Avid Bioservices, Inc. (CDMO) Q1 2009 Earnings Call Transcript
Published at 2008-09-09 11:30:00
Barbara Lindheim – IR, GendeLLindheim BioCom Partners Steve King – President & CEO Paul Lytle – CFO
Kevin Burdick Ren Benjamin – Rodman & Renshaw Stephen Dunn – Dawson James Richard Siracusa – Merrill Lynch
Welcome to the Peregrine Pharmaceuticals first quarter 2009 financial results conference call. All participants will be in a listen-only mode. There will be an opportunity for you to ask questions at the end of today’s presentation. (Operator instructions) For your information, this call is being recorded. I would turn the conference over to Barbara Lindheim with BioCom Partners. Ms. Lindheim?
Good morning and thank you for joining us on today’s call with the management of Peregrine Pharmaceuticals. We are here to discuss the company’s results for the first quarter of fiscal year 2009 reported this morning. Before I turn the call over to Steven King, President and Chief Executive Officer, I would like to read the cautionary note regarding forward-looking statements. This conference call may include statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Peregrine Pharmaceuticals’ current views about future events and financial performance. These forward-looking statements are identified by the use of terms and phrases such as ‘beliefs’, ‘expects’, ‘plans’, ‘anticipates’, ‘on target’ and similar expressions identifying forward-looking statements. These factors include, but are not limited to the risk factors detailed from time to time in Peregrine Pharmaceuticals’ filings with the Securities and Exchange Commission, including but not limited to the Annual Report on Form 10-K for the year ended April 30, 2008. Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from Peregrine Pharmaceuticals’ expectations, and Peregrine Pharmaceuticals expressly does not undertake any duty to update forward-looking statements whether as a result of new information, future events or otherwise. I'd like to now turn the call over to Steve King. Steve, you may begin.
Thank you, Barbara. I'd like to start by thanking everyone who is participating in today's first quarter fiscal year 2009 conference call. I will start with a brief recap of developments since our last conference call. Paul will then go over the financial highlights for the quarter, and I will conclude with a more detailed review of product and corporate development activities. We will then end with a question-and-answer session. The past couple of months have continued to be a very productive time at Peregrine. Since our last quarterly conference call, we continued follow-up on patients in stage 1 of the bavituximab plus docetaxel Phase II breast cancer study. We continued patient enrollment in a second Phase II study testing bavi in combination with carboplatin and paclitaxel in lung cancer patients. And we recently initiated patient enrollment in a third Phase II trial testing bavi in combination with carboplatin and paclitaxel again, this time in patients with advanced breast cancer. We are very pleased that we now have all three of our initial Phase II bavituximab cancer trials underway. While moving our Phase II bavi programs forward, we have continued patient enrollment and follow-up in the other ongoing bavi and Cotara clinical studies. And we have continued to make progress on the preclinical front. In addition to these clinical developments, we recently began work under our contract with the Defense Threat Reduction Agency or DTRA to evaluate and develop bavi and a human equivalent antibody for the treatment and/or prevention of viral hemorrhagic fever virus infections. In addition to advancing our product development efforts, sales at our contract manufacturing subsidiary, Avid Bioservices, continue to show positive signs of growth. I will now turn the call over to Paul and will return later to discuss our clinical and product development efforts in greater detail. Paul?
Thank you, Steve. Thank you Barbara, and thank you everyone for joining us. Early this morning, we released our financial results for the first quarter of fiscal year 2009. This earnings release outlines the financial results in greater detail and includes financial tables, so I encourage everyone to read the entire release. We also plan to file our Form 10-Q later today and both of these documents will be available on our Web site. During the next few minutes, I will take you through our financial results for the first quarter ended July 31, 2008. I will then briefly discuss our current financial position and I will conclude with a discussion covering three other important topics. Now let me begin with the finical results for the first quarter starting with revenues. Total revenues for the quarter ended July 31, 2008 were $1.5 million compared to $1.6 million for the same quarter last year. Most of the revenues were generated from third-party customers of our wholly-owned contract manufacturing business Avid Bioservices. In addition, I am pleased to report that we have a new revenue line item included in our statement of operations called government contract revenue. This new line item will be used to report revenues under our contract with the Defense Threat Reduction Agency that was recently signed on June 30, 2008. As mentioned on the previous call, this contract is potentially worth up to $44.4 million over a 5-year period with up to $22.3 million available for the initial 24-month base period. The contract is on a cost plus fixed fee basis whereby we are reimbursed for all allowable costs under the project plus we receive an additional fee for our efforts. Upon signing the contract, we immediately kicked off the project and built DTRA approximately $1.8 million in the first month, while we are able to report earned revenues of $324,000 in the same period under Generally Accepted Accounting Principles. We have a dedicated project management team devoted to the success of the project and we believe we have already made significant progress. Now shifting to contract manufacturing revenues, we are projecting another record year for Avid in fiscal year 2009, potentially topping $10 million in revenues based on current signed contracts from third-party customers. Revenues from the first quarter were in line with our expectations with most of the projected revenues expected to be recognized in the remaining three quarters of this fiscal year. And this is in addition to the important manufacturing services Avid provides Peregrine and supporting our three ongoing clinical programs. Needless to say, Avid continues to be an important asset for the company in many ways. Now let me turn to expenses. Total costs and expenses slightly increased by about 2.5% to $6.7 million for the current quarter. This compares to total cost and expenses of $6.5 million reported in the same prior year period. This increase was primarily related to an increase in research and development costs as we continue to advance our preclinical programs. This increase was partially offset by a decrease in the cost of contract manufacturing related to lower reported contract manufacturing revenues in the current quarter. In addition, SG&A expenses for the current quarter of $1.7 million remained in line with the prior year quarter. We are pleased to keep SG&A expenses steady in light of our increased SG&A efforts and supports of a newly awarded government contract and the increase in business at our Avid subsidiary. Now onto the other income category; we saw a decrease in interest and other income of $164,000, mostly due to a lower average cash balance on hand compared to the same prior year period. Now let me turn to the bottom line. For the first quarter of fiscal year 2009, Peregrine reported a net loss of approximately $5.1 million or $0.02 per basic and diluted share. This compares to a net loss of approximately $4.7 million or $0.02 per basic and diluted share in the same prior year period. The increase in our net loss was primarily related to an increased investment in research and development of $444,000. Steve King will discuss our R&D progress in more detail later in the call. Now let me shift your attention to the balance sheet. We ended the quarter with approximately $10 million in cash and cash equivalents at July 31, 2008. This compares to $15.1 million in cash and cash equivalents reported at our last fiscal year end date, April 30, 2008. Now if you look at liquid assets on the balance sheet, representing cash and receivables, we had $13.9 million in liquid assets at July 31, 2008 compared to $15.7 million at our fiscal year end April 30, 2008 or a decrease of approximately $1.8 million during the entire quarter. Liquid assets will be an important measure of our capital resources, representing cash on hand and assets that can quickly be converted into cash. Now let me conclude with three additional important points. The first point I would like to address pertains to our financing efforts. We are actively pursuing two parallel paths to raise additional capital. First and foremost, we are pursuing a pure debt transaction such as a term loan. These term loans are generally paid back over a 3-year period with interest-only payments made during the initial 6 months. We are in active negotiations at the moment with potential lenders and we will continue to pursue this debt financing under the best available terms. We believe if we are successful in negotiating a pure-debt transaction, this funding could provide an additional runway of capital as we continue to advance our programs with the intention of bridging ourselves to better market conditions and additional positive clinical data. Our second source of potential capital could come from the full or partial sale of our wholly-owned manufacturing business. We have two major points to consider for any transaction involving Avid. These include an upfront cash payment and guaranteed access to manufacturing capacity for us and for our clients. It is important to note that we have been approached by a number of parties interested in Avid and like all such transactions, these deals take time to secure the right buyer at the right terms. We will keep you apprised of any significant developments coming from these ongoing discussions. The second topic I would like to address pertains to our continued listing on NASDAQ. On September 4, we had an oral hearing before the NASDAQ hearing panel. Prior to that hearing, we submitted to the independent panel and to our NASDAQ Listing Qualification Staff, our definitive plans to regain compliance with the minimum bid price requirement. The NASDAQ Listing Qualification Staff, after reviewing our definitive plan submitted to the independent panel its hearing memorandum. I am pleased to say that the Staff’s hearing memorandum was supportive of our definitive plan of compliance. Further, the staff stated that it would not object if the panel granted Peregrine an exception under the rule not to exceed 180 days from the date of the Staff Determination Letter or until January 20, 2009 within which to regain compliance. If we are granted this exception from the independent NASDAQ panel, our stock would continue to be listed and traded as normal during this exception period. As stated before, last Thursday we attended our oral hearing with the independent panel. At that meeting, we reinforced the company’s commitment to regain compliance under our definitive plan submitted to NASDAQ by effecting a reverse stock split, should we not regain compliance by other means. We also outlined the potential events that could positively influence the company’s stock price and may contribute to regaining and/or sustaining long term compliance with the $1 minimum bid price rule. We now expect a written decision from the independent panel within 30 days of our September 4 meeting. We are optimistic that we have delivered a compelling compliance plan that should allow us to receive an exception and additional time to regain compliance. Nonetheless, I want to note that it is possible that the panel could reject our plans which could result in the suspension and delisting of the company’s securities from the NASDAQ stock market. Although we do not believe this will be the outcome, it is important for stockholders to understand the process and all potential outcomes. As soon as we receive the panel’s letter, we will issue a press release to report their decision. The third and last topic I would like to address pertains to one component of our plan submitted to NASDAQ to regain compliance with a minimum bid price requirement. Since no one can control the price of their stock, NASDAQ requires that a definitive plan to regain compliance with a $1 minimum bid price rule must include a plan for reverse stock split. Therefore, we did exactly what was required by NASDAQ. We filed our definitive proxy on August 28, and requested shareholders to approve a reverse stock split in the range of 3 for 1 to 10 for 1. Although there are valid reasons to support the reverse stock split, and valid reasons to oppose it, there is one overriding reason to those in favor of the reverse stock split. If the company is unable to effect the reverse stock split and our stock becomes delisted from NASDAQ, our access to capital becomes immediately diminished and our cost to capital may significantly increase. Clinical trials are long and expensive and hindering our access to capital could be devastating for the future of Peregrine and our clinical programs. Now many stockholders have asked a question, if the reverse stock split is approved by the stockholders, what is the timeframe to implement the reverse split? What I can say definitively is that a reverse stock split would be implemented no later than 20 trading days prior to any final extension date provided by the NASDAQ panel, provided we have not otherwise regained compliance by that time under normal circumstances. We will continue to closely monitor the market conditions of our stock and the anticipated news flow, so that if we effect a reverse split, we establish the best possible foundation to sustain our market cap and price per share as adjusted for the reverse split. We are also optimistic that we will have access to many more institutional investors if a reverse stock split is implemented and once this threat of delisting is removed. I would like to thank you for your time and attention. This concludes the discussion of the financial results. Steve will now update everyone on the company’s recent achievements and our major objectives for the upcoming months. Steve?
Thank you, Paul. I would now like to go onto more detail on the company highlights I briefly mentioned earlier. We have continued to build considerable momentum, particularly in the bavituximab oncology program. This momentum has come through continuing patient enrollments and follow up in the two bavi Phase II studies started earlier this year; and more recently, by beginning patient treatment in our third Phase II study. Now let me provide a little more detail on these trials. We continue to be pleased with results coming out of the Phase II study, testing bavi in combination with a chemotherapy drug, docetaxel in patients with advanced breast cancer. As a quick reminder, this is a two-stage Phase II study. We completed enrollment in the initial set of 15 patients back in April, and since announced we had already surpassed the primary endpoint with 7 of 14 evaluable patients achieving partial tumor responses by the first evaluation time point of 8 weeks. A partial response represents at least a 30% reduction in primary tumor size with no evidence of new metastatic lesions. I am pleased to report that from continuing follow up and treatment, we now have 9 of the 14 evaluable patients who have achieved partial tumor responses, and continue to be very happy with the follow up results we have seen today. We currently plan to give a more formal update on the first part of this trial when all the patients will have completed their 6-month chemotherapy treatment window. Having met the primary endpoint for the first set of patients, we began making preparations to expand the trial to include an additional 31 patients. These preparations including building drug inventory, procuring chemotherapy supplies, auditing data collected as part of the trial, and oh yes, waiting for hostilities between Russia and Georgia where the trial is being conducted to subside. Our thoughts and prayers certainly go out to all those affected by these hostilities and we are pleased that the fighting between the two nations appears to have now ended and everything seems to be slowly returning to normal. The hostility seemed to have had minimal impact on our clinical trial, with patient follow up in the study proceeding according to plan. However, we did want to make sure that before we started the second stage of the study, we were confident that it could proceed without interruption. We are now ready to move to the second stage of this important study and are working closely with the clinical trial sites to prepare for beginning patient enrollment. We look forward to updating you on activities in this trial and to sharing more data from this study as patient treatment and follow up progresses. While preparing for the second stage of the bavi plus docetaxel study, we have continued patient dosing in the Phase II trial, evaluating the safety and efficacy of bavi in combination with the chemotherapy agents, carboplatin and paclitaxel in patients with non-small cell lung cancer, the leading cause of cancer deaths in the U.S. We began enrollment in the study back in July and it has proceeded as expected with brisk patients’ enrollment. We look forward to updating you on progress in the trial in the near future as we complete enrollment in the first 21 patients of the study who represent the first stage of this two-stage study. Since our last conference call, we also initiated patient enrollment in a third bavituximab Phase II cancer study. This one, also evaluating the safety and efficacy of bavi in combination with carboplatin and paclitaxel in patients with advanced breast cancer. Like the other two Phase II bavi cancer studies, the primary endpoint is an evaluation of overall tumor response rate in patients receiving treatment. Patient enrollment in this study is also proceeding very well, and again, we look forward to updating you on progress in this trial in the near future, as we complete enrollments in the first 15 patients comprising the first stage of the study. Now turning to the bavi anti-viral program, we announced just prior to our last conference call that we had entered into a 5-year contract, potentially worth over $44 million to test and develop bavituximab and a fully human equivalent antibody as potential broad spectrum agents for the treatment or prevention of viral hemorrhagic fever infections. This contract is now successfully underway and we have already begun work and invoicing on a number of fronts for the program, including a considerable amount of work at our Avid manufacturing unit. In addition to the DTRA-funded work on our antiviral program, we are continuing our clinical trial evaluating bavituximab in patients co-infected with HCV and HIV, where enrollment is proceeding at a moderate but steady pace, reflecting the strict enrollment criteria required for this initial study. We are also continuing multiple preclinical collaborations in the antiviral area, in particular, our collaboration with researchers at Duke and other institutions, testing our anti-PS antibodies continues to yield valuable insights into the potential of the technology platform in HIV, and I am happy to report that data from this collaboration will be highlighted this fall at the prestigious AIDS Vaccine 2008 Conference to be held in Cape Town, South Africa from October 13 to 16. This will mark the first time that data from our collaboration has been presented and we are very pleased with the opportunity to share the information with the broader scientific community. These collaborations have allowed us to make considerable progress in understanding the potential of our anti-PS technology platform for the treatment and possible prevention of serious virus infections, and have only served to heighten our excitement over the antiviral potential of this platform. Next, I would like to turn to our Cotara brain cancer program. We have worked over the past months to strengthen the foundation for progress in the Cotara clinical program, by initiating additional clinical sites and continuing outreach for our two ongoing trials of Cotara in patients with GBM. And while these activities have enhanced the number of patients being screened and other associated activities at the clinical sites, patient enrollment has continued to be modest. We will continue our efforts to move the program forward, and are working with the clinical trial sites to address the issues that have complicated patient enrollment. We will continue to closely monitor progress in the trials and to take additional steps to speed patient enrollment for this program, which we believe has great promise in treating this devastating disease. On the corporate side, the biggest advancement in our business operations has continued to be the growth of our Avis contract manufacturing business. While Avid has always been and continues to be a major strategic asset for Peregrine and our clinical programs, we see significant potential in growing the value of this business unit. We are continuing to see very high levels of activity at Avid and we believe Avid has the potential to be a profitable, stand-alone business this year, while also providing valuable services to Peregrine. We look forward to updating you on further advances at Avid as the business continues to grow. On the business development side, interest in our bavituximab, Cotara, and preclinical programs from potential partners remain strong, and is growing as a result of the data we are generating on both the clinical and preclinical fronts. We are engaged in active and ongoing discussions with a number of potential partners and we are confident that a steady flow of upcoming data from our clinical and preclinical programs will result in significant licensing opportunities. Operator, we are now ready to open the floor for questions.
(Operator instructions) Our first question comes from Kevin Burdick [ph], a private investor.
Yes, gentlemen can you hear me?
Hey, good morning Kevin. How you doing?
Yes, I mean I think we clearly feel that our market cap is not representative of the true value of the company, I think you did an excellent job of breaking it into the individual units and when you really break it down and just consider the value that’s currently being given to the technology, it seems extremely depressed currently. When you consider the facts that we are generating Phase II data, we have some very promising things happening on the preclinical side in addition to the $44.4 million potential from the contract with the U.S. government. Clearly, the overall market is down. We feel that particularly small biotech companies have been adversely affected by the overall market conditions maybe more than other sectors. We are really – I think one of the keys is getting beyond the current delisting threat and you know, throw the associated activities with that. I think as we get through that, we will be able to really do a lot more outreach and we are obviously currently doing outreach, but really be able to step up those efforts with institutional investors. We know there is a lot of interest in the company from potential partners. Hopefully, we will be able to close some deals that will bring additional cash in and again provide further outside validation, which should come on several fronts against republications, hopefully some partnering deals as well as some – just generating some additional clinical data which I think is going to be very promising. I think it is perplexing the reason our stock price is depressed. We are certainly working on multiple avenues to get the word out there about the company, the promise of its technologies, and while we can’t control the stock price, there certainly are a lot of exciting things happening that we hope will drive that value in the future.
Our next question comes from Mr. Ren Benjamin of Rodman & Renshaw. Ren Benjamin – Rodman & Renshaw: Thanks for taking the question. I guess a couple of questions here, maybe starting off with the clinical trials. You gave us some updated results from the Phase II trial with bavi and docetaxel, 7 out of 14 patients achieving a PR. Can you comment a little bit or give us an update as to what the duration of response has been that you have been able to achieve in those patients who have gotten a PR. And you mentioned that there would be a formal update at the 6-month follow up; when will that be?
Yes. So really, basically, we are currently at 9 of the 14 patients have now achieved partial tumor responses. The formal update will come at the – it is basically a 6-month chemotherapy window for this trial. So, that 6-month time period we enroll lots [ph] of patients, I believe it was around the middle of April, so that will be coming up by the middle of October, so around that timeframe we should be able to give a more formal update. At that time, we will probably talk a little bit more about things like the duration of response, the time to see more progression and what have you. Obviously for those kind of secondary endpoints; so the primary endpoint was the tumor responses, but for the secondary endpoints, you really just need more time to have the data mature and get patients out far enough for that data to start to make some sense. So we will be able to start addressing that again in the update toward the middle of October, and then obviously continue updates on those patients as we move into the second part of that study, and then also we should be able to start reporting from the other two Phase II studies. Ren Benjamin – Rodman & Renshaw: And will that be at a scientific conference, or – how should we be looking for that update?
Yes, we are looking – there is potential that it could come out at a scientific presentation we have coming up around that timeframe, it will just depend on if the data is ready by then, and other words we have to do scans and then get the data and then crunch it and what have you. The alternative is that we just put out an update probably around the time of our shareholders meeting. Ren Benjamin – Rodman & Renshaw: :
Yes, I think in this trial, so far it has been consistent with what you would expect with the chemotherapy alone. Again, just as we saw in the earlier pilot study. So far, obviously everyone is happy with moving into the larger second part of the study. So we feel that so far it has been very acceptable. Ren Benjamin – Rodman & Renshaw: Okay. Regarding the non-small cell lung cancer trial, I know you only began it in July, but what has been the enrollment progress so far?
Yes. Both those studies are proceeding very nicely. We are making our way very nicely, as I would like to say is promote the breast cancer study and for the lung cancer study we’re at or past the 50% enrollment rate for both of those studies. Again, there’s a few more patients in the first part of the lung cancer study with 21 patients versus 15 in the breast cancer study. But it so far is right on – in fact tracking almost exactly with our projections for getting the trial completed. So I think over the next few weeks, we should be able to get through the initial stage of patients in both of those studies and then again provide some update as we move forward with patient follow up. Ren Benjamin – Rodman & Renshaw: So the enrollment is – for at least the first stage is planned to complete by the beginning of fourth quarter or so, is that about right?
I think we certainly want it completed – yes, by the – during this quarter. Ren Benjamin – Rodman & Renshaw: Okay. And I guess from the Cotara program, you mentioned that there have been – well, the patient enrollment has been modest and that you are addressing the issues that are sort of complicating enrollment. Can you talk a little bit about what those issues are and then, how you plan on addressing?
Certainly, I think part of it is – the initial push was to get the number of clinical sites up to full speed and then to hopefully use that in combination with outreach to drive more patients to the screening process, because that is clearly the key in any clinical study is getting patients into screening and then the ones who make it through will eventually enter into the study. Some of the issues have been relatively specific to India and some other clinical sites. Basically to administer the drug, it requires a collaboration between the neuro/oncology and radiation/oncology groups. In some cases, that is a very smooth cooperation; in other cases we have had to really work with hospitals to bring those two groups together. So we worked through those sorts of issues. Some of the issues we have run across have really been specific to India; again, typically the patients are funneled in from the surrounding area. Even things like transportation, which you more or less take for granted in trials in the U.S. can become a challenge. So, we worked out systems whereby we can help the patients to actually get to the hospitals for – obviously not just their treatment, but for the follow ups and what have you, and for even for the screening and making housing available and those sort of things. So it has really just been a lot of little things, in each side it’s a little bit specific if you will for their particular situation. I don’t see anything that is necessarily something that is a longer term overall concern. I think we will begin the – the efficacy of the drug is there, we believe the drug works and it is just a matter of – again, continuing to really work aggressively with the clinical sites. And so I think we are seeing a big uptick in patients coming to the screening program. It is just now a matter of getting them into the trial as a result of that. Ren Benjamin – Rodman & Renshaw: Okay. And then I guess, milestone wise and drivers-wise, you mentioned several of course one is the Phase II trial on breast cancer, an update hopefully around the November timeframe or so; you have the AIDS Vaccine Conference that is coming up. Could you just summarize sort of sequentially all the drivers that you see for the rest of the year?
Sure. I think if we kind of walk through them; so completing the first stage of the carboplatin and paclitaxel combination therapy studies in breast and lung cancer; should be coming out with an update on the breast cancer study, again around the mid-October, plus the docetaxel combination therapy study. Moving on, around the same timeframe will be AIDS Vaccine 2008 Conference. Then we should start to be getting some significant amounts of data from the – again as it is a patient follow up in the carboplatin and paclitaxel studies, hopefully being able to move pretty quickly into the second parts of those studies as we achieve our pre-established milestones. And then again, continuing follow up from those trials. Those would probably be – we have a few other conferences we will be speaking at, and again an opportunity to highlight some more of the preclinical data. We also have a couple of preclinical publications that are in the works and I would certainly hope that those will be coming out between now and the end of the year. Those are a little harder to project because – we discussed the process of submitting manuscripts and getting them accepted. But certainly we would expect there is a good potential from most of those to be out by the end of the year. Ren Benjamin – Rodman & Renshaw: Okay. And then from a burn point of view and burn guidance, the $10 million or so that you had mentioned earlier, how much longer is that supposed to last the company?
The only thing we said publicly, Ren, is that we believe we have enough cash on hand including the projected revenues coming in from Avid combined with the projected revenues from the DTRA grant to get us through at least April 2009. Ren Benjamin – Rodman & Renshaw: Okay.
Our goal (inaudible) financing way before that time frame this debt type transaction, that should hopefully bridge us to better market conditions and give us time to generate some of this clinical data and then we will reevaluate the financial condition at that point in applying the resources. Ren Benjamin – Rodman & Renshaw: And the Avid revenues, at least the way I had modeled it, it seems to have come in lower than what I had modeled and so I wanted to know is there some seasonality associated with it? Is it just had something to do with when the contracts are actually booked, how should we be looking at the Avid revenues that are coming in?
On the (inaudible), most of our revenues come from contract manufacturing, not really the development services. About 80% are on the manufacturing side, so it’s dependent on the number of manufacturing runs that are in the works at the time. Ren Benjamin – Rodman & Renshaw: So, you believe that the number runs will increase through the remaining quarter?
Absolutely. And if you look at the balance sheet right now, our inventories are up to close to $5 million and inventories those are built up work in process inventories, most of them to be reported in the subsequent period. Ren Benjamin – Rodman & Renshaw: Okay, great.
So, there is a bunch of built up manufacturing inventories that we have been working on that will be reported as revenues in the following quarter. Ren Benjamin – Rodman & Renshaw: Okay, terrific. Thank you very much guys and good luck.
: Stephen Dunn – Dawson James: Hi, Steve and Paul; how are you?
Hey, feeling good Stephen. Stephen Dunn – Dawson James: I think Ren’s one question pretty much answered everything I needed. I would just like a little color, if you will, on the Crucell PER.C6 business?
Yes. So, essentially that is a partnership whereby they will work with us to steer West Coast potential clients toward Avid. I think what is exciting about it from our standpoint is they have gotten some pretty large numbers as far as production with their cell line. And I think the net benefit from the Avid standpoint is the higher the production of the cell lines, the smaller reactors you need and our current top reactors are about a 1,000 liter scale whereas the Boehringer Ingelheim (inaudible) be at the 10,000 plus liter scale, which is really not practical in our existing location here. So, I think what it opens the door for us is many more clients who based on higher production levels can really drive their business through us, and we can maintain their production even on to the market, which again is the key for growing a successful manufacturing business. So, the collaboration is going pretty well. We are out doing some things in collaboration with DSM as far as promoting the partnership and I think we will see some good rewards there as we go forward. Right now, we are just really extremely busy on the Avid side. Again, I think you will see a lot of these show up on the revenues in future quarters as the material is produced and then gets released. But I think it is going to be a really good collaboration for us.
Our next question comes from Richard Siracusa of Merrill Lynch. Richard Siracusa – Merrill Lynch: Steve and Paul, just to clarify two things, regarding the reverse split, I guess we don’t have to concern ourselves about that until 20 days prior to the expiration of the extension if you get one; is that correct?
What we are going to do Dick is we really going to be evaluating the market conditions of the company, evaluating our news flow, anticipated future events, I mean the latest we would do it would be 20 days prior to any extension. But again, we will closely monitor the market conditions of the company where our stock is sitting to make sure that if we have to implement that reverse stock split we give it the best chance for success, and to build market cap from there. Richard Siracusa – Merrill Lynch: Yes, but you say you probably would not do it until 20 days before the end expiration of the extension.
That would be the latest we would do it. Richard Siracusa – Merrill Lynch: Okay. And secondly, the AIDS conference in Africa, is that going to be a comprehensive presentation of everything that Duke has being doing?
Now that will be a question. It’s probably not a comprehensive but it will be certainly laying out an awful lot of the story of what we’ve learned with the anti-PS platform technology and it is what we think is great promise has potentially play role in treating or developing an AIDS vaccine. So, it’s going to be a lot of data. There is still – I mean the bottom line is we generated more data than we could possibly present in one simple presentation. Richard Siracusa – Merrill Lynch: Who will be presenting it?
That will be presented by Bart Haynes. He is the head of the group there and also very well known in the HIV research area. So, there will be a lot of data presented there. But there is a lot more coming. So, I would see really this thing is sort of the kick off, if you will, of a number of potential presentations and publications in this area for the program and our collaboration with Duke and the other institutions involved. Richard Siracusa – Merrill Lynch: Okay. Could a publication, a scientific publication precede this conference or –
It possibly could. And again, that’s – it’s a litter harder to predict. Once things are submitted, the review process, sometimes they sail through and sometimes they want you to make some adjustments to the manuscripts. But yes, I mean I think there is a lot of – we’ve generated so much data, we probably have enough for quite a few future activities around – Richard Siracusa – Merrill Lynch: Okay. Thank you.
Thank you. This concludes today’s question-and-answer session. I will now turn the conference back over to Steven King. Mr. King?
I would like to again thank you all for participating in this conference call and for your continuing support of Peregrine. We are optimistic that we will be successful in maintaining our listing on NASDAQ and believe that the removal of the delisting threat and continued success in our clinical and preclinical programs will enable us to build sustainable value in Peregrine. I look forward to reporting on our continuing progress at the next quarterly conference call. Thank you again.