10-QPeriod: Q1 FY2014

DEXCOM INC Quarterly Report for Q1 Ended Mar 31, 2014

Filed May 1, 2014For Securities:DXCM

Summary

DexCom, Inc. (DXCM) reported its financial and operational results for the quarter ended March 31, 2014. The company saw a significant increase in product revenues, driven by the G4 PLATINUM continuous glucose monitoring (CGM) system, which was commercially launched in October 2012. This growth, combined with a favorable product mix leaning towards the higher-margin G4 PLATINUM, led to a substantial increase in gross profit year-over-year. Despite revenue growth, the company continues to invest heavily in research and development, as well as selling, general, and administrative expenses, leading to a net loss for the quarter. Significant increases in R&D were driven by equity-related expenses, headcount, and clinical trial costs, while SG&A increases were attributed to selling costs and IT infrastructure to support growth. The company maintains a focus on expanding its product offerings and market reach, including the recent FDA approval for a pediatric indication of the G4 PLATINUM system. Liquidity remains a focus, with the company believing its current cash position and access to credit facilities will be sufficient to meet obligations through at least March 31, 2015, though future funding needs may arise.

Financial Statements
Beta

Key Highlights

  • 1Product revenues increased significantly by $18.9 million to $46.7 million for the quarter ended March 31, 2014, compared to $27.8 million in the prior year period, primarily due to increased sales volume of the G4 PLATINUM system.
  • 2Gross profit increased by $14.4 million to $29.8 million, driven by higher revenues and a greater sales mix of the higher-margin G4 PLATINUM system.
  • 3Research and Development (R&D) expenses increased by $5.2 million to $14.5 million, largely due to additional non-cash equity-related expenses, headcount, and clinical trial costs for future product development.
  • 4Selling, General, and Administrative (SG&A) expenses increased by $9.5 million to $27.6 million, primarily due to increased headcount-related selling costs and IT infrastructure to support revenue growth and commercialization efforts.
  • 5The company received FDA approval for a pediatric indication for the DexCom G4 PLATINUM system on February 3, 2014, expanding its addressable market.
  • 6As of March 31, 2014, DexCom had an accumulated deficit of $487.9 million and working capital of $63.9 million, with cash, cash equivalents, and short-term marketable securities totaling $57.4 million.
  • 7The company received a warning letter from the FDA on March 14, 2014, related to administrative deficiencies in filing Medical Device Reporting (MDR) procedures, to which it responded on April 2, 2014.

Frequently Asked Questions

The primary driver of revenue growth is the increased sales volume of the G4 PLATINUM continuous glucose monitoring (CGM) system, which was commercially launched in October 2012. The improved product mix, with a higher proportion of the G4 PLATINUM system sales, also contributed significantly to revenue and gross profit.

Research and Development (R&D) expenses are increasing due to investments in future product development, including non-cash equity-related expenses, additional headcount, and clinical trial costs. Selling, General, and Administrative (SG&A) expenses are rising to support revenue growth and the ongoing commercialization of products, driven by higher selling costs, increased headcount, and IT infrastructure investments.

As of March 31, 2014, DexCom had $57.4 million in cash, cash equivalents, and short-term marketable securities. The company believes this, along with available credit facilities, will be sufficient to meet its obligations through at least March 31, 2015. However, they anticipate continued losses due to commercialization and R&D activities and may need to seek additional funding in the future.

DexCom received a warning letter from the FDA on March 14, 2014, concerning administrative deficiencies in its Medical Device Reporting (MDR) procedures. The company responded to the FDA on April 2, 2014, and the FDA is currently reviewing their response. This indicates an area of compliance focus that investors should monitor.