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Form 8-K SYNERGETICS USA INC For: Dec 11

December 12, 2014 6:02 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):� December 11, 2014

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.
On December 11, 2014, the presentation attached hereto as Exhibit 99.1 and incorporated herein by reference was delivered to stockholders of Synergetics USA, Inc. (the Company) following the Companys 2014 Annual Meeting of Stockholders.
Use of Non-GAAP Financial Measures
The presentation attached hereto as Exhibit 99.1 and incorporated herein by reference includes certain financial information prepared in conformity with generally accepted accounting principles (GAAP) as well as non-GAAP financial information.� The Company measures its performance primarily through its operating profit.� In addition, management uses certain non-GAAP measures, such as adjusted income from continuing operations and adjusted EBITDA, to measure the Companys operating performance.� Definitions of these non-GAAP financial measures and reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included below.
These non-GAAP measures are considered by the Companys Board of Directors and management as a basis for measuring and evaluating the Companys overall operating performance. They are presented to enhance an understanding of the Companys 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 the Companys ability to service debt and measure operating performance. Management believes these non-GAAP measures are useful in evaluating the Companys operating performance compared to other companies in its 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 the Companys results of operations in conjunction with the corresponding GAAP measures.
Reconciliations of Non-GAAP Financial Measures

Fiscal Year Ends July 31
(in thousands, except share and per share data)
FY 2009
FY 2010
FY 2011
FY 2012
FY 2013
FY 2014
Adjusted Income from Continuing Operations
GAAP Income from Continuing Operations
$
1,595
$
5,767
$
5,669
$
5,968
$
2,559
$
3,063
One-Time Events (1)
--
(2,055
)
--
259
1,452
458
Adjusted Income from Continuing Operations
$
1,595
$
3,712
$
5,669
$
6,227
$
4,011
$
3,521
Adjusted EBITDA(2)
GAAP Income from Continuing Operations
$
1,595
$
5,767
$
5,669
$
5,968
$
2,559
$
3,063
Interest
763
491
202
43
28
19
Income Taxes
775
3,109
2,467
2,499
1,130
1,498
Depreciation
1,052
1,002
972
1,093
1,123
1,173
Amortization
908
879
653
600
680
876
One-Time Events (1)
--
3,215
(99
)
367
2,092
682
Adjusted EBITDA from Continuing Operations
$
5,093
$
8,033
$
10,062
$
10,570
$
7,612
$
7,311

(1)
Income from continuing operations (exclusive of one-time events) excludes the following:� (i) 2010 excludes net income of $817,000 pre-tax, $522,000 after-tax, from Stryker Corporation and $2,398,000 pre-tax, $1,533,000 after-tax, from the Companys settlement with Alcon, Inc.; (ii) 2012 excludes impact of inventory write-down ($367,000 pre-tax, $259,000 after tax); (iii) 2013 excludes impact of inventory write-down ($2,092,000 pre-tax, $1,452,000 after tax); and (iv) 2014 excludes impact of exit costs ($682,000 pre-tax, $458,000 after tax).
(2)
The Company defines EBITDA as income from continuing operations (exclusive of one-time events) before interest expense, income taxes, depreciation and amortization.

Item 9.01.
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit No.
Description of Exhibit
Presentation delivered at the Synergetics USA, Inc. Annual Meeting of Stockholders on December 11, 2014.
3

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:������������December 11, 2014

SYNERGETICS USA, INC.
(Registrant)
By:
/s/ Pamela G. Boone
Name:
Pamela G. Boone
Title:
EVP and Chief Financial Officer
4


Exhibit 99.1
�Annual Shareholders Meeting Presentation��December 11, 2014�

�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��2�

�Program��Topic��Presenting��Annual Stockholder Meeting����Business Meeting��Bob Dick ��Stockholder Assembly����Strategy UpdateRecent DevelopmentsOphthalmologyNeuro /OEM��Dave Hable��MarketingBase Business UpdateNew Products Launched ��Jason Stroisch��OperationsEnterprise Wide Continuous Improvement InitiativeKing of Prussia Integration��John Copeland��Finance��Pam Boone��Q & A Session��Bob Blankemeyer, Bob Dick & Dave Hable��3�

�Business Meeting����4�

�Shareholders Business Meeting��Declaration of QuorumElection of DirectorAdvisory (Non Binding) Approval of Compensation of the Companys Named Executive OfficersRatification of the Appointment of UHY LLP as Independent Registered Public Accounting FirmReport of Inspectors of Election��5�

�Strategy Update����6�

�Overall Strategy��Drive Accelerating Growth in our Ophthalmology BusinessDeliver Improved Profitability through our Enterprise-Wide Continuous Improvement InitiativeManage our Neurosurgery and OEM Businesses for Stable Growth and Strong Cash FlowDemonstrate Consistent, Solid Financial PerformanceContinued Growth through Strategic Acquisitions��7�

�Recent Developments����8�

�Recent DevelopmentsOphthalmology��Announced acquisition of Sterimedix  UK Manufacturer/Distributor of ophthalmology cannulas, needles and other disposable productsLaunched 2nd generation VersaVIT vitrectomy machineMaturing product/challenging environment has pressured revenue growth in base ophthalmic businessInternal focus on improving operational excellence and enterprise-wide lean initiativesM.I.S.S. Ophthalmics LTD acquisitionKing of Prussia plant closureBiggest Loser exerciseScrap reduction��9�

�Ophthalmic Surgical Market��10��*Source: Synergetics USA quarterly report on Form 10-Q for period ended April 30, 2013. �

�2011 Global Retinal Surgery Device Market��11��*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��12��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. �

�Ophthalmic Products��Core��VersaPACK"��Directional Laser Probes��DDMS-Diamond Duster Membrane Scraper��Endoilluminator Awh Chandelier��Photon II��New��13��Directional Laser Probe��VersaVIT 2.0"�

�VersaVIT" 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��14�

�Recent Developments OEM (Neurosurgery)��OEM partnerships remain strong - growth in FY 2014A majority of the business is consumablesLaunched slim and irrigating bi-polar forceps in SeptemberKing of Prussia plant will close completely this month��15�

�OEM (Neurosurgery) Products��16��Codman��Stryker��Lesion Generator��SONOPET OMNI Ultrasonic Aspirator��Disposable Tips��Codman Synergy��Disposable Bipolar Forceps����CMC V�

�PRODUCTS��17�

�Anterior Products��I/A Hand Pieces��Injection Cannulas��18�

�Posterior Products��Injection Cannulas��Flute Handle Cannulas��Heavy Liquid Infusion Handles��Scleral Markers��Infusion Lines��Corneal Fixation/Incision Templates��19�

�Aesthetic Products ��Dermal Filler Cannula��Fat Transfer Cannula��Sharp Needle Cannula��20�

�Marketing����21�

�Base Business Update��Several of our base business product platforms have been challenged over the past few yearsLaser ProbesMore and more low cost providers are entering the marketAlcon utilizing new vitrectomy machine with built-in laser to gain businessIridex has new agreement with low cost provider DORC has copied our patented Directional Laser Probe and is offering at aggressively low prices overseasLight pipe business Competition has caught up on technology for light sourcesNew stronger light sources built into new generation vitrectomy machine platformsSeveral other products in our product offering have become commoditized in the retinal space. This includes:Soft tip cannulasIris retractorsEven our popular DDMS is now offered by 4 different companies��22�

�Base Business Update (continued)��How are we dealing with this erosion?Developed key new products launched in FY14 or to be launched in FY15 Tracking lost business on monthly business and going back to accounts to find solution to gain back business Utilizing VersaVIT" platform as vessel for locking down accountsShifting business focus toward vitrectomy machines and packs��23�

�Key new products launched during last 12 monthsOphthalmology VersaVIT 2.0" and Corresponding Packs & AccessoriesDirectional II Laser ProbeFlexible Tapered Illuminated Laser ProbeROP Instrument LineNeurosurgerySlim Bipolar ForcepsIrrigating Bipolar Forceps��New Products Launched Over Last 12 months����24�

�Surgeon Feedback��ProsEfficiency of machine and cutter combinationLight outputDuty cycle controlSimplicity (not a Constellation)Beauty in its simplicityStraight forward KEY ��RecommendationsSilicone oil injectionsRefluxStiffer light pipesImproved system feedbackVial removal potential issue with nursing staff (more of a nuisance) ��25�

�Surgical Staff Feedback��ProsEase of use Compact foot printSimplified setup processImproved pack configurations��RecommendationsMayo tray Sterile barriers��26�

�Sales Force Feedback��Excited by direct feedback from respected surgeons in their territoriesExcited about improved technologyEnergized by and active with 2.0 demosAddition of error codes has improved field diagnosticsNeed 27ga system urgentlyAdditional DEMO units in field to have multiple longer term DEMOs��27�

�Operations����28�

�Enterprise Wide Continuous Improvement Initiative��GoalCreate a culture of continuous improvement through all functional operational areas by driving out waste in processesResultsImproved Service LevelsOverall fill rate increase from 92% in FY13 to 95% in FY14Reduced Costs Scrap ReductionReduced from 5.8% in FY13 to 3.3% in FY14 resulting in $400,000+ savingsLabor Content ReductionCross-functional Continuous Improvement (The Biggest Loser) activities generated over $700,000 in labor savingsFuture State (FY2015)Continue pursuing our Biggest Loser improvement opportunitiesIntroduce formal Project Management methodologies and tools to our more complex Continuous Improvement activitiesProject charterTime tables (Gantt chart)Formal project reviews ��29�

�King of Prussia Integration��GoalCreate a capital equipment center of excellence in our OFallon location and realize reduced operating costsKOP OperationDesign and manufacture of electrosurgical generators for Bipolar coagulation and lesion generationSupply Codman and Stryker24 Employees 14,000 sq. ft. leased spaceProject UpdateProject is on track for Scheduled December 2014 closeFully transitioned Stryker product line to OFallon and ceased production in KOPBegan production of Codman products in OFallon in NovemberFinal builds for Codman products in KOP will be completed late December 2014All capital equipment is now manufactured in one consolidated location ��30�

�Finance����31�

�Sales��(dollars in thousands)��32�

�Net Income from Continuing Operations ��(Exclusive of One-Time Events)��(dollars in thousands)��33�

�EBITDA from Operations��(dollars in thousands)��(dollars in thousands)��(Exclusive of One-Time Events)��34�

�Use of Non-GAAP Financial Measures��This presentation contains certain non-GAAP financial information that management believes is useful to investors in evaluating the Companys performance. More information about these non-GAAP financial measures is included in a Current Report on Form 8-K that the Company filed with the Securities and Exchange Commission immediately prior to this presentation. This Current Report on Form 8-K is available on the Companys website at www.synergeticsusa.com by clicking on Financial Information: SEC Filings under the Investor Relations tab.��35�

�Major Financial Events��Alcon Settlement  April 23, 2010:In April 2010, we entered into a Settlement and License Agreement.Alcon paid the Company $32.0 million in settlement and license proceeds. The net proceeds were $21.4 million, after contingency payments to the attorneys.In 3Q 2010, we recognized a gain of $2.4 million from the settlement.In 1Q 2012, we made a $5.8 million tax payment on the net settlement amount which made our cash flow from operations negative during this time period.In 2Q 2012, Alcon canceled the project, orders and forecasts covering the two products to have been supplied under the Supply Agreement.The remaining portion of the proceeds has been accounted for as an up-front licensing fee and is being deferred over the life of the patents.Currently, we are recognizing $1,288,000 of this deferred revenue annually.��36��Continued�

�Major Financial Events (continued) ��Neurosurgery Distribution Changes are going very well since they were implemented in FY 2010:Codman  Exclusive distribution of disposable bipolar forceps. In the last full year of direct forceps sales (2009), we sold approximately $3.1 million. For FY 2014, we sold approximately $8.2 million of forceps to Codman.Stryker  Exclusive distribution of ultrasonic aspirator tips and accessories. In the last full year of direct ultrasonic aspirator tips and accessories (2009), we sold approximately $4.2 million. For FY 2014, we sold approximately $8.7 million of ultrasonic aspirators tips and accessories to Stryker.��37��Continued�

�Major Financial Events (continued)��Inventory Write-Offs:In the 3Q of FY 2012, we recorded $367,000, primarily for obsolete inventory.In the 2Q of FY 2013, we recorded $2.1 million, primarily for excess inventory.There were no inventory write-offs during fiscal 20143In June 2012, we received regulatory approval for our VersaVIT" vitrectomy system.In June 2014, we announced the launch of the next generation vitrectomy system, VersaVIT 2.0TM.��38�

�Acquisitions��In July 2013, we acquired our long-standing UK distributor, M.I.S.S. Ophthalmics LTD.In May 2014, we acquired a private OEM company.In December 2014, we acquired Sterimedix LTD.��39�

�Q & A Session����40�

�3845 Corporate Centre DriveOFallon, MO 63368(636) 939-5100www.synergeticsusa.com �



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