J. Pearson
Analyst · JPMorgan
Thank you, Laurie. Good morning, everyone, and thank you for joining us. We are pleased to report exceptional results across all financial and operational metrics for our second quarter, driven by strong sales growth and profitability across our regions and businesses, and once again demonstrating the strength of our diversified and decentralized business model.
Before we begin discussing the details of our performance, I want to provide the highlights of the quarter.
We have now delivered 4 consecutive quarters of more than 15% same store organic growth. Strong performance throughout our businesses resulted in both our top and bottom line exceeding the Q2 guidance that we provided on our last call. These results were driven by the continued outperformance of our U.S. businesses and strong market results around the world, including Asia, Australia, Canada, Mexico and the Middle East and North Africa.
I'm also pleased to report that Salix is off to a fast start. The productivity of Salix's R&D portfolio is demonstrated by the approval of Xifaxan for IBS-D in May, and the NDA filing for RELISTOR Oral in June, 2 significant milestones for our G.I. business. We remain focused on reducing Salix's wholesaler inventory and are on plan. Specifically, we have reduced inventory levels for Salix products to approximately 3 to 3.5 months as compared to 4 to 5 months at the April 1 close.
Finally, we have already achieved $500 million in run-rate synergies and fully expect to achieve $530 million by the end of the year.
Third, Dendreon continues to exceed our expectations for both revenue and profitability. We achieved $74 million of revenues for the second quarter, an increase of 18% versus the previous quarter, and gross margins of approximately 64%, an improvement of 15%, and operating margins of approximately 40% to 45%, which we expect to continue to improve during the remainder of the year. This is a huge turnaround for our company that was unprofitable just last year.
On the business development front, we've remained quite active with 8 tuck-in deals already signed and/or closed so far this year. Later in the presentation, we will provide an annual update on M&A performance since 2008.
Based on our stock-based business performance and the approval of Xifaxan for IBS-D, we are raising 2015 cash EPS guidance to $11.50 to $11.80. And our revenue guidance, we're raising to $10.7 billion to $11.1 billion for the year.
We continue to expect total company same-store sales organic growth to exceed 10% for the remainder of the year, despite the genericization of Targretin in July and the expected genericization of Xenazine in August.
For the quarter, our total revenue was $2.7 billion, an increase of 34% over the prior year, largely driven by the exceptionally strong growth in many of our U.S. businesses, which offset negative headwinds from foreign exchange. Adjusting for the negative impact of FX of $173 million, revenue grew 42% over Q2 2014. Cash EPS was $2.56, an increase of 34% over the prior year, which includes the negative impact of $0.13 from the strengthening U.S. dollar. Adjusted for FX, cash EPS grew 41% over Q2 2014.
As mentioned in our press release, Salix had a negative impact of $0.04 on our cash EPS this quarter. Therefore, our cash EPS would have been $2.60 for the quarter without Salix. Rob will take you through the math later in the presentation.
Turning to organic growth, our overall same-store total company organic growth was 19% for the quarter. The exceptional growth of our U.S. businesses, driven by the strength of dermatology, contact lenses, dental and Obagi was complemented by many of our emerging markets, including China, Middle East/North Africa, Russia and South Korea. As we are now halfway through the year, our same-store sales organic growth was 17% for the first 6 months.
Our overall pro forma total company organic growth was primarily impacted by Salix as we continue to reduce inventory in the wholesaler channels. Sales revenues declined by approximately $16 million in Q2 2015 as compared to Q2 2014. Our pro forma total company organic growth, excluding Salix, was 20%.
B&L continues to demonstrate strong organic growth led by our RX Pharmaceuticals in the United States, our U.S. contact lens business and our emerging markets. Q2 revenues increased to $836 million from Q1 revenues of $745 million. We continue to expect B&L organic growth to be approximately 10% for the full year.
As we approach our 2-year anniversary of the B&L acquisition, we have fully integrated the business and manage it as an integrated eye health portfolio. Therefore, this will be the last quarter that we breakout the U.S. B&L organic growth by subcategory.
Turning to our top 20 products. Our top 20 products represented 40% of total second quarter revenue, with the top 10 products contributing approximately 28% of revenue. Our top 20 products delivered organic same-store growth of 32% for the quarter. Excluding new product acquisitions, roughly half of our growth came from volume and half came from price. Our largest product, Xifaxan, represented approximately 5% of Q2 revenues, despite revenues that were muted due to excess inventory in the channel. Jublia is now our second largest product, with annual run rate sales of approximately $450 million. Due to the generic launch of Targretin in July and the generic launch of Xenazine expected in August, we believe both products will fall out of our top 20 products in Q3.
I would also like to note that one of our new products, Glumetza, loses its patent protection in February 2016 and will fall out of the list in 2016.
Our U.S. dermatology business had another excellent quarter, with our launched brands leading the way. Both launched and core brands contributed to the dermatology revenue growth of 55% year-on-year. Jublia scripts grew 37% in Q2 versus Q1, which equates to an increase of 55% on a 4-millimeter equivalent basis. Our DTC campaign, featuring John McEnroe is having a positive impact on the product and continues to expand prescribing volume, particularly with the primary care physician base.
ONEXTON has demonstrated rapid TRx uptake since its January launch, and recently reached 8,000 scripts per week. The fully integrated DTC campaign with TV, print and digital has accelerated growth. The current annualized run rate for ONEXTON is approximately $70 million.
Luzu scripts have reached a new record high, with volume up 55% relative to Q1. Luzu continues to grow with our new DTC campaign driving awareness. The current annualized run rate for Luzu is approximately $26 million.
Lastly, our script transfer our base dermatology business, including Solodyn, Ziana, Atralin, Elidel and Zyclara are all demonstrating strong double-digit growth rates.
Our U.S. eye health business continued its strong growth trend and delivered 10% growth over the prior year. Contact lens grew 19% organically over the prior year. Biotrue ONEday continues to grow 4x faster than its category. Based on the growth of the Biotrue franchise over the last 5 quarters, 6 additional Biotrue lines are currently planned.
B&L's ULTRA contact lens continues to be well received by eye care professionals. Our first commercial manufacturing line for ULTRA is operational and continue to sell to capacity. We recently approved lines 5 and 6 for ULTRA to support the long-term global demand.
Our prescription drug ophthalmology business continues to see strong -- extremely strong growth across promoted brands, fueled by the Lotemax Franchise and Prolensa. We are also quite pleased to announce that we have filed Vesneo with the FDA.
Organic growth for surgical was 1% for the quarter. Adjusted for the continued shift from the sale -- from sales to leasing models of femtosecond lasers, organic growth would have been 3%. We expect to see improving organic growth for the remainder of the year, driven by market share gains across our product lines, including our IOLs and our surgical equipment.
The strong performance of neuro and other as well as the generics portfolio was driven by promoted brands, including Aplenzin, Cuprimine and Syprine. In our consumer business CeraVe, PreserVision and Biotrue Multipurpose Solution, all demonstrated strong double-digit growth demand.
Finally, our dental business continues its track record of strong double-digit growth. In March, we expanded our dental product portfolio through the acquisition of Neutrasal, a treatment for general dry mouth and oral mucositis. When we acquired Neutrasal, its annual revenues were approximately $8 million. After 4 months, the run rate revenue for Neutrasal is over $16 million. This is another example of our ability to quickly have an impact on our acquisitions.
Now turning to the rest of the world. In our emerging markets, organic growth for our business in Asia was 10% versus the prior year. We continue to see strong growth in a number of countries, including China at 15%, and South Korea at 23%. In Latin America, we delivered 7% organic growth, with Mexico at 12%, offsetting more modest growth in Brazil and Argentina.
Central and Eastern Europe, the Middle East/North Africa delivered strong double-digit growth of 18%, and Russia returned to positive organic growth this quarter. Overall growth in other central Eastern European markets were slightly negative this quarter, as they were primarily impacted by Ukraine and Greece. For the rest of the world, developed markets, the underlying business remains strong with our Australian, Canadian and Western European businesses performing well, with 6%, 7% and 5% organic growth, respectively.
Now let me turn to the Salix acquisition. We completed our acquisition of Salix on April 1. We have already achieved several significant R&D milestones with the approval of Xifaxan for IBS-D, the submission of RELISTOR oral NDA and the approval of the RELISTOR injection in Europe. Obviously, the big event was the IBS-D approval, where we saw immediate growth in script uptake of Xifaxan post approval. Our soft launch commenced right after approval, with our sales force undergoing training the first week of June.
At this time, we continue to promote the package insert, as we are still awaiting regulatory approval for our marketing campaign, including our first DTC advertisement. Based on our QuickStart, revenues and EBITDA are both significantly ahead of the deal model, and the integration is nearly completed. In addition to the realignment of the sales force, which we discussed in our last earnings call, we will revamp the sales force compensation model to be in line with our existing performance-based compensation structure versus Salix's structure, which force [ph] ranks the sales team. We believe these adjustments will maximize the effectiveness of our sales team going forward.
Finally, as I mentioned earlier, we are pleased to report that our wholesale inventory reduction program is on plan. We are currently at approximately 3 to 3.5 months as compared to 4 to 5 months at April 1 close. We still expect inventory levels to be reduced to 1.5 months or less by year end. Rob will take you through the details later on the call.
As Slide 15 shows, we have experienced a significant increase in script trends from 15% to 33% year-over-year growth for Xifaxan since the approval for IBS-D on May 27.
Following the close of the acquisition, we held a pipeline review session with the Salix R&D team, the Valeant R&D team and several external experts. The purpose of the session was to provide an in-depth discussion of the pipeline products and determine which ones will move forward. I am pleased to report that a vast majority of the programs are still ongoing and are detailed on Slide 16.
As expected, we continue to be very active with the business development activities. We have closed or signed 8 deals so far this year, with the most significant one being Amoun, an acquisition we announced last week. This acquisition adds approximately $225 million to our existing Middle East/North Africa sales, which is one of the fastest-growing emerging markets in the world. Including Amoun, our Middle East business will be approximately $500 million in 2016.
As we mentioned for a number of quarters, we're continuing to look for opportunities to grow in Latin America, and we recently agreed to acquire Humax, a branded generics company in Colombia, that provides entry into a new market and will complement our current business in Mexico.
Finally, we recently agreed to buy Commonwealth Diagnostics, a company that sells a recently approved test for IBS-D, and we believe this test will represent an important piece of our efforts to tap into the underdiagnosed IBS-D patient population.
When we embarked on a new strategy in 2008, we began to acquire assets that will build a strong foundation and fuel future growth. Since 2008, we have completed over 140 acquisitions, license deals and copromote agreements and deployed over $40 billion in capital. Our IRR hurdles continue to be the highest in the industry. We target IRRs of at least 20%, based on local statutory tax rates, and a cash payback period of 6 years or less. We monitor the process of each deal by tracking both top line and EBITDA by quarter. We share these results with our Board of Directors every quarter, and provide an update to investors on an annual basis.
Today is that update. I'd also like to note that senior management's compensation is tied to past deal performance.
As we break down our deal performance into large, medium and small deals, our track record, I believe, speaks for itself. Our large transactions such as Biovail, Medicis, Bausch + Lomb and Salix, have all performed in line or ahead of the deal model. We believe there are several factors contributing to the success of our large deals, including the benefits of our decentralized model, detailed review of key business drivers and pipeline or other unexpected product upsides.
For our medium-size deals, those $300 million to $1 billion, 10 of the 11 transactions are tracking towards or delivering well above our 20% IRR hurdle, and all have delivered above our cost of capital. We have had a number of homeruns in this category, including Ortho, Dermik, Aton and Sanitas.
Finally, our small deals, approximately 50 of our small acquisitions, approximately 50 which are less than $300 million, in aggregate are performing well above expectation. That is greater than -- return in IRR greater than 20%. This category also includes several homerun deals, deals of greater than 35% IRR fully taxed, such as Coria, Natur Produkt and Targretin. While we have had great success on the small deal front, we do have 4 failed deals, which performed below our cost of capital. Utensil in the U.S., Beta Direct in Russia, PFI in Australia and Bioscience in Canada.
We have analyzed the performance across all of our deals since 2008. Our achieved cumulative EBITDA growth exceeds our deal models by 18%. This reflects performance of our deals before applying the benefits of our lower tax rate. On a cumulative net income basis, the deal model net income reflects our analysis using statutory tax rates, the approach we take when reviewing potential acquisitions.
The cumulative achieved net income includes the benefit of our lower tax rate. When comparing the deal model and accumulated -- achieved cumulative net income, our achieved outcome exceeds our deal models by 59%. Based on our performance of deals to date, our expected IRR, excluding the benefit of our tax rate, is approximately 26%. And our expected IRR, including the benefit of our tax rate, is greater than 37%.
The fourth part of our deal analysis is our targeted 6-year payback period. We have reviewed our largest deals since 2008. We are pleased to report that 5 of these deals have already been paid back entirely, including Coria, Dow, Aton, Biovail, Ortho and Dermik. While many of the smaller midsized deals including Targretin, Elidel and Tecnofarma, which are not included in this page have also been paid back. Other deals, such as B&L, are on track to meet their expected payback period. B&L is approximately 30% paid back after less than 2 years since the closing of the acquisition. Since the time of acquisition, B&L has delivered approximately 30% of Valeant's total EBITDA.
I'd also like to note that B&L, our largest deal prior to Salix, we have approved organic growth from 2% to 9% since acquisition, demonstrating our ability to create value under the Valeant business model. One of the more important parts of our internal deal review is looking back at past acquisitions to determine what has contributed to our success and failure. Slides 24, 25 outlines our key earnings from acquisitions. Now I will turn the call over to Rob.