Tandem Diabetes Care Announces Third Quarter 2024 Financial Results and Increases Full Year 2024 Sales Guidance
Third Quarter 2024 Highlights
-
Worldwide GAAP sales increased 31 percent to
$244.0 million compared to third quarter 2023; worldwide non-GAAP sales(1) increased 25 percent to$242.9 million compared to third quarter 2023. - Grew worldwide pump shipments by more than 25 percent compared to third quarter 2023.
-
Achieved year-over-year growth in new pump starts in
the United States , including growth in new customers starting from multiple daily injections. - Demonstrated positive Adjusted EBITDA and a return to positive free cash flow.
- Completed clinical study in support of a regulatory filing to expand the indication for Control-IQ to include people living with type 2 diabetes.
“The third quarter marked a milestone achievement for
Third Quarter 2024 Sales Results Compared to 2023
From
|
Three Months Ended |
|
|
Nine Months Ended |
||||||||||||||||||||||||||||||
|
|
|
|
|
||||||||||||||||||||||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
||||||||||||||||||||||||
($ in millions) |
GAAP |
|
Non- GAAP(1) |
|
|
GAAP |
|
Non- GAAP(1) |
|
|
GAAP |
|
Non- GAAP(1) |
|
|
GAAP |
|
Non- GAAP(1) |
||||||||||||||||
|
$ |
171.7 |
|
$ |
170.6 |
|
|
$ |
130.2 |
|
$ |
138.5 |
|
|
$ |
458.1 |
|
$ |
458.0 |
|
|
$ |
404.0 |
|
$ |
416.5 |
||||||||
Outside |
|
72.3 |
|
|
|
72.3 |
|
|
|
|
55.4 |
|
|
|
55.4 |
|
|
|
|
199.5 |
|
|
|
199.5 |
|
|
|
|
146.9 |
|
|
|
146.9 |
|
Total Worldwide |
$ |
244.0 |
|
|
$ |
242.9 |
|
|
|
$ |
185.6 |
|
|
$ |
193.9 |
|
|
|
$ |
657.6 |
|
|
$ |
657.5 |
|
|
|
$ |
550.9 |
|
|
$ |
563.4 |
|
Third Quarter 2024 Additional Results Compared to Third Quarter 2023
-
Sales: In
the United States , GAAP sales included$1.0 million incremental sales relating toTandem Choice compared to a sales deferral of$8.2 million . Non-GAAP sales excludeTandem Choice -related sales deferrals or recognition.
Shipments inthe United States were approximately 21,000 pumps, which does not include pumps fulfilled underTandem Choice . Shipments outsidethe United States were nearly 11,000 pumps.
-
Gross profit: GAAP gross profit was
$124.7 million , compared to$89.8 million . GAAP gross margin was 51 percent compared to 48 percent.
Non-GAAP gross profit(1) was$124.3 million compared to$98.0 million . Non-GAAP gross margin(1) was 51 percent in both periods.
-
Operating loss: GAAP operating loss was
$26.1 million , or negative 11 percent of sales, compared to$31.5 million , or negative 17 percent of sales.
Non-GAAP operating loss(1) was$26.5 million , or negative 11 percent of sales, compared to$23.3 million , or negative 12 percent of sales.
-
Net loss: GAAP net loss was
$23.3 million , compared to$33.0 million .
Non-GAAP net loss(1) was$23.6 million compared to$24.7 million .
Adjusted EBITDA(1) was$4.0 million , or 2 percent of sales, compared to$1.5 million , or 1 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 D “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
$903 million to$910 million for the full year.-
Sales in
the United States of$645 million to$650 million . -
Sales outside
the United States of approximately$258 million to$260 million .
-
Sales in
- Non-GAAP gross margin is estimated to be approximately 51 percent.
- Adjusted EBITDA margin is estimated to be breakeven as a percent of sales.
-
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 D “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 for
Tandem Choice was automatic at the time of a t:slim X2 purchase. Customer eligibility ended inFebruary 2024 with the commercial availability of Tandem Mobi. -
Qualifying customers were able to elect participation in
Tandem Choice starting at the end of the second quarter of 2024. -
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 are expected to be recognized in the fourth quarter of 2024. The balance of the Tandem Choice deferral was$30.1 million as ofSeptember 30, 2024 . -
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. 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
|
|||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||
Table A |
|||||||
(in thousands) |
|||||||
|
|
|
|
||||
|
|
|
|
||||
|
|
2024 |
|
|
|
2023 |
|
Assets |
(Unaudited) |
|
|
||||
Current assets: |
|
|
|
||||
Cash, cash equivalents and short-term investments |
$ |
473,305 |
|
$ |
467,912 |
||
Accounts receivable, net |
|
107,188 |
|
|
|
105,555 |
|
Inventories |
|
152,441 |
|
|
|
157,937 |
|
Other current assets |
|
19,892 |
|
|
|
16,585 |
|
Total current assets |
|
752,826 |
|
|
|
747,989 |
|
|
|
|
|
||||
Property and equipment, net |
|
81,064 |
|
|
|
76,542 |
|
Operating lease right-of-use assets |
|
87,393 |
|
|
|
87,791 |
|
Other long-term assets |
|
36,447 |
|
|
|
40,336 |
|
Total assets |
$ |
957,730 |
|
|
$ |
952,658 |
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable, accrued expenses and employee-related liabilities |
$ |
119,752 |
|
|
$ |
105,742 |
|
Current portion of convertible senior notes, net |
|
40,605 |
|
|
|
— |
|
Operating lease liabilities |
|
18,033 |
|
|
|
17,060 |
|
Deferred revenue |
|
42,567 |
|
|
|
43,994 |
|
Other current liabilities |
|
38,319 |
|
|
|
28,462 |
|
Total current liabilities |
|
259,276 |
|
|
|
195,258 |
|
|
|
|
|
||||
Convertible senior notes, net - long-term |
|
307,829 |
|
|
|
285,035 |
|
Operating lease liabilities - long-term |
|
109,479 |
|
|
|
113,572 |
|
Deferred revenue - long-term |
|
11,196 |
|
|
|
13,331 |
|
Other long-term liabilities |
|
32,240 |
|
|
|
31,830 |
|
Total liabilities |
|
720,020 |
|
|
|
639,026 |
|
|
|
|
|
||||
Total stockholders’ equity |
|
237,710 |
|
|
|
313,632 |
|
Total liabilities and stockholders’ equity |
$ |
957,730 |
|
|
$ |
952,658 |
|
|
|||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||||
Table B |
|||||||||||||||
(in thousands, except per share data) |
|||||||||||||||
(Unaudited) |
|||||||||||||||
|
|
|
|
|
|
||||||||||
|
Three Months Ended |
|
Nine months ended |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Sales |
$ |
243,971 |
|
|
$ |
185,622 |
|
|
$ |
657,555 |
|
|
$ |
550,922 |
|
Cost of sales |
|
119,318 |
|
|
|
95,869 |
|
|
|
325,436 |
|
|
|
276,527 |
|
Gross profit |
|
124,653 |
|
|
|
89,753 |
|
|
|
332,119 |
|
|
|
274,395 |
|
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Selling, general and administrative |
|
99,639 |
|
|
|
79,328 |
|
|
|
283,987 |
|
|
|
266,752 |
|
Research and development |
|
51,107 |
|
|
|
41,970 |
|
|
|
146,677 |
|
|
|
127,063 |
|
Acquired in-process research and development expenses |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
78,750 |
|
Total operating expenses |
|
150,746 |
|
|
|
121,298 |
|
|
|
430,664 |
|
|
|
472,565 |
|
Operating loss |
|
(26,093 |
) |
|
|
(31,545 |
) |
|
|
(98,545 |
) |
|
|
(198,170 |
) |
Total other income (expense), net |
|
3,479 |
|
|
|
816 |
|
|
|
6,659 |
|
|
|
9,226 |
|
Loss before income taxes |
|
(22,614 |
) |
|
|
(30,729 |
) |
|
|
(91,886 |
) |
|
|
(188,944 |
) |
Income tax expense |
|
637 |
|
|
|
2,232 |
|
|
|
4,894 |
|
|
|
3,665 |
|
Net loss |
$ |
(23,251 |
) |
|
$ |
(32,961 |
) |
|
$ |
(96,780 |
) |
|
$ |
(192,609 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per share - basic and diluted |
$ |
(0.35 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.48 |
) |
|
$ |
(2.97 |
) |
|
|
|
|
|
|
|
|
||||||||
Weighted average shares used to compute basic and diluted net loss per share |
|
65,538 |
|
|
|
65,117 |
|
|
|
65,287 |
|
|
|
64,834 |
|
|
|||||||||||||||||||||
SALES BY GEOGRAPHY |
|||||||||||||||||||||
Table C(1) |
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
(Unaudited) |
|
|
|
|
|
|
|
|
||||||||||||
($'s in thousands) |
Three Months Ended |
|
|
|
Nine months ended |
|
|
||||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
% Change |
|
|
2024 |
|
|
|
2023 |
|
|
% Change |
||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Pump |
$ |
86,722 |
|
$ |
66,365 |
|
31 |
% |
|
$ |
230,187 |
|
$ |
207,180 |
|
11 |
% |
||||
Supplies and other |
|
83,889 |
|
|
|
72,093 |
|
|
16 |
% |
|
|
227,888 |
|
|
|
209,352 |
|
|
9 |
% |
Net revenue recognized (deferred) for |
|
1,039 |
|
|
|
(8,236 |
) |
|
113 |
% |
|
|
47 |
|
|
|
(12,568 |
) |
|
100 |
% |
Total GAAP Sales in |
$ |
171,650 |
|
|
$ |
130,222 |
|
|
32 |
% |
|
$ |
458,122 |
|
|
$ |
403,964 |
|
|
13 |
% |
Adjustment for |
|
(1,039 |
) |
|
|
8,236 |
|
|
(113 |
)% |
|
|
(47 |
) |
|
|
12,568 |
|
|
(100 |
)% |
Total Non-GAAP Sales in |
$ |
170,611 |
|
|
$ |
138,458 |
|
|
23 |
% |
|
$ |
458,075 |
|
|
$ |
416,532 |
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Outside |
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Pump |
$ |
28,077 |
|
|
$ |
21,672 |
|
|
30 |
% |
|
$ |
79,774 |
|
|
$ |
67,235 |
|
|
19 |
% |
Supplies and other |
|
44,244 |
|
|
|
33,728 |
|
|
31 |
% |
|
|
119,659 |
|
|
|
79,723 |
|
|
50 |
% |
Total Sales Outside the United States |
$ |
72,321 |
|
|
$ |
55,400 |
|
|
31 |
% |
|
$ |
199,433 |
|
|
$ |
146,958 |
|
|
36 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Total GAAP Worldwide Sales |
$ |
243,971 |
|
|
$ |
185,622 |
|
|
31 |
% |
|
$ |
657,555 |
|
|
$ |
550,922 |
|
|
19 |
% |
Adjustment for |
|
(1,039 |
) |
|
|
8,236 |
|
|
(113 |
)% |
|
|
(47 |
) |
|
|
12,568 |
|
|
(100 |
)% |
Total Non-GAAP Worldwide Sales |
$ |
242,932 |
|
|
$ |
193,858 |
|
|
25 |
% |
|
$ |
657,508 |
|
|
$ |
563,490 |
|
|
17 |
% |
(1) A reconciliation of non-GAAP financial measures to their closest GAAP equivalent and additional information can be found in Table D and under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results.”
|
|||||||||||||||
Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) |
|||||||||||||||
Table D |
|||||||||||||||
|
|
|
|
|
|
|
|
||||||||
($'s in thousands) |
Three Months Ended |
|
Nine months ended |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
GAAP sales |
$ |
243,971 |
|
|
$ |
185,622 |
|
|
$ |
657,555 |
|
|
$ |
550,922 |
|
Adjustment for |
|
(1,039 |
) |
|
|
8,236 |
|
|
|
(47 |
) |
|
|
12,568 |
|
Non-GAAP sales |
$ |
242,932 |
|
|
$ |
193,858 |
|
|
$ |
657,508 |
|
|
$ |
563,490 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP gross profit |
$ |
124,653 |
|
|
$ |
89,753 |
|
|
$ |
332,119 |
|
|
$ |
274,395 |
|
Adjustment for |
|
(374 |
) |
|
|
8,236 |
|
|
|
645 |
|
|
|
12,568 |
|
Non-GAAP gross profit |
$ |
124,279 |
|
|
$ |
97,989 |
|
|
$ |
332,764 |
|
|
$ |
286,963 |
|
GAAP gross margin(2) |
|
51 |
% |
|
|
48 |
% |
|
|
51 |
% |
|
|
50 |
% |
Non-GAAP gross margin(3) |
|
51 |
% |
|
|
51 |
% |
|
|
51 |
% |
|
|
51 |
% |
|
|
|
|
|
|
|
|
||||||||
GAAP operating loss |
$ |
(26,093 |
) |
|
$ |
(31,545 |
) |
|
$ |
(98,545 |
) |
|
$ |
(198,170 |
) |
Acquired in-process research and development(4) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
78,750 |
|
Non-recurring facility consolidation costs(5) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14,099 |
|
Severance costs - cash and noncash |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,680 |
|
Adjustment for |
|
(374 |
) |
|
|
8,236 |
|
|
|
645 |
|
|
|
12,568 |
|
Non-GAAP operating loss |
$ |
(26,467 |
) |
|
$ |
(23,309 |
) |
|
$ |
(97,900 |
) |
|
$ |
(90,073 |
) |
GAAP operating margin(2) |
|
(11 |
)% |
|
|
(17 |
)% |
|
|
(15 |
)% |
|
|
(36 |
)% |
Non-GAAP operating margin(3) |
|
(11 |
)% |
|
|
(12 |
)% |
|
|
(15 |
)% |
|
|
(16 |
)% |
|
|
|
|
|
|
|
|
||||||||
GAAP net loss |
$ |
(23,251 |
) |
|
$ |
(32,961 |
) |
|
$ |
(96,780 |
) |
|
$ |
(192,609 |
) |
Income tax expense (benefit) |
|
637 |
|
|
|
2,232 |
|
|
|
4,894 |
|
|
|
3,665 |
|
Interest income, interest expense and other, net |
|
(3,479 |
) |
|
|
(816 |
) |
|
|
(6,659 |
) |
|
|
(9,226 |
) |
Depreciation and amortization |
|
4,211 |
|
|
|
4,023 |
|
|
|
12,362 |
|
|
|
11,684 |
|
Stock-based compensation expense |
|
26,281 |
|
|
|
20,741 |
|
|
|
73,217 |
|
|
|
64,946 |
|
Acquired in-process research and development(4) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
78,750 |
|
Non-recurring facility consolidation costs(5) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14,099 |
|
Severance costs - cash and noncash |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,680 |
|
Adjustment for |
|
(374 |
) |
|
|
8,236 |
|
|
|
645 |
|
|
|
12,568 |
|
Adjusted EBITDA |
$ |
4,025 |
|
|
$ |
1,455 |
|
|
$ |
(12,321 |
) |
|
$ |
(13,443 |
) |
Adjusted EBITDA margin(3) |
|
2 |
% |
|
|
1 |
% |
|
|
(2 |
)% |
|
|
(2 |
)% |
|
|
|
|
|
|
|
|
||||||||
GAAP net loss |
$ |
(23,251 |
) |
|
$ |
(32,961 |
) |
|
$ |
(96,780 |
) |
|
$ |
(192,609 |
) |
Acquired in-process research and development(4) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
78,750 |
|
Non-recurring facility consolidation costs(5) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14,099 |
|
Severance costs - cash and noncash |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,680 |
|
Adjustment for |
|
(374 |
) |
|
|
8,236 |
|
|
|
645 |
|
|
|
12,568 |
|
Non-GAAP net loss |
$ |
(23,625 |
) |
|
$ |
(24,725 |
) |
|
$ |
(96,135 |
) |
|
$ |
(84,512 |
) |
(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
(5) The Company recorded
View source version on businesswire.com: https://www.businesswire.com/news/home/20241106987558/en/
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