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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Insulet Corporation | NASDAQ:PODD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-11.03 | -6.21% | 166.50 | 163.00 | 176.50 | 193.30 | 162.715 | 181.87 | 3,176,414 | 05:00:02 |
Represents 8th Consecutive Year of 20% or More Constant Currency Revenue Growth
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 and full year ended December 31, 2023.
Full Year Financial Highlights:
Fourth Quarter Financial Highlights:
Recent Highlights:
“2023 was another transformational year for Insulet. The rapid adoption of Omnipod 5 helped fuel our eighth consecutive year of more than 20% constant currency revenue growth,” said Jim Hollingshead, President and Chief Executive Officer. “Our team’s outstanding execution and relentless pursuit of innovation further solidify our position as the category leader, strengthen our competitive moats and enable us to deliver our groundbreaking innovation to even more people. We entered 2024 with powerful momentum and are well-positioned for continued profitable growth and value creation as we simplify life for the millions of people with diabetes around the world.”
__________________________________ 1 See description of non-GAAP financial measures contained in this release. 2 Source: Insulet data on file. New Customer Starts represent individuals new to pump therapy and individuals who switched from another manufacturer's pump. 3 This growth rate factors in a revised estimated global customer base of approximately 345,000 one year ago versus the Company’s prior estimate of approximately 360,000. This change relates to the Company’s Classic Omnipod U.S. customer base. 4 Source: Insulet data on file. Most Prescribed represents new prescriptions in the U.S. in 2023. 5 https://doi.org/10.1089/dia.2023.0578. 'Real-world evidence of Omnipod® 5 Automated Insulin Delivery System use in 69,902 people with type 1 diabetes'. First author: Dr. Gregory P Forlenza. 6 https://www.liebertpub.com/doi/10.1089/dia.2023.0506. ‘Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod 5 Automated Insulin Delivery System’. First author: Dr. Daniel J DeSalvo.
2024 Outlook:
Revenue Guidance (in constant currency):
Guidance for the first quarter and full year 2024 reflects an estimated $20 million to $25 million in revenue related to U.S. pharmacy wholesaler orders that were accelerated into the fourth quarter of 2023 from the first quarter of 2024 in advance of the Company’s implementation of a new ERP system on January 1, 2024 (i.e., 2024 growth rates reflect $20 million to $25 million less in U.S. revenue in 2024 and $20 million to $25 million more in 2023):
Gross Margin and Operating Margin Guidance:
For the year ending December 31, 2024, the Company expects gross margin of 68% to 69%, closer to the mid-point of the range. The assumed order timing shift of $20 million to $25 million in revenue noted above is not expected to impact gross margin.
For the year ending December 31, 2024, the Company expects operating margin of approximately 13%. This guidance excludes the estimated 60 basis point negative impact associated with the assumed order timing shift noted above. The year-over-year estimated impact of this shift is 130 basis points.
Conference Call:
Insulet will host a conference call at 4:30 p.m. (Eastern Time) on February 22, 2024 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 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:
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 our dependence on a principal product platform; the impact of competitive products, technological change and product innovation; our ability to maintain an effective sales force and expand our distribution network; our ability to maintain and grow our customer base; our ability to scale the business to support revenue growth; our ability to secure and retain adequate coverage or reimbursement from third-party payors; the impact of healthcare reform laws; our ability to design, develop, manufacture and commercialize future products; 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; our ability to protect intellectual property and other proprietary rights; potential conflicts with the intellectual property of third parties; our 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 our current product and/or commercialize future products; worldwide macroeconomic and geopolitical uncertainty as well as risks associated with public health crises and pandemics, including government actions and restrictive measures implemented in response, supply chain disruptions, delays in clinical trials, and other impacts to the business, our customers, suppliers, and employees; international business risks, including regulatory, commercial and logistics risks; the potential violation of anti-bribery/anti-corruption laws; the concentration of manufacturing operations and storage of inventory in a limited number of locations; supply problems or price fluctuations with sole source or third-party suppliers on which we are dependent; failure to retain key suppliers; challenges to the future development of our non-insulin drug delivery product line; failure of our contract manufacturer or component suppliers to comply with the U.S. Food and Drug Administration’s quality system regulations; 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 current or future Omnipod products; potential adverse impacts resulting from a recall, or discovery of serious safety issues, or product liability lawsuits relating to off-label use; breaches or failures of the Company’s product or information technology systems, including by cyberattack; 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 our 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 our 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.
©2024 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved. All other trademarks are the property of their respective owners. The use of third-party trademarks does not constitute an endorsement or imply a relationship or other affiliation.
INSULET CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
Three Months Ended December 31,
Years Ended December 31,
(dollars in millions, except per share data)
2023
2022
2023
2022
Revenue
$
509.8
$
369.7
$
1,697.1
$
1,305.3
Cost of revenue
148.6
152.4
537.2
499.7
Gross profit
361.2
217.3
1,159.9
805.6
Research and development expenses
42.0
49.5
205.0
180.2
Selling, general and administrative expenses
212.8
144.3
734.9
587.8
Operating income
106.4
23.5
220.0
37.6
Interest expense, net
(0.5
)
(2.7
)
(7.6
)
(26.7
)
Other income (expense), net
1.9
1.5
2.2
(1.1
)
Income before income taxes
107.8
22.3
214.6
9.8
Income tax expense
(4.5
)
(5.3
)
(8.3
)
(5.2
)
Net income
$
103.3
$
17.0
$
206.3
$
4.6
Net income per share:
Basic
$
1.48
$
0.25
$
2.96
$
0.07
Diluted
$
1.44
$
0.24
$
2.94
$
0.07
Weighted-average number of common shares outstanding (in thousands):
Basic
69,860
69,472
69,751
69,375
Diluted
73,614
70,020
73,633
69,910
RECONCILIATION OF DILUTED NET INCOME (UNAUDITED)
Three Months Ended December 31,
Years Ended December 31,
(in millions, except share and per share data)
2023
2022
2023
2022
Net income
$
103.3
$
17.0
$
206.3
$
4.6
Add back interest expense, net of tax attributable to assumed conversion of convertible senior notes
2.6
—
10.4
—
Net income, diluted
$
105.9
$
17.0
$
216.7
$
4.6
INSULET CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
As of December 31,
(dollars in millions)
2023
2022
ASSETS
Cash and cash equivalents
$
704.2
$
674.7
Accounts receivable, net
359.7
205.6
Inventories
402.6
346.8
Prepaid expenses and other current assets
116.4
86.9
Total current assets
1,582.9
1,314.0
Property, plant and equipment, net
664.9
599.9
Goodwill and other intangible assets, net
150.4
127.2
Other assets
190.0
210.0
Total assets
$
2,588.2
$
2,251.1
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable
$
19.2
$
30.8
Accrued expenses and other current liabilities
382.6
306.4
Current portion of long-term debt
49.4
27.5
Total current liabilities
451.2
364.7
Long-term debt, net
1,366.4
1,374.3
Other liabilities
37.9
35.7
Total liabilities
1,855.5
1,774.7
Stockholders’ equity
732.7
476.4
Total liabilities and stockholders’ equity
$
2,588.2
$
2,251.1
INSULET CORPORATION
NON-GAAP RECONCILIATIONS (UNAUDITED)
CONSTANT CURRENCY REVENUE GROWTH
Three Months Ended December 31,
(dollars in millions)
2023
2022
Percent Change
Currency Impact
Constant Currency
Revenue:
U.S. Omnipod
$
394.6
$
276.2
42.9
%
—
%
42.9
%
International Omnipod
106.4
90.2
18.0
%
5.5
%
12.5
%
Total Omnipod
501.0
366.4
36.7
%
1.3
%
35.4
%
Drug Delivery
8.8
3.3
166.7
%
—
%
166.7
%
Total
$
509.8
$
369.7
37.9
%
1.3
%
36.6
%
Years Ended December 31,
(dollars in millions)
2023
2022
Percent Change
Currency Impact
Constant Currency
Revenue:
U.S. Omnipod
$
1,251.0
$
884.8
41.4
%
—
%
41.4
%
International Omnipod
410.1
363.0
13.0
%
1.6
%
11.4
%
Total Omnipod
1,661.1
1,247.8
33.1
%
0.4
%
32.7
%
Drug Delivery
36.0
57.5
(37.4
) %
—
%
(37.4
) %
Total
$
1,697.1
$
1,305.3
30.0
%
0.4
%
29.6
%
INSULET CORPORATION
NON-GAAP RECONCILIATIONS CONTINUED (UNAUDITED)
ADJUSTED GROSS MARGIN, OPERATING MARGIN, NET INCOME AND DILUTED EPS
Three Months Ended December 31, 2023
(in millions)
Gross Profit
Percent of Revenue
Operating Income
Percent of Revenue
Net Income(3)
Net Income,
Diluted
Diluted Earnings per Share
GAAP
$
361.2
70.9
%
$
106.4
20.9
%
$
103.3
$
105.9
$
1.44
Voluntary medical device corrections(1)
(0.9
)
(0.9
)
(0.9
)
(0.9
)
$
(0.01
)
Unrealized gains on investments(2)
—
—
(1.8
)
(1.8
)
$
(0.03
)
Non-GAAP
$
360.3
70.7
%
$
105.5
20.7
%
$
100.6
$
103.2
$
1.40
Year Ending December 31, 2023
(in millions)
Gross Profit
Percent of Revenue
Operating Income
Percent of Revenue
Net Income(3)
Net Income,
Diluted
Diluted Earnings per Share
GAAP
$
1,159.9
68.3
%
$
220.0
13.0
%
$
206.3
$
216.7
$
2.94
Voluntary medical device corrections(1)
(11.5
)
(11.5
)
(11.5
)
(11.5
)
$
(0.16
)
Unrealized gains on investments(2)
—
—
(2.6
)
(2.6
)
$
(0.04
)
Non-GAAP
$
1,148.4
67.7
%
$
208.5
12.3
%
$
192.2
$
202.6
$
2.75
(1)
Represents income resulting from adjustments to estimated costs associated with the voluntary medical device correction notices issued in the fourth quarter of 2022, which is included in cost of revenue.
(2)Represents non-operating gains resulting from fair value adjustments of strategic debt and equity investments.
(3)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)
ADJUSTED GROSS MARGIN, OPERATING MARGIN, NET INCOME AND DILUTED EPS
Three Months Ended December 31, 2022
(in millions)
Gross Profit
Percent of Revenue
Operating Income
Percent of Revenue
Net Income(5)
Diluted Earnings per Share
GAAP
$
217.3
58.8
%
$
23.5
6.4
%
$
17.0
$
0.24
Voluntary medical device corrections(1)
21.1
21.1
21.1
$
0.30
Legal costs(2)
—
(2.1
)
(2.1
)
$
(0.03
)
Non-GAAP
$
238.4
64.5
%
$
42.5
11.5
%
$
36.0
$
0.52
Year Ended December 31, 2022
(in millions)
Gross Profit
Percent of Revenue
Operating Income
Percent of Revenue
Net Income(5)
Diluted Earnings per Share
GAAP
$
805.6
61.7
%
$
37.6
2.9
%
$
4.6
$
0.07
Voluntary medical device corrections(1)
57.9
57.9
57.9
$
0.83
Legal costs(3)
—
25.2
25.2
$
0.36
CEO transition costs(4)
—
3.4
3.4
$
0.05
Non-GAAP
$
863.5
66.2
%
$
124.1
9.5
%
$
91.1
$
1.30
(1)
Represents estimated costs associated with the voluntary medical device correction notices issued in the fourth quarter of 2022, which is included in cost of revenue.
(2)
Represents an adjustment to a legal settlement charge.
(3)
Includes a $20.0 million charge to settle patent infringement litigation, associated legal fees, and a charge to settle a contract dispute.
(4)
Represents costs associated with the retirement and advisory services of the former chief executive officer, including $2.3 million of accelerated stock-based compensation expense.
(5)
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)
ADJUSTED EBITDA
Three Months Ended December 31,
Years Ended December 31,
(dollars in millions)
2023
Percent of Revenue
2022
Percent of Revenue
2023
Percent of Revenue
2022
Percent of Revenue
Net income
$
103.3
20.3
%
$
17.0
4.6
%
$
206.3
12.2
%
$
4.6
0.4
%
Interest expense, net
0.5
2.7
7.6
26.7
Income tax expense
4.5
5.3
8.3
5.2
Depreciation and amortization
18.8
16.2
72.8
63.2
Stock-based compensation expense
12.6
11.2
48.3
38.6
Voluntary medical device corrections(1)
(0.9
)
21.1
(11.5
)
57.9
Unrealized gain on investments(2)
(1.8
)
—
(2.6
)
—
Legal costs(3)
—
(2.1
)
—
25.2
CEO transition costs(4)
—
—
—
3.4
Adjusted EBITDA
$
137.0
26.9
%
$
71.4
19.3
%
$
329.2
19.4
%
$
224.8
17.2
%
(1)
Represents net (income) expense resulting from estimated costs associated with the voluntary medical device correction notices issued in the fourth quarter of 2022 and adjustments to those costs, which is included in cost of revenue.
(2)
Represents non-operating gains resulting from fair value adjustments of strategic debt and equity investments.
(3)
Includes a $20.0 million charge to settle patent infringement litigation, associated legal fees, and a charge to settle a contract dispute.
(4)
Represents costs associated with the retirement and advisory services of the former chief executive officer, including $2.3 million of accelerated stock-based compensation expense.
INSULET CORPORATION
REVENUE GUIDANCE RECONCILIATIONS (UNAUDITED)
Year Ending December 31, 2024
Revenue Growth
GAAP
Currency Impact
Constant Currency
U.S. Omnipod
16% - 21%
—%
16% - 21%
International Omnipod
7% - 10%
—%
7% - 10%
Total Omnipod
13% - 18%
—%
13% - 18%
Drug Delivery
(60)% - (50)%
—%
(60)% - (50)%
Total
12% - 17%
—%
12% - 17%
Three Months Ending March 31, 2024
Revenue Growth
GAAP
Currency Impact
Constant Currency
U.S. Omnipod
19% - 22%
—%
19% - 22%
International Omnipod
6% - 9%
1%
5% - 8%
Total Omnipod
15% - 18%
—%
15% - 18%
Drug Delivery
1,020% - 1,220%
—%
1,020% - 1,220%
Total
17% - 20%
—%
17% - 20%
View source version on businesswire.com: https://www.businesswire.com/news/home/20240221333583/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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