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Agenus Inc. (NASDAQ:AGEN)

Q4 2011 Earnings Conference Call

March 5, 2012 11:00 AM ET

Executives

Jonae Barnes – Vice President of Investor Relations & Communication

Shalini Sharp – Vice President and Chief Financial Officer

Garo Armen – Chairman and Chief Executive Officer

Analysts

Reni Benjamin – Rodman

John Sonnier – William Blair

Megan McCloskey – MLV & Company

Bobby Cohen – Revolution Investment

Operator

Good morning, my name is Melisa and I will be your conference operator today.

At this time I would like to welcome everyone to the Agenus fourth quarter and year end 2011 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks there will be a question-and-answer session. (Operator Instructions)

Thank you. Mr. Jonae Barnes, Vice President of Investor Relations and Communications. You may begin your conference.

Jonae Barnes

Great. Thank you, Melisa and good morning everyone. Welcome to Agenus’ conference call to discuss the financial results for the fourth quarter and 12 months ended 2011. With me today is Garo Armen, Chairman and CEO and Shalini Sharp, CFO.

During this call, we will review our financial results, as well as provide a corporate update. We will then open up the call for a Q&A session. But before we continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding the company’s cash position, timing of potential income streams and development and commercialization efforts, timelines, availability of data and potential efficacy with respect to products and product candidates of the company and its partners.

These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Reference to these risks and uncertainties is made in today’s press release and they are disclosed in more detail in our more recent filings with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this call and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. While evaluating Agenus’ business and securities, investors should give a careful consideration to these risks and uncertainties. As a reminder, this call is being recorded for audio replay.

With that, I will now turn the call over to Shalini to review our financial results for the fourth quarter and year ended 2011.

Shalini Sharp

Thank you, Jonae. Good morning everyone and thank you for joining us on today’s call. By now we hope you have had a chance to review this morning’s press release. For the fourth quarter of 2011 the company reported a net loss attributable to common stock holders of $6.2 million or $0.29 per share compared to the net loss attributable to common stock holders in the fourth quarter of 2010 of $2.6 million or $0.16 per share.

The key reason to the increase in reported loss for the fourth quarter of 2011 was that in 2010 our net loss included non-cash non-recurring gains totaling $4.7 million. For the year ended December 31, 2011 the company incurred a net loss attributable to common stock holders $24.1 million or $1.21 per share compared with the net loss attributable to common stock holders of $22.7 million or $1.41 per share for the comparable period in 2010.

The company’s net cash burn for the year ended December 31, 2011 was $17.1 million compared to $15.7 million for the same period in 2010. The 2011 net cash burn figure reflects primarily the company’s efforts to support the Prophage Series vaccine. Our 2010 cash burn figure it met the non-recurring business development payments and tax credit totaling $2.7 million.

Our cash and cash equivalent were $10.7 million as of December 31, 2011. I’m very pleased to report that subsequent to the end of the year Agenus have strengthen its cash position by more than $15 million with two non-dilutive initiatives, which include $9 million of an extended agreement with GlaxoSmithKline and $6.25 million to a license of non-core technologies. In addition, we raised $2.8 million in equity issuances. Collectively the activities increased the company’s cash position by $18 million from the year end 2011 cash position of $10.7 million, which at our current burn rate will be sufficient to fund operations through 2013.

Our net cash burn for 2012 is anticipated to be in the range of $13 million to $15 million. This burn projection is net of approximately $1.5 million in facilities related savings related to the amendment of our Lexington, Massachusetts lease in April 2011 reflecting our ongoing cost containment efforts.

This concludes the financial portion of the call. Garo will now provide the corporate update.

Garo Armen

Thanks Shalini. I’m very pleased to report that 2012 is already proving to be an exciting year for us on a number of fronts. One, as Shalini indicated we started the year by strengthening our balance sheet by $18 million. Two, the GSK news today of the expected license and manufacturing agreement further validates QS-21 as a key adjuvant and expanded potential use in additional indications in the GSK biologics pipeline. Three, under the terms of the GSK agreement we will receive a non-refundable payment of $9 million. And four, also we agreed to rent GSK the first right to negotiate for the purchase of Agenus or certain of its assets. This first right to negotiate expires after five years.

In addition to all of this we believe that 2012 could be a year marked with significant clinical milestones. And the past year we have seen an acceleration of advances in the field of immunology and cancer vaccines. Both of our technology platforms are poised to benefit from this very exciting new trend. As most of you are aware between Agenus and its partners 18 programs are in clinical development.

QS-21 is being studied in clinical trials of 15 vaccine candidates of which four are in Phase III studies. Importantly, all four Phase III programs are due to report pivotal data over the next year or so. These programs are diversified across different therapeutic areas and address large market opportunities. It is very rare for a small biotech company to be in a position to benefit from such an extensive portfolio of clinical programs. Once again 15 out of 18 clinical programs are being pursued with resources and expertise of the best-in-class large pharmaceutical companies.

Last year we saw significant progress with our two core platform technologies QS-21 containing vaccines advanced in the clinic. As you are probably more and more aware QS-21 is a key component of a substantial number of prophylactic and therapeutic vaccines in clinical development. It strengthens the body’s immune response to an antigen thus making a vaccine more effective.

To highlight some of the progress made with QS-21 in the fourth quarter of last year, the New England Journal of Medicine published results of the Phase III trial of GlaxoSmithKline’s biologics RTS, S malaria vaccine candidate. This candidate contains QS-21. This was a first major milestone for us as it was the first time a QS-21 containing vaccine demonstrated efficacy in a large Phase III trial.

Over the next year we anticipate important data readouts for our Phase III clinical trials of four vaccine candidates of GSK. These include MAGE-A3 Cancer immunotherapeutic for patients with non-small cell lung cancer and separately with melanoma, RTS for malaria and Herpes Zoster for shingles. I would like to point out that the Herpes Zoster program, which enrolled 30,000 subjects had just been added to the list of programs that are new to report data over the next year to 15 months.

Just to reiterate we are entitled to receive milestone payments as QS-21 containing programs advance. As well as royalties our net sales for at least 10 years at the commercial launch of the first prophylactic and the first therapeutic product. Given that QS-21 is being studied in clinical trials for 15 vaccine programs including products in late stage development targeting $1 billion market such as non-small cell lung cancer, melanoma, shingles and Alzheimer's disease, this unique proprietary asset represented significant and unusually diversified value driver for our company.

Again the QS-21 programs are funded entirely by our partners benefiting from their financial development and sales and marketing resources. It is an extraordinary advantage for a company of our size to be in a position to benefit from the success of much larger established companies.

I will now turn to our own proprietary pipeline programs beginning with HerpV. HerpV is a novel and exciting recomponent off-the-shelf therapeutic vaccine for the treatment of genital herpes. Genital herpes is caused by the herpes simplex virus 2 also known as HSV-2. This vaccine uses both of our platform technologies heat shock proteins also referred to as HSPs and QS-21. Not only is HerpV the most advanced herpes vaccine in the clinical trial but is the only one to our knowledge, which uses a polyvalent and Agenus cross drug combined with one of the most powerful antigens available our QS-21.

Last year we reported positive results from a randomized four on placebo controlled Phase I study of HerpV. This study was published in the peer-reviewed journal Vaccine. Our Phase I trial showed that 100% of the evaluable patients receiving HerpV incorporating QS-21 demonstrated a statistically significant CD4+ T-cell response to HSV-2 antigens. In addition, 75% of these patients also demonstrated a CD8+ T-cell response. I would like to note that the both of these types of immune responses is the first of its kind achievement in herpes immunotherapy.

As I mentioned, HerpV is the most herpes 2 vaccine currently in clinical development for the treatment of genital herpes. HerpV contains 32 HSV-2 related antigens and was designed as a highly polyvalent product with the intent of treating a broad population of HSV-2 infected individuals. We are currently in the process of preparing manufacturing lots of HerpV for our Phase II trial, which is expected to commence during the second half of this year. It is anticipated that we could have initial results from this trial as early as the end of 2013.

The Phase II study for HerpV will measure the effect of vaccine on viral shedding in HSV-2 infected individuals. Key experts in this field believe that a reduction in viral shedding could be the best predictor of a reduction in recurrent upgrades and transmissions. Given the significant unmet medical need represented by genital herpes we believe that if HerpV is shown to be safe and effective this therapeutic vaccine has a full blockbuster potential.

Finally, I will now discussed on Oncophage and Prophage series vaccine, which are also referred to as you know as HSPPC-96 or vitespen. Both vaccines are based on our heat shock protein technology. In December, Agenus and NewVac LLC a subsidiary of ChemRar announced a license, development and manufacturing technology transfer agreement for our Oncophage vaccine. ChemRar is a well known entity in Russia and has agreements with large pharmaceutical companies such as Pfizer, Novartis and J&J.

As you may remember Oncophage is approved in Russia for the treatment of adjuvant renal cell carcinoma. Under the agreement we granted NewVac and exclusive license to manufacture market and sell Oncophage as well as pursue development programs for Oncophage in combination with NewVac co-adjuvant technology.

These activities would take place in the Russian Federation and in CIS countries. We are entitled to receive a transfer price and or double digit growth is upon Oncophage product sales as well as potential milestone payments.

Moving along to our Prophage G-Series vaccines Prophage G-Series are currently in clinical trials in two different settings of glioma, newly diagnosed and recurrent disease. Glioma is the deadliest form of brain cancer with an average survival of six to 14 months. Last year at ASCO we presented from a Phase II trial of Prophage G-200 that it showed 93% of the patients were alive at or greater than 26 weeks after surgery with an median overall survival of 11 months. Importantly, measures of immune response post vaccination demonstrated a significant and localized Chimera specific CD8 T-cell response as well as innate immune responses as marked by significant increase in levels of circulating and NK cells.

Promising overall survival results from this trial support advancement of Prophage Series G-200 into a randomized study using a combination regiment. I would like to note that that Dr. Andrew Parsa at the University of California in San Francisco and lead investigator for the trial will be presenting data on Prophage G-200 at the upcoming annual meeting of American Association of Neurological Surgeons, which will be held April 14 to the 18 in Miami, Florida.

Our second glioma program a Phase II trial testing the Prophage Series vaccine G-100 in patients with newly diagnosed glioma is ongoing. In this trial our vaccine is being used on top of the standard of care, which includes Temodar journal Vaccine. Our Phase I trial showed that 100% of the evaluable and radiation it is believed that the efficacy of G-100 could potentially be enhanced through this combination regiment.

In closing, this is a very exciting time for the company between Agenus and its partners there could be as many as eight upcoming milestone events that could be reported over the next 15 months. All of this could be of great value to our company and to our shareholders. With over a dozen clinical programs in development in GSK biologics pipeline, which contain our QS-21 adjuvant we are pleased to be able to participate in this future success of the world’s number one ranked vaccine company.

Thank you for your interest in our company. We hope that you have found this update to be useful and I will now conclude my remarks we are now ready to open up for Q&A.

Question-and-Answer Session

Operator

(Operator Instructions) your first question comes from the line of Reni Benjamin from Rodman. Your line is now open.

Reni Benjamin – Rodman

Hi, good morning and thanks for taking the questions and congratulations on all the progress. A couple of questions for you guys one just having to do with its newly negotiated agreement with Glaxo. It mentions that this is an option not just for other assets that you guys may have but all of Agenus as well. Could you comment can you give us a little bit of color around that is that something that you guys brought up or is they brought up. How did that come about?

Garo Armen

So Reni you are referring to the right to first negotiate and potentially purchase of Agenus or some of its assets and this was I will speculate as to why they want to do this, because we don’t know the details of their decision making process. But clearly QS-21 is a very important asset for Glaxo and if I were Glaxo I wouldn’t want the financial interests of this asset to be in the hands of another third party.

So, because of that the company wanted to have a first right to negotiate a potential transaction and better understandable. From our perspective we are in a situation where we believe as a company that there is a very significant disparity between our intrinsic value and our value in the marketplace. And if we were to look at who is out there most capable of valuing the intrinsic value of Agenus it would be GlaxoSmithKline since they know the programs, they know their potential and should there be an opportunity where the company was being pursued as a target that Glaxo will likely be the best candidate to value it properly. So that is our reason for wanting to do this. Does that answer your question?

Reni Benjamin – Rodman

Yes it does. Thank you for that color. And I guess just moving on with the GSK programs can you just maybe in some sort of order kind of place for us when we might be expecting the data from the ongoing Phase III trials. I know that a thing in the past we were thinking about the potential for the melanoma results to be coming out in the third quarter and maybe non-small cell lung cancer in the fourth or early next year. Could you just give us the latest update on when these results could be expected?

Garo Armen

So I will tell you what GSK has promised on these things so that’s all we are, we have the freedom to disclose at this time.

Reni Benjamin – Rodman

You bet.

Garo Armen

GSK in their published information as said that they expect their I believe MAGE-3 for melanoma to be out in the second half of this year. That, their lung cancer trial will be out sometime perhaps as early as in the first half of next year and in the most recent filings as they have indicated that the shingles program results could be out as early as the next 12 to 15 months. So those are the guidance’s that we can provide now as to the malaria trial they would publicly disclose it by the end of this year there will be additional data coming out on malaria.

Reni Benjamin – Rodman

Okay and just you know I want to make sure that I have this corrected that the first right to negotiate for the purchase of Agenus or your asset does not impede in anyway the ability for you guys to sign on additional partners to utilize the QS-21 in other indications, am I thinking about that correctly or do they have the right to first negotiation in any indication?

Garo Armen

No, they do not. Actually you are absolutely correct that we are free to out license QS-21 for additional indications.

Reni Benjamin – Rodman

Perfect and just a couple of other questions. I believe Shalini in her prepared remarks mentioned that you have enough cash now till to take you through 2013. So that’s 2013 or 2012?

Garo Armen

2013.

Reni Benjamin – Rodman

Okay and then I think in your prepared remarks regarding the HerpV program you mentioned that results could be coming out in early 2013, which at least I thought it would be a trial that would be pretty easy to enroll and potentially have data out earlier. Could you help me understand why look through the data might come out in 2013 I suppose to maybe the end of the year this year?

Garo Armen

Okay, so let me just clarify couple of things we have not yet started our Phase II trial we can’t have data before the trial starts. So, the trial is slated to start by the end of this year Ren and the reason for that is because we are currently manufacturing GMP grade material in order to be able to inject patients with it. So that material will not be ready until the third quarter of this year and so we are anticipating that shortly thereafter the trial will begin and you are absolutely right that there is such a demand for enrollment in a trial like this that would likely drive very quick enrollment. And so if we start the trial by the end of this year and have the kind of anticipated enrollment that we expect we would expect to perhaps as early as within 12 months of the start of the trial, which will put us towards the end of next year.

Reni Benjamin – Rodman

Perfect, okay thank you for the clarification. Just switching gears to Prophage real quick. I know you mentioned that there will be some updated results coming out in April presented by Andrew Parsa. Any other results that we could expect this year maybe at ASCO or AFCR any of the other conferences. And probably more importantly any further considerations regarding a Phase III study with a cooperative group?

Garo Armen

Right, so the answer to your question as to whether or not we will present at ASCO or some other conference? The answer is no, there are no plans at the moment to present at conferences other than what I indicated to you earlier. In terms of cooperative trials those are still very much under consideration and as soon as we have clarity on it or a decision we will certainly put out a news release on the subject.

Reni Benjamin – Rodman

Okay, maybe just one final question on Friday you had issued an 8-K just talking about an ATM that was in place and the termination of a previous ATM. Could you just give us a little bit of color why terminate the previous one and maybe how much was used?

Garo Armen

Right, so let me just give you a broad answer and then we will address the specifics. The broader answer is that as you may recall since we went public we’ve had a shelf facility available and then some years earlier we put in place an ATM facility as well. These are for the purposes of to make sure that the company is in a state of readiness should there be a requirement for cash and should there be an opportunity on the favorable conditions to raise money.

First off during the first quarter we raised a little bit of money under ATM because we weren’t absolutely certain as to the eventuality of these two deals that we announced, which netted us over $15 million. So before that we wanted to have the flexibility and the luxury of having additional financial resources and having these facilities that you are talking about allow us to act quickly on these fronts. I can tell you that currently we have no plans to issue equity at these current prices, which we considered to be significantly undervalue in the intrinsic value of our company.

Particularly given the fact that our as I said earlier eight potential important milestones that maybe upcoming over the next 12 to 18 months each one of which could add significant value to our company. So, those are facilities and I know every time you do a filing there is some confusion as to whether or not you are imminently expecting to issue shares and the answer is particularly after the $15 million non-dilutive cash infusion into the company, we have no plans or doing such at these prices.

Reni Benjamin – Rodman

Perfect, thank you very much. Congratulations and good luck.

Garo Armen

Thank you.

Operator

Your next question comes from the line of John Sonnier from William Blair. Your line is now open.

John Sonnier – William Blair

Hey, thanks for taking my question and congratulations Garo to you and the team there on all the progress. I’m wondering and I apologize if I missed this what was the source of this $6.5 million inflow, which asset specifically did you outline and sort of guessed?

Garo Armen

These are some assets we haven’t disclosed details on this and I apologize for that but we have not and that’s for competitive reasons for the sake of the purchaser. And one thing that I would like to highlight John we said both transactions, particularly this particular transaction is through the divestiture of a non-core asset and this asset is really below the radar screens of anybody. And it involves some of the intellectual property that we had purchased many years ago and so we will obey by the wishes of the purchaser and not disclose the details.

John Sonnier – William Blair

Alright, that’s fair enough and just to be clear with this GSK arrangement strategically it doesn’t preclude a competitive process. Does it essentially just require you of you approached by a party other than GSK to notify GSK?

Garo Armen

Right, so this is a I mean just to be clear this is not a right of first refusal clearly if it was the right of first refusal it would make things a lot more restricted for us. It is the right to first negotiate, which has certain terms and those terms may or may not be made public with our filings soon but so factor to say that none of what we did hampers the value exploration or value enhancement of the company, should there be a competitive process as you suggested.

John Sonnier – William Blair

Okay, thanks a lot.

Operator

Your next question comes from the line of Megan McCloskey from MLV & Company. Your line is now open.

Megan McCloskey – MLV & Company

Hi everyone, thank you so much for taking the call and congratulations on the expanded license announced this morning it was really exciting to see. I have a question in relation to HerpV you know the HerpV product is really ground breaking in my view for being able to list a T-cell response specifically a CD8 T-cell response. How are you designing the Phase II trial moving forward what are your read outs going to be?

Garo Armen

Okay, so we actually have the trial protocols completely worked out and this has been with substantially puts around some of the or I should say perhaps all of them, that is in the field. The trial will allow us to measure the reduction in viral shedding days of already infected individuals. So individuals do what’s called a (Inaudible) for I believe 40 days prior to vaccination. And it is known that in individuals who are infected with herpes shed virus at least on some days not perhaps on everyday but some days. So we will measure the number of viral shedding days prior to vaccination and do the same thing post vaccination. And if there is a say a 30% to 50% reduction in viral shedding days that is considered by the experts to be a very good proxy to clinical outcomes and that will certainly pave the way for us to design an appropriate Phase III trial that will be based on clinical outcomes, which will be reduction in viral outbreaks of herpes.

Megan McCloskey – MLV & Company

Do you have any indication at this point that the T-cell readouts are predictive outside shedding reduction?

Garo Armen

Well the simple fact is the following. Because there are no effective immunotherapeutic for herpes so far it demonstrate the correlation between generation of T-cells and clinical outcomes such a study has never been done to link the two. However, based on all intelligent data so far, which is scientific data there have, we believe there is a very close link particularly when you generate an appropriate dual immune response, which is the combination of CD4 and CD8 positive T-cells. Only because it’s in the clinic a reduction in viral outbreaks and presence of these two cell types immunological cell types have been associated. So while there is no outcomes association there is some suggestion that will be linked.

Megan McCloskey – MLV & Company

Okay. Thank you so much.

Operator

Your next question comes from the line of (Inaudible) Investor. Your line is now open.

Unidentified Participant

Hi, good morning. I have a suggestion as to a financing device you might consider and that is to give your long suffering shareholders consider upon them the right to buy a convertible debenture and properly priced and so forth. Because this is a long, long wait we’ve had and secondly I would like to ask what is suppose to happen when a shareholder writes to the lead director?

Garo Armen

What was the second question again?

Unidentified Participant

What is suppose to happen with the shareholders write to the lead director?

Garo Armen

What is suppose to happen if I shareholder corresponds with a lead director?

Unidentified Participant

Yes.

Garo Armen

I don’t know what suppose to happen but certainly our shareholders free to do that.

Unidentified Participant

Well I was free to do it over a year ago and I never got any response what so ever.

Garo Armen

Well, I would suggest that you check the proper address and I’m sure that you will get the attention of our lead director or who is an extremely diligent person.

Unidentified Participant

Well however directly was a year ago did not response, anyhow my third comment and questions is what are you doing the, to have a more vigorous financial PR.

Garo Armen

Well thank you for the first suggestion and as far as financial communication as you may know Jonae A Barnes joined the company by the year ago. And we haven’t really had that function occupied up until she came on board for quite some time actually. And I think we have already seen a significant streamlining of the vacations, which shareholders as well as the press and the media since her arrival. And it is an area of importance for us because of particularly because of the upcoming year when we expect substantial news flow to be able to drive value for our shareholders.

Unidentified Participant

I was surprised for example after the annual meeting that your website did we see to have nothing, bring your remark that’s and opportunity for you to get comment out there for a company with very small and my suggestion my specific suggestion to you because I did this work for McMillan many years ago. It’s start holding small lunches or dinners with some of the institution investors because then it’s and when we hope your stock hits five they will be familiar with the company and they will be able to buy it. That is not the time to start an educational program with them the time is now and we consider them you know various travels pick the big institutional investor cities and have small dinners.

Garo Armen

Thank you and thanks for all of those very good suggestions we have been doing some of these things and certainly we are on path to accelerate them.

Unidentified Participant

Fine, thank you.

Operator

(Operator Instructions) your next question comes from the line of Bobby Cohen from Revolution Investment. Your line is now open.

Bobby Cohen – Revolution Investment

Hi, thanks for taking my call and congratulations on this past even. My question is I just would like to know over the last 90 days has anyone on the board been approached by anyone to possibly take over the company, it just seems that this Glaxo announcement is almost like a I mean don’t get me wrong, extremely positive. But almost like I can’t verbalize the correct wording but it is almost like a somebody putting something in place because they may have been already been over to church by other parties. I know I’m just speculating but I think that you eight ask you guys that.

Garo Armen

Thank you very much for the question but as you know we have never commented on such speculation and will not going forward. So I cannot deny or verify your comments.

Bobby Cohen – Revolution Investment

I mean I’m not asking anything specific if there was something that (Inaudible) would you have to just state it in an 8-K that the company has been approached or where do you stand on that. Right attorney’s being something to be material in nature we certainly put out a communication regarding that.

Bobby Cohen – Revolution Investment

Okay, thank you. And again terrific job guys thank you.

Operator

There are no further questions at this time.

Jonae Barnes

Great. Thank you. And I’d like to remind listeners that a replay of this call will be available approximately two hours after the call through mid night Eastern Time on September 5, 2012. The replay number is 855-859-2056 domestic or international 404-537-3406. And the access code is 54303509. The replay will also be available on the company’s website approximately two hours after the live call. If you have additional questions after today’s call you may call us at 800-962-AGEN or 2436. Thank you.

Operator

Ladies and gentlemen this does conclude today’s conference call. You may now disconnect.

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