Joseph Papa
Analyst · JPMorgan
Thank you, Paul. Another great review. Let's go through some of the highlights in our B + L/International segment on Slide 14. First, this segment delivered 4% organic growth, as you can see in. the chart. The second quarter's organic growth was driven by an increase in volume, particularly in Global Consumer and Global Vision Care. And looking ahead to future growth drivers for this business, we believe there are mega trends that have the potential to drive demand for eye care products in the years ahead. One of these mega trends myopia or nearsightedness is increasing to epidemic level. Importantly, myopia is also a risk factor for glaucoma, macular degeneration and retinal detachment. And this unfortunately is a global trend. Nearly 40% of North Americans are now affected by myopia and the number of cases have doubled between 1972 and 2004. In Europe, 42% of adults between the age of 25 to 29 have myopia, almost twice the rate of the 55 to 59 year-old, and we're seeing a similar trend in Eastern Asia. 87% of individuals born after 1997 in Hong Kong have myopia compared to 30% born prior to 1950. Bausch + Lomb integrated eye care platform is well positioned, provide products to improve the lives of those with myopia, including corrective lenses, over-the-counter ophthalmic products, surgical offerings and prescription treatments. Turning now to Global Consumer on Slide 15. Our eye vitamins, Ocuvite and PreserVision, grew by 13% organically in the second quarter on a combined basis, driven by brand extensions. LUMIFY continues to outpace expectations, having achieved a weekly market share of more than 35%, just one year after launch. IN the Redness Reliever category, LUMIFY is number one physician-recommended product and number one eye drop on Amazon. E-commerce continues to be an important channel for our Global Consumer product as a second order of Amazon data demonstrates with 83% growth compared to the second quarter of 2018. Onto Slide 16, new products are driving 8% organic growth in Vision Care. International, we saw significant growth in Japan, China, and Russia. And in the U.S., Vision Care had its 21st consecutive month of market-leading growth. If you look at the chart on the bottom left, you can see Bausch + Lomb's estimated U.S. contact lens growth of 13% in the second quarter compared to the industry average of approximately 8%. Globally, B + L grew by 8% compared to the industry average of approximately 5%. I want to highlight one new launch product that is helping drive this growth, ULTRA multifocal contacts for astigmatism. Breaking new ground, this product is the first multifocal toric lens available as a standard offering in fit sets, rather than as a customer order. Now available in the U.S., the ULTRA lenses allow for a seamless transition between distances and given that the limited options for the 32 million people in the U.S. who have both astigmatism and we believe these lenses will have a strong market position and significant growth opportunity. Turning now to Slide 17, Salix had a great quarter, delivering over $500 million of revenue for the first time, driven by XIFAXAN, which had its highest quarterly reported revenue to date. Compared to the prior year quarter, TRx for our promoted brands all grew up nicely in the second quarter. XIFAXAN was up 8%. TRULANCE grew by 31%, and RELISTOR oral was up 12%. Our team also resolved two important property matters. The court upheld the validity in terms of activists infringe our patent protecting RELISTOR tablets, and we resolved the APRISO IP litigation with two out of the four paragraph IV filers. Finally, we anticipate some near-term developments that are expected to be catalyst for this business. These includes three new indication development programs for Rifaximin and a cardiovascular [indiscernible] readout for Amiselimod that we are expecting around the year end. On the right we show our approach to expanding and diversifying the GI business, at the base of our portfolio-promoted products, including TRULANCE lands, which we recently acquired. Building on that basis, the sales team has had a number of additional initiatives that we expect to help grow this business over the longer-term, including new indications for rifaximin, Amiselimod, which is S1P modulator for the treatment of ulcerative colitis, dolcanatide, an investigational compound, which has demonstrated proof-of-concept in treating multiple GI conditions, and investigational treatment for NASH, and finally, and an over-the-counter, probiotic. Overall, we are pleased that progress in our GI pipeline and we're looking forward to a lot of activity over the next 12 months. I want to talk more about XIFAXAN on Slide 18 given its record quarter of 21% reported revenue growth. As Paul discussed earlier, this growth was primarily driven by volume and proactive steps to improve gross to net. We're seeing strong script growth with TRx up 8% versus the second quarter 2018 and up 6% versus just the first quarter sequential of 2019. The primary care of expense is delivering. New Rxs in primary care grew by 16% in the second quarter versus the prior year quarter. You can see the quarterly TRx churn on the right, which shows the TRx growth since the primary care team was added in the first quarter of 2017. And in the second quarter of 2019, XIFAXAN was up approximately 13% in the non-retail channel, compared to the prior year quarter. Onto Slide 19, TRULANCE continues to perform well relative to the 2019 guidance we gave last quarter. In the first quarter of promotion since the acquisition, TRULANCE TRx grew by 31% versus the prior quarter and by 7% over the first quarter. Leveraging Salix existing GI in primary care relation for TRULANCE, we have further integrated TRULANCE with our largest XIFAXAN sales force. As we shown on the bottom ride, we had about 100 reps detailing TRULANCE in the first quarter. We added another 100 sales reps in the second quarter. And as of this month, we've increased that number to approximately 500 sales reps promoting TRULANCE. We also increased GI and Primary Care targets by more than 65% in the second quarter, and increased reach and frequency to healthcare providers by more than 60% since the acquisition. Our team has also done an excellent job in improving market access, commercial coverage as it increased to approximately 86%, and unrestricted access is right around 47%. We've also added 2.4 million covered lives across five regional plans since acquisition and improved coverage for roughly 7 million federal lives through the TRICARE program. Overall, we are very pleased with TRULANCE performance. Moving on to Ortho Dermatologics on Slide 14. While we report a total segment organic revenue decline in the second quarter, the performance of our aesthetic business has been outstanding, up 44% organically driven by the strong launch of Thermage FLX. Another highlight is Dermatology.com, our cash paid prescription program, which is gaining traction. We recently announced that the program will be available at more than 9,500 Walgreens U.S. retail pharmacy locations by the end of this month. We expect approximately 15 products to be available through the Dermatology.com channel before the year end and to launch e-commerce and telemedicine on the platform in 2020. We see a real opportunity for Ortho Dermatologics to be a leader in delivering predictable access to prescription dermatologies at predictable prices. Segment as a whole, we're pleased that new products and aesthetics are driving the transformation of the dermatology business. You can see the progress making on the graph on the bottom of Slide 20. Here we shown the percentage of revenue from Global Solta base business in green and new products, including the Thermage FLX, which are shown at the time line at the bottom of the slide in blue. Beginning in 2017, the revenue from Global Solta generated approximately 15.2% of total segment revenue. In 2018, Global Solta and new products contributed 18.3% and 7.7%, respectively, of total segment revenue. And in the first half of 2019, Global Solta revenue had grown to 21.7% and new products generated 23% of total segment revenue. So with nearly half of total segment revenue being driven by Global Solta and newly launched product, we're moving in the right direction and expecting this trend to continue. On to Slide 21. Early feedback on DUOBRII has been very positive. First and foremost, DUOBRII is a topical treatment you can keep using until your skin is clear before your health care provide instruction. This is a key differentiator. Many healthcare providers recommended benefits of topical products that does not have the duration limitation of other treatments for psoriasis, which is a chronic disease. We're strong momentum and product demand. In the 5th week, post launch, we've delivered more than 1,650 prescriptions. Also DUOBRII's managed care value proposition is compelling. It has the potential to delay some patients from switching to more expensive biological treatment, which could result in an overall healthcare savings. In terms of reimbursement coverage, DUOBRII has more than 30% of covered lives at launch, and we are projecting approximately 75% of covered lives, 12 months post launch. Based on early data, we remain very optimistic about DUOBRII's potential, which combined DUOBRII's efficacy as a treatment. With its potential to create significant cost savings for managed care, we believe there is an enormous opportunity for this product. On to Slide 22, I'm happy to report that all of the Significant Seven products have now been launched. And in the first half of 2019, Significant Segment revenue increased by 76% versus the first half of 2018. On Slide 23, we present our prospective and how the company is positioned for future growth and how we plan to drive long-term shareholder value. First, building on the points that Paul made earlier, we continue to improve and de-risk our balance sheet. We're reduced debt by approximately $8 billion since the first quarter of 2016, and we are successfully managing our maturity profile. Next is growth. We've overcome the primary loss of exclusivity challenge facing the business. And anyway you look at it, we are now growing. The second quarter was our 6th constitutive quarter of total company organic growth. Finally, investment. Our growth is not coming at the expense of tomorrow. We are investing in future growth drivers. We've increased R&D spend and we're getting new products approved and launched, while also strengthening our new product pipeline through business development. We have invested and continue to invest in sales teams to drive commercial growth. Our XIFAXAN Primary Care sales team is delivering growth, and we are deploying 500 sales reps behind TRULANCE as a new driver for our Salix business. We are also expanding sales force were highly and do over it. And we are continuing to build out Solta's geographic footprint. For these reasons, we believe that Bausch Health is well positioned for the future. To wrap up, Slide 24 summarizes the expectations for 2019 that we set forth at the beginning of the year. To review, first, we expect to grow both organically on a reported basis. Second, we expect strong cash flow from operations, R&D is expected to grow by approximately 10%; the Significant Seven revenue is expected to be in 2019; Project CORE is expected to deliver more than $75 million operating profit in 2019; and finally, we've raised our guidance for the year. With that operator, let's open up the lines for questions.