Ariad Pharmaceuticals Management Discusses Q3 2013 Results - Earnings Call Transcript

Nov.12.13 | About: ARIAD Pharmaceuticals, (ARIA)

Ariad Pharmaceuticals (NASDAQ:ARIA)

Q3 2013 Earnings Call

November 12, 2013 8:30 am ET

Executives

Maria E. Cantor - Senior Vice President of Corporate Affairs

Harvey J. Berger - Principal Founder, Chairman of the Board, Chief Executive Officer, President and Chairman of Executive Committee

Edward M. Fitzgerald - Chief Financial Officer, Executive Vice President and Treasurer

Martin J. Duvall - Senior Vice President of Commercial Operations

Timothy P. Clackson - Chief Scientific Officer and President of Research & Development

Frank G. Haluska - Chief Medical Officer and Senior Vice President of Clinical Research & Development

Analysts

Andrew R. Peters - UBS Investment Bank, Research Division

Y. Katherine Xu - William Blair & Company L.L.C., Research Division

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Cory William Kasimov - JP Morgan Chase & Co, Research Division

Ying Huang - Barclays Capital, Research Division

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

Terence C. Flynn - Goldman Sachs Group Inc., Research Division

Michael G. King - JMP Securities LLC, Research Division

Rachel L. McMinn - BofA Merrill Lynch, Research Division

Eun K. Yang - Jefferies LLC, Research Division

Jonathan Eckard - Citigroup Inc, Research Division

Howard Liang - Leerink Swann LLC, Research Division

Jason Kantor - Crédit Suisse AG, Research Division

Bret Holley - Guggenheim Securities, LLC, Research Division

Nicholas Bishop - Cowen and Company, LLC, Research Division

Carol Werther - Summer Street Research Partners

Ling Wang - Chardan Capital Markets, LLC, Research Division

Operator

Thank you for holding for ARIAD Pharmaceuticals Third Quarter 2013 Financial Results Conference Call. [Operator Instructions] Please be advised that this call is being taped at the company's request and will be archived on the company's website for 3 weeks from today. At this time, I would like to introduce Ms. Maria Cantor, ARIAD's Senior Vice President, Corporate Affairs. Please go ahead.

Maria E. Cantor

Good morning, and thank you for joining us. This morning, we report on financial results for the third quarter of 2013 and provide details on our strategic areas of focus. With me on this call are Dr. Harvey Berger, our Chairman and Chief Executive Officer; Ed Fitzgerald, Chief Financial Officer; Tim Clackson, President of R&D and Chief Scientific Officer; Frank Haluska, Chief Medical Officer; and Marty Duvall, Senior Vice President of Commercial Operations.

During this call, we'll be making forward-looking statements. Please note that these statements are subject to factors, risks and uncertainties, including those that are detailed in our Form 10-K for the year ended December 31, 2012, and other SEC filings that may cause actual results to differ materially from the results expressed or implied by such statements. Now here's Dr. Berger with our opening remarks.

Harvey J. Berger

Thank you very much, Maria, and good morning, everyone. Our call today will focus predominantly on ARIAD's strategic path forward to refocus and realign our operating expenses on those activities that we expect will provide near-term shareholder value. We have taken decisive actions over the past several weeks to meaningfully reduce our cash expenses. In total, we have reduced our estimated 2014 cash used in operations by approximately 35% compared to 2013, and as a result now expect to be able to fund operations to mid-2015. Our focused investments will support initiatives to create shareholder value as follows: we started marketing and commercial distribution of Iclusig in the U.S.; Continued and expanded commercialization of Iclusig in 15 countries in Europe, with pricing and reimbursement approvals expected to occur throughout the coming year; focused clinical development of Iclusig in patients with a refractory Philadelphia-positive leukemias, gastrointestinal stromal tumors and certain other cancers through select company-sponsored and investigator-sponsored trials; advancement of AP26113 to a pivotal trial in ALK-positive non-small cell lung cancer patients who are resistant to crizotinib; important clinical data presentations on both Iclusig and 113 at major medical meetings, including ASH next month and ASCO in mid-2014; and lastly, focused drug discovery efforts to advance one of our ongoing programs with the goal of nominating a potential best-in-class development candidate in the second half of 2014.

Key decisions we have made that will result in reduced or deferred expenses include the following: delaying the start of the SPIRIT 3 trial in the U.K.; eliminating plans to build commercial infrastructure in Japan and Canada; eliminating plans to expand beyond the current 15 EU and European countries where we have a commercial presence; stopping enrollment of patients with EGFR, T790M, ROS1 and other non-ALK tumor types in the ongoing clinical development of 113; and lastly, reassessing our plans to occupy our new corporate facility in Cambridge.

We have many details to share with you this morning. Ed Fitzgerald will cover our financials; Marty Duvall will review the U.S. Iclusig launch and EU Commercialization progress; Tim Clackson will provide a broad R&D update; and Frank Haluska will discuss issues relating to Iclusig.

Edward M. Fitzgerald

Good morning, this is Ed Fitzgerald.

As noted in our press release issued this morning, third quarter Iclusig net sales were $16.7 million using the sell-through method of revenue recognition. As of September 30, we had $4.9 million in deferred revenue, representing Iclusig inventory at specialty pharmacies and specialty distributors in the United States, which had not yet shipped to the end customer.

During the third quarter, we shipped $2.9 million of Iclusig to patients in France through the ATU program, which we will not record as revenue until the commercial list price is established in France, which is the anticipated during the first quarter of 2014.

Our net loss for the third quarter of 2013 was $66.3 million or $0.36 per share, compared to a net loss of $53.2 million or $0.32 per share for the same period of 2012. Our R&D expense increased by $6.3 million from the third quarter of 2012 to the third quarter of 2013, reflecting costs to support our clinical development activities for Iclusig and AP26113, as well as discovery research activities. Our SG&A expenses increased by $22.9 million from the third quarter of 2012 to the third quarter of 2013, reflecting our ongoing investment in the commercial launch of Iclusig in the United States and Europe and related activities.

As of September 30, 2013, we reported cash, cash equivalents and marketable securities of $294.4 million, compared to $351.9 million at June 30, 2013.

As a result of our previously announced reduction in our U.S. headcount and other actions we are taking to reduce operating expenses, we now anticipate cash used in operations in 2013 of $240 million to $245 million, compared to our previous range of $245 million to $255 million. We expect research and development expenses of $180 million to $185 million and SG&A expenses of $150 million to $155 million for 2013. We now expect that our cash, cash equivalents and marketable securities at December 31, 2013, will be in the range of $215 million to $220 million.

Over the past 2 weeks, we have begun to implement a revised operating plan that will significantly reduce operating expenses across the entire company through targeted cost reductions in all major areas. As a result of this revised operating plan, we expect to realize a decrease in cash used in operations in 2014 of approximately 35% as compared to 2013. With this revised operating plan, we expect that our current cash, cash equivalents and marketable securities will be sufficient to fund operations to mid-2015. Importantly, this revised operating plan assumes no proceeds from U.S. Iclusig revenue, although we remain focused on all efforts to allow us to restart marketing and distribution of Iclusig in the United States or from partnering, licensing or capital-raising activities.

As Harvey stated earlier, the basis of our investments will be to focus on programs and activities that we expect will provide shareholder value in the near term. We believe that the narrowed business plan that we have established will achieve this goal and provide sustained value and optionality as we move forward.

Let me now turn the call over to Marty to provide detail on the commercialization of Iclusig to date.

Martin J. Duvall

Good morning. I would like to quickly provide an update on our Iclusig commercialization highlights in both the U.S. and our ongoing advancement in Europe. Specific to the U.S., prior to the suspension of marketing and commercial distribution on October 31, the following was achieved: more than 1,000 U.S. patients were treated with Iclusig obtained commercially from January through October; more than 600 patients were actively receiving Iclusig therapy at the end of October; since launch, more than 600 unique physicians had written a prescription for Iclusig, both in the academic and community settings; as measured by IMS, Iclusig total prescriptions tracked 30% higher than the Nilotinib U.S. launch in its first 10 months of availability and 2.5x as many prescriptions were written for Iclusig than bosutinib in that period. Since June, Iclusig was established as the market leader among patients who had failed 2 prior TKIs.

Through the first 3 quarters of launch, cumulative U.S. Iclusig sales were just under $40 million, which excludes October sales in which a record number of bottles were pulled through the distribution channel and will be recognized and reported in Q4. Since early November, in conjunction with the FDA, ARIAD continued to meet physician requests for Iclusig through a single-patient IND program. Through this program, patients are currently receiving Iclusig at no cost. Patients receiving Iclusig through the IND process will not be captured through the IMS data sources. So effective November 1, there will be no Iclusig prescription data reported through IMS.

Turning now to Europe. Our EU commercialization continues in early-launch countries. And following the completion of 23 pricing and reimbursement submissions by year end, our near-term focus remains on P&R approvals, which will lead to right-sized and productive promotional activities in 15 select countries in 2014. We are extremely pleased with our launch progress to date with a small, focused and resourceful team, building awareness in academic centers first, followed by community centers in countries appropriate for commercial activities at this early point in time.

Last week, the EMA provided an update from its Pharmacovigilance Risk Assessment Committee or PRAC meeting. There are 3 important aspects of the PRAC findings and recommendations: first, patients and health care providers may continue to use Iclusig with increased focus on its approved use; second, patients should be monitored carefully for evidence of thromboembolism; and finally, the product information should be updated to include strengthened warnings on the cardiovascular risk and guidance on optimizing the patient's cardiovascular therapy before starting treatment. We expect the CHMP to issue its formal opinion based on the PRAC recommendations during its next meeting, likely later in November. In the third quarter, commercial revenue recognition was limited to Germany, the U.K. and Austria. As mentioned by Ed, third quarter ATU sales reached a new high, with deferred revenue of $2.9 million. Of note, in accordance with ASNM guidelines, the ATU concluded on September 30, representing the 3-month mark since EMA approval. Currently, Iclusig is being provided through commercial channels in France, but promotional activities will commence only after the pricing approval process is completed in the next couple of months.

In Q4, our sales opportunity increases. In Italy, Iclusig has been approved through the L648 pre-approval, non-promoted sales process for patients who cannot benefit from currently available therapies, confirming IFA's [ph] assessment that Iclusig meets an unmet need. Commercial activities have also started in the Netherlands. In the first quarter of 2014, we expect the Swissmedic approval of Iclusig. Additionally, in the first half of 2014, we expect to begin promotional activities in Italy, France, Sweden, Denmark, Norway, Finland and Belgium, followed by Spain in the second half of the year. The EU team will now lead the way for ARIAD in making sure that no resistant/intolerant CML patients are left behind.

In closing, let me say I'm extremely proud of the outstanding achievement of our U.S. sales and market access team. They exceeded expectations across the board, including penetration of Iclusig into earlier lines of treatment, penetration of Iclusig into the community setting and earned superior customer feedback on service levels versus our big pharma competitors in proprietary marketing research. Our team was exceptional, and I look forward to restarting the promotion of Iclusig in the U.S. market and helping to make a real difference in the lives of many patients who can benefit from our drug.

Now let me turn the call over to Tim.

Timothy P. Clackson

Thanks, Marty, and good morning. I would like to provide some additional context around our prioritized R&D investments and also update you on recent discussions with the FDA.

First, on Iclusig, we are in continued discussions with the FDA with the goal of returning Iclusig to the U.S. market as quickly as possible for the appropriate patients with appropriately updated U.S. prescribing information and risk mitigation strategy, including a REMS that incorporates an ETASU program. We are also working diligently to address items related to the partial clinical hold with the goal of addressing as many clinical trials as possible by year end. The populations of each trial are different, and time lines for lifting of the partial clinical hold will vary.

As part of our revised operating plan, we've narrowed our clinical trial investments to focus on the following near-term priorities: Phase I and PACE trial patient follow-up; closeout of the EPIC trial and data analysis, with timing of data presentations to be determined early next year; enrollment of additional resistant or intolerant CML patients, either in the U.S. or otherwise, to further evaluate Iclusig at lower starting doses than in the PACE trial; completion of the Phase II trial in patients with refractory GIST. This trial is almost fully enrolled, and we will submit data for presentation at ASCO next year; continuing to follow patients in our Phase I/II trial in Japanese patients with the resistant or intolerant CML. This trial is now fully enrolled. We also will continue to invest in preparing regulatory filings on Iclusig in Japan; pursuing a refined list of ongoing and future Iclusig IST, investigator-sponsored trials, both in Philadelphia-positive leukemias and others -- and other tumor types, including those driven by FGFR and RET; and finally, the SPIRIT 3 trial is delayed but we are collaborating actively with the NCRI in the U.K. to determine how best to proceed at the appropriate time.

For 113, we will focus only on ALK-positive lung cancer, both treatment-naive and resistant and those with CNS activity. We will no longer enroll EGFR, T790M, ROS1 or other patients in the ongoing Phase I/II trial. The pivotal registration trial of 113 in ALK-positive non-small cell lung cancer patients who are resistant to crizotinib will begin in early 2014 upon confirmation of the safety and efficacy profile of the selected dose of 113 in the ongoing Phase I/II trial. This will be a single-arm, open-label global trial of approximately 150 patients. We will expect full patient enrollment in the trial within less than a year after it begins. We continue to regard 113 as a potential best-in-class ALK inhibitor and are eager to advance the program.

Finally, we decided to maintain our drug discovery efforts but to narrow them substantially with a focused goal of nominating our next development candidate in the second half of 2014. All discovery resources have been refocused for now on a single program driving towards the potential best-in-class development candidate in a class of solid tumors. Another late-stage discovery program has been shelved in concert with the staff reductions that we enacted last week.

Now before turning the call back to Harvey, Frank and I would like to provide clarification on the recent FDA communication regarding the safety data on Iclusig and how it appears that these data has been analyzed by the agency.

On October 31, following our announcement of the temporary marketing suspension of Iclusig in the U.S. in response to the FDA's request, the FDA issued a drug safety communication announcing the suspension and describing the findings of the FDA's own analysis or investigation of the risk of vascular occlusive events in the Phase II PACE trial, as well as the Phase I trial.

The drug safety communication and these analyses were not shared with us in advance. The communication stated that approximately 24% of patients in the Phase II PACE trial with a median treatment duration of 1.3 years and 48% in the Phase I trial with a median treatment duration of 2.7 years have experienced serious adverse vascular events. Our discussions with the agency on a revised U.S. prescribing information and risk mitigation program continue. These discussions remain the primary venue for us to discuss the FDA analysis of these events and how they should be reflected in a new U.S. label. However, given the extensive global visibility that has been garnered by these new and significantly increased percentages, we feel obligated to explain how we believe the FDA analysis was done, its relationship to the agency's own analyses that supported the initial assessment of a positive risk-benefit balance at the time of initial Iclusig approval in the U.S. and its relationship to the safety analysis of the trial investigators and ARIAD.

The safety profile of Iclusig is described in the 2 papers published in the New England Journal of Medicine, and the cardiovascular risk profile is addressed in both the editorial and the perspective that were published most recently in the November 7 issue of the journal.

Now I'd like to turn over to Frank.

Frank G. Haluska

At the time of initial approval of ponatinib, the FDA articulated a category of serious arterial thrombotic events in the U.S. prescribing information. These events were defined using the standard U.S. regulatory definition of a serious adverse event, or SAE, as identified by the treating investigators. Based on the number of patients experiencing SAEs of this category, as of July 2012, 7.6% of patients in the Phase II PACE trial had experienced a serious adverse arterial thrombotic event. This number is the basis of the 8% of events noted in the boxed warning of the USPI by the FDA. As of September 3, 2013, utilizing the data cut that forms the basis of the most recent analyses and using the methodology employed by the FDA in the original approval, 11.8% of patients experienced an arterial thrombotic SAE. This number was reported in the recent New England Journal of Medicine article. Of note, over the period of time from July 2012 to September 2013, the total drug exposure to ponatinib of patients in the PACE trial increased by a factor of 1.7. The number of arterial thrombotic SAEs, by increasing from 7.6% to 11.8%, increased by a factor of 1.55. In its recent drug safety communication, based on the analysis of the same September 3 data, the FDA expressed a frequency of serious vascular occlusive events in the Phase II trial at 24%.

There are at least 2 important differences between the FDA analyses and others: first, a new definition of events has been articulated that lumps together more types of events, adding venous events to arterial events and including events of more diverse nature such as peripheral coldness or single observations of noncardiac chest pain; second, the analysis now considers any adverse event as serious, whether it was designated by the investigator as an SAE or not. These changes provide the impression that the rate of serious events in the trial have dramatically risen. In fact, when we compare the time points of approval, based on the July 2012 data, and today, based on the September 2013 data, using the same methods and the same terminology, the incidence of serious adverse events of cardiac, cerebral or peripheral vascular etiology has changed from 8% to 12% during which the time -- during which time exposure has increased by a factor of 1.7. When venous thrombotic disease is included, the serious adverse event rate has moved from 11% to 15%.

The updated safety data of the PACE trial will be presented at the upcoming ASH annual meeting by the PACE clinical investigators and authors.

A similar analysis has been applied by the FDA to come to a 48% rate in the Phase I trial. Using the methods of the original analysis and counting SAEs, the rate is 22%. One patient out of the 65 Ph+ patients in the trial discontinued ponatinib treatment with a vascular occlusive event. No patient died due to such an event. The drug safety communication highlighted that patients in certain categories have had events, for example, patients in their 20s. A special focus on such a patient is appropriate. We have reviewed all the patients who were in their 20s in our Phase I and Phase II studies. 3 of 42 patients whose age was in their 20s had vascular events, 1 was an SAE or 2%. The overall incidence was 7%. All were ill and had no available treatment options. One patient died with recurrent blast-phase disease and disseminated intravascular coagulation. A second patient with blast-phase was treated for a year with recurrence of his disease. A third has experienced nearly a 3-year response in chronic phase and remains on study.

ARIAD is committed to a full scientifically and medically rigorous analysis of the vascular occlusive effects of Iclusig. We are also committed to identifying the patients where the benefits of Iclusig outweigh the risks based on data and on a careful consideration of the risks of adverse events weighed against the risks of disease progression. We are continuing to work collaboratively with the FDA on these goals, defining the appropriate patient population for use of Iclusig, the appropriate indication for use and the appropriate risk mitigation strategy for the safe use of Iclusig.

Let me now turn the call back to Harvey.

Harvey J. Berger

Thank you very much, Frank. With this update, operator, please open the lines to analysts' questions.

Question-and-Answer Session

Operator

[Operator Instructions] Your first question comes from the line of Matt Roden from UBS.

Andrew R. Peters - UBS Investment Bank, Research Division

This is actually Andrew Peters in for Matt. Just wondering, from a process standpoint, what exactly needs to happen to get the drug back on the market? And when you talk about kind of a narrowed label, what are your impressions of what populations you think that would specifically apply to? And can you help us, I guess, size that opportunity relative to the existing label now?

Harvey J. Berger

Well, Matt, it's Harvey -- or it's not Matt, but Andrew, it's Harvey. In terms of a narrowed label, I think it is really too early to make any comments as to what we envision that label will look like. The key to deciding what the revised U.S. prescribing information will look like is going to be dependent in the end upon agreement what the actual risk is, what sort of REMS and ETASU can be used to help mitigate the risk and to educate and train physicians and patients on the risk, whatever the level of risk might be. So I think we're very focused on working with the agency to define the risk, define the appropriate population. I suspect it will be narrowed relative to the PACE trial entry criteria. But at this point, it's really too early for us to put forth a proposal as to how narrow or broad it actually will be. We certainly don't believe it will be limited to T315I, if that's the implicit question. We think it will be substantially broader than that. But it's just too early to give you that guidance.

Operator

Next question comes from the line of Katherine Xu from RBC Capital Markets.

Harvey J. Berger

Katherine, you're on, from William Blair.

Y. Katherine Xu - William Blair & Company L.L.C., Research Division

Okay. Yes, from William Blair. Okay, just want to make sure. So my question is, what kind of dosing selection is ongoing for 113 before the pivotal starts?

Frank G. Haluska

At present, we're employing the same dosing regimen that was described at ESMO. That is initiating patients at 90 milligrams, and after 7 days of exposure at 90, increasing their dosing to 180 milligrams.

Harvey J. Berger

With the goal then, Katherine, of using the 180 as the going-forward dose, as we previously said, and starting with a lower dose, as put forth at ESMO, to lower the potential risk of any early side effects. We felt strongly, back at ESMO, that we could go forward with that dose. But given everything that has gone on, we've taken the decision to accrue some additional patients with that dosing schedule to just increase our confidence that we have the right safe dose.

Y. Katherine Xu - William Blair & Company L.L.C., Research Division

So what is the gating point for starting that study then? So you're just waiting for this cohort to come up and see whether there is any -- that the coughing and other side effects are lower from this cohort?

Harvey J. Berger

Well, we expect that the incidence of the early pulmonary effects to be largely not present at the 90, 180 dose, 90 for the week and 180 thereafter. And in all the cases where any of the pulmonary effects have been seen, it's been seen in the first week of treatment at the dose. So we'll enroll a small cohort. There's no particular number, but all the cohorts in that trial are about 20 patients. So we're well along the way in having those data since we make the decision right after ESMO, really before any of these recent things about Iclusig cropped up, to collect additional data prior to actually kicking off the pivotal trial.

Y. Katherine Xu - William Blair & Company L.L.C., Research Division

Okay. And onto Iclusig, just one follow-up question. Do you think, with the profile you see so far -- maybe there are some differences in analyses between yours and the FDA's. But do you think Iclusig could go back anytime to the front line setting at all?

Harvey J. Berger

It really depends on the dose and the data we collect in the front line. Clearly, we need to run trials at lower doses. We don't rule out the front line. But it would have to be based upon data, not just hypothesis.

Operator

The next question comes from Michael Yee from RBC Capital Markets.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Two quick questions. Do you expect a ODAC FDA panel? I know that Tim had mentioned that at the end of a call, 2 calls ago. So I just want to clarify where you actually stand on the likelihood of an FDA panel, given recent discussions you've had with the agency. And the second question is, you went through a lot of the differences in how the thrombotic events are counted. I guess, why was the change in the FDA methodology? Where did that come from? And is that what's going to be likely in the label?

Timothy P. Clackson

Mike, this is Tim. Regarding your first question, we don't have any further information on a potential ODAC. It remains a potential. I think it's the kind of event that you could see as logical, given the status of the program. But we don't have anything more definitive. We just wanted to make sure that people were aware of that possibility. And regarding the second question, I think that's not anything that we can comment on or know. But clearly, the nature of the analysis has been evolving. So we're just not really in a position to comment on that.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Okay. And just one last question. Do you guys -- can you confirm -- I think you said this on the call, but can you confirm we should not be showing revenues for Iclusig going forward? I think you said you're not booking revenues. Is that fair?

Harvey J. Berger

In the U.S. We're obviously going to book revenues in Europe. In the U.S., we'll end, I mean, whatever revenues there were through October 31. Those revenues, once we collect the follow-up that's necessary, but there will be revenues through October 31. But we're not charging at the moment for the single patient or emergency INDs.

Michael J. Yee - RBC Capital Markets, LLC, Research Division

Were the product ever come back would that be revenue that came back? Is there credit on that? Or I'm just -- I mean, it matters for cash. I'm just trying to figure out if that's no cash ever coming in from...

Harvey J. Berger

I'm not sure what the question is. I mean, the revenues, unless we charge for the single-patient IND, then there is no revenue now or in the future for the single-patient IND. And at the moment, we're not charging. And charging under the single-patient IND is largely a cost recovery program. And I'm not sure that at the moment we're going to charge either now or into the future.

Operator

The next question is from Cory Kasimov from JPMorgan.

Cory William Kasimov - JP Morgan Chase & Co, Research Division

Can you please break down the thrombotic events on a per 100 patient year exposure analysis and perhaps compare that to Nilotinib? And then second question I have is, do you have any granularity at this point yet when you're looking at the lower doses of Iclusig on how low you may start?

Frank G. Haluska

Cory, thanks. So with your first question, we don't have good data to compare to Nilotinib. We have some front line data. We know of some case reports that suggest that the incidence is real in that patient population, but difficult to compare to ours. Our best estimate of our data is based on the number of arterial thrombotic SAEs, that is the serious adverse events, when normalized for patient exposure. At the time of approval, it was 9.7 per 100 patient years. Now, it's 9.2 per 100 patient years. I'm sorry, there's one other question for Cory. Cory, you asked about the dose that we might start at. Ponatinib is a very potent drug. We know from the observations based on the clinical data that we have collected, especially those that support dose reductions in patients that have been treated on PACE, the dose reductions to 30 milligrams and 15 milligrams support continued maintenance of efficacy. And we know that there's a long tradition in treating advanced leukemia of dose induction and then maintenance therapy strategies. So one aspect of the dose question is whether we can start at higher doses like we have been for patients who are very ill and then dose reduce. With regard to new data on starting at lower doses, we have very little data so far on lower exposures from patients who were started in the Phase I trial at lower doses. But those data also support its substantial potency. So I would have to say that, based on the analyses that we've done, we certainly will test 30 and 15 milligrams. At some point, I wouldn't rule out testing lower doses as well.

Operator

The next question comes from the line of Ying Huang from Barclays.

Ying Huang - Barclays Capital, Research Division

So first one, regarding to the sales expense here, it sounds like you don't assume any sales prior to mid-2015. So when do you expect the expense would ramp down in this period, just regarding sales? And then, whether you have any personnel retained for that purpose? And then secondly, the PRAC committee from EMA put out a press release basically telling the patients to continue on therapy. But then we also expect a CHMP opinion, I think, in about a week. Can you frame us any expectation what the CHMP might recommend?

Harvey J. Berger

Let me try to take the first half -- the first question. We are not assuming revenues in our base conservative plan for Iclusig in the U.S. Obviously, we are assuming revenues in Europe, outside the United States. And so we've obviously cut expenses associated with not assuming revenues in the U.S. That doesn't mean we don't think there could be a restart of commercialization and distribution of Iclusig in the U.S. within the next 18 to 20 months. We're merely, from a budgeting point of view, going on the assumption that we won't have revenues so that we're taking the worst case with respect to U.S. revenues. If, in fact, we are able to get Iclusig back on the market for commercialization, we'll revise the numbers and project what the revenues would be based on what the label is, what the risk mitigation plan is. But we felt that, from a budget-planning point of view, it was absolutely essential to assume the worst case and restarting of commercialization would be a clear upside anytime within the next 18 to 20 months. CHMP, Tim, why don't you take that?

Timothy P. Clackson

Sure. As I think you know, the CHMP will meet in 2 weeks' time to consider, among other things, the recommendation of the PRAC. I don't think we're really in a position to comment more beyond that. We expect that the committee will consider the recommendation and it will be their purview to accept it or otherwise. But it's obviously a near-term event.

Ying Huang - Barclays Capital, Research Division

And if I may, what happens with Japanese development of Iclusig? You didn't mention that in the call.

Timothy P. Clackson

As I mentioned, the Phase I/II trial in Japanese patients is complete. So in terms of enrollment it's complete, and patients are continuing to be followed. We've been in very active continuing discussions with the PMDA around the new safety information to ensure that they are completely aware that we have ongoing discussions without any implications in the Japanese development. Of course, the situation is a little different in that we are not on the market in Japan, so the conversation has a different context. But we're having active and productive discussions with them. We continue to move towards regulatory filings in Japan. And those filings have obviously taken into account the ongoing analyses that we have.

Harvey J. Berger

So we expect to file in Europe with the data that we have -- excuse me, in Japan, and have had -- as Tim pointed out, they're completely aware of the results and of the safety update. So the plan is to move forward with filing, which we will do to continue to add value to the global potential of Iclusig.

Operator

The next question comes from Joel Sendek from Stifel.

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

So my question has to do specifically with the restructuring and how you determined how much to cut and I'm wondering if it's enough. Do you have other approaches that you're considering to extend the runway further? I guess, because even after Iclusig comes back on the market, that won't automatically make you cash flow positive at that point. So I'm wondering if you're considering partnering Iclusig in any jurisdiction. And then more specifically, can you get out of your -- the lease for the new headquarters in Cambridge?

Harvey J. Berger

So let me answer. As we pointed out in the -- in our introductory remarks, the proposed -- or the operating plan going forward that we outlined this morning has a reduction in expenditures that are tied to people, programs, the scope of what we do. We -- as with the answer to the prior question regarding revenues over the next 18 to 24 months, what we've put forth is a worst-case operating plan. It makes no assumptions whatsoever about revenues from partnering, licensing or any other activities, and particularly, none with respect to licensing or partnering. Obviously, there are opportunities outside of Europe. Even in the U.S., Japan and elsewhere, where we certainly have the choice to partner. All that's part of the options that we have. And I think once we have clarified the current situation in the coming few months with the FDA, have confirmation of where we are in Europe, all of those opportunities will be considered with the goal, as you've said, to further extend the runway beyond mid-2015.

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

And the Cambridge lease?

Harvey J. Berger

Oh, Cambridge lease, we have obviously had discussions and will continue to have discussions with our landlord, who's obligated to build the building and to do the tenant improvement, have the tenant improvement expenditures in the building. We really have no obligations in terms of costs near term. And so to the extent that the building will go up, that's a cost that's borne by the developer. To the extent that there are expenditures related to aspects of the internal improvement of the building, we have no expenditures near term. And so we are clearly in discussions and will continue to have discussions with the landlord about what we do long term. There's really very little, if any, expense related to the building in our base plan.

Operator

The next call comes from Terence Flynn from Goldman Sachs.

Terence C. Flynn - Goldman Sachs Group Inc., Research Division

Was just wondering if you can comment at all on what you're seeing in Europe on the sales trends there post all the news. And then, any detail you can give us on what level of revenue you'd need to achieve to breakeven on the European side of the business.

Harvey J. Berger

I think it's too early to answer the second question, given that we've only launched in a few countries and we're pre-commercial and pre-P&R approval in much of Europe. So I think it's just too early to address that issue. But I'll let Marty comment to the extent he can on the first question.

Martin J. Duvall

Yes, I think that's kind of where we're at, Terry. Obviously, the majority of revenues in Q3, given limited revenue recognition opportunity in Europe to the U.K., Austria and Germany in the third quarter, it wasn't a significant part of our revenue in the third quarter. Certainly, on a go-forward basis, the European opportunity is a large opportunity. We've previously disclosed 3,800 switches of TKIs in the European marketplace, so we will provide much greater granularity going forward as we recognize revenue and build our launch revenue in Europe in the quarters going forward.

Operator

The next question comes from the line of Mike King from JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

Just curious. In all this discussion about Iclusig, I've never heard mention made of anything that adverse events that were reported to the FDA's adverse event reporting system, and I'm just wondering if anything in PACE has jived with what has been a logged in the AERS system. If you could just maybe comment on that? I'm also wondering if we can catalog these adverse events by line of therapy and/or whether or not the patient had T359 mutations.

Frank G. Haluska

Mike, the reporting is generally qualitatively in line with what we've observed in the clinical trial setting. Quantitatively, it's very difficult to make -- to draw conclusions from what is reported through that system. The denominator is very difficult to identify. And I think that we and the FDA both assume some degree of underreporting in the field. So by and large, we haven't seen anything from the adverse event reporting that is substantially different from what we've observed in the clinical trials. I think that's been the reason for the focus on the clinical trial numbers because of the certainty about the denominators. I'm sorry, the second part of your question, Mike, was with regard to...

Michael G. King - JMP Securities LLC, Research Division

Was -- yes, whether we can -- whether this [indiscernible] to the line of therapy or the presence or absence of T359 [ph]?

Frank G. Haluska

Well, we've looked -- I'm sorry, there's some interference here. It's hard for me to understand exactly what's coming through. In general, we've performed multivariate analyses that we will be presenting at PACE. And much of this is true for the multivariate analyses that we've performed and shown in the academic setting with regard to other adverse events and with regard to efficacy. The major determinants are dose intensity and a variety of risk factors. So when multivariate analyses are carried out, there's no particular association with mutation status or disease phase, for instance. But things like a past history of ischemic disease, patient age and a history of diabetes are all very important determinants, which, to some extent, explains some of the events that have occurred in the PACE trial.

Martin J. Duvall

And Mike, from a commercialization point of view, while we have a good lens on patients by line of therapy, there really is no way to correlate that data to the AERS information. So we're not able to really provide that type of detail on a line of therapy basis.

Operator

The next question comes from the line of Rachel McMinn from Bank of America.

Rachel L. McMinn - BofA Merrill Lynch, Research Division

I wanted to better understand, just clarify your guidance. Are you making an assumption for European revenues next year when you talk about a 35% reduction in net cash used? And then, I guess, just bigger picture, is it -- I mean, can we really take the guidance of what you're doing in Europe right now? I mean, it just seems like you're right in front of the CHMP decision. You don't really know what's going to happen there. Events are continuing to unfold pretty quickly. So I just want to know how comfortable you are with your strategy to keep marketing in Europe.

Harvey J. Berger

Rachel, certainly, we are making assumptions, internal assumptions about continuing to commercialize in Europe. We think the PRAC committee recommendations are a good guide for Europe. They are not the final bottom line, the approval or reconfirmation by the CHMP, obviously, is the ultimate decision-maker. But the PRAC committee is a very senior committee of regulators and country representatives in Europe. That, I think, is a very good guide for how the EMA will ultimately act via CHMP. So I think it's a very good place, given where we are. And importantly, we're going to know a lot more, almost certainly, in the next couple of weeks, this month, with regard to the assumptions we've made in Europe. Again, the PRAC committee report is public. They've certainly made statements that I think are a good guide, and it's the best information that currently exists. They've seen all of the data that the FDA has seen. They've seen every bit of the analysis that we described -- or that Frank described earlier. So it's not as if they haven't had access to anything. They've had full access to every bit of safety information, all the analyses, and obviously, will be acting with the background of the drug safety communication. So I think it's a good guide, given where we stand today.

Rachel L. McMinn - BofA Merrill Lynch, Research Division

And then just as a follow-up on 113. Can you just give us a sense of what level of discussions you've had with the FDA? I guess, where I'm going with this is just it seems like there's still relatively new information on what the right dose is, given the pulmonary events seen in that first week of dosing and 2 of your competitors have breakthrough status and you were turned down. So I just -- I guess, I want to understand how comfortable you are with moving into a pivotal design if you're on the same page with the FDA.

Timothy P. Clackson

Rachel, we've had the standard types of discussions on [indiscernible] pivotal trial with the FDA and have a full buy-in the trial design. Regarding your comment on breakthrough, we don't see -- obviously, what you say is factually correct -- we don't see that as a -- anything with any implications with regard to the specific design of our trial or the 3 agents. The major reason that was articulated by the FDA for denial of breakthrough status at the time we applied for it was the relatively small number of patients and the relatively short nature of the follow-up. And clearly, the other 2 agents that were submitted had somewhat larger numbers in both of those areas.

Harvey J. Berger

And longer follow-up.

Timothy P. Clackson

Right. So that is not anything that we see as precluding or blocking the development of 113. Everything that we've seen in our data and the discussion with the investigators is consistent with the potential of 113. I think a very strong and important activity in the area, certainly, very impressive activity in the CNS, in particular. And we've seen no indication not to proceed with the trial that we have laid up. We think it's prudent to collect more data, as we discussed earlier, on the loading dose schedule and that's why we'll invest a bit of time to do that and then move very quickly to the Phase II trial, which is essentially keyed up, ready to go.

Operator

The next question comes from Eun Yang from Jefferies.

Eun K. Yang - Jefferies LLC, Research Division

So Merck, for ridaforolimus partner, was planning to develop the drug candidate in different cancer indications besides sarcomas. Do you expect any development in the program from Merck that potentially translating into some milestone payments in the near or medium term?

Timothy P. Clackson

I'll take that. So I'm not sure I would guide to near-term milestones from that collaboration. There are -- we are aware of activities, particularly in breast cancer, that Merck is still executing in certain clinical trials. As you know, but just as a reminder, we have no control or involvement in that program, whatsoever. And so it's difficult for us to really weigh where those programs might go. But given the focused nature of that clinical development program and given the macro situation with Merck, in general, I wouldn't point to that as a revenue source near-term.

Operator

The next question comes from Jonathan Eckard from Citi.

Jonathan Eckard - Citigroup Inc, Research Division

The question I had was, could you just please confirm the projected cash usage in operations for '13 so we could use that for our 35% reductions next year? And then, with regards to the PRAC press release, it also highlighted recommendations for an in-depth analysis of the drug's risk-reward profile. It sounds, based on your earlier comments, that you've provided them with all this information. So would it be reasonable to think that this analysis could be present in the CHMP update next week?

Edward M. Fitzgerald

I'll take the first one. This is Ed, Josh. I'll take the first one. We indicated in our the comments that we now anticipate cash used in operations in 2013 of $240 million to $245 million. And I'll let Tim carry on from there.

Timothy P. Clackson

John, I think it's difficult for us to say, just given the interim situation of the contact between PRAC and CHMP. Our impression, obviously having been very deeply involved in the PRAC process, is that, that is something that will probably follow the CHMP as opposed to be part of the process. But that's not something that's certain at the moment. And I think that -- I think that's a more general comment as opposed to a very specific comment.

Operator

The next question is from Howard Liang from Leerink Swann.

Howard Liang - Leerink Swann LLC, Research Division

I guess the first question is, are you doing a clinical trial on Iclusig with some sort of anticoagulant as risk mitigation strategy? And a follow-up is whether a cardiovascular disease factored into ongoing and future [ph] reimbursement decisions in Europe?

Frank G. Haluska

Howard, I'll take the first question. At this time, we don't have an anticoagulant trial planned. I think the more likely approach will be an anti-platelet agent than an anticoagulant. But that is something that we're talking about. Given the rarity of these events relatively and their long time to follow up, remember, although that we're talking about them in great depth, we're again talking about SAEs that have 12% incidence over 2 years. It's difficult to do a trial in the short term that would incorporate those sort of data. So some of what we're gathering are retrospective data, but I'm sure we'll be looking for a way to prospectively identify a strategy. For the second part, I'll turn it over to...

Harvey J. Berger

I would also add that, more than likely, if we were to add a drug, you might think of something as simple as aspirin.

Martin J. Duvall

So on the pricing and reimbursement question. Yes, as those processes continue to move forward, they will take into consideration all available and emerging data.

Operator

The next question comes from Jason Kantor from Crédit Suisse.

Jason Kantor - Crédit Suisse AG, Research Division

Two questions, one on 113 and one on Iclusig. Just following up on the earlier 113 questions. I mean, given what's happened with Iclusig, do you guys [indiscernible] Feel like it would be prudent to slow down, try to characterize the AE profile a bit better rather than going into an open-label study where it's going to be hard to assess what are the AEs, given that these are pulmonary AEs in a lung cancer patient population? So that's question one. And second, just -- I really appreciate all the information on the event rates for Iclusig, but there just seems to be a pattern where FDA says one thing and then you guys come on the call publicly and say something else. So I'm just wondering, what's the logic of having this debate in a public forum? It just seems like every time you guys do that, they come down hard on you at the next possible opportunity. So I'm just wondering why you think this should be prosecuted in public rather than just in meetings with FDA?

Timothy P. Clackson

Thanks. And this is Tim. Let me take both of those. So firstly, with regard to your comment on wouldn't it be better to slow down and understand the AEs, I would say that's exactly what we're doing. We have elected to take a little bit longer time to bring in a few more patients and fully characterize this finding that we have and confirm that it's mitigated by those REM strategies. So I would agree with you. Secondly, with your comment on the FDA, I tried to articulate the reasons very carefully at the beginning of my remarks. The primary forum for us having discussions with the FDA around the data analysis and around their data analysis is our internal and ongoing discussions with the FDA. However, given the dramatically different numbers that were contained in the drug safety communication, that have created a lot of confusion and questions, not least among the investigators but also to us. We actually felt obligated to, in a very careful way, explain our understanding of how -- of where those numbers came from. The presentation that we anticipate will be made by the investigators of the PACE trial at ASH will be an academically rigorous and appropriate place for a full discussion. However, there's an obligation that we had to clarify those particular numbers. Nothing changes our ongoing commitment and I'm sure the FDA's ongoing commitment to expeditiously conclude the discussions around relabeling and risk mitigation.

Operator

The next question comes from Bret Holley from Guggenheim Securities.

Bret Holley - Guggenheim Securities, LLC, Research Division

I guess as a follow-up to one of the last questions. I'm just wondering with 113, has there any consideration given to potentially running [ph] a randomized trial for the pivotal trial against either best supportive care or physician's choice? It just seems like that would give you a little bit more cover, given the experience with a single-arm data with Iclusig.

Frank G. Haluska

Bret, it's Frank here. I'm not sure the Iclusig experience translates to 113. Despite our slowing down, this is not an ARIAD-specific problem. It's a problem for, I think, a long follow-up in a very potent TKI. And I think the better context for 113's development is the development of the ALK inhibitors, and even more broadly, other targeted agents that have been brought forward in non-small cell lung cancer. And we know what those development programs look like for other targeted agents that inhibit ALK. And we've had very productive discussions with the FDA about our plan forward. So I think for the initial pivotal steps, a trial, as is proposed, is certainly a viable approach. What I thought you might say was a randomized trial that would look at different doses, we've certainly discussed that. And unless something emerges from the Phase I/II trial that suggests that, that would be an apt path forward, we feel that we're better suited to choosing a dose in the Phase I/II setting and taking that forward in the pivotal trial. And then, ultimately, the randomized trial would be a trial in a newly diagnosed patient. So we're pretty comfortable as are the regulatory agencies that we've discussed our program with, not just the FDA but the EMA as well, with a single-arm trial for initial either accelerated or conditional approval and then an additional randomized trial and follow-up.

Operator

The next question is from Nicholas Bishop from Cowen and Company.

Nicholas Bishop - Cowen and Company, LLC, Research Division

Just on interactions with the FDA, again made reference a few times on the call to potential relabeling and a REMS program. But I'm curious about one comment the FDA made in their communication on October 31, which was that the FDA at this time cannot identify dose level or exposure duration that's safe. I'm wondering what you think you need to do to address that point. Do you need new trial data? Do you think the data you have in hand will assuage concerns? Or just kind of what are your thoughts on that.

Timothy P. Clackson

Nicholas, what's ongoing in part is a detailed analysis of all of our -- all of the data from PACE to illuminate the potential dose response relationship between dose exposure and the events. That analysis is ongoing. And the comment you referred to in the drug safety communication was preceded by the phrase "at this time." And so those analyses continue. I think as a longer-term question, certainly, new patients who have begun dosing at lower doses will be an important initiative. But for the currently ongoing discussions, it's focusing on analysis of data that we already have in hand, predominantly from the PACE trial.

Nicholas Bishop - Cowen and Company, LLC, Research Division

Okay. If I could just get in one other quick one. On the guidance for next year, it looks like both R&D and SG&A expenses, based on your guidance for this year, are going to go up in Q4. Just kind of wondering if you can give any kind of qualitative commentary on how rapidly those expenses will go down in the early half of 2014. Is there going to be a big cliff in Q1 or a little more gradual? Just any help here would be great.

Edward M. Fitzgerald

We've -- this is Ed. You should expect to see a pretty quick decrease in operating expenses, both in R&D and G&A. There will be some decrease over time next year. But we expect to be seeing the impact of our decisions relatively quickly here.

Operator

The next question comes from Carol Werther from Summer Street.

Carol Werther - Summer Street Research Partners

Do you think you're going to have any inventory returns? And can you give us some guidance on the restructuring charges?

Edward M. Fitzgerald

This is Ed again. We -- at this point in time, we've been analyzing all of the data we have with regard to the inventory and the sales activity of Iclusig. We don't expect that there would be anything that would have a significant impact on our financial statements. But we are working very closely with specialty pharmacies and specialty distributors to make sure that we have all the information we need in that regard. And any impact that we will have to reflect will be reflected in the fourth quarter. As it relates to restructuring charges, basically, we -- this relates to the workforce reduction that we announced and it relates to severance costs and other related costs to address the departure of the employees that have been part of our workforce but will now be looking for their next opportunity.

Martin J. Duvall

So Carol, maybe one additional comment on the inventory situation, is just keep in mind that our revenue recognition methodology was pull-through. So we were not recognizing any revenue for product that was sitting on shelves. So that return would not have an impact on recognized revenue.

Carol Werther - Summer Street Research Partners

Oh, great. But with the restructuring charges, they'll start this quarter, in the fourth quarter, and probably go through next year? Or can you give us...

Edward M. Fitzgerald

Yes, they will be reflected in the fourth quarter. From a cash point of view, those costs will be paid out largely, well, starting in the fourth quarter of this year but will extend into next year as well, probably through much of next year.

Carol Werther - Summer Street Research Partners

Okay. And if I could squeeze in one last one. Can you give us any more information about the product candidate going into the clinic in the second half of '14?

Timothy P. Clackson

Carol, I think what we said today is what we want to disclose at this time. We've really trained all of our guns on one of the programs that had been running, which is, we think, of great promise. I think we've thought very hard about how best to move forward our discovery programs to keep the core of what we have and focus on near-term delivery of events and shareholder value. We're shooting very hard to identify that candidate at or by the first part of next year. We don't see any really competitive advantage to giving any more color beyond that at this time. But I'm sure we'll give more color as the program progresses.

Operator

The next question comes from Ling Wang from Chardan.

Ling Wang - Chardan Capital Markets, LLC, Research Division

So for the Phase I study for Iclusig, can you clarify the serious adverse events rate for arterial thrombosis? And also, can you comment on the doses these patients had?

Frank G. Haluska

Ling, I think you asked for the -- in the Phase I study. Is that the rate that you're asking about?

Ling Wang - Chardan Capital Markets, LLC, Research Division

Right, right, in the Phase I study.

Frank G. Haluska

So the serious arterial events rate in the entire Phase I study of 81 patients is 20%. In the Ph+ subset, it's 22%. And that's across all doses. But the dosing is complicated and many of those patients were dose escalated. And I shouldn't say all doses. I don't think we've observed anything at patients at 2, 4 or 8. But beginning at 15 milligrams and up, we did observe events. And the second aspect of your question, again, please repeat?

Ling Wang - Chardan Capital Markets, LLC, Research Division

Yes. The second part is what are the low -- I mean, what are the doses these patients had? So you said from 15 mg and up. That's -- so as low as 15 mg, right?

Frank G. Haluska

Starting dose is 15 milligrams, yes. But Ling, I think it's important to understand that multivariate analyses are important in understanding how dose plays into risk and predisposition. So those analyses are ongoing and those discussions are underway with the FDA.

Ling Wang - Chardan Capital Markets, LLC, Research Division

Great. And also, I think you mentioned 3 out of 24 patients. So that's only the younger patients in their 20s? Or...

Frank G. Haluska

Right. The reason we focused on that is, the drug safety communication spoke about patients who are in their 20s. I think it's an appropriate patient population to focus on. But of course, we all are concerned that a patient in their 20s might have less tolerance for risk. But I think another alternative way of looking at it is the patients in their 20s with acute leukemia maybe have more of a tolerance for risk. And understanding what those events were and how they actually influence treatment is an important nuance. So I think understanding that 3 patients out of 42 had those events, one of those patients had an event and continued on therapy is benefiting and the remaining 39 patients did not, I think it just provides context. To one of the earlier callers' points, we're not taking the FDA on here, as it were, but understanding how these events influence patients' treatment outcomes as designated by the investigator is maybe more important than how we count them or how we enumerate. The risk-benefit really is a patient-by-patient equation.

Ling Wang - Chardan Capital Markets, LLC, Research Division

Great. If I may, I just wanted to ask, I mean, since you and the FDA are have -- I mean, kind of don't [ph] Disagree on a definition of the SAEs, I was wondering what are the steps or strategies you're going to take to kind of reach an agreement with the agency?

Frank G. Haluska

I think it's continued discussion. The agency has its perspective and we have ours. But we're dedicated to collaborating with them and finding a path to bring Iclusig back to the market. But I think it's also important to note that the FDA is one audience, but there's a worldwide audience. There's an academic audience, as well. And the FDA's perspective is in the context of a global one, too.

Operator

The next question comes from Mike King from JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

I'm just wondering, is there any evidence, even if it's preclinical, that if Iclusig can eliminate the T315I clone and resensitize CML to any of the other TKIs? Or does that data just not exist?

Timothy P. Clackson

Mike, I'll try and take that on. Eliminate is a big word, even when you have a patient in complete molecular response with undetectable transcript by PCR, it's known that there are many thousands or tens of thousands of transcripts lurking there below the detection -- below the radar. So even in a situation, at least with our current understanding, of a patient in CMR on Iclusig who had T315I at the beginning of his or her treatment, if you take your foot off the gas, the understanding is that the T315I will come back. So I think the scenario you laid out is not one that we could see happening. But our interest continues, I think, in understanding what happens to patients who have deep and durable responses to Iclusig and what their next steps could be, including potential discontinuation.

Operator

And I would like to turn the call back over to Dr. Berger for closing remarks.

Harvey J. Berger

Thank you, everyone, for joining us this morning on the call. We look forward to seeing many of you at ASH in a few weeks. I think as you heard today, some of the academic presentations at ASH will be very interesting and very germane to the discussions we've just had. So thank you very much.

Operator

Thank you for joining today's conference call. This concludes the presentation. You may now disconnect. Good day.

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