APYX Investor Presentation Final 8-18-19apyxmedical.com/.../apyx_investorpresentation_final... ·...
Transcript of APYX Investor Presentation Final 8-18-19apyxmedical.com/.../apyx_investorpresentation_final... ·...
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August 2019
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Certain matters discussed in this presentation and oral statements made from time to time by representatives of the Company may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the Company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved.
Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the Company’s ability to control or predict. Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this presentation can be found in the Company’s filings with the Securities and Exchange Commission including our most recent reports on Form 10-K and Form 10-Q. Copies of these filings are available online from the SEC. For forward-looking statements in this presentation, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements as a result of new information, future events, or otherwise.
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Safe Harbor Statement
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Investment Highlights
Enhanced growth profile and balance sheet fueled by recent strategic transaction
$1.5+ Billion potential market opportunity in U.S. cosmetic surgery
Renuvion Cosmetic Technology: truly differentiated; unique capabilities in cosmetic surgery procedures
Strong early commercial traction and physician feedback for Renuvion
Growth profile benefitting from recent expansion of US distribution footprint and increasing coverage and penetration of key OUS markets
Pursuing multiple strategic initiatives to position “Apyx Medical Corporation”(1)
for sustainable, long-term growth in the cosmetic surgery market
Experienced management team; enhanced with recent hires
(1) Note, company formerly known as Bovie® Medical Corporation; rebranded as Apyx Medical Corporation on 1/1/19 following the transaction with Symmetry Surgical, Inc. which closed on 8/30/18
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Mgmt. Team Member Joined ApyxRepresentative
Previous Experience
Charlie GoodwinChief Executive Officer
December 2017
Tara SembChief Financial Officer
December 2018
Todd HornsbyExecutive Vice President
August 2014
Moshe CitronowiczSenior Vice President
October 1993
Years of Relevant Experience
26
25
19
32 KCR Technologies
Sequential Information Systems
Dr. Topaz KirlewVice President of Quality Assurance & Regulatory Affairs
February 2018
33
Shawn RomanVice President of Research and Development
October 2014
22
Jeff HoffmanVice President of Marketing
February2016
20
Experienced Management Team
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Mgmt. Team Member Joined ApyxRepresentative
Previous ExperienceYears of Relevant
Experience
Scott SandersDirector of Clinical Education and Market Development
March 2018
38
Laura IversenDirector of Global Operations – Advanced Energy
September 2018
21
Kari Larson Senior Director of Clinical Studies
July2019
15
Libet Garber, Ph.D.Director of Global Regulatory Affairs
July2019
15
Experienced Management Team; enhanced with recent hires
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• Medical technology company, formerly known as Bovie Medical Corporation
• Two reportable operating segments:
• “Advanced Energy” – commercializing the company’s Helium Plasma Technology
• A patented technology using helium plasma and proprietary RF waveforms for cutting, coagulation and ablation of soft tissue
• Sold under the Renuvion® Cosmetic Technology brand in the cosmetic surgery market
• Sold under the J-Plasma® brand in the hospital-based surgery markets
• “OEM” – original equipment manufacturer for other medical device manufacturers
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Company Snapshot
Founded: 1978
Locations:• Clearwater, FL • Sofia, Bulgaria
Full-TimeEmployees:
259(1)
(1) As of 6/30/19(2) Market cap. based on common shares outstanding of 33.9M as of 7/29/19 from the Company’s 10-Q SEC filing on 8/7/19;
share price of $7.90 is as of 8/13/19(3) As market close on 8/13/19“LTM” = Last Twelve Months
Year of IPO: 1982
Ticker (Nasdaq) : APYX
Market Cap : ~$268M(2)
Avg. Daily Vol (LTM):
~235,000(3)
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• Apyx Medical retained Advanced Energy and OEM operating segments and manufacturing facilities
- Transaction allows Apyx Medical to focus on most attractive growth opportunity: Advanced Energy operating segment
- Apyx Medical will be OEM-provider of surgical generators to Symmetry Surgical for at least 10-years under generator manufacturing and supply agreement
• $69 million in net after tax proceeds from the transaction significantly enhances balance sheet
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“Apyx Medical”(1)
Enhanced Growth Profile & Balance Sheet Fueled by Recent Strategic Transaction
August 30, 2018: Completed divestiture and sale of “Core” operating segment and the Bovie brand to Symmetry Surgical, Inc. for $97M in gross proceeds.
(1) Note, company formerly known as Bovie Medical Corporation; rebranded as “Apyx Medical Corporation” on 1/1/19following the transaction with Symmetry Surgical, Inc. which closed on 8/30/18
“Apyx Medical”: enhanced growth profile and balance sheet;Increased focus on Advanced Energy segment opportunity
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Apyx Medical: Attractive Market Opportunity
• ~15,000(1) plastic surgeons, cosmetic surgeons & dermatologists
$1.5+ Billion potential market opportunity in U.S. cosmetic surgery
Generators: ~$1.3 billion potential market opportunity(2)
Handpieces: ~$255 million potential annual market opportunity
(1) Source: American Society of Plastic Surgeons (ASPS) database 2016(2) Assumes 15,000 physicians x ~$85,000 generator list price(3) Assumes ~400,000 annual procedures x ~$425 handpiece list price(4) Assumes ~200,000 annual procedures x ~$425 handpiece list price
Primary Market Opportunity: Selling Renuvion (powered by J-Plasma Technology) in the U.S. cosmetic surgery market
• Strong annual addressable market opportunity with initial clinical indication
• Renuvion as a subdermal coagulator following liposuction procedures: ~$170M(3)
• Pursuing additional clinical indications to expand annual addressable market in the U.S.
• Dermal skin resurfacing procedures: ~$85M(4)
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: Revolutionary Technology for the Cosmetic Surgery Market
• Helium plasma and proprietary RF waveform to for cutting, coagulating and ablating soft tissue
• Offers ability to deliver heat to tissue in a way never before possible:
Renuvion’s unique ability to manage tissue temperature allows for improved tissue effect & reduced treatment time
1. Unique heating with helium plasma and proprietary RF energy and near instantaneous cooling
- Allows Renuvion to quickly heat the subdermal tissue to maximum contraction temperatures, while minimizing thermal diffusion to the skin surface
2. Ability to deliver full power to all soft tissues
- Allows for faster and more efficient heating of the subdermal tissue
3. Non-contact energy delivery- Allows for 360° energy application to all desired tissues in the subdermal space
5000 ohms
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: Solving the Tissue Temperature Dilemma
• Traditional mono- and bipolar RF technologies:
- Rely on full thickness heating, which results in inefficient and slow heat delivery
- Difficult to achieve ideal treatment temperature range for subdermal tissue contraction while maintaining safe skin surface temperature
- Struggle between desired immediate tissue effect (internal >65O
C) and safety (external at <~47O C)
Renuvion’s unique ability to manage heat solves the internal-external tissue temperature dilemma
• Renuvion Cosmetic Technology:
- Able to quickly deliver maximum contraction temperatures to subdermal tissue, while maintaining safe skin surface temperature
- Allows for improved tissue effect and time efficiency
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Physician Feedback
“Complete and even tissue contraction is key to great results with this patient group, and Renuvion is the most effective device I have ever used for this purpose. Treatment time is shorter and results are observable sooner…”
-Alfredo Hoyos, MD
Plastic Surgeon
“Renuvion is one of the best investments in my practice that I’ve ever made. I’m expanding my usage with it every day and I’ve even purchased another system for my second office.”
-Kyle Song, MD
Plastic Surgeon
Strong feedback from physicians in the cosmetic surgery market
“I had one of the bipolar systems previously and upgraded to Renuvion because I found it to be faster, and it allows me to give my patients better results.”
-Richard Hodnett, MD Plastic Surgeon
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Commercial Strategy
• Marketing and selling Renuvion to “early adopters” in the U.S. cosmetic surgery market
• Employing a hybrid selling model comprised of >40 representatives, including:(1)
- 29 field-based selling professionals
- 4 sales managers
- 6 independent sales agencies
• Driving growth by expanding customer base and increasing utilization from existing accounts
Expanded U.S. sales and distribution network to drive growth
U.S. Commercial Strategy:
International Commercial Strategy:
• Utilizing a network of distributors, who market and sell into physician’s offices and the hospital surgical suite
- Products sold in >40 countries via distributor network
• Growth fueled by penetrating existing markets and expanding distributor relationships
(1) As of 6/30/2019
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Establishing Foundation for Long-term Growth
1. Enhancing physician and practice support for cosmetic surgery customers
2. Expanding clinical support for Renuvion in cosmetic surgery procedures
3. Formulizing regulatory strategy in the cosmetic surgery market
4. Improving manufacturing capabilities and efficiencies
Focused on building support to facilitate broad-based adoption of Renuvion by:
Pursuing multiple strategic initiatives to position Apyx Medical for sustainable, long-term growth in the cosmetic surgery market
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Establishing Foundation for Long-term Growth1. Enhancing physician and practice support for cosmetic surgery customers
• Channel-specific branding for the cosmetic surgery market
- - Leverages Apyx Medical’s Helium Plasma Technology and initial efforts into this market with the J-Plasma brand
• Created for physicians, with their input
- Physician feedback from early adopters of J-Plasma technology were instrumental in creating a brand/campaign that will resonate with cosmetic surgery customers
• Designed to:
- Enhance physician practice-based marketing
- Provide a more patient friendly brand for the technology
- Leverage the increasing awareness of Renuvion in the cosmetic surgery market
March, 2018 – Launched “Renuvion Cosmetic Technology” brand:
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Establishing Foundation for Long-term Growth2. Expanding clinical support for Renuvion in cosmetic surgery procedures
• 2018 –
• Completed clinical work to explore and demonstrate Renuvion’s unique method of action
• Completed first IDE study evaluating the use of Renuvion in dermal skin resurfacing
• Study used to support withdrawn application for 510(k) clearance. APYX focused on obtaining additional data to support new 510(k) application.
• 2019 –
• Appointed four new members to Medical Advisory Board to inform clinical strategy
• Appointed Kari Larson, Senior Director of Clinical Affairs, to develop and manage clinical research strategy
• Retrospective clinical study examining the subdermal use of Renuvion in liposuction procedures
• Publication anticipated in 2H’19
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Establishing Foundation for Long-term Growth3. Formulizing regulatory strategy in the cosmetic surgery market
• Initial focus: Pursue specific clinical indication for the use of Renuvion in dermal resurfacing procedures
- Premarket Notification 510(k) for dermal resurfacing procedures withdrawn March ‘19
- Next steps: APYX focused on obtaining additional data to support new application for 510(k) clearance for dermal resurfacing procedures
- IDE application for study submitted on July 23rd
• Obtain regulatory clearance in new countries outside the U.S. with large, growing cosmetic surgery markets
• Appointed Libet Garber PhD (recruited from the FDA) as Global Director of Regulatory Affairs to support and manage regulatory strategy
Long-term focus: Develop and execute multi-year strategy to secure specific clinical indications for target cosmetic surgery procedures
- Next indication: skin laxity via subdermal use of Renuvion in the neck
- IDE approval obtained for feasibility study on July 25th
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Establishing Foundation for Long-term Growth4. Improving manufacturing capabilities and efficiencies
Manufacturing Overview:
Facility location: Clearwater, FL Sofia, Bulgaria China
Size: 60,000 sq. ft. 22,000 sq. ft. 70,000 sq. ft.
Owned / Contracted: Owned Owned Contracted
Capabilities:
• Assembly• Integration• Final Testing• Service and repair• Packaging• Sterilization Management
• Manufacturing• Complex Component Assembly• Final Assembly and Testing • Service and repair
• Component Manufacturing• Sub-Assemblies• Finished Medical Devices
(Electrodes)
• Focused on identifying new ways to improve manufacturing capabilities and accommodate anticipated strong future demand for generators and handpieces
- March, 2018 – Appointed Craig Swandal to the Board of Directors
- Overseeing effort to identify and pursue improvements
- September, 2018 – Appointed Laura Iversen as Director of Global Operations - Advanced Energy
- Responsible for operations and manufacturing of Advanced Energy segment
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($ in 000's)
2018 2019 2017 2018
Revenue $3,691 $6,568 $10,234 $16,686
Revenue Growth (Y/Y) 77.9% 63.0%
Cost of Goods Sold 1,154 2,096 3,276 5,893
Gross Profit $2,537 $4,472 $6,958 $10,793
Gross Margin 68.7% 68.1% 68.0% 64.7%
Total Other Costs and Expenses 5,470 8,937 20,843 24,393
Loss from Operations ($2,933) ($4,465) ($13,885) ($13,600)
Q2 FY
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Financial Results Summary – Continuing Operations(1)
(1) Note, the Company has reclassified the financial results of the “Core” segment to discontinued operations for all periods presented.The Company divested and sold the "Core" segment and related intellectual property on August 30, 2018.
• Cash and cash equivalents investments at 6/30/19: $67.4 million
• Gain on the divestiture and sale of the Core segment, net of tax: $68.4 million.
• No debt obligations or outstanding borrowings
• Retired remaining mortgage balance of $2.5 million in conjunction with the Symmetry deal closing on 8/30/18
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FY’19 Guidance Summary
• Total revenue in the range of $26.5 million to $27.5 million, representing growth of 59% to 65% year-over-year, compared to total revenue from continuing operations of $16.7 million in fiscal year 2018.
• Total revenue guidance assumes:
• Advanced Energy revenue in the range of $21.5 million to $22.5 million, representing growth of 65% to 72% year-over-year, compared to Advanced Energy revenue of $13.1 million in fiscal year 2018.
• The Company’s prior guidance range for Advanced Energy revenue was $20.5 million to $21.5 million, representing growth of 57% to 65% year-over-year.
• OEM revenue of $5.0 million, representing growth of 38% year-over-year, compared to $3.6 million for fiscal year 2018.
• GAAP net loss in the range of $22.4 million to $21.4 million, compared to GAAP net loss from continuing operations of $9.5 million in fiscal year 2018.
• The Company’s prior guidance range for GAAP net loss was $23.5 million to $22.5 million.
• Adjusted EBITDA loss in the range of $18.8 million to $17.8 million, compared to adjusted EBITDA loss from continuing operations of $11.7 million in fiscal year 2018.
• The Company’s prior guidance range for Adjusted EBITDA loss was $19.9 million to $18.9 million.
FY’19 revenue growth and long-term path to profitability fueled by strong growth in high-margin AE segment
On August 7, 2019, the Company updated its fiscal year 2019 financial guidance:
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Appendix
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Balance Sheet(1) (Slide 1 of 2)
(In thousands)
(1) Note, the Company’s results are reported on a continuing operations basis. The Company has reclassified the financial results of the “Core” segment to discontinued operationsfor the period ending December 31st, 2018. The Company divested and sold the "Core" segment and related intellectual property on August 30, 2018.
June 30, 2019
Dec 31, 2018
ASSETS
Current assets:
Cash and cash equivalents $ 67,360 $ 16,466
Short term investments — 61,678
Trade accounts receivable, net of allowance of $285 and $428 6,218 5,015
Inventories, net of provision for obsolescence of $402 and $439 6,392 5,212
Prepaid expenses and other current assets 1,987 1,146
Total current assets 81,957 89,517
Property and equipment, net 6,300 5,788
Intangibles 185 191
Deposits 73 73
Other assets 368 41
Total assets $ 88,883 $ 95,610
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Balance Sheet(1) (Slide 2 of 2)
(In thousands)
(1) Note, the Company’s results are reported on a continuing operations basis. The Company has reclassified the financial results of the “Core” segment to discontinued operationsfor the period ending December 31st, 2018. The Company divested and sold the "Core" segment and related intellectual property on August 30, 2018.
June 30, 2019
Dec 31, 2018
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,641 $ 1,423
Accrued expenses 5,848 5,552
Accrued severance and related 408 727
Total current liabilities 7,897 7,702
Note payable 140 140
Long term lease liability 267 —
Total liabilities 8,304 7,842
STOCKHOLDERS' EQUITY
Common stock, $0.001 par value; 75,000,000 shares authorized; 33,847,100 issued and 33,704,525 outstanding as of December 31, 2018, and 34,061,360 issued and 33,918,785 outstanding as of June 30, 2019 34 34
Additional paid-in capital 54,051 52,221
Retained earnings $ 26,494 $ 35,513
Total stockholders' equity 80,579 87,768
Total liabilities and stockholders' equity 88,883 95,610
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Income Statement(1)
(In thousands)
(1) Note, the Company’s results are reported on a continuing operations basis. The Company has reclassified the financial results of the “Core” segment to discontinued operations for theperiods ending June 30, 2018. The Company divested and sold the "Core" segment and related intellectual property on August 30, 2018.
Three Months Ended June 30,
Six Months Ended June 30,
2019 2018 2019 2018
Sales $ 6,568 $ 3,691 $ 12,391 $ 7,088
Cost of sales 2,096 1,154 4,199 2,339
Gross profit 4,472 2,537 8,192 4,749
Other costs and expenses:
Research and development 888 763 1,698 1,277
Professional services 1,633 681 3,424 1,187
Salaries and related costs 3,333 1,813 6,554 3,615
Selling, general and administrative 3,083 2,213 6,184 4,323
Total other costs and expenses 8,937 5,470 17,860 10,402
Loss from operations (4,465) (2,933) (9,668) (5,653)
Interest income 403 — 826 —
Interest expense — (38) — (72)
Other losses (200) — (225) —
Fee associated with refinance — 46 — 20
Total other income (expense), net 203 8 601 (52)
Loss before income taxes (4,262) (2,925) (9,067) (5,705)
Income tax (benefit) expense 76 13 (48) 24
Income from continuing operations (4,338) (2,938) (9,019) (5,729)
Income from discontinued operations, net of tax — 2,666 — 4,522
Net income (loss) (4,338) (272) (9,019) (1,207)
EPS from continuing operations:
Basic $ (0.13) (0.09) $ (0.27) $ (0.17)
Diluted (0.13) (0.09) $ (0.27) $ (0.17)
EPS from discontinued operations:
Basic — 0.08 — 0.13
Diluted — 0.08 — 0.13
EPS from total operations:
Basic $ (0.13) (0.01) $ (0.27) $ (0.04)
Diluted $ (0.13) (0.01) $ (0.27) $ (0.04)
Weighted average number of shares outstanding - basic 33,363 32,890 33,363 32,890
Weighted average number of shares outstanding - dilutive 33,363 32,890 33,363 32,890
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GAAP to Non-GAAP Reconciliation:Net Loss to Adjusted EBITDA(1)
(Unaudited) (In thousands)
(1) Note, the Company’s results are reported on a continuing operations basis. The Company has reclassified the financial results of the “Core” segment to discontinued operations for theperiods ending June 30th, 2018. The Company divested and sold the "Core" segment and related intellectual property on August 30, 2018.
Three Months Ended June 30,
Six Months Ended June 30,
2019 2018 2019 2018
Net loss from continuing operations GAAP Basis $ (4,338) $ (2,938) $ (9,019) $ (5,729)
Interest (income) expense, net (403) 38 (826) 72
Income tax (benefit) expense 76 13 (48) 24
Depreciation and amortization 122 171 316 371
Stock based compensation 856 377 1,715 749
Change in value of derivative liabilities — (46) — (20)
Adjusted EBITDA (3,687) (2,385) (7,862) (4,533)
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Year 2019
Net loss GAAP Basis $ (21,900)
Interest (income) expense, net (1,100)
Income tax (benefit) expense —
Depreciation and amortization 700
Stock based compensation 4,000
Change in fair value of derivative liabilities —
Adjusted EBITDA $ (18,300)
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GAAP to Non-GAAP Reconciliation:FY’19 Financial Guidance
(Unaudited) (In thousands)
The following unaudited table presents a reconciliation of net loss to Adjusted EBITDA for the Company’s 2019 guidance:
The reconciliation assumes the mid-point of the Adjusted EBITDA loss range and the midpoint of each component of the reconciliation, corresponding to guidance for GAAP net loss of $22.4 million to $21.4 million for 2019.
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