TANDEM DIABETES CARE INC – 10-Q – Management's Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis together with our
financial statements and related notes in Part I, Item 1 of this Quarterly
Report on Form 10-Q for the quarter ended
This Quarterly Report contains forward-looking statements within the meaning of the federal securities laws, which statements are subject to considerable risks and uncertainties. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this Quarterly Report, other than statements of historical fact, are forward-looking statements. You can identify forward-looking statements by the use of words such as "may," "will," "could," "anticipate," "expect," "intend," "believe," "continue" or the negative of such terms, or other comparable terminology. Forward-looking statements also include the assumptions underlying or relating to such statements. In particular, forward-looking statements contained in this Quarterly Report may relate to, among other things, our future or assumed financial condition, results of operations, liquidity, trends impacting our financial results, business forecasts and plans, research and product development plans, manufacturing plans, strategic plans and objectives, capital needs and financing plans, product launches, geographic expansion, distribution plans, production capacity, clinical trials, regulatory approvals, competitive position and the impact of changes in the competitive environment, the impact of the COVID-19 global pandemic on our business, supply chain, and the businesses of our contract manufacturers and suppliers, integration of acquisitions and partner technologies, and the application of accounting guidance. We caution you that the foregoing list may not include all of the forward-looking statements made in this Quarterly Report. Our forward-looking statements are based on our management's current assumptions and expectations about future events and trends, which affect or may affect our business, strategy, operations or financial performance. Although we believe that these forward-looking statements are based upon reasonable assumptions, they are subject to numerous known and unknown risks and uncertainties and are made in light of information currently available to us. Our actual financial condition and results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below in the section entitled "Risk Factors" in Part II, Item 1A, and elsewhere in this Quarterly Report, as well as the other public filings we make with theSecurities and Exchange Commission . You should read this Quarterly Report with the understanding that our actual future financial condition and results may be materially different from and worse than what we expect. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for our management to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Forward-looking statements speak only as of the date they were made and, except
to the extent required by law or the rules of the Nasdaq Global Market, we
undertake no obligation to update or review any forward-looking statement
because of new information, future events or other factors.
We qualify all of our forward-looking statements by these cautionary statements.
Overview
We are a medical device company focused on the design, development and commercialization of technology solutions for people living with diabetes. Diabetes management can vary greatly from person-to-person, creating multiple market segments based on clinical needs and personal preferences. Our goal is to lead in insulin therapy management across multiple of these market segments by providing a portfolio of delivery devices, software, and data insight solutions to people living with diabetes, as well as their caregivers and healthcare providers. Since our initial commercial launch, we have rapidly innovated and brought more products to market than our competitors. We have commercially launched seven insulin pump configurations inthe United States since 2012 and three insulin pump configurations outsidethe United States since 2018. Today, our software-updatable t:slim X2 Insulin Delivery System (t:slim X2) hardware platform represents 100% of our new pump shipments. In the four-year period endedSeptember 30, 2022 , we shipped more than 400,000 insulin pumps, which is representative of our estimated global installed customer base, assuming the typical four-year reimbursement cycle. More than 280,000 of these pumps were shipped to customers inthe United States and over 120,000 were shipped in the more than 20 countries in which we operated in the third quarter of 2022 outsidethe United States . 25 -------------------------------------------------------------------------------- Our manufacturing, sales and support activities principally focus on our flagship pump platform, the t:slim X2 and our complementary product offerings. Our simple-to-use t:slim X2 is based on our proprietary technology platform and is the smallest durable insulin pump available inthe United States . We have commercially offered two different automated insulin dosing (AID) algorithms on t:slim X2, including our Control-IQ technology, which is an advanced hybrid-closed loop feature, designed to help increase a user's time in their targeted glycemic range. It was the first system cleared by theU.S. Food and Drug Administration (FDA) to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar based on continuous glucose monitoring (CGM) readings. Our Control-IQ technology launched inthe United States in the first quarter of 2020, and is now available in all of the countries in which we operate. Our Control-IQ technology uses information from Dexcom Inc.'s (Dexcom) G6 sensor, which is the third generation of Dexcom CGM that we have integrated and commercially launched with our pump technology. The t:slim X2 is unique in that it is the only pump on which remote software updates have been made commercially available inthe United States . Now available in the countries we serve worldwide, our Tandem Device Updater (TDU) is a revolutionary tool that allows people to update their t:slim X2 software from a personal computer. InJuly 2022 , we launched a new pump software update though TDU to allow all t:slim X2 pump users inthe United States to bolus insulin using our smartphone app that is available on both iOS and Android device models. Our insulin pump products are generally considered durable medical equipment and have an expected lifespan of at least four years. In addition to insulin pumps, we sell disposable products that are used together with our pumps and are replaced every few days, including cartridges for storing and delivering insulin, and infusion sets that connect the insulin pump to a user's body. Additionally, we sell accessories such as belt clips and cases for use with pumps which are designed to enhance usability. Inthe United States , we also offer t:connect, our data management web application that provides users, their caregivers and their healthcare providers with a fast, easy, and visual way to display diabetes therapy management data from our pumps, integrated CGMs and supported blood glucose meters.
COVID-19 Global Pandemic Impact and Considerations
Our business has been impacted in a variety of ways since the onset of the COVID-19 global pandemic in early 2020, and will likely continue to be impacted for the remainder of 2022. Specific factors that have influenced our financial results and the way in which we operate include fluctuations in shelter-in-place restrictions, supply chain constraints, generalized labor shortages impacting global markets, the timing and extent of vaccine availability and surges in infection and hospitalization rates as new COVID variants have emerged. Most notably, our sales results reflected a high degree of variability across the quarters during this time, unlike historical seasonal trends. Our raw material costs and inventory levels have also fluctuated as we respond to supply chain constraints due to the timing of availability of components from the various suppliers we use to build our products. In addition, we experienced extended regulatory review timelines for new product submissions inthe United States . Throughout this time, we have responded to each of these unique challenges, while prioritizing the health and safety of our employees and customers and working diligently to maintain a continuous supply of products, training and customer support. Overall, we anticipate that our sales and operating results will continue to be impacted and subject to unpredictable variability. The full extent of the impact of the pandemic on our future business and operations is difficult to estimate and will depend on a number of factors including the scope and duration of the COVID-19 global pandemic, and the relative impact of COVID-19 on the business operations of our contract manufacturers, suppliers and competitors and any resulting changes to general economic conditions in the countries in which we operate and sell our products.
Our products under development support our strategy of developing insulin delivery systems as part of a therapy management portfolio that is designed to improve patient experience and outcomes. Our product development efforts fall into three pillars of innovation: delivery devices, device software including algorithms, and data and insights.
Delivery Devices
We are developing a family of delivery device solutions to meet the varying
needs of people living with type 1 and type 2 diabetes by providing choice
within our own portfolio. Preferences in the size, shape, and mode of operation
that comprise an insulin pump's hardware often impact a person's pump purchasing
decision and overall user experience.
26
--------------------------------------------------------------------------------
Mobi
Formerly referred to by its development name, t:sport, Tandem Mobi is approximately half the size of our t:slim X2 pump, and is being designed for people who seek even greater discretion and flexibility with the use of their insulin pump. In addition to being waterproof, Mobi's features include a 200-unit cartridge, an on-pump bolus button, inductive charging, and an AID algorithm. We anticipate that Mobi will be our first insulin pump to support full pump-control from our mobile application.
t:slim X3
Advancing our flagship t:slim platform, the t:slim X3 is being designed to provide a modernized user interface and even greater usability for our planned feature updates. It is also being designed to include enhanced technology, such as greater processing power and capacity to support our advanced algorithms, as well as increased battery life, improved durability, and wireless software update capabilities.
Mobi: Tubeless
This offering is being developed to provide an alternative tubeless infusion site option for Mobi pump users. A goal of this design is to allow people living with diabetes to customize the way they wear their pump with each cartridge change to best suit their personal preferences and lifestyle.
Patch
Our patch pump design is in its early stages and is being developed for people
living with diabetes who want a disposable tubeless solution.
Infusion Sets
Infusion sets provide additional choice and flexibility to people living with diabetes. Our goals for infusion set innovations focus on solutions that extend wear time and enhance user experience, while reducing occlusions, body burden and waste. In support of this effort, inJuly 2022 we acquired infusion set developer,Capillary Biomedical, Inc. (Capillary Biomedical). Capillary Biomedical's unique extended wear infusion set technology is currently in development.
Our device software is used to control our pumps either directly through the pump's interface or through our mobile application. It also includes our AID technology and the software used to support remote pump updatability.
Control-IQ Advancements
We are driving innovation in our algorithms, emphasizing automation, personalization and simplification, all intended to continue to improve therapeutic outcomes and provide a positive patient experience characterized by simplicity and ease of use. Additionally, we have initiated clinical studies to expand the indications of our Control-IQ technology to include people with type 1 diabetes ages 2 to 5 years old, as well as people living with type 2 diabetes. We are also researching the use of different insulins with our Control-IQ technology.
Mobile Control
We are working to expand our mobile control capability. In the future, our
t:connect mobile app is planned to include additional pump control features,
such as full operation of our Mobi pump.
Integration
Building a robust ecosystem and portfolio around our flagship insulin pumps
requires product development efforts to integrate, add, and enhance
complementary system components.
Dexcom CGM: InNovember 2020 , we entered into an agreement with Dexcom to extend our current collaboration to include integration with their future G7 CGM technology. Following integrated product development work, and required regulatory clearances or approvals, this will be the fourth generation of Dexcom CGM that we intend to integrate with our devices. 27 --------------------------------------------------------------------------------Abbott CGM: InJune 2020 , we announced an agreement with Abbott Laboratories (Abbott ), to develop and commercialize integrated diabetes solutions that combineAbbott 's CGM technology with our insulin delivery systems. Following the completion of our integrated product development work, and after obtaining required regulatory clearances or approvals, we intend to focus our initial commercial activities on integrated products in theU.S. andCanada , with additional geographies considered in the future.
Data and Insights
Our goal is to innovate across our digital health platforms by using the vast amount of data that we collect, in combination with technology such as artificial intelligence or machine learning, to provide information and insights to people living with diabetes, their caregivers and healthcare providers and insurance payors. Key areas of development include making these insights easy to understand, provided in a flexible format with mobile or web apps, and available real time. In addition, we are working to integrate health-related information from third-party sources and use our data to support current and future products under development. Tandem Source Expanding the capabilities of our t:connect data management application available for customers inthe United States , Tandem Source is our second-generation web-based data management application that is being designed to be deployed globally. This application enhances clinical data visualization, and provides added interface customization for users to personalize how they engage with their data and for healthcare providers to better manage their care.
Settings Automation
Our automation research and development activities center around opportunities for enhanced user and healthcare provider experience and improved clinical outcomes. In support of this effort, we are working to automate our pump settings adjustments to further enhance ease of use and expand adoption of our insulin pump products. Pump Shipments From inception in 2012 throughJune 2018 , we derived nearly all of our sales from the shipment of insulin pumps and associated supplies to customers inthe United States . Starting in the third quarter of 2018, we began selling our t:slim X2 insulin pump in select geographies outsidethe United States and now offer our technology solutions in more than 20 countries worldwide. We consider the number of insulin pump units shipped to be an important metric for managing our business. Insulin pumps in the markets we serve worldwide are generally subject to a four-year reimbursement cycle, imposed by the third-party insurance carrier, government plan or healthcare system that serves as the primary payor. In the past four years, we have shipped more than 400,000 insulin pumps worldwide, which is representative of our estimated global in-warranty installed customer base. Our estimated worldwide installed base has increased approximately 35% compared to the third quarter of 2021. At the end of the typical four-year reimbursement cycle, customers may be eligible for the purchase of a new insulin pump, subject to the rules and requirements of their primary insurance payor. While warranties generally expire four years from the original pump shipment date, our typical renewal cycle, or time from original pump purchase to a subsequent pump purchase by the same customer, averages five years. The majority of our insulin pump sales through the current period have been generated by new customers, but the opportunity for existing customers to purchase a renewal insulin pump increases each period as additional customer warranties expire. With programs dedicated to customer retention efforts, we expect such renewal purchases to represent a more significant portion of our shipments in the long-term. 28 -------------------------------------------------------------------------------- More than 280,000 pumps were shipped to customers inthe United States in the past four years, which aligns with the standard four-year warranty period. Pump shipments to customers inthe United States by fiscal quarter for the last five years, which aligns more closely with our typical renewal cycle, were as follows:
United States Pump Unit Shipments
for Each of
the Three Months Ended in Respective Years
March 31 June 30 September 30 December 31 Total 2017 2,816 3,427 3,868 6,950 17,061 2018 4,444 5,447 7,379 12,935 30,205 2019 9,669 12,799 13,814 17,453 53,735 2020 13,158 14,735 18,380 24,552 70,825 2021 16,644 20,665 20,296 25,712 83,317 2022 18,658 20,818 20,394 N/A 59,870 Since commencing sales outsidethe United States in the third quarter of 2018, we shipped over 120,000 pumps to customers in more than 20 countries, and are only beginning to complete a full four-year reimbursement cycle in certain of our markets outside ofthe United States . Pump shipments to customers outsidethe United States by fiscal quarter were as follows: Outside the United States Pump Unit Shipments for Each of the Three Months Ended in Respective Years March 31 June 30 September 30 December 31 Total 2018 N/A N/A 1,055 3,233 4,288 2019 5,063 8,459 4,025 2,149 19,696 2020 4,220 3,952 3,641 8,133 19,946 2021 8,708 13,152 11,262 11,873 44,995 2022 9,437 11,296 12,113 N/A 32,846
Trends Impacting Financial Results
Overall, we have experienced considerable sales growth each year since the commercial launch of our first product in the third quarter of 2012, only recognizing an operating profit on a full year basis for the first time in 2021. Our operating results have historically fluctuated on a quarterly or annual basis, particularly in periods surrounding anticipated regulatory approvals, the commercial launch of new products by us and our competitors, the commercial launch of our products in geographies outside ofthe United States and due to general seasonality inthe United States . We expect these periodic fluctuations in our operating results to continue. We believe that our financial condition and operating results, as well as the decision-making process of our current and potential customers, has been and will continue to be impacted by a number of general trends, including the following:
•market acceptance of our products and competitive products by people with
insulin-dependent diabetes, their caregivers and healthcare providers;
•the introduction of new products, treatment techniques or technologies for the
treatment of diabetes, including the timing of the commercialization of new
products by us and our competitors;
•seasonality in
and coinsurance requirements of the medical insurance plans used by our
customers and the customers of our distributors;
•incidence of disease or illness, including the COVID-19 global pandemic, that
may impact customer purchasing patterns or disrupt our supply chain, or create
uncertainty or delay with respect to regulatory approvals;
•global economic and market uncertainty such as recessionary concerns, rising
inflation rates, changes in discretionary spending, increased interest rates,
and other macroeconomic factors;
29
--------------------------------------------------------------------------------
•the timing of holidays and summer vacations, which may vary by geography and
may be further influenced by the lifting or relaxation of COVID-19 related
restrictions and broader availability of vaccines;
•the buying patterns of our distributors and other customers;
•changes in the competitive landscape, including as a result of companies
entering or exiting the diabetes therapy market;
•access to adequate coverage and reimbursement for our current and future
products by third-party payors, and reimbursement decisions by third-party
payors;
•the magnitude and timing of any changes to our facilities, manufacturing
operations and other infrastructure, and factors impacting our ability to access
our facilities;
•the impact of any potential claims, investigations, information requests, or legal, regulatory or administrative proceedings with respect to potential or asserted violations of law, including: sales and marketing practices, anti-corruption and the Foreign Corrupt Practices Act, antitrust, securities, employment, product liability, environmental, data privacy breaches and patent infringement, which may subject us to fines, penalties, expenses, or reputational harm;
•anticipated and actual regulatory approvals of our products and competitive
products; and
•product recalls impacting, or the suspension or withdrawal of regulatory
clearance or approval relating to, our products or the products of our
competitors.
In addition to these general trends, we believe the following specific factors have materially impacted, and could continue to materially impact, our business going forward:
•changes in customer purchasing behavior due to the economic environment such as
inflation or threat of recession;
•anticipated new product launches and the timing of their commercial
availability;
•our recently announced
accounting impact;
•the disruptions caused by the COVID-19 global pandemic on suppliers,
third-party manufacturers, healthcare providers, distributors and our existing
or potential customers;
•continued increase in demand following the commercial launch of t:slim X2 with Control-IQ technology in additional geographies, and the ability to access new pump software using our Tandem Device Updater; •increased opportunity to achieve customer renewals as customers become eligible for insurance reimbursement to purchase a new insulin pump at the end of the typical four-year reimbursement cycle;
•ability to enter into, maintain agreements, and accomplish continued success in
current and future product integrations with CGM partners;
•expansion and new product launches in select geographies outside
States
•ability to effectively scale our operations to support rapid growth, including
expanding our facilities, advancing our research and development efforts,
increasing manufacturing capacity through third-party manufacturers, financial
impact and integration of acquired assets or businesses, and hiring and
retaining employees in customer service and support functions.
In addition to working to achieve our sales growth expectations, in the
long-term we intend to continue to leverage our infrastructure investments to
realize additional manufacturing, sales, marketing and administrative cost
efficiencies with the goal of improving our operating margins and ultimately
achieving sustained profitability. While we have achieved profitability in each
fourth quarter since 2018, we were profitable for the first time on a full-year
basis in 2021. We believe we can ultimately achieve sustained profitability by
driving incremental sales growth in markets worldwide, meeting our pump renewal
sales objectives, maximizing manufacturing efficiencies on increased production
volumes, and leveraging the investments made in our sales, clinical, marketing
and customer support organizations.
30
--------------------------------------------------------------------------------
Components of Results of Operations
Sales
We offer products for people with insulin-dependent diabetes. We commenced commercial sales of our original t:slim insulin pump platform inthe United States in the third quarter of 2012 and continued to launch various iterations of that platform during the following years. InOctober 2016 , we began shipping our flagship pump platform, the t:slim X2 insulin pump. The t:slim X2 insulin pump platform with remote software update capabilities, now represents 100% of our new pump shipments and is used by nearly all of our in-warranty customers. Our products also include disposable insulin cartridges and infusion sets, as well as our complementary t:connect, TDU and mobile application products. We also offer additional accessories including protective cases, belt clips, and power adapters, although sales of these products are not significant. Inthe United States , we primarily sell our products through national and regional distributors on a non-exclusive basis. These distributors are generally providers of medical equipment and supplies to individuals with diabetes. Our primary end customers are people with insulin-dependent diabetes. Similar to other durable medical equipment, the primary payor is generally a third-party insurance carrier and the customer is usually responsible for any medical insurance plan copay or coinsurance requirements. We believe we can continue to increase sales by promoting our products to a greater number of potential customers, caregivers and healthcare providers, although pressures related to the broader economic environment, new competitive product launches and the COVID-19 global pandemic have had, and may continue to have, an adverse impact on our sales. In the third quarter of 2018, we began the launch of our t:slim X2 hardware platform through distribution partners outsidethe United States . Our products are now sold in more than 20 countries, including inCanada ,France andGermany . Today, distributor orders are primarily fulfilled inthe United States . In the first half of 2022, we laid the commercial and operational groundwork, as well as the IT infrastructure, to begin working with a third-party logistics service provider inthe Netherlands to support our distributors inEurope with the intent to scale utilization in the next twelve months. Our independent distributor partners outsidethe United States andCanada perform all sales, customer support and training in their respective markets. InCanada , we market with a direct sales force and, similar tothe United States , use a distributor partner for certain billing and fulfillment activities. Historically, we have experienced consistent levels of reimbursement for our products inthe United States , but we expect the average sales price will vary in markets outsidethe United States based on a number of factors, such as the geographical mix, nature of the reimbursement environment, government regulations and the extent to which we rely on distributor relationships to provide sales, clinical and marketing support. In general, inthe United States we have experienced pump shipments being weighted heavily towards the second half of the year, with the highest percentage of pump shipments expected in the fourth quarter due to the nature of the reimbursement environment. Consistent with these historical seasonality trends, our pump shipments inthe United States have typically decreased significantly from the fourth quarter to the following first quarter. Outsidethe United States , we do not expect this same impact from seasonality associated with reimbursement, although the quarterly sales trends may be impacted by a number of other factors, including summer vacations, the timing of product launches into new geographies and variability in the ordering patterns of our distributor partners. Since early 2020, the COVID-19 global pandemic had a major impact on businesses around the world, as well as our own quarterly trends. Initially, the impact on our business was relatively consistent worldwide but we have since seen varying degrees of impact in individual markets based on local conditions. We anticipate that our sales may not follow historical trends and may continue to be subject to unpredictable variability across the markets in which we operate. The full extent of the impact of the COVID-19 global pandemic on our business and operations will depend on a number of factors, including the scope and duration of the pandemic, varying government responses to the pandemic and potential delays to product development timelines. Separate from any impacts of the COVID-19 global pandemic, our quarterly sales have historically fluctuated, and may continue to fluctuate substantially in the periods surrounding anticipated and actual regulatory approvals and commercial launches of new products by us or our competitors. We believe customers may defer purchasing decisions if they believe a new product may be launched in the future. Additionally, upon the announcement of FDA approval or commercial launch of a new product, either by us or one of our competitors, potential new customers may reconsider their purchasing decisions or take additional time to consider such FDA approval or product launch before making their purchasing decisions. InSeptember 2022 , we launchedTandem Choice , a technology access program that provides in-warranty eligible t:slim X2 customers a path towards ownership of the next generation hardware platform for a fee when available.Tandem Choice expires onDecember 31, 2024 . 31 -------------------------------------------------------------------------------- The accounting treatment forTandem Choice has a high degree of complexity. Initially, the program requires the deferral of some portion of sales for shipments of eligible pumps beginning in the third quarter of 2022. If a customer elects to participate inTandem Choice upon launch of our next generation hardware platform, we will recognize the existing deferral, fees received and the associated costs of providing the new hardware at the time of fulfillment. Any remaining deferrals will be recognized at program expiration. At this time, we are not able to estimate the financial impact for the duration ofTandem Choice . Cost of Sales
Cost of sales includes raw materials, labor costs, manufacturing overhead
expenses, product training costs, royalties, freight, reserves for expected
warranty costs, costs of supporting our digital health platforms, scrap and
charges for excess and obsolete inventories. Manufacturing overhead expenses
include expenses relating to quality assurance, manufacturing engineering,
material procurement, inventory control, facilities, equipment, information
technology and operations supervision and management.
Historically, we have manufactured our pumps and disposable insulin cartridges at our manufacturing facility inSan Diego, California . In early 2020, our third-party cartridge manufacturer completed validation and commenced commercial-scale manufacturing to supplement our existing cartridge manufacturing capacity. By the end of 2021, the majority of our t:slim cartridge manufacturing capacity transitioned to our partner to create capacity for Tandem Mobi cartridge manufacturing in the future. Infusion sets and pump accessories are manufactured by third-party suppliers. Over the long term, we expect our overall gross margin percentage, which for any given period is calculated as sales less cost of sales divided by sales, to improve, as our pump sales increase, as we launch new portfolio products with lower costs to manufacture, improved average selling prices and leverage of our fixed overhead costs. We expect we will be able to achieve this leverage with products that use the same technology platform and manufacturing infrastructure, as well as increased automation, process improvements and raw materials cost reductions. We also expect our warranty cost per unit to decrease as we release additional product features and functionality using the Tandem Device Updater. Pumps have, and are expected to continue to have, a higher gross margin percentage than our pump-related supplies. Therefore, the percentage of pump sales relative to total sales could have a significant impact on our overall gross margin percentage. In the event that customers delay their pump purchasing decisions or physicians pause in prescribing new pumps, it is possible that we may experience a higher percentage of pump-related supply sales than anticipated, which in turn could adversely impact our overall gross margin percentage. However, our overall gross margin percentage may fluctuate in future quarterly periods as a result of numerous factors aside from those associated with production volumes and product mix. For instance, as a result of the COVID-19 global pandemic, we are experiencing higher costs as we manage global supply challenges and anticipate that this will continue for the remainder of 2022 and first half of 2023. In addition, as demand for our products increases, we may continue to make additional investments in manufacturing capacity or increase our reliance on third parties for manufacturing-related services, either of which could have a negative impact on our gross margins. Other factors impacting our overall gross margin percentage may include the changing percentage of products sold to distributors versus directly to individual customers, varying levels of reimbursement among third-party payors in individual markets worldwide, the timing and success of new regulatory approvals and product launches, changes in warranty estimates, training costs, licensing and royalty costs, cost to support our digital health platforms, cost associated with excess and obsolete inventories, and changes in our manufacturing processes, capacity, costs or output.
Selling, General and Administrative
Our selling, general and administrative (SG&A) expenses primarily consist of salary, cash-based incentive compensation, fringe benefits and non-cash stock-based compensation for our sales, marketing and administrative functions, which also includes our clinical, customer support, technical services, insurance verification and regulatory affairs personnel. We had approximately 110 sales territories inthe United States in the third quarter of 2022, up from approximately 95 in 2021. Our existing territories are generally maintained by sales representatives and field clinical specialists, and supported by managed care liaisons, additional sales management and other customer support personnel, which have also been rapidly expanding to support our growing installed base. Our operations inCanada are comprised of approximately ten sales territories. 32 -------------------------------------------------------------------------------- Other significant SG&A expenses typically include those incurred for product demonstration samples, commercialization activities associated with new product launches, travel, trade shows, outside legal fees, independent auditor fees, outside consultant fees, insurance premiums, facilities costs and information technology costs. While we experienced reduced spending in areas such as travel and trade shows in 2021 due to the COVID-19 global pandemic, we may experience additional costs as our employees return to work at our offices and as we adapt to alternative hybrid work models, or as needed to respond to general labor shortages and heightened competition for employees with specialized skills. Overall, we expect our SG&A expenses, including the cost of our customer support infrastructure, to continue to increase as our customer base grows worldwide. In addition, we will continue to evaluate, and may further increase, the number of our field sales and clinical personnel to optimize the coverage of our existing territories. In the longer term, SG&A expenses may also increase due to anticipated costs associated with additional compliance and regulatory reporting requirements. Research and Development Our research and development (R&D) activities primarily consist of engineering and research programs associated with our hardware, software and digital health products under development, as well as activities associated with our core technologies and processes. R&D expenses are primarily related to employee compensation, including salary, cash-based incentive compensation, fringe benefits and non-cash stock-based compensation. We also incur R&D expenses for supplies, development prototypes, outside design and testing services, depreciation, allocated facilities and information services, clinical trial costs, payments under our licensing, development and commercialization agreements and other indirect costs. We expect our R&D expenses to increase as we advance our products under development, develop new products and technologies and support more clinical trials.
Acquired IPR&D reflects costs of external research and development projects
acquired directly in a transaction other than a business combination, that do
not have an alternative future use.
Other Income and Expense
Other income and expense primarily consists of interest expense which includes the amortization of debt issuance costs related to our 1.50% Convertible Senior Notes due 2025, interest earned on our cash equivalents and short-term investments, and changes in the fair value of certain common stock warrants which were issued inOctober 2017 and expire inOctober 2022 . We expect interest income in future quarters to fluctuate depending on the total amount of cash equivalents and short-term investments and market interest rates. We expect interest expense in future quarters to be comparable with the amount expensed in 2021, through the date of conversion or redemption of the Notes.
Income Tax Expense (Benefit)
Because the Company maintains a full valuation allowance against its net
deferred tax assets, income tax expense is expected to primarily consist of
current state and foreign cash tax expense as a result of taxable income
anticipated or incurred in those jurisdictions. Income tax expense (benefit) may
fluctuate in future quarters due to adjustments related to non-recurring
transactions and changes in certain tax assessments.
33 --------------------------------------------------------------------------------
Results of Operations
Three Months Ended
September 30, Nine Months Ended September 30,
(in thousands, except percentages) 2022 2021 2022 2021
Sales:
United States $ 146,035 $ 133,106 $ 422,985 $ 364,025
Outside the United States 58,512 46,521 157,731 128,778
Total sales 204,547 179,627 580,716 492,803
Cost of sales 100,122 82,882 283,252 230,317
Gross profit 104,425 96,745 297,464 262,486
Gross margin 51 % 54 % 51 % 53 %
Operating expenses:
Selling, general and administrative 84,104 64,923 237,989 190,009
Research and development 36,798 24,102 103,529 62,562
Acquired in-process research and development 31,016 - 31,016 -
Total operating expenses 151,918 89,025 372,534 252,571
Operating income (loss) (47,493) 7,720 (75,070) 9,915
Other income (expense), net:
Interest income and other, net 1,708 31 2,858 721
Interest expense (1,576) (1,511) (4,629) (4,526)
Change in fair value of common stock warrants 12 (392) 103 (1,354)
Total other income (expense), net 144 (1,872) (1,668) (5,159)
Income (loss) before income taxes (47,349) 5,848 (76,738) 4,756
Income tax expense (benefit) 1,621 54 2,003 (2)
Net income (loss) $ (48,970) $ 5,794 $ (78,741) $ 4,758
Comparison of the Three Months Ended
Sales. For the three months endedSeptember 30, 2022 , sales were$204.5 million , which included$58.5 million of sales outsidethe United States . For the three months endedSeptember 30, 2022 , we deferred$0.6 million of pump sales as the result of our recently launchedTandem Choice . Sales were$179.6 million for the same period in 2021, which included$46.5 million of sales outsidethe United States . The increase in worldwide sales of$24.9 million in the third quarter of 2022, compared to the third quarter of 2021, was primarily driven by a 25% increase in pump-related supply sales. Sales of pump-related supplies increased primarily due to the 35% growth in our estimated worldwide installed base of customers. Pump sales increased 5% in the third quarter of 2022, net of the deferral associated with the Tandem Choice, which began during the third quarter of 2022.
Sales by product in
Three Months Ended
September 30,
2022 2021
Pump $ 80,696 $ 78,771
Infusion sets 44,839 37,725
Cartridges 20,122 16,289
Other 378 321
Total Sales in
34 -------------------------------------------------------------------------------- Pump sales inthe United States were$80.7 million for the third quarter of 2022, compared to$78.8 million in the third quarter of 2021 as pump shipments increased 1% and pump average selling prices improved compared to the same period in 2021. Pump shipments inthe United States were 20,394 in the third quarter of 2022, compared to 20,296 in the third quarter of 2021. Pump shipments were driven by continued demand for our t:slim X2 insulin pump with Control-IQ technology even with the presence of new competitive product launches during the quarter. We also faced challenging marketplace dynamics and economic conditions brought on by the global pandemic and a deteriorating macroeconomic environment, with inflation and the threat of recession beginning to impact pump purchasing decisions. Sales of pump-related supplies increased primarily due to a 28% increase year over year in our estimated installed base of customers inthe United States . Sales to distributors accounted for 66% and 68% of our total sales inthe United States for the three months endedSeptember 30, 2022 and 2021, respectively, which contributed to modest improvement in average selling prices across all products.
Sales by product outside
Three Months Ended
September 30,
2022 2021
Pump $ 27,385 $ 23,762
Infusion sets 21,964 16,175
Cartridges 8,996 6,269
Other 167 315
Total Sales Outside the United States
Pump sales outsidethe United States were$27.4 million for the third quarter of 2022, compared to$23.8 million in the third quarter of 2021. Pump shipments increased 8% compared to the same period in the prior year due to continued strong demand for our t:slim X2 insulin pump with Control-IQ technology, which is now available in all of the markets we serve. The increase in pump sales was also attributable to an increase in average selling prices. Sales of pump-related supplies benefited from a 57% increase in our estimated installed base of customers outsidethe United States . The ordering patterns of our distributors outsidethe United States for pumps and supplies has been, and may continue to be, highly variable from period to period as distributors continue to gain familiarity with the markets in which they operate and the acceptance of our products in those markets evolves. This variability has been compounded by the differing levels of impact from the global pandemic with regard to access to both physicians and customers, as well as shipping logistics. Sales to distributors accounted for 96% and 96% of our total sales outsidethe United States for the three-month periods endedSeptember 30, 2022 and 2021, respectively. Cost of Sales and Gross Profit. Our cost of sales for the three months endedSeptember 30, 2022 was$100.1 million , resulting in gross profit of$104.4 million , compared to cost of sales of$82.9 million and gross profit of$96.7 million for the same period in 2021. The gross margin for the three months endedSeptember 30, 2022 and 2021 was 51% and 54%, respectively. The increase in our gross profit for the three months endedSeptember 30, 2022 was primarily the result of the$24.9 million increase in total sales, driven by increased supply sales. Gross margin benefits from progress in underlying fundamentals, including an increase in average selling prices and manufacturing efficiencies, as well as leverage of fixed overhead, were more than offset by increased costs associated with global supply chain challenges. More specifically, gross margin was pressured by approximately 2 percentage points from increased pump material costs due to the use of alternative sourcing for certain raw materials to reduce the risk of component shortages in the near-term and higher freight costs consistent with our experience in the second quarter of 2022. We anticipate continued pressure from increased supply chain and material costs through the end of this year into next year as we continue to navigate the challenges of the global pandemic and the challenging economic environment. Other factors that have and may continue to impact the gross margin percentage are changes in product and geographical mix. Pump sales, which have the highest gross margin, were 53% of total worldwide sales in the third quarter of 2022, versus 57% in the third quarter of 2021. 35 -------------------------------------------------------------------------------- Selling, General and Administrative Expenses. SG&A expenses increased 30% to$84.1 million for the three months endedSeptember 30, 2022 , from$64.9 million for the same period in 2021. Employee-related expenses for our SG&A functions comprise the majority of SG&A expenses. The increase compared to 2021 was primarily the result of an$11.8 million increase in salaries, incentive compensation, non-cash stock-based compensation, and other employee benefits due to an increase in personnel to support additional sales territories, higher sales and other services in support of our growing installed customer base. Non-cash stock-based compensation expense allocated to SG&A was$15.1 million for the three months endedSeptember 30, 2022 , compared to$11.3 million in the same period in 2021. We also experienced a$7.4 million increase in facilities and other non-employee discretionary spending, including outside consulting, outside services, travel, and equipment costs. Research and Development Expenses. R&D expenses increased 53% to$36.8 million for the three months endedSeptember 30, 2022 from$24.1 million for the same period in 2021. The increase in R&D expenses was primarily the result of an increase of$8.1 million in salaries, incentive compensation, non-cash stock-based compensation, and other employee benefits due to an increase in personnel to support our product development efforts. Non-cash stock-based compensation expense allocated to R&D was$5.2 million for the three months endedSeptember 30, 2022 , compared to$2.9 million in the same period in 2021. We also experienced a$4.6 million increase in other non-employee discretionary spending, including outside consulting and services, clinical trial expenses, information technology and equipment costs attributable to R&D.Acquired In-Process Research and Development Expenses. Acquired IPR&D expenses of$31.0 million for the three months endedSeptember 30, 2022 represented the value of assets acquired, and acquisition related expenses, in connection with our acquisition of Capillary Biomedical. Other Income (Expense), Net. Total other income (expense), net for the three months endedSeptember 30, 2022 was$0.1 million income, compared to$1.9 million expense in the same period in 2021. Other income, net for the three months endedSeptember 30, 2022 primarily consisted of$1.7 million of interest income earned on our cash equivalents and short-term investments, partially offset by$1.6 million of interest expense which included the amortization of debt issuance costs related to our Convertible Senior Notes. Other expense, net for the three months endedSeptember 30, 2021 primarily consisted of$1.5 million of interest expense which included the amortization of debt issuance costs related to our Notes. Income Tax Expense (Benefit). We recognized income tax expense of$1.6 million on a pre-tax loss of$47.3 million for the three months endedSeptember 30, 2022 , compared to income tax expense of$0.1 million on pre-tax income of$5.8 million for the three months endedSeptember 30, 2021 . Income tax expense for the three months endedSeptember 30, 2022 was primarily attributable to federal, state and foreign income tax expense as a result of current taxable income in certain jurisdictions. Income tax expense for the three months endedSeptember 30, 2021 was primarily attributable to state and foreign income tax expense as a result of current taxable income in certain jurisdictions.
Comparison of the Nine Months Ended
Sales. For the nine months endedSeptember 30, 2022 , sales were$580.7 million , which included$157.7 million of sales outsidethe United States . For the nine months endedSeptember 30, 2022 we deferred$0.6 million of pump sales as a result ofTandem Choice , launched in lateSeptember 2022 . For the nine months endedSeptember 30, 2021 , sales were$492.8 million , which included$128.8 million of sales outsidethe United States . The increase in worldwide sales of$87.9 million in the first nine months of 2022 compared to the first nine months of 2021, was driven by a 34% increase in pump-related supply sales, primarily due to 35% growth in our estimated worldwide installed base of customers. We also had a 7% increase in worldwide pump sales in the first nine months of 2022, compared to the same period in 2021, net of the deferral associated with the Tandem Choice.
Sales by product in
Nine Months Ended September 30,
2022 2021
Pump $ 235,849 $ 221,724
Infusion sets 128,490 97,251
Cartridges 57,502 44,136
Other 1,144 914
Total Sales in the United States $ 422,985 $
364,025
36 -------------------------------------------------------------------------------- Pump sales inthe United States were$235.8 million for the first nine months of 2022, compared to$221.7 million in the first nine months of 2021, as pump shipments increased 4% compared to the same period in the prior year, net of the deferral associated with the Tandem Choice, which began during the third quarter of 2022. Pump average selling prices also improved over the prior period. Domestic pump shipments were 59,870 in the first nine months of 2022 compared to 57,605 in the first nine months of 2021. Sales of pump-related supplies increased primarily due to a 28% increase in our estimated domestic installed base of customers compared toSeptember 30, 2021 . Sales to distributors accounted for 65% and 68% of our total domestic sales for the nine months endedSeptember 30, 2022 and 2021, respectively, which contributed to modest improvement in average selling prices across all products.
Sales outside
Nine Months Ended September 30,
2022 2021
Pump $ 75,515 $ 70,300
Infusion sets 57,258 41,074
Cartridges 24,539 16,878
Other 419 526
Total Sales Outside the United States $ 157,731
Pump sales outsidethe United States were$75.5 million for the first nine months of 2022, compared to$70.3 million in the first nine months of 2021, as the 1% decrease in pump shipments was more than offset by an increase in average selling prices compared to the same period in the prior year. Sales of pump-related supplies increased 41% primarily due to a 57% increase in our estimated installed base of customers outsidethe United States . The ordering patterns of our distributors outsidethe United States for pumps and supplies is highly variable from period to period, as distributors continue to gain familiarity with the markets in which they operate and the acceptance of our products in those markets. This variability was compounded during the period by the differing levels of impact from the global pandemic with regard to both access to physicians and customers, as well as shipping logistics across the more than 20 markets in which we operate outsidethe United States . Sales to distributors accounted for 96% of our total sales outsidethe United States for the nine month period endedSeptember 30, 2022 , and 95% for the same period in 2021. Cost of Sales and Gross Profit. Our cost of sales for the nine months endedSeptember 30, 2022 was$283.3 million resulting in gross profit of$297.5 million , compared to cost of sales of$230.3 million and gross profit of$262.5 million for the same period in 2021. The gross margin for the nine months endedSeptember 30, 2022 was 51% compared to 53% in the same period in 2021. The increase in our gross profit for the nine months endedSeptember 30, 2022 was primarily the result of the$87.9 million increase in total sales. Gross profit benefited from an increase in average selling prices as well as improvement in manufacturing efficiencies and leverage of fixed overhead. Gross margin was pressured by approximately 2 percentage points from increased pump material costs due to the use of alternative sourcing for raw materials to reduce the risk of component shortages in the near-term and higher freight costs we are experiencing in 2022. We anticipate continued pressure from increased supply chain and material costs through the end of this year into next year as we continue to navigate the challenges of the global pandemic and the economic environment. Other factors that have and may continue to impact the gross margin percentage are changes in product and geographical mix and the level of non-cash stock-based compensation allocated to cost of sales. Pump sales, which have the highest gross margin, were 54% of total worldwide sales in the first nine months of 2022 compared to 59% in the same period in 2021. Selling, General and Administrative Expenses. SG&A expenses increased 25% to$238.0 million for the nine months endedSeptember 30, 2022 , from$190.0 million for the same period in 2021. Employee-related expenses for our SG&A functions comprise the majority of SG&A expenses. The increase compared to 2021 was primarily the result of a$34.7 million increase in salaries, incentive compensation, non-cash stock-based compensation, and other employee benefits due to an increase in personnel to support additional sales territories, higher sales and other services in support of our growing installed customer base. Non-cash stock-based compensation expense allocated to SG&A was$40.7 million for the nine months endedSeptember 30, 2022 , compared to$31.6 million in the same period in 2021. We also experienced a$13.3 million increase in facilities and non-employee discretionary spending, including outside services, travel, and software maintenance and supplies costs. 37 -------------------------------------------------------------------------------- Research and Development Expenses. R&D expenses increased 65% to$103.5 million for the nine months endedSeptember 30, 2022 , from$62.6 million for the same period in 2021. The increase in R&D expenses was primarily the result of an increase of$24.4 million in salaries, incentive compensation, non-cash stock-based compensation, and other employee benefits due to an increase in personnel to support our product development efforts. Non-cash stock-based compensation expense allocated to R&D was$14.1 million for the nine months endedSeptember 30, 2022 , compared to$7.5 million in the same period in 2021. We also experienced a$16.6 million increase in other non-employee discretionary spending, including outside consulting and services, clinical trial expenses, information technology, facilities and equipment costs attributable to R&D.Acquired In-Process Research and Development Expenses. Acquired IPR&D expenses of$31.0 million for the nine months endedSeptember 30, 2022 represented the value of IPR&D assets acquired, and acquisition related expenses, in connection with our acquisition of Capillary Biomedical. Other Income (Expense), Net. Total other expense, net for the nine months endedSeptember 30, 2022 and 2021 was$1.7 million and$5.2 million , respectively. Other expense, net for the nine months endedSeptember 30, 2022 primarily consisted of$4.6 million of interest expense which included the amortization of debt issuance costs related to our Convertible Senior Notes, partially offset by$2.9 million of interest income earned on our cash equivalents and short-term investments. Other expense, net for the nine months endedSeptember 30, 2021 primarily consisted of$4.5 million of interest expense which included the amortization of debt issuance costs related to our Notes, and a$1.4 million revaluation loss from the change in the fair value of certain common stock warrants, offset by$0.7 million of interest income earned on our cash equivalents and short-term investments. Income Tax Expense (Benefit). We recognized income tax expense of$2.0 million on pre-tax loss of$76.7 million for the nine months endedSeptember 30, 2022 , compared to an income tax benefit of$2,000 on pre-tax income of$4.8 million for the nine months endedSeptember 30, 2021 . Income tax expense for the nine months endedSeptember 30, 2022 was primarily attributable to federal, state and foreign income tax expense as a result of current taxable income in certain jurisdictions. The benefit for income taxes for the nine months endedSeptember 30, 2021 was primarily attributable to excess tax benefits from stock compensation, offset by state and foreign income tax expense as a result of current taxable income in certain jurisdictions.
Liquidity and Capital Resources
AtSeptember 30, 2022 , we had$608.7 million in cash and cash equivalents and short-term investments. In addition, we had a total available balance of$95.1 million atSeptember 30, 2022 under our Revolving Line of Credit (the Line of Credit), which expires inMay 2025 (see Note 7, "Debt"). We believe that our cash and cash equivalents, short-term investments, borrowing availability under the Line of Credit, and future cash flows from operations will be sufficient to fund our ongoing core business activities. Historically, our principal sources of cash have included cash collected from product sales, private and public offerings of equity securities, exercises of employee stock awards, and debt financing. Our historical cash outflows have primarily been associated with cash used for operating activities such as the development and commercialization of our products, the expansion and support of our sales, marketing, clinical and customer support organizations, the expansion of our R&D activities, the expansion of our commercial activities to select geographies outsidethe United States , the acquisition of intellectual property, equity investments and acquired assets, expenditures related to increases in our manufacturing capacity and improvements to our manufacturing efficiency, overall expansion of our facilities and operations, and other working capital needs. Additionally, we have used cash to pay the interest expense associated with our convertible senior notes. 38 --------------------------------------------------------------------------------
The following table shows a summary of our cash flows for the nine months ended
Nine
Months Ended
2022 2021
Net cash provided by (used in):
Operating activities $ 44,644 $ 91,724
Investing activities (2,609) (110,058)
Financing activities 10,777 36,046
Effect of foreign exchange rate changes on cash (207) 50
Net increase in cash and cash equivalents $
52,605
Operating Activities. Net cash provided by operating activities was$44.6 million for the nine months endedSeptember 30, 2022 , compared to$91.7 million in the same period in 2021. The reduction in net cash provided by operating activities for 2022 compared to 2021 was primarily a result of the$83.5 million increase in net loss as well as working capital changes. Working capital changes during the nine months of 2022, primarily consisted of increases in inventories, accounts payable and accrued expenses, and operating leases and other current liabilities. Accounts receivable increased to$112.8 million atSeptember 30, 2022 , from$110.7 million atDecember 31, 2021 . Inventories increased to$104.8 million atSeptember 30, 2022 from$68.6 million atDecember 31, 2021 . Investing Activities. Net cash used in investing activities was$2.6 million for the nine months endedSeptember 30, 2022 , which was primarily related to$362.5 million of purchases of short-term investments,$28.5 million in purchases of property and equipment, and$25.7 million paid for the acquisition of Capillary Biomedical, including$1.0 million transaction cost. (see Note 2, "Summary of Significant Accounting Policies"), offset by$422.9 million in proceeds from maturities and sales of short-term investments. Net cash used by investing activities was$110.1 million for the nine months endedSeptember 30, 2021 , which was primarily related to$542.8 million of purchases of short-term investments, and$8.4 million in purchases of property and equipment, offset by$450.5 million in proceeds from maturities and sales of short-term investments. Financing Activities. Net cash provided by financing activities was$10.8 million for the nine months endedSeptember 30, 2022 , which primarily consisted of proceeds from the issuance of common stock under our stock plans. Net cash provided by financing activities was$36.0 million for the nine months endedSeptember 30, 2021 , which primarily consisted of proceeds from the issuance of common stock under our stock plans.
Our liquidity position and capital requirements are subject to fluctuation based
on a number of factors. In particular, our cash inflows and outflows are
principally impacted by the following:
•our ability to generate sales, the timing of those sales, the mix of products
sold and the collection of receivables from period to period;
•the timing of any additional financings, and the net proceeds raised from such
financings;
•the timing and amount of the exercise of outstanding warrants, and proceeds
from the issuance of equity awards pursuant to employee stock plans;
•fluctuations in gross margins and operating margins;
•fluctuations in working capital, including changes in accounts receivable, inventories, accounts payable, employee-related liabilities, and operating lease liabilities; and
•the impacts and disruptions caused by the COVID-19 global pandemic.
39 --------------------------------------------------------------------------------
Both our primary short-term and long-term capital needs are expected to include
expenditures related to:
•support of our commercialization efforts related to our current and future
products;
•expansion of our customer support resources for our growing installed customer
base;
•research and product development efforts, including clinical trial costs;
•acquisitions, leasing or licensing of equipment, technology, intellectual
property and other assets;
•additional facilities leases and related tenant improvements;
•investments for the development, improvement and acquisition of manufacturing,
testing and packaging equipment to support business growth and increase
capacity; and
•payments under licensing, development and commercialization agreements.
•acquisition and subsequent integration of businesses, products and
technologies.
Although we believe the foregoing items reflect our most likely uses of cash in the short-term, we cannot predict with certainty all of our particular cash uses or the timing or amount of cash used. In addition, from time to time we may consider opportunities to acquire or license other products or technologies that may enhance our product platform or technology, expand the breadth of our markets or customer base, or advance our business strategies. Any such transaction may require short-term expenditures that may impact our capital needs. If for any reason our cash and cash equivalents balances, or cash generated from operations is insufficient to satisfy our working capital requirements, we may in the future be required to seek additional capital from public or private offerings of our equity or debt securities, or we may elect to borrow capital under the Line of Credit, new credit arrangements or from other sources. We may also seek to raise additional capital from such offerings or borrowings on an opportunistic basis when we believe there are suitable opportunities for doing so. If we issue equity or debt securities to raise additional funds, our existing stockholders may experience dilution, we may incur significant financing or debt service costs, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. There can be no assurance that financing will be available on acceptable terms, or at all. Our ability to raise additional financing may be negatively impacted by a number of factors, including our recent and projected financial results, recent changes in and volatility of our stock price, perceptions about the dilutive impact of financing transactions, the competitive environment in our industry, uncertainties regarding the regulatory environment in which we operate and conditions impacting the capital markets more generally, including economic weakness, inflation, political instability, war and terrorism, natural disasters, incidence of illness or disease, or other events beyond our control.
Indebtedness
InMay 2020 , the Company entered into a purchase agreement with certain counterparties for the sale of an aggregate of$287.5 million principal amount of 1.50% Convertible Senior Notes due 2025 in a private offering to qualified institutional buyers (the Notes). The proceeds from the issuance of the Notes were$244.6 million , net of debt issuance costs and cash used to pay the cost of the Capped Call Transactions (see Note 7, "Debt"). The Notes are the Company's senior unsecured obligations. Interest is payable in cash semi-annually in arrears beginning onNovember 1, 2020 at a rate of 1.50% per year. The Notes mature onMay 1, 2025 unless repurchased, redeemed, or converted in accordance with their terms prior to the maturity date.
Cash payments due by calendar year for our Convertible Senior Notes at
Remaining in
Total 2022 2023 2024 2025
Contractual interest $ 12,938 $ 2,156 $ 4,313 $ 4,313 $ 2,156
Principal amount of convertible
senior notes(1) 287,500 - - - 287,500
Total $ 300,438 $ 2,156 $ 4,313 $ 4,313 $ 289,656
(1) The Convertible Senior Notes may be settled in cash, shares of our common
stock, or a combination of cash and shares of our common stock, at our election.
40 --------------------------------------------------------------------------------
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted inthe United States of America (U.S. GAAP). The preparation of these consolidated financial statements requires management to make estimates and judgments, which present a significant level of estimation uncertainty and that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements and accompanying notes as of the date of the consolidated financial statements. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about our financial condition and results of operations that are not readily apparent from other sources. Actual results may differ from these estimates and have a material impact on our financial condition and results of operations. There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies Involving Management Estimates and Assumptions," included in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , except for the accounting policies and estimates related to an asset acquisition andTandem Choice , which are included in Note 2, "Summary of Significant Accounting Policies" in Part I, Item 1 of this Quarterly Report.
Off-Balance Sheet Arrangements
As ofSeptember 30, 2022 , we are a party to certain standby letter of credit arrangements in support of our operating lease obligations. For a description of the arrangements we consider significant, see Note 12 "Commitments and Contingencies" to the condensed consolidated financial statements in Part I, Item 1 of this Quarterly Report. 41
--------------------------------------------------------------------------------



3Q 2022 Earnings Call Presentation
JAMES RIVER GROUP HOLDINGS, LTD. – 10-Q – Management's Discussion and Analysis of Financial Condition and Results of Operations
Advisor News
- Global economy ‘resilient’ in the wake of massive disruption
- Cryptocurrency legislation takes one step forward with bipartisan support
- IRS CEO FRANK J. BISIGNANO VISITS OHIO TO TOUT WORKING FAMILIES TAX CUTS PROVISIONS ON NO TAX ON CAR LOAN INTEREST, NO TAX ON OVERTIME, ENHANCED DEDUCTION FOR SENIOR CITIZENS
- The hidden flaw in insurance AI adoption for advisors and carriers
- Rising healthcare costs impact 401(k) accounts
More Advisor NewsAnnuity News
- MetLife Expands Guaranteed Retirement Income Offering with Innovative Flexible Annuity Option
- How annuities can help protect retirees from financial scams
- MetLife Inc. (NYSE: MET) Climbs to New 52-Week High
- The Standard and Pacific Guardian Life Announce Entry into Agreement to Transition Individual Annuities Business
- AuguStar Retirement launches StarStream Variable Annuity
More Annuity NewsHealth/Employee Benefits News
- Hecklers disrupt Cedar Rapids campaign rally as Ashley Hinson touts stock trading ban
- Reed: Can these assets be saved?
- Virginia program cuts costs of health insurance under Obamacare
- Retirement, health insurance costs to put pressure on future Baker City budgets
- The United States may be the best place to build universal health care (Opinion)
More Health/Employee Benefits NewsLife Insurance News
- AM Best Affirms Credit Ratings of Halyk-Life, JSC
- AM Best Affirms Credit Ratings of Symetra Financial Corporation and Its Subsidiaries
- AM Best Assigns Credit Ratings to Park Avenue Life Insurance Company
- Nationwide reaches reinsurance agreement with MassMutual on UL policy block
- Best’s Market Segment Report: AM Best Maintains Outlook on Philippines’ Non-Life Insurance Segment at Stable
More Life Insurance News