Adamis Pharmaceuticals Corp (ADMP) 2004 Q2 法說會逐字稿

Welcome to Cellegy Pharmaceuticals' 2004 second-quarter conference call.

At this time all participants are in a listen-only mode.

Following management's prepared remarks we will hold a Q&A session. (Operator Instructions).

As a reminder this conference is being recorded today, August 11, 2004 and will also be available for replay beginning at 1:30 PM Eastern Standard Time today through August 13, 2004 11:59 PM.

The dial-in number for the replay is 1-800-642-1687, or 706-645-9291, with conference ID number 9269635.

With that I would now like to turn the conference over to Mr. Rich Juelis, CFO for Cellegy Pharmaceuticals.

Welcome to (technical difficulty) and welcome to Cellegy's conference call.

I will first review the financials for the quarter and then turn it over to Mike Forrest, who will cover some of the highlights.

Before we start, though, I would like to remind you that we will be making forward-looking statements that involve certain risks and uncertainties, particularly with regard to product regulatory approvals and reviews by the U.S.

FDA, and also authorities within the UK and in Sweden.

And we would encourage you to review the risk factors in our annual report for 2003 on Form 10-K and the Form 10-Q quarterly report that we filed yesterday.

And with that, let me cover the financials.

Revenues for the six-month period through June were 768,000 compared with 655,000 for the last year's six-month period.

And notably, sales in Australia of Rectogesic were 259,000, which is a 50 percent increase over the 171,000 sales last year.

So Rectogesic continues to do very well in Australia and we believe that this bodes well for potential product approvals of Cellegesic in the U.S. and in Europe.

On the operating expense side, expenses were lower by about 1.4 million for the first six months of this year compared with last year.

Clinical activity during the first six months of this year was lower than it was in prior years -- in the prior year.

We expect expenses to be well controlled and at this level -- at these levels through the third quarter, and potentially to pick up an increase during the fourth quarter as we ramp up our clinical activity and begin some pre-launch marketing activities for Cellegesic in the United States.

Our cash position has been beefed up with the completion of a pipe financing in July.

Our current cash position is now at about $15 million, including the $10.3 million private placement -- and Mike Forrest will talk a little bit more about that.

Our burn rate, cash use per month is at about 900 million.

Again, we expect 900,000, and we expected to remain at that level through the third quarter and again pick up during the fourth quarter.

So with that financial review, I would like to now turn it over to Mike Forrest.

Mike?

(technical difficulty) and good afternoon or good morning, depending on wherever you are.

As you can see, we had a very decent second quarter as well as the first six months from a financial standpoint, having reduced our operating losses quite dramatically from the previous periods.

And we also made very good progress, as you might have seen from some of our press releases, over the past three months.

So I would like to review and highlight some of those events, because I think they are really quite important for both Cellegy and its shareholders.

To begin with, Cellegy filed its NDA for our lead product, Cellegesic, on June 30th, 2004.

And as you know, this product was filed on the basis of a pivotal Phase III clinical trial that was the subject of a Special Protocol Assessment that was negotiated with the FDA.

A Special Protocol Assessment is one in which all of the parameters of the trial -- including the end and the number of patients in the trial, the statistical methodology that one uses to analyze the trial, the primary, secondary, and tertiary end-points -- and is designed to essentially provide a company with a strong assurance that the product will be approved if the primary end-point is hit, following the Special Protocol Assessment procedures.

This trial took six months to complete; began in June of last year and was completed by December of 2003, and we announced the results very shortly thereafter in January.

It was a 187-patient trial that took eight weeks under which the subjects all underwent eight weeks of therapy.

In the announcement of the results, we achieved the primary end-point with a statistically significant result in terms of reduction of pain associated with chronic anal fissures over the first 21 days.

And the tertiary end-points were also significant from a pain reduction standpoint over the entire eight-week period -- that is, average 24 hour pain over eight weeks was statistically significant campaign, and pain upon defecation -- which is usually the point at which the pain is most severe -- was also significantly reduced over the entire eight-week course of the therapy.

When one takes the data or the analytical methodology that was employed and agreed to with the FDA for this Special Protocol Assessment and retroactively applies it to the first two Phase III clinical trials that were conducted by Cellegy, the results are that the -- every single end-point with the exception of a difference between placebo on healing was strongly statistically significant, and this entire body of data -- the Phase III clinical trial that is pivotal, as well as the combined data, analyzed on the basis of the way we agreed to do so under the Special Protocol Assessment with the FDA -- was all very powerfully significant, and, we believe, represents quite a compelling body of data for representing the potential approval of this product.

The side effects in the last trial were mostly mild to moderate headache, which were similar to the -- in fact, slightly less in terms of their incidence then what we saw in the first two clinical trials.

So nothing unusual from a side effect standpoint, and I would conclude that the data from our perspective looks good.

But I will have to add that because we believe that the data looks good, there is not any way in which we can give you a guarantee that the FDA will approve it.

All we can say is that if the FDA follows the letter of the Special Protocol Assessment, there is no reason for us to expect that the product will not be accepted for approval.

And in fact, speaking of acceptance, since it was filed -- the NDA was filed at the end of June, we now expect the FDA to accept the package for review sometime in early September, at which time they will assign a PDUFA date, which at this point we would expect to be the normal 10-month review period.

So the next step with having filed the NDA would be to prepare ourselves for commercialization, and as such, we've already begun the process of interviewing a number of contract sales organizations who would initially help us with the marketing of the product.

We need to, as we get a little bit closer and get a better fix on the approvability of the product, hire a VP of sales and marketing.

And then after approval, we would go ahead and begin the hiring of the sales force.

I will remind you that the market for anal fissures is about $150 million in the United States.

This is on the basis of some 700,000 to perhaps 1.25 million patients suffering from chronic anal fissure, at the price that Cellegy expects the product will be sold at.

The sales force that we expect to put forth to market this product calling on gastroenterologists us colon and rectal surgeons would number about 75 specialty reps, and the cost to field this sales force, as well as to -- the ancillary promotional efforts that would need to take place, sampling and the like, would be about $22 million a year.

And this represents only about 15 percent of the market.

So if Cellegy achieves 15 percent market share out of the $150 million, then we will be at the breakeven point on this product.

So you can see it's a relatively low breakeven, and we fully expect to be able to achieve that relatively expeditiously.

I will also mention to you that while the market for chronic anal fissures is $150 million, there also is very considerable potential for use of this product in the treatment of both hemorrhoids, for which there are 12 million people suffering from this condition in the United States, and another 5 million women who suffer from a very serious painful disorder called Dyspareunia.

It's a painful vaginal syndrome.

And neither of these two indications have any adequate product -- medical treatment available on the market today.

So while we expect a very decent penetration into the fissure market, there is the potential for off-label use in these other two indications.

And we expect on the basis of all three of these indications, as well as some evidence that we have in the product's performance, as converted from Australia into United States, that this product -- if the Australian sales were to be converted in the United States, they would currently be running at about a 50 to a $55 million rate, and on the basis of fissures alone.

So you can see that our expectations in the United States would be easily in that range if not higher, and anything that we're able to get from the other indications would be additive to that.

And we can say quite confidently that we think that this product has the potential to be a multi-$100 million product.

The Second event that took place during the course of the quarter is that we received notice from the UK, the MHRA in the UK -- which is the equivalent of the Food and Drug Administration in the United States -- that Cellegesic had received the status of approvable in the United Kingdom.

The product in the UK and in Europe will be called Rectogesic as opposed to Cellegesic, because of trademark differentiations.

And at this point, assuming that there are no further data requests from the regulatory authority in the UK, we would expect as the application works its way through the normal sign-off process, that we would expect formal approval sometime next month.

Now, we look at this as really quite a validating event in the sense that this data that was supplied to the UK is the same data that we filed with the U.S.

FDA as part of our second Phase III clinical trial.

The only difference that we had -- there is in fact no difference -- but the FDA chose to not accept the statistical methodology that Cellegy employed, although they agreed that it was a valid statistical methodology; it just was that we did not adequately tell them in advance that we were going to use such a methodology.

This does not -- this was not an issue for the UK authorities and it is exactly the same data on which they will be granting approval in the United Kingdom.

So we feel very good that our original approach to the preparation and analysis of our second Phase III clinical trial is being accepted by a major regulatory body outside of the United States.

The next steps for Rectogesic in Europe is, obviously, going to be one of partnering.

And in that context, we have received expressions of very strong interest from five companies in Europe who seek rights to the product from a commercialization perspective in that part of the world.

We would expect to go through the process of looking at each one of these possible deals and picking the best possible one for us, and would do that as quickly as possible.

The third event that's taken place during the course of the quarter is that in July we announced the signing of a licensing deal with a company called Strakan LLC for Tostrex in Europe.

And this is a very interesting deal because once again it provides us with some validation that there is a great demand for a product like Tostrex in the European theater.

And I will talk a little bit more about that in a moment.

Strakan is a company that is founded by and whose chairman is the original founder and CEO of Shire Pharmaceuticals.

He turned that into a very promising company and ultimately sold it and left and moved on to another thing, and began to do his own second generation sort of specialty pharmaceutical company in Europe.

The Company is a very healthy firm that has about a 60-person sales force already operative in the UK in the area of bone and joint disorders and osteoporosis.

They have the specialty sales force in the UK that is complemented by sales forces in France, Germany, and soon-to-be in Sweden.

And they are very actively looking at acquisitions of other companies in Europe in order to round out their overall business model for the European theater.

The Company has about a $400 million market cap.

It is a private company, and is backed by Warburg Pincus, who owns about 50 percent of the Company.

So it's a very healthy company indeed, and we have great confidence that the expertise of Harry Strakan, who is the CEO of the Company, along with his team -- I'm sorry -- Harry Stratford, along with the support from his team of dedicated professionals, will be able to produce very satisfactory results for Tostrex in Europe.

Now, Tostrex -- the market for this product in Europe is larger in terms of numbers of patients than it is in the United States, but the market is not as quiet as well developed from a penetration standpoint, and may resemble the market in the U.S. probably three or four years ago.

But it is taking on the characteristics of rapid penetration and rapid growth, and we've all seen what has happened in the United States as the gel products have taken hold.

And we -- as I said, I believe that ultimately this will reach the same potential as in the United States, although it is in a slightly earlier stage of development.

The product is under review by the regulatory authorities in Sweden, so we filed the same regulatory package that we filed in the United States in the European theater, using Sweden as the regulatory -- the initial target regulatory body.

All of the indications are at this point in time that they are satisfied with the regulatory filing.

And Strakan did all of their due diligence of the U.S. data package and the package that we filed in Sweden, and is convinced that the product will get approved.

We certainly hope that that is the case, and if it is the case, that should take place sometime during the fourth quarter of this year.

In the meantime, Strakan is gearing up to launch the product as quickly possible, and the two products -- both Rectogesic in Tostrex -- now provide Cellegy with -- if these events come to pass -- a flow of revenue from the European sales of both Rectogesic and Tostrex beginning in 2005.

So it is a good source of additional revenue, in addition to the sales that we might realize from the sale of Cellegesic in the United States.

The fourth event that I would like to report to you is the private placement that took place at just the week or so ago of $10.3 million -- about 3 million shares of Cellegy common stock.

This was an important financing for us because it once again represented the kind of quality investors that Cellegy has behind it.

The major shareholders all stepped up with their pro rata shares -- pro rata portion of the 3 million shares, and we were able to bring in one or two other new investors who were -- either we had been talking to or had been referred by the existing shareholders.

So John Gregory, through S.J.

Strategic Investments, took 30 percent of the transaction.

The Tisch Family took their 19.5 percent share of the transaction.

And we were able to bring in some new investors, including a group called Kingsway, which is the brother of John Gregory, Joe Gregory, who brought a million shares in this deal.

And we had good participation from Fuller & Thaler, and from Broadwood Capital -- who's an existing shareholder -- and a group called Silver Oak in San Francisco.

So we were very pleased to be able to get this deal done in a relatively short period of time by simply making telephone calls, and we are thankful that we're continuing to enjoy very strong support from our existing shareholders, and a lot of interest from even some new parties that have decided to get involved with Cellegy.

This gives us about literally 16 months to 17 months of cash, so we have all the operating requirements that we need for the next 17 to 18 months.

A couple of other items that I wanted to bring you up to date on that have transpired and/or are transpiring as we speak.

First of all, with Fortigel in the United States;

Cellegy continues its discussions with the FDA in an attempt to arrive at an agreement on a Special Protocol Assessment that would cover the design of a final Phase III clinical trial that would be conducted by Cellegy in order to obtain approval in the United States.

We have not quite arrived at agreement with the FDA on that trial, but we're confident that the product parameters and capabilities itself can meet the requirements that the FDA has put forth for other products that have been approved in the United States market.

So it is a matter of time before we are able to get that resolution with the FDA and move on to conduct this trial and get the product on the market in the United States for marketing by our partner, PDI.

The last thing that I will mention before opening the floor up for questions is our progress that we're making on Tostrelle.

And this is actually outstanding progress that we're making on this testosterone gel for the treatment of female -- declining female libido in post-menopausal women.

Some of you may recall that earlier we announced that we had, on our first interim analysis of results that were conducted in a Phase II study, that 71 percent of the women who were undergoing this trial responded very favorably in terms of improved sexual activity, frequency, and quality of sexual activity, as opposed to only 13 percent who are receiving the placebo gel.

This was very encouraging results because -- these were encouraging results because there was such a big difference between the active and the placebo.

And so that -- in our minds at least -- said that there is a very good expectation that the product will ultimately be able to overcome any kind of a placebo response.

We have decided to expand the trial which at that time was really limited to surgically menopausal women, and we began to include women who were naturally menopausal as well.

We are now doing another interim analysis on the first -- on many patients, and I will have to go into that -- not at this point in time -- but just to give you a little preview of things to come.

There is over 100 patients that are in this trial.

We are going to be doing -- we are in the process of doing an interim analysis -- a second interim analysis, and will report on those results in the next couple of weeks.

I can tell you we are very excited; this is a major product with blockbuster potential in the United States and Europe, and we feel we are in the lead with the development of a gel product, and hope to be the very first testosterone gel product into the market behind Procter & Gamble's patch, which will probably come on stream sometime -- the consensus has it probably sometime late next year.

As you all know on the basis of the way gel products have been received in the U.S. male testosterone market, we think that gels are far more acceptable from a patient preference standpoint, especially to women, than the patches.

And we have extremely high expectations of garnering a very significant market share with our product Tostrelle in the United States and Europe.

So a preview of things to come; stay tuned, and you should be hearing more about this exciting product in the next couple of weeks.

At this point I will stop and open the floor up for any questions you might have.

And if I can't answer them, I'm sure my colleague, Rich, will be able to chip in.

(Operator Instructions).

Harry Lindberg, Perkins Capital Management.

I just had a couple of questions regarding the Cellegesic.

If a ten month review were to start in September, would you anticipate then, roughly, if you had approval, that you would see sales the second half of '05?

And the second part of the question would be -- with the money that was just raised and with the burn rate, would you anticipate that there would be any need to raise money between now and then?

Good questions.

Thank you, Harry.

In response to the first on timing, actually the PDUFA date, the review period begins from the time you file the NDA, not from the time that they accept it for review.

When they accept it for review, 60 days or two months would already have expired.

So if there is a full ten-month review, a period that takes place, we should be getting approval in the beginning -- at the end of April or beginning of May of next year.

And the answer then to your second question is yes, we would expect revenues shortly thereafter, and would begin to ramp quickly through 2005, and from our perspective, should get us to a breakeven sometime in 2006.

Harry, with your financing question, we would likely do an additional financing to commercialize the product, and the size of that financing will depend in part on the kind of contract sales organization deal that we would do.

And so potentially, we would look to finance to launch Cellegesic either late this year or early next year.

Thanks, Rich.

And the amount of the financing would also be a function of the amount and flow of revenue that we're getting from our two products coming out of Europe, and any other licensing deals that we might be able to do for, perhaps, Tostrelle or even for Cellegesic and Tostrex in Japan.

So there's a number of potential significant deals that are on Cellegy's agenda for the next 12 months.

Austin Hall, Credit Suisse First Boston.

For Rectogesic in Europe, do you plan to seek a partner before final approval, or do you anticipate finding a partner after final approval in the UK?

Our feeling is that there is really no -- nothing that we expected will put a wrench in the works in terms of the final approval; it's just now going through the normal review and sign-off process.

It's already cleared the pharmacology and the medical review process, who have recommended the product for approval.

So it is really going through an internal bureaucracy that needs to take place before the final signature is obtained.

We expect that approval to be -- assuming there is no wrenches that get thrown into the works, which we don't think there will be -- that should come some time next month.

So on that basis, we are already in discussions with partners.

And it is likely that the approval will have already come by the time we sign a deal, but that is not going to prevent somebody from signing, because this is essentially pretty much of a done deal in terms of an approval for the European -- for the UK.

There are other approvals that need to take place for the rest of the European common market, but the British regulatory authorities have already agreed to act as the member state representative for filing throughout the rest of the European theater.

And that process usually takes six to 10 months from the time of approval in the UK.

So if this gets approved, then the first launch will be in the United Kingdom, and that could take place relatively quickly, followed by a roll-out into the other European markets six to nine months later.

John LaForge, First Albany.

Looks like a couple of my questions were asked, but the two I had left were -- you didn't talk at all about an accelerated review potential with the FDA here.

Is that on the table?

And my second one was -- I'm sorry -- my second one was the timeline for the marketing partner, and that was taken care of.

We are assuming that the product will go for the full 10 months of review, because that's what the FDA granted the last time.

There is always the possibility that since they are familiar with the product they will give a shortened review period.

We did ask them for accelerated review.

There is no guarantee that they will do that.

So I think for the purposes of conservatism, we should assume that it is going to take the entire 10 months review period.

The FDA is not known to be kind to sort of anybody.

If they are kind to us this time, it could be as early as six months.

But we are planning from Cellegy's prospective, and I think from a market perspective it would be prudent to plan for a review process that is going to take the entire 10 months.

Do you know when they're going to respond to you one way or the other?

The typical timeframe that they let you know what they're designated PDUFA date will be is when they accept the NDA for review, and that usually takes place 60 days after the filing of the NDA.

And that 60 days is up at the end of August, so we should know quickly.

So by the end of August you'll know if they've given you accelerated review?

That's correct.

(Operator Instructions).

David Pariss (ph), private investor.

I just had one question about whether there is a Phase II trial underway to use Cellegesic for hemorrhoids, and if so, when do you anticipate releasing any results from that trial?

Yes, there is a trial.

There actually are two trials underway using Cellegesic for hemorrhoids.

We by necessity are actually going relatively slowly with this trial, although it's accumulated probably a couple of hundred patients at this point in time.

And by necessity meaning that we don't have as much cash as we would like to do to complete in a hurry a large Phase II and then a Phase III program for a hemorrhoid program, which would require a large number of patients to be statistically valid.

So the Phase II program is ongoing.

We are likely to have some sort of results that could be announceable sometime next year.

We would like to be able to do that probably post-approval of the product for the treatment of fissures, and that would result in data that could be published, David, in reputable journals that could be referred to by physicians, showing the product's potential efficacy in the treatment of hemorrhoids.

Similarly, we're doing Phase II studies with -- using the product for the treatment of Dyspareunia.

And we're following a similar strategy there as well.

Once the product gets approved for fissures, using the revenue from that source, as well as from the European sales of Tostrex and Rectogesic, we will have the cash flow necessary to be able to accelerate the Phase II programs, complete those, and then launch into Phase III to get definitive approval for the indication.

Right now we have to just shepherd our resources in accordance with the status of development of the Company.

I understand.

Thank you.

Utin Uhm (ph), Kingsbridge (ph).

A couple of questions.

Can you just give us an idea of what the full sales potential for Tostrex is in Europe, as well as for Cellegesic?

I can give you sort of order of magnitude projections, but I think ultimately it is going to be the responsibility of -- not projections rather, but sort of ballpark types of parameters -- but ultimately the sales of those two products will have to be committed to by the partners that we appoint.

So in the case of Tostrex, the European market for hypogonadal men is probably -- in the United States it's 5 million men; in Europe it's probably easily 6-plus million men, maybe closer to 7 million men -- just on the basis of the population of the pro rata portion of people with Hypogonadism in that population.

The pricing in Europe typically, for all forms of pharmaceutical products, is about 65 percent of that in the United States.

There's about a 35 percent discount to the U.S. prices.

The U.S. market is currently at about $600 million-plus, growing still very rapidly, and we expect that it should be up to $1 billion within the next couple of years, and maybe significantly more than that on the basis of it's current rate of growth.

I would think that the European theater can reach $1 billion market potential for all forms of testosterone.

I think our partner is excited, very excited about the potential for this product in the European theater, has some very aggressive marketing plans, some very aggressive -- for sales forces and for DR (ph) and things like this that need to take place in order to sensitize the market.

But the market is a little bit -- in a little bit earlier stages of development.

So it is probably going to take another two or three years to catch up to the level of the United States, or it will be two or three years behind the growth pattern of the United States.

But every indicator from a market research standpoint says that with the proper kind of marketing and the proper type of public awareness campaigns, that the desire for men to use testosterone supplementation is there.

So the exact numbers I can't give you;

I would say we should probably put in our heads that in three years or four years the market would be about at a $1 billion total level, and the question is what percentage of that would our partner get?

We think that it would be sort of in the minimalistly (ph) 10 million and maximally probably 30 to 35 percent of that market.

So that gives you sort of an idea of approximately what they may be able to generate.

Cellegy's piece of that is we're getting a 10 percent -- I'm sorry -- we're getting a low double-digit, 10 percent royalty, and that increases to 15 percent depending on the level of sales, as they hit certain sales thresholds.

So it is an attractive deal for us and one that is -- there is a no-cost basis for us, but simply pulls revenue down from the sales of our partner.

Now the second question is Cellegesic.

Again, because of the population basis, if one assumes that there are -- for the sake of using round numbers -- that there are 1 million patients in the United States with fissures, there's probably 1.5 million people or 1.3 million people easily in the European theater.

And it's just like the United States but not like the Tostrex market.

It's a very well-defined market; it's something that people are suffering from fissures and not getting adequate therapy, and the only thing that they can currently do is to receive this lateral internal sphincterotomy -- which is a painful procedure -- and one which causes incontinence in up to 35 percent of patients.

The other problem with the European healthcare system, or at least the characteristics of the European healthcare system, is that for a procedure such as this which is not for a life-threatening disorder, people often go into the waiting list for months and months and months if not years before they can get the elective surgery to take place.

So this is a very -- a product for a very quick uptake within the European theater.

And the question then will be how much can the partner get in the various countries and what is the pricing levels that will be established for the product.

If we assume that it's going to be a 65 Percent range, I think this product -- you can easily look at it as a 50 to a $100 million product out of Europe.

And the deal that we will seek to get is something in the order of at least a 20 percent royalty on those sales.

We probably will end up with something even more attractive.

So the revenue flow from these two products, beginning from the time of their introduction -- one, it will probably be more quickly on Cellegesic because of the lack of competition in the market, but the ultimate size of the market will come on strong for Tostrex.

And then again, same situation exists for off-label sales in Europe for Cellegesic for hemorrhoids and for Dyspareunia.

So the product has the potential to be quite a big product in Europe as well, and we just have to be patient and see how that all shakes out and what the -- how the doctors react to the type of promotion that we intend to put in place in that country.

But these are very important events that have just taken place for Cellegy to essentially put in place a source of revenue from the European theater which was not previously into our business model.

Thank you.

One last question.

It's regarding Dyspareunia.

I think you're in the midst of doing about a 30 to 40-patient study.

Is that still on track to have the results announced sometime third, fourth quarter this year?

I would say it's probably fourth quarter this year.

We said that we would try to get that done so we could announce results toward the end of the year, but that is at this point in time on track.

And if that changes we will certainly let you know.

An upon successful results from that trial, will you be going further for a Phase II, or what would be your next clinical steps?

We would move into a more advanced Phase II, or potentially we might move straight into a Phase III, depending on the results.

There are no further questions at this time.

I would now like to turn the call back over to management for any further comments or any closing remarks.

This is Rich again, and just a brief remark to close out.

We have also made very good progress on the manufacturing side.

We do get questions about that frequently.

We are in the process of producing validation batches for the European theater for both of our products, and looking at alternative manufacturing sites in the U.S., should make sure we have a backup in the manufacturing area.

So good progress there, and we fully expect to be ready for launches throughout the world in a couple of different manufacturing locations.

I would like to close the conference by saying that as I have attempted to point out, that there are lots of exciting things happening at Cellegy due to our teams' very hard work on behalf of you, the shareholders.

We've completed a number of important and value-adding events during the course of the quarter -- the NDA filing on Cellegesic, the approval of Rectogesic in the UK, the licensing deal for Tostrex in Europe with Strakan, and the private placement for $10.3 million, which gives us about 16 to 18 months worth of operating cash.

There is a lot more progress to be expected in the near future, and those things off the top of my head are -- acceptance of the NDA for review by the FDA toward the end of this month; formal approval of Rectogesic in the UK; approval of Tostrex in Sweden; signing of a partnering deal on Rectogesic in Europe; and as I said before, these two products -- completing the deal and getting final approval for Tostrex should guarantee us a decent revenue stream beginning in 2005 from these two products coming out of Europe.

We are in the process of putting together an interim analysis on our Phase II -- second portion of our Phase II study on Tostrelle.

This is the female testosterone gel for the treatment of female sexual dysfunction.

We believe that this is a blockbuster product with major, major potential.

And we will be in the process of putting together some additional information that we can announce to you sometime in the next couple of weeks.

And finally, I would like to remind you that Cellegy has always had an active in-licensing and M&A activity.

And this is something that we do continue and will continue.

While these events are much less predictable in terms of timing than some of the other things that I've talked to you about, we will continue to pursue all of these avenues as sources of additional pipeline expansion and/or increasing the competitiveness of our overall company, and adding value to the shareholder constituency.

So thank you very much for your participation on the second-quarter conference call.

And as always, if any of you have any other questions that you would care to raise, we are here, always available for you, to answer those questions at Cellegy.

Thank you very much.

Thank you again, ladies and gentlemen for participating. (OPERATOR INSTRUCTIONS).

Thank you very much.