UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________
FORM 8-K
____________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 2, 2024
____________________________
(Exact name of registrant as specified in its charter)
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| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
| (Zip Code) | ||||||||||||||
| (Address of principal executive offices) | ||||||||||||||
Registrant’s telephone number, including area code: (858 ) 366-6900
N/A
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Item 2.02 Results of Operations and Financial Condition.
On May 2, 2024, we issued a press release reporting our financial results for the quarter ended March 31, 2024. This press release has been furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.
The information under this Item 2.02 and Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Number | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Tandem Diabetes Care, Inc. | ||||||||
| By: | /s/ SHANNON M. HANSEN | |||||||
| Shannon M. Hansen | ||||||||
| Chief Legal, Privacy & Compliance Officer; Secretary | ||||||||
Date: May 2, 2024
3
Exhibit 99.1
Media Contact:
858-366-6900
media@tandemdiabetes.com
Investor Contact:
858-366-6900
IR@tandemdiabetes.com
FOR IMMEDIATE RELEASE
Tandem Diabetes Care Announces First Quarter 2024 Financial Results
and Updates Full Year 2024 Financial Guidance
San Diego, May 2, 2024 - Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, today reported its financial results for the quarter ended March 31, 2024 and increased sales guidance for the year ending December 31, 2024.
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.
•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 $316.3 million senior convertible notes offering primarily used for the repurchase of existing senior convertible notes.
“Our outperformance in the first quarter was driven by demand for both the t:slim X2 and our newly launched Tandem Mobi, validating our portfolio strategy that allows us to address a greater market by meeting the needs and preferences of more people living with diabetes,” said John Sheridan, president and chief executive officer. “We are well-positioned to deliver on our 2024 objectives, along with longer-term growth and profitability goals.”
1
Exhibit 99.1
First Quarter 2024 Sales Results Compared to 2023
From September 2022 through February 2024, the Company offered the Tandem Choice Program (Tandem Choice) to eligible t:slim X2 customers to provide a pathway to ownership of its newest hardware platform, Tandem Mobi, for a fee when available. As a result of this program, the Company is providing select financial results for both GAAP and non-GAAP. Additional information, including the accounting treatment of this program and other non-GAAP measures, can be found under Table E “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release. See also “Non-GAAP Financial Measures” below.
| Three Months Ended | ||||||||||||||||||||||||||
| March 31, | ||||||||||||||||||||||||||
| 2024 | 2023 | |||||||||||||||||||||||||
Approximate Pump Shipments | ||||||||||||||||||||||||||
| United States | 15,000 | 17,000 | ||||||||||||||||||||||||
| Outside United States | 10,000 | 6,000 | ||||||||||||||||||||||||
| Total Worldwide | 25,000 | 23,000 | ||||||||||||||||||||||||
| ($ in millions) | GAAP | Non-GAAP | GAAP | Non-GAAP | ||||||||||||||||||||||
| Sales | ||||||||||||||||||||||||||
| United States | $ | 129.8 | $ | 130.9 | $ | 131.2 | $ | 133.3 | ||||||||||||||||||
| Outside United States | 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 to Tandem Choice, compared to a deferral of $2.0 million. Non-GAAP sales do not include Tandem 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.
2
Exhibit 99.1
2024 Financial Guidance
The Company’s non-GAAP guidance for the fiscal year ending December 31, 2024 is set forth below. The most directly comparable GAAP financial measures are not accessible on a forward-looking basis due to the high degree of complexity in the accounting treatment for the Tandem Choice program. For a description of non-GAAP sales, non-GAAP gross margin, and Adjusted EBITDA margin, as well as an illustration of the reconciliation from the most directly comparable GAAP financial measures, refer to 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.
For the year ending December 31, 2024, the Company is updating its 2024 financial guidance as follows:
•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.
•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.
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 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. The total Tandem Choice deferral was $31.5 million as of March 31, 2024. If a customer elects to participate in Tandem Choice, the Company will recognize the existing deferral, incremental fees received and the associated costs of providing the new insulin pump at the time of fulfillment. 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 at program expiration.
3
Exhibit 99.1
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 in February 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 is December 31, 2024.
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/BI12c72cd6ea054b01881ba78dd494dcc0) and you will be provided with dial-in details, including a personal pin.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.
Tandem Diabetes Care, the Tandem logo, Control-IQ, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries.
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 the United States for new products; 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, or may otherwise negatively impact the purchasing trends of customers; 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.
# # #
4
Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| Table A | |||||||||||
| (in thousands) | |||||||||||
| March 31, | December 31, | ||||||||||
| 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 | |||||||
5
Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||
| Table B | |||||||||||
| (in thousands, except per share data) | |||||||||||
| (Unaudited) | |||||||||||
Three Months Ended March 31, | |||||||||||
| 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 | |||||||||
6
Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||
| SALES BY GEOGRAPHY | |||||||||||
Table C(1) | |||||||||||
| (Unaudited) | |||||||||||
| ($'s in thousands) | Three Months Ended March 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| United States: | |||||||||||
| Pump | $ | 61,720 | $ | 66,457 | |||||||
| Supplies and other | 69,187 | 66,808 | |||||||||
| Deferral for Tandem Choice | (1,146) | (2,023) | |||||||||
| Total GAAP Sales in the United States | $ | 129,761 | $ | 131,242 | |||||||
| Adjustment for Tandem Choice | 1,146 | 2,023 | |||||||||
| Total Non-GAAP Sales in the United States | $ | 130,907 | $ | 133,265 | |||||||
| Outside the United States: | |||||||||||
| 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 Tandem Choice | 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.”
| TANDEM DIABETES CARE, INC. | |||||||||||
| PUMP SHIPMENTS (Unaudited) | |||||||||||
| Table D | |||||||||||
| Three Months Ended March 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Pumps Shipped: | |||||||||||
| United States | 15,000 | 17,000 | |||||||||
| Outside the United States | 10,000 | 6,000 | |||||||||
| Total Pumps Shipped | 25,000 | 23,000 | |||||||||
7
Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||
| Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) | |||||||||||
| Table E | |||||||||||
| ($'s in thousands) | Three Months Ended March 31, | ||||||||||
| 2024 | 2023 | ||||||||||
| GAAP sales | $ | 191,674 | $ | 169,383 | |||||||
Adjustment for Tandem Choice (1) | 1,146 | 2,023 | |||||||||
| Non-GAAP sales | $ | 192,820 | $ | 171,406 | |||||||
| GAAP gross profit | $ | 94,672 | $ | 82,907 | |||||||
Adjustment for Tandem Choice(1) | 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 Tandem Choice(1) | 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 Tandem Choice(1) | 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 Tandem Choice(1) | 1,146 | 2,023 | |||||||||
| Non-GAAP net loss | $ | (41,569) | $ | (40,420) | |||||||
(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) 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 AMF Medical SA in 2023.
8