David Bernstein - General Counsel and Chief Intellectual Property Counsel
Steve Tulipano - Chief Financial Officer
Martin Driscoll - Chief Executive Officer
Daniel Carr - Vice Chairman and Chief Medical Officer
Mark Matthews - Vice President of Commercial Affairs
Adam Green - JP Morgan
Elemer Piros - Rodman & Renshaw
Gary Nachman - Leerink Swann
Adam Cutler - Canaccord Adams
Javelin Pharmaceuticals, Inc. (JAV) Q4 2007 Earnings Call March 6, 2008 4:15 PM ET
Good day and welcome to the Javelin Pharmaceuticals Fourth Quarter 2007 Conference Call. As a reminder, today's call is being reordered. At this time I'd like to turn the conference over to Mr. David Bernstein. Please go ahead sir.
David Bernstein - General Counsel and Chief Intellectual Property Counsel
Thank you Sarah and good afternoon everyone. I have with us this afternoon Mr. Martin Driscoll, CEO of Javelin Pharmaceuticals, Dr. Daniel Carr, the Vice-Chairman and Chief Medical Officer, Stephen Tulipano, The Chief Finical Officer, Mark Matthews, our Vice President of Commercial Affairs and Rick Pierce our Vice President of Investor Relation.
For those of you who are not aware, today we will be following a slide presentation which is available in the investor information section as well as on the homepage of our website at www.javelinpharma.com.
If you're not currently viewing the slides you can simply follow the directions to the site in order to access and follow along with the slide deck.
Before we begin I will review Javelin’s safe harbor statements you can find this on slide 2. Certain statements made in the course of this presentation may be forward-looking and involve a number of risks and uncertainties. These forward-looking statements include statements about the following; our product development efforts, anticipated operating losses and capital, anticipated regulatory filing dates and clinical trail initiation dates, our estimates regarding our capital requirements and our needs for additional financing. They also include our estimates for future revenues and profitability, our selection and licensing of product candidates, our ability to attract partners with acceptable development regulatory and commercialization expertise, the benefits to be derived from corporate collaborations, license agreements and other collaborative efforts, including those relating to the development and commercialization of our products candidates and sources of revenue and anticipated revenues including contributions from corporate collaboration, license agreements and other collaborative efforts for the development and commercialization of our product candidates and the continued viability and duration of those agreements and efforts.
The matter is discussed in our forward-looking statements are subject to known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements or industry results to be materially different from the results, performance, or achievement expressed or implied by our forward looking statements.
You can now advance to slide number 3. And again, I would like to thank you all for joining us today. First, our Vice Chairman and Chief Medical Officer Dr. Daniel Carr, will introduce Javelin's new CEO Martin Driscoll. Then Stephen Tulipano, our CFO will comment on Javelin's financial results. Dr. Carr will then give a clinical overview followed by Mark Mathews, VP of Commercial Affairs providing a brief commercial update. The call will conclude with Martin Driscoll, who will communicate his vision for Javelin as the company’s new CEO. Then as a customary after a brief pause, we will open the call up for some questions. Dan?
Daniel Carr - Vice Chairman and Chief Medical Officer
Thank you, David. I would like to give you some background on Martin Driscoll and to do so I would like to have the next slide, slide 4 up on the screen that gives you a little mini bio of Martin. I have collaborated with Martin on a number of matters in his role as a Director of Javelin during the last year and a half.
Many of you are aware that Martin recently became Javelin's new CEO to lead the company into its commercial phase. I am delighted to continue as Javelin's Chief Medical Officer and have taken on the additional role of Vice Chairman of Javelin's Board of Directors. I will again be focusing my full attention to the clinical and regulatory aspects of our late stage portfolio of three novel pain products.
I want to emphasize that Martin has a one and half year track record on Javelin's Board of Directors. When he was brought in at that time our plan is right to strengthen our efforts in commercialization. You can see from his bio that he is extensively experienced and successful in commercial affairs in the pharmaceutical industry.
Martin and I have been working together behind the scenes for many months focusing on business development and manufacturing. During this time, Javelin has grown to the point where one person can't fill both the CEO and CMO roles effectively. We are growing quickly. We have a lot going on.
With the commercialization, we emphasis on partnering, becoming increasingly important, it made total sense for me to again focus on our clinical and regulatory programs and have Martin focused and take the lead on commercialization in business development and manufacturing.
I can tell you on first hand basis that our skills are highly complimentary and also that it has been pleasure to work alongside Martin for many months. Having said that, let Martin take the stance.
Martin Driscoll - Chief Executive Officer
Thank you, Dan. As Dan has indicated I have got a chance to know the end of the last year and half since I became a Director on the Board of Javelin. I have great admiration for the development successes in leadership of Dan and his team and what they have achieved for Javelin over the period that I have known them. But more importantly, I have been able to see first hand the commitment that Dan himself has to the development of effective treatment that benefit patients, and we all have to realize after all that’s really the main reason why we are in this business. Dan and I have been collaborating as he indicated for sometime on a number of Javelin initiatives. We have good report; I have no doubt that's going to continue. I have great respect for his skills and I think what we are going to be doing is quite complimentary.
As Dan indicated, Javelin has entered a new exciting phase called commercialization. This young company received its first commercial approval late last year in U.K. With this comes a culture, where we have to embrace change and my colleague and I are demonstrating this change in our actions. The actions that we have taken recently and these actions are going to focused on enhancing and unlocking shareholder value.
The timing for me joining this company as CEO is optimal for me and my ability to apply my 26 years of experience in pharma, skills and all aspects of pharmaceutical commercialization, general management, and business development, and I think that's important, so we can maximize the potential for Javelin's three late stage products.
Having been a director since then middle part of 2006 and working with this team all around this table alternatively hit the ground running. I am placing a particular emphasis on refining Javelin strategy. We have an emphasis on global partnership across the globe.
I am taking a direct role in our global and our partnering discussions, as well as evaluating our current recourses of how we are deploying our capital and how we intend to do that in the future. I can assure you that our shareholders niches will come first. When we delay decision about how we deploy or how we are creating resources and capital.
I have been asked to take this role and requested from my fellow Directors on the Board that we create a new committee what we call the Strategic Commercial or Partnership Committee, and I wanted made up of those individuals and it is, those individuals were pharmaceutical licensing and capital markets execution. This is evidence of the action that we are taking. We can align our interest with our shareholders. We are focused on creating robust partnership. We will be actually going at it and we closely take advantage of the opportunities that could come to a company with three late stage compounds in an important area like pain that is highly specialized.
Our priority will be to continue to develop the drug development portfolio, here at Javelin. While we do this, we will concentrate on executing effective partnerships across the globe.
With that, I would now like to introduce Steve Tulipano, our Chief Financial Officer, who is going to take us through Javelin’s financial results. Steve?
Steve Tulipano - Chief Financial Officer
Thanks Martin. Let me take just a few brief movements to review Javelin’s results of the year in the fourth quarter. On a year-to-date basis our loss was approximately $31 million or $0.68 per share with weighted average shares of 45.5 million. For the quarter the company had a net loss of $9.7 million or $0.20 per share with weighted average shares outstanding of 48.7 million.
At the end of the year we had approximately 37.3 million and marketable securities. Accounts payable and accrued expenses were 8.6 million at December 31, 2007.
In terms of revenue as you all might remember, the company recorded the lost of its contract revenues associated with the reimbursement under the Department of Defense contract supporting the PMI program at the end of fourth quarter of 2006. As a result, there are no revenues for the 12 months of 2007.
In terms of expenses, Javelin had total operating expenses of approximately 32.9 for the year or 10.2 million for the quarter. Operating expenses included 19 million and 5.7 million for the year and the quarter respectively related to research and development which includes manufacturing cost not capitalized as inventory.
For the year, R&D expenses increased approximately 8.2 million over the same period in the prior year and 2.8 million for the quarter as compared to same quarter of 2006. All these increases were driven largely as a result of increased clinical trial expenses including, clinical site fees, lab fees, data management cost, manufacturing and process development cost, as well as increased headcount cost.
We also had 13.8 million in SG&A expenses for the year and 4.5 million in SG&A expense for the quarter. Our SG&A increased by about 4.2 million from 12 months period and 1.4 million for the 3 months period as compared to same period in the prior year. The increases in SG&A were primarily due to increased cost associated with our commercial scale activities including field sale force in the second half of the year and market research and other marketing costs related to the launch of Dyloject in the UK.
Also included, operating expenses were approximately 3.5 million related to stock based compensation expense for the year. We also have 1.9 million in interest income during the year and 547,000 during the quarter.
Let me now turn the conversation back over to Martin.
Martin Driscoll - Chief Executive Officer
Thanks Steve. I would now like to the turn the call over to Dan, who is going to review our 2007 clinical highlights and provide some insight into our plans for 2008. Probably then Mark Matthews, our Vice President of Commercial Affairs will take just a few minutes to share some of the exciting initial feedback on Dyloject's early performance in its first market, the UK. Dan?
Daniel Carr – Vice Chairman and Chief Medical Officer
Thank you, Martin. I'm now going to slide 6 that shows our clinical and regulatory highlights in 2007 which was an extremely busy and productive year for Javelin.
With respect to our lead product Dyloject, we completed all pharmacokinetic studies required for filing our US NDA. We also announced successful top line clinical trial data from the first of two Pivotal Phase III trials. We initiated the second of these two Pivotal Phase III trials; and moreover announced some exciting results from our Phase I platelet study that I'll speak to in just a few slides.
With respect to PMI-150, our intranasal ketamine product, we initiated a Pivotal Phase III multicenter trial on breakthrough cancer pain for a second indication besides acute pain. We also completed all of our necessary Phase I PK data up to an including multidose studies for filing the NDA. For Rylomine or intranasal morphine, we completed successfully a Pivotal Phase III trial and announced top line and secondary data.
The next slide, slide 7, speaks to what we have in store for 2008. Touching upon the highlights, we anticipate completing the second of the two US Pivotal Phase III trials for Dyloject. We anticipate beginning the US Pivotal Phase III study in acute pain for PMI-150. We are going to continue the US Pivotal trial in breakthrough cancer pain also for PMI-150.
We are making our plans according to an anticipated German approval of Dyloject in mid 2008 and we anticipate filing the US NDA for Dyloject at the end of the year or early 2009.
Next slide, slide 8, speaks to Dyloject's launch about which we'll hear more in a moment from Mark Matthews. Let me remind you that this is an improved formulation of diclofenac; the most widely prescribed injectable NSAID. Our product is given as a simple IV bolus injection, chiefly imposed of pain but also for other kinds of acute pain. It is differentiated from the competition by having a very quick onset and very low incidence of vein irritation. It was approved in October 2007, priced in November 2007, and launched in January 2008.
The next slide, slide 9, shows you the platelet data that we are so excited about. Let me keep a review in NSAID. Our concern that there might potentially be bleeding. So, we addressed this project head on by comparing the higher of the two doses that we see as therapeutically useful for Dyloject, an oral form of Dyloject called Cataflam and then injectable Ketorolac, the North American competitor and aspirin.
This graph shows the time it takes for platelets to form a plug and the upper limit of normal is about 160. As you can see, the injection of the higher of the two anticipated US doses of Dyloject brings this up to the upper limit of normal. In contrast, Ketorolac is several folds greater than normal as is aspirin consistent with the lower clinical tendency of Ketorolac or aspirin to be associated with bleeding.
Now what I'd like to do is have Mark Matthews provide some early feedback on the UK launch of this exciting product. As everybody knows, Dyloject is successfully driven by the hospital market. In fact Mark started his career in hospital sales in the UK and has extensive experience in sales and marketing including the launch of Cataflam, an oral diclofenac product whose data we showed you in the platelet slide.
Mark Matthews - Vice President of Commercial Affairs
Alright, thanks Dan. I'll now provide a brief update on the UK launch of Dyloject beginning on slide 10. My communication will emphasize four key points. One that it is still early. Two, the clinical profile of Dyloject is very strong and has allowed Javelin to obtain very favorable pricing in the UK. Three, early customer feedback in order to achieving our expectations, and four we can expect more positive events over the coming year.
As Dan communicated earlier, we received UK approval of Dyloject at the very end of October but we did not stop promoting the product broadly until January. The price for this approved by the Pharmaceutical Price Regulation Scheme was our initial proposal of £4.80 which is approximately $10 in US currency. This is significantly higher than the key competitor which is Voltarol, which is about $1.6 of our.
And now moving on to slide 11, this is a very simple and visual slide that some simply can communicate several of the key benefits of Dyloject compared to its main competitor. And as you can readily see our product is much simpler and quicker than the old slow administered formulation.
And now moving to slide 12, in assessing Dyloject's potential it is important to understand why physicians will want to choose our products over the competition. In the UK Voltarol is used most often to treat postoperative pain. Other drugs like Toradol are used but to a much lesser extent.
Dyloject contains the same active ingredient as Voltarol. The Javelin's formulation contains a unique solubilizing agent which allows Dyloject to be given simply and quickly, unlike Voltarol which must be buffered, diluted, and administered over at least 30 minutes. As a result, Dyloject alleviates pains faster, causes less vein irritation, and is much easier to give.
This translates to significant cost savings which we estimate to be approximately £50 per patient. Compared to Toradol, Dyloject has a broader indication and a more favorable safety profile which means that there are no restrictions on the duration of injectable node therapy and it also means that the drug can be used in a broader population.
I will now move on to slide 13. I'd like to conclude by providing you some early feedback regarding the UK launch of Dyloject. In January, Javelin attended the Association of Anesthetists Congress in London, where interest in Dyloject was extremely high. I was personally present at that meeting.
In January, we also initiated a German (inaudible) campaign to increase early awareness and demand for the product. As a result of our initial launch activities, 81 National Health Service Hospitals, and these are very large influential hospitals, have already placed Dyloject on the formulary. And we have further 60 formulary reviews scheduled over the next two to three months.
I think it is important to note that no hospital has rejected Dyloject and our initial orders are certainly exceeding our earlier expectations. Surely we expect the SMC or Scottish Medicines Consortium to announce their decision regarding the use Dyloject in Scotland following their recent assessment.
If this outcome is positive, we will rapidly expand our sales force, I think two laps to access the approximately 8% of the UK market potential in this country. If favorable, the SMC decision will have a positive influence throughout the remainder of the UK hospital system.
We are also busy preparing for the launch of Dyloject, as Dan indicated, in Germany slowly and if all goes well, we anticipate launch during the second half of the year.
So, in summary, we are very pleased with the results so far and we will be looking to expand our base of prescribers and repeat customers over the coming months.
I'll now hand it back to Martin.
Martin Driscoll – Chief Executive Officer
Thank you, Mark. I would like to summarize our discussion of presentation with you today by summarizing our key priorities at this time. One continued successful clinical development of our portfolio will remain our top priority. Two, we also have homed a commercialization strategy. We have emphasized on partnerships around the globe. Three our partnership emphasis will be focussed on the following: In efforts to accelerate the market uptake for our brands in the major markets. Two, we’re minimizing our commercialization risk. And three, emphasizing near-term value to Javelin which switch over to reduce our future capital needs. And number four, we will be shareholder focussed. We will be investor-centric and most totally they are going to be action oriented. I look forward to leading this fine team as we deliver on our milestones and execute before we talk to you today. With that, it finishes our remarks; I would like to turn it over to questions.
Thank you. (Operator Instructions).
And we will take Adam Green with JP Morgan for our first question.
Thanks. Good Afternoon everyone. Couple of questions. First, trying to get a better sense on the timing for Ketamine NDA, what exactly do you think the Phase III trials will start, how long is the trial scheduled to last and anymore details, can you give us some granularity and that would be helpful. Then the question for Steve in terms of 2008, how should you think about cash burn for 2008 and R&D spending relative to the PMI trials that you are starting?
Adam, Thank you. This is Martin. Thanks for the question. Two questions, I will let Dan take the first one and I will take the second one. Dan?
Sure. The Phase 3 acute pain Ketamine trial we anticipate starting within the next several months by this year certainly and this will last approximately in all of spaces, approximately one year to recruit sites, monitor them, get new studies, write up the clinical study report, cleanup the data et cetera.
Adam, In regard to your second question in terms of the cash, we have not given enough money. I can imagine a company with three late stage compounds seeking to run out of cash. As we indicated earlier we have multiple options to finance our business. What we’re going to do and what I am going to insist is that the decisions will be inline with our shareholders including emphasis on partnerships and the like.
Thank you, Adam.
Next we will hear from (Ron Sanchez) (inaudible).
Good Afternoon guys.
Just want to get a reminder on the number of formularies that exists in the United Kingdom and how much time will it take for you guys to visit most of them. I mean, so far your hit rate has been a 100%, but how much more time and what it takes to actually get into this formularies? And the second question is when -- if you’re going to pull the trigger or investing in a commercial organization in Germany and what will be the timing of those expenses?
Ron, let me take the first part and then I will turn over to Mark with the specific answer on the formulary used. As you all know it's a hospital based product. As companies, our priority first with this getting an optimal price and a difficult pricing environment that was achieved. And the next step of course is to establish formulary acceptance Mark and his team has focused on the major institutions, so far they have added a 100, and now they are focusing to move down to the other hospitals. So Mark, can you communicate the total number that you are seeking address?
Yeah sure. The goal and its realistic goal is to get a formulary review with all of the key in each hospitals between six to nine months following approval, we think that’s very realistic. In addition to the formularies we’re going received as I may have mentioned earlier, we already have sixteen formulary reviews lined up from both over the next 2 to 3 months. So, that’s a different run rate. But I would say between six to nine months, we expect to have vindicated and got decisions on all of the major formularies that we are currently targeting.
Based on the current efforts, it's quite likely that formulary use will be completed with over 80% of the institutions representing the bulk of the potential use in that country before the end of the second quarter this year.
Thanks. Well on Germany, I have the question on Germany.
That’s correct. I am welcoming the team to examine the plans for the German launch. We are pursuing across the German regulatory approval and I want to examine what Mark would have up in chart. So at this point just to make sure that we focus on driving on market update, also I want to incorporate that each will be the discussions we have in the potential partners.
Alright thank you.
Unidentified Company Representative
We will take our next question from Elemer Piros Rodman & Renshaw.
Yes good afternoon and congratulation Martin on your appointment.
Thank you very much.
The first question a strategical one. Do you consider all of the product candidates as potentially subject for global partnership or do you have some sort of priority in mind?
Alright. The direct answer to your question is yes. And the priority will be back to those partnerships that maximize value for our shareholders. We are building the first and foremost its dose that can rapidly generate market uptick and minimize our commercialization risk and reduce our capital needs externally, and we have multiple conversations going on and just have to determine we have to achieve those priorities I just mentioned.
Okay. Thank you. And just one last question if I may. So, Ketamine for emergency is, is this application completely off the table at the moment?
Dan, would you like to take that?
Sure, its not off the table at all, in fact, what we anticipate is that the initial indication will be a broader indication right out of the starting gate in the acute pain which encompasses emergency and military use, as well as postoperative use.
Okay. So that would be covered first itself, but applications for Ketamine for this broad label would cowardly go in, in the latter part of next year or early part of 2010 or so.
Okay, thank you very much.
Thank you Elemer.
Next we will hear from Gary Nachman Leerink Swann.
Hi good afternoon. First Mark, just a followup on earlier question. How should we think on a revenue ramp in the UK based on the formulary acceptances that you are talking about, I guess in its timeline that you discussed earlier?
Yeah, I have communicated previously what we continue communicate is that we do anticipate that the first six to nine months is primarily, both primarily focused 8 and getting a good price for the product and we are very pleased with the price that we receive from UK authorities. And then secondly going through the formulary process, and as I indicated earlier we anticipate to look seeing the majority of key hospital formularies within that six to nine timeframe. We’ve entered the product is on formulary and then we can expect to see more of a ramp up.
Could you give us a sense of what that ramp up could look like, and from the time that they accepted on the formulary, its just based on the demand that you’ve been seeing so far just so we can sort of get arms around that a little bit?
Gary I must say, as you know the product is just introduced in January, its very early and we show activities ahead of us, the forecast and expectations for the brand, its very difficult for us to estimate a ramp up based on just 8 to 9.
Okay. Dan for you, the platelet slide is very interesting, are you guys doing more platelet work? And are there any other things that you are doing to try and differentiate the product from the safety standpoint? And, is that platelet that you’re going to be published up with?
First of all, we agree this is tremendous result on platelets. We – I will try to give you a little more background is the current state-of-the art most projective test you can do that correlates with clinical bleeding. So in terms of platelets per se, we don’t need to do more work, there is other data that we got from the same trial that we have not disclosed, each plan as we do with all of our scientific and clinical studies. The results to present this at a major international meeting within the next six months and to follow that with a pre-review publication authored by a professor of medicine at Harvard whose career interest is Thrombosis. As far as safety work is concerned, to date we've seen no serious adverse events related to our drug in any of the trials. And, as we go further towards the NDA, we'll be preparing the integrated summary of safety which matches by the way the excellent safety record of diclofenac in the literature over 30 years with about a billion patient’s runs of exposure.
And Gary I'd like to build on Dans point. This platelet h data coupled with the first pivotal trail for US registration L04 data. Coupled with the early UK experience, in particular, the optimal pricing, that’s each increased the interest in the compound at other firms.
Okay. And Dan when are we going to see the data from the second Phase III? I know you're planing on filing maybe late this year or early next. But, I think you said previously maybe mid-year, that’s well on track, the top line data?
We always put a large bracket around these, I'd say around Q3, just to be conservative on this. But I can tell you that we're experiencing no particular issues with the trial, and the model itself is a perfectly standard postop model in this abundant clinical efficacy data already for a less effective formulation that’s been published.
Okay. And then lastly for Marty, I know, you said you’re not going to run out of cash you have a lot of options, but just to Adam’s question earlier, what kind of a cash burn should we think about for this year, given all the studies that you're running?
I'm not going to be providing projections. I just want to emphasize that we are taking a close look at our recent capital and making certain that will be efficient. We are focussed on our priorities. And now, you can be certain that we’re going to finance our business in accordance of these priorities, and we’re going to line this interest in the shareholders.
Well, thank you Gary.
(Operator Instructions). Next we will Adam Cutler, Canaccord Adams.
Hi, thanks for taking the question. I am wondering if you can just give us a little bit more color, I know it sounds like you’re being intentionally vague because you're looking to be as opportunistic as possible on the partnership front, and that potentially all of your products are on the table for partnership. But, do you still intent to build a commercial infrastructure in the US? Maybe you can just give us a little bit of color on what the potential structures are which ones are maybe the most ideal for you in terms of partnership?
I haven’t negotiated many deals that is effective to describe concepts of deals here on the phone. However, what I would mention is that, even the late stage portfolio here is especially market with a lot of unmet need. That generally leads to a lot of interest. In terms of future commercial capability, if we focus on rapid market uptick of the brand and reducing our commercialization risk, that can take many forms in a collaboration. And, I would rather focus on establishing and accelerating the value of the brand and order portfolio before we determine what’s the optimal commercialization strategy. It begins with the brands, the opportunity in the marketplace. And, the most effective way to do that let me drive with our, internally what we should may choose to do in a commercial basis strategy.
Okay. And then I guess, it sounds like you're not willing to make projections at this point on how long you're current cash could last.. But I guess, at what point, if at all this year in the absence of any cash generating partnerships would you start to look at reducing your spending?
At the right time. We take a look at how we deploy our capital today. We have many opportunities. We have a lot of flexible options available to us, and we will do the right things. I've established this committee with my board, made up people who have done many deals and who understand the capital markets. And I can assure you that we will do it inline with the shareholders interest
That is all the time we have for questions today. Mr. Driscoll I'll turn the conference back over to you for any additional or closing comments.
Again I'd like to thank everyone for listening today and for participating. We look forward to coming out and meeting many of you in person I particular do. We thank you for your support and then we look forward to executing on what we talked about today successfully. Thank you.
And that does conclude today's program. We thank you all for joining us.
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