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 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 May 9, 2016, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the first 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 May 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: May 9, 2016 | By: | /s/ Karen Witte Duros | ||||
| Name: Karen Witte Duros | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Stereotaxis, Inc. Earnings Press Release dated May 9, 2016 | |
Exhibit 99.1
Stereotaxis Reports 2016 First Quarter Financial Results
| • | Ventricular tachycardia procedures increased 27% year over year, representing the third consecutive quarter of 20%+ quarterly volume growth |
| • | Fourth Niobe® system shipped to Japan |
| • | Patient enrollment completed for Niobe® post-market surveillance in Japan |
| • | Clinical literature expands to more than 260 peer-reviewed articles |
| • | Operating expenses decreased 4% from the year-ago quarter |
| • | Conference call today at 4:30 p.m. Eastern Time |
ST. LOUIS, MO, May 9, 2016—Stereotaxis, Inc. (NASDAQ: STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today reported financial results for the first quarter ended March 31, 2016.
“We made significant progress in several strategic areas in the first quarter, including continued year-over-year growth of ventricular tachycardia (VT) procedures and further momentum in our newest major market—Japan,” said William C. Mills, Stereotaxis Chief Executive Officer. “With our third consecutive quarter of greater than 20% year-over-year growth in VT procedures, we are beginning to see the benefits of our ongoing efforts to build awareness worldwide of the outstanding efficacy, efficiency, and safety of our technology with these complex and, typically, very challenging procedures.
“In March, we announced the publication of a special supplement to the Journal of Cardiovascular Electrophysiology, which features seven peer-reviewed clinical papers studying the results of the use of our magnetic navigation platform in ablation of complex arrhythmias, including VT. As the body of independent clinical evidence supporting the unique capabilities of our platform in VT ablations continues to grow, we believe we are well positioned to build a significant franchise in this relatively untapped market. At the same time, we are very gratified by the improved clinical outcomes being achieved with our platform in atrial fibrillation (AF) procedures, such as those reported recently by Lund University Hospital in Sweden. Physicians should continue to see outstanding results in AF as we further develop and commercialize an expanded set of cutting-edge automation features. This progress, combined with our growing success in VT, helped stabilize total procedure count for the quarter compared to last year and enabled our highest quarterly volume since the fourth quarter of 2014.
“During the quarter, we shipped our fourth Niobe® system to Japan and reached a milestone of more than 120 patients treated with the Niobe system at Takatsuki General Hospital, which completed patient enrollment for the required post-market surveillance in this key market. The Asia-Pacific market is emerging as a meaningful contributor to procedure growth, with procedures increasing
approximately 100% year over year in the first quarter and now representing nearly 10% of our total procedures worldwide,” Mr. Mills concluded.
First Quarter 2016 Financial Results
Revenue for the first quarter of 2016 totaled $8.6 million, a decrease of 9% from $9.5 million in the prior year first quarter and down 6% sequentially from $9.2 million in the fourth quarter of 2015. System revenue was $2.1 million, down 27% from $2.8 million in the prior year quarter and 14% sequentially from $2.4 million in the fourth quarter. During the first quarter, the Company recognized revenue of $1.2 million on one Niobe ES system and one Niobe ES upgrade, along with $0.9 million in Odyssey® solution sales. Recurring revenue was $6.6 million in the first quarter, compared to $6.7 million in the prior year quarter and $6.8 million in the fourth quarter. Total procedures were unchanged from the prior year quarter, while VT procedures increased 27% year over year.
The Company did not generate new capital orders in the first quarter, following new capital orders totaling $5.1 million in the 2015 fourth quarter. Ending capital backlog for the 2016 first quarter was $3.9 million.
Gross margin in the quarter was $6.5 million, or 74.8% of revenue, versus $6.9 million, or 72.4% of revenue, in the first quarter of 2015 and $6.8 million, or 73.7% of revenue, in the fourth quarter of 2015. Operating expenses in the first quarter were $8.0 million, a 4% improvement from $8.3 million in the prior year quarter and down sequentially from $8.2 million in the fourth quarter.
Operating loss in the first quarter was $(1.5) million, compared to an operating loss of $(1.4) million in both the prior year first quarter and fourth quarter. Interest expense was $0.8 million in all three quarters.
Net loss for the 2016 first quarter was $(2.3) million, or $(0.11) per share, compared to a net loss of $(3.1) million, or $(0.15) per share, reported in the first quarter of 2015. Excluding mark-to-market warrant revaluation, the Company would have reported a net loss of $(2.3) million, or $(0.11) per share, for the 2016 first quarter compared to a net loss of $(2.2) million, or $(0.11) per share, for the 2015 first quarter. The weighted average diluted shares outstanding for the first quarters of 2016 and 2015 totaled 21.6 million and 20.7 million, respectively.
At March 31, 2016, Stereotaxis had cash and cash equivalents of $1.6 million and unused borrowing capacity of $4.9 million on its revolving line of credit with Silicon Valley Bank, resulting in total liquidity of $6.5 million. Cash burn was $3.2 million for the trailing twelve months, including cash burn of $3.9 million during the 2016 first quarter and free cash flow of $1.6 million during the fourth quarter. Cash burn in the first quarter 2016 increased compared to the prior year first quarter cash burn of $3.3 million due to working capital adjustments. The Company has total debt of $18.1 million related to HealthCare Royalty Partners long-term debt, net of deferred financing costs of $0.3 million.
Conference Call and Webcast
Stereotaxis will host a conference call and webcast today, May 9, 2016, at 4:30 p.m. Eastern Time, to discuss first quarter results. To access the conference call, dial 888-471-3843 (US and Canada) or 719-325-2472 (International) and give the participant pass code 4919601. Participants are asked to call the above numbers 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. 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 continued listing on the NASDAQ Capital Market, 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 March 31, |
||||||||
| 2016 | 2015 | |||||||
| Revenue |
||||||||
| Systems |
$ | 2,075,019 | $ | 2,831,178 | ||||
| Disposables, service and accessories |
6,572,987 | 6,699,848 | ||||||
|
|
|
|
|
|||||
| Total revenue |
8,648,006 | 9,531,026 | ||||||
| Cost of revenue |
||||||||
| Systems |
1,083,099 | 1,400,267 | ||||||
| Disposables, service and accessories |
1,097,715 | 1,230,370 | ||||||
|
|
|
|
|
|||||
| Total cost of revenue |
2,180,814 | 2,630,637 | ||||||
| Gross margin |
6,467,192 | 6,900,389 | ||||||
| Operating expenses: |
||||||||
| Research and development |
1,473,086 | 1,485,706 | ||||||
| Sales and marketing |
3,894,113 | 4,034,371 | ||||||
| General and administrative |
2,586,791 | 2,794,590 | ||||||
|
|
|
|
|
|||||
| Total operating expenses |
7,953,990 | 8,314,667 | ||||||
|
|
|
|
|
|||||
| Operating loss |
(1,486,798 | ) | (1,414,278 | ) | ||||
| Other income (expense) |
31,294 | (892,377 | ) | |||||
| Interest income |
222 | 862 | ||||||
| Interest expense |
(819,019 | ) | (829,788 | ) | ||||
|
|
|
|
|
|||||
| Net loss |
$ | (2,274,301 | ) | $ | (3,135,581 | ) | ||
|
|
|
|
|
|||||
| Net loss per common share: |
||||||||
| Basic |
$ | (0.11 | ) | $ | (0.15 | ) | ||
| Diluted |
$ | (0.11 | ) | $ | (0.15 | ) | ||
|
|
|
|
|
|||||
| Weighted average shares used in computing net loss per common share: |
||||||||
| Basic |
21,611,612 | 20,742,932 | ||||||
| Diluted |
21,611,612 | 20,742,932 | ||||||
STEREOTAXIS, INC.
BALANCE SHEETS
| March 31, 2016 |
December 31, 2015 |
|||||||
| (Unaudited) | ||||||||
| Assets |
||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 1,602,951 | $ | 5,593,582 | ||||
| Accounts receivable, net of allowance of $155,964 and $93,478 in 2016 and 2015, respectively |
6,397,660 | 6,376,470 | ||||||
| Inventories |
4,446,363 | 4,504,282 | ||||||
| Prepaid expenses and other current assets |
1,150,631 | 668,659 | ||||||
|
|
|
|
|
|||||
| Total current assets |
13,597,605 | 17,142,993 | ||||||
| Property and equipment, net |
969,927 | 1,067,321 | ||||||
| Intangible assets, net |
586,059 | 635,889 | ||||||
| Other assets |
32,341 | 31,693 | ||||||
|
|
|
|
|
|||||
| Total assets |
$ | 15,185,932 | $ | 18,877,896 | ||||
|
|
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|
|
|||||
| Liabilities and stockholders’ deficit |
||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 2,042,246 | $ | 1,840,135 | ||||
| Accrued liabilities |
5,245,395 | 6,058,390 | ||||||
| Deferred revenue |
6,627,020 | 7,445,935 | ||||||
| Warrants |
762,836 | 794,130 | ||||||
|
|
|
|
|
|||||
| Total current liabilities |
14,677,497 | 16,138,590 | ||||||
| Long-term debt |
18,078,308 | 18,080,159 | ||||||
| Long-term deferred revenue |
1,782,155 | 2,009,198 | ||||||
| Other liabilities |
270,433 | 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, 21,738,923 and 21,551,173 shares issued at 2016 and 2015, respectively |
21,739 | 21,551 | ||||||
| Additional paid-in capital |
448,794,778 | 448,517,472 | ||||||
| Treasury stock, 4,015 shares at 2016 and 2015 |
(205,999 | ) | (205,999 | ) | ||||
| Accumulated deficit |
(468,232,979 | ) | (465,958,678 | ) | ||||
|
|
|
|
|
|||||
| Total stockholders’ deficit |
(19,622,461 | ) | (17,625,654 | ) | ||||
|
|
|
|
|
|||||
| Total liabilities and stockholders’ deficit |
$ | 15,185,932 | $ | 18,877,896 | ||||
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