Operator
Operator
Welcome to the DexCom third quarter 2015 earnings release conference call. My name is Anna, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Kevin Sayer. Kevin, you may begin. Kevin Ronald Sayer - President, CEO, Chief Operating Officer & Director: Thank you very much and welcome, everybody, to the third quarter 2015 DexCom earnings call. We'll start off by turning the time over to Steve Pacelli with our Safe Harbor statement. Steven Robert Pacelli - Executive VP-Strategy & Corporate Development: Thanks, Kevin. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans, and performance, and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our Annual Report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC. We undertake no obligation to update publicly or revise these forward-looking statements for any reason. Additionally, we will discuss certain financial information that has not been prepared in accordance with GAAP with respect to our cash-based operating results. This non-GAAP information is provided to enhance your overall understanding of our current financial performance. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Kevin? Kevin Ronald Sayer - President, CEO, Chief Operating Officer & Director: Thank you, Steve. Joining me today are Jess Roper, our Chief Financial Officer; and Steve Pacelli, our Executive Vice President of Strategy and Corporate Development. Before I turn the call over to Steve to review our financial results, I would like to provide you with some additional color regarding our pre-release a few weeks ago, as I'm confident that many of you were taken a bit by surprise when we announced our Q3 sales numbers and provided some commentary on our payer relationships. On the morning of October 14, a report was issued indicating that we were having trouble processing UnitedHealthcare and Anthem patients under the provisions of our new pharmacy contracts. The investment community reacted to this immediately and we were flooded with calls. As we have said on numerous occasions, payer relationships are challenging. Our efforts to streamline payer operations are never-ending, and we remain fully committed to moving our business primarily to the pharmacy channel over the next few years to increase access to CGM and develop more scalable business processes for the long term. In this instance, because of the confusion created by this report, we felt it was appropriate to alleviate market concerns, pre-release of our Q3 revenues, and provide some additional color regarding our payer relationships. Rest assured, we will not make this a regular policy, more from me later. I'll turn the call back over to Steve. Steven Robert Pacelli - Executive VP-Strategy & Corporate Development: Thanks, Kevin. DexCom reported revenue of $105 million for the third quarter of 2015 compared to $69 million for the same quarter in 2014, a $36 million or 52% increase. Sequentially, revenue for Q3 of 2015 increased $12 million, up 13% from the prior quarter. Our gross profit totaled $75 million, generating a gross margin of 71% for the third quarter of 2015 compared to a gross profit of $47 million and a gross margin of 68% for the same quarter in the prior year. I'd like to take this opportunity to give clarity on the Q3 financial impact of our sooner than expected FDA approval of G5 Mobile. Under the terms of the upgrade program we've previously announced, all U.S. patients who purchased a G4 Platinum with Share system in the 30 days prior to our public announcement of the approval of G5 Mobile until our commercial launch have the right to receive a free upgrade to the G5 Mobile. This upgrade program required us to defer $800,000 of revenue in Q3, related primarily to upgrade transmitters which were not shipped prior to quarter's end. However, we expect to recognize this revenue in Q4 as we ship the balance of G5 Mobile upgrades. We are now at the upper end of our gross margin targets on our sensor disposables and on our hardware, but we remind investors that our gross margin on hardware should be slightly lower for a period of time due to the introduction of the G5 Mobile transmitter, which has a shorter useful life and a lower ASP. Some final thoughts on our revenues and our gross profits, our mix between durable and consumable products remained steady at approximately 30% durable and 70% consumable. ASP for sensors fell within a range of $70 to $75 per sensor, and the ASP for our hardware was approximately $800 to $850 per starter kit. We do note that quarter-to-quarter variability within these ASP ranges stems from our ever-changing payer mix, including direct DME contracts, third-party DME contracts, and pharmacy contracts. Finally, our international business continued to perform, representing $14 million or 13% of our revenues in the quarter. We also note that our split between hardware and sensors OUS is similar to our split in the U.S. Research and development expense totaled $65 million for Q3 of 2015, which included a non-cash charge of $36.5 million related to our license of certain technology from Google Life Sciences, pursuant to which we issued 404,591 shares of common stock. Excluding this one-time upfront payment to Google, R&D expense totaled $28 million for Q3 compared to approximately $19 million in Q3 of 2014, with the increase due primarily to additional payroll-related costs and expenses related to work on our near-term product pipeline and work on our advanced product pipeline. Selling, general and administrative expense totaled $52 million in Q3 of 2015 compared to $34 million during the same quarter in 2014, with the increase due primarily to year-over-year increases in head count in our sales organization, including both field sales and internal sales support staff, as well as additional marketing expenses in connection with our awareness campaign and some investments in our IT infrastructure. Our net loss for the third quarter of 2015 totaled $42.5 million, which included $62 million in non-cash expenses, centered primarily again in one-time $36.5 million charge related to the Google transaction, as well as $22.6 million in non-cash share-based compensation expense across all functional areas of our business. Absent these non-cash charges, cash-based net income was $20 million for Q3, representing 19% of revenue, or put another way, 100% increase over cash-based net income in Q3 2014 of $10 million. Our loss per share for the quarter was $0.53. Again, absent the non-cash charge related to our Google transaction, our loss per share for the quarter was $0.07. With respect to our balance sheet, we ended the third quarter with $113 million in cash and marketable securities, an increase of $16 million from Q2 of this year. And consistent with past practices, we take this opportunity to update our full-year revenue guidance. We are now comfortable that our revenue for the full year will exceed the top end of our range of $375 million. Before I turn the call over to Kevin, I would like to add some additional color around our OpEx spend for the balance of this year and into 2016. Yes, we are continuing to make a significant investment in our future. We have seen exceptional growth since the launch of G4 Platinum in 2012, and we have clearly demonstrated that technology innovation is key to driving this growth. We will continue to take advantage of near-term opportunities to invest in our core business through system performance improvement, such as improved accuracy, extended duration, and reduced calibration; work on our advanced integrated insulin delivery systems; and simplification of our sensor deployment through a new applicator. And we are engaged in numerous clinical trials necessary to demonstrate improved outcomes and lower costs to drive favorable payer policies. But beyond our core business, we have several key initiatives that will require additional investment through the balance of this year and into next. We will look to expand our manufacturing capacity and continue to automate our manufacturing operations to meet ever-increasing demand. We need to invest in our advanced technology development efforts with Google. We anticipate growing our foreign operations, particularly as we see reimbursement evolving outside the U.S. And we need to invest in our data and analytics platforms as we see this as a key differentiator for DexCom going forward. And of course, we can never forget that our obligations to patients come first, and we will make sure that we invest in resources to bring our technology to as many new patients as possible and serve our existing patients appropriately. With that, I'll turn the call back to Kevin for a business update. Kevin? Kevin Ronald Sayer - President, CEO, Chief Operating Officer & Director: Thank you, Steve. We've had a very exciting first three quarters of 2015. Since January, we've introduced the G4 Platinum with Share, apps to enable CGM display on the Apple Watch. We entered into an extremely exciting collaboration with the Life Sciences team at Google, and we launched our G5 Mobile CGM system both in U.S. and in Europe. On top of all that, we've had a $96 million increase or 55% increase year-to-date in sales, and a $27 million or 155% year-to-date increase in cash-based net income. Not a bad nine months. Our G5 Mobile system is the first and only CGM system approved by the FDA for both adults and children as young as two years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The response in the diabetes community for mobile connectivity has been exceptional, and demand from new patients is at an all-time high. We have received numerous letters, emails, and messages of gratitude for this latest technology advance. We also now receive much more advice from our patients on how to make the experience on the (10:20) better, much of which we will consider in the future. As you know, we received approval for this product in late August. And while our initial production plans were targeting a Q4 2015 launch, we made the decision not to delay and began shipping in September. We also initiated an upgrade program whereby all users of a G4 Platinum system with Share from August 1, 2015 until we commence shipping the G5 Mobile system are eligible to receive a no-cost upgrade to G5. And we are also offering a low-cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing systems. I would add that this upgrade program has had a much greater response than previous programs of this nature. The combination of an earlier than expected launch, exceptional demand, and a well-received upgrade program have put a lot of pressure on our manufacturing operations. As a result, we have experienced some transmitter inventory challenges over the past several weeks, which have resulted in some shipping delays to new patients and has limited our ability to quickly fill upgrades to existing patients. We are confident that our transmitter inventory challenges will be resolved in the coming weeks, and they should not have any impact on our fourth quarter performance. A few additional points of interest on G5 Mobile, like its predecessor, the G4 Platinum with Share, users can also select up to five designated recipients or followers who can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere. We plan to launch the Android version of G5 Mobile next year, and note that the Android phone application is already available. Our G5 Mobile launch in Europe not only introduced connectivity to this market, but the CE Mark G5 Mobile is the first-ever continuous glucose monitor that does not require confirmatory finger sticks when making treatment decisions, although a minimum of two finger sticks a day remain necessary for calibration. We have always said that CGM will ultimately be the standard of care in diabetes management, and we see a clear path to the day when the only reason to take a finger stick will be to calibrate your sensor for a safety check to ensure proper sensor – or for a safety check to ensure proper sensor performance. With G5 Mobile, we are now receiving millions of real-time data points each day, and we're expanding our data analytics team to develop platforms that will make CGM even more valuable to patients, healthcare providers, and payers. Finally, with G5 Mobile, we also launched the first phase of our CLARITY cloud-based data platform, which was developed by our Portland-based software development team. Patients can now get an intuitive, retrospective view of their CGM data right on their phone without the need to plug a receiver into a computer or visit their physician for a data download. The first version of CLARITY is geared primarily for patients. Future feature sets will be added to provide healthcare professionals with more advanced tools, and we will ultimately have a CLARITY payer platform as well. Obviously, with ever-increasing demand comes ever-increasing revenue aspirations for the balance of this year and especially in 2016. So we continue to invest on the commercial side of our business. Our number one priority is to increase awareness. Our initial DTC campaigns for G5 Mobile are beginning to roll out this month. And while early feedback is encouraging, it is much too early to report anything more than that. Future DTC investments will be evaluated based on the results of our initial campaigns, which extend through the first half of next year. We need to continue to drive awareness in the healthcare community as well. In connection with the launch of G5 Mobile, I have spent several days in the field over the past few months. And I believe we are in a much stronger position with healthcare professionals than we have ever been, but there's still a lot of work to do. CGM first rings true for many, but not enough. We want to further simplify and expand access for our patients. Pharmacy benefit is the future for us. While we have more than achieved our internal 2015 goal related to the number of covered lives under pharmacy benefit, we have also learned that entering into a pharmacy contract is just the beginning and not without administrative pitfalls. A couple of examples include inconsistent application of pre-authorization policies and failure of individual plans to actually move reimbursement from DME to pharmacy in spite of the contract. Also, there's a common misperception in the investment community that our move to the pharmacy will disrupt our pricing models. This has simply not been the case. And we note that in many instances, we see increased pricing with the direct contract for pharmacy benefit versus pricing with the payer with a third-party DME distributor. But above all in my travels, it becomes abundantly clear that we need Medicare approval for adults and Medicaid approval especially for children. For Medicare, we continue to work on all fronts, administrative, legislative, and judicial. And we work state by state with Medicaid plans and continue to see advancement, but we need to do more. Turning to the Google relationship we entered into this quarter, our objectives for this development are far-reaching. We intend to work together to develop simple low-cost sensor systems integrated into advanced data analytics platforms to improve diabetes care from pre-diabetes all the way through intensive insulin therapy. We expect these advances will make diabetes management much more convenient and flexible than ever before, and we are excited for the promise this technology holds for patients and caregivers. Turning to our core internal product pipeline, we continue to make progress on our advanced Sensor technologies, including Gen 6 and beyond. Activities related to an FDA-approved insulin dosing plan continue to evolve, and we continue to have discussions with the FDA regarding the data that will be required, both pre and post-market, to support such a claim. We need to finalize the requirements before offering more specific guidance regarding the timing of both the dosing claim and G6, as we have no intention of ever moving backwards from a non-injunctive claim once we establish it. We continue to make good progress on the next insertion system, a new lower-cost, high-quality receiver, and several generations of transmitters, all designed to be more convenient for our patients and to reduce costs for DexCom. The new insertion system will be used initially with the G5 sensor and algorithm. From an operations perspective, the new insertion system is one of the most complicated tasks we have ever taken on, but we are confident that it will be a great experience for our patients. We plan to launch both the new receiver and the new insertion system in the U.S. in the second half of next year. We continue to study sensors with no calibration requirements. And based upon the performance we have seen with our advanced sensor technologies and the capabilities of our next-generation algorithm platform, we continue to believe that calibrations can be completely eliminated in the future. We are also making significant investment in next-generation apps with additional features and functionality for our patients. With respect to our pump partners, J&J and Tandem have reported their results and appear to be pleased with their G4 Platinum-enabled product launches. Continued development by the existing commercial pump companies and by several early-stage companies is promising but have not been major drivers of our revenues here to date. One final note, as we look towards the second half of next year, it appears that we will have early data from our DIaMonD study and European studies to demonstrate the therapeutic and cost benefit of full-time CGM use, regardless of the method of insulin delivery, so stay tuned. We'd now like to open up the call for questions.