Tuesday, September 27, 2022

Apyx Medical Company Stories Second Quarter 2022 Monetary Outcomes and Updates Full Yr 2022 Monetary Outlook

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CLEARWATER, Fla., August 11, 2022–(BUSINESS WIRE)–Apyx Medical Company (NASDAQ:APYX) (the “Firm”), the producer of a proprietary helium plasma and radiofrequency expertise marketed and bought as Renuvion®, immediately reported monetary outcomes for its second quarter ended June 30, 2022, and up to date monetary expectations for the total yr ending December 31, 2022.

Second Quarter 2022 Monetary Abstract:

  • Whole income of $10.3 million, down 8% year-over-year.

    • Superior Power income of $8.4 million, down 16% year-over-year.

    • OEM income of $1.9 million, up 55% year-over-year.

  • Internet loss attributable to stockholders of $5.4 million, in comparison with $4.0 million for the second quarter of 2021.

  • Adjusted EBITDA lack of $3.4 million, in comparison with adjusted EBITDA lack of $2.4 million for the second quarter of 2021.

Second Quarter 2022 Working Abstract:

  • On April 4, 2022, the Firm introduced the submission of a 510(ok) premarket notification (“510(ok) submission”) to the U.S. Meals and Drug Administration (“FDA”). The 510(ok) submission was meant to increase the Firm’s basic indication to incorporate a selected indication for using the Renuvion APR Handpiece in subcutaneous dermatological and aesthetic procedures to enhance the looks of lax (unfastened) pores and skin within the neck and submental area.

  • On Could 26, 2022, the Firm introduced it obtained 510(ok) clearance from the FDA for using the Renuvion Dermal Handpiece for particular dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for dermatological procedures for the remedy of reasonable to extreme wrinkles and rhytides, restricted to sufferers with Fitzpatrick pores and skin sorts I, II or III.

    • On June 2, 2022, the FDA up to date the Medical System Security Communication (“MDSC”) associated to the Firm’s Superior Power merchandise to acknowledge this new 510(ok) clearance.

Highlights & Developments Subsequent to Quarter Finish:

  • On July 8, 2022, the Firm introduced that the outcomes of the pivotal Part II of its Investigational System Exemption (“IDE”) examine evaluating the protection and effectiveness of the Renuvion system to enhance the looks of lax pores and skin within the neck and submental area are actually out there on ClinicalTrials.gov.

  • On July 18, 2022, the Firm introduced it obtained 510(ok) clearance from the FDA for using the Renuvion APR Handpieces for sure pores and skin contraction procedures. The Renuvion APR Handpieces are actually indicated to be used in subcutaneous dermatological and aesthetic procedures to enhance the looks of lax (unfastened) pores and skin within the neck and submental area.

    • On July 21, 2022, the FDA up to date the MDSC associated to the Firm’s Superior Power merchandise to acknowledge this new 510(ok) clearance.

  • On July 27, 2022, the Firm introduced its first reporting of environmental, social and governance (“ESG”) information by way of a newly launched tear sheet. This information offers context to the Firm’s ESG targets and priorities necessary to its enterprise and stakeholders.

Administration Feedback:

“Our complete income within the second quarter decreased 8% year-over-year, because of the affect of the Medical System Security Communication on world gross sales of our Superior Power merchandise,” mentioned Charlie Goodwin, President and Chief Govt Officer. “Internationally, we noticed softer-than-expected Superior Power generator and handpiece demand from distributors in choose international locations, which represented the biggest contributor to the 16% year-over-year lower in world Superior Power gross sales throughout the quarter. Particularly, Superior Power worldwide generator and handpiece gross sales decreased greater than 45% and 30% year-over-year, respectively. Within the U.S., we have been happy by our efficiency throughout the quarter, which exceeded our expectations. Whereas we continued to expertise slower U.S. gross sales of our Superior Power merchandise as anticipated, we noticed materials enchancment in our enterprise tendencies throughout every month of the quarter.”

Mr. Goodwin continued: “We’re updating our steerage immediately to replicate the home and worldwide efficiency in our Superior Power enterprise throughout the second quarter, and revised expectations for the second half of 2022. Our crew has made robust progress in latest months, securing 510(ok) clearances for particular indications associated to using our Renuvion expertise in dermal resurfacing procedures and to enhance the looks of lax, or unfastened, pores and skin. These clearances present necessary validation for the protection and effectiveness of our Renuvion expertise and increase our addressable market alternative to incorporate roughly 200,000 wrinkle discount procedures and 200,000 neck contouring procedures carried out within the U.S. yearly. We’re additionally happy that the FDA up to date the Medical System Security Communication to replicate our receipt of those new 510(ok) clearances. We stay up for getting into full commercialization for these new indications by the top of 2022, and proceed to consider that the headwinds skilled throughout the second quarter will in the end show to be transitory.”

The next tables current income by reportable section and geography:

Three Months Ended

June 30,

Improve/Lower

Six Months Ended June 30,

Improve/Lower

(In hundreds)

2022

2021

$ Change

% Change

2022

2021

$ Change

% Change

Superior Power

$

8,364

$

9,978

$

(1,614

)

(16.2

) %

$

19,178

$

17,638

$

1,540

8.7

%

OEM

1,928

1,246

682

54.7

%

3,607

2,224

1,383

62.2

%

Whole

$

10,292

$

11,224

$

(932

)

(8.3

) %

$

22,785

$

19,862

$

2,923

14.7

%

Three Months Ended June 30,

Improve/Lower

Six Months Ended June 30,

Improve/Lower

(In hundreds)

2022

2021

$ Change

% Change

2022

2021

$ Change

% Change

Home

$

7,947

$

7,383

$

564

7.6

%

$

15,495

$

12,949

$

2,546

19.7

%

Worldwide

2,345

3,841

(1,496

)

(38.9

) %

7,290

6,913

377

5.5

%

Whole

$

10,292

$

11,224

$

(932

)

(8.3

) %

$

22,785

$

19,862

$

2,923

14.7

%

Second Quarter 2022 Outcomes:

Whole income for the three months ended June 30, 2022 decreased $0.9 million, or 8% year-over-year, to $10.3 million, in comparison with $11.2 million within the prior yr interval. Superior Power section gross sales decreased $1.6 million, or 16% year-over-year, to $8.4 million, in comparison with $10.0 million within the prior yr interval. OEM section gross sales elevated $0.7 million, or 55% year-over-year to $1.9 million, in comparison with $1.2 million within the prior yr interval. For the second quarter of 2022, income in the USA elevated $0.6 million, or 8% year-over-year, to $7.9 million, and worldwide income decreased $1.5 million, or 39% year-over-year, to $2.3 million. The year-over-year lower in Superior Power income was as a consequence of decreased world demand for the Firm’s handpieces and mills following the FDA Security Communication on March 14, 2022. The year-over-year enhance in OEM income was pushed by greater gross sales to present clients, together with Symmetry Surgical, in addition to gross sales associated to the completion of the event portion of among the Firm’s OEM growth agreements.

Gross revenue for the three months ended June 30, 2022, decreased $0.6 million, or 8% year-over-year, to $6.9 million, in comparison with $7.5 million within the prior yr interval. Gross margin for the three months ended June 30, 2022, was 67.2%, in comparison with 67.1% within the prior yr interval. The rise in gross revenue margins for the three months ended June 30, 2022 from the prior yr interval was primarily attributable to geographic combine throughout the Firm’s Superior Power section, with home gross sales comprising the next share of complete gross sales and the combo of newer product fashions because the Firm obtains registrations permitting these merchandise to be launched into the markets it serves.

Working bills for the three months ended June 30, 2022 elevated $1.3 million, or 11% year-over-year, to $12.9 million, in comparison with $11.6 million within the prior yr interval. The year-over-year change in working bills was pushed by a $0.5 million enhance in salaries and associated prices, a $0.5 million enhance in skilled companies and a $0.3 million enhance in promoting, basic and administrative bills.

Revenue tax expense for the three months ended June 30, 2022 and 2021 was $0.1 million.

Internet loss attributable to stockholders for the three months ended June 30, 2022 was $5.4 million, or $0.16 per share, in comparison with a web lack of $4.0 million, or $0.12 per share, within the prior yr interval.

Adjusted EBITDA loss for the three months ended June 30, 2022 was $3.4 million, in comparison with adjusted EBITDA lack of $2.4 million within the prior yr interval.

First Six Months of 2022 Outcomes:

Whole income for the six months ended June 30, 2022, elevated $2.9 million, or 15%, to $22.8 million, in comparison with $19.9 million within the prior yr interval. Superior Power section gross sales elevated $1.5 million, or 9% year-over-year, to $19.2 million, in comparison with $17.6 million within the prior yr interval. OEM section gross sales elevated $1.4 million, or 62% year-over-year, to $3.6 million, in comparison with $2.2 million within the prior yr interval. For the primary half of 2022, income in the USA elevated $2.5 million, or 20% year-over-year, to $15.5 million, and worldwide income elevated $0.4 million, or 6% year-over-year, to $7.3 million.

Internet loss attributable to stockholders for the six months ended June 30, 2022 was $11.4 million, or $0.33 per share, in comparison with a web lack of $8.9 million, or $0.26 per share, within the prior yr interval.

Full Yr 2022 Monetary Outlook:

The Firm is updating monetary steerage for the yr ending December 31, 2022 to:

  • Whole income within the vary of $51.0 million to $56.4 million, representing progress of roughly 5% to 16% year-over-year, in comparison with complete income of $48.5 million for the yr ended December 31, 2021. The Firm’s prior steerage vary for complete income was $52.5 million to $59.0 million, representing progress of 8% to 22% year-over-year.

  • Internet loss attributable to stockholders within the vary of $20.1 million to $16.6 million, in comparison with web loss attributable to stockholders of $15.2 million for the yr ended December 31, 2021. The Firm’s prior steerage vary for web loss attributable to stockholders was $19.0 million to $14.7 million.

  • Adjusted EBITDA loss within the vary of $11.8 million to $8.2 million, in comparison with adjusted EBITDA lack of $8.8 million for the yr ended December 31, 2021. The Firm’s prior steerage vary for Adjusted EBITDA loss was $10.1 million to $6.4 million.

Convention Name Particulars:

Administration will host a convention name at 5:00 p.m. Japanese Time on August 11, 2022 to debate the outcomes of the quarter and to host a query and reply session. To hearken to the decision by telephone, events could dial 877-407-8289 (or 201-689-8341 for worldwide callers) and supply entry code 13731067. Individuals ought to ask for the Apyx Medical Company Name. A reside webcast of the decision might be accessible by way of the Investor Relations part of the Firm’s web site and at:

https://occasion.choruscall.com/mediaframe/webcast.html?webcastid=4ztO7TPi

A telephonic replay might be out there roughly two hours after the top of the decision by means of the next two weeks. The replay could be accessed by dialing 877-660-6853 for U.S. callers or 201-612-7415 for worldwide callers and utilizing the replay entry code: 13731067. The webcast might be archived on the Investor Relations part of the Firm’s web site.

About Apyx Medical Company:

Apyx Medical Company is a complicated vitality expertise firm with a ardour for elevating individuals’s lives by means of progressive merchandise, together with its Helium Plasma Know-how merchandise marketed and bought as Renuvion® within the beauty surgical procedure market and J-Plasma® within the hospital surgical market. Renuvion® and J-Plasma® provide surgeons a singular capacity to offer managed warmth to tissue to attain their desired outcomes. The Firm additionally leverages its deep experience and a long time of expertise in distinctive waveforms by means of OEM agreements with different medical system producers. For additional details about the Firm and its merchandise, please seek advice from the Apyx Medical Company web site at www.ApyxMedical.com.

Cautionary Assertion on Ahead-Wanting Statements:

Sure issues mentioned on this launch and oral statements made on occasion by representatives of the Firm could represent forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995 and the Federal securities legal guidelines. Though the Firm believes that the expectations mirrored in such forward-looking statements are based mostly upon affordable assumptions, it can provide no assurance that its expectations might be achieved.

All statements aside from statements of historic truth are statements that could possibly be deemed forward-looking statements, together with however not restricted to, any statements concerning the potential affect of the COVID-19 pandemic and the actions by governments, companies and people in response to the state of affairs; projections of web income, margins, bills, web earnings, web earnings per share, or different monetary gadgets; projections or assumptions in regards to the potential receipt by the Firm of any regulatory approvals from any authorities company or instrumentality together with however not restricted to the U.S. Meals and Drug Administration, provide chain disruptions, element shortages, manufacturing disruptions or logistics challenges; or macroeconomic or geopolitical issues and the affect of these issues on the Firm’s monetary efficiency.

Ahead-looking statements and knowledge are topic to sure dangers, tendencies and uncertainties that would trigger precise outcomes to vary materially from these projected. Many of those components are past the Firm’s capacity to regulate or predict. Vital components that will trigger the Firm’s precise outcomes to vary materially and that would affect the Firm and the statements contained on this launch embody however usually are not restricted to dangers, uncertainties and assumptions referring to the regulatory setting wherein the Firm is topic to, together with the Firm’s capacity to achieve requisite approvals for its merchandise from the U.S. Meals and Drug Administration and different governmental and regulatory our bodies, each domestically and internationally; the affect of the latest FDA Security Communication on our enterprise and operations; components referring to the consequences of the COVID-19 pandemic; sudden or excessive volatility in commodity costs and availability, together with provide chain disruptions; adjustments normally financial, enterprise or demographic situations or tendencies; adjustments in and results of the geopolitical setting; liabilities and prices which the Firm could incur from pending or threatened litigations, claims, disputes or investigations; and different dangers which are described within the Firm’s Annual Report on Type 10-Okay for the fiscal yr ended December 31, 2021 and the Firm’s different filings with the Securities and Trade Fee. For forward-looking statements on this launch, the Firm claims the safety of the protected harbor for forward-looking statements contained within the Personal Securities Litigation Reform Act of 1995. The Firm assumes no obligation to replace or complement any forward-looking statements whether or not on account of new data, future occasions or in any other case.

APYX MEDICAL CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In hundreds, besides per share information)

(Unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2022

2021

2022

2021

Gross sales

$

10,292

$

11,224

$

22,785

$

19,862

Price of gross sales

3,378

3,690

7,652

6,468

Gross revenue

6,914

7,534

15,133

13,394

Different prices and bills:

Analysis and growth

1,070

1,084

2,228

2,199

Skilled companies

2,389

1,889

4,675

3,410

Salaries and associated prices

4,892

4,343

10,073

8,588

Promoting, basic and administrative

4,539

4,261

10,004

7,985

Whole different prices and bills

12,890

11,577

26,980

22,182

Loss from operations

(5,976

)

(4,043

)

(11,847

)

(8,788

)

Curiosity revenue

18

4

20

7

Curiosity expense

(3

)

(2

)

(11

)

(6

)

Different loss, web

607

97

586

4

Whole different loss, web

622

99

595

5

Loss earlier than revenue taxes

(5,354

)

(3,944

)

(11,252

)

(8,783

)

Revenue tax expense

96

107

166

173

Internet loss

(5,450

)

(4,051

)

(11,418

)

(8,956

)

Internet loss attributable to non-controlling curiosity

(24

)

(5

)

(47

)

(9

)

Internet loss attributable to stockholders

$

(5,426

)

$

(4,046

)

$

(11,371

)

$

(8,947

)

Loss per share

Fundamental and Diluted

$

(0.16

)

$

(0.12

)

$

(0.33

)

$

(0.26

)

Weighted common variety of shares excellent – primary and diluted

34,464

34,321

34,447

34,312

APYX MEDICAL CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(In hundreds, besides share and per share information)

June 30,

2022

(Unaudited)

December 31,
2021

ASSETS

Present belongings:

Money and money equivalents

$

20,063

$

30,870

Commerce accounts receivable, web of allowance of $629 and $430

10,340

13,038

Revenue tax receivables

7,642

7,642

Different receivables

33

483

Inventories, web of provision for obsolescence of $360 and $263

9,677

6,778

Pay as you go bills and different present belongings

2,770

1,926

Whole present belongings

50,525

60,737

Property and tools, web

6,842

6,575

Working lease right-of-use belongings

659

121

Finance lease right-of-use belongings

176

178

Different belongings

1,269

1,110

Whole belongings

$

59,471

$

68,721

LIABILITIES AND EQUITY

Present liabilities:

Accounts payable

$

2,587

$

2,631

Accrued bills and different liabilities

8,570

10,287

Present portion of working lease liabilities

110

122

Present portion of finance lease liabilities

85

165

Whole present liabilities

11,352

13,205

Lengthy-term working lease liabilities

514

Lengthy-term finance lease liabilities

93

18

Lengthy-term contract liabilities

1,207

1,323

Different liabilities

142

166

Whole liabilities

13,308

14,712

EQUITY

Widespread inventory, $0.001 par worth; 75,000,000 shares approved; 34,493,085 issued and excellent as of June 30, 2022, and 34,409,912 issued and excellent as of December 31, 2021

34

34

Further paid-in capital

69,793

66,221

Gathered deficit

(23,922

)

(12,551

)

Whole stockholders’ fairness

45,905

53,704

Non-controlling curiosity

258

305

Whole fairness

46,163

54,009

Whole liabilities and fairness

$

59,471

$

68,721

APYX MEDICAL CORPORATION
RECONCILIATION OF GAAP NET LOSS RESULTS TO NON-GAAP ADJUSTED EBITDA
(Unaudited)

Use of Non-GAAP Monetary Measure

We current the next non-GAAP measure as a result of we consider such measure is a helpful indicator of our working efficiency. Our administration makes use of this non-GAAP measure principally as a measure of our working efficiency and believes that this measure is helpful to traders as a result of it’s regularly utilized by analysts, traders and different events to guage firms in our trade. We additionally consider that this measure is helpful to our administration and traders as a measure of comparative working efficiency from interval to interval. The non-GAAP monetary measure introduced on this launch shouldn’t be thought-about as an alternative choice to, or preferable to, the measures of monetary efficiency ready in accordance with GAAP.

The Firm has introduced the next non-GAAP monetary measure on this press launch: adjusted EBITDA. The Firm defines adjusted EBITDA as its reported web revenue (loss) attributable to stockholders (GAAP) plus revenue tax expense (profit), curiosity, depreciation and amortization, and stock-based compensation expense.

(In hundreds)

Three Months Ended

June 30,

Six Months Ended

June 30,

2022

2021

2022

2021

Internet loss attributable to stockholders

$

(5,426

)

$

(4,046

)

$

(11,371

)

$

(8,947

)

Curiosity revenue

(18

)

(4

)

(20

)

(7

)

Curiosity expense

3

2

11

6

Revenue tax expense

96

107

166

173

Depreciation and amortization

247

213

472

440

Inventory based mostly compensation

1,714

1,369

3,364

2,563

Adjusted EBITDA

$

(3,384

)

$

(2,359

)

$

(7,378

)

$

(5,772

)

The next unaudited desk presents a reconciliation of web loss attributable to stockholders to Adjusted EBITDA loss for the yr ending December 31, 2022. The reconciliation assumes the mid-point of the Adjusted EBITDA loss vary and the midpoint of every element of the reconciliation, akin to steerage for GAAP web loss attributable to stockholders of $20.1 million to $16.6 million for the yr ending December 31, 2022.

(In hundreds of thousands)

Yr Ending December 31, 2022

Internet loss attributable to stockholders

$

(18.4

)

Curiosity revenue

Curiosity expense

Revenue tax expense

0.4

Depreciation and amortization

1.0

Inventory based mostly compensation

7.0

Adjusted EBITDA

$

(10.0

)

View supply model on businesswire.com: https://www.businesswire.com/information/house/20220811005510/en/

Contacts

Investor Relations Contact:

ICR Westwicke on behalf of Apyx Medical Company
Mike Piccinino, CFA
investor.relations@apyxmedical.com



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