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Compugen Ltd. (NASDAQ:CGEN)

Q4 2013 Earnings Conference Call

February 11, 2014 10:00 AM ET

Executives

Martin Gerstl - Chairman of the Board

Dr. Anat Cohen-Dayag - President and CEO

Analysts

Keay Nakae - Chardan Capital

Craig Haack - Ascendant Capital

Operator

Ladies and gentleman, thank you for standing by. Welcome to the Compugen Limited Fourth Quarter and full year 2013 Financial Results Conference Call. All participants are present in a listen only mode. Following managements’ formal presentation instructions will be given for the question and answer session. (Operator instructions) As a reminder, this conference is being recorded February 11, 2014. With us online today are Mr. Martin Gerstl, Chairman of the Board; Dr. Anat Cohen-Dayag, President and CEO.

I would like to remind everyone that the Safe Harbor language contained in Company’s corporate presentation also pertains to all contents of this conference call. If you have not received the copy of today’s release, and would like to do so, please contact Marty Rickman, at 972-3765-8175 or 415-373-0565 extension 320.

Mr. Gerstl, would you like to begin.

Martin Gerstl

Yes, thank you very much. On behalf of our associates and all the employees of Compugen, welcome to our year end 2013 conference call, thanks for joining us today. Pleased to say that looking at the participant list once again we have a record number of participants on our call and I want to welcome those who are participating for the first time. In the drug industry, discovery of novel drugs is by far the most major challenge and key determinant of corporate success. As we begin 2014 Compugen up to more than a decade of pioneering science and infrastructure building is now an emerging leader in directing this challenge and opportunity through the use of our proprietary predictive methodologies and our success to date and competitive advantage is provided by our unique discovery capability are now being demonstrated by our proven ability to predict novel, highly attractive, potential drug candidates even in areas that have been and are being heavily researched by others in both academia and industry. The major portion of our prepared remarks today will be a review by Anat of our performance, against publicly stated key objectives for 2013 and to discover certain key objectives for 2014. First, however, in the absence of Dikla our CFO who is now concluding her maternity leave I would like to briefly comment on our year-end financial results that were reported today and on our overall financial status.

With respect to 2013, reported revenues for the fourth quarter and full year, although the $10 million upfront payment under our Bayer agreement signed in August has been received in full and is unrefundable under US GAAP accounting principles, it must be recognized over time resulting in the amount shown on the statement of operations in today’s press release. I will not comment on other individual line items on the statement of operations. But, in general, the report reflects an increase in corporate activity during 2013, although about 30% to 40% over 2012 and an approximate doubling of our total corporate assets.

I will be glad to answer any specific questions about these reported results during the Q&A session. Before turning the call over to Anat I would like to take a few minutes to discuss two financial items that I believe may need further explanation in order not to lead to misunderstandings regarding our results or financial status. The first item arises from how we provide financial guidance each year. Our practices relate mostly to cash in the outfit, especially our recent disclosure that we have budgeted, a greater than 60% increase in R&D cash expenditures for 2014.

We provide such information on a cash, rather than accounting basis since it is our belief that at the present time for Compugen, cash is more relevant to focus on and evaluate in our financial status than the accounting base figures that appear in the financial statement. However, it is important to note that when comparing such cash amounts with accounting based figures with the same category, the cash amounts will often be significantly lower since they do not include any non-cash items such as stock based compensation or depreciation or allocated items such as direct overhead. For example, our budgeted cash R&D expenditures for 2014 about $16 million will likely result in a significantly higher than $16 million R&D expense on the statement of operations for the year as was the case for 2013. Also and more importantly, with respect to how we provide financial guidance each year, our guidance relates only to expected cash uses such as our disclosure in our press release today that we have budgeted total cash uses of approximately $24 million for the calendar 2014. This guidance does not include in any way expected or potential cash received. Therefore, this $24 million in budgeted cash usage should not be interpreted as our expected cash burn since it only refers to cash [indiscernible] without taking to consideration any expected or possible cash that will be received during the year from existing or new collaborations or any other operating or financial sources. For example with respect to last year, in early 2013, we disclosed our budget for total cash usage of approximately $16 million. However, during 2013, total cash received was approximately $42 million, which as previously described was not included in our disclosure, therefore counting the year 2013 rather than a cash burn we had a positive cash increase of approximately $26 million. This resulted in our beginning 2014 with cash of approximately $47 million not including the value of our remaining leveraging shares.

The second item that could potentially lead to misunderstanding regarding our financial status relates to the liability side of the balance sheet. In today’s press release, the amount of approximately $2.4 million shown for trade and other accounts payable represents an actual amount that company will need to pay in when due in cash. However, three of the remaining four amounts listed as liabilities result solely from the required accounting for certain arrangements we have entered into and will not require the company to make any cash payments in the future except with respect for the payment of our small percentage occurred in future revenues if and when such specific future revenues are received by us. And the remaining one, the accounts of accrued severance pay has already set off with a similar amount on the asset side of the balance sheet.

In total, these four items can be misunderstood to represent a future cash liability of over $20 million. But the effect this cash had over the -- effectively does not actually exist. Lastly, before turning the call over to Anat I will like to say a few words about her prepared remarks.

As I stated earlier Compugen has reached a stage where we are now demonstrating a competitive advantage in the most important determinant by far of success in the pharmaceutical industry. That is a systematic addition and highly and broadly applicable novel drug candidate discovery. So the question for Compugen and its investors is no longer can we do predictive discovery? The question is now how can we use this competitive advantage to create in the shortest time possible with a highly profitable, rapidly growing and long-term sustainable company?

Our answer to this question can be divided into three categories. First, how do we plan to get value out of the discoveries we have made to date and in particular the result of our first focused discovery program for immune checkpoint proteins. Second, how do we plan to leverage our competitive advantage into new and additional fields? And three, how do we not only maintain but also continue to enhance our competitive advantage?

As previously stated, in her presentation today, Anat will be discussing our performance against our 2013 objectives, and disclosing certain objectives with current year. However, we will do so in term of how they impact these three categories relating to our competitive advantage and predictive drug discovery. Without our achievements in these three categories, we’ll also be determined both our short-term and long-term corporate success. And of course those of you are interested in a listing of our objective for 2014 can obtain this information in today’s press release. Anat?

Dr. Anat Cohen-Dayag

In my prepared remarks today I would like to review our performance against our publicly stated key objectives for 2013 and to disclose certain key objectives for 2014. However, as Martin stated, I would like to provide this information by adding perspective regarding the company’s competitive advantage and discovery aiming to provide the continuing flow of potential first-in-class drug candidates for major unmet medical needs and thereby increasing both short-term and long-term shareholder value.

These certain objective for 2014 are listed in our press release issued today. As Martin described, all of our R&D and business efforts and objectives relate to our competitive advantage in predictive drug discovery and can be divided into three categories. First, achieving shareholder value for our existing discoveries in the form of first-in-class product candidate, either for future early stage licensing cost, further future development by the company; second, leveraging our unique predictive capability into new [indiscernible] area. And third, continuing to extend and enhance the underlying science and broadly applicable technology platform.

With respect to the first category, achieving shareholder value for our existing discoveries in the form of first-in-class product candidates, we’re pleading over for last year to enter into our first patent program collaboration and license agreement, for the research, development and commercialization of anti-body based therapeutics for cancer immunotherapies against two of our immune checkpoint candidates.

This was the major objective for 2013 that has provided key validation for our technology from a major pharmaceutical company. A second objective for 2013 in this category was to advancing on our pipeline program, the next wave of new checkpoint based product candidate from our initial focused discovery program. This objective was also accomplished during 2013 as a selected group of our predicted immune checkpoint proteins were tested utilizing driving (Ph) some new modulation of iTregs system. In this regard it is important to note that to-date on the attraction (Ph) of our predicted immune checkpoint target discovery for oncology has been disclosed either publicly or through potential collaborators. In addition to these new proteins that have been disclosed along with encouraging experiment and support for oncology, I am pleased to report that all of the other checkpoint protein tested to-date have shown initial positive results in one or more experimental system, with respect to confirmation of our projected immuno regulatory function of that protein.

The third key objective for 2013 with respect to achieving shareholder value for our recent discovery was to conduct initial validation study of monoclonal antibodies generated by our South San Francisco subsidiary against a Compugen oncology target and had active programs for at least five monoclonal antibody programs by year-end. We are very glad to report that this objective was also achieved.

The South San Francisco team is working very closely with a team in Israel and the operation is always contributing to the company’s overall progress. With the budgeted substantial increase in funding for this unit beginning this year, we are looking forward to additional fee contribution during the next few years. During the course of 2013, we made a decision that impacted through of our objective for 2013, by midyear it was apparent to us that in order to maximize the value of the rapidly growing industry interest in immune checkpoints for oncology, we should modify our R&D priority.

This resulted in our decision disclosed at the beginning of this year to aggressively advance our new checkpoint candidate for cancer immunotherapy, so that this can serve for future early stage licensing or further internal development by the company. Accordingly, in line with the decision during the second half of last year, as we continue to increase our R&D activity higher than originally planned portion of our resources were committed to oncology rather than immunology. At the same time, our recognition in the industry was increased in this area largely based on our successful checkpoint target discoveries and product candidate along with the grown industry interest in the field.

Publicly, this was and continues to be evident by the rapidly increasing number of key industry and scientific forums where we present our discovery and the interest being demonstrated by leading pharma companies in our disclosed product candidates. When we stated our objective for 2013, our intent was to exam CGEN-15001based on its unique mode for its human clinical trials for the potential treatment of autoimmune diseases. However, our decision to increase our focus on immuno-oncology during the second half of last year resulted in our decision not to move forward with the activities required to meet this objective, which was therefore not achieved.

This year, we have a similar objective but now it is anticipated to be in the form of advancing one or more new checkpoint candidates internally for oncology rather than CGEN-15001 for autoimmune disease. With respect to CGEN-15001, with its unique and highly promising mechanism of action for potentially treating autoimmune diseases, we will continue to fund this program at its 2013 expenditure level. This activity in support of CGEN-15001 are intended to further investigate its unique mechanism of action and potential to offset the fundamental mechanism underlying autoimmunity such as the investment of immune, demonstrate translational potential, it’s mode effects and to patients and thereby enhance CGEN-15001 competitive edge in a crowded field of therapeutics for autoimmune diseases.

The last objective in this category of achieving shareholder value for our existing discoveries in 2013 was to undertake project development towards GMP manufacturer of one of our lead Fc fusion protein candidates. This objective was also not met due to our increased profit on oncology. With respect to 2014, we look forward to demonstrating continued success in gaining value from our existing discovery and have set three key objectives in this categories for the current year. These are enter into one or more additional title for one collaboration, achieve [indiscernible] goals and milestones for existing collaboration and aggressively advancing parallel additional target research in therapeutic antibody discovery program for multiple immune checkpoints for cancer immunotherapy including one or more to be taken towards future clinical trials in oncology by the company.

In order to allow for these increased activities, recently we announced more than 60% increase in our annual and research expenditures for the current year compared with 2013. A substantial portion of this increase relates to the parallel advancement of additional pipeline product candidate with a primary focus on cancer immunotherapy. This involves substantially expanding target research and validation activities in Israel and significantly increasing therapeutic antibody efforts at our South San Francisco subsidiary. As the year began we already started the selective addition of highly qualified personnel mainly in the field of immune-oncology both in San Francisco and in Israel and we’ve entered into a lease agreement for the relocation of our South San Francisco subsidiary to larger facilities.

We expect that our multiple checkpoint programs will serve as the basis for future state licensing and for our selection of one or more new checkpoint product candidates to be taken towards future clinical trials in oncology. We look forward to disclosing our progress throughout the year as we undertake a significantly expanded effort.

Moving to the second category, leveraging our broadly applicable technology into additional fields within our focused areas, we anticipate that for at least the next few years our phase of focus will remain oncology and immunology drug therapies with an expected emphasis on oncology. In April of last year, we achieved a key objective in each category when we disclosed the initiation of our second focused discovery program aimed at identification of novel targets for antibody-drug conjugates, cancer therapies focusing on clinical situations with poor survival rate and or recurrent cancers. We also stated that based on the success of our first effort we expected initial target discovery by year end by further expanding this scope and diversity of the cancer therapy on a parallel pipeline.

Indeed by the end of 2013, we announced a predictive discovery and selection of five candidate target of antibody-drug conjugate cancer therapy. These five potential ADC targets are now entering experimental validation to be followed by antibody discovery and development activity for validated candidates. This achievement further demonstrated the ability to quickly and successfully focus our predictive infrastructure towards new areas of discovery.

One of our objectives for 2014 is to achieve initial experimental validation for a few of these potential ADC oncology target candidates, which is expected to be achieved in the second half of the year. In addition, one important objective for 2014 in this category of leveraging our capabilities is to establish a biomarker discovery program for selected checkpoint candidates. Certain biomarker started containing diagnostics are expected to be highly beneficial in this rapidly growing field of immune-oncology. We plan to establish a predictive biomarker discovery program for certain of our product candidates which we believe will enhance the value proposition and further differentiate the strategic packages being offered for the company for licensing.

Of course for the long-term value of our company, we will continue to enhance our competitive advantage in predictive discovery which is the third category of activity. The key requirements for success in this endeavor is not the amount of resources employed but the availability of an experienced team of highly talented, multi disciplinary scientist from both the exact and lab sciences, an integrated infrastructure that the company has built for more than a decade.

In July of last year, we achieved our key 2013 objective in this last category with our disclosure of a new predictive structure – the infrastructure platform for the enhanced discovery of novel drugs. The flexibility of this platform creates the potential to provide a wide range of drug discovery capabilities and applications including the ability to target specific protein-protein interaction. It is done to computationally identify the functional interaction type of proteins, which are of substantial importance for rational design of novel drugs. The current application of these new infrastructure capability aims at the enhanced discovery of functional monoclonal antibodies.

For 2014, an additional key objective is to utilize this capability in other aspects of the company’s predictive discovery infrastructure to further enhancing intellectual property position of selected product candidates creating higher value for our products candidates. And last but by no means least, I would like to point out that with respect with all of our efforts in building in something a unique predictive discovery capability and developing and commercializing our pipeline program candidate, we are very fortunate to have the guidance and wisdom of an exceptional scientific advisory board which was established in 2013 and expanded during the past few months with the addition of Professor Antoni Ribas and Professor Drew Pardoll.

That concludes my prepared remarks for today. I hope that you find this information and the format in which it was presented useful in your evaluation of Compugen.

And with that we will begin the Q&A portion of this conference call.

Question-and-Answer Session

Operator

Ladies and gentlemen, at this time we will begin the question-and-answer session. (Operator Instruction) The first question is from Keay Nakae of Chardan Capital, please go ahead.

Keay Nakae - Chardan Capital

My first question relates to one of your objectives for this year which is to advance one year mAb candidates. Can you talk specifically about where to what point you want to advance, I mean are you looking to take it to a point where you can get an MVA to go into a first-in-man study, where actually should we think about you being able to advance one year lead mAb candidates on your own.

Dr. Anat Cohen-Dayag

In general the capabilities that we have built in the organization by incorporating some initial or early drug development expertise allow us to move ahead with the program to the stages to even to get into human clinical trials. And we did state in one of the objectives that we aim to be able to select let’s say one of the programs that would be advanced to these stages. So in general we can take programs to very late stages. Having said that, we do expect to balance between early-stage licensing and partnership of later development stages. And we are committed to work upon the objectives that we have stated in the press release but we can definitely get to later stages as a company.

Keay Nakae - Chardan Capital

Yes, I just thought of asking you, do you think you will be at a point where you can file an IND by the end of this year?

Dr. Anat Cohen-Dayag

I wish to say that our programs are early and we did not give a guideline as to exactly as to when we are going to get into clinical trials for filing an IND. But just to make it clear, it won’t be this year. We won’t get into clinical trials this year.

Keay Nakae - Chardan Capital

And just if I can, with respect to your other objective of advancing your activities under your current licensed mAb with Bayer, and your use of the word milestone, for achieving milestones, should we interpret that as you being able to achieve the preclinical milestones under the agreement such that you’re able to receive the funds associated with those preclinical activities?

Dr. Anat Cohen-Dayag

In general the information regarding a milestone or the joined preclinical research that we’re doing together is confidential information, and having said that at this stage that we are entitled to up to $30 million that are related to preclinical milestones at this time that we will achieve the milestone it could be reported by the company in terms of the payments that we would get not the stage that we have got.

Keay Nakae - Chardan Capital

Okay so we should make distinction between your use of the word milestone in your objectives for 2014 as activities, but not necessarily receiving payments as stipulated under the agreement with Bayer.

Dr. Anat Cohen-Dayag

No, what I said is the reverse, when we will get milestone payments we will report that we will not report that for the stages which we had achieved.

Keay Nakae - Chardan Capital

Thank you for that clarification.

Operator

The next question is from [indiscernible]; please go ahead, [indiscernible]

Unidentified Analyst

First of all thank you for taking the question and congratulations on all the progress you’ve made over the past year and beyond that; my question in essence has to do around your comments around partnership opportunities and I was wondering given the very successful deal that’s struck with bio last year. Could you please perhaps characterize the current activities in potential partnering; I know one of the stated goals is additional partnership. But can you just give a sense of how the partnering discussion environment is right now? Thank you.

Dr. Anat Cohen-Dayag

Thank you, Craig. First we cannot really discuss and disclose or in other with instances with investors’ information that relates to details of discussions with the potential pharma partners. What I wish to say it that we’re very focused due to the activities for advance programs that we have in the pipeline and to make sure that we maximize the value to the shareholders while speaking -- through exploring the business model of the company. And I think this is the only information that we can provide, I think that taking an objective, we have an objective for this year to enter into such arrangements and speak for itself.

Martin Gerstl

Let me add a little to that, this is Martin. I think, first, we don’t know and no company knows when they are going to sign an agreement with another organization, it takes both organizations to agree. And so once you are prepared to accept whatever is offered to you, which clearly we’re not prepared to do into negotiation and once you are into one there isn’t any way to really accurately know how long it will take. I can assure you that we have highly attractive product candidates and significant interest by a number of pharmaceutical companies in evaluating possible arrangements with us. That doesn’t necessarily mean that anything will come of these, or [indiscernible] you never, until you actually go through the negotiations and actually get the approval in many places all the way through the Board of Directors of the other company. It’s not that we’re not telling you, it’s we really don’t know.

Unidentified Analyst

I appreciate that. Maybe another way to think about things is, as you find yourself in perhaps potential partnering discussions. What are the key criteria about the company looks at in terms of things you might look for in a partner, whether it’s financial terms? Whether it’s quality of the partner, kind of their expertise maybe flushing out how composite things about that process?

Dr. Anat Cohen-Dayag

Sure, of course we relate through different parameters some of which you have already mentioned and it is really case by case depends on the asset that we’re discussing or the structure. But in general I would say that except the finance service, definitely we’re focused on making sure that this is the right partner that will give the right attention to the programs that we have in our pipeline, the programs that we’re having early and we will also need to make sure, probably when we progress, but we need to make sure that the right attention is given. And making sure that we’re involved in some of the works and that we’re gradually transferring to the partners, the responsibility. And also we look at what the partners has in the pipeline, how much competition there is in the pipeline for the assets that we have. And on the other way how much expertise the partner brings to the table, we discuss these. So it’s kind contradicting because those that have fair experience usually and have some assets, related assets in the pipeline. So it’s multiple parameter.

Martin Gerstl

I would like to just make sure that one of the things that was not mentioned; I know it’s very important for us because of the relatively early stage that these are being transferred. Our goal is to be involved in the early stages to continue to participate and have the true collaboration with the partner and as Anat said to gradually transfer. Some companies, some of the larger pharmaceutical companies would prefer to just -- they will license something in, they wanted to license it in and [indiscernible] the reports and now it’s their program. In general we would -- that's negative for us, we really do want to be involved during the early stages.

Unidentified Analyst

Okay, great. And one last question, I will jump back in the queue, in terms of next new slow for the company and it may not, say hard to predict when you might have news. But are there any perhaps scientific meetings where you know that you will be presenting data that we could look forward to or investors can look forward to?

Dr. Anat Cohen-Dayag

Yes, we are always updating out website with the conference that we attend and there are a couple of conference that I believe in March that are already updated in our website.

Unidentified Analyst

Okay, great. Thank you very much.

Operator

The next question is from John [indiscernible]. Please go ahead.

Unidentified Analyst

Hello there and thank you for taking my call. My question is I think in 2013 you guys talked about creating a team to handle deal negotiation and I was curious if that group is in place and if so where they be handling any deals that may come to pass in 2014?

Dr. Anat Cohen-Dayag

The group was generated in order to sign the first deal that we have had and this group is in place, yes.

Martin Gerstl

And it’s the same team both internal and external is continuing with the discussions, negotiations that are now going on.

Unidentified Analyst

Okay. So, you have both on internal, external. Are you going to rely on both internal and external teams going forward?

Martin Gerstl

Yeah, the way we look at it is that the external team brings a certain level of expertise and experience than very advantage internal team that we really want to sort of both make sure that we have the best expertise that’s available with respect to these types of deals, negotiations while at the same time be building the internal capability for the future because the whole competitive advantage is our ability to discover multiple product candidate which may in certain time will run and we would assume that we are going to have more and more negotiations ongoing. So, it’s very important that we not just rely on external people but that we build this capability internally.

Unidentified Analyst

Okay, all right. Thank you very much.

Operator

The next question is a follow-up question from Craig Haack from Ascendant Capital. Please go ahead.

Craig Haack - Ascendant Capital

Yeah, two questions. One, could you tell us specifically what the amount of cash you raised on your ATM facility in 2013?

Dr. Anat Cohen-Dayag

I believe this information is going to be disclosed in our 20th…

Martin Gerstl

I mean we don’t mean to keep it as the secret but we haven’t disclosed it and it will be in the 2015 which we will be filed relatively soon. And it’s probably not appropriate to mention, I think from a overall standpoint the total amount of cash that we raised during, not that we raised but the total cash inflow to the company during 2013 was approximately $42 million. And so that was, the Bayer, the ATM and some other, and there was a base payment. So there is a bunch of thing but from the standpoint of understanding the overall financial situation as I said we brought in cash of $42 million last year.

It is important to note that the registration statement under which the ATM was active has expired. So, as of now we do not have an active ATM and as we probably know in order to actually create one, there would have to be a public announcement filing that we’re entering into new realty and we have not made any such announcement.

Craig Haack - Ascendant Capital

Okay, thanks. And then just a follow-up to an earlier question regarding upcoming presentations, any of your data. Did you submit any abstracts on your pre-clinical data to ASCO?

Dr. Anat Cohen-Dayag

No, we did not. ASCO is mainly focused on clinical data and we did not.

Operator

There are no further questions at this time. This part I ask Anat Cohen-Dayag to go ahead with the closing statement. I would like to remind participants that a replay of this call is scheduled to begin in 2 hours for a period of 72 hours in U.S. please call 1888-782-4291, in Israel please call 039-255-918, internationally please call 9723-9255-918. Dr. Cohen-Dayag would you would like to make your concluding statement.

Dr. Anat Cohen-Dayag

Thank you. We really thank all of you for participating in this conference call and giving us the opportunity to provide some insight into how we intend to build our company based on our competitive advantage in predictive drug discovery. During the past four years, as we began to utilize the unique infrastructure that has been established at Compugen, our company had selected two areas of high pharma industry interest from which to focus our discovery possibilities and demonstrate the uniqueness of our approach, established a large and promising early stage discovery pipeline based totally on our own discovery, incorporated early drug development expertise in our areas of focus mainly with the establishment of a U.S. based operation for the generation of monoclonal antibodies against our novel target discovery, validated our business plan by way of initial licensing deal with Bayer involving two of our top line candidates, achieved substantial recognition and interest in the industry for our initial product candidate and significantly enhanced our discovery infrastructure with new platforms and other capabilities. We are very proud of these accomplishments and look forward to building the program in 2014 as I earlier discussed. Again thanks for joining us today.

Operator

This concludes the Compugen Ltd fourth quarter and full year 2013 financial results conference call. Thank you for your participation. You may go ahead and disconnect.

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