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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2014 - Q3
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Operator

Good morning. My name is Holly and I will be your conference operator today. At this time, we would like to welcome everyone to the Actavis Third Quarter 2014 Earnings Conference Call. (Operator Instructions). I would now like to turn today's event over to Lisa DeFrancesco. Please go ahead ma'am..

Lisa DeFrancesco

Thank you, Holly and good morning, everyone. I would like to welcome you to the Actavis third quarter 2014 earnings conference call. Earlier this morning we issued a press release reporting Actavis' earnings for the third quarter ended September 30, 2014.

The press release together with additional materials including our slide deck are available on a website at www.actavis.com. We're conducting a live webcast of this call, a replay of which is also available on our website after its conclusion.

Please note that today's call is copyrighted material of Actavis and cannot be rebroadcast without the company's expressed written consent.

Turning to slide 2, I would also like to remind you that during the course of this call, management will make projections or other forward-looking remarks regarding future events or the future financial performance of the company.

Important to note that such statements and that event are anticipated after the results, process or other non-historical facts are forward-looking statements and reflect our current perspective of the business trends and information as of today's date.

Actual results may differ materially from current expectations and projection, depending on a number of factors affecting the Actavis business. These factors are detailed in our periodic public filings with the Securities and Exchange Commission.

Actavis disclaims any intent or obligation to update these forward-looking statements except as expressly required by law.

With us on today's call today are Brent Saunders, our CEO and President who will provide an overview of our third quarter financial and business highlights and update to our 2014 forecast and additional commentary on our road map for growth. Todd Joyce, our Chief Financial Officer will then discuss the Actavis third quarter results in more detail.

Also on the call and available during the Q&A are Paul Bisaro, our Executive Chairman, Bob Stewart, our Chief Operating Officer, Bill Meury, Executive Vice President of Commercial Operations for North American Brands; David Buchen, Executive Vice President of Commercial Operations for North American Generics International; David Nicholson, Senior Vice President of Global Brands, Research and Development and Bob Bailey, our Chief Legal Officer.

With that, I'll turn the call over to Brent..

Brent Saunders

Thank you, Lisa. Good morning, everyone and thank you for joining us this morning for this update on our third quarter financial results and business performance. We're pleased to report an exceptionally strong third quarter. Our first, following the combination of Actavis and Forest into a single company.

We achieved a number of objectives during the quarter, we drove dramatic growth in both revenues and earnings. We delivered strong growth in our key brands in our North American generics and international businesses; we continue to invest in both brand and generic R&D to expand our product pipelines.

We used strategic investment and business development to expand our anti-infective and GI portfolios and we accelerated our integration activities across the board and are on target to pull forward synergy capture more rapidly than we originally estimated and complete our integration ahead of schedule.

As a result, we’re increasing our forecast for the remainder of the year. We’re proud to report an 83% increase in total revenue to $3.7 billion.

This increase in revenues was driven by strong sales of key products in our North American brands business continued strong performance across our North American generic and international businesses and by strength in our Anda Distribution business. Adjusted EBITDA increased 158% to $1.3 billion. Non-GAAP earnings per diluted share rose 53% to $3.19.

Our Actavis North American brands business delivered revenue of $1.6 billion. I would like to share some highlights across key brand therapeutic categories and there are many, as you can see from slide 6. In our CNS franchise, we continued to focus on the conversion of Namenda IR to XR with XR sales increasing as we enhanced manufacturing capacity.

Viibyrd, Fetzima and Saphris also continued to deliver solid results. In GI, we saw growth continue for Linzess, benefiting from the resumption of DTC efforts and our Asacol HD and Delzicol franchise has stabilized following the right-sizing and training efforts with our sales force following the integration in August.

We also continued to strengthen our GI business with the announcement of our option to acquire Rhythm Health, Inc. In our women's health franchise, Lo Loestrin and Estrace Cream have both grown steadily for three consecutive quarters.

And finally, our products in respiratory and anti-infective continued to respond favorably to focused sales and marketing initiatives and we have strong development momentum particularly with Caz-Avi and our pending acquisition of Durata.

Patient, caregivers and healthcare providers continue to respond favorably to the benefits of once-daily dosing of Namenda XR. With inventory building, the conversion rate from IR to XR has climbed steadily to 38% which is in-line with our expectations following the supply constraints.

We believe that we’re on a solid growth trajectory to achieve approximately 50% conversion by year end. As a result, we now plan to discontinue the general sale and distribution of Namenda IR immediate release tablets in January 2015.

After that date, we will make the immediate release tablets available through a nationwide specialty pharmacy for prescribing to patients upon an indication of medical need, as determined by their physician.

While there is lawsuit brought by the New York State Attorney General seeking to force continued distribution of Namenda IR, we're defending our right to make and implement this decision and have made these plans accordingly. Going forward, we will continue to focus on educating physicians and caregivers about the benefits of once-daily formulation.

We’re also preparing for the potential introduction of the fixed dose combination of Namenda and Donepezil as well as key brand and therapeutic innovation for patient care. Moving to Linzess, sales of the product were strong, up almost 30% quarter over quarter.

We expect this trend to continue as we support the brand with our fully integrated sales force and continued DTC initiatives which we resumed in September. As you can see on slide 9, we're seeing steady growth for Lo Loestrin oral contraceptive.

In addition, we received positive news in October with the Federal Circuit Court of Appeals upholding our patent and finding it infringed by Lupin and Amneal. We’re pleased that the patent protection on Lo Loestrin is secure to 2029.

We will launch a focused consumer campaign beginning in December to accelerate the growth of this product into 2015 and beyond. On slide 10, in early October we announced the proposed acquisition of Durata Therapeutics, a development and commercialization stage company focused on innovation in unmet infectious diseases.

We’re extremely excited about this acquisition. It is an example of the kind of focused, strategic investment that we'll be making to drive long term growth for our anti-infective portfolio. Durata's lead product, Dalvance is the first and only IV antibiotic for acute bacterial skin and skin structure infections with once-a-week dosing for two weeks.

Dalvance is positioned uniquely in this space due to its dosing benefits versus vancomycin and the impact reduced dosing can have on hospital admissions and cost associated with long term inpatient treatment for skin infections.

It will complement our existing inpatient-focused antibiotic Teflaro as well as our late stage development product ceftazidime-avibactam which has an FDA action date during the first quarter of next year.

In addition to the near term revenue for Dalvance, the company's pipeline also includes a next-generation Dalvance with a potential for use as a single-dose treatment in uncomplicated skin infections, as well as other infection types including osteomyelitis.

Last week, we received FTC clearance for the transaction and we remain on target for a close by end of year. Our business development activities also focused on expanding our GI pipeline. On July 2nd, we completed the acquisition of Furiex Pharmaceuticals including Furiex's lead product, eluxadoline.

In October, we announced an exclusive option to acquire Rhythm Health, Inc. and its diabetic gastroparesis product, Relamorelin. Eluxadoline is a potential first-in-class treatment of symptoms of diarrhea-predominant irritable bowel syndrome or IBSD, a condition that affects approximately 28 million patients in the United States and Europe.

Earlier this quarter, FDA accepted our NDA submission for eluxadone and a European marketing authorization is under review. We anticipate an FDA approval decision during the second quarter of 2015 and a possible launch of the product in late 2015 or early 2016. If approved, eluxadoline would represent a significant advance for patients with IBSD.

Our exclusive option to acquire Rhythm Health, Inc., announced in early October, would bring another significant opportunity to our GI franchise with Relamorelin, a potential best-in-class Phase 2 agent for the treatment of diabetic gastroparesis, a significant GI complication that could impact up to 40% of a Type 1 and up to 30% of a Type 2 diabetes patients who have not benefited from a new treatment for diabetic gastroparesis for more than 30 years.

Both of these acquisitions bring important opportunities that we expect will contribute to long term revenue generation in our GI business. It would be highly complementary to our flagship product, Linzess, our Asacol HD/Delzicol franchise and five other promoted GI products.

Looking at our late stage pipeline development on slide 12, we’ve a number of key drivers in the months ahead that will continue to fuel our North American brands growth. Near term, we're expecting regulatory decisions by the end of 2014 and into the first half of 2015 for 5 pipeline programs.

We’ve PDUFA dates for our Bystolic and Namenda fixed dose combination submissions later this year. In early 2015, we will be preparing for PDUFA dates for Lyleta [ph], our IUD contraceptive previously referred to as Levosert; Viibryd low dose and Caz-Avi or ceftazidime-avibactam, an important part of our growing anti-infective portfolio.

We’re expecting to resubmit our NDA for cariprazine for bipolar mania and schizophrenia, to the FDA this quarter. In addition, we continue to support the development of Esmya for uterine fibroids with an ongoing Phase 3 study and sarecycline for acne which we will initiate a Phase 3 program this quarter.

Turning to our sales force on slide 13, in August, we completed a significant sales force realignment to right-size the organization and provide significant training on core products within our core franchises.

We now have completed that effort and have right-sized the activist North American sales team to approximately 3,500 sales representatives and managers focused on conducting 13 million sales calls to 250,000 healthcare providers.

We also enhanced our sales efforts in 1,600 academic and community hospitals and reached into 400 national and regional health plans and GPOs. We believe that our sales organization has been right-sized to continue to drive product sales and in terms of number of calls, we lead the industry.

We believe we’re among the most effective and efficient field force in the industry with an extensive portfolio across the key therapeutic categories. We’re relevant for our physician and healthcare provider customer base. On slide 14 in our generics business, our North American and international base business continued to perform strongly.

We continue to see strength in the base business, partially offset by additional generic competition of certain key products including generic versions of Lidoderm and our authorized generic version of Concerta. Our Anda Distribution business also saw a strong quarter, driven by increased business with key retailers and independent pharmacies.

Anda continues to represent a significant strategic asset and the performance throughout 2014 has proven the power of Anda.

In our international generics business, we continue to see strong contributions across our global markets including the UK where our teams have continued to deliver strong performance due to their ability to identify product shortages and changing market demands.

Our business in Russia and some of our Eastern European markets are outperforming the market as a result of our combination of generic, branded generic and OTC products that make us an important player in these markets. Turning to generics R&D on slide 16, we're continuing to build the leading generics pipeline in the industry.

In the United States, we have approximately 228 ANDAs pending review at the FDA, 60 of which are first-to-file. Year-to-date 2014, we’ve announced 19 first-to-file opportunities in our pipeline. We're fully committed to supporting organic growth in our business by continuing to lead the industry in first-to-file opportunities.

Internationally, we're poised for continued long term growth in generics with 1200 marketing authorizations pending across various international regulatory agencies and 570 marketing authorizations approved this year to fuel near term international growth.

With that, I'll now turn the call over to Todd who will provide you with an overview of our financial performance during the quarter.

Todd?.

Todd Joyce

Thanks, Brent. I'll begin with an overview of our updated reporting structure on slide 18. As a result of the merger with Forest on July 1st, we're now reporting three operating segments which include North American brands, North American generics combined with our businesses outside of North America and our Anda Distribution business.

Earlier today, we filed a Form 8-K disclosing our segment results on this basis for 2013 and for the first and second quarter of 2014.

As a reminder, the current year third quarter results include full quarter contributions from the recently completed Forest acquisition and the Warner Chilcott acquisition that was completed on October 1st of last year.

These acquisitions have had a significant impact on our results of operation including revenues and operating expenses in comparison to our prior year results. Turning now to our results for the third quarter on slide 19, consolidated net revenues for the third quarter was $3.683 billion.

Revenues from all three segments are tracking in-line or slightly above our expectations. Non-GAAP R&D investment for the quarter was $307 million compared to $136 million in the prior year period. Non-GAAP R&D spending for generics, brands and biosimilars was $114 million, $164 million and $29 million respectively.

GAAP amortization expense for the quarter was $874 million compared to $146 million in the prior year period. Non-GAAP earnings per diluted share for the quarter increased to $3.19 compared to $2.09 in the third quarter of 2013. Our non-GAAP tax rate improved from 27.2% in the year-ago period to 16.6% in the current-year quarter.

Adjusted EBITDA for the quarter was $1.26 billion compared to $489 million in the prior year. Cash flow from operations for the third quarter was $522 million. Our third quarter operating cash flow is net of $166 million in acquisition and integration costs and $62 million related to the early redemption of the 7.75% Warner Chilcott bonds.

Turning to our segment results on slide 20, North American brand revenue was $1.6 billion for the quarter driven by strong sales in key promoted products including Namenda, Bystolic, Linzess, Lo Loestrin Fe, Daliresp, Tudorza and Estrace Cream.

Adjusted gross margin for North American brands increased 84.4% and non-GAAP SG&A as a percentage of adjusted net revenues was 29.7%. On slide 21, we see that our North American generics and international business continues to achieve strong results with revenues of $1.641 billion for the quarter, up 5.6% from the prior year period.

On a non-GAAP basis, adjusted gross margin increased 3.8 percentage points compared to the year-ago quarter. Adjusted SG&A as a percent of adjusted net revenues for our North American generics and international segment was 20.3%. On slide 22, we provide details of our Anda results for the quarter.

Revenues increased to $423 million in the current-year period, up from $307 million in the prior year, an increase of 38%. Gross margin for Anda grew 80 basis points and the segment contribution increased 170% compared to the prior year period.

On slide 23, you see that our cash position remains strong with cash flow from operations growing 155% in the first three quarters of 2014 compared to the prior year period. We expect operating cash flow to increase significantly in the fourth quarter to roughly $900 million.

Fourth quarter operating cash flow will be impacted by acquisition and integration-related payments, but to a lesser extent than in the third quarter. Slide 24 details our debt capitalization as of September 30. During the quarter, we repaid approximately $750 million of debt which reduced our leverage to approximately 3.3 times adjusted EBITDA.

As a company, we remain committed to driving shareholder return while maintaining investment grade financial strength for the long term sustainability of the company. Before I turn the call back over to Brent, I would like to make a few comments regarding my plan to retire early next year.

My 17 years with Actavis has been extraordinary both from a career and a personal perspective. I have had a unique opportunity particularly over the past five years to be part of the fundamental transformation of our company into an exceptional global specialty pharmaceutical company.

I've also had the pleasure of managing an industry leading team of finance professionals that have made tremendous contributions to the success of the company. I want to thank our finance organization around the world for their continued hard work and commitment to the success of Actavis.

I also want to thank Brent, Paul and my colleagues on the leadership team for a once in a lifetime opportunity to be part of such a vibrant and exciting company. I look forward to supporting the transition once the successor has been named to ensure that we continue to capitalize on the momentum we’ve built for the remainder of 2014 and into 2015.

I would now like to turn the call back over to Brent to review our updated forecast..

Brent Saunders

Thanks, Todd and on behalf of the management team, our colleagues across the company, investors and shareholders we appreciate your contributions to Actavis more than we can adequately state. Thank you for your participation in supporting a smooth transition in the months ahead.

Turning now to our forecast for the remainder of 2014 on slide 26, we provided an update forecast for the second half of 2014 revenue for North American brands, North American generics, international and Anda Distribution businesses. We now anticipate total revenues of $7.4 billion.

We’ve also updated our franchise level revenue expectations for our North American brands business. Revenue growth in the second half of 2014 will continue to be driven by key products such as Namenda, Lo Loestrin, Estrace Cream and Linzess.

We are also seeing solid results from other key products including Viibyrd, Fetzima and our respiratory products Daliresp and Tudorza.

On slide 28, we've updated our forecast for the second half and full year 2014 and now estimate second half non-GAAP earnings between $6.60 and $6.70 per share compared with the previous range of $6.25 and $6.50 per share.

Our assumptions include no additional competition on our generic version of Lidoderm, minimal contribution from our generic version of Oxycontin and continued strong sales of our key North American brand products as well as investments in consumer campaigns for Namenda XR and Lo Loestrin.

We are well-positioned as we enter the last couple of months of the year and I couldn't be more pleased with how our business is performing. We expect strong momentum in 2014 to continue into 2015 and we will provide a detailed update to our 2015 guidance as planned early next year.

We're currently planning a business and R&D update in conjunction with our fourth quarter earnings to more fully describe our deep and rich pipeline and business growth potential. Finally, I would like to close with an update on the significant progress we are making on our road map for accelerated growth.

We’ve executed exceptionally well on our objectives to combine these two successful and growing companies, accelerating integration and synergy capture while making sure both the generics and brand business continue to deliver strong results and we've done this while continuing to invest in organic growth.

We're well on our way to cementing a solid foundation for accelerating growth in 2016 and beyond.

We'll generate a significant amount of cash that we plan to deploy strategically including adding to long duration assets to expand our franchises with both marketed products and pipeline opportunities and we will continue to focus on expanding our commercial presence and strong growth markets internationally and globalizing our existing franchises.

By continuing to follow this road map, I'm confident that we can achieve our goal of accelerating growth to $20 per share in earnings and further establish ourselves as one of the fastest growing and most dynamic pharmaceutical companies in the world. With that let me now turn the call back over to Lisa to get the Q&A underway..

Lisa DeFrancesco

Thank you, Brent. If I could ask everyone to limit yourself to one question. If you have a follow-up, please reenter the queue.

Holly with that can we start the Q&A?.

Operator

(Operator Instructions). And your first question will come from the line of Jami Rubin with Goldman Sachs..

Jami Rubin

Todd, how much you weigh the pros and cons of embarking on another large transformational deal at this time? Is your organization ready for such a transformational deal? And as part of that question, how would you weigh accretion on earnings or just simply a simple IRR calculation and considering a deal versus accretion on a multiple if you were to acquire a high PE stock? Thanks..

Brent Saunders

Let me address, Todd, he is not going anywhere that quickly. We've got him on here until we get a successor in place. We're having fun together. Look, I think as we think about our business and our ability to execute, we have a terrific team.

I think the quarter demonstrated that you can execute an integration successfully while growing our business at the same time. And the quality of our growth was really quite high. We saw growth in our branded business; we saw growth in our generics business and our Anda Distribution business.

We saw our supply chain execute on all cylinders across the board, we saw all of our back office functions doing great things. Our pipeline advanced, we did three business development deals to add to our pipeline into our marketed products during the quarter.

So, you can see, I think, evidence is strong that this team just knows how to execute with excellence while maintaining momentum and growth in the business. So, I think that we’ve proven that we know how to do deals. We know how to do integrations by the Forest integration, the previous integrations; both companies have done prior to getting together.

I think our track record is clear, Jami. So if there was an opportunity, I think we've demonstrated as a team that if it was the right strategic opportunity with strong financial fundamentals that created long term enduring growth for our company, we would be very interested and we would only act if we believe we could execute on it.

So, I think that answers the first half of the question. I guess, as you think about how do you stay financially disciplined and looking at deals and what's more important, accretion or IRRs, I think at the end of the day, every deal has to be looked on its own merit.

One of the things that Paul and I have always agreed on, is the strategic rationale of the deal has to be clear. Once that’s hurdle is behind you, then you turn to the financials. I think we've demonstrated a very consistent disciplined approach to doing deals. EPS accretion, in fairness, is easy today.

Cost of capital – well everybody can get to earnings accretion on almost any deal.

I think you have to look at; can you create value for the long term? Can you drive accretion to your topline? Do you have long duration assets and strong pipelines for organic growth? And I think when those things – when you step back and look at that, obviously you want to have strong internal rates of return, but you also want to make sure that they are NPV positive and over the long term you’re going to create shareholder value because that's why we're in this business.

I don't know Paul, if you’ve anything you would add?.

Paul Bisaro

No I think you said it perfectly. That's exactly the way we look at it over the years and we continue to look at it that way. I think we will just take each one as it comes along..

Operator

Your next question will come from the line of Shibani Malhotra with Sterne Agee..

Shibani Malhotra

Todd, best wishes for whatever you plan to do next. And I’ve got a couple of basic questions for the Generic team. Two products that we’re interested in, one Pulmicort, can you provide us an update on where you are with that product? And then two, we've been hearing that you’re focusing on respiratory pipeline as well in Generics.

Can you just give us some color on that in particular if you are doing any work on Generic Advair? Thank you..

Brent Saunders

Respiratory, as we have said many times is clearly the next frontier for growth in the generics business. We're very dedicated and focused on being successful in respiratory development. Maybe for Pulmicort I will ask David to answer the question specifically..

David Buchen

The trial is ongoing and I understand it, we do have final approval for the products. And we're ready to go, the supply chain is performing well and we're building inventory. So we will wait and see how the court case turns out.

But we’re pleased with the way it's going so far according to what I've seen in the public domain and as soon as the court rolls we will be ready to go..

Brent Saunders

Yes with respect to Advair and the other respiratory, maybe Bob Stewart can chime in..

Bob Stewart

Regarding Advair as well as our entire respiratory portfolio, we’re investing a considerable amount of time, effort and resources to building out a respiratory portfolio within our generics business. Advair is clearly one of them.

Obviously with Advair you have got the complications of not only passing PK study but obviously clinical endpoint as well as the inter-changeability of the device, itself. Regarding who's the front-runner, I know there has been public disclosures out there regarding starting clinical endpoint studies.

I don't think there has actually been enrollment yet. So our policy is not to issue a purchase order when we contract a CRO. So I won't comment on who's the front runner at this point, all I will say is just stay tuned..

Brent Saunders

I think he meant press release..

Bob Stewart

Yes press release..

Brent Saunders

But Shibani, I would summarize it as we're fully engaged in respiratory development. And I think one of the many connecting rods between our combination here is the expertise we’ve in respiratory across brands and generic R&D as well as our ability to do clinical endpoint study has only being enhanced by this combination.

We feel we’re very well-positioned..

Operator

Your next question will come from the line of Ken Cacciatore with Cowen and Company..

Ken Cacciatore

Just a question, you've always been friendly in the way you've approached companies to acquire.

I was wondering if you could ever envision a scenario where it becomes a little bit less friendly and just also wondering, do you characterize what's going on in the industry right now as a unique window in time in terms of assets available and interest rates that you could borrow at? Thank you..

Brent Saunders

I think we have always viewed ourselves as a team that does friendly deals. I think that's particularly important when you're buying businesses where people matter. And integrations in and of themselves tend to fail more than half the time. And I think when you do one in a hostile environment they tend to fail almost all the time.

People have been trained to hate each other for months and perhaps years during a hostile fight. The rhetoric is ramped up and a lot of value can be destroyed in losing key talent and key relationships. And so I think we've always viewed that our deals are about value creation.

And when people matter we're not going to do a deal that would be value destroyed. I think that being said, you never want to say never. So there are opportunities where people don't matter.

I'll go to an extreme example, when you're just going out and buying a file like we did with Eluxadoline, certainly the people at Furiex are incredibly important but they are only a handful of people.

And could you can conceive in the future doing something like that with a little more aggressive posture if you had to? Maybe you would, because the people are less important to a transaction like that, but, it's not our style, not something I think you would see us do. But you never want to be backed into a corner and say never on something.

And I think with respect to the time, I do think it's a bit of a unique window. I think given the need for consolidation and what's happening in our industry, coupled with a low interest-rate environment and relatively available capital, companies that aren't investing for long term value creation and long term growth are missing an opportunity.

And I think you've got to distinguish that with just going out and buying stuff. There are a lot of people who are looking at low growth or declining assets and they're not going to create value over the long term. They may create accretion in the short term but they're not going to great value over the long term.

And I think as you look at the types of deals we've done, whether it be Actavis Forest or Durata or Furiex or Rhythm Health Inc., we're looking at creating long term value creating assets and things that are going to drive growth for our shareholders over the long term and I think if you missed this window as a company, our management team as a CEO, you are going to regret it if you just used your money to buy shares and pay dividends.

I think you've not deployed your capital wisely..

Operator

Your next question comes from the line of Douglas Tsao with Barclays..

Douglas Tsao

Brent, perhaps along those lines, just curious in terms of the company's commitment to maintain its investment grade rating and also thinking about leverage in the context of potentially additional transformational deals and then just one quick follow-up, if you could provide a same store organic growth number for the quarter that would be helpful.

Thank you..

Brent Saunders

Yes so I think with respect to our investment grade, Todd said it in the script. We're committed to maintaining our investment grade. We think that's an important asset for us for the long term. And that's something that we're absolutely focused on. We don't think that impairs our ability to do large deals.

We think there are lots of different ways to get things done. And we generate a lot of cash, so we know we can continue to delever and use our capital both strategically and in a disciplined way. I think with respect to organic growth, we clearly focus on that internally. We don't provide an external number.

But I think you can look at the growth we're seeing across the Board in our products. You’re seeing 17 products in our North American brands business that drives 90% of our sales. If you look at those Top 17, 14 of them are growing year-over-year and some of them, like Linzess, up 100% year-over-year.

Daliresp 23%, Tudorza is 70%, even Namenda is up 6% year-over-year. So very, very strong growth, I think on the generic and international business, you're seeing strong base business trends in the United States. You're seeing that our commitment to our first-to-file pipeline leading the industry again.

And frankly, statistically if you look at it, we're almost beating all of our key competitors combined. Canada we're now in the Top 5, Russia, for us has got year-over-year growth in the same period, of over 32% on revenue and 64% on profit.

So, we know that our business is firing on all cylinders across the board and growing and we’ve strong momentum and we believe that will continue into 2015..

Operator

Your next question comes from the line of Gregg Gilbert with Deutsche Bank..

Gregg Gilbert

I have a longer term strategic question for Brent and perhaps, Paul. I will skip the Actergan question for right now. Was curious how important you think biologics our, branded generic or otherwise, to your long term vision. And as the arrangement with Amgen just the tip of the iceberg of what you need to do to ensure success? Thanks..

Brent Saunders

So is that like better for or – you coined the first new phrase there..

Gregg Gilbert

Just wanted to get it on the record..

Brent Saunders

Look, I think biologics are incredibly important to us on both the brand and biosimilar generic side. And I can ask David Nicholson to comment as well but our partnership with Amgen, I've said it many times is a terrific partnership.

I've said it to Paul even with the benefit of hindsight it was the absolute right decision and smart way for us to enter the biosimilar arena. Our teams have learned a lot from Amgen.

I think hopefully, Amgen would say they've learned a lot from us and the collaboration is strong and we're looking very carefully about expanding our relationship with Amgen as well as investing in the future of biosimilars.

I think – as you think about our generic business, clearly, the growth in generics are going to come from our ability to execute on how to make smaller products and in combination we will drive tremendous growth. The next frontier in respiratory and then after that it's biosimilar.

So, we need to – for our long term growth profile, we need to be in the biosimilar space and we need to continue to invest. And that may be with Amgen and that may also be on our own.

On the branded side, as we continue to move ourselves off the innovation curve, we've learned a lot about biologics, with our biosimilar experience, but we also have people like David, who've done logic development in the past.

And so we have a team in our R&D organization on the brand side that know how to do it and if we could find the right project with the right risk profile and the right innovation, we will be very open to it.

I don't know, David, if you would add any thoughts to that?.

David Nicholson

Thanks, Brent. I think basically you nailed it, in my view, in today's R&D space, we need to have the expertise in our organization to be able to work with both small molecules as well as with large molecules if we're going to capitalize on our therapeutic area expertise.

I’ve been working in the biosimilar space, it's valuable and relatively low risk group [ph] into building expertise with large molecules and delivering products to the market. The team here at Actavis loves working with Amgen.

It's really building our expertise and as you said, Brent, it would be great from an R&D perspective as well as hopefully from a commercial perspective to build on that collaboration. We already have two projects in Phase 3 development, it's going well..

Operator

Your next question will come from the line of Liav Abraham with Citi..

Liav Abraham

A question for Paul or perhaps Bill. I'm interested in your thoughts on pricing trends in the branded business. How concerned are you about incremental pricing pressure or higher rebating within the primary care space in particular given some the commentary from some of your larger and smaller peers recently.

How focused are you on this? And I'm interested in what you're hearing from peers. Thank you very much..

Paul Bisaro

I think, to a great extent, the pricing pressures have been built-in to our projections going forward. It's fairly customary right now for health plans to incorporate some type of price protection into contracts. In fact, for all of our major products, we’ve some degree of price protection.

And so, we've appropriately captured that in our financial estimates. I think that one of the benefits that we’ve right now is generally speaking, all of our products are at a very economical price-point relative to alternatives.

I also think that most health plans consider us a fairly predictable and the way we take increases which helps us when we're attempting to get our products put on formulary.

And if you just look at the numbers right now, for most of our key primary care products, we have unrestricted coverage rates that range from 60% to upwards of – for a product like Namenda XR or Bystolic upwards of 85% – 90%.

And it's something we're just going to have to manage moving forward and it will be very realistic about what we expect from price over the next several years..

Bill Meury

Maybe the other thing we have is, with our best in class field force, we continue to expand users. So you’ve drugs Bystolic, with 300,000 writers [ph]. That helps in terms of having leverage with the plans because obviously they need to minimize member disruption, as well..

Operator

And your next question will come from the line of David Risinger with Morgan Stanley..

David Risinger

So my question relates to future deals. I just wanted to get a sense for whether a shareholder vote matters or not, meaning that – will you try to avoid a shareholder vote on future deals which could potentially trigger some store of an interloper. So if you could comment on that, that would be helpful. Thank you..

Brent Saunders

I think I mean, we’re going to follow the rules. We always take the high road and we always do what's right. And to the extent we do a deal that requires us to have a shareholder vote, we wouldn't to the deal if we didn't think our shareholders would be supportive. We're very shareholder oriented management team.

We try to always keep in mind that everything we do is for the benefit of our shareholders and our colleagues and patients and in that order. And so, we would never do anything to try to slip one by our shareholders or anything like that, David. I think we're pretty straightforward when it comes to that.

If the deal couldn’t survive a shareholder vote then we shouldn't be doing it..

Operator

Your next question will come from the line of Chris Schott with JPMorgan..

Chris Schott

Just a couple quick ones here, first just following up on Doug's question from earlier. Is there a leveraged ceiling we should think about for the company given that commitment you talked about earlier to investment grade? And just where is that ceiling? The second question is just a longer term one.

When you look out over time and the branded business continues to grow, ACT becomes a much larger company, does this hybrid brand generic portfolio for the company continue to make sense? Or will a come a time at some time in the future where it maybe it makes sense to separate these businesses into more of a traditional brand business and traditional generic portfolio? Thanks very much..

Brent Saunders

We have kind of a soft ceiling of 3.5 times leverage that we tend to look at, as Todd said and I answered in the earlier question, we're absolutely focused on maintaining our investment grade to the extent we would have to go over 3.5 times, we would probably want to make sure the rating agencies were on board, that we had a plan to delever rapidly, so that we could get back into investment grade.

So, I think you would see us, potentially try to – if the deal is right and strong strategic deal and the financials made a lot of sense, tried to do it in a way that would maintain our investment grade. We don't believe that's any kind of obstacle for us to doing what we think we need to do. So, that's kind of where we stand.

I think in terms of long term, do these businesses together make sense? They do. I think we've seen nothing but our expectations exceeded, in terms of how these businesses have come together.

When you look at how the team is working together, how opportunities in R&D have been strengthened by our combined expertise, how our ability to go to our customers has only been strengthened by understanding their needs in a more robust way, our ability to execute in markets around the world with a blended portfolio. And as the lines in the U.S.

will probably continue to blur and who the real customer ultimately is and the consolidation of the customer, we think it's strategic to have a broad, diverse offering.

I think that being said, over the long term and we're talking now several years out, we're always going to be open to value creation for shareholders because that's how we run the company.

So if there is another configuration of the company in the distant future that creates value or marks value, we're going to listen to that, think about it and make the right decision..

Operator

And your next question will come from the line of Randall Stanicky with RBC Capital Markets..

Randall Stanicky

I just have two quick ones, Brent, are using evidence at this point that the primary care overlay to the specialty selling process is adding to results? And then the follow-up would be to Paul. Any update on Revlimid and how you’re thinking about that opportunity? Thanks..

Brent Saunders

Sure. On the primary care, I would tell you that we absolutely believe that that's a strategic asset. I think as everyone else has run away from primary care, we look at it as where all the volume is. And so, you need to get adoption in the specialty but you are going to drive volume in primary care. But Bill could weigh in on that as well..

Bill Meury

Yes I think there is a interplay between primary care and specialist in many categories. Big categories like depression, hypertension, most of the GI markets and even in women's health that you can only capitalize on if you have coverage of both audiences.

And I think you see that in the numbers, I mean four of our Top Five products, when you look at quarter-over-quarter, year-over-year trends are fairly strong. And then there is a pure specialty play, as is the case in urology or dermatology or infectious disease, we're fully resourced to take advantage of that.

I think it's difficult now given that Brent mentioned the blending of customers, whether it's brand or generic or even primary care and specialty to not have both capabilities..

Brent Saunders

I think with respect to Revlimid I will turn over to Paul, but I would be remiss if I didn't say that tenants [ph] only gets weaker with time..

Paul Bisaro

We continue to pursue this patent case and all of our patent cases with bigger – and we think that – we did have the market [ph] hearing back in May as I'm sure you were aware. There has been a lot written about that. I think our view is that we certainly think we advanced the ball.

We're going to continue to pursue this litigation with all deliberate speed and I think as I have continually said, our case only gets better from here. So, we're looking forward to finding hopefully resolution at some point. But if not, we'll continue to pursue litigation..

Randall Stanicky

Paul are there any – what's next in that case that we should watch for that could help us understand where that's going?.

Paul Bisaro

I think expert discovery closes early next year and I think that will be the next time when we have an update..

Operator

Your next question will come from the line of Aaron Gal with Bernstein..

Aaron Gal

Question, I'm getting a lot these days, it's about value that you can add in those vertical that you currently are not participating in.

Brent, you mentioned strategic trade is very good, if you were to combine to another vertical, call it lets say oncology [ph], what would be the kind of synergies that you could generate in a vertical like this? And if I can sneak one for Todd. Todd, we all are doing kind of the math on your leverage.

We kind of look at a year or two out and just take out all the one timers, , what's the ballpark free cash flow you guys could generate?.

Todd Joyce

In terms of the cash flow, we've given prior guidance on 2015 and we think we can generate over $4 billion of free cash flow in 2015. We had a strong current quarter, if you take out the one-time items, we’re approaching almost $800 million.

As I mentioned in the script, we’re going to be even with some one-time items in the fourth quarter, we expect to be roughly around $900 million of operating cash flow.

So cash flow generation is strong, delevering at the end of this year roughly three times, at the end of next year two times, so, solid from a balance sheet and cash flow perspective..

Brent Saunders

I think, as you hypothetically think about entering new verticals. I think there are obviously always cost synergies and back office – any time you enter a market. There is sales trading to sales administration, samples management, compliance, HR, all that type of stuff which is pretty typical for anyone. But I think it's very vertical dependent.

But let's say when I was at Bausch & Lomb, for example, there were plenty of products that if we could've taken to primary care during the allergy season, a pre [ph] for example that we had for an antihistamine eye drop. We had ability to drive that into primary care during allergy season where they see a lot of that.

Other things like pink eye, when you’ve a good anti-infective. You need to drive that into pediatricians and primary care and we couldn't do that. So I think there are always opportunities. You got to look at vertical specific, product line specific. But we’ve always shown in every situation that we're in, we look at it holistically.

We look at it across all of our assets, whether using Anda for direct distribution to a customer, whether it's our generic capability to do formulation and lifecycle management work, whether it's our branded business to drive things to a large prescriber base.

Those are all assets that when deployed right can bring a lot of leverage to anything you do..

Operator

Your next question will come from the line of Umer Raffat with Evercore..

Umer Raffat

I had a quick question on Namenda. So I know you mentioned you’re expecting to do a hard switch by January 2015, assuming the injunction isn't granted in favor of (indiscernible).

So my question is this, are there other states and other state Attorney General that have been preliminary request for hard switch detail and are you expecting to see any other lawsuits come up in the next couple of months before a hard switch actually happens?.

Bob Bailey

In terms of other states asking for additional information, the State of Texas has made a request at this point but it's not on a timeline similar to the State of New York..

Brent Saunders

Yes, I think the short answer is, New York is the litigation you need to watch..

Umer Raffat

Okay, just to be clear, if A, if they block you, is it New York only that gets locked or nationwide?.

Bob Bailey

It's in Federal Court, so it would be potential I guess nationwide. But we’re going to defend ourselves vigorously. We have a very good case..

Operator

And your next question will come from the line of David Maris with BMO Capital Markets..

David Maris

Brent, can you talk a little bit about the integration process? The results were very strong. Cost cuts are coming in ahead of schedule.

But where do think you are in the salesforce rationalization from an effectiveness standpoint versus where you want to be? And when you think of the R&D rationalization process that you mentioned will this be a major shift or just a pruning? And do think the end result will be more to limit the rate of growth or will it be to reduce the current spending rate? Thank you..

Brent Saunders

David, I think as you think about our integration of Forest Actavis, we're firing on all cylinders. The teams have deep experience from both companies on how to do integrations. I think you are seeing that demonstrated in states and our ability to execute with excellence. We have essentially taken most of the big actions necessary for integration.

You will see that play out as it builds upon itself in terms of synergies throughout 2015. But, my sense is, in terms of decisions and actions taken, we are largely done. It's now about letting that flow through and hit our P&L. There is some work to be done in some international markets still.

But in terms of rough guidance, we're probably 85%, 90% done as we go into 2015 with the big decisions and we will just do some cleanup that requires longer lead time after that. I think in terms of the salesforce, we're basically done. We did all the heavy lifting in August and September. We did a lot of the training in September and October.

The field force is settled, they are trained and they're fired up. I got to meet with – what was it, 900 of the managers a few weeks ago. We had a great town hall with them. Bill had a great three or four days with them and it was – they are really pumped up.

I don't know, Bill, you want to comment on the sales force?.

Bill Meury

Brent's right. Our aim was to be done with this by basically September and we were other than sales trends, which are the ultimate measure of effectiveness, we are looking closely at turnover, vacancy and call activity. It's all right where it needs to be.

The sales force delivers on a per-day basis or per-rep per-day basis more sales calls than any other sales force in the industry. So, we like where we are right now. We were fair but decisive when it came to integrating..

Brent Saunders

Bill didn't say this, but we took the opportunity to create the strongest sales force in the industry. I think the talent level in our sales force is the highest. Their commitment is the highest. They outwork everybody else and it's an absolute strategic asset.

Unlike, I think some of our competitors; we internally place a lot of value on our sales force. We're not shy about it. We know that they are our sales representatives. We expect them to sell in accordance with the rules and the laws in our compliance guidelines. But they are sales representatives and they're professionals, they're well trained.

We are trying to treat them as more as therapeutic experts; they like that. They like the professional development we give to them. So, I think we are poised to do great things with our sales force..

David Maris

On the R&D rationalization process?.

Brent Saunders

That's ongoing, as David and Bob Stewart continue to look at the portfolio. I don't think you are going to see a huge move. I think you are going to see thoughtful, realistic planning. We are going to invest behind both things that we believe have a higher success of being approved and become products, but also have a commercial opportunity.

As we've talked about, me too drugs and the fifth or sixth drug coming into a category are just not going to be successful anymore. So, we want to make sure we are driving innovation and we're driving things that we believe are worth spending our money on.

Bob, David anything you want to add?.

Bill Meury

I think what you're saying also too is the benefits of the integration, as we talked about before. When you take the best of one organization, you put it up against the best of another organization, you are seeing a good synergy in terms of formulation development.

You're seeing good synergy in terms of clinical expertise and we are able to leverage the strength of what each organization has brought forward here to create an overall – more productive R&D organization. I think you see some of that coming through already with some of the spending favorability..

Brent Saunders

I would caution too, the integration of the R&D organization is ahead of where we want it to go. It's not that we are not willing to invest. We had said we'd spend about $1.2 billion and I think that's where we will get to.

If we’ve more things to spend behind, because we think they are value creating, we will do that and if we have things that we don't think are worth spending on, we will spend less. We are not going to peg ourselves to a number and then just spend recklessly against that number.

We are going to look at each project and each opportunity and make sure we are building our business for the long term..

Operator

And today's final question will come from the line of Marc Goodman with UBS..

Marc Goodman

First of all, Brent, can you talk about the Namenda franchise, big picture? How should we look at this? How do you look at it over the next three or four years? You've got a $400 millionish a quarter, so call it $1.6 billion.

What kind of step down are you thinking about in 2015 as you make this transition? As we move into 2016, there's the potential that you have XR with the 30 month stay and obviously you have the combo that's going to come in.

How should we be thinking about this franchise, 2, 3, 4 years down the line? Second question is maybe you could also talk about this new opportunity in the antibiotic coming, the Caz-Avi opportunity, the combo.

Obviously, Cubist has a pretty strong franchise there, so how do you think about this and how it plays out and what kind of ramp should we be expecting there? How competitively is it? And then I guess I'll ask a third question since I have it.

Can you talk about the key generic product launches in 2015 and any notable cases we need to be watching? Thanks..

Brent Saunders

On Namenda, we’re absolutely committed to the Alzheimer's space. We’re committed to investing for innovation for this horrible epidemic. As you think about Namenda, we are going to continue to drive Namenda XR as the most innovative product that we have. We're going to continue to promote it. We talked about a DTC campaign to expand the market.

What's interesting, if you look at Namenda year-over-year, you’re seeing very positive growth in market expansion when it declined last year and it's growing this year. So we believe that with the right the DTC outreach with the right product, Namenda XR once-daily dosing, we can continue to expand the market.

That being said, when the generics enter in the late summer of 2015, it will become a highly competitive marketplace. The generics will be – generic competitors will be all over trying to switch patients back to IR. They'll have many benefits of state switching laws and others on their side.

So, we’re going to continue to hang our hat on our innovation. We're going to launch our fixed dose combination that will really simplify the pill burden for patients. We know that that's important in this population. We know that resonates with caregivers and physicians.

So, we’re going to continue to drive that innovation and we’re going to look to continue to extend our franchise in Alzheimer's with either other innovations around delivery (indiscernible) or perhaps in other areas. And David and his team are looking at other ways for us to maintain our position in Alzheimer's.

Bill other thoughts on that?.

Bill Meury

I think that's right. I would also keep in mind that only 30% of Alzheimer patients today receive a combination of Namenda and Aricept. If you take a look at the guidelines or even were to serve at a neurology community, that figure could easily be upwards of 50% or 60%. So, I think there's a lot of upside as it relates to the fixed dose combination.

The trends on XR look very good because it's a more attractive product to caregivers and physicians and I think the DTC campaign should be very well received too..

David Nicholson

The unmet medical need right now in hospitals for infections caused by gram-negative bacteria is as high as it was for gram-positive bacteria or Mercer infections over 10 years ago. Ceftazidime-avibactam is one of only two products that will cover three different gram-negative pathogens, that's Pseudomonas, ESPLs and KPCs.

The only other product is Colistin, which doesn't have a great benefit-risk ratio. This is going to be used primarily in the ICU for very serious infections. It complements Teflara. It complements Dalvance, we’ve a great deal of capability right now in the hospital market. Our sales force is terrific.

The have a great deal of experience and so the expectations on Ceftazidime-avibactam are very high. As it relates to Cubist, I would say there is room for two alternatives in this market, that product will perhaps be more focused on Pseudomonas, where as we are more focused on KPCs..

Brent Saunders

David, do you want to comment on key generic launches?.

David Nicholson

Sure. First of all, I'll repeat something Brent mentioned. We do have the – what I believe is the industry's best pipeline with well over 200 ANDAs at the FDA, 60 which are first file. We have so many shots on goal that we think we will be very successful.

If you look out over the next 12 to 18 months, we've got some big launches coming up that we are gearing up for, including generic version of Oxycontin and Celebrex, (indiscernible) Daytrana patch androGel and of course, in 2016 Crestor which is going to be a big one.

If you look at some of our pending lawsuits, we've got Pulmicort, we've got Epiduo, we've got the Xopenex HFA, products as well as the (indiscernible) Fortesta and testing the testosterone replacement products. Very, very strong pipeline both on the big certain launches, as well as the pending litigation opportunities..

Lisa DeFrancesco

Okay. Thank you everyone.

Brent, do have any closing comments?.

Brent Saunders

Yes. Lisa, thank you. I would just like to underscore a couple quick things. First, I want to thank Todd, although he's not leaving so quickly. I think his track record in 17 years here have been nothing but a sign of excellence.

And to be fair, I've said this many times a sign of a great leader is seen and evidenced by the team that surrounds that person. Our finance team at Actavis under Todd is best in class and that's just a demonstration of his leadership and commitment to excellence. Second, I would just say, we’re very pleased with the quality of our quarter.

We saw strong momentum in 2014. We expect that that momentum will continue into continue into 2015 and we're excited to update you, as regularly scheduled. This will include our R&D update, as well as our business update at the fourth quarter earnings call. But thank you for your time and we look forward to keeping you updated..

Lisa DeFrancesco

Thank you..

Operator

Once again, we would like to thank you for your participation on today's call. You may now disconnect..

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