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 September 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
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04-3523891 |
(State or other jurisdiction of incorporation or
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(I.R.S. Employer Identification Number) |
organization) |
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9 Oak Park Drive
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01730 |
Bedford, Massachusetts
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(Zip Code) |
(Address of principal executive offices) |
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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):
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Large accelerated filer o |
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company) |
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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 November 7, 2008, the registrant had 27,762,578 shares of common stock outstanding.
INSULET CORPORATION
TABLE OF CONTENTS
(i)
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
INSULET CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEET
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As of |
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As of |
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September 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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$ |
74,134 |
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$ |
94,588 |
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Accounts receivable, net |
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11,842 |
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4,783 |
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Inventories |
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16,467 |
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7,990 |
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Prepaid expenses and other current assets |
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3,521 |
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1,391 |
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Total current assets |
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105,964 |
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108,752 |
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Property and equipment, net |
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26,080 |
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21,304 |
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Other assets |
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3,288 |
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685 |
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Total assets |
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$ |
135,332 |
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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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$ |
5,965 |
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$ |
4,544 |
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Accrued expenses |
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7,587 |
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4,464 |
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Deferred revenue |
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2,271 |
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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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15,823 |
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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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2,861 |
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1,431 |
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Total liabilities |
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103,684 |
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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 September 30, 2008 and
December 31, 2007.
Issued
and outstanding: zero shares
at September 30, 2008 and
December 31, 2007 |
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Common stock, $.001 par value: |
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Authorized: 100,000,000
shares at September 30, 2008
and December 31, 2007.
Issued and outstanding:
27,748,162 and 27,223,820
shares at September 30, 2008
and December 31, 2007,
respectively |
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29 |
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28 |
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Additional paid-in capital |
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251,706 |
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247,835 |
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Accumulated deficit |
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(220,087 |
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(155,579 |
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Subscription receivable |
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(9 |
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Total stockholders equity |
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31,648 |
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92,275 |
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Total liabilities and stockholders equity |
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$ |
135,332 |
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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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Nine Months Ended |
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September 30, |
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September 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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$ |
10,110 |
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$ |
3,791 |
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$ |
24,198 |
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$ |
9,011 |
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Cost of revenue |
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10,197 |
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7,583 |
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29,980 |
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19,054 |
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Gross loss |
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(87 |
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(3,792 |
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(5,782 |
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(10,043 |
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Operating expenses: |
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Research and development |
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3,263 |
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2,231 |
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9,569 |
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7,221 |
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General and administrative |
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6,308 |
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3,388 |
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16,900 |
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8,845 |
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Sales and marketing |
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10,176 |
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4,144 |
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29,735 |
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10,652 |
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Impairment of assets |
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1,027 |
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1,027 |
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Total operating expenses |
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19,747 |
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10,790 |
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56,204 |
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27,745 |
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Operating loss |
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(19,834 |
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(14,582 |
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(61,986 |
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(37,788 |
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Interest income |
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481 |
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1,418 |
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1,554 |
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2,435 |
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Interest expense |
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(1,399 |
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(475 |
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(4,076 |
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(2,444 |
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Net interest income (expense) |
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(918 |
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943 |
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(2,522 |
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(9 |
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Change in value of preferred stock
warrant liability |
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(74 |
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Net loss |
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(20,752 |
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(13,639 |
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(64,508 |
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(37,871 |
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Net loss per share basic and diluted |
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$ |
(0.75 |
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$ |
(0.52 |
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$ |
(2.34 |
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$ |
(2.85 |
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Weighted average number of shares
used in calculating basic and
diluted net loss per share |
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27,716,473 |
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26,322,763 |
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27,560,258 |
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13,294,107 |
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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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Nine Months Ended |
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September 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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$ |
(64,508 |
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$ |
(37,871 |
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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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4,665 |
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3,352 |
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Amortization of debt discount |
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596 |
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179 |
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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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2,618 |
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939 |
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Provision for bad debts |
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2,012 |
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682 |
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Loss on impairment and disposal of assets |
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1,027 |
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Non cash interest expense |
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856 |
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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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(9,071 |
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(2,608 |
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Inventory |
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(8,477 |
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(1,182 |
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Prepaids and other current assets |
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(2,130 |
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64 |
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Other assets |
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9 |
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(478 |
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Accounts payable and accrued expenses |
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4,544 |
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276 |
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Other long term liabilities |
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2,330 |
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1,012 |
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Deferred revenue, short term |
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921 |
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427 |
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Net cash used in operating activities |
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(65,635 |
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(34,164 |
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Cash flows from investing activities |
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Purchases of property and equipment |
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(9,441 |
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(8,340 |
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Net cash used in investing activities |
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(9,441 |
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(8,340 |
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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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81,532 |
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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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1,254 |
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113,486 |
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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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54,622 |
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113,486 |
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Net increase (decrease) in cash and cash equivalents |
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(20,454 |
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70,982 |
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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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$ |
74,134 |
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$ |
104,213 |
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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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$ |
2,368 |
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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 unaudited condensed consolidated financial statements in this Quarterly Report on Form
10-Q have been prepared in accordance with accounting principles generally accepted in the United
States (GAAP) 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 GAAP for complete financial statements. In the opinion of management, all
adjustments, consisting of normal recurring adjustments, considered necessary for a fair
presentation have been included. Operating results for the three and nine month periods ended
September 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 in this Quarterly Report on Form 10-Q should
be read in conjunction with the Companys consolidated financial statements and notes thereto
contained in the Companys Annual Report on Form 10-K for the year ended December 31, 2007.
Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most significant estimates used
in these financial statements include the valuation of inventories 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 in this Quarterly Report on Form 10-Q 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, patients and third-party
distributors. 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 was selling the OmniPods and PDMs at a loss. Since June 30, 2008, the Companys inventory
of finished OmniPods has been presented at cost, as the costs to produce OmniPods are lower than
the Companys selling price. The Companys inventory of PDMs continue to be stated at the market
value as the costs to produce PDMs continue to be greater than the Companys selling price. 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 and Equipment
Property and equipment is stated at cost and depreciated using the straight-line method over
the estimated useful lives of the respective assets. Leasehold improvements are amortized over
their useful life or the life of the lease, whichever is shorter. Assets capitalized under capital
leases are amortized in accordance with the respective class of owned assets and the amortization
is included with depreciation expense. Maintenance and repair costs are expensed as incurred.
Impairment of Property and 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 nearly all of its revenue from sales of its OmniPod Insulin Management
System to diabetes patients and third-party distributors who resell the product 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 for sales
directly to patients or a purchase order for sales to a third-party distributor. |
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Transfer of title and risk and rewards of ownership are passed to the patient or
distributor upon their receipt of the products. |
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The selling prices for all sales are fixed and agreed with the patient or
third-party distributor, and, if applicable, the patients third-party insurance
provider(s), prior to shipment and are based on established list prices or, in the case
of certain third-party insurers, contractually agreed upon prices. Provisions for
discounts and rebates to customers are established as a reduction to revenue in the
same period the related sales are recorded. |
5
The Company has considered the requirements of Emerging Issues Task Force 00-21, Revenue
Arrangements with Multiple Deliverables (EITF 00-21), 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. 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 a 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 September 30, 2008 would have been larger by $1.2 million.
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 initial 5-year term of the agreement, and the non-current portion of the agreement
fee is included in other long-term liabilities. Under the amended Abbott agreement, beginning July
1, 2008, Abbott agreed to pay an amount to the Company for services performed by Insulet in
connection with each sale of a PDM that includes an Abbott Discrete Blood Glucose Monitor to a new
customer. The Company recognizes the revenue related to this portion of the Abbott agreement at
the time the revenue is recognized on the sale of the PDM to the patient. In the three and nine
months ended September 30, 2008, the Company recognized $1.2 million and $1.4 million of revenue,
respectively, related to the amended Abbott agreement. There was no impact to cost of revenue
related to this agreement.
The Company had deferred revenue of $2.3 million and $1.4 million as of September 30, 2008 and
December 31, 2007, respectively. The deferred revenue recorded as of September 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 or third-party
distributors, the majority of shipments are billed to third-party insurance payors. As of
September 30, 2008, the two largest third-party payors accounted for 6% and 5% 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.
6
As of September 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
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 Company adopted SFAS 150 in the first quarter of fiscal year 2008. 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 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 should be separated between 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, results of operations or cash
flows.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162). 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.
SFAS 162 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
7
the notes. The 5.375% Notes will be convertible for cash up to their principal amount and
shares of the Companys common stock for the remainder of the conversion value in excess of the
principal amount. The Company does not have the right to redeem any of the 5.375% Notes prior to
maturity. If a fundamental change, as defined in the Indenture for the 5.375% Notes, occurs at any
time prior to maturity, holders of the 5.375% Notes may require the Company to repurchase their
notes in whole or in part for cash equal to 100% of the principal amount of the notes to be
repurchased, plus accrued and unpaid interest, including any additional interest, to, but
excluding, the date of repurchase.
If a holder elects to convert its 5.375% Notes upon the occurrence of a make-whole fundamental
change, as defined in the Indenture for the 5.375% Notes, the holder may be entitled to receive an
additional number of shares of common stock on the conversion date. These additional shares are
intended to compensate the holders for the loss of the time value of the conversion option and are
set forth in the Indenture to the 5.375% Notes. In no event will the number of shares issuable
upon conversion of a note exceed 62.7746 per $1,000 principal amount (subject to adjustment as
described in the Indenture for the 5.375% Notes).
The Company incurred interest expense of approximately $1.1 million and $1.3 million for the
three and nine months ended September 30, 2008, respectively, related to the 5.375% Notes. The
Company incurred deferred financing costs related to this offering of approximately $3.5 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 $81.5 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
$0.4 million, a termination fee related to the term loan of $0.9 million, and incurred certain
other expenses related to the repayment and termination of the term loan. The Company incurred
interest expense of approximately $0 and $1.5 million for the three and nine months ended September
30, 2008, respectively, and approximately $0.9 million and $2.6 million for the three and nine
months ended September 30, 2007 respectively, related to the term loan. The term loan was subject
to a loan origination fee of $0.9 million, 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 $0.6 million 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 in May 2007. The Company recorded the $0.8 million fair value of the warrants as a
discount to the term loan. Upon repayment and termination of the term loan, the Company recognized
approximately $0.5 million 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 nine months ended September 30, 2008 and 2007, 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:
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Convertible notes |
|
|
3,981,970 |
|
|
|
|
|
|
|
3,981,970 |
|
|
|
|
|
Outstanding options |
|
|
2,887,178 |
|
|
|
2,866,928 |
|
|
|
2,887,178 |
|
|
|
2,866,928 |
|
Outstanding warrants |
|
|
62,752 |
|
|
|
78,440 |
|
|
|
62,752 |
|
|
|
78,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
6,931,900 |
|
|
|
2,945,368 |
|
|
|
6,931,900 |
|
|
|
2,945,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5. Accounts Receivable
The components of accounts receivable are as follows:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
Trade receivables |
|
$ |
14,217 |
|
|
$ |
5,992 |
|
Allowance for doubtful accounts |
|
|
(2,375 |
) |
|
|
(1,209 |
) |
|
|
|
|
|
|
|
|
|
$ |
11,842 |
|
|
$ |
4,783 |
|
|
|
|
|
|
|
|
6. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
Raw materials |
|
$ |
5,137 |
|
|
$ |
2,994 |
|
Work-in-process |
|
|
192 |
|
|
|
1,583 |
|
Finished goods |
|
|
11,138 |
|
|
|
3,413 |
|
|
|
|
|
|
|
|
|
|
$ |
16,467 |
|
|
$ |
7,990 |
|
|
|
|
|
|
|
|
The Company is currently producing the OmniPod on a partially automated manufacturing line at
a facility in China, operated by a subsidiary of Flextronics International Ltd. The Company also
produces certain sub-assemblies for the OmniPod as well as maintains packaging operations in its
facility in Bedford, Massachusetts. The Company purchases complete OmniPods from Flextronics,
pursuant to its agreement with Flextronics entered into on January 3, 2007 and revised on October
4, 2007. The initial term of the agreement is three years from January 3, 2007, with automatic
one-year renewals.
Inventories of finished goods were adjusted by $12,000 and $625,000 as of September 30, 2008
and December 31, 2007, respectively, to reflect values at the lower of cost or market. As of
September 30, 2008 and December 31, 2007, 1% 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 were lower than the current market price for the OmniPod. Since June 30, 2008, the Companys
inventory of finished OmniPods has been presented at cost, as the costs to produce OmniPods are
lower than the Companys selling price. The Companys inventory of PDMs continue to be stated at
the market value as the costs to produce PDMs continue to be greater than the Companys selling
price.
9
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
|
(In thousands) |
|
Balance at the beginning of period |
|
$ |
1,500 |
|
|
$ |
392 |
|
|
$ |
865 |
|
|
$ |
193 |
|
Warranty expense |
|
|
1,103 |
|
|
|
509 |
|
|
|
2,873 |
|
|
|
1,129 |
|
Warranty claims settled |
|
|
(669 |
) |
|
|
(331 |
) |
|
|
(1,804 |
) |
|
|
(752 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period |
|
$ |
1,934 |
|
|
$ |
570 |
|
|
$ |
1,934 |
|
|
$ |
570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Composition of balance: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term |
|
|
801 |
|
|
|
276 |
|
|
|
801 |
|
|
|
276 |
|
Long-term |
|
|
1,133 |
|
|
|
294 |
|
|
|
1,133 |
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total warranty balance |
|
$ |
1,934 |
|
|
$ |
570 |
|
|
$ |
1,934 |
|
|
$ |
570 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 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.
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.
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.
10
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.
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 nine months ended September 30, 2008, 44,052 and 518,347 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 |
|
|
816,329 |
|
|
|
16.99 |
|
|
|
|
|
Exercised |
|
|
(518,347 |
) |
|
|
2.29 |
|
|
|
7,845,200 |
(1) |
Canceled |
|
|
(102,777 |
) |
|
|
16.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2008 |
|
|
2,887,178 |
|
|
|
10.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested, September 30, 2008 |
|
|
1,341,395 |
|
|
|
4.82 |
|
|
|
12,276,206 |
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to
vest, September 30, 2008
(3) |
|
|
2,471,806 |
|
|
|
|
|
|
|
|
|
|
|
|
(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 September 30, 2008, and the exercise
price of the underlying options. |
|
(3) |
|
Represents the number of vested options as of September 30, 2008, plus the number of unvested
options expected to vest as of September 30, 2008, based on the unvested options outstanding
at September 30, 2008, adjusted for an estimated forfeiture rate of 12%. |
In the three and nine months ended September 30, 2008 and 2007, no shares were contingently
issued under the employee stock purchase plan (ESPP). In the three and nine months ended
September 30, 2008, the Company recorded compensation charges of approximately $10,000 and $24,000
respectively, of stock-based compensation charges related to the ESPP. For the three and nine
months ended September 30, 2007, the Company recognized $5,000 of compensation charges related to
the ESPP.
Employee stock-based compensation expense under SFAS 123R recognized in the three and nine
months ended September 30, 2008 was $1.0 million and $2.6 million, respectively. For the three and
nine months ended September 30, 2007, the Company recognized employee stock-based compensation
expense of approximately $0.4 million and $0.9 million, respectively.
11
10. Impairment of Property and Equipment
The Company evaluates financial and operational impact of possible improvements of its
manufacturing processes. The evaluation of new processes involves assessment of vendors, product
cost and product quality, among other things, and there is no assurance that process improvements
are implemented. During the three months ended September 30, 2007, the Company completed the
evaluation of an upgrade of its manufacturing processes, and as a result, the Company performed a
review of certain production equipment. The review resulted in a non-cash charge of $1.0 million
for the write-down of certain impaired assets. The impaired assets, which had no future use,
consist of manufacturing equipment. The impairment charges were recorded following determination
of the fair value of cash flows resulting from use of the affected assets, and the carrying value
of the assets has been reduced to reflect their fair value. There were no impairment charges
recorded in the three or nine months ended September 30, 2008.
11. 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.
12
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 condensed consolidated financial statements and the accompanying notes to
those financial statements included in this Quarterly Report on Form 10-Q. This Quarterly Report
on Form 10-Q contains forward-looking statements. These forward-looking statements are based on
our current expectations and beliefs concerning future developments and their potential effects on
us. There can be no assurance that future developments affecting us will be those that we have
anticipated. These forward-looking statements involve a number of risks, uncertainties (some of
which are beyond our control) or other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these forward-looking statements. These
risks and uncertainties include, but are not limited to: risks associated with our dependence on
the OmniPod System; our ability to 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; 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 raise additional funds in the future; our ability to maintain
compliance with the restrictions and related to our indebtedness; 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 disposable OmniPod 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, to having full availability of the OmniPod System in the entire United States. We focus
our sales towards key diabetes practitioners, academic centers and clinics specializing in the
treatment of diabetic patients.
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.
13
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.
We are currently producing the OmniPod on a partially automated manufacturing line at a
facility in China, operated by a subsidiary of Flextronics International Ltd. We also produce
certain sub-assemblies for the OmniPod as well as maintain packaging operations in our facility in
Bedford, Massachusetts. We have automated certain steps in the manufacturing process which were
being performed manually in the past, allowing us to increase our manufacturing capacity and
decrease our per-unit cost of goods sold, thereby beginning to generate gross profits.
We purchase complete OmniPods 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 September 30, 2008 was in excess of 200,000 OmniPods
per month. 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, third-party payors
and third-party distributors. Our marketing strategy is to build awareness for the benefits of the
OmniPod System through a wide range of education programs, patient demonstration programs, support
materials and events at the national, regional and local levels. In addition, we are using
third-party distributors to improve our access to managed care and government reimbursement
programs, expand our commercial presence and provide access to additional potential patients.
During the nine months ended September 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 nine
months ended September 30, 2008, we incurred net losses of $20.8 million and $64.5 million,
respectively. As of September 30, 2008, we had an accumulated deficit of $220.1 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 September 30, 2008, we
had $85 million of convertible debt outstanding. Since inception, we have received aggregate net
proceeds of $327.0 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 reducing our per-unit production 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
14
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 $1.1 million and $1.3 million for the three and
nine months ended September 30, 2008, respectively, related to the 5.375% Notes. We incurred
deferred financing costs related to this offering of approximately $3.5 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 $81.5 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 $0.4 million, a termination fee
related to the term loan of $0.9 million, and incurred certain other expenses related to the
repayment and termination of the term loan. We incurred interest expense of approximately $0 and
$1.5 million for the three and nine months ended September 30, 2008, respectively, and
approximately $0.9 million and $2.6 million for the three and nine months ended September 30, 2007,
respectively, related to the term loan. The term loan was subject to a loan origination fee of
$0.9 million, 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 $0.6 million 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 in May 2007. We
recorded the $0.8 million fair value of the warrants as a discount to the term loan. Upon
repayment and termination of the term loan, we recognized approximately $0.5 million 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.
15
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 and third-party distributors who resell the
product to diabetes patients. The OmniPod System is comprised of two devices: the OmniPod, a
disposable insulin infusion device that the patient wears for up to three days and then replaces;
and the Personal Diabetes Manager (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 or third-party distributors of OmniPods and Starter Kits, which include the PDM, two
OmniPods, the OmniPod System User Guide and OmniPod System Interactive Training CD, and from the
subsequent sales of additional OmniPods to existing customers. Customers generally order a
three-month supply of OmniPods. For the three and nine months ended September 30, 2008 and for
preceding periods, materially all of our revenue was derived from sales within the United States.
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 with Abbott, We are recognizing the payment as revenue over the 5 year term of the
agreement. Under the amended Abbott agreement, beginning July 1, 2008, Abbott agreed to pay us an
amount for services performed by us in connection with each sale of a PDM that includes an Abbott
Discrete Blood Glucose Monitor to a new customer. We recognize the revenue related to this portion
of the Abbott agreement at the time the revenue is recognized on the sale of the PDM to the
patient. In the three and nine months ended September 30, 2008, we recognized $1.2 million and
$1.4 million of revenue, respectively, related to the amended Abbott agreement. There was no
impact to cost of revenue related to this 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 45 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 September 30, 2008 would have been larger by approximately $1.2
million. As of September 30, 2008, the balance of deferred revenue was $2.3 million, which
includes the current portion of deferred revenue related to the 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. 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 continue to increase, 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
16
activities, including distribution of units used in our demonstration kit programs. In 2008,
we expect sales and marketing expenses to continue to increase significantly compared to 2007, as
we hired additional sales and marketing personnel, are incurring additional sales commission
expense related to sales growth and are expanding our sales and marketing efforts, which 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 continue to
increase compared to 2007 as we add personnel and increase our 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
nine months ended September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
2008 |
|
|
2007 |
|
|
% Change |
|
|
|
(In thousands) |
|
|
|
(Unaudited) |
|
Revenue |
|
$ |
10,110 |
|
|
$ |
3,791 |
|
|
|
167 |
% |
|
$ |
24,198 |
|
|
$ |
9,011 |
|
|
|
169 |
% |
Cost of revenue |
|
|
10,197 |
|
|
|
7,583 |
|
|
|
34 |
% |
|
|
29,980 |
|
|
|
19,054 |
|
|
|
57 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross loss |
|
|
(87 |
) |
|
|
(3,792 |
) |
|
|
98 |
% |
|
|
(5,782 |
) |
|
|
(10,043 |
) |
|
|
42 |
% |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
3,263 |
|
|
|
2,231 |
|
|
|
46 |
% |
|
|
9,569 |
|
|
|
7,221 |
|
|
|
33 |
% |
General and
administrative |
|
|
6,308 |
|
|
|
3,388 |
|
|
|
86 |
% |
|
|
16,900 |
|
|
|
8,845 |
|
|
|
91 |
% |
Sales and
marketing |
|
|
10,176 |
|
|
|
4,144 |
|
|
|
146 |
% |
|
|
29,735 |
|
|
|
10,652 |
|
|
|
179 |
% |
Impairment of
assets |
|
|
|
|
|
|
1,027 |
|
|
|
|
|
|
|
|
|
|
|
1,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating
expenses |
|
|
19,747 |
|
|
|
10,790 |
|
|
|
83 |
% |
|
|
56,204 |
|
|
|
27,745 |
|
|
|
103 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(19,834 |
) |
|
|
(14,582 |
) |
|
|
36 |
% |
|
|
(61,986 |
) |
|
|
(37,788 |
) |
|
|
64 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net |
|
|
(918 |
) |
|
|
943 |
|
|
|
197 |
% |
|
|
(2,522 |
) |
|
|
(83 |
) |
|
|
2939 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(20,752 |
) |
|
$ |
(13,639 |
) |
|
|
52 |
% |
|
$ |
(64,508 |
) |
|
$ |
(37,871 |
) |
|
|
70 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparison of the Three and Nine Months Ended September 30, 2008 and 2007
Revenue
Our total revenue was $10.1 million and $24.2 million for the three and nine months ended
September 30, 2008, respectively, compared to $3.8 million and $9.0 million for the same periods in
2007. The increase in revenue is primarily due to an increased number of patients using the
OmniPod. In addition, the increase in patients resulted in additional revenue related to the
Abbott agreement of $1.2 million and $1.4 million in the three and nine months ended September 30,
2008, respectively . Furthermore, due to a change in our estimate of deferred revenue, revenue for
the three and nine months ended September 30, 2008 was impacted favorably by $0.1 million and $1.2
million, 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 $10.2 million and $30.0 million for the three and nine months ended
September 30, 2008, respectively, compared to $7.6 million and $19.1 million for the same periods
in 2007. The increase is due to increased sales volume offset by efficiencies resulting from
increased manufacturing capacity. Cost of revenue includes adjustment of inventory to lower of
cost or market and indirect costs. The per-unit cost to manufacture the
17
OmniPod decreased in the
three and nine months ended September 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 automation in our
manufacturing process, increased purchases of subassemblies with a lower cost from Flextronics, and
supplies of complete OmniPods from Flextronics.
Research and Development
Research and development expenses increased $1.0 million, or 46%, to $3.3 million for the
three months ended September 30, 2008 compared to $2.2 million for the same period in 2007.
Research and development expenses increased $2.3 million, or 33%, to $9.6 million for the nine
months ended September 30, 2008, compared to $7.2 million for the same period in 2007. For the
three months ended September 30, 2008, the increase in research and development expenses was
primarily attributable to an increase of $0.8 million in employee related expenses, $0.1 million
for tools and supplies and $0.2 million for other expenses. For the nine months ended September
30, 2008, the increase in research and development expenses was primarily attributable to an
increase of $0.9 million in consulting services related to our ongoing development projects, $1.9
million increase in employee related expenses, $0.3 million for tools and supplies, partly offset
by a reduction of $0.2 million in prototype expenses.
General and Administrative
General and administrative expenses increased $2.9 million, or 86%, to $6.3 million for the
three months ended September 30, 2008, compared to $3.4 million for the same period in 2007.
General and administrative expenses increased $8.1 million, or 91%, to $16.9 million for the nine
months ended September 30, 2008, compared to $8.8 million for the same period in 2007. For the
three months ended September 30, 2008, the increase in general and administrative expenses was
primarily due to an increase of $0.2 million in employee compensation and benefit costs associated
with the hiring of additional employees, $0.2 million in distribution expenses, $0.6 million
related to increased allowances and write-offs for doubtful trade accounts receivables, $0.7
million in consulting and legal expenses, $0.2 million in depreciation expense and $0.1 million in
insurance expenses. For the nine months ended September 30, 2008, the increase in general and
administrative expenses was primarily due to an increase of $2.1 million in employee compensation
and benefit costs associated with the hiring of additional employees, $1.2 million related to
increased allowances and write-offs for doubtful trade accounts receivables, $1.1 million in
consulting and legal expenses, $0.7 million in distribution expenses, $0.4 million in insurance
expenses, $0.5 million in depreciation expense and $0.2 million in travel expenses. .
Sales and Marketing
Sales and marketing expenses increased $6.0 million, or 146%, to $10.2 million for the three
months ended September 30, 2008, compared to $4.1 million for the same period in 2007. Sales and
marketing expenses increased $19.1 million, or 179%, to $29.7 million for the nine months ended
September 30, 2008, compared to $10.7 million for the same period in 2007. For the three months
ended September 30, 2008, the increase in sales and marketing expenses was primarily due to an
increase of $3.2 million in employee compensation and benefit costs resulting from the hiring of
additional employees in our sales and marketing areas, $0.8 million related to Patient
Demonstration Kits, $0.7 million in travel and trade show expenses used to support our selling
efforts, $0.9 million in outside consulting services, which include our external trainers, and $0.4
million in other expenses. For the nine months ended September 30, 2008, the increase in sales and
marketing expenses was primarily due to an increase of $8.9 million in employee compensation and
benefit costs resulting from the hiring of additional employees in our sales and marketing areas,
$3.5 million related to Patient Demonstration Kits, $2.3 million in travel and trade show expenses
used to support our selling efforts, $2.2 million in outside consulting services, which include our
external trainers, and $1.2 million in printing costs.
Asset Impairment
From time to time, we evaluate financial and operational impact of possible improvements of
our manufacturing processes. The evaluation of new processes involves assessment of vendors,
product cost and product quality, among other things, and there is no assurance that process
improvements are implemented. During
18
the three months ended September 30, 2007, we completed the
evaluation of an upgrade of our manufacturing processes, and as a result we performed a review of
certain production equipment. The review resulted in a non-cash charge of $1.0 million for the
write-down of certain impaired assets. The impaired assets, which had no future use, consist of
manufacturing equipment. The impairment charges were recorded following determination of the fair
value of cash flows resulting from use of the affected assets, and the carrying value of the assets
has been reduced to reflect their fair value. There were no impairment charges recorded in the
three or nine months ended September 30, 2008.
Other Income (Expense)
Interest income was $0.5 million and $1.6 million for the three and nine months ended
September 30, 2008, respectively, compared to $1.4 million and $2.4 million for the same periods in
2007. For the three months ended September 30, 2008, the decrease was caused primarily by lower
cash balances and interest rates. For the nine months ended September 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 $1.4 million and
$4.1 million for the three and nine months ended September 30, 2008, respectively, compared to $0.5
million and $2.4 million for the same periods in 2007. For the three months ended September 30,
2008, the increased expenses were primarily caused by $1.1 million related to interest on the
5.375% Notes. For the nine months ended September 30, 2008, the increase was caused by $1.3
million related to interest on the 5.375% Notes, $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 September 30, 2008, we had $85.0 million of
convertible debt outstanding. Since inception, we have received net proceeds of $327.0 million
from the issuance of redeemable convertible preferred stock, common stock and convertible debt. As
of September 30, 2008, we had $74.1 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 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 our common stock at an initial conversion rate of 46.8467 shares of common stock
per $1,000 principal amount of the 5.375% Notes, which is equivalent to a conversion price of
approximately $21.35 per share, representing a conversion premium of 34% to the last reported sale
price of our common stock on the NASDAQ Global Market on June 10, 2008, 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 $81.5 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
19
our existing term loan in the aggregate of approximately $21.8
million in its entirety. Additionally, we paid a prepayment fee related to the term loan of
approximately $0.4 million, a termination fee related to the term loan of $0.9 million, 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:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
2008 |
|
2007 |
|
|
(In thousands) |
Cash used in operating activities |
|
$ |
(65,635 |
) |
|
$ |
(34,164 |
) |
Net loss |
|
$ |
(64,508 |
) |
|
$ |
(37,871 |
) |
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
receivables 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:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
2008 |
|
2007 |
|
|
(In thousands) |
Cash used in investing activities |
|
$ |
(9,441 |
) |
|
$ |
(8,340 |
) |
Cash provided by financing activities |
|
$ |
54,622 |
|
|
$ |
113,486 |
|
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 September 30, 2008, we
had an outstanding letter of credit which totaled $0.2 million to cover our security deposits for
lease obligations. This letter of credit will expire on October 30, 2009.
20
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 September 30, 2008, we did not have any off-balance sheet financing arrangements.
Critical Accounting Policies and Estimates
Our financial statements are based on the selection and application of generally accepted
accounting principles, which require us to make estimates and assumptions about future events that
affect the amounts reported in our financial statements and the accompanying notes. Future events
and their effects cannot be determined with certainty. Therefore, the determination of estimates
requires the exercise of judgment. Actual results could differ from those estimates, and any such
differences may be material to our financial statements. We believe that the policies set forth
below may involve a higher degree of judgment and complexity in their application than our other
accounting policies and represent the critical accounting policies and estimates used in the
preparation of our financial statements. If different assumptions or conditions were to prevail,
the results could be materially different from our reported results.
Revenue Recognition
We generate nearly all of our revenue from sales of our OmniPod Insulin Management System to
diabetes patients or third-party distributors who resell the product to diabetes patients. The
initial sale to a new customer or a third-party distributor 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 for sales
directly to patients or a purchase order for sales to a third-party distributor. |
|
|
|
|
Transfer of title and risk and rewards of ownership are passed to the patient or
third-party distributor upon their receipt of the products. |
|
|
|
|
The selling prices for all sales are fixed and agreed with the patient or
third-party distributor, and, if applicable, the patients third-party insurance
provider(s) prior to shipment and are based on established list prices or, in the case
of certain third-party insurers, contractually agreed upon prices. Provisions for
discounts and rebates to customers are established as a reduction to revenue in the
same period the related sales are recorded. |
We have considered the requirements of Emerging Issues Task Force 00-21, Revenue Arrangements
with Multiple Deliverables
(EITF 00-21), 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.
21
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 a comparison of historical return data to their related sales. Historical rates
of return are adjusted for known or expected changes in the marketplace when appropriate.
Historically, sales returns have amounted to approximately 3% of gross product sales.
When doubt exists about reasonable assuredness of collectibility from specific customers, we
defer revenue from sales of products to those customers until payment is received.
Prior to January 1, 2008, we 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, we concluded that we had sufficient historical data on
which to base our estimated returns from January 1, 2008. If we had continued to defer all initial
shipments until the 45-day right of return had expired, deferred revenue as of September 30, 2008
would have been larger by $1.2 million
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. Under the amended Abbott agreement, beginning July 1, 2008, Abbott agreed
to pay us an amount for services performed by us in connection with each sale of a PDM that
includes an Abbott Discrete Blood Glucose Monitor to a new customer. We recognize the revenue
related to this portion of the Abbott agreement at the time the revenue is recognized on the sale
of the PDM to the patient. In the three and nine months ended September 30, 2008, we recognized
$1.2 million and $1.4 million of revenue, respectively, related to the amended Abbott agreement.
There was no impact to cost of revenue related to this agreement.
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 September 30, 2008, we had no interest and penalty accrual or expense.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable consist of amounts due from third-party payors, patients and third-party
distributors.
22
In estimating whether accounts receivable can be collected, we perform 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.
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 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 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 should be separated between 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, results of operations or cash
flows.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162). 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.
SFAS 162 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 are 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.
23
As of September 30, 2008, we had outstanding debt recorded at $85.0 million related to our
5.375% Notes. As the interest rate on the 5.375% 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 September 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, as amended) under the
supervision and with the participation of our chief executive officer and chief financial officer.
In designing and evaluating our disclosure controls and procedures, we and our management recognize
that any controls and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and our management necessarily
was required to apply its judgment in evaluating and implementing possible controls and procedures.
Based upon that evaluation, 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.
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 September 30, 2008 that have materially affected, or are reasonably likely
to materially affect, our internal control over financial reporting.
24
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.
We need to expand our distribution network to maintain and grow our business and revenues. If we
fail to expand and maintain an effective sales force or successfully develop our relationship with
distributors, our business, prospects and brand may be materially and adversely affected.
We currently promote, market and sell substantially all of our OmniPod Systems through our own
direct sales force. As part of our growth plan, we intend to increase the number of distributors we
utilize to distribute our OmniPod System. We cannot assure you that we will be able to successfully
develop our relationships with third-party distributors. If we fail to do so, our sales could fail
to grow or could even decline, and our ability to grow our business could be adversely affected.
Distributors that are in the business of selling other medical products may not devote a sufficient
level of resources and support required to generate awareness of our products and grow or maintain
product sales. If our distributors are unwilling or unable to market and sell our products, or if
they do not perform to our expectations, we could experience delayed or reduced market acceptance
and sales of our products.
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
25
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 September 30, 2008, we have used approximately $108 million of the net proceeds we
received from the offering for working capital and other general corporate purposes, including
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).
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of
Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
10.1
|
|
Amended and Restated 2007 Stock
Option and Incentive Plan |
|
|
|
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. |
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.
|
|
|
|
|
|
|
INSULET CORPORATION
(Registrant) |
|
|
|
|
|
|
|
Date: November 13, 2008
|
|
/s/ Duane DeSisto
Duane DeSisto
|
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
|
Date: November 13, 2008
|
|
/s/ Carsten Boess
Carsten Boess
|
|
|
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
|
27
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
10.1
|
|
Amended and Restated 2007 Stock
Option and Incentive Plan |
|
|
|
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. |
28