e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2011
OR
|
|
|
o |
|
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)
|
|
|
Delaware
(State or Other Jurisdiction of Incorporation or
Organization)
|
|
04-3523891
(I.R.S. Employer Identification No.) |
|
|
|
9 Oak Park Drive
Bedford, Massachusetts
(Address of Principal Executive Offices)
|
|
01730
(Zip Code) |
Registrants Telephone Number, Including Area Code: (781) 457-5000
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
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
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
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 4, 2011, the registrant had 45,964,642 shares of common stock outstanding.
INSULET CORPORATION
TABLE OF CONTENTS
PART I FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
INSULET CORPORATION
CONSOLIDATED
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
As of |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(Unaudited) |
|
|
|
(In thousands, except share data) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
104,488 |
|
|
$ |
113,274 |
|
Accounts receivable, net |
|
|
15,009 |
|
|
|
16,841 |
|
Inventories |
|
|
12,199 |
|
|
|
11,430 |
|
Prepaid expenses and other current assets |
|
|
1,841 |
|
|
|
912 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
133,537 |
|
|
|
142,457 |
|
Property and equipment, net |
|
|
14,256 |
|
|
|
12,522 |
|
Other assets |
|
|
1,133 |
|
|
|
1,254 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
148,926 |
|
|
$ |
156,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
6,213 |
|
|
$ |
4,895 |
|
Accrued expenses |
|
|
8,742 |
|
|
|
9,808 |
|
Deferred revenue |
|
|
1,842 |
|
|
|
4,247 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
16,797 |
|
|
|
18,950 |
|
Long-term debt |
|
|
70,857 |
|
|
|
69,433 |
|
Other long-term liabilities |
|
|
1,492 |
|
|
|
1,619 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
89,146 |
|
|
|
90,002 |
|
Stockholders Equity |
|
|
|
|
|
|
|
|
Preferred stock, $.001 par value: |
|
|
|
|
|
|
|
|
Authorized: 5,000,000 shares at March 31,
2011 and December 31, 2010.
Issued and outstanding: zero shares at March
31, 2011 and December 31, 2010 |
|
|
|
|
|
|
|
|
Common stock, $.001 par value: |
|
|
|
|
|
|
|
|
Authorized: 100,000,000 shares at March 31,
2011 and December 31,
2010. Issued and outstanding: 45,829,569 and
45,440,839 shares at
March 31, 2011 and December 31, 2010,
respectively |
|
|
46 |
|
|
|
45 |
|
Additional paid-in capital |
|
|
453,435 |
|
|
|
450,039 |
|
Accumulated deficit |
|
|
(393,701 |
) |
|
|
(383,853 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
59,780 |
|
|
|
66,231 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
148,926 |
|
|
$ |
156,233 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
3
INSULET CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(Unaudited) |
|
|
|
(In thousands, except share and per share |
|
Revenue |
|
$ |
28,258 |
|
|
$ |
20,807 |
|
Cost of revenue |
|
|
14,725 |
|
|
|
12,422 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
13,533 |
|
|
|
8,385 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
4,589 |
|
|
|
3,847 |
|
General and administrative |
|
|
7,211 |
|
|
|
6,959 |
|
Sales and marketing |
|
|
9,006 |
|
|
|
8,309 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
20,806 |
|
|
|
19,115 |
|
|
|
|
|
|
|
|
Operating loss |
|
|
(7,273 |
) |
|
|
(10,730 |
) |
|
|
|
|
|
|
|
Interest income |
|
|
37 |
|
|
|
24 |
|
Interest expense |
|
|
(2,612 |
) |
|
|
(3,785 |
) |
|
|
|
|
|
|
|
Other
expense, net |
|
|
(2,575 |
) |
|
|
(3,761 |
) |
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,848 |
) |
|
$ |
(14,491 |
) |
|
|
|
|
|
|
|
Net loss per share basic and diluted |
|
$ |
(0.22 |
) |
|
$ |
(0.38 |
) |
|
|
|
|
|
|
|
Weighted average number of shares used in
calculating basic and diluted net loss per share |
|
|
45,583,242 |
|
|
|
37,888,258 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
4
INSULET CORPORATION
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(Unaudited) |
|
|
|
(In thousands) |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,848 |
) |
|
$ |
(14,491 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities |
|
|
|
|
|
|
|
|
Depreciation |
|
|
1,163 |
|
|
|
1,438 |
|
Amortization of debt discount |
|
|
1,424 |
|
|
|
1,789 |
|
Stock-based compensation expense |
|
|
1,961 |
|
|
|
1,311 |
|
Provision for bad debts |
|
|
367 |
|
|
|
1,083 |
|
Non cash interest expense |
|
|
121 |
|
|
|
217 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
1,465 |
|
|
|
(1,327 |
) |
Inventories |
|
|
(770 |
) |
|
|
3,486 |
|
Prepaid expenses and other current assets |
|
|
(930 |
) |
|
|
(769 |
) |
Accounts payable and accrued expenses |
|
|
(287 |
) |
|
|
(2,437 |
) |
Deferred revenue |
|
|
(2,405 |
) |
|
|
557 |
|
Other long term liabilities |
|
|
(127 |
) |
|
|
(35 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(7,866 |
) |
|
|
(9,178 |
) |
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(2,897 |
) |
|
|
(1,090 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(2,897 |
) |
|
|
(1,090 |
) |
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of offering expenses |
|
|
1,977 |
|
|
|
610 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,977 |
|
|
|
610 |
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(8,786 |
) |
|
|
(9,658 |
) |
Cash and cash equivalents, beginning of period |
|
|
113,274 |
|
|
|
127,996 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
104,488 |
|
|
$ |
118,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
|
|
|
$ |
681 |
|
|
|
|
|
|
|
|
|
|
Non-cash financing activities |
|
|
|
|
|
|
|
|
Unissued restricted stock units |
|
$ |
(538 |
) |
|
$ |
|
|
The accompanying notes are an integral part of these consolidated financial statements.
5
INSULET CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of the Business
Insulet Corporation (the Company) 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.
In January 2010, the Company entered into a five year distribution agreement with Ypsomed
Distribution AG, or Ypsomed, to become the exclusive distributor of the OmniPod System in eleven
countries. Through the Companys partnership with Ypsomed, the OmniPod System is now available in
seven markets, namely Germany, the United Kingdom, France, the Netherlands, Sweden, Norway, and
Switzerland. The Company expects that Ypsomed will begin distribution of the OmniPod System,
subject to approved reimbursement, in the other markets under the agreement in the last half of
2011 or 2012. In February 2011, the Company entered into a distribution agreement with
GlaxoSmithKline Inc., or GSK, to become the exclusive distributor of the OmniPod System in Canada.
The Company expects that GSK will begin distributing the OmniPod System, subject to approved
reimbursement, in the second quarter of 2011.
2. Summary of Significant Accounting Policies
Basis of Presentation
The unaudited consolidated financial statements in this Quarterly Report on Form 10-Q have
been prepared in accordance with GAAP for interim financial information and with the instructions
to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these unaudited consolidated financial
statements do not include all of the information and footnotes required by GAAP for complete
financial statements. In the opinion of management, all adjustments, consisting of normal recurring
adjustments, considered necessary for a fair presentation have been included. Operating results for
the three month period ended March 31, 2011, are not necessarily indicative of the results that may
be expected for the full year ending December 31, 2011, or for any other subsequent interim period.
The unaudited consolidated financial statements in this Quarterly Report on Form 10-Q should
be read in conjunction with the Companys consolidated financial statements and notes thereto
contained in the Companys Annual Report on Form 10-K for the year ended December 31, 2010.
Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the financial statements, and the reported
amounts of revenue and expense during the reporting periods. The most significant estimates used in
these financial statements include the valuation of inventories, accounts receivable and equity
instruments, the lives of property and equipment, as well as warranty reserves and allowance for
doubtful accounts calculations. Actual results may differ from those estimates.
Principles of Consolidation
The unaudited consolidated financial statements in this Quarterly Report on Form 10-Q include
the accounts of the Company and its wholly-owned subsidiaries. All material intercompany balances
and transactions have been eliminated in consolidation.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable consist of amounts due from third-party payors, patients and third-party
distributors. The allowance for doubtful accounts is recorded in the period in which revenue is
recorded or at the time potential collection risk is identified. The Company estimates its
allowance based on historical experience, assessment of specific risk, discussions with individual
customers and various assumptions and estimates that are believed to be reasonable under the
circumstances.
Inventories
Inventories are held at the lower of cost or market, determined under the first-in, first-out
(FIFO) method. Inventory has been recorded at cost as of March 31, 2011 and December 31, 2010.
Work in process is calculated based upon a build up in the stage of completion using estimated
labor inputs for each stage in production. Costs for PDMs and OmniPods include raw material, labor
and manufacturing overhead. The Company periodically reviews inventories for potential impairment
based on quantities on hand and expectations of future use.
6
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.
Warranty
The Company provides a four year warranty on its PDMs and may replace any OmniPods that do not
function in accordance with product specifications. The Company estimates its warranty reserves at
the time the product is shipped based on historical experience and the estimated cost to service
the claims. Cost to service the claims reflects the current product cost, which has been decreasing
over time. As these estimates are based on historical experience, and the Company continues to
introduce new versions of existing products, the Company also considers the
anticipated performance of the product over its warranty period in estimating warranty reserves.
Revenue Recognition
The Company generates nearly all of its revenue from sales of its OmniPod Insulin Management
System to diabetes patients and third-party distributors who resell the product to diabetes
patients. The initial sale to a new customer or third-party distributor typically includes OmniPods
and a Starter Kit, which includes the PDM, the OmniPod System User Guide and the OmniPod System
Interactive Training CD. Subsequent sales to existing customers typically consist of additional
OmniPods.
Revenue recognition requires that persuasive evidence of a sales arrangement exists, delivery
of goods occurs through transfer of title and risk and rewards of ownership, the selling price is
fixed or determinable and collectability is reasonably assured. With respect to these criteria:
|
|
|
The evidence of an arrangement generally consists of a
physician order form, a patient information form, and if
applicable, third-party insurance approval for sales
directly to patients or a purchase order for sales to a
third-party distributor. |
|
|
|
|
Transfer of title and risk and rewards of ownership are
passed to the patient or third-party distributor upon
shipment of the products. |
|
|
|
|
The selling prices for all sales are fixed and agreed with
the patient or third-party distributor, and, if applicable,
the patients third-party insurance provider(s), prior to
shipment and are based on established list prices or, in
the case of certain third-party insurers, contractually
agreed upon prices. Provisions for discounts and rebates to
customers are established as a reduction to revenue in the
same period the related sales are recorded. |
The Company assesses whether 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 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. When doubt exists about reasonable assuredness of collectability from specific
customers, the Company defers revenue from sales of products to those customers until payment is
received.
In March 2008, the Company received a cash payment from Abbott Diabetes Care, Inc. (Abbott)
for an agreement fee in connection with execution of the first amendment to the development and
license agreement between the Company and Abbott. The Company recognizes revenue on the agreement
fee from Abbott over the initial five year term of the agreement, and the non-current portion of
the agreement fee is included in other long-term liabilities. Under the amended Abbott agreement,
beginning July 1, 2008, Abbott agreed to pay an amount to the Company for services performed in
connection with each sale of a PDM that includes an Abbott Discrete Blood Glucose Monitor to
certain customers. In July 2010, the Company entered into a second amendment to the development and
license agreement with Abbott. Under the terms of the second amendment, Abbott agreed to pay
certain amounts to the Company for services performed in connection with each sale of a PDM that
includes an Abbott Discrete Blood Glucose Monitor to customers in certain additional territories.
The Company recognizes revenue related to this portion of the Abbott agreement at the time it meets
the criteria for revenue recognition, typically at the time the revenue is recognized on the sale
of the PDM to the patient. In the three month periods ended March 31, 2011 and 2010, the Company
recognized revenue related to the amended Abbott agreement of $1.2 million and $1.1 million,
respectively. There was no impact to cost of revenue related to this agreement.
The Company had deferred revenue of $2.3 million and $4.8 million as of March 31, 2011 and
December 31, 2010, respectively. The deferred revenue recorded as of March 31, 2011 was comprised
of product-related revenue as well as the non-amortized agreement fee related to the Abbott
agreement.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk primarily consist of cash, cash
equivalents and accounts receivable. The Company maintains the majority of its cash with two
accredited financial institutions. Although revenue is recognized from shipments directly to
patients or third-party distributors, the majority of shipments are billed to third-party insurance
payors. There were no third-party payors that accounted for more than 10% of gross accounts
receivable as of March 31, 2011 or December 31, 2010.
7
Segment Reporting
Operating segments are defined as components of an enterprise about which separate financial
information is available that is evaluated on a regular basis by the chief operating
decision-maker, or decision-making group, in deciding how to allocate resources to an individual
segment and in assessing performance of the segment. In light of the Companys current product
offering, and other considerations, management has determined that the primary form of internal
reporting is aligned with the offering of the OmniPod System. Therefore, the Company believes that
it operates in one segment.
Income Taxes
FASB Accounting Standard Codification, or ASC 740-10, Income Taxes, clarifies the accounting
for uncertainty in income taxes recognized in an entitys financial statements. FASB ASC 740-10
prescribes a recognition threshold and measurement attribute for the financial statement
recognition and measurement of a tax position taken or expected to be taken in a tax return. In
addition, FASB ASC 740-10 provides guidance on derecogniton, classification, interest and
penalties, accounting in interim periods, and disclosure and transition.
The Company has accumulated significant losses since its inception in 2000. Since the net
operating losses may potentially be utilized in future years to reduce taxable income (subject to
any applicable limitations), all of the Companys tax years remain open to examination by the major
taxing jurisdictions to which the Company is subject.
The Company recognizes estimated interest and penalties for uncertain tax positions in income
tax expense. As of March 31, 2011, interest and penalties are immaterial to the consolidated
financial statements.
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of FASB ASC 718-10,
Compensation Stock Compensation. FASB ASC 718-10 requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the income statement based on their
fair values.
Nonpublic companies that used the minimum value method for either recognition or pro forma
disclosures were required to apply the fair value method under FASB ASC 718-10 using the
prospective-transition method. As such, the Company will continue to apply the minimum value method
in future periods to equity awards outstanding that were originally measured using the minimum
value method.
The Company uses the Black-Scholes option pricing model to determine the weighted average fair
value of options granted. The Company recognizes the compensation expense of share-based awards on
a straight-line basis over the vesting period of the award.
The determination of the fair value of share-based payment awards utilizing the Black-Scholes
model is affected by the stock price and a number of assumptions, including expected volatility,
expected life, risk-free interest rate and expected dividends. The expected life of the awards is
estimated based on the SEC Shortcut Approach as defined in SAB 107, which is the midpoint between
the vesting date and the end of the contractual term. The risk-free interest rate assumption is
based on observed interest rates appropriate for the terms of the awards. The dividend yield
assumption is based on company history and expectation of paying no dividends. Forfeitures are
estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Stock-based compensation expense recognized in the
financial statements is based on awards that are ultimately expected to vest. The Company evaluates
the assumptions used to value the awards on a quarterly basis and if factors change and different
assumptions are utilized, stock-based compensation expense may differ significantly from what has
been recorded in the past. If there are any modifications or cancellations of the underlying
unvested securities, the Company may be required to accelerate, increase or cancel any remaining
unearned stock-based compensation expense.
Prior to April 1, 2006, the exercise prices for options granted were set by the Companys
board of directors based upon guidance set forth by the American Institute of Certified Public
Accountants. The board considered a number of factors in determining the option price, including
the following factors: (1) prices for the Companys preferred stock, which the Company had sold to
outside investors in arms-length transactions, and the rights, preferences and privileges of the
Companys preferred stock and common stock in the Series A through Series E financings, (2)
obtaining FDA 510(k) clearance, (3) launching the OmniPod System and (4) achievement of budgeted
revenue and results.
The Company retrospectively estimated the fair value of its common stock based upon several
factors, including the following factors: (1) operating and financial performance, (2) progress and
milestones attained in the business, (3) past sales of convertible preferred stock, (4) the results
of the retrospective independent valuations and (5) the expected valuation obtained in an initial
public offering. The Company believes this to have been a reasonable methodology based on the
factors above and based on several arms-length transactions involving the Companys stock
supportive of the results produced by this valuation methodology.
See Note 9 for a
summary of the stock option activity under our stock-based employee
compensation plan.
3. Long Term Debt
Convertible Notes
In June 2008, the Company sold $85.0 million principal amount of 5.375% Convertible Senior
Notes due June 15, 2013 (the 5.375% Notes) in a private placement to qualified institutional
buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The interest rate on the
notes is 5.375% per annum on the principal amount from June 16, 2008, payable semi-annually in
arrears in cash on December 15 and June 15 of each year. The 5.375% Notes are convertible into the
Companys common stock at an initial conversion rate of
8
46.8467 shares of common stock per $1,000 principal amount of the 5.375% Notes, which is equivalent to a conversion price of approximately
$21.35 per share, representing a conversion premium of 34% to the last reported sale price of the
Companys common stock on the NASDAQ Global Market on June 10, 2008, subject to adjustment under
certain circumstances, at any time beginning on March 15, 2013 or under certain other circumstances
and prior to the close of business on the business day immediately preceding the final maturity
date of the notes. The 5.375% Notes will be convertible for cash up to their principal amount and
shares of the Companys common stock for the remainder of the conversion value in excess of the
principal amount. The Company does not have the right to redeem any of the 5.375% Notes prior to
maturity. If a fundamental change, as defined in the Indenture for the 5.375% Notes, occurs at any
time prior to maturity, holders of the 5.375% Notes may require the Company to repurchase their
notes in whole or in part for cash equal to 100% of the principal amount of the notes to be
repurchased, plus accrued and unpaid interest, including any additional interest, to, but
excluding, the date of repurchase. If a holder elects to convert its 5.375% Notes upon the
occurrence of a make-whole fundamental change, as defined in the Indenture for the 5.375% Notes,
the holder may be entitled to receive an additional number of shares of common stock on the
conversion date. These additional shares are intended to compensate the holders for the loss of the
time value of the conversion option and are set forth in the Indenture to the 5.375% Notes. In no
event will the number of shares issuable upon conversion of a note exceed 62.7746 per $1,000
principal amount (subject to adjustment as described in the Indenture for the 5.375% Notes).
The Company recorded a debt discount of $26.9 million to equity to reflect the value of its
nonconvertible debt borrowing rate of 14.5% per annum. This debt discount is being amortized as
interest expense over the five year term of the 5.375% Notes.
The Company incurred deferred financing costs related to this offering of approximately $3.5
million, of which $1.1 million has been reclassified as an offset to the value of the amount
allocated to equity. The remainder is recorded as other assets in the consolidated balance sheet
and is being amortized as a component of interest expense over the five year term of the 5.375%
Notes. The Company incurred interest expense related to the 5.375% Notes of approximately $2.7
million for the three months ended March 31, 2011, of which approximately $1.6 million relates to
amortization of the debt discount and deferred financing costs and $1.1 million relates to cash
interest. For the three months ended March 31, 2010, the Company incurred interest expense related
to the 5.375% Notes of approximately $2.5 million, of which approximately $1.4 million relates to
amortization of the debt discount and deferred financing costs and $1.1 million relates to cash
interest.
As of March 31, 2011, the outstanding amounts related to the 5.375% Notes of $70.9 million are
included in long-term debt in the consolidated balance sheet and reflect the debt discount of $14.1
million. As of December 31, 2010, the outstanding amounts related to the 5.375% Notes of $69.4
million are included in long-term debt and reflect the debt discount of $15.6 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 over the five year term of the notes. The Company recorded
$1.4 million and $1.2 million of interest expense related to the debt discount in the three months
ended March 31, 2011 and 2010, respectively. As of March 31, 2011, the 5.375% Notes have a
remaining term of 2.25 years.
The Company received net proceeds of approximately $81.5 million from this offering.
Approximately $23.2 million of the proceeds from this offering was used to repay and terminate the
Companys then-existing term loan, including outstanding principal and accrued and unpaid interest
of $21.8 million, a prepayment fee related to the term loan of approximately $0.4 million and a
termination fee of $0.9 million. 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. As of March 31, 2011, warrants to purchase 62,752 shares of common
stock remain outstanding and exercisable at a price of $9.56 per share and expire on December 27,
2013.
Facility Agreement and Common Stock Warrants
In March 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. Total financing costs,
including the transaction fee, were $3.0 million and were amortized as interest expense over the 42
months of the Facility Agreement.
In connection with the execution of the Facility Agreement, the Company issued to the lenders
fully exercisable warrants to purchase an aggregate of 3.75 million shares of common stock of the
Company at an exercise price of $3.13 per share. The warrants qualified for permanent treatment as
equity, and their relative fair value of $6.1 million on the issuance date was recorded as
additional paid-in capital and debt discount. The debt discount was amortized as non-cash interest
expense over the term of the loan.
In September 2009, the Company entered into an Amendment to the Facility Agreement whereby the
Company repaid the $27.5 million originally drawn and promptly drew down the remaining $32.5
million available under the Facility Agreement. The annual interest rate was 8.5%, payable
quarterly in arrears. In connection with the Amendment to the Facility Agreement, the Company
entered into a Securities Purchase Agreement with the lenders whereby the Company sold 2,855,659
shares of its common stock to the lenders at $9.63 per share, a $1.9 million discount based on the
closing price of the Companys common stock of $10.28 on that date. The Company recorded the $1.9
million as a debt discount which was amortized as interest expense over the remaining term of the
loan. The Company received aggregate proceeds of $27.5 million in connection with the sale of its
shares. All principal amounts outstanding under the Facility Agreement were payable in September
2012.
In June 2010, the Company entered into a Second Amendment to its Facility Agreement whereby
the Company paid a $0.5 million amendment fee in exchange for the reduction of the prepayment
penalties and the modification of certain other terms of the Agreement. The fee was recorded as
additional debt discount and was amortized as interest expense over the remaining term of the loan.
9
In December 2010, the Company paid $33.3 million to the lenders, of which $32.5 million
related to principal and $0.8 million related to
interest and prepayment fees, to extinguish this debt. The Company recorded a non-cash interest
charge of $7.0 million in the fourth quarter of 2010 related to the write-off of the remaining debt
discounts and financing costs included in other assets which were being amortized to interest
expense over the term of the debt.
In the three months ended March 31, 2010, the Company recorded cash interest related to the
Facility Agreement of approximately $0.7 million and non-cash interest of approximately $0.6
million. Non-cash interest in the three months ended March 31, 2010 consists of amortization of the
debt discount from the issuance of warrants and transaction fee in March 2009, amortization of the
discount on the shares sold in connection with the amendment in September 2009, and amortization of
the issuance costs associated with the debt. No interest related to the Facility Agreement was
recorded in the three months ended March 31, 2011 as the debt was repaid in December 2010.
As of March 31, 2011, all warrants to acquire 3.75 million shares of the Companys common
stock issued in connection with the Facility Agreement were exercised.
4. 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, 2011 and 2010, all
potential common shares have been excluded from the computation of the diluted net loss per share
for all periods presented, as the effect would have been anti-dilutive. Such potentially dilutive
common share equivalents consist of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
Convertible notes |
|
|
3,981,969 |
|
|
|
3,981,969 |
|
Unvested restricted common shares |
|
|
|
|
|
|
1,776 |
|
Unvested restricted stock units |
|
|
591,677 |
|
|
|
305,999 |
|
Outstanding options |
|
|
3,087,641 |
|
|
|
3,505,216 |
|
Outstanding warrants |
|
|
62,752 |
|
|
|
3,812,752 |
|
|
|
|
|
|
|
|
Total |
|
|
7,724,039 |
|
|
|
11,607,712 |
|
|
|
|
|
|
|
|
5. Accounts Receivable
The components of accounts receivable are as follows:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Trade receivables |
|
$ |
20,336 |
|
|
$ |
22,273 |
|
Allowance for doubtful accounts |
|
|
(5,327 |
) |
|
|
(5,432 |
) |
|
|
|
|
|
|
|
|
|
$ |
15,009 |
|
|
$ |
16,841 |
|
|
|
|
|
|
|
|
6. Inventories
Inventories consist of the following:
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Raw materials |
|
$ |
2,304 |
|
|
$ |
1,892 |
|
Work-in-process |
|
|
1,254 |
|
|
|
2,378 |
|
Finished goods |
|
|
8,641 |
|
|
|
7,160 |
|
|
|
|
|
|
|
|
|
|
$ |
12,199 |
|
|
$ |
11,430 |
|
|
|
|
|
|
|
|
10
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., or Flextronics. The Company produces certain
sub-assemblies for the OmniPod and maintains packaging operations in its facility in Bedford,
Massachusetts. The Company purchases complete OmniPods from Flextronics. Inventories of finished
goods were held at cost at March 31, 2011 and December 31, 2010.
7. Product Warranty Costs
The Company provides a four year warranty on its PDMs and may replace any OmniPods that do not
function in accordance with product specifications. Warranty expense is estimated and recorded in
the period that shipment occurs. The expense is based on the Companys historical experience and
the estimated cost to service the claims. A reconciliation of the changes in the Companys product
warranty liability is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Balance at the beginning of period |
|
$ |
1,873 |
|
|
$ |
1,820 |
|
Warranty expense |
|
|
724 |
|
|
|
320 |
|
Warranty claims settled |
|
|
(761 |
) |
|
|
(392 |
) |
|
|
|
|
|
|
|
Balance at the end of the period |
|
$ |
1,836 |
|
|
$ |
1,748 |
|
|
|
|
|
|
|
|
Composition of balance: |
|
|
|
|
|
|
|
|
Short-term |
|
$ |
848 |
|
|
$ |
770 |
|
Long-term |
|
|
988 |
|
|
|
978 |
|
|
|
|
|
|
|
|
Total warranty balance |
|
$ |
1,836 |
|
|
$ |
1,748 |
|
|
|
|
|
|
|
|
8. Commitments and Contingencies
Operating Leases
The Company leases its facilities, which are accounted for as operating leases. The leases
generally provide for a base rent plus real estate taxes and certain operating expenses related to
the leases. In 2008, the Company extended the lease of its Bedford, Massachusetts headquarters
facility containing research and development and manufacturing space, and in 2010 the Company
extended the lease of its additional office space in Bedford, Massachusetts. Following the
extension, the leases expire in September 2014. The leases contain 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 consolidated balance sheet.
Legal Proceedings
In
August 2010, Becton, Dickinson and Company, or BD, filed a lawsuit in the United States
District Court in the State of New Jersey against the Company alleging that the OmniPod System
infringes three of its patents. BD seeks a declaration that the Company has infringed its patents,
equitable relief, including an injunction that would enjoin the Company from infringing these
patents, and an unspecified award for monetary damages. The Company believes that the OmniPod
System does not infringe these patents. The Company expects that this litigation will not have a
material adverse impact on its financial position or results of operations. The Company believes it
has meritorious defenses to this lawsuit; however, litigation is inherently uncertain and there can
be no assurance as to the ultimate outcome or effect of this action. The Company does not believe
it has any financial exposure at March 31, 2011.
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.
9. Equity
In October 2009, in a public offering, the Company issued and sold 6,900,000 shares of its
common stock at a price to the public of $10.25 per share. In connection with the offering, the
Company received total gross proceeds of $70.7 million, or approximately $66.1 million in net
11
proceeds after deducting underwriting discounts and offering expenses.
In December 2010, in a public offering, the Company issued and sold 3,450,000 shares of its
common stock at a price of $13.27 per share. In connection with the offering, the Company received
total gross proceeds of $47.8 million, or approximately $45.4 million in net proceeds after
deducting underwriting discounts and offering expenses.
The Company grants share-based awards to employees in the form of options to purchase the
Companys common stock, the ability to purchase stock at a discounted price under the employee
stock purchase plan and restricted stock units. Stock-based compensation expense related to
share-based awards recognized in the quarters ended March 31, 2011 and 2010 was $2.0 million and
$1.3 million, respectively, and was calculated based on awards ultimately expected to vest. At
March 31, 2011, the amount of stock-based compensation capitalized as part of inventory was not
material. At March 31, 2011, the Company had $19.1 million of total unrecognized compensation
expense related to stock options and restricted stock units.
Stock Options
The following summarizes the activity under the Companys stock option plans:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Intrinsic |
|
|
|
Options(#) |
|
|
Price($) |
|
|
Value($) |
|
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
Balance, December 31, 2010 |
|
|
3,018,469 |
|
|
$ |
8.74 |
|
|
|
|
|
Granted |
|
|
424,000 |
|
|
|
16.65 |
|
|
|
|
|
Exercised |
|
|
(330,689 |
) |
|
|
7.43 |
|
|
$ |
3,667 |
(1) |
Canceled |
|
|
(24,139 |
) |
|
|
12.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2011 |
|
|
3,087,641 |
|
|
$ |
9.94 |
|
|
$ |
33,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested, March 31, 2011 |
|
|
1,684,936 |
|
|
$ |
8.20 |
|
|
$ |
21,110 |
(2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, March 31, 2011 (3) |
|
|
2,572,061 |
|
|
|
|
|
|
$ |
28,525 |
(2) |
|
|
|
(1) |
|
The aggregate intrinsic value was calculated based on the
positive difference between the fair market value of the
Companys common stock as of the date of exercise and the
exercise price of the underlying options. |
|
(2) |
|
The aggregate intrinsic value was calculated based on the
positive difference between the fair market value of the
Companys common stock as of March 31, 2011, and the exercise
price of the underlying options. |
|
(3) |
|
Represents the number of vested options as of March 31, 2011,
plus the number of unvested options expected to vest as of March
31, 2011, based on the unvested options outstanding as of March
31, 2011, adjusted for the estimated forfeiture rate of 16%. |
At the time of grant, options granted under the Companys 2000 Stock Option and Incentive Plan
(the 2000 Plan) are typically immediately exercisable, but subject to restrictions. Therefore,
under the 2000 Plan, the number of options exercisable is greater than the number of options vested
until all options are fully vested. At March 31, 2011 there were 3,087,641 options outstanding with
a weighted average exercise price of $9.94 per share and a weighted average remaining contractual
life of 7.1 years. At March 31, 2011 there were 1,687,813 options exercisable with a weighted
average exercise price of $8.21 per share and a weighted average remaining contractual life of 5.7
years.
Employee stock-based compensation expense related to stock options recognized in the three
months ended March 31, 2011 and 2010 was $1.1 million and $1.2 million, respectively, and was based
on awards ultimately expected to vest. At March 31, 2011, the Company had $10.1 million of total
unrecognized compensation expense related to stock options that will be recognized over a weighted
average period of 1.4 years.
Employee Stock Purchase Plan
As of March 31, 2011 and 2010, no shares were contingently issued under the
employee stock purchase plan (ESPP). In the three months ended March 31, 2011 and 2010, the
Company recorded no significant stock-based compensation charges related to the ESPP.
Restricted Stock Units
In the three months ended March 31, 2011, the Company awarded 339,500 restricted stock units
to certain employees. The restricted stock units were granted under the Companys 2007 Stock Option
and Incentive Plan (the 2007 Plan) and vest annually over three years from the grant date. The
restricted stock units granted have a weighted average fair value of $17.00 per share based on the
closing price of the Companys common stock on the date of grant. The restricted stock units
granted were valued at approximately $5.8 million at their grant date, and the Company is
recognizing the compensation expense over the three year vesting period. Approximately $0.9 million
and $0.1 million of stock-based compensation expense related to the vesting of restricted stock
units was recognized in the three months ended March 31, 2011
12
and 2010, respectively. Approximately
$9.0 million of the fair value of the restricted stock units remained unrecognized as of March 31,
2011. Under the terms of the award, the Company will issue shares of common stock on each of the
vesting dates. During the three months ended March 31, 2011, 88,822 restricted stock units
originally granted in March 2010 vested. The following table summarizes the status of the Companys
restricted stock units:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
|
Shares |
|
|
Fair Value |
|
Balance, December 31, 2010 |
|
|
355,999 |
|
|
$ |
14.99 |
|
Granted |
|
|
339,500 |
|
|
|
17.00 |
|
Vested |
|
|
(88,822 |
) |
|
|
15.08 |
|
Forfeited |
|
|
(15,000 |
) |
|
|
15.11 |
|
|
|
|
|
|
|
|
|
Balance, March 31, 2011 |
|
|
591,677 |
|
|
$ |
16.11 |
|
|
|
|
|
|
|
|
|
Restricted Common Stock
During the year ended December 31, 2008, the Company awarded 4,000 shares of restricted common
stock to a non-employee. The shares of restricted common stock were granted under the 2007 Plan and
vest over two years. The shares of restricted common stock granted had a weighted average fair
value of $8.04 per share based on the closing price of the Companys common stock on the date of
grant. The Company recognized the total compensation expense of $32,000 over the two year vesting
period.
The following table summarizes the status of the Companys restricted common stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Number of |
|
|
Average |
|
|
|
Shares |
|
|
Fair Value |
|
Balance, December 31, 2010 |
|
|
444 |
|
|
$ |
8.04 |
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
(444 |
) |
|
|
8.04 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2011 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
10. Income Taxes
Deferred income taxes reflect the net tax effects of temporary differences between the
carrying amount of assets and liabilities for financial reporting purposes and the amounts used for
income tax purposes. The Company provided a valuation allowance for the full amount of its net
deferred tax asset for all periods because realization of any future tax benefit cannot be
determined as more likely than not, as the Company does not expect income in the near-term.
13
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
You should read the following discussion of our financial condition and results of operations
in conjunction with our consolidated financial statements and the accompanying notes to those
financial statements included in this Quarterly Report on Form 10-Q. This Quarterly Report on Form
10-Q contains forward-looking statements. These forward-looking statements are based on our current
expectations and beliefs concerning future developments and their potential effects on us. There
can be no assurance that future developments affecting us will be those that we have anticipated.
These forward-looking statements involve a number of risks, uncertainties (some of which are beyond
our control) or other assumptions that may cause actual results or performance to be materially
different from those expressed or implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to: our historical operating losses; our dependence on
the OmniPod System; our ability to achieve and maintain market acceptance of the OmniPod System;
our ability to increase customer orders and manufacturing volume; adverse changes in general
economic conditions; potential adverse effects of healthcare reform legislation; our ability to
raise additional funds in the future; our ability to anticipate and effectively manage risks
associated with doing business internationally, particularly in China; our dependence on
third-party suppliers; 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 effects 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; our ability to maintain our customer base; our ability to attract and retain
key personnel; our ability to manage our growth; potential adverse effects of any acquisitions or
investments; our ability to maintain compliance with the restrictions and related to our
indebtedness; our ability to successfully maintain effective internal controls; the volatility of
the price of our common stock; and other risks and uncertainties described in our Annual Report on
Form 10-K for the year ended December 31, 2010, which was filed with the Securities and Exchange
Commission on March 10, 2011 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. In
October 2005, we shipped our first commercial OmniPod System. We have progressively expanded our
marketing efforts from an initial focus in the Eastern United States to having availability of the
OmniPod System in the entire United States. In January 2010, we entered into a five year
distribution agreement with Ypsomed Distribution AG, or Ypsomed, to become the exclusive
distributor of the OmniPod System in eleven countries, subject to approved reimbursement. Through
our partnership with Ypsomed, the OmniPod System is now available in
seven markets, namely
Germany, the United Kingdom, France, the Netherlands, Sweden, Norway and Switzerland. We expect
that Ypsomed will begin distribution of the OmniPod System, subject to approved reimbursement, in
the other markets under the agreement in the last half of 2011 and 2012. In February 2011, we
entered into a distribution agreement with GlaxoSmithKline Inc., or GSK, to become the exclusive
distributor of the OmniPod System in Canada. We expect that GSK will begin distributing the OmniPod
System, subject to approved reimbursement, in the second qurter of 2011. We focus our sales
initiatives towards key diabetes practitioners, academic centers and clinics specializing in the
treatment of diabetes patients, as well as individual diabetes patients.
We currently produce the OmniPod on a partially automated manufacturing line at a facility in
China operated by a subsidiary of Flextronics International Ltd., or Flextronics. We purchase complete OmniPods
pursuant to our agreement with Flextronics. Under the agreement, Flextronics has agreed to supply
us, as a non-exclusive supplier, with OmniPods at agreed upon prices per unit pursuant to a rolling
12-month forecast that we provide. The agreement may be terminated at any time by either party upon
prior written notice given no less than a specified number of days prior to the date of
termination. The specified number of days is intended to provide the parties with sufficient time
to make alternative arrangements in the event of termination. By purchasing OmniPods manufactured
by Flextronics in China, we have been able to substantially increase production volumes for the
OmniPod and reduce our per unit production cost.
To achieve profitability, we continue to seek to increase manufacturing volume and reduce the
per-unit production cost for the OmniPod. By increasing production volumes of the OmniPod, we have
been able to reduce our per-unit raw material costs and improve absorption of manufacturing
overhead costs. This, as well as the introduction of our next generation OmniPod, are important as
we strive to achieve profitability. We believe our current manufacturing capacity is sufficient to
meet our expected 2011 demand for OmniPods.
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
14
benefits of the OmniPod System through a wide
range of education programs, social networking, patient demonstration programs, support materials,
media advertisements and events at the national, regional and local levels. We are using
third-party distributors to improve our access to managed care and government reimbursement
programs, expand our commercial presence and provide access to additional potential patients.
As a medical device company, reimbursement from third-party payors is an important
element of our success. If patients are not adequately reimbursed for the costs of using the
OmniPod System, it will be much more difficult for us to penetrate the market. We continue to
negotiate contracts establishing reimbursement for the OmniPod System with national and regional
third-party payors. As we expand our sales and marketing focus, increase our manufacturing capacity
and expand to international markets, we will need to maintain and expand available reimbursement
for the OmniPod System.
Since our inception in 2000, we have incurred losses every quarter. In the three months ended
March 31, 2011, we incurred net losses of $9.8 million. As of March 31, 2011, we had an accumulated
deficit of $393.7 million. We have financed our operations through private placements of debt and
equity securities, public offerings of our common stock and a private placement of our convertible
debt and borrowings under certain debt agreements. As of March 31, 2011, we had $85.0 million of
convertible debt outstanding.
Our long-term financial objective is to achieve and sustain profitable growth. Our efforts for
the remainder of 2011 will be focused primarily on the development, production and regulatory
approval of our next generation OmniPod System, the continued reduction in our per-unit production
costs on our existing product and the expansion of sales through both domestic and international
markets. Achieving these objectives is expected to require additional investments in certain
personnel and initiatives to allow for us to increase our penetration in the United States and
international markets. We believe that we will continue to incur net losses in the near term in
order to achieve these objectives. However, we believe that the accomplishment of our near term
objectives will have a positive impact on our financial condition in the future.
We believe that our cash and cash equivalents, together with the cash expected to be generated
from product sales, will be sufficient to meet our projected operating and debt service
requirements for the next twelve months.
Financial Operations Overview
Revenue. 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, or PDM, a
handheld device much like a personal digital assistant that wirelessly programs the OmniPod with
insulin delivery instructions, assists the patient with diabetes management and incorporates a
blood glucose meter. Revenue is derived from the sale to new customers or third-party distributors
of OmniPods and Starter Kits, which include the PDM, the OmniPod System User Guide and our
Interactive Training CD, and from the subsequent sales of OmniPods to existing customers. Customers
generally order a three-month supply of OmniPods. We are currently
selling our product through our partnership with Ypsomed in seven markets, namely Germany, the United Kingdom, France, the
Netherlands, Sweden, Norway and Switzerland. We expect that Ypsomed will begin distributing the
OmniPod System, subject to approved reimbursement, in the other markets under the agreement in the
last half of 2011 or in 2012. In February 2011, we entered into a distribution agreement with GSK
to become the exclusive distributor of the OmniPod System in Canada. We expect that GSK will begin
distributing the OmniPod System, subject to approved reimbursement,
in the second quarter of 2011.
In March 2008, we received a cash payment from Abbott Diabetes Care, Inc., or Abbott, for an
agreement fee in connection with execution of the first amendment to the development and license
agreement with Abbott. We are recognizing the payment as revenue over the five year term of the
agreement. Under the amended Abbott agreement, beginning July 1, 2008, Abbott agreed to pay us
certain amounts for services performed in connection with each sale of a PDM that includes an
Abbott Discrete Blood Glucose Monitor to certain customers. In July 2010, we entered into a second
amendment to the development and license agreement with Abbott. Under the terms of the second
amendment, Abbott agreed to pay certain amounts to us for services we performed in connection with
each sale of a PDM that includes an Abbott Discrete Blood Glucose Monitor to customers in certain
additional territories. We recognize the revenue related to this portion of the Abbott agreement at
the time we meet the criteria for revenue recognition, typically at the time of the sale of the PDM
to a new patient. In the three months ended March 31, 2011 and 2010, we recognized $1.2 million and
$1.1 million of revenue, respectively, related to the amended Abbott agreement.
As of March 31, 2011 and December 31, 2010, we had deferred revenue of $2.3 million and
$4.8 million, respectively. These amounts include product-related revenue as well as the
unrecognized portion of the agreement fee related to the Abbott agreement. For the year ending
December 31, 2011, we expect our revenue to continue to increase as we gain new customers in the
United States and continue expansion in Europe and certain other international markets. Increased
revenue will be dependent upon the success of our sales efforts, our ability to produce OmniPods in
sufficient volumes and other risks and uncertainties.
Cost of revenue. Cost of revenue consists primarily of raw material, labor, warranty and
overhead costs related to the OmniPod System. Cost of revenue also includes depreciation, freight
and packaging costs. The increase in our OmniPod production volume, including the production of our
next generation OmniPod, together with our ability to gain cost savings on our bill of materials,
is expected to reduce the per-unit cost of manufacturing the OmniPods by allowing us to reduce our
direct costs and spread our fixed and semi-fixed overhead costs over a greater number of units.
15
Research and development. Research and development expenses consist primarily of
personnel costs within our product development, regulatory and clinical functions, and the costs of
market studies and product development projects. We expense all research and development costs as
incurred. For the year ending December 31, 2011, we expect overall research and development
spending to decrease slightly compared to 2010 as we have completed a
significant amount of the development work on our next generation Omnipod.
General and administrative. General and administrative expenses consist primarily of
salaries and other related costs for personnel serving the executive, finance, information
technology and human resource functions, as well as legal fees, accounting fees, insurance costs,
bad debt expenses, shipping, handling and facilities-related costs. We expect general and
administrative expenses to increase slightly in 2011 compared to 2010
as we grow our administrative functions to meet the needs of our
expanding business.
Sales and marketing. Sales and marketing expenses consist primarily of personnel costs within
our sales, marketing, reimbursement support, customer support and training functions, sales
commissions paid to our sales representatives and costs associated with participation in medical
conferences, physician symposia and promotional activities, including distribution of units used in
our demonstration kit programs. We expect sales and marketing expenses to increase slightly
compared to 2010 to expedite and support the growth of our business.
Results of Operations
The following table presents certain statement of operations information for the three months
ended March 31, 2011 and 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2011 |
|
|
2010% |
|
|
Change |
|
|
|
(In thousands) |
|
Revenue |
|
$ |
28,258 |
|
|
$ |
20,807 |
|
|
|
36 |
% |
Cost of revenue |
|
|
14,725 |
|
|
|
12,422 |
|
|
|
19 |
% |
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
13,533 |
|
|
|
8,385 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,589 |
|
|
|
3,847 |
|
|
|
19 |
% |
General and administrative |
|
|
7,211 |
|
|
|
6,959 |
|
|
|
4 |
% |
Sales and marketing |
|
|
9,006 |
|
|
|
8,309 |
|
|
|
8 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
20,806 |
|
|
|
19,115 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(7,273 |
) |
|
|
(10,730 |
) |
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
|
(2,575 |
) |
|
|
(3,761 |
) |
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,848 |
) |
|
$ |
(14,491 |
) |
|
|
32 |
% |
|
|
|
|
|
|
|
|
|
|
|
Comparison of the Three Months Ended March 31, 2011 and 2010
Revenue
Our total revenue was $28.3 million and $20.8 million for the three months ended March 31,
2011 and 2010, respectively. The increase in revenue is primarily due to continued adoption of the
OmniPod System by patients in the United States and internationally. We expect our revenue to
increase as we continue to add new patients, introduce the OmniPod System in additional
territories, and generate a higher volume of reorders based on our expanding patient base.
Cost of Revenue
Cost of revenue was $14.7 million and $12.4 million for the three months ended March 31, 2011
and 2010, respectively. The increase in cost of revenue is primarily due to a significant increase
in sales volume offset by cost efficiencies related to the bill of material and production volume.
Revenue increased by 36% from the three months ended March 31, 2010 to the three months ended March
31, 2011, while cost of revenue increased by 19% in the same period as a result of these cost
efficiencies. Gross margin improved by 8% as described by the increased sales and efficiencies above.
Research and Development
Research and development expenses increased $0.7 million, or 19%, to $4.6 million for the
three months ended March 31, 2011, compared to $3.8 million for the same period in 2010. The
increase was primarily a result of $0.4 million increase in employee related expenses, of which
$0.2 million was from an increase in stock-based compensation, and a $0.3 million increase for
materials and equipment utilized in the development of our next
generation OmniPod System.
16
General and Administrative
General and administrative expenses increased $0.2 million, or 4%, to $7.2 million for the
three months ended March 31, 2011, compared to $7.0 million for the same period in 2010. The
increase in general and administrative expenses was primarily due to an increase of $0.8 million in
employee related expenses including key management additions, merit increases, stock-based compensation of $0.2 million, and a $0.2 million
increase in product shipping expenses. These increases were offset by a decrease of $0.7 million in
allowances and write-offs of trade accounts receivable.
Sales and Marketing
Sales and marketing expenses increased $0.7 million, or 8%, to $9.0 million for the three
months ended March 31, 2011, compared to $8.3 million for the same period in 2010. The increase in
sales and marketing expenses was due to an increase of $0.7 million in employee related expenses
including employee additions, merit increases, and a $0.5 million increase in stock-based compensation. The increase is primarily a result
of growth within our sales team.
Other Expense, Net
Net interest expense was $2.6 million for the three months ended March 31, 2011, compared to
$3.8 million for the same period in 2010. The decrease in net interest expense was primarily due to
cash interest savings of $0.7 million and $0.6 million of
non-cash interest savings on our Facility Agreement which was repaid in December 2010.
Liquidity and Capital Resources
We commenced operations in 2000 and to date we have financed our operations primarily through
private placements of common and preferred stock, secured indebtedness, public offerings of our
common stock and issuance of convertible debt. As of March 31, 2011, we had $104.5 million in cash
and cash equivalents. We believe that our current cash and cash equivalents, together with the cash
expected to be generated from product sales, will be sufficient to meet our projected operating and
debt service requirements for at least the next twelve months.
Equity
In October 2009, in a public offering, we issued and sold 6,900,000 shares of our common stock
at a price to the public of $10.25 per share. In connection with this offering, we received total
gross proceeds of $70.7 million, or approximately $66.1 million in net proceeds after deducting
underwriter discounts and offering expenses.
In December 2010, we issued and sold 3,450,000 shares of our common stock pursuant to an
underwriting agreement with Canaccord Genuity at a price of $13.27 per share. In connection with
the offering, we received total gross proceeds of $47.8 million, or approximately $45.4 million in
net proceeds after deducting underwriting discounts and offering expenses. Approximately $33.3
million of the proceeds was used to repay all amounts outstanding under our Facility Agreement.
Convertible Notes
In June 2008, we sold $85.0 million principal amount of 5.375% Notes due June 15, 2013 (the
5.375% Notes) in a private placement to qualified institutional buyers pursuant to Rule 144A
under the Securities Act of 1933, as amended. The interest rate on the notes is 5.375% per annum on
the principal amount from June 16, 2008, payable semi-annually in arrears in cash on December 15
and June 15 of each year. The 5.375% Notes are convertible into 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.
If a holder elects to convert its 5.375% Notes upon the occurrence of a make-whole fundamental
change, as defined in the Indenture for the 5.375% Notes, the holder may be entitled to receive an
additional number of shares of common stock on the conversion date. These additional shares are
intended to compensate the holders for the loss of the time value of the conversion option, and are
set forth in the Indenture for the 5.375% Notes. In no event will the shares issuable upon
conversion of a note exceed 62.7746 per $1,000 principal amount (subject to adjustment as described
in the Indenture for the 5.375% Notes).
We recorded a debt discount of $26.9 million to equity to reflect the value of our
nonconvertible debt borrowing rate of 14.5% per annum. This debt discount is being amortized as
interest expense over the five year term of the 5.375% Notes.
We incurred interest expense related to the 5.375% Notes of approximately $2.7 million
for the three months ended March 31, 2011, of which approximately $1.6 million relates to
amortization of the debt discount and deferred financing costs and $1.1 million relates to cash
17
interest. We incurred interest expense related to the 5.375% Notes of approximately $2.5 million
for the three months ended March 31, 2010, of which approximately $1.4 million related to
amortization of the debt discount and deferred financing costs and $1.1 million related to cash
interest. 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 amount allocated to
equity. The remainder is recorded in the consolidated balance sheet and is being amortized as a
component of interest expense over the five year term of the notes.
As of March 31, 2011, the outstanding amounts related to the 5.375% Notes of $70.9
million are included in long-term debt in the consolidated balance sheet and reflect the debt
discount of $14.1 million. As of December 31, 2010, the outstanding amounts related to the 5.375%
Notes of $69.4 million are included in long-term debt and reflect the debt discount of $15.6
million. The debt discount represents the difference between our nonconvertible debt borrowing rate
and the stated rate on the 5.375% Notes and 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
five year term of the notes. As of March 31, 2011, the 5.375% Notes have a remaining life of 2.25
years.
We received net proceeds of approximately $81.5 million from the 5.375% Notes offering.
Approximately $23.2 million of the net proceeds from this offering was used to repay and terminate
our then-existing term loan, including outstanding principal and accrued and unpaid interest of
$21.8 million, a prepayment fee related to the term loan of approximately $0.4 million, a
termination fee of $0.9 million and incurred certain other expenses related to the prepayment and
termination of the term loan. 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. Warrants to purchase 62,752 shares of our common stock remain outstanding at
March 31, 2011 and expire on December 27, 2013.
Facility Agreement and Common Stock Warrants
In March 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. Total financing costs, including the
transaction fee were $3.0 million and were being amortized as interest expense over the forty-two
month term of the Facility Agreement.
In connection with the execution of the Facility Agreement, we issued to the lenders fully
exercisable warrants to purchase an aggregate of 3.75 million shares of our common stock at an
exercise price of $3.13 per share. The warrants qualified for permanent treatment as equity, and
their relative fair value of $6.1 million on the issuance date was recorded as additional paid-in
capital and debt discount. The debt discount was amortized as non-cash interest expense over the
term of the loan.
In September 2009, we entered into an Amendment to the Facility Agreement whereby we
repaid the $27.5 million originally drawn and promptly drew down the remaining $32.5 million
available under the Facility Agreement. The annual interest rate was 8.5%, payable quarterly in
arrears. In connection with the Amendment to the Facility Agreement, we entered into a Securities
Purchase Agreement with the lenders whereby we sold 2,855,659 shares of our common stock to the
lenders at $9.63 per share, a $1.9 million discount based on the closing price of our common stock
of $10.28 on that date. We recorded the $1.9 million as additional paid-in capital and debt
discount and amortized it to interest expense over the remaining term of the loan. We received
aggregate proceeds of $27.5 million in connection with the sale of our shares. All principal
amounts outstanding under the Facility Agreement were payable in September 2012.
In June 2010, we entered into a Second Amendment to the Facility Agreement whereby we paid a
$0.5 million amendment fee to the lenders in exchange for the reduction of the prepayment penalties
as well as the modification of certain other terms in the Facility Agreement. The fee was recorded
as additional debt discount and amortized to interest expense over the remaining term of the loan.
In December 2010, we paid $33.3 million to the lenders, of which $32.5 million related to
principal and $0.8 million related to interest
and prepayment fees, to extinguish this debt. We recorded a non-cash interest charge of $7.0
million in the fourth quarter of 2010 related to the write-off of the remaining debt discount and
financing costs included in other assets which were amortized to interest expense over the term of
the debt.
In the three months ended March 31, 2010, we recorded approximately $0.7 million of cash
interest related to the Facility Agreement and $0.6 million of non-cash interest. Non-cash
interest in the three months ended March 31, 2010 consisted of amortization of the debt discount
from the issuance of warrants and transaction fee in March 2009, amortization of the discount on
the shares sold in connection with the amendment in September 2009, and amortization of the
issuance costs associated with the debt. No interest related to the Facility Agreement was recorded
in the three months ended March 31, 2011 as the debt was repaid in December 2010.
As of March 31, 2011, all warrants to acquire 3.75 million shares of our common stock issued
in connection with the Facility Agreement were exercised.
Operating Activities
The following table sets forth the amounts of cash used in operating activities and net loss
for each of the periods indicated:
18
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Cash used in operating activities |
|
$ |
(7,328 |
) |
|
$ |
(9,178 |
) |
Net loss |
|
$ |
(9,848 |
) |
|
$ |
(14,491 |
) |
For each of the periods above, the net cash used in operating activities was attributable
primarily to the growth of our operations after adjustment for non-cash. Adjustments for non-cash
items were approximately $5.0 million and $5.8 million in the three months ended March 31, 2011 and
March 31, 2010, respectively. Significant uses of cash from operations in the three months ended
March 31, 2011 include increases in prepaid expenses and other current assets for the renewal of annual infrastructure and insurance contracts,
and inventories due to increased production and a
decrease in deferred revenue as a result of revenue recognized on certain distributor shipments.
These uses of cash in the three months ended March 31, 2011 were offset by a decrease in accounts
receivable, primarily attributable to improved collections. Accounts receivable are shown net of
allowances for doubtful accounts in the consolidated balance sheets.
Investing and Financing Activities
The following table sets forth the amounts of cash used in investing activities and cash
provided by financing activities for each of the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
Cash used in investing activities |
|
$ |
(2,897 |
) |
|
$ |
(1,090 |
) |
Cash provided by financing activities |
|
$ |
1,977 |
|
|
$ |
610 |
|
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 increased significantly in the three months ended March, 31, 2011,
compared to the three months ended March 31, 2010, as we purchased equipment to be used to
manufacture our next generation product. Capital expenditures are expected to continue to increase
in 2011 compared to 2010. Cash provided by financing activities in the three months ended March 31,
2011 and March 31, 2010 mainly consisted of the net proceeds from the issuance of common stock in
connection with the exercise of employee stock options.
Lease Obligations
We lease our facilities, which are accounted for as operating leases. The lease of our
facilities in Bedford and Billerica, Massachusetts, generally provides for a base rent plus real
estate taxes and certain operating expenses related to the lease. All operating leases contain
renewal options and escalating payments over the term of the lease. As of March 31, 2011, we had an
outstanding letter of credit which
totaled $0.2 million to cover our security deposits for lease obligations.
Off-Balance Sheet Arrangements
As of March 31, 2011, we did not have any off-balance sheet financing arrangements.
Critical Accounting Policies and Estimates
Our financial statements are based on the selection and application of generally accepted
accounting principles, which require us to make estimates and assumptions about future events that
affect the amounts reported in our financial statements and the accompanying notes. Future events
and their effects cannot be determined with certainty. Therefore, the determination of estimates
requires the exercise of judgment. Actual results could differ from those estimates, and any such
differences may be material to our financial statements. We believe that the policies set forth
below may involve a higher degree of judgment and complexity in their application than our other
accounting policies and represent the critical accounting policies and estimates used in the
preparation of our financial statements. If different assumptions or conditions were to prevail,
the results could be materially different from our reported results.
Revenue Recognition
We generate nearly all of our revenue from sales of our 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 or a third-party distributor typically includes OmniPods and a
Starter Kit, which is comprised of the PDM, the OmniPod System User Guide and our OmniPod System
Interactive Training CD. Subsequent sales to existing customers typically consist of additional
OmniPods.
Revenue recognition requires that persuasive evidence of a sales arrangement exists, delivery
of goods occurs through transfer of title and risk and rewards of ownership, the selling price is
fixed or determinable and collectibility is reasonably assured. With respect to these criteria:
|
|
The evidence of an arrangement generally consists of a physician
order form, a patient information form, and if applicable,
third-party |
19
|
|
insurance approval for sales directly to patients or a
purchase order for sales to a third-party distributor. |
|
|
|
Transfer of title and risk and rewards of ownership are passed to
the patient or third-party distributor typically upon shipment of
the products. |
|
|
|
The selling prices for all sales are fixed and agreed with the
patient or third-party distributor, and, if applicable, the
patients third-party insurance provider(s) prior to shipment and
are based on established list prices or, in the case of certain
third-party insurers, contractually agreed upon prices. Provisions
for discounts and rebates to customers are established as a
reduction to revenue in the same period the related sales are
recorded. |
We assess whether the different elements qualify for separate accounting. We recognize revenue
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 our Starter Kits sales, and we defer revenue to reflect
estimated sales returns in the same period that the related product sales are recorded. Returns are
estimated through a comparison of historical return data to their related sales. Historical rates
of return are adjusted for known or expected changes in the marketplace when appropriate.
Historically, sales returns have amounted to approximately 3% of gross product sales.
When doubt exists about reasonable assuredness of collectibility from specific customers, we
defer revenue from sales of products to those customers until payment is received.
In March 2008, we received a cash payment from Abbott Diabetes Care, Inc., or Abbott, for an
agreement fee in connection with execution of the first amendment to the development and license
agreement between us and Abbott. We recognize the agreement fee received from Abbott over the
initial five year term of the agreement, and the non-current portion of the agreement fee is
included in other long-term liabilities. Under the amended Abbott agreement, beginning July 1,
2008, Abbott agreed to pay us certain amounts for services performed in connection with each sale
of a PDM that includes an Abbott Discrete Blood Glucose Monitor to certain customers. In July 2010,
we entered into a second amendment to the development and license agreement with Abbott. Under the
terms and conditions of the second amendment, Abbott agreed to pay certain amounts to us for
services performed in connection with each sale of a PDM that includes an Abbott Discrete Blood
Glucose Monitor to customers in certain additional territories. We recognize revenue related to
this portion of the Abbott agreement at the time we meet the criteria for revenue recognition,
typically at the time the revenue is recognized on the sale of the PDM to the patient. In the three
months ended March 31, 2011, we recognized revenue related to the amended Abbott agreement of $1.2
million. In the three months ended March 31, 2010, we recognized revenue related to the amended
Abbott agreement of $1.1 million. There was no impact to cost of revenue related to this agreement.
We had deferred revenue of $2.3 million as of March 31, 2011. The deferred revenue recorded as
of March 31, 2011 was comprised of product-related revenue as well as the non-amortized agreement
fee related to the Abbott agreement.
Income Taxes
FASB ASC 740-10, Income Taxes, clarifies the accounting for uncertainty in income taxes
recognized in an entitys financial statements.
FASB ASC 740-10 prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return. In addition, FASB ASC 740-10 provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure and transition. As of March 31, 2011, we
had $0.2 million of unrecognized tax benefits recorded.
Stock-Based Compensation
We account for stock-based compensation under the provisions of FASB ASC 718-10,
Compensation Stock Compensation. FASB ASC 718-10 requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the income statement based on their
fair values.
We have continued to apply the minimum value method in future periods to equity awards
outstanding that were originally measured using this method. We use the Black-Scholes option
pricing model to determine the weighted average fair value of options granted. We determine the
intrinsic value of restricted stock and restricted stock units based on the closing price of our
common stock on the date of grant. We recognize the compensation expense of share-based awards on a
straight-line basis over the vesting period of the award.
The determination of the fair value of share-based payment awards utilizing the
Black-Scholes model is affected by the stock price and a number of assumptions, including expected
volatility, expected life, risk-free interest rate and expected dividends. The expected life of the
awards is estimated based on the SEC Shortcut Approach as defined in SAB 107, which is the
midpoint between the vesting date and the end of the contractual term. The risk-free interest rate
assumption is based on observed interest rates appropriate for the terms of the awards. The
dividend yield assumption is based on company history and expectation of paying no dividends.
Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if
actual forfeitures differ from those estimates. Stock-based compensation expense recognized in the
financial statements is based on awards that are ultimately expected to vest. We evaluate the
assumptions used to value the awards on a quarterly basis and if factors change and different
assumptions are utilized, stock-based compensation expense may differ significantly from
20
what has
been recorded in the past. If there are any modifications or cancellations of the underlying
unvested securities, we may be required to accelerate, increase or cancel any remaining unearned
stock-based compensation expense.
In the three months ended March 31, 2011 and March 31, 2010, we recorded $2.0 million and
$1.3 million of stock based compensation expense, respectively.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable consist of amounts due from third-party payors, patients and third-party
distributors. The allowance for doubtful accounts is recorded in the period in which revenue is
recorded or at the time potential collection risk is identified. We estimate our allowance based on
historical experience, assessment of specific risk, discussions with individual customers and
various assumptions and estimates that we believe to be reasonable under the circumstances.
Warranty
We provide a four year warranty on our PDMs and may replace any OmniPods that do not function
in accordance with product specifications. We estimate our warranty at the time the product is
shipped based on historical experience and the estimated cost to service the claims. Cost to
service the claims reflects the current product cost which has been decreasing over time. As these
estimates are based on historical experience, and we continue to introduce new
versions of existing products, we also consider the anticipated performance of the product over its
warranty period in estimating warranty reserves. At March 31, 2011 and December 31, 2010, the
warranty reserve was $1.8 million and $1.9 million, respectively.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We do not use derivative financial instruments in our investment portfolio and have no foreign
exchange contracts. Our financial instruments consist of cash, cash equivalents, accounts
receivable, accounts payable, accrued expenses and long-term obligations. We consider investments
that, when purchased, have a remaining maturity of 90 days or less to be cash equivalents. The
primary objectives of our investment strategy are to preserve principal, maintain proper liquidity
to meet operating needs and maximize yields. To minimize our exposure to an adverse shift in
interest rates, we invest mainly in cash equivalents. We do not believe that a 10% change in
interest rates would have a material impact on the fair value of our investment portfolio or our
interest income.
As of March 31, 2011, we had outstanding debt recorded on our consolidated balance sheet of
$70.9 million related to our 5.375% Notes. As the interest rate on the 5.375% Notes is fixed,
changes in interest rates do not affect the value of our debt.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
As of March 31, 2011, our management conducted an evaluation of the effectiveness of the
design and operation of our disclosure controls and procedures, (as such term is defined in Rules
13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) under the
supervision and with the participation of our chief executive officer and chief financial officer.
In designing and evaluating our disclosure controls and procedures, we and our management recognize
that any controls and procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives, and our management necessarily
was required to apply its judgment in evaluating and implementing possible controls and procedures.
Based upon that evaluation of our disclosure controls and procedures as of March 31, 2011, our
chief executive officer and chief financial officer concluded that they believe that, as of such
date, 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, 2011 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
In August 2010, Becton,
Dickinson and Company, or BD, filed a lawsuit in the United States
District Court in the State of New Jersey against us alleging that the OmniPod System infringes
three of its patents. BD seeks a declaration that we have infringed its patents, equitable relief,
including an injunction that would enjoin us from infringing these patents, and an unspecified
award for monetary damages. We believe that the OmniPod System does not infringe these patents. We
do not expect this litigation to have a material adverse impact on our financial position or
results of operations. We believe we have meritorious defenses to this lawsuit; however, litigation
is inherently uncertain and there can be no assurance as to the ultimate outcome or effect of this
action. We do not believe we have any financial exposure at March 31, 2011.
We are, from time to time, involved in the normal course of business in various legal
proceedings, including intellectual property, contract
21
employment and product liability suits.
Although we are unable to quantify the exact financial impact of any of these matters, we believe
that none of these currently pending matters will have an outcome material to our financial
condition or business.
Item 1A. Risk Factors
In addition to the other information set forth in this report, you should carefully consider
the factors discussed in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K for the
year ended December 31, 2010, which could materially affect our business, financial condition or
future results. These risks are not the only risks we face. Additional risks and uncertainties not
currently known to us or that we currently deem to be immaterial also may materially adversely
affect our business, financial condition and/or operating results. There have been no material
changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the year
ended December 31, 2010.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. (Removed and Reserved)
Item 5. Other Information
None.
Item 6. Exhibits
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
10.1(1)
|
|
Offer Letter by and between Insulet Corporation and Charles Liamos, dated January 10, 2011 |
|
|
|
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. |
|
|
|
(1) |
|
Incorporated by reference to our Current Report on
Form 8-K, filed January 10, 2011 |
22
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 10, 2011 |
/s/ Duane DeSisto
|
|
|
Duane DeSisto |
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Date: May 10, 2011 |
/s/ Brian Roberts
|
|
|
Brian Roberts |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
23
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
10.1(1)
|
|
Offer Letter by and between Insulet Corporation and Charles Liamos, dated January 10, 2011 |
|
|
|
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. |
|
|
|
(1) |
|
Incorporated by reference to our Current Report on
Form 8-K, filed January 10, 2011 |
24