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8-K - CURRENT REPORT - Corindus Vascular Robotics, Inc.cvrs-8k_030816.htm

 

Corindus Vascular Robotics, Inc. 8-K

 

Exhibit 99.1

 

 

Corindus Vascular Robotics Reports Fourth Quarter and Year End 2015 Results

 

WALTHAM, MA March 8, 2016 – Corindus Vascular Robotics, Inc. [NYSE MKT: CVRS], a leading developer of precision vascular robotics, today reported financial results for the three and twelve months ended December 31, 2015.

 

Recent Highlights and Accomplishments

 

Appointed Mark J. Toland as President and Chief Executive Officer

 

oMr. Toland joins Corindus from Boston Scientific, a global medical technology leader with a significant focus on cardiovascular solutions, where he most recently held the position of Senior Vice President, Corporate Accounts & Global Healthcare Solutions

 

oMr. Toland brings more than 20 years of operating experience in the cardiovascular medical device industry to Corindus and spent more than 18 years at Boston Scientific where he led large divisional and corporate teams responsible for U.S. commercial sales and operations across multiple cardiovascular business segments, including Interventional Cardiology, Peripheral, Structural Heart, and Electrophysiology

 

Installed four new CorPath® Systems in the fourth quarter of 2015 increasing the total installed base to 38 CorPath Systems

 

Revenues of $0.8 million for the fourth quarter of 2015, compared to $0.6 million for the same period in the prior year

 

Launched a CorPath robotic-assisted coronary intervention program at Massachusetts General Hospital enabling physicians to perform percutaneous coronary interventions (PCI) using the CorPath System while protected from radiation exposure in the system's radiation-shielded control cockpit; simultaneously installed the facility’s first CorPath System

 

UC San Diego Health purchased a second CorPath System reflecting continued expansion of use of the technology

 

Strengthened the Board of Directors with the addition of Campbell Rogers, M.D., a veteran in the medical technology industry and field of healthcare with over 30 years of experience in commercialization, development, education and research

 

oDr. Rogers is the Chief Medical Officer of HeartFlow, a cardiovascular diagnostics company providing the first non-invasive solution that enables physicians to more accurately evaluate significant coronary artery disease based on both anatomy and physiology

 

oPreviously, Dr. Rogers was the Chief Scientific Officer and Global Head of R&D for Cordis at Johnson & Johnson and earlier in his career, Dr. Rogers was Associate Professor of Medicine at Harvard Medical School and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital in Boston

 

 

 

 

"We are pleased to report fourth quarter results which reflect building momentum of the CorPath System which is still in early stages of commercialization. We had many accomplishments in 2015 which strengthened our commercial efforts, product indication expansion efforts and market development. We continue to expand our collaborations with the leading cardiology centers across the country in order to continue to increase the awareness of our technology platform," said David Long, Senior Vice President and Chief Financial Officer of Corindus.

 

"I am thrilled to have joined Corindus at such an exciting time in the company’s growth trajectory, and I look forward to working with the team here to further drive commercialization of the CorPath System," said Mark Toland, President and Chief Executive Officer of Corindus. "The global opportunity for precision vascular robotics is tremendous, and we are strategically focused on expanding and supporting our customers in their mission of bringing high value care to patients while protecting cath lab workers from harmful radiation and other occupational hazards."

 

Fourth Quarter 2015 Financial Results

 

Revenues for the fourth quarter of 2015 were $0.8 million compared to $0.6 million for the same period in the prior year. The increase is due primarily to an increase in revenue from our CorPath Systems.

 

Gross loss for the fourth quarter 2015 was $0.4 million compared to $1.0 million for the fourth quarter of 2014. Cost of revenues for the fourth quarter 2015 continued to include the effect of under-utilization of production facilities which is expected to continue in 2016.

 

Research and development expenses were $2.2 million for the fourth quarter of 2015 compared to $1.8 million in the fourth quarter of 2014. The increase is primarily due to increased headcount and other support costs related to the development of the next generation CorPath System. Selling, general and administrative expenses were $4.3 million in the fourth quarter of 2015, compared to $3.5 million in the fourth quarter of 2014. The increase is due to incremental employee related costs resulting from the expansion of the direct sales force and increased commercial initiatives, partially offset by a decline in general and administrative expenses versus prior period.

 

Net loss was $7.2 million for the fourth quarter of 2015, compared to a loss of $6.5 million for the fourth quarter of 2014.

 

Cash, cash equivalents, and marketable securities as of December 31, 2015 were $42.7 million. 

 

Conference Call

 

Management will host an investment community conference call today beginning at 4:30 p.m. ET. Investors interested in listening to the conference call may do so by dialing (877) 201-0168 for domestic callers, or (647) 788-4901 for international callers (Conference ID: 51786960), or from the webcast on the "Investor Relations" section of the Company’s website at: www.corindus.com. Following the call, a replay will be available on the Investor Relations section of the Company’s website.

 

About Corindus Vascular Robotics, Inc.

 

Corindus Vascular Robotics, Inc. is a global technology leader in robotic-assisted percutaneous coronary interventions (PCIs). The company's CorPath System is the first FDA-cleared medical device to bring robotic-assisted precision to PCI procedures. During the procedure, the interventional cardiologist sits at a radiation-shielded workstation to advance stents and guidewires with millimeter-by-millimeter precision. The workstation allows the physician greater control and the freedom from wearing heavy lead protective equipment that causes musculoskeletal injuries. With the CorPath System, Corindus Vascular Robotics brings robotic precision to radial and complex PCI procedures to help optimize clinical outcomes and minimize the costs associated with complications of improper stent placement with manual PCI procedures. Corindus stands behind its product with its unique $1,000 hospital credit "One Stent Program." For additional information, visit www.corindus.com and follow @CorindusInc.

 

 

 

 

Forward Looking Statements

 

Statements made in this release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Corindus Vascular Robotics to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. In addition to statements that explicitly describe such risks and uncertainties, readers are urged to consider statements in the conditional or future tenses or that includes terms such as “believes,” “belief,” “expects,” “estimates,” “intends,” “anticipates” or “plans” to be uncertain and forward-looking. Forward-looking statements may include comments as to Corindus Vascular Robotics’ beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of Corindus Vascular Robotics. Examples of such statements include statements regarding the potential benefits of the CorPath System and robotic-assisted PCI for hospitals, patients and physicians. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others: the rate of adoption of the CorPath System and the rate of use of CorPath Cassettes; risks associated with market acceptance, including pricing and reimbursement; Corindus Vascular Robotics' ability to enforce its intellectual property rights; the need for additional funds to support operations; the ability to manage expenses and cash flow; factors relating to engineering, regulatory, manufacturing, sales and customer service challenges; potential safety and regulatory issues that could slow or suspend sales; and the effect of credit, financial and economic conditions on capital spending by potential customers. More information on potential factors that could affect Corindus Vascular Robotics’ financial results is included from time to time in the “Forward-Looking Statements,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Corindus Vascular Robotics’ periodic and current filings with the SEC, as well as those discussed under the “Risk Factors” and “Forward-Looking Statements” section of Corindus Vascular Robotics' Annual Report on Form 10-K filed with the SEC on March 30, 2015 and available on its website at http://www.corindus.com/about-corindus/investor-relations. Forward-looking statements speak only as of the date they are made and Corindus Vascular Robotics undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, that occur after that date.

 

# # #

 

Media Contacts:  
Corindus Vascular Robotics, Inc.  
Brett Prince Yuliya Kutuzava
(508) 653-3335 ext. 231 203-504-8230 ext. 131
brett.prince@corindus.com corindus@knbpr.com

 

Investor Contact:

Lynn Pieper Lewis

415-309-5999

ir@corindus.com

 

 

 

 

 

CORINDUS VASCULAR ROBOTICS, INC.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS DATA

(In thousands, except share and per share amounts)

 

   Three Months Ended
December 31,
  For the Years Ended
December 31,
   2014  2015  2014  2015
Revenue  $622   $832   $2,983   $2,729 
Cost of revenue   1,670    1,260    4,904    3,724 
Gross loss   (1,048)   (428)   (1,921)   (995)
Operating expenses:                    
Research and development   1,751    2,182    6,607    10,033 
Selling, general and administrative   3,548    4,260    13,002    16,143 
Restructuring charge   —      —      175    —   
Total operating expense   5,299    6,442    19,784    26,176 
Operating loss   (6,347)   (6,870)   (21,705)   (27,171)
Other expense:                     
Warrant revaluation   —      —      (2,421)   —   
Interest and other expense   (201)   (359)   (415)   (1,592)
Total other expense, net   (201)   (359)   (2,836)   (1,592)
Net loss  $(6,548)  $(7,229)  $(24,541)  $(28,763)
Net loss per share--basic and diluted  $(0.06)  $(0.06)  $(0.29)  $(0.25)
                     
Weighted-average common shares used in computing net loss per share--basic and diluted   105,883,157    118,621,833    84,990,198    113,254,925 

 

 

 
 

 

CORINDUS VASCULAR ROBOTICS, INC.

UNAUDITED CONSOLIDATED BALANCE SHEETS DATA

(In thousands, except share and per share amounts)

 

   December 31,  December 31,
   2014  2015
Assets      
Current Assets:      
Cash and cash equivalents  $28,526   $22,142 
Marketable securities   —      20,524 
Accounts receivable net   473    878 
Inventories, net   1,519    1,329 
Prepaid expenses and other current assets   574    591 
Total current assets   31,092    45,464 
Property and equipment, net   1,284    1,382 
Deposits and other assets   222    166 
Deferred inventory costs   102    —   
Notes receivable due from stockholders   136    136 
Total assets  $32,836   $47,148 
           
Liabilities and stockholders' equity          
Current Liabilities:          
Accounts payable  $2,005   $1,538 
Accrued expenses   1,137    1,199 
Deferred revenue   202    701 
Current portion of long-term debt   1,517    4,038 
Total current liabilities   4,861    7,476 
           
Long-term liabilities:          
Deferred revenue, net of current portion   531    106 
Other liabilities   68    42 
Long-term debt, net of current portion   7,594    3,677 
Total long-term liabilities   8,193    3,825 
Total liabilities   13,054    11,301 
           
Stockholders' equity:          
Common stock, $0.0001 par value; 250,000,000 shares authorized;
105,883,157 shares at December 31, 2014 and 118,832,441 shares at
December 31, 2015 issued and outstanding
   11    12 
Additional paid-in capital   104,648    149,489 
Accumulated other comprehensive loss   —      (14)
Accumulated deficit   (84,877)   (113,640)
Total stockholders' equity   19,782    35,847 
Total liabilities and stockholders' equity  $32,836   $47,148