Transcript of Presentation by Mitchell Gold- CEO of Dendreon at the 12th Annual Bio CEO and Investor Conference

Below is a transcript of the presentation that Dendreon’s  (Nasdaq: DNDN) CEO Mitchell Gold gave at the BIO CEO and Investor conference February 9, 2010.  

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Dendreon CEO Mitchell Gold:

Dendreon is a company that is exclusively focused in the field of oncology. Our lead product is a product called Provenge, which goes by the generic name sipuleucel-T. Sipuleucel-T is a new class of product called ACIs (Active Cellular Immunotherapies) that are designed to engage a patient’s own immune system and to stimulate the immune system against a particular antigen found on the surface of cancer cells.

We’ve conducted multiple phase 3 clinical studies that have shown that Provenge prolongs survival in men with metastatic androgen-independent prostate cancer. We’ve begun, on the heels of this phase 3 data and completing our BLA filing to the FDA, to build up the commercial infrastructure to prepare for the launch of Provenge with a PDUFA date occurring in the middle of this year. The PDUFA date is May 1. The company currently has about 450 employees and that will obviously increase as we get closer to launching Provenge in the middle of 2010.

One of the key aspects of our approach to harnessing the patient’s own immune system is a proprietary piece of technology that we developed called an antigen delivery cassette. The cassette has really two key components that you see here (slide 5).

Slide from Dendreon's BIO presentation

The orange helical structure is the target antigen, for Provenge that (target) is Prostatic Acid Phosphatase (PAP), which is found in almost all prostate cancer tissue. We fuse that via a dipeptide link to a GM-CSF head. That fusion protein allows us to get about 1,000-fold more efficient antigen recognition than if we just used a naked antigen all by itself. We make this in large scale bioreactors just as you would any traditional recombinant protein. By using this approach we can get a very reproducible and robust immune response that is extremely well characterized. We are able to generate an immune response against the antigen in 100% of the patients that are immunized.

The other key raw material for the manufacture of our product is the patient’s own antigen-presenting cells. We collect these through a standard blood collection procedure known as a leukapheresis. What we do is we ship these collected antigen-presenting cells to one of our manufacturing facilities.

Provenge is actually going to be launched out of a facility in Morris Plains, New Jersey that will support the initial launch of the product. We are also building out facilities in Atlanta, Georgia and in Los Angeles, California so we will have three facilities across the country that support the manufacturing approaches I am describing here.

So we take the patient’s own immature antigen-presenting cells and we combine that with the antigen delivery cassette. The cassette is taken up, most likely be a receptor-mediated endocytosis, taken into the androgen-presenting cell (APC), and then broken down into peptide fragments where it is displayed on the surface of the APC.

The APC goes through a maturation process. As it’s digesting the antigen, it becomes activated and is to able to very efficiently display these antigens to the patient’s own immune system. Those activated APCs are then infused into the patient where they elicit a T-cell based immune response against the tumor.

There are certain cell surface markers that we look at on the surface of the antigen-presenting cells that are a measure of product potency. The key one is CD54, also known as ICAM-1, and what we’ve seen in our clinical studies is that the amount of CD54 up-regulation correlates directly with overall survival in our clinical studies.

The patient population that we’ve studied Provenge in is men with metastatic androgen-independent prostate cancer. If you look at the continuum of prostate cancer, men that are initially diagnosed with prostate cancer will have some form of primary definitive therapy; either surgery or radiation therapy. About 40% of men or 30% of men will recur (relapse) after definitive therapy and they will classically go on some form of androgen-deprivation therapy.

That will last anywhere from 2-5 years. All men eventually fail androgen-deprivation therapy. They become what is known as androgen-independent. Today, for patients with metastatic androgen-independent prostate cancer there is only one approved therapy and that is the chemotherapeutic agent known as Taxotere or docetaxel. That (Taxotere) is typically reserved for men with symptomatic disease. It has been shown to prolong survival by about 2.5-3.0 months in clinical studies.

We are positioning Provenge as a front-line treatment for men with metastatic castrate-resistant prostate cancer so prior to the initiation of docetaxel-based therapy. In the U.S. there are about 103,000 men in that particular labeled indication. (slide 7)

Slide from Dendreon's BIO presentation

If you look at the treatment modalities available to these men today, it really is comprised just of docetaxel, which provide about 2.0-3.0 months improvement in overall survival. Most men elect to either delay (docetaxel use) either they are either symptomatic or not go on it at all because of the significant side effects associated with chemotherapy so there is an urgent need for better tolerated, less toxic treatment options that prolong survival and allow men to maintain their quality of life.

The first phase 3 study that we completed was a study known as 9901. This study was started in 1999 and we published (its results) in JCO (Journal of Clinical Oncology) in July of 2006. This was a 127 patient study that had as its primary endpoint, time to disease progression, and the study protocol required that we follow all men for the most relevant endpoint in this patient population which was overall survival.

What we saw in this study, and this was the initial basis of our (Biologic License Application) to the FDA in 2006, what we saw is this study was a trend in prolonging time-to-progression but on the survival endpoint we showed a 4.5 month improvement in overall survival. This was statistically significant and at 3 years we had 34% of men on drug alive (versus) 11% (of those) on placebo.

This was the basis of our license application into the FDA in 2006. It went to a panel meeting. At the panel meeting, the panel voted 13-4 that this represented substantial evidence of efficacy. Subsequent to that the company received a Complete Response letter from the agency asking to see additional evidence of a survival benefit from another phase 3 study known as IMPACT.

The IMPACT phase 3 study was almost identical in design to 9901. It was a double blind randomized placebo controlled study. It was much larger in size. Instead of 127 men, it was 512 men and now we made the primary endpoint overall survival, which is the most important endpoint, the least biased (endpoint) in men with metastatic androgen independent prostate cancer. This study was conducted under a special protocol assessment that we have with the FDA.

When we look at this study it is very similar to the results that we saw in the 9901 study. Median survival again at 4.1 months improvement of overall survival in those men randomized to Provenge compared to those men randomized to placebo and at 3 years, 32% of patients on drug alive compared to 23% on placebo and it met the primary endpoint of the study with statistical significance. This allowed us to amend our application with the FDA, which has been completed, and we are waiting for the FDA decision on a May 1 PDUFA date.

This data held up to multiple sensitivity analyses and data from the IMPACT study were very robust. Whether we looked at it on the Cox model or the unadjusted log-rank test, the results were statistically significant.  Adjusting for both the use and timing of docetaxel did not significantly impact the overall survival results and prostate cancer specific mortality was similarly prolonged in patients who received Provenge compared to those patients randomized to placebo. We will continue to share additional evidence of the robustness of the data from the IMPACT study through multiple scientific presentations throughout the course of this year.

One of the most appealing aspects of this new form of treatment is the side effect profile. So the benefit to risk profile of this new therapeutic approach of ACIs is that you have the clinical benefit of prolonging overall survival but you are able to avoid many of the toxicities that you would classically see with the chemotherapy type of regimens. The most common side effects that we’ve seen in our clinical studies of Provenge are fevers and chills. They are usually of low grade and short duration. They last for about 1-2 days around the time of infusion and then they go away.

From a regulatory perspective as I’ve said already, the IMPACT study is a pivotal study that supports the licensure of Provenge. The FDA agreed in our special protocol assessment with them as well as their feedback to us from the complete response letter that a positive improvement in overall survival from the IMPACT study would be sufficient for licensure. There is a lot of consistency between the IMPACT study and those that we’ve seen in 9901 and we are awaiting an FDA decision by May 1 of this year.

So that is the clinical story and moving on to the commercial setting for Provenge, as I’ve said, this is for men with metastatic androgen-independent prostate cancer. The typical physician segment that takes care of these men are both urologists and medical oncologists. Our plan is to commercialize this product ourselves in the United States and we are currently evaluating potential structures for partnering outside of the United States. There will be about 100 sales reps and about 25 medical science liaisons that support the commercialization of Provenge in the U.S. market.

When you think about this from a patient’s perspective and a physician’s perspective, it is extremely convenient. A typical course of chemotherapy would (see you) coming in every 3 weeks to get infused with the product and the classic number of cycles that a patient would get for a course of docetaxel would be 7 cycles so that would be 21 weeks on chemotherapy and during that whole time, you’re having to deal with the side effects of chemotherapy and the eventual outcome would be a 2.5 to 3 month improvement in overall survival.

With Provenge, patients get their blood collected on day 1. It is sent off to our manufacturing facility and 3 days later it is sent back to your physician’s office where they administer the product over a 60 minute I.V. infusion in their office. In fact the urologists that were involved in our clinical studies just used an exam room and they infused this right in their exam room in their offices.

This process is repeated 3 times over a 1 month period and then they are done so they don’t need to keep coming into the physician’s office every 3 weeks for several months. They can go on and they can live their normal lives so the convenience of this is extremely apparent to the patients.

What’s unique about Provenge is that it’s the first autologous product to be brought into the marketplace in an oncology setting and the only thing that Dendreon has to create new here are the cell processing centers that we are building out in New Jersey, Atlanta, and L.A. The rest of the supply chain already exists in the commercial setting and we are just tapping in to existing partners there so the call center, the leukapheresis centers that we have a principle agreement with the American Red Cross that provides the leukapheresis services for us, the transportation…all that already exists so we are just leveraging and tapping into that infrastructure. We coordinate the logistics of Provenge around the unique advanced planning system called Intellivenge.

Talk a little bit about the build-out of our manufacturing plants: the plant that we are going to launch from is our plant that exists in Morris Plains, New Jersey. That has been built out to 25% of its capacity and that 25% that will be part of the FDA’s inspection will be the initial 25% that we launch from for the U.S. launch of Provenge.

We have already begun to build out the remaining 75% of the New Jersey capacity and that will come online in the first half of 2011. At full capacity New Jersey can support somewhere between $500 million and $1 billion in annual revenue.

Given the anticipated large demand for this product, we’ve already begun to build out 2 additional facilities. As I’ve mentioned earlier, one in Atlanta and the other in Orange County, California (L.A.). The financing that we completed in December allowed us to accelerate the build out of these plants so now we expect them to be online by mid 2011. Within 1 year of potential approval, we will be at full capacity in terms of our manufacturing infrastructure that we are able to supply into the marketplace. These will be slightly smaller facilities. There will be 36 work stations each and as a result each of them will supply $375 to $750 million in revenue or support that amount of revenue in the marketplace. In total we will have the potential capacity to support about $1.2 to $2.5 billion in annual sales off of these 3 plants that we are building in L.A., Atlanta, and New Jersey.

To me, what is most unique about Dendreon as a company, not only are we bringing the first ACI program forward in terms of Provenge, but we really have a whole platform of products that are based on the antigen delivery cassette technology sitting behind it. Behind Provenge, we have programs (Neuvenge) targeting HER2/neu+ tumors such as breast, ovarian, colorectal, but also HER2/neu+ bladder cancer and our plan is to initiate a phase 2 study in metastatic bladder cancer later on this year or early in 2011. (slide 20)

Slide from Dendreon's BIO presentation

Many years ago we in-licensed two antigens from Bayer Diagnostics; both CEA which you know well as a diagnostic marker for colorectal cancer but one you may not know as well is CA9. CA9 is the most prolific and well understood marker for metastatic renal cell carcinoma, renal cell (carcinoma) being obviously a highly immunoresponsive tumor.

We plan to move the CA9 program forward into phase 1 studies in 2011 and then CEA in 2012. So one new ACI candidate going into the clinic each year for the next 3 years allows us to really build on the momentum of Provenge and the validation of our ACI product platform.

Now we do have a single small molecule program TRPM8 targeting the TRPM8 channel. We discovered that ourselves through our own in-house antigen discover program. It’s a small molecule that activates the TRP-M8 channel and we’re studying that right now in phase 1 clinical studies.

In terms of the cash, as I mentioned earlier, we did do a cash raise in December. The cash we raised in December allowed us to have a very strong balance sheet. As of December we had approximately $600 million on our balance sheet and that cash will allow us to commercialize Provenge, bring it into the market, and allow us to execute on our operating plan going forward.

I do believe Dendreon offers a unique investment opportunity. Provenge is a first in class active cellular immunotherapy targeting men with late-stage prostate cancer that have few appealing treatment options, that offers a favorable benefit to risk profile for men with this stage of the disease. The commercialization of this product is something that the FDA needs to make a decision on by May 1 of this year, that is the PDUFA date. We will be presenting additional data that supports the robustness of the overall clinical package at upcoming scientific meetings this year.

We’ve made a strategic decision to maintain ownership of 100% of the commercial rights to the product and we are currently evaluating partnering opportunities outside the U.S. and we have the ability to expand the Provenge technology into other disease states using our ACI platform. (end of speech)

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Transcript of Presentation by John McLaughlin- CEO of PDL BioPharma at 12th Annual Bio CEO and Investor Conference

Below is a transcript of most of the presentation that PDL BioPharma’s  (Nasdaq: PDLI) CEO John McLaughlin gave at the BIO CEO and Investor conference February 08, 2010.  Anything in brackets “( )” represents our words in an attempt to clarify unusual speech patterns or McLaughlin’s reference to a particular slide. If you want to see the slides that go with the speech then look at PDL’s 8-k issued on the same day found directly here:  www.sec.gov/Archives/edgar/data/882104/000119312510024206/dex991.htm

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PDL CEO John McLaughlin:

We think that PDL represents a unique opportunity in the landscape of biotech companies and today I’ll tell you a little bit more about why we think that’s attractive for investors.

As you can seen here (slide 4), the technology that is at the core of PDL is the humanization of antibodies. It is incorporated in products that last year’s revenues were somewhat in excess of $18 billion worth and we’re seeking new licenses. We do have a number of licenses that I’ll talk more about those today and we’re looking to get some more. As you can see they represent some of the most important companies in the biotech industry.

If you look at our 2009 performance for a second (slide 6) it gives you a good instance into how we intend to manage the new PDL on a going-forward basis. You can see that our revenues were in excess of $315 million. We are a considerably smaller enterprise than the PDL of years ago where it was upwards of 200 (employees), 400 (employees) and some years as high as 1,200 (employees). There are 10 of us. We manage the portfolio. We are domiciled in Nevada. We have a portfolio we think could be worth $1 billion or $2 billion. The fact that there is no state (corporate income) tax in Nevada is obviously consequential in terms of increasing returns for our shareholders.

You can see that in 2009 we paid 3 dividends: two dividends that we announced at the beginning of the year to shareholders of $0.50 each and then a third one at the end of the year of $1.67 from a securitization that we did towards the end of the year. Our goal is to pay dividends each year in or of around a $1.00, perhaps more. We’ve announced a dividend policy for 2010 and we will pay two dividends of $0.50 each.

We’ve signed one new license (in 2009) and we hope that you’ll see some additional licenses signed in calendar year 2010. The one thing we don’t do, and that is pretty much unlike everyone else you’ll see today, we don’t spend any money on R&D….and we’re not gonna.

When you have a broad patent portfolio such as the Queen patents, and I say that as a former general counsel of Genentech, they are often subject to attack. That is true for these patents as well.  Here (slide 7) you can see a brief summary of some of the past and current litigation. You can see back in 2003 there was a significant dispute with Genentech. It was resolved and as part of the settlement agreement Genentech acknowledged the validity and the infringement of the patents as well as took out a number of licenses that cover some existing products such as Herceptin, Xolair, Avastin, and (now withdrawn from the market) Raptiva.

(With) Alexion there was a dispute that began in 2007. It was successfully resolved in 2008 with a one-time payment of $25 million (to PDL) as well as options for 4 additional licenses.

Our most recent dispute involves a company called MedImmune (which is) owned by AstraZeneca. They market a product called Synagis. It’s an antibody to a virus more commonly known as RSV (Respiratory Syncytial Virus). They had been a licensee for a number of years- -10 years in fact– and prior to the initiation of litigation paid us about $240 million. In late 2008 they filed a lawsuit alleging that the (Queen) patents were invalid and not infringed (upon by them). Subsequently they have modified that (lawsuit) to add an additional (claim) to suggest that they are entitled to a lower royalty rate based on certain agreements we’ve done with third parties (i.e. the Alexion agreement). We don’t think they are entitled to a lower royalty rate. Most recently, in late December 2009, we declared MedImmune in breach (of the license) agreement. We did that for two reasons: First of which was there was evidence that they were not paying us all the royalties due and second, they effectively blocked our contractual right to audit them as is typical in most license agreements to determine whether or not we were being paid the appropriate amounts. As of right now they are not a licensee. We do not expect to receive royalties from them. The consequence of this is that if in fact they are patent infringer they are subject to treble damages and all the other sorts of remedies a licensee can have against infringers.

We have one other dispute and that is a patent interference (case) with UCB Celltech. You can see that it has now expanded into two (interference proceedings) and this is ongoing and this involves some applications made by UCB Celltech many, many years ago.

We do have some debt (slide 8). Some we inherited and some we generated ourselves.  Initially we had almost $500 million in convertible notes in two tranches. You can see the 2.75% convertible notes. We’ve been buying those down periodically. We’ve picked up $50 million as the price dipped and we will also periodically go into the marketplace for both of those notes and opportunistically buy them down. You can see that the conversion ratio for those is about $6.07 a share so they are in-the-money. The holders have various put rights; the first of which comes up in August, 2010. You can see they (the put rights) are followed two years later and then out at 2018.

What is interesting about the 2010 put is that at the noteholder’s discretion they can ask for either cash or stock. We don’t think there are going to be many notes put to us simply because as you can see (the notes) are trading at around $115 and they have been bouncing around someplace between $110, $111 and as high as almost $120. It is (thus) not an economically wise decision at this point to be putting them to us (at that rate).

If you look at the 2000 notes you can see that we’ve repurchased some of those. They are down to about $228 million (in notes outstanding). The conversion ratio there is about $8.38 (per share). They are out-of-the-money right now. Our stock is bouncing around $6 and $7 a share and they (the notes) are trading in the $96 range.

We did do a securitization towards the end of 2009. It is a different kind of note offering. What that means is that we pledged some of our future royalty income to securitize this note for $300 million. We are anticipating the final maturity is December 2012. The legal maturity is out in 2015. It represents about 60% of the Genentech royalties. At the end of when this note is paid off (the rights to the 60% of the Genentech royalties) reverts back to us. We have distributed about $200 million of that $300 million as a dividend at the end of 2009 and we’ve held about $100 million for some other corporate purposes which I’ll talk about in a minute.

To give you a quick overview of our corporate governance (slide 9), previously I held positions such as executive vice president of Genentech and I’ve founded and managed a number of biotech companies. Chris Larson, our CFO who is with me today, has been a CFO of biotech companies as well as has a great deal of experience with many of kinds of instruments we have been talking about today because the PDL of today is a biotech company but is also a financial instrument and her expertise is quite relevant there. Chris Stone, our general counsel, has worked in a number of biotech companies including those that deal with antibodies and has great experience in both patent prosecution and management of litigation. Karen Wilson rounds out our finance group with also great experience. Fred Frank is a banker of long term theme, now with Peter J. Solomon. Skip Klein, an investor on the buy-side of many years. Jody Lindell comes from KPMG and has an accounting background, chairs our audit committee, and has great financial experience, but also experience in healthcare. Paul Sandman used be general counsel at Boston Scientific (which is) important given that we do have some litigation. Barry Selick is currently the CEO of Threshold (Pharmaceuticals) and is actually one of the inventors of the Queen Technology.

PDL's royalty revenue growth from 2000-2009 (slide 11 of company presentation at BIO CEO and Investor Conference Feb 08, 2010)(click on image to open larger version in new window)

If I may talk a little bit about our revenue streams here (slide 11). You can see in this chart depicting from 2000 up through the end of 2009, the contributions (to revenue from) various products. You can see here significant growth (in revenue). Predominantly (PDL’s revenue comes from) the Genentech/Roche products but you see nice year-to-year growth and I’ll talk in a second about why we think that’s going to continue.

length of time it takes to manufacture antibodies (slide 12 of company presentation at BIO CEO and Investor Conference Feb 08, 2010)(click on image to open larger version in new window)

Our patents expire generally in 2013 and most of them in 2014 (slide 12). One of the questions we are often asked is “how long are you going to get paid (royalties)?” There (are) a couple of (items to consider) about (this). The first (thing to consider) is that we are paid a quarter in arrears so in fact we will get monies (from royalties) up through the first quarter of 2015 but the real answer (to this question) is depicted on this slide which has to do with how antibodies are manufactured.

This is an example of an antibody manufacturing schedule. The top panel represents the manufacture of bulk and the bottom panel represents fill and finish. What you can see here is that there is a substantial amount of time it takes to manufacture, release, and eventually have the product available for sale. Why that is important to us is because of this line here (showing that PDL gets royalties on all product made before the expiration of the patents even if sold after patents have expired). (PDL’s) patents cover when a product is made, used, or sold. The relevance here is the concept of manufacture because a product that is made prior to the expiration of our patents but sold after the expiration of our patents we still receive a royalty on.

So if, for example, a particular manufacturer keeps product in inventory for 12 months we’ll get paid (royalties on this product) 12 months after expiration (of our Queen patents). 24 months (of inventory time means PDL will get paid 24 months (after the expiration of the Queen patents) and on. This is particularly important for us…as Roche moves toward reconciling the Genentech and Roche philosophies in terms of how they inventory product.

Those of you that saw Roche’s announcement (of year-end earnings) last week where they made a number of disclosures. One of the things they did talk about was the restructuring of the manufacturing by the end of this year so that will provide some important information for us. One upside that could come from that restructuring of manufacturing is depicted on this slide (13).

PDL's royalty rates on Genentech/Roche products(slide 13 of company presentation at BIO CEO and Investor Conference Feb 08, 2010)(click on image to open larger version in new window)

As you can see here, for product that is made and sold in the United States we get tiered royalties which decrease with increasing volume. Another way to think about that is, for product that is made and sold in the United States by Genentech and Roche, our effective royalty rate is some place between 1.2% and 1.3% each year and that changes (decreases) if the volume (of sales) goes up.

For product that is made and sold outside the U.S., we get a flat 3% (royalty) that is not tiered. Currently only about 15% or so of the product that we are paid royalties on is made ex-U.S. while those markets represent between 50-55% of the overall worldwide market.

What we’ve seen in the last couple of months are announcements from Roche/Genentech that they are closing one of the (two Vacaville, California) facilities . There are two plants in Vacaville, which is about an hour outside of South San Francisco where Genentech is headquartered.

We’ve seen announcements that they are opening two plants in Singapore: one to make full length antibodies (a Chinese Hamster Ovary cell line plant) and one to make fragments such as Lucentis and that both of those are anticipated to be operational either this year or next year. To the extent that the mix moves more towards the ex-U.S. made and sold, that would give us some upside as we move from an effective royalty rate of 1.2-1.3% to a flat 3%.

This is not an eye chart (slide 14) but we were trying to give you some sense of some of the licensees we have. Some that are still in development and one of them (teplizumab) that we just signed towards the end of 2009.

You can see here that a substantial number of products are Genentech products… (reads listing of products)…

Here are two (products) I will spend just a second on: These two (bapineuzumab and solanezumab) are antibodies to Alzheimer’s (disease). Both target beta-amyloid. One of them (bapineuzumab) Johnson and Johnson just bought 50% rights into* They paid $700 million plus upfront and another $500 million in committed financing. There is some evidence that this trial that some people were thinking would conclude in 2011…will have data available towards the end of 2010 (as they have dropped the highest dose bapineuzumab cohort from the study). Solanezumab, similar target, data is expected in 2011.

*our note: actually Johnson and Johnson bought approximately 25% rights into the overall bapineuzumab program and approximately 50% rights into Elan’s half of the program. McLaughlin was unclear on this in his presentation.

To give you some idea of the highlights of news flow….(for several minutes goes into some of the recent and upcoming milestones for antibodies partners are developing)…

(to 22:42 mark in speech)

Our focus is really on optimizing return for our shareholders so we make decisions about (our) dividend or should we securitize or sell assets. Our focus is really on how can we increase the ROI for our shareholders. As you can see we paid dividends in 2009 and we intend to pay additional dividends in 2010.

Other things we will do to try and enhance shareholder return is we will periodically look at buying back some of the converts. We have done that previously when it has been opportunistic and favorable for our shareholders. Sometimes we will look at repurchasing shares. We will also look at selling the company when that makes sense, if we think we can get an appropriate price for it.

We are also looking at purchasing some of the commercial stage assets out there. There are a number of royalty streams out there. We wouldn’t buy products to be clear, we would be buying the royalties associated with those products (such as) commercial stage biotech products to see if we can enhance shareholder returns in that regards.

Lastly, we did do a securitization in 2009 and people have asked if we are going to do another one or sell more of our royalty assets in 2010 and the answer is no. We have probably (in 2009) optimized returns from that perspective.

If you were thinking about buying PDL shares the reason you were thinking about buying them is because it gives you a play on commercial stage products. They are mature (products). There is (the potential for) additional indications with substantial upside associated with (these products) without any of the risk in terms of financial exposure to R&D and clinical (activities). We are an efficient operation. We have a low (cash burn) as you can see most of the money goes out to shareholders and the best proof of that is we are shipping it out. (end of speech)

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