Executives
Timothy Enns - SVP, Corporate Communications and Business Development
James Manuso - Chairman, President and CEO
Michael Molkentin - CFO and Corporate Secretary
Greg Berk - Chief Medical Officer
Michael McCullar - VP, Drug Discovery Operations
Dr. David Bearss - Chief Scientist;
Analysts
Derek Jellinek - Susquehanna Financial Group
Ram Selvaraju - Rodman & Renshaw
Matthew Osborne - Lazard Capital Markets
SuperGen, Inc. (SUPG) F3Q08 Earnings Call November 4, 2008 4:30 PM ET
Operator
Good day, ladies and gentlemen, and welcome to the third quarter 2008 SuperGen earnings conference call. This is Francine, and I am your coordinator for today. At this time all participants are in a listen only mode. We will be facilitating a question-and-answer session towards the end of today’s conference. (Operator instructions).
I would now like to turn the presentation over to your host for today’s conference Mr. Timothy Enns, Senior Vice President of Corporate Communications and Business Development. Please proceed, sir.
Timothy Enns
Thank you, Operator. Good afternoon and thank you for joining us today to discuss SuperGen's 2008 third quarter financial results. With me today on the call are Dr. James Manuso, President and Chief Executive Officer; Michael Molkentin, Chief Financial Officer; Dr. Greg Berk, Chief Medical Officer; and Dr. David Bearss, Chief Scientist; and Michael McCullar, Vice President of Drug Discovery Operations.
In a few moments, James Manuso and Michael Molkentin will deliver remarks on the 2008 third quarter financial results and provide a summary of our business outlook. After our prepared comments, we will open the line for questions. A copy of the press release is available on 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 90 days.
During the call, we anticipate making projections and forward-looking statements that are based on management's expectations. Actual results may differ materially from these forecasts due to various factors. There are significant risks and uncertainties in biotechnology research and development. There can be no guarantee that our products or product candidates will progress in clinical trials as we expect or that we will ultimately obtain approvals for the indications that we seek. Moreover, if the products or product candidates are approved in the future, we cannot guarantee that they will become commercially successful.
The Company's results may also be affected by such factors as competitive developments, launches of new products, the timing of anticipated regulatory approvals, other regulatory actions or 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 Exchange Commission including reports on our most recently filed Form 10-K and Form 10-Q. The Company undertakes no duty to update forward-looking statements.
For those of you interested to learning more about SuperGen at an upcoming investor event, we will be presenting at Rodman & Renshaw Healthcare Conference, November 10, and at Lazard Healthcare Conference, November 18 in New York. These events will be webcast live and available for replay via the Investor Relations section of our website.
I will now turn the call over to Dr. James Manuso, who will provide highlights of our 2008 third quarter.
James Manuso
Thank you very much, Tim. Good afternoon and thank you for joining us today for SuperGen's 2008 third quarter financial results conference call. Despite the troubles in the economic climate particularly for via technology companies, our third quarter and year-to-date financial performance was positive. Operationally, the third quarter was one of consistent execution. We advanced our diverse oncology pipeline and had numerous presentations at a number of important conferences.
In August, the US Food and Drug Administration (FDA) had granted orphan drug designation for our lead drug candidate MP-470 for the treatment of glioblastoma multiform. And in September we presented data at both the 33rd European Society of Medical Oncology (ESMO) Meeting and at the American Society for Therapeutic Radiology and Oncology Annual Meeting also known as ASTRO.
We ended the quarter with approximately $88.7 million in current and noncurrent unrestricted cash, cash equivalents and marketable securities and we continued to be debt free.
Royalty revenues from the Dacogen license for the third quarter increased 67% year-over-year $10.2 million. We are increasing our previous 2008 Dacogen royalty revenue guidance from a range of $32 million to $35 million to a new range of $33 million to $36 million.
As you know our royalty structure begins at 20% on the first $50 million of net sales. The percentage increases by 2.5% for each $50 million of net sales. A tops out is 30% and resets every calendar year.
The Dacogen license covers all indications of the drug worldwide for 20 years from 2004 regardless of whether Esai or Johnson and Johnson makes a given sale.
Notably as part of our commitment to efficiently manage our fiscal resources and difficult financial times, we lowered our operating expenses for the quarter and revised downward our expense guidance for the full year. Michael Molkentin, our Chief Financial Officer will provide you with more precise details shortly.
In July, Esai announced preliminary results from a Phase 3 clinical trial initiated in 2002 and conducted by the European Organization for Research and Treatment of Cancer or known as the EORTC trial. This trial compared a three-day intensive regimen of Dacogen for injection to best supportive care in elderly patients with myelodysplastic syndromes or MDS.
Unfortunately, the data did not demonstrate a statistically significant advantage of Dacogen treatment on median survival compared to best supportive care. Full results of the study will be presented at the American Society of Hematology or ASH annual meeting which is scheduled for the first week of December.
Looking ahead, within the first quarter of 2009 Esai expects to file with the FDA, a supplemental new drug application intended to expand the existing label of Dacogen to include the five-day regimen. Dacogen is currently being investigated in more than 30 clinical trials including one for acute myeloid leukemia results of which may be available during 2010.
Now, I will discuss the progress made on our product pipeline and highlight, develop and plans for each of our products. We have several updates concerning our most advanced drug, MP-470 and oral DNA repair suppressor and selective tyrosine kinase inhibitor.
Phase 1 single agent and Phase 1b combination therapy trials are ongoing in patients with solid tumors. MP-470 appears to be improving the activity of chemotherapies. This drug has consistently demonstrated a very benign toxicity profile. The motive action of MP-470 together with its synergism with other agents and its benign safety profile, leads us to believe MP-470 has very broad clinical potential.
Phase 1 interim results have shown that MP-470 is safe and well tolerated with no dose limiting toxicities at doses of up to 1200 milligrams daily. Dose escalation is continuing on a twice daily schedule. Preliminary single agent activity has been noted in a patient with a refractory gastrointestinal stromal tumor or GIST tumor.
The MP-470 Phase 1b trial is a combination study. There are five separates arms in the study where an MP-470 is combined with carboplatin and paclitaxel or carboplatin and etoposide or topotecan, docetaxel or erlotinib.
In the Phase 1b study more than 70 of 105 patients have been treated thus far and the drug continues to demonstrate a benign safety profile without apparent additive toxicities. Although dose escalation is ongoing, preliminary activity has been noted in patients with neuroendocrine and small cell lung cancers.
In addition, based on clinical data from a steadfast study, we initiated an advanced work on a new oral formulation that we believe will show improve vial availability. We are on scheduled to complete this work next year.
As a result of the promising activity, we have seen in the Phase 1b combination therapy program we expect to advance MP-470 into Phase 2 next year. The likely disease targets will be small cell lung cancer and neuroendocrine cancer. In addition, we anticipate initiating a Phase 1b trial with MP-470 in combination with radiation and temezolamide, the current standard of care for glioblastoma multiform. Our most advance preclinical drug is SGI-1776, a highly potent and potential first-in-class inhibitor of PIM 1, 2, and 3.
PIM is a novel but critical target for cancer drug development as it is involved in a variety of processes known to be important for tumor growth, including suppression of program cell death, or apoptosis; regulation of transcription; regulation of cell cycle progression; and drug resistance. We have observed the activity for SGI-1776 across the broad range of xenograft models consistent with the anticipated broad clinical applications of PIM inhibition.
We continued to target year end for the Investigational New Drug or IND application for SGI-1776 to be cleared by the FDA and forward to go into effect to start treating patients. We expect initial clinical development to focus on prostate cancer and on lymphomas and subsequently on leukemia indications were intend to cures to be strongly over expressed.
We are excited about SGI-1776 is likely first-in-class status as it is expected to be the first PIM inhibitor to enter the clinic.
The next product I will highlight is MP-529 or aurora-A kinase inhibitor. MP-529 has several desirable properties, including rapid onset of hepatosis and a long half-life and it is distinguished from other aurora kinase inhibitors by at 1000-fold greater selectivity for aurora-A versus aurora-B kinases. The drug has potentially broad clinical applications to tumors of the colon, prostate, pancreas, and breast. Further development of MP-529 is focused on external collaborations, to optimize the formulation and enrich partnering activity.
S-110, a preclinical drug in our pipeline is a second generation highly potent DNA hypomethylating agent. It is pro-drug of decitabine. It shows encouraging activity in animal models. While we have planned in the IND submission for S-110 during the first half of 2009 and relapse to refractory MDS, this submission is contingent on securing favorable toxicities data relative to decitabine.
Finally, SGI-1252, a potent-orally vial available JAK2 inhibitor is in the preclinical stage of development. Notably, it inhibits the V617F mutants of JAK2, a protein that place a causal role in myeloproliferative diseases. In addition, SGI-1252 avoids the immune suppression noted with inhibition of JAK3. Given a number of JAK2 inhibitors currently in development, we are seeking a commercial partner for the drug and anticipate it may have broad applications within the area of inflammatory diseases.
Before I turn this call over to Michael Molkentin for our financial overview, I would like to reiterate my strategic comments from our last earnings call. With regard to business development as it impacts our long term corporate strategy, we expect to manage our expenses and especially our product development costs by monetizing multiple assets through strategic partnerships. The strategic is intended to help fund or discovery upgrades while minimizing our committed costs for later stage development. Over both the short and long terms, we believe the strategy will sustain a growing and diverse pipeline to create enhance shareholder value within a framework of fiscal discipline. We believe that we are in a solid position financially with more than $88 million in cash and no debt.
Further, I am pleased to acknowledge that we do not anticipate the need to top the capital markets through next year. We remain focused on the following five key strategic initiatives: First, to develop one IND ready compound each year. Second, to continue a policy of conservative fiscal management. Third, to advance our product pipeline at our expense to or through Phase 2 and or to partner our compounds by Phase 2 clinical trials. Fourth, to advance internal compounds to Phase 3 only as they are funded by a development partnership and fifth, to secure discovery collaborations that are both synergistic with our strategic goals and financially attractive.
That said, at this time, I would like to turn the call over to Michael Molkentin, who will provide details of our 2008 third quarter and an update on our 2008 annual financial guidance. Michael?
Michael Molkentin
Thank you, Jim. As today's press release indicates total revenues for the 2008 third quarter were $10.2 million or 26% increase over the $8.1 million we received in the second quarter and a 67% increase over the $6.1 million we recorded for the same quarter last year. Total revenues for the current and same prior year quarter consisted entirely of royalty revenue. Our royalty revenue is earned pursuant to the license agreement entered into with MGI Pharma, which was required by Esai Corporation of North America in January 2008 that grants to them exclusive rights to develop, manufacture, commercialize, and distribute Dacogen. We recognize royalty revenue on a cash basis when it is received.
Excluding gain on sale of products, total costs and operating expenses for the 2008 third quarter was $11.4 million compared with $9.2 million for the same prior year quarter. The primary reason for the increase in our operating expenses for the current year quarter were higher preclinical and clinical development costs, offset in part by a reduction in general and administrative expenses related to the cessation of our European operation and lower stock based compensation expense. The closure of the European operation was effective October 1, 2008 and we will reduce future operating expenses by up to $1 million annually.
Stock based compensation expenses included in operating expenses were $642,000 for 2008 third quarter compared with $904,000 million for the same prior year period. There was no gain on sale of products for the 2008 third quarter compared with $1.8 million for the same prior year quarter. The gain on sale of products for the 2007 third quarter related to the receipt of a milestone payment in the amount of $1.8 million due to the achievement of annual Nipent product sales target in North America by Hospira. These annual sales targets were not achieved in the current year and therefore no milestone payment returned.
Loss from operations for the 2008 third quarter was $1.1 million compared with $1.3 million for the same prior year quarter. The Company reported a net loss for the 2008 third quarter of $569,000 or $0.01 per fully diluted share compared with net income of $192,000 or $0.00 per fully diluted share for the same prior year quarter. The net loss for the 2008 third quarter includes an income tax benefit of $42,000 compared with the tax benefit of $427,000 for the same prior year quarter.
The Company had approximately $88.7 million in current and noncurrent unrestricted cash, cash equivalents and marketable securities as of September 30, 2008 and we continued to be debt free..
At this time, I will provide an update on our annual financial guidance for 2008. The Company has revised its annual guidance improving the anticipated overall financial results of 2008. We have revised upward our royalty revenues for 2008 to now fall within a range of $33 million to $36 million, an increase from a previous guidance of $32 million to $35 million. Our anticipated gain on sale of products has been revised downward and is forecasted to be approximately $1.8 million for 2008.
Research and development expenses have been revised slightly for 2008 and are now expected to range from $33 million to $35 million a decrease from our previous guidance of $34 million to $36 million. The growth and R&D expense over 2007 continues to be influenced by anticipated preclinical and clinical development cost.
We expect to record a charge during the fourth quarter of 2008 in the amount of $5.2 million for acquired in-process research and development resulting from a milestone payment to the former Montigen shareholders. This potential payment is contingent on the filing of an IND with the FDA of a second drug emanating from the acquired technology.
Anticipated selling, general and administrative expenses have been further reduced from our previous guidance of $13 million to approximately $12 million for this year. Included in our revised total operating expenses are lower noncash stock based compensation charges of approximately $3 million for 2008 a decrease from prior guidance of $3.5 million.
Based on the Company’s revised financial guidance for 2008 we have from a GAAP perspective reduced our estimated loss from operations to a range from $14.4 million to $15.4 million down from our previous guidance of $16.6 million to $18.6 million. On a cash basis this would translate into an estimated annual P&L cash burn rate ranging from $6.2 million to $7.2 million. And lastly, the Company’s annual weighted average shares outstanding for 2008 remained essentially unchanged at 57.7 million common shares.
This concludes the review of our financial results for the 2008 third quarter and a revised annual financial guidance for 2008. I will now turn the call back to Dr. Manuso for closing comments.
James Manuso
Thank you very much, Michael. Before we open the line to questions I would like to provide an update on our recent participation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Geneva, Switzerland. We had five poster presentations in total highlighting clinical and nonclinical advances. We had three poster presentations on our lead product candidates, MP-470, one poster on SGI-1776, and one on SGI-1252.
First, we presented confirmed tumor regression data in the first two-arms of the ongoing Phase 1b clinical trial examining MP-470 combined with five standards of care anti-cancer treatments. Dr. Anthony Tolcher, Director of Clinical Research at the South Texas Accelerated Research Therapeutics Operation in San Antonio Texas known as START, highlighted data showing tumor regression in four patients in the two-arms of platinum doublet arms indicating that MP-470 may sensitize or re-sensitize tumors to the effects of standard of care DNA damaging agents. Of note MP-470 did not increase the types or severity of adverse events. However, a primary endpoint of the trial determining the maximum tolerated dose of MP-470 co-administered with standard of care regimens has not been reached and those escalations is continuing. These results a very encouraging and we look forward to presenting updated results on MP-470 in combination with all standards of care arms of the trial in the future.
Second, we presented data highlighting that the positive effects of food on MP-470s absorption is considerably greater than the effect of gender on the pharmacokinetics of the drugs.
Third, data we presented showed that MP-470 is about 5 to 70 folds less toxic to human bone marrow stem cells compared to carboplatin and etoposide.
Fourth, we presented data that SGI-1776 is readily vial available and successfully localizes in tumors when delivered orally as a bisulfite salt. And in the fifth poster, we presented data describing SGI-1252s low nanomolar to low micromolar activity against a variety of hematological and solid tumor’s cell lines.
In closing, we are very pleased to advance further SGI-1776, our PIM kinase inhibitor towards Phase 1 clinical trials. This will be our second noble drug in clinical development and we believe the first PIM kinase inhibitor to enter the clinic.
To remind you, all of the drugs in our portfolio are either owned outright by your company or licensed exclusively on very favorable terms to us on a worldwide basis.
I look forward to keeping you updated on the progress of our strategic initiatives and as Company milestones are achieved for the remainder of 2008 and beyond. As always we thank you for your interest in and support of SuperGen. This now concludes our prepared remarks and at this time Dr. Greg Berk, Michael Molkentin, Dr. David Bearss, Michael McCullar, Tim Enns and I would be happy to answer your questions.
Operator we will take questions at this time.
Question-and-Answer-Session
Operator
Ladies and gentlemen, (Operator Instruction). Your first question comes from Matthew Osborne - Lazard Capital Markets.
Matthew Osborne - Lazard Capital Markets
First Michael, can you remind us what the second quarter sales were for Dacogen on a worldwide basis?
Michael Molkentin
Sales? I believe sales were presented by Esai at $42 million.
Matthew Osborne - Lazard Capital Markets
Then how do you net that to $10 million in your royalty revenue?
Michael Molkentin
It is based on, there are certain adjustments that are made in the calculation process. Those adjustments of, Esai reports what we would call the equivalent of GAAP revenue, but we actually get royalty revenue on gross worldwide sales. So, there is some adjustment factors that go in there and there is no, it does not directly correlate in approximately correlation.
Matthew Osborne - Lazard Capital Markets
And then, there was a prior indication perhaps for MP470 and non-small cell lung cancer? Is there an either combination with tarceba failures? Is that still something you would anticipate looking at next year?
Greg Berk
Matt, this is Greg. We are still interested in the combination and for sure the indication. Because, as you know Platinum are standard, platinum double are standard frontline therapy. Our drug should potentate that.
We have seen to date our best results in our phase-1b trial in small cell on newer endocrine levels. We are still accruing plenty of non-small cell [10:50]. The elatonin story is also very interesting because our drug does actually help avoid resistance to elatonin and probably through net inhibitory activity. So, we are still very interested in non-small cell, we have not ruled it out. We are just at the, sort of, planning stage of what our potential phase-2 strategy will be.
Matthew Osborne - Lazard Capital Markets
Last question on S-110, Jimmy mentioned in the prepared remarks, you are waiting on toxicity data since comparable to Dacogen. Can you explain a little bit further on that?
Greg Berk
Yes indeed. In order for us to proceed, we want to be assured that there will be a significant advantage of S-110 over decitabine onto itself. While on the one hand, we are convinced that there is the equivalent potentiality for therapeutic efficacy based on the in vitro and some Zenograph data that we have collected, we are finalizing the review of the compound in light of its comparative toxicity relative to decitabine.
Dave, maybe you would like to comment on that study.
Dr. David Bearss
Matt, what we were really looking at is trying to, because we know the mechanism of action of S-110 is identical to decitabine. But since it is a pro drug of decitabine, we wanted to really fully understand the potential differences involved to powerful kinetics on toxicology to make sure that we have a good idea of differentiating characteristics of, things-110 compared to decitabine.
Greg Berk
Based on the conclusion of those data which should be before the end of this year, we will make a clear or next step with S-110.
Matthew Osborne - Lazard Capital Markets
Okay, thank you.
Operator
Your next question comes from Analyst for Derek Jellinek - Susquehanna Financial Group LLLP.
Analyst for Derek Jellinek - Susquehanna Financial Group LLLP
Speaking for my partnership perspective, looking across the pipeline, which programs are you seeing getting the most attention from potential partners? Specifically for MP470, what sort of data do you think you would need to; actually have a partner move in on that program.
Michael Molkentin
With respect to MP470, we have entered into a number of discussions. I think, there is heightened interest based on the clinical data that is emanating from the phase 1b as was presented in Geneva and indeed as we will be updating going forward. We were seeing what to our perspective, is a set of positive responses that could potentially be related to the combination of MP470 with, particularly, the Platinum doublet arms of the trial. That has, needless to say, attracted the interest of potential partners.
Our ideal strategy for MP470 would be a partnership based in a particular region, say in Asia that would help to underwrite our expenses in advancing of the drug into stay phase 2 while retaining the rights for North America and Europe.
With respect to interests in some of the others, clearly there is an interest in S-110 and we have held off entering into discussions on that. Pending the toxicity data that Dave mentioned earlier.
In addition, there is a clear interest in the potential for our JAK2 inhibitor given how ever that this is a highly competitive field and our propensity is to focus more on the first in class potential drugs such as our PIM inhibitor.
Then there is a lot of interest in PIM especially since it is increasingly recognized that PIM inhibition may be a requirement for continued efficacy of [m4] inhibition. I would say that finally that is pretty much a wrap up where we are.
Analyst for Derek Jellinek - Susquehanna Financial Group LLLP
Specifically for MP470, looking at small cell 110. So, do you see it, kind of a first line therapy or more for the platinum refractory setting patients?
Greg Berk
We are most interested in front line Platinum-etoposide combinations.
Dr. David Bearss
That is where the drug works fast, as far as potentiating platinum. There is a data that resistance to drugs like platinum and etoposide, specifically in small cell have partially mediate [Inaudible]. That is where we were most interested in.
Analyst for Derek Jellinek - Susquehanna Financial Group LLLP
Just given the difficulty that a company like [Ponyard] has seen with its phase three small cell lung cancer platinum. What sort of timing do you think you will be looking at for a potential deal?
Greg Berk
We have not given guidance on that. What I can say is that we are actively interested in generating a deal. We also want to, of course, complete the bridging studies in order to move on to the enhanced formulation that I spoke off. And yet, regardless of that formulation, we still are observing what appeared to be some highly positive potential clinical effects of the combination. It is currently under a variety of reviews and it is in our interest to generate the best deal.
As I said publicly, we have a turned down deals that we did not perceive to be in the best interest of our shareholders.
Analyst
Just briefly on Dacogen. It does not really seem like its market share has been hit significantly after the EORTC study data coming out. Do you see that trend continuing? Could you comment on how you see that market shaping up going forward?
Michael Molkentin
Surely, let us begin with, the clear and widespread observation that the MDS market is growing on a worldwide basis, and I think, as a result of the failure of the EORTC trial, it will be difficult to challenge, shall I say, for Dacogen to penetrate into Europe at this point in time. I think, the real impact on the next big step for Dacogen sales will come contingent on a positive AML trial, and that is not going to be, as I said, we would not really have results on that until probably around 2010.
With that being said, as long as we can retain a meaningful percentage of a growing market and ultimately that translates into significant royalty revenues for our Company. We will very please with that outcome. And then finally, we have to acknowledge that the publication of the EORTC trial results will not be available for full reviews until following ash of this year. I would think therefore that everyone will be in a much better position to assess the market share between this competitor drug Vidaza and Dacogen, probably six to nine months out, when everyone had an opportunity to digest the data.
Finally, I have to say that many people perceive as their analysts have recently reported Dacogen to be a faster acting, more potent form of decitabine on the one hand. Also, if there is… a by days of failure, there is not much choice that you can go to. I think there are a variety of dynamics that are underway here and the answer is not going to be cast in stone until we were out into the future a little bit further. However, your point is well taken, market share has not diverged drastically, but I would expect there to be some impact on the recommendation for approval of Vidaza in the EU.
Operator
I believe there are no further questions at this time.
Michael Molkentin
If there are no further questions I would like to thank every one for their interest and please do not hesitate to contact us if you do have additional questions. Thank you and good afternoon.
Operator
Ladies and gentlemen this concludes our presentation. Thank you for your attendance, you may now disconnect. Good day.
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