powerpoint presentation - bovie medical...2017/06/20 · the statements contained in this...
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June 2017
Safe Harbor Statement
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.
Investment Highlights
3
Established commercial business segments in “Core” and “OEM” with strong profitability and cash flow profiles
Advanced Energy segment is ‘engine of growth’ for Bovie Medical
Advanced Energy segment growth fueled by commercialization of J-Plasma® & PlazXact™
J-Plasma®: transformational technology; growth profile enhanced by focused selling efforts, growing clinical support and pending new product launches in 2H’17
Experienced Management Team
Improving growth and profitability profile supported by solid balance sheet condition
Advanced Energy segment supported by strong, and growing, IP portfolio
Experienced Management Team
Executive Joined Bovie Representative Previous Experience
Rob Gershon Chief Executive Officer December 2013
Jay Ewers Chief Financial Officer June 2014
Todd Hornsby Vice President of Sales August 2014
Shawn Roman Vice President of Research &
Development October 2014
4
Rob Saron President and Director January 1978
Moshe Citronowicz Senior Vice President October 1993
Years of Relevant Experience
28
34
15
15
35
30 KCR Technologies Sequential Information Systems
Jack McCarthy Chief Commercialization Officer March 2014 28
5
Company Snapshot
Core
Advanced energy-based medical device company specializing in developing, manufacturing and marketing a range of electrosurgical products and technologies, as well as related medical products used in doctor’s offices, surgery centers and hospitals worldwide.
Founded: 1978
Locations: • Purchase, NY • Clearwater, FL • Sofia, Bulgaria
Full-Time Employees: ~217**
Commercial Profile: >300 products sold in >150 countries
LTM Sales (3/31/17): $37.2M
Operating Segments: • Core • OEM • Advanced Energy
Year of IPO: 1982
NYSE MKT : BVX
Market Cap : ~$73M*
Avg. Daily Vol (LTM): ~125,000*
*As of market close on 6/16/2017 **As of 12/31/2016
Operating Segment: “Core” • Legacy business focused on the design and manufacture of
products used in doctor’s offices and ambulatory surgery centers
• Products primarily consist of electrosurgical generators & accessories (43% FY’16 “core” sales) and battery-operated cauteries (26% of FY’16 “core” sales)
• Marketed and sold by distributors worldwide under private label and Bovie’s well-respected brands (Bovie®, IDS™, ICON™ & DERM™)
6
Long-standing relationships with “Big 7” distributors: Sample Products:
“Core” segment profile: mid-single digit revenue growth with attractive profitability
Core: $27.8M
76% of FY’16 Revenue
$24.3M $26.1M $27.8M
$29.5M
FY'14 FY'15 FY'16 FY'17Guidance
Mid Pt.
• Manufacturing electrosurgery technologies to meet design-specific needs of large, well-known medical device companies
• Leveraging Bovie’s established R&D/innovation capabilities
• Compelling operating profitability
- OEM segment FY’16 EBIT margin: ~57%
• Segment revenue growth fluctuates based on timing of orders/demand from medical device customers
Operating Segment: “OEM”
7
“OEM” segment profile: leverages R&D/innovation capabilities; generates strong profitability/cash flows
OEM: $5.3M
15% of FY’16 Revenue
$3.2M $2.1M
$5.3M
$3.7M
FY'14 FY'15 FY'16 FY'17Guidance
Mid Pt.
• Advanced electrosurgical and plasma technology surgical products (generators and handpieces)
• Primary driver of Bovie’s long-term revenue growth
• Commercialized products marketed through direct selling ( ) and sales channel partnerships ( )
• Targeted medical specialties:
- Plastic Surgery - Surgical Oncology - Gynecology - Orthopedic arthroscopy / sports medicine
Operating Segment: “Advanced Energy”
8
“Advanced Energy” segment is the growth engine of Bovie Medical
Advanced Energy: $3.5M 10% of FY’16
Revenue
$0.2M $1.3M
$3.5M
$5.9M
FY'14 FY'15 FY'16 FY'17Guidance
Mid Pt.
J-Pl
asm
a Pl
azXa
ct
Advanced Energy: J-Plasma®
• Revolutionary technology ionizes helium to create stream of plasma for cutting, coagulating and ablating soft tissue
• Superior precision, with limited thermal spread
- Stable, thin, focused stream of ionized helium gas
- Wide range of control
- No conductive currents through the patient during surgery
• Allows surgeons to safely perform procedures on or around delicate structures
• Commercial focus on plastic surgery and surgical oncology procedure categories; ~2.7 million U.S. procedures annually
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Transformational technology; potential to replace ‘standard of care’ in a variety of surgical procedures
Unique Retractable Blade
J-Plasma®: Limited Thermal Damage vs. Energy-based Surgical Tools*
• Prospective study compared levels of unintended thermal damage to peritoneal tissue (membrane lining the abdominal cavity) among other energy-based surgical tools vs. J-Plasma®
• Red areas represent the
depth of thermal or energy damage each tool left below the tissue surface; blue areas represent unaffected tissue
• J-Plasma® demonstrated far
lowest amount of collateral thermal injury to healthy tissue surrounding the operative site
*Reference: Pedroso J, Gutierrez M, Volker W. J-Plasma, monopolar pencil, argon beam and CO2 laser electrosurgery: comparative evaluation of thermal spread in a porcine tissue model (white paper). Bovie Medical Corporation. June 2014 10
J-Plasma®: Demonstration Video
11 Video URL: http://www.boviemedical.com/downloads/J-Plasma_Demonstration_Video.mp4
J-Plasma®: Sample Clinician Feedback
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“J-Plasma is one of the most significant innovations in energy in more than a decade, and it has the potential to be of tremendous benefit to patients undergoing surgery for prostate cancer.”
-Vipul R. Patel, MD, FACS Urologist and Robotic Surgeon
“This is something in my career for 20 years that I was hoping could be developed, and now it is, which is extremely exciting.”
-Dr. Craig E. McCoy, DO, FACOG OB/GYN Surgeon
“This is fantastic, innovative technology that will create a huge paradigm shift of how we operate in the future.”
-Stephen M. Cohen, MD, MBA, FACS, FASCRS Colorectal Surgeon
“There is an incredible amount of control in terms of depth-of-penetration because it is so safe; because it’s not delivering a burning energy” “It’s a chance to be artistic, because you are using a device more like a paintbrush than an atom bomb.”
-Joseph B. DeLozier III, MD, FACS Plastic Surgeon
J-Plasma®: Expanding Product Portfolio
13
Continued innovation in J-Plasma technologies with recent handpiece and generator clearances
Precise 360® Handpiece
Precise® Handpiece
Ultimate® Generator (Gen. 2)
FDA 510(k): May 2017 CE Mark: Mar. 2017
Existing Product Portfolio:
Precise Flex Robotic Handpiece
FDA 510(k): May 2017 CE Mark: May 2017
Expected Commercial Launch: 2H’17
Open Handpiece Redesign
FDA 510(k): March 2017 CE Mark: Mar. 2017
Expected Commercial Launch: 2H’17
2017 Clearances; Pending Full Commercialization:
Ultimate® Generator (Gen. 1)
Open Handpiece
J-Plasma®: Clinical Validation
14
• White Papers:
- Gynecology: 5 - Plastic Surgery: 3 - Other: 2
• Preclinical and Clinical Studies:
Procedure Area Design IRB/IACUC Submission
Enrollment Initiated Completed Published
Preclinical Evaluation of Tissue Effect
2H’17
Gynecologic Oncology 2H’17
Lymphocele Reduction 2H’17
Pediatric Heart Surgery 1H’18
Dermal Resurfacing (IDE) 1H’17
• Sterile, single-use device for cutting, coagulating and ablating soft tissue
• Efficient tip design translates into the following advantages:
- Low power requirement to initiate ablation - Lower power = lower heat: safer for the patient - Compatible with any generator
• Distribution partner:
- Global sales channel partnership agreement for PlazXact™ to be marketed as the UltrAblator Bipolar® series
• Compelling addressable market: - >1.2M estimated knee, shoulder, elbow & ankle
arthroscopy procedures in U.S. alone
Advanced Energy: Ablator
15 Material contributor to Advanced Energy segment growth beginning in 2018
PlazXact™
Initial FDA 510(k): January 2016
CE Mark: January 2016
Commercial Launch: March 2017
• Established IP portfolio; pending approvals focused on Advanced Energy segment:
IP & New Product Development
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Growing IP portfolio and continued progress in new product development
Patents Issued Patents Pending
United States 37 16
International 24 10
Total 61 26
Advanced Energy products comprise: 38% of issued patents and
92% of pending patents
Progress (2010 – 2013):
- 4 510(k) clearances - 2 CE Mark clearances - 4 Products commercialized
Progress since January, 2014:
- 9 510(k) clearances - 9 CE Mark clearances - 8 Products commercialized
• Product development pipeline reinvigorated in 2014:
Medical Advisory Board • Five surgeon thought-leaders representing a variety of
medical specialties
• Focused on identifying, and maximizing, the clinical applications of our innovative surgical technology, J-Plasma®
• Expect to add at least 1 surgeon member in FY’17
17
Dr. Husam Balkhy, Director, Minimally Invasive & Robot Cardiac Surgery, Duhossois Center for Advanced Medicine
Dr. Robert J. Cerfolio, Section Chief, Thoracic Surgery University of Alabama Hospital
Founding member: Dr. Vipul Patel, world renowned robotic surgeon, Medical Director of Global Robotics Institute, Florida
Dr. Craig McCoy, Women’s Wellness Center, Columbia MO. Obstetrics & Gynecology Specialist
Dr. Dennis Chi, Deputy Chief and Head of Ovarian Cancer Surgery, Gynecology Service at Memorial Sloan Kettering Cancer Center
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State-of-the-Art Manufacturing Footprint
Clearwater, FL Sofia, Bulgaria China
Size: 60,000 sq. ft. 16,000 sq. ft. • 70,000 sq. ft.
Owned / Contracted: Owned Owned Contracted
Capabilities:
• Assembly • Integration • Final Testing • Packaging • Sterilization Management
• Manufacturing • Complex Component
Assembly • Initial Testing
• Component Manufacturing • Sub-Assemblies • Finished Medical Devices
(Electrodes)
The company also rents office space of 3,650 sq. ft. in Purchase, NY
Capacity to increase output from existing facilities
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Historical Financial Summary
($ in 000's)2016 2017 2015 2016
Revenue $7,775 $8,389 $29,520 $36,627Revenue Growth 26.9% 7.9% 6.6% 24.1%
Cost of Goods Sold 4,452 4,163 16,963 18,712
Gross Profit $3,323 $4,226 $12,557 $17,915Gross Margin 42.7% 50.4% 42.5% 48.9%
Operating Expenses 5,316 5,963 19,543 21,707
Loss from Operations ($1,993) ($1,737) ($6,986) ($3,792)
Cash on hand as of March 31, 2017 $11,508
Q1 FY
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FY’17 Guidance Summary
• Total GAAP revenue in the range of $38.3 million to $40.3 million, representing growth of 5% to 10% year-over-year, compared to $36.6 million in fiscal year 2016.
• Core sales growth: +4% to +8% year-over-year
• Advanced Energy sales growth: +60% to +80% year-over-year
• OEM sales decline: (25%) to (35%) year-over-year
• Adjusted EBITDA loss in a range of $1.2 million to $1.4 million, compared to a loss of $2.2 million in fiscal year 2016.
Excluding sales of $2.3 million in fiscal year 2016 related to unique generator demand from a large OEM customer, total Company revenue expected to
increase in the range of 12% - 17% year-over-year in 2017
Financial Appendix
Balance Sheet
22
March 31,2017
December 31,2016
ASSETSCurrent assets:
Cash and cash equivalents 11,508$ 14,456$ Restricted cash 779 779Trade accounts receivable, net 4,279 4,733Inventories, net 7,422 6,158Prepaid expenses and other current assets 639 413
Total current assets 24,627 26,539Property and equipment, net 6,368 6,449Brand name and trademark 1,510 1,510Purchased technology and l icense rights, net 188 215Goodwill 185 185Deposits 71 109Other assets 143 103
Total assets 33,092$ 35,110$
LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:
Accounts payable 2,176$ 1,606$ Accrued payroll 229 419Accrued vacation 431 404Current portion of mortgage note payable 239 239Accrued and other l iabil ities 1,853 2,604
Total current liabilities 4,928 5,272Mortgage note payable, net of current portion 2,635 2,694Note payable 140 140Deferred rents 13 14Deferred tax l iabil ity 564 564Derivative l iabil ities 115 203
Total liabilities 8,395 8,887EQUITY
STOCKHOLDERS' EQUITYSeries B convertible preferred stock, $0.001 par value; 3,588,139 authorized and 975,639 issued and outstanding as of March 31, 2017 and December 31, 2016 1 1Common stock, $0.001 par value; 40,000,000 shares authorized; 31,002,832 issued and 30,859,753 outstanding as of March 31, 2017 and December 31, 2016 31 31Additional paid-in capital 49,784 49,625Accumulated deficit (25,119) (23,434)
Total stockholders' equity 24,697 26,223Total liabilities and stockholders' equity 33,092$ 35,110$
(Unaudited) (In thousands)
Income Statement
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2017 2016Sales 8,389$ 7,775$ Cost of sales 4,163 4,452Gross profit 4,226 3,323Other costs and expenses:Research and development 709 668Professional services 390 357Salaries and related costs 2,460 2,100Sell ing, general and administrative 2,404 2,191Total other costs and expenses 5,963 5,316Loss from operations (1,737) (1,993)Interest expense, net (31) (38)Change in fair value of derivative l iabil ities, net 88 87Total other income, net 57 49Loss before income taxes (1,680) (1,944)Income tax expense 5 —Net loss (1,685)$ (1,944)$
Loss per shareBasic (0.05)$ (0.07)$ Diluted (0.06)$ (0.07)$
Weighted average number of shares outstanding - basic 30,860 27,051Weighted average number of shares outstanding - dilutive 30,887 27,051
Three Months EndedMarch 31,
(Unaudited) (In thousands, except per share data)
Reconciliation Between GAAP and Non-GAAP
24
2017 2016Net loss GAAP Basis (1,685)$ (1,944)$ Interest expense, net 31 38Income tax expense 5 - Depreciation and amortization 178 182Stock based compensation 159 176 Change in fair value of derivative l iabil ities, net (88) (87)Adjusted EBITDA (1,400) (1,635)
Three Months EndedMarch 31,
(Unaudited) (In thousands)