J. Pearson
Analyst · Goldman Sachs
Thank you, Laurie. Good morning, everyone, and thank you for joining us. On today's call, I will begin by reviewing Valeant's second quarter results by major products and by major business segments. I will then provide an update on our business development activities and our recent product launches and finally, review our product status and early thoughts on the Allergan integration.
I will turn the call over to Howard, who will provide an update on Valeant's guidance for the second half of 2014 and our outlook for 2015 and '16, both as a stand-alone company and as a potentially combined company with Allergan. Finally, we will provide you with a brief update on our offer for Allergan. After our remarks, Howard and I will be available for Q&A.
The second quarter of 2014 was highlighted by strong growth and strong performance across our entire business. We are pleased to report that as expected, organic growth is accelerating and significantly improved from the first quarter. As previously reported, Bausch + Lomb grew organically at 12%, and we have now successfully launched 17 new products in the U.S. alone.
This past May, we announced that we were selling our injectable products to Galderma. By selling these assets early, we were able to clear the major FTC hurdle towards the June regulatory approval for Allergan and realize the full value for these products. We closed the sale to Galderma on July 10. The $1.4 billion raised by this transaction will be used for Allergan -- for the Allergan transaction and/or other future business development opportunities.
We were excited this quarter to receive FDA approval for Jublia, earlier than expected and with the addition of a stronger label than anticipated. The physician and patient interest in Jublia has been exceptional.
During the quarter, we also signed 3 important emerging market business development deals. We acquired branded generic companies in both Indonesia and the Middle East and North Africa, while we also acquired a colored contact lens company in Korea that serves Asia. We continue to actively pursue tuck-in opportunities to expand and enhance our current operations.
Finally, we are pleased to report that we have reached an agreement with the Irish government and the local unions to successfully restructure the Bausch + Lomb contact lens plant in Waterford, bringing the plant's cost structure in line with our plant in Rochester and allowing us to make a long-term commitment to our Waterford operations.
For the quarter, we delivered total revenue in excess of $2 billion, an increase of over 86% from the prior year. Our cash EPS was $1.91, and adjusted cash flow from operations was $500 million for the quarter, an increase of 18% over the prior year.
Organic growth accelerated this quarter as we had previously guided. We achieved same-store organic growth of 4% for the total company, including the full impact of all generics, for the second quarter of 2014. As is our practice, we excluded assets held for sale, in this case, the facial injectables we were selling to Galderma, from the calculations. I will discuss this business in a few minutes.
Given that we have passed the anniversary of the loss of exclusivity for Zovirax, we no longer exclude the impact of Zovirax generics from our organic growth, although the product obviously continues to decline. Excluding the impact of generics Retin-A Micro and Vanos in the U.S., and Wellbutrin XL in Canada, same-store organic growth was 10% in Q2.
Excluding generics, our U.S. business exhibited outstanding same-store sales organic growth of 15%. Our emerging market segment delivered a same-store organic growth rate of 8% and pro forma organic growth of 10% for the quarter. And on an overall pro forma basis, Valeant reported 8% organic growth for the quarter, including the impact of all generics.
Given the ongoing commentary by Allergan, we thought it would be helpful to provide an overview of our acquisition of Medicis 18 months ago. We acquired the Medicis operations for approximately $2.6 billion back in December 2011 (sic) . We acquired 2 main businesses: medical dermatology and aesthetics. On the aesthetics side, we recently sold certain facial injectable products to Galderma for approximately $1.4 billion, for a gain of over $300 million. We are pleased to report that under Valeant's ownership, we accelerated the sales performance of the Medicis aesthetics assets through Q1 of this year compared to the performance under previous Medicis ownership. In April, we announced our offer for Allergan and publicly stated that we would be divesting these aesthetics products.
As expected, the aesthetics business deteriorated in Q2. The physicians were confused as to what products we wanted them to buy: our legacy Medicis products or our soon-to-have Allergan products. The uncertain status of our MVP Program also created concern for the doctors. Our reps and management were focused on pleasing their new owners and holding back sales until they worked for the new company, and our competitors were discounting heavily and disproportionately trying to take a temporary share to demonstrate weakness in our business.
As a result, our sales dropped approximately 40% in Q2. Fortunately, these assets are now safely in Galderma's hands, and we can now focus on the rest of our business.
Turning to medical dermatology. We realized a weaker-than-planned performance in 2013 due primarily from the sales force disruptions during integrations, coupled by significant channel loading by Medicis prior to their sale of this asset. For example, we inherited a business with over 6 months of Solodyn in the channel. The business has now stabilized with a new management team, and the branded market share has increased across all key Medicis products since the beginning of 2014. This includes Solodyn, Ziana and Zyclara.
In addition, we recently received approval for 2 new products, Luzu and BV MetroGel, which will be marketed by our partner Actavis. These 2 products have combined peak sales potential of well over $100 million. Perhaps most importantly, we learned from experience and applied these learnings to the B&L integration, specifically in not disrupting the sales forces. So despite the early challenges, the Medicis acquisition will still deliver significant returns to shareholders and a payback of less than 6 years.
Turning to our top brands. As promised, we will now be breaking out our top 20 products each quarter. On the following 2 pages, we show revenue for the second quarter and year-to-date and indicate whether the product is showing growth and whether the primary growth driver is price or volume. The top 20 products represent revenue of approximately $1.2 billion in the first half of 2014 or approximately 31% of total Valeant revenue. In total, these products grew 22% year-over-year year-to-date, with approximately 45% of the growth coming from volume, which excludes obviously the declining products such as Zovirax, which went generic last year.
Slides 9 and 10 show our top 20 products. We have excluded the aesthetic facial fillers as these products have now been divested. It is interesting to note that 7 of our top 20 products are nonprescription products and 8 of the top 20 are Bausch + Lomb products. 15 of the 20 products are growing, with 3 running flat as compared to last year. These flat performers are mostly older contact lens solution brands. We will continue to provide this list each quarter going forward, but unlike most pharmaceutical companies that have very large products, the products are likely to change to some degree each quarter.
Moving to our performance by business. I would like to touch on the growth and performance of our developed market operations, excluding the Bausch + Lomb businesses. In the U.S., dermatology grew approximately 7% in the quarter, including the headwinds from generics, driven by the continued growth of Acanya, Targretin and Elidel. Furthermore, we successfully launched Luzu in the quarter, and we are excited by the early market response.
Our U.S. consumer business grew approximately 6%, driven primarily by the growth in CeraVe, which delivered growth of over 20%. Our dental business continued its double-digit growth track record as we expanded our sales force and introduced new products. Our neuro and other portfolio also grew double-digit this quarter as several of our promoted brands within this portfolio, Xenazine, Wellbutrin and Syprine contributed to the strength. Finally, our operations in Canada and Australia negatively impacted our growth as Canada dealt with the headwinds from the generitization of Wellbutrin XL, and Australia was affected by the loss of exclusivity for Tambocor and Aldara.
Turning to our emerging markets. Our operations in Europe, the Middle East and Africa delivered strong organic growth of 12% as we saw a rebound in the Polish and Russian markets. We continue to see pressure in the Ukraine where our business is down over 20% year-to-date. But as our sales in the Ukraine are relatively small, this is not a material impact to our overall results.
In Southeast Asia and South Africa, we reported 17% organic growth as we continue to see strong demand for our products, especially in Southeast Asia and in China, while South Africa was essentially flat year-over-year, but it is expected to improve in the back half of 2014. Latin America did decline this quarter as Brazil suffered from an economic slowdown and increased competition in our sports nutrition business. We also realized a temporary decline in Mexico due to delayed regulatory approvals of Atlantis products, which have been recently transferred to our Valeant plant. This issue is now complete, and we expect Mexico to rebound in the back half of the year. Finally, we've also realized softer sales in Venezuela due to government-imposed currency restrictions.
As we reported on our last few calls, the Bausch + Lomb operations have continued their strong performance since we closed the transaction nearly one year ago. In the U.S., the Bausch + Lomb operations delivered 14% organic growth, while the emerging markets delivered growth at 13%; and the other developed markets, such as Western Europe, delivered high single-digit growth. These results demonstrate the strength of our decentralized business model that empowers our general managers and their teams to focus on growing their local businesses.
Overall, Bausch + Lomb's organic growth rate was once again double-digit, with a 12% growth rate in the quarter. With 90% or more of the growth coming from volume, we believe that this continued strong performance is especially important and will serve as a model for what we hope to achieve with Allergan.
We believe that some of the questions around the growth of Bausch + Lomb stems from a general lack of understanding about the overall business, both in terms of the size of each of the units and how much of the business is truly nonprescription. We hope the information disclosed in this deck will help assist investors by providing a clearer picture of the key elements of the business.
It would not be a Valeant conference call without mentioning business development activities. We closed the PreCision transaction in early July, 2 months later than originally expected due to delays with the regulatory review. Following regulatory review, we were required to divest both Tretin-X and the generic tretinoin products. This impacts us by about $10 million in expected sales in the second half of this year.
During the quarter, we continued to expand our operations in several emerging markets, including South Africa, where we acquired several OTC products primarily in women's health; in Indonesia, where we are acquiring a branded generics business with a direct presence in a market of over 240 million people, which is expected to close in the third quarter; in South Korea, where we acquired a full range of contact lens modalities for both clear and colored lenses, with a strong presence in Asia and in addition, a low-cost manufacturing facility, giving us the opportunity to expand to the product lines internationally; finally, we bought a company in the Middle East, which expanded our direct presence and country coverage into Saudi Arabia, Egypt and Jordan, with branded generic products and manufacturing capabilities.
As I mentioned before, we have now successfully launched 17 products thus far in 2014 in the United States. The highlights in dermatology are the launch of Luzu, which has now gained over 12% market share in the branded market; and the recent launch of Jublia, which has received strong reception in the 3 weeks it has been available and has achieved over 1,300 scripts in the week ended July 18, despite the fact that our promotional materials are not yet approved by the FDA and the only way we can promote is off-the-package insert.
In eye health, we have launched new products in both contact lenses and surgical products this year. We have talked quite a bit about our excitement around the potential for renewed growth in contact lenses following the launch of Ultra, our monthly, silicon hydrogel contact lens, and we are currently selling every lens that we can make. We are underway with construction for 2 additional manufacturing lines in Rochester, and we'll plan for an additional line which we will be ordering imminently.
We -- in addition, we have seen accelerated growth from our Biotrue ONEday line, which we expect to continue with the launch of Biotrue ONEday for presbyopia. In surgical, we have received strong physician feedback given our new approval for lens fragmentation with the VICTUS machine and expect this to be a catalyst for future installations. In addition, the approval of additional Trulign ranges will provide further options and access to our premium IOL range for both doctors and patients.
Finally, we have launched several new products and line extensions to existing products in our consumer portfolio. The launch of PeroxiClear has gone particularly well, garnering 9% market share after 1 quarter in the peroxide market. We also relaunched a new and improved formulation of Soothe XP, which we are detailing to eye care professionals, and we expect to see this product on major retailer shelves by August. Finally, we continue to expand our popular CeraVe moisturizing brand with a new CeraVe Baby product offering.
Given the strong reception from both physicians and patients of our recently launched products, Jublia, Ultra and Luzu, each of them has exceeded our expectations. As I mentioned, after only 3 weeks of being available, last week's script demand for Jublia exceeded over 1,300 scripts. This trend is expected to accelerate as regulatory approval for marketing materials are received and our dermatology sales force is appropriately trained. We are adding a new in-house podiatry sales force of 50 representatives. We are adding a new 80-person -- or 100-person primary care sales force through a CSO, and we are expanding our dermatology field force by at least 30 reps.
Luzu is running ahead of forecast with 12% market share of the branded markets 4 months after launch. Luzu will also benefit from expanded dermatology, podiatry and primary care sales force, as well as the increased investment in sales and marketing. Finally, we have made a decision to launch a major DTC program for Jublia. Given the label and the safety requirements, we think this can be a direct-to-consumer product, and we plan an extensive TV, print and radio DTC program and digital DTC program in the latter half of this year.
Finally, Ultra. Our new silicone hydrogel contact lens, as I mentioned, is selling to capacity, and we are planning to expand the field force by 50%, ahead of an expected national launch to prepare for the increased capacity that's coming online in Rochester.
We have made the decision to substantially increase our investment in sales, marketing and promotion and in the medical side to support the business in the second half of 2014, which we estimate will be approximately $80 million. This is -- we believe this decision will maximize long-term value of these products for our shareholders even at the end of some short -- temporary short-term results.
We have recently updated you as to our strong R&D pipeline, so I will not go through each item on this slide. Today, I will highlight the 2 compounds that are nearing significant clinical milestones.
Brimonidine, our eye whitening product, successfully met its Phase III study endpoints. We have enrolled the safety study, expect to receive data in the third quarter. Our current expectations are to file with the FDA in the first quarter of 2015. Additionally, latanoprostene, our glaucoma product, we're expecting to see data from our first Phase III study in the third quarter, with the second Phase III study to be completed and data received in the fourth quarter. As we mentioned on our call, we estimate that peak sales from these products could be in the $1.1 billion to $2.4 billion range.
Before I turn the call over to Howard, I want to provide a few thoughts on the Allergan acquisition. As we have stated before, we believe that the Bausch + Lomb transaction will serve as the blueprint for the Allergan integration. We have learned from our past integrations, including Medicis, that focusing on customer relationships is key, and we plan to err on the side of caution with the Allergan business.
A number of our key initiatives would include keeping the global aesthetics team for Allergan largely intact, keeping the dry eye and glaucoma commercial team largely intact, retaining the neurology and urology teams from Allergan and thoughtfully integrating the dermatology team to minimize disruption to customers. We also want to retain key R&D people for the high-value-added R&D programs, and we will primarily focus on achieving our synergies through expense reduction and noncustomer-facing personnel, specifically targeting corporate, global functions and regional functions. Finally, organizations outside the United States will be integrated into our decentralized model to fuel growth and efficiencies.
With that, I will turn the call over to Howard.