Joseph Papa
Analyst · Guggenheim. Please go ahead
Thank you, Linda. On Slide 16, you see Valeant’s stabilization plan. I’ve been at Valeant for approximately one month now, and I’d like to outline on this page areas that we need to address and approve. I believe it’s a three-step process to be clear. First, the stabilization process of Valeant, which I think will take three to six months, that would be followed by a turnaround stage and ultimately a transformation stage that will take a multiyear processor for Valeant. Today’s discussion is really going to be limited to the stabilization plan, and what we think are the important elements of that stabilization plan. Number one, we need to drive engagement in the company. We need to re-recruit Valeant employees back to the company. We need to add some additional outside talent and we’re going to work very hard to reengage with our partners, the patients, the prescribers, the payers, and investors. Number two, we want to reallocate strategic resources at Valeant to fix the dermatology business, accelerate Salix growth, which is already quite good as Rob mentioned. But I just want to clearly reaccelerate that growth. Number three, we want to refocus R&D dollars into investment for core assets of ophthalmology, dermatology, GI, and consumer. We want to manage the neuro and other business for cash generation and to pay down debt. Finally, we want to execute on the priorities that we already know to exist. We want to improve patient access and address pricing issues. We want to execute on non-core asset sales to help reduce the complexity of Valeant business. We want to focus on debt reduction and tend to cooperate with all government inquiries and seek expedited resolution. On Slide 17, we have identified an action plan and begun its implementation for dermatology. First, we must repair our corporate reputation and regain trust with all of our stakeholders. This will be done through a number of initiatives, including CEO actions of customer engagement and overall pricing and access. We also will reiterate our support to the fields of dermatology and podiatry, both R&D and corporate investment. We also must rebuild the access with the Walgreen program and the independent pharmacy. We’ve been launching a new coupon program with independent pharmacies in June, and we will continue working with Walgreens to improve the patient and prescriber experiences. We must restore profitability at Walgreens through the importation of reimbursement and prior authorization support via qualified third-parties. We have contracted with third-party vendor that will take over this process in June. With respect to dermatology, I want to make sure that you’re aware. A significant portion of our Walgreens prescriptions have profitability significantly below our internal projections and meaningfully below non-Walgreen prescriptions. In some instances, these prescriptions actually have a negative average selling price. The vast majority of the revenue shortfall in dermatology in our revised guidance relates to this average selling price shortfall. The good news is that we believe this problem is fixable and we’re working collaboratively with our partners to address these issues. It is in Walgreens and Valeant’s interest to fix this problem. If we are successful in improving the Walgreens ASP, there will be an additional upside to our current derm latest estimate. We will continue to advance our rich pipeline and demonstrate our commitment to the field of dermatology also in terms of the action plans for dermatology. Now, on Slide 18, there are some early indications of recovery. We have begun to see the process to stabilize this business and see some early indications of recovery. We’ve seen an uptick in prescription in May, which obviously is an encouraging sign, but we still have a lot more to do. We’re just about to launch an access program for independent pharmacies that will improve the patient experience. On Slide 19, as with dermatology, we have a plan to accelerate the Salix franchise. The problem with the Salix franchise, we had significant sales turnover with the Salix integration over the last 12 months. We have appointed a new leader to stabilize the organization accelerate growth. We have also launched a new hepatic encephalopathy education and sales material to both doctors and patients and we’ve also deployed an additional 67% incremental sales reps for hepatic encephalopathy to drive growth. We’ve also reached out to 12 major teaching institution and launched a new educational program about HE. In addition to education, we are improving patient access and adherence to the optimization of our reimbursement hub and other patient assistant programs. On Slide 20, you can see that Xifaxan retail TRx was growing 32% versus last year. But we see tremendous opportunity for the brand, given the new indication and the continued potential with HE. There remains a significant unmet medical need in HE patients, as experts estimate that up to 5.5 million patients in the U.S. have cirrhosis. Of this population, it’s estimated up to 2.2 million are at the risk of developing overt HE. Annually, over 600,000 patients are discharged from the hospital with HE being the primary diagnosis. We estimate the total market revenue opportunity in the U.S. for HE is at over $5 billion. On the IBS-D opportunity, roughly 10% to 15% of the U.S. adult patient population suffers from IBS, and 65% of these have a diarrheal component. Despite new treatment options, many of them are undiagnosed and are not treated. This represents another Xifaxan growth opportunity. On Slide 21, we continue to see steady growth in Xifaxan scripts on a year-over-year basis, but to be clear, they’re below our previous expectations. The performance of new sales team should accelerate the franchise and other Salix brand continue to show additional growth. Finally, we continue to invest in the pipeline opportunity sustained long-term growth, including Oral Relistor. Moving to Slide 22. So although Valeant has areas that need stabilization and improvement, I believe, we have a solid future ahead. We have a strong global portfolio of brands. We have a plan to fix dermatology and drive momentum in Salix. We have a steady performance and consumer contact lens, dentistry, oncology, generics and in Asia. We have an attractive R&D pipeline that will drive future growth. We have improved our U.S. market access and a strong cash flow generation. Let me talk about a few those. Slide 23, provides a brief view of our numerous Valeant brand and the magnitude of our franchises. On Slide 24, we summarize we have approximately $3.5 billion of consumer oriented durable products that collectively have operating margin of roughly 37% and growing in the mid single-digits. This would include the Bausch & Lomb products, lens, solutions, as well CeraVe and other topical products. I’ll let others speculate on this the value of this part of our Valeant business, but a durable global growing business with a 37 EBITDA margin is certainly a very valuable asset. On Slide 25, Dendreon is another valuable, but underappreciated business within our portfolio. Provenge delivers a statistically significant benefit, a 38% improvement in three-year survival rate versus control. Over the past year, the team has turned the business to a profitable growing business by targeting the right prescribers and improving the gross margin by more than 10%. We expect to see this business continue to grow nicely as urologists now make up 49% of the business and have increased their enrollments for Provenge infusion by 22% year-over-year in Q1. On Slide 26, over the past few months, there has been much discussion about managed-care access across our portfolio. We have made significant progress in forging new relationships with our partners and feel that things are stable for our products. We are improving our commercial access with several key brands, as well as improving our Medicare Part D coverage in the second-half of 2016. Beginning June 1, Jublia is now covered on AARP with prior authorization – without a prior authorization and the Lotemax family of products moved to a preferred brand on the Aetna Medicare Saver Rx plan. Finally, our managed care team is now focusing their efforts to maximize formulary access for our upcoming launch of products. In summary, from a U.S. market access perspective, we are well-positioned for 2016, 2017, and beyond. Now, I’m going to turn the call over to Tage, who heads up our R&D operations. Tage?