DexCom, Inc.

DexCom, Inc.

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Medical - Devices

DexCom, Inc. (DXCM) Q4 2008 Earnings Call Transcript

Published at 2009-03-21 00:21:21
Executives
Terry Gregg – President and CEO Steve Pacelli – Chief Administrative Officer Jess Roper – VP and CFO
Analysts
Matthew O'Brien [ph] – William Blair Thom Gunderson – Piper Jaffray Bill Plovanic – Canaccord Adams Raj Kalia [ph] – Sanders Morris and Harris Shawn Fitz – Stephens Incorporated
Steve Pacelli
Thanks, Terry.
Terry Gregg
Thanks, Steve.
Jess Roper
Thank you, Terry. DexCom finished the year strong generating product revenues of approximately $2.45 million during the fourth quarter of 2008 compared to $1.5 million for the same quarter in 2007. Product revenues totaled $8.1 million for the year ended 2008 compared to $4.6 million in 2007. Sequentially product revenue increased $588,000 from Q3 to Q4 of 2008. During Q4, we sold approximately 1,200 SEVEN System Starter kits compared to 770 in Q3. From 2007 to 2008 Sensor revenues were up 105%. Sequentially Sensor revenues were up 25% from Q3 to Q4 of 2008. Total revenue for 2008 was $9.8 million, which included $1.7 million in development grant revenue. As we have discussed previously, DexCom entered into three separate development agreements during 2008, which included Insulet Corporation, Animas Corporation, and Edwards Lifesciences. Animas and Edwards made upfront payments towards development dollars of $13.5 million in 2008. Excluding milestone payments, Edwards is scheduled to make additional development payments of approximately $10.5 million through Q2 of 2010 and Animas made a $250,000 payment in Q1 of 2009. With these up front and development payments we expect to recognize development grant revenue on a straight-line basis over the period of the expected performance obligation. Changes in estimates could impact amounts recognized in future periods. Based on our current estimates, we expect to recognize development grant revenue under these arrangements of $2.8 million per quarter through Q4 of 2010. This quarterly estimate excludes any milestone-based payments that we may also earn. Cost of sales including product and non-product in 2008 totaled $15.4 million compared to $12.7 million in 2007. Product cost of sales totaled $13.4 million for the year ended 2008 compared to $12.7 million in 2007. Our product gross margin loss was $5.3 million in 2008 compared to $8.1 million in 2007. We have experienced an improvement in our negative margin primarily due to increased sales volumes in 2008. Development cost of sales totaled $2 million in 2008 compared to none in 2007. Research and development expense increased by $3.5 million to $19.6 million in 2008 compared to $16.1 million in 2007. Changes in R&D expense included $2.1 million in higher development costs, $1.4 million in higher clinical, regulatory, and quality assurance costs. Major elements of increased R&D costs included $1.2 million increased consulting fees, $1.2 million in facilities costs and $415,000 in supplies. Selling, general and administrative expense totaled $27.7 million in 2008 compared to $22.4 million in 2007. The increase was primarily due to higher selling, legal and marketing costs. Major components of increased SG&A expense included approximately $1.4 million in higher share based compensation, $850,000 increased facilities cost, and $825,000 higher salary cost. Net interest expense totaled $2.4 million compared to net interest income of approximately $800,000 in 2007. The increase in net interest expense was primarily due to lower average balances of our cash and marketable securities combined with lower yields earned on those balances. Our net loss totaled $55 million for the year, included $11.6 million in non-cash expenses centered primarily in share based compensation, depreciation and amortization. We ended the year with $31 million in cash and marketable securities, which included approximately $4 million in restricted cash, and we had working capital of $17 million. Cash, marketable securities, and restricted cash increased by about $1.1 million during the quarter and included a $13 million payment from one of our development partners. Excluding the development payment our cash usage in Q4 was $11.9 million. During the year, we invested $2.5 million in capital equipment and facilities to support our business. On February 4, 2009 we completed a follow-on public offering selling an aggregate of approximately 16 million shares of our common stock for net proceeds of approximately $45.6 million after deducting underwriting discounts, commissions and estimated offering expenses.
Terry Gregg
Thanks Jess. Obviously, we were extremely pleased with our performance in the fourth quarter of 2008 and the year, especially in terms of total product revenue, new patient adds and sensor sales. Highlighting some key performance metrics for Q4, '08, total product revenue grew approximately 31% sequentially from Q3 to Q4. As Jess mentioned, we sold approximately 1200 starter kits for the SEVEN System in the fourth quarter amounting to about a 55% increase in sales kits compared to Q3. We were pleased to see an increase of approximately 25% in Sensor revenues quarter to quarter, which we believe bodes well for the long-term prospects of our business. As we look to 2009, we continue to see tremendous progress on the reimbursement front, both in terms of the adoption of new coverage policies for CGM and the establishment of contracts with payers to cover our products. In early January, UnitedHealthcare adopted a positive coverage policy for CGM. As you know, United was the last of the national payers to issue a policy and in doing so, United established the most comprehensive coverage to date. United policy should make access to CGM available to all of UnitedHealthcare's Type 1 patients with an A1c greater than 7% as well as those patients with an A1c of less than 7% who have experienced hypoglycemic unawareness. Just last week we entered into a contract with CareCentrix to become a provider of specialty diabetic durable medical equipment. CareCentrix is a provider of ancillary care benefit management services for major managed care organizations and has a national contract to coordinate the provision of diabetic DME to Cigna Healthcare members. This means we have the ability to process claims in-house for the nearly 12 million covered lives under the Cigna umbrella of affiliated companies. We now have contracts with five of the seven largest payers and are working diligently to secure contracts with the remaining national payers as well as smaller regional payers. And on a weekly basis, Blue Cross Blue Shield state and regional plans are adopting coverage for CGM. We estimate that today in the US, there are over 130 million covered lives under CGM policies and expect that number to continue to grow during 2009. As expected with the increase in number of coverage policies, we continue to witness a shift in our business from a cash pay model to a broad reimbursement model. In Q4 '08, for example, approximately 70% of our new starter kit sales were through the reimbursement channel and we continue to see a shift from cash pay to reimbursement for our recurring sensor sales. During our third quarter call, we mentioned we were not lacking in patients, but rather we were lacking the ability to process patients effectively. This was due primarily to payers creating administrative burdens for patients and their physicians to demonstrate medical necessity and ultimately receive reimbursement for CGM products under these newly adopted coverage policies. During the fourth quarter, we brought in a team that has worked for me in my former life as President of MiniMed to revamp our customer service organization. They have made tremendous changes in terms of how our back office operates. However, we are still functioning largely on a manual basis in terms of our interaction with the payer system. We need to move to a more automated system and expect to make progress on that front in the coming quarters. So where do we stand as we look out to 2009? We are convinced more than ever that patient demands for CGM is real and is growing. We were pleased to learn in January, that the American Diabetes Association revised its 2009 clinical practice recommendations upgrading CGM from a potential supplemental tool to a useful tool in adults over 25 years of age. This is important because these clinical practice recommendations have traditionally carried considerable weight within the medical community. We believe the reimbursement bottleneck is easing, but there are still challenges as the requirements for documentation still exist at a number of payers. We continue to believe that as insurance companies gain experience in processing CGM claims, they will gain a better understanding of what information is appropriate and necessary to make a coverage decision. We have seen signs of this as Aetna in November of last year revised its coverage policy on the heels of the JDRF clinical trial data to include all Type 1's over the age of 25 without the requirement for additional documentation. Similarly UnitedHealthcare, in January, adopted a comprehensive coverage policy which we believe will enable us to process claims without the need for excessive documentation. Ultimately, we expect these administrative challenges to resolve themselves at the payer level while at the same time we will continue to improve our back office systems and processing capabilities to meet expected increases in patient demand. Moving now to clinical and regulatory, we are pleased to announce that we recently received approval from the Food and Drug Administration to begin commercially marketing our third generation Continuous Glucose Monitoring System which we are branding the SEVEN Plus. So what's new about the SEVEN Plus? Well first, more on-time performance, an updated algorithm delivers more robust data with fewer data gaps and improved sensor performance. Improved overall accuracy. Our clinical study data shows an increase in overall accuracy as defined by median mean absolute relative difference. We have added event markers which let patients note specific activities or events, such as exercise, food intake, sick days, insulin dosing, to help make better diabetes related decisions. Glucose change arrows. These simple icons instantly tell the patient direction and rate of glucose change to help pre-empt a high or low event. A more discreet transmitter, now in a lighter color to help blend into the sensor to make it almost invisible under clothing for maximum discretion. More customization. The SEVEN Plus allows the patient to customize alert and turn features on and off to make for a more personal experience with the system. And finally, 12 and 24-hour trend screens are added to the library of 1, 3, and 6 hour trend screens. So what stayed the same? Well, certainly we continue to be the market leading performance and accuracy in the hypoglycemic zone. We believe this is a critical area where patients require the greatest sensor accuracy. The only fixed hypo safety alarm. Open choice calibration, patients can continue to calibrate the system using any FDA cleared blood glucose meter and a tiny, flexible, most body friendly sensor. Unlike other sensors who use rigid rectangular sensors, the DexCom flexible round bendable platinum wire is designed to be comfortable and it is still the only sensor approved to be worn for up to seven days. With the SEVEN Plus, we continue to provide leadership to the continuous glucose monitoring category by bringing a third generation product in just the third year following our first product introduction, and we believe the SEVEN Plus is the only CGM system that meets the key criteria demanded by physicians, educators and patients. Convenience, performance and simplicity. We announced in November that we entered into a definitive collaboration agreement with Edwards Lifesciences relating to the development and commercialization of a hospital based continuous glucose monitoring system. As we have discussed on previous calls, there is a growing clinical evidence that closely monitoring glucose levels in critically ill patients can positively impact patient care and outcomes. In addition, as of October 1st, 2008, Medicare will no longer reimburse hospitals for the cost of treating what the agency considers to be preventable in-patient complications unless those conditions are also secondary diagnosis upon admission. CMS specifically identified blood glucose control complications including DKA, Hyper and Hypoglycemia and coma as examples of preventable complications. Just last week at an international diabetes meeting in Europe, Dr. Jeffrey Joseph reported on a study of 1,826 consecutive ICU patients, noting that the rate of mortality dramatically increased as the glucose levels increased. As an example, in patients with an average glucose range of just 160 to 179 milligrams per deciliter during their ICU stay, the rate of mortality was approximately 18% higher than patients with a normal glucose range. And in that same patient population, as patients averaged glucose greater than 300 milligrams per dl, the rate of mortality was 40% greater than patients with a normal average glucose range. Also reported was a study concluding that all in-hospital mortality in patients with hyperglycemia, in this study defined as average glucose levels greater than 150 milligrams per deciliter was more than eight times higher than patients with normal average glucose levels. Hyperglycemia results in increased length of stay, increased admission to the ICU and increased discharge to rehabilitation facilities, not their home, all contributing to increased costs associated with lack of adequate glycemic control. Unfortunately today there is no methodology other than utilizing traditional bedside finger stick measurements for monitoring glucose levels and controlling hyperglycemia in the hospital. As we approach the end of the first quarter of 2009, we couldn't be more pleased with the development progress we have made to bring our continuous glucose sensing technology to the critical care setting. Our joint technical teams are operating extremely well together and we believe we are still on track to launch our first generation product in the second half of this year. A quick update on our insulin pump partnerships with Animas and Insulet. In January of this year, we announced an expansion of our Animas relationship to an exclusive agreement to develop and market integrated insulin pump CGM systems in markets outside the US. In return, Animas will pay us $5 million upon receipt of a CE Mark for the first OUS commercial product that is expected either later this year or early in 2010. And in addition Animas will pay DexCom a royalty of $200 per CGM enabled pump sold in any OUS market. As parts of this agreement, Animas will also serve as a nonexclusive distributor of transmitters and sensors to purchasers of the Animas CGM enabled pumps outside the US. This exclusive arrangement has an initial term of three years. We continue our development work on the integrated insulin pumps CGM systems with our pump partners. Our continued goal is to complete all development, clinical and regulatory efforts on these joint development projects and be positioned to launch a first product with Animas during 2009 and with Insulet sometime the following year. But as you are well aware, the timing of the regulatory process is uncertain. In summary, for the past 15 years, I have strongly believed the role of CGM in treating diabetes to be one of the most significant advances in technology since the discovery of insulin. We now know that A1c is a less-than-optimal surrogate marker for glucose control but remains a standard. There is a rapidly growing body of evidence that glycemic variability is more important than A1c in determining clinical outcomes for patients. Researchers are reporting on the role of excessive glycemic variability in pro inflammatory processes, such as oxidated stress resulting in cell and vascular damage. Multiple clinical studies have demonstrated the reduction of glycemic variability with the utilization of continuous glucose monitoring. Just last week, Dr. Lori Laffel of the Joslin Diabetes Center presented data from the JDRF CGM prospective randomized clinical trial on a group of 129 patients who entered the study with an A1c less than 7%. The CGM treated group spent an average of 37 fewer minutes per day in the hypoglycemic range, therefore an increase in target range, over the 26-week study period. In addition, their A1c remains stable while the SMBG group experienced a rise in A1c over that same period. As we look to 2009 and beyond we are extremely excited about our prospects, both in the ambulatory and the in-hospital setting. As you are aware in late January, we completed a follow-on public offering of our common stock raising gross proceeds of $48 million. Prior to the financing, we were often told by investors and analysts that one of their primary concerns regarding the company was a concern over our balance sheet and our need to raise capital in what has become the worse economic downturn since the great depression. Thankfully, with the support of many of our long term stockholders together with a group of new stockholders, we were able to raise the needed capital and we now believe we have appropriately addressed the balance sheet concern. Together with our cash on hand at year end and the additional proceeds we expect to receive from Edwards and Animas, we believe the proceeds from this financing will be sufficient to take us to profitability. That said, we will continue to spend wisely and we will remain laser focused on our mission critical priorities, namely continued commercialization of our ambulatory continuous glucose monitoring systems; continued development of our in-hospital platform together with Edwards Lifesciences, and continued development of our integrated insulin pump systems with our pump partners. DexCom is uniquely focused on sensor technology. It is in our DNA. Our origin was based on a fully implanted subcutaneous sensor, which we have dubbed our sleeping beauty, who may awaken at some point in the future. We've leveraged our implantable technology into the 3-day sensor, two generations of our 7-day sensor, and an intravenous glucose sensor for the ICU. We believe we will see the day that insulin-dosing decisions will be made on the basis of interstitial fluid glucose readings. Key opinion leaders are talking about it from the podium today and we feel extremely well positioned to lead the way. Thank you. We will entertain questions.
Operator
Matthew O’Brien – William Blair:
Jess Roper
Matthew O’Brien – William Blair:
Jess Roper
Matthew O’Brien – William Blair:
Terry Gregg
Matthew O’Brien – William Blair:
Steve Pacelli
Matthew O’Brien – William Blair:
Operator
Thom Gunderson – Piper Jaffray:
Terry Gregg
The first question with regard to the SEVEN Plus, Tom, we will introduce that shortly in terms of everything that's being shipped out of here from this point forward is a SEVEN Plus system. There is an upgrade program that will allow, at least from a sophomore standpoint, in terms of the attributes of it, a backward compatible download. We are FDA approved for a web enabled download system, so patients will be able to utilize that. There will be a requirement for a new transmitter. This transmitter has got some new attributes to it that will allow it to expand its communication to a wide variety of products beyond what it does today to our receiver such as other pumps, as an example. But that program will be spelled out shortly as to the upgrade. It is premium priced over the existing SEVEN system, although not dramatically so. But those prices are being put into place now.As far as Europe, we did ship a small amount of product into Sweden and Finland. And we are continuing – we just got back from a European meeting last week and met with a number of distributors. We are beginning to sign those contracts. And yes, we are CE marked for the SEVEN system and we will begin to expand that out as we roll out the rest of the year. We are going about it in a very diligent way. It is not going to be a very large effort this year as we begin to structure things appropriately. Thom Gunderson – Piper Jaffray:
Operator
Bill Plovanic – Canaccord Adams:
Terry Gregg
Bill Plovanic – Canaccord Adams:
Terry Gregg
Bill Plovanic – Canaccord Adams:
Terry Gregg
Bill Plovanic – Canaccord Adams:
Terry Gregg
No, we are not beefing up the distribution model. What we really expect to do quite frankly is as we leverage our relationship with our pump partners that that distribution will be able to, at least from a field standpoint, in terms of contact with customers that we currently don't call on, we will be able to leverage our partner relationships from that standpoint. Bill Plovanic – Canaccord Adams:
Operator
Raj Kalia – Sanders Morris and Harris:
Terry Gregg
Raj Kalia – Sanders Morris and Harris:
Terry Gregg
I don't think I said the SEVEN Plus is optimal. I think what – and I will take this portion and then get back to the first part. I think my comment had to do with the key metrics that are demanded by physicians and patients in that there is a factor to the product that simplistic the performance and convenience of utilization of it make it optimal or what I would consider maybe another better statement, is best in category, from that standpoint, meeting all the attributes that are demanded by the constituents. With regards to accuracy, there is more data capture. There is less lost data, so from a new algorithm development, in all of these CGM categories, you will lose data at times. It's basically once you turn a signal on or a transmitter on, it is constantly transmitting data. If for some reason the data is noisy, for biological reasons, then there will be data lost in terms of the capture. Raj Kalia – Sanders Morris and Harris:
Terry Gregg
We really don't, Raj. At this point we are still trying to get the systems in place to measure this. But one of the confounding portions of this, as an example, during that same time frame, a patient may enter into the system as a cash patient. So, let’s go back a year. A year ago, there were no – at this time, there were no coverage decisions by any national payers. So if they entered into the system under a cash pay, they would typically be buying one box. Now in that next period of time, four months, six months, eight months, they move from cash pay to a reimbursement. They now may receive up to three boxes of sensors. And so there is no baseline by which to measure because that baseline keeps shifting on us as the contracts get into place. So that's why I'm saying the metric – and quite frankly, we are not spending a huge amount of time and drill down and track that directly. Raj Kalia – Sanders Morris and Harris:
Jess Roper
Raj Kalia – Sanders Morris and Harris: Okay. Gentlemen, thank you very much.
Operator
Shawn Fitz – Stephens Incorporated:
Terry Gregg
Shawn Fitz – Stephens Incorporated:
Terry Gregg
Shawn Fitz – Stephens Incorporated:
Terry Gregg
Shawn Fitz – Stephens Incorporated:
Terry Gregg
Shawn Fitz – Stephens Incorporated:
Operator
That concludes today's conference. Have a pleasant day.