Kieran T. Gallahue - President and Chief Executive Officer
Analyst · Natixis. Please proceed
All right. Thanks Brett. All right. I'll make a few comments and what [inaudible] questions that are frequently asked and try to answer those in advance. And then I'll open the call up to more general Q&A. First you can see; we now had our 51st quarter of record results. And those results are in spite of the fact that we had anticipated both Q1 and Q2 of this year to be challenging due to difficult base year comps, GAAP period in our product introductions cycle and the response to earlier price challenges. I should also note that Q2 should be the last quarter where we expect our motor business to negatively impact our Americas growth rate. Q2 represented a few milestones and I'll be remissive if we pass by this call and I didn't note them. This was the first quarter in the company's history that we surpassed $200 million in revenue for a single quarter. And I am very pleased to report that both the Americas and ex-Americas market both contributed over $100 million each, that’s a very nice balance of geographic revenues. All right. Let's transition to talk you about the future and let me say this as a header note. I feel extremely optimistic about this industry as we look forward and I feel just as optimistic about the role that ResMed can play within this industry. And let me tell you why I feel that way. I'm going to cover three basic topics although there're certainly many more that we can go through. I'll talk about our planned, product introductions schedule, a heart failure clinical study that we're initiating and finally the preliminary decision by CMS to allow home sleep testing. First our planned new product introduction schedule. In this quarter, we are launching and in fact in the past few days we've launched two important new products in the Americas. First, the VPAP Auto, which is a bilevel device. The second is the Mirage Micro nasal mask. All right, first on to the VPAP Auto, so what's different about it? First it's our first bilevel product we introduced into the more compact S8 body. It is far smaller than our previous generations bilevel. Second, it will use the same accessory sets such as our S8 humidifier as we use with the more general S8 product line. This helps to provide scale economies for ResMed, while eliminating non-value added changes for our customers reducing their inventory challenges. Third, it's powered by a unique patented double-ended motor, it's the same motor that powers our S8 II CPAPs that we are currently selling outside the Americas. This motor is a core component in our next round of product introduction, because it vastly increases the efficiency of the motor, allowing us to increase performance, while simultaneously reducing noise generated by the device. Because noise is an important factor in user comfort and compliance, we feel this is going to be a very highly valued future of our customers and in fact since it's in the S8 II device that's been launched ex-U.S. we've already being receiving very positive feedback about that. The fourth value proposition for the VPAP Auto is the integration of our unique Easy-Breathe waveform and you will be hearing a lot more about the Easy-Breathe waveform in the coming months. The Easy-Breathe waveform is an extremely comfortable flow pattern that once again improves user comfort and as we know that's a major factor in driving compliance. So, we are very optimistic about the launch of the VPAP Auto, given the timing of the release we should see some of the impact in Q3 although it's going to be a partial impact in this quarter and more full impact in Q4. Second product we’ve introduced within the past few days is the Mirage Micro Mask, and this is our first product introduction into the standard nasal mask category in four years. Just as the quadro set of new standard for a full-face mask performance, we believe the Mirage Micro will set a new standard for comfort, ease of fitting and performance within the standard nasal mask category. As we look to Q4, we should have a full quarter of impact both from the Mirage Micro and the VPAP Auto and then we are going to introduce another series of products during the fourth quarter. Let me go through those for just a minute. On the CPAP side, we will be introducing several of the S8 II product series in to market, in the Americas that we've already launched during Q2 in Europe or outside the Americas. Once again, the products will be powered by our unique double-ended motor technology that has allowed us to improve performance and at the same time lowering noise levels. Just like the VPAP Auto, we will retain the current S8 design and accessories in order to minimize transition challenges for our customers while maintaining our on supply chain scale efficiencies. Finally, we expect to be introducing of new mask product into the nasal pillows category also during Q4 and we will provide more detail on that product as the product launches. So as you can see, we've got a fantastic new product flow over next five months or so and it is a... it is a product line that is built up with innovative technologies, but is also consistent with our strategy of maintaining efficiencies with the customer in our own supply chain. All right, next I would like to address the industry drivers and first, let's talk about congestive heart failure. In January this year, we have begun the recruitment of our first patients into the predominantly European-based clinical study in heart failure. We've long noted the critical role of the treatment of SDB can have on very serious and very costly co-morbidities such as congestive heart failure, such as diabetes, hypertension and others. This study represents a very tangible stake in the ground of our commitment to both providing and generating value from the these co-morbidities. This study, which is intended to be conducted over a five or so year time frame is targeted to the use of adaptive servo-ventilation and very specifically to the use of the ResMed ACS2 product in severe heart failure patients. The primary end points measured by the end points, which are meaningful to the heart failure and to the payer communities, mortality and hospitalizations. The study will engage two primary critical medical specialties, cardiologists and respirologists or pulmonologists. Heart failure costs government billions of dollars per annum to treat and we're optimistic that the use of ResMed's adaptive servo-ventilation, very specifically the ACS2 products will provide clinical benefits but positive economic benefits. While we don't intend to report specifically on the study as it progresses, we'll provide updates as material information or results become available. Finally, let me briefly comment on the preliminary national coverage decision that CMS in December. First of all let me highlight that this decision is preliminary and a final decision is due out in mid March of this year. Now, our reading in the preliminary decision is that CMS has recognized that SVD is an enormous public health issue and they're seeking to increase the access to diagnose this in treatment of the 90% of the patients who have not yet been diagnosed or treated. We also see the decision as an indication that home testing will be complimentary to the current diagnostic pathway and we're hopeful and confident that our valued partners in the sleep community will continue to play a pivotal role in treating patients and we plan to support our partners as they evolve and thrive in this new environment. From the perspective of impact on the SVD device community, this represents an additional driver for growth over the long haul, and one more reason for us to believe that the industry continues to have bright prospects. We remain in an industry that is 90% unpenetrated and achieving sustainable industry growth in the 15% to 20% range is supported by these types of drivers. Now, importantly, there's some water to flow under the bridge before this decision is finalized, and before we feel its full impact in the industry. In general, medical community takes a bit of time to absorb change and it wouldn't be surprising to us if it is 18 months to 24 months to pass before this thing sorts itself out. Nonetheless, it remains a very positive change for the industry and one that we look forward to supporting. So in summary, we're very optimistic about the future of the industry and the role that ResMed can play in our industry's growth and we're looking forward to the positive forward momentum that we'll see not only from our new product introductions that we'll be seeing over the next five months, but also these positive developments in the industry as a whole. All right, with that why don't I take a break and turn it over to Q&A. Akiya? Question and Answer