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 March 31, 2009
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-33462
Insulet Corporation
(Exact name of Registrant as specified in its charter)
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Delaware
(State or other jurisdiction of incorporation or
organization)
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04-3523891
(I.R.S. Employer Identification Number) |
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9 Oak Park Drive
Bedford, Massachusetts
(Address of principal executive offices)
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01730
(Zip Code) |
Registrants telephone number, including area code: (781) 457-5000
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o (Do not check if a smaller reporting company) | Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As
of May 5, 2009, the registrant had 27,852,700 shares of common stock outstanding.
INSULET CORPORATION
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION |
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1 |
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Item 1. Condensed Consolidated Financial Statements |
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1 |
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Condensed Consolidated Balance Sheets at March 31, 2009 and December 31, 2008 (unaudited) |
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1 |
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Condensed Consolidated Statements of Operations for the three months ended March 31,
2009 and 2008 (unaudited) |
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2 |
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Condensed Consolidated Statements of Cash Flows for the three months ended March 31,
2009 and 2008 (unaudited) |
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3 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
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4 |
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
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15 |
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Item 3. Quantitative and Qualitative Disclosures About Market Risk |
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27 |
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Item 4. Controls and Procedures |
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27 |
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PART II. OTHER INFORMATION |
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28 |
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Item 1. Legal Proceedings |
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28 |
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Item 1A. Risk Factors |
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28 |
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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28 |
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Item 3. Defaults Upon Senior Securities |
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28 |
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Item 4. Submission of Matters to a Vote of Security Holders |
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28 |
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Item 5. Other Information |
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28 |
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Item 6. Exhibits |
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28 |
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Signatures |
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29 |
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(i)
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
INSULET CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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As of |
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As of |
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December 31, |
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March 31,
2009 |
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2008
(Restated) |
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(In thousands, except share and per 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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$ |
68,164 |
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$ |
56,663 |
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Accounts receivable, net |
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13,291 |
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11,938 |
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Inventories |
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15,147 |
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16,870 |
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Prepaid expenses and other current assets |
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3,385 |
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3,028 |
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Total current assets |
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99,987 |
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88,499 |
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Property and equipment, net |
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16,423 |
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17,564 |
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Other assets |
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3,442 |
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2,170 |
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Total assets |
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$ |
119,852 |
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$ |
108,233 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities |
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Accounts payable |
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$ |
5,979 |
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$ |
7,291 |
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Accrued expenses |
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11,327 |
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7,300 |
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Deferred revenue |
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2,484 |
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2,377 |
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Total current liabilities |
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19,790 |
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16,968 |
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Long-term debt, net of current portion |
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81,446 |
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60,172 |
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Other long-term liabilities |
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3,159 |
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2,987 |
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Total liabilities |
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104,395 |
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80,127 |
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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
March 31, 2009 and
December 31, 2008. |
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Issued and
outstanding: zero
shares at March 31,
2009 and December
31, 2008 |
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Common stock, $.001 par value: |
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Authorized: 100,000,000 shares
at March 31, 2009
and December 31,
2008. |
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Issued and outstanding: 27,839,115 and 27,778,921 shares at March 31, 2009 and December 31, 2008, respectively |
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29 |
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29 |
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Additional paid-in capital |
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285,423 |
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278,427 |
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Accumulated deficit |
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(269,995 |
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(250,350 |
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Total stockholders equity |
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15,457 |
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28,106 |
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Total liabilities and stockholders equity |
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$ |
119,852 |
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$ |
108,233 |
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December
31, 2008 balances have been restated to reflect the retrospective
adoption of FSP APB 14-1.
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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(In thousands, except share and per share data) |
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Revenue |
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$ |
12,469 |
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$ |
6,671 |
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Cost of revenue |
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10,474 |
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9,998 |
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Gross profit (loss) |
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1,995 |
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(3,327 |
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Operating expenses: |
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Research and development |
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3,204 |
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2,923 |
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General and administrative |
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7,491 |
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5,197 |
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Sales and marketing |
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8,772 |
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8,565 |
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Total operating expenses |
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19,467 |
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16,685 |
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Operating loss |
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(17,472 |
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(20,012 |
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Interest income |
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101 |
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713 |
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Interest expense |
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(2,274 |
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(575 |
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Net interest income (expense) |
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(2,173 |
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138 |
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Net loss |
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(19,645 |
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(19,874 |
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Net loss per share basic and diluted |
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$ |
(0.71 |
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$ |
(0.73 |
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Weighted average number of shares
used in calculating basic and
diluted net loss per share |
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27,804,603 |
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27,394,322 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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(In thousands) |
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Cash flows from operating activities |
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Net loss |
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$ |
(19,645 |
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$ |
(19,874 |
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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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1,306 |
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1,358 |
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Amortization of debt discount |
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1,039 |
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58 |
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Stock compensation expense |
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1,201 |
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674 |
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Provision for bad debts |
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1,238 |
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572 |
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Non-cash interest expense |
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121 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(2,591 |
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(3,012 |
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Inventory |
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1,723 |
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484 |
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Prepaids and other current assets |
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(357 |
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(1,452 |
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Other assets |
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50 |
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Accounts payable and accrued expenses |
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2,715 |
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4,929 |
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Other long term liabilities |
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172 |
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2,115 |
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Deferred revenue, short-term |
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107 |
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(13 |
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Net cash used in operating activities |
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(12,971 |
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(14,111 |
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Cash flows from investing activities |
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Purchases of property and equipment |
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(165 |
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(5,279 |
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Net cash used in investing activities |
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(165 |
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(5,279 |
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Cash flows from financing activities |
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Principal payments of long-term loan |
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(2,727 |
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Proceeds from issuance of facility agreement, net of financing expenses |
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24,513 |
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Proceeds from issuance of common stock, net of offering expenses |
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124 |
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555 |
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Proceeds from payment of subscription receivable |
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9 |
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Net cash provided by (used in) financing activities |
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24,637 |
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(2,163 |
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Net increase (decrease) in cash and cash equivalents |
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11,501 |
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(21,553 |
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Cash and cash equivalents, beginning of period |
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56,663 |
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94,588 |
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Cash and cash equivalents, end of period |
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$ |
68,164 |
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$ |
73,035 |
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Supplemental disclosure of cash flow information |
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Cash paid for interest |
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$ |
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$ |
708 |
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Non-cash financing activities |
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Allocation of fair value of warrants from net proceeds from issuance
of facility agreement |
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$ |
6,065 |
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$ |
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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 and
marketing of an insulin infusion system for people with insulin-dependent diabetes. The Company was
incorporated in Delaware in 2000 and has its corporate headquarters in Bedford, Massachusetts.
Since inception, the Company has devoted substantially all of its efforts to designing, developing,
manufacturing and marketing the OmniPod Insulin Management System (OmniPod), which consists of
the OmniPod disposable insulin infusion device and the handheld, wireless Personal Diabetes Manager
(PDM). The Company commercially launched the OmniPod Insulin Management System in August 2005
after receiving FDA 510(k) approval in January 2005. The first commercial product was shipped in
October 2005.
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 month period ended March 31, 2009
are not necessarily indicative of the results that may be expected for the full year ending
December 31, 2009, 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, 2008.
Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most significant estimates used
in these financial statements include the valuation of inventories, accounts receivable, stock
options and warrants, the lives of property and equipment, and warranty and doubtful account
allowance reserve 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
intercompany balances and transactions have been eliminated in consolidation. To date there has
been minimal activity in Sub-Q Solutions, Inc.
Reclassifications
Certain previously reported amounts have been reclassified to conform to the current year
presentation.
Accounts Receivable and Allowance for Doubtful Accounts
4
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 third-party payors, patients and third-party distributors 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.
Inventories
Inventories are stated at the lower of cost or market, determined under the first-in,
first-out (FIFO) method. Inventory has been recorded at cost at December 31, 2008 and March 31,
2009. Work in process is calculated based upon a build-up in the stage of completion using
estimated labor inputs for each stage in production. Costs for PDMs and OmniPods include raw
material, labor and manufacturing overhead. The Company evaluates inventory valuation on a
quarterly basis for 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.
Restructuring Expenses and Impairment of Assets
In connection with its efforts to pursue improved gross margins, leverage operational
efficiencies and better pursue opportunities for low-cost supplier sourcing of asset costs, the
Company periodically performs an evaluation of its manufacturing processes and 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. This review of manufacturing processes and equipment can result in restructuring
activity or an impairment of assets based on current net book value and potential future use of the
assets.
The Companys restructuring expenses may also include workforce reduction and related costs
for one-time termination benefits provided to employees who are involuntarily terminated under the
terms of a one-time benefit arrangement. The Company records these one-time termination benefits
upon incurring the liability provided that the employees are notified, the plan is approved by the
appropriate level of management, the employees to be terminated and the expected completion date
are identified, and the benefits the identified employees will be paid are established. Significant
changes to the plan are not expected when the Company records the costs. In recording the workforce
reduction and related costs, the Company estimates related costs such as taxes and outplacement
services which may be provided under the plan. If changes in these estimated services occur, the
Company may be required to record or reverse restructuring expenses associated with these workforce
reduction and related costs.
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 upon
transfer to the third party carrier; transfer of title and risk and rewards of
ownership are passed to the distributor typically 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. |
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.
In March 2008, the Company received a cash payment from Abbott Diabetes Care, Inc. (Abbott)
for an agreement fee in connection with execution of the first amendment to the development and
license agreement between the Company and Abbott. The Company recognizes revenue on the agreement
fee from Abbott over the initial 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 months ended March 31, 2009 and 2008, the Company recognized $1.1 million and $38,000 of
revenue, respectively, related to the Abbott agreement. There was no impact to cost of revenue
related to this agreement.
The
Company had deferred revenue of $3.9 million and $4.0 million as of March 31, 2009 and
December 31, 2008, respectively. The deferred revenue recorded as of March 31, 2009, 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, cash equivalents and accounts receivable. 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 March
31, 2009, the two largest third-party payors each accounted for 5% of gross accounts receivable
balances. As of December 31, 2008, the two largest third-party payors accounted for 7% and 4% of
gross accounts receivable balances, respectively.
6
Income Taxes
The Company files federal and state tax returns. The Company has accumulated significant
losses since its inception in 2000. Since the net operating losses may potentially be utilized in
future years to reduce taxable income, all of the Companys tax years remain open to examination by
the major taxing jurisdictions to which the Company is subject.
The Company recognizes estimated interest and penalties for uncertain tax positions in income
tax expense. As of March 31, 2009, the Company had no interest and penalty accrual or expense.
Adoption of New Accounting Standard
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. FSP APB 14-1 was applied retrospectively to all periods presented. Any
cumulative effect of the change in accounting principle on prior periods must be recognized as of
the beginning of the first period presented. The Company adopted the provisions of FSP APB 14-1 as
of January 1, 2009 and has reclassified $26.9 million of its long-term debt to equity as of the
issuance date of the convertible notes. During the three months ended March 31, 2009, the Company
recorded $1.0 million of additional interest expense related to the provisions of FSP APB 14-1.
There was no impact to the three months ended March 31, 2008, as the convertible notes were not
outstanding during that period.
Recent Accounting Pronouncements
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. Facility Agreement and Common Stock Warrants
On March 13, 2009, the Company entered into a Facility Agreement with certain institutional
accredited investors, pursuant to which the investors agreed to loan
the Company up to $60 million, subject to
the terms and conditions set forth in the Facility Agreement. Following the initial disbursement
of $27.5 million on March 31, 2009, the Company may, but is not required to, draw down on the
facility in $6.5 million increments at any time until November 2010 provided that the Company meets
certain financial performance milestones. In connection with this Financing, the Company paid Deerfield
Management Company, L.P., an affiliate of the lead Lender, a one-time transaction fee of $1.2
million. Total financing costs, including the transaction fee, as of March 31, 2009, were $3.0
million and are being amorlized as interest expense over the 42
months of the Facility Agreement.
Any amounts drawn under the Facility Agreement accrue interest at a rate of 9.75% per annum,
and any undrawn amounts under the Facility Agreement accrue interest at a rate of 2.75% per annum.
Accrued interest is payable quarterly in cash in arrears beginning on June 1, 2009. The Company has
the right to prepay any amounts owed without penalty unless the prepayment is in connection with a
major transaction. All principal amounts outstanding under the Facility Agreement are payable in
September 2012.
Additionally, any amounts drawn under the Facility Agreement may become immediately due and
payable upon (i) an event of default, as defined in the Facility Agreement, in which case the
Lenders would have the right to require the Company to re-pay 100% of the principal amount of the
loan, plus any accrued and unpaid interest thereon, or (ii) the consummation of certain change of
control transactions, in which case the Lenders would have
7
the right to require the Company to re-pay 106% of the outstanding principal amount of the
loan, plus any accrued and unpaid interest thereon. The Facility Agreement also provides for
higher interest rates to be paid by the Company in the event of default.
Because the consummation of certain change in control transactions would result in the payment
of a premium on the outstanding principal, the premium feature is a derivative that is required to
be bifurcated from the host debt instrument and recorded at fair value at each quarter end. Because
an event of default results in a higher interest rate, the default interest is also a derivative.
The default interest payment does not meet the criteria to be accounted for separately. Any
changes in fair value of the premium feature will be recorded as interest expense and the
difference between the face value of the outstanding principal on the Facility Agreement and the
amount remaining after the bifurcation will be recorded as a discount to be amortized over the term
of the Facility Agreement.
At March 31, 2009, the premium feature associated with the
Facility Agreement had no value as the Company does not currently
expect a change in control transaction to occur.
The premium feature related to the Facility Agreement will be reassessed and marked-to-market
through earnings on a quarterly basis.
At March 31, 2009, of the $27.5 million of outstanding debt related to the Facility Agreement,
$20.2 million is included in long-term debt in the condensed consolidated balance sheet, which
reflects the net proceeds reduced by the fair value of the warrants of $6.1 million and the $1.2
million transaction fee paid to Deerfield Management Company, L.P. The $7.3 million debt discount
will be recorded as interest expense over the 42 months of the loan. No interest expense was
recorded in the three months ended March 31, 2009.
Common Stock Warrants
On March 13, 2009, in connection with the execution of the Facility Agreement, the Company
issued to the Lenders fully exercisable warrants to purchase an aggregate of 3.75 million shares of common stock of
the Company at an exercise price of $3.13 per share. Pursuant to the Facility Agreement, the
Company has the right to request from the Lenders one or more cash disbursements in the minimum
amount of $6.5 million per disbursement. Each additional $6.5 million disbursement shall be
accompanied by the issuance to the Lenders of warrants to purchase an aggregate of 0.3 million
shares of common stock, at an exercise price equal to 120% of the average volume weighted average
price of the Companys common stock on the fifteen consecutive trading days beginning with the date
following receipt by the Lenders of the disbursement request. If the Company, in its discretion,
draws down the entire $60 million credit facility, the Company will have issued warrants to
purchase a total of 5.25 million shares of its common stock.
If the Company issues or sells shares of its common stock (other than (i) pursuant to a
registered public offering or shelf takedown, (ii) in a transaction that does not require
shareholder approval, (iii) to partners in connection with a joint venture, distribution or other
partnering arrangement in a transaction that does not require shareholder approval, (iv) upon the
exercise of options granted to our employees, officers, directors and consultants, (v) of
restricted stock to, or purchases of, our common stock under our employee stock purchase plan by
employees, officers, directors or consultants or (vi) upon the exercise of the warrants) after
March 13, 2009, the Company will issue concurrently therewith additional warrants to purchase such
number of shares of common stock as will entitle the Lenders to maintain the same beneficial
ownership in the Company after the issuance as they had prior to such issuance, as adjusted on a
pro rata basis for repayments of the outstanding principal amount under the loan, with such
warrants being issued at an exercise price equal to the greater of $3.13 per share and the closing
price of the common stock on the date immediately prior to the issuance.
All warrants issued under the Facility Agreement remain unexercised as of March 31, 2009,
expire on March 13, 2015 and contain certain limitations that prevent the holder from acquiring
shares upon exercise of a warrant that would result in the number of shares beneficially owned by
it to exceed 9.98% of the total number of shares of Company common stock then issued and
outstanding.
In addition, upon certain change of control transactions, or upon certain events of default
(as defined in the warrant agreement), the holder has the right to net exercise the warrants for an amount
of shares of Company common stock equal to the Black-Scholes value of the shares issuable under the
warrants divided by 95% of the closing price of the common stock on the day immediately prior to
the consummation of such change of control or event of default, as applicable. In certain
circumstances where a warrant or portion of a warrant is not net exercised in connection with a
8
change of control or event of default, the holder will be paid an amount in cash equal to the
Black-Scholes value of such portion of the warrant not treated as a net exercise.
In
accordance with EITF 00-19, Accounting for Derivative Financial
Instruments Indexed to, and Potentially settled in, a Companys
Own Stock, the warrants issued in connection with the Facility Agreement
qualify for permanent classification as equity and their relative fair value of $6.1 million
on issuance date was recorded as additional paid in capital and debt
discount to be amortized as interest expense over
the term of the Facility Agreement.
4. Convertible Notes and Repayment and Termination of Term Loan
In June 2008, the Company sold $85 million principal amount of 5.375% Convertible Senior Notes
due June 15, 2013 (the 5.375% Notes) in a private placement to qualified institutional buyers
pursuant to Rule 144A under the Securities Act of 1933, as amended. The interest rate on the notes
is 5.375% per annum on the principal amount from June 16, 2008, payable semi-annually in arrears in
cash on December 15 and June 15 of each year, beginning December 15, 2008. The 5.375% Notes are
convertible into the Companys common stock at an initial conversion rate of 46.8467 shares of
common stock per $1,000 principal amount of the 5.375% Notes, which is equivalent to a conversion
price of approximately $21.35 per share, representing a conversion premium of 34% to the last
reported sale price of the Companys common stock on the NASDAQ Global Market on June 10, 2008,
subject to adjustment under certain circumstances, at any time beginning on March 15, 2013 or under
certain other circumstances and prior to the close of business on the business day immediately
preceding the final maturity date of the notes. The 5.375% Notes will be convertible for cash up
to their principal amount and shares of the Companys common stock for the remainder of the
conversion value in excess of the principal amount. The Company does not have the right to redeem
any of the 5.375% Notes prior to maturity. If a fundamental change, as defined in the Indenture
for the 5.375% Notes, occurs at any time prior to maturity, holders of the 5.375% Notes may require
the Company to repurchase their notes in whole or in part for cash equal to 100% of the principal
amount of the notes to be repurchased, plus accrued and unpaid interest, including any additional
interest, to, but excluding, the date of repurchase.
If a holder elects to convert its 5.375% Notes upon the occurrence of a make-whole fundamental
change, as defined in the Indenture for the 5.375% Notes, the holder may be entitled to receive an
additional number of shares 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 adopted the provisions of FSP APB 14-1, Accounting for Convertible Debt
Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement), on
January 1, 2009. 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. FSP APB 14-1 was applied retrospectively to all periods presented.
Accordingly, the Company recorded a debt discount of $26.9 million to equity to reflect the value
of its nonconvertible debt borrowing rate of 14.5% per annum. This debt discount is being
amortized as interest expense beginning June 15, 2008 over the 5 year life of the 5.375% Notes.
The Company incurred interest expense of approximately $2.2 million for the three months ended
March 31, 2009, related to the 5.375% Notes. Of the $2.2 million, approximately $1.0 million
relates to additional interest expense recognized under the provisions of FSP APB 14-1. There was
no interest expense related to the 5.375% Notes in the three months ended March 31, 2008. The
Company incurred deferred financing costs related to this offering of approximately $3.5 million,
of which $1.1 million has been reclassified as an offset to the
value of the amount allocated to equity. The remainder
is recorded in the condensed consolidated balance sheet and is being amortized as a component of
interest expense over the five year term of the 5.375% Notes.
At March 31, 2009, the outstanding amounts related to the 5.375% Notes of $61.2 million are
included in long-term debt in the condensed consolidated balance sheet and reflect the debt
discount of $23.8 million. At December 31, 2008, the outstanding amounts related to the 5.375%
Notes of $60.2 million are included in long-term debt and have
been retroactively restated as required by FSP APB 14-1 to reflect the debt discount of $24.8
million. The debt discount includes the equity allocation of $25.8 million
9
($26.9 million less the financing costs allocated to the equity of $1.1 million) offset by the
accretion of the debt discount through interest expense from the
issuance date in 2008 over the 5 year life
of the notes. The Company recorded $1.0 million of interest expense related to the debt discount
in the three months ended March 31, 2009. At March 31, 2009, the 5.375% Notes have a remaining
life of 4.25 years. No interest expense was recorded in the
three months ended March 31, 2008. The statement of operations
for the 2008 periods subsequent to the debt issuance on June 15,
2008, will be retroactively restated to reflect the additional
interest expense pursuant to FSP APB 14-1.
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 $0.7 million for the three months ended March 31, 2008, 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.
5. Restructuring Expenses and Impairments of Assets
In December 2008, the Company recorded restructuring and impairment charges of $8.2 million
for the impairment of certain manufacturing equipment no longer in use as well as workforce
reduction and related costs. As part of the Companys strategic goal to pursue improved gross
margins, leverage operational efficiencies and better pursue opportunities for low-cost supplier
sourcing, the Company transitioned the manufacturing of completed OmniPods to Flextronics
International Ltd., located in China. The Company determined that it would no longer use certain
manufacturing equipment located in its Bedford facility. In addition, this transition resulted in a
reduction in workforce of approximately 30 employees, mainly in the manufacturing and quality
departments. As a result of these actions, the Company recorded $7.4 million as a non-cash charge
related to impairments of assets and $0.8 million in workforce and related charges.
Employees terminated were mainly in the manufacturing and quality departments. In addition,
certain members of senior management were terminated. This reduction was primarily in response to
the successful transition of portions of the manufacturing process to Flextronics as well as
on-going alignment of the Companys infrastructure.
During the third quarter of 2008, the Company successfully transitioned its production of
completed OmniPods to the manufacturing line operated by Flextronics. Pursuant to the Companys
agreement with Flextronics, Flextronics will supply, as a non-exclusive supplier, OmniPods at
agreed upon prices per unit pursuant to a rolling 12-month forecast provided by the Company. 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 Company
continues to manufacture certain sub-assemblies and maintain packaging operations in its Bedford,
Massachusetts facility.
The Company ceased to use certain assets in its Bedford facility, in connection with the
transition of manufacturing to Flextronics. The Company continued to evaluate Flextronics ability
to manufacture completed OmniPods against the rolling forecast as well as anticipated capacity and
demand throughout the fourth quarter. During the fourth quarter the Company concluded that the
capacity of the manufacturing line operated by Flextronics is considered adequate to meet
anticipated demand and quality standards in the future. As the Company
10
determined on December 1, 2008, that it would no longer use the Bedford equipment on December
1, 2008, the Company recorded an impairment charge for the remaining net book value of the assets
of $7.4 million on that date. The equipment has no expected salvage value as it is highly
customized equipment that can only be used for the manufacture of OmniPods.
At March 31, 2009 and December 31, 2008, the Companys accrued expense for restructuring was
$0.4 million and $0.6 million, respectively, for final payments of severance and will be fully
utilized in 2009.
The following is a summary of restructuring activity for the three months ended March 31,
2009:
|
|
|
|
|
|
|
3 Months Ended |
|
|
|
March 31, 2009 |
|
|
|
Workforce and |
|
|
|
related |
|
|
|
|
|
|
Balance at the beginning of year |
|
$ |
612 |
|
Restructuring expense |
|
|
|
|
Payments |
|
|
(211 |
) |
|
|
|
|
Balance at the end of the year |
|
$ |
401 |
|
|
|
|
|
6. Net Loss Per Share
Basic net loss per share is computed by dividing net loss by the weighted average number of
common shares outstanding for the period, excluding unvested restricted common shares. Diluted net
loss per share is computed using the weighted average number of common shares outstanding and, when
dilutive, potential common share equivalents from options 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 months ended March 31, 2009 and 2008, all
potential common shares have been excluded from the computation of the diluted net loss per share
for all periods presented, as the effect would have been anti-dilutive. Such potentially dilutive
common share equivalents consist of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2009 |
|
2008 |
Convertible debt |
|
|
3,981,969 |
|
|
|
|
|
Unvested restricted common shares |
|
|
3,552 |
|
|
|
|
|
Outstanding options |
|
|
3,448,215 |
|
|
|
2,975,098 |
|
Outstanding warrants |
|
|
3,812,752 |
|
|
|
62,752 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
11,246,488 |
|
|
|
3,037,850 |
|
|
|
|
|
|
|
|
|
|
11
7. Accounts Receivable
The components of accounts receivable are as follows:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(In thousands) |
|
Trade receivables |
|
$ |
18,184 |
|
|
$ |
15,738 |
|
Allowance for doubtful accounts |
|
|
(4,893 |
) |
|
|
(3,800 |
) |
|
|
|
|
|
|
|
|
|
$ |
13,291 |
|
|
$ |
11,938 |
|
|
|
|
|
|
|
|
8. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(In thousands) |
|
Raw materials |
|
$ |
3,443 |
|
|
$ |
3,518 |
|
Work-in-process |
|
|
854 |
|
|
|
997 |
|
Finished goods |
|
|
10,850 |
|
|
|
12,355 |
|
|
|
|
|
|
|
|
|
|
$ |
15,147 |
|
|
$ |
16,870 |
|
|
|
|
|
|
|
|
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 held at cost at March 31, 2009 and December 31, 2008. The
Companys production process has a high degree of fixed costs and due to the early stage of market
acceptance for its products, sales and production volumes may vary significantly from one period to
another. 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. During the third
quarter of 2008, the Company began presenting its inventory of completed OmniPods at cost, as the
cost to produce OmniPods was lower than the Companys selling price.
9. 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 |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
(In thousands) |
|
Balance at the beginning of period |
|
$ |
2,268 |
|
|
$ |
865 |
|
Warranty expense |
|
|
1,139 |
|
|
|
717 |
|
Warranty claims settled |
|
|
(735 |
) |
|
|
(486 |
) |
|
|
|
|
|
|
|
Balance at the end of the period |
|
$ |
2,672 |
|
|
$ |
1,096 |
|
|
|
|
|
|
|
|
Composition of balance: |
|
|
|
|
|
|
|
|
Short-term |
|
$ |
991 |
|
|
$ |
494 |
|
Long-term |
|
|
1,681 |
|
|
|
602 |
|
|
|
|
|
|
|
|
Total warranty balance |
|
$ |
2,672 |
|
|
$ |
1,096 |
|
|
|
|
|
|
|
|
12
10. 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-cancelable lease for additional office
space in Bedford, Massachusetts. The lease expires in September 2010 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 research and
development and manufacturing space. Following the extension, the lease expires in September 2014.
The lease is non-cancelable 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
liabilities in the accompanying balance sheet. The Company has considered FASB Technical Bulletin
88-1, Issues Relating to Accounting for Leases, and FASB Technical Bulletin 85-3, Accounting for
Operating Leases with Scheduled Rent Increases, in accounting for these lease provisions.
Indemnifications
In the normal course of business, the Company enters into contracts and agreements that
contain a variety of representations and warranties and provide for general indemnifications. The
Companys exposure under these agreements is unknown because it involves claims that may be made
against the Company in the future, but have not yet been made. To date, the Company has not paid
any claims or been required to defend any action related to its indemnification obligations.
However, the Company may record charges in the future as a result of these indemnification
obligations.
In accordance with its bylaws, the Company has indemnification obligations to its officers and
directors for certain events or occurrences, subject to certain limits, while they are serving at
the Companys request in such capacity. There have been no claims to date and the Company has a
director and officer insurance policy that enables it to recover a portion of any amounts paid for
future claims.
11. Equity
13
Stock-Based Compensation Plans
Activity under the Companys stock option plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Average |
|
Aggregate |
|
|
Number of |
|
Exercise |
|
Intrinsic |
|
|
Options |
|
Price |
|
Value |
|
|
|
Balance, December 31, 2008 |
|
|
2,933,832 |
|
|
$ |
9.47 |
|
|
$ |
6,080,097 |
|
Granted |
|
|
763,500 |
|
|
|
6.79 |
|
|
|
|
|
Exercised |
|
|
(60,194 |
) |
|
|
2.07 |
|
|
$ |
293,488 |
(1) |
Canceled |
|
|
(188,923 |
) |
|
|
15.45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2009 |
|
|
3,448,215 |
|
|
$ |
8.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested, March 31, 2009 |
|
|
1,539,819 |
|
|
$ |
6.42 |
|
|
$ |
1,306,175 |
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, March 31, 2009 (3) |
|
|
2,801,840 |
|
|
|
|
|
|
|
|
|
|
|
|
(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 March 31, 2009, and the exercise price
of the underlying options. |
|
(3) |
|
Represents the number of vested options as of March 31, 2009, plus the number of unvested
options expected to vest as of March 31, 2009, based on the unvested options outstanding at
March 31, 2009, adjusted for an estimated forfeiture rate of 16%. |
In the three months ended March 31, 2009 and 2008, no shares were contingently issued under
the employee stock purchase plan (ESPP). In the three months ended March 31, 2009 and 2008, the
Company recorded no significant stock-based compensation charges related to the ESPP.
Employee stock-based compensation expense under SFAS 123R recognized in the three months ended
March 31, 2009 and 2008 was $1.2 million and $0.7 million, respectively.
12. 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.
14
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, 2008, which was filed with the Securities and
Exchange Commission on March 16, 2009 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 and markets an insulin infusion
system for people with insulin-dependent diabetes. Our proprietary OmniPod Insulin Management
System consists of our disposable OmniPod insulin infusion device and our handheld, wireless
Personal Diabetes Manager.
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 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.
During 2008, construction was completed on a partially automated manufacturing line at a
facility in China operated by a subsidiary of Flextronics International Ltd. We purchase complete
OmniPods pursuant to our
15
agreement with Flextronics entered into on January 3, 2007 and revised on October 4, 2007. 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 specified
number of days is intended to provide the parties with sufficient time to make alternative
arrangements in the event of termination. By purchasing OmniPods manufactured by Flextronics in
China, we were able to substantially increase production volumes for the OmniPod and reduce our per
unit production cost. We also produce certain sub-assemblies for the OmniPod as well as maintain
packaging operations at our facility in Bedford, Massachusetts.
Our OmniPod manufacturing capacity as of March 31, 2009 was in excess of 200,000 OmniPods per
month. By increasing production volumes of the OmniPod, we have been able to reduce our per-unit
raw material costs and improve absorption of manufacturing overhead costs. This, as well as the
installation of automated manufacturing equipment, collaboration with contract manufacturers and
reduction of cost of supplies of raw materials and sub-assemblies, 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.
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.
Our continued growth is dependent on our ability to generate interest in our products through
sales and marketing activities. We also depend on our ability to effectively and correctly
evaluate the extent of patients reimbursement coverage under applicable reimbursement programs in
order to convert customer inquiries into shipments and revenue.
Since our inception in 2000, we have incurred losses every quarter. In the three months ended
March 31, 2009, we incurred net losses of $19.6 million. As of March 31, 2009, we had an
accumulated deficit of $270.0 million. We have financed our operations through the private
placement of debt and equity securities, public offerings of our common stock as well as a private
placement of our convertible debt. As of March 31, 2009, we had $85 million of convertible debt
outstanding and $27.5 million of outstanding debt relating to a Facility Agreement entered into
March 13, 2009. Under the Facility Agreement, we have the ability to borrow up to a total of $60
million upon meeting certain financial performance milestones. Since inception, we have received aggregate
net proceeds of $351.6 million from the issuance of redeemable convertible preferred stock, common
stock and debt.
Our long-term financial objective is to achieve and sustain profitable growth. Our efforts
for the remainder of 2009 will be focused primarily on continuing to reduce our per-unit production
costs, expanding sales to domestic and international markets and reducing our spending on
manufacturing overhead and operating expenses. The continued expansion of our manufacturing
capacity will help us to achieve lower material costs due to volume purchase discounts and improved
absorption of manufacturing overhead costs, reducing our cost of revenue as a percentage of
revenue. Achieving these objectives is expected to require additional investments in certain
personnel and initiatives to allow for us to increase our market penetration in the United States
market and enter certain international markets. We believe that we will continue to incur net
losses in the near term in order to achieve these objectives, particularly in light of the
recession in the United States and the slowdown of economic growth in the
16
rest of the world which is creating a challenging near term business environment. However, we
believe that the accomplishment of our near term objectives will have a positive impact on our
financial condition in the future.
Facility Agreement and Common Stock Warrants
On March 13, 2009, we entered into a Facility Agreement with certain institutional accredited
investors, pursuant to which the investors agreed to loan us up to $60 million, subject to the terms
and conditions set forth in the Facility Agreement. Following the initial disbursement of $27.5
million on March 31, 2009, we may, but are not required to, draw down on the facility in $6.5
million increments at any time until November 2010 provided that we meet certain financial
performance milestones. In connection with this financing, we paid Deerfield Management Company, L.P., an
affiliate of the lead Lender, a one-time transaction fee of $1.2 million. Total financing costs,
including the transaction fee, as of March 31, 2009, were
$3.0 million and are being amortized as interest expense over
the 42 months of the Facility Agreement.
Any amounts drawn under the Facility Agreement accrue interest at a rate of 9.75% per annum,
and any undrawn amounts under the Facility Agreement accrue interest at a rate of 2.75% per annum.
Accrued interest is payable quarterly in cash in arrears beginning on June 1, 2009. We have the
right to prepay any amounts owed without penalty unless the prepayment is in connection with a
major transaction. All principal amounts outstanding under the Facility Agreement are payable in
September 2012.
Additionally, any amounts drawn under the Facility Agreement may become immediately due and
payable upon (i) an event of default, as defined in the Facility Agreement, in which case the
Lenders would have the right to require us to re-pay 100% of the principal amount of the loan, plus
any accrued and unpaid interest thereon, or (ii) the consummation of certain change of control
transactions, in which case the Lenders would have the right to require us to re-pay 106% of the
outstanding principal amount of the loan, plus any accrued and unpaid interest thereon. The
Facility Agreement also provides for higher interest rates to be paid by us in the event of
default.
Because the consummation of certain change in control transactions would result in the payment
of a premium of the outstanding principal, the premium feature is a derivative that is required to
be bifurcated from the host debt instrument and recorded at fair value at each quarter end. Because
an event of default results in a higher interest rate, the default interest is also a derivative.
The default interest payment does not meet the criteria to be accounted for separately. Any
changes in fair value of the premium feature will be recorded as interest expense and the
difference between the face value of the outstanding principal on the Facility Agreement and the
amount remaining after the bifurcation will be recorded as a discount to be amortized over the term
of the Facility Agreement.
At March 31, 2009, the premium feature associated with the Facility
Agreement had no value as we do not currently expect a change in
control transaction to occur.
The embedded derivatives related to the Facility Agreement will be reassessed and marked-to-market
through earnings on a quarterly basis.
At March 31, 2009, of the $27.5 million of outstanding debt related to the Facility Agreement,
$20.2 million is included in long-term debt in the condensed consolidated balance sheet, which
reflects the net proceeds reduced by the fair value of the warrants of $6.1 million and the $1.2
million transaction fee paid to Deerfield Management Company, L.P. The $7.3 million debt discount
will be recorded as interest expense over the 42 months of the loan. No interest was recorded in
the three months ended March 31, 2009.
On March 13, 2009, in connection with the execution of the Facility Agreement, we issued to
the Lenders fully exercisable warrants to purchase an aggregate of 3.75 million shares of common stock at an exercise
price of $3.13 per share. Each additional $6.5 million disbursement shall be accompanied by the
issuance to the Lenders of warrants to purchase an aggregate of 0.3 million shares of common stock,
at an exercise price equal to 120% of the average volume weighted average price of our common stock
on the fifteen consecutive trading days beginning with the date following receipt by the Lenders of
the disbursement request. If we, in our discretion, draw down the entire $60 million credit
facility, we will have issued warrants to purchase a total of 5.25 million shares of our common
stock.
If we issue or sell shares of our common stock (other than (i) pursuant to a registered public
offering or shelf takedown, (ii) in a transaction that does not require shareholder approval, (iii)
to partners in connection with a joint
17
venture, distribution or other partnering arrangement in a transaction that does not require
shareholder approval, (iv) upon the exercise of options granted to our employees, officers,
directors and consultants, (v) of restricted stock to, or purchases of, our common stock under our
employee stock purchase plan by employees, officers, directors or consultants or (vi) upon the
exercise of the warrants) after March 13, 2009, we will issue concurrently therewith additional
warrants to purchase such number of shares of common stock as will entitle the Lenders to maintain
the same beneficial ownership in us after the issuance as they had prior to such issuance, as
adjusted on a pro rata basis for repayments of the outstanding principal amount under the loan,
with such warrants being issued at an exercise price equal to the greater of $3.13 per share and
the closing price of the common stock on the date immediately prior to the issuance.
All warrants issued under the Facility Agreement remain unexercised as of March 31, 2009,
expire on March 13, 2015 and contain certain limitations that prevent the holder from acquiring
shares upon exercise of a warrant that would result in the number of shares beneficially owned by
it to exceed 9.98% of the total number of shares of our common stock then issued and outstanding.
In addition, upon certain change of control transactions, or upon certain events of default
(as defined in the warrant agreement), the holder has the right to net exercise the warrants for an amount
of shares of our common stock equal to the Black-Scholes value of the shares issuable under the
warrants divided by 95% of the closing price of the common stock on the day immediately prior to
the consummation of such change of control or event of default, as applicable. In certain
circumstances where a warrant or portion of a warrant is not net exercised in connection with a
change of control or event of default, the holder will be paid an amount in cash equal to the
Black-Scholes value of such portion of the warrant not treated as a net exercise.
In accordance
with EITF 00-19, Accounting for Derivative Financial Instruments
Indexed to, and Potentially Settled in, a Companys Own
Stock, the warrants issued in connection with the Facility Agreement
qualify for permanent classification as equity and their relative fair
value of $6.1 million on issuance date was recorded as additional paid in capital and debt
discount to be amortized as interest expense over the term of the Facility Agreement.
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 our common stock at an initial conversion rate of 46.8467 shares of common stock
per $1,000 principal amount of the 5.375% Notes, which is equivalent to a conversion price of
approximately $21.35 per share, representing a conversion premium of 34% to the last reported sale
price of our common stock on the NASDAQ Global Market on June 10, 2008, subject to adjustment under
certain circumstances, at any time beginning on March 15, 2013 or under certain other circumstances
and prior to the close of business on the business day immediately preceding the final maturity
date of the notes. The 5.375% Notes will be convertible for cash up to their principal amount and
shares of our common stock for the remainder of the conversion value in excess of the principal
amount. We do not have the right to redeem any of the 5.375% Notes prior to maturity. If a
fundamental change, as defined in the Indenture for the 5.375% Notes, occurs at any time prior to
maturity, holders of the 5.375% Notes may require us to repurchase their notes in whole or in part
for cash equal to 100% of the principal amount of the notes to be repurchased, plus accrued and
unpaid interest, including any additional interest, to, but excluding, the date of repurchase.
If a holder elects to convert its 5.375% Notes upon the occurrence of a make-whole fundamental
change, as defined in the Indenture for the 5.375% Notes, the holder may be entitled to receive an
additional number of shares of common stock on the conversion date. These additional shares are
intended to compensate the holders for the loss of the time value of the conversion option and are
set forth in the Indenture to the 5.375% Notes. In no event will the number of shares issuable
upon conversion of a note exceed 62.7746 per $1,000 principal amount (subject to adjustment as
described in the Indenture for the 5.375% Notes).
We adopted the provisions of FSP APB 14-1, Accounting for Convertible Debt Instruments That
May Be Settled in Cash upon Conversion (Including Partial Cash Settlement), on January 1, 2009.
FSP APB 14-1 clarifies that convertible debt instruments that may be settled in cash upon
conversion should be separated between the
18
liability and equity components in a manner that will reflect the entitys nonconvertible debt
borrowing rate when interest cost is recognized in subsequent periods. FSP APB 14-1 was applied
retrospectively to all periods presented. Accordingly, we recorded a debt discount of $26.9
million to equity to reflect the value of our nonconvertible debt borrowing rate of 14.5% per
annum. This debt discount is being amortized as interest expense
beginning June 15, 2008 over the 5 year life of the 5.375% Notes.
We incurred interest expense of approximately $2.2 million for the three months ended March
31, 2009, related to the 5.375% Notes. Of the $2.2 million, approximately $1.0 million relates to
additional interest expense recognized under the provisions of FSP APB 14-1. There was no interest
expense related to the 5.375% Notes in the three months ended March 31, 2008. We incurred deferred
financing costs related to this offering of approximately $3.5 million, of which $1.1 million has
been reclassified as an offset to the value of the amount allocated
to equity. The remainder is recorded in the
condensed consolidated balance sheet and is being amortized as a component of interest expense over
the five year term of the 5.375% Notes.
At March 31, 2009, the outstanding amounts related to the 5.375% Notes of $61.2 million are
included in long-term debt in the condensed consolidated balance sheet and reflects the debt
discount of $23.8 million. At December 31, 2008, the outstanding amounts related to the 5.375%
Notes of $60.2 million are included in long-term debt and have
been retroactively restated as required by FSP APB 14-1 to reflect the debt discount of $24.8
million. The debt discount includes the equity allocation of $25.8 million (which represents $26.9
million less the $1.1 million of allocated financing costs) offset by the accretion of the debt
discount through interest expense from the issuance date in 2008 over the 5 year life of the notes. We
recorded $1.0 million of interest expense related to the debt discount in the three months ended
March 31, 2009. At March 31, 2009, the 5.375% Notes have a remaining life of 4.25 years. No
interest expense was recorded in the three months ended
March 31, 2008. The statement of operations for the 2008 periods
subsequent to the debt issuance on June 15, 2008, will be
retroactively restated to reflect the
additional interest expense pursuant to FSP APB 14-1.
We 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 our outstanding
term loan, and we are using 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 $0.7 million for the
three months ended March 31, 2008, 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.
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
19
existing customers. Customers generally order a three-month supply of OmniPods. For the three
months ended March 31, 2009, 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 months ended March 31, 2009 and 2008, we recognized $1.1 million and $38,000
of revenue, respectively, related to the Abbott agreement. There was no impact to cost of revenue
related to this agreement.
As of March 31, 2009 and December 31, 2008, we had deferred revenue of $2.5 million and $2.4
million, respectively 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, freight
and packaging costs. For the remainder of 2009, 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, increases in our OmniPod manufacturing capacity as the supply of
complete OmniPods and subassemblies from Flextronics increases and reduction in our scrap and other
period expenses. The increase in our OmniPod production volume 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 2009, we expect overall research and development spending to be in
line with current levels in order to support our current research and development efforts, which
are focused primarily on increased functionality, design for ease of use and reduction of
production cost, as well as developing a new OmniPod System that incorporates continuous glucose
monitoring technology.
Sales and marketing. Sales and marketing expenses consist primarily of personnel costs
within our sales, marketing, reimbursement support, customer support and training functions, sales
commissions paid to our sales representatives and costs associated with participation in medical
conferences, physician symposia and promotional activities, including distribution of units used in
our demonstration kit programs. For the remainder of 2009, we expect sales and marketing expenses
to decrease as a percentage of sales as we believe we have aligned our sales and marketing efforts
with our current business needs.
General and administrative. General and administrative expenses consist primarily of
salaries and other related costs for personnel serving the executive, finance, information
technology and human resource functions, as well as legal fees, accounting fees, insurance costs,
bad debt expenses, shipping, handling and facilities-related costs. In 2009, we expect general and
administrative expenses to continue to improve slightly from current levels.
20
Results of Operations
The following table presents certain statement of operations information for the three months
ended March 31, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
|
% Change |
|
|
|
(Unaudited) |
|
|
|
(In thousands) |
|
Revenue |
|
$ |
12,469 |
|
|
$ |
6,671 |
|
|
|
87 |
% |
Cost of revenue |
|
|
10,474 |
|
|
|
9,998 |
|
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
Gross margin (loss) |
|
|
1,995 |
|
|
|
(3,327 |
) |
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,204 |
|
|
|
2,923 |
|
|
|
10 |
% |
General and administrative |
|
|
7,491 |
|
|
|
5,197 |
|
|
|
44 |
% |
Sales and marketing |
|
|
8,772 |
|
|
|
8,565 |
|
|
|
2 |
% |
Total operating expenses |
|
|
19,467 |
|
|
|
16,685 |
|
|
|
17 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(17,472 |
) |
|
|
(20,012 |
) |
|
|
13 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(2,173 |
) |
|
|
138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(19,645 |
) |
|
$ |
(19,874 |
) |
|
|
1 |
% |
|
|
|
|
|
|
|
|
|
|
|
Comparison of the Three Months Ended March 31, 2009 and 2008
Revenue
Our total revenue was $12.5 million for the three months ended March 31, 2009, compared to
$6.7 million for the same period in 2008. The increase in revenue is primarily due to an increased
number of patients using the OmniPod. In addition to the increase in the number of reorders from
our growing patient base, the increase in patients also resulted in additional revenue related to
the Abbott agreement of $1.1 million in the three months ended March 31, 2009. We expect our
revenue to continue to increase in 2009 as we continue to add new patients and generate an
increased number of reorders based on our expanding patient base.
Cost of Revenue
Cost of revenue was $10.5 million for the three months ended March 31, 2009, compared to $10.0
million for the same period in 2008. The increase is due to increased sales volume offset by
efficiencies resulting from increased manufacturing capacity, lower depreciation and increased
utilization of Flextronics as the sole manufacturer of complete OmniPods. Cost of revenue in the
three months ended March 31, 2008, includes adjustment of inventory to lower of cost or market and
indirect costs. The per-unit cost to manufacture the OmniPod decreased in the three months ended
March 31, 2009, compared to the same period in 2008, resulting in improvement of our gross margin.
Research and Development
Research and development expenses increased $0.3 million, or 10%, to $3.2 million for the
three months ended March 31, 2009 compared to $2.9 million for the same period in 2008. For the
three months ended March 31, 2009, the slight increase in research and development expenses was
primarily attributable to an increase of $0.4 million in employee related expenses including
stock-based compensation and an increase of $0.4 million in tools and supplies used for research
and development activities, offset by a reduction of $0.5 million in outside services and temporary
help.
21
General and Administrative
General and administrative expenses increased $2.3 million, or 44%, to $7.5 million for the
three months ended March 31, 2009, compared to $5.2 million for the same period in 2008. For the
three months ended March 31, 2009, the increase in general and administrative expenses was
primarily due to an increase of $0.7 million in allowances and write-offs for doubtful trade
accounts receivables, $0.4 million increase in employee compensation and benefit costs, including
stock-based compensation, associated with the hiring of additional employees, $0.3 million in
audit-related fees, $0.1 million in other consulting and legal expenses and $0.2 million in
depreciation expense.
Sales and Marketing
Sales and marketing expenses increased $0.2 million, or 2%, to $8.8 million for the three
months ended March 31, 2009, compared to $8.6 million for the same period in 2008. For the three
months ended March 31, 2009, the increase in sales and marketing expenses was primarily due to an
increase of $1.1 million in employee compensation and benefit costs resulting from the hiring of
additional employees in our sales and marketing areas throughout 2008, $0.1 million in travel
expenses due in part to the national sales meeting held in the first quarter of 2009 and $0.3
million in outside consulting services, which include our external trainers. These increases were
offset by a $1.3 million reduction in the use of samples and Patient Demonstration Kits in the
three months ended March 31, 2009.
Other Income (Expense)
Net interest expense was $2.2 million for the three months ended March 31, 2009, compared to
net interest income of $0.1 million for the same period in 2008. For the three months ended March
31, 2009, the increase in interest expense was caused by the interest on the 5.375% Notes issued in
June 2008, as well as adoption of FSP APB 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. We adopted the provisions of FSP
APB 14-1 as of January 1, 2009 and reclassified $26.9 million of our long-term debt to equity as of
the issuance date of the convertible notes. During the three months ended March 31, 2009, we
recorded $2.2 million of interest expense related to the cash interest on the 5.375% Notes as well
as the provisions of FSP APB 14-1. There was no impact to the three months ended March 31, 2008,
as the convertible notes were not outstanding. We anticipate interest expense to increase as a result of the issuance
of the Facility Agreement in March 2009.
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 March 31, 2009, we had $68.2 million in cash
and cash equivalents. We believe that our current cash and cash equivalents, together with the
cash expected to be generated from product sales and our borrowing capacity, will be sufficient
to meet our projected operating and debt service requirements for at least the next twelve months.
Financial
Resources
On March 13, 2009, we entered into a Facility Agreement with certain institutional accredited
investors, pursuant to which the investors agreed to loan us up to $60 million, subject to the terms
and conditions set forth in the Facility Agreement. Following the initial disbursement of $27.5
million on March 31, 2009, we may, but are not required to, draw down on the facility in $6.5
million increments at any time until November 2010 provided that we meet certain financial performance
milestones. In connection with this financing, we paid Deerfield Management Company, L.P., an
affiliate of the lead Lender, a one-time transaction fee of $1.2 million. Total financing costs,
including the transaction fee, as of March 31, 2009 were $3.0 million.
Any amounts drawn under the Facility Agreement accrue interest at a rate of 9.75% per annum,
and any undrawn amounts under the Facility Agreement accrue interest at a rate of 2.75% per annum.
Accrued interest is
22
payable quarterly in cash in arrears beginning on June 1, 2009. We have the right to prepay
any amounts owed without penalty unless the prepayment is in connection with a major transaction.
All principal amounts outstanding under the Facility Agreement are payable in September 2012.
In connection with the Facility Agreement, we issued to the Lenders warrants to purchase 3.75
million shares of common stock at an exercise price of $3.13 per share. Each additional $6.5
million disbursement shall be accompanied by the issuance to the Lenders of warrants to purchase an
aggregate of 0.3 million shares of common stock, at an exercise price equal to 120% of the average
volume weighted average price of our common stock on the fifteen consecutive trading days beginning
with the date following receipt by the Lenders of the disbursement request. At March 31, 2009, all
warrants issued under the Facility Agreement remained unexercised.
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 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.
Operating Activities
The following table sets forth the amounts of cash used in operating activities and net loss
for each of the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2009 |
|
2008 |
|
|
(In thousands) |
Cash used in operating activities |
|
$ |
(12,971 |
) |
|
$ |
(14,111 |
) |
Net loss |
|
$ |
(19,645 |
) |
|
$ |
(19,874 |
) |
For each of the periods above, the net cash used in operating activities was attributable
primarily to the growth of our operations after adjustment for non-cash charges, such as
depreciation, amortization of the debt discount and stock-based compensation expense as well as
changes to working capital. Significant uses of cash from operations include increases in accounts
receivable and other current assets. The increase in accounts
23
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. 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:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2009 |
|
2008 |
|
|
(In thousands) |
Cash used in investing activities |
|
$ |
(165 |
) |
|
$ |
(5,279 |
) |
Cash provided by (used in) financing
activities |
|
$ |
24,637 |
|
|
$ |
(2,163 |
) |
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. Our cash used in
investing activities has decreased significantly in the three months ended March 31, 2009, compared
to the three months ended March 31, 2008 as we completed building the majority of our manufacturing
equipment in 2008. Capital expenditures are expected to remain at lower levels in 2009 compared to
2008. Cash provided by financing activities in the three months ended March 31, 2009, mainly
consisted of the net proceeds from the Facility Agreement entered into on March 13, 2009.
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 March 31, 2009, 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.
Off-Balance Sheet Arrangements
As of March 31, 2009, 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 most 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.
24
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 upon
transfer to the third party carrier; transfer of title and risk and rewards of
ownership are passed to the distributor typically 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.
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.
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 months ended March 31, 2009 and 2008, we recognized $1.1
million and $38,000 of revenue, respectively, related to the Abbott agreement. There was no impact
to cost of revenue related to this agreement.
Restructuring Expense and Impairment of Assets
As part of our efforts to pursue improved gross margins, leverage operational efficiencies and
better pursue opportunities for low-cost supplier sourcing of asset costs, we periodically perform
an evaluation of our manufacturing processes and review the carrying value of our property and
equipment to assess the recoverability of these assets whenever events indicate that impairment may
have occurred. As part of this assessment, we review the planned use of the assets as well as 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. This review of manufacturing processes and equipment can result in restructuring
activity or an impairment of assets based on current net book value and potential future use of the
assets.
25
Our restructuring expenses may also include workforce reduction and related costs for one-time
termination benefits provided to employees who are involuntarily terminated under the terms of a
one-time benefit arrangement. We record these one-time termination benefits upon incurring the
liability provided that the employees are notified, the plan is approved by the appropriate level
of management, the employees to be terminated and the expected completion date are identified and
the benefits the identified employees will be paid are established. Significant changes to the plan
are not expected when we record the costs. In recording the workforce reduction and related costs,
we estimate related costs such as taxes and outplacement services which may be provided under the
plan. If changes in these estimated services occur, we may be required to record or reverse
restructuring expenses associated with these workforce reduction and related costs.
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 our
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 March 31, 2009, 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. In estimating whether accounts receivable can be collected, we perform evaluations
of customers and continuously monitor 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.
Adoption of New Accounting Standard
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. FSP APB 14-1 should be applied retrospectively to all periods presented. Any
cumulative effect of the change in accounting principle on prior periods should be recognized as of
the beginning of the first period presented. We adopted the provisions of FSP APB 14-1 as of
January 1, 2009 and reclassified $26.9 million of our long-term debt to equity as of the issuance
date of the convertible notes. During the
26
three months ended March 31, 2009, we recorded $1.0 million of additional interest expense related
to the provisions of FSP APB 14-1. There was no impact to the three months ended March 31, 2008,
as the convertible notes were not outstanding.
Recent Accounting Pronouncements
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.
As of March 31, 2009, we had outstanding debt recorded at $61.2 million related to our 5.375%
Notes and $20.2 million related to our Facility Agreement. As the interest rates on the 5.375%
Notes and the Facility Agreement are fixed, changes in interest rates do not affect the value of
our debt.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
As of March 31, 2009, our management conducted an evaluation of the effectiveness of the
design and operation of our disclosure controls and procedures, (as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) under the
supervision and with the participation of our chief executive officer and chief financial officer.
In designing and evaluating our disclosure controls and procedures, we and our management recognize
that any controls and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and our management necessarily
was required to apply its judgment in evaluating and implementing possible controls and procedures.
Based upon that evaluation, 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 March 31, 2009 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
27
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, 2008, 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. 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, 2008.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
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 |
|
|
|
4.1
|
|
Form of Warrant to purchase shares of common stock of Insulet
Corporation (incorporated by reference to Exhibit 4.1 of the
Companys Current Report on Form 8-K filed on March 16, 2009). |
|
|
|
10.1
|
|
Offer Letter by and between Insulet Corporation and Brian Roberts
dated March 2, 2009 (incorporated by reference to Exhibit 10.1 of
the Companys Current Report on Form 8-K filed on March 5, 2009). |
|
|
|
10.2
|
|
Facility Agreement, dated March 13, 2009, by and among Insulet
Corporation and the lenders named therein (incorporated by
reference to Exhibit 10.1 of the Companys Current Report on Form
8-K filed on March 16, 2009). |
|
|
|
10.3
|
|
Registration Rights Agreement, dated March 13, 2009, by and among
Insulet Corporation and the investors named therein (incorporated
by reference to Exhibit 10.2 of the Companys Current Report on
Form 8-K filed on March 16, 2009). |
|
|
|
10.4
|
|
Security Agreement, dated March 13, 2009, by and among Insulet
Corporation and the secured parties named therein (incorporated by
reference to Exhibit 10.3 of the Companys Current Report on Form
8-K filed on March 16, 2009). |
|
|
|
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 Brian Roberts, Chief Financial Officer, pursuant
to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of Duane DeSisto, President and Chief Executive
Officer, and Brian Roberts, Chief Financial Officer, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
28
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: May 8, 2009 |
/s/ Duane DeSisto
|
|
|
Duane DeSisto |
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
Date: May 8, 2009 |
/s/ Brian Roberts
|
|
|
Brian Roberts |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
29
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
4.1
|
|
Form of Warrant to purchase shares of common stock of Insulet
Corporation (incorporated by reference to Exhibit 4.1 of the
Companys Current Report on Form 8-K filed on March 16, 2009). |
|
|
|
10.1
|
|
Offer Letter by and between Insulet Corporation and Brian Roberts
dated March 2, 2009 (incorporated by reference to Exhibit 10.1 of
the Companys Current Report on Form 8-K filed on March 5, 2009). |
|
|
|
10.2
|
|
Facility Agreement, dated March 13, 2009, by and among Insulet
Corporation and the lenders named therein (incorporated by
reference to Exhibit 10.1 of the Companys Current Report on Form
8-K filed on March 16, 2009). |
|
|
|
10.3
|
|
Registration Rights Agreement, dated March 13, 2009, by and among
Insulet Corporation and the investors named therein (incorporated
by reference to Exhibit 10.2 of the Companys Current Report on
Form 8-K filed on March 16, 2009). |
|
|
|
10.4
|
|
Security Agreement, dated March 13, 2009, by and among Insulet
Corporation and the secured parties named therein (incorporated by
reference to Exhibit 10.3 of the Companys Current Report on Form
8-K filed on March 16, 2009). |
|
|
|
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 Brian Roberts, Chief Financial Officer, pursuant
to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section
302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certification of Duane DeSisto, President and Chief Executive
Officer, and Brian Roberts, Chief Financial Officer, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
30