and cross-border person-to-person (P2P), business-to-small business (B2SB) and business-to-consumer (B2C) use cases, such as insurance disbursements, marketplace seller payouts, providing workers faster access to their earnings, as well as remittances.

Visa’s clients and partners around the world are launching new money-movement programs enabled by Visa Direct Payouts.

  • Standard Chartered Bank (Hong Kong) Limited is enhancing its digital International Transfer services for its retail banking customers
  • MoneyGram is launching an enhanced money-movement optionality for its customers who are sending and receiving money to loved ones across borders
  • KyckGlobal, a Visa fintech partner, enables a variety of B2SB and B2C use cases through its payments engine, including insurance claims payouts, fast funds settlement for SMB marketplaces and quick access to earned wages for independent contractors and hourly workers

Visa Direct Payouts Client and Partner Quotes

“With 152% year-over-year cross-border digital transactions growth for MoneyGram Online in 2020 and an impressive 650% transaction growth for Visa Direct in the fourth quarter3, consumer demand for our digital P2P payment capabilities continues to skyrocket,“ said Alex Holmes, MoneyGram Chairman and CEO. “Our continued expansion with Visa Direct is an important component of our customer-centric strategy to provide a streamlined, frictionless customer journey and real-time transfer capabilities to millions across the globe who rely on our essential service.”

“Our clients work with a diverse set of payees, including contractors and gig economy workers, each with different payment needs, such as a commission payment, expense reimbursement or insurance claim payout,” said Ashish Bahl, KyckGlobal CEO and Founder. “With Visa Direct, we are able to ensure our customers’ clients are paid quickly and securely wherever they access funds, which is more important than ever in today’s economic environment.”

With the addition of Visa Direct Payouts, Visa Direct now provides multi-rail access to 5 billion cards and accounts combined across more than 200 geographies, supporting 160 currencies, connecting to 16 card-based networks4, 65 domestic Automated Clearing House (ACH) schemes, seven Real-Time Payment (RTP) networks and five payment gateways. For Visa Direct transactions, Visa offers value-added services, including security and tokenization, bringing peace of mind for SMBs and consumers as they pay and get paid, and move money internationally.

For more information and to connect with our team, please visit the Visa Direct Payouts page.

About Visa

Visa (NYSE: V) is the world’s leader in digital payments. Our mission is to connect the world through the most innovative, reliable and secure payment network – enabling individuals, businesses and economies to thrive. Our advanced global processing network, VisaNet, provides secure and reliable payments around the world, and is capable of handling more than 65,000 transaction messages a second. The company’s relentless focus on innovation is a catalyst for the rapid growth of digital commerce on any device for everyone, everywhere. As the world moves from analog to digital, Visa is applying our brand, products, people, network and scale to reshape the future of commerce. For more information, visit About Visa, visa.com/blog and @VisaNews.

_________________

1 Actual fund availability varies by receiving financial institution, receiving account type, region, and whether the transaction is domestic or cross-border.

2 Actual fund availability varies by receiving financial institution, receiving account type, region, and whether the transaction is domestic or cross-border.

3 Source: https://ir.moneygram.com/news-releases/news-release-details/moneygram-international-reports-fourth-quarter-and-full-year-5

4 Visa offers the Visa Push Payment Gateway Service to enable push-to-card capabilities for non-Visa cards in the U.S and Canada

Aida Hadzibegovic

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Technology Finance Security Professional Services Small Business Software Networks Internet Data Management

MEDIA:

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Visa Expands Global Money Movement Capabilities Beyond the Card with Visa Direct Payouts (Graphic: Business Wire)