Tandem Diabetes Care Announces First Quarter 2024 Financial Results and Updates Full Year 2024 Financial Guidance
First Quarter 2024 Highlights Compared to First Quarter 2023:
-
Worldwide GAAP sales increased 13 percent to
$191.7 million ; worldwide non-GAAP sales increased 12 percent to$192.8 million . - Worldwide pump shipments increased 9 percent to approximately 25,000 pumps from 23,000 pumps.
-
First quarter 2024 commercial launches:
-
Launched Tandem Mobi with Dexcom G6 continuous glucose monitoring (CGM) sensor integration in
the United States . -
Launched t:slim X2 integration with the Abbott Freestyle Libre 2 Plus CGM sensor in
the United States . -
Initiated rolling launch of t:slim X2 with Dexcom G7 sensor integration outside
the United States .
-
Launched Tandem Mobi with Dexcom G6 continuous glucose monitoring (CGM) sensor integration in
-
Received U.S. Food and Drug Administration clearance to expand the Tandem Mobi pump indication for use in individuals two years of age and older. - Began enrollment for extended wear infusion set clinical trial.
-
Completed a
$316.3 million senior convertible notes offering primarily used for repurchase of existing senior convertible notes.
“Our outperformance in the first quarter was driven by demand for both the t:slim X2 and our newly launched Tandem Mobi, validating our portfolio strategy that allows us to address a greater market by meeting the needs and preferences of more people living with diabetes,” said
First Quarter 2024 Sales Results Compared to 2023
From
|
Three Months Ended |
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|
|||||||||||
|
2024 |
|
|
2023 |
||||||||
Approximate Pump Shipments |
|
|
|
|
|
|
|
|
||||
|
15,000 |
|
|
17,000 |
||||||||
Outside |
10,000 |
|
|
6,000 |
||||||||
Total Worldwide |
25,000 |
|
|
23,000 |
||||||||
|
|
|
|
|
|
|
|
|
||||
($ in millions) |
GAAP |
|
Non-GAAP |
|
|
GAAP |
|
Non-GAAP |
||||
Sales |
|
|
|
|
|
|
|
|
||||
|
$ |
129.8 |
|
$ |
130.9 |
|
|
$ |
131.2 |
|
$ |
133.3 |
Outside |
|
61.9 |
|
|
61.9 |
|
|
|
38.1 |
|
|
38.1 |
Total Worldwide |
$ |
191.7 |
|
$ |
192.8 |
|
|
$ |
169.3 |
|
$ |
171.4 |
First Quarter 2024 Additional Financial Results Compared to First Quarter 2023
-
Sales: In
the United States , GAAP sales included a$1.1 million deferral relating toTandem Choice , compared to a deferral of$2.0 million . Non-GAAP sales do not includeTandem Choice related sales deferrals.
-
Gross profit: GAAP gross profit was
$94.7 million , compared to$82.9 million . GAAP gross margin was 49 percent for both periods
Non-GAAP gross profit(1) was$95.8 million compared to$84.9 million . Non-GAAP gross margin(1) was 50 percent for both periods.
-
Operating income (loss): GAAP operating loss totaled
$41.7 million , or negative 22 percent of sales, compared to operating loss of$127.8 million , or negative 75 percent of sales.
Non-GAAP operating loss(1) totaled$40.5 million , or negative 21 percent of sales, compared to$44.4 million or negative 26 percent of sales.
-
Net income (loss): GAAP net loss was
$42.7 million , compared to net loss of$123.9 million .
Non-GAAP net loss(1) was$41.6 million compared to$40.4 million .
Adjusted EBITDA(1) was negative$14.4 million , or negative 7 percent of sales, compared to negative$20.2 million , or negative 12 percent of sales.
(1) A reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures and additional information can be found in Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release. Also see “Non-GAAP Financial Measures” below for additional information. |
See tables for additional financial information.
2024 Financial Guidance
The Company’s non-GAAP guidance for the fiscal year ending
For the year ending
-
Non-GAAP sales are estimated to be approximately
$868 million for the full year and$205 million in the second quarter.-
Sales in
the United States of approximately$634 million for the full year and$150 million in the second quarter. -
Sales outside
the United States of approximately$234 million for the full year and$55 million in the second quarter.
-
Sales in
- Non-GAAP gross margin is estimated to be approximately 51 percent for the full year and approximately and 50 percent in the second quarter.
- Adjusted EBITDA margin is estimated to be breakeven as a percent of sales for the full year and approximately negative 5 percent in the second quarter.
-
Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately
$120 million . This includes:-
Approximately
$100 million non-cash, stock-based compensation expense. -
Approximately
$20 million depreciation and amortization expense.
-
Approximately
Non-GAAP Financial Measures
Certain non-GAAP financial measures are presented in this press release 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 uses 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 historical GAAP financial measures to the most directly comparable historical non-GAAP financial measures has been provided in Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release.
The Company has not provided a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures in reliance on the “unreasonable efforts” exception set forth in the applicable regulations, because there is substantial uncertainty associated with predicting any future adjustments that may be made to the Company’s GAAP financial measures in calculating the non-GAAP financial measures.
In particular, the accounting treatment for
Notably:
- Offering the program does not impact the economics associated with how or when the initial pump sale is reimbursed.
-
Customer eligibility was automatic and no election was necessary to participate in
Tandem Choice at the time of a t:slim X2 purchase. Customer eligibility ended inFebruary 2024 with the commercial availability of the new hardware platform, Tandem Mobi. -
An affirmative election is required for the customer to participate in
Tandem Choice , at which time any customer fees will be received and recognized as a sale. Any remaining deferrals will be recognized at program expiration. -
The expiration date of
Tandem Choice isDecember 31, 2024 .
Conference Call
The Company will hold a conference call and simultaneous webcast today at
About
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 and the ability to achieve other operational and commercial goals, including longer term growth and profitability. 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 products; products marketed and sold or under development by competitors; the Company’s ability to establish and sustain operations to support international sales, including expanding 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 successfully commercialize its products; the Company’s ability to develop and launch new products; risks associated with the regulatory approval process outside
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CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||
Table A |
|||||
(in thousands) |
|||||
|
|
|
|
||
|
|
|
|
||
|
2024 |
|
2023 |
||
Assets |
(Unaudited) |
|
|
||
Current assets: |
|
|
|
||
Cash, cash equivalents and short-term investments |
$ |
467,810 |
|
$ |
467,912 |
Accounts receivable, net |
|
92,965 |
|
|
105,555 |
Inventories |
|
153,893 |
|
|
157,937 |
Other current assets |
|
20,525 |
|
|
16,585 |
Total current assets |
|
735,193 |
|
|
747,989 |
|
|
|
|
||
Property and equipment, net |
|
77,530 |
|
|
76,542 |
Operating lease right-of-use assets |
|
88,286 |
|
|
87,791 |
Other long-term assets |
|
40,036 |
|
|
40,336 |
Total assets |
$ |
941,045 |
|
$ |
952,658 |
|
|
|
|
||
Liabilities and Stockholders’ Equity |
|
|
|
||
Current liabilities: |
|
|
|
||
Accounts payable, accrued expenses and employee-related liabilities |
$ |
100,751 |
|
$ |
105,742 |
Operating lease liabilities |
|
17,320 |
|
|
17,060 |
Deferred revenue |
|
44,562 |
|
|
43,994 |
Other current liabilities |
|
30,338 |
|
|
28,462 |
Total current liabilities |
|
192,971 |
|
|
195,258 |
|
|
|
|
||
Convertible senior notes, net - long-term |
|
347,497 |
|
|
285,035 |
Operating lease liabilities - long-term |
|
112,732 |
|
|
113,572 |
Deferred revenue - long-term |
|
12,299 |
|
|
13,331 |
Other long-term liabilities |
|
32,482 |
|
|
31,830 |
Total liabilities |
|
697,981 |
|
|
639,026 |
|
|
|
|
||
Total stockholders’ equity |
|
243,064 |
|
|
313,632 |
Total liabilities and stockholders’ equity |
$ |
941,045 |
|
$ |
952,658 |
|
|||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||
Table B |
|||||||
(in thousands, except per share data) |
|||||||
|
|||||||
|
(Unaudited) |
||||||
|
Three Months Ended |
||||||
|
2024 |
|
2023 |
||||
Sales |
$ |
191,674 |
|
|
$ |
169,383 |
|
Cost of sales |
|
97,002 |
|
|
|
86,476 |
|
Gross profit |
|
94,672 |
|
|
|
82,907 |
|
Operating expenses: |
|
|
|
||||
Selling, general and administrative |
|
90,106 |
|
|
|
89,814 |
|
Research and development |
|
46,244 |
|
|
|
42,160 |
|
Acquired in-process research and development expenses |
|
— |
|
|
|
78,750 |
|
Total operating expenses |
|
136,350 |
|
|
|
210,724 |
|
Operating loss |
|
(41,678 |
) |
|
|
(127,817 |
) |
Total other income (expense), net |
|
2,149 |
|
|
|
4,231 |
|
Loss before income taxes |
|
(39,529 |
) |
|
|
(123,586 |
) |
Income tax expense |
|
3,186 |
|
|
|
287 |
|
Net loss |
$ |
(42,715 |
) |
|
$ |
(123,873 |
) |
|
|
|
|
||||
Net loss per share - basic and diluted |
$ |
(0.65 |
) |
|
$ |
(1.92 |
) |
|
|
|
|
||||
Weighted average shares used to compute basic and diluted net loss per share |
|
65,326 |
|
|
|
64,549 |
|
|
|||||||
SALES BY GEOGRAPHY |
|||||||
Table C(1) |
|||||||
|
|
|
|
||||
|
(Unaudited) |
||||||
($'s in thousands) |
Three Months Ended |
||||||
|
2024 |
|
2023 |
||||
|
|
|
|
||||
Pump |
$ |
61,720 |
|
|
$ |
66,457 |
|
Supplies and other |
|
69,187 |
|
|
|
66,808 |
|
Deferral for |
|
(1,146 |
) |
|
|
(2,023 |
) |
Total GAAP Sales in |
$ |
129,761 |
|
|
$ |
131,242 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Total Non-GAAP Sales in |
$ |
130,907 |
|
|
$ |
133,265 |
|
|
|
|
|
||||
Outside |
|
|
|
||||
Pump |
$ |
25,567 |
|
|
$ |
18,247 |
|
Supplies and other |
|
36,346 |
|
|
|
19,894 |
|
Total Sales Outside the United States |
$ |
61,913 |
|
|
$ |
38,141 |
|
|
|
|
|
||||
Total GAAP Worldwide Sales |
$ |
191,674 |
|
|
$ |
169,383 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Total Non-GAAP Worldwide Sales |
$ |
192,820 |
|
|
$ |
171,406 |
|
(1) A reconciliation of non-GAAP financial measures to their closest GAAP equivalent and additional information can be found in Table E and under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results.” |
|
|||
PUMP SHIPMENTS (Unaudited) |
|||
Table D |
|||
|
|
||
|
Three Months Ended |
||
|
2024 |
|
2023 |
Pumps Shipped: |
|
|
|
|
15,000 |
|
17,000 |
Outside |
10,000 |
|
6,000 |
Total Pumps Shipped |
25,000 |
|
23,000 |
|
|||||||
Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) |
|||||||
Table E |
|||||||
|
|
|
|
||||
($'s in thousands) |
Three Months Ended |
||||||
|
2024 |
|
2023 |
||||
GAAP sales |
$ |
191,674 |
|
|
$ |
169,383 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Non-GAAP sales |
$ |
192,820 |
|
|
$ |
171,406 |
|
|
|
|
|
||||
GAAP gross profit |
$ |
94,672 |
|
|
$ |
82,907 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Non-GAAP gross profit |
$ |
95,818 |
|
|
$ |
84,930 |
|
GAAP gross margin(2) |
|
49 |
% |
|
|
49 |
% |
Non-GAAP gross margin(3) |
|
50 |
% |
|
|
50 |
% |
|
|
|
|
||||
GAAP operating loss |
$ |
(41,678 |
) |
|
$ |
(127,817 |
) |
Acquired in-process research and development(4) |
|
— |
|
|
|
78,750 |
|
Severance costs - cash and noncash |
|
— |
|
|
|
2,680 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Non-GAAP operating loss |
$ |
(40,532 |
) |
|
$ |
(44,364 |
) |
GAAP operating margin(2) |
|
(22 |
)% |
|
|
(75 |
)% |
Non-GAAP operating margin(3) |
|
(21 |
)% |
|
|
(26 |
)% |
|
|
|
|
||||
GAAP net loss |
$ |
(42,715 |
) |
|
$ |
(123,873 |
) |
Income tax expense (benefit) |
|
3,186 |
|
|
|
287 |
|
Interest income, interest expense and other, net |
|
(2,149 |
) |
|
|
(4,231 |
) |
Depreciation and amortization |
|
4,043 |
|
|
|
3,396 |
|
Stock-based compensation expense |
|
22,039 |
|
|
|
20,805 |
|
Acquired in-process research and development(4) |
|
— |
|
|
|
78,750 |
|
Severance costs - cash and noncash |
|
— |
|
|
|
2,680 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Adjusted EBITDA |
$ |
(14,450 |
) |
|
$ |
(20,163 |
) |
Adjusted EBITDA margin(3) |
|
(7 |
)% |
|
|
(12 |
)% |
|
|
|
|
||||
GAAP net loss |
$ |
(42,715 |
) |
|
$ |
(123,873 |
) |
Acquired in-process research and development(4) |
|
— |
|
|
|
78,750 |
|
Severance costs - cash and noncash |
|
— |
|
|
|
2,680 |
|
Adjustment for |
|
1,146 |
|
|
|
2,023 |
|
Non-GAAP net loss |
$ |
(41,569 |
) |
|
$ |
(40,420 |
) |
(1) The accounting treatment for |
(2) GAAP margins including GAAP gross margin and GAAP operating margin are calculated using GAAP sales. |
(3) Non-GAAP margins including non-GAAP gross margin, non-GAAP operating margin, and adjusted EBITDA margin are calculated using non-GAAP sales. |
(4) Acquired in-process research and development charges representing the value of acquired in-process research and development assets with no alternative future use and acquisition related expenses recorded in connection with the acquisitions of |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240502565186/en/
Media Contact:
858-366-6900
media@tandemdiabetes.com
Investor Contact:
858-366-6900
IR@tandemdiabetes.com
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