0001193125-14-289711.txt : 20140731 0001193125-14-289711.hdr.sgml : 20140731 20140731162104 ACCESSION NUMBER: 0001193125-14-289711 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140731 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140731 DATE AS OF CHANGE: 20140731 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TANDEM DIABETES CARE INC CENTRAL INDEX KEY: 0001438133 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 204327508 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36189 FILM NUMBER: 141006540 BUSINESS ADDRESS: STREET 1: 11045 ROSELLE STREET STREET 2: SUITE 200 CITY: San Diego STATE: CA ZIP: 92121 BUSINESS PHONE: 858-366-6900 MAIL ADDRESS: STREET 1: 11045 ROSELLE STREET STREET 2: SUITE 200 CITY: San Diego STATE: CA ZIP: 92121 8-K 1 d764664d8k.htm FORM 8-K Form 8-K

 

 

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): July 31, 2014

 

 

Tandem Diabetes Care, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36189   20-4327508

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

11045 Roselle Street, San Diego, CA   92121
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 366-6900

N/A

(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:

 

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

 

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

 

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

 

¨ 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 July 31, 2014, we issued a press release announcing our financial results for the quarter ended June 30, 2014. This press release has been furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.

The information under this Item 2.02 and Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Number

  

Description

99.1    Press release of Tandem Diabetes Care, Inc. dated July 31, 2014.


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.

 

      Tandem Diabetes Care, Inc.
Date: July 31, 2014      

/s/ David B. Berger

      David B. Berger
      General Counsel


INDEX TO EXHIBITS

 

Number

  

Description

99.1    Press release of Tandem Diabetes Care, Inc. dated July 31, 2014.
EX-99.1 2 d764664dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

FOR IMMEDIATE RELEASE

Tandem Diabetes Care Reports Second Quarter 2014 Financial Results

San Diego, July 31, 2014 – Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today reported its financial results for the quarter ended June 30, 2014.

In comparing the second quarter of 2014 to the same period of 2013:

 

    Sales grew 86 percent to $10.3 million from $5.5 million

 

    t:slim Pump shipments grew 64 percent to 2,235 pumps from 1,363 pumps

In comparing six months ended June 30, 2014 to the same period of 2013:

 

    Sales grew 67 percent to $18.3 million from $11.0 million, which included $1.9 million of t:slim Pump sales recognized in the first quarter 2013 that were shipped in the fourth quarter of 2012

 

    t:slim Pump shipments grew 79 percent to 3,958 pumps from 2,215 pumps

“In addition to seeing continued, increased adoption of the t:slim Pump and meaningful gross margin improvement in the second quarter, we also made significant progress with our new products in development,” said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. “We recently submitted a PMA application to the FDA for the t:slim G4™ Insulin Pump System, which integrates our t:slim technology with the Dexcom® G4® Platinum CGM System. This is an important milestone for Tandem as we work to expand our product portfolio to meet the various needs of the diabetes community.”

For the quarter ended June 30, 2014, gross margin was 34 percent compared to 7 percent for the same period of 2013. The second quarter of 2014 benefited from improvements in the manufacturing process and increased production volumes.

For the second quarter of 2014, operating expenses totaled $21.8 million compared to $14.1 million for the same period of 2013. The increases in operating expenses are primarily associated with the expansion of commercial operations and non-cash, stock-based compensation.

Operating loss for the second quarter of 2014 was $18.3 million, compared to $13.7 million for the same period of 2013. This included non-cash, stock-based compensation of $3.5 million for the quarter ended June 30, 2014 compared to $0.5 million for the comparable period of 2013.

As of June 30, 2014, the Company had $96.3 million in cash, cash equivalents and short-term investments.

For the year ending December 31, 2014, the Company’s guidance is as follows:

 

    sales are estimated to be in the range of $48.0 million to $54.0 million, and

 

    operating margin is estimated to be in the range of negative 130 percent to 140 percent, which includes approximately $15.0 million to $16.0 million in non-cash, stock-based compensation expense.


Conference Call

The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To listen to the conference call via phone, please dial 855-427-4396 (U.S./Canada) or 484-756-4261 (International) and use the participant code “72496087”.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with insulin-dependent diabetes. The Company manufactures and sells the t:slim Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, and the first and only insulin pump with a high resolution, color touch screen. Tandem is based in San Diego, California.

t:slim, t:connect and Tandem Diabetes Care are registered trademarks of Tandem Diabetes Care, Inc.

Dexcom and G4 Platinum are registered trademarks of Dexcom, Inc.

Follow Tandem Diabetes Care:

Twitter @tandemdiabetes, use #tslim, #tconnect and $TNDM.

Facebook at www.facebook.com/TandemDiabetes

LinkedIn at www.linkedin.com/in/tandemdiabetes

Forward Looking Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to the Company’s projected financial results, the Company’s ability to further drive adoption of the t:slim® Insulin Pump in the insulin dependent diabetes market, the Company’s ability to manage manufacturing costs, the Company’s ability to expand its product portfolio and the Company’s ability to gain FDA approval and commercially launch the t:slim G4 Insulin Delivery System. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, successful commercialization of the Company’s products may be negatively impacted by lack of market acceptance by physicians and people with diabetes. Other risks and uncertainties include the Company’s inability to manufacture products in commercial quantities at an acceptable cost and in accordance with quality requirements; the Company’s inability to contract with additional third-party payors for reimbursement of the Company’s products; possible delays in the Company’s product development programs; possible future actions of the U.S. Food and Drug Administration or any other regulatory body or governmental authority; and other risks identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

# # #


TANDEM DIABETES CARE, INC.

CONDENSED BALANCE SHEETS

(in thousands)

 

     June 30, 2014      December 31,2013  
     (unaudited)         

Assets

     

Current assets:

     

Cash, cash equivalents and short-term investments

   $ 94,305       $ 129,480   

Restricted cash

     2,000         2,050   

Accounts receivable, net

     4,362         5,299   

Inventory, net

     11,121         10,330   

Other current assets

     2,635         1,830   
  

 

 

    

 

 

 

Total current assets

     114,423         148,989   

Property and equipment, net

     12,476         9,886   

Other long term assets

     3,118         3,340   
  

 

 

    

 

 

 

Total assets

   $ 130,017       $ 162,215   
  

 

 

    

 

 

 

Liabilities and stockholders’ equity

     

Current liabilities:

     

Accounts payable, accrued expense and employee-related liabilities

   $ 9,705       $ 10,102   

Deferred revenue

     514         411   

Other current liabilities

     2,992         4,086   
  

 

 

    

 

 

 

Total current liabilities

     13,211         14,599   

Notes payable—long-term

     29,392         29,397   

Other long-term liabilities

     3,867         2,682   

Total stockholders’ equity

     83,547         115,537   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 130,017       $ 162,215   
  

 

 

    

 

 

 


TANDEM DIABETES CARE, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands – except per share data)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2014     2013     2014     2013  

Sales

   $ 10,255      $ 5,528      $ 18,320      $ 10,986   

Cost of sales

     6,806        5,122        14,005        8,540   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     3,449        406        4,315        2,446   

Operating expenses:

        

Selling, general and administrative

     18,069        11,324        36,109        18,208   

Research and development

     3,698        2,759        7,362        5,081   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     21,767        14,083        43,471        23,289   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (18,318     (13,677     (39,156     (20,843

Other expense, net

        

Other expense, net

     (879     (1,171     (2,003     (2,337

Change in fair value of stock warrants

     —          (453     —          (3,284
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

     (879     (1,624     (2,003     (5,621
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (19,197   $ (15,301   $ (41,159   $ (26,464
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.83   $ (72.50   $ (1.79   $ (75.42
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares used to compute basic and diluted net loss per share

     23,098        211        23,017        351   
  

 

 

   

 

 

   

 

 

   

 

 

 

Media Contact:

Steve Sabicer

714-907-6264

ssabicer@thesabicergroup.com

Investor Contact:

Susan Morrison

858-366-6900 x7005

smorrison@tandemdiabetes.com

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