e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-33462
INSULET CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware
(State or Other Jurisdiction of Incorporation or
Organization)
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04-3523891
(I.R.S. Employer Identification No.) |
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9 Oak Park Drive
Bedford, Massachusetts
(Address of Principal Executive Offices)
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01730
(Zip Code) |
Registrants Telephone Number, Including Area Code: (781) 457-5000
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of August 3, 2011, the registrant had 47,289,602 shares of common stock outstanding.
INSULET CORPORATION
TABLE OF CONTENTS
2
PART I FINANCIAL INFORMATION
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Item 1. |
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Consolidated Financial Statements |
INSULET CORPORATION
CONSOLIDATED BALANCE SHEETS
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As of |
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As of |
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June 30, |
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December 31, |
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2011 |
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2010 |
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(Unaudited) |
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(In thousands, except share data) |
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ASSETS |
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Current Assets |
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Cash and cash equivalents |
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$ |
106,746 |
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$ |
113,274 |
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Accounts receivable, net |
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20,361 |
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16,841 |
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Inventories |
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15,957 |
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11,430 |
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Prepaid expenses and other current assets |
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4,770 |
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912 |
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Total current assets |
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147,834 |
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142,457 |
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Property and equipment, net |
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16,125 |
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12,522 |
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Intangible assets, net |
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32,400 |
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Goodwill |
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26,727 |
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Other assets |
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3,104 |
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1,254 |
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Total assets |
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$ |
226,190 |
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$ |
156,233 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
9,369 |
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$ |
4,895 |
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Accrued expenses |
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12,276 |
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9,808 |
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Deferred revenue |
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3,725 |
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4,247 |
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Other current liabilities |
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1,241 |
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Total current liabilities |
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26,611 |
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18,950 |
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Long-term debt |
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104,177 |
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69,433 |
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Other long-term liabilities |
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1,303 |
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1,619 |
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Total liabilities |
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132,091 |
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90,002 |
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Stockholders Equity |
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Preferred stock, $.001 par value: |
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Authorized: 5,000,000 shares at June 30, 2011 and December 31, 2010.
Issued and outstanding: zero shares at June 30, 2011 and December 31,
2010, respectively |
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Common stock, $.001 par value: |
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Authorized: 100,000,000 shares at June 30, 2011 and December 31, 2010.
Issued and outstanding: 47,254,163 and 45,440,839 shares at June 30,
2011 and December 31, 2010, respectively |
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47 |
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45 |
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Additional paid-in capital |
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507,174 |
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450,039 |
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Accumulated deficit |
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(413,122 |
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(383,853 |
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Total stockholders equity |
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94,099 |
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66,231 |
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Total liabilities and stockholders equity |
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$ |
226,190 |
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$ |
156,233 |
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The accompanying notes are an integral part of these consolidated financial statements.
3
INSULET CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2011 |
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2010 |
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2011 |
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2010 |
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(Unaudited) |
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(In thousands, except share and per share data) |
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Revenue |
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$ |
32,211 |
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$ |
22,937 |
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$ |
60,469 |
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$ |
43,744 |
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Cost of revenue |
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17,673 |
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13,051 |
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32,398 |
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25,473 |
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Gross profit |
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14,538 |
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9,886 |
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28,071 |
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18,271 |
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Operating expenses: |
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Research and development |
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6,832 |
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4,583 |
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11,421 |
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8,430 |
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General and administrative |
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12,996 |
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6,190 |
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20,206 |
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13,149 |
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Sales and marketing |
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9,625 |
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9,013 |
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18,631 |
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17,322 |
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Total operating expenses |
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29,453 |
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19,786 |
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50,258 |
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38,901 |
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Operating loss |
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(14,915 |
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(9,900 |
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(22,187 |
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(20,630 |
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Interest income |
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39 |
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36 |
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76 |
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60 |
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Interest expense |
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(4,547 |
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(3,847 |
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(7,158 |
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(7,631 |
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Other expense, net |
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(4,508 |
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(3,811 |
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(7,082 |
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(7,571 |
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Net loss |
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$ |
(19,423 |
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$ |
(13,711 |
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$ |
(29,269 |
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$ |
(28,201 |
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Net loss per share basic and diluted |
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$ |
(0.42 |
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$ |
(0.36 |
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$ |
(0.64 |
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$ |
(0.74 |
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Weighted average number of shares used in
calculating basic and diluted net loss per share |
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46,377,843 |
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38,285,628 |
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45,995,069 |
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38,088,041 |
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The accompanying notes are an integral part of these consolidated financial statements.
4
INSULET CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
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Six Months Ended |
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June 30, |
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2011 |
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2010 |
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(Unaudited) |
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(In thousands) |
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Cash flows from operating activities |
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Net loss |
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$ |
(29,269 |
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$ |
(28,201 |
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Adjustments to reconcile net loss to net cash used in operating activities |
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Depreciation and amortization |
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2,847 |
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2,696 |
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Amortization of debt discount |
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2,849 |
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3,624 |
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Stock-based compensation expense |
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3,816 |
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2,685 |
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Provision for bad debts |
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806 |
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1,685 |
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Non cash interest expense |
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2,235 |
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440 |
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Impairment of assets |
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1,021 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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1,061 |
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(2,523 |
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Inventories |
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(2,191 |
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(145 |
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Deferred revenue |
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(522 |
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848 |
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Prepaid expenses and other current assets |
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(434 |
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(244 |
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Accounts payable, accrued expenses, and other liabilities |
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2,170 |
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3,098 |
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Other long term liabilities |
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(316 |
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(42 |
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Net cash used in operating activities |
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(16,948 |
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(15,058 |
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Cash flows from investing activities |
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Purchases of property and equipment |
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(5,560 |
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(1,986 |
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Acquisition of Neighborhood Diabetes |
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(37,855 |
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Net cash used in investing activities |
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(43,415 |
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(1,986 |
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Cash flows from financing activities |
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Proceeds from issuance of long-term debt, net of issuance costs |
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138,937 |
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Payments to retire long-term debt |
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(88,195 |
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Payment of transaction fees related to credit facility amendment |
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(468 |
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Proceeds from issuance of common stock, net of offering expenses |
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3,093 |
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7,587 |
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Net cash provided by financing activities |
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53,835 |
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7,119 |
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Net decrease in cash and cash equivalents |
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(6,528 |
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(9,925 |
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Cash and cash equivalents, beginning of period |
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113,274 |
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127,996 |
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Cash and cash equivalents, end of period |
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$ |
106,746 |
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$ |
118,071 |
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Supplemental disclosure of cash flow information |
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Cash paid for interest |
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$ |
2,284 |
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$ |
3,662 |
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Non-cash investing and financing activities |
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Issuance of common stock for the acquisition of Neighborhood Diabetes |
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$ |
24,432 |
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$ |
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The accompanying notes are an integral part of these consolidated financial statements.
5
INSULET CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of the Business
Insulet Corporation (the Company) has been principally engaged in the development,
manufacture and marketing of an insulin infusion system for people with insulin-dependent diabetes.
The Company was incorporated in Delaware in 2000 and has its corporate headquarters in Bedford,
Massachusetts. Since inception, the Company has devoted substantially all of its efforts to
designing, developing, manufacturing and marketing the OmniPod Insulin Management System
(OmniPod), which consists of the OmniPod disposable insulin infusion device
and the handheld, wireless Personal Diabetes Manager (PDM). The Company commercially launched the
OmniPod Insulin Management System in August 2005 after receiving FDA 510(k) approval in January
2005. The first commercial product was shipped in October 2005.
In January 2010, the Company entered into a five year distribution agreement with Ypsomed
Distribution AG, or Ypsomed, to become the exclusive distributor of the OmniPod System in eleven
countries. Through the Companys partnership with Ypsomed, the OmniPod System is now available in
seven markets, namely Germany, the United Kingdom, France, the Netherlands, Sweden, Norway, and
Switzerland. The Company expects that Ypsomed will begin distribution of the OmniPod System,
subject to approved reimbursement, in the other markets under the agreement in 2011 or 2012. In
February 2011, the Company entered into a distribution agreement with GlaxoSmithKline Inc., or GSK,
to become the exclusive distributor of the OmniPod System in Canada. The Company shipped OmniPods
to GSK during the second quarter and expects that GSK will begin distributing the OmniPod System,
subject to approved reimbursement, in the coming months.
On June 1, 2011, the
Company completed the acquisition of Neighborhood Holdings, Inc. and its wholly-owned subsidiaries (collectively Neighborhood Diabetes), a leading durable medical equipment
distributor, specializing in direct to consumer sales of diabetes supplies. Neighborhood Diabetes
is based in Woburn, Massachusetts with additional facilities in Brooklyn, New York and Orlando,
Florida. Neighborhood Diabetes serves more than 60,000 customers with Type 1 and Type 2 diabetes
primarily in the northeast and southeast regions of the United States. Neighborhood Diabetes supplies
these customers with blood glucose testing supplies, insulin pumps, pump supplies,
pharmaceuticals, as well as other products for the treatment and management of diabetes. See Footnote 3 for further description of the acquisition.
2. Summary of Significant Accounting Policies
Basis of Presentation
The unaudited consolidated financial statements in this Quarterly Report on Form 10-Q have
been prepared in accordance with generally accepted accounting principles (GAAP) for interim financial information and with the instructions
to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these unaudited consolidated financial
statements do not include all of the information and footnotes required by GAAP for complete
financial statements. In the opinion of management, all adjustments, consisting of normal recurring
adjustments, considered necessary for a fair presentation have been included. Operating results for
the three and six month periods ended June 30, 2011, are not necessarily indicative of the results
that may be expected for the full year ending December 31, 2011, or for any other subsequent
interim period.
The unaudited consolidated financial statements in this Quarterly Report on Form 10-Q should
be read in conjunction with the Companys consolidated financial statements and notes thereto
contained in the Companys Annual Report on Form 10-K for the year ended December 31, 2010.
Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most significant estimates used in
these financial statements include the valuation of inventories, accounts receivable and equity
instruments, the lives of property and equipment and intangible assets, as well as warranty
reserves and allowance for doubtful accounts calculations. Actual results may differ from those
estimates.
Principles of Consolidation
The unaudited consolidated financial statements in this Quarterly Report on Form 10-Q include
the accounts of the Company and its wholly-owned subsidiaries. All material intercompany balances
and transactions have been eliminated in consolidation.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable consist of amounts due from third-party payors,
patients, third-party
distributors, and government agencies. The allowance for doubtful accounts is recorded in the
period in which revenue is recorded or at the time potential collection risk is identified. The
Company estimates its allowance based on historical experience, assessment of specific risk,
discussions with individual customers and various assumptions and estimates that are believed to be
reasonable under the circumstances.
6
Inventories
Inventories are held at the lower of cost or market, determined under the first-in, first-out
(FIFO) method. Inventory has been recorded at cost as of June 30, 2011 and December 31, 2010.
Work in process is calculated based upon a build up in the stage of completion using estimated
labor inputs for each stage in production. The Company periodically reviews inventories for
potential impairment based on quantities on hand and expectations of future use.
Property and Equipment
Property and equipment is stated at cost and depreciated using the straight-line method over
the estimated useful lives of the respective assets. Leasehold improvements are amortized over
their useful life or the life of the lease, whichever is shorter. Assets capitalized under capital
leases are amortized in accordance with the respective class of owned assets and the amortization
is included with depreciation expense. Maintenance and repair costs are expensed as incurred.
Intangibles and Other Long-Lived Assets
The Companys finite-lived intangible assets are stated at cost less accumulated amortization.
The Company assesses its intangible and other long lived assets for impairment
whenever events or changes in circumstances suggest that the carrying value of
an asset may not be recoverable. At June 30, 2011, intangible assets related to the acquisition of
Neighborhood Diabetes consisted of $29.6 million of customer relationships and $2.8 million of
tradenames. The Company recognizes an impairment loss for intangibles and other finite-lived
assets if the carrying amount of a long-lived asset is not recoverable based on its
undiscounted future cash flows. Any such impairment loss is measured as the difference between the
carrying amount and the fair value of the asset. The estimation of useful lives and expected cash
flows requires the Company to make significant judgments regarding future periods that are subject
to some factors outside its control. Changes in these estimates can result in significant revisions
to the carrying value of these assets and may result in material charges to the results of
operations. The estimated life of the acquired tradename asset is 15 years. The estimated life of
the acquired customer relationships asset is 10 years. Intangible assets with determinable
estimated lives are amortized over these lives.
Goodwill
Goodwill represents the excess of the cost of the acquired Neighborhood Diabetes businesses
over the fair value of identifiable net assets acquired. The Company will perform an
assessment of its goodwill for impairment on at least an annual basis or whenever events or changes
in circumstances indicate there might be impairment.
Goodwill is evaluated at the reporting unit level. To test for impairment, the Company
compares the carrying value of the reporting unit to its fair value. If the reporting units
carrying value exceeds its fair value, the Company would record an impairment loss to the extent
that the carrying value of goodwill exceeds its implied fair value.
Warranty
The Company provides a four year warranty on its PDMs and may replace any OmniPods that do not
function in accordance with product specifications. The Company estimates its warranty reserves at
the time the product is shipped based on historical experience and the estimated cost to service
the claims. Cost to service the claims reflects the current product cost, which has been decreasing
over time. As these estimates are based on historical experience, and the Company continues to
introduce new versions of existing products, the Company also considers the anticipated performance
of the product over its warranty period in estimating warranty reserves.
Revenue Recognition
The Company generates nearly all of its revenue from sales of its OmniPod Insulin Management
System and other diabetes related products including blood glucose testing supplies, insulin pumps,
pump supplies and pharmaceuticals to customers and third-party distributors who resell the product
to patients with diabetes.
Revenue recognition requires that persuasive evidence of a sales arrangement exists, delivery
of goods occurs through transfer of title and risk and rewards of ownership, the selling price is
fixed or determinable and collectability is reasonably assured. With respect to these criteria:
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The evidence of an arrangement generally consists of a
physician order form, a patient information form, and if
applicable, third-party insurance approval for sales
directly to patients or a purchase order for sales to a
third-party distributor. |
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Transfer of title and risk and rewards of ownership are
passed to the patient or third-party distributor upon
shipment of the products. |
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The selling prices for all sales are fixed and agreed with
the patient or third-party distributor, and, if applicable,
the patients third-party insurance provider(s), prior to
shipment and are based on established list prices or, in
the case of certain third-party insurers, contractually
agreed upon prices. Provisions for discounts and rebates to
customers are established as a reduction to revenue in the
same period the related sales are recorded. |
The Company assesses whether different elements qualify for separate accounting. The Company
recognizes revenue once all elements have been delivered.
The Company offers a 45-day right of return for its OmniPod Insulin Management System Starter
Kits sales, and defers revenue to reflect estimated sales returns in the same period that the
related product sales are recorded. Returns are estimated through a comparison of the
7
Companys
historical return data to their related sales. Historical rates of return are adjusted for known or
expected changes in the marketplace when appropriate. When doubt exists about reasonable
assuredness of collectability from specific customers, the Company defers revenue from sales of
products to those customers until payment is received.
In March 2008, the Company received a cash payment from Abbott Diabetes Care, Inc. (Abbott)
for an agreement fee in connection with execution of the first amendment to the development and
license agreement between the Company and Abbott. The Company recognizes revenue on the agreement
fee from Abbott over the initial five year term of the agreement, and the non-current portion of
the agreement fee is included in other long-term liabilities. In addition, Abbott agreed to pay an
amount to the Company for services performed in connection with each sale of a PDM that includes an
Abbott Discrete Blood Glucose Monitor to customers in certain territories. The Company recognizes
revenue related to this portion of the Abbott agreement at the time it meets the criteria for
revenue recognition, typically at the time the revenue is recognized on the sale of the PDM to the
patient.
The Company had deferred revenue of $3.7 million and $4.8 million as of June 30, 2011 and
December 31, 2010, respectively. The deferred revenue recorded as of June 30, 2011 was comprised of
product-related revenue as well as the non-amortized agreement fee related to the Abbott agreement.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk primarily consist of cash, cash
equivalents and accounts receivable. Although revenue is recognized from shipments directly to
patients or third-party distributors, the majority of shipments are billed to third-party insurance
payors. There were no third-party payors that accounted for more than 10% of gross accounts
receivable as of June 30, 2011 or December 31, 2010.
Segment Reporting
Operating segments are defined as components of an enterprise about which separate financial
information is available that is evaluated on a regular basis by the chief operating
decision-maker, or decision-making group, in deciding how to allocate resources to an individual
segment and in assessing performance of the segment. In light of the Companys current product
offering, and other considerations, management has determined that the primary form of internal
reporting is aligned with the offering of diabetes-related products and supplies. Therefore, the
Company believes that it operates in one segment.
Income Taxes
FASB Accounting Standard Codification, or ASC 740-10, Income Taxes, clarifies the accounting
for uncertainty in income taxes recognized in an entitys financial statements. FASB ASC 740-10
prescribes a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return. In
addition, FASB ASC 740-10 provides guidance on derecogniton, classification, interest and
penalties, accounting in interim periods, and disclosure and transition.
The Company has accumulated significant losses since its inception in 2000. Since the net
operating losses may potentially be utilized in future years to reduce taxable income (subject to
any applicable limitations), all of the Companys tax years remain open to examination by the major
taxing jurisdictions to which the Company is subject.
The Company recognizes estimated interest and penalties for uncertain tax positions in income
tax expense. As of June 30, 2011, interest and penalties were immaterial to the consolidated
financial statements.
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of FASB ASC 718-10,
Compensation Stock Compensation. FASB ASC 718-10 requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the income statement based on their
fair values.
The Company uses the Black-Scholes option pricing model to determine the weighted average fair
value of options granted. The Company recognizes the compensation expense of share-based awards on
a straight-line basis over the vesting period of the award.
The determination of the fair value of share-based payment awards utilizing the Black-Scholes
model is affected by the stock price and a number of assumptions, including expected volatility,
expected life, risk-free interest rate and expected dividends. The expected life of the awards is
estimated based on the SEC Shortcut Approach as defined in SAB 107, which is the midpoint between
the vesting date and the end of the contractual term. The risk-free interest rate assumption is
based on observed interest rates appropriate for the terms of the awards. The dividend yield
assumption is based on company history and expectation of paying no dividends. Forfeitures are
estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Stock-based compensation expense recognized in the
financial statements is based on awards that are ultimately expected to vest. The Company evaluates
the assumptions used to value the awards on a quarterly basis and if factors change and different
assumptions are utilized, stock-based compensation expense may differ significantly from what has
been recorded in the past. If there are any modifications or cancellations of the underlying
unvested securities, the Company may be required to accelerate, increase or cancel any remaining
unearned stock-based compensation expense.
See Footnote 12 for a summary of the stock option activity under our stock-based employee
compensation plan.
8
3. Acquisition of Neighborhood Diabetes
On June 1, 2011,
the Company acquired all of the outstanding shares
of privately-held Neighborhood Diabetes, a durable medical
equipment distributor specializing in direct to consumer sales of diabetes supplies, including
pharmaceuticals, and support services. Neighborhood Diabetes serves more than 60,000 customers with
Type 1 and Type 2 diabetes primarily in the northeast and southeast regions of the United States with
blood glucose testing supplies, insulin pumps, pump supplies, pharmaceuticals, as well as other products for the
management and treatment of diabetes.
Neighborhood Diabetes is based in Woburn, Massachusetts, with additional offices in
Brooklyn, New York and Orlando, Florida. At the time of the acquisition, Neighborhood Diabetes
employed approximately 200 people across its three locations. The acquisition of Neighborhood
Diabetes provides the Company with full suite diabetes management product offerings, accelerates
the Companys sales force expansion, strengthens the Companys back office support capabilities, expands the
Companys access to insulin dependent patients, and provides pharmacy adjudication capabilities to
drive incremental sales higher. The aggregate purchase price of
approximately $62.4 million consisted of approximately $37.9 million in cash paid at closing,
1,197,631 shares of the Companys common stock valued at approximately $24.4 million, or $20.40 per
share based on the closing price of the Companys common stock on the acquisition date, and
contingent consideration with a fair value of approximately $0.1 million. Of the $37.9 million of
cash, $6.6 million is being held in an escrow account to reimburse the Company and its affiliates
for certain claims for which they are entitled to be indemnified pursuant to the terms of the
agreement and plan of merger with Neighborhood Diabetes.
The Company has accounted for the acquisition of Neighborhood Diabetes as a business
combination. Under business combination accounting, the assets and liabilities of Neighborhood
Diabetes were recorded as of the acquisition date, at their respective fair values, and
consolidated with the Company. The excess of the purchase price over the fair value of net assets
acquired was recorded as goodwill. The operating results of Neighborhood Diabetes have been
included in the consolidated financial statements since June 1, 2011, the date
the acquisition was completed. For the three and six months ended June 30, 2011, the Company included approximately
$2.7 million of revenue from the sale of testing and other supplies sold by Neighborhood Diabetes.
If the acquisition had occurred as of January 1, 2010, consolidated revenue would have been approximately
$85.4 million and $71.9 million for the six months ended June 30, 2011 and 2010, respectively. The purchase price allocation, including an independent appraisal for intangible assets,
has been prepared based on the information that was available to management at the time the
consolidated financial statements were prepared, and revisions to the preliminary purchase price
allocation will be made as additional information becomes available. The preliminary purchase price
has been allocated as follows (in thousands):
|
|
|
|
|
Calculation of allocable purchase price: |
|
|
|
|
Cash |
|
$ |
37,855 |
|
Common stock |
|
|
24,432 |
|
Contingent consideration obligations |
|
|
61 |
|
|
|
|
|
Total allocable purchase price |
|
$ |
62,348 |
|
|
|
|
|
|
|
|
|
|
Preliminary allocation of purchase price: |
|
|
|
|
Accounts receivable |
|
$ |
5,387 |
|
Inventories |
|
|
2,336 |
|
Prepaid expenses and other current assets |
|
|
242 |
|
Property and equipment |
|
|
391 |
|
Customer relationships |
|
|
30,100 |
|
Tradenames |
|
|
2,800 |
|
Goodwill |
|
|
26,727 |
|
Other assets |
|
|
233 |
|
Accounts payable |
|
|
4,109 |
|
Accrued expenses |
|
|
1,700 |
|
Other long-term liabilities |
|
|
59 |
|
|
|
|
|
|
|
$ |
62,348 |
|
|
|
|
|
The Company incurred transaction costs of $3.2 million, which
consisted primarily of banking, legal,
accounting and other administrative fees. These costs have been recorded as general and
administrative expense in the three and six months ended June 30, 2011.
9
4. Other Intangible Assets
Other intangible assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2011 |
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
Cost |
|
|
Amortization |
|
|
Net Book Value |
|
Customer relationships |
|
$ |
30,100 |
|
|
$ |
(484 |
) |
|
$ |
29,616 |
|
Tradename |
|
|
2,800 |
|
|
|
(16 |
) |
|
|
2,784 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
32,900 |
|
|
$ |
(500 |
) |
|
$ |
32,400 |
|
|
|
|
|
|
|
|
|
|
|
The Company recorded $32.9 million of other intangible assets in the six months ended June 30,
2011 as a result of the acquisition of Neighborhood Diabetes (see Footnote 3 for further
description). The Company determined that the estimated useful life of the customer relationships
asset is 10 years and that the estimated useful life of the tradename is 15 years and is amortizing
the assets over these estimated lives accordingly. The amortization of other intangible assets was
approximately $0.5 million for the three and six months ended June 30, 2011. No amortization
expense was recorded in any period prior to the three months ended June 30, 2011. Amortization
expense for the year ending December 31, 2011 is expected to be approximately $3.9 million.
5. Long-Term Debt
At June 30, 2011 and December 31, 2010, the Company had outstanding long-term debt and related
deferred financing costs on its balance sheet as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
Liabilities: |
|
|
|
|
|
|
|
|
Principal amount of the 5.375%
Convertible Notes |
|
$ |
15,000 |
|
|
$ |
85,000 |
|
Principal amount of the 3.75%
Convertible Notes |
|
|
143,750 |
|
|
|
|
|
Unamortized discount of liability
component |
|
|
(54,573 |
) |
|
|
(15,567 |
) |
|
|
|
|
|
|
|
|
|
$ |
104,177 |
|
|
$ |
69,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred financing costs |
|
$ |
2,861 |
|
|
$ |
1,173 |
|
Equity net carrying value |
|
$ |
51,727 |
|
|
$ |
25,812 |
|
5.375% Convertible Notes
|
|
|
In June 2008, the Company sold $85.0 million principal amount of 5.375%
Convertible Senior Notes due June 15, 2013 (the 5.375% Notes) in a private placement to qualified
institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The
interest rate on the notes is 5.375% per annum on the principal amount from June 16, 2008, payable
semi-annually in arrears in cash on December 15 and June 15 of each year. The 5.375% Notes are
convertible into the Companys common stock at an initial conversion rate of 46.8467 shares of
common stock per $1,000 principal amount of the 5.375% Notes, which is equivalent to a conversion
price of approximately $21.35 per share, representing a conversion premium of 34% to the last
reported sale price of the Companys common stock on the NASDAQ Global Market on June 10, 2008,
subject to adjustment under certain circumstances, at any time beginning on March 15, 2013 or under
certain other circumstances and prior to the close of business on the business day immediately
preceding the final maturity date of the notes. The 5.375% Notes will be convertible for cash up to
their principal amount and shares of the Companys common stock for the remainder of the conversion
value in excess of the principal amount. |
The Company does not have the right to redeem any of the 5.375% Notes prior to maturity. If a
fundamental change, as defined in the Indenture for the 5.375% Notes, occurs at any time prior to
maturity, holders of the 5.375% Notes may require the Company to repurchase their notes in whole or
in part for cash equal to 100% of the principal amount of the notes to be repurchased, plus accrued
and unpaid interest, including any additional interest, to, but excluding, the date of repurchase.
If a holder elects to convert its 5.375% Notes upon the occurrence of a make-whole fundamental
change, as defined in the Indenture for the 5.375% Notes, the holder may be entitled to receive an
additional number of shares of common stock on the conversion date. These additional shares are
intended to compensate the holders for the loss of the time value of the conversion option and are
set forth in the Indenture to the 5.375% Notes. In no event will the number of shares issuable upon
conversion of a note exceed 62.7746 per $1,000 principal amount (subject to adjustment as described
in the Indenture for the 5.375% Notes).
The Company recorded a debt discount of $26.9 million to equity to reflect the value of its
nonconvertible debt borrowing rate of 14.5% per annum. This debt discount is being amortized as
interest expense over the five year term of the 5.375% Notes.
10
The Company incurred deferred financing costs related to this offering of approximately $3.5
million, of which $1.1 million has been reclassified as an offset to the value of the amount
allocated to equity. The remainder is recorded as other assets in the consolidated balance sheet
and is being amortized as a component of interest expense over the five year term of the 5.375%
Notes. Interest expense related to the Notes was included in interest expense on the consolidated
statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
Contractual coupon interest |
|
$ |
1,142 |
|
|
$ |
1,142 |
|
|
$ |
2,284 |
|
|
$ |
2,284 |
|
Amortization of debt issuance costs |
|
|
1,425 |
|
|
|
1,238 |
|
|
|
2,849 |
|
|
|
2,476 |
|
Accretion of debt discount |
|
|
121 |
|
|
|
121 |
|
|
|
243 |
|
|
|
243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,688 |
|
|
$ |
2,501 |
|
|
$ |
5,376 |
|
|
$ |
5,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On June 29, 2011, in connection with the issuance of $143.75 million of 3.75% Convertible
Notes due June 2016 (the 3.75% Notes), the Company repurchased
$70 million in principal amount of the 5.375%
Notes for $85.1 million, a 21.5% premium on the principal amount. The investors that held the $70
million of repurchased 5.375% Notes also purchased $59.5 million
in principal amount of the 3.75% Notes. The
transaction was treated as a modification of a portion of the 5.375% Notes held by those investors. See
3.75% Convertible Notes for additional detail on the modification.
As
of June 30, 2011, the 5.375% Notes have a remaining term of two years.
Facility Agreement and Common Stock Warrants
In March 2009,
the Company entered into a facility agreement with certain
institutional accredited investors (the Facility Agreement), pursuant to which the investors agreed to loan the Company up
to $60 million, subject to the terms and conditions set forth in the Facility Agreement. Total
financing costs, including the transaction fee, were $3.0 million and were amortized as interest
expense over the 42 months of the Facility Agreement. In September 2009, the Company entered into
an amendment to the Facility Agreement whereby the Company repaid the $27.5 million originally
drawn and promptly drew down the remaining $32.5 million available under the Facility Agreement.
The annual interest rate was 8.5%, payable quarterly in arrears. In connection with the amendment
to the Facility Agreement, the Company entered into a securities purchase agreement with the
lenders whereby the Company sold 2,855,659 shares of its common stock to the lenders at $9.63 per
share, a $1.9 million discount based on the closing price of the Companys common stock of $10.28
on that date. The Company recorded the $1.9 million as a debt discount which was amortized as
interest expense over the remaining term of the loan. The Company received aggregate proceeds of
$27.5 million in connection with the sale of its shares. All principal amounts outstanding under
the Facility Agreement were payable in September 2012.
In connection with the execution of the Facility Agreement, the Company issued to the lenders
fully exercisable warrants to purchase an aggregate of 3.75 million shares of common stock of the
Company at an exercise price of $3.13 per share. The warrants qualified for permanent treatment as
equity, and their relative fair value of $6.1 million on the issuance date was recorded as
additional paid-in capital and debt discount. The debt discount was amortized as non-cash interest
expense over the term of the loan. As of June 30, 2011, all warrants to acquire 3.75 million
shares of the Companys common stock issued in connection with the Facility Agreement were
exercised.
In December 2010, the Company paid $33.3 million to the lenders, of which $32.5 million
related to principal and $0.8 million related to interest and prepayment fees, to extinguish this
debt. The Company recorded a non-cash interest charge of $7.0 million in the fourth quarter of 2010
related to the write-off of the remaining debt discounts and financing costs included in other
assets which were being amortized to interest expense over the term of the debt. At June 30, 2011
and December 31, 2010, there were no amounts related to the Facility Agreement included in
long-term debt on the Companys balance sheet.
Interest expense related to the Facility Agreement was included in interest expense on the
consolidated statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2010 |
|
Contractual coupon interest |
|
$ |
696 |
|
|
$ |
1,377 |
|
Amortization of debt issuance costs |
|
|
579 |
|
|
|
1,130 |
|
Accretion of debt discount |
|
|
101 |
|
|
|
197 |
|
|
|
|
|
|
|
|
|
|
$ |
1,376 |
|
|
$ |
2,704 |
|
|
|
|
|
|
|
|
3.75% Convertible Notes
In June 2011, the Company sold $143.8 million principal amount of 3.75% Convertible Notes due
June 15, 2016 (the 3.75% Notes). The interest rate on the notes is 3.75% per annum, payable
semi-annually in arrears in cash on December 15 and June 15 of each year. The 3.75% Notes are
convertible into the Companys common stock at an initial conversion rate of 38.1749 shares of
common stock per $1,000
11
principal amount of the 3.75% Notes, which is equivalent to a conversion
price of approximately $26.20 per share, subject to adjustment under certain circumstances. The
3.75% Notes are convertible prior to March 15, 2016 only upon the occurrence of certain circumstances.
On and after March 15, 2016 and prior to the close of business on the second scheduled trading day
immediately preceding the final maturity date of the 3.75% Notes, the notes may be converted
without regard to the occurrence of any such circumstances. The 3.75% Notes and any unpaid interest will be convertible at
the Companys option for cash, shares of the Companys common stock or a combination of cash and
shares of the Companys common stock for the principal amount.
The Company intends to settle the principal in cash.
The Company may not redeem the 3.75% Notes prior to June 20, 2014. From June 20, 2014 to June
20, 2015 the Company may redeem the 3.75% Notes, at its option, in whole or in part only if the
last reported sale price per share of the Companys common stock has been at least 130% of the
conversion price then in effect for at least 20 trading days during a period of 30 consecutive
trading days. On and after June 25, 2015, the Company may redeem the 3.75% Notes, at its option
(without regard to such sale price condition), in whole or in part. If a fundamental change, as
defined in the Indenture for the 3.75% Notes, occurs at any time prior to maturity, holders of the
3.75% Notes may require the Company to repurchase their notes in whole or in part for cash equal to
100% of the principal amount of the 3.75% Notes to be repurchased, plus accrued and unpaid interest. If a
holder elects to convert its 3.75% Notes upon the occurrence of a make-whole fundamental change, as
defined in the Indenture for the 3.75% Notes, the holder may be entitled to receive an additional
number of shares of common stock on the conversion date. These additional shares are intended to
compensate the holders for the loss of the time value of the conversion option and are set forth in
the Indenture to the 3.75% Notes. In no event will the number of shares issuable upon conversion of
a note exceed 50.5816 per $1,000 principal amount (subject to adjustment as described in the
Indenture for the 3.75% Notes). The 3.75% Notes are unsecured and are equal in right of payment to
the 5.375% notes.
The
Company evaluated certain features of the 3.75% Notes to determine whether these features are
derivatives which should be bifurcated and accounted for at fair value. The Company identified
certain features related to a portion of the 3.75% Notes, including the holders ability to require
the Company to repurchase their notes and the higher interest payments required in an event of
default, which are considered embedded derivatives and should be accounted for at fair value. The
Company assesses the value of each of these embedded derivatives at each balance sheet date. At
June 30, 2011, the Company separately accounted for and determined that these derivatives have de
minimus value.
In
connection with the issuance of the 3.75% Notes, the Company
repurchased $70 million in principal amount of the 5.375% Notes for $85.1 million, a 21.5% premium on the principal amount. The
investors that held the $70 million of repurchased 5.375% Notes
purchased $59.5 million in principal amount
of the 3.75% Notes. This transaction was treated as a modification of
a portion of the 5.375% Notes.
The Company accounted for this modification of existing debt separately from the issuance of the
remainder of the 3.75% Notes.
Prior to the transaction, the $70 million principal of repurchased 5.375% Notes had a debt
discount of $10.5 million. This amount remained in debt discount related to the modified $59.5
million 3.75% Notes. The Company recorded additional debt discount of $15.1 million related to the
premium payment in connection with the repurchase and $0.2 million related to the increase in the
value of the conversion feature. The offset to the debt discount related to the value of the
conversion feature was recorded as additional paid-in capital. The
total debt discount of $25.8
million related to the modified debt is being amortized at the
effective rate of 16.5% as interest expense
over the five year remaining term of the modified debt. The Company paid transaction fees of
approximately $2.0 million related to the modification which were recorded as interest expense in
the three and six months ended June 30, 2011. Interest expense on the debt discount and the
deferred financing costs related to the modified portion of the 3.75% Notes was de minimus in the
three and six months ended June 30, 2011 and 2010.
Of the $143.8 million of 3.75% Notes issued in June 2011, $84.3 million was considered to be
an issuance of new debt. The Company recorded a debt discount of $26.6 million related to the $84.3
million new debt. The Company included $57.7 million on its balance sheet related to these notes at
June 30, 2011. The debt discount was recorded as additional paid-in capital to reflect the value
of its nonconvertible debt based on a borrowing rate of 12.4% per annum. This debt discount is being amortized
as interest expense over the five year term of the 3.75% Notes. The Company incurred deferred
financing costs related to this offering of approximately $2.8 million, of which $0.9 million has
been reclassified as an offset to the value of the amount allocated to equity. The remainder is
recorded as other assets in the consolidated balance sheet and is being amortized as a component of
interest expense over the five year term of the 3.75% Notes. Interest expense on the debt discount and the
deferred financing costs related to the new portion of the
3.75% Notes was de minimus in the three and six months ended June 30, 2011 and 2010.
As
of June 30, 2011, the 3.75% Notes have a remaining term of five years.
6. Restructuring Expenses and Impairments of Assets
During the three months ended June 30, 2010, the Company performed an evaluation of its
Construction in Process related to its manufacturing equipment for its next generation OmniPod. As
a result of this evaluation as well as the additional information obtained in connection with the
completion of the Companys pilot manufacturing line for its next generation OmniPod, the Company
determined that approximately $1.0 million of previously capitalized costs relating to the project
no longer meet the capitalization criteria. Accordingly, the Company expensed these costs as
research and development expense in the three months ended June 30, 2010. There were no
restructuring or impairment charges recorded in the three and six months ended June 30, 2011.
7. Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of
common shares outstanding for the period, excluding unvested restricted common shares. Diluted net
loss per share is computed using the weighted average number of common shares outstanding and, when
dilutive, potential common share equivalents from options, restricted stock units, and warrants
(using the treasury-stock
12
method), and potential common shares from convertible securities (using
the if-converted method). Because the Company reported a net loss for the three and six months
ended June 30, 2011 and 2010, all potential common shares have been excluded from the computation
of the diluted net loss per share for all periods presented, as the effect would have been
anti-dilutive. Such potentially dilutive common share equivalents consist of the following:
|
|
|
|
|
|
|
|
|
|
|
Three and Six Months Ended |
|
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
5.375% Convertible notes |
|
|
702,701 |
|
|
|
3,981,969 |
|
3.75% Convertible notes |
|
|
5,487,642 |
|
|
|
|
|
Unvested restricted stock units |
|
|
635,215 |
|
|
|
396,331 |
|
Outstanding options |
|
|
2,938,921 |
|
|
|
3,524,285 |
|
Outstanding warrants |
|
|
62,752 |
|
|
|
1,687,752 |
|
|
|
|
|
|
|
|
Total |
|
|
9,827,231 |
|
|
|
9,590,337 |
|
|
|
|
|
|
|
|
8. Accounts Receivable
The components of accounts receivable are as follows:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Trade receivables |
|
$ |
25,531 |
|
|
$ |
22,273 |
|
Allowance for doubtful accounts |
|
|
(5,170 |
) |
|
|
(5,432 |
) |
|
|
|
|
|
|
|
|
|
$ |
20,361 |
|
|
$ |
16,841 |
|
|
|
|
|
|
|
|
9. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Raw materials |
|
$ |
3,618 |
|
|
$ |
1,892 |
|
Work-in-process |
|
|
874 |
|
|
|
2,378 |
|
Finished goods |
|
|
11,465 |
|
|
|
7,160 |
|
|
|
|
|
|
|
|
|
|
$ |
15,957 |
|
|
$ |
11,430 |
|
|
|
|
|
|
|
|
10. Product Warranty Costs
The Company provides a four year warranty on its PDMs and may replace any OmniPods that do not
function in accordance with product specifications. Warranty expense is estimated and recorded in
the period that shipment occurs. The expense is based on the Companys historical experience and
the estimated cost to service the claims. A reconciliation of the changes in the Companys product
warranty liability is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Balance at the beginning of period |
|
$ |
1,836 |
|
|
$ |
1,748 |
|
|
$ |
1,873 |
|
|
$ |
1,820 |
|
Warranty expense |
|
|
655 |
|
|
|
649 |
|
|
|
1,379 |
|
|
|
969 |
|
Warranty claims settled |
|
|
(696 |
) |
|
|
(457 |
) |
|
|
(1,457 |
) |
|
|
(849 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
|
$ |
1,795 |
|
|
$ |
1,940 |
|
|
$ |
1,795 |
|
|
$ |
1,940 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Composition of balance: |
|
|
|
|
|
|
|
|
Short-term |
|
$ |
866 |
|
|
$ |
880 |
|
Long-term |
|
|
929 |
|
|
|
993 |
|
|
|
|
|
|
|
|
Total warranty balance |
|
$ |
1,795 |
|
|
$ |
1,873 |
|
|
|
|
|
|
|
|
11. Commitments and Contingencies
Operating Leases
The Company leases its facilities in Bedford and Billerica, Massachusetts. In addition, in
connection with its acquisition of Neighborhood Diabetes, the Company acquired leases of facilities
in Woburn, Massachusetts, Brooklyn, New York and Orlando, Florida. The Companys leases are
accounted for as operating leases. The leases generally provide for a base rent plus real estate
taxes and certain operating expenses related to the leases. The Company has extended the leases of
its facilities in Bedford and Billerica, Massachusetts. Following the extensions, these leases
expire in September 2014. The leases for Bedford contain a five year renewal option and escalating
payments over the life of the lease. The leases in Woburn, Brooklyn and Orlando expire in June
2013, April 2015 and September 2012, respectively.
The Companys operating lease agreements contain scheduled rent increases which are being
amortized over the terms of the agreement using the straight-line method and are included in other
liabilities in the accompanying consolidated balance sheet.
Legal Proceedings
In August 2010, Becton, Dickinson and Company, or BD, filed a lawsuit in the United States
District Court in the State of New Jersey against the Company alleging that the OmniPod System
infringes three of its patents. BD seeks a declaration that the Company has infringed its patents,
equitable relief, including an injunction that would enjoin the Company from infringing these
patents, and an unspecified award for monetary damages. The Company believes that the OmniPod
System does not infringe these patents. The Company expects that this litigation will not have a
material adverse impact on its financial position or results of operations. The Company believes it
has meritorious defenses to this lawsuit; however, litigation is inherently uncertain and there can
be no assurance as to the ultimate outcome or effect of this action.
Indemnifications
In the normal course of business, the Company enters into contracts and agreements that
contain a variety of representations and warranties and provide for general indemnifications. The
Companys exposure under these agreements is unknown because it involves claims that may be made
against the Company in the future, but have not yet been made. To date, the Company has not paid
any claims or been required to defend any action related to its indemnification obligations.
However, the Company may record charges in the future as a result of these indemnification
obligations.
In accordance with its bylaws, the Company has indemnification obligations to its officers and
directors for certain events or occurrences, subject to certain limits, while they are serving at
the Companys request in such capacity. There have been no claims to date and the Company has a
director and officer insurance policy that enables it to recover a portion of any amounts paid for
future claims.
12. Equity
In December 2010, in a public offering, the Company issued and sold 3,450,000 shares of its
common stock at a price of $13.27 per share. In connection with the offering, the Company received
total gross proceeds of $47.8 million, or approximately $45.4 million in net proceeds after
deducting underwriting discounts and offering expenses.
In June 2011, in connection with the acquisition of Neighborhood Diabetes, the Company issued
1,197,631 shares of its common stock at a price of $20.40 per share, as partial consideration for
the acquisition.
The Company grants share-based awards to employees in the form of options to purchase the
Companys common stock, the ability to purchase stock at a discounted price under the employee
stock purchase plan and restricted stock units. Stock-based compensation expense related to
share-based awards recognized in the three and six months ended June 30, 2011 was $1.8 million and
$3.8 million, respectively, and was calculated based on awards ultimately expected to vest.
Employee stock-based compensation expense recognized in the three and six months ended June 30,
2010 was $1.3 million and $2.7 million, respectively. At June 30, 2011, the amount of stock-based
compensation capitalized as part of inventory was not material. At June 30, 2011, the Company had
$19.9 million of total unrecognized compensation expense related to stock options and restricted
stock units.
14
Stock Options
The following summarizes the activity under the Companys stock option plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Intrinsic |
|
|
|
Options |
|
|
Price |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Balance, December 31, 2010 |
|
|
3,018,469 |
|
|
$ |
8.74 |
|
|
|
|
|
Granted |
|
|
536,500 |
|
|
|
17.52 |
|
|
|
|
|
Exercised |
|
|
(527,936 |
) |
|
|
7.36 |
|
|
$ |
6,387 |
(1) |
Canceled |
|
|
(88,112 |
) |
|
|
13.15 |
|
|
|
|
|
Balance, June 30, 2011 |
|
|
2,938,921 |
|
|
$ |
10.46 |
|
|
$ |
34,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested, June 30, 2011 |
|
|
1,621,898 |
|
|
$ |
8.56 |
|
|
$ |
22,141 |
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, June 30, 2011 (3) |
|
|
2,454,857 |
|
|
|
|
|
|
$ |
29,651 |
(2) |
|
|
|
(1) |
|
The aggregate intrinsic value was calculated based on the
positive difference between the fair market value of the
Companys common stock as of the date of exercise and the
exercise price of the underlying options. |
|
(2) |
|
The aggregate intrinsic value was calculated based on the
positive difference between the fair market value of the
Companys common stock as of June 30, 2011, and the exercise
price of the underlying options. |
|
(3) |
|
Represents the number of vested options as of June 30, 2011, plus
the number of unvested options expected to vest as of June 30,
2011, based on the unvested options outstanding as of June 30,
2011, adjusted for the estimated forfeiture rate of 16%. |
At June 30, 2011 there were 2,938,921 options outstanding with a weighted average exercise
price of $10.46 per share and a weighted average remaining contractual life of 7.0 years. At June
30, 2011 there were 1,621,898 options exercisable with a weighted average exercise price of $8.56
per share and a weighted average remaining contractual life of 5.7 years.
Employee stock-based compensation expense related to stock options recognized in the three and
six months ended June 30, 2011 was $1.0 million and $2.1 million, respectively, and was based on
awards ultimately expected to vest. Employee stock-based compensation
expense related to stock options recognized in the three and six months ended June 30, 2010 was
$1.1 million and $2.3 million, respectively. At June 30, 2011, the Company had $10.1 million of
total unrecognized compensation expense related to stock options that will be recognized over a
weighted average period of 1.3 years.
Employee Stock Purchase Plan
As of June 30, 2011 and 2010, no shares were contingently issued under the employee stock
purchase plan (ESPP). In the six months ended June 30, 2011 and 2010, the Company recorded no
significant stock-based compensation charges related to the ESPP.
Restricted Stock Units
In the six months ended June 30, 2011, the Company awarded 430,200 restricted stock units to
certain employees. The restricted stock units were granted under the Companys 2007 Stock Option
and Incentive Plan (the 2007 Plan) and vest annually over three to four years from the grant
date. The restricted stock units granted have a weighted average fair value of $17.75 per share
based on the closing price of the Companys common stock on the date of grant. The restricted stock
units granted during the six months ended June 30, 2011 were valued at approximately $7.6 million at
their grant date, and the Company is recognizing the compensation expense over the vesting period.
Approximately $0.8 million and $1.7 million of stock-based compensation expense related to the
vesting of restricted stock units was recognized in the three and six months ended June 30, 2011,
respectively. Approximately $0.3 million and $0.4 million of stock-based compensation expense
related to the vesting of restricted stock units was recognized in the three and six months ended
June 30, 2010, respectively. Approximately $9.8 million of the fair value of the restricted stock
units remained unrecognized as of June 30, 2011. Under the terms of the award, the Company will
issue shares of common stock on each of the vesting dates. During the six months ended June 30,
2011, 119,761 restricted stock units originally granted in 2010 vested. The following table
summarizes the status of the Companys restricted stock units:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
|
Shares |
|
|
Fair Value |
|
Balance, December 31, 2010 |
|
|
355,999 |
|
|
$ |
14.99 |
|
Granted |
|
|
430,200 |
|
|
|
17.75 |
|
Vested |
|
|
(119,317 |
) |
|
|
14.93 |
|
Forfeited |
|
|
(31,667 |
) |
|
|
15.87 |
|
|
|
|
|
|
|
|
Balance, June 30, 2011 |
|
|
635,215 |
|
|
$ |
16.82 |
|
|
|
|
|
|
|
|
15
Restricted Common Stock
During the year ended December 31, 2008, the Company awarded 4,000 shares of restricted common
stock to a non-employee. The shares of restricted common stock were granted under the 2007 Plan and
vested over two years. The shares of restricted common stock granted had a weighted average fair
value of $8.04 per share based on the closing price of the Companys common stock on the date of
grant. The remaining 444 unvested shares at December 31, 2010 vested during the six months ended
June 30, 2011. The Company recognized the total compensation expense of $32,000 over the two year
vesting period.
13. Income Taxes
Deferred income taxes reflect the net tax effects of temporary differences between the
carrying amount of assets and liabilities for financial reporting purposes and the amounts used for
income tax purposes. The Company provided a valuation allowance for the full amount of its net
deferred tax asset for all periods because realization of any future tax benefit cannot be
determined as more likely than not, as the Company does not expect income in the near-term.
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
You should read the following discussion of our financial condition and results of operations
in conjunction with our consolidated financial statements and the accompanying notes to those
financial statements included in this Quarterly Report on Form 10-Q. This
Quarterly Report on Form 10-Q contains forward-looking statements. These forward-looking statements
are based on our current expectations and beliefs concerning future developments and their
potential effects on us. There can be no assurance that future developments affecting us will be
those that we have anticipated. These forward-looking statements involve a number of risks,
uncertainties (some of which are beyond our control) or other assumptions that may cause actual
results or performance to be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include, but are not limited to: risks
associated with our dependence on the OmniPod System; our ability to increase customer orders and
manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform
legislation; our inability to raise additional funds in the future on acceptable terms or at all;
potential supply problems or price fluctuations with sole source or other third-party suppliers on
which we are dependent; international business risks; our inability to obtain adequate coverage or
reimbursement from third-party payors for the OmniPod System and potential adverse changes in
reimbursement rates or policies relating to the OmniPod; potential adverse effects resulting from
competition with competitors; technological innovations adversely affecting our business; potential
termination of our license to incorporate a blood glucose meter into the OmniPod System; our
ability to protect our intellectual property and other proprietary rights; conflicts with the
intellectual property of third parties, including claims that our current or future products
infringe the proprietary rights of others; adverse regulatory or legal actions relating to the
OmniPod System; failure to obtain timely regulatory approval for the sale of the next generation
OmniPod System; failure of our contract manufacturers or component suppliers to comply with FDAs
quality system regulations, the potential violation of federal or state laws prohibiting
kickbacks or protecting patient health information, or any challenges to or investigations into
our practices under these laws; product liability lawsuits that may be brought against us; reduced
retention rates; unfavorable results of clinical studies relating to the OmniPod System or the
products of our competitors; potential future publication of articles or announcement of positions
by physician associations or other organizations that are unfavorable to our products; the
expansion, or attempted expansion, into foreign markets; the concentration of substantially all of
our manufacturing capacity at a single location in China and substantially all of our OmniPod
System inventory at a single location in Massachusetts; our ability to attract and retain key
personnel; our ability to manage our growth; failure to integrate successfully the Neighborhood
Diabetes business; intense competition among distributors of diabetes supplies impairing
Neighborhood Diabetes business; loss by Neighborhood Diabetes of an opportunity to sell insulin
pumps supplied by our competitors; failure by Neighborhood Diabetes to retain key supplier and
payor partners; failure by Neighborhood Diabetes to retain supplier pricing discounts and achieve
satisfactory gross margins; failure by Neighborhood Diabetes to retain and manage successfully its
Medicare and Medicaid business; existence of unanticipated liabilities arising in connection with
the Neighborhood Diabetes business; fluctuations in quarterly results of operations; risks
associated with potential future acquisitions; our ability to generate sufficient cash to service
all of our indebtedness; the expansion of our distribution network; our ability to successfully
maintain effective internal controls; and other risks and uncertainties described in our Annual
Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 10, 2011
in the section entitled Risk Factors, and in our other filings from time to time with the
Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize,
or should any of our assumptions prove incorrect, actual results may vary in material respects from
those projected in these forward-looking statements. We undertake no obligation to publicly update
or revise any forward-looking statements.
Overview
We are a medical device company that develops, manufactures and markets an insulin infusion
system for people with insulin-dependent diabetes. Our proprietary OmniPod Insulin Management
System (the OmniPod System) consists of our disposable OmniPod insulin infusion device and our handheld, wireless
Personal Diabetes Manager, or PDM. The U.S. Food and Drug Administration, or FDA, approved the
OmniPod System in January 2005. In October 2005, we shipped our first commercial OmniPod System.
16
We have progressively expanded our marketing efforts from an initial focus in the Eastern
United States to having availability of the OmniPod System in the entire United States. In January
2010, we entered into a five year distribution agreement with Ypsomed Distribution AG, or Ypsomed,
to become the exclusive distributor of the OmniPod System in eleven countries, subject to approved
reimbursement. Through our partnership with Ypsomed, the OmniPod System is now available in seven
markets, namely Germany, the United Kingdom, France, the Netherlands, Sweden, Norway and
Switzerland. We expect that Ypsomed will begin distribution of the OmniPod System, subject to
approved reimbursement, in the other markets under the agreement in 2011 or 2012. In February 2011,
we entered into a distribution agreement with GlaxoSmithKline Inc., or GSK, to become the exclusive
distributor of the OmniPod System in Canada. We made an initial shipment of OmniPods to GSK during
the second quarter and expect that GSK will begin distributing the OmniPod System, subject to
approved reimbursement, in the coming months. We focus our sales initiatives towards key diabetes
practitioners, academic centers and clinics specializing in the treatment of diabetes patients, as
well as individual diabetes patients.
On June 1, 2011,
we consummated the acquisition of
Neighborhood Holdings, Inc. and its wholly-owned subsidiaries (collectively, Neighborhood Diabetes), a leading durable medical equipment distributor, specializing in direct to
consumer sales of diabetes supplies. Neighborhood Diabetes is based in Woburn, Massachusetts with
additional facilities in Brooklyn, New York and Orlando, Florida. Neighborhood Diabetes serves more
than 60,000 customers with Type 1 and Type 2 diabetes primarily in the northeast and southeast
regions of the United States. Neighborhood Diabetes supplies these customers with blood glucose testing
supplies, insulin pumps, pump supplies, pharmaceuticals, and
other products for the management and treatment of diabetes.
We
currently produce the OmniPod System on a partially automated manufacturing line at a facility in
China operated by a subsidiary of Flextronics International Ltd., or Flextronics. We purchase
complete OmniPods pursuant to our agreement with Flextronics. Under the agreement, Flextronics has
agreed to supply us, as a non-exclusive supplier, with OmniPods at agreed upon prices per unit
pursuant to a rolling 12-month forecast that we provide. The agreement may be terminated at any
time by either party upon prior written notice given no less than a specified number of days prior
to the date of termination. The specified number of days is intended to provide the parties with
sufficient time to make alternative arrangements in the event of termination. By purchasing
OmniPods manufactured by Flextronics in China, we have been able to substantially increase
production volumes for the OmniPod and reduce our per unit production cost.
To achieve profitability, we continue to seek to increase manufacturing volume and reduce the
per-unit production cost for the OmniPod. By increasing production volumes of the OmniPod, we have
been able to reduce our per-unit raw material costs and improve absorption of manufacturing
overhead costs. This, as well as the introduction of our next generation OmniPod, are important as
we strive to achieve profitability. We believe our current manufacturing capacity is sufficient to
meet our expected 2011 demand for OmniPods.
Neighborhood Diabetes is a distributor of blood glucose testing supplies, insulin
pumps, pump supplies, pharmaceuticals and other products for the management and treatment of diabetes. Neighborhood Diabetes purchases products from
manufacturers at contracted rates and supplies these products to its customers. Based on market
penetration, payor plans and other factors, certain manufacturers provide rebates based on product
sold. Neighborhood Diabetes records these rebates as a reduction to cost of goods sold as they are
earned.
Our sales and marketing effort is focused on generating demand and acceptance of the OmniPod
System among healthcare professionals, people with insulin-dependent diabetes, third-party payors
and third-party distributors. Our marketing strategy is to build awareness for the benefits of the
OmniPod System through a wide range of education programs, social networking, patient demonstration
programs, support materials, media advertisements and events at the national, regional and local
levels. We are using third-party distributors to improve our access to managed care and government
reimbursement programs, expand our commercial presence and provide access to additional potential
patients.
Neighborhood Diabetes has built a strong infrastructure in the reimbursement, billing and
collection areas that provide for adjudication of claims as either
durable medical equipment or through pharmacy
benefits. Claims are adjudicated under private insurers, Medicaid or Medicare. Neighborhood
Diabetes business model requires collaboration with physicians, medical device manufacturers,
pharmaceutical distributors, private insurers and public insurers such as The Center for Medicare &
Medicaid Services, or CMS, who we collectively refer to as partners. Neighborhood Diabetes net
sales are primarily generated from distributing diabetes supplies and pharmaceuticals pursuant to
agreements with its partners.
As a medical device company, reimbursement from third-party payors is an important element of
our success. If patients are not adequately reimbursed for the costs of using the OmniPod System,
it will be much more difficult for us to penetrate the market. We continue to negotiate contracts
establishing reimbursement for the OmniPod System with national and regional third-party payors. As
part of the integration of Neighborhood Diabetes, we are aligning third-party payor contracts, both
ours and those of Neighborhood Diabetes to be able to better leverage our cross-selling initiatives. As we
expand our sales and marketing focus, increase our manufacturing capacity, expand to international
markets and leverage the Neighborhood Diabetes model, we will need to maintain and expand available
reimbursement for our product offerings.
Since our inception in 2000, we have incurred losses every quarter. In the three and six
months ended June 30, 2011, we incurred net losses of $19.4 million and $29.3 million,
respectively. As of June 30, 2011, we had an accumulated deficit of $413.1 million. We have
financed our operations through private placements of debt and equity securities, public offerings
of our common stock and issuances of convertible debt and borrowings under certain other debt
agreements. As of June 30, 2011, we had $158.8 million of convertible debt outstanding. Of the
$158.8 million of convertible debt outstanding, approximately $15 million matures in June 2013 and
approximately $143.8 million matures in June 2016.
Our long-term financial objective is to achieve and sustain profitable growth. Our efforts for
the remainder of 2011 will be focused primarily on the development, production and regulatory
approval of our next generation OmniPod System, the expansion of sales by
continuing to add new patients as well as increasing the sales to existing patients by offering
additional products and services, and the integration of our acquired Neighborhood Diabetes.
Achieving these objectives is expected to
require additional investments in certain personnel and initiatives to allow for us to increase our
penetration in the United States and international markets. We
17
believe that we will continue to incur net losses in the near term in order to achieve these
objectives. However, we believe that the accomplishment of our near term objectives will have a
positive impact on our financial condition in the future.
We believe that our cash and cash equivalents, together with the cash expected to be generated
from product sales, will be sufficient to meet our projected operating and debt service
requirements for the next twelve months.
Acquisition of Neighborhood Diabetes
On June 1, 2011,
we acquired all of the outstanding shares of
Neighborhood Diabetes, a durable medical equipment
distributor specializing in direct to consumer sales of diabetes supplies, including
pharmaceuticals, and support services. Neighborhood Diabetes serves more than 60,000 customers with
Type 1 and Type 2 diabetes primarily in the northeast and southeast
regions of the United States with
blood glucose testing supplies, insulin pumps, pump supplies, pharmaceuticals, as well as other products for the management and treatment of diabetes. Neighborhood Diabetes is based in Woburn, Massachusetts, with additional offices in
Brooklyn, New York and Orlando, Florida. At the time of the acquisition, Neighborhood Diabetes
employed approximately 200 people across its three locations. The acquisition of Neighborhood
Diabetes provides us with full suite diabetes management product offerings, accelerates our sales
force expansion, strengthens our back office support capabilities, expands our access to insulin
dependent patients, and provides pharmacy adjudication capabilities to drive incremental sales
higher. The aggregate purchase price of approximately $62.4 million consisted of approximately
$37.9 million in cash paid at closing, 1,197,631 shares of our common stock valued at approximately
$24.4 million, or $20.40 per share based on the closing price of our common stock on the
acquisition date, and contingent consideration with a fair value of approximately $0.1 million. Of
the $37.9 million of cash, $6.6 million is being held in an escrow account to reimburse us and our
affiliates for certain claims for which they are entitled to be indemnified pursuant to the terms
of the agreement and plan of merger with Neighborhood Diabetes.
We have accounted for the acquisition of Neighborhood Diabetes as a business combination.
Under business combination accounting, the assets and liabilities of Neighborhood Diabetes were
recorded as of the acquisition date, at their respective fair values, and consolidated with our
results. The excess of the purchase price over the fair value of net assets acquired was recorded
as goodwill. The operating results of Neighborhood Diabetes have been included in the consolidated
financial statements since June 1, 2011, the date the acquisition was completed.
For the three and six months ended June 30, 2011, we included approximately $2.7 million of revenue related to
sale of testing and other supplies by Neighborhood Diabetes. The purchase price
allocation, including an independent appraisal for intangible assets, has been prepared based on
the information that was available to management at the time the consolidated financial statements
were prepared, and revisions to the preliminary purchase price allocation will be made as
additional information becomes available. The preliminary purchase price has been allocated as
follows (in thousands):
|
|
|
|
|
Calculation of allocable purchase price: |
|
|
|
|
Cash |
|
$ |
37,855 |
|
Common stock |
|
|
24,432 |
|
Contingent consideration obligations |
|
|
61 |
|
|
|
|
|
Total allocable purchase price |
|
$ |
62,348 |
|
|
|
|
|
|
|
|
|
|
Preliminary allocation of purchase price: |
|
|
|
|
Accounts receivable |
|
$ |
5,387 |
|
Inventories |
|
|
2,336 |
|
Prepaid expenses and other current assets |
|
|
242 |
|
Property and equipment |
|
|
391 |
|
Customer relationships |
|
|
30,100 |
|
Tradenames |
|
|
2,800 |
|
Goodwill |
|
|
26,727 |
|
Other assets |
|
|
233 |
|
Accounts payable |
|
|
4,109 |
|
Accrued expenses |
|
|
1,700 |
|
Other long-term liabilities |
|
|
59 |
|
|
|
|
|
|
|
$ |
62,348 |
|
|
|
|
|
We incurred transaction
costs of $3.2 million, which consisted primarily of banking, legal,
accounting and other administrative fees. These costs have been recorded as general and
administrative expense in the three and six months ended June 30, 2011.
Financial Operations Overview
Revenue.
Prior to the acquisition of Neighborhood Diabetes, we derived nearly all of our revenue from the sale of the OmniPod System and other
diabetes related products including blood
18
glucose testing supplies, insulin pumps, pump supplies and pharmaceuticals to customers and
third-party distributors who resell the product to diabetes patients. The OmniPod System is
comprised of two devices: the OmniPod, a disposable insulin infusion device that the patient wears
for up to three days and then replaces; and the Personal Diabetes Manager, or PDM, a handheld
device much like a personal digital assistant that wirelessly programs the OmniPod with insulin
delivery instructions, assists the patient with diabetes management and incorporates a blood
glucose meter. We are currently selling our OmniPod System through our partnership with Ypsomed in
seven markets, namely Germany, the United Kingdom, France, the Netherlands, Sweden, Norway and
Switzerland. We expect that Ypsomed will begin distributing the OmniPod System, subject to approved
reimbursement, in the other markets under the agreement in 2011 or in 2012. In February 2011, we
entered into a distribution agreement with GSK to become the exclusive distributor of the OmniPod
System in Canada. We shipped OmniPods to GSK during the second quarter and expect that GSK will
begin distributing the OmniPod System, subject to approved reimbursement, in the coming months. In
connection with our June 1, 2011 acquisition of Neighborhood Diabetes, we also provide more than
60,000 Type 1 and Type 2 diabetes patients with blood glucose testing supplies, insulin pumps, pump
supplies and pharmaceuticals.
In March 2008, we received a cash payment from Abbott Diabetes Care, Inc., or Abbott, for an
agreement fee in connection with execution of the first amendment to the development and license
agreement with Abbott. We are recognizing the payment as revenue over the five year term of the
agreement. In addition, Abbott agreed to pay us certain amounts for services performed in
connection with each sale of a PDM that includes an Abbott Discrete Blood Glucose Monitor to
customers in certain territories. We recognize the revenue related to this portion of the Abbott
agreement at the time we meet the criteria for revenue recognition, typically at the time of the
sale of the PDM to a new patient.
As of June 30, 2011 and December 31, 2010, we had deferred revenue of $3.7 million and $4.8
million, respectively. These amounts include product-related revenue as well as the unrecognized
portion of the agreement fee related to the Abbott agreement. For the year ending December 31,
2011, we expect our revenue to continue to increase as we gain new customers and increase our
product offerings to existing customers in the United States and continue expansion in Europe,
Canada and certain other international markets. Increased revenue will be dependent upon the
success of our sales efforts, our ability to produce OmniPods in sufficient volumes and other risks
and uncertainties.
Cost of revenue. Cost of revenue consists primarily of raw material, labor, warranty and
overhead costs such as freight, depreciation and packaging costs, related to the OmniPod System and
the cost for which we acquire our other products from third party suppliers distributed through our
Neighborhood Diabetes business. On a per unit basis for the OmniPod System, the cost of revenue is
expected to be consistent for the remainder of the year. Cost of revenue related to the
Neighborhood Diabetes business is expected to reduce our overall gross margin as we resell other
diabetes supplies to our combined customers. We have filed for 510(K) clearance from the Food and
Drug Administration on our next generation OmniPod. Once approved, we expect improvement in our
gross margins in connection with the introduction of this next generation product.
Research and development. Research and development expenses consist primarily of personnel
costs within our product development, regulatory and clinical functions, and the costs of market
studies and product development projects, including regulatory approval of our next generation
product. We expense all research and development costs as incurred. For the year ending December
31, 2011, we expect overall research and development spending to increase compared to 2010 as we
finalize the validation of our next generation product manufacturing line with Flextronics and work
with the regulatory agencies on obtaining approval of the next generation product.
General and administrative. General and administrative expenses consist primarily of salaries
and other related costs for personnel serving the executive, finance, information technology and
human resource functions, as well as legal fees, accounting fees, insurance costs, bad debt
expenses, shipping, handling and facilities-related costs. We expect general and administrative
expenses to increase in 2011 compared to 2010, mainly as a result of our acquisition of
Neighborhood Diabetes on June 1, 2011.
Sales and marketing. Sales and marketing expenses consist primarily of personnel costs within
our sales, marketing, reimbursement support, customer support and training functions, sales
commissions paid to our sales representatives and costs associated with participation in medical
conferences, physician symposia and promotional activities, including distribution of units used in
our demonstration kit programs. We expect sales and marketing expenses to increase in 2011 as
compared to 2010 as a result of the growth of our existing business, our acquisition of
Neighborhood Diabetes as well as our efforts to enhance the products we offer to our existing
patients.
19
Results of Operations
The following table presents certain statement of operations information for the three and six
months ended June 30, 2011 and 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
|
|
June 30, |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
% Change |
|
|
2011 |
|
|
2010 |
|
|
% Change |
|
|
|
(in thousands) |
|
|
|
|
|
(in thousands) |
|
|
|
|
Revenue |
|
$ |
32,211 |
|
|
$ |
22,937 |
|
|
|
40 |
% |
|
$ |
60,469 |
|
|
$ |
43,744 |
|
|
|
38 |
% |
Cost of revenue |
|
|
17,673 |
|
|
|
13,051 |
|
|
|
35 |
% |
|
|
32,398 |
|
|
|
25,473 |
|
|
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
14,538 |
|
|
|
9,886 |
|
|
|
47 |
% |
|
|
28,071 |
|
|
|
18,271 |
|
|
|
54 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
6,832 |
|
|
|
4,583 |
|
|
|
49 |
% |
|
|
11,421 |
|
|
|
8,430 |
|
|
|
35 |
% |
General and administrative |
|
|
12,996 |
|
|
|
6,190 |
|
|
|
110 |
% |
|
|
20,206 |
|
|
|
13,149 |
|
|
|
54 |
% |
Sales and marketing |
|
|
9,625 |
|
|
|
9,013 |
|
|
|
7 |
% |
|
|
18,631 |
|
|
|
17,322 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
29,453 |
|
|
|
19,786 |
|
|
|
49 |
% |
|
|
50,258 |
|
|
|
38,901 |
|
|
|
29 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(14,915 |
) |
|
|
(9,900 |
) |
|
|
51 |
% |
|
|
(22,187 |
) |
|
|
(20,630 |
) |
|
|
8 |
% |
Other expense, net |
|
|
(4,508 |
) |
|
|
(3,811 |
) |
|
|
18 |
% |
|
|
(7,082 |
) |
|
|
(7,571 |
) |
|
|
6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(19,423 |
) |
|
$ |
(13,711 |
) |
|
|
42 |
% |
|
$ |
(29,269 |
) |
|
$ |
(28,201 |
) |
|
|
4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparison of the Three and Six Months Ended June 30, 2011 and 2010
Revenue
Our total revenue was $32.2 million and $60.5 million for the three and six months ended June
30, 2011, compared to $22.9 million and $43.7 million for the same periods in 2010. The increase in
revenue is primarily due to continued adoption of the OmniPod System by patients in the United
States and internationally, as well of the sale of testing and other supplies related to our
acquisition of Neighborhood Diabetes. We expect our revenue to increase as we continue to add new
patients, introduce the OmniPod System in additional territories, generate a higher volume of
reorders based on our expanding patient base and continue to realize revenue growth from our
Neighborhood Diabetes business.
Cost of Revenue
Cost of revenue was $17.7 million and $32.4 million for the three and six months ended June
30, 2011, compared to $13.1 million and $25.5 million for the same periods in 2010. The increase in
cost of revenue is primarily due to a significant increase in sales volume offset by cost
efficiencies related to the bill of material and production volume on our OmniPod System as well as
the impact on cost of sales of the lower gross margin profile Neighborhood Diabetes business. We
expect gross margins for the remainder of the year in the range of 43% to 45% of revenue.
Research and Development
Research and development expenses increased $2.2 million, or 49%, to $6.8 million for the
three months ended June 30, 2011, compared to $4.6 million for the same period in 2010. For the
three months ended June 30, 2011, the increase was primarily a result of $1.2 million of additional
materials and equipment utilized in the development of our next generation OmniPod System, $0.6
million in higher employee related expenses, and $0.2 million of additional manufacturing equipment
depreciation.
Research and development expenses increased $3.0 million, or 35%, to $11.4 million for the six
months ended June 30, 2011, compared to $8.4 million for the same period in 2010. For the six
months ended June 30, 2011, the increase was primarily a result of $1.3 million of additional
materials and equipment utilized in the development of our next generation OmniPod System, $1.1
million in higher employee related expenses, and $0.4 million of additional manufacturing equipment
depreciation.
General and Administrative
General and administrative expenses increased $6.8 million, or 110%, to $13.0 million for the
three months ended June 30, 2011, compared to $6.2 million for the same period in 2010. This
increase was primarily a result of $3.2 million of transaction costs for the acquisition of
Neighborhood Diabetes, $0.6 million related to higher audit and legal fees, a $0.5 million of
amortization on acquired intangibles, and an increase in employee related expenses of $2.1 million,
including $0.9 million related to Neighborhood Diabetes and $0.9 million related to new hires,
merit increases and stock based compensation. The remainder of the increase was largely due to
administrative expenses including $0.2 million from Neighborhood Diabetes.
General and administrative expenses increased $7.1 million, or 54%, to $20.2 million for the
six months ended June 30, 2011, compared to $13.1 million for the same period in 2010. This
increase was primarily a result of $3.2 million of transaction
costs for the acquisition of Neighborhood Diabetes, $0.6
million related to higher audit and legal fees, a $0.5 million of amortization on acquired
intangibles, and an increase in employee related expenses of $2.9 million, including $0.9 million
related to the acquisition of Neighborhood Diabetes and $1.5 million related to new hires, merit
increases and stock based compensation. The remainder of the increase was due to administrative
expenses including $0.2 million from Neighborhood Diabetes. These increases are offset by a $0.5
million decrease in selling costs.
20
Sales and Marketing
Sales and marketing expenses increased $0.6 million, or 7%, to $9.6 million for the three
months ended June 30, 2011, compared to $9.0 million for the same period in 2010. This increase in
sales and marketing expenses was due to an increase of $0.4 million in employee related expenses,
including $0.2 million from Neighborhood Diabetes, and an increase of $0.6 million in outside
services. These increases are offset by a $0.5 million decrease in selling costs.
Sales and marketing expenses increased $1.3 million, or 8%, to $18.6 million for the six
months ended June 30, 2011, compared to $17.3 million for the same period in 2010. The increase in
sales and marketing expenses for the six months ended June 30, 2011 was due to an increase of $1.1
million in employee related expenses, including $0.2 million from Neighborhood Diabetes and an
increase of $0.6 million in outside services. These increases are offset by a $0.6 million decrease
in selling costs.
Other Expense, Net
Net interest expense was $4.5 million for the three months ended June 30, 2011, compared to
$3.8 million for the same period in 2010. Net interest expense was $7.1 million for the six months
ended June 30, 2011, compared to $7.6 million for the same period in 2010. The increase in net
interest expense in the three months ended June 30, 2011 was primarily due to $2.0 million of
additional expense related to the modification of the 5.375% Notes in June 2011. These savings were
offset by cash and non-cash interest savings of $1.4 million related to our Facility Agreement
which was repaid in December 2010. The decrease in net interest expense in the six months ended
June 30, 2011 was primarily due to cash and non-cash interest savings of $2.7 million related to our
Facility Agreement, offset by $2.0 million of additional expense related to the modification of the
5.375% Notes in June 2011.
Liquidity and Capital Resources
We commenced operations in 2000 and to date we have financed our operations primarily through
private placements of common and preferred stock, secured indebtedness, public offerings of our
common stock and issuances of convertible debt. As of June 30, 2011, we had $106.7 million in cash
and cash equivalents. We believe that our current cash and cash equivalents, together with the cash
expected to be generated from product sales, will be sufficient to meet our projected operating and
debt service requirements for at least the next twelve months.
Equity
In December 2010, we issued and sold 3,450,000 shares of our common stock at a price of $13.27
per share. In connection with the offering, we received total gross proceeds of $47.8 million, or
approximately $45.4 million in net proceeds after deducting underwriting discounts and offering
expenses. Approximately $33.3 million of the proceeds was used to repay all amounts outstanding
under our Facility Agreement.
In June 2011, in connection with the acquisition of Neighborhood Diabetes, we issued 1,197,631
shares of our common stock with a value of $20.40 per share on the issuance date, as partial
consideration for the acquisition.
Long-Term Debt
At June 30, 2011 and December 31, 2010, we had outstanding long-term debt and related deferred
financing costs on our balance sheet as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
Liabilities: |
|
|
|
|
|
|
|
|
Principal amount of the 5.375% Convertible Notes |
|
$ |
15,000 |
|
|
$ |
85,000 |
|
Principal amount of the 3.75% Convertible Notes |
|
|
143,750 |
|
|
|
|
|
Unamortized discount of liability component |
|
|
(54,573 |
) |
|
|
(15,567 |
) |
|
|
|
|
|
|
|
|
|
$ |
104,177 |
|
|
$ |
69,433 |
|
|
|
|
|
|
|
|
|
Deferred financing costs |
|
$ |
2,861 |
|
|
$ |
1,173 |
|
Equity net carrying value |
|
$ |
51,727 |
|
|
$ |
25,812 |
|
5.375% Convertible Notes
In June 2008, we sold $85.0 million principal amount of 5.375% Convertible
Senior Notes due June 15, 2013 (the 5.375% Notes) in a private placement to qualified
institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The
interest rate on the notes is 5.375% per annum on the principal amount from June 16, 2008, payable
semi-annually in arrears in cash on December 15 and June 15
21
of each year. The 5.375% Notes are convertible into our common stock at an initial conversion rate of 46.8467 shares of common stock
per $1,000 principal amount of the 5.375% Notes, which is equivalent to a conversion price of
approximately $21.35 per share, representing a conversion premium of 34% to the last reported sale
price of our common stock on the NASDAQ Global Market on June 10, 2008, subject to adjustment under
certain circumstances, at any time beginning on March 15, 2013 or under certain other circumstances
and prior to the close of business on the business day immediately preceding the final maturity
date of the notes. The 5.375% Notes will be convertible for cash up to their principal amount and
shares of our common stock for the remainder of the conversion value in excess of the principal
amount.
We do not have the right to redeem any of the 5.375% Notes prior to maturity. If a fundamental
change, as defined in the Indenture for the 5.375% Notes, occurs at any time prior to maturity,
holders of the 5.375% Notes may require us to repurchase their notes in whole or in part for cash
equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid
interest, including any additional interest, to, but excluding, the date of repurchase. If a holder
elects to convert its 5.375% Notes upon the occurrence of a make-whole fundamental change, as
defined in the Indenture for the 5.375% Notes, the holder may be entitled to receive an additional
number of shares of common stock on the conversion date. These additional shares are intended to
compensate the holders for the loss of the time value of the conversion option and are set forth in
the Indenture to the 5.375% Notes. In no event will the number of shares issuable upon conversion
of a note exceed 62.7746 per $1,000 principal amount (subject to adjustment as described in the
Indenture for the 5.375% Notes).
We recorded a debt discount of $26.9 million to equity to reflect the value of our
nonconvertible debt borrowing rate of 14.5% per annum. This debt discount is being amortized as
interest expense over the five year term of the 5.375% Notes.
We incurred deferred financing costs related to this offering of approximately $3.5 million,
of which $1.1 million has been reclassified as an offset to the value of the amount allocated to
equity. The remainder is recorded as other assets in the consolidated balance sheet and is being
amortized as a component of interest expense over the five year term of the 5.375% Notes. Interest
expense related to the Notes was included in interest expense on the consolidated statements of
operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
Contractual coupon interest |
|
$ |
1,142 |
|
|
$ |
1,142 |
|
|
$ |
2,284 |
|
|
$ |
2,284 |
|
Amortization of debt issuance costs |
|
|
1,425 |
|
|
|
1,238 |
|
|
|
2,849 |
|
|
|
2,476 |
|
Accretion of debt discount |
|
|
121 |
|
|
|
121 |
|
|
|
243 |
|
|
|
243 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,688 |
|
|
$ |
2,501 |
|
|
$ |
5,376 |
|
|
$ |
5,003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On June 29, 2011, in connection with the issuance of $143.75 million of 3.75% Convertible
Notes due June 2016 (the 3.75% Notes), we repurchased
$70 million in principal amount of the 5.375% Notes for
$85.1 million, a 21.5% premium on the principal amount. The investors that held the $70 million of
repurchased 5.375% Notes purchased $59.5 million in principal
amount of the 3.75% Notes. The transaction was
treated as a modification of a portion of the 5.375% Notes. See 3.75% Convertible Notes for
additional detail on the modification.
As
of June 30, 2011, the 5.375% Notes have a remaining term of two years.
Facility Agreement and Common Stock Warrants
In March 2009,
we entered into the Facility Agreement with certain institutional
accredited investors, pursuant to which the investors agreed to loan us up to $60 million, subject
to the terms and conditions set forth in the Facility Agreement. Total financing costs, including
the transaction fee, were $3.0 million and were amortized as interest expense over the 42 months of
the Facility Agreement. In September 2009, we entered into an amendment to the Facility Agreement
whereby we repaid the $27.5 million originally drawn and promptly drew down the remaining $32.5
million available under the Facility Agreement. The annual interest rate was 8.5%, payable
quarterly in arrears. In connection with the amendment to the Facility Agreement, we entered into a
securities purchase agreement with the lenders whereby we sold 2,855,659 shares of our common stock
to the lenders at $9.63 per share, a $1.9 million discount based on the closing price of our common
stock of $10.28 on that date. We recorded the $1.9 million as a debt discount which was amortized
as interest expense over the remaining term of the loan. We received aggregate proceeds of $27.5
million in connection with the sale of our shares. All principal amounts outstanding under the
Facility Agreement were payable in September 2012.
In connection with the execution of the Facility Agreement, we issued to the lenders fully
exercisable warrants to purchase an aggregate of 3.75 million shares of our common stock at an
exercise price of $3.13 per share. The warrants qualified for permanent treatment as equity, and
their relative fair value of $6.1 million on the issuance date was recorded as additional paid-in
capital and debt discount. The debt discount was amortized as non-cash interest expense over the
term of the loan. As of June 30, 2011, all warrants to acquire 3.75 million shares of our common
stock issued in connection with the Facility Agreement were exercised.
In December 2010, we paid $33.3 million to the lenders, of which $32.5 million related to
principal and $0.8 million related to interest and prepayment fees, to extinguish this debt. We
recorded a non-cash interest charge of $7.0 million in the fourth quarter of 2010 related to the
write-off of the remaining debt discounts and financing costs included in other assets which were
being amortized to interest expense over the term of the debt. At June 30, 2011 and December 31,
2010, there were no amounts related to the Facility Agreement included in long-term debt on our
balance sheet.
22
Interest expense related to the Facility Agreement was included in interest expense on the
consolidated statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, 2010 |
|
Contractual coupon interest |
|
$ |
696 |
|
|
$ |
1,377 |
|
Amortization of debt issuance costs |
|
|
579 |
|
|
|
1,130 |
|
Accretion of debt discount |
|
|
101 |
|
|
|
197 |
|
|
|
|
|
|
|
|
|
|
$ |
1,376 |
|
|
$ |
2,704 |
|
|
|
|
|
|
|
|
As the Facility Agreement was repaid in December 2010, no amounts were included in interest
expense in the consolidated statements of operations in the three and six months ended June 30,
2011.
3.75% Convertible Notes
In June 2011, we sold $143.8 million principal amount of 3.75% Convertible Notes due June 15,
2016 (the 3.75% Notes). The interest rate on the notes is 3.75% per annum, payable semi-annually
in arrears in cash on December 15 and June 15 of each year. The 3.75% Notes are convertible into
our common stock at an initial conversion rate of 38.1749 shares of common stock per $1,000
principal amount of the 3.75% Notes, which is equivalent to a conversion price of approximately
$26.20 per share, subject to adjustment under certain circumstances. The 3.75% Notes are
convertible prior to March 15, 2016 only upon the occurrence of certain circumstances. On and after
March 15, 2016 and prior to the close of business on the second scheduled trading day immediately
preceding the final maturity date of the 3.75% Notes, the notes may be converted without regard to
the occurrence of any such circumstances. The 3.75% Notes and any unpaid interest will be convertible at our option for
cash, shares of our common stock or a combination of cash and shares of our common stock for the
principal amount. We intend to settle the principal in cash.
We may not redeem the 3.75% Notes prior to June 20, 2014. From June 20, 2014 to June 20, 2015,
we may redeem the 3.75% Notes, at our option, in whole or in part only if the last reported sale
price per share of our common stock has been at least 130% of the conversion price then in effect
for at least 20 trading days during a period of 30 consecutive trading days. On and after June 25,
2015, we may redeem the 3.75% Notes, at our option (without regard to such sale price condition),
in whole or in part. If a fundamental change, as defined in the Indenture for the 3.75% Notes,
occurs at any time prior to maturity, holders of the 3.75% Notes may require us to repurchase their
notes in whole or in part for cash equal to 100% of the principal amount of the notes to be
repurchased, plus accrued and unpaid interest. If a holder elects to convert its 3.75% Notes upon
the occurrence of a make-whole fundamental change, as defined in the Indenture for the 3.75% Notes,
the holder may be entitled to receive an additional number of shares of common stock on the
conversion date. These additional shares are intended to compensate the holders for the loss of the
time value of the conversion option and are set forth in the Indenture to the 3.75% Notes. In no
event will the number of shares issuable upon conversion of a 3.75% Note exceed 50.5816 per $1,000
principal amount (subject to adjustment as described in the Indenture for the 3.75% Notes). The
3.75% Notes are unsecured and are equal in right of payment to the 5.375% notes.
We evaluated certain features of the 3.75% Notes to determine whether these features are derivatives
which should be bifurcated and valued. We identified certain features related to a portion of the
3.75% Notes, including the holders ability to require us to repurchase their notes and the higher
interest payments required in an event of default, which are considered embedded derivatives and
should be valued. We assess the value of each of these embedded derivatives at each balance sheet
date. At June 30, 2011, we determined that these derivatives have de minimus value.
In connection with the issuance of the 3.75% Notes, we repurchased $70 million in principal amount of
the 5.375% Notes for $85.1 million, a 21.5% premium on the principal amount. The investors that
held the $70 million of repurchased 5.375% Notes purchased $59.5 million in principal amount of the 3.75%
Notes. This transaction was treated as a modification of the existing 5.375% Notes. We accounted
for this modification of a portion of the 5.375% Notes separately from the issuance of the remainder of the 3.75%
Notes.
Prior to the transaction, the $70 million principal of repurchased 5.375% Notes had a debt
discount of $10.5 million. This amount remained in debt discount related to the modified $59.5
million 3.75% Notes. We recorded additional debt discount of $15.1 million related to the premium
payment in connection with the repurchase and $0.2 million related to the increase in the value of
the conversion feature. The offset to the debt discount related to the value of the conversion
feature was recorded as additional paid-in capital. The total debt discount of $25.8 million
related to the modified debt is being amortized at the effective rate
of 16.5% as interest expense over the
five year term of the modified debt. We paid transaction fees of approximately $2.0 million
related to the modification which were recorded as interest expense in the three and six months
ended June 30, 2011. Interest expense on the debt discount and the deferred financing costs
related to the modified portion of the 3.75% Notes was de minimus in the three and six months ended
June 30, 2011 and 2010.
Of the $143.8 million of 3.75% Notes issued in June 2011, $84.3 million was considered to be
an issuance of new debt. We recorded a debt discount of $26.6 million related to the $84.3 million
new debt. We included $57.7 million on our balance sheet related to these notes at June 30, 2011.
The debt discount was recorded as additional paid-in capital to reflect the value of our
nonconvertible debt borrowing rate of 12.4% per annum. This debt discount is being amortized as
interest expense over the five year term of the 3.75% Notes. We incurred deferred financing costs
related to this offering of approximately $2.8 million, of which $0.9 million has been reclassified
as an offset to the value of the amount allocated to equity. The remainder is recorded as other
assets in the consolidated balance sheet and is being amortized as a component of interest expense
over the five year term of the 3.75% Notes. Interest expense on the debt discount and the
deferred financing costs related to the new portion of the 3.75% Notes was de minimus in the three
and six months ended June 30, 2011 and 2010.
23
As of June 30, 2011, the 3.75% Notes have a remaining term of 5 years.
Operating Activities
The following table sets forth the amounts of cash used in operating activities and net loss
for each of the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Cash used in operating activities |
|
$ |
(16,948 |
) |
|
$ |
(15,058 |
) |
Net loss |
|
$ |
(29,269 |
) |
|
$ |
(28,201 |
) |
For each of the periods above, the net cash used in operating activities was attributable
primarily to the growth of our operations after adjustment for non-cash. Adjustments for non-cash
items were approximately $12.6 million and $12.2 million in the six months ended June 30, 2011 and
June 30, 2010, respectively. Non-cash items mainly consist of depreciation, stock-based
compensation and non-cash interest expense. Significant uses of cash from operations in the six
months ended June 30, 2011 include an increase in inventories of $2.2 million due to increased
production and a decrease in deferred revenue primarily as a result of revenue recognized on
certain distributor shipments. These uses of cash in the six months ended June 30, 2011 were offset
by a decrease in accounts receivable of $1.1 million, primarily attributable to improved
collections and an increase of $2.2 million in accounts payable and accruals.
Investing and Financing Activities
The following table sets forth the amounts of cash used in investing activities and cash
provided by financing activities for each of the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Cash used in investing activities |
|
$ |
(43,415 |
) |
|
$ |
(1,986 |
) |
Cash provided by financing activities |
|
$ |
53,835 |
|
|
$ |
7,119 |
|
Cash used in investing activities in the six months ended June 30, 2011 primarily related to
the acquisition of Neighborhood Diabetes. We paid approximately $37.9 million in cash as partial
consideration. In addition, we purchased fixed assets primarily for use in the development and
manufacturing of the OmniPod System. In the six months ended June 30, 2010 cash used in investing
activities was primarily for the purchase of fixed assets for use in the development and
manufacturing of the OmniPod System. Capital expenditures are expected to continue to increase in
2011 compared to 2010.
In the six months ended June 30, 2011 cash provided by financing activities related to the net
proceeds from the issuance of the 3.75% Notes, offset by the repurchase of $70 million principal of
the 5.375% Notes for $85.1 million. Cash provided by financing activities in the six months ended
June 30, 2010 mainly consisted of the net proceeds from the issuance of common stock in connection
with the exercise of employee stock options.
Lease Obligations
We lease our facilities, which are accounted for as operating leases. The lease of our
facilities in Bedford and Billerica, Massachusetts, generally provides for a base rent plus real
estate taxes and certain operating expenses related to the lease. In addition, in connection with
our acquisition of Neighborhood Diabetes, we acquired leases of facilities in Woburn,
Massachusetts, Brooklyn, New York and Orlando, Florida. As of June 30, 2011, we had an
outstanding letter of credit which totaled $0.1 million to cover our security deposits for lease
obligations.
Off-Balance Sheet Arrangements
As of June 30, 2011, we did not have any off-balance sheet financing arrangements.
Critical Accounting Policies and Estimates
Our financial statements are based on the selection and application of generally accepted
accounting principles, which require us to make estimates and assumptions about future events that
affect the amounts reported in our financial statements and the accompanying notes. Future events
and their effects cannot be determined with certainty. Therefore, the determination of estimates
requires the exercise of judgment. Actual results could differ from those estimates, and any such
differences may be material to our financial statements. We believe that the policies set forth
below may involve a higher degree of judgment and complexity in their application than our other
accounting policies and represent the critical accounting policies and estimates used in the
preparation of our financial statements. If different assumptions or conditions were to prevail,
the results could be materially different from our reported results.
24
Revenue Recognition
We generate nearly all of our revenue from sales of our OmniPod Insulin Management System and
other diabetes related products including blood glucose testing supplies, insulin pumps, pump
supplies and pharmaceuticals to customers and third-party
distributors who resell the product to patients with
diabetes.
Revenue recognition requires that persuasive evidence of a sales arrangement exists, delivery
of goods occurs through transfer of title and risk and rewards of ownership, the selling price is
fixed or determinable and collectibility is reasonably assured. With respect to these criteria:
|
|
The evidence of an arrangement generally consists of a physician order form, a patient information form, and
if applicable, third-party insurance approval for sales directly to patients or a purchase order for sales to a third-party distributor. |
|
|
|
Transfer of title and risk and rewards of ownership are passed to the patient or third-party distributor
typically upon shipment of the products. |
|
|
|
The selling prices for all sales are fixed and agreed with the patient or third-party distributor, and, if
applicable, the patients third-party insurance provider(s) prior to shipment and are based on established
list prices or, in the case of certain third-party insurers, contractually agreed upon prices. Provisions
for discounts and rebates to customers are established as a reduction to revenue in the same period the
related sales are recorded. |
We assess whether the different elements qualify for separate accounting. We recognize revenue
once all elements have been delivered.
We offer a 45-day right of return for our OmniPod Insulin Management System Starter Kits
sales, and we defer revenue to reflect estimated sales returns in the same period that the related
product sales are recorded. Returns are estimated through a comparison of historical return data to
their related sales. Historical rates of return are adjusted for known or expected changes in the
marketplace when appropriate. Historically, sales returns have amounted to approximately 3% of
gross product sales.
When doubt exists about reasonable assuredness of collectibility from specific customers, we
defer revenue from sales of products to those customers until payment is received.
In March 2008, we received a cash payment from Abbott for an
agreement fee in connection with execution of the first amendment to the development and license
agreement between us and Abbott. We recognize the agreement fee received from Abbott over the
initial five year term of the agreement, and the non-current portion of the agreement fee is
included in other long-term liabilities. In addition, Abbott agreed to pay us certain amounts for
services performed in connection with each sale of a PDM that includes an Abbott Discrete Blood
Glucose Monitor to customers in certain territories. We recognize revenue related to this portion
of the Abbott agreement at the time we meet the criteria for revenue recognition, typically at the
time the revenue is recognized on the sale of the PDM to the patient.
We had deferred revenue of $3.7 million as of June 30, 2011. The deferred revenue recorded as
of June 30, 2011 was comprised of product-related revenue as well as the non-amortized agreement
fee related to the Abbott agreement.
Income Taxes
FASB ASC 740-10, Income Taxes, clarifies the accounting for uncertainty in income taxes
recognized in an entitys financial statements. FASB ASC 740-10 prescribes a recognition threshold
and measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. In addition, FASB ASC 740-10 provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure
and transition. As of June 30, 2011, we had $0.2 million of unrecognized tax benefits recorded.
Stock-Based Compensation
We account for stock-based compensation under the provisions of FASB ASC 718-10, Compensation
Stock Compensation. FASB ASC 718-10 requires all share-based payments to employees, including
grants of employee stock options, to be recognized in the income statement based on their fair
values.
25
We have continued to apply the minimum value method in future periods to equity awards
outstanding that were originally measured using this method. We use the Black-Scholes option
pricing model to determine the weighted average fair value of options granted. We determine the
intrinsic value of restricted stock and restricted stock units based on the closing price of our
common stock on the date of grant. We recognize the compensation expense of share-based awards on a
straight-line basis over the vesting period of the award.
The determination of the fair value of share-based payment awards utilizing the Black-Scholes
model is affected by the stock price and a number of assumptions, including expected volatility,
expected life, risk-free interest rate and expected dividends. The expected life of the awards is
estimated based on the SEC Shortcut Approach as defined in SAB 107, which is the midpoint between
the vesting date and the end of the contractual term. The risk-free interest rate assumption is
based on observed interest rates appropriate for the terms of the awards.
The dividend yield assumption is based on company history and expectation of paying no dividends.
Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if
actual forfeitures differ from those estimates. Stock-based compensation expense recognized in the
financial statements is based on awards that are ultimately expected to vest. We evaluate the
assumptions used to value the awards on a quarterly basis and if factors change and different
assumptions are utilized, stock-based compensation expense may differ significantly from what has
been recorded in the past. If there are any modifications or cancellations of the underlying
unvested securities, we may be required to accelerate, increase or cancel any remaining unearned
stock-based compensation expense.
In the three and six months ended June 30, 2011, we recorded $1.8 million and $3.8 million of
stock based compensation expense, respectively. In the three and six months ended June 30, 2010, we
recorded $1.3 million and $2.7 million of stock based compensation expense, respectively.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts
receivable consist of amounts due from third-party payors, patients, third-party
distributors and government agencies. The allowance for doubtful accounts is recorded in the period
in which revenue is recorded or at the time potential collection risk is identified. We estimate
our allowance based on historical experience, assessment of specific risk, discussions with
individual customers and various assumptions and estimates that we believe to be reasonable under
the circumstances.
Intangibles and Other Long-Lived Assets
Our
finite-lived intangible assets are stated at cost less accumulated amortization. We assess
our intangible and other long lived assets for impairment, whenever events
or changes in circumstances suggest that the carrying value of an asset may not be recoverable. At
June 30, 2011, intangibles assets related to the acquisition of Neighborhood Diabetes and consisted
of $29.6 million of customer relationships and $2.8 million of tradenames. We recognize an
impairment loss for intangibles and other long-lived assets if the carrying amount of a long-lived
asset is not recoverable based on its undiscounted future cash flows. Any such impairment loss is
measured as the difference between the carrying amount and the fair value of the asset. The
estimation of useful lives and expected cash flows requires us to make significant judgments
regarding future periods that are subject to some factors outside its control. Changes in these
estimates can result in significant revisions to the carrying value of these assets and may result
in material charges to the results of operations. The estimated life of the acquired tradename is
15 years. The estimated life of the acquired customer
relationships asset is 10 years. Intangible assets
with determinable estimated lives are amortized over these lives.
Goodwill
Goodwill represents the excess of the cost of the acquired Neighborhood Diabetes business over
the fair value of identifiable net assets acquired. We perform an assessment of our goodwill
for impairment on at least an annual basis or whenever events or changes in circumstances indicate
there might be impairment.
Goodwill is evaluated at the reporting unit level. To test for impairment, we compare the
carrying value of the reporting unit to its fair value. If the reporting units carrying value
exceeds its fair value, we would record an impairment loss to the extent that the carrying value of
goodwill exceeds its implied fair value.
Warranty
We provide a four year warranty on our PDMs and may replace any OmniPods that do not function
in accordance with product specifications. We estimate our warranty at the time the product is
shipped based on historical experience and the estimated cost to service the claims. Cost to
service the claims reflects the current product cost which has been decreasing over time. As these
estimates are based on historical experience, and we continue to introduce new versions of existing
products, we also consider the anticipated performance of the product over its warranty period in
estimating warranty reserves. At June 30, 2011 and December 31, 2010, the warranty reserve was $1.8
million and $1.9 million, respectively.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We do not use derivative financial instruments in our investment portfolio and have no foreign
exchange contracts. Our financial instruments consist of cash, cash equivalents, accounts
receivable, accounts payable, accrued expenses and long-term obligations. We consider investments
that, when purchased, have a remaining maturity of 90 days or less to be cash equivalents. The
primary objectives of our investment strategy are to preserve principal, maintain proper liquidity
to meet operating needs and maximize yields. To minimize our exposure to an adverse shift in
26
interest rates, we invest mainly in cash equivalents. We do not believe that a 10% change in
interest rates would have a material impact on the fair value of our investment portfolio or our
interest income.
As of June 30, 2011, we had outstanding debt recorded on our consolidated balance sheet of
$12.8 million related to our 5.375% Notes and $91.4 million related to our 3.75% Notes. As the
interest rate on the 5.375% and 3.75% Notes is fixed, changes in interest rates do not affect the
value of our debt.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
As of June 30, 2011, our management conducted an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures, (as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) under the
supervision and with the participation of our chief executive officer and chief financial officer.
In designing and evaluating our disclosure controls and procedures, we and our management recognize
that any controls and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and our management necessarily
was required to apply its judgment in evaluating and implementing possible controls and procedures.
Based upon that evaluation of our disclosure controls and procedures as of June 30, 2011, our chief
executive officer and chief financial officer concluded that as of such date,
our disclosure controls and procedures were effective to provide reasonable assurance
that material information required to be disclosed in the reports that we file or submit
under the Exchange Act is recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commissions rules and forms, including ensuring that
such material information is accumulated and communicated to our management, including our chief
executive officer and our chief financial officer, as appropriate to allow timely
decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during
the three months ended June 30, 2011 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
In August 2010, Becton, Dickinson and Company, or BD, filed a lawsuit in the United States
District Court in the State of New Jersey against us alleging that
the OmniPod Insulin Management System (the OmniPod System) infringes
three of its patents. BD seeks a declaration that we have infringed its patents, equitable relief,
including an injunction that would enjoin us from infringing these patents, and an unspecified
award for monetary damages. We believe that the OmniPod System does not infringe these patents. We
do not expect this litigation to have a material adverse impact on our financial position or
results of operations. We believe we have meritorious defenses to this lawsuit; however, litigation
is inherently uncertain and there can be no assurance as to the ultimate outcome or effect of this
action.
We are, from time to time, involved in the normal course of business in various legal
proceedings, including intellectual property, contract employment and product liability suits.
Although we are unable to quantify the exact financial impact of any of these matters, we believe
that none of these currently pending matters will have an outcome material to our financial
condition or business.
Item 1A. Risk Factors
In addition to the other information set forth in this report, you should carefully consider
the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the
year ended December 31, 2010, which could materially affect our business, financial condition or
future results. These risks are not the only risks we face. Additional risks and uncertainties
not currently known to us or that we currently deem to be immaterial also may materially adversely
affect our business, financial condition and/or operating results. Except as set forth below,
there have been no material changes in our risk factors from those disclosed in our Annual Report
on Form 10-K for the year ended December 31, 2010.
We have updated or added the following risk factors to reflect our recent issuance of our
3.75% Convertible Senior Notes:
We may not be able to generate sufficient cash to service all of our indebtedness, which
currently consists of our 5.375% Convertible Senior Notes due June 15, 2013 and our 3.75%
Convertible Senior Notes due June 15, 2016. We may be forced to take other actions to satisfy
our obligations under our indebtedness or we may experience a financial failure.
Our ability to make scheduled payments or to refinance our debt obligations depends on our
financial and operating performance, which is subject to prevailing economic and competitive
conditions and to certain financial, business and other factors beyond our control. We cannot
assure you that we will maintain a level of cash flows from operating activities sufficient
to permit us to pay the principal, premium, if any, and interest on our indebtedness. If our
cash flows and capital resources are insufficient to fund our debt service obligations, we
may be forced to reduce or delay capital expenditures, sell assets or operations, seek
additional capital or restructure or refinance our indebtedness, including the notes. We
cannot assure you that we would be able to take any of these actions, that these actions
would be successful and permit us to meet our scheduled debt service obligations or that
these actions would be
27
permitted under the terms of our future debt agreements. In the
absence of sufficient operating results and resources, we could face substantial liquidity
problems and might be required to dispose of material assets or operations to meet our debt
service and other obligations. We may not be able to consummate those dispositions or obtain
sufficient proceeds from those dispositions to meet our debt service and other obligations
then due.
We may need to raise additional funds in the future, and these funds may not be available on
acceptable terms or at all.
Our capital requirements will depend on many factors, including:
|
|
|
revenue generated by sales of the OmniPod System and any other future products that we
may develop; |
|
|
|
|
costs associated with adding further manufacturing capacity, including capacity to
manufacture our next-generation product; |
|
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|
|
costs associated with expanding our sales and marketing efforts in the United States
and internationally; |
|
|
|
|
expenses we incur in manufacturing and selling the OmniPod System; |
|
|
|
|
costs of developing new products or technologies and enhancements to the OmniPod System; |
|
|
|
|
the cost of obtaining and maintaining FDA approval or clearance of our current or
future products; |
|
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|
costs associated with any expansion; |
|
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|
|
costs associated with capital expenditures; |
|
|
|
|
costs associated with litigation; and |
|
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|
the number and timing of any acquisitions or other strategic transactions. |
We believe that our current cash and cash equivalents, together with the cash to be generated
from expected product sales, will be sufficient to meet our projected operating requirements
for at least the next twelve months.
We may in the future seek additional funds from public and private stock offerings,
borrowings under credit lines or other sources. In December 2010, we sold 3.45 million shares
of our common stock at a price of $13.27 per share, resulting in net proceeds to us of
approximately $45.4 million. We used a portion of the net proceeds to repay amounts
outstanding under the Facility Agreement we entered into with certain institutional
accredited investors in March 2009, as amended in September 2009 and June 2010 and repaid in
December 2010. In addition, in June 2011 we issued $143.75 million of our 3.75% Convertible
Senior Notes and repurchased $70 million of our outstanding 5.375% Convertible
Senior Notes. The 3.75% Convertible Senior Notes will mature in June 2016 and the remaining
$15 million of our 5.375% Convertible Senior Notes will mature in June 2013. If
we issue equity or debt securities to raise additional funds, our existing stockholders may
experience dilution, and the new equity or debt securities may have rights, preferences and
privileges senior to those of our existing stockholders. In addition, if we raise additional
funds through collaboration, licensing or other similar arrangements, it may be necessary to
relinquish valuable rights to our potential future products or proprietary technologies, or
grant licenses on terms that are not favorable to us.
Our ability to raise additional capital may be adversely impacted by current economic
conditions, including the effects of the continued disruptions to the credit and financial
markets in the United States and worldwide. As a result of these and other factors, we do not
know whether additional capital will be available when needed, or that, if available, we will
be able to obtain future additional capital on terms favorable to us or our stockholders.
If we are unable to raise additional capital due to these or other factors, we may need to
further manage our operational expenses to reflect these external factors, including
potentially curtailing our planned development activities. If we cannot raise additional
funds in the future on acceptable terms, we may not be able to develop new products, execute
our business plan, take advantage of future opportunities or respond to competitive pressures
or unanticipated customer requirements. If any of these events occur, it could adversely
affect our business, financial condition and results of operations.
Future sales of shares of our common stock in the public market, or the perception that such
sales may occur, may depress the market price of our common stock.
28
We have been a public company only since May 2007. For much of this period, the average daily
trading volume of our common stock on The NASDAQ Global Market has been fewer than 300,000
shares.
In addition to our outstanding shares of common stock, we have recently issued $143.75
million of 3.75% Convertible Senior Notes. In addition, there are approximately $15 million
of our 5.375% Convertible Senior Notes outstanding. A substantial number of shares of our
common stock could potentially be issued upon the conversion of these Convertible Senior
Notes. The issuance of substantial amounts of common stock underlying the Convertible Senior
Notes, or the perception that such issuance may occur, could adversely affect the market
price of our common stock.
Furthermore, the price of our common stock also could be affected by possible sales of our
common stock by investors who view the Convertible Senior Notes as a more attractive means of equity participation in us and by
hedging or arbitrage trading activity that we expect will develop involving our common stock.
A decline in the price of shares of our common stock might impede our ability to raise
capital through the issuance of additional shares of our common stock or other equity
securities.
We, our directors and our executive officers are subject to lock-up agreements for a
period of 90 days after June 23, 2011, representing approximately 3.2 million shares, or
7.1%, of our outstanding common stock as of February 1, 2011. Following the termination of
this lock-up period, these stockholders will have the ability to sell a substantial number
of shares of common stock in the public market in a short period of time. Sales of a
substantial number of shares of common stock in the public trading markets, whether in a
single transaction or a series of transactions, or the perception that these sales may occur,
could also have a significant effect on volatility and market price of our common stock.
Conversion of any of our 3.75% Convertible Senior Notes or 5.375% Convertible Senior Notes
may dilute the ownership interest of existing stockholders.
The conversion of some or all of the 3.75% Convertible Senior Notes or the 5.375% Convertible
Senior Notes may dilute the ownership interests of existing stockholders. Any sales in the
public market of any of our common stock issuable upon such conversion could adversely affect
prevailing market prices of our common stock. In addition, the anticipated conversion of the
Convertible Senior Notes into a combination of cash and shares of our common stock could
depress the price of our common stock.
Our ability to use net operating loss carryforwards may be subject to limitation.
Section 382 of the U.S. Internal Revenue Code of 1986, as amended, imposes an annual limit on
the amount of net operating loss carryforwards that may be used to offset taxable income when
a corporation has undergone significant changes in its stock ownership or equity structure.
Our ability to use net operating losses may be limited by prior changes in our ownership, and
may be further limited by the issuance of common stock in connection with the conversion of
our Convertible Senior Notes, or by the consummation of other transactions. As a result, if
we earn net taxable income, our ability to use net operating loss carryforwards to offset
U.S. federal taxable income may become subject to limitations, which could potentially result
in increased future tax liabilities for we have.
We have added the following
risk factors as a result of our recent acquisition (the
Acquisition) of Neighborhood Holdings, Inc. and its wholly-owned subsidiaries (Neighborhood Diabetes). In addition to these
risks, Neighborhood Diabetes business is subject to risks that apply to our business relating to
the OmniPod System, including the risks associated with operating in a highly regulated environment
that is subject to numerous laws relating to patient protection and the safe, effective and
cost-efficient provision of medical products that are described in our Annual Report on Form 10-K
for the year ended December 31, 2010.
Competition among distributors in the diabetes testing supply and insulin pump and pump
supply market, as well as the broader healthcare industry, is significant and could impair
Neighborhood Diabetes ability to attract and retain clients.
Competition among distributors in the diabetes testing supply and insulin pump and pump
supply market, which Neighborhood Diabetes serves, is significant. Neighborhood Diabetes
competes with a wide variety of market participants, including national, regional and local
distributors such as Liberty Medical Supply Inc., CCS Medical,
Simplex Healthcare, Inc. and
Edgepark Medical Supplies. Neighborhood Diabetes competitors include many profitable and
well-established companies that have significantly greater financial, marketing and other
resources than we have.
Neighborhood Diabetes competes primarily on the basis of its high touch service model, which
we believe distinguishes it from other market participants. To attract new clients and retain
existing clients, Neighborhood Diabetes must continually provide quality services to its
clients and assist healthcare providers and insurers with managing their costs. We cannot be
sure that Neighborhood Diabetes will continue to remain competitive, nor can we be sure that
we will be able to market Neighborhood Diabetes distribution capabilities and services to
clients successfully.
Part of Neighborhood Diabetes ability to remain profitably competitive in winning and
retaining business relies on its ability to maintain reimbursement rates and product supply
costs in ranges that produce a positive sales margin. Decreased competition among
29
product manufacturers and payors may impact Neighborhood Diabetes ability to achieve favorable
terms. Neighborhood Diabetes largest payor partner, the Medicare Program, represented a
significant portion of Neighborhood Diabetes net sales for the
fiscal year ended June 30, 2010 and
the nine months ended March 31, 2011. Medicare reimbursement
rates are reset annually by the Centers for Medicare and Medicaid
Services (CMS)
and are typically subject to downward pressure. Significant reimbursement decreases by
Medicare without a corresponding ability to secure lower supply costs could materially and
adversely affect operations.
Consolidation of payor entities within the markets Neighborhood Diabetes serves, as well as
the consolidation of competitors, or suppliers could impair Neighborhood Diabetes ability to
attract and retain clients.
Certain of our leading competitors are key suppliers of Neighborhood Diabetes.
Certain
of our competitors that manufacture and sell insulin pumps and related supplies
that compete directly with the OmniPod System are key suppliers of Neighborhood Diabetes.
Revenue generated from these supply agreements accounted for a significant portion of
Neighborhood Diabetes net sales for the year ended June 30, 2010 and the nine months ended
March 31, 2011. In addition, Neighborhood Diabetes contracts with these competitors contain
change of control clauses that entitle them to terminate their supply agreements as a result
of the Acquisition. One of these competitors has reduced significantly its shipments to
Neighborhood Diabetes. Any advantages that we gain by our ability to market the OmniPod
System to Neighborhood Diabetes current patients could be outweighed by our inability to
preserve Neighborhood Diabetes relationships with its key suppliers. If these suppliers
terminate their supply agreements with Neighborhood Diabetes, or if they seek to renegotiate
them on less attractive terms, Neighborhood Diabetes financial condition, margins and
results of operations could be materially and adversely affected, which in turn could
materially and adversely affect our business and results of operations.
Failure to retain key payor partners and their members, either as a result of economic
conditions, increased competition or other factors, could result in significantly decreased
revenues and decreased profitability of the Neighborhood Diabetes business.
If several of Neighborhood Diabetes payor partners terminate, cancel or do not renew their
agreements with Neighborhood Diabetes or stop contracting with Neighborhood Diabetes for some
of the products Neighborhood Diabetes provides because they accept a competing proposal or
for any other reason, and Neighborhood Diabetes is not successful in generating new sales
with comparable operating margins to replace the lost business, Neighborhood Diabetes
revenues and results of operations could suffer, which in turn could materially and adversely
affect our revenues and results of operations.
In addition, Neighborhood Diabetes business may not be immune to the general risks and
uncertainties affecting many other companies, such as overall U.S. and non-U.S. economic and
industry conditions, global economic slowdown or geopolitical events. Neighborhood Diabetes
revenues and results of operations could suffer, for example, if employers drop healthcare
coverage for some or all of their employees, including retirees, as a result of weakness in
the economy, changes in law, rising costs or for any other reason, which in turn could
materially and adversely affect our revenues and results of operations.
Government efforts to reduce healthcare costs and alter healthcare financing practices could
lead to a decreased demand for Neighborhood Diabetes distribution services or to reduced
profitability.
During the past several years, the U.S. healthcare industry has been subject to an increase
in governmental regulation at both the federal and state levels. Efforts to control
healthcare costs, including prescription drug costs, are underway at the federal and state
government levels. The recently enacted healthcare reform legislation, along with associated
proposed and interim final rule-making, may have an adverse impact on Neighborhood Diabetes
business. For example, the federal Retiree Drug Subsidy is less valuable to Neighborhood
Diabetes clients due to the change in tax treatment of the subsidy. As a result,
Neighborhood Diabetes clients may choose to drop or limit retiree prescription drug
coverage. Further, private plan sponsors may react to the new laws and the uncertainty
surrounding them by reducing, foregoing or delaying engaging Neighborhood Diabetes to
distribute products. We cannot accurately predict the complete impact of healthcare reform
legislation, but it could lead to a decreased demand for Neighborhood Diabetes distribution
services and other outcomes that could adversely impact Neighborhood Diabetes business and
financial results, which in turn could materially and adversely impact our business and
financial results.
In addition, the healthcare reform legislation significantly increased regulation of managed
care plans and decreased reimbursement to Medicare managed care and fee-for-service programs.
Some of these initiatives purport to, among other things, require that health plan members
have greater access to drugs not included on a plans formulary. Moreover, to alleviate
budget shortfalls, states have reduced or frozen payments to Medicaid managed care plans.
While we expect the U.S. Congress and state legislatures to continue to consider legislation
affecting managed care plans, we cannot predict the extent of the impact of future
legislation on Neighborhood Diabetes. However, these initiatives could limit business
practices and impair Neighborhood Diabetes ability to serve its clients, which could in turn
materially and adversely affect our business and results of operations.
30
If Neighborhood Diabetes does not continue to earn and retain purchase discounts and rebates
from manufacturers at current levels, gross margins may decline, which could adversely affect
our business and results of operations.
Neighborhood Diabetes has contractual relationships with product device manufacturers,
pharmaceutical manufacturers and wholesalers that provide Neighborhood Diabetes with purchase
discounts and rebates on products distributed by Neighborhood Diabetes and drugs dispensed
from Neighborhood Diabetes mail-order pharmacies. These discounts and rebates are
generally passed on to payors in the form of lower contracted reimbursement rates.
Manufacturer rebates often depend on Neighborhood Diabetes ability to meet contractual
market share or other requirements.
Neighborhood Diabetes payor partners often have contractual rights relating to their
formulary structure, and while Neighborhood Diabetes programs aim to maximize savings to payors, they are often making specific choices
regarding which products and drugs to place on their formularies. Neighborhood Diabetes
profitability can be impacted by these payor decisions. In addition, the pharmaceutical
industry (both manufacturers of brand-name drugs, as well as generic drugs) continues to
consolidate and this may impact Neighborhood Diabetes drug purchasing costs and
profitability.
Changes in existing federal or state laws or regulations or in their interpretation by courts
and agencies or the adoption of new laws or regulations (such as the Patient Protection and
Affordable Care Act enacted on March 23, 2010) relating to patent term extensions, purchase
discount and rebate arrangements with manufacturers, as well as some of the other services
Neighborhood Diabetes provides to manufacturers, could also reduce the discounts or rebates
Neighborhood Diabetes receives and adversely impact its business, financial condition,
liquidity and operating results, which in turn could materially and adversely affect our
business and results of operations.
Neighborhood Diabetes business is dependent on its relationships with a limited number of
suppliers and health plans. As such, the loss of one or more of these relationships, could
significantly impact our ability to sustain and/or improve our financial performance.
Neighborhood Diabetes derives a significant percentage of its net sales and profitability
from its relationships with a limited number of suppliers and payors. Neighborhood Diabetes
agreements with its suppliers and payors may be short-term and cancelable by either party
without cause on 30 to 365 days prior notice. These agreements may limit Neighborhood
Diabetes ability to provide distribution services for competing products during the term of
the agreement and allow the supplier to distribute through channels other than Neighborhood
Diabetes. Further, certain of these agreements allow pricing and other terms of these
relationships to be periodically adjusted for changing market conditions or required service
levels. A termination or modification to any of these relationships could have a material
adverse effect on Neighborhood Diabetes business, financial condition and results of
operations, which in turn could have a material and adverse effect on
our business and results of operations.
Neighborhood Diabetes has received a significant percentage of its historical net sales from
Medicare reimbursement. Medicare reimbursement rates are reset annually by CMS and are
typically subject to downward pressure. Furthermore, the Medicare Program is able to reset
reimbursement rates and terminate contracts at will. In addition, participation in the
Medicare program requires strict compliance to a complex set of regulatory requirements.
Failure by Neighborhood Diabetes to meet those requirements could result in the loss of the ability to participate as a
Medicare supplier, which could have an adverse effect on our business and results of
operations.
Certain revenues from diabetes testing supplies and Neighborhood Diabetes Medicare Part D
offerings expose Neighborhood Diabetes to increased billing, cash application and credit
risks. Additionally, current economic conditions may expose Neighborhood Diabetes to
increased credit risk.
Net sales from Neighborhood Diabetes distribution of diabetes testing supplies depend on the
continued availability of reimbursement by government and private insurance plans. The
governments Medicare regulations are complex and, as a result, the billing and collection
process is time-consuming and typically involves the submission of claims to multiple payors
whose payment of claims may be contingent upon the payment of another payor. Because of the
coordination with multiple payors and the complexity in determining reimbursable amounts,
these accounts receivable have higher risk in collecting the full amounts due and applying
the associated payments.
The Medicare Part D product offerings that Neighborhood Diabetes distributes require premium
payments from members for receipt of ongoing benefit, as well as amounts due from CMS. As a result
of the demographics of the consumers covered under these programs and the complexity of the
calculations, as well as the potential magnitude and timing of settlement for amounts due
from CMS, these accounts receivable are subject to heightened billing and realization risk.
Additionally, Neighborhood Diabetes may be subject to increased credit risk associated with
state and local government agencies experiencing increased fiscal challenges. As a result of
these aforementioned risks, Neighborhood Diabetes may be required to record bad debt
expenses, which could materially and adversely affect our results of operations and
liquidity.
31
The implementation of a national-mail order competitive bid program by CMS could negatively
affect Neighborhood Diabetes operating results.
Relative to Neighborhood Diabetes diabetes testing supplies business, the Durable Medical
Equipment, Prosthetics, Orthotics and Supplies Competitive Bid Program, or the
Program, provides for a phased-in program for competitive bidding on certain durable medical
equipment items, including mail-order diabetes testing supplies. In July 2010, as part of the
Program, CMS announced new single payment amounts for diabetes testing supplies, which
averaged 56% off the current fee schedule amounts for such supplies under round one.
The new limited single pay amounts impact a limited number of geographic areas. Neighborhood Diabetes bid was not aligned
with these single payment amounts. In November 2010, CMS announced the names of the winners for
round one, for which reimbursement rates became effective January 2011 for the limited number of
geographic areas. Although Neighborhood Diabetes will not be a contracted supplier in the
competitively bid areas, round one of the Program affects a small portion of Neighborhood
Diabetes base membership. However, Congressional action has provided CMS with additional
authority to use pricing information gathered during the Program for purposes of establishing
reimbursement rates in geographic areas not subject to competitive bidding. CMS also
announced in November 2010 some general parameters relating to a national mail-order
competitive bid program. While CMS implementation of a national mail-order competitive bid
program is not expected until at least 2013, if such a program is implemented and depending
upon the level of reduction in reimbursement rates of the final bid program, Neighborhood
Diabetes operating results could be materially and adversely affected, which in turn could
materially and adversely affect our operating results.
We will incur significant transaction, integration and other costs in connection with the
Acquisition and these costs may exceed the realized benefits, if any, of the synergies and
efficiencies from the Acquisition.
We have incurred significant transaction costs related to the Acquisition. In addition, we
will incur integration costs as we integrate the Neighborhood Diabetes business with our
own. Financial, managerial and operational challenges of the Acquisition may include:
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disruption of our ongoing businesses and diversion of management attention; |
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difficulties in integrating Neighborhood Diabetes products and technologies; |
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risks associated with acquiring intellectual property; |
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difficulties in operating Neighborhood Diabetes profitably; |
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the inability to achieve anticipated synergies, cost savings or growth; |
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potential loss of key employees, particularly those of Neighborhood Diabetes; |
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difficulties in transitioning and maintaining key customer, distributor and supplier
relationships; |
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risks associated with entering markets in which we have no or limited prior experience; |
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unanticipated costs; and |
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potential disputes with the sellers of Neighborhood Diabetes. |
No assurances can be given that the expected benefit of synergies and efficiencies of the
Acquisition will exceed the transaction and integration costs and the costs associated with
these potential financial, managerial and operational challenges, or that expected benefits
and synergies and efficiencies will be achieved in the near term or at all.
Certain of Neighborhood Diabetes contracts with its key partners contain change of control
clauses, and we may be unable to obtain the consents that are required to be given under such
contracts in connection with the Acquisition.
Neighborhood Diabetes agreements with certain of its partners contain change of control
clauses that could allow its contractual counterparties to terminate their commercial
relationships with Neighborhood Diabetes as a result of the Acquisition. These agreements
include Neighborhood Diabetes supply agreements with certain blood glucose testing supply
manufacturers and pump and pump supply companies. If any portion of these companies whose
agreements with Neighborhood Diabetes generate a significant portion of Neighborhood
Diabetes net sales terminate their relationships with Neighborhood Diabetes, it could have a
material adverse effect on Neighborhood Diabetes business, financial condition and results
of operations, which in turn could materially and adversely affect our business and results
of operations.
32
Neighborhood Diabetes may have unknown liabilities or liabilities which exceed our estimates.
Any such liabilities could adversely affect the financial position of the combined company.
Neighborhood Diabetes primary business activities center around the sale of diabetes related
products, equipment and pharmaceuticals in the Eastern United States. These activities may
have associated with them various potential liabilities relating to the conduct of its
business prior to the Acquisition, including, but not limited to, product liability,
liability for unpaid taxes, claims by governmental or regulatory authorities or third parties regarding the marketing and
distribution of, or the reimbursement for the sale of its products and other potential
liabilities that could adversely affect the financial position of the combined company. Upon
consummating the Acquisition on June 1, 2011, we assumed these potential liabilities. While
we have evaluated and continue to evaluate what we believe to be the most significant of
these potential liabilities, it is possible that certain unknown liabilities could be
realized and other liabilities (including those that we have fully evaluated and those that
we have not fully evaluated) may exceed our estimates. Further adjustments may be made to our
preliminary pro forma purchase price to account for adjustments based on the completion of the
final valuation of the Acquisition and other reviews. Specifically, we will complete a
valuation of Neighborhood Diabetes fixed assets and intangible assets and evaluation of
contingent liabilities, and our final valuation may include the realization or quantification
of contingent liabilities that are currently not included in the preliminary pro forma
purchase price adjustments, which could adversely affect the financial position of the
combined company.
33
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. (Removed and Reserved)
Item 5. Other Information
None.
Item 6. Exhibits
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Exhibit |
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Number |
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Description of Document |
2.1
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Merger Agreement by and among the Company, Nectar Acquisition I Corporation, a
Delaware corporation and wholly-owned subsidiary of the Company, and Neighborhood
Holdings, Inc., a Delaware corporation, and its subsidiaries dates as of June 1,
2011 (previously filed as Exhibit 2.1 to the Registrants Current Report on Form 8-K
filed May 5, 2011 and incorporated herein by reference). |
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4.1
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Indenture, dated as of June 29, 2011, between Insulet Corporation and Wells Fargo
Bank, National Association, as Trustee (previously filed as Exhibit 4.1 to the
Registrants Current Report on Form 8-K filed on July 5, 2011 and incorporated by
reference herein) |
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4.2
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Form of 3.75% Convertible Senior Notes due 2016 (included in Exhibit 4.1) |
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31.1
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Certification of Duane DeSisto, President and Chief Executive Officer, pursuant to
Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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31.2
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Certification of Brian Roberts, Chief Financial Officer, pursuant to Rule 13a-14(a)
and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1
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Certification of Duane DeSisto, President and Chief Executive Officer, and Brian
Roberts, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101§
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The following financial statements from Insulet Corporations Quarterly Report on
Form 10-Q for the quarter ended June 30, 2011, as filed with the SEC on August 9,
2011, formatted in XBRL (eXtensible Business Reporting Language), as follows: |
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(i) Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010 (Unaudited) |
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(ii) Consolidated Statements of Operations for the Three and Six Months Ended June
30, 2011 and June 30, 2010 (Unaudited) |
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(iii) Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2011
and June 30, 2010 (Unaudited) |
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(iv) Notes to Condensed Consolidated Financial Statements (Unaudited) |
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§ |
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As provided in Rule 406T of Regulation S-T, this information is
furnished and not filed for purposes of Sections 11 and 12 of the
Securities Act of 1933, as amended, and Section 18 of the
Securities Exchange Act of 1934, as amended. |
34
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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INSULET CORPORATION
(Registrant)
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Date: August 9, 2011 |
/s/ Duane DeSisto
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Duane DeSisto |
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President and Chief Executive Officer
(Principal Executive Officer) |
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Date: August 9, 2011 |
/s/ Brian Roberts
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Brian Roberts |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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35
EXHIBIT INDEX
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Exhibit |
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Number |
|
Description of Document |
2.1
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|
Merger Agreement by and among the Company, Nectar Acquisition I Corporation, a
Delaware corporation and wholly-owned subsidiary of the Company, and Neighborhood
Holdings, Inc., a Delaware corporation, and its subsidiaries dates as of June 1,
2011 (previously filed as Exhibit 2.1 to the Registrants Current Report on Form 8-K
filed May 5, 2011 and incorporated herein by reference). |
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4.1
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Indenture, dated as of June 29, 2011, between Insulet Corporation and Wells Fargo
Bank, National Association, as Trustee (previously filed as Exhibit 4.1 to the
Registrants Current Report on Form 8-K filed on July 5, 2011 and incorporated by
reference herein) |
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4.2
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Form of 3.75% Convertible Senior Notes due 2016 (included in Exhibit 4.1) |
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31.1
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Certification of Duane DeSisto, President and Chief Executive Officer, pursuant to
Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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31.2
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Certification of Brian Roberts, Chief Financial Officer, pursuant to Rule 13a-14(a)
and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1
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Certification of Duane DeSisto, President and Chief Executive Officer, and Brian
Roberts, Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
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|
101§
|
|
The following financial statements from Insulet Corporations Quarterly Report on
Form 10-Q for the quarter ended June 30, 2011, as filed with the SEC on August 9,
2011, formatted in XBRL (eXtensible Business Reporting Language), as follows: |
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(i) Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010 (Unaudited) |
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|
(ii) Consolidated Statements of Operations for the Three and Six Months Ended June
30, 2011 and June 30, 2010 (Unaudited) |
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(iii) Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2011
and June 30, 2010 (Unaudited) |
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(iv) Notes to Condensed Consolidated Financial Statements (Unaudited) |
|
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§ |
|
As provided in Rule 406T of Regulation S-T, this information is
furnished and not filed for purposes of Sections 11 and 12 of the
Securities Act of 1933, as amended, and Section 18 of the
Securities Exchange Act of 1934, as amended. |
36