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Inspire(INSP) - 2022 Q1 - Earnings Call Transcript
2022-05-04 02:26
Financial Data and Key Metrics Changes - Inspire Medical Systems reported a strong first quarter with total revenue of $69.4 million, representing a 72% increase compared to $40.4 million in Q1 2021 [45] - U.S. revenue was $66.4 million, a 76% increase from $37.8 million in the prior year period, while international revenue increased 14% to $3 million [46] - Gross margin improved to 85.6% from 85.2% in the prior year due to manufacturing efficiencies and higher sales volume [48] - The net loss for Q1 was $16.7 million, slightly higher than the $16.2 million loss in the prior year, with a net loss per share of $0.61 [50] Business Line Data and Key Metrics Changes - The company added 74 new U.S. implanting centers, bringing the total to 733 centers, with ambulatory surgical centers (ASCs) making up 22% of all U.S. centers [14][15] - The average selling price (ASP) in the U.S. was $23,800, consistent with the prior year, while the ASP outside the U.S. was $22,200, down from $24,400 due to exchange rates [47] Market Data and Key Metrics Changes - The number of visitors to the company's website increased by 170% year-over-year to approximately 4.7 million, leading to about 24,000 physician contacts [22] - The company is expanding its direct-to-consumer advertising campaign, which has significantly increased web activity and patient engagement [24] Company Strategy and Development Direction - Inspire Medical Systems is focused on increasing utilization at existing centers and expanding capacity by opening and training new centers [42] - The company plans to implement a 5% price increase for all U.S. centers starting in May, which is expected to have a minimal impact on 2022 revenue [20] - The company is optimistic about its international business, particularly in Germany, and has received countrywide reimbursement approval in France [31][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business outlook for the remainder of 2022, citing positive trends in implant activity and planned expansions [12] - The company has increased its full-year 2022 revenue guidance to a range of $336 million to $344 million, reflecting a 44% to 47% growth over 2021 [53] - Management acknowledged the challenges posed by COVID-19 but noted a strong rebound in procedure volumes as the quarter progressed [9][52] Other Important Information - The company has partnered with digital health companies to improve patient access to sleep studies, which is crucial for Inspire therapy eligibility [27][29] - Inspire Medical Systems is working on developing a fifth-generation neurostimulator, targeting FDA approval in late 2023 [41] Q&A Session Summary Question: Insights on March and April performance and COVID impact - Management noted a strong rebound in March and April after a slow start in January due to COVID, which allowed for an increase in guidance [57][58] Question: Details on the price increase and cost pressures - The price increase is phased in over several quarters, and while there are some increased costs, gross margins are expected to remain stable [59][60] Question: Feedback on CPAP supply shortages and patient inquiries - There has been an increase in patients seeking Inspire therapy due to CPAP shortages, and sleep physicians are more frequently discussing alternative therapies [66][68] Question: Pipeline for new centers and growth in ASCs - The company is seeing enthusiasm for new centers, with a focus on both ASCs and hospitals, and expects continued growth in both areas [71][72] Question: International growth prospects and contributions - Management is optimistic about international growth, particularly in Germany and France, and anticipates significant contributions from these markets in the future [108][110] Question: Operational expenses and future guidance - Operating expenses are expected to remain comparable to previous quarters, with a focus on growth rather than immediate profitability [112]
Inspire(INSP) - 2022 Q1 - Quarterly Report
2022-05-03 20:08
[Forward-Looking Statements](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements regarding future financial results, business strategy, product approvals, and R&D costs - This report contains forward-looking statements covered by safe harbor provisions, including those related to future financial results, business strategy, product approvals, reimbursement levels, R&D costs, and management objectives[10](index=10&type=chunk) - Key risks and uncertainties include operating losses, dependency on the Inspire system, commercial success, reimbursement levels, competition, impact of COVID-19, ability to expand indications, and supply chain reliance[12](index=12&type=chunk)[16](index=16&type=chunk) PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited interim financial statements, including Balance Sheets, Statements of Operations, Stockholders' Equity, and Cash Flows [Balance Sheets](index=5&type=section&id=Balance%20Sheets) Metric (in thousands) | Metric (in thousands) | March 31, 2022 | December 31, 2021 | | :-------------------- | :------------- | :---------------- | | Total assets | $289,720 | $295,084 | | Total liabilities | $64,665 | $66,036 | | Total stockholders' equity | $225,055 | $229,048 | | Cash and cash equivalents | $203,291 | $214,467 | | Inventories | $22,198 | $17,231 | - Total assets decreased by **$5.36 million** from December 31, 2021, to March 31, 2022, primarily driven by a decrease in cash and cash equivalents[19](index=19&type=chunk) [Statements of Operations and Comprehensive Loss](index=6&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Metric (in thousands) | Metric (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change ($) | Change (%) | | :-------------------- | :-------------------------------- | :-------------------------------- | :--------- | :--------- | | Revenue | $69,382 | $40,352 | $29,030 | 71.9% | | Cost of goods sold | $10,004 | $5,981 | $4,023 | 67.3% | | Gross profit | $59,378 | $34,371 | $25,007 | 72.8% | | Operating expenses | $75,434 | $50,060 | $25,374 | 50.7% | | Operating loss | $(16,056) | $(15,689) | $(367) | 2.3% | | Net loss | $(16,694) | $(16,216) | $(478) | 2.9% | | Net loss per share, basic and diluted | $(0.61) | $(0.60) | $(0.01) | 1.7% | - Revenue increased significantly by **71.9%** year-over-year, reaching **$69.4 million**, while net loss slightly increased by **2.9%** to **$16.7 million**[21](index=21&type=chunk)[149](index=149&type=chunk) [Statements of Stockholders' Equity](index=7&type=section&id=Statements%20of%20Stockholders'%20Equity) Metric (in thousands) | Metric (in thousands) | Balance at Dec 31, 2021 | Stock options exercised | Stock-based compensation expense | Net loss | Balance at Mar 31, 2022 | | :-------------------- | :---------------------- | :---------------------- | :------------------------------- | :------- | :---------------------- | | Additional Paid-In Capital | $508,465 | $3,086 | $9,721 | — | $521,308 | | Accumulated Deficit | $(279,389) | — | — | $(16,694) | $(296,083) | | Total Stockholders' Equity | $229,048 | $3,087 | $9,721 | $(16,694) | $225,055 | - Stockholders' equity decreased from **$229.0 million** at December 31, 2021, to **$225.1 million** at March 31, 2022, primarily due to the net loss of **$16.7 million**, partially offset by stock-based compensation expense and stock option exercises[24](index=24&type=chunk) [Statements of Cash Flows](index=8&type=section&id=Statements%20of%20Cash%20Flows) Cash Flow Activity (in thousands) | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(12,748) | $(10,401) |\n| Net cash used in investing activities | $(1,465) | $(1,321) |\n| Net cash provided by financing activities | $3,044 | $3,550 |\n| Decrease in cash and cash equivalents | $(11,176) | $(8,170) |\n| Cash and cash equivalents at end of period | $203,291 | $182,348 | - The company experienced a net decrease in cash and cash equivalents of **$11.2 million** for the three months ended March 31, 2022, primarily driven by cash used in operating activities[26](index=26&type=chunk)[167](index=167&type=chunk) [Notes to Financial Statements](index=9&type=section&id=Notes%20to%20Financial%20Statements) [1. Organization](index=9&type=section&id=1.%20Organization) - Inspire Medical Systems, Inc. is a medical technology company focused on developing and commercializing minimally invasive solutions for obstructive sleep apnea (OSA)[28](index=28&type=chunk) - Its proprietary Inspire system is the first and only FDA-approved neurostimulation technology for moderate to severe OSA, with commercial availability in Europe since **2011**, Japan since **2021**, and Australia approved in **2020** (seeking reimbursement)[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - Financial statements are prepared in accordance with GAAP for interim reporting, using estimates and assumptions that may differ from actual results[29](index=29&type=chunk) - The company measures certain financial assets and liabilities at fair value on a recurring basis, classifying them into a three-tier hierarchy (Level 1, 2, 3) based on input observability[37](index=37&type=chunk)[38](index=38&type=chunk) Fair Value Measurements as of March 31, 2022 (in thousands) | Asset Type | Estimated Fair Value | Level 1 | | :----------------------- | :------------------- | :------ | | Money market funds | $189,379 | $189,379 | | U.S. government securities | $9,796 | $9,796 |\n| Total | $199,175 | $199,175 | - Revenue from product sales is recognized when the customer obtains control, typically upon shipment or receipt, adjusted for variable consideration and returns (historically immaterial)[56](index=56&type=chunk)[57](index=57&type=chunk)[61](index=61&type=chunk) - Stock-based compensation expense is recognized for equity awards (RSUs, PSUs, stock options, ESPP) based on grant date fair value, using the Black-Scholes model for options and ESPP, and closing price for RSUs/PSUs[66](index=66&type=chunk) [3. Investments](index=17&type=section&id=3.%20Investments) Long-Term Investments (Available-for-Sale) (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :----------------------- | :------------- | :---------------- | | Amortized Cost | $9,994 | $9,993 | | Unrealized Gross Losses | $(198) | $(55) |\n| Aggregate Fair Value | $9,796 | $9,938 | - All long-term investments consist of U.S. government securities with contractual maturities of less than two years, and are not considered other-than-temporarily impaired[76](index=76&type=chunk) [4. Leases](index=17&type=section&id=4.%20Leases) - The company leases approximately **70,000 square feet** for its corporate headquarters, with the lease expiring **May 31, 2028**[77](index=77&type=chunk) Lease Balances (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :-------------------------------- | :------------- | :---------------- | | Operating lease right-of-use asset | $7,659 | $7,919 |\n| Total operating lease liabilities | $9,226 | $9,108 | - As of March 31, 2022, the remaining lease term was **6.2 years** with a weighted average discount rate of **5.3%**[80](index=80&type=chunk) [5. Long-Term Debt](index=18&type=section&id=5.%20Long-Term%20Debt) - As of March 31, 2022, the company had **$24.5 million** outstanding under its credit facility, which matures on **March 1, 2024**, with interest-only payments until **April 1, 2022**[81](index=81&type=chunk) - The credit facility includes affirmative and restrictive covenants, and the company was in compliance as of March 31, 2022[82](index=82&type=chunk)[83](index=83&type=chunk) [6. Employee Retirement Plan](index=18&type=section&id=6.%20Employee%20Retirement%20Plan) - The company sponsors a defined contribution employee retirement plan and began making voluntary matching contributions of **50%** of the first **6%** of employee contributions (up to **3%** of eligible earnings) starting **January 1, 2022**[84](index=84&type=chunk) - Discretionary contributions to the plan totaled **$0.7 million** for the three months ended March 31, 2022[84](index=84&type=chunk) [7. Stock-Based Compensation](index=19&type=section&id=7.%20Stock-Based%20Compensation) Stock-Based Compensation Expense (in thousands) | Component | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Stock options | $7,761 | $5,657 |\n| Restricted stock units | $565 | $19 |\n| Performance stock units | $1,010 | — |\n| Employee stock purchase plan | $385 | $321 |\n| Total | $9,721 | $5,997 | - Total stock-based compensation expense increased by **62.1%** to **$9.7 million** for the three months ended March 31, 2022, driven by increases across all award types, particularly stock options and the introduction of PSUs[88](index=88&type=chunk) - As of March 31, 2022, unrecognized stock-based compensation expense was **$94.2 million** for stock options (expected over **2.5 years**), **$13.4 million** for RSUs (expected over **2.9 years**), and **$23.1 million** for PSUs (expected over **3.0 years**)[92](index=92&type=chunk)[99](index=99&type=chunk)[103](index=103&type=chunk) [8. Income Taxes](index=22&type=section&id=8.%20Income%20Taxes) - A full valuation allowance was recorded against all deferred tax assets due to the company's cumulative net loss position[106](index=106&type=chunk)[109](index=109&type=chunk) - As of December 31, 2021, the company had gross federal net operating loss carryforwards of **$286.3 million** and state NOLs of **$198.2 million**, along with **$6.7 million** in R&D credit carryforwards[107](index=107&type=chunk) [9. Segment Reporting and Revenue Disaggregation](index=23&type=section&id=9.%20Segment%20Reporting%20and%20Revenue%20Disaggregation) - The company operates as a single reporting segment[112](index=112&type=chunk) Revenue by Geographic Region (in thousands) | Region | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------- | :-------------------------------- | :-------------------------------- | | United States | $66,426 | $37,769 |\n| All other countries | $2,956 | $2,583 |\n| Total revenue | $69,382 | $40,352 | - **95.7%** of revenue for the three months ended March 31, 2022, was derived from the U.S[126](index=126&type=chunk) [10. Loss Per Share](index=23&type=section&id=10.%20Loss%20Per%20Share) - Basic and diluted net loss per share are identical due to the company reporting a net loss, rendering all potentially dilutive shares anti-dilutive[114](index=114&type=chunk) Anti-Dilutive Common Stock-Based Awards | Award Type | March 31, 2022 | March 31, 2021 | | :-------------------------- | :------------- | :------------- | | Common stock options outstanding | 2,763,215 | 2,750,375 |\n| Unvested restricted stock units | 60,785 | 2,275 |\n| Unvested performance stock units | 78,351 | — |\n| Shares issuable under the ESPP | 5,435 | 5,785 |\n| Total | 2,907,786 | 2,758,435 | [11. Subsequent Event](index=24&type=section&id=11.%20Subsequent%20Event) - On **April 27, 2022**, Inspire invested **$10.0 million** in a minority interest of EnsoData, Inc. to advance its digital health platform[117](index=117&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operations, business developments, COVID-19 impact, revenue, expenses, liquidity, and capital resources [Overview](index=25&type=section&id=Overview) - Inspire Medical Systems commercializes the Inspire system, an FDA-approved neurostimulation technology for moderate to severe OSA, sold to hospitals and ASCs in the U.S., Europe, and Japan[120](index=120&type=chunk)[121](index=121&type=chunk) - The company has secured positive coverage policies with U.S. commercial payors (covering **~260 million lives**) and all seven Medicare Administrative Contractors (MACs)[122](index=122&type=chunk) - New Category I CPT codes for hypoglossal nerve stimulator services (**64582, 64583, 64584**) and Drug-Induced Sleep Endoscopy (**42975**) went into effect **January 1, 2022**, with **2022** Medicare reimbursement rates of approximately **$30,063** for hospitals and **$24,828** for ASCs[123](index=123&type=chunk)[124](index=124&type=chunk) - For Q1 **2022**, revenue was **$69.4 million** (**85.6%** gross margin) with a net loss of **$16.7 million**, compared to Q1 **2021** revenue of **$40.4 million** (**85.2%** gross margin) and a net loss of **$16.2 million**[128](index=128&type=chunk) - The company continues to invest in R&D for next-generation Inspire systems and expanded indications, including recent FDA approval for a Bluetooth-enabled remote and a two-incision surgical implant procedure[129](index=129&type=chunk) - Direct-to-consumer marketing, including national TV advertising (started **Jan 2022**), and the Inspire Advisor Care Program (ACP), which serves **~600 U.S. centers**, are key growth drivers[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - The Philips Respironics CPAP recall is believed to be increasing patient inquiries and flow for Inspire therapy, though the impact is not yet quantifiable[133](index=133&type=chunk) - The company expanded to **174 U.S. sales territories** and **733 U.S. implanting medical centers** (**22%** ASCs) as of **March 31, 2022**[134](index=134&type=chunk) [COVID-19 Pandemic Update](index=27&type=section&id=COVID-19%20Pandemic%20Update) - COVID-19 resurgences in Q1 **2022**, similar to Q1 **2021**, impacted revenue and clinician/patient access, though surgical volumes generally returned to pre-pandemic levels by quarter-end[136](index=136&type=chunk) - The company has not experienced significant supply chain disruptions or reduced capital expenditures due to the pandemic[137](index=137&type=chunk) [Components of Our Results of Operations](index=28&type=section&id=Components%20of%20Our%20Results%20of%20Operations) [Revenue](index=28&type=section&id=Revenue) - Revenue is primarily derived from selling the Inspire system to hospitals and ASCs in the U.S., Europe, and Japan, recognized when customers gain control of the product[138](index=138&type=chunk) - Revenue fluctuates quarterly due to factors like seasonality (higher in Q4, lower in Q1) and the impact of the COVID-19 pandemic[139](index=139&type=chunk) [Cost of Goods Sold and Gross Margin](index=28&type=section&id=Cost%20of%20Goods%20Sold%20and%20Gross%20Margin) - Cost of goods sold includes acquisition costs for components, overhead, scrap, inventory obsolescence, warranty, and distribution expenses[140](index=140&type=chunk) - Gross margin is influenced by manufacturing costs, average selling price, cost-reduction strategies, inventory obsolescence, sales mix (U.S. vs. international), and potential increases in material/labor prices due to supply chain issues and inflation[141](index=141&type=chunk) [Research and Development Expenses](index=28&type=section&id=Research%20and%20Development%20Expenses) - R&D expenses cover product development, engineering, clinical studies, regulatory affairs, quality assurance, and personnel costs[142](index=142&type=chunk) - R&D expenses are expected to increase with the development of next-generation Inspire systems and expansion of clinical studies into new markets[143](index=143&type=chunk) [Selling, General and Administrative Expenses](index=28&type=section&id=Selling,%20General%20and%20Administrative%20Expenses) - SG&A expenses primarily consist of compensation for sales, finance, IT, and HR personnel, marketing, advertising, training, and general corporate costs[144](index=144&type=chunk)[145](index=145&type=chunk) - SG&A expenses are anticipated to continue increasing due to commercial infrastructure expansion, headcount growth, and higher stock-based compensation[146](index=146&type=chunk) [Other Expense](index=29&type=section&id=Other%20Expense) - Other expense primarily includes interest expense from the credit facility, realized foreign currency losses, and interest income[147](index=147&type=chunk) [Seasonality](index=29&type=section&id=Seasonality) - The company historically experiences seasonality, with higher sales in Q4 (due to met insurance deductibles) and lower sales in Q1 (due to deductible resets) in the U.S[148](index=148&type=chunk) - German sales previously saw Q1 reductions due to NUB coverage determination, but full integration into the G-DRG system since **January 2021** may reduce these fluctuations[148](index=148&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) [Comparison of the Three Months Ended March 31, 2022 and 2021](index=30&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20March%2031,%202022%20and%202021) Financial Performance Comparison (in thousands, except percentages) | Metric | March 31, 2022 | March 31, 2021 | $ Change | % Change | | :-------------------------- | :------------- | :------------- | :------- | :------- | | Revenue | $69,382 | $40,352 | $29,030 | 71.9% |\n| Cost of goods sold | $10,004 | $5,981 | $4,023 | 67.3% |\n| Gross profit | $59,378 | $34,371 | $25,007 | 72.8% |\n| Gross margin | 85.6% | 85.2% | | |\n| Total operating expenses | $75,434 | $50,060 | $25,374 | 50.7% |\n| Operating loss | $(16,056) | $(15,689) | $(367) | 2.3% |\n| Net loss | $(16,694) | $(16,216) | $(478) | 2.9% | [Revenue](index=30&type=section&id=Revenue%20(sub-section%20of%20comparison)) - Total revenue increased by **$29.0 million** (**71.9%**) to **$69.4 million** for Q1 **2022**, driven by increased market penetration, new territory expansion, and greater awareness of the Inspire system[150](index=150&type=chunk) Revenue by Region (in thousands, except percentages) | Region | 2022 Amount | 2022 % of Revenue | 2021 Amount | 2021 % of Revenue | $ Change | % Change | | :------------- | :---------- | :---------------- | :---------- | :---------------- | :------- | :------- | | United States | $66,426 | 95.7% | $37,769 | 93.6% | $28,657 | 75.9% |\n| All other countries | $2,956 | 4.3% | $2,583 | 6.4% | $373 | 14.4% |\n| Total revenue | $69,382 | 100.0% | $40,352 | 100.0% | $29,030 | 71.9% | - U.S. revenue grew by **75.9%** to **$66.4 million**, while international revenue increased by **14.4%** to **$3.0 million**, primarily in Germany and Japan, despite unfavorable exchange rates[151](index=151&type=chunk)[152](index=152&type=chunk) [Cost of Goods Sold and Gross Margin](index=31&type=section&id=Cost%20of%20Goods%20Sold%20and%20Gross%20Margin%20(sub-section%20of%20comparison)) - Cost of goods sold increased by **$4.0 million** (**67.3%**) to **$10.0 million**, primarily due to higher sales volume[153](index=153&type=chunk) - Gross margin improved slightly to **85.6%** from **85.2%**, attributed to increased sales volume and manufacturing efficiencies[154](index=154&type=chunk) [Research and Development Expenses](index=31&type=section&id=Research%20and%20Development%20Expenses%20(sub-section%20of%20comparison)) - R&D expenses rose by **$3.7 million** (**45.6%**) to **$11.9 million**, mainly due to increased compensation and employee-related expenses (**$1.9 million**) and ongoing development costs for Inspire Cloud and next-generation systems (**$1.8 million**)[155](index=155&type=chunk) [Selling, General and Administrative Expenses](index=31&type=section&id=Selling,%20General%20and%20Administrative%20Expenses%20(sub-section%20of%20comparison)) - SG&A expenses increased significantly by **$21.7 million** (**51.7%**) to **$63.6 million**[156](index=156&type=chunk) - Key drivers include a **$12.5 million** increase in compensation (salaries, commissions, stock-based compensation) due to headcount growth, and a **$7.1 million** rise in marketing expenses for direct-to-consumer initiatives and national TV ads[156](index=156&type=chunk) [Other Expense](index=31&type=section&id=Other%20Expense%20(sub-section%20of%20comparison)) - Other expense remained stable at **$0.5 million** for both Q1 **2022** and Q1 **2021**[157](index=157&type=chunk) [Income Taxes](index=31&type=section&id=Income%20Taxes%20(sub-section%20of%20comparison)) - The company recorded a nominal income tax provision of approximately **$0.1 million** for both Q1 **2022** and Q1 **2021**[158](index=158&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity Metrics (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :-------------------------------- | :------------- | :---------------- | | Cash, cash equivalents and available-for-sale securities | $213,100 | $224,400 |\n| Working capital | $219,300 | $227,200 | - Working capital decreased by **$7.9 million**, primarily due to an **$11.2 million** decrease in cash and cash equivalents used for operations, a **$5.4 million** increase in accounts payable, and a **$3.1 million** reclassification of long-term debt to current liabilities[159](index=159&type=chunk)[160](index=160&type=chunk) - The company had **$24.5 million** outstanding under its credit facility as of March 31, 2022, with no further borrowings available, and began principal payments in **April 2022**[161](index=161&type=chunk) - Existing cash, cash equivalents, and investments of **$213.1 million** are believed to be sufficient to meet cash needs and fund operations for at least the next **12 months**, though long-term requirements are uncertain and may necessitate additional funding[165](index=165&type=chunk)[166](index=166&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(12,748) | $(10,401) |\n| Net cash used in investing activities | $(1,465) | $(1,321) |\n| Net cash provided by financing activities | $3,044 | $3,550 | - Operating activities used **$12.7 million** in cash, primarily due to a net loss of **$16.7 million**, partially offset by non-cash charges of **$10.5 million** (e.g., stock-based compensation)[168](index=168&type=chunk) - Investing activities used **$1.5 million**, mainly for purchases of property and equipment (**$1.2 million**) and other investments (**$0.3 million**)[169](index=169&type=chunk) - Financing activities provided **$3.0 million**, primarily from stock option exercises (**$3.1 million**)[170](index=170&type=chunk) [Contractual Obligations and Commitments](index=33&type=section&id=Contractual%20Obligations%20and%20Commitments) - There have been no material changes to contractual obligations and commitments since the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[171](index=171&type=chunk) [Critical Accounting Policies and Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - The critical accounting policies and estimates remain unchanged from those described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[172](index=172&type=chunk)[173](index=173&type=chunk) [Recent Accounting Pronouncements](index=34&type=section&id=Recent%20Accounting%20Pronouncements) - Recently issued accounting pronouncements are not expected to have a significant impact on the company's financial statements or operations[174](index=174&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discusses the company's exposure to market risks, including interest rate, credit, foreign currency, and inflation risks - Interest rate risk is primarily limited to cash equivalents and short-term investments; a hypothetical **1%** change in interest rates would not materially impact financial statements[175](index=175&type=chunk) - There have been no material changes to market risks related to credit, foreign currency, and inflation since the Annual Report on Form 10-K for the year ended December 31, 2021[176](index=176&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of disclosure controls and procedures and reports on internal control changes [Evaluation of disclosure controls and procedures](index=34&type=section&id=Evaluation%20of%20disclosure%20controls%20and%20procedures) - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2022[177](index=177&type=chunk) [Changes in internal control over financial reporting](index=34&type=section&id=Changes%20in%20internal%20control%20over%20financial%20reporting) - There were no material changes in internal control over financial reporting during the quarter ended March 31, 2022[178](index=178&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not party to any material legal proceedings[180](index=180&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section refers to previously disclosed risk factors and confirms no material changes - There have been no material changes to the risk factors disclosed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[181](index=181&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report - None[182](index=182&type=chunk) [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities - None[183](index=183&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to the company - Not applicable[184](index=184&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) There is no other information to report - None[185](index=185&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and XBRL documents - Exhibits include certifications from the Principal Executive Officer and Principal Financial Officer (**31.1, 31.2, 32.1, 32.2**) and various Inline XBRL documents (**101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, 101.PRE, 104**)[186](index=186&type=chunk) [Signatures](index=37&type=section&id=Signatures) This section contains official signatures of the President, CEO, and CFO, certifying the report - The report is signed by Timothy P. Herbert, President, Chief Executive Officer and Director, and Richard J. Buchholz, Chief Financial Officer, on **May 3, 2022**[190](index=190&type=chunk)
Inspire Medical Systems (INSP) Investor Presentation - Slideshow
2022-02-26 07:50
Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. February 2022 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' '' ...
Inspire Medical Systems (INSP) Investor Presentation - Slideshow
2022-02-16 13:15
Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. February 2022 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' '' ...
Inspire(INSP) - 2021 Q4 - Annual Report
2022-02-15 21:07
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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: 001-38468 Inspire Medical Systems, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...
Inspire(INSP) - 2021 Q3 - Earnings Call Transcript
2021-11-03 02:10
Inspire Medical Systems, Inc. (NYSE:INSP) Q3 2021 Earnings Conference Call November 2, 2021 5:00 PM ET Company Participants Megan Rowekamp - Director of Financial Reporting Tim Herbert - President & Chief Executive Officer Rick Buchholz - Chief Financial Officer Conference Call Participants Jon Block - Stifel Danielle Antalffy - SVB Leerink Chris Pasquale - Guggenheim Robbie Marcus - JPMorgan Larry Biegelsen - Wells Fargo Adam Maeder - Piper Sandler Michael Polark - Baird Ravi Misra - Berenberg Capital Sura ...
Inspire(INSP) - 2021 Q3 - Quarterly Report
2021-11-02 20:16
Table of Contents For the quarterly period ended September 30, 2021 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: 001-38468 ______________________________ Inspire Medical Systems, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________________ FORM 10-Q ________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITI ...
Inspire(INSP) - 2021 Q2 - Earnings Call Presentation
2021-08-06 11:46
Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. August 2021 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''pr ...
Inspire(INSP) - 2021 Q2 - Earnings Call Transcript
2021-08-04 03:12
Inspire Medical Systems, Inc. (NYSE:INSP) Q2 2021 Earnings Conference Call August 3, 2021 5:00 PM ET Company Participants Bob Yedid - MD, LifeSci Advisors, IR Tim Herbert - President and CEO Rick Buchholz - CFO Conference Call Participants Robbie Marcus - JPMorgan Chris Pasquale - Guggenheim Larry Biegelsen - Wells Fargo Brad Bowers - Bank of America Merrill Lynch Richard Newitter - SVB Leerink Michael Polark - Baird Adam Maeder - Piper Sandler Ravi Misra - Berenberg Suraj Kalia - Oppenheimer Operator Greet ...
Inspire(INSP) - 2021 Q2 - Quarterly Report
2021-08-03 20:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________________ FORM 10-Q ________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 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: 001-38468 ______________________________ Inspire Med ...