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Executives

Timothy Enns – SVP, Corporate Communications and Business Development

James Manuso – Chairman, President and CEO

Michael Molkentin – CFO and Corporate Secretary

Mohammed Azab – Chief Medical Officer

Analysts

George Zavoico – MLV

Aaron Reames – Wells Fargo Securities

Robin Davison – Edison Investment

Krishna Gaurdi [ph] – JP Morgan

SuperGen Inc. (SUPG) Q1 2010 Earnings Call Transcript April 26, 2010 4:30 PM ET

Operator

Good afternoon. My name is Stephanie and I will be your conference operator today. At this time, I would like to welcome everyone to the SuperGen Q1 2010 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remark, there will be a question-and-answer session. (Operator Instructions) Thank you. I would now like to turn the conference over to Timothy Enns, Senior Vice President of Corporate Communications and Business Development. Please go ahead sir.

Timothy Enns

Thank you, operator. Good afternoon and thank you for joining us today for SuperGen's 2010 first quarter financial results. With me today are Dr. James Manuso, President and Chief Executive Officer, Michael Molkentin, Chief Financial Officer, Dr. Mohammed Azab, Chief Medical Officer and Michael McCullar, Senior Vice President, Strategy and Discovery Operations.

In a few moments, Jim Manuso and Michael Molkentin will deliver remarks on the 2010 first 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 via 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 uncertainty 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 they 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 not guarantee they will be commercially successful. The company's results may also be affected by a variety of factors, such as competitive development, 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 codevelopment – or codevelop 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 the most recently filed Form 10-K. The company undertakes no duty to update forward-looking statements.

In the coming months, we'll be presenting at several investor conferences, including the Rodman & Renshaw Global Investment Conference May 16 to 18, the Jefferies Global Science Conference, June 8 to 11 and Needham Healthcare Conference, June 9 and 10. Live and archived webcasts of these presentations will be posted in the Investor Relations section of our corporate website. We will also host our annual shareholders meeting here at our Dublin headquarters on June 10. I will now turn the call over to Dr. James Manuso, who will provide highlights of our accomplishments during the 2010 first quarter. Jim.

James Manuso

Thank you, Tim. Good afternoon and thank you for joining us today for SuperGen's 2010 first quarter conference call. SuperGen started 2010 with a fine first quarter. We ended the quarter with a net profit of $4.7 million, bringing our unrestricted cash, cash equivalents and current and non-current marketable securities balance as of March 31 to approximately $106 million. Our strong financial position will enable us to readily advance the discovery and development of our first-in-class pipeline products.

We are pleased that our two products in the clinic were the subject of poster presentations at last week's American Association for Cancer Research or AACR, conference held in Washington DC. Fourth-quarter 2009 Dacogen sales in over twenty countries were reported by Eisai and Johnson & Johnson and are recognized as first quarter 2010 royalty revenues by SuperGen. Taken together, our partners logged Dacogen sales that generated an increase in royalty revenue of approximately 11% during our 2010 first quarter when compared to the same period last year.

We anticipate the release of data from the Phase III elderly AML Dacogen trial later in our second quarter. The primary endpoint of this trial is survival. The protocol for the Phase III elderly AML trial underwent a Special Protocol Assessment or SPA with the Food and Drug Administration. This means that if the trial achieves its primary objective of significant survival improvement with acceptable safety then the drug would have fulfilled the requirements for approval by FDA.

Dacogen could become the only drug in the United States approved for the elderly AML indication. Eisai and Johnson & Johnson have guided to FDA and EMEA submissions for Dacogen respectively in the second half of 2010.

As I mentioned earlier, SuperGen's two clinical programs were featured in posters at the AACR meeting last week. Final clinical data of the amuvatinib Phase I single agent clinical trial were presented, along with pharmacokinetic data from the new lipid formulation of the product.

Amuvatinib was well-tolerated with no dose limiting toxicities and there was a minor response in a heavily pretreated gastrointestinal stromal tumor or GIST patient. The new lipid suspension formulation demonstrated a superior pharmacokinetic profile, evidenced in part by greater bioavailability of the drug. This new formulation will be the one used in any future studies with this agent.

Data analysis from the Phase IB combination trial of amuvatinib will be completed during the current quarter. Following this analysis we will determine our development plans for this drug. Also at AACR, M.D. Anderson Cancer Center investigators presented extensive preclinical AML data on our first-in-class Pim kinase inhibitor, SGI-1776.

These data demonstrated the significant effect of SGI-1776 in modulating its targets and inhibiting AML cells in vitro and in animal models. These results provide a compelling rationale for commencing a Phase I clinical trial of SGI-1776 in refractory leukemias. In anticipation of an FDA clearance, we expect to initiate this trial during the present quarter.

As you know, SGI-1776 is in Phase I clinical testing in patients with refractory prostate and lymphoma. The trial has achieved its primary objective of defining the maximum tolerated dose or MTD of the drug. The only identified dose limiting toxicity was grade three prolongation of the QTC interval as measured by electrocardiographic monitoring. Such toxicity is not uncharacteristic of a number of approved Tyrosine Kinase inhibitors. The details of the preliminary data from this first-in-human trial of SGI-1776 will be presented at a scientific conference later this year.

Furthermore, one of our development stage products was also featured at AACR. SGI-110, a next-generation decitabine product was referenced by Standup to Cancer funded researchers as an exciting compound that will be the subject of a clinical trial later this year. Standup to Cancer is a consortium of celebrities, scientists, clinicians and philanthropists who have come together to make progress in the fight against cancer. To do so, Standup to Cancer is funding research to be carried out by a limited number of anti-cancer dream teams.

One of the dream teams created in 2009 is tasked with bringing epigenetic therapy to the forefront of cancer management. This team has elected to work with SuperGen and SGI-110 to help make their goal a reality. We are very honored that the world-class epigenetic dream team has selected our product to take into clinical trials. It is a distinct honor for SuperGen professionals to be working with this remarkable group of researchers from some of our country's foremost research institutions.

In addition, the development of SGI-110 is on schedule. The drug will be the subject of an Investigational New Drug Application or IND, later this quarter. Following FDA clearance of the IND, the Phase I first-in-human study will be initiated in concert with the Standup to Cancer epigenetic dream team during the second half of 2010.

With respect to staffing, I am pleased to welcome to our Discovery and Operations Groups, three senior professionals. These include a senior Director of Medicinal Chemistry, a Director of Clinical Pharmacology and the newest member of our senior management team, Dr. Peter Lassota, who will join SuperGen as of May 3 to serve as Vice President of Discovery Biology. Dr. Lassota joins our Company from Caliper Life Sciences. Previously, he led Novartis' U.S. oncology pharmacology unit within the Novartis Institutes for Biomedical Research.

To summarize, the first quarter of 2010 may be characterized as successful. Financially, we were profitable. We have sufficient funds to execute our strategy going forward. Our professional team has been augmented with tremendous talent and we continued to advance all of our discovery and development programs.

In addition, our partnership with GSK, GlaxoSmithKline, is proceeding nicely. At this time, I will turn the call over to Michael Molkentin, our Chief Financial Officer. Michael will provide details on our 2010 first quarter financial results and comment on our financial guidance for the year.

Michael Molkentin

Thank you, Jim. I would now like to make a few comments on our 2010 first quarter financial results. Total revenues for the 2010 first quarter were $14.4 million compared with $12.9 million for the same prior year period. Total revenues for the 2010 first quarter includes royalty revenue of $14.3 million compared with $12.9 million for the same prior year period.

Royalty revenue is earned pursuant to a worldwide license agreement for Dacogen and is generally recognized when received. Total revenues for the 2010 first quarter also include $127,000 of development and license revenue for recognition of deferred revenue relating to payments received pursuant to the license and research 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 costs and operating expenses for the 2010 first quarter were $9.8 million compared with $9.6 million for the same prior year period. The primary reason for the modest increase in total costs and operating expenses for the 2010 first quarter were due to slightly higher general corporate expenses, offset in part by lower stock-based compensation expense.

Included in total operating expenses is non-cash stock-based compensation expense for the 2010 first quarter of $247,000 compared with $600,000 for the same prior year quarter. The company reported no gain on sale of products for the 2010 first quarter, whereas $500,000 was reported for the same prior year period. The gain on sale of products reported for the 2009 first quarter related to the receipt of an additional payment resulting from the sale of the company's commercial franchise in a prior year of the worldwide rights for Nipent to Hospira.

The payment was not contractually due until the 2009 second quarter, although it was paid and recognized in a quarter earlier. Net income for the 2010 first quarter is $4.7 million or $0.08 per basic and diluted share, compared with $4 million or $0.07 per basic and diluted share for the same prior year period.

We continue to maintain a strong financial position. As of March 31, 2010 we had approximately $106 million in unrestricted cash, cash equivalents and current and non-current marketable securities, compared with $101 million at December 31, 2009.

Our financial guidance for 2010 remains essentially unchanged as follows. We continue to anticipate that royalty revenue may increase up to 10% above the prior year to a range from $41 million to $45 million. An additional payment to be classified as a gain on sale of products in the amount of $700,000 is related to the prior sale of a commercial franchise for Nipent and is forecasted to be received during our 2010 second quarter.

We are also guiding to the recognition of development and license revenue during 2010 of approximately $500,000 that represents the recognition of deferred revenue resulting from initial payments received pursuant to the research and license agreement executed with GSK during our 2009 fourth quarter.

Research and development expenses are expected to increase from the prior year level of approximately $30 million to a range from $34 million to $37 million during 2010. The growth in expenses will be influenced by the timing of increasing costs related to our clinical trial programs, primarily for amuvatinib, SGI-1776 and SGI-110, ongoing product development efforts that will advance our overall product pipeline and additional investment primarily targeting research and development areas that will further enhance our overall drug research and development capabilities.

General and administrative expenses are expected to increase modestly from $9 million during 2009 to approximately $9.5 million during 2010. Considering all the revenue and operating expense elements in our financial guidance for 2010, we continue to expect our net loss will be less than $1 million for the year.

Included in total operating expenses for 2010 is our estimated annual non-cash stock-based compensation expense that has been reduced from $3 million in our prior financial guidance to approximately $2.5 million. Excluding the non-cash stock-based compensation expense from the anticipated net loss for 2010, we estimate our operations could be slightly cash flow positive, consistent with our goal of being at or near cash flow neutral before any incremental economic benefits resulting from existing or new partnerships.

And lastly, our annual average shares outstanding are expected to be approximately 61 million common shares during 2010. This concludes the review of our financial results for the 2010 first quarter and comments on our annual financial guidance for 2010. I will now turn the call back to Dr. Manuso for closing comments.

James Manuso

Thank you, Michael. We started 2010 on a positive note. We completed the first quarter with a profit. Our financial strength enables us to advance further amuvatinib and SGI-1776 and move SGI-110 into the clinic this year. By the close of 2010, we could have up to three products in the clinic.

In addition, we anticipate the announcement of top line results of the Dacogen Phase III elderly AML trial later this quarter. The fight against cancer has many participants. I am personally and professionally gratified to continue to have SuperGen products and programs recognized as worthy of support.

Stand up to Cancer's epigenetic dream team is just one more world-class group that has partnered with SuperGen in this fight. Together with Eisai, Johnson & Johnson and GlaxoSmithKline, we have a chance to make a difference.

On behalf of the entire team at SuperGen, we thank you for your continued support. With that, Dr. Mohammed Azab, Michael Molkentin, Dr. Michael McCullar, Timothy Enns and I are now ready to answer your questions.

Operator, we'll take questions at this time please.

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of George Zavoico with MLV.

George Zavoico – MLV

Hi, everyone. Congratulations on another profitable quarter. It is a nice trend you're developing.

James Manuso

Thank you, George.

George Zavoico – MLV

I have a question about – first of all about the QTC prolongation.

James Manuso

Yes.

George Zavoico – MLV

Can you provide any more details on that or is that going to await scientific conference?

James Manuso

Well, the details will certainly await the scientific conferences; however, I will give this one to Mohammed for clarification.

Mohammad Azab

All right. It will be the same answer, George. As you know, the trials with all the data, well we will – as appropriate we will present them all in the scientific conference. And once we have that scientific conference poster date, we will probably provide a press release that will have some of the highlights of that poster to provide the information to all our investors and shareholders but the details will be in the meeting when we provide all the data for the study.

George Zavoico – MLV

Okay. So you can't say – you won't be able to say how many dose levels you have gone through before you hit the DLT then, right? That has to await the conference too.

Mohammad Azab

Well, that will be part. I mean, we said we tested several dose levels. We have previously indicated that we have been advancing the dose levels appropriately. What I can say is that the dose levels that we have now are within the expected therapeutic range.

George Zavoico – MLV

Okay, well that is added information. That is good. Okay. With regard to your royalty revenue from Dacogen, congratulations on getting an increase of another 10%. At this rate, I mean, it looks like you will do better than your projection – can you – for the year. Can you comment on that?

James Manuso

I will hand this over to Michael Molkentin but just before hand let me comment that typically the fourth quarter of each year is the strongest and that was the case last year. And Michael, I don't think is in a position at this point to change guidance.

Michael Molkentin

Yes. What Jim is saying is accurate. If you recall, our royalty revenues is recorded on a cash basis. In effect, it is a quarter in arrears and it is based on the highest potential effective royalty rate that we would earn because it is based on product sales that Eisai and J&J had during their fourth quarter of 2009. So what you would expect to happen is now that it is resetting for 2010, the royalty revenue we earned in the second quarter will be based on the first quarter financial results from Eisai and J&J. And thus we will be at a 20% royalty rate and will be less than what we are seeing for the first quarter.

So when you look at it on an annual basis, it would be hard to predict at this point in time if – will we exceed the current year and by how much at this point in time. It is a little bit early to really ascertain that and we will take a closer look at that probably after the second quarter closes.

George Zavoico – MLV

Okay. Thank you. Finally, regarding the Standup to Cancer dream team, what kind of cooperation is there? Are they paying for some of the trials, all of the trials or is this an open door to get into – to get more patients more efficiently and faster?

James Manuso

Well, we have not yet given a clear indication as to what that looks like because we haven't finalized the agreement. But Mohammad may have some comments about that.

Mohammad Azab

Yes. Let me – the expectation from all the discussions that we had with the dream team that they are – first of all, they are excited about our novel drug, which is probably the first DNA methylation inhibitor to enter the clinic since the approval of decitabine and we – in that negotiation, they made it clear that there will be part of the funding from the Standup to Cancer epigenetic dream team will go into the trial. So there will be some costs of the trial that will be covered by the epigenetic dream team funding from the Standup to Cancer. But as Jim said, we have not finalized the clinical trial agreement yet. That will be done in the course of the next few months in order to know exactly the amount of that cost that would be covered by Standup to Cancer.

James Manuso

And George, just a final comment. There is indeed a great deal of interest in the potential of S110 in solid tumor indications and that is something that we have to learn more about in the years ahead.

George Zavoico – MLV

Very well. Thank you and I wait with anticipation the results of the Phase III AML trial.

James Manuso

Same here.

George Zavoico – MLV

Thank you. Good luck with that.

James Manuso

Thank you so much. Next question, please.

Operator

Your next question comes from the line of Aaron Reames of Wells Fargo Securities.

Aaron Reames – Wells Fargo Securities

Congratulations on the quarter.

James Manuso

Thank you, Aaron.

Aaron Reames – Wells Fargo Securities

You're welcome. Just from looking at last year's R&D and SG&A, there was a slight dip in the second quarter, kind of that was in line with the drop in royalty rates. So should we expect that same type of dip or is there just more trials ongoing at this point in time? Just from a modeling perspective how should we allocate expenses over the course of the year is what I'm really asking?

James Manuso

Michael, would you like to take that?

Michael Molkentin

Sure. You're talking about allocating the R&D expenses?

Aaron Reames – Wells Fargo Securities

R&D, SG&A, yes.

Michael Molkentin

Well, actually a way to approach that – it is always hard to predict the timing of when we incur the expenses on several of the trials in addition to or just recurring efforts in the drug development perspective. And so from a forecasting aspect what is the thing you need to keep in mind is the guidance that we provide as it relates to the potential clinical trials that we may have starting in the second half of the year. And those will cause an upward pressure or increase on the R&D expense side. So from a forecasting perspective, I think you would probably lean towards showing higher R&D expenses in the second half of the year than you would in the first half.

Aaron Reames – Wells Fargo Securities

Okay. That's helpful. Then just going over to the Phase III 016 trial. When patients progress typically what agents are available in the study for them to move on to after they would progress either beyond cytarabine or beyond decitabine and are there any exclusions or limitations?

Mohammad Azab

I don't think there – the details of that particular question, I don't think that was made publicly available in the clinical trials that come. But I believe that in most trials the expectation will be that once the patient progresses that they will have any available therapy as advised by their physician so that will be the expectation. But I don't think that is my guess. I don't think the answer to the question is actually in the publicly available information from that trial.

Aaron Reames – Wells Fargo Securities

Okay. Maybe another way, were they – were patients in the cytarabine arm allowed to cross over to decitabine upon progressions?

Mohammad Azab

The trial has no crossover design. But as we said, once the patient progresses their physician might dictate any therapy, including of course available therapies and decitabine and ara-C are both available therapies.

Aaron Reames – Wells Fargo Securities

Okay. Thank you. I appreciate you taking my questions.

James Manuso

Thank you, Aaron. Next question, please.

Operator

Your next question comes from the line of Robin Davison with Edison Investment.

Robin Davison – Edison Investment

Hello, there.

James Manuso

Hello Robin.

Robin Davison – Edison Investment

I have got a couple of quick questions. Firstly, on Dacogen, can you say if the rate of increase in the royalties reflected the underlying sales growth or whether there is some kind of milestones in there which may have affected the comparison?

James Manuso

No, Robin there are no milestones in that fourth quarter sales result that we gave you that gave rise to the first quarter revenues. That is strictly and solely revenues or royalty revenues as a result of Q4 sales but as Michael Molkentin pointed out earlier, the marginal rate in the fourth quarter is higher than it is in the first quarter. And so it gradually goes up because of the blended nature of the royalty rate. But there were no milestones achieved in the fourth quarter of last year. There are a number of milestones outstanding that we can achieve going forward but none were achieved in the fourth quarter of last year. And those have primarily to do with approval of the drug in Japan and the EU.

Robin Davison – Edison Investment

Okay. On amuvatinib, I am sorry – you were sort of gauging the level of partner interest in that molecule ahead of that sort of decision whether to – whether you would be suitably [ph] funding further studies with the new formulation or potentially partnering early? Can you say anything from a qualitative view about that sort of decision and what the level of partnerships you are seeing at the moment?

James Manuso

Yes. We can say a number of things. I think first and foremost is the critical importance of us garnering the data from a complete analysis that is currently underway and as we pointed out, in the present quarter we expect to complete that analysis. And that in turn will guide us with respect, not only to further development of the drug but also with respect to the partnering potential as has traditionally been the case, there is usually more interest based on greater degrees of data available. And Mohammad, would you like to comment on the data analysis that is under way?

Mohammad Azab

Just that it is on schedule, the main part of the analysis from the clinical point of view, of course, is the data on the Phase I in combination with standard of care chemotherapy in which we have seen some significant responses and combinations in heavily pre-treated patients. So we are analyzing the synergy or the potential synergies between amuvatinib and both chemotherapy. Most of them are increasingly damaging agents, such as the platinums and VP-16 or etoposide. So based on that analysis we will be deciding on the most appropriate avenue for combination or also single agent for the drug moving forward into a Phase II.

James Manuso

And further to your question, to the extent that the data reveals something of significant note that would have an impact on partnering discussions going forward. And as is typically the case, once you enter a clinical trial, there is frequently a great deal of interest in the results prior to further partnering discussions.

Robin Davison – Edison Investment

Right. Just finally, can you say whether you have any papers accepted for presentation at ASCO yet?

Mohammad Azab

We have not submitted papers for ASCO.

Robin Davison – Edison Investment

Not. Okay.

James Manuso

However it is not – well, let's see, ASCO is too soon, no, no. I was thinking of our partners, but no. Okay, Robin?

Robin Davison – Edison Investment

Yes. Thank you very much.

James Manuso

Okay. Thank you, Robin. I appreciate it. If there is an additional question, please.

Operator

Your last question comes from the line of Krishna Gaurdi [ph] with JP Morgan.

James Manuso

Yes. Hello Krishna.

Krishna Gaurdi – JP Morgan

Hi. My question is, if you – can you give us some color on the Dacogen market share in MDS at this point?

James Manuso

Yes, by all means. We have been holding very steady over the last almost two years at approximately 60/40, the 60 for Vidaza, 40 for Dacogen. Now that is IMS data for North America alone. We do not break out data separately in the EU or BRICK countries or Asia generally. However, what we've reminded people is that the drug is approved in more than 20 countries and most recently, it was approved in China, which although we clearly do not have good clinical data, we believe that the Chinese population with MDS could be higher than many other – in many other countries. Mohammad, would you care to muse on that?

Mohammad Azab

I think we don't have data generated in China but of course we have a lot of data that they know J&J were able to use for a submission, which is similar to the data that we use for submission and approval in the U.S. But it just highlights the fact that there are – these patients are available on a worldwide basis and actually I believe I think the market, particularly in elderly AML and MDS, is unfortunately growing rapidly in these countries as well.

Krishna Gaurdi – JP Morgan

Are you seeing any growth in the patient trends in Dacogen compared to last year?

James Manuso

Tim?

Timothy Enns

We don't actually follow patients here on a per patient basis. Eisai would track that on a script basis by a number of different databases that they would subscribe to. We follow primarily IMS where we do show that the combined sales of Dacogen and Vidaza are increasing. Whether that increase is due to more patients coming in or whether that is due to more cycles, we don't break that out or follow that directly. That is followed by Eisai but that it is not information that we would be providing publicly. That would be for Eisai to disseminate and discuss their markets.

Krishna Gaurdi – JP Morgan

Great. Thanks very much.

Timothy Enns

Thank you.

James Manuso

Thank you very much. If there are no further questions, we'd like to thank you again for your time and consideration and appreciate your support. Thank you and of course as we have mentioned previously, if you have an interest in accessing this conference call, you may do so through our website in the Investor Relations section at www.supergen.com. Thank you very much. Good afternoon.

Operator

Thank you. This concludes today's conference call. You may now disconnect.

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