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, 2008
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 Number) |
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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 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. (Check one):
Large accelerated filer o |
Accelerated filer o |
Non-accelerated filer þ (Do not
check if a smaller reporting company) |
Smaller reporting company o |
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 11, 2008, the registrant had 27,707,824 shares of common stock outstanding.
INSULET CORPORATION
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2008
TABLE OF CONTENTS
(i)
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
INSULET CORPORATION
CONDENSED 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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2008 |
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2007 |
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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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$ |
99,108 |
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$ |
94,588 |
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Accounts receivable, net |
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9,760 |
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4,783 |
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Inventories |
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13,336 |
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7,990 |
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Prepaid expenses and other current assets |
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2,748 |
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1,391 |
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Total current assets |
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124,952 |
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108,752 |
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Property and equipment, net |
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26,244 |
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21,304 |
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Other assets |
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3,377 |
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685 |
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Total assets |
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$ |
154,573 |
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$ |
130,741 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
5,984 |
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$ |
4,544 |
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Accrued expenses |
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7,869 |
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4,464 |
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Deferred revenue |
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1,681 |
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1,350 |
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Current portion of long-term debt |
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10,671 |
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Total current liabilities |
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15,534 |
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21,029 |
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Long-term debt, net of current portion |
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85,000 |
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16,006 |
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Other long-term liabilities |
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2,748 |
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1,431 |
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Total liabilities |
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103,282 |
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38,466 |
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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, 2008 and
December 31, 2007. Issued and outstanding: zero shares at June 30, 2008 and
December 31, 2007, respectively |
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Common stock, $.001 par value: |
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Authorized:
100,000,000 shares at June 30, 2008 and December 31, 2007
Issued and outstanding: 27,704,110 and 27,223,820 shares at June
30, 2008 and December 31, 2007, respectively |
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28 |
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28 |
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Additional paid-in capital |
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250,598 |
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247,835 |
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Accumulated deficit |
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(199,335 |
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(155,579 |
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Subscription receivable |
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(9 |
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Total stockholders equity |
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51,291 |
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92,275 |
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Total liabilities and stockholders equity |
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$ |
154,573 |
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$ |
130,741 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
INSULET CORPORATION
CONDENSED 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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2008 |
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2007 |
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2008 |
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2007 |
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(In thousands, except share and per share data) |
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(Unaudited) |
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Revenue |
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$ |
7,417 |
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$ |
3,212 |
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$ |
14,088 |
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$ |
5,220 |
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Cost of revenue |
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9,785 |
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6,899 |
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19,783 |
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11,471 |
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Gross loss |
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(2,368 |
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(3,687 |
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(5,695 |
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(6,251 |
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Operating expenses: |
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Research and development |
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3,382 |
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2,520 |
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6,306 |
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4,990 |
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General and administrative |
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5,395 |
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2,798 |
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10,592 |
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5,457 |
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Sales and marketing |
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10,994 |
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3,404 |
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19,559 |
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6,508 |
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Total operating expenses |
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19,771 |
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8,722 |
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36,457 |
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16,955 |
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Operating loss |
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(22,139 |
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(12,409 |
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(42,152 |
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(23,206 |
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Interest income |
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360 |
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713 |
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1,073 |
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1,017 |
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Interest expense |
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(2,103 |
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(986 |
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(2,677 |
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(1,969 |
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Net interest income (expense) |
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(1,743 |
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(273 |
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(1,604 |
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(952 |
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Change in value of preferred stock warrant liability |
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10 |
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(74 |
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Net loss |
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(23,882 |
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(12,672 |
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(43,756 |
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(24,232 |
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Net loss per share basic and diluted |
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$ |
(0.87 |
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$ |
(0.99 |
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$ |
(1.59 |
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$ |
(3.63 |
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Weighted average number of shares used in
calculating basic and diluted net loss per share |
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27,568,296 |
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12,791,190 |
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27,481,292 |
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6,671,807 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
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Six Months Ended |
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June 30, |
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2008 |
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2007 |
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(In thousands) |
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(Unaudited) |
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Cash flows from operating activities |
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Net loss |
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$ |
(43,756 |
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$ |
(24,232 |
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Adjustments to reconcile net loss to net cash used in operating activities |
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Depreciation |
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2,884 |
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2,019 |
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Amortization of debt discount |
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596 |
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119 |
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Redeemable convertible preferred stock warrant expense |
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74 |
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Stock compensation expense |
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1,658 |
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507 |
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Provision for bad debts |
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1,122 |
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389 |
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Non cash interest expense |
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684 |
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(57 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(6,099 |
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(1,605 |
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Inventory |
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(5,346 |
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(739 |
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Prepaids and other current assets |
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(1,357 |
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579 |
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Other assets |
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9 |
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(546 |
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Accounts payable and accrued expenses |
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4,845 |
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696 |
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Other long term liabilities |
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2,217 |
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918 |
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Deferred revenue, short term |
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331 |
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479 |
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Net cash used in operating activities |
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(42,212 |
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(21,399 |
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Cash flows from investing activities |
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Purchases of property and equipment |
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(7,824 |
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(5,510 |
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Net cash used in investing activities |
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(7,824 |
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(5,510 |
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Cash flows from financing activities |
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Principal payments of long term loan |
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(5,454 |
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Net proceeds from convertible note offering |
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81,615 |
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Redemption of long term loan |
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(22,719 |
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Proceeds from issuance of common stock, net of offering expenses |
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1,105 |
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113,496 |
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Proceeds from payment of subscription receivable |
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9 |
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Net cash provided by financing activities |
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54,556 |
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113,496 |
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Net decrease in cash and cash equivalents |
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4,520 |
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86,587 |
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Cash and cash equivalents, beginning of period |
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94,588 |
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33,231 |
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Cash and cash equivalents, end of period |
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$ |
99,108 |
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$ |
119,818 |
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Supplemental disclosure of cash flow information |
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Cash paid for interest |
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$ |
1,746 |
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$ |
1,472 |
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Non-cash financing activities |
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Conversion of preferred stock to common stock upon initial public offering |
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$ |
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$ |
119,509 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
INSULET CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of Business
Insulet Corporation (the Company) is principally engaged in the development, manufacture,
marketing and selling 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
developing, manufacturing, marketing and selling 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 May 2007, the Company completed an initial
public offering of its common stock.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial information and with
the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include
all of the information and footnotes required by U.S. generally accepted accounting principles 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, 2008 are not necessarily indicative of
the results that may be expected for the full year ending December 31, 2008, or for any other
subsequent interim period.
The condensed consolidated financial statements 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, 2007.
Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with generally accepted accounting
principles in the United States 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 and stock options, the lives of property and equipment, and warranty and
doubtful account allowance calculations. Actual results may differ from those estimates.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned
subsidiary, Sub-Q Solutions, Inc. All material inter-company balances and transactions have been
eliminated in consolidation. To date there has been no activity in Sub-Q Solutions, Inc.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable consist of amounts due from third-party payors and patients. In estimating
whether accounts receivable can be collected, the Company performs evaluations of customers and
continuously monitors collections and payments and estimates an allowance for doubtful accounts
based on the aging of the underlying invoices, experience to date and any payor specific collection
issues that have been identified.
4
Inventories
Inventories are stated at the lower of cost or market, determined under the first-in,
first-out (FIFO) method. Prior to June 30, 2008, inventory was recorded at market value as the
Company currently sells the OmniPod at a loss. As of June 30, 2008, the Companys inventory of
finished OmniPods was presented at cost, as the costs to produce OmniPod were lower than the
Companys selling price in the three months ended June 30, 2008. Work in process is calculated
based upon the stage of completion using estimated labor inputs for each stage in production.
Costs for PDMs and OmniPods include raw materials, labor and manufacturing overhead. The Company
evaluates inventory valuation on a quarterly basis for excess, obsolete or slow-moving items.
Property & 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.
Impairment of Property & Equipment
The Company reviews the carrying value of its property and equipment to assess the
recoverability of these assets whenever events indicate that impairment may have occurred. As part
of this assessment, the Company reviews the future undiscounted operating cash flows expected to be
generated by those assets. If impairment is indicated through this review, the carrying amount of
the asset would be reduced to its estimated fair value.
Revenue Recognition
The Company generates revenue from sales of its OmniPod Insulin Management System to diabetes
patients. The initial sale to a new customer typically includes OmniPods and a Starter Kit, which
is comprised of the PDM, two OmniPods, the OmniPod System User Guide and the OmniPod System
Interactive Training CD. Subsequent sales to existing customers typically consist of additional
OmniPods.
Revenue is recognized in accordance with Staff Accounting Bulletin No. 104, Revenue
Recognition in Financial Statements (SAB 104), which 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:
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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. |
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Transfer of title and risk and rewards of ownership are passed to the patient upon
the patients receipt of the products. |
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The selling prices for all sales are fixed and agreed with the patient, 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 has considered the requirements of Emerging Issues Task Force (EITF) 00-21,
Revenue Arrangements with Multiple Deliverables, when accounting for the OmniPods and Starter Kits.
EITF 00-21 requires the Company to assess whether the different elements qualify for separate
accounting. The Company recognizes revenue for the initial shipment to a patient or other third
party once all elements have been delivered.
The Company offers a 45-day right of return for its Starter Kits sales, and, in accordance
with SFAS No.
5
48, Revenue Recognition When the Right of Return Exists, the Company defers revenue to reflect
estimated sales returns in the same period that the related product sales are recorded. Returns
are estimated through comparison of the Companys 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, the
Company defers revenue from sales of products to those customers until payment is received.
Prior to January 1, 2008, the Company deferred the revenue and related costs of revenue for
all initial shipments until the 45-day right of return had lapsed. With the accumulation of
approximately 2 years of data for sales and return rates, the Company concluded that it had
sufficient historical data on which to base its estimated returns from January 1, 2008. If the
Company had continued to defer all initial shipments until the 45-day right of return had expired,
deferred revenue as of June 30, 2008 would have been larger by $1,080,000 compared to the amount
recorded as of June 30, 2008.
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 the agreement fee from
Abbott over the 5-year term of the agreement, and the non-current portion of the agreement fee is
included in other long-term liabilities.
The Company had deferred revenue of $1,681,000 and $1,350,000 as of June 30, 2008 and December
31, 2007, respectively. The deferred revenue recorded as of June 30, 2008 was comprised of product
related revenue as well as the current portion of the agreement fee related to the Abbott
agreement.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk primarily consist of cash and
cash equivalents. The Company maintains the majority of its cash with one accredited financial
institution.
Although revenue is recognized from shipments directly to patients, the majority of shipments
are billed to third party insurance payors. As of June 30, 2008, the two largest third party
payors accounted for 8% and 7% of gross accounts receivable balances, respectively. As of December
31, 2007, the two largest third party payors accounted for 8% and 4% of gross accounts receivable
balances, respectively.
Income Taxes
The Company files federal and state tax returns. 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, 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, 2008, the Company had no interest and penalty accrual or expense.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). This
standard defines fair value, establishes a framework for measuring fair value in accounting
principles generally accepted in the United States, and expands disclosure about fair value
measurements. This pronouncement applies under other accounting standards that require or permit
fair value measurements. Accordingly, this statement does not require any new fair value
measurement. This statement is effective for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. The Company adopted SFAS 157 in the first quarter of
6
fiscal year 2008. The adoption of SFAS 157 did not have a material effect on the Companys
financial position, results of operations, or cash flows.
In February 2007, the FASB issued SFAS No. 159, Fair Value Option for Financial Assets and
Financial Liabilities Including an amendment of FASB Statement 115 (SFAS 159), which permits
entities to choose to measure many financial instruments and certain other items at fair value.
SFAS 159 is effective as of the beginning of an entitys first fiscal year that begins after
November 15, 2007. The adoption of SFAS 159 did not have a material effect on the Companys
financial position, results of operations, or cash flows.
In February 2008, the FASB issued FASB Staff Position FAS 157-2, Effective Date of FASB
Statement No. 157 (FSP FAS 157-2). FSP FAS 157-2 delays the effective date of SFAS 157 to fiscal
years beginning after November 15, 2008 for all non-financial assets and non-financial liabilities,
except those that are recognized or disclosed at fair value in the financial statements on a
recurring basis, at least annually. FSP FAS 157-2 is effective for fiscal years beginning after
September 1, 2009. The adoption of FSP FAS 157-2 is not expected to have a material impact on the
Companys financial position, results of operations, or cash flows.
In May 2008, the FASB issued Staff Position No. Accounting Principles Board 14-1, Accounting
for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial
Cash Settlement) (FSP APB 14-1), which is effective for fiscal years beginning after December 15,
2008. FSP APB 14-1 clarifies that convertible debt instruments that may be settled in cash upon
conversion are not addressed by paragraph 12 of Accounting Principles Board Opinion No. 14,
Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants. FSP APB 14-1 also
specifies that issuers of such instruments should separately account for the liability and equity
components in a manner that will reflect the entitys nonconvertible debt borrowing rate when
interest cost is recognized in subsequent periods. The Company is currently evaluating the effect
of FSP APB 14-1 and it has not yet determined the impact of the standard on its financial position
or results of operations.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles. This standard identifies the sources of accounting principles and the framework for
selecting the principles to be used in the preparation of financial statements that are presented
in conformity with generally accepted accounting principles in the United States. The standard is
effective 60 days following the SECs approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, The Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles. The Company is currently evaluating the potential effect of implementing
this standard.
3. Convertible Notes and Repayment and Termination of Term Loan
In June 2008, the Company sold $85 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, beginning December 15, 2008. 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
7
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 incurred interest expense of approximately $190,000 for the three months ended
June 30, 2008, related to the 5.375% Notes. The Company incurred deferred financing costs related
to this offering of approximately $3.4 million, which are recorded in the condensed consolidated
balance sheet and are being amortized as a component of interest expense over the five year term of
the notes.
The Company received net proceeds of approximately $81.6 million from this offering.
Approximately $23.2 million of the proceeds from this offering were used to repay and terminate the
Companys outstanding term loan and the Company intends to use the remainder for general corporate
purposes. On June 16, 2008, the Company repaid the entire outstanding principal balance, plus
accrued and unpaid interest, under its existing term loan in the aggregate of approximately $21.8
million. Additionally, the Company paid a prepayment fee related to the term loan of approximately
$436,000, a termination fee related to the term loan of $900,000, and incurred certain other
expenses related to the repayment and termination of the term loan. The Company incurred interest
expense of approximately $858,000 and $1.5 million for the three and six months ended June 30,
2008, respectively, and approximately $858,000 and $1.7 million for the three and six months ended
June 30, 2007 respectively, related to the term loan. The term loan was subject to a loan
origination fee of $900,000, which was recorded in the condensed consolidated balance sheet and was
amortized as a component of interest expense over the term of the loan. The remaining balance of
deferred financing costs of approximately $570,000 was written off at the repayment and termination
date. In connection with this term loan, the Company issued warrants to the lenders to purchase up
to 247,252 shares of Series E preferred stock at a purchase price of $3.64 per share. The warrants
automatically converted into warrants to purchase common stock on a 1-for-2.6267 basis at a
purchase price of $9.56 per share at the closing of the Companys initial public offering. The
Company recorded the $835,000 fair value of the warrants as a discount to the term loan. Upon
repayment and termination of the term loan, the Company recognized approximately $497,000 as
interest expense for the unamortized balance of the warrants fair value. The difference between
the amount paid, including the prepayment fee, and the carrying value of the term loan, including
the remaining deferred financing costs and unamortized warrants to purchase common stock, was
recognized as a $1.5 million loss from early extinguishment of the term loan.
4. Net Loss Per Share
Basic net loss per share is computed by dividing net loss attributable to common stockholders
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
and warrants (using the treasury-stock 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, 2008 and 2007, respectively, all potential common shares have been
excluded from the computation of the dilutive 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 Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Convertible notes |
|
|
3,981,970 |
|
|
|
|
|
|
|
3,981,970 |
|
|
|
|
|
Outstanding options |
|
|
2,863,384 |
|
|
|
2,511,691 |
|
|
|
2,863,384 |
|
|
|
2,765,148 |
|
Outstanding warrants |
|
|
62,752 |
|
|
|
219,981 |
|
|
|
62,752 |
|
|
|
204,293 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
6,908,106 |
|
|
|
2,731,672 |
|
|
|
6,908,106 |
|
|
|
2,969,441 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares contingently issued under the Companys employee stock purchase plan (ESPP) are
presented as
8
issued and outstanding. As of June 30, 2008, the Company had 5,995 shares
contingently issued under its ESPP.
5. Accounts Receivable
The components of accounts receivable are as follows:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
Trade receivables |
|
$ |
11,518 |
|
|
$ |
5,992 |
|
Allowance for doubtful accounts |
|
|
(1,758 |
) |
|
|
(1,209 |
) |
|
|
|
|
|
|
|
|
|
$ |
9,760 |
|
|
$ |
4,783 |
|
|
|
|
|
|
|
|
6. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
Raw materials |
|
$ |
3,882 |
|
|
$ |
2,994 |
|
Work-in-process |
|
|
1,473 |
|
|
|
1,583 |
|
Finished goods |
|
|
7,981 |
|
|
|
3,413 |
|
|
|
|
|
|
|
|
|
|
$ |
13,336 |
|
|
$ |
7,990 |
|
|
|
|
|
|
|
|
Inventories of finished goods were adjusted by $18,000 and $625,000 as of June 30, 2008 and
December 31, 2007, respectively, to reflect values at the lower of cost or market. As of June 30,
2008 and December 31, 2007, 3% and 43%, respectively, of the reported finished goods inventory was
valued below the Companys cost. The Companys production process has a high degree of fixed costs
due to the early stage of capacity build-up and market penetration of its products. Prior to June
30, 2008, sales and production volumes were not adequate to result in per-unit costs that are lower
than the current market price for the OmniPod. As of June 30, 2008, the Companys inventory of
finished OmniPods was recorded at cost, and the adjustment to lower of cost or market is solely
related to PDMs.
7. Product Warranty Costs
The Company provides a four-year warranty on its PDMs and replaces 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 follows:
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Balance at the beginning of period |
|
$ |
1,096 |
|
|
$ |
279 |
|
|
$ |
865 |
|
|
$ |
193 |
|
Warranty expense |
|
|
1,053 |
|
|
|
352 |
|
|
|
1,769 |
|
|
|
620 |
|
Warranty claims settled |
|
|
(649 |
) |
|
|
(239 |
) |
|
|
(1,134 |
) |
|
|
(421 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
|
$ |
1,500 |
|
|
$ |
392 |
|
|
$ |
1,500 |
|
|
$ |
392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Composition of balance: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term |
|
|
647 |
|
|
|
225 |
|
|
|
647 |
|
|
|
225 |
|
Long-term |
|
|
853 |
|
|
|
167 |
|
|
|
853 |
|
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total warranty balance |
|
$ |
1,500 |
|
|
$ |
392 |
|
|
$ |
1,500 |
|
|
$ |
392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8. Commitments and Contingencies
Operating Leases
The Company leases its facilities, which 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.
In March 2008, the Company extended the lease of its Bedford, Massachusetts headquarters
facility containing office, research and development and manufacturing space. Following the
extension, the lease expires in September 2014. The lease is non-cancellable and contains a
five-year renewal option and escalating payments over the life of the lease.
In February 2008, the Company entered into a non-cancellable lease for additional office space
in Bedford, Massachusetts. The lease expires in February 2013, and provides a renewal option of
five years and escalating payments over the life of the lease.
The Company also leases warehouse facilities in Billerica, Massachusetts. This lease expires
in December 2012.
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
long-term liabilities in the accompanying balance sheet. The Company has considered FASB Technical
Bulletin 88-1, Issues Relating to Accounting for Leases, and FASB Technical Bulletin 85-3,
Accounting for Operating Leases with Scheduled Rent Increases, in accounting for these lease
provisions.
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.
10
9. Equity
On April 12, 2007, the Companys Board of Directors approved a 1-for-2.6267 reverse stock
split of the Companys common stock, which was executed on May 10, 2007. All share and per share
amounts of common and preferred stock in the accompanying condensed consolidated financial
statements have been restated for all periods to give retroactive effect to the stock split.
In the three and six months ended June 30, 2008, 165,317 and 474,295 common shares were issued
related to exercises of employee stock options, respectively.
Stock-Based Compensation Plans
Activity under the Companys Stock Option Plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Intrinsic |
|
|
|
Options (#) |
|
|
Price ($) |
|
|
Value ($) |
|
|
|
|
Balance, December 31, 2007 |
|
|
2,691,973 |
|
|
|
6.94 |
|
|
|
|
|
Granted |
|
|
719,829 |
|
|
|
17.32 |
|
|
|
|
|
Exercised |
|
|
(474,295 |
) |
|
|
2.19 |
|
|
|
7,317,490 |
(1) |
Canceled |
|
|
(74,123 |
) |
|
|
16.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2008 |
|
|
2,863,384 |
|
|
|
10.13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested, June 30, 2008 |
|
|
1,256,182 |
|
|
|
4.32 |
|
|
|
14,333,037 |
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, June 30, 2008 (3) |
|
|
2,519,778 |
|
|
|
|
|
|
|
|
|
|
|
|
(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, 2008, and the exercise price of
the underlying options. |
|
(3) |
|
Represents the number of vested options as of June 30, 2008, plus the number of unvested
options expected to vest as of June 30, 2008, based on the unvested options outstanding at
June 30, 2008, adjusted for an estimated forfeiture rate of 12%. |
In the three and six months ended June 30, 2008, 5,995 shares were contingently issued under
the employee stock purchase plan (ESPP). No shares were contingently issued for the ESPP in the
three and six months ended June 30, 2007. In the three and six months ended June 30, 2008, the
Company recorded compensation charges of approximately $7,000 and $14,000, respectively, of stock
compensation charges related to the ESPP. For the three and six months ended June 30, 2007, the
Company recognized no compensation charges related to the ESPP.
Employee stock-based compensation expense under SFAS 123R recognized in the three and six
month ended June 30, 2008 was $984,000 and $1,658,000, respectively. For the three and six months
ended June 30, 2007, the Company recognized approximately $298,000 and $507,000, respectively.
10. 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.
11
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 selected financial data, our financial statements and the accompanying
notes to those financial statements included in this Quarterly Report on Form 10-Q. These
forward-looking statements are based on our current expectations and beliefs concerning future
developments and their potential effects on it. There can be no assurance that future developments
affecting it will be those that it has 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 achieve and maintain
market acceptance of the OmniPod System; potential manufacturing problems, including damage,
destruction or loss of any of our automated assembly units or difficulties in implementing our
automated manufacturing strategy; our ability to anticipate and effectively manage risks associated
with doing business internationally, particularly in China; potential problems with sole source or
other third-party suppliers on which we are dependent; our ability to obtain favorable
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; adverse regulatory or legal actions relating to the OmniPod
System; the potential violation of federal or state laws prohibiting kickbacks and false and
fraudulent claims or adverse affects of challenges to or investigations into our practices under
these laws; product liability lawsuits that may be brought against us; 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; our ability to attract and retain key
personnel; our ability to manage our growth; risks associated with potential future acquisitions;
our ability to maintain compliance with the restrictions and covenants contained in our existing
credit and security agreement; our ability to successfully maintain effective internal controls;
and other risks and uncertainties described in our Annual Report on Form 10-K for the year ended
December 31, 2007, which was filed with the Securities and Exchange Commission on March 20, 2008 as
updated by Part II, Item 1A., Risk Factors of this Quarterly Report on Form 10-Q. 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, markets and sells an innovative,
discreet and easy-to-use insulin infusion system for people with insulin-dependent diabetes. Our
proprietary OmniPod Insulin Management System, which consists of our OmniPod disposable insulin
infusion device and our handheld, wireless Personal Diabetes Manager, is the only
commercially-available insulin infusion system of its kind.
The U.S. Food and Drug Administration, or FDA, approved the OmniPod System in January 2005 and
we began commercial sale of the OmniPod System in the United States in October 2005. We have
progressively expanded our marketing and sales efforts from an initial focus in the Eastern United
States, as well as some key diabetes practitioners, academic centers and clinics elsewhere in the
United States, then to the Midwest and most recently to parts of the Western United States. As of
June 30, 2008, the OmniPod System was available throughout the United States.
We believe a key contributing factor to the overall attractiveness of the OmniPod System is
the disposable OmniPod insulin infusion device. Each OmniPod is worn for up to three days before
it is replaced, so in order to manufacture sufficient volumes of the OmniPod and achieve a low per
unit production cost, we have designed the OmniPod to be manufactured through a highly automated
process.
To achieve profitability, we are seeking to reduce the per unit production cost for the
OmniPod through installation of automated manufacturing equipment, collaboration with contract
manufacturers and reduction of cost of supplies of raw materials and sub-assemblies,
12
We are currently producing the OmniPod on a partially automated manufacturing line at our
facility in Bedford, Massachusetts. During the third quarter of 2008, we expect to complete the
planned automation of this manufacturing line. In addition to the existing manufacturing line in
Bedford, we expect to complete construction of a partially automated manufacturing line at a
facility in China, operated by a subsidiary of Flextronics International Ltd. The additional
manufacturing line in China is expected to be completed during 2008. Pending construction and
installation of the remaining automated manufacturing equipment that we plan to use, we are
manually performing these steps in the manufacturing process, and this limits our ability to
increase our manufacturing capacity and decrease our per unit cost of goods sold, thereby causing
us to continue to incur gross losses.
We currently purchase complete OmniPods as well as a sub-assembly of some of the OmniPods
components from Flextronics, pursuant to our agreement with Flextronics entered into on January 3,
2007 and revised on October 4, 2007. We began to purchase complete OmniPods from Flextronics
during the three months ended June 30, 2008. 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 to Flextronics. The initial term of the agreement is three years
from January 3, 2007, with automatic one-year renewals. 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 notice period is intended to provide the parties with sufficient time
to make alternative arrangements in the event of termination.
Our OmniPod manufacturing capacity as of June 30, 2008 was approximately 200,000 OmniPods per
month. We expect to complete the planned automation of our existing manufacturing line in Bedford,
Massachusetts in the third quarter of 2008, and by purchasing complete OmniPods from Flextronics,
we expect to increase the production capacity of OmniPods to in excess of 200,000 OmniPods per
month toward the end of 2008. By increasing production volumes of the OmniPod, we will be able to
reduce our per-unit raw material costs and improve absorption of manufacturing overhead costs. This
is important to allow us to achieve profitability.
Our sales and marketing effort is focused on generating demand and acceptance of the OmniPod
System among healthcare professionals, people with insulin-dependent diabetes and third-party
payors. Our marketing strategy is to build awareness for the benefits of the OmniPod System
through a wide range of education programs, patient demonstration programs, support materials and
events at the national, regional and local levels.
During the six months ended June 30, 2008, we made the OmniPod System available in all 50
states, the District of Columbia and Puerto Rico. We also increased our direct-to-consumer
promotion and advertising activities. Among other activities, we began television advertising, and
we intend to maintain, improve and refine our marketing efforts.
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,
and we believe that substantially all of the units sold have been reimbursed by third-party payors,
subject to applicable deductible and co-payment amounts. As we expand our sales and marketing
coverage area and increase our manufacturing capacity, we will need to maintain and expand
available reimbursement for the OmniPod System.
Since our inception in 2000, we have incurred losses every quarter. In the three and six
months ended June 30, 2008, we incurred net losses of $23.7 million and $43.6 million,
respectively. As of June 30, 2008, we had an accumulated deficit of $199.2 million. We have
financed our operations through the private placement of equity securities, public offerings of our
common stock as well as a private placement of our convertible debt. As of June 30, 2008, we had
$85 million of convertible debt outstanding. Since inception, we have received net proceeds of
$326.9 million from the issuance of redeemable convertible preferred stock, common stock and
convertible debt.
Our long-term financial objective is to achieve and sustain profitable growth. Our efforts
for the remainder of 2008 will be focused primarily on expanding our production capacity, reducing
our per-unit production costs and expanding our sales and marketing efforts for the OmniPod System.
The expansion of our manufacturing capacity will allow us to increase production volumes which
will help us to achieve lower material costs due to volume
13
purchase discounts and improve the absorption of manufacturing overhead costs. Achieving
these objectives is expected to require additional investments in manufacturing and additional
hiring of sales and administrative personnel with the goal of increasing our market penetration. We
believe that we will continue to incur net losses in the near term in order to achieve these
objectives, although we believe that the accomplishment of these combined efforts will have a
positive impact on our financial condition in the future.
Convertible Notes and Repayment and Termination of Term Loan
In June 2008, we sold $85 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, beginning December 15, 2008. 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 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 for the 5.375% Notes. In no event will the 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 incurred interest expense of approximately $190,000 for the three months ended June 30,
2008, related to the 5.375% Notes. We incurred deferred financing costs related to this offering
of approximately $3.4 million, which are recorded in the condensed consolidated balance sheet and
are being amortized as a component of interest expense over the five year term of the notes.
We received net proceeds of approximately $81.6 million from this offering. Approximately
$23.2 million of the net proceeds from this offering were used to repay and terminate our
outstanding term loan and we intend to use the remainder for general corporate purposes. On June
16, 2008, we repaid the entire outstanding principal balance, plus accrued and unpaid interest,
under our existing term loan in the aggregate of approximately $21.8 million. Additionally, we
paid a prepayment fee related to the term loan of approximately $436,000, a termination fee related
to the term loan of $900,000, and incurred certain other expenses related to the repayment and
termination of the term loan. We incurred interest expense of approximately $858,000 and $1.5
million for the three and six months ended June 30, 2008 respectively, and approximately $858,000
and $1.7 million for the three and six months ended June 30, 2007 respectively, related to the term
loan. The term loan was subject to a loan origination fee of $900,000, which was recorded in the
condensed consolidated balance sheet and was amortized as a component of interest expense over the
term of the loan. The remaining balance of deferred financing costs of approximately $570,000 was
written off at the repayment and termination date. In connection with this term loan, we issued
warrants to the lenders to purchase up to 247,252 shares of Series E preferred stock at a purchase
price of $3.64 per share. The warrants automatically converted into warrants to purchase common
stock on a 1-for-2.6267 basis at a purchase price of $9.56 per share at the closing of our initial
public offering. We recorded the $835,000 fair value of the warrants as a discount to the term
loan. Upon repayment and termination of the term loan, we recognized approximately $497,000 as
interest expense for the unamortized balance of the warrants fair value. The difference between
the amount paid, including the prepayment fee, and the carrying value of the term loan,
14
including the remaining deferred financing costs and unamortized warrants to purchase common
stock, was recognized as a $1.5 million loss from early extinguishment of the term loan.
Financial Operations Overview
Revenue. Revenue is recognized in accordance with Securities and Exchange Staff Accounting
Bulletin No. 104 (SAB 104) and Statement of Financial Accounting Standards No. 48, Revenue
Recognition when the Right of Return Exists (SFAS 48). We derive nearly all of our revenue from
the sale of the OmniPod System directly to 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 (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. Revenue is
derived from the sale to new customers of OmniPods and Starter Kits, which include the PDM, two
OmniPods, the OmniPod System User Guide and our Interactive Training CD, and from the follow-on
sales of OmniPods to existing customers. Customers generally order a three-month supply of
OmniPods. For the three and six months ended June 30, 2008 and for preceding periods, materially
all of our revenue was derived from sales within the United States.
We recognize the payment of an agreement fee under the first amendment to our development and
license agreement with Abbott Diabetes Care, Inc. (Abbott) over the term of the agreement.
Prior to January 1, 2008, we deferred recognition of revenue from the OmniPods and Starter Kit
shipped as part of a customers initial shipment for forty-five days during which time the items
could be returned and completely refunded. Effective for shipments made after December 31, 2007,
we have deferred revenue based on estimated returns, assessment of collectibility and the transfer
or risk and title. If we had continued to defer all initial shipments until the 45-day right of
return had expired, deferred revenue as of June 30, 2008 would have been larger by $1.1 million
compared to the amount recorded as of June 30, 2008. As of June 30, 2008, the balance of deferred
revenue was $1.7 million, which includes the current portion of deferred revenue related to an
agreement fee received under the first amendment to our development agreement with Abbott.
Cost of revenue. Cost of revenue consists primarily of raw materials, labor, warranty and
overhead costs related to the OmniPod System. Cost of revenue also includes depreciation,
distribution, freight and packaging costs. For the remainder of 2008, we expect the cost of
revenue to decrease as a percentage of revenue due to expected reductions in per-unit raw materials
costs associated with volume purchase discounts and increases in our OmniPod manufacturing capacity
as the supply of complete OmniPods and subassemblies from Flextronics increases and our OmniPod
manufacturing process becomes more automated. The increase in our OmniPod manufacturing capacity
is expected to reduce the per-unit cost of manufacturing the OmniPods by allowing us to spread our
fixed and semi-fixed overhead costs over a greater number of units. However, if sales volumes do
not increase or we are not successful in our efforts to automate the OmniPod manufacturing process,
then the average cost of revenue per OmniPod may not decrease and we may continue to incur gross
losses.
Research and development. Research and development expenses consist primarily of personnel
costs within our product development, regulatory and clinical functions, as well as the costs of
market studies and product development projects. We expense all research and development costs as
incurred. For the remainder of 2008, we expect overall research and development spending to remain
significant and at a level comparable with previous periods in order to support our current
research and development efforts, which are focused primarily on increased functionality, design
for ease of use and reduction of production cost, as well as developing a new OmniPod System that
incorporates continuous glucose monitoring technology.
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. In 2008, we expect sales and marketing expenses to increase
significantly compared to 2007, as we hire additional sales and marketing personnel, incur
additional sales commission expense related to sales growth and expand our sales and marketing
efforts, which
15
will include the implementation of broader direct-to-consumer marketing programs and the
continuation of our Patient Demonstration Kit Program.
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
and costs related to our facilities. We expect general and administrative expenses to increase
compared to 2007 as we add personnel and use of external services in support of our commercial
expansion.
Results of Operations
The following table presents certain statement of operations information for the three and six
months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
|
(In thousands) |
|
|
|
(Unaudited) |
|
Revenue |
|
$ |
7,417 |
|
|
$ |
3,212 |
|
|
|
131 |
% |
|
$ |
14,088 |
|
|
$ |
5,220 |
|
|
|
170 |
% |
Cost of revenue |
|
|
9,785 |
|
|
|
6,899 |
|
|
|
42 |
% |
|
|
19,783 |
|
|
|
11,471 |
|
|
|
72 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross loss |
|
|
(2,368 |
) |
|
|
(3,687 |
) |
|
|
36 |
% |
|
|
(5,695 |
) |
|
|
(6,251 |
) |
|
|
9 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,382 |
|
|
|
2,520 |
|
|
|
34 |
% |
|
|
6,306 |
|
|
|
4,990 |
|
|
|
26 |
% |
General and administrative |
|
|
5,395 |
|
|
|
2,798 |
|
|
|
93 |
% |
|
|
10,592 |
|
|
|
5,457 |
|
|
|
94 |
% |
Sales and marketing |
|
|
10,994 |
|
|
|
3,404 |
|
|
|
223 |
% |
|
|
19,559 |
|
|
|
6,508 |
|
|
|
201 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
19,771 |
|
|
|
8,722 |
|
|
|
127 |
% |
|
|
36,457 |
|
|
|
16,955 |
|
|
|
115 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(22,139 |
) |
|
|
(12,409 |
) |
|
|
78 |
% |
|
|
(42,152 |
) |
|
|
(23,206 |
) |
|
|
82 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(1,743 |
) |
|
|
(263 |
) |
|
|
563 |
% |
|
|
(1,604 |
) |
|
|
(1,026 |
) |
|
|
56 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(23,882 |
) |
|
$ |
(12,672 |
) |
|
|
88 |
% |
|
$ |
(43,756 |
) |
|
$ |
(24,232 |
) |
|
|
81 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparison of the Three and Six Months Ended June 30, 2008 and 2007
Revenue
Our total revenue was $7.4 million and $14.1 million for the three and six months ended June
30, 2008, respectively, compared to $3.2 million and $5.2 million for the same periods in 2007.
The increase in revenue is primarily due to an increased number of patients using the OmniPod.
Furthermore, due to a change in our estimate of deferred revenue, revenue for the three and six
months ended June 30, 2008 was impacted unfavorably by
$131,000 and favorably by $1,080,000, respectively. As we continue our sales and marketing
efforts, and add more patients that use the OmniPod System, we expect our revenue to increase.
Cost of Revenue
Cost of revenue was $9.8 million and $19.8 million for the three and six months ended June 30,
2008, respectively, compared to $6.9 million and $11.5 million for the same periods in 2007. The
increase is due to increased sales volume. Cost of revenue includes adjustment of inventory to
lower of cost or market and indirect costs. The per-unit cost to manufacture the OmniPod decreased
in the three and six months ended June 30, 2008, respectively, compared to the same periods in
2007, resulting in improvement of our gross margin. The decrease is a result of increased
production volumes, which improved the absorption of manufacturing overhead costs, increased
purchases of subassemblies with a lower cost from Flextronics, and supplies of complete OmniPods
from Flextronics.
16
Research and Development
Research
and development expenses increased $862,000, or 34%, to $3.4 million for the three
months ended June 30, 2008 compared to $2.5 million for the same period in 2007. Research and
development expenses increased $1.3 million, or 26%, to $6.3 million for the six months ended
June 30, 2008, compared to $5.0 million for the same period in 2007. For the three months ended
June 30, 2008, the increase in research and development expenses was primarily attributable to an
increase of $547,000 in employee related expenses, $447,000 for increased consulting services
related to our ongoing development projects and $50,000 for other expenses, partly offset by a
reduction of $114,000 in prototype expenses, and a reduction of $67,000 for tools and supplies.
For the six months ended June 30, 2008, the increase in research and development expenses was
primarily attributable to an increase of $753,000 in consulting services related to our ongoing
development projects, $602,000 increase in employee related expenses, $103,000 for tools and
supplies and $51,000 for other expenses, partly offset by a reduction of $193,000 in prototype
expenses.
General and Administrative
General and administrative expenses increased $2.6 million, or 93%, to $5.4 million for the
three months ended June 30, 2008, compared to $2.8 million for the same period in 2007. General
and administrative expenses increased $5.1 million, or 94%, to $10.6 million for the six months
ended June 30, 2008, compared to $5.5. million for the same period in 2007. For the three months
ended June 30, 2008, the increase in general and administrative expenses was primarily due to an
increase of $1.2 million in employee compensation and benefit costs associated with the hiring of
additional employees, $245,000 in distribution expenses, $226,000 related to increased allowances
and write-offs for doubtful trade accounts receivables, $166,000 in consulting and legal expenses,
$146,000 in depreciation expense, $117,000 in insurance expenses, $94,000 in travel expenses, and
$393,000 in various other expense categories. For the six months ended June 30, 2008, the increase
in general and administrative expenses was primarily due to an increase of $2.0 million in employee
compensation and benefit costs associated with the hiring of additional employees, $757,000 related
to increased allowances and write-offs for doubtful trade accounts receivables, $498,000 in
consulting and legal expenses, $456,000 in distribution expenses, $288,000 in insurance expenses,
$278,000 in depreciation expense, $183,000 in travel expenses, and $652,000 in various other
expense categories.
Sales and Marketing
Sales and marketing expenses increased $7.6 million, or 223%, to $11.0 million for the three
months ended June 30, 2008, compared to $3.4 million for the same period in 2007. Sales and
marketing expenses increased $13.1 million, or 201%, to $19.6 million for the six months ended June
30, 2008, compared to $6.5 million for the same period in 2007. For the three months ended June
30, 2008, the increase in sales and marketing expenses was primarily due to an increase of $3.1
million in employee compensation and benefit costs resulting from the hiring of additional
employees in our sales and marketing areas, $2.1 million related to Patient Demonstration Kits,
$1.5 million in travel and trade show expenses used to support our selling efforts, $789,000 in
outside consulting services, which include our external trainers, and $132,000 in other expenses.
For the six months ended June 30, 2008, the increase in sales and marketing expenses was primarily
due to an increase of $5.9 million in employee
compensation and benefit costs resulting from the hiring of additional employees in our sales
and marketing areas, $3.0 million related to Patient Demonstration Kits, $2.6 million in travel and
trade show expenses used to support our selling efforts, $1.5 million in outside consulting
services, which include our external trainers, and $100,000 in various other expense categories.
Other Income (Expense)
Interest income was $360,000 and $1.1 million for the three and six months ended June 30,
2008, respectively, compared to $713,000 and $1.0 million for the same periods in 2007. For the
three months ended June 30, 2008, the decrease was caused primarily by lower cash balances and
interest rates. For the six months ended June 30, 2008, the impact of higher average cash balances
was offset by lower interest rates. Interest income was earned from cash deposits and short-term
interest bearing instruments. Interest expense was $2.1 million and $2.7 million for the three and
six months ended June 30, 2008, respectively, compared to $1.0 million and $2.0 million for the
same periods in 2007. For the three months ended June 30, 2008, the increased expenses were primarily
17
caused by $1.5 million related to the repayment and termination of our term loan, partly
offset by lower interest payment on the term loan, due to lower principal balances and interest
rates. For the six months ended June 30, 2008, the increase was caused by $1.5 million related to
the repayment and termination of our term loan, partly offset by lower interest payments on our
term loan due to lower principal balances and interest rates.
Liquidity and Capital Resources
We commenced operations in 2000 and to date we have financed our operations primarily through
private placement of common and preferred stock, secured indebtedness, public offerings of our
common stock and issuance of convertible debt. As of June 30, 2008, we had $85.0 million of
convertible debt outstanding. Since inception, we have received net proceeds of $326.9 million
from the issuance of redeemable convertible preferred stock, common stock and convertible debt. As
of June 30, 2008, we had $99.1 million in cash and cash equivalents. We believe that our current
cash and cash equivalents, including the net proceeds from our initial and secondary public
offerings and offering of convertible debt, together with our short-term investments and 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.
Resources
In June 2008, we sold $85 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, beginning December 15, 2008. 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 our common stock on the NASDAQ Global Market on June 10, 2008, per $1,000
principal amount of the 5.375% Notes, 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.
We received net proceeds of approximately $81.6 million from this offering. On June 16, 2008,
we used a portion of the net proceeds to repay the entire outstanding principal balance, plus
accrued and unpaid interest, under our existing term loan in the aggregate of approximately $21.9
million in its entirety. Additionally, we paid a prepayment fee related to the term loan of
approximately $436,000, a termination fee related to the term loan of $900,000, and incurred
certain other expenses related to the repayment and termination of the term loan.
See OverviewConvertible Notes and Repayment and Termination of Term Loan above for more
information about the private placement of our convertible notes and the repayment and termination
of our term loan.
Operating Activities
The following table sets forth the amounts of cash used in operating activities and net loss
for each of the periods indicated:
18
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2008 |
|
2007 |
|
|
(In thousands) |
Cash used in operating activities |
|
$ |
(42,212 |
) |
|
$ |
(21,399 |
) |
Net loss |
|
$ |
(43,756 |
) |
|
$ |
(24,232 |
) |
For each of the periods above, the increase in net cash used in operating activities was
attributable primarily to the growth of our operations after adjustment for non-cash charges, such
as depreciation, amortization and stock-based compensation expense as well as changes to working
capital. Significant uses of cash from operations include increases in accounts receivable and
inventory and other current assets. The increase in accounts
receivable is primarily attributable to our
increased sales, and to some extent increased aging of receivable
balances. Accounts receivable are shown net of increased allowances for doubtful debt in the consolidated balance
sheets. The increase in inventory balance is caused by the recent increase of our production
volume made possible by increased capacity. Cash used in operating activities is partly offset by
increases in accounts payable, accrued expenses and deferred revenue.
Investing 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, |
|
|
2008 |
|
2007 |
|
|
(In thousands) |
Cash used in investing activities |
|
$ |
(7,824 |
) |
|
$ |
(5,510 |
) |
Cash provided (used) by financing
activities |
|
$ |
54,556 |
|
|
$ |
113,496 |
|
Cash used in investing activities in both periods was primarily for the purchase of fixed
assets for use in the development and manufacturing of the OmniPod System.
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. All operating leases contain
renewal options and escalating payments over the life of the lease. As of June 30, 2008, we had an
outstanding letter of credit which totaled $200,000 to cover our security deposits for lease
obligations. This letter of credit will expire on October 30, 2009.
Capital Expenditures
During the remainder of 2008, we will be expending funds in connection with, among other
things, our efforts to expand our automated manufacturing process and increase our production
capacity, and expand our sales and marketing activities. We expect total capital expenditure
purchases in the full year 2008 to be at least $10 million in connection with our efforts to expand
our automated manufacturing process and increase our manufacturing capacity.
Off-Balance Sheet Arrangements
As of June 30, 2008, we did not have any off-balance sheet financing arrangements.
19
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.
Revenue Recognition
We generate revenue from sales of its OmniPod Insulin Management System to diabetes patients.
The initial sale to a new customer typically includes OmniPods and a Starter Kit, which include the
PDM, two OmniPods, the OmniPod System User Guide and the OmniPod System Interactive Training CD.
Subsequent sales to existing customers typically consist of additional OmniPods.
Revenue is recognized in accordance with Staff Accounting Bulletin No. 104, Revenue
Recognition in Financial Statements (SAB 104), which 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. |
|
|
|
|
Transfer of title and risk and rewards of ownership are passed to the patient upon
the patients receipt of the products. |
|
|
|
|
The selling prices for all sales are fixed and agreed with the patient, 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 have considered the requirements of Emerging Issues Task Force (EITF) 00-21, Revenue
Arrangements with Multiple Deliverables, when accounting for the OmniPods and Starter Kits. EITF
00-21 requires us to assess whether the different elements qualify for separate accounting. We
recognize revenue for the initial shipment to a patient or other third party once all elements have
been delivered.
We offer a 45-day right of return for its Starter Kits sales, and in accordance with SFAS No.
48, Revenue Recognition When the Right of Return Exists, we defer revenue to reflect estimated
sales returns in the same period that the related product sales are recorded. Returns are
estimated through 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 Diabetes Care, Inc. (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
5-year term of the agreement, and the non-current portion of the agreement fee is included in other
long-term liabilities.
20
Asset Valuation
Asset valuation includes assessing the recorded value of certain assets, including accounts
receivable, inventory and fixed assets. We use a variety of factors to assess valuation, depending
upon the asset. Actual results may differ materially from our estimates. Fixed 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. We review long-lived assets, including property and
equipment and intangibles, for impairment whenever events or changes in business circumstances
indicate that the carrying amount of the assets may not be fully recoverable. We also review assets
under construction to ensure certainty of their future installation and integration into the
manufacturing process. An impairment loss would be recognized when estimated undiscounted future
cash flows expected to result from the use of the asset and its eventual disposition is less than
its carrying amount. Impairment, if any, is measured as the amount by which the carrying amount of
a long-lived asset exceeds its fair value. We consider various valuation factors, principally
discounted cash flows, to assess the fair values of long-lived assets.
Income Taxes
We file federal and state tax returns. We have accumulated significant losses since its
inception in 2000. Since the net operating losses may potentially be utilized in future years to
reduce taxable income, all of our tax years remain open to examination by the major taxing
jurisdictions to which we are subject.
We recognize estimated interest and penalties for uncertain tax positions in income tax
expense. As of June 30, 2008, we had no interest and penalty accrual or expense.
Allowance for doubtful accounts
Accounts receivable consist of amounts due from third-party payors and patients. We account
for doubtful accounts using the allowance method. The allowances for doubtful accounts are
recorded in the period in which the revenue is recorded. We base our allowance on historical
experience, assessment of specific risk, discussions with individual customers or various
assumptions and estimates that are believed to be reasonable under the circumstances.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). This
standard defines fair value, establishes a framework for measuring fair value in accounting
principles generally accepted in the United States, and expands disclosure about fair value
measurements. This pronouncement applies under other accounting standards that require or permit
fair value measurements. Accordingly, this statement does not require any new fair value
measurement. This statement is effective for fiscal years beginning after November 15, 2007, and
for interim periods within those fiscal years. We adopted SFAS 157 in the first quarter of 2008.
The adoption of SFAS-157 did not have a material effect on our financial position, results of
operations, or cash flows.
In February 2007, the FASB issued SFAS No. 159, Fair Value Option for Financial Assets and
Financial Liabilities Including an amendment of FASB Statement 115 (SFAS 159), which permits
entities to choose to measure many financial instruments and certain other items at fair value.
SFAS 159 became effective for fiscal years that began after November 15, 2007. We adopted SFAS 159
in the first quarter of 2008. The adoption of SFAS-159 did not have a material effect on our
financial position, results of operations, or cash flows.
In February 2008, the FASB issued FASB Staff Position FAS 157-2, Effective Date of FASB
Statement No. 157 (FSP FAS 157-2). FSP FAS 157-2 delays the effective date of SFAS 157 to fiscal
years beginning after November 15, 2008 for all non-financial assets and non-financial liabilities,
except those that are recognized or
21
disclosed at fair value in the financial statements on a recurring basis, at least annually. FSP FAS 157-2 is effective for fiscal years beginning after September 1, 2009. The adoption of FSP FAS 157-2 is not
expected to have a material impact on our financial position, results of operations, or cash flows.
In May 2008, the FASB issued Staff Position No. Accounting Principles Board 14-1, Accounting
for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial
Cash Settlement) (FSP APB 14-1), which is effective for fiscal years beginning after December 15,
2008. FSP APB 14-1 clarifies that convertible debt instruments that may be settled in cash upon
conversion are not addressed by paragraph 12 of Accounting Principles Board Opinion No. 14,
Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants. FSP APB 14-1 also
specifies that issuers of such instruments should separately account for the liability and equity
components in a manner that will reflect the entitys nonconvertible debt borrowing rate when
interest cost is recognized in subsequent periods. We are currently evaluating the effect of FSP
APB 14-1 and have not yet determined the impact of the standard on our financial position or
results of operations.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles. This standard identifies the sources of accounting principles and the framework for
selecting the principles to be used in the preparation of financial statements that are presented
in conformity with generally accepted accounting principles in the United States. The standard is
effective 60 days following the SECs approval of the Public Company Accounting Oversight Board
amendments to AU Section 411, The Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles. We ares currently evaluating the potential effect of implementing this
standard.
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, short-term
investments, 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 interest rates, we invest mainly in cash equivalents and short-term investments
and maintain an average maturity of six months or less. 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, 2008, we had outstanding debt recorded at $85.0 million related to our 5.375%
convertible notes. As the interest rate on the notes is fixed, changes in interest rates do not
affect the value of our debt.
Item 4T. Controls and Procedures
Disclosure Controls and Procedures
As of June 30, 2008, 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) 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, our chief executive officer and chief financial officer have concluded that they
believe that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our
disclosure controls and procedures were effective at the reasonable assurance level.
22
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, 2008 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
23
PART II OTHER INFORMATION
Item 1. Legal Proceedings.
None.
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, 2007, 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. Other than 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, 2007.
We may not be able to generate sufficient cash to service all of our indebtedness, including our
5.375% Convertible Senior Notes due June 15, 2013, and 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, including the
$85 million in indebtedness incurred in connection with the sale in June 2008 of 5.375% Convertible
Senior Notes due June 15, 2013. 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 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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On May 14, 2007, our registration statements on Form S-1 (Registration Nos. 333-140694 and
333-142952), as amended, were declared effective for our initial public offering, pursuant to which
we offered and sold 8,365,000 shares of common stock and received net proceeds of approximately
$113.4 million, after deducting underwriting discounts and offering commissions of approximately
$8.8 million and other offering costs of approximately $3.3 million. None of the underwriting
discounts and commissions or offering expenses were incurred or paid to directors or officers of
ours or their associates or to persons owning 10% or more of our common stock or to any affiliates
of ours. All of the shares of common stock issued pursuant to the registration statements were
sold at a price to the public of $15.00 per share. The managing underwriters were J.P. Morgan
Securities Inc., Merrill Lynch, Pierce, Fenner & Smith Incorporated, Thomas Weisel Partners LLC and
Leerink Swann & Co., Inc.
As of June 30, 2008, we have used approximately $83.3 million of the net proceeds we received
from the offering for working capital and other general corporate purposes, including the financing
our growth, the expansion of our OmniPod production capacity, the continued expansion of our sales
and marketing activities and the funding of our research and development efforts. Pending such
usage, we have invested the net proceeds in short-term, interest-bearing investment-grade
securities. There has been no material change in the planned use of proceeds from our initial
public offering as described in the final prospectus filed with the Securities and Exchange
Commission pursuant to Rule 424(b).
24
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders.
At the Annual Meeting of Stockholders held on May 8, 2008 our stockholders voted as follows:
(a) |
|
To elect three members to the Board of Directors as Class I Directors, to serve
until the Companys 2011 annual meeting of stockholders and until their successors are duly
elected and qualified or until their earlier resignation or removal. |
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Nominee |
|
Vote "For" |
Vote "Withheld" |
Alison de Bord |
|
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21,977,367 |
|
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508,261 |
|
Regina Sommer |
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22,193,467 |
|
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292,161 |
|
Joseph Zakrzewski |
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22,195,667 |
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289,961 |
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There were no broker non-votes or abstentions with respect to this matter. The terms in
office of Ross Jaffe, M.D., Gary Eichhorn, Charles Liamos, Duane DeSisto and Steven Sobieski
continued after the annual meeting. |
|
(b) |
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To approve an amendment to the Companys 2007 Stock Option and Incentive Plan to
increase the aggregate number of shares authorized for issuance under such plan by 600,000
shares of the Companys common stock. |
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Vote "For" |
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Vote "Against" |
|
Abstentions |
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Broker Non-Votes |
|
12,619,980 |
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7,468,918 |
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7,938 |
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2,388,792 |
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(c) To ratify the appointment of Ernst & Young LLP as the Companys independent registered public
accounting firm for the fiscal year |
ending December 31, 2008. |
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Vote "For" |
|
Vote "Against" |
|
Abstentions |
|
Broker Non-Votes |
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22,327,288 |
|
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7,293 |
|
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151,047 |
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Item 5. Other Information
None.
Item 6. Exhibits
|
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Exhibit |
|
|
Number |
|
Description of Document |
|
|
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4.1(1)
|
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Indenture, dated as of June 16, 2008, between Insulet Corporation and Wells Fargo Bank, N.A. |
|
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10.1(2)
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Amendment to the Companys 2007 Stock Option and Incentive Plan. |
|
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10.2(2)
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Executive Severance Plan |
|
|
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10.3(1)
|
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Registration Rights Agreement, dated as of June 16, 2008, among Insulet Corporation, J.P.
Morgan Securities Inc. and Merrill Lynch, Pierce, Fenner & Smith Incorporated. |
|
|
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31.1*
|
|
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. |
25
|
|
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Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
31.2*
|
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Certification of Carsten Boess, 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. |
|
|
|
32.1*
|
|
Certification of Duane DeSisto, President and Chief Executive Officer, and Carsten Boess,
Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
* |
|
Filed herewith |
|
(1) |
|
Incorporated by reference to Insulet Corporations Current Report on Form 8-K filed on June
20, 2008 (File No. 001-33462). |
|
(2) |
|
Incorporated by reference to Insulet Corporations Current Report on Form 8-K filed on May
14, 2008 (File No. 001-33462). |
26
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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|
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INSULET CORPORATION
(Registrant)
|
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Date: August 13, 2008 |
/s/ Duane DeSisto
|
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Duane DeSisto |
|
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President and Chief Executive Officer
(Principal
Executive Officer) |
|
|
|
|
|
Date: August 13, 2008 |
/s/ Carsten Boess
|
|
|
Carsten Boess |
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Chief Financial Officer
(Principal Financial and
Accounting Officer) |
|
27
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
4.1(1)
|
|
Indenture, dated as of June 16, 2008, between Insulet Corporation and Wells Fargo Bank, N.A. |
|
|
|
10.1(2)
|
|
Amendment to the Companys 2007 Stock Option and Incentive Plan. |
|
|
|
10.2(2)
|
|
Executive Severance Plan |
|
|
|
10.3(1)
|
|
Registration Rights Agreement, dated as of June 16, 2008, among Insulet Corporation, J.P.
Morgan Securities Inc. and Merrill Lynch, Pierce, Fenner & Smith Incorporated. |
|
|
|
31.1*
|
|
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. |
|
|
|
31.2*
|
|
Certification of Carsten Boess, 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. |
|
|
|
32.1*
|
|
Certification of Duane DeSisto, President and Chief Executive Officer, and Carsten Boess,
Chief Financial Officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
* |
|
Filed herewith |
|
(1) |
|
Incorporated by reference to Insulet Corporations Current Report on Form 8-K filed on June
20, 2008 (File No. 001-33462). |
|
(2) |
|
Incorporated by reference to Insulet Corporations Current Report on Form 8-K filed on May
14, 2008 (File No. 001-33462). |
28