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): August 14, 2018

 

RESHAPE LIFESCIENCES INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

1-33818

 

48-1293684

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification
Number)

 

1001 Calle Amanecer
San Clemente, CA

 

92673

(Address of principal executive offices)

 

(Zip Code)

 

(949) 429-6680

(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:

 

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))

 

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 o

 

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. o

 

 

 



 

Item 2.02                                           Results of Operations and Financial Condition.

 

On August 14, 2018, ReShape Lifesciences Inc. (the “Company”) issued a press release announcing its financial results for the three months ended June 30, 2018. The Company also announced that it will be hosting a conference call at 4:30 p.m. Eastern Time on August 14, 2018 to discuss its financial results for the three months ended June 30, 2018. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information furnished herewith pursuant to Item 2.02 of this Current Report and in Exhibit 99.1 hereto is being “furnished” in accordance with General Instruction B.2 of Form 8-K and 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 it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01                                           Financial Statements and Exhibits.

 

(d)         Exhibits.

 

Exhibit No.

 

Description

99.1

 

Press Release dated August 14, 2018

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

RESHAPE LIFESCIENCES INC.

 

 

 

 

 

 

By:

/s/ Scott P. Youngstrom

 

 

Scott P. Youngstrom

 

 

Chief Financial Officer

 

 

Dated: August 14, 2018

 

 

3


Exhibit 99.1

 

 

ReShape Lifesciences Announces Second Quarter 2018 Financial Results

 

San Clemente, CA August 14, 2018 — ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of minimally invasive medical devices to treat obesity and metabolic diseases, today reported financial results for the three months ended June 30, 2018.

 

Recent Highlights and Accomplishments

 

·                  Achieved revenues of $653 thousand for the second quarter of 2018

 

·                  Sold 680 ReShape BalloonsTM in the quarter, a 12% decrease compared to the first quarter of 2018

 

·                  Placed 8 ReShape vBlocTM units in the second quarter of 2018, completing the vBloc Now program

 

·                  Assembled a world class scientific advisory board, comprised of several past-presidents of the American Society for Metabolic and Bariatric Surgery (ASMBS)

 

·                  Was granted method and device patent by USPTO covering a combination of blocking and stimulating the vagus and celiac nerve branches to treat gastrointestinal disorders, including type 2 diabetes

 

·                  Received notification by USPTO for a patent covering the concept and technology for the ReShape Vest

 

·                  Completed three registered direct equity offerings with total net proceeds of approximately $7.35 million

 

“We have made a lot of meaningful progress this quarter at ReShape, with particular success in our product development efforts as we advance our platform for future use and applications in additional large markets such as type 2 diabetes,” said Dan Gladney, President, Chief Executive Officer and Chairman of the Board. “Despite cutbacks and reductions in our teams, our sales force also really stepped up and increased productivity substantially in the quarter.  We remain confident in our ability to establish our products as the standard of care for obesity.”

 

Second Quarter 2018 Financial Results

 

For the three months ended June 30, 2018, the Company reported revenues of $653 thousand with gross profit totaling $19 thousand.  The Company placed 8 ReShape vBloc units, primarily from the vBloc Now program, compared to 42 units in the second quarter of 2017.

 

As of June 30, 2018 the Company had cash and cash equivalents totaling $1.9 million and has no debt.  This includes the $7.35 million in net proceeds from the registered direct offerings completed on April 3, 2018, June 8, 2018 and June 21, 2018.

 

Conference Call

 

Management will host an investment community conference call today beginning at 1:30 p.m. Pacific Time /4:30 p.m. Eastern Time.

 



 

Individuals interested in listening to the conference call may do so by dialing (877) 280-7473 for domestic callers or (707) 287-9370 for international callers, using Conference ID: 4849065. To listen to a live webcast or a replay, please visit the investor relations section of the Company website at: http://ir.reshapelifesciences.com/.

 

About ReShape Lifesciences Inc.

 

ReShape Lifesciences™ is a medical device company focused on technologies to treat obesity and metabolic diseases. The FDA-approved ReShape Balloon™ System involves a weight loss procedure that uses advanced gastric balloon technology, inserted through an endoscopic procedure, designed to take up room in the stomach to help people with a 30-40 kg/m2 Body Mass Index (BMI) and at least one co-morbidity lose weight. ReShape vBloc™ Therapy, delivered by an FDA-approved pacemaker-like device called the ReShape vBloc System, is designed to help patients with a 40-45 kg/m2, or a 35-39.9 kg/m2 BMI and at least one co-morbidity feel full and eat less by intermittently blocking hunger signals on the vagus nerve. The ReShape Vest™ System is an investigational, minimally invasive, laparoscopically implanted medical device that wraps around the stomach, emulating the gastric volume reduction effect of conventional weight-loss surgery, and is intended to enable rapid weight loss in obese and morbidly obese patients without permanently changing patient anatomy.

 

Forward-Looking Safe Harbor Statement:

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include the statement that we remain confident in our ability to establish our products as the standard of care for obesity. These forward-looking statements generally can be identified by the use of words such as “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. These forward-looking statements are based on the current expectations of our management and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others: risks and uncertainties related to our acquisitions of ReShape Medical, Inc. and BarioSurg, Inc.; risks related to the U.S. Food and Drug Administration’s announcement to alert health care providers of unanticipated deaths involving the ReShape Balloon; our proposed ReShape Vest product may not be successfully developed and commercialized; our ability to continue as a going concern if we are unsuccessful in our pursuit of various funding options; our limited history of operations; our losses since inception and for the foreseeable future; our limited commercial sales experience; the competitive industry in which we operate; our ability to maintain compliance with the Nasdaq continued listing requirements; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for our ReShape Vest and any modifications to our vBloc system or ReShape Balloon; physician adoption of our products; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; the cost and management time of operating a public company; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in our annual report on Form 10-K filed April 2, 2018 and quarterly report on Form 10-Q filed May 15, 2018. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

 

Investor Contact:

Scott Youngstrom

Chief Financial Officer

ReShape Lifesciences Inc.

949-429-6680 x106

syoungstrom@reshapelifesci.com

or

Debbie Kaster

 



 

Investor Relations

Gilmartin Group
415-937-5403

debbie@gilmartinir.com

 



 

RESHAPE LIFESCIENCES INC.

Condensed Consolidated Statements of Operations

(unaudited)

 

 

 

Three Months Ended June 30, 

 

Six Months Ended June 30, 

 

 

 

2018

 

2017

 

2018

 

2017

 

Product sales

 

$

633,554

 

$

93,060

 

$

1,574,985

 

$

133,100

 

Other revenue

 

19,815

 

 

28,382

 

 

Total revenue

 

653,369

 

93,060

 

1,603,367

 

133,100

 

 

 

 

 

 

 

 

 

 

 

Cost of revenue

 

634,774

 

54,472

 

1,463,731

 

83,995

 

Gross profit

 

18,595

 

38,588

 

139,636

 

49,105

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

6,710,518

 

5,560,787

 

16,756,075

 

11,489,773

 

Research and development

 

2,439,337

 

1,352,075

 

5,126,856

 

2,476,488

 

Total operating expenses

 

9,149,855

 

6,912,862

 

21,882,931

 

13,966,261

 

Operating loss

 

(9,131,260

)

(6,874,274

)

(21,743,295

)

(13,917,156

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Interest income

 

263

 

 

674

 

100

 

Interest expense

 

 

 

(2,735

)

 

Goodwill impairment expense

 

(27,186,620

)

 

(27,186,620

)

 

Change in value of warrant liability

 

369

 

34,395

 

1,494

 

(288,735

)

Other, net

 

(142,145

)

(298

)

(144,416

)

(1,198

)

Loss before income taxes

 

(36,459,393

)

(6,840,177

)

(49,074,898

)

(14,206,989

)

 

 

 

 

 

 

 

 

 

 

Income tax benefit

 

1,208,560

 

 

2,590,613

 

 

Net loss

 

$

(35,250,833

)

$

(6,840,177

)

$

(46,484,285

)

$

(14,206,989

)

Net loss per share—basic and diluted

 

$

(14.23

)

$

(13.68

)

$

(20.45

)

$

(32.13

)

Shares used to compute basic and diluted net loss per share

 

2,477,910

 

500,114

 

2,273,160

 

442,191

 

 



 

RESHAPE LIFESCIENCES INC.

Condensed Consolidated Balance Sheets (unaudited)

(in thousands)

 

 

 

June 30, 

 

December 31, 

 

 

 

2018

 

2017

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

1,863,217

 

$

10,163,208

 

Accounts receivable (net of allowance for bad debts of $155,872 at June 30, 2018 and December 31, 2017)

 

446,027

 

488,613

 

Inventory

 

2,101,017

 

2,817,112

 

Prepaid expenses and other current assets

 

919,543

 

467,783

 

Total current assets

 

5,329,804

 

13,936,716

 

Property and equipment, net

 

303,206

 

438,621

 

Goodwill

 

 

27,186,620

 

Other intangible assets, net

 

44,802,230

 

46,152,577

 

Other assets

 

76,827

 

990,015

 

Total assets

 

$

50,512,067

 

$

88,704,549

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,201,239

 

$

1,088,271

 

Accrued expenses

 

4,499,875

 

5,955,518

 

Total current liabilities

 

8,701,114

 

7,043,789

 

 

 

 

 

 

 

Deferred income taxes

 

2,700,681

 

5,292,291

 

Common stock warrant liability

 

74

 

1,600

 

Total liabilities

 

11,401,869

 

12,337,680

 

Commitments and contingencies (Note 7)

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, 5,000,000 shares authorized:

 

 

 

 

 

 

 

 

 

 

 

Series B convertible preferred stock, $0.01 par value; 20,000 shares issued and 2,957 and 6,055 shares outstanding at June 30, 2018 and December 31, 2017, respectively

 

30

 

61

 

Series C convertible preferred stock, $0.01 par value; 187,772 shares issued and 95,388 shares outstanding at June 30, 2018 and December 31, 2017

 

954

 

954

 

Series D convertible preferred stock, $0.01 par value; 6,000 shares issued and 4,750 and zero shares outstanding at June 30, 2018 and December 31, 2017

 

48

 

 

Common stock, $0.01 par value; 275,000,000 shares authorized at June 30, 2018 and December 31, 2017; 3,610,009 and 2,063,808 shares issued and outstanding at June 30, 2018 and December 31, 2017

 

36,100

 

20,640

 

Additional paid-in capital

 

424,158,496

 

411,104,568

 

Accumulated deficit

 

(385,085,430

)

(334,759,354

)

Total stockholders’ equity

 

39,110,198

 

76,366,869

 

Total liabilities and stockholders’ equity

 

$

50,512,067

 

$

88,704,549