UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  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): March 2, 2017

 

SUNSHINE HEART, INC.

(Exact Name of Registrant as Specified in its Charter)

 


 

Delaware
(State or other jurisdiction of incorporation)

 

001-35312
(Commission File No.)

 

68-0533453
(IRS Employer
Identification No.)

 

12988 Valley View Road

Eden Prairie, Minnesota  55344

(Address of Principal Executive Offices)  (Zip Code)

 

(952) 345-4200

(Registrant’s Telephone Number, Including Area Code)

 

Not Applicable

(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):

 

o       Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o       Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o       Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o       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 March 2, 2017, Sunshine Heart, Inc. (the “Company”) issued a press release reporting its financial results for the fourth quarter and year ended December 31, 2016.  A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

 

Item 9.01    Financial Statements and Exhibits.

 

(d)

 

Exhibit No.

 

Description

99.1

 

Press Release, dated March 2, 2017, reporting the Company’s financial results for the fourth quarter and year ended December 31, 2016.

 

2



 

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.

 

Date: March 2, 2017

SUNSHINE HEART, INC.

 

 

 

By:

/S/ CLAUDIA DRAYTON

 

Name:

Claudia Drayton

 

Title:

Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release, dated March 2, 2017, reporting the Company’s financial results for the fourth quarter and year ended December 31, 2016.

 

4


Exhibit 99.1

 

 

Sunshine Heart Announces Fourth Quarter 2016 Financial Results and Provides Company Update

 

Eden Prairie, MN: March 2, 2017: (GLOBE NEWSWIRE) Sunshine Heart, Inc. (NASDAQ: SSH) announced today its financial results for the fourth quarter ended December 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 the Company’s performance and financing transactions.

 

To access the live webcast, please visit the Investors page of the Sunshine Heart website at 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 77588684. An audio archive of the webcast and a transcript of the call will be available following the call at ir.sunshineheart.com.

 

Business Highlights

 

·                  The Company continues to execute near-term strategy to drive growth with the recently acquired Aquadex FlexFlow business.

 

·                  Direct field organization providing service to the top 55 hospital accounts that have purchased Aquadex over the past 12 months; expanding sales efforts to re-engage an additional 110 hospital accounts. The Company is on track and currently has 115 active hospital accounts ordering products.

 

·                  Pursuing growth strategies in 4 primary areas: i) identifying diagnostic technologies to optimize utilization, ii) data generation to optimize reimbursement, iii) application expansion into other areas of the hospital, and iv) expanding use to outpatient setting.

 

·                  Completed a registered direct offering and a private placement of convertible preferred shares and stock warrants during the quarter for total gross proceeds of approximately $3.6 million.

 

·                  Reduced total costs and expenses by 40% and operating cash utilization by 43% from same quarter last year.

 

·                  Received NASDAQ notification that Company is in compliance with minimum bid price requirement; the Company has until March 20th to evidence compliance with the $2.5M minimum shareholder equity requirement.

 

“Our focus remains on serving the large number of heart failure patients in the U.S. with fluid overload who could benefit from our Aquadex therapy” said John Erb, Chairman and CEO. “We are confident that our strategies will drive sustained growth.”

 

FINANCIALS

 

SUNSHINE HEART, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited and in thousands, except per share amounts)

 

 

 

Three months ended
December 31

 

Twelve months ended
December 31,

 

 

 

2016

 

2015

 

2016

 

2015

 

Net sales

 

$

746

 

$

 

$

1,289

 

$

59

 

Costs and Expenses:

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

526

 

 

713

 

 

Selling, general and administrative

 

2,685

 

2,086

 

8,129

 

8,345

 

Research and development

 

598

 

4,268

 

8,109

 

17,672

 

Total costs and expenses

 

3,809

 

6,354

 

16,951

 

26,017

 

Loss from operations

 

(3,063

)

(6,354

)

(15,662

)

(25,958

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(245

)

(504

)

(743

)

Loss on early retirement of long-term debt

 

 

 

(500

)

 

Other income (expense), net

 

 

(5

)

2

 

(6

)

Change in fair value of warrant liability

 

172

 

 

818

 

 

Total other income (expense)

 

172

 

(250

)

(184

)

(749

)

Loss before income taxes

 

(2,891

)

(6,604

)

(15,846

)

(26,707

)

Income tax benefit (expense), net

 

(10

)

 

54

 

124

 

Net loss

 

$

(2,901

)

$

(6,604

)

$

(15,792

)

$

(26,583

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per share

 

$

(4.64

)

$

(10.81

)

$

(27.06

)

$

(44.01

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding — basic and diluted

 

726

 

611

 

654

 

604

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income:

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

$

1

 

$

(4

)

$

(11

)

$

(26

)

Total comprehensive loss

 

$

(2,900

)

$

(6,608

)

$

(15,803

)

$

(26,609

)

 



 

SUNSHINE HEART, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited and in thousands, except share and per share amounts)

 

 

 

December 31,
2016

 

December 31,
2015

 

ASSETS

 

 

 

 

 

Current assets

 

 

 

 

 

Cash and cash equivalents

 

$

1,323

 

$

23,113

 

Accounts receivable

 

282

 

 

Inventory

 

677

 

 

Other current assets

 

137

 

479

 

Total current assets

 

2,419

 

23,592

 

Property, plant and equipment, net

 

540

 

535

 

Intangible assets, net

 

4,392

 

 

Goodwill

 

99

 

 

Other assets

 

21

 

323

 

TOTAL ASSETS

 

$

7,471

 

$

24,450

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities

 

 

 

 

 

Current portion of long-term debt

 

$

 

$

3,798

 

Accounts payable and accrued expenses

 

2,351

 

2,832

 

Accrued compensation

 

909

 

1,368

 

Total current liabilities

 

3,260

 

7,998

 

Long-term debt, net of discount and financing fees

 

 

3,881

 

Common stock warrant liability

 

1,843

 

 

Other liabilities

 

126

 

400

 

Total liabilities

 

5,229

 

12,279

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

Temporary Stockholders’ equity

 

 

 

 

 

Series D convertible preferred stock as of December 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 900 shares, issued and outstanding 700 and 0, respectively

 

485

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Series A junior participating preferred stock as of December 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 30,000 shares, none outstanding

 

 

 

Series B-1 convertible preferred stock as of December 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 1,824.4 and 0 shares, respectively, issued and outstanding 1,824.4 and 0, respectively

 

 

 

Series C convertible preferred stock as of December 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 2,900 and 0 shares, respectively, issued and outstanding 2,900 and 0, respectively

 

 

 

 

Preferred stock as of December 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 39,964,375 and 39,970,000 shares, respectively, none outstanding

 

 

 

Common stock as of December 31, 2016 and December 31, 2015, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 777,238 and 611,483, respectively

 

 

 

Additional paid-in capital

 

169,496

 

164,107

 

Accumulated other comprehensive income:

 

 

 

 

 

Foreign currency translation adjustment

 

1,235

 

1,246

 

Accumulated deficit

 

(168,974

)

(153,182

)

Total stockholders’ equity

 

1,757

 

12,171

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

7,471

 

$

24,450

 

 



 

SUNSHINE HEART, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited, in thousands)

 

 

 

For the years ended December
31,

 

In thousands

 

2016

 

2015

 

Operating Activities

 

 

 

 

 

Net loss

 

$

(15,792

)

$

(26,583

)

Adjustments to reconcile net loss to cash flows from operating activities:

 

 

 

 

 

Depreciation and amortization

 

697

 

325

 

Stock based compensation expense, net

 

949

 

2,154

 

Amortization of debt discount and financing fees

 

187

 

263

 

Loss on retirement of long-term debt

 

500

 

 

Change in fair value of warrant liability

 

(818

)

 

Changes in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(282

)

59

 

Inventory

 

(677

)

 

Other current assets

 

342

 

(181

)

Other assets and liabilities

 

(464

)

(92

)

Accounts payable and accrued expenses

 

(934

)

1,066

 

Net cash used in operations

 

(16,292

)

(22,989

)

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

Purchase of property and equipment

 

(117

)

(199

)

Purchase of Aquadex product line

 

(4,000

)

 

Net cash used in investing activities

 

(4,117

)

(199

)

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Net proceeds from the sale of preferred stock, common stock and warrants

 

6,636

 

7,055

 

Proceeds from borrowings on long-term debt

 

 

 

8,000

 

Repayments of long-term debt

 

(8,000

)

 

Net cash provided by (used in) financing activities

 

(1,364

)

15,055

 

 

 

 

 

 

 

Effect of exchange rate changes on cash

 

(17

)

(47

)

Net decrease in cash and cash equivalents

 

(21,790

)

(8,180

)

Cash and cash equivalents—beginning of period

 

23,113

 

31,293

 

Cash and cash equivalents—end of period

 

$

1,323

 

$

23,113

 

 

 

 

 

 

 

Supplemental schedule of non-cash activities

 

 

 

 

 

Warrants issued in connection with debt financing

 

$

 

$

355

 

Common stock issued for business acquisition

 

$

950

 

$

400

 

 

 

 

 

 

 

Supplemental cash flow information

 

 

 

 

 

Interest paid on debt borrowings

 

$

840

 

$

388

 

Cash paid for income taxes

 

$

47

 

$

 

 



 

About Sunshine Heart

 

Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical device company focused on commercializing the Aquadex FlexFlow® System. The Company’s commercial product, the Aquadex system, is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. Our objective is to improve the quality of life for patients with heart failure and related conditions. Sunshine Heart is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia and Ireland. The Company has been listed on the NASDAQ Capital Market since February 2012.

 

Forward-Looking Statements

 

Certain statements in this release are forward-looking statements that are based on management’s beliefs, assumptions, expectations, and information currently available to management. All statements that address future operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation, our ability to execute on our recently announced strategic realignment, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses. The risk factors described in our filings with the SEC could cause actual events to adversely differ from the expectations indicated in these forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. Sunshine Heart does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Sunshine Heart may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility that regulatory authorities do not accept our application or approve the marketing of our therapy, the possibility we may be unable to raise the funds necessary for the development and commercialization of our therapy and other risks and uncertainties described in our filings with the SEC. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

For further information, please contact:

 

Claudia Napal Drayton

Investor Relations

Chief Financial Officer

Sunshine Heart Inc.

Sunshine Heart, Inc.

ir@sunshineheart.com

T: +1-952-345-4205