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): November 14, 2019

 

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)

 

(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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company [  ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

 

 

 

Item 2.02 Results of Operations and Financial Condition

 

On November 14, 2019, Stereotaxis, Inc. (the “Company”) issued a press release (the “Earnings Press Release”) setting forth its financial results for the 2019 third quarter. 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 November 14, 2019.

 

 

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: November 14, 2019	By:	/s/ Kimberly R. Peery
	Name:	Kimberly R. Peery
	Title:	Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

Stereotaxis Reports 2019 Third Quarter Financial Results

 

ST. LOUIS, MO, Nov. 14, 2019 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, today reported financial results for the third quarter ended September 30, 2019.

 

“The third quarter was highlighted by successful reengagement with the capital markets, meaningful progress in our commercial growth strategy, and continued innovation and industry collaboration,” said David Fischel, Chairman and CEO. “We are pleased with the methodical progress across all aspects of Stereotaxis.”

 

“In the quarter, we listed on the NYSE American exchange and closed a $25 million equity financing. These reflect increasing awareness and confidence in Stereotaxis’ significant clinical value and growth opportunity. Stereotaxis is in the strongest financial position in its history, and will use this strength to accelerate the development and commercial introduction of innovations in electrophysiology and beyond.”

 

“Our revenue growth and net income in the quarter is reflective of the positive impact a resurgence of robotic system sales can have on our financial performance. Stereotaxis continues to make tangible progress in the regulatory process, supply-chain optimization, and commercial discussions necessary for a broad launch of the Genesis RMN^® System. As we plan towards 2020 and the broad commercialization of Genesis, we expect an exciting year of significant growth.”

 

“Development of Stereotaxis’ proprietary catheter continues to advance well in accordance with previously disclosed timelines. The multiple, recently announced collaborations to integrate advanced preoperative mapping information enhance the robotic ecosystem and will increasingly drive personalized patient-specific therapy in electrophysiology.”

 

Third Quarter 2019 Financial Results

 

Revenue for the third quarter of 2019 totaled $8.2 million, up 9% from $7.6 million in the prior year third quarter. Recurring revenue for the quarter was $6.3 million and system revenue for the quarter was $1.7 million. System revenue primarily reflects the establishment of a new robotic electrophysiology program.

 

Gross margin in the quarter was $6.4 million or 78% of revenue, consistent with the 78% reported in the third quarter of 2018. Gross margin on recurring revenue and system revenue were 85% and 61%, respectively. Operating expenses in the third quarter of $6.4 million increased from $6.0 million in the prior year quarter.

 

Operating and net income for the quarter were both near breakeven, with an operating loss of ($41,000) and net income of $44,000, compared to an operating loss and net loss of ($0.1) million in the third quarter of 2018. Negative free cash flow for the quarter was ($0.4) million.

 

Cash Balance and Liquidity

 

At September 30, 2019, Stereotaxis had cash and cash equivalents of $31.7 million and no debt.

 

 

Forward Looking Expectations

 

Stereotaxis’ innovation accomplishments support an expectation of robust revenue growth in 2020, accelerating throughout the year.

 

Conference Call and Webcast

 

Stereotaxis will host a conference call and webcast today, November 14, 2019, at 9:00 a.m. Eastern Time. To access the conference call, dial 1-800-367-2403 (US and Canada) or 1-334-777-6978 (International) and give the participant pass code 4492256. 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 the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ robotic technology has received various regulatory clearances in the United States, European Union, Japan, Canada, China, and elsewhere. The Stereotaxis Genesis RMN System is CE marked and will become available in other global geographies subject to regulatory approvals. Stereotaxis Imaging Model S is CE marked and FDA cleared. 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, or to obtain additional financing, in either case 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 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 Contacts:

David L. Fischel

Chairman and Chief Executive Officer

 

Kimberly R. Peery

Chief Financial Officer

 

314-678-6100

investors@stereotaxis.com

 

 

STEREOTAXIS, INC.

STATEMENTS OF OPERATIONS

(Unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2019				2018				2019				2018
Revenue:
Systems		$	1,696,964			$	715,484			$	1,755,015			$	1,043,510
Disposables, service and accessories			6,258,252				6,839,995				19,515,125				21,035,002
Sublease			246,532				-				739,593				-
Total revenue			8,201,748				7,555,479				22,009,733				22,078,512
Cost of revenue:
Systems			665,463				596,869				722,828				1,257,980
Disposables, service and accessories			919,599				1,036,589				2,928,718				3,029,875
Sublease			246,531				-				739,592				-
Total cost of revenue			1,831,593				1,633,458				4,391,138				4,287,855
Gross margin			6,370,155				5,922,021				17,618,595				17,790,657
Operating expenses:
Research and development			1,751,081				2,000,780				7,405,462				5,995,800
Sales and marketing			3,120,632				2,819,101				9,666,975				9,911,514
General and administrative			1,539,648				1,215,920				4,186,277				3,753,703
Total operating expenses			6,411,361				6,035,801				21,258,714				19,661,017
Operating loss			(41,206	)			(113,780	)			(3,640,119	)			(1,870,360	)
Other income			-				-				-				2,590,361
Interest income (expense)			84,954				(2,515	)			133,329				(33,271	)
Net income (loss)		$	43,748			$	(116,295	)		$	(3,506,790	)		$	686,730
Cumulative dividend on convertible preferred stock			(360,647	)			(361,447	)			(1,071,351	)			(1,072,553	)
Net loss attributable to common stockholders		$	(316,899	)		$	(477,742	)		$	(4,578,141	)		$	(385,823	)
Net loss per share attributed to common stockholder:
Basic		$	(0.00	)		$	(0.01	)		$	(0.07	)		$	(0.01	)
Diluted		$	(0.00	)		$	(0.01	)		$	(0.07	)		$	(0.01	)
Weighted average number of common shares and equivalents:
Basic			64,294,153				59,008,219				61,405,083				49,733,553
Diluted			64,294,153				59,008,219				61,405,083				49,733,553

 

 

STEREOTAXIS, INC.

BALANCE SHEETS

 

		September 30, 2019				December 31, 2018
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	31,650,559			$	10,796,072
Accounts receivable, net of allowance of $368,191 and $398,847 in 2019 and 2018, respectively			3,830,395				5,021,111
Inventories, net			1,546,716				1,191,666
Prepaid expenses and other current assets			1,022,322				963,700
Total current assets			38,049,992				17,972,549
Property and equipment, net			270,751				343,693
Operating lease right-of-use assets			4,771,187				-
Other assets			214,042				198,365
Total assets		$	43,305,972			$	18,514,607
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable		$	1,031,975			$	1,726,360
Accrued liabilities			2,641,254				2,642,481
Deferred revenue			5,283,783				5,825,536
Current portion of operating lease liabilities			2,235,465				-
Total current liabilities			11,192,477				10,194,377
Long-term deferred revenue			560,508				407,151
Operating lease liabilities			2,574,469				-
Other liabilities			260,947				641,461
Total liabilities			14,588,401				11,242,989
Series A - Convertible preferred stock:
Convertible preferred stock, Series A, par value $0.001; 23,780 and 23,900 shares outstanding at 2019 and 2018			5,929,749				5,960,475
Stockholders’ equity:
Convertible preferred stock, Series B, par value $0.001; 10,000,000 shares authorized, 5,610,121 and no shares outstanding at 2019 and 2018			5,610				-
Common stock, par value $0.001; 300,000,000 shares authorized, 66,677,111 and 59,058,297 shares issued at 2019 and 2018, respectively			66,677				59,058
Additional paid-in capital			503,149,814				478,179,574
Treasury stock, 4,015 shares at 2019 and 2018			(205,999	)			(205,999	)
Accumulated deficit			(480,228,280	)			(476,721,490	)
Total stockholders’ equity			22,787,822				1,311,143
Total liabilities and stockholders’ equity		$	43,305,972			$	18,514,607