Liam Kelly
Analyst · Morgan Stanley. Your line is open
Thank you, Jake and good morning everyone. It’s a pleasure to speak with you again. Let me start by saying how pleased we are with our fourth quarter results and the strong finish we saw to the year. We executed well across many of our business units, particularly in the second half of 2018. This was led by performance within our Interventional Urology North America, Interventional Access North America, Asia and OEM businesses. As expected, we gained momentum as we moved throughout the year delivering accelerated organic revenue growth in the second half of the year as compared to the first half, resulting in full year organic constant currency revenue growth of 5.1%. This top line achievement, coupled with continued execution on various restructuring initiatives drove approximately 18% adjusted earnings per share growth during 2018. We also achieved several important clinical and regulatory milestones that should position us well for the next several years. Some of those milestones include: publishing new clinical and real world data on UroLift; receiving UroLift Shonin approval in Japan; obtaining the 510(k) for Percuvance, and on February 1 receiving the PMA for MANTA, our recently acquired large-bore vascular closure product. With that as a summary, let me provide you with an overview of our fourth quarter results. During quarter four, revenue grew 7.8% on a reported basis and 9.4% on a constant currency basis, with only a small contribution from M&A, fourth quarter organic constant currency revenue growth was 9.1% driven by NeoTract becoming organic in quarter four combined with strong growth from legacy product families. Turning to NeoTract, or as we call it, Interventional Urology, the business had an outstanding fourth quarter and full year. Fourth quarter revenues were $57.8 million, up nearly 48% compared to the prior year period. And full year revenues were $196.7 million, up nearly 57% year-over-year as physicians continued to rapidly adopt UroLift into their practices. The team of relevant clinical data publications continued in quarter four with the published 12-month data from the use of UroLift in men with an obstructive median lobe showing outcomes consistent with our 5-year LIFT study while we also conducted a separate survey, which demonstrated a very low level of awareness among men of minimally invasive treatment option for benign prostate hyperplasia. Turning to Vascular Solutions, global fourth quarter revenues reached $56.4 million, which represented growth of over 27% compared to the prior year period. Vascular Solutions worldwide revenue growth was once again robust in both North America and EMEA, which continues to benefit from the distributor conversions we initiated in the second half of 2017. For the full year, VSI revenues globally were $209.9 million, up about 18% year-over-year. Turning to some other key metrics, during the quarter, our adjusted gross and operating margins reached 57.6% and 26.5% respectively both expanding 110 basis points over the prior year period. This translated into adjusted earnings per share of $2.77 for the quarter, which is an increase of 13.5% over fourth quarter 2017. But from a full year perspective, our adjusted earnings per share was $9.90 up approximately 18% from 2017 and near the top end of our previously increased guidance range. With that as an overview, let’s now look at quarter four revenue in more detail. Fourth quarter 2018 revenue totaled $641.6 million, which is an increase of 9.4% on a constant currency basis. Beginning with the components of organic revenue growth, during quarter four, we saw organic constant currency revenue growth of 9.1%. Our 9.1% organic growth consisted of 5.4% from product volumes, excluding the impact of the surgical product line exit and the shipping day impact and 1.7% from new product introductions. We had 1 additional shipping day in the fourth quarter, which added 1.4%, and positive pricing, which added about 80 basis points. These constant contributors were partially offset by the surgical product line exit, which negatively impacted quarter four growth by about 20 basis points. This should be the last period in which we have any meaningful impact from the surgical product line divestiture. In addition to growing our revenues organically 9.1%, we also had contribution from M&A of about 30 basis points, thereby making our total constant currency revenue growth in quarter four ‘18, 9.4%. Turning next to our revenue performance by segment, Vascular North America fourth quarter revenue increased 6.3% on a constant currency basis to $85.7 million driven by strong growth in PICC, visual navigation products and EZ-IO. Moving to Interventional North America, fourth quarter revenue was $69.7 million, which is an increase of approximately 13.3% on a constant currency basis. The increase here is primarily the result of higher sales of Vascular Solutions products as well as growth in OnControl. Turning to Anesthesia North America, fourth quarter revenue was $50.8 million, which is an increase of 2.1% on a constant currency basis. Growth in this segment was driven by our airway and EZ-IO products. Shifting to our Surgical North America business, revenue decreased 3% on a constant currency basis to $42.4 million. Surgical revenues were impacted by our decision to exit a low-margin surgical product in 2017, which caused a headwind of about $1 million in quarter four. Moving to our overseas operations, fourth quarter EMEA revenues were up 8.2% on a constant currency basis to $150.9 million. Growth in EMEA was largely driven by distributor convergence as well as increased sales of vascular access products. Now to Asia, fourth quarter revenue increased 5.5% on a constant currency basis to $79.8 million. From a product standpoint, growth in this region was driven by interventional access and surgical products. But from a country perspective, revenue growth was strong within Southeast Asia, Japan and China whose revenues expanded approximately 5.2% despite the most difficult comparison of the year. Next, I would like to brief you on our OEM segment. During the fourth quarter, revenue was up approximately 15.4% on a constant currency basis and reached $52.7 million. The increase in OEM revenues was due to continued strong sales volumes of catheter and performance fiber products. And lastly, fourth quarter revenue for the businesses within our All Other category was up 21.4% on a constant currency basis, totaling $109.6 million. Growth here is primarily attributable to UroLift. That completes my comments on quarter four revenue performance. Turning to a brief update on UroLift, the fourth quarter closed out a spectacular year for UroLift, not only did revenue grow by nearly 57%, but the interventional urology business unit achieved important milestones in the clinical, reimbursement and regulatory categories. Let me highlight a few of the more recent milestone achievements. In November, we were very pleased to announce UroLift received Shonin approval in Japan. Given that this approval came a bit earlier than expected, we have decided to accelerate some pre-commercial investments to work with key opinion leading urologists ahead of obtaining reimbursement and our expected limited launch in mid-2020. As a reminder, our plan to build a market for UroLift in Japan will follow a methodical process like how we are building the U.S. market. We continue to believe that obtaining reimbursement will be at 12 to 18-month process. Once reimbursement is established, we will begin commercialization with academic centers to build strong initial clinical experience, followed by a full commercial launch. In parallel with commercialization, we will begin enrolling a PMDA-mandated postmarket clinical study using many of our initial implanting physicians. In December, 12-month results from a study of UroLift for BPH in men with an obstructive median lobe were published in prostate cancer and prostatic disease, showing significant improvements in BPH symptoms and quality of life consistent with the 5-year LIFT study. This provides an additional tool for the commercial team as they complete their physician training on the median lobe technique. Seeing clinical outcomes improve as the product moves from the clinical to the real world is a rare achievement in medical devices and we are thrilled to have accomplished this with UroLift over the past few years. We also recently commissioned a survey to better understand patient awareness of BPH and its available treatment options. The survey demonstrated that only 6% of patients surveyed in the U.S. were aware that minimally invasive treatments for BPH were available. Additionally, over 90% said that they were either very likely or somewhat likely to seek minimally invasive procedures if they carry less risk of impotence or incontinence. Clearly, we have only scratched the surface of penetrating this very large market. And as the only BPH therapy that has shown 0 incident of new-onset sexual dysfunction, UroLift is clearly positioned for continued leadership in the minimally invasive treatment of BPH. More recently, we announced our reimbursement milestone of receiving a positive coverage decision from Humana, adding approximately 9 million covered lives, bringing UroLift total covered lives to over 270 million in the United States. And lastly, we are thrilled to announce that, to date, UroLift has helped over 100,000 men treat their large prostate with a highly efficacious solution that has completely revolutionized the patient experience in treating the symptoms of BPH. We think its obvious UroLift is an exceptionally strong position and expect full year 2019 Interventional Urology revenues to grow by approximately 30% year-over-year as more physicians adopt UroLift deeper into their practice. Longer term, we continue to have high confidence in our multi-year financial objective for the business and believe that UroLift will become the standard of care for the treatment of BPH. Turning to MANTA, we were pleased to announce on February 1, 2019, that MANTA received pre-market approval from the FDA. This was ahead of our anticipated second quarter 2019 approval assuming no FDA panel review. With this approval, MANTA is now the first commercially available biomechanical vascular closure device designed specifically for large-bore femoral arterial access site closure. We continue to believe the global market for MANTA to be approximately $200 million to $300 million. And our U.S. commercial effort in 2019 will include a limited market release in the second quarter to ensure strong initial outcomes with key thought-leading physicians that we invest in further building the commercial infrastructure to support the long-term growth of this product. As such, we do not expect a significant amount of MANTA revenues in the U.S. in the 2019 time frame. Let me now take a moment to articulate our primary strategic initiatives for 2019. At the top of the list is driving the continued penetration of UroLift. The Interventional Urology business unit is starting 2019 with strong momentum and several tailwinds that we think will result in another year of significant revenue growth. The sales organization is motivated, more physicians are adopting UroLift deep into their practice, the body of strong clinical evidence continues to grow and reimbursement is well established. We don’t plan to change the playbook significantly in 2019. We simply plan to continue executing our proven go-deep commercial strategy as we methodically expand the commercial organization and leverage UroLift’s broad coverage in the United States. The next initiative is to invest in our growth businesses. We have proactively decided to either accelerate or expand key investments in 2019 that we believe will support accelerated organic constant currency revenue growth that is sustainable over a multi-year period. While this will create some headwinds to operating margin expansion in the near term, we think it is the right long-term strategic decision for our company. As such, given the earlier than expected approval for UroLift in Japan, we are accelerating pre-commercial investments in that country. These investments will be focused on key opinion leading urologists to address what we believe is a $2 billion market. We are also expanding our direct-to-consumer and digital marketing initiatives in 2019 following a positive pilot in 2018. Following the acquisition of Essential Medical, we are further building the commercial infrastructure to support MANTA with a focus on accelerating its revenue growth in 2020 and 2021. Next, EZ-IO continues to be a growth driver and we are putting additional resources behind that product. And lastly, we expect our Asia business to continue to drive meaningful growth through 2021, and we plan to support that region with additional sales and clinical resources. Moving to the advancement of some key pipeline products, we continue to be focused on completing the BLA submission for RePlas, which we anticipate occurring in the third quarter of 2019. Following the submission, our focus will shift to TACs that we will need to complete following RePlas approval. First, we need to begin enrollment in the confirmatory post-approval efficacy study that is mandated by the FDA. Second, we will be focused on building capacity for RePlas to support this efficacy study and some initial commercial scale. We remain very enthusiastic about this product and its longer-term outlook. Turning to UroLift 2, once the sales force has trained our physician base on the medium lobe technique, we will begin the rollout of UroLift 2, which we continue to expect in the latter half of 2019 with a full conversion of the U.S. physician base from UL 1 to UL 2 in 2021. Our focus for Percuvance in 2019 is to methodically reintroduce the product to key thought-leading physicians in the U.S. and affects initial market demand. Like RePlas, we are assuming an immaterial amount of Percuvance revenue in our 2019 guidance with no change to our longer term revenue assumptions for this product line. And lastly, non-revenue-dependent margin expansion continues to be a key strategic priority for Teleflex. Our focus in 2019 will be to deliver top savings of previously announced programs while initiating work on our new 2019 restructuring program announced in conjunction with today’s earnings press release. This program involves the relocation of certain manufacturing operations from higher cost locations to existing Teleflex facilities in lower cost geographies and related workforce reductions. In total, we expect to achieve annual pre-tax savings of between $12 million and $14 million once fully completed and we should begin to realize some initial savings beginning in 2021. Overall, our restructuring initiatives remain on track, further supporting our confidence in our ability to achieve our previously provided long-term adjusted growth and operating margin target. When you take a step back and look at 2019 in the context of these strategic initiatives, we believe we can deliver between 6% and 7% constant currency revenue growth and deliver double-digit earnings growth, all while overcoming foreign exchange, tariffs and tax headwinds and make significant investments to position our business for sustainable long-term growth. One last headwind we are overcoming in 2019 is our first quarter divestiture of our vein reprocessing business, which came to us through the acquisition of VSI. Vein reprocessing was a non-strategic business for Teleflex and was not a fit with our long-term vision. While non-strategic, this business contributed $0.06 to our adjusted earnings in 2018. Finally, before turning the call over to Tom, I would like to draw your attention to what we believe is an improvement to our segment reporting structure, which we have implemented in the first quarter of 2019. On this slide, you see our segments as they are reported in today’s earnings release on the left. While on the right is our new segment reporting structure the Americas, EMEA, Asia, OEM and other. In addition to these segment changes, beginning with the first quarter of 2019, as part of our quarterly earnings conference call and messaging, we will provide information concerning our global product family revenue, including global vascular access, interventional access, anesthesia, surgical, interventional urology, OEM and other with the other category capturing our respiratory and urology pipeline. We believe this reporting structure is an improvement and will provide investors with greater visibility into the global performance of our product family. In conjunction with the filing of our 10-K, we will also be posting new supplemental financial information on the Investors section of our website, which provides a quarterly historical breakdown of our newly defined segment and global product family revenues. That completes my prepared remarks. At this time, I would like to thank Teleflex employees and investors for the tremendous amount of support you have provided during my first year as CEO. Now I will turn the call over to Tom for a detailed review of our fourth quarter and full year 2018 financials and to provide our 2019 guidance. Tom?