Tandem Diabetes Care Announces First Quarter 2022 Financial Results and Updated Full Year 2022 Financial Guidance
First Quarter Financial Highlights:
-
First quarter 2022 sales increased 25 percent to
$175.9 million compared to the same period of 2021. - Worldwide pump shipments increased 11 percent to 28,095 pumps compared to the same period of 2021.
-
$635.4 million in cash, cash equivalents & short-term investments as ofMarch 31, 2022 , increased$11.6 million in the first quarter of 2022.
Recent Strategic Highlights:
-
Received U.S. Food and Drug Administration (FDA) clearance for the t:slim X2 insulin pump to bolus using the t:connect mobile app on iOS and Android operating systems. -
Completed expansion of
U.S. field sales force, providing greater resources to drive awareness of the Company’s technology solutions among people living with diabetes and healthcare providers. - Launched Control-IQ® advanced hybrid closed-loop technology in remaining international geographies bringing its features and benefits to all countries the Company serves worldwide.
-
Presented positive Control-IQ technology data that showed immediate and sustained improvements in glycemic control, quality of life outcomes, and user-reported reduced burden of diabetes management(1) at the 15th
International Conference on Advanced Technologies and Treatments for Diabetes . - Completed enrollment for the Control-IQ Observational (CLIO) study, an ongoing real-world study of more than 2,000 people living with type 1 diabetes using Control-IQ.
- Successfully executed the largest pivotal human factors study in the Company’s history for the Mobi insulin pump, which will be included in a regulatory filing to the FDA.
“Our first quarter performance demonstrated the strength with which we are executing across all areas of our business,” said
First Quarter 2022 Financial Results Compared to First Quarter 2021
-
Sales: Worldwide sales increased 25 percent to
$175.9 million , which included sales outsidethe United States of$44.6 million . This is compared to worldwide sales of$141.0 million , which included sales of$37.7 million outsidethe United States . -
Gross profit: Gross profit increased 24 percent to
$91.1 million , compared to$73.3 million . Gross margin was 52 percent, which was the same as the first quarter of 2021. -
Operating loss: Operating loss totaled
$15.3 million , or negative 9 percent of sales, compared to$3.2 million , or negative 2 percent of sales. Adjusted EBITDA(2) was$6.4 million , compared to$13.2 million , or 4 percent and 9 percent of sales, respectively. -
Net loss: Net loss was
$14.7 million , compared to$5.0 million .
See tables for additional financial information.
2022 Annual Guidance Update
For the year ending
-
Sales are estimated to be in the range of
$850 million to$865 million , which represents an annual sales growth of 21 percent to 23 percent compared to 2021. The Company’s prior sales guidance for 2022 was estimated to be in the range of$845 million to$860 million .-
Sales inside
the United States of approximately$635 million to$645 million , an increase from the prior guidance of$630 million to$640 million -
Sales outside
the United States of approximately$215 million to$220 million
-
Sales inside
- Gross margin is estimated to be approximately 54 percent
- Adjusted EBITDA(2) is estimated to be in the range of 14 percent to 15 percent of sales
-
Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately
$95 million , an increase from the Company’s prior guidance. This includes:-
Approximately
$80 million non-cash, stock-based compensation expense, compared to the prior guidance of$75 million -
Approximately
$15 million depreciation and amortization expense
-
Approximately
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(1) |
Singh H, Alencar G, Manning M, et al. Long-Term Improvements In Patient-Reported Outcomes Irrespective of Baseline Glycemic Control and Previous Insulin Delivery Method with the t:Slim X2 Pump with Control-IQ Technology. Poster presented at 15th Annual |
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(2) |
See "Non-GAAP Financial Measures" below. EBITDA is a non-GAAP financial measure defined as net income (loss) excluding income taxes, interest and other non-operating items and depreciation and amortization. Adjusted EBITDA further adjusts for the change in fair value of common stock warrants and non-cash stock-based compensation expense. This definition of Adjusted EBITDA may differ from similar measures used by other companies, even when similar terms are used to identify such measures. Adjusted EBITDA is a key measure used by the Company to evaluate operating performance, generate future operating plans and make strategic decisions for the allocation of capital. The Company presents Adjusted EBITDA to provide information that may assist investors in understanding its financial results. However, Adjusted EBITDA is not intended to be a substitute for net income (loss). |
Non-GAAP Financial Measures
Certain non-GAAP financial measures are presented in this press release, including adjusted EBITDA, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. We believe these non-GAAP financial measures are important indicators of our operating performance because they exclude items that are unrelated to, and may not be indicative of, our core operating results. These non-GAAP financial measures, as we calculate them, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent, and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. To the extent we utilize such non-GAAP financial measures in the future, we expect to calculate them using a consistent method from period to period. A reconciliation of each of the GAAP financial measures to the most directly comparable non-GAAP financial measures has been provided under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results” in the financial statement tables attached to this press release. Consistent with
Conference Call
The Company will hold a conference call and simultaneous webcast today at
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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements include statements regarding, among other things, the Company’s projected financial results. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, the Company’s ability to achieve projected financial results will be impacted by market acceptance of the Company’s existing products and products under development by physicians and people with diabetes; the Company’s ability to establish and sustain operations to support international sales, including expansion into additional geographies; changes in reimbursement rates or insurance coverage for the Company’s products; the Company’s ability to meet increasing operational and infrastructure requirements from higher customer interest and a larger base of existing customers; the Company’s ability to complete the development and launch of new products when anticipated; the potential that newer products, or other technological breakthroughs for the monitoring, treatment or prevention of diabetes, may render the Company’s products obsolete or less desirable; the depth and duration of the evolving COVID-19 pandemic, and the global response thereto; reliance on third-party relationships, such as outsourcing and supplier arrangements; global economic conditions; and other risks identified in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other documents that the Company files with the
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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Table A |
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(in thousands) |
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2022 |
|
2021 |
||
|
Assets |
(Unaudited) |
|
|
||
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Current assets: |
|
|
|
||
|
Cash, cash equivalents and short-term investments |
$ |
635,391 |
|
$ |
623,811 |
|
Accounts receivable, net |
|
94,133 |
|
|
110,725 |
|
Inventories |
|
79,987 |
|
|
68,551 |
|
Other current assets |
|
8,953 |
|
|
8,433 |
|
Total current assets |
|
818,464 |
|
|
811,520 |
|
|
|
|
|
||
|
Property and equipment, net |
|
49,987 |
|
|
50,386 |
|
Operating lease right-of-use assets |
|
131,058 |
|
|
27,503 |
|
Other long-term assets |
|
15,768 |
|
|
15,728 |
|
Total assets |
$ |
1,015,277 |
|
$ |
905,137 |
|
|
|
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
|
|
|
||
|
Accounts payable, accrued expenses and employee-related liabilities |
$ |
89,961 |
|
$ |
89,007 |
|
Operating lease liabilities |
|
8,080 |
|
|
9,279 |
|
Deferred revenue |
|
10,881 |
|
|
10,182 |
|
Other current liabilities |
|
22,893 |
|
|
23,388 |
|
Total current liabilities |
|
131,815 |
|
|
131,856 |
|
|
|
|
|
||
|
Convertible senior notes, net - long-term |
|
281,905 |
|
|
281,467 |
|
Operating lease liabilities - long-term |
|
129,195 |
|
|
23,922 |
|
Deferred revenue - long-term |
|
17,531 |
|
|
16,940 |
|
Other long-term liabilities |
|
17,449 |
|
|
17,840 |
|
Total liabilities |
|
577,895 |
|
|
472,025 |
|
|
|
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|
||
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Total stockholders’ equity |
|
437,382 |
|
|
433,112 |
|
Total liabilities and stockholders’ equity |
$ |
1,015,277 |
|
$ |
905,137 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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Table B |
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(in thousands, except per share data) |
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(Unaudited) |
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Three Months Ended |
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2022 |
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2021 |
||||
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Sales |
$ |
175,907 |
|
|
$ |
141,037 |
|
|
Cost of sales |
|
84,814 |
|
|
|
67,750 |
|
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Gross profit |
|
91,093 |
|
|
|
73,287 |
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Operating expenses: |
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|
|
||||
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Selling, general and administrative |
|
73,271 |
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|
|
58,563 |
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Research and development |
|
33,160 |
|
|
|
17,961 |
|
|
Total operating expenses |
|
106,431 |
|
|
|
76,524 |
|
|
Operating loss |
|
(15,338 |
) |
|
|
(3,237 |
) |
|
Total other expense, net |
|
(1,101 |
) |
|
|
(1,924 |
) |
|
Loss before income taxes |
|
(16,439 |
) |
|
|
(5,161 |
) |
|
Income tax benefit |
|
1,724 |
|
|
|
117 |
|
|
Net loss |
$ |
(14,715 |
) |
|
$ |
(5,044 |
) |
|
|
|
|
|
||||
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Net loss per share, basic and diluted |
$ |
(0.23 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
||||
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Weighted average shares used to compute basic and diluted net loss per share |
|
63,880 |
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|
|
62,448 |
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SALES BY GEOGRAPHY |
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Table C |
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(Unaudited) |
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($'s in thousands) |
Three Months Ended |
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2022 |
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2021 |
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% Change |
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Pump |
$ |
73,497 |
|
$ |
62,912 |
|
17 |
% |
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Infusion sets |
|
39,741 |
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|
27,392 |
|
45 |
% |
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Cartridges |
|
17,677 |
|
|
12,765 |
|
38 |
% |
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Other |
|
368 |
|
|
270 |
|
36 |
% |
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Total Sales in |
$ |
131,283 |
|
$ |
103,339 |
|
27 |
% |
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Outside |
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Pump |
$ |
22,332 |
|
$ |
18,908 |
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18 |
% |
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Infusion sets |
|
14,999 |
|
|
12,734 |
|
18 |
% |
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Cartridges |
|
7,177 |
|
|
5,949 |
|
21 |
% |
|
Other |
|
116 |
|
|
107 |
|
8 |
% |
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Total Sales Outside the United States |
$ |
44,624 |
|
$ |
37,698 |
|
18 |
% |
|
|
|
|
|
|
|
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Total Worldwide Sales |
$ |
175,907 |
|
$ |
141,037 |
|
25 |
% |
|
|
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PUMP SHIPMENTS |
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Table D |
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Three Months Ended |
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|
|||
|
|
2022 |
|
2021 |
|
% Change |
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Pumps Shipped: |
|
|
|
|
|
|
|
|
18,658 |
|
16,644 |
|
12 |
% |
|
Outside |
9,437 |
|
8,708 |
|
8 |
% |
|
Total Pumps Shipped |
28,095 |
|
25,352 |
|
11 |
% |
|
|
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Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) |
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Table E |
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(in thousands) |
Three Months Ended |
||||||
|
|
2022 |
|
2021 |
||||
|
GAAP net loss |
$ |
(14,715 |
) |
|
$ |
(5,044 |
) |
|
Income tax benefit |
|
(1,724 |
) |
|
|
(117 |
) |
|
Interest income and other, net |
|
(381 |
) |
|
|
(272 |
) |
|
Interest expense |
|
1,516 |
|
|
|
1,506 |
|
|
Depreciation and amortization |
|
3,628 |
|
|
|
3,485 |
|
|
EBITDA |
|
(11,676 |
) |
|
|
(442 |
) |
|
Change in fair value of common stock warrants |
|
(34 |
) |
|
|
690 |
|
|
Stock-based compensation expense |
|
18,110 |
|
|
|
12,947 |
|
|
Adjusted EBITDA(2) |
$ |
6,400 |
|
|
$ |
13,195 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220504005468/en/
Media Contact:
714-907-6264
ssabicer@thesabicergroup.com
Investor Contact:
858-366-6900
IR@tandemdiabetes.com
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