-- Two recently published clinical studies highlight how the tubing-free
design of the OmniPod System helps people better control their
diabetes. In one study, published in the most recent issue of
Infusystems USA, researchers at Albany College of Pharmacy and Health
Sciences and The Endocrine Group concluded that the OmniPod System
improved blood glucose control in diabetes patients who previously
received insulin through multiple daily injections. Study investigators
noted the benefits of a tubing-free insulin pump, which can help
patients overcome their fear of insertion sets or unsightly tubing and
achieve the clinical benefits of insulin pump therapy. In a separate
study, published in the Journal of Diabetes Science and Technology,
researchers at Sansum Diabetes Research Institute and University of
California, Santa Barbara concluded that changing the height of a
conventional insulin pump in relation to its tubing and infusion set
can significantly impact expected insulin delivery rates. The study
noted that the tubing-free OmniPod System, with its integrated
cannula, was the least affected by pumping orientation and direction.
Previous research has demonstrated how disconnecting from a traditional
infusion set impacts glucose levels. These studies collectively offer
insight into how the tubing-free OmniPod System may help patients
reduce their glycemic variability and better control their diabetes.
-- In January 2010, the Company entered into an exclusive agreement with
Ypsomed AG for the distribution of the OmniPod System in nine countries
across Europe as well as China and Australia. Under the agreement,
Ypsomed will have the exclusive right to promote, advertise, market,
distribute and sell the OmniPod System in the eleven countries covered
by the agreement, beginning in Germany, France and the United Kingdom
in mid-2010. At the minimum annual purchase levels called for in the
agreement, the Company would recognize in excess of $100 million in
revenue over its five year term. The minimum annual purchase levels
are heavily weighted towards the final years of the term; accordingly,
it is expected that the Company's 2010 revenues under the agreement
will not be material.
-- In October 2009, the Company sold 6.9 million shares of its common
stock in a public offering at a price of $10.25 per share resulting
in net proceeds to the Company of approximately $66.1 million.
Guidance
For the full year 2010, the Company is estimating revenue to be in the
range of $90 to $100 million and its operating loss to be in the range of
$30 to $40 million. The Company is estimating revenue of $20 to $21
million in the first quarter of 2010.
Conference Call
Insulet will host a conference call on Tuesday, February 9, 2010 at 5:00PM
Eastern time to discuss the Company's fourth quarter and full year 2009
results and present information concerning its business, strategies and
outlook. To listen to the conference call, please dial 800-901-5218 for
domestic callers and 617-786-4511 for international callers. The passcode
is 78048665. A replay of the conference call will be available two hours
after the start of the call through February 16, 2010 by dialing
888-286-8010 (domestic) and 617-801-6888 (international), passcode
95682410. An online archive of the conference call will also be available
by accessing the Investor Information section of the company's website at
http://investors.insulet.com.
Forward-Looking Statement
The fourth quarter and full year 2009 financial results contained in this
news release are subject to finalization in connection with the preparation
of the Company's Annual Report on Form 10-K for the year ended December 31,
2009. This press release contains forward-looking statements concerning
Insulet's expectations, anticipations, intentions, beliefs or strategies
regarding the future, including those related to its expected revenue and
operating losses, the timing of the Company's development of its next
generation OmniPod and PDM with integrated continuous glucose monitoring,
the Company's expansion in the United States and abroad, the revenue
relating to the Company's agreement with Ypsomed, product demand and sales
productivity in the United States and in new markets, the results and
subsequent impact of third-party clinical studies, market potential and
financial performance. These forward-looking statements are based on its
current expectations and beliefs concerning future developments and their
potential effects on it. There can be no assurance that future developments
affecting it will be those that it has anticipated. These forward-looking
statements involve a number of risks, uncertainties (some of which are
beyond its 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: the significant operating losses incurred by
Insulet since inception; Insulet's dependence on the OmniPod System;
Insulet's ability to reduce the per unit cost of producing the OmniPod by
increasing customer orders and manufacturing volumes; adverse changes in
general economic conditions; impact of healthcare reform legislation;
Insulet's inability to raise additional funds in the future on acceptable
terms or at all; potential supply problems or price fluctuations with sole
source or other third-party suppliers on which Insulet is dependent;
international business risks; Insulet's inability to obtain adequate
coverage or reimbursement from third-party payors for the OmniPod System
and potential adverse changes in reimbursement rates or policies relating
to the OmniPod; potential adverse effects resulting from competition with
competitors; technological innovations adversely affecting the Company's
business; potential termination of Insulet's license to incorporate a blood
glucose meter into the OmniPod System; Insulet's ability to protect its
intellectual property and other proprietary rights; conflicts with the
intellectual property of third parties, including claims that Insulet's
current or future products infringe the proprietary rights of others;
adverse regulatory or legal actions relating to the OmniPod System; failure
of Insulet's contract manufacturers or component suppliers to comply with
FDA's quality system regulations, the potential violation of federal or
state laws prohibiting "kickbacks" or protecting patient health
information, or any challenges to or investigations into Insulet's
practices under these laws; product liability lawsuits that may be brought
against Insulet; reduced retention rates; unfavorable results of clinical
studies relating to the OmniPod System or the products of Insulet's
competitors; potential future publication of articles or announcement of
positions by physician associations or other organizations that are
unfavorable to Insulet's products; the expansion, or attempted expansion,
into foreign markets; the concentration of substantially all of Insulet's
manufacturing capacity at a single location in China and substantially all
of Insulet's inventory at a single location in Massachusetts; Insulet's
ability to attract and retain key personnel; Insulet's ability to manage
its growth; fluctuations in quarterly results of operations; risks
associated with potential future acquisitions; Insulet's ability to
generate sufficient cash to service all of its indebtedness; the expansion
of Insulet's distribution network; Insulet's ability to successfully
maintain effective internal controls; and other risks and uncertainties
described in its Annual Report on Form 10-K, which was filed with the
Securities and Exchange Commission on March 16, 2009 in the section
entitled "Risk Factors," and in its other filings from time to time with
the Securities and Exchange Commission. Should one or more of these risks
or uncertainties materialize, or should any of its assumptions prove
incorrect, actual results may vary in material respects from those
projected in these forward-looking statements. Insulet undertakes no
obligation to publicly update or revise any forward-looking statements.
About Insulet Corporation
Insulet Corporation is an innovative medical device company dedicated to
improving the lives of people with diabetes. The Company's OmniPod Insulin
Management System is a revolutionary, discreet and easy-to-use insulin
infusion system that features two easy-to-use parts with no tubing and
fully-automated cannula insertion. Through the OmniPod System, Insulet
seeks to expand the use of continuous subcutaneous insulin infusion (CSII)
therapy among people with insulin-dependent diabetes. Founded in 2000,
Insulet is based in Bedford, MA.
INSULET CORPORATION
Selected Financial Data
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS DATA:
Three months ended Year ended
December 31, December 31,
------------------------ ------------------------
2009 2008 2009 2008
(Restated) (Restated)
----------- ----------- ----------- -----------
(In thousands, except share and per share data)
Revenue $ 20,211 $ 11,861 $ 66,032 $ 36,059
Cost of revenue 12,877 10,663 47,735 40,643
----------- ----------- ----------- -----------
Gross profit (loss) 7,334 1,198 18,297 (4,584)
Operating expenses:
Research and
development 3,350 3,535 13,231 13,104
General and
administrative 7,267 6,850 26,842 23,750
Sales and marketing 8,677 9,999 37,583 39,734
Restructuring and
impairment of assets - 8,170 - 8,170
----------- ----------- ----------- -----------
Total operating
expenses 19,294 28,554 77,656 84,758
----------- ----------- ----------- -----------
Operating loss (11,960) (27,356) (59,359) (89,342)
Net interest expense (2,972) (1,842) (20,182) (5,430)
----------- ----------- ----------- -----------
Net loss $ (14,932) $ (29,198) $ (79,541) $ (94,772)
=========== =========== =========== ===========
Net loss per share
basic and diluted $ (0.42) $ (1.05) $ (2.68) $ (3.43)
=========== =========== =========== ===========
Weighted-average number
of shares used in
calculating net loss
per share 35,164,348 27,762,136 29,727,106 27,611,003
=========== =========== =========== ===========
Results for the year ended December 31, 2008 have been restated to reflect
the retrospective adoption of certain provisions of FASB ASC 470-20
CONDENSED CONSOLIDATED BALANCE SHEET DATA:
As of As of
December 31, December 31,
2009 2008
(Restated)
------------ ------------
(In thousands, except share
and per share data)
ASSETS
Current Assets
Cash $ 127,996 $ 56,663
Accounts receivable, net 14,962 11,938
Inventories 10,086 16,870
Prepaid expenses and other current assets 1,260 3,028
------------ ------------
Total current assets 154,304 88,499
Property and equipment, net 15,482 17,564
Other assets 1,862 2,170
------------ ------------
Total assets $ 171,648 $ 108,233
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities
Accounts payable $ 5,870 $ 7,291
Accrued expenses 9,973 7,300
Deferred revenue 3,970 2,377
------------ ------------
Total current liabilities 19,813 16,968
Long-term debt, net of current portion 96,979 60,172
Other long-term liabilities 1,999 2,987
------------ ------------
Total liabilities 118,791 80,127
Stockholders' equity
Preferred stock, $.001 par value:
Authorized: 5,000,000 shares at December 31,
2009 and 2008.
Issued: zero shares at December 31, 2009 and
2008. - -
Common stock, $.001 par value:
Authorized: 100,000,000 shares at December 31,
2009 and 2008.
Issued: 37,755,254 and 27,778,921 shares at
December 31, 2009 and 2008, respectively. 39 29
Additional paid-in capital 382,709 278,427
Accumulated deficit (329,891) (250,350)
------------ ------------
Total stockholders' equity 52,857 28,106
------------ ------------
Total liabilities and stockholders' equity $ 171,648 $ 108,233
============ ============
December 31, 2008 balances have been restated to reflect the retrospective
adoption of certain provisions of FASB ASC 470-20.
Contact Information: Contact: Stephanie Marks for Insulet Corporation 877-PODD-IR1 (877-763-3471)