Peter C. Farrell
Analyst · Bank of America
Great. Thanks, Connie. I'll begin as usual with a summary and then turn the call over to Brett to go through the numbers in a little more detail. And then if there's any time left, we'll take questions. Just kidding about that. First, finances, we finished with another very solid quarter. Global revenue in Q1 '13 grew 8% to approximately $340 million, up 12% on a constant currency basis. Revenue in the Americas grew an encouraging 15% year-over-year to $194.4 million. ROW revenue at $145.4 million grew 9% in constant currency terms, and we believe that our superior product offerings continue to drive our growth as does awareness of the seriousness and importance of diagnosing and treating sleep apnea. Net income for the quarter increased 41% to $71 million, while GAAP EPS increased a robust 48% to a record $0.49 for the quarter. And if we exclude amortization of acquired intangibles, EPS was a record $0.50. And I should note that the net income figure of $71 million is actually 21% of revenues, which shows a pretty solid performance. With respect to product performance, I'll start with masks. Again, all mask categories showed strong growth across all geographies. Accessories also grew strongly, as both large and small DMEs and HMEs are becoming more systematic and effective with resupplied patients who need them. With the success of MS recent mask line, we are seeing the benefits of the replenishment of these masks, as patients are happy to stay with what is most comfortable and most effective. Global growth in Flow Generators this quarter was primarily driven again by AutoSet but also bilevels and VPAP Adapt, our adaptive servo-ventilation product. We are seeing excellent acceptance also for our new high-end S9 products from physicians, especially cardiologists. In the Americas, the S9 AutoSet and the VPAP Adapt ST did particularly well. Growth in the Flow Generator segment was also driven by a continued positive mix from basic CPAP to APAP due to the ongoing growth of home sleep testing, as well as physician preference to put patients on AutoSet since it provides flexible therapy but also improved patient comfort, as well as enhanced compliance. The new EasyCare Online system, which helps compliance management, continues to be well received, and we are seeing a solid uptake from existing but also new accounts. With new technology and superior algorithms, we believe we are taking Flow Generators, and EasyCare Online are certainly one of the benefits which our customers value. There is still uncertainty in Europe, but many countries had very good quarters, especially the U.K., Germany and the Nordics. Despite the challenging economic climate throughout all of Europe, as well as the fiscal constraints therein, the focus is still on treatment that keeps patients out of hospital and keeps them healthy. Our Stellar products did well again this quarter, and EasyCare Online is also gaining traction. We are continuing to see attention and focus on cardiology and its connection with sleep-disordered breathing. There was also a great deal more focused on compliance, especially in France, which, of course, positions us well with our high-quality products. In Asia Pac, we also had a solid quarter, particularly in Japan, due to sales in both Stellar and the AutoSet CS, which is equivalent to the Adapt product sold in the U.S. With the increase in reimbursement in Japan for respiratory and bilevel, we are seeing solid growth in the high-end Flow Generator line. Japan is also very focused on compliance and ensuring that the patient is using the therapy. We are also planning to replicate the Japanese cardiology model, if possible, in other parts of the world. Cardiologists see the quality of life improved on adaptive servo-ventilation therapy, even independent of the level of sleep-disordered breathing, that is in half-value [ph] patients. In short, we're seeing that cardiologists in Japan are actually using adaptive servo-ventilation to dry up the lungs and the pleura, independent of the extent of the sleep-disordered breathing. Emerging markets like India, China and the Middle East also did well in this quarter, with encouraging sales, in particular, of ventilation products in India. Ventilation sales again of Stellar 100 and Stellar 150 continue to grow, especially in Europe, Latin America and, as I indicated, in Japan and India. We are still awaiting regulatory approval in other geographies. Stellar is a very competitive noninvasive ventilation offering for the emerging markets, and the Stellar 150, which includes iVAPS, the intelligent Volume-Assisted Pressure Support system, which is our new automatic bilevel mode, is being extremely well-received. In the humidification area, the HumiCare D900 is now fully launched in Europe and is also being well-received, and we have made our submission to the FDA on the D900 as well. With respect to sales of Stellar products in the U.S., we've decided to discontinue our distribution partnership with CareFusion. It was a mutual decision, and it will allow both of us to more closely align the activities of our field organizations with the priorities of our own businesses. We continue to invest in the development of an advanced ventilation products, and we'll sell the Stellar products and HumiCare D900 to institutions through our own respiratory care sales force. And we've already begun to build that sales force. Our strategy is to sell Stellar into institutional care settings and provide homecare patients with our VPAP ST-A also with iVAPS. And just by parenthetically there, the VPAP ST-A with iVAPS has been approved for respiratory insufficiency, and we've launched this with the S9 platform. Our new Narval mandibular repositioning device, which was recently launched in the U.S., is being well-received, but it is, of course, early days. However, the Narval products, well-received in Europe where it's already been launched. On the home sleep testing front, by next month, 4 out of 5 of the largest commercial payers will require prior authorization for attended PSG in an effort to steer providers and patients towards home sleep testing. United goes live in all its territories, which constitutes 34 million lives on November 1, and certain regions under the world point plan will have the requirement in place by November as well. As a result, 70% of covered lives will need pre-authorization for PSG, and we estimated that in 2011, about 15% of all sleep tests were HST. We expect to see this at around 25% by the end of this calendar year. We continue to see a steady increase in the number of sleep labs involved in HST, over 30% in the last 12 months and 41% in August. We're also participating in primary care physician awareness, as HST continues to advance with PCPs becoming more involved and more important, in fact, in the diagnosis and management of the sleep apnea patient. Self-reported data suggests 10% of PCPs are using 1 of the 3 HST models, that is sleep lab HST, IDTF, mail order HST or PCP direct HST. And another 40% are evaluating HST. So we'll continue to grow. In addition to the studies mentioned in the press release on how diagnosing and treating sleep-disordered breathing can improve health care outcomes, lower hospitalization and readmission risks and also reduce medical expenses, CMS is rolling out 2 major pay-for-performance programs to cut readmission rates and improve hospital care overall. Hospitals with high Medicare patient readmission rates for heart attack, heart failure, as well as pneumonia, will face penalties, and those penalties are slated to grow over the next 3 years for hospitals that fail to drive down readmission rates. Whether it stays in place or works out is a question, of course, but the premise is good and the clinical data show treating sleep-disordered breathing does bring down hospital readmission. And that bodes well for us. Finally, David Pendarvis, Glenn Richards, our Medical Director, and I attended the second meeting at the Society of Anesthesia -- Anesthesiology and Sleep Medicine, which was held 2 weeks ago in Washington, D.C. The conference shows continued interest by clinicians in the perioperative management of sleep-disordered breathing. In fact, data presented showed that patients with sleep apnea have a significantly higher risk of post-surgery complications, ranging from longer hospital stays to even death. Several leading institutions, particularly the Mayo Clinic and Northwestern University, have initiated protocols to screen patients going under the knife for sleep apnea and to monitor and treat those patients after surgery. Their protocols we've had are extremely impressive, and we aim to collect some more detail from both these institutions. All of the peer-reviewed literature continues to make it abundantly clear that untreated sleep-disordered breathing is at best, seriously debilitating and costly to the health care system and, at worst, life threatening. These findings add to the continually mounting evidence connecting serious health disorders to untreated sleep-disordered breathing and point to the necessity of making the diagnosis and treatment of sleep-disordered breathing a standard of care in all medical practice. At this point, I'll turn over to Brett for additional detail on the financials. Brett?