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): May 2, 2011
STEREOTAXIS, INC.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
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000-50884 |
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94-3120386 |
(Commission File Number) |
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(IRS Employer Identification No.) |
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4320 Forest Park Avenue, Suite 100, St. Louis, Missouri |
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63108 |
(Address of Principal Executive Offices) |
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(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 May 2, 2011, Stereotaxis, Inc. issued a press release (the "Press Release") setting forth its financial results for the first quarter of fiscal 2011. A copy of the Press Release is being filed as Exhibit 99.1 hereto, and the statements contained therein are incorporated by reference herein.
In accordance with General Instruction B.2. of Form 8-K, the information contained in Item 2.02 and the Exhibit 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 Press release dated May 2, 2011.
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 hereto duly authorized.
STEREOTAXIS, INC.
Date: May 2, 2011 By: /s/ Daniel J. Johnston
Name: Daniel J. Johnston
Title: Chief Financial Officer
Exhibit 99.1
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Company Contact: Dan Johnston Chief Financial Officer 314-678-6007
Investor Contact: EVC Group, Inc. Doug Sherk & Gregory Gin 415-896-6820 / 646-445-4801
Media Contact: Rick Green Stereotaxis, Inc. 314-678-6172 |
Stereotaxis Reports First Quarter 2011 Financial Results
-Strong Growth in Odyssey New Capital Orders and Revenue from Year Ago Period-
-Recurring Revenues up 10.3% from Year Ago Quarter-
-Key Product Advancements to be Introduced at Heart Rhythm Society's Annual Meeting-
-Conference Call Today at 4:30 p.m. Eastern Time-
ST. LOUIS, MO, May 2, 2011Stereotaxis, Inc. (NASDAQ: STXS) today reported financial results for the first quarter ended March 31, 2011. First quarter results included continued strong momentum in new capital orders and revenue for the Companys OdysseyTM systems and growth in recurring revenue. In addition, the Company announced that its new Stereotaxis EpochTM platform, which enhances the efficiency and versatility of the Niobe system, will be unveiled at the Heart Rhythm Society's (HRS) 32nd Annual Scientific Sessions in San Francisco during May 5-7, 2011.
Revenue for the first quarter 2011 totaled $10.2 million, compared to $10.6 million in the first quarter 2010. The Company recognized revenue of $1.4 million in Niobe® robotic systems. As the Company previously announced, installation delays due to production constraints with one of its imaging partners impacted revenue growth during the first quarter 2011. Odyssey systems revenue in the first quarter totaled $2.7 million, compared to $0.8 million in the first quarter 2010. Disposables, services and accessories revenue for the quarter ended March 31, 2011 was $5.9 million, up 10.3% from the year-ago quarter.
The continued strong momentum for Odyssey in the first quarter reflects the growing market demand from both standard and robotic electrophysiology (EP) labs for this unique data integration and clinical networking platform, said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis. We remain focused on establishing our Niobe robotic platform as a new standard of care for EP interventional medicine, and will introduce at the upcoming HRS annual meeting our Stereotaxis Epoch solutions system that we believe dramatically enhances efficiency and versatility of robotic interventional procedures while offering improved safety and efficacy over manual treatments. In addition, we continue to expect resolution of our imaging partners supply issue that impacted first quarter installations will be completed in the second quarter 2011.
The Company generated global new capital orders in the first quarter 2011 of $7.1 million, compared to $7.2 million in capital orders placed during the first quarter 2010. Global orders for the Niobe robotic system in the first quarter 2011 totaled $4.6 million, compared to $5.7 million in Niobe orders reported in the year ago quarter. Odyssey system orders in the first quarter 2011 were $2.5 million, up 66.7% from the $1.5 million in Odyssey orders in the year ago quarter. New capital orders from North America were $3.3 million, or 47% of total orders in the first quarter of 2011.
Product Advancements to be Featured at Heart Rhythm Society's 32nd Annual Scientific Sessions
Stereotaxis announced that its new Stereotaxis EpochTM platform, which enhances the efficiency and versatility of the Niobe system, will be unveiled at the Heart Rhythm Society's (HRS) 32nd Annual Scientific Sessions in San Francisco during May 5-7, 2011. The Stereotaxis Epoch solution is designed to meet the broad range of clinical needs physicians face today and in the future. Building on the strength of Magnetic Navigation's exceptional safety profile and significant radiation reduction, the Epoch platform features the latest technological breakthroughs in Magnetic Navigation, which will lead to faster, more efficient, and dynamic magnetic catheter control.
We remain focused on developing solutions that meet the most critical needs of our customers, while supporting any preferred clinical treatment technique. Epoch is designed to significantly reduce procedure time for all types of robotic-assisted EP procedures, especially for complex ablation procedures. We believe the Epoch platform will enable a much more efficient and enhanced EP workflow while maintaining our excellent profile in safety, radiation reduction and clinical outcomes, stated Mr. Kaminski.
First Quarter 2011 Financial Performance
Gross margin for the first quarter ended March 31, 2011 was $7.2 million, or 70.6% of net sales. Gross margin for the year ago quarter was $7.7 million, or 72.5% of net sales. Operating expenses for first quarter 2011 totaled $16.0 million. Cash burn for the first quarter of 2011 was $11.0 million.
The operating loss for the first quarter 2011 was $(8.8) million, compared to an operating loss of $(6.3) million for the first quarter 2010. The net loss for the first quarter 2011 was $(9.5) million, or $(0.17) per share, compared to a net loss of $(8.4) million, or $(0.17) per share, reported for the first quarter 2010. The weighted average shares for the first quarter of 2011 totaled 54.7 million compared with 49.6 million in the first quarter of 2010. The increase was due in large part to the issuance of 4.6 million shares as part of the stock offering completed in November 2010.
At March 31, 2011, Stereotaxis had cash and cash equivalents of $30.4 million, compared to $35.2 million on December 31, 2010. Total debt was $33.5 million, including $17.1 million drawn against the Companys $30 million line of credit.
2011 Financial Outlook
The Company updated its outlook for 2011 operating expense, and reiterated its outlook for 2011 as follows:
Conference Call Information
Stereotaxis will hold a conference call today, May 2, 2011 at 4:30 p.m. Eastern Time, to discuss first quarter results and operational highlights. The dial-in number for the conference call is 1-877-941-2927 for domestic participants and 1-480-629-9724 for international participants. An audio replay of the call will be available for seven days following the call, and can be accessed by dialing 1-800-406-7325 for domestic callers and 303-590-3030 for international callers, both using passcode 4434733#. The call will also be available on the Internet live and for 90 days thereafter at www.stereotaxis.com.
About Stereotaxis www.stereotaxis.com www.odysseyexperience.com
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Niobe® Remote Magnetic Navigation System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure.
Stereotaxis Odyssey portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. Odyssey Vision integrates data for magnetic and standard interventional labs, enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. Odyssey Enterprise Cinema then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Odyssey then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to maximize referrals and promote collaboration.
The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. For more information, please visit www.stereotaxis.com and www.odysseyexperience.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, 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 our systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., 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.
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BALANCE SHEETS |
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(Unaudited) |
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March 31 |
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December 31, | ||||
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ 30,394,919 |
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$ 35,248,819 | ||||
Accounts receivable, net of allowance of $377,147 and $367,536 in 2011 and 2010, respectively |
13,216,666 |
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13,915,569 | ||||
Current portion of long-term receivables |
30,800 |
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30,800 | ||||
Inventories |
6,042,337 |
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5,441,475 | ||||
Prepaid expenses and other current assets |
4,390,171 |
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4,557,718 | ||||
Total current assets |
54,074,893 |
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59,194,381 | ||||
Property and equipment, net |
3,814,995 |
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3,840,622 | ||||
Intangible assets |
2,504,028 |
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2,578,986 | ||||
Long-term receivables |
111,270 |
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109,266 | ||||
Other assets |
43,789 |
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38,537 | ||||
Total assets |
$ 60,548,975 |
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$ 65,761,792 | ||||
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Liabilities and stockholders' equity |
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Current liabilities: |
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Current maturities of long-term debt |
$ 26,499,626 |
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$ 20,894,091 | ||||
Accounts payable |
7,365,096 |
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8,796,182 | ||||
Accrued liabilities |
7,659,186 |
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6,966,571 | ||||
Deferred contract revenue |
6,253,875 |
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6,600,313 | ||||
Warrants |
3,521,452 |
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3,541,798 | ||||
Total current liabilities |
51,299,235 |
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46,798,955 | ||||
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Long-term debt, less current maturities |
7,000,000 |
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8,000,000 | ||||
Long-term deferred contract revenue |
408,881 |
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478,850 | ||||
Other liabilities |
5,972 |
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8,741 | ||||
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Stockholders' equity: |
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Preferred stock, par value $0.001; 10,000,000 shares authorized at 2011 and 2010; none outstanding at 2011 and 2010 |
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Common stock, par value $0.001; 100,000,000 shares authorized at 2011 and 2010; 55,326,172 and 54,746,240 issued at 2011 and 2010, respectively |
55,326 |
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54,746 | ||||
Additional paid-in capital |
354,911,764 |
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354,002,770 | ||||
Treasury stock, 40,151 shares at 2010 and 2009 |
(205,999) |
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(205,999) | ||||
Accumulated deficit |
(352,926,204) |
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(343,376,271) | ||||
Total stockholders' equity |
1,834,887 |
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10,475,246 | ||||
Total liabilities and stockholders' equity |
$ 60,548,975 |
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$ 65,761,792 | ||||
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STEREOTAXIS, INC. |
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STATEMENTS OF OPERATIONS |
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(Unaudited) |
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Three Months Ended |
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2011 |
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2010 |
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Revenue |
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System |
$ 4,288,176 |
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$ 5,233,755 |
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Disposables, service and accessories |
5,936,528 |
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5,382,854 |
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Total revenue |
10,224,704 |
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10,616,609 |
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Cost of revenue |
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System |
2,184,478 |
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2,076,717 |
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Disposables, service and accessories |
820,501 |
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843,953 |
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Total cost of revenue |
3,004,979 |
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2,920,670 |
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Gross margin |
7,219,725 |
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7,695,939 |
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Operating expenses: |
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Research and development |
3,394,259 |
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3,369,538 |
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Sales and marketing |
8,338,336 |
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6,695,117 |
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General and administration |
4,250,269 |
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3,890,336 |
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Total operating expenses |
15,982,864 |
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13,954,991 |
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Operating loss |
(8,763,139) |
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(6,259,052) |
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Other income/(expense) |
20,346 |
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(1,537,169) |
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Interest income |
3,187 |
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2,782 |
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Interest expense |
(810,327) |
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(633,118) |
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Net loss |
$ (9,549,933) |
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$ (8,426,557) |
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Net loss per common share: |
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Basic and diluted |
$ (0.17) |
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$ (0.17) |
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Weighted average shares used in computing net |
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Basic and diluted |
54,719,677 |
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49,621,318 |
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