Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
November 2018
Safe Harbor StatementCertain 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
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 inflection from planned expansion of distribution footprint in U.S.
Pursuing multiple strategic initiatives to position “New-Co”(1)
for sustainable, long-term growth in the cosmetic surgery market
Experienced management team; enhanced with recent hires
(1) “New-Co” refers to the Company’s business on a continuing operations basis, following thetransaction with Symmetry Surgical, Inc. which closed on 8/30/18
Experienced Management TeamMgmt. Team Member Joined Bovie Representative Previous Experience
Charlie GoodwinChief Executive Officer
December 2017
Jay EwersChief Financial Officer June 2014
Todd HornsbyVice President & General
Manager of Advanced EnergyAugust 2014
4
Moshe CitronowiczSenior Vice President
October 1993
Years of Relevant Experience
25
35
18
31 KCR Technologies Sequential Information Systems
Dr. Topaz KirlewExec Director of Regulatory Affairs & Quality Assurance
February 2018 30
Experienced management team; enhanced with recent hires
Scott SandersDirector of Clinical Education
& Market Development March 2018 37
Shawn RomanVice President of
Research and DevelopmentOctober 2014 21
Laura IversenDirector of Global Operations –
Advanced EnergySeptember 2018 20
5
Company Snapshot• Medical technology company
• Two reportable operating segments:
• “Advanced Energy” – commercializing J-Plasma®, a patented plasma-based surgical device for cutting, coagulation and ablation of soft tissue
- J-Plasma sold under the Renuvion™ Cosmetic Technology brand in the cosmetic surgery market
• “OEM” – original equipment manufacturer for other medical device manufacturers
Founded: 1978
Locations: • Clearwater, FL • Sofia, Bulgaria
Full-Time Employees: ~142 in US(1)
~70 in Bulgaria
(1) As of 9/30/2018
(2) Market cap. based on shares outstanding of 33.2M as of 10/29/2018 from the Company’s 10-Q SEC filing on 11/2/18;
share price of $6.65 is as of market close on 11/9/2018
(3) As market close on 11/9/18
“LTM” = Last Twelve Months
Year of IPO: 1982
Ticker (NYSE MKT) : BVX
Market Cap : ~$221M(2)
Avg. Daily Vol (LTM): ~121,000(3)
6
“New-Co”: enhanced growth profile and balance sheet;Increased focus on Advanced Energy segment opportunity
• “New-Co” retained Advanced Energy and OEM operating segments and manufacturing facilities
- Transaction allows “New-Co” to focus on most attractive growth opportunity: Advanced Energy operating segment
- “New-Co” 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
“New-Co”(1)
Enhanced Growth Profile & Balance Sheet Fueled by Recent Strategic Transaction
(1) “New-Co” refers to the Company’s business on a continuing operations basis, followingthe transaction with Symmetry Surgical, Inc. which closed on 8/30/18
(2) Note, new company name for “New-Co” expected in early 2019
August 30, 2018: Completed divestiture and sale of “Core” operating segment and the Bovie brand(2) to Symmetry Surgical, Inc. for $97M in gross proceeds.
“New-Co”: Attractive Market Opportunity
• ~15,000(1) plastic surgeons, cosmetic surgeons & dermatologists
7$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)
• Ionizes helium to create a stream of plasma for cutting, coagulating and ablating soft tissue
• Offers ability to deliver heat to tissue in a way never before thought possible:
8
Renuvion’s unique ability to manage heatallows for improved tissue effect & treatment time
: Revolutionary Technology for the Cosmetic Surgery Market
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(1)
- 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
(1) Bovie Ultimate Electrosurgical Generator User’s Guide
5000 ohms
• 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)
9
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
: Solving the Tissue Temperature Dilemma
10
“[…] The thermal characteristics of this energy-based device are unlike any devices currently available.”
-Richard Gentile, M.D., MBAPlastic Surgeon
“There is an incredible amount of control in terms of depth-of-penetration; because it’s not delivering a burning energy […]”
-Joseph B. DeLozier III, MD, FACSPlastic Surgeon
Physician Feedback
Strong feedback from physicians in the cosmetic surgery market
“Using the Renuvion device has allowed me to expand the types of procedures I can offer to my patients. I now have a more predictable and effective option to chose from.”
-Ryan Neinstein, MDPlastic Surgeon
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)
- 19 field-based selling professionals
- 11 independent sales agencies
• Investing proceeds from recent transaction to enhance & expand field sales team
- Milestone: Expand sales organization to approach 50 representatives by year’s end
• Driving growth by expanding customer base and increasing utilization from existing accounts
11Expanding 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 the hospital surgical suite
- Selling in 26 countries(1) ; current distributor network consists of 23 distribution partners(1)
• Growth fueled by penetrating existing markets and expanding distributor relationships
(1) As of 9/30/2018
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
12
Pursuing multiple strategic initiatives to position “New-Co” for sustainable, long-term growth in the cosmetic surgery market
Focused on building support to facilitate broad-based adoption of Renuvion by:
Establishing Foundation for Long-term Growth1. Enhancing physician and practice support for cosmetic surgery customers
• Channel-specific branding for the cosmetic surgery market
- - New Co’s J-Plasma technology is marketed and sold in the cosmetic surgery market under the Renuvion brand name
• Created for physicians, with their input
- Physician feedback from early adopters of J-Plasma technology instrumental in creating a brand/campaign that will resonate with cosmetic surgery customers
• Designed to:
- Enhance physician practice-based marketing - Leverage the increasing awareness of Renuvion in the
cosmetic surgery market
13
March, 2018 – Launched “Renuvion Cosmetic Technology” brand:
Establishing Foundation for Long-term Growth2. Expanding clinical support for Renuvion in cosmetic surgery procedures
• Conducting IDE clinical study evaluating the use of Renuvion in dermal skin resurfacing, a new target procedure
• Completed study enrollment on May 14, 2018
- Currently focused on patient follow-up and data evaluation
14
- Multi-center, single arm, evaluator-blind prospective study
- Designed to evaluate the safety and efficacy of Renuvion in the improvement of facial appearance by reducing facial wrinkles and rhytides
- 55 study subjects
- Primary outcome measures:
- Improvement in Fitzpatrick Wrinkle and Elastosis Scale Score
- Adverse Event Rate and Duration
IDE Clinical Study Overview
Establishing Foundation for Long-term Growth3. Formulizing regulatory strategy in the cosmetic surgery market
• Initial focus: pursuing specific clinical indication for the use of
Renuvion in dermal skin resurfacing procedures
- IDE clinical study data expected to be used to support 510(k) submission
- Milestone: Expect to submit for FDA 510(k) clearance by the end of 2018
• Long-term focus: Developing multi-year strategy to secure
specific clinical indications for target cosmetic surgery
procedures
- March, 2018 – Appointed Dr. Topaz Kirlew as Director of Regulatory
Affairs, a new position, to oversee development of strategy
15
Establishing Foundation for Long-term Growth4. Improving manufacturing capabilities and efficiencies
16
Manufacturing Overview:Facility location: 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)
• 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- Advising 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
17
Financial Results Summary – Continuing Operations(1)
($ in 000's)2017 2018 2017 2018
Revenue $2,651 $3,672 $6,576 $10,760Revenue Growth (Y/Y) 38.5% 63.6%
Cost of Goods Sold 738 1,151 2,314 3,490
Gross Profit $1,913 $2,521 $4,262 $7,270Gross Margin 72.2% 68.7% 64.8% 67.6%
Operating Expenses 4,746 5,317 14,910 15,719
Loss from Operations ($2,833) ($2,796) ($10,648) ($8,449)
Adjusted EBITDA ($2,471) ($2,404) ($9,589) ($6,937)
Q3 First 9 Months
(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 marketable securities at 9/30/18: $96.1 million
• Net after tax cash proceeds from the divestiture and sale of the Core segment: $69.1 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
FY’18 Revenue Guidance Summary
• Total revenue from continuing operations in the range of $15.8 million to $16.2 million, representing growth of 55% to 58% year-over-year.
- Prior guidance range was $15.2 million to $15.6 million, representing growth of 49% to 53% year-over-year.
• Total revenue from continuing operations is driven by:
- Advanced Energy revenue in the range of approximately $12.4 million to $12.8 million, representing growth of 63% to 67% year-over-year.
- Prior guidance range was $11.8 million to $12.2 million, representing growth of 55% to 60% year-over-year.
- OEM revenue of approximately $3.4 million, representing growth of 31% year-over-year.
18
Growth driven by strong commercial traction in Advanced Energy segment;+63% to 67% Advanced Energy revenue growth expected in 2018
On November 1, 2018, the Company updated its fiscal year 2018 financial guidance on a continuing operations basis, which continues to reflect the consummation of the Core segment sale transaction which closed on August 30, 2018.
FY’18 P&L Guidance Summary
• GAAP net loss from continuing operations in the range of $9.2 million to $8.8 million, compared to GAAP net loss from continuing operations of $11.9 million in fiscal year 2017.
• Adjusted EBITDA loss from continuing operations in the range of $10.4 million to $10.0 million, compared to adjusted EBITDA loss from continuing operations of $12.0 million in fiscal year 2017.
Prior to the consummation of the Core segment sale transaction, the Company’s fiscal year 2018 guidance ranges for GAAP net loss and adjusted EBITDA included contributions from the Core segment of:
• GAAP net income in the range of approximately $7.5 million to $8.0 million,
• Adjusted EBITDA income in the range of approximately $9.0 million to $9.5 million
19
FY’18 GAAP and Non-GAAP profitability impacted by the ‘Core’ segment sale; Long-term path to profitability fueled by strong growth in high-margin AE segment
On November 1, 2018, the Company updated its fiscal year 2018 financial guidance on a continuing operations basis, which continues to reflect the consummation of the Core segment sale transaction which closed on August 30, 2018.
Appendix
Balance Sheet(1) (Slide 1 of 2)
21
(Unaudited) (In thousands)
September 30, 2018
December 31, 2017
ASSETSCurrent assets:
Cash and cash equivalents 40,663$ 9,949$
Restricted cash — 719
Short term investments 55,480 —
Trade accounts receivable, net of allowance of $311 and $204 4,080 4,857
Inventories, net 6,037 4,274
Prepaid expenses and other current assets 627 433
Current assets of discontinued operations — 2,315
Total current assets 106,887 22,547
Property and equipment, net 5,842 6,033
Purchased technology and license rights, net 32 67
Goodwill 185 185
Deposits 46 92
Other assets 122 67
Non-current assets of discontinued operations — 1,997
Total assets 113,114$ 30,988$
(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.
Balance Sheet(1) (Slide 2 of 2)
22
(Unaudited) (In thousands)September 30,
2018December 31,
2017
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable 2,348$ 1,583$ Accrued severance and related 95 1,242Accrued payroll 163 447Current portion of mortgage note payable — 239Accrued taxes and other l iabil ities 19,066 214Current l iabil ities of discontinued operations — 2,248
Total current liabilities 21,672 5,973Mortgage note payable, net of current portion — 2,455Note payable 140 140Deferred tax l iabil ity — 368Derivative l iabil ities — 20
Total liabilities 21,812$ 8,956$ STOCKHOLDERS’ EQUITY
Common stock, $0.001 par value; 75,000,000 shares authorized; 33,763,019 issued and 33,620,444 outstanding as of September 30, 2018 and 75,000,000 shares authorized; 33,021,170 issued and 32,878,091 outstanding as of December 31, 2017, respectively 33 33Additional paid-in capital 51,798 50,495Retained earnings (accumulated deficit) 39,471 (28,496)
Total stockholders’ equity 91,302 22,032Total liabilities and stockholders’ equity 113,114$ 30,988$
(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.
Income Statement(1)
23
(Unaudited) (In thousands, except per share data)2018 2017 2018 2017
Sales 3,672$ 2,651$ 10,760$ 6,576$ Cost of sales 1,151 738 3,490 2,314Gross profit 2,521 1,913 7,270 4,262Other costs and expenses:Research and development 613 487 1,890 1,600Professional services 628 421 1,815 1,291Salaries and related costs 2,119 1,826 5,734 6,016Selling, general and administrative 1,957 2,012 6,280 6,003Total other costs and expenses 5,317 4,746 15,719 14,910Loss from operations (2,796) (2,833) (8,449) (10,648)Interest income (expense), net 105 (36) 33 (103)Other losses (155) — (155) —Change in fair value of derivative l iabil ities — (69) 20 57Total other expense, net (50) (105) (102) (46)Loss from continuing operations before income taxes (2,846) (2,938) (8,551) (10,694)Income tax (benefit) expense (2,408) 6 (2,384) 15Net loss from continuing operations (438)$ (2,944)$ (6,167)$ (10,709)$ Income from discontinued operations, net of tax 540 1,699 5,062 6,471Gain on sale of the Core Business, net of tax 69,072 — 69,072 —Total income from discontinued operations, net of tax 69,612 1,699 74,134 6,471Net income (loss) 69,174$ (1,245)$ 67,967$ (4,238)$ Loss per share from continuing operations
Basic (0.01)$ (0.09)$ (0.19)$ (0.35)$ Diluted (0.01)$ (0.09)$ (0.19)$ (0.35)$
Income per share from discontinued operationsBasic 2.09$ 0.05$ 2.25$ 0.21$ Diluted 1.99$ 0.05$ 2.19$ 0.21$
Income (loss) per shareBasic 2.08$ (0.04)$ 2.06$ (0.14)$ Diluted 1.98$ (0.04)$ 2.00$ (0.14)$
Weighted average number of shares outstanding - basic 33,275 31,078 33,014 30,932Weighted average number of shares outstanding - dilutive 34,934 31,078 33,952 30,932
Three Months EndedSeptember 30,
Nine Months EndedSeptember 30,
(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.
24
(Unaudited) (In thousands)
GAAP to Non-GAAP Reconciliation:Net Loss to Adjusted EBITDA(1)
2018 2017 2018 2017Net loss GAAP Basis (438)$ (2,944)$ (6,167)$ (10,709)$
Interest income (expense), net (105) 36 (33) 103
Income tax (benefit) expense (2,408) 6 (2,384) 15
Depreciation and amortization 58 171 429 527
Stock based compensation 489 191 1,238 532
Change in fair value of derivative liabilities — 69 (20) (57)
Adjusted EBITDA (2,404) (2,471) (6,937) (9,589)
Three Months EndedSeptember 30,
Nine Months EndedSeptember 30,
(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.
25
(Unaudited) (In thousands)
The following table presents a reconciliation of GAAP Net Income/(Loss) from Continuing Operations to Non-GAAP Adjusted EBITDA/(Loss) from Continuing Operations for the Company’s 2018 guidance:
The reconciliation assumes the mid-point of the Adjusted EBITDA loss from continuing operations range and the midpoint of each component of the reconciliation, corresponding to guidance of $10.4 million to $10.0 million for 2018.
Year Ended2018
GAAP Net loss from continuing operations (9,000)$ Interest, net (350)Income tax expense (3,200)Depreciation and amortization 650Stock based compensation 1,700Adjusted EBITDA, From continuing operations (10,200)
GAAP to Non-GAAP Reconciliation for FY’18 Financial Guidance from Continuing Operations
26
As ReportedPro Forma
Adjustments (b)As Adjusted As Reported
Pro Forma Adjustments (b)
As Adjusted
Sales 38,883 (28,649) 10,234 36,627 (27,808) 8,819 Cost of sales 19,122 (15,846) 3,276 18,712 (15,009) 3,703 Gross profit 19,761 (12,803) 6,958 17,915 (12,799) 5,116 Other costs and expenses:Research and development 2,455 (514) 1,941 2,618 (1,585) 1,033 Professional services 1,771 (2) 1,769 1,486 (13) 1,473 Salaries and related costs 7,906 (986) 6,920 9,038 (1,221) 7,817 Selling, general and administrative 11,370 (2,681) 8,689 8,565 (2,380) 6,185 Severance and related expense 1,524 - 1,524 - - Total other costs and expenses 25,026 (4,183) 20,843 21,707 (5,199) 16,508 Loss from operations (5,265) (8,620) (13,885) (3,792) (7,600) (11,392)Interest expense, net (136) - (136) (158) - (158)Change in fair value of derivative liabilities 183 - 183 64 - 64 Total other income (expense), net 47 - 47 (94) - (94)Loss before income taxes (5,218) (8,620) (13,838) (3,886) (7,600) (11,486)Income tax expense (benefit) (156) (1,810) (1,966) 64 (1,596) (1,532)Net loss (5,062) (6,810) (11,872) (3,950) (6,004) (9,954)
Loss per shareBasic (0.16) (0.38) (0.14) (0.36)Diluted (0.17) (0.38) (0.15) (0.36)
Weighted avg. shares out.- basic 31,420 31,420 27,433 27,433 Weighted avg. shares out.- dilutive 31,427 31,427 27,449 27,449
Twelve Months Ended December 31, 2017 Twelve Months Ended December 31, 2016
PRO FORMA CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Pro Forma Income Statement –Adjusted for Divestiture and Sale of Core Operating Segment(1)
(Unaudited) (In thousands)
(1) Pro forma income statement has been prepared assuming the Asset Sale Transaction occurred as of 1/1/16, the first day ofthe first year presented. For additional information, see exhibit 99.2 of the Company’s 8-K filed with the SEC on 8/30/18
(b) For additional information, see “Notes to Pro Forma Condensed Consolidated Financial Information” in exhibit 99.2 of theCompany’s 8-K filed with the SEC on 8/30/18