Tandem Diabetes Care(TNDM)

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Tandem Diabetes Care(TNDM) - 2024 Q1 - Quarterly Report
2024-05-02 20:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________________________________________ FORM 10-Q _____________________________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Trans ...
Tandem Diabetes Care(TNDM) - 2024 Q1 - Quarterly Results
2024-05-02 20:07
Media Contact: 858-366-6900 media@tandemdiabetes.com Investor Contact: 858-366-6900 IR@tandemdiabetes.com Exhibit 99.1 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 Decembe ...
Tandem Diabetes Care(TNDM) - 2023 Q4 - Earnings Call Transcript
2024-02-22 03:47
Financial Data and Key Metrics Changes - U.S. sales in Q4 were $163 million, with full-year sales reaching $580 million, driven by supply and installed base growth, with about half of the annual sales coming from supplies [51] - Worldwide sales exceeded expectations at $209 million in Q4, bringing full-year sales to $773 million [70] - Gross margin for 2023 was 51%, down from 52% in 2022, impacted by unfavorable product mix and a rebate pricing adjustment in France [72] Business Line Data and Key Metrics Changes - Total renewal shipments year-over-year grew by more than 50%, indicating strong customer satisfaction and retention [5] - Supply sales grew 35% year-over-year in Q4, reflecting variability in ordering patterns from the previous year [63] - The company anticipates U.S. sales in Q1 2024 to be approximately $122 million, with a significant portion expected from renewals [74] Market Data and Key Metrics Changes - The installed base in the U.S. reached over 310,000 people, an increase of 7% compared to the end of 2022 [51] - Full-year sales outside the U.S. were $193 million, affected by an $8 million rebate reduction in Q4 and a $20 million headwind in the first half of the year [52] - The company is focused on expanding its international market presence, with many markets still less than 20% penetrated [3] Company Strategy and Development Direction - The company is advancing its multichannel managed care strategy and anticipates signing contracts in 2024 to serve Mobi customers through the pharmacy channel [8] - The launch of new products, including Mobi and its integration with DexCom G7, is expected to drive growth and improve market share [60][67] - The company aims to achieve a long-term gross margin target of 65%, with Mobi expected to be a significant contributor [9][87] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth opportunities in 2024, projecting worldwide non-GAAP sales of approximately $850 million, reflecting a 10% growth [53] - The competitive landscape is becoming increasingly challenging, particularly outside the U.S., but the company believes its new product offerings will help capture market share [79] - Management noted that the first quarter of 2024 may see a more pronounced decline in pump shipments due to the timing of Mobi's launch [65] Other Important Information - The company funded several key initiatives in 2023, including $69 million for acquisitions and $27 million for capital expenditures [7] - The company is working on future product enhancements, including a tubeless option for Mobi and a rechargeable patch pump [29][49] Q&A Session Summary Question: What are the expectations for Mobi sales compared to t:slim? - Management indicated that Mobi is expected to accelerate sales as it becomes more widely available, with positive early feedback from users [20][92] Question: How does the company view the competitive landscape? - Management acknowledged increased competition but emphasized the unique advantages of their product offerings and the potential for Mobi to regain market share from multiple daily injections [78][92] Question: What is the outlook for Type 2 diabetes products? - The company is actively engaged in clinical studies for Type 2 diabetes products, with expectations for market entry around 2025 [82]
Tandem Diabetes Care(TNDM) - 2023 Q4 - Annual Report
2024-02-21 21:33
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _________________________________________________________________ FORM 10-K _________________________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-36189 ______ ...
Tandem Diabetes Care(TNDM) - 2023 Q4 - Annual Results
2024-02-21 21:09
Financial Performance - Q4 2023 GAAP sales in the U.S. were $163.5 million, while total worldwide sales were $209.4 million, reflecting a decrease from $220.5 million in Q4 2022[7] - Total sales for Q4 2023 were $196.8 million, a decrease of 11% compared to $220.5 million in Q4 2022[21] - Non-GAAP sales for Q4 2023 were $209.3 million, down 6% from $223.5 million in Q4 2022[27] - For the full year 2023, GAAP net loss was $222.6 million, compared to a net loss of $94.6 million in 2022[8] - Net loss for Q4 2023 was $30.0 million, or $0.46 per share, compared to a net loss of $15.9 million, or $0.25 per share, in Q4 2022[21] - Adjusted EBITDA for Q4 2023 was $4.3 million, or 2% of sales, down from $25.7 million, or 11% of sales in Q4 2022[7] Gross Profit and Margins - GAAP gross profit for Q4 2023 was $93.3 million, resulting in a gross margin of 47%, down from 52% in Q4 2022[7] - Gross profit for Q4 2023 was $93.3 million, down from $115.5 million in Q4 2022, resulting in a gross margin of 47%[21] - Non-GAAP gross margin is estimated to be approximately 51% for the full year 2024 and 48% for Q1 2024[10] Shipments and Installed Base - The worldwide installed base increased by 7% to approximately 452,000 in-warranty customers compared to Q4 2022[4] - In Q4 2023, total worldwide pump shipments were 27,000, down from 36,000 in Q4 2022, with U.S. shipments at 21,000 and international shipments at 6,000[6] - Pump shipments in the U.S. decreased by 13% to 21,000 units in Q4 2023 from 24,000 units in Q4 2022[25] Research and Development - Research and development expenses increased to $42.6 million in Q4 2023 from $35.6 million in Q4 2022[21] New Products and Sales Deferral - The company launched four new products in the U.S. in 2023, including the Tandem Mobi and Tandem Source platforms[4] - The Tandem Choice program resulted in a GAAP sales deferral of $12.5 million in Q4 2023, compared to $3.0 million in Q4 2022[7] Assets and Liabilities - Total assets decreased to $952.7 million in Q4 2023 from $1,052.8 million in Q4 2022[19] - Total liabilities increased to $639.0 million in Q4 2023 from $612.8 million in Q4 2022[19] Future Projections - The company expects non-GAAP sales of approximately $850 million for the full year 2024, with $175 million projected for Q1 2024[10]
Tandem Diabetes Care(TNDM) - 2023 Q3 - Earnings Call Transcript
2023-11-02 02:22
Financial Data and Key Metrics Changes - Third quarter sales reached $194 million worldwide, exceeding baseline expectations, primarily driven by U.S. sales of $138 million from 17,000 pump shipments [9][28] - Supply sales grew by 10%, aligning with the installed base of nearly 445,000 customers [9][27] - Gross margin remained stable at 51%, consistent with the prior year, despite pressures from high-cost raw materials [29][13] - Adjusted EBITDA is expected to be at least breakeven for the year, with operating expenses flat compared to the previous year at $121 million [13][152] Business Line Data and Key Metrics Changes - The installed base in the U.S. reached 308,000 people, with renewals growing sequentially to nearly half of the pumps shipped in the quarter [27][28] - International sales in the third quarter were $55 million, with 8,000 pumps shipped, reflecting typical commercial dynamics during the European summer holiday season [28][11] - The proportion of pumps worldwide represented 45% of sales in Q3 2023, down from 53% in the prior year [12] Market Data and Key Metrics Changes - The company anticipates worldwide sales expectations for the full year 2023 to be $765 million, including $190 million from outside the U.S. [13][28] - The company is experiencing strong double-digit growth rates in several international markets, despite some disruptions [84][105] Company Strategy and Development Direction - The company is focused on expanding pump penetration and addressing unmet customer needs through innovation, including the launch of the t:slim X2 integration with DexCom's G7 sensor and Abbott's FreeStyle Libre 2 sensor [5][15] - The company is in late-stage discussions with the FDA regarding enhancements to the Control-IQ algorithm, aiming to lower age indications and expand feature sets [16][15] - The company is preparing for the broader launch of Mobi in the U.S. in early 2024, with significant interest from healthcare providers and users [6][7] Management's Comments on Operating Environment and Future Outlook - Management noted that 2023 has been a year of transition, with a focus on scaling operations for future growth [9][138] - The management expressed confidence in meeting the adjusted EBITDA guidance due to expected sales increases and cost containment efforts [66][67] - There is a high level of enthusiasm for new product launches, with customers waiting for Mobi and G7, which may impact near-term sales [142][141] Other Important Information - The company is analyzing the potential financial impact of newly enacted reimbursement changes in France, which may affect revenue generation [151][125] - The company ended the quarter with approximately $500 million in total cash and investments, providing financial flexibility for strategic investments [30][13] Q&A Session Summary Question: Can you discuss the pattern of U.S. pump shipments and the impact of the Tandem Choice program? - Management indicated that new customers are expected to defer purchases until 2024, while renewals remain strong, contributing to overall stability [19][37] Question: What gives confidence in hitting the breakeven goal for adjusted EBITDA? - Confidence stems from expected sales increases in Q4 and continued cost containment efforts [66][67] Question: How should we think about the renewal versus new pumpers in Q4? - Renewals are expected to grow, with a 20% increase in warranty expirations compared to Q3, which may encourage new purchases [68][150] Question: Can you clarify the impact of the G7 launch on guidance? - The G7 launch is anticipated to contribute positively, but there may be some initial disruptions as distributors adjust to new product offerings [62][40] Question: What is the expected timeline for Mobi and G7 launches? - Mobi is expected to be a first-quarter product for revenue, while G7 is anticipated to have full availability by the end of the current quarter [60][41]
Tandem Diabetes Care(TNDM) - 2023 Q3 - Quarterly Report
2023-11-01 20:08
Financial Performance - Total sales for the three months ended September 30, 2023, were $185.622 million, a decrease of 9.3% compared to $204.547 million in the same period of 2022[10]. - Gross profit for the nine months ended September 30, 2023, was $274.395 million, down from $297.464 million in the same period of 2022, reflecting a decrease of 7.7%[10]. - Operating loss for the three months ended September 30, 2023, was $31.545 million, an improvement from a loss of $47.493 million in the same period of 2022[10]. - Net loss for the nine months ended September 30, 2023, was $192.609 million, compared to a net loss of $78.741 million in the same period of 2022, indicating a significant increase in losses[10]. - The company reported a comprehensive loss of $192.998 million for the nine months ended September 30, 2023, compared to a comprehensive loss of $83.189 million in the same period of 2022[10]. - Net loss for the nine months ended September 30, 2023, was $192.6 million, compared to a net loss of $78.7 million for the same period in 2022, representing an increase of 144%[19]. - Net loss for Q3 2023 was $32.961 million, compared to a net loss of $48.970 million in Q3 2022, representing a 32.6% reduction[10]. - Comprehensive loss for Q3 2023 was $33.974 million, down from $49.752 million in Q3 2022[10]. - The company reported a net loss per share of $0.51 for Q3 2023, an improvement from $0.76 in Q3 2022[10]. Cash and Assets - Cash and cash equivalents decreased to $79.611 million as of September 30, 2023, from $172.517 million as of December 31, 2022[9]. - Total assets decreased to $939.909 million as of September 30, 2023, down from $1.052 billion as of December 31, 2022[9]. - Total stockholders' equity decreased to $314.000 million as of September 30, 2023, from $439.947 million as of December 31, 2022[9]. - Total current assets decreased to $758.1 million as of September 30, 2023, from $850.0 million as of December 31, 2022[9]. - The Company’s total stockholders' equity at September 30, 2023, was $421.8 million, down from $433.1 million at December 31, 2021, reflecting a decrease of 2.9%[16]. - Cash and cash equivalents at the end of the period decreased to $79.6 million in 2023 from $123.8 million in 2022, a decline of 36%[19]. - Total financial assets measured at fair value as of September 30, 2023, amounted to $482.4 million, a decrease from $595.1 million as of December 31, 2022, representing a decline of approximately 19%[53]. - Cash equivalents decreased from $150.7 million in December 2022 to $63.8 million in September 2023, a reduction of about 58.6%[53]. Expenses and Liabilities - Research and development expenses for the nine months ended September 30, 2023, increased to $127.063 million, compared to $103.529 million in the same period of 2022, reflecting a growth of 22.7%[10]. - Stock-based compensation expense increased to $65.3 million in 2023 from $60.5 million in 2022, reflecting a rise of approximately 8%[19]. - The company incurred an operating lease impairment charge of $14.1 million in 2023, which was not present in 2022[19]. - Total liabilities increased to $625.9 million as of September 30, 2023, from $612.8 million as of December 31, 2022[9]. - The Company recognized total interest expense of $8.079 million for the nine months ended September 30, 2023, compared to $4.629 million for the same period in 2022, reflecting an increase of 74.5%[77]. - The Company has accrued approximately $3.1 million in additional interest on the Notes since May 2021, with overdue unpaid interest accruing at a rate of 2.50% per annum[76]. Revenue and Sales - The Company’s revenue recognition is primarily from sales of insulin pumps and related disposable products, with revenue recognized upon transfer of control to customers[35]. - Total revenue for the three months ended September 30, 2023, was $185.6 million, a decrease of 9.2% compared to $204.5 million for the same period in 2022[97]. - Revenue from the United States for the three months ended September 30, 2023, was $130.2 million, down from $146.0 million in 2022, representing a decline of 10.0%[97]. - Revenue from outside the United States for the three months ended September 30, 2023, was $55.4 million, a decrease of 5.5% from $58.5 million in the same period of 2022[97]. - The Company completed the acquisition of AMF Medical on January 19, 2023, for a total consideration of CHF 62.4 million, plus contingent earnout payments of up to CHF 129.6 million[100]. - The Company recorded a $78.8 million charge for acquired in-process research and development assets related to the AMF Medical acquisition[101]. - The acquisition of Capillary Biomedical was completed for total cash consideration of $24.7 million, with an assumption of $4.7 million in long-term debt[102]. Inventory and Receivables - Accounts receivable, net as of September 30, 2023, was $100.318 million, down from $114.717 million at December 31, 2022[49]. - Total inventories as of September 30, 2023, amounted to $143.492 million, significantly higher than $111.117 million at December 31, 2022[51]. - The allowance for credit losses increased to $5.355 million as of September 30, 2023, compared to $4.327 million at December 31, 2022[50]. - The total provision for expected credit losses for the nine months ended September 30, 2023, was $4,066,000, compared to $2,955,000 in the same period of 2022, reflecting an increase of approximately 37.6%[50]. Legal and Compliance - The Company is involved in various legal proceedings, including a putative securities class action complaint filed on September 8, 2023, alleging violations of the Securities Exchange Act[105]. - The Company believes it is not currently a party to any legal proceedings or regulatory matters for which a material loss was considered probable as of September 30, 2023[106]. Stock and Equity - The Company granted 208,082 restricted stock units (RSUs) during the three months ended September 30, 2023, with a weighted average grant date fair value of $29.19 per share[88]. - The Company has reserved 11,617 thousand shares of common stock for future issuance as of September 30, 2023[83]. - The Capped Call Transactions were recorded at a net cost of $34.1 million, intended to reduce potential dilution beyond a conversion price of $112.57[78].
Tandem Diabetes Care(TNDM) - 2023 Q2 - Earnings Call Transcript
2023-08-04 02:16
Financial Data and Key Metrics Changes - The company achieved $198 million in worldwide sales for Q2 2023, with over 29,000 pump shipments, reflecting operational execution despite market pressures [57] - U.S. sales were $145 million in Q2, with pump shipments increasing by 12% sequentially to 19,000 compared to Q1 [26] - Gross margin improved to 52% in Q2, up nearly 2 percentage points year-over-year, driven by a favorable product mix [60] - Adjusted EBITDA returned to profitability at 3% of sales in Q2, with operating expenses improved by $3 million from Q1 [61] Business Line Data and Key Metrics Changes - The installed base of warranty customers in the U.S. reached approximately 305,000, driving a 10% growth in supply sales year-over-year [27] - International sales generated $53 million in Q2, with 11,000 pumps shipped, growing the installed base by over 20% year-over-year to nearly 135,000 [27] - Renewal shipments increased each quarter, with over 60% of 2022 expirations already renewed, reflecting high customer satisfaction [58] Market Data and Key Metrics Changes - The company noted a high level of activity in diabetes devices, with increased competition expected as new products launch both in the U.S. and internationally [49] - The anticipated increase in competition may create turbulence in the market, particularly with the launch of new products [8][9] Company Strategy and Development Direction - The company is focused on expanding its product portfolio with the launch of new innovations, including Tandem Mobi and new sensor integrations [45][52] - A strategic reset of 2023 guidance was implemented to account for market dynamics and the timing of new product launches [9][31] - The company aims for a baseline sales growth of 10% in 2024, starting from revised 2023 sales guidance [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve sales targets despite market uncertainties and competitive pressures [66] - The company anticipates that the fourth quarter will represent the strongest quarter for pump shipments in the U.S. due to seasonality [32] - Management highlighted the importance of customer education and marketing efforts as new products are launched [125] Other Important Information - The company is transitioning to a new European distribution center, which will support approximately 70% of international sales going forward [59] - The company plans to introduce promotional pricing for the Tandem Choice program to encourage purchases ahead of new product availability [46] Q&A Session All Questions and Answers Question: What is the expected impact of the upgrade program on guidance? - The guidance was set with a baseline level in mind, without factoring in potential benefits from the upgrade program [38] Question: How does the company view the competitive landscape with new product launches? - The company expects some turbulence from new entrants but believes it can manage through the competition [100] Question: What are the expectations for adjusted EBITDA in 2024? - The company remains confident in achieving long-term goals, but the timing of product uptake will influence future targets [87] Question: How is the company addressing the pausing dynamics in the market? - The company is taking a conservative approach to guidance, factoring in potential pausing as customers await new product availability [92][112] Question: What is the anticipated growth in the U.K. pump market? - The company did not provide specific guidance but indicated that the U.K. market may have similar penetration levels to the U.S. [147]
Tandem Diabetes Care(TNDM) - 2023 Q2 - Quarterly Report
2023-08-03 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Tandem Diabetes Care, Inc. Washington, D.C. 20549 ____________________________________________________________________________________________ FORM 10-Q _____________________________________________________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ...
Tandem Diabetes Care(TNDM) - 2023 Q1 - Earnings Call Transcript
2023-05-04 03:42
Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Q1 2023 Earnings Conference Call May 3, 2023 4:30 PM ET Company Participants Susan Morrison - Executive Vice President and Chief Administrative Officer John Sheridan - President and Chief Executive Officer Brian Hansen - Executive Vice President and Chief Commercial Officer Leigh Vosseller - Executive Vice President and Chief Financial Officer Conference Call Participants Matthew Miksic - Barclays Steven Lichtman - Oppenheimer Christopher Pasquale - Nephron Research ...