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Edited Transcript of AAAP earnings conference call or presentation 23-Mar-17 2:00pm GMT

Thomson Reuters StreetEvents

Q4 2016 Advanced Accelerator Applications SA Earnings Call

St. Genis Pouilly Mar 23, 2017 (Thomson StreetEvents) -- Edited Transcript of Advanced Accelerator Applications SA earnings conference call or presentation Thursday, March 23, 2017 at 2:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Jordan Silverstein

Advanced Accelerator Applications S.A. - Director of IR

* Heinz Mausli

Advanced Accelerator Applications S.A. - CFO

* Stefano Buono

Advanced Accelerator Applications S.A. - CEO

* Victor Paulus

Advanced Accelerator Applications SA - Head of Regulatory Affairs

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Conference Call Participants

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* John Newman

Canaccord Genuity - Analyst

* Peter Welford

Jefferies & Co. - Analyst

* Mike King

JMP Securities - Analyst

* Jim Birchenough

Wells Fargo Securities - Analyst

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Presentation

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Operator [1]

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Greetings and welcome to the Advanced Accelerator Applications year-end 2016 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Jordan Silverstein, Director of Investor Relations. Please go ahead, sir.

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Jordan Silverstein, Advanced Accelerator Applications S.A. - Director of IR [2]

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Thank you for joining us today and welcome to the Advanced Accelerator Applications year-end 2016 earnings conference call. Joining us today are Stefano Buono, Chief Executive Officer; Heinz Mausli, Chief Financial Officer; Victor Paulus, Head of Regulatory Affairs; Claude Hariton, Head of Research and Development; and Roger Estafanos, North American Head of Market Access and Pricing.

Before we begin, I will remind all listeners that this conference call contains forward-looking statements. All statements other than statements of historical facts contained in this conference call, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, and objective of management are forward-looking statements.

The words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, continue, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements reflect the Company's current expectations regarding future events and various matters, including expected timing of filings with the FDA and EMA, approval dates, and expansion of NETSPOT. These forward-looking statements involve risks and uncertainties that may cause actual results, events, or developments to be materially different from any future results, events, or developments expressed or implied by such forward-looking statements.

Such factors include, but are not limited to, changing market conditions; the successful and timely completion of clinical studies; the timing of our submission of applications for regulatory approvals; EMA, FDA, and other regulatory approvals for our product candidates; the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies for raw materials for Lutathera and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our product or product candidates by third parties; any problems with the manufacture, quality, or performance of our product or product candidates; the rate and degree of market acceptance in the clinical utility of Lutathera and our other product or product candidates; our estimates regarding the market opportunity for Lutathera; our other product candidate and other existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy, including expansion in the US; our ability to sustain and create additional sales, marketing, and distribution capabilities; our intellectual property and licensing position, legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access, or distribution channels, regulatory actions or litigation, and general economic, political, demographic, and business conditions in Europe, the US, and elsewhere.

Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements whether as a result of new information, future events, or otherwise.

Heinz will start today's call with a review of the financial and operational highlights from 2016. Stefano will then share updates on Lutathera and the outlook for the remainder of 2017. We will then open the call for questions.

Heinz, please began.

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Heinz Mausli, Advanced Accelerator Applications S.A. - CFO [3]

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Thank you, Jordan, and thank you, everyone, for joining us today. Before we go through the financial results, please note that all monetary conversions from euros to dollars are provided for convenience and based on a noon buying rate of EUR1 equals $1.0552 on December 30, 2016.

2016 proved to be another strong year of growth, with a compound annual growth rate of 28% between 2012 and 2016. Total sales for 2016 were EUR109.3 million, that is $115.4 million, a 23% year-on-year increase compared to EUR88.6 million or $93.5 million in 2015. All of our 4 product categories -- PET therapy, SPECT, and other products -- contributed to this growth.

The biggest percentage sales increase was in the therapy category, where sales in 2016 reached EUR20 million, that is $21.1 million, an increase of 81% versus the year 2015. Most of this increase was attributed to Lutathera sales in France, where the product is reimbursed on the basis of a temporary authorization.

The second-biggest category sales increase was in PET, where 2016 sales reached EUR66.5 million, that is $70.1 million, an increase of 11% versus 2015. Our overall sales growth is the result of organic and acquisition-based growth, with contributions from the newly acquired IDB Group in the Netherlands and our acquisition of the right to operate two F-18 radiopharmaceutical production sites in Germany.

Operating loss for 2016 was EUR19.5 million, that is $20.6 million, compared to a loss of EUR9.5 million, that is $10.1 million for 2015. The increase in operating loss was primarily attributable to higher personnel and general operating expenses.

Personnel costs increased by EUR12.2 million, that is $12.9 million, versus the previous year. Headcount increased by 98 people, from 403 in 2015 to 501 in 2016, primarily because of the 2 acquisitions previously mentioned and the growth in our commercial organization, particularly in the US as we launched NETSPOT. Share-based payments, i.e. stock options and employee shares, accounted for 44% of the total personnel cost increase.

General operating expenses, such as leaves, administrative expenses, professional services, and other items increased by EUR8.8 million or $9.3 million during the year. The majority of this cost increase is due to a provision of EUR5.1 million or $5.4 million that we took as a result of an ongoing audit of our R&D tax credit in France.

The conclusion of this inspection remains uncertain at this time. The rest of the cost increase in general operating expenses is mostly due to increased sales and other administrative expenses and higher transfer costs and increased sales.

For the full year of 2016, the Company reported a net loss of EUR25.3 million, that is $26.7 million, compared to a loss of EUR17 million, that is $17.9 million, for 2015. As noted in the reconciliation table in this morning's press release, the adjusted EBITDA for the year was negative EUR7.5 million or $7.9 million compared to a positive EUR1.8 million or $1.9 million for the prior-year period.

We strengthened our balance sheet in October 2016 with a $172.5 million follow-on public offering. This additional cash will be used in part to support Lutathera's anticipated commercial launch and the continued development of our current theragnostic pipeline as well as our efforts to opportunistically expand this pipeline with a focus on high-value therapeutic opportunities and general corporate purposes.

From an operation perspective, 2016 was a very positive and important year with many successes for AAA. We obtained approval for four new PET diagnostic products in a six-month period, including receiving Swiss approval for DOPAVIEW and AAACholine, which has since been launched into the market. The FDA's approval of NETSPOT was a historic moment for the Company, marking the launch of our first product in the US.

This was notable accomplishment for two reasons. First, we were able to achieve this approval in just 23 months following our first pre-IND meeting with the FDA. And second, because we introduced the major innovations to neuroendocrine tumor community, one, that several physicians and patients are saying provides great value and will lead to significant changes in patient management.

The enthusiasm for NETSPOT resulted in initial sales of about $1.6 million in the first 6 months following its approval. We are pleased to share that this momentum has carried into 2017. We are on track to sell more than 1,000 units of NETSPOT in the first quarter.

We are currently delivering NETSPOT to institutions around the country from our 20 existing partner pharmacy sites. And our plan is to increase the number of partner pharmacies to 40 the first half of the year.

CMS granted NETSPOT transitional pass-through status under an A-code in December. And this same code is being used with prior payers, streamlining billing and reimbursement. More recently, NETSPOT was included in the National Comprehensive Cancer Network, or NCCN, clinical practical guidelines oncology update for the evaluation of NETs. This should facilitate coverage from prior payers and increase access for many patients.

In December 2016, we also received approval from the European Commission for SomaKit TOC, the sister product of NETSPOT. Following the warm reception for NETSPOT in the US, we are eager for the upcoming launch for SomaKit TOC in Europe, which is planned for next month.

We've strengthened our supply chain and manufacturing capabilities over the past year with several key acquisitions, and invested in the expansion of our existing global production network. The acquisition of IDB Group in the Netherlands provided us with our own source of lutetium 177, supporting our anticipated launch of Lutathera as well as future lu-177-based therapeutic candidates in our pipeline.

The purchase of the right to operate two F-18 manufacturing plants in Germany expanded our presence in that market and established a new R&D relationship with the University Hospital of Munich. The agreement with ITEL Telecomunicazioni enables manufacturing and commercialization of F-18 radiopharmaceuticals for hospitals and imaging centers in selected regions of Southern Italy.

As for AAA's production network, we increased our capacity for Lutathera production at our Ivrea site in Italy and established our first US manufacturing distribution center in Millburn, New Jersey. The Millburn site will serve as a national distribution center for NETSPOT and will produce the North American supply of Lutathera once the product is approved and the appropriate certifications are obtained. We are currently preparing to start protection of Lutathera in the US for the expanded access program.

Our theragnostic pipeline of oncology products was expanded in 2016 with the in-licensing of two new compounds: NeoBOMB1 and PSMA-R2, both of which are transitioning into the clinic in 2017. We believe that the theragnostic pairing of diagnostic and therapeutic drugs utilizing the same targeting molecule is the future of nuclear medicine innovation, particularly in oncology. The addition of these compounds to our development pipeline extends our list of potential indications to include prostate and breast cancer as well as gastrointestinal stromal tumors, or GIST.

We also continue to pursue additional indications for our lead investigational product Lutathera. In July 2016, we signed a clinical trial agreement with the National Cancer Institute, or NCI, where the NCI will sponsor and conduct a study of Lutathera in patients with inoperable pheochromocytoma and paraganglioma.

There are six additional investigator-initiated studies currently ongoing with Lutathera in indications such as primary refractory or relapsed high-risk neuroblastoma, FDG-positive and negative GEP-NETs, and unresectable progressive well-differentiated neuroendocrine pancreatic carcinoma. We believe in the potential of combination with immunotherapy as well and are pursuing investigator-initiated studies in this direction.

With that, I will pass the call to Stefano for an update on Lutathera and our outlook for the remainder of the year.

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [4]

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Thank you, Heinz. With all the positive events just described in 2016, there was one significant disappointment: the delay in the FDA approval process for Lutathera.

As we have previously disclosed in December 2016, we received a complete response letter, or CRL, from the FDA regarding the Lutathera filing. The CRL refers to issue with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical data sets, which are precluding FDA reviewers from performing the required independent analysis of this clinical status.

In addition, the CRL requests subgroup analysis for gender, age, and racial subgroups as well as other certification factors. A safety update on clinical and nonclinical studies, which was already in process, was also requested in the CRL.

Finally, the CRL noted that any observation made during inspection of manufacturing facilities supporting the NDA needed to be resolved prior to approval of the NDA. No additional clinical studies were requested in the CRL and there were no comments at the time on other sections of the NDA submission. We have dedicated a task force to resolving the issue raised, and I'm very pleased to report that we have made significant progress.

We believe we have completed the majority of the work required to revise the data sets to meet the Agency's stated requirements. And based on our current estimates, we further believe we are on track to complete our resubmission to the FDA in mid-2017.

The revised clinical data sets are currently undergoing a rigorous review by our internal statistical team and specialized consultants. The same procedure will be applied for the entire clinical session of our NDA prior to submission to the FDA. We have chosen reviewers with specific expertise in preparation and review of oncology submission to the FDA and are requesting a full critique of our filing, with the goal of pressure testing, as we would expect of FDA reviewers.

Throughout this process, we have also been addressing certain clarification requests by the EMA during a review of the marketing authorization for Lutathera. And we anticipate the completion of review on receipt of a CHMP opinion from the EMA in the third quarter, with the European commission approval following about two months after, as it is customary.

We are looking forward to the rest of 2017. The year started on a high note with the publication of the NETTER-1 results in the New England Journal of Medicine. We have the infrastructure and capabilities to build on our success with NETSPOT and execute the product launches for SomaKit TOC and eventually Lutathera following its approval.

We are still increasing market penetration in both the US and Europe. We continue to generate additional clinical data for Lutathera and other investigational products in our pipeline. And we believe we are well capitalized to execute on our strategy and present our leadership as a key innovator in the molecular nuclear medicine segment.

With that, we will open the line for questions. Thank you for joining us today. We greatly appreciate your continued support. Operator, please begin the Q&A.

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Questions and Answers

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Operator [1]

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(Operator Instructions) John Newman, Canaccord.

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John Newman, Canaccord Genuity - Analyst [2]

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Thanks for taking my question. My question is could you describe a bit more about the process that you are going through in terms of the data set formatting? And I'm just curious, generally speaking, if you have received any requests or additional clarifications from the Agency at this point time or if that would only come after you resubmit the filing. Thank you.

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [3]

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Well, as I described before, the essential part of the work, which is the programming, has been done. So now we are really at the moment where we are making the stress test on the results from the data sets to anticipate any possible issue and facilitate the work of the FDA reviewer with appropriate information to go through these data sets.

And for this process, of course, we are even more comfortable than before about the quality of the data. So that is why I am -- we are positive about the current situation.

We did not address any particular needs of the FDA during our last meeting. We -- so anything we can probably after the resubmission. We have the possibility to anticipate test data sets to the FDA even before the resubmission. So we'll be gaining additional comfort on the quality of these deficits even before we are completing the submission.

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John Newman, Canaccord Genuity - Analyst [4]

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Okay, great, thank you.

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Operator [5]

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Peter Welford, Jefferies.

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Peter Welford, Jefferies & Co. - Analyst [6]

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Thanks for taking my questions. I've got a couple. Firstly, just on NETSPOT, I wonder if we could -- if you'd just clarify: was it over 1,000 doses or 1,000 doses in the first quarter? Can you just talk a little bit about the number of doses that typically are being put through at the moment each generator.

And you planned as far as the footprint of radiopharmacies in the US. And how you see at the moment typically the order patterns at those radiopharmacies coming through.

And just a few for Heinz -- for admin, if possible. On the sale, wonder if you could possibly disclose the sales of SPECTs for 2016. And then also talk a little bit about the cost of goods. Raw materials seems to have risen quite a bit during this year, particularly the fourth quarter. Can you perhaps go into a little bit of detail on that. And also what the change in contingent consideration was in the financial lines during 2016 financial income. Thank you.

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [7]

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A lot of questions. So let me start from NETSPOT. As you may understand, we are pretty excited of this launch. The reason is that it was technically difficult to introduce a completely new drug labeled with a compound after reconstitution is only for our shelf life.

And these difficulties link also to the fact that we have to equip a number of other pharmacies around the country with generators. And at the moment, we are only essentially [head out] for the way. So we will move from 20 to 40 radiopharmacy in the next really few months. So there is potential for further growth.

In 2016 we have shipped 485 doses, so -- and every dose is essentially a patient. I don't think any patient already repeated the examinations so far. So essentially, we have about 1,600 doses probably already shipped so far.

A generator can easily make 60 doses per month. That is -- with only one production per generator. So it's -- I don't think a generator number will be a limit. We own the generator. We will be spreading the number of generators we need over these radiopharmacies, so there will never be any limit from this point of view, I would say. It is pretty straightforward.

Then I will let Heinz answer on the other points.

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Heinz Mausli, Advanced Accelerator Applications S.A. - CFO [8]

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Hi, Peter. The -- so SPECT sales have increased by -- from EUR7.4 million to EUR9.5 million this year. That is quite a significant increase, a bit better than what we expected. It's a combination of just bringing in products better into the market. And also generally a question of having acquired the company in Spain and managing that company better and with that also achieving better sales results.

To your question on the raw material costs and the profit margin decrease, that is true. We did have some decrease there. It's about 3 percentage points. It is again a combination of a product mix slightly changed, factoring also some exchange rate variations, not necessarily in our favor.

And we also have some sales provision taken that is a bit complicated to explain on tax issues, whereby we actually had the sales, but we anticipate that we might have to reimburse it to healthcare authorities of Italy and France some of the sales. And that decreased the sales, but we did have the costs. So that explains to some extent why the raw material costs relative to sales have increased.

On the contingent liability, by far the biggest item is the royalties that we will have to pay on Lutathera sales to the former owners of BioSynthema. And there, we still calculate with an 80% success probability as agreed with our auditors and other experts.

Discount rate hasn't changed. What has changed is a new business case with more opportunistic assumptions regarding price as well as number of doses sold. The price assumptions in particular in the US is where we have increased, and that results then in higher sales forecast and with that also resulting higher royalties that we will have to pay.

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Peter Welford, Jefferies & Co. - Analyst [9]

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And sorry, can you give roughly what was the euro change that went through the financial line of the contingent consideration and negative adjustment charge?

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Heinz Mausli, Advanced Accelerator Applications S.A. - CFO [10]

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Hold on, let me see that. The charts on the BioSynthema contingent consideration was about EUR8.5 million. As you know, we do have some other contingent considerations related to the Atreus acquisition, but that really doesn't matter. So it is all about BioSynthema and that is about EUR8.5 million.

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Peter Welford, Jefferies & Co. - Analyst [11]

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Thank you.

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Operator [12]

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Mike King, JMP Securities.

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Mike King, JMP Securities - Analyst [13]

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Thanks for taking the question. Just wondered if you would comment -- and a little bit of analogous question to John Newman's. It just seems the process is taking a bit longer than expected.

And I'm just wondering if you are -- I'm pretty sure you are not going to introduce any new data, but I'm just wondering if you are building in assumptions for new analyses or other re-examination of current -- of scans or anything else like that, or adjudication of survival events and such that are being included in the database. I just wonder if you could talk about whether any kind of reanalysis of the raw data needs to be undertaken.

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [14]

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There will be no analysis of new data being undertaken. It's -- we will speak to the statistical analysis plan. Our primary endpoint is the one that we delivered the first time and that would remain the same.

Any -- we are integrating any doubts and questions that the inspectors and the work that has been done before into the new data sets. And we -- the result does not change at all. So it is essentially really the same results that we have been proposing on the first time.

We are not really taking additional time. We really wanted to focus on delivering a very high-quality data and really facilitate the work of the FDA reviewer. So we are really using this time for any possible check. And for really a guide -- as much as possible in writing throughout the review that the FDA reviewer will have to do. So our effort is to make things as clear as possible in order to reduce that time as much as possible.

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Mike King, JMP Securities - Analyst [15]

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Okay. And if I might just follow-up. Stefano, you were recently quoted in one of the wire services interview commenting about the approval of Lutathera by year-end. Did that pertain to Europe or did that pertain to the US or is that still your general commentary for overall approval in both territories?

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [16]

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Yes, it regards essentially US because we expect an approval in Europe before. We expect the approval in Europe in the third quarter.

The process in Europe has not really changed. We have taken a little bit more time because we wanted to align the requests of both the Agency and also the same possibility to have exactly, exactly the same labor, the same information to both the agencies. So we have delayed a little bit some answer to the EMA, but we are within the process and we forecast to end the process in the third quarter.

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Mike King, JMP Securities - Analyst [17]

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Thank you for taking the questions.

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Operator [18]

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Jim Birchenough, Wells Fargo.

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Jim Birchenough, Wells Fargo Securities - Analyst [19]

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Thanks for taking the questions. Just wanted to confirm, in terms of your expected time horizon for review, do you expect a two-month or a six-month review? I know you've been asked this before, but as you are doing all the work on the resubmission, has it changed? And remind us what your assumption is.

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [20]

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Unfortunately, we have to take the worst assumption. That's why we focused the possibility of [in the] market authorization by the end of the year. It's very difficult to be in the mind of the FDA. We just want to make their work as easy as possible. This is why we are investing in human resources, time, and focus so much in these weeks and months.

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Jim Birchenough, Wells Fargo Securities - Analyst [21]

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Is there anything in your interaction with them that would suggest possibility of an [erdach] panel or do you think that's unlikely?

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [22]

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We have never been -- we have never had a request for a panel so far, but we cannot anticipate anything from the FDA. We never discuss about that and they never ask us -- allocate this -- the possibility of a panel.

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Jim Birchenough, Wells Fargo Securities - Analyst [23]

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And then just on what you might be learning from the expanded access program, as patients are enrolling in that, are you seeing primarily NETTER-1 population? Or are you seeing a broader population in midgut neuroendocrine tumors? Maybe if you could talk about the patient type expanded access program?

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [24]

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As we have stated before, there has been a significant effort offering to the FDA the best possible quality in the Phase 2 data. I would say that a lot of work has been focusing on cleaning the data on the Phase 2. Try to figure out every possible gap in that database in order to offer the best quality of data.

And we have -- so our focus remain significant for the fact that we have an argument for them. But of course only after the clinical review from the FDA, we will be able to enter into more details about that.

We don't see a black-and-white situation. I think that would be the possibility for this drug to be prescribed not only into midgut carcinoids after approval, even if the indication will be that one. This is a general feeling that we are sharing with the community of payers, of doctors, etc. But -- and of course, this will greatly depend on the NCC guidelines, if they will be -- where in the guidance we land with our drug.

The -- concerning the [relixis] program, we are fostering this program at the moment. We are expanding the program. We have now 15 centers that are activated. As mentioned also before, we will be using the Millburn facility to deliver drugs to these centers.

We believe the machine from Europe is really perfect because we are delivering a lot of doses. I remind you that we almost delivered almost 5,000 doses already between Europe and US. So this is what (technical difficulty) and we would like to start using the facility in Millburn to serve the North American market for the relixis program.

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Jim Birchenough, Wells Fargo Securities - Analyst [25]

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And just a final question, following up on Peter's question on the contingent consideration, what is the price that's assumed in that calculation?

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Heinz Mausli, Advanced Accelerator Applications S.A. - CFO [26]

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I'm not disclosing that, but it is higher than we used last year. As you may know, we have a pricing assessment, so we have a reasonably good idea what it could be. I think with some of the obviously investors generally, we say we will compare the product's due cost nowadays and how we position ourselves or how we would like to position ourselves with these comparative products. But I'm not going to disclose the price yet that we used in the business case.

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Jim Birchenough, Wells Fargo Securities - Analyst [27]

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Okay. Thank you, guys.

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Operator [28]

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John Newman, Canaccord.

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John Newman, Canaccord Genuity - Analyst [29]

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Thanks for taking my follow-up question. The question was -- I just wondered if you could give us a sense as to whether or not we might see clinical data this year for NeoBOMB1 and your PSMA asset. Thank you.

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [30]

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Yes, NeoBOMB is already in the clinical trials for what regards diagnostics. Of course, we are not communicating any results yet, but we hope to do it as soon as the collaboration we feel we could do it.

And the aim is also to bring PSMA into clinical trials by the end of the year. I must confess that the effort on Lutathera has caused us to accelerate some hirings because we wanted to concentrate the people who had a history on Lutathera and the clinical trial to the remediation plan. So we had to accelerate some hirings to be able to push forward our plans from PSMA and BOMB with the pace that we wanted for this year.

And -- but the -- we remain focused in moving the -- both candidates into a clinical trial also for therapy by the end of the year.

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John Newman, Canaccord Genuity - Analyst [31]

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And one additional question. It sounds like the facility in New Jersey is moving along well. Can you say whether -- will any of the material that is manufactured for the expanded access program, would any of that material be able to be used for commercial sale in the United States? Or would you have to go through a specific process for the plant before that would be possible? Thanks?

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Victor Paulus, Advanced Accelerator Applications SA - Head of Regulatory Affairs [32]

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This is Victor Paulus. I am the regulatory person. For the expanded access program out of Millburn, the initial shipments out of Millburn will be only for expanded access. The -- once approved, the NDA will be supplemented via a prior approval supplement to add Millburn as a licensed manufacturing site. So an initial commercial supply to the US will be supplied from our two facilities in Italy, and then Millburn will be brought online.

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John Newman, Canaccord Genuity - Analyst [33]

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Okay, great. Thank you.

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Operator [34]

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Mike King, JMP Securities.

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Mike King, JMP Securities - Analyst [35]

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Thanks for taking the follow-up, guys. I may have missed it, but can you comment about whether you need to -- are you going to continue to submit, I guess would be the (technical difficulty) the data from Erasmus? And do you have to perform the same kind of analysis and reformatting with that data set as you have from NETTER-1?

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Stefano Buono, Advanced Accelerator Applications S.A. - CEO [36]

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Yes, of course, we reformat also those data. The aim is that we will be able to navigate through Phase 1, Phase 3 with the same tools and with the same easiness.

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Mike King, JMP Securities - Analyst [37]

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Thank you.

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Operator [38]

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(Operator Instructions) Thank you. That concludes our question-and-answer session. A webcast replay will be accessible on the investor relations section of our website within the hour. A teleconference replay will also be available by dialing 877-481-4010 and entering replay ID 10274.

This does conclude today's teleconference and you may now disconnect your lines at this time. Thank you for your participation.