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 30, 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 July 30, 2015, we issued a press release announcing our financial results for the quarter ended June 30, 2015. This press release has been furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.
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 8.01 Other Events
On July 30, 2015, we issued a press release announcing that we have entered into Development Agreements with Dexcom to allow the integration of future generation Tandem insulin pumps with the Dexcom G5 and G6 continuous glucose monitoring systems. The press release announcing the Development Agreements is attached hereto as Exhibit 99.2 and 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 it 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 July 30, 2015, announcing second quarter 2015 financial results. |
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99.2 |
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Press release of Tandem Diabetes Care, Inc. dated July 30, 2015, announcing entering into Development Agreements with Dexcom. |
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: July 30, 2015 |
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/s/ David B. Berger |
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David B. Berger |
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General Counsel and Secretary |
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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 July 30, 2015, announcing second quarter 2015 financial results. |
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99.2 |
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Press release of Tandem Diabetes Care, Inc. dated July 30, 2015, announcing entering into Development Agreements with Dexcom. |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Tandem Diabetes Care Reports Second Quarter 2015 Financial Results
San Diego, July 30, 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 ended June 30, 2015.
In comparing the second quarter of 2015 to the same period of 2014:
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· |
Sales grew 53 percent to $15.7 million from $10.3 million |
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· |
Total pump shipments grew 49 percent to 3,331 pumps from 2,235 pumps |
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· |
Operating margin improved to negative 119 percent from negative 179 percent |
In comparing the first six months of 2015 to the same period of 2014:
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· |
Sales grew 53 percent to $28.0 million from $18.3 million |
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· |
Total pump shipments grew 47 percent to 5,818 pumps from 3,958 pumps |
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· |
Operating margin improved to negative 140 percent from negative 214 percent |
“Our strong sales momentum continued in the second quarter, which was highlighted by our successful launch of the t:flex Pump,” said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. “This launch marks our achievement of a strategic Company goal to leverage our infrastructure by offering multiple products that address different needs of the diabetes community.”
Gross margin was 31 percent for the quarter ended June 30, 2015 compared to 34 percent in the same period of 2014.
For the second quarter of 2015, operating expenses increased 8 percent to $23.5 million from $21.8 million for the same period of 2014.
Operating loss for the second quarter of 2015 was $18.7 million, compared to $18.3 million for the same period of 2014. This included non-cash, stock-based compensation of $3.3 million for the quarter ended June 30, 2015, compared to $3.5 million for the same period of 2014.
As of June 30, 2015, the Company had $99.7 million in cash, cash equivalents and short-term investments.
For the year ending December 31, 2015, the Company’s guidance is as follows:
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· |
Sales are estimated to be in the range of $70.0 million to $75.0 million, which includes $4.0 million to $6.0 million of t:flex Insulin Pump sales |
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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 |
Conference Call
The Company will hold a conference call and simultaneous webcast today at 5:30pm Eastern Time (2:30pm 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 "81630278".
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 and sells 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.
Exhibit 99.1
Follow Tandem Diabetes Care:
Twitter @tandemdiabetes, use #tslim, #tflex, #tconnect and $TNDM.
Facebook at www.facebook.com/TandemDiabetes
LinkedIn at www.linkedin.com/company/tandemdiabetes
Forward Looking Statements
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 offer multiple products to leverage its infrastructure and achieve operating efficiencies, and the Company’s ability to sustain sales momentum for during the remainder 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 and customers may delay purchasing decisions for the Company’s existing products until the t:slim G4 Insulin Pump is commercially available. 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.
# # #
Exhibit 99.1
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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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June 30, |
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December 31, |
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2015 |
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2014 |
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(Unaudited) |
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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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$ |
97,746 |
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$ |
67,282 |
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Restricted cash |
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2,000 |
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2,000 |
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Accounts receivable, net |
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7,473 |
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7,652 |
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Inventory, net |
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14,670 |
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11,913 |
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Other current assets |
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2,170 |
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1,904 |
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Total current assets |
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124,059 |
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90,751 |
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Property and equipment, net |
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14,325 |
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12,581 |
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Other long term assets |
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2,950 |
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3,132 |
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Total assets |
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$ |
141,334 |
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$ |
106,464 |
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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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$ |
14,590 |
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$ |
14,591 |
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Deferred revenue |
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1,038 |
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840 |
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Other current liabilities |
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2,857 |
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2,663 |
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Total current liabilities |
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18,485 |
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18,094 |
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Notes payable-long-term |
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29,479 |
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29,440 |
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Other long-term liabilities |
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5,618 |
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4,358 |
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Total liabilities |
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53,582 |
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51,892 |
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Total stockholders’ equity |
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87,752 |
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54,572 |
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Total liabilities and stockholders’ equity |
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$ |
141,334 |
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$ |
106,464 |
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Exhibit 99.1
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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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(unaudited) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2015 |
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2014 |
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2015 |
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2014 |
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Sales |
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$ |
15,706 |
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$ |
10,255 |
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$ |
28,014 |
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$ |
18,320 |
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Cost of sales |
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10,905 |
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6,806 |
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20,406 |
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14,005 |
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Gross profit |
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4,801 |
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3,449 |
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7,608 |
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4,315 |
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Operating expenses: |
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Selling, general and administrative |
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19,599 |
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18,068 |
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38,954 |
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36,109 |
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Research and development |
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3,873 |
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3,699 |
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7,735 |
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7,362 |
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Total operating expenses |
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23,472 |
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21,767 |
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46,689 |
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43,471 |
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Operating loss |
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(18,671 |
) |
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(18,318 |
) |
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(39,081 |
) |
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(39,156 |
) |
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Other income (expense), net: |
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Interest and other income |
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61 |
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31 |
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160 |
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49 |
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Interest and other expense |
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(923 |
) |
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(910 |
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(1,821 |
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(2,052 |
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Total other income (expense), net |
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(862 |
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(879 |
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(1,661 |
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(2,003 |
) |
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Net loss |
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$ |
(19,533 |
) |
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$ |
(19,197 |
) |
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$ |
(40,742 |
) |
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$ |
(41,159 |
) |
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Net loss per share, basic and diluted |
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$ |
(0.65 |
) |
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$ |
(0.83 |
) |
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$ |
(1.47 |
) |
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$ |
(1.79 |
) |
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Weighted average shares used to compute basic and diluted net loss per share |
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29,902 |
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23,098 |
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27,723 |
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23,017 |
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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
Exhibit 99.2
Media Contact:
Steve Sabicer
714-907-6264
ssabicer@thesabicergroup.com
Investor Contact:
Susan Morrison
858-366-6900 x7005
smorrison@tandemdiabetes.com
FOR IMMEDIATE RELEASE
Tandem Diabetes Care Announces Development Agreement with Dexcom
for Integration of Future Generation CGM Systems
San Diego, July 30, 2015 – Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, today announced that it has entered into non-exclusive Development Agreements with Dexcom, Inc. to allow the integration of future generation Tandem insulin pumps with the Dexcom G5 and G6 continuous glucose monitoring (“CGM”) systems.
“Integrating Tandem’s next generation pump platform with Dexcom’s future CGM systems is an important step in aligning our technologies to be used in automated insulin delivery applications,” said Kim Blickenstaff, President and Chief Executive Officer of Tandem Diabetes Care. “We are committed to continue advancing the clinical applications of Tandem’s technology and are pleased to expand our relationship with Dexcom in support of this effort.”
“Using CGM data to direct insulin delivery is fundamental to offering the diabetes community an artificial pancreas solution,” said Steve Pacelli, EVP, Strategy & Corporate Development at Dexcom. “Our efforts with Tandem began with the display of CGM data on their pump and we are pleased to take this next step in the integration of our future products to support automated insulin delivery.”
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.
Exhibit 99.2
About Dexcom, Inc.
Dexcom, Inc., headquartered in San Diego, California, develops and markets continuous glucose
monitoring systems for use by people with diabetes, as well as blood glucose monitoring systems used by healthcare providers in hospital critical care settings. For more information on the Dexcom CGM, visit www.dexcom.com.
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 development agreements to integrate Dexcom’s CGM systems with a future generation Tandem insulin pump, and for the integrated system’s potential use in automated insulin delivery applications. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including: risks associated with the development of new products generally, including possible delays in the Company’s product development programs; possible future actions of the FDA or any other regulatory body or governmental authority, including the potential that the FDA may not agree with our proposed pathway for regulatory approval; the potential that the Company’s agreements with Dexcom could be terminated; and other risks identified in the Company’s most recent Annual Report on Form 10-K, 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.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes, use #tslim, #tflex, #tconnect, #tsimulator and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/TandemDiabetes.
t:slim and Tandem Diabetes Care are registered trademarks, and t:flex is a trademark of Tandem Diabetes Care, Inc. Dexcom is a registered trademark of Dexcom, Inc.
# # #