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Astex Pharmaceuticals (NASDAQ:ASTX)

Q4 2011 Earnings Call

March 05, 2012 4:30 pm ET

Executives

Timothy L. Enns - Senior Vice President of Investor Relations, Business Development & Corporate Communications, Senior Vice President of Corporate Communications & Business Development and Vice President of Business Development

James S. J. Manuso - Chairman of the Board and Chief Executive Officer

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

Robert Corringham -

Harren Jhoti - Founder, Chief Executive officer and Director

Analysts

Boris Peaker - Oppenheimer & Co. Inc., Research Division

Thomas Yip - McNicoll, Lewis & Vlak LLC, Research Division

Robin Davison - Edison Investment Research Limited

Operator

Good day, ladies and gentlemen, and thank you for standing by, and welcome to the Astex Pharmaceuticals Fourth Quarter and Year End 2011 Earnings Conference Call. [Operator Instructions] As a reminder, this conference may be recorded. And now it's my pleasure to turn the call over to Timothy Enns, Senior Vice President, Corporate Communications and Marketing. Sir, the floor is yours.

Timothy L. Enns

Thank you, operator. Good day and thank you for joining us for Astex Pharmaceuticals 2011 Fourth Quarter and Annual Financial Results conference call. With me today are Dr. James Manuso, Chairman and Chief Executive Officer; Dr. Harren Jhoti, President and member of the Board of Directors; Dr. Martin Buckland, Chief Business Officer; Michael Molkentin, Chief Financial Officer; Dr. Robert Corringham, Vice President of Clinical Development; and Dr. David Smith, Vice President of Regulatory and Quality Affairs.

In a few moments, Jim Manuso and Michael Molkentin will deliver remarks on the 2011 fourth quarter and fiscal year financial results and our business outlook for 2012. After prepared comments, we will open the line for questions. Earlier today, we issued a press release with our financial results. A copy of the press release is available in the Investor Relations section of our website at www.astx.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'll 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, preclinically 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 that 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 action, the actions of our strategic partners and collaborators with respect to the products we license 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. The company undertakes no duty to update forward-looking statements. In a few weeks, we'll be hosting our Annual Analyst and Investor Day on Tuesday, March 27 in New York. Live and archived webcasts of these presentations will be available in the Investor Relations section of our corporate website.

I will now turn the call over to Dr. James Manuso, who will provide highlights of our accomplishments during the 2011 fourth quarter and fiscal year. Jim?

James S. J. Manuso

Thank you, Tim. Good morning, and thank you for joining us for Astex Pharmaceuticals' 2011 fourth quarter and year-end conference call. 2011 was a busy year for our company. We completed a major acquisition, rationalized our combined operations and enhanced and prioritized our portfolio of novel drugs. We ended the year with 4 company-sponsored Phase II programs and 4 partner-sponsored drugs in clinical trials. At the same time, we managed our financial resources conservatively, permitting us to deliver a profit for the fourth year out of the last 5 years. It has been 7 years since we last raised money in the markets. For 2012 financial performance, we are guiding to the achievement of approximate cash flow neutrality.

Dacogen royalty revenue rose to $60.5 million last year, representing an increase of 15% from the prior year. The company reported net income of $5.5 million, and we ended the year in a strong cash and marketable securities position of $128 million. As you know, our partner, Eisai, submitted to the U.S. Food and Drug Administration a supplemental new drug application or sNDA, seeking approval of Dacogen in the elderly acute myeloid leukemia or AML indication. We expect to learn the outcome of the FDA's final decision on this application tomorrow, March 6, the PDUFA date. While the FDA's Oncologic Drugs Advisory Committee or ODAC voted 10 to 3 that data in the supplemental NDA did not support a favorable benefit risk profile of Dacogen for the treatment of AML in adults 65 years of age or older, the FDA is not obliged to follow its advisory committee's recommendation. There is currently no approved therapy for elderly AML patients.

Within the second half of this year, the EMA will rule on Janssen-Cilag's Marketing Authorization Application or MAA for Dacogen in elderly AML. The Astex Pharmaceuticals' pipeline now includes 8 potential medicines that are advancing in the clinic, 5 of which are funded and managed by partners. We expect to announce the results of 4 Phase II clinical trial readouts later this year. AT13387, our second-generation HSP90 inhibitor, continues to progress in an imatinib combination Phase II trial for patients with tyrosine kinase inhibitor-resistant gastrointestinal stromal tumors or GIST. Additionally, we will expand the clinical program on AT13387 during the year, and clinical data on the drug will be presented at this year's ASCO conference.

Our second-generation hypomethylating agent, SGI-110, continues to accrue patients in a first-in-human Phase I-2 trial for patients with myelodysplastic syndromes or MDS and AML. The Phase I dose escalation segment will be completed soon, and the dose expansion Phase II portion of the trial is anticipated to begin by midyear. This program will expand into solid tumors with a Phase II trial commencing before year end. New SGI-110 clinical data has been submitted for presentation at the upcoming AACR Meeting. The amuvatinib or MP-470 Phase II clinical proof-of-concept trial in small cell lung cancer continues to accrue patients who either lacked a response to platinum/etoposide treatment or failed on treatment altogether. Preliminary results are expected at year end. There is a large unmet medical need for small cell lung cancer patients who are refractory to primary platinum/etoposide therapy. The last FDA-approved drug for small cell lung cancer patients was Topotecan in 1998.

AT7519 is a small-molecule targeted inhibitor of several cyclin-dependent kinases. It is currently in one ongoing Phase II study, and 2 additional studies are planned. The ongoing study is a U.S.-based trial in which AT7519 is given in combination with bortezomib in patients with multiple myeloma. The other planned AT7519 Phase II trials to be conducted in Canada are for the treatment of patients with chronic lymphocytic leukemia or CLL and mantle cell lymphoma or MCL. Novartis has an option to develop and commercialize AT7519.

In addition, late last year, a second clinical trial was initiated with our JAK/Aurora inhibitor, AT9283, by Cancer Research U.K.'s Drug Development Office. In the trial, AT9283 will be given to patients aged 6 months to 18 years, who are suffering from acute lymphoblastic leukemia or ALL and acute myeloid leukemia or AML. AT9283 is also in a clinical trial sponsored by Cancer Research U.K. in the treatment of pediatric patients with solid tumors.

Our partners, Novartis and AstraZeneca, continued to progress the clinical development of medicines derived from our discovery collaborations, and we have made good progress in our partnerships with GSK and Janssen-Cilag, a Johnson & Johnson company. Our leadership in fragment-based drug discovery has led to a recently published peer-reviewed article that noted Astex's compounds possess more drug-like properties when compared head-to-head with compounds produced by the world's largest pharmaceutical companies. Later this year, we will communicate more about a number of preclinical candidates that have been generated by our Pyramid drug discovery process.

At this time, I will turn the call over to Michael Molkentin, our Chief Financial Officer. Michael will provide details on our 2011 financial results, as well as our initial fiscal guidance for 2012. Michael?

Michael Molkentin

Thank you very much, Jim. First, I would like to remind the listeners on today's call that we completed the acquisition of Astex Therapeutics Limited on July 20, 2011. This entity is now a wholly owned subsidiary of Astex Pharmaceuticals, Inc., and all financial and operational results of the U.K. subsidiary have been consolidated in our operations effective July 20, 2011, forward as required by Generally Accepted Accounting Principles. Inclusion of the operating results of the acquisition in 2011 will be a primary reason for increased reported operating activity during the latter part of 2011 when compared to the same prior-year period.

Astex Pharmaceuticals reported positive financial results for the 2011 financial period. Net income for the 2011 fourth quarter was $220,000 or $0.00 per basic and diluted share compared with net income of $6.7 million or $0.11 per basic and diluted share for the same prior-year period. For the year ended December 31, 2011, the company reported net income of $5.5 million or $0.07 per basic and diluted share, compared with net income of $16.3 million or $0.27 per basic and diluted share for the same prior-year period.

I will now comment on our 2011 fourth quarter financial results. Total revenues for the 2011 fourth quarter were $21.2 million compared with $15.3 million for the same prior year period. Total revenues for the 2011 fourth quarter include royalty revenue of $15.4 million compared with $15.2 million for the same prior year period. Our royalty revenue is earned pursuant to our worldwide license agreement for Dacogen and is generally recognized when received. Total revenues for the 2011 fourth quarter also include development and license revenue of $5.8 million compared with $127,000 for the same prior year period.

The development and license revenue represents both milestones earned and the amortization of deferred revenue relating to payments previously received pursuant to various collaborative and research and license arrangements. Included in our development and license revenue for the 2011 fourth quarter are multiple milestones earned, totaling approximately $4.4 million related to our GSK collaboration, while there was no similar revenue for the same prior-year period. Total operating expenses for the 2011 fourth quarter were $21.9 million compared with $8.8 million for the same prior-year period. The primary reasons for the increase in total operating expenses for the 2011 fourth quarter when compared with the same prior-year period are the consolidation of research and development and general and administrative expenses related to the acquisition of Astex Therapeutics Limited; increased research and development activities from product development and clinical trial programs associated with SGI-110, AT13387 and amuvatinib; amortization of intangible assets, including an impairment charge; severance costs related to a reduction in force; and an increase in stock-based compensation expense.

For the 2011 fourth quarter, amortization of intangible assets, including an impairment charge, totaled $3 million while we had no similar charges for the same prior-year period. Our 2011 fourth quarter also includes severance costs associated with a reduction in force in the amount of $216,000, while there was no similar cost for the same prior-year period. Stock-based compensation expense was $769,000 for the 2011 fourth quarter compared with $183,000 for the same prior-year period. As previously indicated, the company reported net income for the 2011 fourth quarter of $220,000 or $0.00 per basic and diluted share compared with net income of $6.7 million or $0.11 per basic and diluted share for the same prior-year period. The net income for the 2011 fourth quarter included an income tax benefit of $986,000, compared with an income tax provision of $26,000 for the same prior-year period.

The income tax benefit for the 2011 fourth quarter was primarily due to the recognition of a tax benefit associated with the amortization of deferred tax liabilities resulting from the acquisition and the utilization of a foreign research and development tax credit related to the U.K. subsidiary. We continue to report a strong financial position. As of December 31, 2011, the company had approximately $128 million in unrestricted cash, cash equivalents and current and noncurrent marketable securities compared to approximately $120 million at December 31, 2010.

I will now comment on our initial financial guidance for 2012. We anticipate that royalty revenue for Dacogen will increase up to 10% from the prior year to a range from $64 million to $67 million. Development and license revenue is currently estimated at $1.4 million, representing recognition of deferred revenue relating to prior payments received pursuant to a research and license agreement with GSK. Though we anticipate earning additional development and license revenue in the future, we will not guide to such revenue since achievement of any particular milestone is uncertain with respect to its timing and scientific and technical progress. In many cases, progression of the various programs is in the control of our partner companies.

The last remaining payment of $700,000 relating to the sale of our commercial franchise during 2007 will be classified as a gain on sale of products and is expected to be received during 2012. Research and development expenses are expected to increase from the prior year to a range from $62 million to $67 million. The growth in expenses will be primarily influenced by increasing costs associated with our current clinical trial programs for amuvatinib, AT13387 and SGI-110, ongoing product development efforts that will advance our product pipeline and additional investment in our discovery, preclinical, regulatory and clinical areas.

Amortization of intangible assets, a noncash charge, is estimated to be $7.6 million. General and administrative expenses are expected to decrease from the prior year to a range from $14 million to $15 million. An estimated income tax benefit associated primarily with the amortization of deferred tax liabilities resulting from the acquisition and a foreign research and development tax credit related to the U.K. subsidiary is currently anticipated to be in a range from $4 million to $5 million for the year.

Based on the level of anticipated revenue and operating expenses, we are initially forecasting a net loss in the range from $13 million to $15 million for 2012. In addition to the amortization of intangible assets, included in total operating expenses are other recurring noncash operating charges such as stock-based compensation expense and depreciation estimated at $3.5 million for 2012. We are anticipating that our average annual shares outstanding for 2012, used for calculating per share results, will be approximately 93 million common shares.

This concludes the review of our financial results for the 2011 fourth quarter and fiscal year and comments on our initial annual financial guidance for 2012. I will now turn the call back to Dr. Manuso for closing remarks.

James S. J. Manuso

Thanks very much, Michael. Well, there you have it. 2011 has been a very successful year in terms of our corporate, financial and product development efforts. We're a larger, well-financed company with a deep pipeline. We reported a profit for 2011, and we are once again in an admirable position in terms of our year-end cash and cash equivalents. We do not expect to raise money in the markets in the current year, and we look forward to the European Medicines Authority's decision on Janssen's Marketing Authorization Application on Dacogen in elderly AML expected in the second half of 2012. We intend to accomplish a great deal in 2012 with the potential of 4 Phase II readouts on company-sponsored clinical trials. Partner-sponsored development of our proprietary compounds will advance further, and we are accelerating the output of discovery stage deals for our partners, GlaxoSmithKline and Janssen. We look forward to updating you in the coming months on our progress across many fronts. Dr. Harren Jhoti, Dr. Robert Cunningham (sic) [Corringham], Dr. Martin Buckland, Dr. David Smith, Michael Molkentin, Tim Enns and I are now ready to answer your questions.

Operator, we will take questions at this time, please.

Question-and-Answer Session

Operator

[Operator Instructions] Our first questioner in queue is Boris Peaker with Oppenheimer.

Boris Peaker - Oppenheimer & Co. Inc., Research Division

My question is I wanted to probe a little bit on Dacogen. Could you give us any more details in terms of any subpopulation analysis? Or are there any kind of biomarkers that may enable to segment the data that may identify a patient population where it's more effective than just the general pool that was included in the study?

James S. J. Manuso

Well, before I turn this over to Dr. Corringham, let me simply say that recall that there were 2 cuts of data, one prespecified, of course, and that was on 82% of the patients. That was not statistically significant. That was the primary end point. And then the second cut on 92% of the patients, which was a retrospective analysis, and that did appear to make it clear that there was a clinical benefit for patients. In addition, there was, of course, the CR rates, and those were statistically significant, and then there are a number of issues surrounding the comparison at the median. But I'll turn this over to Dr. Corringham for his commentary. Bob?

Robert Corringham

Thanks, Jim. Well, we're still looking at the data, all the data being generated from the study. There were regional differences that need further interrogation and explanation because the study was not actually stratified for these, and there were imbalances in certain regions like Europe, for example. So I think it’s still early to give you the direct answer to your question. We're still looking at the data. We do have some ideas about specific patient populations, but it'd be a bit premature at this time to give you that information.

Boris Peaker - Oppenheimer & Co. Inc., Research Division

And have you discussed -- after the panel, have you had a discussion with the J&J representative just to get a sense, if the FDA comes back and asks for another study, I mean, do they have an appetite for conducting such a study? Or are they basically done with it at that point?

James S. J. Manuso

Well, there's been no such discussion at this juncture. And frankly, it's the belief of many that the data are relatively clear with respect to the high likelihood of there being a benefit for patients. The rest is a statistical set of arguments, and Bob, any comments about that?

Robert Corringham

Well, I think it was very much down to statistics in the discussion at ODAC. I think one has to appreciate that there is definitely benefit to patients in terms of response rate, which in AML, as you know, is very significant in terms of the quality of life of patients. And we saw here a much greater increment in terms of complete responses in the Dacogen arm than in the control group. So I think the question is still out there and needs further analysis.

James S. J. Manuso

And lastly, appreciate, Boris, that J&J holds the rights for Dacogen outside North America. And they sell the drug presently in a variety of locations. And their decisions vis-à-vis of the drug, given that it is presently the subject of an MAA in the EU, will be driven by jurisdiction-by-jurisdiction decisions. And the drug, remember, is sold in more than 30 countries, so they have a lot of choices in that respect.

Boris Peaker - Oppenheimer & Co. Inc., Research Division

And when does your -- my last question is when does your exclusivity or your royalty run out for Dacogen?

James S. J. Manuso

It's a very unique circumstance, and it works like this. It's 20 years on a jurisdiction-by-jurisdiction basis from the point at which it is approved. So if for example, 5 years from now and it's approved in Japan for any indication, that takes us out 25 years. And that's regardless of the indication, regardless of whether or not the drug is off-patent or off-orphan designation in any given jurisdiction. So it takes us out quite a ways.

Boris Peaker - Oppenheimer & Co. Inc., Research Division

And how many years are remaining on the current jurisdictions? I mean, what's the span? Is it a few years or is it some of them are pretty new? Where do we stand there?

James S. J. Manuso

Well, no. As I said, if 5 years from today it's approved in Japan, it takes us out 25 years altogether. It's staggered. It depends on when it was approved in any given jurisdiction. As you know, in the U.S., it's a slightly different matter because the drug goes off orphan designation in 2013. In the U.S. for example, we're covered from 2006 to 2026, although the drug goes off orphan designation in 2013.

Operator

Our next questioner in the queue is Thomas Yip with MLV & Co.

Thomas Yip - McNicoll, Lewis & Vlak LLC, Research Division

My first question is can you tell us a little bit more about the planned Montigen spin-off?

James S. J. Manuso

Montigen, yes. As you know, we're in the midst of a financing at this point. And as a result, we're in a quiet period. So the best I can do is refer you to the bankers involved, the Rodman & Renshaw, and to the President-elect Mike McCullar. Because we're in the selling phase, we simply can't comment on that.

Thomas Yip - McNicoll, Lewis & Vlak LLC, Research Division

Okay, I understand. So the assets that were planned to transfer over, I am assuming there are no changes at this point?

James S. J. Manuso

No changes at all. And as you know, everything is contingent on the closing. So that's what we're waiting for.

Thomas Yip - McNicoll, Lewis & Vlak LLC, Research Division

Okay, great. Can you give us a little more detail about perhaps Dacogen x U.S. market? Do you see it growing in 2012?

James S. J. Manuso

Well, certainly as we've given you guidance on, we do expect our royalty revenues to increase. And we don't, however -- we're barred actually from giving specifics on from whence the sales that form the base of that royalty revenue. But what we can say is that the worldwide market is approaching $1 billion and that we expect that to continue to increase by and large at a rate near 10% per year. And that we've recently observed a shift in -- an increase, really, in the IMS-charted sales of Dacogen versus Vidaza in the U.S. It's now approximately 42% market share for Dacogen and 58% for Vidaza. And as you know, for many, many months, it was 60-40 in favor of Vidaza. So the drug continues to perform well in North America. J&J is clearly committed to the development, sales and marketing of the drug outside of North America, and we have no reason to believe that, that would change going forward. And finally, as I've also said, the drug is the subject of a variety of applications, and J&J is advancing it as we speak.

Thomas Yip - McNicoll, Lewis & Vlak LLC, Research Division

I have one final question regarding the tax benefit. I assume -- is that a onetime event? Or is that recurring?

James S. J. Manuso

Michael Molkentin will take that question.

Michael Molkentin

Yes. I mean, the tax benefit, as I indicated, consists of 2 fundamental elements. It consists of the recognition of a tax benefit that's associated with the amortization of deferred tax liabilities. You'll see something on our balance sheet, and that will be recognized over a period of time and pulled back into the P&L over probably a 5- to 7-year-type timeframe. And then the other element of the tax benefit is a foreign research and development tax credit related to the U.K. subsidiary, and that will be utilized -- it's not a onetime event. It's an encouragement by the U.K. taxing authorities or the U.K. government to encourage the development of drugs in the U.K., and based on certain expenditures being made in that country, they qualify for this credit, and that will be something that will be ongoing.

Operator

[Operator Instructions] Our next questioner in queue is Robin Davison with Edison Investment.

Robin Davison - Edison Investment Research Limited

I'm interested in potential new trial starts this year. I mean, I'm sure you're probably saving this for the R&D event. But I'm kind of wondering about 13387, I think there's been some talk of possible new indications that you may pursue there. And also for 7519, I wonder if might be able to tells us if it will stay in the direction you're planning with those 2 programs.

James S. J. Manuso

And let's not forget SGI-110, but I'll pass that along to Bob.

Robert Corringham

Thanks, Jim. Yes, well, we have study starts planned. We have a study start for AT13387 for later this year and possibly a second study start also later on this year in 2 solid tumors in addition to our GIST trial, which is ongoing. And then in AT7519M, we have 2 studies planned with the National Cancer Institute of Canada. The first study, which will start possibly in the first half, will be in patients with chronic lymphocytic leukemia, and the second study, which we anticipate will start in the second half, will be in patients with mantle cell lymphoma. In addition, with SGI-110, we anticipate starting the Phase II expansion part of our current study, and the data is looking very promising and will be presented at AACR next month from the escalation stage of the study. And we also anticipate starting at least one solid tumor study with SGI-110 in the second half of this year.

Robin Davison - Edison Investment Research Limited

Have you completed the dose escalation phase? I wasn't quite clear whether that’s SGI-110 now.

Robert Corringham

I think we're getting close. We haven't actually completed it yet. We still have more data coming in right now. We've involved 6 cohorts in the study. And I think it will be dependent on the data that we see. We still have the opportunity to dose escalate. We certainly haven't reached dose limiting toxicity at this point.

James S. J. Manuso

And I think we could also add that as we anticipated, we are -- and expected to observe a slightly decreased Cmax and an extended AUC, suggesting that there may be improved tolerability, and that's something that we'll be able to comment on as the data become more clarified.

Robert Corringham

Yes. That's absolutely right, Jim.

Robin Davison - Edison Investment Research Limited

Okay. Also I just wanted to -- I think you sort of hinted that you have some interesting sort of preclinical compounds under development arising from the Pyramid technology. I was wondering, is it possible we might see a sort of Phase I trial start with some new programs this year?

James S. J. Manuso

Bob, would you like to…

Robert Corringham

Yes, I think so. I think Harren Jhoti could comment further on that.

James S. J. Manuso

Harren, would you comment on that please?

Harren Jhoti

Yes, sure. Robin, we're at the stage of selecting clinical candidates for a couple of new programs, and we'll be looking to do that within the next month or so. We'll then obviously be projecting a clinical trial for those. I couldn't say exactly when we will initiate those trials, but there’s certainly a couple of programs which continue to make good progress, which will replenish the pipeline.

Operator

And at this time, it looks like there are no additional questioners in the queue. I'd like to turn the program back over to Dr. James Manuso for any closing remarks.

James S. J. Manuso

Well, again, thank you very much for listening in. And by all means, if you have additional questions, don't hesitate to contact us. We tend to post things fairly rapidly on our website, so I encourage you to stay in touch with that. And then finally, please, by all means, follow up with respect to our Analyst Day coming up. And again, thanks so much for your time and consideration today. Have a good afternoon.

Operator

Thank you, sir. Again, ladies and gentlemen, this does conclude today's program. Thank you for your participation, and have a wonderful day. Attendees, you may log off at this time.

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