Cytogen: The Wall Street Analyst Forum Presentation Transcript

| About: Cytogen Corp. (CYTO)


Cytogen Corporation, Inc. (CYTO)

The Wall Street Analyst Forum

September 20, 2007 9:50 am ET


Kevin Bratton - SVP, Finance and CFO

Michael Becker - President and CEO


Good morning, ladies and gentlemen. In our ongoing attempt to adhere to the published schedule, I'll go into – I am going to get started with my piece of the program here, before I introduce the management. And as a reminder for those of you that are physically here, the webcasts are retrievable off our website for 30 days following the event. And you can also access the transcripts of all the presentations of all the companies, including the Q&A session word-for-word on the website, and they have that web searchable on Yahoo Finance and Google Finance. But it probably would be the easiest to go right to the Seeking Alpha website. See the transcription service out of Israel, I got to know what time that is there, nine or something, that are doing the transcriptions and they will be web searchable in about six hours as a way for us to extend the conference beyond those that are physically here in New York City and beyond the traditional webcasting itself.

Cytogen is a specialty pharmaceutical company dedicated to advancing the treatment and care of patients by building, developing and commercializing a portfolio of oncology products. The company markets three therapeutic products and one diagnostic product in the US. CAPHOSOL is a oral rinse for the treatment of oral mucositis and dry mouth. I must have dry mouth. QUADRAMET, samarium Sm-153 lexidronam injection is the treatment of pain in patients whose cancer has spread to the bone. PROSTASCINT is a PSMA-targeting monoclonal antibody-based imaging agent for prostate cancer and SOLTAMOX is a liquid hormonal therapy for breast cancer.

So for further introduction, I introduce Kevin Bratton, Chief Financial Officer. And we just ask Kevin to repeat the question during the Q&A for the benefit of the webcast attendees.


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Kevin Bratton

Thank you. Good morning. I'd like to thank the Wall Street Analyst Forum for giving us the opportunity to make this presentation this morning. And as is consistent with most public companies that are present today, we'd like to remind everybody that the presentation today may contain forward-looking statements. So, we ask everybody to refer to our appropriate SEC filings that contain the risk factors that affect our business.

Who is Cytogen? We are focused on developing, building and commercializing specialty oncology products with supportive care and therapeutic treatment for cancer patients. And how do we do that? We have four marketed products addressing underserved or unmet medical needs, and we have these products distributed and marketed through an established 50-person commercial infrastructure. We have a data-driven commercial strategy that has a robust strategy to take the clinical data and publish it, so that we have a broader awareness supporting the physician community. We have an (inaudible) pipeline that is augmented by an active in-licensing program. And importantly, we have an experienced enterprising management team that has been recently strengthened by the addition of Steve Ross, our new Senior Vice President of Sales and Marketing, about whom I'll speak more later.

In discussing our product portfolio right now, CAPHOSOL, which I'll spend most of my time on today, because it is the product that has the most significant near and long-term growth opportunities for the company, is an electrolyte solution for the treatment of both oral mucositis and xerostomia, or dry mouth, which are both common side effects from the treatment of cancer patients.

QUADRAMET is for the treatment of pain in patients, whose cancer has spread to the bone. PROSTASCINT is a monoclonal antibody-based imaging agent to determine the extent and spread of prostate cancer. And SOLTAMOX is a liquid formulation of tamoxifen used as a hormonal therapy for certain breast cancer settings. This product is basically to give a patient an alternative form of delivery.

As I indicated, CAPHOSOL has the greatest near and long-term growth opportunities for the company. So, we are spending most of our time on this, this morning. It is a patented supersaturated calcium phosphate rinse that has approved as a prescription medical device for the treatment of oral mucositis and xerostomia, which are debilitating side effects from the cancer treatments. This is a product that we in-licensed because of the strong clinical data that is supporting this product. There has been a clinical study that was done a couple of years ago in the medical center that has proven that this product is effective in reducing the incidence and severity of oral mucositis.

Importantly for us, it is a synergistic acquisition, and that it gives us the opportunity to leverage our sales force, was already calling on medical and radiation oncologists. We obtained the rights to product in October 2006 for the North American market. We also obtained options for the European and Asian market, and our intent would be to try to develop partners to commercialize the products in those markets. And we view this as a product that is a near-term driver that was lunched in the first quarter of 2007 and we have some slides later on that we will go into with the market acceptance of the product today.

Oral mucositis is a debilitating condition that is suffered by about 400,000 plus cancer patients every year. It is a clinically significant side effect of both chemotherapy and radiation therapies. And as can be shown on the visuals to the right, it's a pretty debilitating effect that can lead to either stopping, or in interruption of treatment, as well as some other problems associated with nutritional issues, and just patient discomfort and a pretty significant impact on the patient's quality of life.

There are various stages of oral mucositis and CAPHOSOL is a supersaturated calcium phosphate solution, and the mechanism of action is that calcium and phosphate have known beneficial effects in terms of tissue repair, wound healing, blood clotting and a number of other aspects, and these are very important along the various stages of progression of oral mucositis. So, these are beneficial effects all the way through the development of oral mucositis.

As I indicated earlier, one of the reasons we acquired this product was because of the significant efficacy data. It is the only approved oral rinse that has clinical benefits that have been validated through a traditional, randomized, double-blind, placebo-controlled trial. It occurred in a transplantation environment. So, these patients were given high dosage chemotherapy in advance to stem cell transplantation. So, these patients are known to have a very high incidence of oral mucositis and very severe cases of oral mucositis. So, these are somewhat of the worst of the worst patients.

So by doing it in the setting, it actually set a very high bar in terms of proving efficacy of the product. It has some pretty significant clinical endpoints in terms of days of mucositis, the duration of pain and the days of morphine that the patients underwent.

And as you can see by the slide here, we had pretty dramatic improvements in each one of those endpoints, and importantly, this data was published in the peer-reviewed journal, Bone Marrow Transplantation, which gives our sales force a pretty strong marketing tool to go to physicians to increase the awareness and efficacy of this product.

There were other factors that are really impressive in terms of the output of the study. The number of days of observation were less than a half of the placebo group. The median peak level of mucositis was three in the placebo group versus grade one in the control group and importantly, the percentage of patients with mucositis that did not exceed grade one was 19% in the placebo group and 40% in the CAPHOSOL group. These are pretty significant improvements when compared to that, and it gives us a pretty strong device or a pretty strong marketing tool in terms of trying to increase the physician awareness to prove the efficacy of the product.

In terms of the market opportunity for CAPHOSOL, we believe that the market opportunity is approximately $250 million. If you look at the estimated new cases of cancer every year, the percentage that undergo chemotherapy, the number of treatment cycles, the fact that there will be four to ten doses per day and the fact that approximately 40% of all patients will develop oral mucositis. So, this comes up with a market potential of about $250 million and that’s based upon using most of the factors on the left end of the range here, if you use the right end, I think the potential market opportunity could be significantly greater.

As I indicated earlier, we launched the products in March this year towards the end of the first quarter. So, we have tried to show here is some data points to measure how the launch is progressing right now. If you look at the blue line that is the total prescribed boxes on a fully growing total basis and that is based on data that is prepared by IMS. But since we know that IMS doesn’t capture all the data, including the use of the product at hospitals, we have also shown in the red line the number of boxes that are shipped to our wholesalers and we believe this -- there is pretty closely the DDD data on a monthly basis. So that you can see there's a pretty decent trajectory since the product was launched.

And the third line, which is a dotted green line, represents the number of boxes that we have sampled. We think this product is very heavily sampled where we can leave samples with the docs, and that if you notice the trajectory of that line, mirrors the other line. We think that that proves that the sampling program has increased the awareness at the physician level and what it has proved is that as patients and doctors experience CAPHOSOL, it turns into scripts based upon their success in using the product on a sample basis.

There are a number of demand drivers that we believe are going to contribute to the success of the product launch. As we have mentioned, this is the only oral rinse that has approved for the treatment of both oral mucositis and xerostomia that is backed by significant clinical data. There are number of other rinses and top of devices on the market but this is the only one that is supported by this type of clinical data. We have recently enhanced our market initiatives by really focusing our sales force on marketing of CAPHOSOL.

As we said, we have four marketed products, and what we have done since this is the greatest growth opportunity for us, it has changed the focus of the sales force. So, this is now their primary product that they are covering in their meetings with docs and also increases our access to medical oncologists, and therefore, gives us some type of cross selling benefit with our other products. We are also doing more targeting sales efforts now in terms of looking at the medical oncologist, the radiation oncologist and the hematological oncologist who are the higher subscribers of products for oral mucositis.

And another factor is that, as we indicated, the oral mucositis traditionally last about four to six weeks. And so, our goal would be to try to get the docs to write a script for four to six boxes of the products. Initially, you can imagine as you get to the launch and there is not a great awareness for the product, the docs are using this on a much less prescribed basis than that. So, what we have seen is that the number of boxes per script has been rising and we think that’s contributing to the increase in August.

The other factor is, as we indicated we had the ex-US rights to the product. And our hope is that, over time, as we are successful in terms of licensing this product to the other sections of the world, that we are successful in terms of grading or creating some type of brand awareness in other areas of the world that will contribute to the success of CAPHOSOL.

One thing before we move to our other products, we have to make sure we cover in terms of CAPHOSOL is that this product has two indications, oral mucositis and also xerostomia of dry mouth. And while we are a specialty pharmaceutical company focusing on cancer applications, obviously, you can see that the primary focus is in the cancer applications in the near term. However, there are potentially some greater other applications of CAPHOSOL to non-oncology markets. There are certain diseases such as diabetes and the autoimmune disorder, Sjögren syndrome, of which xerostomia or dry mouth is a significant side effect of the disease. There are also about 400 drugs right now that have xerostomia as a side effect.

So, the potential is to bring CAPHOSOL to those other markets and this is probably done through opportunities to either co-market or co-promote the product with other entities. So, we think that in addition to the near-term oncology focus, there is a lot of other opportunity for CAPHOSOL.

Switching gears now to QUADRAMET, this is a novel product that is designed to palliate pain in any tumor that has spread to the skeletal system. It is a targeted radiopharmaceutical and that it is a small molecule that is targeted to growth or new bone formation of skeletal system and carries with it then a radiation, so that it results in a very targeted application of radiation to the site of the bone tumor. It is estimated that there are about 100,000 patients in the U.S. every year that will develop painful bone metastases from the spread of cancer.

There are high usages of opioid analgesic products. We think QUADRAMET has some significant benefits over that, because we are all aware that the opioid products had some side effects, including clinical constipation, nausea, and the potential for abuse or addiction. So, we think that QUADRAMET provides an effective alternative for that. We think, it's a best-in-class compound, in that it has a half life of about 48 hours, compared to 50 days for some of the earlier generation products, such as Metastron. It is fast acting, in that for one 60 second infusion, the patients can feel benefit in a week – as soon as a week’s time, and the benefit can last for up to four months. It also will then result in decreased pain and reduced use of the opioid analgesics.

QUADRAMET is included in the class of radiopharmaceutical products that would also include items such as BEXXAR and ZEVALIN, and I am not sure everybody is aware, but this whole class of products had had some problems in the last couple of years. There had been some historical barriers to greater usage of these types of products. The first is control, whereby the medical oncologist, as the prescriber, often times doesn't have the ability to administer these types of medications, so then he has to refer the patient to a radiation oncologist or a nuclear medicine physician.

There has been a lack of data that would support the benefits and the tolerability of using radiopharmaceuticals in connection or combination with contemporary chemotherapy products. And there has been a lack of safety data, so that in large parts, doctors have been very concerned about side effects of radiopharmaceuticals, including mild suppression. So as result, they have tended to use these types of products at patient's end-of-life on this very advanced cancer.

And the last problem is economics, whereby the medical oncologist has to refer the patient to the radiation or nuclear medicine physician. Thereby, there is an economic disconnect between the doctors in that particular case, which is suspected of creating some underutilization of these products.

We think there are some short-term opportunities for products like QUADRAMET. In that first, because of our focus on CAPHOSOL, we are increasing our frequency of calls to medical oncologists, which we believe gives us an opportunity to speak about QUADRAMET to the medical oncologists community, and we have also come out with last year or so with a lot of clinical data, favoring clinical data that supports the use of QUADRAMET in combination with other chemotherapy drugs.

So, we think this goes to the issue of combinability that we discussed earlier. For this class of drugs, there is an evolving landscape that could result in greater use of this class of products over the future, and these factors include a changing reimbursement environment, an increasing number of nuclear medicine physicians at oncology GPOs, new clinical data, and also increasing public awareness of the underutilization of these products, which have some pretty strong clinical data. So we think that over the long-term, the evolving landscape could potentially drive increased usage of this product class. And we also think that QUADRAMET has potential as we evaluate its potential use as a cancer therapeutic and not just a targeted agent.

Moving on to PROSTASCINT, this is our monoclonal antibody-based agent used to image the extent and spread of prostate cancer, and you may say, why is that important? It's important because when a patient is diagnosed with prostate cancer, there are two forms of treatments used. It would be localized or systemic.

And if the prostate – if the cancer is confined to the prostate, you can use therapies such as surgically removing the prostate or freezing it or using brachytherapy. But if the cancer has spread outside the prostate, these treatment forms are not effective. So PROSTASCINT gives the physician an opportunity to have a non-invasive imaging agent to determine whether or not the cancer has spread outside the prostate, in which case the patient and the physician can discuss the appropriate treatment regimen.

PROSTASCINT is, as I indicated, it’s a monoclonal antibody-based product that is targeted to PSMA, which is a protein that is expressed on prostate cancer cells. And it too has had some historical barriers to greater use, and what we have seen over the last two years is that there have been significant improvements in the camera technology or imaging technology that have resulted in much better images. And I think that if we all look at the improvements that have been made to cell phones, personal computer and devices like that over the last few years, it’s easy to understand how the imaging technology in nuclear imaging have improved over the last few years. So we are making some inroads in terms of publications of data to make the doctors aware of the improvements in this and how effective PROSTASCINT is right now in determining the image, the staging in the extent of the disease.

Our last product is SOLTAMOX, and this is a liquid form of tamoxifen, which is oral liquid hormonal therapy that is used in certain breast cancer settings, and this is potentially a potent product, although it’s a very niche product, because they are a number of patients out there who have difficulty swallowing or who would just prefer an alternative to a tablet. If you go to your local drug store or CVS, I am sure, as you walk down any aisle you will see there are various forms of most common medications. There are tablets, gel caps, liquid, and patches. We think SOLTAMOX just offers patients an alternative form of treatment. It could be effective in increasing compliance in the future.

The product was launched in the fourth quarter of 2006. We view this as a product that is not driven by our sales reps, but is something that will be driven by marketing, as we look towards direct-to-physician or direct-to-consumer marketing to increase the utilization of this product.

In terms of our pipeline, what we have right now is CYT-500, which is a PSMA-targeting antibody using the same antibody that’s in PROSTASCINT, but instead of pairing it with an imaging radioactive agent, it is paired with a therapeutic imaging – therapeutic radioactive agent. And we believe that the clinical risk in this product is less than other products, because it is based on the monoclonal antibody that has been administered to thousands of patients through PROSTASCINT. So, this is a product that we have initiated our Phase I clinical trial in the first quarter of 2007.

In terms of our business development strategies, we discussed earlier, we are using this to augment our own developed products and the objective here would be to leverage our sales force by adding some additional clinical stage or marketed compounds. We would be looking for products that are in the therapeutic or supportive care area, and that they will be complementary to our existing commercial infrastructure, so we would be able to leverage these into our existing sales force, and we would expect that any candidate would be synergistic to our existing product line and that could be realizable over the next 12 to 24 months.

And because of the issues that we have talked about in terms of the whole class of radio pharmaceutical products, we are probably looking more for specialty pharmaceutical products, and increasing our focus in that area over the next few years. And the other aspect would be to monetize assets that we don’t feel are aligned with our proprietary focus. So, for example, we have discussed the fact that we have options to exercise the rights to CAPHOSOL in Europe and Japan. Our intent would be to try to leverage those through a partnering arrangement.

We have indicated earlier that the company has a strong management team, and this has been augmented recently by the addition of Steve Ross as Senior Vice President of Sales and Marketing, who joined the company in July of this year. Steve came to us after 15 plus years at GSK. He has spent a large part of his career in oncology applications, so he is familiar with the types of products that Cytogen offers. And we believe if you would ask Steve what brought him to a company like Cytogen, I think, he would say that he is excited by the possibilities for CAPHOSOL, the things that this could do to oral mucositis, the same things that even MediQuest did for cancer patients suffering from nausea.

Our Board of Directors is an experienced Board that has a lot of experience with both biotech and large pharmaceutical companies, including The Liposome Company, Bristol-Myers, Pharmacopeia and a number of other pharmaceutical companies.

Here is some brief selected financial data through the second quarter of this year. It's important to note what's not on here is basically the revenues that are primarily from PROSTASCINT and QUADRAMET. We did recognize some small revenues from CAPHOSOL in the second quarter of this year. So, we have been able to grow our existing products and haven't seen yet the benefit from CAPHOSOL. And secondly, the cash position here does not reflect the $10.1 million financing that was completed in early July of this year.

In terms of our performance this year, in terms of achievement of our goals, we have secured new commercial leadership with the addition of Steve Ross. In July, with respect to CAPHOSOL, we did launch the product in March of this year and we are initiating prior Phase IV trials to broaden our clinical experience. We have a cancer registry underway, to give us greater indications in terms of the use of CAPHOSOL.

For QUADRAMET and PROSTASCINT, we have presented a new clinical data at a number of medical meetings, and we are presently working on manuscripts that we hope to have published in peer-review journals. [As well in] March, we are developing our new marketing strategy that is designed to focus on direct-to-physician and direct-to-customer, and take it out of the whole sales base – sales rep based area. We have initiated the Phase I study in March for CYT-500. For QUADRAMET, we have initiated new clinical studies through cooperative groups. We are working on our discussions to try to monetize the ex-U.S. rights for CAPHOSOL.

From a financial perspective, we have identified items where we could reduce our cost. Just recently we reduced our guidance for R&D spending for 2007 as we try to focus our efforts in terms of the launch of CAPHOSOL.

I guess, in summary, as we indicated, we are an oncology-focused company. We do have four marketed products. In that we are able to commercialize through a 50 plus person commercial organization. We have a robust data-driven strategy, and increasing the number of publications of our clinical data. We have an aggressive program to in-license products to augment our own products, and we have an experienced management team.

So with that, that concludes the formal presentation, and I'll open the floor to questions.

Question-and-Answer Session

Unidentified Audience Member

[Inaudible Question]

Kevin Bratton

The question is how many physicians have we seen in our efforts right now to launch CAPHOSOL? I am not sure I have an exact number of that. We have gone to a number of shows and attended programs like the Oncology Nursing Society Show earlier this year. And we have a number of promotional marketing materials that have been distributed. I think what’s important to note is the change in the marketing focus that we discussed. I think that if you looked at early in the year, we had four products and the sales force trying to cover four products. And I think that what's important now is changing our focus to use CAPHOSOL as a primary product, and we want to – the sales people to develop their efforts too. We are also becoming much more targeted in terms of which physicians we are going to go after, and so we are paying more effort now to the high decile prescribers of oral mucositis products. So, this is increasing our efforts to speak to medical oncologists, and also we have now started to talk to hematological oncologists. So, the goal really is to start focusing on those doctors that are the high prescribers for oral mucositis type products. Yes.

Unidentified Audience Member

[Inaudible Question]

Kevin Bratton

The question is how much cash we need I guess before we become a self-sustaining company or…?

Unidentified Audience Member

[Inaudible Question]

Michael Becker

I am Michael Becker, and I am the President and CEO of Cytogen. Our cash utilization on an annual basis has been a little a bit north of $30 million per year. So, that's been the historical product sales run rate. So the real opportunity to reduce our cash requirements is obviously through the new growth opportunities such as the launch of CAPHOSOL, SOLTAMOX to a smaller extent, and also the expansion of our radio pharmaceutical business. If you look at our P&L right now, you can see that we are at slightly less than a 50% gross margin on the sales that we generate, and again those are historically solely from the radiopharmaceutical business, PROSTASCINT and QUADRAMET. So, we did $17.3 million in sales in 2006 at a – you know let’s just use round numbers at a 50% gross margin. Obviously, we need to generate much more in terms of top line revenue at that gross margin in order to be self-sustainable.

So, once you get into the larger sales of the products, which results in some manufacturing efficiency, you can start to talk about self-sustainability probably in the $50 million to $60 million top line run rate, and again we are at $17.3 million as of 2006. So, the real opportunity there is to launch CAPHOSOL and capture as much of that $250 million market opportunity as we can in order to become self-sustainable within a very short time period. Yes.

Unidentified Audience Member

What kind of commercial infrastructure will you need to get there?

Kevin Bratton

The average sales rep can handle about $1 million worth of product sales per year. That’s an industry metric right now. So, we have 50 sales reps, those should be sufficient to get to about a $50 million top line run rate. I am sorry, and the question was how many – what size sales force would we need to achieve those revenue numbers?

Unidentified Audience Member

[Inaudible Question]

Kevin Bratton

One box contains 60 amps, and each box contains 30 amps of calcium solution and 30 ampules of phosphate solution. The patient mixes the two in a cup, rinses, and then expectorates, and the average use is expected to be approximately four times a day, so a box is about a week’s supply.

Unidentified Audience Member

[Inaudible Question]

Kevin Bratton

The patients – the question is whether patients comply with four times a day or whether they use it less or more? The package insert is actually that the product can be used as low as or as infrequent as four times a day, but up to 10 times a day. What we have seen in the feedback that we have received from patients is that they actually enjoy the sensation of rinsing with this solution, the reason for that is many of these patients are suffering from dry mouth. So lubricating the oral cavity in and of itself has a therapeutic benefit for them.

And then obviously, the reduction in the oral mucositis aspect is certainly that the main focus or the main utility behind CAPHOSOL, but the patients very much like the taste, which is maybe best described as a slightly saline tasting solution. It's a neutral pH solution, so it doesn't sting or burn or anything like that. And that’s very important, because many of the other agents that they would theoretically be rinsing with such as lidocaine and others do often cause those types of burning or have a bad taste associated with them.

These cancer patients that lack the ability to produce saliva have an altered taste sensation. So sometimes what’s sweet to you and I would be sour to them, and many other kind of perverse effect on taste. And so, if you have a compound that has a minty taste or a liquorice flavor to it, those are often not well received by cancer patients. Did that answer your question?

Unidentified Audience Member

Not really. I just wanted to know whether or not patients are actually taking it four times a day, or if it seems that they are taking it more than that, or if it seems that they are taking it less than that?

Kevin Bratton

Yeah. They seem to be taking it per the prescribed factor of it, four times a day. They do increase from that, but I would say right now we probably don’t have any hard data on it, exactly on a patient-by-patient level how many times per day they are rinsing? We will be able to theoretically capture that from a registry that we just initiated, so that registry program for CAPHOSOL is designed to capture those types of endpoints.

Okay. If there are no other questions I guess, we will conclude.


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