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Executives

Susanna Chau – Manager, IR

James Manuso – Chairman, President and CEO

Michael Molkentin – CFO and Secretary

Mohammad Azab – Chief Medical Officer

Michael McCullar – SVP, Strategy & Discovery Operations

Analysts

Boris Peaker – Rodman & Renshaw

Robin Davison – Edison Investment

George Zavoico – MLV

SuperGen, Inc. (SUPG) Q2 2010 Earnings Call Transcript August 2, 2010 4:30 PM ET

Operator

Good afternoon. My name is Cassidy and I will be your conference operator today. At this time, I would like to welcome everyone to the SuperGen quarter-two 2010 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. I would now like to turn the conference over to Ms. Susanna Chau, Manager of Investor Relations. You may begin.

Susanna Chau

Thank you, operator. Good afternoon and thank you for joining us today for SuperGen's 2010 second quarter financial results. With me today are Dr. James Manuso, President and Chief Executive Officer; Michael Molkentin, Chief Financial Officer; Dr. Mohammad Azab, Chief Medical Officer; Dr. Michael McCullar, Senior Vice President, Strategy and Discovery Operations; and Timothy Enns, Senior Vice President of Corporate Communications and Business Development.

In a few moments, Jim Manuso and Michael Molkentin will deliver remarks on the 2010 second quarter financial results and provide a summary of our business outlook. After our prepared comments, we will open the line for questions. Earlier today, we issued a press release of our financial results. A copy of the press release is available in the Investor Relations section of our website at www.supergen.com. In addition, this call is being webcast and may be accessed through the Investor Relations section of our website. A webcast replay will be available for 30 days.

During the call, we will make projections and forward-looking statements that are based on management's current expectations. Actual results may differ materially from these forecasts and projections due to various factors. There are significant risks and uncertainties in biotechnology research and development. There can be no guarantee that our projects, products, or product candidates will progress pre-clinically or clinically as we expect or that we will ultimately obtain approvals for the indications that we seek.

Moreover, even if our products or product candidates are approved in the future, we cannot guarantee they will be commercially successful. The company's results may also be affected by a variety of factors, such as competitive developments, launches of new products, the timing of anticipated regulatory approvals or other regulatory actions, the actions of our strategic partners and collaborators with respect to the products we license or co-develop, and patent disputes and litigation.

For additional information and discussion concerning the risk factors that affect the company's business, please refer to the company's filings with the Securities and Exchange Commission, including reports on our most recently filed Form 10-K and 10-Q. The company undertakes no duty to update forward-looking statements.

In the coming months, we will be presenting at several investor conferences, including the BMO Capital Markets Focus on Healthcare Conference, August the 5th; the Rodman & Renshaw Annual Global Investment Conference, September 13; and the UBS Global Life Sciences Conference, September 20 to 22nd. Live and archived webcasts of these presentations will be posted in the Investor Relations section of our corporate website, www.supergen.com.

I will now turn the call over to Dr. James Manuso, who will provide highlights of our accomplishments during the 2010 second quarter.

James Manuso

Thank you, Susanna. Good afternoon and thank you for joining us today for SuperGen's 2010 second quarter conference call. In the second quarter, SuperGen’s fiscal performance continued to improve. At $9.8 million, Dacogen’s second quarter royalty revenue increased 62% over the same quarter last year.

The quarter ended with a net profit of $1 million, bringing our unrestricted cash, cash equivalents, and current and non-current marketable securities balance as of June 30 to nearly $107 million. This strong financial position enables SuperGen to readily advance the discovery and development of pipeline products without seeking external financing.

With respect to SGI-110, our novel, second-generation hypomethylating agent, I’m pleased to announce that last week, the US Food and Drug Administration, or FDA, cleared the Investigational New Drug, or IND, application for this drug. Our clinical development team is finalizing preparations to commence first in human Phase I clinical trials of SGI-110 in patients with myelodysplastic syndromes, or MDS, and acute myeloid leukemia, or AML. This important drug will be in the clinic later this year.

As you may recall, SGI-110 is the only new hypomethylating drug that the epigenetics Dream Team of the Stand Up to Cancer Foundation selected for collaborative development in a first-in-human trial. Our development organization is privileged to be working with the foundation and its funded researchers to advance SGI-110 through its initial clinical trial. SGI-110 is a second generation hypomethylator that follows up on the Dacogen decitabine for injection franchise. Its preclinical profile has demonstrated potent hypomethylation activity in both hematological and solid tumor models.

SGI-110 is a low volume, less than one milliliter, high concentration, subcutaneous product that will allow less frequent dosing schedules compared to currently marketed products. In addition, unlike approved hypomethylating agents, SGI-110 has a composition of matter patent that issued in April of this year.

I’ll now update you on recent Dacogen news. During the second quarter, preliminary information about the Dacogen Phase III trial in elderly acute myeloid leukemia, or AML, was released. Analysis of the trial results continues by our Dacogen partners. Although with respect to the primary endpoint of survival, Dacogen did not achieve statistically significant superiority over the AML control arm in the trial. A trend was evident.

By March 31, 2011, Eisai intends to submit to the FDA a Supplemental New Drug Application, or SNDA, for Dacogen in AML. Johnson & Johnson reiterated its commitment to the Dacogen franchise in their earnings call late last month. They intend to file a Marketing Authorization Application, or MAA, for Dacogen in AML in the EU next year.

Global annual hypomethylator sales consisting of Dacogen and Vidaza sales continue to grow and could be in the $700 million range in 2010. Dacogen retains an approximate 40% share of the hypomethylation market in North America. And Johnson & Johnson’s subsidiary Janssen-Cilag is selling the drug in more than 25 countries outside of North America, including China. We are privileged to have Eisai and J&J as our partners.

To update you on amuvatinib, or MP-470, data analysis from the Phase Ib combination trial was completed in the second quarter and the data will be presented at a major scientific meeting next year. After we have consulted our medical advisors and other opinion leaders, we will determine and announce our plans for a focused Phase II trial of this drug.

Our first-in-class PIM kinase inhibitor, SGI-1776, is on schedule to begin a Phase I/II clinical trial in refractory leukemias during the second half of this year. This new trial will complement the ongoing Phase I trial of SGI-1776 in refractory prostate and lymphomas, for which the maximum tolerated dose or MTD has been achieved. The details of the preliminary data from this first-in-human prostate and lymphomas trial of SGI-1776 will be presented at a scientific conference next year.

In summary, in the second quarter of 2010, SuperGen strengthened further its balance sheet. Dacogen revenues enabled us to continue to achieve our discovery and development goals and added to our cash reserves. With 92 employees, SuperGen now has two products advancing in the clinic, one product entering the clinic, one product transitioning from discovery into IND enabling studies, and a discovery collaboration with GlaxoSmithKline that is pushing the front gears of epigenetics.

Importantly, our partners Eisai and Johnson & Johnson have both committed to extending the Dacogen franchise, given the announcements of their intentions to file marketing applications next year in the US and in the EU respectively. Finally, based on increasing Dacogen sales, we are revising upward our revenue and earnings guidance for this year.

At this time, I’ll turn the call over to Michael Molkentin, our Chief Financial Officer. Michael will provide details on our 2010 second quarter financial results and comment on our revised financial guidance for the year. Michael?

Michael Molkentin

Thank you, Jim. I’m pleased to comment on our 2010 second quarter financial results. Total revenues for the 2010 second quarter were $9.9 million compared with $6.0 for the same prior year period. Total revenues for the 2010 second quarter includes royalty revenue of $9.8 million compared with $6.0 million for the same prior year period.

Our prior year royalty revenue was influenced by a decline in quarterly product sales reported by Eisai that resulted from a third-party wholesaler adjusting its near-term inventory purchases. Our royalty revenue is earned pursuant to a worldwide license agreement for Dacogen entered into with Eisai Corporation of North America and is generally recognized when it is received.

Also included in the 2010 second quarter revenue is $127,000 of development and license revenue resulting from the recognition of deferred revenue relating to payments received pursuant to the research and license agreement entered into with GSK during October 2009. There was no similar development and license revenue for the same prior year period.

Excluding gain on sale of products, total operating expenses for the 2010 second quarter were $9.7 million compared with $8.7 million for the same prior year period. The primary reasons for the increase in total operating expenses during the second quarter were higher research and development expenses relating to our clinical trial activities and various smaller increases in general corporate expenses.

During the 2010 second quarter, total operating expenses include non-cash stock-based compensation expense of $488,000 compared with $505,000 for the same prior year period. The gain on sale of products for the 2010 second quarter was $700,000 whereas no gain was reported in the same prior year period. The gain on sale of products relates to the receipt of additional contractual payments resulting from the 2007 sale of our worldwide franchise for Nipent to Hospira. The payment is not contractually due until the second quarter of the year although during 2009 the $500,000 gain was received and recognized a quarter earlier.

Our net income for the 2010 second quarter is $1 million, or $0.02 per basic and diluted share, compared with a net loss of $2.4 million, or $0.04 per basic and diluted share, for the same prior year period. As of June 30, 2010, our financial position remained strong with approximately $106.5 million in unrestricted cash, cash equivalents, and current and non-current marketable securities compared to $105.5 million at March 31, 2010.

Our financial guidance for 2010 has been modified as follows. Royalty revenue for Dacogen has been revised upward and is now expected to increase up to 17% from the prior year. We have modified the range in our prior guidance from $41 million to $45 million to a revised range from $44 to $48 million. Our development and license revenue remains unchanged from our prior guidance and is estimated at $500,000. This revenue represents the recognition of deferred revenue relating to prior payments received pursuant to the research and license agreement with GSK.

No additional gain on sale of products resulting from the 2007 sale of a worldwide franchise for Nipent is anticipated during 2010 beyond the $700,000 already received during the 2010 second quarter. Research and development expenses are estimated to decrease slightly from our prior guidance of $34 million to $37 million to a revised range from $32.5 million to $35.5 million. Research and development expenses continued to be influenced by the timing and amount of financial commitments for the various activities relating to our clinical trial programs and other discovery and development activities.

General and administrative expenses remain unchanged from our prior guidance and continue to be estimated at approximately $9.5 million, representing a modest increase from the prior year. The company’s annual net operating results had been modified from our prior guidance of a net loss of less than $1 million for the year to an estimated net income of less than $4.5 million for 2010. Total annual operating expenses also include non-cash stock-based compensation expense estimated at $2.5 million for 2010, while our average annual shares outstanding are expected to be approximately 61 million common shares.

This concludes the review of our financial results for the 2010 second quarter and comments on our revised 2010 annual financial guidance. I will now turn the call back to Dr. Manuso for closing comments.

James Manuso

Thank you, Michael. In the first half of 2010, SuperGen exceeded several corporate goals, including cash flow neutrality. In fact, we achieved profitability. The IND clearance of SGI-110 paves the way for an extension of SuperGen’s epigenetics franchise. We will have three promising cancer drugs in clinical trials within the second half of 2010.

The collaboration with the Stand Up to Cancer’s Epigenetics Dream Team is a clear testament to our drug discovery and development capabilities. Dream Team consists of funded clinicians, academic researchers and industry scientists dedicated to the advancement of the field of epigenetics. It is the goal of this team and of the Stand Up to Cancer Foundation to provide innovative therapies for hematology and oncology patients.

In the second half of this year, we will start the first-in-human Phase I trial of SGI-110. We will initiate a Phase I/II trial for SGI-1776, the first and only PIM kinase inhibitor in the clinic today. Recall that 1776 was the first product to emerge from our advanced computational drug discovery platform, CLIMB.

During the second half of this year, details of the planned amuvatinib Phase II trial will be announced. In addition, data from two Phase I clinical trials, one testing SGI-1776 in prostate cancer and lymphomas and the other examining amuvatinib in combination with chemotherapies will be submitted for presentation at major medical and scientific conferences.

During the second half of 2010, we will continue to execute our strategy of discovering and developing novel therapeutics for cancer patients without accessing the public markets. We expect to hit a number of important clinical milestones in the months ahead. I look forward to updating you on our progress. On behalf of the entire team at SuperGen, we thank you for your continued support.

With that, Dr. Mohammad Azab, Michael Molkentin, Dr. Michael McCullar, Timothy Enns, and I are now ready to answer your questions. Operator, we will take questions at this time, please.

Question-and-Answer Session

Operator

Thank you. (Operator instructions) Our first question comes from the line of Boris Peaker with Rodman & Renshaw.

Boris Peaker – Rodman & Renshaw

Do you hear me?

James Manuso

Yes. Hello. How are you, Boris?

Boris Peaker – Rodman & Renshaw

Good. How are you? And congratulations on an excellent quarter.

James Manuso

Thank you.

Boris Peaker – Rodman & Renshaw

I have a couple of questions just on the AML data. I’m just wondering – have you had a chance to speak to Eisai, J&J and just learn any more insight on the data set itself?

James Manuso

We indeed speak to them with great frequency. On the other hand, they are in the process at this point of continuing to examine the data. As you might well expect, they want to release anything in anticipation of the filing with the FDA. So that’s where they are. But I’ll ask Dr. Azab to comment on that.

Mohammad Azab

As they have mentioned in their press releases, they are continuing to analyze the data, not just the primary endpoint of survival, but also all the supportive data and the secondary endpoints that would be surrogate for clinical benefit. On the basis of these data, the combination or the basic – the totality of the data that they have decided that they will be submitting for approvals with the FDA here and J&J will be submitting in Europe next year.

Boris Peaker – Rodman & Renshaw

So the time to that filing, and you said next year, is because of the complexity of the analysis? Are we waiting for anything else or is it just further thinking on how we’ll position this data?

Mohammad Azab

Eisai did not have any delay. They have all the analysis. They will file in their current fiscal year, which ends in 31st of March of next year. So Eisai, there is no delay. J&J, there is a delay from this year to next year, but that was probably more related to the fact that the analysis was available later than expected. I think they were expecting to have the first analysis done early this year. And as you know, when the preliminary results were announced, that was later – that was towards the very last week of June. So – because they had the preliminary analysis available in the end of June, I don’t think it’s unusual that the filing of that nature will take six months or more to get done. So I think that was kind of more related to the timing of the analysis rather than the complexity of the data.

Boris Peaker – Rodman & Renshaw

That makes sense. And do you know how they plan on or have they mentioned at some point disclosing the data at a medical meeting in the near future once they complete their analysis?

Mohammad Azab

They have stated that they are committed to providing the details of the analysis at a major medical meeting, but they have not communicated yet which one would that be.

James Manuso

I think, Boris, from our perspective, the most important information here is that both companies very rapidly after they had announced that the results as we reiterated have simply indicated that they are proceeding with filings. So that’s really the big news as far as we are concerned.

Boris Peaker – Rodman & Renshaw

Okay. And that sounds interesting. And any thoughts on which medical meeting we can learn more on the MP-470 data? Do you have a meeting earmarked or are you still considering a few different ones?

Mohammad Azab

We had kind of recently actually did those planned for next year. We’re planning the full Phase I combination trial that was enough richness of the data and really interesting clinical activity that we are submitting that for ASCO next year.

Boris Peaker – Rodman & Renshaw

Okay. All right. Great. Thank you very much for taking my questions. And once again, congratulations on an excellent quarter.

James Manuso

Thank you very much, Boris.

Operator

Thank you. Our next question comes from the line of Robin Davison with Edison Investment.

Robin Davison – Edison Investment

Hello, Jim.

James Manuso

Hello, Robin, how are you?

Robin Davison – Edison Investment

Very well, thanks. Congratulations as well.

James Manuso

Thank you.

Robin Davison – Edison Investment

Just wondering if you can say anything about what you are planning with SGI-110, whether at the sort of the size, perhaps at the sort of Phase I program, how soon you will get to what you might call the clinical proof of concept with that one.

James Manuso

Okay. First let me reiterate that we intend to get that into the clinic well before the end of this year, on the one hand. And also just again to point out that we will be working closely with the Stand Up to Cancer Foundation’s Epigenetics Dream Team, which is really a great honor. But relative to the specifics of your question, I’ll pass that to Mohammad.

Mohammad Azab

So the timing is, as Jim indicated, I think everybody is excited here about the start of the trial, including also our outside collaborators, external collaborators from the Stand Up to Cancer Foundation’s Epigenetics Dream Team. The trial is designed to provide us with preliminary evidence of proof of concept as well. So it’s more of a design of a Phase I/II in which we do dose escalation and once we reach biologically effective or an MTD, we will be considering dosing the patients with a size of number of patients of 20, 30 patients included in that particular dose expansion segment of the peripheral to give us a preliminary evidence of the proof of concept.

So we expect that the end of this trial will have the initial evidence of proof of concept in both MDS and elderly AML. These are the two indications that we are targeting for this Phase I/II trial. We have not communicated a timing for completing that because that trial hasn’t even had the first patient in yet. But once we get enrolling patients and we have an idea about the rate of enrollment and all of those, I think we will be more comfortable with communicating our plans probably early next year with our usual forecast of the year’s activity and milestone.

Robin Davison – Edison Investment

Okay. Is there any aim [ph] like that you might explore solid tumor indications with SGI-110 before the completion of that study?

Mohammad Azab

There is a lot of interest in solid tumors. So far, that interest is being confined to doing several preclinical studying S-110 in several preclinical models. There are several of our academic collaborators who are interested in those activities, both the single agent and in combination with other epigenetic drugs. And we are exploring these – basically the activity in solid tumors at a preclinical level now. We have not communicated any clinical activity in solid tumors yet.

Robin Davison – Edison Investment

All right. Okay. Just as a final one. I know you cannot say much about it, but sort of the GSK collaboration, is there likely to be any sort of visibility on what’s going on there this year?

James Manuso

I’d like to ask Dr. Mike McCullar to comment on that one because he is in charge of discovery operations. Mike?

Michael McCullar

Thanks, Jim. At this point, that’s still something that we are in research stage. We are not saying much about that at this point, but things may change between now and next year.

Robin Davison – Edison Investment

All right. Okay, good. Thank you very much.

James Manuso

Thank you very much, Robin.

Operator

Thank you. Our final question comes from the line of George Zavoico with MLV.

George Zavoico – MLV

Hi, Jim. Hi, everyone. Congratulations on yet another profitable quarter.

James Manuso

Thank you.

George Zavoico – MLV

You’re welcome. And also now that you are guiding for profitable year, I think that’s terrific.

James Manuso

It does happen.

George Zavoico – MLV

I have a question. You had – so that your R&D expenses are estimated to decrease slightly from a prior guidance, given the fact that you are projecting to initiate a couple of new trials this year, how do you square that with your revised guidance downward?

James Manuso

Based on a couple of counts, recall that we had pretty significant five-arm study with amuvatinib, and that of course increased our spend in the past. That is behind us at this point. And Dr. Azab and his clinical team are working through the potential of a Phase II trial in that setting. And then in addition, we certainly intend to have very focused proof of concept oriented trials to the extent that we can and to ask the really critical questions. So I think much of it relates to that. Mohammad, do you have any comments on that?

Mohammad Azab

That is correct, Jim. I just – it's just the timing of some of the expenses, George. It’s not related to any decreased activity of any kind. Remember that our guidance still is higher than last year. So even with the revised guidance, we are still actually spending a little bit higher than last year.

James Manuso

And appreciate also though we’re not giving any specifics around this, some of the biomarker diagnostic expenses relative to SGI-110 will be borne by the Stand Up to Cancer Foundation. So we get some – an extra ride in that regard.

George Zavoico – MLV

Yes. That actually leads into my next question. Stand Up to Cancer Foundation, I mean, it’s a great thing to have their support. But I know you may not be able to give precise guidance, but clearly they are going to provide some funding for some of the SGI-110 trials. Is there any more details you can provide regarding how that might reduce your R&D spend?

James Manuso

It will be marginal. I mean, the real intent here is to have the benefit of working with the researchers that help constitute that team. As I said, the primary focus would be on some biomarkers, diagnostics and PK/PD data. Mohammad, would you care to comment on that?

Mohammad Azab

Yes. I mean, that’s correct, Jim. It’s just that we have not finalized all the budget details for the trial. We are currently doing that in anticipation for the first patient in after the clearance from the FDA last week. We are not communicating details, but there will be some funding provided by the Stand Up to Cancer basically trying to understand more of the basic science behind S-110, behind the hypomethylation, the different markers that we can use actually to do more of the individualized therapy or personalized therapy based on the effect of the drug on these markers. So there will be a lot of actually benefit for us, not just on the financial side of measuring those markers but being able to have access basically to the academic labs that are the experts in this area. So we are very pleased about that.

George Zavoico – MLV

Let me ask you in a slightly different way. With this collaboration of Stand Up to Cancer, are they – are you now enabled in doing some experiments, some studies that you otherwise may not have done due to your own financial constraints yet would add value outside of what might otherwise had been, say, critically necessary to advance the drug forward? In other words, in addition to what would be critically necessary to advance the drug forward?

James Manuso

Let me simply comment that we are not terribly constrained. But separate and apart from that, Mohammad might have some ideas about the additive value of that collaboration.

Mohammad Azab

Yes. I mean, I don’t think we looked at this program as kind of trying to get out of certain financial constraint by looking at this. As Jim said, I think we have the financial resources to do these markers and to do these additional studies. Having said that, it’s actually access to these additional – these academic laboratories with their experts in measuring and providing us with those markers. As you know, many of the things that we will be studying looking at the effective S-110, these are not commercially available markers.

These are markers developed by those experts that are only measured in their centers only when we have the evidence that these markers are helpful in the clinical context of study 100 that we will take those markers certainly further in terms of being them developed as an accompanying diagnostics and so forth. But having access actually to those kinds of unique measurements and assessments in these laboratories, particularly in MD Anderson and USC where we are conducting the trial. That was really the major additional benefit of the collaboration.

James Manuso

And appreciate also, George, that – let's name some of the people who are on the Dream Team because these are really the luminaries that have made this whole space. It’s Peter Jones from USC, it’s Jean-Pierre Issa from MD Anderson, it’s Steve Baylin. To have that easy access, that’s totally paid for. And the extent of involvement with them is something that sometimes you can even buy, you know. So –

George Zavoico – MLV

Yes, of course.

James Manuso

Yes. So we are really grateful that they selected SGI-110 as the only new drug that they are going to be working with. This is, we thought, quite an honor. And we think the drug is very promising, obviously.

George Zavoico – MLV

Alternately, assuming you find some biomarkers, do you see this as enabling better designed later stage trials that would have you pre-select patients that were more likely to respond and therefore in some ways accelerate or reduce the risk of those later trials?

Mohammad Azab

Yes. I mean, that’s certainly one of the potential benefits of doing those biomarkers. And that’s the hope that we will be able to tailor a little bit focus the design of the development program and tailor the therapy to the patients who could benefit the most.

George Zavoico – MLV

Yes. I think that’s a great direction to be going in. And to have the risk of discovering and researching those biomarkers shared by an organization like Stand Up to Cancer certainly is a great advantage to you. All right. Thank you very much. And again, congratulations on a good quarter.

James Manuso

Thank you very much, George. Appreciate it. Are there any further questions, operator?

Operator

Not at this time. So I’d like to turn the conference over back to Dr. Manuso for closing.

James Manuso

Well, thank you then. In that case, I want to extend our appreciate to everyone who listened in and to also indicate that we are very excited about the second half of this year for some of the reasons that we’ve discussed, and look forward always to updating you on our progress. Have a wonderful afternoon, evening, wherever you may be. And thank you. Bye now.

Operator

Thank you for joining today’s conference call. You may now disconnect.

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