Thomas Prescott
Analyst · Roth Capital Partners
Thanks, Shirley. Good afternoon everyone. On the call today, I’ll briefly recap Q4 highlights, review our performance by product and customer channel, and update you on our strategic growth initiatives, including the activity and investments surrounding our scanner and CAD/CAM services business. Ken will discuss our Q4 financial results and outlook for Q1 in more detail and provide some qualitative commentary on how we view 2012. I’ll come back and summarize a few key points and open the call up to questions.
The fourth quarter was a strong finish to the year for Align, and we’re pleased to have delivered better than expected revenue and earnings, driven by increased Invisalign case volume and lower than projected operating expenses. We continue to see solid performance of Invisalign across all customer channels and believe that our continuing focus on Invisalign product evolution and market expansion is at the core of this progress.
I’ll start with an overview of key highlights for Invisalign, where our record Q4 Invisalign case volume of 82,600 cases increased 4.1% sequentially and 30.1% year-over-year. Like I said earlier, a strong finish to a good year.
For North American GP dentists, Q4 case volume increased 6.4% from Q3 and 31% year-over-year to a record 33,100. During the quarter, we saw solid growth of Invisalign across our GP customer base, particularly with Invisalign Full and Assist.
Results of our recent customer survey, which included 300 GP practices, show that GPs attribute increased use of Invisalign to better marketing of their practices, increased clinical confidence with Invisalign, and increased patient demand overall. The survey also found that overall satisfaction with Invisalign has increased among GP dentists over the past year, particularly among newly certified doctors. We believe this is due in part to the improved Invisalign doctor site and ClinTec software user interface launched with Invisalign G3, that has proven to be far more intuitive and easier to use.
North American ortho case volume for Q4 was 29,890 cases, a slight decrease of a few hundred cases from Q3 as expected, due to normal seasonality in orthodontic case starts. Recall that more teenagers begin treatment in the summer than in the fall, and our North American ortho starts are typically down somewhat in Q4.
On a year-over-year basis, Q4 ortho case volume increased 36.3%, reflecting increased penetration of Invisalign across our ortho customer base from all products. Since the launch of Invisalign G3 in October of 2010, we have continued to see strong growth among ortho customers. The customer survey I just referenced also included 200 orthos who attributed increased use of Invisalign to a number of factors, starting with higher patient demand created by our consumer advertising, along with clinical improvements that have resulted in improved predictability, delivering better outcomes and giving them increased confidence with Invisalign. This input is consistent with other feedback regarding Invisalign G3 that we’ve heard from customers all year. We believe the additional new features and innovations launched in Invisalign G4 will continue to build on the progress we’ve seen to-date with Invisalign G3 and help doctors gain greater confidence and achieve even better clinical results when treating more complex cases.
On the international front, Q4 case volume of 19,600 cases increased 7.9% sequentially, driven by our core European countries. Specifically, we saw an uptick in Italy, France, and Spain as they rebounded from their seasonally slower Q3 summer period, while Germany and France continued solid growth. On a year-over-year basis, international case volume increased 20.3%, reflecting that good growth from Germany and France, which are benefiting from increased sales force coverage and marketing program investments over the past year. In addition, growth from our distribution partners in the Asia-Pacific, EMEA, and Latin American regions continues to outpace the rest of the world and contributed to strong year-over-year growth.
Now let’s review the key Invisalign metrics that measure our customer penetration: utilization rates, or what we call same-practice sales of our product; as well as the number of new doctors trained as we continue to grow our base of submitting practices.
Overall, Q4 utilization increased to 4.1 cases per doctor. Utilization among North American GPs increased to 3 cases per doctor. Utilization among North American orthos decreased slightly to 7 cases per doctor, reflecting the seasonality in their teen case starts, and international doctor utilization increased slightly to 4.1 cases per doctor.
During Q4 we trained a total of 1,925 new doctors, compared to 1,585 in Q3. In North America, we trained 955 new docs, an increase of 30% from last quarter, as we typically train more GPs after the summer months.
Across our international geographies, we trained 970 new doctors, up from the 855 we trained in Q3. And of the newly trained international doctors in Q4, several hundred were trained by our distribution partners in anticipation of full commercial Invisalign launches in Russia and the Middle East. It also reflects our direct efforts to support the continued ramp in China by training some new doctors.
I’ll now turn to an update on our key strategic initiatives and discuss progress in each area. To do that, I’ll start with product and clinical innovation by providing a brief update on the launch of Invisalign Express 5. I’ll touch on our continued progress in the teenage orthodontic segment using all Invisalign products, including Invisalign Teen, and increased use of Invisalign Assist with newly trained GPs. I’ll also touch on our efforts to accelerate development for our scanner technology, including new software releases as well as some of the new offerings announced by Straumann and BIOMET 3i.
Let’s get that started with Invisalign. We recently announced Invisalign Express 5, a cost-effective treatment option for very minor crowding, spacing, or orthodontic relapse treatments requiring 5 or fewer stages of Invisalign aligners. We believe that many patients want to correct a little crowding or their minor malocclusions but don’t actually pursue or accept treatment because they believe orthodontic treatment is too expensive for those minor corrections.
Invisalign Express 5 gives doctors a new option for these patients, and unlike lab-based, manually produced aligners, Invisalign Express 5 has all of the cutting edge technology of Invisalign and delivers the benefits of straighter teeth at a price consistent with those minor fixes. Invisalign Express 5 is a shorter-duration option to Invisalign Express 10, and is available to our North American customers beginning this week for $549.
This product ensures that Align can be a more complete competitor in clear aligner therapy by addressing a growing segment with a best-in-class product at a very competitive price. Since announcing Invisalign Express 5 in early January, initial feedback from customers has been very positive, and we are excited about the potential for Invisalign Express 5 in the market.
Now moving on to the teenage orthodontic segment, which for us consists of teenagers 19 and younger using any Invisalign product. Teenagers are still the largest segment of new orthodontic case starts, and they represent a great opportunity for us to continue taking share from existing wires and brackets case starts to increase our share of chair.
In Q4, the number of teenagers starting treatment with Invisalign products was 18,140, or 22% of total case volume, as compared to 20,170, or 25.4% of total case volume in Q3. As expected, teenage cases declined sequentially, reflecting normal seasonality in the orthodontic market. Q4 teenage case starts increased 32% year-over-year compared to 8% in Q4 last year.
We had similar trends with the Invisalign Teen product this quarter, which declined sequentially but still grew 41% year-over-year to 9,805 cases. For the full year, total teenagers using Invisalign were 68,885, an increase of 18% from 2010. Overall, we’re very pleased with our results in the teenager segment.
Our estimates of current orthodontic market growth imply a low single-digit growth rate, and against that framework it appears we are continuing to gain share while helping the increased category growth over the long term. We’re confident that we’ll continue to make steady progress increasing Invisalign’s share, especially among the teen population.
Usage of Invisalign Assist, which is designed to help newly trained and lower-volume GPs gain confidence using Invisalign, continues to increase steadily as well. In Q4, Invisalign Assist case shipments were 5,695, an increase of 9% sequentially and 50% from the same quarter last year. 5-0. 50% from the same quarter last year.
Our integrated consumer marketing platform combines traditional print and broadcast media with a balanced mix of PR, event marketing, and social media. The goal of this consumer platform is to raise awareness of Invisalign and Invisalign Teen as the best options for a healthy, beautiful smile among adults and teens. In addition, this platform enables us to help prospective patients find a great practice that can meet their needs.
One of the ways we measure progress on this front is through activity on our consumer website, where prospective patients can get more information and search for an Invisalign doctor in their area. In 2011, we had more than 4 million visits to invisalign.com, with a growing number of leads and ever-improving conversion to patient starts. In Q4, we continued building awareness and demand for Invisalign with this integrated platform, although with a significantly lower profile in TV advertising due to typically pre-holiday competition for airtime and consumer attention.
On a public relations front, Invisalign was featured in 2 of the nation’s most popular women’s lifestyle magazines, Women’s Day and Women’s Health, in articles about best treatment options and age-proofing your smile. October provided an opportunity to reach more than 17 million consumer households by focusing on the benefits of Invisalign Teen in 2 “Halloween tips and treats” satellite media tours.
On the digital and social media front, we continued our campaign to develop valuable online advocates and social media content through our Invisalign Mom advisory board and blogger events across North America, including a successful Invisalign Teen campaign targeting Canadian moms.
As for event marketing, in December we wrapped up the “Disney’s Next Big Thing” tour, sponsored by Invisalign Teen. The tour gave local doctors and Invisalign reps in each market the opportunity to engage with thousands of parents and kids at each event and created millions of media and online impressions through its related traditional PR and social media aspects.
Moving forward into Q1, we are stepping up our media spend with national and cable TV advertising primarily focused on moms and teens, and expanding our presence in top markets with radio advertising to complement our TV ads.
Turning now to international. Our continued growth in these geographies requires us to integrate all of our strategic initiatives, particularly technology and product innovation, which helps doctors treat more complex cases. In addition, we are very focused on enhancing the customer experience, sales effectiveness, and professional education programs across all our direct geographies.
The good news here is that Europe and other regions are even more underpenetrated than North America for both Invisalign and orthodontic treatment, and the cases they treat are more complex. For that reason, we believe that Invisalign G3 and G4 will continue to support growth into these markets with those more-difficult cases.
When we factor in the economic headwinds in Europe into these opportunities, it has motivated us to accelerate some of our planned evolution in sales coverage, sales and marketing efficiency, clinical education, and the Invisalign platform itself that we went through several years ago in the U.S. We’re still early in this process, but are seeing positive signs of progress and are confident we can drive growth here.
Outside of Europe, Japan continues to exhibit solid growth, albeit on a small base. In China, our newest direct country market, we continue to make progress on executing our strategy of working initially with the key opinion leaders and leading public and private doctors. To that end, the fourth quarter capped off a very successful inaugural year for Invisalign in China. During Q4, we hosted several well-attended Invisalign orthodontist lectures in the key hospitals for our 4 core target cities, and we held additional Invisalign training courses for opinion leaders and other key doctors. We also made advancements in getting Invisalign entered into the pricing system of major public hospitals. Finally, while still on a very small base, we received more initial and follow-on cases from early influential users.
In Q1, we’ll continue to focus on execution of our KOL-focused [ph]strategy and continue heavy clinical education and support for our practitioners. Overall, the level of interest and encouragement and engagement among doctors who are advocating for Invisalign is strong, and I’ll keep you posted on our continued progress there.
We also continue to expand our base internationally through entry into new countries using distribution partners to cover these smaller, but still very important, country markets of Asia-Pacific, EMEA, and Latin America. Collectively, they continue to make very good progress and represent 14% of international Invisalign revenue, with growth rates outpacing those of Europe and North America.
We recently launched Invisalign in the Middle East and received regulatory approval in Russia, which we announced earlier this month. And on a smaller scale, we have good efforts going on in Brazil and Argentina, places that should be a good fit for the Invisalign value proposition, for both practitioners and patients. We have great opportunities in these other regions, and while individually these are smaller in scale, collectively they represent great long-term opportunity. And while we’re still far behind North America in terms of orthodontic and Invisalign penetration, it just means we have greater head room for future growth in all these geographies.
Moving on to our scanner and CAD/CAM services products, Q4 revenues for both was $10 million, compared to $11.6 million in Q3. Q4 scanner sales were $5.2 million, compared to $5.4 million in Q3. Q4 CAD/CAM service sales were $4.7 million, compared to $6.2 million in Q3. The sequential decrease in Q4 revenue reflects lower than expected scanner sales in Europe based on lower procedure volume and lab activity as well as lower scanner-related CAD/CAM services.
In North America, scanner sales continued to benefit from leveraging our sales and marketing resources, including Invisalign and industry events, to introduce scanners to our customers. We generated a lot of interest for iTero scanners at the American Dental Association meeting in Las Vegas in October as well as the Greater New York Dental Show at the end of November. Overall, we are doing better than our original expectations in North America but yet not enough to offset the softness in Europe.
Part of the reason for that solid performance was our progress with the technology. In December, we announced a significant software enhancement for the iTero 3D scanning system using dental practices for a wide range of restorative dental procedures. The latest version of iTero software includes the Invisalign scanning protocol for full interoperability with Invisalign treatment, including links to the Invisalign doctor’s site and the Invisalign case gallery for patient education. It also includes the important enhancements to software tools that will help deliver faster, more accurate 3D impressions of the patient’s dentition and greater efficiency for iTero customers.
The value proposition for inter-oral scanning for GP dentists remains compelling. As we’ve described before, GPs primarily do restorative work that makes up the majority of their day-to-day workflow. When it comes time for GPs to start an orthodontic case, they have to kind of switch gears to ortho mode. They stop what they’re doing in all the restorative work, and recalibrate their office and staff on a procedure they still do infrequently.
To help make it easier for them, we are developing chair-side applications to run on our inter-oral scanning systems for use with Invisalign treatment. The goal is to enhance Invisalign case assessment and treatment planning by bringing digital tools chair-side in the practice. Providing real-time chair-side applications on our scanners will make it much easier for GPs to set up an Invisalign case, discuss the scope of treatment, and set expectations with the patient.
During 2012, we’ll start rolling out these chair-side applications to begin helping our lower-volume doctors integrate these tools into their practices in a way that complements their existing workflow in the office. Our first chair-side application is currently in beta testing with a small number of North American GPs. We’ll start to wrap up this beta test soon, and begin collecting and analyzing feedback in preparation for commercial launch this summer.
Among our core Invisalign orthodontist customers, we are leveraging our direct sales force and also utilizing established customer events like our series of Invisalign regional ortho forums to help drive sales of iOC scanners. This is especially attractive for those ortho customers who are looking to differentiate their practices by further integrating digital technologies such as inter-oral scanners and replacing the cost and unpleasant experience of PVS impressions altogether.
This trend toward accelerating digitization is very positive, as we have been one of the very few treatment modalities in dentistry that rely fully upon digital technologies. As the Invisalign process has improved for our customers, more and more initial Invisalign case submissions are transmitted to us on a digital basis, including digital records like x-rays and photos and treatment plans, except for the physical PVS impressions themselves. Approximately 80% of our incoming Invisalign case submissions now are fully digital, except for those PVS impressions, which patients consistently report as the worst part of their otherwise wonderful Invisalign experience.
Since making interoperability with Invisalign available on IOC in May, we’ve seen digital impressions begin to replace traditional PVS impressions among ortho practices with our scanner. In fact, of the 80% of the cases I just referenced, 6% of them now are fully digital and include that iOS digital impression instead of a PVS impression. This trend is positive for both Align and our customers, as they get their clin check and final cases faster, with less hassle for patients, and all reports to-date indicate aligner fit is even better.
Straumann, our distribution partner in Europe, and BIOMET 3i, are both leaders in dental implants. They each provide custom dental implant abutment solutions on the iTero scanner, and because we have an open architecture platform, anyone can use what we call our STL files. That means that customers can export our STL digital files to any third-party lab of choice for additional restorative options.
We’ve entered into a limited market release for the Straumann implant analog digital workflow. This workflow allows oral surgeons, periodontists, and general dentists the ability to take an iTero scan of the Straumann scan body and utilize a stock Straumann repositionable analog and abutment to complete the restoration. This new digital workflow gives the clinician the open choice to utilize the Straumann digital workflow with custom in-stock abutments. We expect the analog workflow to be in general availability in the near future. Beyond these product initiatives, we continue to work with the Straumann team on restaging growth in their European territory.
We are also continuing to actively collaborative with BIOMET 3i to support their Bella Tek Encode digital workflow with the iTero scanner. Our collaborative educational and marketing events are providing exciting opportunities for BIOMET 3i implant customers to adopt the new digital workflow with iTero. We expect this collaboration within our field sales and marketing teams to grow over the coming months with expansion of our iTero field sales teams.
I’ll now turn the call over to Ken for more detail on our fourth quarter financials and outlook for Q1, and I’ll come back for a few closing remarks. Ken?