Shacey Petrovic
Analyst · Canaccord. Your line is open
Thanks, Deb and good afternoon everyone. I am pleased to join you for my first earnings call as CEO of Insulet and to do so from our new company headquarters and U.S. manufacturing facility in Acton, Massachusetts. As most of you know, I assume the role at the start of this year after serving for the last few years as President and Chief Operating Officer. I am so proud of all of the company and our dedicated employees have achieved over this time. Insulet has made remarkable progress having just delivered our third consecutive year of over 20% revenue growth, improving gross margins from the mid 40s a few years ago to the mid 60s now and achieving net income for the first year in Insulet’s almost 20-year history. As Insulet begins a new chapter our team remains focused on achieving our long-term strategic, financial, and operational goals. We are at an important inflection point transitioning the profitability, expanding globally and creating new pathways for how we can improve the lives of those with diabetes. I would like to review the highlights of our financial results in the fourth quarter and present some color on progress we have continued to make in executing our strategic initiatives. I will turn the call over to Mike to walk through our results in more detail and I will then come back to discuss our outlook for 2019. Mike and I will then take questions. Our fourth quarter financial results once again demonstrate our strong commercial and operational execution. It was another record quarter and we made demonstrable progress toward achieving our 2021 financial targets of delivering $1 billion in revenue, 70% gross margin and a mid-teens operating margin. In the fourth quarter, we delivered revenue of $165 million, representing year-over-year growth of 26%. We drove gross margin to 67%, a 600 basis point improvement from 1 year ago and we achieved over $16 million of operating income. This strong quarter resulted in both positive operating income and net income for the full year for the first time in Insulet’s history. I continue to be incredibly pleased with our team’s focus, drive and deep commitment to our customers. We are in a great position to create value for our shareholders in the near and long-term. I will now provide additional color on the progress we made throughout 2018, which was a year of tremendous execution and foundation building for long-term sustainable and profitable growth. We began 2018 with the much anticipated guidance from CMS that Omnipod can now be covered through the Medicare Part D or pharmacy channel. Securing this coverage has provided us with a direct pathway to the pharmacy as well as to state Medicaid coverage. And by the end of the year, we successfully secured Omnipod coverage for about one-third of all Medicare lives and almost half of all Medicaid lives. Together with the in-network coverage for Omnipod through UnitedHealthcare that we secured in early 2018, we have expanded our access to the additional 40% of the U.S. diabetes market we didn’t have access to previously. We have already started to see the impact of this significant increase in access, which helped drive our record Q4 U.S. revenue and new patient growth. This expanded access establishes a strong foundation to fuel growth over the long-term. In June, we received FDA clearance for our next generation mobile platform Omnipod DASH. DASH is designed to be the simplest and most preferred insulin delivery system on the market as well as the foundation for our future innovation. We are wrapping up our limited market release and we look forward to kicking off our full commercial release in a matter of weeks. In a short period of time, we have already secured impressive coverage for DASH. We will leverage this coverage position and launched DASH in the U.S. through the pharmacy channel providing several competitive and strategic advantages for us. In the pharmacy by eliminating the upfront cost of the Personal Diabetes Manager, we are providing a better customer experience for the patient coupled with lower out-of-pocket costs. For the physician, Omnipod DASH can be prescribed with a simple e-script and less burdensome paperwork. And for payers, we have established a true pay-as-you-go model, which offers them less risk as they don’t have to pay the thousands of dollars upfront for our product they would otherwise would for a traditional tubed pump. While we expect the shift in business model away from an upfront charge to be a significant win for Omnipod, we anticipate it will result in a temporary headwind in our year-over-year U.S. revenue growth comparisons. However, this impact to be limited to the initial months of the DASH launch and we anticipate very healthy U.S. Omnipod demand and revenue growth for 2019. And longer term DASH has the potential to dramatically reduce barriers to pump therapy adoption. Beyond our DASH system, we have already announced that with our Omnipod Horizon automated insulin delivery system, which we expect to launch in the second half of next year, we will make both hybrid closed loop and personal smartphone control of the part of reality. We are incredibly excited about our progress on Horizon development and proud that Insulet will be the first to deliver this experience to the diabetes community. According to recent independent market research from Seagrove Partners, Omnipod Horizon is the single biggest winner as a standalone AP product and respond installed that our patch pump design with phone control is the best embodiment of an AP pump. Omnipod Horizon will be game changing for people with diabetes taking glycemic control, ease of use and discretion to a whole new level. In addition to substantial progress on our new product innovation, last year marked significant progress on our global footprint with our successful midyear transition to a direct model in Europe. We have more than 120 talented team members with extensive diabetes experience up and running across Europe. We are now better able to support our large and growing European customer base and to gain market insights to help inform our innovation pathway and global expansion opportunities. Add to this, the significant top line and gross margin benefits and we have established a robust business with incredible growth potential. I spent time with our team in Europe a couple of weeks ago and it is clear we are strengthening our relationships with clinicians and payers adding new patients across the continent and improving on the legacy European customer experience. The most recent independent survey data from dQ&A shows that in the last 6 months, our European team has made an incredible impact and just as we see in the United States, our net promoter score in Europe is number one compared to all other insulin pumps. Finally, I want to touch on our new highly automated state-of-the-art U.S. manufacturing facility. As you know, over the past 2 years, we have made a significant investment in sophisticated custom designed automation that will enable us to reduce costs, continue to raise the bar on product quality and increased capacity. In fact even after all of the improvements we have made in China over the last couple of years, one line in the United States will provide up to 50% of the capacity of our total China operations with up to 90% less headcount. It is great to see our manufacturing automation in the clean room and undergoing validation. We are looking forward to being up and running shortly. This is truly an investment in the future, one that strengthens our supply chain and creates important redundancy and scalable capacity. We had a terrific 2018, which is reflected in our record results and our achievement of profitability. Our team continues to execute successfully on our strategic initiatives driving financial and operational improvements while improving our customers, while ensuring our customers remain at the core of everything we do. With that, I will turn the call over to Mike.