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Form 8-K SYNERGETICS USA INC For: Jan 12

January 12, 2015 7:58 AM EST

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K
CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (date of earliest event reported):� January 12, 2015

SYNERGETICS USA, INC.
(Exact name of registrant as specified in its charter)

Delaware
001-10382
20-5715943
(State or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)

3845 Corporate Centre Drive
OFallon, Missouri
63368
(Address of principal executive offices)
(Zip Code)

(636) 939-5100
(Registrant's telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


Written communications pursuant to Rule 425 under the Securities Act.

Soliciting material pursuant to Rule 14a-12 under the Exchange Act.

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.


Item 7.01. Regulation FD Disclosure.
During the week of January 12, 2015, management of Synergetics USA, Inc. will deliver the investor presentation attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information included in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth under this Item 7.01 shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.

Item 9.01.
Financial Statements and Exhibits.

(d)
Exhibits.
Exhibit No.
Description of Exhibit
Investor presentation to be delivered by management of Synergetics USA, Inc. during the week of January 12, 2015.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:���� January 12, 2015

SYNERGETICS USA, INC.
(Registrant)
By:
/s/ Pamela G. Boone
Name:
Pamela G. Boone
Title:
EVP and Chief Financial Officer
3

Exhibit 99.1
�NEUROSURGERY��OPHTHALMOLOGY��QUALITY. PERFORMANCE. INNOVATION.��Investor Presentation��January 2015�

�Certain statements made in this presentation are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. This presentation may include statements concerning managements expectations of future financial results, potential business, potential acquisitions, government agency approvals, additional indications and therapeutic applications for medical devices, as well as their outcomes, clinical efficacy and potential markets and similar statements, all of which are forward looking. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted results. For a discussion of such risks and uncertainties, please refer to the information set forth under Risk Factors included in Synergetics USA, Inc.s Annual Report on Form 10-K for the year ended July 31, 2014, and information contained in subsequent filings with the Securities and Exchange Commission. These forward looking statements are made based upon our current expectations and we undertake no duty to update information provided in this presentation.��Safe Harbor Statement��*�

�Overview��Corporate Information��Market Information��NASDAQ: SURGMarket Cap: $107.5mm52 Week Range: $2.93  $4.62Shares Outstanding: 25mmInstitutional Ownership: 52.25%Russell Microcap Index��*��Synergetics USA, Inc. is a medical device company focused in the fast-growing ophthalmology and neurosurgery marketsFormed through a reverse merger of Synergetics, Inc. and Valley Forge Scientific Corp. in 2005Synergetics, Inc. was founded in 1991 and Valley Forge was founded in 1980Corporate Headquarters: OFallon, MOManufacturing Facilities: OFallon, MO, King of Prussia, PA, California and Redditch, UK��*Source: NASDAQ, as of 01/07/15.�

�Track Record of Growth��*��*Fiscal Year 2013 gross and operating margins are displayed on a non-GAAP basis to exclude inventory write-down. Fiscal Year 2014 operating margins are displayed on a non-GAAP basis to exclude exit costs. See non-GAAP reconciliation table at the end of this presentation for additional details. �

�FY 2014 Revenue Mix��Ophthalmic sales represent our largest and highest margin businessIn the U.S., we sell ophthalmic surgical products directly to end-users at hospitals, ambulatory surgery centers and surgeon offices throughout the country Internationally, we sell and distribute ophthalmic surgical products in over 50 countries, including four emerging marketsWe serve as a marketing partner and have key OEM relationships with J&Js Codman division and Stryker for neurosurgery products ��*�

�Overall Strategy ��Drive Accelerating Growth in our Ophthalmology BusinessDeliver Improved Profitability through our Enterprise-Wide Continuous Improvement InitiativesManage our Neurosurgery and OEM Businesses for Stable Growth and Strong Cash FlowDemonstrate Consistent, Solid Financial PerformanceContinued Growth through Strategic Acquisitions��*�

�Sterimedix Acquisition��We purchased all of the outstanding shares of Sterimedix Limited for net cash consideration of $13.5 million.Sterimedix is a private manufacturer of cannulas, needles and other disposable products for ophthalmic and aesthetic procedures.Sterimedix generated $6.4 million in sales in its fiscal year ending December 31, 2013 with 85% of sales coming from the ophthalmic market and the balance coming from aesthetics.��*�

�Sterimedix Acquisition (Contd.)��Sterimedix is anticipated to grow approximately 15% on a constant currency basis for the full year 2014 period.We plan to let Sterimedix continue to operate its business as a largely independent operation going forward.We expect the acquisition to improve operating and financial results for our entire international business in addition to providing diversification of our reported results towards international sales. ��*�

�Products��*�

�Anterior Products��*��I/A Hand Pieces��Injection Cannulas�

�Posterior Products��*��Injection Cannulas��Flute Handle Cannulas��Heavy Liquid Infusion Handles��Scleral Markers��Infusion Lines��Corneal Fixation/Incision Templates�

�Aesthetic Products ��*��Dermal Filler Cannula��Fat Transfer Cannula��Sharp Needle Cannula��from Sterimedix. A world leader in single-use surgical products�

�Ophthalmic Surgical Market��*�

�Recent DevelopmentsOphthalmology��Launched 2nd generation VersaVIT" vitrectomy machine in the second half of June Maturing product/challenging environment has pressured revenue growth in base ophthalmic business in recent quartersInternal focus on improving operational excellence and enterprise-wide continuous improvement initiativesM.I.S.S. Ophthalmics LTD acquisitionKing of Prussia plant closureBiggest Loser exerciseScrap reduction��*�

�Ophthalmic Surgical Market��*��*Source: Synergetics USA annual report on Form 10-K for period ended July 31, 2012. �

�2011 Global Retinal Surgery Device Market��*��*Source: Synergetics USA quarterly report on Form 10-Q for period ended April 30, 2013. ��Market Size = $935 million*Synergetics products compete in ~22% of the retinal device market (shaded in black)�

�2014 Global Retinal Surgery Device Market��*��Estimated Market Size = $1.22 Billion*Implied Annual Growth = ~7%Synergetics products compete in ~69% of the retinal device market (shaded in black)��*Source: Synergetics USA quarterly report on Form 10-Q for period ended April 30, 2013. Market Scope data estimates that the vitreoretinal market will grow approximately 7 percent to $1.2 billion in 2014, as compared to 2013. �

�ASC vs. Hospital��Ambulatory Surgery Center (ASC)��Physicians control care for patientsTypically owned by surgeons or corporationsMore efficient  less time wastedSpecialized (ophtho, ortho, etc.)Highly focused on profitabilityLower costs to patients and government (2014 vitrectomy reimbursement rate of $1,655)��Hospital Out-Patient Department (HOPD)��Challenging patient flow (pre, intra, post)Staff not specialized and are trained to handle multiple specialtiesPatient frustrations  parking, long walks to OR, confusing, etc.Equipped to handle more difficult proceduresHigher costs to patients and government (2014 vitrectomy reimbursement rate of $2,820) ��*�

�Ophthalmic Products��Core��VersaPACK"��VersaVIT 2.0"��Directional Laser Probes��DDMS-Diamond Dusted Membrane Scraper��Endoilluminator Awh Chandelier��Photon II��New��*��Directional Laser Probe�

�VersaVIT 2.0": Next Generation Vitrectomy System��VersaVIT 2.0" is our second product for the lucrative vitrectomy machine market valued at $235�million (machines only)A new concept in retinal surgery Highly portableModerately priced Easy to useComparable clinical performanceCompact, lightweight and portableSmall footprint< 25 pounds Capable of running on battery power and gas cartridgesIdeally suited for ASCs, as a traveling unit for satellite offices and potentially for in-office proceduresDemonstrably lower total cost of ownership and operation��*��Performed over 12,185 retinal procedures with VersaVIT" to date, up more than 21% sequentially in Q115, and more than 121% year over year.�

�VersaVIT 2.0" vs. the Competition��*��VersaVIT" vs. ACCURUS� (25lbs vs. 90lbs)��CONSTELLATION� Vision System��CONSTELLATION� Vision System and ACCURUS� are registered trademarks of Alcon� Laboratories, a division of Novartis�

�VersaVIT 2.0": Strategic Growth Plan & Progress Update��Introduced on June 4, 2014Commercial launch in the second half of June targeting two primary segments: high volume ASC facilities that perform the majority of vitrectomy proceduresselect teaching institutions U.S. Market: 22 direct sales reps; International markets: hybrid distribution of direct and dealers Anticipate progress towards broader market adoption of our next generation vitrectomy technology in fiscal 2015��*�

�Ophthalmology Product Video��*�

�Neurosurgery Market��*�

�Recent DevelopmentsOEM (Neurosurgery)��OEM partnerships remain strong  sales increased 8.3% year-over-year during fiscal 2014. Codman contract has been renewed.A majority of the business is consumables.Launched slim and irrigating bipolar forceps in September.King of Prussia plant will close completely this quarter.��*�

�Neurosurgery Overview��Best-in-class neurosurgical technologiesUltrasonic aspirators Disposable tips and tubingElectrosurgical generators Disposable bipolar forceps Strong OEM partnershipsJ&Js Codman division distributes our electrosurgical generators and bipolar forcepsStryker distributes our ultrasonic aspirator disposablesLong-term relationships with Codman and Stryker�provide stable annual growth, attractive operating margins and high barriers to entry��*�

�OEM (Neurosurgery) Products��*��Codman��Stryker��Lesion Generator��SONOPET OMNI Ultrasonic Aspirator��Disposable Tips��Codman Synergy��Disposable Bipolar Forceps��CMC V�

�Neurosurgery Product Video��*�

�Financials��*�

�Financial Comparison  Quarterly ��*��Revenues from OEM represent sales and royalties to Codman, Stryker and other.Revenues from Other represent direct neurosurgery revenues and other miscellaneous revenues. �

�Financial Comparison  Annual ��*��Revenues from OEM represent sales and royalties to Codman, Stryker and other.Revenues from Other represent direct neurosurgery revenues and other miscellaneous revenues. Adjusted Operating Margin for FY 2014 excludes impact of exit costs ($682,000 pre-tax, $458,000 after tax). Adjusted Gross Margin, Adjusted Operating Margin and Adjusted Net Income from Operations for FY 2013 exclude impact of inventory write-downs ($2.1 million pre-tax, $1.5 million after-tax for FY 2013). See non-GAAP reconciliation slides at the end of this presentation for additional details. �

�Investment Rationale��Key medical device manufacturer supplying ophthalmic and neurosurgery markets with leading technologiesRetinal surgery a compelling segment of ophthalmologyNew product introductions  foremost of which is the VersaVIT 2.0" vitrectomy machine  drives total Company revenue growth over long termBusiness model fueled by the combination of high margin disposables and innovative capital equipment Long-term profit margin opportunities driven by improving operational efficiency and continuous improvement initiatives��*�

�Management Team��David M. Hable  President, CEOOver 30 years of progressive responsibility in sales, marketing, new business development and general management in the medical device industry. Over 20 years with J&J/Codman. Pamela Boone  Executive Vice President, CFOPreviously served as CFO, VP and Corporate Controller for Maverick Tube Corporation. Over 25 years of financial expertise.Michael Fanning  Vice President, SalesOver 20 years in sales and management roles, working in service, medical device and manufacturing sectors.Jason Stroisch  Vice President, Marketing & TechnologyOver 15 years in the medical device industry covering engineering, international sales and marketing management roles.Joan Kraus  Vice President, Regulatory Affairs / Quality AssurancePreviously served as Senior Director Global Compliance for Teleflex Medical. Over 25 years in quality systems and process improvement roles working in medical devices, manufacturing, and distribution sectors.��*�

�Non-GAAP Reconciliations(1)��*��See slide 35 for full description of the use of non-GAAP financial information.Non-operating adjustments include: exit costs ($682,000 pre-tax, $458,000 after-tax, or $0.02 per diluted shares, for FY 2014) and inventory write-downs ($2.1 million pre-tax, $1.5 million after-tax, or $0.06 per diluted share, for FY 2013).Represents diluted weighted average common shares outstanding.�

�(1)Use of Non-GAAP Financial Information��We measure our performance primarily through our operating profit. In addition to our consolidated financial statements presented in accordance with GAAP, management uses certain non-GAAP measures, including adjusted gross margin, adjusted operating margin and adjusted net income from operations, to measure our operating performance. We provide a definition of the components of these measurements and reconciliation to the most directly comparable GAAP financial measure. �These non-GAAP measures are presented to enhance an understanding of our operating results and are not intended to represent cash flow or results of operations. The use of these non-GAAP measures provides an indication of our ability to service debt and measure operating performance. We believe these non-GAAP measures are useful in evaluating our operating performance compared to other companies in our industry, and are beneficial to investors, potential investors and other key stakeholders, including creditors who use this measure in their evaluation of performance.�These non-GAAP measures are not in accordance with, or an alternative to, measures prepared in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the Companys results of operations as determined in accordance with GAAP. These measures should only be used to evaluate our results of operations in conjunction with the corresponding GAAP measures.��*�

�NEUROSURGERY��OPHTHALMOLOGY��QUALITY. PERFORMANCE. INNOVATION.��Investor Presentation��January 2015��3845 Corporate Centre DriveOFallon, MO 63368(636) 939-5100www.synergeticsusa.com�



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