Sunshine Heart Announces First Quarter 2016 Financial Results and Provides Company Update
EDEN PRAIRIE, Minn., May 03, 2016 (GLOBE NEWSWIRE) -- Sunshine Heart, Inc. (NASDAQ:SSH) announced today its financial results and provided a company update for the first quarter ended March 31, 2016. 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 business strategy.
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 99913745. An audio archive of the webcast and a transcript of the call will be available following the call at http://ir.sunshineheart.com.
Business Update:
- Company is making solid progress on pursuing a more optimal clinical strategy to expedite the approval of C-Pulse therapy in the U.S.
- Advancing the development of a fully implantable system by conducting an acute first-in-man study in 2016 that measures neuromodulation effects
- Expect to submit clinical protocol for a short-term study of CP-1 to the FDA by the end of Q3; estimate protocol approval and commencement of patient enrollment in the U.S. by early 2017
- Data from OPTIONS-HF study showing improvements in cardiac remodeling, functional capacity, and quality of life, to be presented at the European Society of Cardiology Heart Failure conference May 21st, 2016 in Florence, Italy
- Meaningful progress on reducing operating cash-burn in Q1; down 35% from Q1 a year ago.
- Ended Q1 with $16.5 million in cash, $7.1 million in borrowings; management continues to expect to raise capital in 2016
“After my first two months as CEO, I continue to be excited by the significant opportunity in front us at Sunshine Heart,” said John Erb, Chairman and CEO. “The entire organization is focused on pursuing a business and clinical strategy that will allow us to realize the full potential of C-Pulse therapy in helping heart failure patients. We have learned a great deal about the treatment of heart failure patients and we are leveraging that knowledge. In that regard, I am pleased with the clinical progress we are making. We intend to submit our protocol for a short-term clinical study to the FDA by the end of the third quarter. This will allow us to collect additional clinical evidence to support the development of our fully implantable system.”
FINANCIALS
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 0 SUNSHINE HEART, INC. AND SUBSIDIARIES 1 Condensed Consolidated Statements of Operations and Comprehensive Loss 2 (Unaudited) 3 (In thousands, except per share amounts) 4 5 Three months ended March 31, 6 2016 2015 7 Net sales $ — $ 59 8 Operating expenses: 9 Selling, general and administrative 1,349 2,186 10 Research and development 3,206 4,865 11 Total operating expenses 4,555 7,051 12 Loss from operations (4,555 ) (6,992 ) 13 Interest expense (229 ) (63 ) 14 Other income (expense), net 1 (3 ) 15 Loss before income taxes (4,783 ) (7,058 ) 16 Income tax expense 3 5 17 Net loss $ (4,786 ) $ (7,063 ) 18 19 Basic and diluted loss per share $ (0.26 ) $ (0.40 ) 20 Weighted average shares outstanding – basic and diluted 18,353 17,509 21 22 Other comprehensive income: 23 Foreign currency translation adjustments $ (4 ) $ 10 24 Total comprehensive loss $ (4,790 ) $ (7,053 )
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 0 SUNSHINE HEART, INC. AND SUBSIDIARIES 1 Condensed Consolidated Balance Sheets 2 (Dollars in thousands, except share amounts) 3 4 March 31, 2016 December 31, 2015 5 (unaudited) 6 ASSETS[/B] 7 Current assets 8 Cash and cash equivalents $ 16,470 $ 23,113 9 Other current assets 547 479 10 Total current assets 17,017 23,592 11 Property, plant and equipment, net 462 535 12 Other assets 299 323 13 TOTAL ASSETS $ 17,778 $ 24,450 14 15 LIABILITIES AND STOCKHOLDERS’ EQUITY 16 Current liabilities 17 Current portion of long-term debt $ 3,867 $ 3,798 18 Accounts payable and accrued expenses 2,410 2,832 19 Accrued salaries, wages, and other compensation 555 1,368 20 Total current liabilities 6,832 7,998 21 Long-term debt, net of discount 2,934 3,881 22 Other Liabilities 400 400 23 Total liabilities 10,166 12,279 24 Commitments and contingencies — — 25 26 Stockholders’ equity 27 Series A junior participating preferred stock as of March 31, 2016 and December 31, 2015, $0.0001 par value per share; authorized 30,000 shares, none outstanding — — 28 Preferred stock as of March 31, 2016 and December 31, 2015, $0.0001 par value per share; authorized 39,970,000 shares, none outstanding — — 29 Common stock as of March 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 100,000,000 shares; issued and outstanding 18,368,849 and 18,344,478 shares, respectively 2 2 30 Additional paid-in capital 164,336 164,105 31 Accumulated other comprehensive income: 32 Foreign currency translation adjustment 1,242 1,246 33 Accumulated deficit (157,968 ) (153,182 ) 34 Total stockholders’ equity 7,612 12,171 35 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 17,778 $ 24,450
USE OF NON-GAAP MEASURES
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 0 SUNSHINE HEART, INC. AND SUBSIDIARIES 1 Condensed Consolidated Statements of Cash Flows 2 (Unaudited)[/B] 3 (in thousands) 4 5 Three months endedMarch 31, 6 2016 2015 7 Operating activities: 8 Net loss $ (4,786 ) $ (7,063 ) 9 Adjustments to reconcile net loss to cash flows used in operating activities: 10 Depreciation 81 80 11 Stock-based compensation expense, net 231 743 12 Amortization of debt discount and financing fees 84 14 13 Changes in operating assets and liabilities: 14 Other current assets (67 ) (561 ) 15 Other assets 2 (135 ) 16 Accounts payable and accrued expenses (1,241 ) (162 ) 17 Net cash used in operations (5,696 ) ( 7,084 ) 18 [/B] 19 Investing activities:[/B] 20 Purchases of property and equipment (8 ) (72 ) 21 Net cash used in investing activities (8 ) (72 ) 22 23 Financing activities:[/B] 24 Net proceeds from the sale of common stock — 6,902 25 Proceeds from (repayments on) borrowings on long-term debt (940 ) 6,000 26 Net cash provided by financing activities (940 ) 12,902 27 28 Effect of exchange rate changes on cash 1 (12 ) 29 Net increase (decrease) in cash and cash equivalents (6,643 ) 5,734 30 Cash and cash equivalents - beginning of period 23,113 31,293 31 Cash and cash equivalents - end of period $ 16,470 $ 37,027 32
Management uses non-GAAP measures to establish operational goals and cash flows, and believes that non-GAAP measures may assist investors in analyzing underlying trends in the Company's business over time. Investors should consider these non-GAAP measures in addition to, and not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this press release, the Company has reported non-GAAP measures of operating expenses, net loss and loss per share, which exclude equity compensation expenses related to stock options, warrants, restricted stock units and common stock awards, and reconcile to GAAP operating expense, GAAP net loss and GAAP loss per share as follows:
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9 0 SUNSHINE HEART, INC. AND SUBSIDIARIES 1 Reconciliation of non-GAAP amounts to GAAP 2 (Unaudited) 3 (In thousands, except per share amounts) 4 5 Three months ended March 31, 6 2016 2015 7 Operating Expenses[/B] 8 GAAP operating expenses $ 4,555 $ 7,051 9 Equity compensation costs (247 ) (867 ) 10 Non-GAAP operating expenses $ 4,308 $ 6,184 11 Net Loss 12 GAAP net loss $ (4,786 ) $ (7,063 ) 13 Equity compensation costs 247 867 14 Non-GAAP net loss $ (4,539 ) $ (6,196 ) 15 Loss Per Share 16 GAAP basic and diluted loss per share $ (0.26 ) $ (0.40 ) 17 Non-GAAP basic and diluted loss per share $ (0.25 ) $ (0.35 ) 18 19 Weighted average shares outstanding – basic and diluted 18,353 17,509
