0001193125-16-676758.txt : 20160809 0001193125-16-676758.hdr.sgml : 20160809 20160809161033 ACCESSION NUMBER: 0001193125-16-676758 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160809 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160809 DATE AS OF CHANGE: 20160809 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Stereotaxis, Inc. CENTRAL INDEX KEY: 0001289340 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 943120386 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36159 FILM NUMBER: 161818002 BUSINESS ADDRESS: STREET 1: 4320 FOREST PARK AVENUE STREET 2: SUITE 100 CITY: ST.LOUIS STATE: MO ZIP: 63108 BUSINESS PHONE: 314-678-6100 MAIL ADDRESS: STREET 1: 4320 FOREST PARK AVENUE STREET 2: SUITE 100 CITY: ST.LOUIS STATE: MO ZIP: 63108 8-K 1 d208402d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): August 9, 2016

 

 

STEREOTAXIS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

001-36159   94-3120386
(Commission File Number)   (IRS Employer Identification No.)
4320 Forest Park Avenue, Suite 100, St. Louis, Missouri   63108
(Address of Principal Executive Offices)   (Zip Code)

(314) 678-6100

(Registrant’s Telephone Number, Including Area Code)

(Former Name or Former Address, if Changed Since Last Report)

 

 

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 (see General Instruction A.2. below):

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02 Results of Operations and Financial Condition

On August 9, 2016, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the second quarter of fiscal year 2016. A copy of the Earnings Press Release is being filed as Exhibit 99.1 hereto, and the statements contained therein are incorporated by reference herein.

Forward-Looking Statements and Additional Information

Statements are made herein or incorporated herein that are “forward-looking statements” as defined by the Securities and Exchange Commission (the “SEC”). All statements, other than statements of historical fact, included or incorporated herein that address activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. These statements are not guarantees of future events or the Company’s future performance and are subject to risks, uncertainties and other important factors that could cause events or the Company’s actual performance or achievements to be materially different than those projected by the Company. For a full discussion of these risks, uncertainties and factors, the Company encourages you to read its documents on file with the SEC. Except as required by law, the Company does not intend to update or revise its forward-looking statements, whether as a result of new information, future events or otherwise.

In accordance with General Instruction B.2. of Form 8-K, the information contained in Item 2.02 and Exhibit 99.1 attached hereto shall not be deemed “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 they 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.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1    Stereotaxis, Inc. Earnings Press Release dated August 9, 2016.


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.

 

    STEREOTAXIS, INC.
Date: August 9, 2016     By: /s/ Karen Witte Duros                                        
    Name:   Karen Witte Duros


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Stereotaxis, Inc. Earnings Press Release dated August 9, 2016
EX-99.1 2 d208402dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Stereotaxis Reports 2016 Second Quarter Financial Results

 

    Ventricular tachycardia procedures increased 24% year over year, representing the 10th consecutive quarter of year-over-year volume growth

 

    Three Niobe® system installations completed, including the second installation in Japan

 

    Enhanced V-CAS Deflect catheter advancement system released in Europe

 

    Lowest first-half operating loss in Company history

 

    Conference call today at 4:30 p.m. Eastern Time

ST. LOUIS, MO, August 9, 2016—Stereotaxis, Inc. (OTCQX:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today reported financial results for the second quarter ended June 30, 2016.

“This is our 10th consecutive quarter of year-over-year growth in ventricular tachycardia (VT) procedures and the fourth quarter in a row that we have driven VT volume growth above 20%,” said William C. Mills, Stereotaxis Chief Executive Officer. “Our success reflects ongoing efforts to build on a steadily growing body of clinical evidence supporting the capability of our technologies to significantly outperform traditional therapies in safety, acute success and long-term outcomes for this very difficult, life-changing procedure. As more physicians turn to and become proficient using our Niobe® magnetic navigation system for VT ablation, we move closer to becoming the standard of care for a complex intervention that is growing worldwide at an average annual rate of 10%. While we continue to gain market share in VT, our increased volume in combination with strong service revenue has resulted in consistently healthy, high-margin recurring revenues.

“During the second quarter, we were pleased to celebrate the launch of our Niobe ES system at several prestigious medical institutions, including Kakogawa Central City Hospital in Japan, which held an opening ceremony for the public and healthcare community in June. Kakogawa represents our second system installation in Japan and the first in this prefecture of 5.5 million people to offer remotely controlled interventions for cardiac arrhythmias, as part of a new, expanded state-of-the-art facility. We also completed the installation and clinical start-up of our Niobe system and Vdrive® robotic navigation system at Montreal Heart Institute, our first customer site in the province of Quebec.

“Furthering our commitment to product advancements that yield better outcomes through improved lesion creation in all four chambers of the heart, we announced the market release of our second generation V-CAS Deflectcatheter advancement system in Europe. The V-CAS Deflect system is designed to remotely control a proprietary robotic deflectable sheath, which supports better stability and maneuverability of the magnetic ablation catheter during a procedure using the Niobe system. With this iteration, we have included features to enhance the mapping and maneuverability of the deflectable sheath in challenging anatomies, which we expect to deliver safer, more efficient and efficacious single-operator procedures for complex arrhythmias,” Mr. Mills concluded.


Second Quarter 2016 Financial Results

Revenue for the second quarter of 2016 totaled $7.9 million, a 19% decrease from $9.7 million in the prior year second quarter and a 9% decline from $8.6 million in the first quarter 2016. System revenue was $0.9 million, down 70% from $3.1 million in the prior year quarter and 55% sequentially from $2.1 million in the first quarter. During the second quarter, the Company recognized revenue of $0.3 million on Niobe ES system installations, $0.5 million in Odyssey® solution sales and $0.1 million in Vdrive system installations. Recurring revenue was $6.9 million in the second quarter, up from $6.6 million both in the prior year quarter and the first quarter. Total procedures were relatively unchanged, with VT procedures increasing 24% year over year.

The Company generated new capital orders of $0.8 million, compared to $1.6 million in the prior year second quarter and no new capital orders in the first quarter. Ending capital backlog for the 2016 second quarter was $3.5 million.

Gross margin in the quarter was $6.8 million, or 86.1% of revenue, on a higher mix of recurring revenue as well as strong capital and recurring margins, versus $6.7 million, or 69.5% of revenue, in the second quarter of 2015 and $6.5 million, or 74.8% of revenue, in the first quarter of 2016. Operating expenses in the second quarter were $8.4 million, compared to $8.4 million in the prior year quarter and $8.0 million in the first quarter.

Operating loss in the second quarter was $(1.6) million, a 5% improvement from $(1.7) million in the prior year second quarter and a 10% increase from $(1.5) million in the first quarter. Interest expense was $0.8 million in all three quarters.

Net loss for the 2016 second quarter was $(2.3) million, or $(0.11) per share, compared to a net loss of $(1.5) million, or $(0.07) per share, reported in the second quarter of 2015. Excluding mark-to-market warrant revaluation, the Company would have reported a net loss of $(2.5) million, or $(0.11) per share, for the 2016 second quarter compared to $(2.5) million, or $(0.12) per share, for the 2015 second quarter. The weighted average diluted shares outstanding for the second quarters of 2016 and 2015 totaled 21.8 million and 21.0 million, respectively.

Cash burn was $0.7 million, compared to $0.9 million in the year ago quarter and $3.9 million in the first quarter.

Six-Month Financial Results

Revenue for the first six months of 2016 was $16.5 million, down 14% compared to $19.2 million in the first six months of 2015. System revenue was $3.0 million, compared to $5.9 million in the first half of 2015, a 49% decrease. Recurring revenue was $13.5 million, compared to $13.3 million in the prior year period. Total procedures were unchanged from the same period last year, with VT procedures increasing 26%.

Gross margin was $13.2 million, or 80.2% of revenue, compared with $13.6 million, or 71.0% of revenue, in the first six months of the prior year. Operating expenses were $16.4 million, a 2% decrease from $16.8 million in the same period of 2015. Operating loss was $(3.1) million for the first six months of 2016 and was slightly lower than the comparable 2015 period.


Interest expense was $1.6 million in both the first half of 2016 and 2015.

Net loss for the first six months of 2016 was $(4.6) million, or $(0.21) per share, compared to a net loss of $(4.7) million, or $(0.22) per share, for the comparable period in 2015. Excluding mark-to-market warrant revaluation, net loss for the first six months would have been $(4.8) million, or $(0.22) per share, compared to a net loss of $(4.8) million, or $(0.23) per share, in the first half 2015.

Cash burn for the first half of 2016 was $4.6 million, compared to $4.3 million in the first half of 2015.

At June 30, 2016, Stereotaxis had cash and cash equivalents of $3.9 million and unused borrowing capacity of $1.0 million on its revolving line of credit, resulting in total liquidity of $4.9 million. At June 30, 2016, total debt was $21.1 million, which consisted of $3.0 million borrowed against the revolving line of credit and the remaining balance related to HealthCare Royalty Partners long-term debt.

Conference Call and Webcast

Stereotaxis will host a conference call and webcast today, August 9, 2016, at 4:30 p.m. Eastern Time, to discuss second quarter results. To access the conference call, dial 800-381-2652 (US and Canada) or 1-719-457-2619 (International) and give the participant pass code 8079214. Participants are asked to call 5-10 minutes prior to the start time. To access the live and replay webcast, please visit the investor relations section of the Stereotaxis website at www.stereotaxis.com.

About Stereotaxis

Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, and the Vdrive® robotic navigation system and consumables.

The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the United States, Canada, and the European Union. The V-CAS Deflect catheter advancement system is available for use in the European Union. For more information, please visit www.stereotaxis.com.

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance


indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the United States, including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

 

  Company Contact:      Investor Contact:
  Martin C. Stammer      Todd Kehrli / Jim Byers
  Chief Financial Officer      MKR Group, Inc.
  314-678-6155      323-468-2300
       stxs@mkr-group.com


STEREOTAXIS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2016     2015     2016     2015  

Revenue

        

Systems

   $ 935,978      $ 3,092,935      $ 3,010,997      $ 5,924,113   

Disposables, service and accessories

     6,938,645        6,571,315        13,511,632        13,271,163   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     7,874,623        9,664,250        16,522,629        19,195,276   

Cost of revenue

        

Systems

     395,898        1,849,275        1,478,996        3,249,542   

Disposables, service and accessories

     699,173        1,093,988        1,796,888        2,324,359   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost of revenue

     1,095,071        2,943,263        3,275,884        5,573,901   

Gross margin

     6,779,552        6,720,987        13,246,745        13,621,375   

Operating expenses:

        

Research and development

     1,421,380        1,419,826        2,894,465        2,905,533   

Sales and marketing

     4,211,706        4,250,779        8,105,819        8,285,150   

General and administrative

     2,786,046        2,772,708        5,372,838        5,567,297   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     8,419,132        8,443,313        16,373,122        16,757,980   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (1,639,580     (1,722,326     (3,126,377     (3,136,605

Other income

     135,370        999,169        166,664        106,792   

Interest income

     140        493        362        1,355   

Interest expense

     (829,046     (816,023     (1,648,066     (1,645,810
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (2,333,116   $ (1,538,687   $ (4,607,417   $ (4,674,268
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic

   $ (0.11   $ (0.07   $ (0.21   $ (0.22

Diluted

   $ (0.11   $ (0.07   $ (0.21   $ (0.22
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used in computing net loss per common share:

        

Basic

     21,793,583        21,007,103        21,702,597        20,871,244   

Diluted

     21,793,583        21,007,103        21,702,597        20,871,244   


STEREOTAXIS, INC.

BALANCE SHEETS

 

     June 30,
2016
    December 31,
2015
 
     (Unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 3,858,089      $ 5,593,582   

Accounts receivable, net of allowance of $251,993 and $93,478 in 2016 and 2015, respectively

     5,057,503        6,376,470   

Inventories

     5,334,687        4,504,282   

Prepaid expenses and other current assets

     569,825        668,659   
  

 

 

   

 

 

 

Total current assets

     14,820,104        17,142,993   

Property and equipment, net

     857,869        1,067,321   

Intangible assets, net

     536,229        635,889   

Other assets

     44,774        31,693   
  

 

 

   

 

 

 

Total assets

   $ 16,258,976      $ 18,877,896   
  

 

 

   

 

 

 

Liabilities and stockholders’ deficit

    

Current liabilities:

    

Short-term debt

   $ 3,000,000      $ —     

Accounts payable

     2,427,697        1,840,135   

Accrued liabilities

     5,431,055        6,058,390   

Deferred revenue

     7,435,975        7,445,935   

Warrants

     627,466        794,130   
  

 

 

   

 

 

 

Total current liabilities

     18,922,193        16,138,590   

Long-term debt

     18,114,408        18,080,159   

Long-term deferred revenue

     620,945        2,009,198   

Other liabilities

     270,296        275,603   

Stockholders’ deficit:

    

Preferred stock, par value $0.001; 10,000,000 shares authorized, none outstanding at 2016 and 2015

     —          —     

Common stock, par value $0.001; 300,000,000 shares authorized, 21,846,095 and 21,551,173 shares issued at 2016 and 2015, respectively

     21,846        21,551   

Additional paid-in capital

     449,081,382        448,517,472   

Treasury stock, 4,015 shares at 2016 and 2015

     (205,999     (205,999

Accumulated deficit

     (470,566,095     (465,958,678
  

 

 

   

 

 

 

Total stockholders’ deficit

     (21,668,866     (17,625,654
  

 

 

   

 

 

 

Total liabilities and stockholders’ deficit

   $ 16,258,976      $ 18,877,896   
  

 

 

   

 

 

 
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