Showing posts with label Companies. Show all posts
Showing posts with label Companies. Show all posts

Friday, 27 September 2013

Kelly Close: State Of Diabetes Treatment, Companies In The Sector And Challenges Patients Face

As president and founder of Close Concerns, a healthcare information firm focused on diabetes and obesity, Kelly Close says her passion comes from her extensive professional work as well as her personal experience, contracting Type 1 diabetes 25 years ago. Prior to starting Close Concerns, she worked in the financial sector, including stints as an analyst at Goldman Sachs, as an equity research analyst covering medical technology at Merrill Lynch, and as a management consultant at McKinsey & Co., where a majority of her work focused on for-profit and nonprofit healthcare organizations. Ms. Close and her colleagues at Close Concerns attend more than 40 scientific, regulatory and economic conferences around the world focused on diabetes and obesity, analyze key medical literature, and cover more than 50 private and public companies and nonprofit organizations. Recognized as an expert on the diabetes and obesity markets, and as a frequent speaker on the public health implications of these conditions, Ms. Close is a tireless advocate for patients. In this interview Ms. Close discusses the state of the industry and challenges that patients face.

Can you describe your mission?

It's to make everyone - researchers, clinicians, scientists, companies, and patients - smarter about diabetes and obesity in order to improve patient outcomes. Our team studies new research, and we synthesize news and insights on therapies and technologies on diabetes and obesity.

Why diabetes and obesity?

I have a deep personal interest in diabetes, so my goal once on Wall Street was always to narrow my focus from writing about medical technology (and helping biotech and pharma analysts) to working on all parts of diabetes, in a way you can't do as an analyst. In other words, I wanted to work on medical devices, pharmaceuticals and biotech all at once. Then, there's obesity. Well, the association between obesity and Type 2 diabetes has long been recognized. You can't separate the two; they are inextricably linked. Cases of diabetes have risen nearly tenfold since I was diagnosed in 1986. There were about 30 million people globally with diabetes then. Today there are 30 million in the US alone, with nearly 400 million globally, with much of the trend due to the increasing prevalence of risk factors, including obesity. And around 80% of Type 2 diabetics are either overweight or obese.

Tell me a little about your information services.

Our first publication in 2003 was Diabetes Close Up, where we simply updated news about different companies and conferences that we attended. In 2007, we started Closer Look, which goes out several times a week - sometimes daily - and the two publications now keep researchers and members of the industry abreast of scientific breakthroughs. Our online newsletter, diaTribe, began in 2005 as a free service, with the goal of keeping patients up-to-date on the latest research, products, and advice from the diabetes scientific community. And through dQ&A, our sister company that we started in 2009, we offer corporate clients market research and consulting services.

When I began Close Concerns, 18 million Americans had diabetes, and the sector had $14-billion in revenue. Today, in 2013, the industry has expanded to more than $40-billion, and there's widespread agreement that diabetes and obesity have turned into global epidemics that cannot be sustained. We absolutely must change diabetes management to make sure patient treatment, therapy and advice are optimized from the time of diagnosis throughout the entire spectrum of the condition.

What are some of the challenges you see today?

It's never been a more challenging time in terms of reimbursement and patient access to medicines and healthcare professionals. In much of the world, patients still don't have access to insulin or other medications. On the other hand, extensive progress has been made on the actual tools that are available. Access is so much more challenging, however, regardless of whether we are talking first world or third world. Doctors, for example, may reach a common diagnosis of diabetes, but the pressure they face with patients is prescribing the correct treatment, determining what patients will adhere to, and what insurance will cover. And that is patients with insurance. Medicare is missing the forest for the trees on some of its new reimbursement decisions in the U.S., and globally, patients certainly are not getting the treatment, therapy and advice they need to keep them healthy. Finally, there are major issues with patient advocacy - it must be much stronger, but lingering stigmas about this disease continue.

What about treatment challenges today?

The positives are that medications have improved dramatically and the technology exists to see which medications work and don't work. Today, the emphasis is on early, optimized treatments, given that nearly 50% of Type 2 diabetics are not at their glycemic target even here in the U.S. Because there are many more oral medications available before a patient is moved to insulin, the best healthcare providers no longer take a wait-and-see approach if a patient can't control their HbA1c (a three-month average measurement of glucose in the blood); they prescribe a new medication, often a combination of drugs. Another bonus of having many more drugs available today is that treatments can be customized for a patient, which is the promise of personalized medicine - again, this varies with access. Adherence is such a challenge that it will be great to move several medications to one - one pill and one co-pay for patients in the U.S. and, ideally, better adherence. Adherence studies have been very hard to do historically, and this is one of the biggest challenges ever. Historically, taking insulin has also been very challenging. We hope this will become easier all over the globe and that the stigma of taking insulin will begin to dissipate.

Can you talk about emerging trends in technology?

Absolutely. One really dispiriting area is that in the U.S., we see pricing pressure and reduced access to good technology. This is driven by CMS wanting to save money, and while it may sound good for patients, we worry that it winds up resulting in less product innovation, fewer funds going to R&D, less customer education and customer service, etc. We're seeing better insulin pumps coming out all the time, combined with continuous glucose monitoring. Monitors used to be inaccurate and unreliable, but the technology is much improved and readings from meters are getting closer to readings from actual blood tests. The data we've seen on the Dexcom (NASDAQ:DXCM) G4 Platinum, for example, is better than some glucose monitors. But lots of people still dose their insulin based on counting carbohydrates, and there are lots of reasons why scores can be incorrect.

What's the status of oral insulin?

I thought we'd never see it because there are so many challenges associated with it. But I'm much more optimistic than ever before. It's still very early stage, but Novo Nordisk (NYSE:NVO) is working on it, and that's a very positive sign. We're beginning to see positive data come out, and the flat truth is just that we need more alternatives to injected insulin. MannKind (NASDAQ:MNKD) and its inhaled insulin therapy, AFREZZA, has driven our optimism. It has taken a long time to get to a second-generation inhaled insulin that is practical, easy to use and effective, but the data, especially that on hypoglycemia, look good.

What are your thoughts on the potential of GLP-1?

This is the first new class of therapeutics to come to market that doesn't cause hypoglycemia and doesn't cause weight gain. That's awesome because insulin has had all of those problems. Novo Nordisk's GLP-1 reached $1 billion in sales a year before the company expected - again, this has been easier for patients to take and provides a valuable step between traditional orals and insulin. What's really compelling in combination therapy is the potential for GLP-1 plus insulin. SGLT2 inhibitors are also interesting - we'll definitely see fixed-dose combinations here too, eventually. Earlier this year, the FDA approved Johnson & Johnson's (NYSE:JNJ) SGLT2 inhibitor, Invokana, which has efficacy closer to GLP-1 and, judging by the early data, a safety profile closer to DPP-4 inhibitors, which have the best side-effect profile of all. We'll see - we'll be eager to watch the emerging data.

Have you seen any interesting new data in GLP-1 research?

Transition Therapeutics (NASDAQ:TTHI; TSX:TTH) announced some really exciting data in the summer for TT401, which targets GLP-1 and glucagon receptors for obese diabetic patients and may provide clinical effects superior to those of GLP-1 agonists. (BT note: the proof-of-concept data prompted partner Eli Lilly (NYSE:LLY) to acquire an option on the drug candidate to complete clinical development.) We're also really looking forward to seeing more data on iDegLira, which is the combination of next-generation insulin degludec, which the FDA recently delayed, surprisingly, and on Victoza, from Novo Nordisk. BMS/AZ is also working on a Bydureon pen as well as a once-monthly formulation, and Intarcia is working on implantable GLP-1. There's no doubt this class will continue to grow as the applications become even easier and as the efficacy and safety data continue to grow.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)


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Monday, 9 September 2013

The Cooper Companies Management Discusses Q3 2013 Results - Earnings Call Transcript

The Cooper Companies, Inc. (COO): The Cooper Companies Management Discusses Q3 2013 Results - Earnings Call Transcript - Seeking Alpha (function(_,e,rr,s){_errs=[s];var c=_.onerror;_.onerror=function(){var a=arguments;_errs.push(a); c&&c.apply(this,a)};var b=function(){var c=e.createElement(rr),b=e.getElementsByTagName(rr)[0]; c.src="//beacon.errorception.com/"+s+".js";c.async=!0;b.parentNode.insertBefore(c,b)}; _.addEventListener?_.addEventListener("load",b,!1):_.attachEvent("onload",b)}) (window,document,"script","4ffae9d6f05d1da630000008"); if (SA.Data && SA.Data.Cache) { var adata = SA.Data.Cache.get('campaign_content'); }.market_currents_list li .ticker_date_left .mc_list_tickers a{font-weight: normal} var ms_slug = ''; var article_dashboards = 'transcript'; var article_sectors_themes = '@transcripts@us@medical-instruments-supplies@healthcare@article@'; var ratings_hash={} var ARTICLE_ID = 1677112 ; var ARTICLE_TYPE = 'transcript'; var ARTICLE_LOCK = ""; var availableABVersions=["ver_a"]; var abOBJ = new ABTest('transcript_pagination', availableABVersions); var machine_id = cookieExists('machine_cookie') ? parseInt(readCookie('machine_cookie')) : 0; var abVersion = abOBJ.value; var sliceSize = 4000; try {window.sessionStorage.setItem("/article/"+ARTICLE_ID, '1');} catch (error) {}var mone_article_tags = "{coo};;;{healthcare};;;{transcripts,us,medical-instruments-supplies};;;{}"var ord = Math.floor(Math.random()*1000000000);Seeking Alpha Seeking Alpha Portfolio App for iPad Finance (1) var ipadData; SeekingAlpha.Initializer.AddAfterLoad(function(){ if (SA.Utils.Env.isIPad && !/3/.test(SA.Data.Cookies.get("user_devices"))){ Mone.event("ipad_promotion_top","top_ipad_banner_large","ipad_promotion_displayed"); ipadData = new SA.Data.iPad(); ipadData.instanceName = "ipadData"; var responseHandler = new Object(); responseHandler.handleResponse = function(data){ if (!data.averageUserRating) return; var stars = data.averageUserRating Home | Portfolio | Market Currents | Investing Ideas | Dividends & Income | ETFs | Macro View | ALERTS | PRO   This transcript was sent to 333 people who get email alerts on  . Which cover: new articles | breaking news | earnings results | dividend announcements Get email alerts on   » This transcript was sent to   people who get the newsletter. Get the newsletter » The Cooper Companies Management Discusses Q3 2013 Results - Earnings Call Transcript Sep 5 2013, 21:20  |  about: COO BOOKMARKED / READ LATER Bookmarked

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Executives

Kim Duncan - Senior Director of Investor Relations

Robert S. Weiss - Chief Executive Officer, President, Director and Member of Science & Technology Committee

Gregory W. Matz - Chief Financial Officer and Vice President

Analysts

Kimberly Weeks Gailun - JP Morgan Chase & Co, Research Division

Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division

Matthew O'Brien - William Blair & Company L.L.C., Research Division

Jeffrey D. Johnson - Robert W. Baird & Co. Incorporated, Research Division

Steve Willoughby - Cleveland Research Company

Joanne K. Wuensch - BMO Capital Markets U.S.

Christopher C. Cooley - Stephens Inc., Research Division

Jonathan D. Block - Stifel, Nicolaus & Co., Inc., Research Division

Amit Bhalla - Citigroup Inc, Research Division

The Cooper Companies (COO) Q3 2013 Earnings Call September 5, 2013 5:00 PM ET

Operator

Good day, ladies and gentlemen. Welcome to the Third Quarter 2013 The Cooper Companies, Inc. Earnings Conference Call. My name is Cecilia, and I'll be your operator for today. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to your host for today, Ms. Kim Duncan, Senior Director Investor Relations. Please proceed.

Kim Duncan

Good afternoon, and welcome to The Cooper Companies' Third Quarter 2013 Earnings Conference Call. I'm Kim Duncan, Senior Director of Investor Relations. And joining me today -- on today's call are Bob Weiss, Chief Executive Officer; Greg Matz, Chief Financial Officer; and Al White, Chief Strategy Officer.

Before we get started, I'd like to remind you that this conference call contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, including all revenue and earnings per share guidance and other statements regarding anticipated results of operations, market conditions and integration of any acquisitions. Forward-looking statements depend on assumptions, data or methods that may be incorrect or imprecise and are subject to risks and uncertainties. Events that could cause our actual results and future actions of the company to differ materially from those described in the forward-looking statements are set forth under the caption Forward-Looking Statements in today's earnings release and are described in our SEC filings, including the business section of Cooper's annual report on Form 10-K. These are publicly available and on request from the company's Investor Relations department.

Now before I turn the call over to Bob, let me comment on the agenda for the call. Bob will begin by providing highlights on the quarter, followed by Greg, who will then discuss the third quarter financial results. We will keep the formal presentation to roughly 30 minutes, then open the call for questions. We expect the call to last approximately 1 hour. [Operator Instructions] Should you have any additional questions, please call our Investor line at (925) 460-3663 or email ir@cooperco.com. As a reminder, this call is being webcast and a copy of the earnings release is available through the Investor Relations section of The Cooper Companies' website. And with that, I'll turn the call over to Bob for his opening remarks.

Robert S. Weiss

Thank you, Kim. First of all, to some of you on the call, happy new year both to you and your families. Our apologies for having our release date the first date of -- first day of Rosh Hashanah.

On to results. Another solid quarter, we march on: top line growth of 9%, GAAP earnings per share of $1.79, up 32% versus the prior year; non-GAAP earnings per share, $1.74, is up $0.29 or 20%; and free cash flow of $64.5 million means our trailing-12-month free cash flow was $245 million.

Some highlights and key events. Our silicone hydrogel family of soft contact lenses continues to show strong growth with worldwide sales up 22% in constant currency, now accounting for 43% of CooperVision revenues. Additionally, I'm proud to announce that just this week, we have officially launched our branded daily silicone hydrogel lens, MyDay, in Europe. Demand is very strong for this lens, and we're very optimistic about the future. We also continue to see a lot of success in our entire silicone hydrogel family of products with Biofinity and Avaira. The combination of these products should continue our momentum for years to come.

With the most recent calendar quarter, we grew 2x the market, which grew 4%. We achieved 23% operating income and even exceeded 20% in net income as a percent of revenues. We are very pleased with our IVF or fertility growth, which was 180%, and adjusting for acquisition comparability, grew 20% over the prior year comparable period. Our free cash flow delivery resulted in our debt-to-cap now moving to single digits. We have a very strong balance sheet, as well as a strong free cash flow.

On the revenue results, during the third quarter, our silicone hydrogel family continued to drive our top line and our bottom line. Silicone hydrogel revenues were $143 million, the halo effect of Biofinity Toric in Japan continues. In Japan, Biofinity constant currency sales are up over 100% versus the prior year. The halo effect of Avaira Toric is contributing to solid growth of the Avaira 2-week family.

As previously mentioned, we have launched MyDay, our branded single-use silicone into Europe this month. We expect this newest addition to our silicone hydrogel portfolio of soft contact lenses to help continue our silicone hydrogel revenue growth momentum for many years to come.

I'm extremely happy to say that we believe we, once again this calendar quarter ended June 30, gained share across the board. All regions, all modalities, all lens types, sphere, torics and multifocal in both materials, silicone hydrogel and non-silicone hydrogel. This demonstrates the breadth of our reach and the product portfolio.

Geographically, foreign exchange headwinds continue to reduce CooperVision revenues, down 4% in the quarter. Excluding foreign exchange, CVI constant currency growth was 9%. Last year, it was the euro and this year, it's the yen which is down 25% versus the third quarter of 2012. It was over $200 million of revenue in Japan. This is not only impacting our revenue, but is also negatively impacting our gross margin, as well as our operating income and bottom line, I might add. But even with this major nuisance on the strength of our product lines, we are putting up some solid numbers. From a revenue perspective regionally, we have put up solid constant currency growth in all locations: Americas up 9%; EMEA or Europe, 8%; Asia-Pac, 8%; and worldwide, 9%. Our growth drivers in the Americas: trading up Biofinity, including the halo effect of Biofinity multifocal with the entire family doing well. Also, while off a much smaller base, Proclear 1 Day and the Avaira Toric and family are a significant contributor.

In Europe right now, currency is helping off at some of the yen. Driving our 8% constant currency growth in this region is the entire Biofinity family and 1 Day, including single-use silicone hydrogel.

In Asia-Pac, while foreign exchange took its toll on revenue, our constant currency revenue is up 8%. Drivers include tremendous success of the Biofinity family, especially with the halo effect of Biofinity Toric and Proclear 1 Day.

The worldwide soft contact lens market in the second quarter -- calendar quarter was up 4% in constant currency, while CooperVision was up 10%. For the trailing 12 months ended June 30, the soft contact lens market, now $7.2 billion worldwide, was up 4% in constant currency. CooperVision was up 11% on the strength of Biofinity, Proclear 1 Day and Avaira.

For the calendar quarter, the market was up, growth was sponsored by 1 Day. While industry data is no longer available for silicone hydrogel material, most likely, this trade-up material remains a solid growth material. CooperVision was up 22% in constant currency in fiscal third quarter of 2013, and CooperVision silicone hydrogel now is 43% of our revenues. Soft contact lens market continues to be a trade-up market. This includes the premium products: silicone hydrogel lenses; torics and multifocals; and trade-up of a 1 Day disposable expands patient revenues by 400% to 600%. Even more important, the 1 Day wearer generates 300% to 500% more profit. Also, it is important to understand that torics and multifocals have a long way to go in capturing the market opportunity, especially outside the United States. Geographically, growth is reasonably balanced with the Americas and Europe up 4%, and Asia-Pac up 5% in the calendar quarter, second quarter. Drivers continue as 1 Days in silicone hydrogel trade-up. Also, we believe torics and multifocals continue to expand faster, off of a lower base outside the United States.

CooperSurgical, our women's health care franchise, turned in $81.5 million in revenue, up 27% versus the prior year's third quarter on the strength of a $27 million contribution from our IVF business or fertility business, which now accounts for 1/3 of CooperSurgical revenues. Revenue growth of our fertility business was up 180%. And adjusting for acquisition comparability, the IVF product growth was 20% over the prior year's comparable period. And we're pleased to see our office and surgical procedures product lines achieve a breakeven following last quarter's declines. This reflects some returning momentum in the surgical procedure area in spite of continued softness with our closure device. And remember, we are in a transition mode with this product of Carter-Thomason CloseSure device as we roll out an upgrade of the product. This, in essence, results in lost revenues during a trial period -- trialing period. We continue working through this rollout and remain optimistic we'll see improvements over time. Adjusting for acquisition comparability, including the 20% for fertility, CooperSurgical growth was 6% above the prior year.

In terms of guidance, we have taken our non-GAAP earnings per share range and have again taken up our bottom line end of our guidance range for revenue for fiscal year 2013. This results from the strength of our third quarter results, the bottom line brought about by solid top-line moderating foreign exchange movement, a 23% operating income margin and the third quarter and favorable tax movement. The favorable tax movement includes the effects of geographic mix, tax rate reduction, specifically in the U.K., and the effects of some positive discrete tax items. The yen took its toll with about a $13 million hit on revenue due to a 25% decline in the yen versus the prior year. In spite of this, we overcame it and its effects with our positive top line performance and the strength of our gross profit percent in prior year's comparable -- versus prior year's comparable periods. Our new guidance for non-GAAP earnings per share for the fiscal year is $6.23 to $6.28 versus our prior guidance of $6.15 to $6.25. This reflects the ongoing strength of our product portfolio, including Biofinity and the Proclear 1 Day, as well as the lower effective tax rate for this fiscal year. Importantly, in spite of increasing our guidance, we continue to invest in geographic expansion and R&D, with emphasis on D or product development. This D is what has accelerated our rollout of new products, like MyDay, our new branded 1 Day silicone hydrogel. This branded product is now launching in Europe this month.

Regarding free cash flow guidance, we're increasing our free cash flow range to $180 million to $210 million, while reducing our CapEx to $180 million to $210 million. This mainly reflects the timing of CapEx or capital expenditure payments as we continue to aggressively manage our free cash flow.

As a general comment on capital expenditures, our production plans remain on schedule. And I am pleased to say our manufacturing for MyDay and other products is meeting or beating our internal expectations. I might add one other thing, we are pleased with our -- how we're progressing with fiscal year 2013 and how it's shaping up, and are anticipating low double-digit earnings per share growth again next fiscal year.

On strategy, we are continuing with our successful strategy, which I have frequently articulated in the past. We believe it is solid and it has delivered results. CooperSurgical is putting up solid results and is leveraging its infrastructure. This franchise was built with the solid understanding of the value of critical mass in the women's health care market, targeting the OB/GYNs. We follow the professional wherever they go, be it the office, the surgicenter, hospital or IVF centers. Although the call points are different for each, the leverage is considerable. CooperSurgical's third quarter gross profit percent was 64%, its operating margin was 20% and due to minimal capital requirements, CooperSurgical is a significant contributor to our free cash flow. We are dedicated to the strategy and will continue tuck-in acquisitions to leverage the CooperSurgical structure and products.

At CooperVision, the strategy is more complex and is much more global in nature. The $7.2 billion soft contact lens industry, because of the uniqueness of our manufacturing platforms and product portfolio, we are the only participant that aggressively promotes silicone hydrogel and non-silicone hydrogel, that is the Proclear family. We emphasize branded and non-branded products. Note private label does not mean lower operating margins. We actively promote and specialize in custom lenses with a high gross profit, I might add. We support all modalities that the eye care professional prescribed for 1 Day, 2-week, as well as monthly lenses. And we support all type of lenses, spheres, torics and multifocals. With approximately 30% share in the high-growth specialty lens categories, torics and multifocals, it is acknowledged by eye care professionals that we're pretty good at specialty contact lenses. Few eye care professionals would challenge why the success of Biofinity Toric for astigmatism put a great design together with a great material and great things can happen. We happen -- we have seen similar successes for this same reason with Biofinity Multifocal, which shipped to market in the middle of calendar year 2011.

On the capacity front, with the possible exception of Avaira Toric, we are ahead of plan to deliver considerably more product where we had previously been supply-constrained. The Biofinity family, Proclear 1 Day are all in good capacity shape. Our newest challenge will be to ramp up 1 Day silicone hydrogel as we -- as it is yet a niche market.

On pricing, like the rest of the soft contact lens industry, we have a trade-up strategy. Our new wearers and existing wearers are targeted for silicone hydrogel lenses, the Proclear family and the 1 Day or our single-use lenses. Each creates more revenue per patient. A 1 Day modality, for example, results in 4x to 6x more revenue per patient. While this strategy sacrifices the gross profit margin, it generally creates 3x to 5x more profit per wearer. Of course, the strategy competes head on with the lens care space since we are shifting the wearers' resources from lens care to contact lenses only. Competing for lens care dollars is more of a problem for some of our competitors. In my opinion, we continue to be one of the most focused company in the industry lacking many distractions that some of our competitors are going through. I might add, with Biofinity, Avaira and Proclear, we have a lot to talk about with eye care professionals around the globe.

As we look down the road over the next several years, we expect to continue improving operating margins and de-leveraging -- or delivering above-average shareholder returns. We expect to continue to average double-digit earnings per share growth while investing in geographic expansion and new product development. In today's market, we have a solid product portfolio to leverage in all modality, multiple materials, all lens types and we retain our expertise to emphasize customizing lenses for the 10% to 20% of those lens wearers requiring other than standard lens sizes and/or designs. We have a lot of work to do before we come anywhere close to having exploited our #1 contact lens family, Biofinity. This is particularly true when it comes to geographic expansion and fully developing the Biofinity family of Torics and Multifocals around the world. The same applies to Avaira, where the Avaira Sphere was anxiously awaiting the relaunch of Avaira Toric. This combination has now put us in a much better position to exploit the U.S. 2 week space owned by Johnson & Johnson and to also exploit our private label strategy more aggressively with this family. While we already have pretty respectable gross profit and operating margins, from a cost perspective, we have considerable upside yet to be fully developed. Upsides include the complete elimination of silicone hydrogel royalty, with the expiration of patents in September 2014 in the United States and in March 2016 in the rest of the world. The reduction of our manufacturing cost by, among other things, improving molding cycle times, increasing capacity utilization and improving yields in general. Each of these are key goals for us. As previously mentioned, our expansion plans include: a low-cost labor location in Costa Rica that is now being built. This is a multi-year project that will further help us minimize costs or manage our costs.

Also, given the considerable amount of free cash flow we generate, we will continue to look for tuck-in acquisitions and geographic expansion opportunities like Origio in our 2 businesses. The key requirement, however, is that each acquisition must exceed our minimum investment hurdle rates. Each must achieve, over time, a hurdle rate that exceeds 10%. Additionally, the markets for both women's health care and soft contact lenses are much less developed outside the United States and we generate a considerable amount of cash offshore due in part to our level of manufacturing outside the United States. And as such, we will continue to be -- to aggressively invest in global expansion opportunities. With over 95% of the people on the planet outside the United States, we believe we will find opportunities to invest in other countries for decades to come, thereby sustaining our low effective tax rate indefinitely. And finally, we again this year demonstrated we are opportunistic when it comes to buying back our stock in order to enhance total shareholder return.

In summary, before I turn it over to Greg, let me say how pleased I remain with our ongoing progress on many fronts. We continue to outperform the marketplace, most recently growing 2x to 3x the market rate of growth. Our top line growth in a so-so economy, a low inflationary economy remains solid, and I am very pleased at our upper single-digit organic constant currency growth at CooperVision during the quarter.

Our family of products, Biofinity, Avaira, Proclear 1 Day and now 1 Day silicone hydrogel, MyDay, as well as women's health care, our global fertility products are all promising growth going forward. We continue to execute well and invest in geographic expansion in a new product pipeline. While we are still very early in our expansion programs in each of the BRIC countries and there are challenges in each, I am very pleased with our progress to date. Our women's health care franchise has now become more global with the Origio acquisition made 1 year ago. Our balance sheet is very strong. Our debt-to-cap, which was near 40% only a few years ago is now single digit at 9%. We remain keenly focused on delivering consistently improving results, mindful of our desire to invest and leverage prudently, thereby delivering a respectable total shareholder return. Lastly, as always, a reminder that at Cooper, our #1 asset is our employees. To them, a big thank you for consistently delivering great results. And now, I'll turn it to -- over to Greg to cover more financial highlights.

Gregory W. Matz

Thanks, Bob. And good afternoon, everyone. As Bob shared with you a pretty thorough review of the market and our revenue picture, let me start with gross margins. Looking at gross margins in Q3, the consolidated GAAP and non-GAAP gross margins were 65.1% compared with 63.5% for GAAP and non-GAAP in Q3 last year. We continue to see strong headwinds due to the impact of foreign exchange, predominantly the yen, on our revenue and the related direct impact on gross margins, which had approximately a 90-basis-point impact year-over-year.

In addition, we continue to experience a negative mix impact due to Origio, which we purchased in July 2012. Despite these headwinds, we continue to run favorable margins due to a reduced CIBA royalty strong product mix led by Biofinity and increased manufacturing efficiencies. Looking sequentially, we saw our gross margin drop from a high of 66.2% to 65.1%. This is primarily attributable to our normal seasonality of manufacturing variances, including the impact of the December plant shutdown as that inventory turns, as well as FX. We saw the continued degradation of the yen, which add a 30-basis-point impact. For Q4, we're looking for gross margins to be in the range of 65.5% to 66%.

CooperVision, on a GAAP and a non-GAAP basis, reported a gross margin of 65.4% versus 62.8% for GAAP and non-GAAP in Q3 last year. Factors driving the year-over-year gross margin improvement were the reduction of our royalty expense, product mix and manufacturing efficiencies. The major headwind on gross margin was FX, largely the weakening of the yen.

CooperSurgical had a GAAP and a non-GAAP gross margin of 64.1%, which compares to Q3 '12 of 67.1%. As previously discussed, our margin is primarily attributable to our acquisition of Origio in July of 2012.

Now looking at operating expenses. In the quarter on a GAAP basis, SG&A expenses increased by 6% from Q3 last year to $152.1 million, and were 37% of revenue versus 38% of revenue in the prior year. Part of this increase reflects CooperVision's continued investments in geographic expansion. Also remember that we acquired Origio in July 2012 and our current quarter has 3 months of expenses versus the 1 month in the prior year. On a non-GAAP basis SG&A grew 9% year-over-year. The difference is GAAP SG&A for Q3 '12 included $4 million of Origio deal costs, which was excluded to get to non-GAAP last year. SG&A was up 1% sequentially. As we discussed in the past, CooperSurgical was impacted by the medical device excise tax. And we had about 700k of medical device excise tax in the quarter that hit SG&A, we expect about $2.4 million in 2013.

R&D expenses. As we look at R&D in Q3, R&D increased by approximately 13% year-over-year to $14.9 million, or up about $1.7 million. R&D was 3.6% of revenue, up from 3.5% in Q3 '12 and down from 3.8% sequentially. As we discussed in the prior quarter, we would expect that R&D will continue to grow slightly faster than sales in fiscal 2013.

Depreciation, amortization. In Q3, depreciation was $23.4 million, up $1.5 million or 7% year-over-year; and amortization was $7.7 million, up $1.8 million or 31% year-over-year, for a total of $31.1 million. Origio amortization for the quarter was approximately $2.1 million.

Moving to operating margins. For Q3, consolidated GAAP and non-GAAP operating income and margins were $93.6 million, or 22.7% of revenue, versus $77.3 and 20.4% of revenue for GAAP, and $81.3 million and 21.5% for non-GAAP in Q3 '12. This represents a 21% increase in operating income over Q3 '12 GAAP numbers and a 15% increase over non-GAAP. The increase in GAAP operating margins is due to a combination of improved gross margin and the elimination of the 2012 Origio deal cost and GAAP operating expenses.

Interest expense was $2.3 million for the quarter, down 2% year-over-year. Looking at the effective tax rate, in Q3, the GAAP and the non-GAAP effective tax rate was 2.3% and 5%, respectively, versus Q2 -- I'm sorry, Q3 '12 GAAP and non-GAAP effective tax rate of 6.2% and 6.1%, respectively. As we discussed before and as Bob mentioned, the effective tax rate continues to be below the U.S. statutory rate as a majority of our income is earned in foreign jurisdictions with lower tax rates.

In Q3, the single biggest factor impacting our effective tax rate was the drop in U.K. statutory rates from 23% to 20%, which was enacted in July. This had a favorable quarterly impacts of about 230 basis points, so our 5% non-GAAP rate would have been 7.3% without this. We now expect the full year GAAP effective tax rate to be in the range of 5.5% to 7%, and the non-GAAP effective tax range to be in the range of 7% to 8%. This will result in an estimated Q4 non-GAAP rate of 9.5% to 10.5%. When thinking about these ranges in our future effective tax rate, remember, there were some nonrecurring items so far this year, including the U.K. statutory rate reduction impact and our deferred tax liabilities I just mentioned, the favorable settlement of a foreign tax authority audit we mentioned in Q2 and the multiple years of R&D tax credit, which was renewed in Q1. These will amount to roughly 200-basis-point reduction effective tax rate this year.

Another driver in the lower effective tax rate is the reduction of the CIBA royalty, which increased offshore profits, and which we will continue to see going forward.

Earnings per share. Our Q3 earnings per share on a GAAP and non-GAAP basis were $1.79 and $1.74, respectively, versus $1.36 and $1.45 on a GAAP and non-GAAP basis in Q3 '12. Our earnings per share is up 32% and 20% on a GAAP and non-GAAP basis, respectively, versus the prior year.

Touching on share repurchase. There was no share repurchase activity in Q3. There still remains $184.5 million available under this program. Regarding foreign exchange, currency continues to have a big impact on our business from a year-over-year perspective, and even some continued negativity since we gave guidance on our Q2 earnings call. From a year-over-year perspective, currency negatively impacted us by $0.17 and this was mainly driven by the yen, which was down 25% year-over-year. From our Q2 earnings call when we last gave guidance, currency negatively impacted Q3 EPS by $0.02 and is projected to negatively impact Q4 by an additional $0.02. As we look at the fourth quarter, we continue to see a significant negative impact on a year-over-year basis of around $0.16. This does include some favorable impact of seeing some of our lower cost pound inventory flow through the P&L in Q4. Regarding our Q4 guidance, we used roughly today's rates of euro being EUR 1.32 and the yen at JPY 100.

Looking at the balance sheet and liquidity, in Q3, we had cash provided by operations of $103.1 million, capital expenditures of $38.6 million, resulting in $64.5 million of free cash flow. Inventories were basically flat at $340 million from last quarter. For the quarter, we're seeing months on hand at 7.1 months, up from months on hand to 6.6 months last year, and down from 7.8 months last quarter. AR continues to be well managed with DSOs at 53 days, up slightly from 52 days last year but down from 54 days at the end of last quarter.

Before I turn it back to Kim, I wanted to touch on guidance for Q4. And Bob mentioned some of this, but just to reiterate it, total company revenue for Q4 is expected in the range of $410 million to $425 million for a year-over-year growth rate of 4% to 8%. We expect CooperVision's Q4 revenue to be in the range of $330 million to $340 million or a year-over-year growth rate of 4% to 7%. This equates to a constant currency growth rate for CooperVision of 8% to 11%. We expect CooperSurgical's revenue in the range of $80 million to $85 million with a year-over-year growth rate of 3% to 9%. We expect non-GAAP gross margin in Q4 to be in the range of 65.5% to 66%. Non-GAAP OpEx to be around 41.5%, non-GAAP operating margin to be in the range of 24% to 24.5%. As I mentioned earlier, we expect the Q4 non-GAAP effective tax rate to be 9.5% to 10.5%. Our Q4 GAAP earnings per share is estimated in the range of $1.76 to $1.81 and excludes the impact of the potential Aime transaction. Our Q4 non-GAAP earnings per share is also estimated in the range of $1.76 to $1.81. This being based on a diluted share count of 49.9 million shares. Finally, we expect capital expenditures for the year of $180 million to $210 million and free cash flow of $180 million to $210 million. With that, let me turn it back to Kim for the Q&A session.

Kim Duncan

Operator, we're ready to open up the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] The first question comes from the line of Kim Gailun, JPMorgan.

Kimberly Weeks Gailun - JP Morgan Chase & Co, Research Division

So just 2 quick ones, the first is on gross margin. And as we look at it sequentially in the quarter, you were down just over 100 basis points and gave a lot of detail in the call, so thanks for that. And I think essentially, what you're saying was FX sequentially was about 30 bps worse. And most of the rest of that was manufacturing variances. So just hoping you could clarify that, was there any mix impact sequentially? And then the follow-up is just with the lower tax that we're seeing this year and how we should be thinking about earnings growth for next year. You had a bunch of different moving parts in the tax rate this year, and how we should think about that number as we get into '14?

Robert S. Weiss

Great. Yes, thanks. On the gross margin, I think you nailed it. We basically had that the yen go against this a little bit from our last guidance. So from a sequential standpoint, we did see about a 30-basis-point impact. And we do have, if you look back and I just have data for the last 5 or 6 years in front of me, and you can see that Q3 is always kind of our lowest gross margin quarter. We see that dip, it's normal. We have a number of manufacturing variances that come through, including we have traditionally shut down our plants in December in order to do some maintenance and get it prepared for the year, and that flows through naturally in the Q3 timeframe. On the tax side, we have had a lot of kind of 1x items pop up this year. We're not in a position where we want to give guidance for next year. I did want to highlight that there are some things that are 1x in nature, and that's kind of why I brought that out. On the other side, I did mention but you have a certain amount number of discrete items that reversed occasionally each year, and the size of those items are really -- we don't know those in advance, and so that has an impact that can actually raise the rates. So at this point, we're not going to go through and give yearly guidance for 2014 on the tax rate.

Operator

The next question comes from the line of Larry Biegelsen, Wells Fargo.

Lawrence Biegelsen - Wells Fargo Securities, LLC, Research Division

I wanted to focus on MyDay, if I could. So obviously, you just launched the product. Bob, you mentioned that demand is strong. Could you give us an update on pricing relative to DAILIES TOTAL1 and TruEye? Will you be able to meet capacity, meet demand -- do you have enough capacity to meet demand going forward in fiscal 2014? Any more color on the U.S. approval timing and the production plan? And just lastly, Bob, on MyDay. Could you just give us some reassurance that as you ramp up, we won't have production issues that we did with Biofinity?

Robert S. Weiss

All right. As far as the pricing of MyDay, I'm not going to get into all the details other than to say we're obviously not going to price at the high point at both TruEye and TOTAL 1 are, which is the reason that the market remains a niche market. So expect our pricing is not -- it's going clearly be below that sphere of -- in that tier of pricing. As far as demand, demand is going to be -- it's certainly exceeding our capacity throughout 2013, throughout 2014. And once again, that is purely a function of our ability to ramp up in long lead times on equipment that are 12 to 18 months, which really will push us out to 2015 and beyond. As far as the timing in U.S. and what we expect in the U.S., the approval to sell in the U.S., we expect within the next 12 months. Whether or not we immediately go-to-market once we get that approval will be a function of not overextending our reach. So if the demand is robust in Europe and we've committed to customers, we're going to honor those commitments first in Europe and then we'll take it from there as we ramp up. As far as the risk of not being able to ramp up, it's more about plugging -- getting the equipment, plugging it in, validating it. It is not novel equipment, it's equipment we have been using in the production of both Avaira, as well as the production of MyDay. So I think it's more execution, unlike Biofinity when that really got started way back when in 2006, '07 and '08. It was a material that was challenging to us and a huge learning curve, not only the equipment -- that the production equipment came into play, but also the material came into play. So I think we'll be on that.

Operator

The next question comes from the line of Matthew O'Brien, William Blair.

Matthew O'Brien - William Blair & Company L.L.C., Research Division

To kind of follow up a little bit on Larry's question about MyDay. As I recall, the big market right now that's the big chunk of overall daily silicone hydrogel revenue is Japan. And I'm just curious, I think I get the strategy as far as going to Europe first, but when you've talked about some pretty big demand there, and I think that's a relatively small market. So is it fair to characterize that, that potential revenue opportunity is something along the lines of a few million dollars, maybe $10 million at the high end over the next 12 months or so? And then within there, as MyDay gets to be a bigger and bigger piece of the overall business, certainly, it's going to weigh on gross margins, but the absolute contribution on the revenue side may be much higher. So should we expect a higher level of share repurchases or a higher dividend rate to offset what may be going on throughout the P&L?

Robert S. Weiss

I kind of lost you some place along there, but let me comment on Japan. You're correct, Japan is the biggest 1 Day silicone hydrogel market. The gating of the 1 Day silicone hydrogel market and the rate limiter has much more to do with price points than it does whether or not demand is there for silicone hydrogel. So the reason we're not going straight to Japan has a lot to do with the approval process we are embarking on going down that path, and we'll get to Japan at some point in time. As far as is the product limited by way of revenue potential, I think, not. In the next couple of years, we're not worrying about can we sell the product. It's kind of where do we sell it in 1 order and how do we control the process so we don't offend people that can't get the product? So that's really the rate limiter. But in the perfect world, if Japan were available, who knows we might have that -- meaning we have the approval process, we might very well go there first, but that's theoretical. As far as I think some of those other questions you asked, you're going to have to maybe repeat them.

Gregory W. Matz

Buyback.

Robert S. Weiss

On the buyback.

Gregory W. Matz

Yes, I think, Matt, when you mentioned buyback, we just don't -- we don't really comment on that.

Robert S. Weiss

In other words, any buyback done by us, we have the approval to go into the market and we go into the market opportunistically, but we clearly do not define what that means or the parameters of that. I would view that as not linked with anything else we're doing. Maybe the only limiter would be use of cash in terms of investment opportunities and other things on our plate.

Operator

The next question comes from the line of Jeff Johnson, Robert Baird.

Jeffrey D. Johnson - Robert W. Baird & Co. Incorporated, Research Division

Let me ask Bob 1 question and then I do have a follow-up after that. But it might be picky and you guys have good fourth quarter revenue guidance out there for CVI. But if I look at your fiscal third quarter growth of 9% constant currency for CVI and then your calendar 2Q was 10%, does that -- is it overreading to say July slowed down? Can you give us any kind of July or maybe kind of what you're seeing so far to start this quarter off, update on the CVI side?

Robert S. Weiss

I think it is, #1, July, of course, is in the reported period and I think you're doing a bifurcation of maybe the calendar data and the CLI data and...

Jeffrey D. Johnson - Robert W. Baird & Co. Incorporated, Research Division

Exactly.

Robert S. Weiss

But relative to the guidance we're giving, I think it's pretty in sync with the run rate we had, both in the quarter ended June 30, which was the 10%, and the 3 months ended in July, which is the fiscal period, which was 9%. But quite frankly, that got weighted somewhat by a non-soft contact lens piece, the Aime products business, if you will. So I don't think you can read any slowing in the bifurcation or in our guidance.

Jeffrey D. Johnson - Robert W. Baird & Co. Incorporated, Research Division

Okay, that's helpful. And then just another couple of questions here on MyDay. First, I just want to confirm, it doesn't sound like there is really any revenue or margin implications for MyDay in the quarter. And then, Bob, I'd like to hear -- in the quarter you just reported, sorry. And then, Bob, I'd like to hear kind of maybe your bigger-picture thought on MyDay. It sounds like you guys are probably going to come out at a $500 to $550 price point somewhere in there for MyDay. But long term, do you think we have to get that price point down into the $400, $450 range? Where do you think daily si-hy pricing has to settle out? If we look at traditionally kind of a 20% or 25% trade-up cost is what takes these lenses out of niche territory into more of a reasonable trade-up range, where do you think long term that pricing on daily silicone in general needs to go for users to really start taking it up faster?

Robert S. Weiss

Well, I think if we look way down the road, you're going to end up with products in different categories at that cost. As cost comes down over time, the -- it will start taking on a profile a lot more traditional albeit the strategy of the industry has always been trade-up and hold the premium, some premium. My only problem with TOTAL1 and TruEye is that there is a limit and you're -- what you're trying to hone in on is where is that limit? There's no doubt that moist establishes a good guideline of what is affordable, it's the biggest product in the category. And so you know the price point can be at least moist. And you know the price point since moist is not -- silicone hydrogel can be higher than moist. So I think that's one parameter of that we know works in the marketplace. There is -- the market is willing to pay a premium for silicone hydrogel above hydrogel, so it's some place above moist. But clearly, there's a point where it cuts off, and that's where the sharpening of the pencil comes into play, which is we're not going to get too far into the details on that.

Gregory W. Matz

Yes. And, Jeff, to your other question on margin. Obviously, MyDay has a margin well below our standard margin, but it's in the rounding based on the volume of the product at this point for the quarter.

Robert S. Weiss

Yes. So to your point, we did not -- it was not a contributor to the quarter and that the rollout of the MyDay itself is a fourth quarter event as we speak now in Europe.

Operator

The next question comes from the line of Steve Willoughby, Cleveland Research.

Steve Willoughby - Cleveland Research Company

Just 1 follow-up question on a comment that was just made on MyDay first. And then I have 1 follow-up, too. If you could -- can you just give us an update on your progression in improving the yields and margins on MyDay and kind of where you stand? I think in the past, you've talked about maybe a 10% gross margin on that product. Just wondering where that is now.

Robert S. Weiss

Let's just say we're still early in the startup cycle, the production. And there are things on the new equipment as it comes in that will be more accommodating to the product. And you're right, the learning curve will continue to improve. We're well into the last meeting when we initially started the product and when we initially rolled it out as a private label. The private label product for the most part was a negative gross margin. The costs have come down so we're in positive territory, but we have a long way to go relative to where we expect to take it.

Steve Willoughby - Cleveland Research Company

Okay, great. And then my next question is just on the competitive environment now that TOTAL1 is both in the U.S. and in Europe. I was just wondering, it looks like you guys are still obviously continuing to outgrow the market in overall in the dailies. I was just wondering about what your thoughts are maybe longer-term on some of your competitors start to launch new lenses, Sauflon gets FDA approval, things like that.

Robert S. Weiss

Well, I think as long as the price point is where it is on TOTAL1 and TruEye, this is the market that today is, let's say, something around or a little less than 5% of global market, or around that number, predicated mainly or targeted mainly at Japan. So it's, I would say, not all that much is happening in Europe and the U.S. in the extreme premium part of this market. As part as Sauflon is concerned and Clariti, it's my understanding they do have approval in the U.S. But having said that, I think they now have order for equipment, so I think like the other people in this space, everyone is in the process of ordering equipment, whether you're J&J or Alcon or Cooper or Sauflon, your -- there is a lead time on equipment in ramping up.

Operator

The next question comes from the line of Joanne Wuensch, BMO Capital Markets.

Joanne K. Wuensch - BMO Capital Markets U.S.

Can we turn for a second into CSI? What was the Origio contribution in the quarter?

Robert S. Weiss

The Origio, we had -- Greg, you want -- do you have that number?

Gregory W. Matz

Well, Origio was accretive. We've incorporated that into our business model, so we don't break that out separately.

Joanne K. Wuensch - BMO Capital Markets U.S.

Okay. And it looks as if in your guidance, you tightened the guidance range and looks like the CSI came down a little bit on the top end. Any particular reason for that?

Robert S. Weiss

I just think that's in sync with our run rate off the quarter. I think we brought it down $5 million at the top end, and that's a reflection that they're kind of marching more towards the middle of the range than towards the top of the range this time. I think the closure, as the year progressed, the closure device and our conversion there, which started a little in the third quarter in terms of the numbers we put up in the third quarter kind of ripple into the fourth quarter, and it's more whether or not you round it in the -- round it down in the third quarter.

Operator

Next question comes from the line of Chris Cooley, Stephens.

Christopher C. Cooley - Stephens Inc., Research Division

Just 2 quick ones. One, when I think about silicone hydrogel sales as a percentage of total CVI, just looking back over the last roughly 8 quarters, it's flat sequentially here in the 3Q. Should I think about that as greater growth obviously with ClearSight and Proclear in the dailies category? Or is there anything structural that we should be thinking about just in terms of your portfolio products in terms of what the ceiling may or may not be for silicone hydrogel as a percentage of total CVI revenue? And then just as a quick second one, any update on the immediate transaction there in terms of estimated time of closure, so I'm assuming we have to change that or make adjustments for that to the full year once that closes?

Robert S. Weiss

I think, Aime?

Christopher C. Cooley - Stephens Inc., Research Division

Yes, Aime.

Gregory W. Matz

Yes. So, Chris, on the Aime transaction, we're still working through that. Once we determine that it is definite and that we definitely have a deal at that point, we will book that and you will see that flow our -- through our earnings. We are hoping that's in Q4, but again, we have a couple of milestones that we're still working through at this point.

Robert S. Weiss

Chris, on the second comment on silicone hydrogel, as far as it being I think 43% in the second and third quarter, I think that's just your -- when does it round up to next level. Obviously, we're happy with the 22% growth on a much larger base, and so the constant currency contribution in growth is much higher than the total. And clearly, it continues to gain the size of our pot, if you will, as well as the market at a very respectable rate. So no, I don't read anything into the 43% and the 43%.

Operator

A question from the line of Jon Block, Stifel.

Jonathan D. Block - Stifel, Nicolaus & Co., Inc., Research Division

The EPS growth is certainly very solid this year, and I guess you can make the argument adjusted for some of the FX headwinds. It looks like it could even be mid-20% growth year-over-year or higher. I know you quickly mentioned, Bob, low double-digit next year. And I'm not asking for detailed guidance, but just wondering at a high level if you can talk to some of the variables that may lead to the deceleration. I'm guessing one is a potentially higher tax rate, but just any other stuff to point to, is it investments getting rated for greater ramp in MyDay? Anything there would be helpful.

Robert S. Weiss

I guess I would just say, we continue to invest money in the company, both on geographic expansion, as well as R&D that is expanded more rapidly than the top line, meaning the emphasis to D, not the R. So it's only a matter of having time to digest that. And also keep in mind that as the yen has declined throughout the year, we still already have a hurdle to overcome first quarter next year as that will still take its toll. And those numbers have been pretty big. I think Greg pointed out the $0.17 for this quarter, $0.16 forecast for next quarter, which I think adds up to $0.54 for the year. So that's been a big hurdle and granted we've had some good things go that have minimized that this year from the point of view of the royalty and other factors in our cost of goods area. So when you put it all together, it's clearly too early to go beyond the guidance we're giving in our -- in my comment, if you will, that is going to be low double-digit.

Operator

Final question comes from the line of Amit Bhalla, Citi.

Amit Bhalla - Citigroup Inc, Research Division

A question for Greg. If you look to the fourth quarter for the gross margin guidance, you're expecting a sequential ramp-up. Please correct me if I'm wrong, but I think that would assume that 1 Day degradation on gross margin is just really not going to happen. And so as you look to 2014, can you talk about the gross margin impact from the 1 Day rollout? And secondly, how do you think about 2014, Bob? Maybe you could talk a little bit about your expectations for market growth and maybe any comments on top line for the company.

Gregory W. Matz

Yes, I mean on the gross margin, I think if you look back in the last few years, and again, I mentioned that I have 5 years in front of me, that Q3 has always been the lowest gross margin of the year, and you will see our -- and you will see it go back up in Q4. So you've got a natural process and a lot of it is around manufacturing variances, a little bit more revenue in the quarter. All of that stuff contributes to a higher margin in Q4. And so from that perspective, we feel very comfortable with the guidance that we've given. Again, we're not going to give guidance in the next year. MyDay is still -- it's still a small product compared to our other product portfolios. So even though it has a lower-than-average gross margin, it's -- again, it's not going to drive our gross margins in the coming year just based on the volume.

Robert S. Weiss

Just a couple of comments on your questions. Piggybacking on what Greg just -- comment he just made that MyDay is not going to be a major influence next year. That is still predicated on timing of equipment. The equipment lead times are 12 months to 18 months, you're only as fast as the longest piece of equipment it takes to get. So it is unlikely. Quite frankly, impossible to get the equipment in, get it plugged in, get it assembled, get it validated, make products and have the product make it out the door to any significance next year relative to any equipment we now have on order. So that is -- clearly, capacity is the governor in 2014. And therefore, MyDay is just not going to be a big factor in that process. Relative to market outlook, I would say that we're, there is no indicator I've seen that says the market should be outside of that range we've given in the past 4% to 6% in a kind of a post deep recession economy that we had. So we're now, in my opinion, at the 4% to 6% range and we've been running most recently towards the bottom end of that range at 4%. But I do think we'll start to accelerate a bit. As far as our guidance, our guidance would be eliminated at this point in time to say and we continue to expect to gain share. We're not saying we're going to match what we've done the last 1 to 2 years at 2x to 3x the market. We're going to gain share, by how much that is one we're not going to attempt to put a lot of color around right now.

Operator

With no further questions, we'll turn the call over to Mr. Bob Weiss for closing remarks. Please proceed, sir.

Robert S. Weiss

Well, I want to thank everyone for calling in today. And once again, for those of you that have New Year's activities, our apologies for the overlap and have a great happy New Year. For everyone, I look forward to updating you on our year-end results in December, I think it's December 5, very much like today, the 5th. So we look forward to giving you update on just how well 2013 went at that point in time. Thank you.

Operator

Ladies and gentlemen, that concludes today's conference. Thank you for your participation. You may now disconnect. Have a great day.

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The Cooper Companies Inc. Discusses Q3 2013 Results (Webcast)

The following audio is from a conference call that will begin on September 05, 2013 at 17:00 PM ET. The audio will stream live while the call is active, and can be replayed upon its completion.

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Theravance Is Splitting Into Two Very Appealing Companies With Medium-Term Upside Of At Least 50%

There have been several healthcare spinoffs recently that have enjoyed much fanfare and success. These are the Abbott Labs (ABT) and Abbvie (ABBV), Elan (ELN) and Prothena (PRTA) and the Covidien (COV) and Mallinkrodt (MNK), to be specific. But the latest spinoff announced, Theravance Biopharma, is smaller than the other healthcare spins and has remained largely unnoticed by the investment community. Historically, after a spin, the parent and spun company have higher probabilities of being bought out relative to the rest of the market. This happened with ELN, whereas the ABBV/ABT and PFE/ZTS spins were of such a size that no other company would bother a takeover of them. Because Theravance(NYSE:THRX) has a market cap of around $4B, as well as significant ties to GlaxoSmithKline (NYSE:GSK), I feel that Theravance will be targeted for a buyout soon after it is split in two.

Theravance is a biopharmaceutical research company with both approved and pipeline drugs. On April 25th of this year Theravance announced that it was going to spin off its drug research unit under the name Theravance Biopharma. From the language used in the 10-12b, it looks as though THRX is planning to complete the spin before Q1 2014, however the company has given itself leeway to delay or cancel the spin. I'm generally not one for healthcare stocks, and do not profess any special knowledge of drug companies, but a corporate restructuring could squeeze out some value that the market will notice.

Theravance Biopharma:

Theravance Biopharma will hold the rights to VIBATIV, a treatment for serious bacterial skin infections that has won FDA approval. VIBATIV is scheduled for sale in Europe by Clinigen Group plc, and in the Middle East by Hikma Pharmaceuticals. Theravance Biopharma will receive royalty payments on 20-30% of VIBATIV's net sales for at least 15 years, and will hold about a dozen VIBATIV patents. This spin will have $300M cash backing and a 2% equity interest in Theravance.

Moreover, Theravance Biopharma will start off with a bunch of Phase I and Phase II drugs in the pipeline. Long-Acting Muscarinic Antagonist (LAMA)-TD-4208 is currently in Phase 2b study with completion anticipated before January 2014. TD-1792, a treatment for hospital-acquired pneumonia, is about to begin Phase II studies in Russia. Theravance Biopharma will also receive economic interests in UMEC/VI/FF and the MABA programs from a previous partnership between Theravance and GSK. Theravance Biopharma is partnering with Alfa Wassermann società per azioni (S.p.A.) on a Phase II trial for Velusetrag, with potential royalties of up to 20% of future sales. Theravance Biopharma is also working with Merck (NYSE:MRK) on preclinical research programs initiated with Theravance, but with all proceeds assigned to Theravance Biopharma.

Now, assuming for argument's sake that each and every one of the Phase II and Phase I drugs are worthless, a conservative valuation for Theravance Biopharma can be based off of VIBATIV's commercialization, Theravance Biopharma's stake in Theravance, and the MABA program partnership with GSK.

The commercialization for VIBATIV should net Theravance about $50M per year for at least 15 years. Assuming a healthy 15% discount on the cash flows, 0% growth in royalties, and a market penetration of only about $500M in sales per year, that would equate to ~$336M in today's cash. Theravance's Biopharma's equity 2% stake in Theravance at current prices would equate to $80M in value. Since Elan recently bought 21% of Theravance's RELVAR ELLIPTA/BREO ELLIPTA, ANORO ELLIPTA, MABA and vilanterol monotherapy programs for $1 Billion, it can be assumed that the public market would value the relatively new MABA programs attributable to Theravance Biopharma for at least $100M. This results in a valuation floor of at least $516M, which along with the $300M cash infusion, totals to $816M.

(click to enlarge)

Theravance:

Theravance itself will retain full interests in RELVAR, ELLIPTA/BREO, ELLIPTA, ANORO ELLIPTA and vilanterol monotherapy programs, which are all partnered with GSK.

It's well known that the market can give a conglomerate discount to companies with multiple divisions and complicated business relationships. Splitting a company's mature products from its longer-term research pipeline decreases operational costs for the mature products while increasing the amount of attention and fundraising capabilities for the pipeline. Because GSK has been a partner with Theravance for every project that will remain with the parent post-spin, it's possible that GSK will just want to take over Theravance after the spin.

Why would GSK attempt a buyout, and not buyout all of Theravance now? First, a regulatory decision for Theravance's Anoro drug is due on December 18th 2013, which will be a large factor in Theravance's valuation. Since GSK has continued to increase the number of shares it owns, GSK is most likely waiting until Anoro is approved before proceeding on determining a buyout price. Piper Jaffray alluded to this possibility in a memo several months back, with a target buyout price of $51. I'm guessing that GSK is holding back because it wants to pay the least amount of money possible for a portfolio of drugs that are currently sellable to consumers. GSK is currently hurting on the drug markets, with very little annualized growth in earnings, book value, and sales over the past five years. GSK is also issuing dividends that are taking up a larger and larger percent of earnings each year. GSK also does not have any new drugs that have been developed in-house lately. Thus, GSK is a bit strapped for cash and future earnings, so it will need to buy new drugs for its portfolio. This puts Theravance in a convenient position. GSK's biggest product currently is Advair (20% of GSK's sales, or around $8 Billion per year), which has dominated the asthma and COPD treatment markets. But Advair has recently come off patent, and there is competition from similar products by AstraZeneca and Pfizer, along with new drug developments from Pfizer, Novartis, and Forest Laboratories in the pipeline. While Advair has been difficult for generics to replicate so far, sales for Advair are dropping and GSK needs a successor quickly in order to stave off competition. Theravance arguably has a better drug called BREO in its portfolio that is only taken once daily. BREO can succeed Advair and allow GSK to stay ahead of the competition for asthma and COPD treatments. So ideally the catalyst of Theravance's buyout price will be if Anoro is approved. Assuming approval on Dec. 18th, (which should increase the value of THRX beyond what its current price assumes, along with my current valuation of THRX) GSK will have interests in another drug with patent protection for the asthma and COPD markets, and it will most likely move to keep all future profits for itself. If Anoro turns out to be worthless, GSK can lower its buyout price for Theravance and get BREO. The last thing GSK needs right now is a cash-draining pipeline that GSK did not have much interest in the first place, hence the creation of Theravance Biopharma. If GSK had attempted to buy out Theravance before the spin-off, it would undervalue Theravance Biopharma's pipeline and increase its own future R&D costs in an nonstrategic manner, with added risk of Anoro possibly failing approval only a few months later. This would be a lose-lose situation for both investors and GSK.

The other reason that GSK is biding its time is that GSK will most likely be the only company bidding for Theravance, since GSK already owns over 26% of Theravance's equity. Although another major company could step in for a takeover, the purchase would require a significant premium to justify GSK releasing its interest in all of THRX's projects. Because the market has known about GSK's position for years, I don't see how GSK could buy out THRX from current shareholders without a large premium from current prices. However, if Theravance's drugs are appealing to competitors, GSK does not own enough of Theravance to block another takeover if it initially cuts a raw deal.

Result:

I estimate the total market value of both Theravance and Theravance Biopharma within the next twelve months to be at least $6.1 Billion, which is a 50% premium to THRX's current price. After Theravance spins off its drug pipeline, the parent will probably sell itself to GSK for at least a 30% premium within 2 years, assuming that the healthcare sector and macro environment continue to be stable enough for takeovers. Also, if GSK and other institutions immediately sell their stakes in Theravance Biopharma out of disinterest, individual investors can pick up shares for cheap. Theravance Biopharma will most likely attract enough interest by institutions and other drug companies to warrant a decent market capitalization soon after the spin, thereby resulting in a nice profit for those investors who might not want to stick around long enough to see the pipeline to completion. A small position in THRX for around $33-$36 per share would make a good medium-term investment, based on an increased likelihood of a buyout and an extra bit of value created by the spin.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in THRX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)


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Monday, 2 September 2013

Theravance Is Splitting Into Two Very Appealing Companies With Medium-Term Upside Of At Least 50%

There have been several healthcare spinoffs recently that have enjoyed much fanfare and success. These are the Abbott Labs (ABT) and Abbvie (ABBV), Elan (ELN) and Prothena (PRTA) and the Covidien (COV) and Mallinkrodt (MNK), to be specific. But the latest spinoff announced, Theravance Biopharma, is smaller than the other healthcare spins and has remained largely unnoticed by the investment community. Historically, after a spin, the parent and spun company have higher probabilities of being bought out relative to the rest of the market. This happened with ELN, whereas the ABBV/ABT and PFE/ZTS spins were of such a size that no other company would bother a takeover of them. Because Theravance(NYSE:THRX) has a market cap of around $4B, as well as significant ties to GlaxoSmithKline (NYSE:GSK), I feel that Theravance will be targeted for a buyout soon after it is split in two.

Theravance is a biopharmaceutical research company with both approved and pipeline drugs. On April 25th of this year Theravance announced that it was going to spin off its drug research unit under the name Theravance Biopharma. From the language used in the 10-12b, it looks as though THRX is planning to complete the spin before Q1 2014, however the company has given itself leeway to delay or cancel the spin. I'm generally not one for healthcare stocks, and do not profess any special knowledge of drug companies, but a corporate restructuring could squeeze out some value that the market will notice.

Theravance Biopharma:

Theravance Biopharma will hold the rights to VIBATIV, a treatment for serious bacterial skin infections that has won FDA approval. VIBATIV is scheduled for sale in Europe by Clinigen Group plc, and in the Middle East by Hikma Pharmaceuticals. Theravance Biopharma will receive royalty payments on 20-30% of VIBATIV's net sales for at least 15 years, and will hold about a dozen VIBATIV patents. This spin will have $300M cash backing and a 2% equity interest in Theravance.

Moreover, Theravance Biopharma will start off with a bunch of Phase I and Phase II drugs in the pipeline. Long-Acting Muscarinic Antagonist (LAMA)-TD-4208 is currently in Phase 2b study with completion anticipated before January 2014. TD-1792, a treatment for hospital-acquired pneumonia, is about to begin Phase II studies in Russia. Theravance Biopharma will also receive economic interests in UMEC/VI/FF and the MABA programs from a previous partnership between Theravance and GSK. Theravance Biopharma is partnering with Alfa Wassermann società per azioni (S.p.A.) on a Phase II trial for Velusetrag, with potential royalties of up to 20% of future sales. Theravance Biopharma is also working with Merck (NYSE:MRK) on preclinical research programs initiated with Theravance, but with all proceeds assigned to Theravance Biopharma.

Now, assuming for argument's sake that each and every one of the Phase II and Phase I drugs are worthless, a conservative valuation for Theravance Biopharma can be based off of VIBATIV's commercialization, Theravance Biopharma's stake in Theravance, and the MABA program partnership with GSK.

The commercialization for VIBATIV should net Theravance about $50M per year for at least 15 years. Assuming a healthy 15% discount on the cash flows, 0% growth in royalties, and a market penetration of only about $500M in sales per year, that would equate to ~$336M in today's cash. Theravance's Biopharma's equity 2% stake in Theravance at current prices would equate to $80M in value. Since Elan recently bought 21% of Theravance's RELVAR ELLIPTA/BREO ELLIPTA, ANORO ELLIPTA, MABA and vilanterol monotherapy programs for $1 Billion, it can be assumed that the public market would value the relatively new MABA programs attributable to Theravance Biopharma for at least $100M. This results in a valuation floor of at least $516M, which along with the $300M cash infusion, totals to $816M.

(click to enlarge)

Theravance:

Theravance itself will retain full interests in RELVAR, ELLIPTA/BREO, ELLIPTA, ANORO ELLIPTA and vilanterol monotherapy programs, which are all partnered with GSK.

It's well known that the market can give a conglomerate discount to companies with multiple divisions and complicated business relationships. Splitting a company's mature products from its longer-term research pipeline decreases operational costs for the mature products while increasing the amount of attention and fundraising capabilities for the pipeline. Because GSK has been a partner with Theravance for every project that will remain with the parent post-spin, it's possible that GSK will just want to take over Theravance after the spin.

Why would GSK attempt a buyout, and not buyout all of Theravance now? First, a regulatory decision for Theravance's Anoro drug is due on December 18th 2013, which will be a large factor in Theravance's valuation. Since GSK has continued to increase the number of shares it owns, GSK is most likely waiting until Anoro is approved before proceeding on determining a buyout price. Piper Jaffray alluded to this possibility in a memo several months back, with a target buyout price of $51. I'm guessing that GSK is holding back because it wants to pay the least amount of money possible for a portfolio of drugs that are currently sellable to consumers. GSK is currently hurting on the drug markets, with very little annualized growth in earnings, book value, and sales over the past five years. GSK is also issuing dividends that are taking up a larger and larger percent of earnings each year. GSK also does not have any new drugs that have been developed in-house lately. Thus, GSK is a bit strapped for cash and future earnings, so it will need to buy new drugs for its portfolio. This puts Theravance in a convenient position. GSK's biggest product currently is Advair (20% of GSK's sales, or around $8 Billion per year), which has dominated the asthma and COPD treatment markets. But Advair has recently come off patent, and there is competition from similar products by AstraZeneca and Pfizer, along with new drug developments from Pfizer, Novartis, and Forest Laboratories in the pipeline. While Advair has been difficult for generics to replicate so far, sales for Advair are dropping and GSK needs a successor quickly in order to stave off competition. Theravance arguably has a better drug called BREO in its portfolio that is only taken once daily. BREO can succeed Advair and allow GSK to stay ahead of the competition for asthma and COPD treatments. So ideally the catalyst of Theravance's buyout price will be if Anoro is approved. Assuming approval on Dec. 18th, (which should increase the value of THRX beyond what its current price assumes, along with my current valuation of THRX) GSK will have interests in another drug with patent protection for the asthma and COPD markets, and it will most likely move to keep all future profits for itself. If Anoro turns out to be worthless, GSK can lower its buyout price for Theravance and get BREO. The last thing GSK needs right now is a cash-draining pipeline that GSK did not have much interest in the first place, hence the creation of Theravance Biopharma. If GSK had attempted to buy out Theravance before the spin-off, it would undervalue Theravance Biopharma's pipeline and increase its own future R&D costs in an nonstrategic manner, with added risk of Anoro possibly failing approval only a few months later. This would be a lose-lose situation for both investors and GSK.

The other reason that GSK is biding its time is that GSK will most likely be the only company bidding for Theravance, since GSK already owns over 26% of Theravance's equity. Although another major company could step in for a takeover, the purchase would require a significant premium to justify GSK releasing its interest in all of THRX's projects. Because the market has known about GSK's position for years, I don't see how GSK could buy out THRX from current shareholders without a large premium from current prices. However, if Theravance's drugs are appealing to competitors, GSK does not own enough of Theravance to block another takeover if it initially cuts a raw deal.

Result:

I estimate the total market value of both Theravance and Theravance Biopharma within the next twelve months to be at least $6.1 Billion, which is a 50% premium to THRX's current price. After Theravance spins off its drug pipeline, the parent will probably sell itself to GSK for at least a 30% premium within 2 years, assuming that the healthcare sector and macro environment continue to be stable enough for takeovers. Also, if GSK and other institutions immediately sell their stakes in Theravance Biopharma out of disinterest, individual investors can pick up shares for cheap. Theravance Biopharma will most likely attract enough interest by institutions and other drug companies to warrant a decent market capitalization soon after the spin, thereby resulting in a nice profit for those investors who might not want to stick around long enough to see the pipeline to completion. A small position in THRX for around $33-$36 per share would make a good medium-term investment, based on an increased likelihood of a buyout and an extra bit of value created by the spin.

Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in THRX over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)


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Tuesday, 20 August 2013

Big Pharma Companies will meet at the Geriatric Safe Medicines Summit to discuss performing clinical trials in older people, 16-17 September, London

Main Category: Conferences
Article Date: 19 Aug 2013 - 8:00 PDT Current ratings for:
Big Pharma Companies will meet at the Geriatric Safe Medicines Summit to discuss performing clinical trials in older people, 16-17 September, London
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Patients over the age of 65 are prescribed the majority of prescription drugs used in the UK but are significantly under-represented in clinical trials. Statistics show that although over 65's carry 60% of the disease burden they are only represented at a rate of 32% in phase I-III Clinical Trials. Why do clinical trial recruitment designs neglect this patient population? 

Challenges which include co-morbidities, polypharmacy drug-drug interactions, adherence formulation challenges are just some of the difficulties faced when performing clinical trials in this population, not to mention the problems of delivery.

SMi's inaugural Geriatrics Safe Medicines Summit, taking place on the 16th-17th of September 2013 in London, will look to tackle these issues and will address Benefit-risk in this patient population and how clinical trials could be better designed to facilitate the participation of the elderly in clinical trials.

According to Nina Lee Barnett, Consultant pharmacist, Northwick Park Hospital who is speaking on day one "I am really looking forward to participating in this meeting. It is great to see a programme which includes internationally renowned contributors from a wide variety of backgrounds, all delivering sessions which support safer use of medicines in older people. This meeting is an opportunity to foster collaboration on research projects which include older people and to break down barriers preventing studies in this age demographic."

Through a novel range of case studies attendees will discover new market gaps, market strategies and focus on EMA geriatric medicines strategy and how modelling and simulation along with new patient reporting systems support clinical trials in older people.

Keynote speakers include Solange Rohou, Director Regulatory Affairs, AstraZeneca who will be presenting on: What has been done since the revision of the ICH E7 guideline? The Companies' view and Barbro Westerholm, Member of Swedish Parliament, who will speak on: Patient perspectives on healthy ageing.

Event highlights include:

Discover the benefits of performing clinical trials in older people Identify the key challenges and considerations when conducting clinical trials in older people Address reasons for clinical trial retention difficulties Discuss how modelling and simulation along with new patient reporting systems support clinical trials in older people Explore new market gaps and discover new market strategy Focus on the EMA geriatric medicines strategy

For the full conference programme and further information please visit:? http://www.smi-online.co.uk/goto/geriatricsummit55.asp

Alternatively contact Jonathan Collins on +44 (0)20 7827 6734 or email: jcollins@smi-online.co.uk

Sponsorship opportunities are available for this event, please contact Alia Malick on +44(0) 20 7827 6168.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our conferences section for the latest news on this subject.

About SMi Group

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries.

We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries. For more information, please visit http://www.smi-online.co.uk

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