Latest News by Industry
SAN DIEGO--(BUSINESS WIRE)--Feb 22, 2023--
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter and year ended December 31, 2022 and provided its financial guidance for the year ending December 31, 2023.
2022 Financial Highlights
In comparing the year ended December 31, 2022 to the same period of 2021:
Recent Strategic Highlights
“In 2022, we continued to expand the worldwide insulin pump market, bringing the benefits of our t:slim X2 technology to more people living with diabetes,” said John Sheridan, president and chief executive officer. “In the year ahead, we are focused on driving growth by promoting our best-in-class Control-IQ technology, with future acceleration to come from delivering multiple new product innovations.”
Fourth Quarter and Year End 2022 Sales Results Compared to 2021
In September 2022, the Company began offering the Tandem Choice Program (Tandem Choice) to eligible t:slim X2 customers to provide a pathway to ownership of its newest hardware platform when available. As a result of this program, and as previously announced, the Company is now providing select financial results on both a GAAP and non-GAAP basis. Additional information, including the accounting treatment of this program, can be found under the heading “Reconciliation of GAAP versus Non-GAAP Financial Results” in this press release.
| Three Months Ended |
|
| Twelve Months Ended | ||||||||||||||||
| December 31, |
|
| December 31, | ||||||||||||||||
$ in millions | 2022 |
| 2022 |
| 2021 |
|
| 2022 |
| 2022 |
| 2021 | ||||||||
| GAAP |
| Non-GAAP |
|
| GAAP |
|
| GAAP |
| Non-GAAP |
|
| GAAP | ||||||
Pump Shipments |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
United States |
| 23,684 |
|
| N/A |
|
|
| 25,712 |
|
|
| 83,554 |
|
| N/A |
|
|
| 83,317 |
Outside United States |
| 11,939 |
|
| N/A |
|
|
| 11,873 |
|
|
| 44,785 |
|
| N/A |
|
|
| 44,995 |
Total Worldwide |
| 35,623 |
|
| N/A |
|
|
| 37,585 |
|
|
| 128,339 |
|
| N/A |
|
|
| 128,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
United States | $ | 165.8 |
| $ | 168.7 |
|
| $ | 160.9 |
|
| $ | 588.8 |
| $ | 592.3 |
|
| $ | 524.9 |
Outside United States |
| 54.7 |
|
| 54.7 |
|
|
| 49.1 |
|
|
| 212.4 |
|
| 212.4 |
|
|
| 177.9 |
Total Worldwide | $ | 220.5 |
| $ | 223.4 |
|
| $ | 210.0 |
|
| $ | 801.2 |
| $ | 804.7 |
|
| $ | 702.8 |
Fourth Quarter 2022 Additional Financial Results Compared to Fourth Quarter 2021
The fourth quarter 2022 non-GAAP (1) additional financial results exclude the $3.0 million impact associated with the Tandem Choice program, as well as $12.4 million for certain facility consolidation costs and $28.1 million non-cash depreciation and stock-based compensation charges.
Full Year 2022 Additional Financial Results Compared to Full Year 2021
The full year 2022 non-GAAP (1) additional financial results exclude the $3.5 million impact associated with the Tandem Choice program, as well as $12.4 million for certain facility consolidation costs, $31.0 million for certain Capillary Biomedical, Inc. acquisition costs and $99.2 million non-cash depreciation and stock-based compensation charges.
See tables for additional financial information.
2023 Financial Guidance
For the year ending December 31, 2023, the Company is providing financial guidance as follows:
(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.”
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 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 in Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release.
In particular, the accounting treatment for Tandem Choice has a high degree of complexity. In September 2022 when the program was launched, the Company began deferring a portion of sales for each eligible t:slim X2 pump shipped in the United States. Such deferrals will be recognized on a customer-by-customer basis following the commercial launch of the Company’s new hardware platform. The timing of recognition will be based on either a) an affirmative election to participate in Tandem Choice or b) expiration of the right to participate. Notably:
Consistent with SEC regulations, 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.
Conference Call
The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To access the call by phone, please use this link ( https://register.vevent.com/register/BI676b1bca7fca4eeaa60be7e9c39f206b ) and you will be provided with dial-in details, including a personal pin.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company headquartered in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The Company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com.
Tandem Diabetes Care is a registered trademark and t:slim X2 and Control-IQ are trademarks of Tandem Diabetes Care, Inc.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2 and $TNDM.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.
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 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 Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Tandem undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.
TANDEM DIABETES CARE, INC. | |||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||
Table A | |||||
(in thousands) | |||||
|
|
|
| ||
| December 31, |
| December 31, | ||
| 2022 |
| 2021 | ||
Assets |
|
|
| ||
Current assets: |
|
|
| ||
Cash, cash equivalents and short-term investments | $ | 616,901 |
| $ | 623,811 |
Accounts receivable, net |
| 114,717 |
|
| 110,725 |
Inventories |
| 111,117 |
|
| 68,551 |
Other current assets |
| 7,241 |
|
| 8,433 |
Total current assets |
| 849,976 |
|
| 811,520 |
|
|
|
| ||
Property and equipment, net |
| 68,552 |
|
| 50,386 |
Operating lease right-of-use assets |
| 110,626 |
|
| 27,503 |
Other long-term assets |
| 23,631 |
|
| 15,728 |
Total assets | $ | 1,052,785 |
| $ | 905,137 |
|
|
|
| ||
Liabilities and Stockholders’ Equity |
|
|
| ||
Current liabilities: |
|
|
| ||
Accounts payable, accrued expenses and employee-related liabilities | $ | 104,007 |
| $ | 89,007 |
Operating lease liabilities |
| 13,121 |
|
| 9,279 |
Deferred revenue |
| 18,837 |
|
| 10,182 |
Other current liabilities |
| 29,325 |
|
| 23,388 |
Total current liabilities |
| 165,290 |
|
| 131,856 |
|
|
|
| ||
Convertible senior notes, net - long-term |
| 283,232 |
|
| 281,467 |
Operating lease liabilities - long-term |
| 123,524 |
|
| 23,922 |
Deferred revenue - long-term |
| 16,874 |
|
| 16,940 |
Other long-term liabilities |
| 23,918 |
|
| 17,840 |
Total liabilities |
| 612,838 |
|
| 472,025 |
|
|
|
| ||
Total stockholders’ equity |
| 439,947 |
|
| 433,112 |
Total liabilities and stockholders’ equity | $ | 1,052,785 |
| $ | 905,137 |
TANDEM DIABETES CARE, INC. | |||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Table B | |||||||||||||||
(in thousands, except per share data) | |||||||||||||||
| |||||||||||||||
| (Unaudited) |
| Year Ended December 31, | ||||||||||||
| 2022 |
|
| 2021 |
| 2022 |
| 2021 | |||||||
Sales | $ | 220,502 |
|
| $ | 209,996 |
|
| $ | 801,217 |
|
| $ | 702,799 |
|
Cost of sales |
| 104,979 |
|
|
| 96,267 |
|
|
| 388,231 |
|
|
| 326,584 |
|
Gross profit |
| 115,523 |
|
|
| 113,729 |
|
|
| 412,986 |
|
|
| 376,215 |
|
|
|
|
|
|
|
|
| ||||||||
Operating expenses: |
|
|
|
|
|
|
| ||||||||
Selling, general and administrative |
| 97,692 |
|
|
| 71,498 |
|
|
| 335,681 |
|
|
| 261,508 |
|
Research and development |
| 35,585 |
|
|
| 29,493 |
|
|
| 139,114 |
|
|
| 92,054 |
|
Acquired in-process research and development expenses |
| 23 |
|
|
| — |
|
|
| 31,039 |
|
|
| — |
|
Total operating expenses |
| 133,300 |
|
|
| 100,991 |
|
|
| 505,834 |
|
|
| 353,562 |
|
Operating income (loss) |
| (17,777 | ) |
|
| 12,738 |
|
|
| (92,848 | ) |
|
| 22,653 |
|
Total other income (expense), net |
| 1,664 |
|
|
| (1,593 | ) |
|
| (4 | ) |
|
| (6,752 | ) |
Income (loss) before income taxes |
| (16,113 | ) |
|
| 11,145 |
|
|
| (92,852 | ) |
|
| 15,901 |
|
Income tax expense (benefit) |
| (261 | ) |
|
| 337 |
|
|
| 1,742 |
|
|
| 335 |
|
Net income (loss) | $ | (15,852 | ) |
| $ | 10,808 |
|
| $ | (94,594 | ) |
| $ | 15,566 |
|
|
|
|
|
|
|
|
| ||||||||
Net income (loss) per share - basic | $ | (0.25 | ) |
| $ | 0.17 |
|
| $ | (1.47 | ) |
| $ | 0.25 |
|
Net income (loss) per share - diluted | $ | (0.25 | ) |
| $ | 0.16 |
|
| $ | (1.47 | ) |
| $ | 0.24 |
|
|
|
|
|
|
|
|
| ||||||||
Weighted average shares used to compute basic net income (loss) per share |
| 64,384 |
|
|
| 63,650 |
|
|
| 64,146 |
|
|
| 63,000 |
|
Weighted average shares used to compute diluted net income (loss) per share |
| 64,384 |
|
|
| 65,927 |
|
|
| 64,146 |
|
|
| 64,349 |
|
TANDEM DIABETES CARE, INC. | |||||||||||||||||||
SALES BY GEOGRAPHY | |||||||||||||||||||
Table C (1) | |||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
| (Unaudited) |
|
|
|
|
|
| ||||||||||||
($'s in thousands) | Three Months Ended December 31, |
| Twelve Months Ended December 31, | ||||||||||||||||
|
| 2022 |
|
| 2021 |
| % Change |
|
| 2022 |
|
| 2021 |
| % Change | ||||
United States: |
|
|
|
|
|
|
|
|
|
|
| ||||||||
Pump | $ | 92,614 |
|
| $ | 98,174 |
| (6 | )% |
| $ | 329,061 |
|
| $ | 319,898 |
| 3 | % |
Infusion sets |
| 53,088 |
|
|
| 43,136 |
| 23 | % |
|
| 181,578 |
|
|
| 140,387 |
| 29 | % |
Cartridges |
| 22,685 |
|
|
| 19,239 |
| 18 | % |
|
| 80,187 |
|
|
| 63,375 |
| 27 | % |
Other |
| 344 |
|
|
| 333 |
| 3 | % |
|
| 1,488 |
|
|
| 1,247 |
| 19 | % |
Deferral for Tandem Choice |
| (2,950 | ) |
|
| — |
| — | % |
|
| (3,549 | ) |
|
| — |
| — | % |
Total GAAP Sales in the United States | $ | 165,781 |
|
| $ | 160,882 |
| 3 | % |
| $ | 588,765 |
|
| $ | 524,907 |
| 12 | % |
Adjustment for Tandem Choice |
| 2,950 |
|
|
| — |
| — | % |
|
| 3,549 |
|
|
| — |
| — | % |
Total Non-GAAP Sales in the United States | $ | 168,731 |
|
| $ | 160,882 |
| 5 | % |
| $ | 592,314 |
|
| $ | 524,907 |
| 13 | % |
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
Outside the United States: |
|
|
|
|
|
|
|
|
|
|
| ||||||||
Pump | $ | 27,347 |
|
| $ | 26,158 |
| 5 | % |
| $ | 102,846 |
|
| $ | 96,458 |
| 7 | % |
Infusion sets |
| 19,654 |
|
|
| 15,989 |
| 23 | % |
|
| 76,912 |
|
|
| 57,063 |
| 35 | % |
Cartridges |
| 7,434 |
|
|
| 6,631 |
| 12 | % |
|
| 31,973 |
|
|
| 23,509 |
| 36 | % |
Other |
| 286 |
|
|
| 336 |
| (15 | )% |
|
| 721 |
|
|
| 862 |
| (16 | )% |
Total Sales Outside the United States | $ | 54,721 |
|
| $ | 49,114 |
| 11 | % |
| $ | 212,452 |
|
| $ | 177,892 |
| 19 | % |
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
Total GAAP Worldwide Sales | $ | 220,502 |
|
| $ | 209,996 |
| 5 | % |
| $ | 801,217 |
|
| $ | 702,799 |
| 14 | % |
Adjustment for Tandem Choice |
| 2,950 |
|
|
| — |
| — | % |
|
| 3,549 |
|
|
| — |
| — | % |
Total Non-GAAP Worldwide Sales | $ | 223,452 |
|
| $ | 209,996 |
| 6 | % |
| $ | 804,766 |
|
| $ | 702,799 |
| 15 | % |
(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.” | |||||||||||||||||||
TANDEM DIABETES CARE, INC. | |||||||||||||
PUMP SHIPMENTS | |||||||||||||
Table D | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|
| ||
| Three Months Ended December 31, |
| Twelve Months Ended December 31, | ||||||||||
| 2022 |
| 2021 |
| % Change |
| 2022 |
| 2021 |
| % Change | ||
Pumps Shipped: |
|
|
|
|
|
|
|
|
|
|
| ||
United States | 23,684 |
| 25,712 |
| (8 | )% |
| 83,554 |
| 83,317 |
| — | % |
Outside the United States | 11,939 |
| 11,873 |
| 1 | % |
| 44,785 |
| 44,995 |
| — | % |
Total Pumps Shipped | 35,623 |
| 37,585 |
| (5 | )% |
| 128,339 |
| 128,312 |
| — | % |
TANDEM DIABETES CARE, INC. | |||||||||||||||
Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) | |||||||||||||||
Table E | |||||||||||||||
|
|
|
|
|
|
|
| ||||||||
($'s in thousands) | Three Months Ended December 31, |
| Twelve Months Ended December 31, | ||||||||||||
|
| 2022 |
|
|
| 2021 |
|
|
| 2022 |
|
|
| 2021 |
|
GAAP sales | $ | 220,502 | $ | 209,996 | $ | 801,217 | $ | 702,799 | |||||||
Adjustments for Tandem Choice (1) |
| 2,950 |
|
|
| — |
|
|
| 3,549 |
|
|
| — |
|
Non-GAAP sales | $ | 223,452 |
|
| $ | 209,996 |
|
| $ | 804,766 |
|
| $ | 702,799 |
|
|
|
|
|
|
|
|
| ||||||||
GAAP gross profit | $ | 115,522 |
|
| $ | 113,729 |
|
| $ | 412,986 |
|
| $ | 376,215 |
|
Adjustments for Tandem Choice (1) |
| 2,950 |
|
|
| — |
|
|
| 3,549 |
|
|
| — |
|
Non-GAAP gross profit | $ | 118,472 |
|
| $ | 113,729 |
|
| $ | 416,535 |
|
| $ | 376,215 |
|
Non-GAAP gross margin (4) |
| 53 | % |
|
| 54 | % |
|
| 52 | % |
|
| 54 | % |
|
|
|
|
|
|
|
| ||||||||
GAAP operating income (loss) | $ | (17,778 | ) |
| $ | 12,738 |
|
| $ | (92,848 | ) |
| $ | 22,653 |
|
Acquired in-process research and development (2) |
| 23 |
|
|
| — |
|
|
| 31,039 |
|
|
| — |
|
Non-recurring facility consolidation costs (3) |
| 12,420 |
|
|
| — |
|
|
| 12,420 |
|
|
| — |
|
Adjustments for Tandem Choice (1) |
| 2,950 |
|
|
| — |
|
|
| 3,549 |
|
|
| — |
|
Non-GAAP operating income (loss) | $ | (2,385 | ) |
| $ | 12,738 |
|
| $ | (45,840 | ) |
| $ | 22,653 |
|
Non-GAAP operating margin (4) |
| (1 | )% |
|
| 6 | % |
|
| (6 | )% |
|
| 3 | % |
|
|
|
|
|
|
|
| ||||||||
GAAP net income (loss) | $ | (15,853 | ) |
| $ | 10,808 |
|
| $ | (94,594 | ) |
| $ | 15,566 |
|
Income tax expense (benefit) |
| (261 | ) |
|
| 337 |
|
|
| 1,742 |
|
|
| 335 |
|
Interest income and other, net |
| (3,199 | ) |
|
| 47 |
|
|
| (6,057 | ) |
|
| (674 | ) |
Interest expense |
| 1,579 |
|
|
| 1,514 |
|
|
| 6,208 |
|
|
| 6,040 |
|
Depreciation and amortization |
| 3,641 |
|
|
| 3,520 |
|
|
| 14,330 |
|
|
| 13,845 |
|
EBITDA | $ | (14,093 | ) |
| $ | 16,226 |
|
| $ | (78,371 | ) |
| $ | 35,112 |
|
Change in fair value of common stock warrants |
| (44 | ) |
|
| 32 |
|
|
| (147 | ) |
|
| 1,386 |
|
Stock-based compensation expense |
| 24,441 |
|
|
| 17,099 |
|
|
| 84,918 |
|
|
| 60,752 |
|
Acquired in-process research and development (2) |
| 23 |
|
|
| — |
|
|
| 31,039 |
|
|
| — |
|
Non-recurring facility consolidation costs (3) |
| 12,420 |
|
|
| — |
|
|
| 12,420 |
|
|
| — |
|
Adjustments for Tandem Choice (1) |
| 2,950 |
|
|
| — |
|
|
| 3,549 |
|
|
| — |
|
Adjusted EBITDA | $ | 25,697 |
|
| $ | 33,357 |
|
| $ | 53,408 |
|
| $ | 97,250 |
|
Adjusted EBITDA Margin (4) |
| 12 | % |
|
| 16 | % |
|
| 7 | % |
|
| 14 | % |
|
|
|
|
|
|
|
| ||||||||
GAAP net income (loss) | $ | (15,853 | ) |
| $ | 10,808 |
|
| $ | (94,594 | ) |
| $ | 15,566 |
|
Acquired in-process research and development (2) |
| 23 |
|
|
| — |
|
|
| 31,039 |
|
|
| — |
|
Non-recurring facility consolidation costs (3) |
| 12,420 |
|
|
| — |
|
|
| 12,420 |
|
|
| — |
|
Adjustments for Tandem Choice (1) |
| 2,950 |
|
|
| — |
|
|
| 3,549 |
|
|
| — |
|
Non-GAAP net income (loss) | $ | (460 | ) |
| $ | 10,808 |
|
| $ | (47,586 | ) |
| $ | 15,566 |
|
(1) The accounting treatment for Tandem Choice has a high degree of complexity. Additional information can be found under the heading “Non-GAAP Financial Measures.” | |||||||||||||||
(2) The Company recorded a $31.0 million charge representing the value of acquired in-process research and development assets with no alternative future use, and acquisition related expenses. | |||||||||||||||
(3) The Company recorded $12.4 million of facility consolidation costs primarily related to our office space in Boise, Idaho. | |||||||||||||||
(4) 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/20230222005784/en/
CONTACT: Media Contact:
858-255-6388
media@tandemdiabetes.comInvestor Contact:
858-366-6900
IR@tandemdiabetes.com
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: DIABETES HEALTH MEDICAL DEVICES
SOURCE: Tandem Diabetes Care, Inc.
Copyright Business Wire 2023.
PUB: 02/22/2023 04:05 PM/DISC: 02/22/2023 04:05 PM
http://www.businesswire.com/news/home/20230222005784/en