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Executives

Mohammad Azab - Chief Medical Officer

Michael Molkentin - Chief Financial Officer, Principal Accounting Officer and Corporate Secretary

Timothy Enns - Senior Vice President of Corporate Communications & Business Development

Michael McCullar - Head of Discovery Operations

James Manuso - Chairman, Chief Executive Officer and President

Analysts

George Zavoico - McNicoll, Lewis & Vlak LLC

Robin Davison - Edison Investment Research Limited

Boris Peaker - Rodman & Renshaw, LLC

SuperGen (SUPG) Q3 2010 Earnings Call October 25, 2010 4:30 PM ET

Operator

Good afternoon. My name is Chastity, and I will be your conference operator today. At this time, I would like to welcome everyone to the SuperGen Q3 2010 Earnings Conference Call. [Operator Instructions] Thank you. I will now turn the call over to Mr. 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 Presentation of the Third Quarter Financial Results. With me today are Dr. James Manuso, President and Chief Executive Officer; Michael Molkentin, Chief Financial Officer; and Dr. Mohammad Azab, Chief Medical Officer; and Dr. Michael McCullar, Senior Vice President, Strategy and Discovery Operations. In a few moments, Jim Manuso and Michael Molkentin will deliver remarks on the 2010 third quarter financial results and provide a summary of the quarter and the 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. The 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 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 co-develop, and patent disputes and litigations. 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 or Form 10-Q. The company undertakes no duty to update forward-looking statements.

Additionally, on November 16, SuperGen will be presenting at the Lazard Capital Markets 7th Annual Healthcare Conference in New York. We will provide additional information closer to the conference, but live and archived webcast of this presentation will be available through the same section of our website.

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

James Manuso

Thank you, Tim. Good afternoon, and thank you for joining us today for SuperGen's 2010 Third Quarter Conference Call. In the third quarter, SuperGen's fiscal performance improved significantly. At $13.4 million, Dacogen's third quarter royalty revenue increased 28% over the same quarter last year. The quarter tallied a net profit of approximately $4 million, bringing our unrestricted cash, cash equivalents and current and noncurrent marketable securities balance as of September the 30th to approximately $112 million.

For the third time in our history, we expect to be profitable on an annual basis. Our increasingly stronger financial position enables us to readily advance the discovery and development of our pipeline products and to consider product candidates during licensure without seeking external financing. During the third quarter, Dacogen sales grew more substantially than anticipated. In addition, total market size has increased, and based on IMS reports, Dacogen's market share in the United States has grown to more than 41%.

Sales of Dacogen in the rest of the world have also increased. These results are attributed to the aggressive development, sales and marketing initiatives instituted by our partners, Eisai and Johnson & Johnson. With respect to the potential for label expansion or regulatory approvals based on the Dacogen Phase III trial in elderly acute myeloid leukemia, or AML, we are encouraged by guidance from both Eisai and Johnson & Johnson. Both companies have committed to file in 2011. The release and discussion of the data from the Phase III AML trial will be presented at an as yet unspecified scientific forum next year.

Last quarter, I announced the clearance to proceed into first-in-human studies by the Food and Drug Administration, or FDA, of SGI-110, our novel, second-generation hypomethylating agent. The SGI-110 team has advanced this important project. The clinical sites have been initiated, thereby enabling the dosing of MDS and AML patients next month. We're very pleased to be working with a epigenetics Dream Team of the Stand Up To Cancer Foundation on this trial.

One of the goals of the Dream Team is the development of functional epigenetic therapies that demonstrate utility, not only in hematological malignancies, as was the case with Dacogen, but also in solid tumors. We're excited to be at the forefront of epigenetic therapeutics discovery, development and commercialization. SGI-110 is a next-generation hypomethylator intended to follow-up on the Dacogen franchise. This drug is a low-volume, high-concentration, subcutaneous product with a preclinical profile that has demonstrated potent hypomethylation and epigenetic modulation. Its preclinical anticancer and hypomethylating effects have been observed in both hematological and solid tumor models, sometimes with dosing schedules less frequent than currently marketed products.

To update you on amuvatinib, or MP470, we are concluding preparation of the clinical proof of concept, or POC Phase II trial. The trial will use a Simon's two-stage design enrolling 21 to 50 small cell lung cancer patients who are either do not respond to platinum and etoposide treatment or who relapsed shortly after such treatment. WeÕre asking the question, can the addition of amuvatinib to platinum and etoposide treatment in patients who have either not responded or relapsed shortly after this treatment restore the tumor sensitivity to those agents. This trial will be initiated in early 2011 in North America at approximately 10 clinical Centers. A report on the final results of the Phase Ib trial of amuvatinib in combination with standard of care chemotherapy, including platinum and etoposide will be submitted for next year's ASCO meeting being held in Chicago in early June.

Regarding our PIM Kinase Inhibitor, SGI-1776, as was discussed during our second quarter conference call, we identified the dose limiting toxicity of cardiac QTc prolongation. Accordingly, we have been evaluating thoroughly the safety pharmacokinetics and cardiac response patterns from patients enrolled in the Phase I program. This evaluation is ongoing for all new patients. At the same time, we're actively evaluating back-up PIM Kinase Inhibitors. Our discovery scientists have synthesized several back-up compounds that appear to offer the potential of better preclinical cardiac safety profiles without compromising the potency or selectivity of the compounds.

In summary, during the third quarter of 2010, SuperGen strengthened further its cash position. Dacogen royalty revenues enabled us to continue to achieve our discovery and development goals, and we have added to our cash reserves. With slightly more than 90 employees, SuperGen now has two products treating patients 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 frontiers of epigenetics. Importantly, our partners Eisai and Johnson & Johnson have both committed to extending the Dacogen franchise worldwide, given their sales and marketing efforts and their respective intentions to file marketing applications next year in the U.S. and in the EU.

At this time, I will turn the call over to Michael Molkentin, our Chief Financial Officer. Michael will provide details on our 2010 third 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 third quarter financial results. Total revenues for the 2010 third quarter were $13.4 million compared with $10.4 million for the same prior-year period. Total revenues for the 2010 third quarter include royalty revenue of $13.2 million, representing a 28% increase when compared with $10.4 million for the same prior year period. Our royalty revenue is earned pursuant to a worldwide license agreement for Dacogen entered into with Eisai Corporation.

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

Total operating expenses for the 2010 third quarter were $9.5 million compared with $9.7 million for the same prior year period. The primary reasons for the nominal decrease in total operating expenses for the 2010 third quarter were modestly lower research and development expenses, compared to the same prior-year period and lower stock-based compensation expense offset in part by a modest increase in general corporate expense.

Total operating expenses for the 2010 third quarter include non-cash, stock-based compensation expense of $514,000, compared with $709,000 for the same prior year period. Net income for the 2010 third quarter was $3.9 million or $0.06 per basic and diluted share, compared with net income of $833,000 or $0.01 per basic and diluted share for the same prior year period.

As of September 30, 2010, the company maintained its strong financial position, ending the quarter with $112.1 million in unrestricted cash, cash equivalents, and current and noncurrent marketable securities compared to $106.5 million at June 30, 2010. We have modified further our 2010 financial guidance from the prior quarter. Specifically, royalty revenue for 2010 continues to be stronger than originally anticipated. Therefore, royalty revenue guidance for Dacogen has been increased from our prior estimates of $44 million to $48 million. We now expect an increase of up to 26% from the prior year to a revised amount of up to $52 million in royalty revenue. Our development and license revenue remains unchanged from our prior guidance and is estimated at $500,000. This revenue represents recognition of deferred revenue relating to prior payments received pursuant to the GSK research and license agreement.

No additional gain on sale of products resulting from 2007 of our worldwide franchise for Nipent is anticipated during 2010 beyond the $700,000 already received earlier this year. Estimated research and development expenses had been further refined downward, slightly from our prior guidance of $32.5 million to $35.5 million, to a revised range from $30 million to $32 million.

As is typical with research and development efforts, our expenses are continuously influenced by the timing and amount of financial commitments for the various costs related 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.

Based on better-than-expected royalty revenue and revised research and development expenses, we are increasing our prior annual net income guidance of $4.5 million to our revised annual net income guidance of approximately $12 million from 2010. Total operating expenses also include non-cash stock-based compensation expense, which was reduced from $2.5 million to $2 million for 2010. Average annual shares outstanding are expected to remain unchanged at approximately $61 million Common Shares.

This concludes the review of our financial results for the 2010 third 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 three quarters of 2010, SuperGen exceeded several corporate goals within the realms of profitability and productivity. As a result of our team's work, we will have three promising cancer drugs in clinical trials within the next 30 days. The collaboration with the Stand Up To Cancer's Epigenetics Dream Team is a clear testament to our drug discovery and development capabilities.

In the remaining quarter of this year, we will start the first-in-human Phase I trial of SGI-110. We will present data from our preclinical work at the EORTC-NCI-AACR meeting in November. We will prepare for the initiation of the amuvatinib Phase II trial in small-cell lung cancer. Simultaneously, we will continue to advance the discovery and preclinical development of novel drugs for cancer indications.

In the months ahead, I will update you on our progress with respect to drug discovery and development, and Dacogen regulatory development and royalty revenues. On behalf of the entire team at SuperGen, we thank you for your continued support. And with that, Dr. Mohammad Azab, Michael Molkentin, Dr. Michael McCullar, Tim 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] Our first question comes from the line of Boris Peaker with Rodman & Renshaw.

Boris Peaker - Rodman & Renshaw, LLC

I have a couple of questions on Dacogen, let's start with that. What do you think the key drivers are for Dacogen sales that we're seeing? And are there any changes in the standard of care that may have been part of that?

James Manuso

I'll mention a couple of things, then I'll turn it over to Dr. Azab. But I appreciate that next year, in June, the competing drug goes off orphan drug indications. So there's been a lessening, we believe, in the sales and marketing efforts on their part. In other words, Celgene is beginning to milk Vidaza in North America. We think that's one potential. Also, we believe that there are more cycles per patient at this point in time that could be another factor here. And then finally, as more scripts were written for Vidaza, you will end up with more Vidaza failures. And then, the only backup drug there is Dacogen. Those are a few things that come to my mind. Mohammad, what are your thoughts?

Mohammad Azab

I mean, I think, Jim, you're right that it's hard to see exactly kind of a key, just one key driver, but there are several things. And I would add to that there have been -- a lot of investigators have published on the AML, not of course the Phase III trial, we don't have the full data yet, but have been an excellent publication this year in elderly AML, and that was published in the Journal of Clinical Oncology earlier this year. And that might have provoked some off-label use in that indication. And also, the fact that Jim mentioned that there is really no other hypomethylating agents that approved other than Vidaza and Dacogen. And there have been clear publication also that there's a lack of cross resistance between the two. So if the patient fails Vidaza, they are likely candidates for Dacogen. That's kind of a couple of things that will come to mind.

Boris Peaker - Rodman & Renshaw, LLC

And do you guys know when a patient is a Vidaza failure or they haven't been exposed to Vidaza before? Or get a sense of approximately of what fraction of your sales go to Vidaza failures?

James Manuso

We don't have that sort of breakdown but perhaps Mohammad could comment on the movement from one drug to another. If you fail on Vidaza, what now?

Mohammad Azab

I think just the soft information, Boris, is that what we've been hearing is that many of the scripts of Dacogen are in Vidaza failures. So although Vidaza might have more than the 60% in terms of the first script that there's a lot of second line of scripts going for Dacogen, at least in the U.S. One other thing also, as you know, in March this year, there was finally the approval on the label of the five-day regimen, which Eisai had not been able to promote previously because of what went wrong with the label. And since that regimen is much better tolerated and still provides the same efficacy, I think that allowed them also to promote that five-day regimen aggressively.

Boris Peaker - Rodman & Renshaw, LLC

And just in terms of your exposure to world currencies in dollars, been depreciating, how much does that impact your royalties?

Michael Molkentin

Well, in fact, in North America, it has little bearing. And the EU, as you known and in the U.K., the drug is not marketed as this time. So the primary exposure would be in the remaining approximately 25 countries. And that's all over the map. In some instances, you might have an appreciation of the dollar relative to the local currency and in others a decline. Michael what are your thoughts on that?

Michael McCullar

Well, really, based on the fact that the drug is not improved in Europe, even though we are not in a position to disclose what the North American versus rest of the world percentage of sales are, most of the sales are generated from North America and are dollar-based. So there's virtually no foreign exchange impact at this point.

Boris Peaker - Rodman & Renshaw, LLC

A couple of questions on preclinical data for Dacogen. You mentioned that SGI-110 there, you're considering going into solid tumors. So there's some preclinical data for solid tumor activity, and was just wondering if there is any preclinical data for Dacogen in solid tumors and how did those two compare?

James Manuso

Mike, would you care to comment on that?

Michael McCullar

Yes, certainly, Jim. There's been studies in solid tumors for quite some time. I think the expectation is that -- but the expectation is that S-110 will probably get much better exposures in the tumor cells. So we'll be able to catch those hypo-creating cells in S phase and we think that's probably a key to getting a more active drug in solid tumors.

Boris Peaker - Rodman & Renshaw, LLC

And why would you expect better exposure with 110 versus Dacogen?

Michael McCullar

From what we've seen, we think that the nucleotide is much more stable, and that would lead us to expect that we get much better exposure when you give it to people. So that's kind of the basis of our thought. Like I said, we know that, unless you get cells that are replicating in S phase, you won't get the decitabine [ph] incorporating it into the DNA. We think with S-110, that should give us a better chance to get active in solid tumors.

Boris Peaker - Rodman & Renshaw, LLC

And how did their half-lives differ?

Michael McCullar

Well, the half-life of decitabine itself, when you give it in vivo is in an order of minutes. So when we see in the preclinical data with S-110 we get half-life significantly longer than that. So we think like I mention the key is when you get those cells at replicating phase, it should get much better uptake into the tumor.

James Manuso

Perhaps Mohammad had a comment on that as well.

Mohammad Azab

Just to add that thereÕs been actually clinical data published on Dacogen already on solid tumors and always showed some level of activity, but it wasn't to the level that resulted in actually full development. But now, with the availability of other models with the fact that there has been a lot of synergistic combination between, for example, the DNA Methyltransferase Inhibitor and the HVAC inhibitors [ph] that has been published and the fact we have run some models ourselves and shown both very good activity in some of the solid tumor models like the platinum-resistant ovarian cancer models, for example. I think there's a lot of excitement about the use of these agents and solid tumors. The important thing, as Mike mentioned, is that because of the excellent things -- it's a new chemical entity over the dinucleotides structure. It is actually results in a more prolonged release of decitabine into the system than if you just give decitabine intravenously. And also the fact that subcutaneous formulation helps that more even and prolonged exposure after the injection, which allows us to use once weekly subcutaneous injection in the Phase I program.

Operator

Our next question comes from the line of Robin Davison with Edison Research.

Robin Davison - Edison Investment Research Limited

Just a couple of points I think you talked a lot earlier. Just on SGI-110, I'm just sort of wondering given the strong position of the company from the point of view of your cash and royalties, whether you may be able to consider sort of accelerating that development program or taking it further, you might have done [indiscernible] (0:40:10) earlier on per se?

James Manuso

Yes, you're perfectly right, Robin. Our intent has always been to develop the drug as rapidly as is regulatorily feasible on the one hand. And we've always believed that by taking the drug all the way through Phase III, we would have a much higher opportunity for monetizing it. And that's something as we become even stronger financially, that is clearly, an opportunity for us. However, that should not detract us from the possibility of doing a regional deal. For example, doing an Asian deal that would underwrite many of the expenses, if not all of the expenses, of the later development of the drug taken all the way up the line for submission and the U.S. and the EU. So there are a number of alternatives that will be assessing as we move forward to include the possibility of solid tumor applications. Mohammad, what are your thoughts on that?

Mohammad Azab

Yes, I mean, Jim is right in terms of kind of the partnering strategy. In terms of accelerating the development, this is the first-in-human study so we have to do that first trial. What we can do, of course, is enlarging sort of adding to the number of centers. And we're actually doing that. Usually in a Phase I cancer trial, we will have two on three centers. For this trial, we're having at least five or six centers. So we're actually increasing the usual number of centers that we would like to include in a first-in-human study. So we are doing everything we can to make sure that we accelerate that program. I also would like to remind everybody that, that clinical trial is built as an first-in-human for using two different regimen, and also it would allow the continuation of either one or the two regimens into a Phase II setting once we find the optimal dose, which is the biologically effective dose, or the MTD, the maximum tolerated dose.

Robin Davison - Edison Investment Research Limited

And just to clarify what you're saying on the PIM Kinase 1776, is it that it's possible that you may bring a backup compound in before determining whether that will go forward or not?

James Manuso

Well, it's our intention to make a clear determination as to the continued development of 1776. And it's important to have backups for drugs as you move them through development. So it's very consistent with our philosophy. And as we've said from time to time, we listen to the data that our drugs provide. And to the extent that our internal assessment and our assessment on the parts of our advisors is that there's a therapeutic window that may overlap with some of the lower regions of toxicity, we would take that under advisement. Surely, we want the save patients' lives, not endanger them. Mohammad, any comments on that?

Mohammad Azab

Yes, I mean you're right, Jim. Robin, of course, we will -- 1776 is already in the clinic. We're collecting data. And it's based on those data we'll determine whether to keep continuing forward with 1776 or bringing a backup compound. I don't think we will bring two PIM Kinase Inhibitors in the clinic at the same time. So I think the kind of the progression of PIM Kinase backup Inhibitor would only depend on the decision on 1776, once we complete the evaluation of the ongoing Phase I.

Operator

Our next question comes from the line of the George Zavoico with MLV.

George Zavoico - McNicoll, Lewis & Vlak LLC

I wanted to just a couple of follow-up questions to what's already been asked. You mention subcutaneous injection for SGI-110, right? I'm wondering what kind of injection site reactions have you seen? And is that at all dose limiting?

James Manuso

Mohammad?

Mohammad Azab

Not on the thing we did -- there is really very limited or any kind of local reactions from the preclinical studies. Of course, we haven't studied yet in human. As Jim indicated, the first patient is expected next month.

George Zavoico - McNicoll, Lewis & Vlak LLC

So in your animal studies, absolutely, was not Ð itÕs not appearing to be emerging as an issue?

Mohammad Azab

No, it's not emerging as an issue. And also, as you know, that we have been stressing the fact that, that's a low-volume, high-concentration formulation and that we're able to put up to 100-milligram for each milliliter. So the injection volume in humans, since we're expecting the dose to be well below 100-milligram per injection, the dose that we will give would be less than 1 mil.

George Zavoico - McNicoll, Lewis & Vlak LLC

And with regard to the Vidaza, the end of the orphan drug status, are you preparing at all -- what are your expectations for changes in script patterns once Vidaza goes off the orphan drug status? Do you see an uptick? Do you predicting an uptick in Vidaza scripts at the expense of Dacogen as the price changes?

James Manuso

No, not at all. As was mentioned earlier, there's a lack of cross resistance between the two drugs there. There are not in fact, easily -- one easily replacing the other. And as was mentioned also, a large number of scripts are written for Vidaza failures for Dacogen. So we don't see any of those dynamics changing. We believe that the dynamics of the hypomethylator marketplace can change here drastically as 110 finally becomes commercialized, down the road, obviously some years from now. But at the present time, no, we do not see that there would be any significant alteration. On the other hand, in terms of dollar volume, there may be an increase as far as IMS reported, dollars sales of Dacogen versus Vidaza occur. And that would be expressed in the form of the market share of Dacogen versus Vidaza. That may go up because of the dollar volume side of it. And we do expect that there's going to be significant genericization of Vidaza upon its loss of orphan drug designation. But there are no signals that we have, George, to suggest that Dacogen sales will be hurt. In fact, we anticipate they could go up.

George Zavoico - McNicoll, Lewis & Vlak LLC

I understand that once on Vidaza, it's unlikely to switch -- once on Dacogen, unlikely to switch to Vidaza in this case. I'm just thinking more in terms of the first script with the lower price in terms of reimbursement in third-party payers, that they might change the reimbursement policy in favor of Vidaza at the expense of Dacogen for first prescribers, not for those that are already being treated, and Vidaza failures of course.

James Manuso

Right. From a sales and marketing perspective, why don't we turn that to Tim?

Timothy Enns

George, you typically don't see this hypomethylating therapeutic agent where people are switching due to cost. These are not considered switchable agents from that perspective. You go back and look at other therapeutic agents where you had competing classes of drugs that were thought to be similar. Look at the Taxanes, Taxol and Taxotere, you didn't see this happen when Taxol went generic in that situation, you got Taxatere coming behind it. You don't see this type of switching. Already, Vidaza is thought to have the lion's share of the first patient dose here and Dacogen would have follow on when those patients fail and some first patient dose. But we don't anticipate a major shift in the market due to the economics of the product here. Really, itÕs the therapeutic data and the patient selection that physicians have.

George Zavoico - McNicoll, Lewis & Vlak LLC

What about a new IND in 2010? Is that...

James Manuso

No, no. 2011 maybe. Remember, our goal is on average, every 12 to 18 months. And we're sticking to that. We're hopeful with respect to an actual program that we've had underway for some time and that could well evolve into an IND submission next year.

Operator

There are no further questions at this time. I would like to turn the conference over to Dr. Manuso for closing remarks.

James Manuso

Thank you very much, everyone, for joining in on the call. And as you know, should you have any questions, please don't hesitate to contact us, and have a good afternoon. Bye now.

Operator

Thank you for joining today's SuperGen Q3 2010 Earnings Conference Call. You may now disconnect.

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