Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the
global leader in tubeless insulin pump technology with its Omnipod®
brand of products, today announced financial results for the three
months ended March 31, 2023.
First Quarter Financial Highlights:
- First quarter 2023 revenue of $358.1 million, up 21.2%, or
23.3% in constant currency1, compared to $295.4 million in the
prior year
- Total Omnipod revenue of $357.6 million, an increase of 32.7%,
or 34.9% in constant currency
- U.S. Omnipod revenue of $259.0 million, an increase of
48.8%
- International Omnipod revenue of $98.6 million, an increase of
3.4%, or an increase of 9.6% in constant currency
- Drug Delivery revenue of $0.5 million, a decrease of 98.1%
- Gross margin of 67.2%, down 380 basis points. Adjusted gross
margin1 of 64.9% excludes income of $8.0 million associated with
the voluntary medical device correction (MDC) notices issued in
2022
- Operating income of $27.7 million, or 7.7% of revenue, compared
to $37.9 million, or 12.8% of revenue, in the prior year. Adjusted
operating income1 of $19.7 million, or 5.5%, excludes income of
$8.0 million noted above
- Net income of $23.8 million, or $0.34 per diluted share,
compared to $27.8 million, or $0.40 per diluted share, in the prior
year. Adjusted net income1 of $15.8 million, or $0.23 per diluted
share, excludes income of $8.0 million noted above
- Adjusted EBITDA1 of $48.8 million, or 13.6% of revenue,
compared to $63.0 million, or 21.3% of revenue, in the prior
year
Recent Strategic Highlights:
- Achieved record U.S. and Total Omnipod new customer starts for
any first quarter
- Received U.S. FDA clearance of Omnipod GOTM, a
first-of-its-kind basal-only insulin Pod
- On track to commercially launch Omnipod 5 in the United Kingdom
mid-year and in Germany in the fall
- Advanced sustainability across the Company, as detailed in
Insulet's 2022 Sustainability Report2
“Our first quarter results demonstrate strong financial
performance, including unprecedented results for U.S. Omnipod, and
ongoing strategic progress,” said Jim Hollingshead, President and
Chief Executive Officer. “Omnipod 5 is quickly transforming
diabetes management in the U.S. by offering improved outcomes and
quality of life and we remain on track to begin our staged
international roll-out in a matter of months. We expect 2023 to be
another successful year as we build on our momentum and further
execute our mission to improve the lives of people with
diabetes.”
_____________________________
1 See description of non-GAAP financial
measures contained in this release.
2 Insulet’s 2022 Sustainability report can
be found at: 2022 Sustainability Report.
2023 Outlook:
Revenue Guidance (in constant
currency):
- For the year ending December 31, 2023, the Company is raising
its expected revenue growth of 18% to 22% (previously 14% to 19%).
Revenue growth ranges by product line are:
- Total Omnipod of 21% to 25% (previously 17% to 22%)
- U.S. Omnipod of 27% to 31% (previously 21% to 26%)
- International Omnipod of 6% to 10% (unchanged)
- Drug Delivery of (55)% to (45)% (unchanged)
- For the quarter ending June 30, 2023, the Company expects
revenue growth of 27% to 30%. Revenue growth ranges by product line
are:
- Total Omnipod of 29% to 32%
- U.S. Omnipod of 37% to 40%
- International Omnipod of 13% to 16%
- Drug Delivery of (25)% to (20)%
Gross Margin and Operating Margin
Guidance:
For the year ending December 31, 2023, the Company is
reaffirming its expected gross margin of 65% to 66%, excluding
income of $8.0 million (approximately 50 basis points) associated
with the voluntary MDCs issued in 2022.
For the year ending December 31, 2023, the Company is
reaffirming its expected operating margin of high-single digits,
excluding income of $8.0 million noted above.
Conference Call:
Insulet will host a conference call at 4:30 p.m. (Eastern Time)
on May 4, 2023 to discuss the financial results and outlook. The
link to the live call will be available on the Investor Relations
section of the Company’s website at investors.insulet.com, “Events
and Presentations,” and will be archived for future reference. The
live call may also be accessed by dialing (888) 770-7129 for
domestic callers or (929) 203-2109 for international callers,
passcode 5904836.
About Insulet Corporation:
Insulet Corporation (NASDAQ: PODD), headquartered in
Massachusetts, is an innovative medical device company dedicated to
simplifying life for people with diabetes and other conditions
through its Omnipod product platform. The Omnipod Insulin
Management System provides a unique alternative to traditional
insulin delivery methods. With its simple, wearable design, the
tubeless disposable Pod provides up to three days of non-stop
insulin delivery, without the need to see or handle a needle.
Insulet’s flagship innovation, the Omnipod® 5 Automated Insulin
Delivery System, integrates with a continuous glucose monitor to
manage blood sugar with no multiple daily injections, zero
fingersticks, and can be controlled by a compatible personal
smartphone or the Omnipod 5 Controller. Insulet also leverages the
unique design of its Pod by tailoring its Omnipod technology
platform for the delivery of non-insulin subcutaneous drugs across
other therapeutic areas. For more information, please visit:
insulet.com and omnipod.com.
Non-GAAP Measures:
The Company uses the following non-GAAP financial measures:
- Constant currency revenue growth, which represents the change
in revenue between current and prior year periods using the
exchange rate in effect during the applicable prior year period.
Insulet presents constant currency revenue growth because
management believes it provides meaningful information regarding
the Company’s results on a consistent and comparable basis.
Management uses this non-GAAP financial measure, in addition to
financial measures in accordance with generally accepted accounting
principles in the United States (GAAP), to evaluate the Company’s
operating results. It is also one of the performance metrics that
determines management incentive compensation.
- Adjusted gross margin, adjusted gross margin as a percentage of
revenue, adjusted operating income, adjusted operating income as a
percentage of revenue, adjusted net income, and adjusted diluted
earnings per share, all of which exclude the impact of certain
significant transactions or events, such as legal settlements,
medical device corrections and loss on extinguishment of debt, that
affect the period-to-period comparability of the Company's
performance, as applicable.
- Adjusted EBITDA, which represents net income (loss) plus net
interest expense, income tax expense (benefit), depreciation and
amortization, stock-based compensation expense and other
significant transactions or events, such as legal settlements,
medical device corrections and loss on extinguishment of debt, that
affect the period-to-period comparability of the Company's
performance, as applicable, and adjusted EBITDA as a percentage of
revenue.
Insulet presents the above non-GAAP financial measures because
management uses them as supplemental measures in assessing the
Company’s performance, and the Company believes they are helpful to
investors, and other interested parties as measures of comparative
performance from period to period. They also are commonly used
measures in determining business value and the Company uses them
internally to report results.
These non-GAAP financial measures should be considered
supplemental to, and not a substitute for, the Company’s reported
financial results prepared in accordance with GAAP. Furthermore,
the Company’s definition of these non-GAAP measures may differ from
similarly titled measures used by others. Because non-GAAP
financial measures exclude the effect of items that will increase
or decrease the Company’s reported results of operations, Insulet
strongly encourages investors to review the Company’s consolidated
financial statements and publicly filed reports in their
entirety.
Forward-Looking Statement:
This press release contains forward-looking statements
regarding, among other things, future operating and financial
performance, product success and efficacy, the outcome of studies
and trials and the approval of products by regulatory bodies. These
forward-looking statements are based on management’s current
beliefs, assumptions and estimates and are not intended to be a
guarantee of future events or performance. If management’s
underlying assumptions turn out to be incorrect, or if certain
risks or uncertainties materialize, actual results could vary
materially from the expectations and projections expressed or
implied by the forward-looking statements.
Risks and uncertainties include, but are not limited to adverse
changes in general economic conditions as well as risks associated
with public health crises and pandemics, such as the COVID-19
global pandemic, government actions and restrictive measures
implemented in response, supply chain disruptions, delays in
clinical trials, and other impacts to the business, customers,
suppliers, and employees; dependence on a principal product
platform; ability to maintain and grow the Company's customer base;
ability to scale the business to support revenue growth, maintain
an effective sales force and expand distribution network; ability
to secure and retain adequate coverage or reimbursement from
third-party payors; impact of healthcare reform laws; impact of
competitive products, technological change and product innovation;
ability to design, develop, manufacture and commercialize future
products; inability to maintain or enter into new license or other
agreements with respect to continuous glucose monitors, data
management systems or other rights necessary to sell current
product and/or commercialize future products; challenges to the
future development of the Company's non-insulin drug delivery
product line; international business risks, including regulatory,
commercial and logistics risks; supply problems or price
fluctuations with sole source or third-party suppliers on which the
Company is dependent; failure to retain key suppliers; ability to
protect intellectual property and other proprietary rights and
potential conflicts with the intellectual property of third
parties; extensive government regulation applicable to medical
devices as well as complex and evolving privacy and data protection
laws; adverse regulatory or legal actions relating to the Omnipod
System or future products; failure of the Company's contract
manufacturer or component suppliers to comply with the U.S. Food
and Drug Administration’s quality system regulations; potential
adverse impacts resulting from a recall, or discovery of serious
safety issues, or product liability lawsuits relating to off-label
use; the potential violation of anti-bribery/anti-corruption laws;
breaches or failures of the Company's product or information
technology systems, including by cyberattack; unfavorable results
of clinical studies, including issues with third parties conducting
any studies, or future publication of articles or announcement of
positions by diabetes associations or other organizations that are
unfavorable; the concentration of manufacturing operations and
storage of inventory in a limited number of locations; loss of
employees or inability to identify and recruit new employees; risks
associated with potential future acquisitions or investments in new
businesses; ability to generate sufficient cash to service
indebtedness or raise additional funds on acceptable terms or at
all; the volatility of the trading price of the Company's common
stock; risks related to the conversion of outstanding Convertible
Senior Notes; and potential limitations on the Company's ability to
use net operating loss carryforwards.
For a further list and description of these and other important
risks and uncertainties that may affect the Company's future
operations, see Part I, Item 1A - Risk Factors in the most recent
Annual Report on Form 10-K filed with the Securities and Exchange
Commission, which the Company may update in Part II, Item 1A - Risk
Factors in Quarterly Reports on Form 10-Q the Company has filed or
will file hereafter. Any forward-looking statement made in this
release speaks only as of the date of this release. Insulet does
not undertake to update any forward-looking statement, other than
as required by law.
©2023 Insulet Corporation. Omnipod, Omnipod GO and Omnipod 5 are
registered trademarks of Insulet Corporation.
INSULET CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED)
Three Months Ended March
31,
(dollars in millions, except per share
data)
2023
2022
Revenue
$
358.1
$
295.4
Cost of revenue
117.6
85.7
Gross profit
240.5
209.7
Research and development expenses
50.1
43.1
Selling, general and administrative
expenses
162.7
128.7
Operating income
27.7
37.9
Interest expense, net
(2.9
)
(8.9
)
Other (expense) income, net
(0.2
)
0.3
Income before income taxes
24.6
29.3
Income tax expense
(0.8
)
(1.5
)
Net income
$
23.8
$
27.8
Net income per share:
Basic
$
0.34
$
0.40
Diluted
$
0.34
$
0.40
Weighted-average number of common
shares outstanding (in thousands):
Basic
69,583
69,254
Diluted
70,096
69,858
INSULET CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS (UNAUDITED)
(dollars in millions)
March 31, 2023
December 31, 2022
ASSETS
Cash and cash equivalents
$
620.7
$
674.7
Accounts receivable, net
217.2
205.6
Inventories
386.1
346.8
Prepaid expenses and other current
assets
106.0
86.9
Total current assets
1,330.0
1,314.0
Property, plant and equipment, net
596.6
599.9
Goodwill and other intangible assets,
net
151.9
127.2
Other assets
210.6
210.0
Total assets
$
2,289.1
$
2,251.1
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable
$
85.9
$
30.8
Accrued expenses and other current
liabilities
269.6
306.4
Current portion of long-term debt
27.8
27.5
Total current liabilities
383.3
364.7
Long-term debt, net
1,368.8
1,374.3
Other liabilities
34.2
35.7
Total liabilities
1,786.3
1,774.7
Stockholders’ equity
502.8
476.4
Total liabilities and stockholders’
equity
$
2,289.1
$
2,251.1
INSULET CORPORATION
NON-GAAP RECONCILIATIONS
(UNAUDITED)
CONSTANT CURRENCY REVENUE
GROWTH
Three Months Ended March
31,
(dollars in millions)
2023
2022
Percent Change
Currency Impact
Constant Currency
Revenue:
U.S. Omnipod
$
259.0
$
174.1
48.8%
—%
48.8%
International Omnipod
98.6
95.4
3.4%
(6.2)%
9.6%
Total Omnipod
357.6
269.5
32.7%
(2.2)%
34.9%
Drug Delivery
0.5
25.9
(98.1)%
—%
(98.1)%
Total
$
358.1
$
295.4
21.2%
(2.1)%
23.3%
ADJUSTED GROSS MARGIN,
OPERATING MARGIN, NET INCOME, DILUTED EPS
Three Months Ended March 31,
2023
(in millions)
Gross Profit
Percent of Revenue
Operating Income
Percent of Revenue
Net Income(2)
Diluted Earnings per
Share
GAAP
$
240.5
67.2
%
$
27.7
7.7
%
$
23.8
$
0.34
Voluntary medical device
corrections(1)
(8.0
)
(8.0
)
(8.0
)
(0.11
)
Non-GAAP
$
232.5
64.9
%
$
19.7
5.5
%
$
15.8
$
0.23
ADJUSTED EBITDA
Three Months Ended March
31,
(dollars in millions)
2023
Percent of Revenue
2022
Percent of Revenue
Net income
$
23.8
6.6
%
$
27.8
9.4
%
Interest expense, net
2.9
8.9
Income tax expense
0.8
1.5
Depreciation and amortization
17.2
15.3
Stock-based compensation expense
12.1
9.5
Voluntary medical device correction(1)
(8.0
)
—
Adjusted EBITDA
$
48.8
13.6
%
$
63.0
21.3
%
(1) Represents income resulting from an
adjustment to estimated costs associated with the voluntary MDC
notices issued in the fourth quarter of 2022, which is included in
cost of revenue.
(2) The tax effect on non-GAAP adjustments
is calculated based on the applicable local statutory tax rates,
including any valuation allowance.
INSULET CORPORATION
NON-GAAP RECONCILIATIONS
CONTINUED (UNAUDITED)
REVENUE GUIDANCE
Year Ending December 31,
2023
Revenue Growth
GAAP
Currency Impact
Constant Currency
U.S. Omnipod
27% - 31%
—%
27% - 31%
International Omnipod
8% - 12%
2%
6% - 10%
Total Omnipod
21% - 25%
—%
21% - 25%
Drug Delivery
(55)% - (45)%
—%
(55)% - (45)%
Total
18% - 22%
—%
18% - 22%
Three Months Ended June 30,
2023
Revenue Growth
GAAP
Currency Impact
Constant Currency
U.S. Omnipod
37% - 40%
—%
37% - 40%
International Omnipod
14% - 17%
1%
13% - 16%
Total Omnipod
29% - 32%
—%
29% - 32%
Drug Delivery
(25)% - (20)%
—%
(25)% - (20)%
Total
27% - 30%
—%
27% - 30%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230504005357/en/
Investor Relations: Deborah R. Gordon Vice President,
Investor Relations (978) 600-7717 dgordon@insulet.com Media:
Angela Geryak Wiczek Senior Director, Corporate Communications
(978) 932-0611 awiczek@insulet.com
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