EDEN PRAIRIE, Minn., March 17, 2015 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (Nasdaq:SSH) today announced its financial results and provided a corporate update for the fourth quarter and year ended December 31, 2014. The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on its ongoing clinical studies.
To access the live webcast, please visit the Investors page of the Sunshine Heart website at http://ir.sunshineheart.com. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID 96024417. An audio archive of the webcast will be available following the call at http://ir.sunshineheart.com.
“This past quarter has been an important period of growth across clinical and corporate fronts. We continued to make great overall strides in advancing the COUNTER HF and OPTIONS HF trials, bolstered our management team and made significant progress with the development of the fully implantable C-Pulse System. We remain optimistic that the current pause in the COUNTER HF study will be resolved expeditiously. In fact, the CEC (Clinical Events Committee) has adjudicated all four events as non-device and non-procedure related deaths and we look forward to receiving a positive response from the FDA no later than April 16th,” commented Dave Rosa, President and Chief Executive Officer of Sunshine Heart.
Fourth Quarter Corporate Highlights:
- Twenty one sites activated in the C-Pulse COUNTER HF U.S. pivotal study, up from nineteen at the end of third quarter 2014 with 15 sites having enrolled patients by the end of 2014.
- Thirteen additional patients enrolled in the C-Pulse COUNTER HF study in the fourth quarter with two new centers enrolling their first patients.
- Two additional implants completed in the European OPTIONS HF study in the fourth quarter at newly activated sites in Germany and Austria, bringing total EU implants performed to 12.
- Presented data on the positive effects of C-Pulse on Left Ventricular (LV) stroke volume and wall stress demonstrating improvements in reduction of Wasted Energy and Tension Time index, key metrics in assessing myocardial oxygen consumption.
- Hired Dimitrious Georgakopolous as Chief Scientific Officer.
Fourth Quarter and Full Year Financial Highlights:
- Revenue totaled $177,000 in Q4 2014 vs. no revenue in the similar quarter in 2013. For the year, revenue was $295,000 in 2014 and $59,000 in 2013.
- Operating expenses totaled $6.8 million in Q4 2014 vs $7.0 million in a similar period a year ago. Total year operating expenses were $26.1 million in 2014 vs. $22.9 million in 2013.
- Net loss per share was $(0.40) for Q4 2014 vs. $(0.42) for Q4 2013. Total year net loss per share was $(1.51) for 2014 vs. $(1.71) for 2013.
- Cash used in operations was $22.6 million in 2014 vs. $17.4 million in 2013. Cash and cash equivalents at December 31, 2014 were $31.3 million vs. $54.1 million at December 31, 2013.
FINANCIALS
The Company had revenue of $177,000 and $295,000 for the three and twelve months ended December 31, 2014. For the year ended December 31, 2013, revenue was $59,000. There was no revenue in the fourth quarter of 2013. All revenue relates to reimbursement received for implants performed under the Company’s U.S. COUNTER HF study. Although the Company’s C-Pulse System is not approved for commercial sale in the U.S., the FDA has assigned the C-Pulse System to a Category B designation, making it eligible for reimbursement at some U.S. sites during clinical studies. There are no revenues associated with the Company’s post market OPTIONS HF study in Europe.
Operating expenses in the fourth quarter of 2014 totaled $6.8 million, compared to $7.0 million in the similar period of 2013. The decrease in operating expenses over the prior period related to decreased stock compensation expense. Operating expenses for the twelve months ended December 31, 2014 totaled $26.1 million, compared to $22.9 million in the similar period in 2013. The increase in operating expenses over the prior year twelve month period was primarily attributable to increased clinical research expenses and increased development expense associated with our fully-implantable device.
Included in the full year results are income tax benefits from the receipt of R&D tax credit refunds in Australia totaling $0.25 million for 2014 and $1.2 million for 2013.
Net loss in the three and twelve month periods ended December 31, 2014 was $6.7 million or $0.40 per share, and $25.6 million or $1.51 per share, respectively. This compares to losses of $7.1 million or $0.42 per share; and $21.8 million, or $1.71 per share in the comparable periods in 2013. Excluding equity compensation expense, three and twelve month periods ended December 31, 2014 net non-GAAP losses totaled $5.8 million or $0.34 per share, and $22.5 million, or $1.33 per share, respectively. This compares to $5.4 million or $0.32 per share, and $17.9 million, or $1.41 per share, in the comparable periods of 2013.
Cash used in operating activities totaled $22.6 million for the year ended December 31, 2014 compared to $17.4 million for the similar period in 2013, with the increase driven primarily by higher clinical research and development expenses. The Company had $31.3 million in cash and cash equivalents at December 31, 2014, compared to $54.1 million at December 31, 2013.
In anticipation of the capital needed to fund the fully implantable system, Sunshine Heart began to evaluate the effectiveness of utilizing a $40 million At-the-Market (ATM) equity facility, which was put in place in 2014. Starting November 2014, the Company began utilizing this facility selectively and in the first two months of 2015, it generated approximately $7 million from equity offerings. In addition, subsequent to year end, the Company secured a debt arrangement with Silicon Valley Bank for proceeds of up to $10 million of which $6 million was funded at closing, an additional $2 million became available upon the announcement that the FDA had granted the Company approval to conduct an interim analysis, and the remaining $2 million will be available upon reaching the 100th patient enrollment milestone in the COUNTER HF study on or before September 30, 2015. The Company believes that the combination of the ATM and the debt facility should provide the Company with sufficient capital to fund its operations through 2016.
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