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Astex Pharmaceuticals (NASDAQ:ASTX)

Q4 2012 Earnings Call

February 25, 2013 4:30 pm ET

Executives

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

James S. J. Manuso - Chairman and Chief Executive Officer

Mohammad Azab - Chief Medical Officer

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

Analysts

Jason Zhang - Edison Investment Research Limited

Michael G. King - JMP Securities LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Astex Pharmaceuticals Quarter 4 Year-End 2012 Earnings Call. [Operator Instructions] Today's conference is being recorded. I would now like to turn the call over to Timothy Enns, Senior Vice President, Corporate Communications & Marketing. Please go ahead, Sir.

Timothy L. Enns

Thank you, operator. Good day, and thank you for joining us for Astex Pharmaceuticals' 2012 Fourth Quarter and Annual Financial Results Conference Call. With me today are Dr. James Manuso, Chairman and Chief Executive Officer; Dr. Mohammad Azab, Chief Medical Office; Dr. Martin Buckland, Chief Business Officer; and Michael Molkentin, Chief Financial Officer.

In a few moments, Dr. Manuso, Dr. Azab, and Michael Molkentin will deliver remarks on the 2012 fourth quarter and fiscal year financial results and our business outlook for the year. 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 this 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 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 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 or 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 the remainder of the quarter, we will be participating in 2 Investor Conferences. These include the RBC Capital Markets Healthcare Conference, February 26 and 27, in New York City; and the ROTH Conference, March 17 to 20, in Laguna Niguel.

I'll now turn the call over to Dr. James Manuso, who will provide highlights of our accomplishments during the 2012 fourth quarter and fiscal year. Jim?

James S. J. Manuso

Thank you, Tim. Good afternoon, thank you for joining the Astex Pharmaceuticals 2012 Fourth Quarter and Year End Conference Call. 2012 was a very good year for our company. We increased our revenue and cash reserves and we advanced several compounds into new clinical trials. We benefited financially from our partner's commencement of new clinical trials with our medicines. Our partner, Janssen, has rapidly registered Dacogen for sales, marketing and reimbursement in the EU and elsewhere.

Dacogen continues to be the prime driver of our revenue streams. In 2012, there was a 17.5% increase in Dacogen royalty revenues over 2011. Dacogen was also approved in the European Union, or EU, for the treatment of patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukemia, or AML, for a not suitable for induction chemotherapy. The Dacogen European market is protected by a 10-year, orphan drug designation that was granted at the time of the product's approval. We also earned significant milestone revenues from partners.

Internally, we continued to advance in the clinic, our prioritized products. We initiated 3 Phase II trials for SGI-110, our next-generation hypomethylator and 2 Phase II trials for AT13387, a fully synthetic HSP90 inhibitor.

We managed our financial resources conservatively, permitting us to deliver a profit for the fifth year out of the last 6 years. We ended 2012 with a strong cash balance of $138 million, as compared to $128 million at the end of 2011. Our company continues its long-standing tradition of maintaining financial strength.

We're extremely pleased with the EU approval of Dacogen for the treatment of elderly patients with AML. It is the first medicine in the world ever to be specifically approved for this subset of a very difficult disease. The incidence of AML in the EU is about 18,000 patients of which 10,000 are over 65 years of age.

Our 2013 royalty revenue guidance considers both the influence of Dacogen's U.S. Orphan Drug exclusivity lapsing in MDS and expanding product sales in the EU by Janssen-Cilag. Janssen-Cilag, the Dacogen sublicensee outside of North America, is actively registering this important medicine for elderly AML in the EU and elsewhere. In fact, Janssen has obtained marketing approval for Dacogen in the MDS indication in over 35 countries.

The growth of the worldwide HMA market is substantial. 2012 global sales of hypomethylators, or HMAs, exceeded $1.1 billion. As one of the innovators in the HMA field, Astex will continue to receive a blended, escalating royalty rate of 20% to 30% on all net sales of Dacogen worldwide regardless of indication and irrespective of which of our partners makes the sale.

Our prioritized products, SGI-110 and next-generation HMA and AT13387, a fully synthetic HSP90 inhibitor, are being advanced in multiple Phase II clinical trials. Multiple clinical readouts on these medicines were reported during 2012, and data reporting scheduled for this year is substantial. I will turn the call over to our Chief Medical Officer, Dr. Mohammad Azab, who will discuss our clinical programs in more detail. Mohammad?

Mohammad Azab

Thank you, Jim. And good afternoon, everybody. Astex continues to achieve significant clinical progress with our 2 prioritized pipeline products, that's SGI-110 and AT13387. As you know, SGI-110 is a novel pharmaceutically stable, low-volume subcutaneous hypomethylating agent with a proven potent biological activity and promising clinical activity in the clinical trial that is currently ongoing. In an oral presentation last December at the American Society of Hematology, or ASH, we reported that SGI-110 delivers decitabine in a sustained manner, resulting in an improved PK with doubling of the exposure time of cancer cell to decitabine and 4-fold longer half-life than Dacogen intravenous -- than decitabine released from the Dacogen intravenous infusion. Despite that the data presented were from a Phase I dose escalation trial in heavily pre-treated patients with MDS or AML, we reported 10 responders, 5 MDS and 5 AML, regardless of whether these patients received prior azacytidine or Vidaza, or prior Dacogen.

More interestingly, we noticed that the responses in AML patients in particular appear to correlate with the demethylation potency achieved by SGI-110. This trial has now expanded to the Phase II part, where MDS and AML patients, including those previously untreated, are being randomized to 2 different doses using the dailyx5 regimen, which showed the best biological activity. We are planning to update the results from this large and important trial at several meetings this year, starting with the European Hematology Association meeting in June; at the ASCO meeting; ESMO, European Society of Medical Oncology, in September; and the American Society of Hematology in December, and that's all during the course of this year. So this will be a very active year in terms of data updates on SGI-110.

Furthermore, the establishment of a biologically effective dose of SGI-110 allowed us to initiate 2 new trials in solid tumors. The first of which is a randomized Phase II trial in platinum-resistant ovarian cancer in combination with carboplatinum. This trial will evaluate the role of SGI-110 in reversing the epigenetic base resistance to platinum in ovarian cancer patients. We also initiated a second Phase II study in solid tumors and that study is in the treatment of hepatocellular carcinoma or liver cancer in patients failing prior sorafenib or Nexavar. In this trial, patients will be evaluated for their methylation status of the tumor suppressor genes for their global DNA methylation levels and the levels of the demethylation potency in addition to the standard clinical responses and safety. These 2 Phase II studies in solid tumors are based on prior preclinical and clinical work suggesting promising activities of SGI-110 in both platinum-resistant ovarian cancer and hepatocellular carcinoma.

Coming now to the other aspects prioritized pipeline program, which is AT13387, a second-generation fully synthetic and potent HSP90 initiator. In 2012, we initiated 2 Phase II trials, both of which are randomized trials, in castration-resistant prostate cancer and in non-small cell lung cancer that harbored ALK translocation or ALKpositive lung cancer. The choice of these 2 indications was based on strong preclinical activity of AT13387, as well as prior responses observed in these tumors with HSP90 inhibition. We designed the trials using a stepwise approach, and Part A of these trials will mainly establish the biological activity and safety in combination with other active targeted agents in these indications. Once this is established, subsequent expansion of the trials will be allowed with randomization of the patients so that we can establish activity of AT13387 both as a single agent and in combination with the selected target agent. The selected target agents are abiraterone acetate, or Zytiga, for prostate cancer, and crizotinib, or Xalkori, in ALK-positive non-small cell lung cancer. Achievement of the combination of safety and biological activity will be a prerequisite for our expansion into the randomized Phase II parts of both the prostate and the lung cancer trials.

The preclinical data on SGI-110, AT13387 and other earlier-stage molecules from Astex will be showcased in 11 data presentations of these drugs at the American Association of Cancer Research, or AACR, later in April this year. In addition, we will present clinical updates of SGI-110 data in the treatment of AML and MDS in several meetings, as I alluded earlier, mainly at ASCO and ASH this year. Based on the emerging clinical data by year end, Astex's expects to select a lead disease indication for SGI-110 Phase III trial. With that, I will now turn the call back to Jim.

James S. J. Manuso

Thank you, Mohammad. In addition to our internal clinical work, our pharmaceutical company partners made steady clinical progress developing those medicines that have been licensed to them. There are now 5 Astex compounds in Phase I clinical trials that are being executed by our partners. These include LEE011, a CDK4 inhibitor licensed to Novartis; AZD5363, a PKB/Akt inhibitor licensed to AstraZeneca; JNJ42756493, an FGFR inhibitor licensed to Janssen; AZD3293, a base inhibitor in Alzheimer's disease, licensed to AstraZeneca; and AT13148, an AGC kinase inhibitor in collaborative development with the U.K. based Institute for Cancer Research and Cancer Research Technology.

With respect to our discovery program, Astex began 2 major collaborations in 2012, each of which has the potential to yield novel compounds targeting unique pathways of cancer. These collaborations provide to us access to world-class science and technology and are intended to generate compounds for future development. They leverage our renowned expertise and fragment-based drug discovery. One of the collaborations is with Cancer Research Technology and Newcastle University in the U.K. It is focused on novel cancer drug target biology. The other collaboration, an epigenetics drug discovery partnership, is with the Institute of Cancer Research and Cancer Research Technology Limited, also in the U.K. Astex is honored and excited to be working with these prestigious institutions to complement our efforts in early discovery.

At this time, I will turn the call over to Michael Molkentin, our Chief Financial Officer. Michael will provide details on our 2012 fourth quarter and fiscal year financial results. He will also provide an update on our revised financial guidance for 2013. Michael?

Michael Molkentin

Thank you very much, Jim. First, I would like to remind the listeners on today's call that the acquisition of a U.K. based subsidiary was completed during July 2011. While the subsidiary's results are fully included in our consolidated 2012 annual operating and financial results, they are include for shorter periods in our consolidated 2011 annual operating financial results from the acquisition date effective July 20, 2011, forward as required by generally accepted accounting principles.

Astex Pharmaceuticals reported positive financial results for the 2012 financial period. Net income for the 2012 fourth quarter was $4.5 million, or $0.05 per basic and diluted share, compared with net income of $220,000 or $0.00 per basic and diluted share for the same prior-year period. For the year ended December 31, 2012, the company reported net income of $8.2 million or $0.09 per basic and $0.08 per diluted share compared with net income of $5.5 million or $0.07 per basic and diluted share for the same prior-year period.

I will now comment on our 2012 fourth quarter financial results. Total revenues for the 2012 fourth quarter were $24.1 million compared with $21.2 million for the same prior year period. Total revenues for the 2012 fourth quarter include royalty revenue of $19.1 million compared with $15.4 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 2012 fourth quarter also include development and license revenue of $5 million compared with $5.8 million for the same prior year period. Our development and license revenue for the 2012 fourth quarter represents a $5 million milestone earned under the worldwide license agreement with Eisai, triggered by the first commercial sale of Dacogen in the EU. While the same prior year period included a $4.4 million milestone earned under our GSK collaboration agreement.

Total operating expenses for the 2012 fourth quarter were $22.8 million compared with $21.9 million for the same prior year period. The primary reasons for the increase in total operating expenses for the 2012 fourth quarter when compared with the same prior year period are due to increased research and development efforts associated primarily with the SGI-110 and AT13387 programs, offset by lower overall general and administrative expenses and no charges for the impairment of intangibles.

The noncash charge for amortization of intangibles was $2 million for the 2012 fourth quarter compared with $1.7 million for the same prior year period. There was no charge for impairment of intangibles for the 2012 fourth quarter compared with $1.3 million for the same prior year period.

Stock-based compensation expense, a noncash expense, was $624,000 for the 2012 fourth quarter compared with $769,000 for the same prior-year period.

As previously indicated, the company reported net income for the 2012 fourth quarter of $4.5 million compared with net income of $220,000 for the same prior year period. The net income for the 2012 fourth quarter included an income tax benefit of $3.1 million compared with an income tax benefit of $1 million for the same prior year period. The income tax benefit for the current and prior year fourth quarter is primarily due to the recognition of a tax benefit associated with the amortization of deferred tax liabilities, resulting from the acquisition, a change in the U.K. tax rates 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, 2012, the company had approximately $138 million in unrestricted cash, cash equivalents and current and non-current marketable securities, compared to approximately $128 million at December 31, 2011. Reflected in today's news release is the company's revised financial guidance for 2013. Selected comments on our revised financial guidance include a decrease in the forecasted annual royalty revenue for 2013 from our previous guidance of $60 million to our revised $55 million. The reduction from 2012 is based on revised expectations of lower Dacogen product sales in the U.S. as Orphan Drug exclusivity is anticipated to lapse in May of this year when subsequent product sales will be influenced by increasing generic competition. We do expect and have conservatively considered in our guidance that the decrease in royalty revenue in the U.S. territory will be partially offset by incremental royalty revenue expected from increasing Dacogen product sales, occurring primarily in the EU, as J&J enhances the selling and marketing efforts in the European market and broadens its efforts in the rest of the world.

Though we anticipate the potential of earning additional development and license revenue from our partner programs during 2013, we do not guide to such revenue due to the general uncertainty around and timing of milestone achievements and payments. We continue to forecast that research and development expenses will increase from 2012 to $67 million for 2013. The increase from the prior year reflects the continuing ramp up of the Phase II clinical trials related to our SGI-110 and AT13387 development programs.

The noncash charge related to the amortization of intangible assets is anticipated to be approximately $8 million for 2013, while general and administrative expenses are expected to decrease modestly from the prior year to $15 million. And the estimated income tax benefit is now forecasted at $5 million for the year.

Considering the impact of the operational initiatives influencing our financial guidance, we are forecasting a net loss for 2013 of approximately $30 million versus the $22 million indicated in our previous guidance for 2013, keeping in mind that this forecast event loss does not reflect any anticipated development in license revenue that may result during this period nor does it speak to our cash flow status for the year. Noncash operating charges for 2013 included in total operating expenses continue to be estimated at approximately $12 million.

This concludes the review of our 2012 fourth quarter and year-end financial results and comments on our updated annual financial guidance for 2013.

I will now turn the call back to Dr. Manuso for closing remarks.

James S. J. Manuso

Thank you very much, Michael. In 2012, Astex's financial strengths, clinical achievements and discovery prowess built upon the foundation that has been put in place over previous years. Dacogen was approved in the EU for elderly AML. 2012 Dacogen royalty revenue, at more than $71 million, was record-setting. A number of innovative trials for our prioritized pipeline products, SGI-110 and AT13387, were initiated in 2012, and we will report on their progress during 2013. Indeed, we plan to announce SGI-110 proof-of-concept data in the MDS and AML indications later this year as we plan for a Phase III program of SGI-110 to commence in 2014. We will announce the selection of a disease indication for the Phase III trial of SGI-110 before year end. Finally, we're preparing to file an IND for a new compound during 2013 and we anticipate new data on novel compounds to continue to emanate from our discovery group. In short, Astex is poised to generate significant value in the relative short-term.

The Astex management team and I look forward to updating you on our progress. Dr. Mohammad Azab, Dr. Martin Buckland, 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] The first question comes from Jason Zhang from Edison Investment Research.

Jason Zhang - Edison Investment Research Limited

A question for Jim, maybe. Have you in the past divided the revenue from -- that was reported by Eisai or Janssen? I just wanted to get a sense of how much is from the U.S. and ex-U.S.? And also related to that is, I guess, IP positioning for Dacogen, outside of the U.S., outside of Europe. And I know in the U.S. you were expecting generics. So what's the status of the rest of the world other than Europe? And I would like to get that, get a sense of how the revenue will grow outside of the 2 major markets.

James S. J. Manuso

Right, by all means. Well, we've typically not broken out the data. But recently, we have. And I'll ask Michael to comment on that.

Michael Molkentin

Yes, we started last year disclosing the breakout of primarily between the U.S. and the rest -- or North America and the rest of the world in our quarterly filings because we thought that was helpful information for people to better understand where the revenue is being generated, particularly with the lapsing of Orphan Drug exclusivity later this year and then the ramping up of sales on our European side. So for the year, what we will disclose in our 10-K will be on the U.S. side that there was approximately $225 million worth of sales. On the rest of the world side, about $57 million, for a total of $281 million. Now keep in mind that, that number is adjusted on a cash basis and corresponds with the recognition of a royalty revenue that we recognize a quarter in arrears.

James S. J. Manuso

And relative to the IP of Dacogen, as you know, we're going off orphan designation in May of this year. But we recently achieved the orphan designation when the drug was approved in the EU. And that lasts for a full decade. Elsewhere around the world, there may be generic competition, and it depends on the particular jurisdiction. What's most important, however, is that we do anticipate genericization [ph] fairly rapidly in the U.S. after the May 2 date. And then with respect to the drugs being sold in the rest of the world, it's really on a jurisdiction by jurisdiction basis, aside from the fact that it enjoys a 10-year orphan designation in the EU. And we'll update you as the ramp is revealing itself to us. The other thing is that -- and we have no knowledge to date as to the prospects of the drug being taken to Japan, where if it were to be approved for elderly AML in Japan, that would allow for an additional 10 years of orphan exclusivity there.

Jason Zhang - Edison Investment Research Limited

And also, I just have one follow up, Jim, if I may, which is the pediatric indication in the U.S. I know Eisai -- or you have said that Eisai was at least trying to do that. And when -- if they have been trying that, when would we know that they have gotten indication for pediatric use or not? I guess, that certainly change...

James S. J. Manuso

Yes, there was the prospect of that. The agency did in fact reveal to Eisai that they did not qualify for the extension. So the drug is going off orphan designation on May 2, as indicated previously.

Operator

The next question comes from Mike King from JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

I just wanted to see if Mohammad could help us understand how we can think about the derisking process behind SGI-110. And what I mean by that is, that since you got 2 indications -- and potential indications anyway, MDS and AML, and within AML you've got under 65 and over 65. What kind of -- yes, everything so far has been done in a single arm basis. What kind of clinical endpoints should we be thinking of as we look to see further derisking steps for the compound?

Mohammad Azab

Well, actually, we'll get most of this data from the Phase 2 expansion because we saw several important points you raised. First, in terms of the actual patient population. The current Phase II expansion inclusion is actually stratified by 3 different strata, each one of them representing a different patient population. So one strata is a previously untreated MDS, and that's important to try to evaluate those data in the context of prior data from Dacogen or Vidaza.

Michael G. King - JMP Securities LLC, Research Division

Is that high risk MDS?

Mohammad Azab

Yes. Intermediate or high risk MDS [indiscernible]. And the second strata or second patient population is the elderly AML patients not suitable for induction, more than 65 years of age. Because that also would allow us to assess the data in comparison or in the context of prior data published for Dacogen in the Phase III, as you know. And the third strata or patient population is the relapse AML. Those of course, there is nothing approved in the relapse AML settings. And all the 5 AML responders, or we have seen in Phase I, are of course, in the setting of relapse AML because that's the only patient population that we allowed in the Phase I. So actually there are 3 different patient populations the trial is stratified for that. In addition, we will also have information from the actual dose that we would like to select for the Phase III because, as you know, the expansion is randomized. All these 3 strata are randomized between the 60 milligrams per meter square, which we assessed as the biologically effective dose, and 90 milligrams per meter square, which was very well tolerated by both MDS and AML patients. So based on the data from the Phase II expansion, as I explained it, that would really guide us in terms of the selection of the Phase III, and that's why we have not yet committed to one particular indication at this point in time.

Michael G. King - JMP Securities LLC, Research Division

Okay, and if I could just ask a couple of quick follow-ups. So I presume in MDS your registration endpoint would be transfusion dependence? Or would it be progression to leukemia?

Mohammad Azab

There was so far -- the FDA had accepted several endpoints, but that would be a subject of discussion with the agency. As you know, Dacogen was approved based on response rate with a supplementary kind of endpoint of transfusion independence. Vidaza was initially presented as response rate that later have been improved survival, so that's another endpoint. And recently, as you know, the overall azacitidine work in Phase III had focused on transfusion independence for low-risk MDS. So that seems to be in agreement with the FDA. So there seems to be there are different options for endpoints in MDS depending on the patient population.

Michael G. King - JMP Securities LLC, Research Division

Okay. And then when comes to elderly AML, previously untreated, what are you doing to tighten up the inclusion and exclusion criteria so that these are truly patients who would not get or are truly not suitable whether it be by performance status or other measure, cytogenetics, et cetera? What kind of things are you looking at there that can again derisk the program?

Mohammad Azab

Yes, that's a very good point, Michael, and actually, we had an initial discussion of the IND stage with the FDA on that. So in the current trial, we do have certain criteria for those patients, not just simply based on age. But they need to have other poor risk criteria and they are different. So that includes either having a compromised organ function and there are certain definition of those. They're poor cytogenetics and once again, there are certain definition of those in the protocol. Or having a secondary AML because secondary AML also is a poor prognostic criteria for those patients. So there are certain definitions in the protocol that tighten the patient population, and that was done in agreement with the FDA at the IND stage.

Michael G. King - JMP Securities LLC, Research Division

Okay. And then it may be premature to ask this question, but I'm going to ask it anyway. The registration strategy in elderly AML?

Mohammad Azab

We have not disclosed that yet. We have not committed to that yet, Mike. But nice try.

James S. J. Manuso

We'll get back to you before the end of the year, Mike.

Operator

I am showing no further questions. I would now like to turn the call back over to Dr. Manuso.

James S. J. Manuso

In that case, I would like to thank everyone for listening in. And please, by all means, contact us if you have any questions. And we'll be reporting on an ongoing basis our achievements throughout the year. So thank you again and have a wonderful afternoon. Bye.

Operator

Ladies and gentlemen, that does conclude the conference for today. Again, thank you for your participation. You may all disconnect. Have a good day.

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