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): February 24, 2015
Tandem Diabetes Care, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-36189 |
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20-4327508 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(I.R.S. Employer |
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11045 Roselle Street, San Diego, CA |
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92121 |
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(Address of principal executive offices) |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 February 24, 2015, we issued a press release announcing our financial results for the fourth quarter and full year ended December 31, 2014. A copy of the press release is attached hereto as Exhibit 99.1.
The information provided under this Item 2.02, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities 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.
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Number |
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Description |
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99.1 |
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Press release of Tandem Diabetes Care, Inc. dated February 24, 2015. |
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.
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Tandem Diabetes Care, Inc. |
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Date: February 24, 2015 |
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/s/ David B. Berger |
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David B. Berger |
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General Counsel |
INDEX TO EXHIBITS
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Number |
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Description |
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99.1 |
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Press release of Tandem Diabetes Care, Inc. dated February 24, 2015. |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Tandem Diabetes Care Reports Fourth Quarter and Full Year 2014 Financial Results
San Diego, February 24, 2015 – Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, today reported its financial results for the quarter and year ended December 31, 2014.
In comparing the fourth quarter of 2014 to the same period of 2013:
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· |
Sales grew 75 percent to $17.9 million from $10.2 million |
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· |
t:slim pump shipments grew 63 percent to 3,929 pumps from 2,406 pumps |
In comparing the year ended December 31, 2014 to the same period of 2013:
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Sales grew 71 percent to $49.7 million from $29.0 million, which included $1.9 million of t:slim pump sales recognized in the first quarter of 2013 that were shipped in the fourth quarter of 2012 |
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t:slim pump shipments grew 67 percent to 10,822 pumps from 6,472 pumps |
“We more than doubled our installed base since the end of 2013 and independent surveys continue to rank the t:slim pump #1 in overall user satisfaction and product features1,” said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. “We look to further our commitment to the diabetes community in 2015 with additional new product introductions, such as t:flex, and by advancing the clinical and consumer applications of our unique technology platform.”
For the year ended December 31, 2014, gross margin was 31 percent compared to a gross margin of 21 percent for the same period of 2013. Gross margin was 37 percent for the quarter ended December 31, 2014 compared to 12 percent for the same period of 2013. Included in the gross margins for the year and quarter ended December 31, 2013 were the direct costs associated with the previously announced voluntary cartridge recall that impacted the gross margin by 5 and 13 percentage points, respectively.
For the year ended December 31, 2014, operating expenses totaled $90.9 million compared to $55.6 million for the same period of 2013. For the fourth quarter of 2014, operating expenses totaled $24.0 million compared to $17.7 million for the same period of 2013. The increases in operating expenses are primarily associated with the expansion of commercial operations, increased incentive compensation associated with higher sales, and non-cash stock-based compensation.
For the year ended December 31, 2014, operating loss was $75.7 million compared to $49.4 million for the same period of 2013. Operating loss for the fourth quarter of 2014 was $17.5 million, compared to $16.5 million for the same period of 2013. Operating loss included non-cash stock-based compensation for the year and quarter ended December 31, 2014 of $15.0 million and $3.9 million, respectively, compared to $4.5 million and $2.8 million for the comparable periods of 2013.
As of December 31, 2014, the Company had $69.3 million in cash, cash equivalents and short-term investments.
For the year ending December 31, 2015, the Company is providing its guidance as follows:
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· |
Sales are estimated to be in the range of $70.0 million to $75.0 million, which includes $1.0 million to $3.0 million of t:flex Insulin Pump sales, and |
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· |
Operating margin is estimated to be in the range of negative 100 percent to negative 110 percent, which includes approximately $13.0 million to $14.0 million in non-cash stock-based compensation expense. |
The Company’s guidance reflects its current plan to begin commercial sales of the t:flex Insulin Pump during the second quarter of 2015.
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 "80785395".
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 diabetes who use insulin. The Company manufactures the t:slim Insulin Pump, the slimmest and smallest durable insulin pump currently on the market, and the t:flex Insulin Pump, the first pump designed for people with greater insulin requirements. Tandem is based in San Diego, California.
t:flex is a trademark, and t:slim and Tandem Diabetes Care are registered trademarks of Tandem Diabetes Care, Inc.
Follow Tandem Diabetes Care:
Twitter @tandemdiabetes, use #tslim, #tconnect and $TNDM.
Facebook at www.facebook.com/TandemDiabetes
LinkedIn at www.linkedin.com/company/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 achieve operating efficiencies, the Company’s ability to further drive adoption of the t:slim® Insulin Pump in the insulin dependent diabetes market, and the Company’s ability to commercially launch the t:flex Insulin Pump during the second quarter of 2015. 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, 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.
# # #
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TANDEM DIABETES CARE, INC. |
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CONDENSED BALANCE SHEETS |
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(in thousands) |
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December 31, |
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2014 |
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2013 |
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Assets |
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Current assets: |
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Cash and cash equivalents and short-term investments |
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$ |
67,282 |
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$ |
129,480 |
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Restricted cash |
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2,000 |
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2,050 |
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Accounts receivable, net |
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7,652 |
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5,299 |
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Inventory |
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11,913 |
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10,330 |
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Other current assets |
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1,904 |
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1,830 |
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Total current assets |
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90,751 |
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148,989 |
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Property and equipment, net |
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12,581 |
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9,886 |
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Other long term assets |
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3,132 |
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3,340 |
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Total assets |
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$ |
106,464 |
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$ |
162,215 |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable, accrued expense, and employee-related liabilities |
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$ |
14,591 |
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$ |
10,102 |
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Deferred revenue |
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840 |
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411 |
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Other current liabilities |
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2,663 |
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4,086 |
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Total current liabilities |
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18,094 |
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14,599 |
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Notes payable—long-term |
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29,440 |
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29,397 |
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Other long-term liabilities |
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4,358 |
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2,682 |
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Total liabilities |
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51,892 |
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46,678 |
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Total stockholders’ equity |
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54,572 |
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115,537 |
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Total liabilities and stockholders’ equity |
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$ |
106,464 |
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$ |
162,215 |
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TANDEM DIABETES CARE, INC. |
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CONDENSED STATEMENTS OF OPERATIONS |
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(in thousands, except per share data) |
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2014 |
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2013 |
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2014 |
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2013 |
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Sales |
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$ |
17,889 |
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$ |
10,245 |
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$ |
49,722 |
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$ |
29,007 |
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Cost of sales |
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11,352 |
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9,057 |
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34,474 |
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22,840 |
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Gross profit |
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6,537 |
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1,188 |
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15,248 |
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6,167 |
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Operating expenses: |
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Selling, general and administrative |
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20,117 |
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14,305 |
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75,121 |
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44,522 |
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Research and development |
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3,922 |
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3,346 |
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15,791 |
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11,079 |
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Total operating expenses |
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24,039 |
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17,651 |
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90,912 |
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55,601 |
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Operating loss |
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(17,502 |
) |
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(16,463 |
) |
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(75,664 |
) |
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(49,434 |
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Other expense, net |
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(892 |
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(1,160 |
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(3,789 |
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(4,703 |
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Change in fair value of stock warrants |
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— |
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(5,990 |
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— |
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(9,002 |
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Total other expense, net |
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(892 |
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(7,150 |
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(3,789 |
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(13,705 |
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Loss before taxes |
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(18,394 |
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(23,613 |
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(79,453 |
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(63,139 |
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Provision for income tax expense |
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71 |
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- |
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71 |
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- |
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Net loss |
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$ |
(18,465 |
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$ |
(23,613 |
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$ |
(79,524 |
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$ |
(63,139 |
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Net loss per share, basic and diluted |
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$ |
(0.78 |
) |
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$ |
(2.14 |
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$ |
(3.42 |
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$ |
(21.46 |
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Weighted average shares used to compute basic and diluted net loss per share |
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23,571 |
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11,046 |
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23,272 |
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2,942 |
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Media Contact:
Steve Sabicer
714-907-6264
ssabicer@thesabicergroup.com
Investor Contact:
Susan Morrison
858-366-6900 x7005
smorrison@tandemdiabetes.com
1 dQ&A Patient Panel, Q2 2014, and dQ&A Patient Panel, Q4 2014