Tandem Diabetes Care Announces Third Quarter 2022 Financial Results and Updated Full Year 2022 Financial Guidance
Third Quarter 2022 Financial Highlights Compared to Third Quarter 2021:
- Worldwide installed base increased 35 percent to more than 400,000 customers.
-
Worldwide sales increased 14 percent to
$204.5 million .-
Renewal pump shipments in
the United States increased nearly 70 percent. -
Sales outside
the United States increased 26 percent to$58.5 million .
-
Renewal pump shipments in
-
$608.7 million in cash, cash equivalents & short-term investments as ofSeptember 30, 2022 .
Recent Strategic Highlights:
-
Submitted a 510(k) pre-market notification to the
U.S. Food and Drug Administration for the Mobi Insulin Delivery System. -
Launched two customer benefit programs in
the United States : the Tandem Choice technology access program (Tandem Choice ) and Flexible Payment Plans. - Achieved the milestone of having more than 100 million patient days using the t:slim X2 with Control-IQ technology.
-
Launched the t:slim X2 with Control-IQ technology in
Israel andPortugal . - Completed feasibility study for people living with type 2 diabetes using Control-IQ technology.
“More than 400,000 people worldwide have chosen Tandem and the t:slim X2 insulin pump for their therapy needs, and broad feedback from clinicians supports that we are leading in automated insulin dosing with our Control-IQ technology,” said
Third Quarter 2022 Financial Results Compared to Third Quarter 2021
Starting with the third quarter 2022, the Company is providing more expansive financial results on both a GAAP and non-GAAP basis as detailed in Table E.
-
Sales: Sales in the Unites States increased 10 percent to
$146.0 million , compared to$133.1 million . InSeptember 2022 , the Company deferred$0.6 million ofUnited States pump sales as a result ofTandem Choice . Sales outsidethe United States increased 26 percent to$58.5 million , compared to$46.5 million .
-
Gross profit: Gross profit increased 8 percent to
$104.4 million , compared to$96.7 million . Gross margin was 51 percent, compared to 54 percent.
-
Operating loss: GAAP operating loss totaled
$47.5 million and non-GAAP operating loss* totaled$15.9 million , compared to operating income of$7.7 million .
Adjusted EBITDA* was$9.9 million , compared to$26.9 million , or 5 percent and 15 percent of non-GAAP sales*, respectively.
-
Net loss: GAAP net loss was
$49.0 million , compared to net income of$5.8 million . Non-GAAP net loss* for the third quarter 2022 was$17.4 million .
See tables for additional financial information.
2022 Annual Guidance Update
“In this highly variable environment, we are factoring greater caution into our guidance to re-baseline expectations for the next few quarters,” said
For the year ending
-
Non-GAAP sales* are estimated to be in the range of
$800 million to$805 million , which represents an annual sales growth of 14 percent to 15 percent compared to 2021. The Company’s prior sales guidance for 2022 was estimated to be in the range of$835 million to$845 million .-
Sales inside
the United States of approximately$592 million to$595 million , compared to the prior guidance of$620 million to$625 million . -
Sales outside
the United States of approximately$208 million to$210 million , compared to the prior guidance of$215 million to$220 million .
-
Sales inside
- Non-GAAP gross margin* is estimated to be approximately 52 percent, compared to the prior guidance of 52 percent to 53 percent.
- Adjusted EBITDA margin* is estimated to be approximately 7 percent to 8 percent of sales, compared to the prior guidance of 11 percent of sales.
-
Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately
$100 million , an increase from the Company’s prior guidance. This includes:-
Approximately
$85 million non-cash, stock-based compensation expense. -
Approximately
$15 million depreciation and amortization expense.
-
Approximately
* See Table E for reconciliation of non-GAAP financial measures
Non-GAAP Financial Measures
Certain non-GAAP financial measures are presented in this press release, including non-GAAP sales, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating loss, non-GAAP net loss, EBITDA and adjusted EBITDA, as well as adjusted EBITDA margin, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important operating performance indicators because they exclude items that are unrelated to, and may not be indicative of, the Company’s core operating results. These non-GAAP financial measures, as calculated, 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 the Company utilizes such non-GAAP financial measures in the future, they will be calculated 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
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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
|
||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
Table A |
||||||
(in thousands) |
||||||
|
|
|
||||
|
|
|
|
|||
|
2022 |
|
2021 |
|||
Assets |
(Unaudited) |
|
||||
Current assets: |
|
|
||||
Cash, cash equivalents and short-term investments |
$ |
608,727 |
$ |
623,811 |
||
Accounts receivable, net |
|
112,805 |
|
110,725 |
||
Inventories |
|
104,774 |
|
68,551 |
||
Other current assets |
|
7,997 |
|
8,433 |
||
Total current assets |
|
834,303 |
|
811,520 |
||
|
|
|
||||
Property and equipment, net |
|
72,905 |
|
50,386 |
||
Operating lease right-of-use assets |
|
116,474 |
|
27,503 |
||
Other long-term assets |
|
23,838 |
|
15,728 |
||
Total assets |
$ |
1,047,520 |
$ |
905,137 |
||
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
||||
Current liabilities: |
|
|
||||
Accounts payable, accrued expenses and employee-related liabilities |
$ |
117,396 |
$ |
89,007 |
||
Operating lease liabilities |
|
12,120 |
|
9,279 |
||
Deferred revenue |
|
12,974 |
|
10,182 |
||
Other current liabilities |
|
31,140 |
|
23,388 |
||
Total current liabilities |
|
173,630 |
|
131,856 |
||
|
|
|
||||
Convertible senior notes, net - long-term |
|
282,787 |
|
281,467 |
||
Operating lease liabilities - long-term |
|
127,109 |
|
23,922 |
||
Deferred revenue - long-term |
|
19,143 |
|
16,940 |
||
Other long-term liabilities |
|
23,029 |
|
17,840 |
||
Total liabilities |
|
625,698 |
|
472,025 |
||
|
|
|
||||
Total stockholders’ equity |
|
421,822 |
|
433,112 |
||
Total liabilities and stockholders’ equity |
$ |
1,047,520 |
$ |
905,137 |
|
||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||||||
Table B |
||||||||||||||||
(in thousands, except per share data) |
||||||||||||||||
(Unaudited) |
||||||||||||||||
|
||||||||||||||||
|
Three Months Ended |
Nine Months Ended |
||||||||||||||
|
2022 |
2021 |
2022 |
2021 |
||||||||||||
Sales |
$ |
204,547 |
|
$ |
179,627 |
|
$ |
580,716 |
|
$ |
492,803 |
|
||||
Cost of sales |
|
100,122 |
|
|
82,882 |
|
|
283,252 |
|
|
230,317 |
|
||||
Gross profit |
|
104,425 |
|
|
96,745 |
|
|
297,464 |
|
|
262,486 |
|
||||
|
|
|
|
|
||||||||||||
Operating expenses: |
|
|
|
|
||||||||||||
Selling, general and administrative |
|
84,104 |
|
|
64,923 |
|
|
237,989 |
|
|
190,009 |
|
||||
Research and development |
|
36,798 |
|
|
24,102 |
|
|
103,529 |
|
|
62,562 |
|
||||
Acquired in-process research and development expenses |
|
31,016 |
|
|
— |
|
|
31,016 |
|
|
— |
|
||||
Total operating expenses |
|
151,918 |
|
|
89,025 |
|
|
372,534 |
|
|
252,571 |
|
||||
Operating income (loss) |
|
(47,493 |
) |
|
7,720 |
|
|
(75,070 |
) |
|
9,915 |
|
||||
Total other income (expense), net |
|
144 |
|
|
(1,872 |
) |
|
(1,668 |
) |
|
(5,159 |
) |
||||
Income (loss) before income taxes |
|
(47,349 |
) |
|
5,848 |
|
|
(76,738 |
) |
|
4,756 |
|
||||
Income tax expense (benefit) |
|
1,621 |
|
|
54 |
|
|
2,003 |
|
|
(2 |
) |
||||
Net income (loss) |
$ |
(48,970 |
) |
$ |
5,794 |
|
$ |
(78,741 |
) |
$ |
4,758 |
|
||||
|
|
|
|
|
||||||||||||
Net income (loss) per share, basic |
$ |
(0.76 |
) |
$ |
0.09 |
|
$ |
(1.23 |
) |
$ |
0.08 |
|
||||
Net income (loss) per share, diluted |
$ |
(0.76 |
) |
$ |
0.09 |
|
$ |
(1.23 |
) |
$ |
0.07 |
|
||||
|
|
|
|
|
||||||||||||
Weighted average shares used to compute basic net income (loss) per share |
|
64,236 |
|
|
63,167 |
|
|
64,066 |
|
|
62,780 |
|
||||
Weighted average shares used to compute diluted net income (loss) per share |
|
64,237 |
|
|
64,784 |
|
|
64,067 |
|
|
64,198 |
|
|
||||||||||||||||||
SALES BY GEOGRAPHY |
||||||||||||||||||
Table C |
||||||||||||||||||
(Unaudited) |
||||||||||||||||||
|
|
|
|
|
|
|||||||||||||
($'s in thousands) |
Three Months Ended |
Nine Months Ended |
||||||||||||||||
|
2022 |
2021 |
% Change |
2022 |
2021 |
% Change |
||||||||||||
|
|
|
|
|
|
|
||||||||||||
Pump(1) |
$ |
80,696 |
$ |
78,771 |
2 |
% |
$ |
235,849 |
$ |
221,724 |
6 |
% |
||||||
Infusion sets |
|
44,839 |
|
37,725 |
19 |
% |
|
128,490 |
|
97,251 |
32 |
% |
||||||
Cartridges |
|
20,122 |
|
16,289 |
24 |
% |
|
57,502 |
|
44,136 |
30 |
% |
||||||
Other |
|
378 |
|
321 |
18 |
% |
|
1,144 |
|
914 |
25 |
% |
||||||
Total Sales in |
$ |
146,035 |
$ |
133,106 |
10 |
% |
$ |
422,985 |
$ |
364,025 |
16 |
% |
||||||
|
|
|
|
|
|
|
||||||||||||
Outside |
|
|
|
|
|
|
||||||||||||
Pump |
$ |
27,385 |
$ |
23,762 |
15 |
% |
$ |
75,515 |
$ |
70,300 |
7 |
% |
||||||
Infusion sets |
|
21,964 |
|
16,175 |
36 |
% |
|
57,258 |
|
41,074 |
39 |
% |
||||||
Cartridges |
|
8,996 |
|
6,269 |
43 |
% |
|
24,539 |
|
16,878 |
45 |
% |
||||||
Other |
|
167 |
|
315 |
(47 |
)% |
|
419 |
|
526 |
(20 |
)% |
||||||
Total Sales Outside the United States |
$ |
58,512 |
$ |
46,521 |
26 |
% |
$ |
157,731 |
$ |
128,778 |
22 |
% |
||||||
|
|
|
|
|
|
|
||||||||||||
Total Worldwide Sales(1) |
$ |
204,547 |
$ |
179,627 |
14 |
% |
$ |
580,716 |
$ |
492,803 |
18 |
% |
1) |
Reduced by |
|
||||||||||||||
PUMP SHIPMENTS |
||||||||||||||
Table D |
||||||||||||||
|
|
|
|
|
|
|
||||||||
|
Three Months Ended |
Nine Months Ended |
||||||||||||
|
2022 |
2021 |
% Change |
2022 |
2021 |
% Change |
||||||||
Pumps Shipped: |
|
|
|
|
|
|
||||||||
|
20,394 |
20,296 |
0 |
% |
59,870 |
57,605 |
4 |
% |
||||||
Outside |
12,113 |
11,262 |
8 |
% |
32,846 |
33,122 |
(1 |
)% |
||||||
Total Pumps Shipped |
32,507 |
31,558 |
3 |
% |
92,716 |
90,727 |
2 |
% |
|
||||||||||||||||
Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) |
||||||||||||||||
Table E |
||||||||||||||||
|
|
|
|
|
||||||||||||
($'s in thousands) |
Three Months Ended |
Nine Months Ended |
||||||||||||||
|
2022 |
2021 |
2022 |
2021 |
||||||||||||
GAAP sales |
$ |
204,547 |
|
$ |
179,627 |
|
$ |
580,716 |
|
$ |
492,803 |
|
||||
Adjustments for |
|
599 |
|
|
— |
|
|
599 |
|
|
— |
|
||||
Non-GAAP sales |
$ |
205,146 |
|
$ |
179,627 |
|
$ |
581,315 |
|
$ |
492,803 |
|
||||
|
|
|
|
|
||||||||||||
GAAP gross profit |
$ |
104,425 |
|
$ |
96,745 |
|
$ |
297,464 |
|
$ |
262,486 |
|
||||
Adjustments for |
|
599 |
|
|
— |
|
|
599 |
|
|
— |
|
||||
Non-GAAP gross profit |
$ |
105,024 |
|
$ |
96,745 |
|
$ |
298,063 |
|
$ |
262,486 |
|
||||
Non-GAAP gross margin(3) |
|
51 |
% |
|
54 |
% |
|
51 |
% |
|
53 |
% |
||||
|
|
|
|
|
||||||||||||
GAAP operating income (loss) |
$ |
(47,493 |
) |
$ |
7,720 |
|
$ |
(75,070 |
) |
$ |
9,915 |
|
||||
Acquired in-process research and development(2) |
|
31,016 |
|
|
— |
|
|
31,016 |
|
|
— |
|
||||
Adjustments for |
|
599 |
|
|
— |
|
|
599 |
|
|
— |
|
||||
Non-GAAP operating income (loss) |
$ |
(15,878 |
) |
$ |
7,720 |
|
$ |
(43,455 |
) |
$ |
9,915 |
|
||||
Non-GAAP operating margin(3) |
|
(8 |
) % |
|
4 |
% |
|
(7 |
) % |
|
2 |
% |
||||
|
|
|
|
|
||||||||||||
GAAP net income (loss) |
$ |
(48,970 |
) |
$ |
5,794 |
|
$ |
(78,741 |
) |
$ |
4,758 |
|
||||
Income tax expense (benefit) |
|
1,621 |
|
|
54 |
|
|
2,003 |
|
|
(2 |
) |
||||
Interest income and other, net |
|
(1,708 |
) |
|
(31 |
) |
|
(2,858 |
) |
|
(721 |
) |
||||
Interest expense |
|
1,576 |
|
|
1,511 |
|
|
4,629 |
|
|
4,526 |
|
||||
Depreciation and amortization |
|
3,508 |
|
|
3,400 |
|
|
10,689 |
|
|
10,325 |
|
||||
EBITDA |
|
(43,973 |
) |
|
10,728 |
|
|
(64,278 |
) |
|
18,886 |
|
||||
Change in fair value of common stock warrants |
|
(12 |
) |
|
392 |
|
|
(103 |
) |
|
1,354 |
|
||||
Stock-based compensation expense |
|
22,236 |
|
|
15,729 |
|
|
60,477 |
|
|
43,653 |
|
||||
Acquired in-process research and development(2) |
|
31,016 |
|
|
— |
|
|
31,016 |
|
|
— |
|
||||
Adjustments for |
|
599 |
|
|
— |
|
|
599 |
|
|
— |
|
||||
Adjusted EBITDA |
$ |
9,866 |
|
$ |
26,849 |
|
$ |
27,711 |
|
$ |
63,893 |
|
||||
Adjusted EBITDA Margin(3) |
|
5 |
% |
|
15 |
% |
|
5 |
% |
|
13 |
% |
||||
|
|
|
|
|
||||||||||||
GAAP net income (loss) |
$ |
(48,970 |
) |
$ |
5,794 |
|
$ |
(78,741 |
) |
$ |
4,758 |
|
||||
Acquired in-process research and development(2) |
|
31,016 |
|
|
— |
|
|
31,016 |
|
|
— |
|
||||
Adjustments for |
|
599 |
|
|
— |
|
|
599 |
|
|
— |
|
||||
Non-GAAP net income (loss) |
$ |
(17,355 |
) |
$ |
5,794 |
|
$ |
(47,126 |
) |
$ |
4,758 |
|
(1) |
In |
|
(2) |
The Company recorded a |
|
(3) |
Non-GAAP margins including non-GAAP gross margin, non-GAAP operating margin, and adjusted EBITDA margin are calculated using non-GAAP sales. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20221102005457/en/
Media Contact:
858-255-6388
media@tandemdiabetes.com
Investor Contact:
858-366-6900
IR@tandemdiabetes.com
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