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 4, 2022
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(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 4, 2022, we issued a press release reporting our financial results for the quarter ended March 31, 2022. 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). | |||||||
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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 | ||||||||
| Senior Vice President & General Counsel | ||||||||
Date: May 4, 2022
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Exhibit 99.1
Media Contact:
Steve Sabicer
714-907-6264
ssabicer@thesabicergroup.com
Investor Contact:
Susan Morrison
858-366-6900
IR@tandemdiabetes.com
FOR IMMEDIATE RELEASE
Tandem Diabetes Care Announces First Quarter 2022 Financial Results
and Updated Full Year 2022 Financial Guidance
San Diego, May 4, 2022 - Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading global insulin delivery and diabetes technology company, today reported its financial results for the quarter ended March 31, 2022 and updated its financial guidance for the year ending December 31, 2022.
First Quarter Financial Highlights:
•First quarter 2022 sales increased 25 percent to $175.9 million compared to the same period of 2021.
•Worldwide pump shipments increased 11 percent to 28,095 pumps compared to the same period of 2021.
•$635.4 million in cash, cash equivalents & short-term investments as of March 31, 2022, increased $11.6 million in the first quarter of 2022.
Recent Strategic Highlights:
•Received U.S. Food and Drug Administration (FDA) clearance for the t:slim X2 insulin pump to bolus using the t:connect mobile app on iOS and Android operating systems.
•Completed expansion of U.S. field sales force, providing greater resources to drive awareness of the Company’s technology solutions among people living with diabetes and healthcare providers.
•Launched Control-IQ® advanced hybrid closed-loop technology in remaining international geographies bringing its features and benefits to all countries the Company serves worldwide.
•Presented positive Control-IQ technology data that showed immediate and sustained improvements in glycemic control, quality of life outcomes, and user-reported reduced burden of diabetes management(1) at the 15th International Conference on Advanced Technologies and Treatments for Diabetes.
•Completed enrollment for the Control-IQ Observational (CLIO) study, an ongoing real-world study of more than 2,000 people living with type 1 diabetes using Control-IQ.
•Successfully executed the largest pivotal human factors study in the Company’s history for the Mobi insulin pump, which will be included in a regulatory filing to the FDA.
“Our first quarter performance demonstrated the strength with which we are executing across all areas of our business,” said John Sheridan, president and chief executive officer. “We continue to make meaningful progress in our mission to bring the benefits of advanced diabetes technology to more people living with diabetes, which is reflected in our growing market share that is now an estimated 30 percent of people using an insulin pump in the markets we serve worldwide.”
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Exhibit 99.1
First Quarter 2022 Financial Results Compared to First Quarter 2021
•Sales: Worldwide sales increased 25 percent to $175.9 million, which included sales outside the United States of $44.6 million. This is compared to worldwide sales of $141.0 million, which included sales of $37.7 million outside the United States.
•Gross profit: Gross profit increased 24 percent to $91.1 million, compared to $73.3 million. Gross margin was 52 percent, which was the same as the first quarter of 2021.
•Operating loss: Operating loss totaled $15.3 million, or negative 9 percent of sales, compared to $3.2 million, or negative 2 percent of sales. Adjusted EBITDA(2) was $6.4 million, compared to $13.2 million, or 4 percent and 9 percent of sales, respectively.
•Net loss: Net loss was $14.7 million, compared to $5.0 million.
See tables for additional financial information.
2022 Annual Guidance Update
For the year ending December 31, 2022, the Company is updating its financial guidance as follows:
•Sales are estimated to be in the range of $850 million to $865 million, which represents an annual sales growth of 21 percent to 23 percent compared to 2021. The Company’s prior sales guidance for 2022 was estimated to be in the range of $845 million to $860 million.
▪Sales inside the United States of approximately $635 million to $645 million, an increase from the prior guidance of $630 million to $640 million
▪Sales outside the United States of approximately $215 million to $220 million
•Gross margin is estimated to be approximately 54 percent
•Adjusted EBITDA(2) is estimated to be in the range of 14 percent to 15 percent of sales
•Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $95 million, an increase from the Company’s prior guidance. This includes:
▪Approximately $80 million non-cash, stock-based compensation expense, compared to the prior guidance of $75 million
▪Approximately $15 million depreciation and amortization expense
(1) Singh H, Alencar G, Manning M, et al. Long-Term Improvements In Patient-Reported Outcomes Irrespective of Baseline Glycemic Control and Previous Insulin Delivery Method with the t:Slim X2 Pump with Control-IQ Technology. Poster presented at 15th Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); April 27-30, 2022; Barcelona, Spain.
(2) See "Non-GAAP Financial Measures" below. EBITDA is a non-GAAP financial measure defined as net income (loss) excluding income taxes, interest and other non-operating items and depreciation and amortization. Adjusted EBITDA further adjusts for the change in fair value of common stock warrants and non-cash stock-based compensation expense. This definition of Adjusted EBITDA may differ from similar measures used by other companies, even when similar terms are used to identify such measures. Adjusted EBITDA is a key measure used by the Company to evaluate operating performance, generate future operating plans and make strategic decisions for the allocation of capital. The Company presents Adjusted EBITDA to provide information that may assist investors in understanding its financial results. However, Adjusted EBITDA is not intended to be a substitute for net income (loss).
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Exhibit 99.1
Non-GAAP Financial Measures
Certain non-GAAP financial measures are presented in this press release, including adjusted EBITDA, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. We believe these non-GAAP financial measures are important indicators of our operating performance because they exclude items that are unrelated to, and may not be indicative of, our core operating results. These non-GAAP financial measures, as we calculate them, 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 we utilize such non-GAAP financial measures in the future, we expect to calculate them 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 SEC regulations, we have 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 we may make to our GAAP financial measures in calculating our 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 listen to the conference call via phone, please dial 855-427-4396 (U.S./Canada) or 484-756-4261 (International) and use the participant code “2354706.”
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based 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.
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Exhibit 99.1
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 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.
# # #
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Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| Table A | |||||||||||
| (in thousands) | |||||||||||
| March 31 | December 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| Assets | (Unaudited) | ||||||||||
| Current assets: | |||||||||||
| Cash, cash equivalents and short-term investments | $ | 635,391 | $ | 623,811 | |||||||
| Accounts receivable, net | 94,133 | 110,725 | |||||||||
| Inventories | 79,987 | 68,551 | |||||||||
| Other current assets | 8,953 | 8,433 | |||||||||
| Total current assets | 818,464 | 811,520 | |||||||||
| Property and equipment, net | 49,987 | 50,386 | |||||||||
| Operating lease right-of-use assets | 131,058 | 27,503 | |||||||||
| Other long-term assets | 15,768 | 15,728 | |||||||||
| Total assets | $ | 1,015,277 | $ | 905,137 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable, accrued expenses and employee-related liabilities | $ | 89,961 | $ | 89,007 | |||||||
| Operating lease liabilities | 8,080 | 9,279 | |||||||||
| Deferred revenue | 10,881 | 10,182 | |||||||||
| Other current liabilities | 22,893 | 23,388 | |||||||||
| Total current liabilities | 131,815 | 131,856 | |||||||||
| Convertible senior notes, net - long-term | 281,905 | 281,467 | |||||||||
| Operating lease liabilities - long-term | 129,195 | 23,922 | |||||||||
| Deferred revenue - long-term | 17,531 | 16,940 | |||||||||
| Other long-term liabilities | 17,449 | 17,840 | |||||||||
| Total liabilities | 577,895 | 472,025 | |||||||||
| Total stockholders’ equity | 437,382 | 433,112 | |||||||||
| Total liabilities and stockholders’ equity | $ | 1,015,277 | $ | 905,137 | |||||||
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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, | |||||||||||
| 2022 | 2021 | ||||||||||
| Sales | $ | 175,907 | $ | 141,037 | |||||||
| Cost of sales | 84,814 | 67,750 | |||||||||
| Gross profit | 91,093 | 73,287 | |||||||||
| Operating expenses: | |||||||||||
| Selling, general and administrative | 73,271 | 58,563 | |||||||||
| Research and development | 33,160 | 17,961 | |||||||||
| Total operating expenses | 106,431 | 76,524 | |||||||||
| Operating loss | (15,338) | (3,237) | |||||||||
| Total other expense, net | (1,101) | (1,924) | |||||||||
| Loss before income taxes | (16,439) | (5,161) | |||||||||
| Income tax benefit | 1,724 | 117 | |||||||||
| Net loss | $ | (14,715) | $ | (5,044) | |||||||
| Net loss per share, basic and diluted | $ | (0.23) | $ | (0.08) | |||||||
| Weighted average shares used to compute basic and diluted net loss per share | 63,880 | 62,448 | |||||||||
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Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||||||||
| SALES BY GEOGRAPHY | |||||||||||||||||
| Table C | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
| ($'s in thousands) | Three Months Ended March 31, | ||||||||||||||||
| 2022 | 2021 | % Change | |||||||||||||||
| United States: | |||||||||||||||||
| Pump | $ | 73,497 | $ | 62,912 | 17% | ||||||||||||
| Infusion sets | 39,741 | 27,392 | 45% | ||||||||||||||
| Cartridges | 17,677 | 12,765 | 38% | ||||||||||||||
| Other | 368 | 270 | 36% | ||||||||||||||
| Total Sales in the United States | $ | 131,283 | $ | 103,339 | 27% | ||||||||||||
| Outside the United States: | |||||||||||||||||
| Pump | $ | 22,332 | $ | 18,908 | 18% | ||||||||||||
| Infusion sets | 14,999 | 12,734 | 18% | ||||||||||||||
| Cartridges | 7,177 | 5,949 | 21% | ||||||||||||||
| Other | 116 | 107 | 8% | ||||||||||||||
| Total Sales Outside the United States | $ | 44,624 | $ | 37,698 | 18% | ||||||||||||
| Total Worldwide Sales | $ | 175,907 | $ | 141,037 | 25% | ||||||||||||
| TANDEM DIABETES CARE, INC. | |||||||||||||||||
| PUMP SHIPMENTS | |||||||||||||||||
| Table D | |||||||||||||||||
| Three Months Ended March 31, | |||||||||||||||||
| 2022 | 2021 | % Change | |||||||||||||||
| Pumps Shipped: | |||||||||||||||||
| United States | 18,658 | 16,644 | 12% | ||||||||||||||
| Outside the United States | 9,437 | 8,708 | 8% | ||||||||||||||
| Total Pumps Shipped | 28,095 | 25,352 | 11% | ||||||||||||||
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Exhibit 99.1
| TANDEM DIABETES CARE, INC. | |||||||||||
| Reconciliation of GAAP versus Non-GAAP Financial Results (Unaudited) | |||||||||||
| Table E | |||||||||||
| (in thousands) | Three Months Ended March 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| GAAP net loss | $ | (14,715) | $ | (5,044) | |||||||
| Income tax benefit | (1,724) | (117) | |||||||||
| Interest income and other, net | (381) | (272) | |||||||||
| Interest expense | 1,516 | 1,506 | |||||||||
| Depreciation and amortization | 3,628 | 3,485 | |||||||||
| EBITDA | (11,676) | (442) | |||||||||
| Change in fair value of common stock warrants | (34) | 690 | |||||||||
| Stock-based compensation expense | 18,110 | 12,947 | |||||||||
Adjusted EBITDA(2) | $ | 6,400 | $ | 13,195 | |||||||
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