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DexCom(DXCM) - 2023 Q3 - Earnings Call Transcript
2023-10-26 23:57
Dexcom, Inc. (NASDAQ:DXCM) Q3 2023 Earnings Conference Call October 26, 2023 4:30 PM ET Company Participants Sean Christensen - Director, Corporate Affairs & Head of IR Kevin Sayer - Executive Chairman, CEO & President Jereme Sylvain - EVP, CFO & CAO Jake Leach - EVP, Chief Operating Officer Terry Lauver - Chief Commercial Officer Conference Call Participants Robert Marcus - JPMorgan Chase & Co. Margaret Kaczor - William Blair & Company Larry Biegelsen - Wells Fargo Securities Danielle Antalffy - UBS Matt T ...
DexCom(DXCM) - 2023 Q3 - Earnings Call Presentation
2023-10-26 21:12
• • • • Three Months Ended September 30, Three Months Ended September 30, (In millions) 2023 2022 (In millions, except per share data) 2023 2022 GAAP gross profit $ 623.3 $ 494.2 GAAP net income $ 120.7 $ 101.2 Amortization of intangible assets (1) 7.1 — Amortization of intangible assets (1) 8.8 1.8 Non-GAAP gross profit $ 630.4 $ 494.2 Business transition and related costs (2) 1.1 1.6 Intellectual property litigation costs (3) 23.5 9.9 GAAP operating income $ 205.5 $ 147.5 Income from equity investments (4 ...
DexCom(DXCM) - 2023 Q3 - Quarterly Report
2023-10-25 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-51222 DEXCOM, INC. (Exact name of registrant as specified in its charter) Delaware 33-0857544 (State or other jurisdiction of incorporat ...
DexCom(DXCM) - 2023 Q2 - Earnings Call Transcript
2023-07-28 00:14
Financial Data and Key Metrics Changes - The company reported worldwide revenue of $871 million for Q2 2023, a 26% increase compared to $696 million in Q2 2022 [17] - U.S. revenue totaled $617 million, up 21% from $511 million in the same quarter last year [17] - International revenue grew 38% to $255 million, with organic revenue growth of 40% [18] - Gross profit was $553.5 million, representing 63.5% of revenue, down from 64.6% in Q2 2022 [20] - Operating income was $158.4 million, or 18.2% of revenue, compared to $101.9 million or 14.6% in the same quarter last year [22] - Net income for Q2 was $139.4 million, or $0.34 per share, with cash and cash equivalents exceeding $3.6 billion [22] Business Line Data and Key Metrics Changes - The G7 product launch has attracted a significant number of new users, with 8,000 new physicians prescribing G7 in the U.S. [8][9] - The majority of G7 users are new to Dexcom, indicating successful market penetration [8] - The company has seen a notable uptick in demand in the Medicare business, marking Q2 as the highest new patient quarter in its history [12] Market Data and Key Metrics Changes - The company expanded its international G7 launch into six new markets, including Canada and Argentina [13] - The U.K. has shown significant growth due to broadened reimbursement and new clinical recommendations [19] - The company has established over 60% commercial coverage for basal insulin users, validating its value proposition [11] Company Strategy and Development Direction - The company aims to broaden access to its products and has successfully expanded reimbursement coverage for G7 [9][10] - A new product specifically for non-insulin users is expected to launch early next year, leveraging G7 hardware with tailored software [15][76] - The company is focused on operational efficiency and cost management, generating over 450 basis points of operating expense leverage [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong demand and successful product launches [7][25] - The company raised its full-year revenue guidance to a range of $3.50 billion to $3.55 billion, reflecting a strong start to the year [23] - Management noted that the initial response from the clinical community regarding basal insulin coverage has been encouraging [12] Other Important Information - The company has begun commercial production at its Malaysia facility, which is expected to become its largest operation [22] - The company is actively working on reimbursement for its products and has seen rapid progress in this area [9] Q&A Session Summary Question: What drove the international growth this quarter? - Management attributed international growth to increased access, the successful G7 launch in 13 countries, and the Dexcom ONE portfolio strategy [30][31] Question: What is the source of confidence behind the raised guidance? - The raised guidance is based on strong performance outside the U.S. and successful coverage wins domestically, particularly with the G7 launch [34] Question: How much of the sequential improvement in U.S. revenue was from basal? - Management indicated that while basal contributed nominally in Q2, the majority of growth was driven by taking share in existing markets [40] Question: Is there any concern regarding the guidance for the second half of the year? - Management expressed no concerns about the back half of the year, emphasizing confidence in the raised guidance and record patient growth [44] Question: Can you quantify the contribution of Dexcom ONE to international growth? - Management did not provide specific numbers but indicated that Dexcom ONE is contributing positively to growth in newly launched markets [48][50] Question: How is the competitive environment changing? - Management noted that they are gaining share across major reimbursed geographies and that G7 has been well received, with strong pricing trends [60]
DexCom(DXCM) - 2023 Q2 - Earnings Call Presentation
2023-07-27 21:11
• • • • Three Months Ended June 30, Three Months Ended June 30, (In millions) 2023 2022 (In millions, except per share data) 2023 2022 GAAP gross profit $ 546.4 $ 449.5 GAAP net income $ 115.9 $ 50.9 Amortization of intangible assets (1) 7.1 — Amortization of intangible assets (1) 8.8 1.9 Non-GAAP gross profit $ 553.5 $ 449.5 Business transition and related costs (2) 0.7 13.8 Intellectual property litigation costs (3) 20.8 9.2 GAAP operating income $ 128.1 $ 77.0 Adjustments related to taxes (4) (6.8) (6.3) ...
DexCom(DXCM) - 2023 Q2 - Quarterly Report
2023-07-26 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-51222 DEXCOM, INC. (Exact name of registrant as specified in its charter) Delaware 33-0857544 (State or other jurisdiction of incorporation o ...
DexCom(DXCM) - 2023 Q1 - Earnings Call Transcript
2023-04-28 01:12
Dexcom, Inc. (NASDAQ:DXCM) Q1 2023 Earnings Conference Call April 27, 2023 4:30 PM ET Company Participants Sean Christensen - Director, Corporate Affairs & Head of IR Kevin Sayer - Executive Chairman, CEO & President Jereme Sylvain - EVP, CFO & CAO Conference Call Participants Robert Marcus - JPMorgan Chase & Co. Jeffrey Johnson - Robert W. Baird & Co. Lawrence Biegelsen - Wells Fargo Securities Cecilia Furlong - Morgan Stanley Danielle Antalffy - UBS Mathew Blackman - Stifel, Nicolaus & Company Margaret Ka ...
DexCom(DXCM) - 2023 Q1 - Quarterly Report
2023-04-26 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-51222 DEXCOM, INC. (Exact name of registrant as specified in its charter) Delaware 33-0857544 (State or other jurisdiction of incorporation ...
DexCom(DXCM) - 2022 Q4 - Earnings Call Transcript
2023-02-10 02:31
Financial Data and Key Metrics Changes - For Q4 2022, the company reported worldwide revenue of $815 million, a 20% increase from $698 million in Q4 2021, with U.S. revenue growing 17% to $606 million from $517 million [15][16] - International revenue grew 15% to $209 million, with organic revenue growth of 27% in Q4 [17] - Operating income was $172.1 million, representing 21.1% of revenue, compared to $12 million or 1.7% in Q4 2021 [19] - Adjusted EBITDA for Q4 was $237.1 million, or 29.1% of revenue, compared to $67.3 million or 9.6% in Q4 2021 [19] - The company closed the quarter with approximately $2.5 billion in cash and cash equivalents, providing flexibility for growth opportunities [19] Business Line Data and Key Metrics Changes - The company added nearly 450,000 new users in 2022, ending the year with close to 1.7 million customers globally [6] - The G7 product received positive feedback, with 97% of initial users finding it easy to use, and production capacity ramped up to over 100,000 sensors per day [11][12] Market Data and Key Metrics Changes - The proposed Medicare coverage expansion could nearly double the addressable reimbursed market in the U.S. for the basal-only type 2 diabetes population, estimated at 3 million people [9] - International access initiatives expanded reimbursed coverage by 3.5 million lives over the past 18 months [10] Company Strategy and Development Direction - The company aims to build a foundation for sustainable growth through new product launches, market development, and enhancing connectivity [8] - The G7 product launch is seen as a pivotal moment, with plans to increase awareness through marketing efforts, including a Super Bowl commercial [13][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the G7 launch and its potential impact on growth, with expectations for total revenue in 2023 to be between $3.35 billion and $3.49 billion, reflecting a growth rate of 15% to 20% [20] - The company anticipates a temporary decline in gross profit margin due to the G7 launch but expects to return to long-term targets as production scales [22][43] Other Important Information - The company emphasized the importance of driving awareness among physicians and patients regarding Medicare coverage decisions [49] - The company plans to invest significantly in commercial infrastructure and marketing to support the G7 launch and international expansion [58][59] Q&A Session All Questions and Answers Question: What percentage of covered lives are currently in the commercial channel for G7 and expectations for the next quarter? - Management indicated that they are ahead of schedule with pharmacy contracts, reducing expected impacts from the bridge program [26] Question: What is the expected growth contribution from the type 2 basal population in 2023? - Management conservatively estimates a 1% contribution, with potential for higher exit velocity as coverage expands [30][31] Question: How is the adoption pace for type 2 basal expected to evolve over the next 18-24 months? - Management noted that awareness and marketing efforts will be crucial for driving adoption in this segment [33] Question: What is the feedback on G7 in European markets and its impact on share against competitors? - Initial responses to G7 have been positive, with growth driven by established products and new coverage [39][40] Question: How will gross margins ramp throughout 2023? - Management expects lower margins in the first half due to the G7 launch but anticipates improvement as production scales [42][43] Question: What is the expected impact of the bridging program on revenue and gross margins? - The bridging program is trending better than expected, which may positively influence revenue and margins [46] Question: How aware are physicians and patients of the Medicare decision, and what is the plan to drive awareness? - Management acknowledged the need to actively promote awareness among both physicians and patients [49] Question: What are the expectations for U.S. growth in the first quarter and the impact of the Super Bowl ad? - Management expects continued strong new patient growth, with the Super Bowl ad anticipated to drive significant interest [50][53] Question: What are the sources of operating expense growth in 2023? - The largest increases will be in commercial spending to support G7 and international expansion [56][58] Question: How does the company view the long-term gross margin outlook with G7? - Management remains committed to a long-term gross margin target of 65%, with potential for improvement as production efficiencies are realized [62][63]
DexCom(DXCM) - 2022 Q4 - Annual Report
2023-02-08 16:00
Pricing and Reimbursement Challenges - The company has experienced and anticipates continued pricing pressure on its products due to managed care organizations and increased competition, which may adversely affect its financial condition and cash flows [74]. - As of December 31, 2022, the eight largest private third-party payors have issued coverage policies for continuous glucose monitoring (CGM) devices, but reimbursement-related barriers remain, impacting sales [77]. - Medicare currently covers CGM devices only for patients taking at least three doses of insulin daily, limiting coverage for many patients; proposed changes could expand coverage to those using insulin at least once daily [78]. - The company faces risks related to obtaining adequate reimbursement for its products, which is critical for market acceptance and sales growth [78]. - Downward pressure on product pricing may continue if cost-containment efforts by third-party payors are not offset by increased patient access to products [74]. - The company may need to lower net sales prices to secure additional reimbursement arrangements, potentially limiting revenue growth [78]. - Current reimbursement from third-party payors for Type 2 diabetes is generally limited to individuals on intensive insulin therapy [81]. Product Development and Manufacturing - The development of new products requires significant investment in research and development, regulatory approvals, and third-party reimbursement, which may impact future revenue generation [79]. - The company expects that sales of its current CGM systems will account for substantially all product revenue for the foreseeable future, with potential migration to next-generation systems upon their release [80]. - Manufacturing capabilities may not be sufficient to meet market demand, leading to potential growth limitations [83]. - The company has faced challenges in scaling manufacturing operations to provide adequate product supply, resulting in backorders and limited sales efforts [83]. - Manufacturing disruptions at facilities could adversely affect operations and product sales, increasing expenses [84]. - The company relies on single or sole-source suppliers for critical components, which poses risks of supply interruptions [85]. Market Competition and Acceptance - The company faces intense competition in the glucose monitoring device market, with major competitors including Abbott Laboratories and Medtronic [90]. - Market acceptance of the products by physicians and people with diabetes depends on demonstrating safety, effectiveness, reliability, cost-effectiveness, and ease of use [82]. - The relative immaturity of the CGM market internationally limits reimbursement and acceptance of CGM systems outside the United States [81]. International Operations and Risks - The company generated 26% of its revenue from international operations for the twelve months ended December 31, 2022 [94]. - The company’s operations are subject to various international risks, including fluctuations in foreign currency exchange rates and political instability [94]. - The company is exposed to risks related to foreign currency exchange rates, which may reduce the reported value of revenues and cash flows [97]. - The company may encounter barriers to marketing its Continuous Glucose Monitoring (CGM) systems in the U.K. and E.U. due to regulatory changes following Brexit [97]. - The company has limited commercial efforts in various regions and may seek to expand its market presence, contingent on obtaining necessary regulatory approvals [99]. Regulatory Compliance and Legal Risks - The company operates in a heavily regulated healthcare industry, facing extensive foreign, federal, state, and local laws and regulations [107]. - Compliance failures could lead to significant penalties, including civil and criminal penalties, and potential exclusion from government programs [108]. - The company is subject to various federal laws regarding reimbursement, including the federal civil False Claims Act and the Anti-Kickback Statute, which could lead to significant penalties if violated [114]. - The company faces risks related to the completion of pre-clinical studies and clinical trials necessary for regulatory applications, which are long and expensive processes [117]. - Changes in FDA or foreign regulatory approval standards could delay or prevent product approvals, impacting the company's ability to market new products [117]. Cybersecurity and Data Protection - The company is subject to stringent cybersecurity standards and may incur significant costs to comply with evolving data protection laws [102]. - Cybersecurity risks could lead to significant operational disruptions and financial losses, including litigation and regulatory fines [105]. - The company has implemented multiple layers of security measures to protect sensitive information but remains vulnerable to sophisticated cyber threats [105]. - Cybersecurity incidents could result in unauthorized access to personal health information, impacting the company's ability to deliver services [106]. Financial Condition and Capital Management - The company has incurred significant operating losses in the past and may continue to do so, impacting stockholders' equity [134]. - The company raised substantial net proceeds through the private sale of convertible notes but may require additional financing for product commercialization and development [136]. - The company may face challenges in repurchasing its Notes upon a fundamental change or repaying amounts due under the Notes if certain conditions are not met [151]. - The company’s ability to obtain additional financing may be impaired due to its current level of debt and restrictive covenants [150]. Economic and Market Conditions - The ongoing COVID-19 pandemic has caused significant disruptions in sales and marketing activities, particularly in Europe, impacting customer demand [92]. - The company faces significant risks due to global economic uncertainty, including inflation and rising interest rates, which could adversely affect product demand and revenue [161]. - Inflation has led to increased costs in labor, components, and shipping, potentially impacting the company's financial condition and results of operations [164].