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`NPS Pharmaceuticals' CEO Discusses FDA Approval and
`Commercial launch of Gattex (Transcript)
`
`Jan. 2, 2013 11:33 PM
`ET
`
`SA Transcripts
`
`bout: NPS Pharmaceuticals, Inc. (NPSP)
`
`| | A
`
`Operator
`
`Good day, ladies and gentlemen, and welcome to the NPS Pharmaceuticals Conference Call. My name is Caris and I
`will be your coordinator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a
`question-and-answer session. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.
`
`And I would now like to hand the call over to your host for today, Susan Mesco, Senior Director of Investor Relations
`and Corporate Communications. Please proceed.
`
`Susan Mesco
`
`Thank you, Caris. Welcome to today’s conference call to discuss the commercial launch of Gattex. Before we start, let
`me remind you that today’s call will include forward-looking statements based on current expectations. Such
`statements represent our judgment as of today and may involve risks and uncertainties. Please refer to our filings with
`the SEC, which are available from the SEC or our website for information concerning the risk factors that could affect
`the company.
`
`Joining me on today’s call are Dr. Francois Nader, our President and CEO; Eric Pauwels, our Chief Commercial
`Officer, and other members of our senior management team.
`
`I will now turn the call over to Dr. Francois Nader.
`
`Francois Nader
`
`Thank you, Susan. Good afternoon and a very Happy New Year to everyone joining us on today’s call. This was a
`very exciting holiday season for the NPS team and we were thrilled to close 2012 with an outstanding
`accomplishment with the U.S. approval of Gattex. After completing the most comprehensive clinical development
`program to-date in short bowel syndrome, it is very gratifying to finally be able to deliver this much needed therapy to
`patients.
`
`For nearly 40 years, short bowel syndrome patients have relied on parenteral support to receive the nutrients and
`fluids that they need to live, but have risked serious life-threatening complications along the way. With the approval of
`Gattex, the lives of these patients can change.
`
`Gattex is the first and only long-term targeted therapy that addresses the underlying issue of short bowel syndrome,
`which is mal-absorption. As you know, short bowel syndrome patients can be hooked to an intravenous line 10 hours
`to 12 hours each day. The Gattex studies showed that over half of the patients gained at least one infusion-free day
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`each week, and nearly a quarter of patients achieved three or more infusion-free days each week. These data could
`translate into anywhere from 50 days to 150 days of independence from parenteral support each year.
`
`The interim results of our two years study of Gattex in short bowel syndrome showed that 72% of patients achieved at
`least a 20% or greater reduction of parenteral support, after a year of Gattex treatment, with a 40% mere reduction in
`weekly volume. Further, what is especially exciting is that many patients achieved complete independence from
`parenteral support, while on Gattex, after being chronically dependent on PN, for up to 18 years.
`
`Freedom for – from parenteral support allows patients to experience the simple activities that many of us take for
`granted by joining family functions, traveling from home for a weekend or just a simple night of uninterrupted sleep
`and that importantly completely eliminate the risk inherent to parenteral support. We are very pleased with the
`outcome of our label negotiations with FDA and as you probably know it by now, Gattex is indicated for the treatment
`of adult patients with short bowel syndrome, who are dependent on parenteral support. And it is approved for clinic
`use, making Gattex the first long-term treatment for short bowel syndrome. As such the label provides the flexibility for
`physicians to determine the best time to initiate Gattex therapy for their patients.
`
`With respect to safety, the warnings and precautions are consistent with the non-pharmacology of Gattex, as well as
`the complications associated with short bowel syndrome and its underlying etiologies and certain clinical
`assessments are defined to ensure the continued safe use of the product.
`
`We believe the risk evaluation and mitigation strategy or REMS program is very practical and aligns very well with our
`commitment to ensure that Gattex is used appropriately and that patient initiations are successful and sustainable.
`NPS and the FDA recognized the need and importance of conducting a voluntary long-term patient registry, which has
`been defined as a post-marketing requirement. We believe the registry will be instrumental in gaining a better
`understanding of Gattex for the long-term treatment of short bowel syndrome.
`
`I would like now to address the commercial opportunity that Gattex represents. We previously reported from the
`literature and our own prevalent studies, an estimated 10,000 to 15,000 adult short bowel syndrome patients, who are
`chronically dependent on parenteral support in the U.S. However, based on precedence in the orphan space, we have
`also noted on many occasions that there is a high degree of inherent variability using top-down prevalence estimates
`for rare diseases, because of the small number of patients and the even smaller sample size used in prevalent
`studies.
`
`The recent month, we initiated a bottom-up and added this to more precisely quantified addressable population.
`Important sources of patients were those managed by the top five national home infusion companies. Additional
`patients were identified through our website shortbowelsupport.com, through previous clinical trial participants and
`information gathered from our MSLs.
`
`We also worked with various patient advocacy groups that support SBS patients or its underlying etiologies. Based on
`our findings, short bowel syndrome qualifies as an ultra-orphan disorder with an estimated Gattex addressable
`population of 3,000 patients to 5,000 patients in the U.S. While the addressable market is less than our initial
`prevalence estimate, we were very pleased with the results of our pricing research.
`
`More recently, our commercial team commissioned a rigorous pricing and access study, with an internationally
`recognized consulting firm, who has specific experience in pricing multiple successful ultra-orphan products on the
`market today. Many factors were considered in establishing the price including the fact that Gattex is the first and only
`long-term approved therapy for short bowel syndrome, which is a life-threatening disorder.
`
`The value Gattex provides to patients by improving the absorptive capacity of their intestines and reducing or
`completely eliminating the need for parenteral support, payors’ understanding of the direct and indirect burden of short
`bowel syndrome, the limitations and costs of current supportive care options and the need for an effective long-term
`treatment like Gattex; also, the potential of Gattex to address the long-term complications associated with short bowel
`syndrome and the chronic use of parenteral support, the minimal budget impact of Gattex, given the size of the
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`addressable patient population and the ultra-orphan status of Gattex and last, but certainly not least, NPS investment
`in the most comprehensive research and development program conducted to-date in short bowel syndrome.
`
`Consequently, and based on these considerations, we have set the annual list price of Gattex at $295,000. At this
`price level and given the expected patients’ adherence and compliance rates of 70% to 80%, we expect Gattex to
`achieve annual peak revenues well in excess of the $350 million per year that we previously expected. Our pricing
`strategy will go hand-in-hand with a focus on ensuring broad and sustainable coverage from both private and public
`payors.
`
`The NPSP did not spare any efforts over the last couple of years to ensure comprehensive commercial readiness and
`are undoubtedly ready to successfully launch Gattex in the U.S.
`
`At this time, I would like to invite Eric Pauwels, our Chief Commercial Officer to comment on our launch plans. Eric?
`
`Eric Pauwels
`
`Thank you, Francois, and good afternoon to everyone on today’s call. One of our very first elements of ensuring the
`successful commercialization of Gattex was to assemble a truly world-class team of passionate industry veterans.
`These individuals came to NPS from leadership roles at rare disease biopharmaceutical companies and many with
`specific expertise in successfully launching orphan products.
`
`Gattex launch-readiness focused on five key areas. Building our field-based organization; physician targeting; patient
`identification; NPS Advantage, our concierge-like patient support program; and ensuring rapid and comprehensive
`market access.
`
`With regard to our field-based organization, our leadership team has been in place for a couple of months and
`includes three key account directors and three regional business directors. For our sales organization, we are
`extremely pleased with the level of interest and talent that we’ve attracted, which went up to 24 area business
`specialists for the approval of more than 250 qualified applicants. The sales team who will market Gattex is now
`comprised of seasoned professionals with an average of 15 years of pharmaceutical industry experience and a
`successful track record with injectable orphan biologics.
`
`Our field force will be fully deployed in February, after we conduct our national sales meeting. In addition, NPS
`Medical Affairs has deployed a team of eight medical science liaisons, who have been building awareness amongst
`SBS thought leaders for over a year and are well positioned to educate the medical community on the clinical value
`and profile of Gattex.
`
`We are pleased that the launch of Gattex will be supported by an impressive number of peer-review publications,
`including the results of our Phase III STEPS study, which appeared in the December issue of Gastroenterology.
`
`Our next strategic objective was to identify physician targets. As we mentioned on our last call, we developed an initial
`target list comprised of approximately 6,000 physicians who are practicing in roughly 1,000 institutions that includes
`centers of experience and large GI practices. These potential prescribers will be better refined once our field force
`begins calling on them individually.
`
`Now, switching to patient identification. Given the ultra-orphan status of short bowel syndrome, along with the fact that
`this is a condition of a condition, without a formal support of organization, patient identification is a critical strategic
`objective. Despite the limitations of finding patients in advance of having an approved product, I’m very happy to
`report that we have identified over 1,000 unique short bowel syndrome patients who are eligible for Gattex therapy.
`Now that we have secured approval, our patient identification activities will increase as our field organization will
`communicate the value of Gattex to physicians and other stakeholders and identify additional eligible SBS patients.
`
`The fourth critical success factor is our personalized patient support service. NPS Advantage has been fully
`operational since late November. Our care coordinators are trained and ready to provide patients and healthcare
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`providers with individualized support including personalized case management, reimbursement assistance, product
`shipment scheduling, time-based deployment, product refills and prescription renewals. We’re also leveraging the
`relationships that we have established with a number of patient advocacy groups such as the Oley Foundation, of
`course, to play an important role communicating the availability of Gattex to their members and disseminating
`educational materials.
`
`The last area I would like to cover is the importance of ensuring their access to Gattex. Our market research shows
`that most short bowel patients have insurance coverage, and it’s approximately 60% covering by commercial plans
`versus 40% were covered by government and publicly insured. And, the majority of the product is being Medicare.
`
`Our key account directors have deployed – have been deployed since October and are targeting the 75 key payor
`accounts that cover up to 80% of the U.S. insured population. Government have our label approved, we’ve been – we
`will put the final touches on our payor communication and educational materials, including the AMCP dossier. These
`tools characterize the SBS burden and the value of Gattex.
`
`Based on the indications, we expect payors to provide broad access to Gattex. In our market access studies, payors
`clearly recognized the high unmet medical needs of short bowel syndrome, as well as the therapeutic improvement
`that Gattex represents over current treatment options. The value proposition is also notably strengthened by the many
`patients who achieved complete independence from parenteral support with long-term Gattex therapy. All payors
`indicated they would cover Gattex with an anticipated tier placement and restrictions fairly typical of other ultra-orphan
`products.
`
`Here also our care coordinators are ready to help stakeholders, especially patients, successfully navigate the
`reimbursement hurdles such as prior optimizations and other restrictions. In addition, we have established a
`comprehensive patient assistance program.
`
`First, our patients with commercial coverage, copay assistance will be coordinated through NPS Advantage to
`minimize or even eliminate our pocket burden. We also utilize third-party foundations for patients covered by public
`plans. And lastly, to those rare cases in which patients do not qualify for assistance or to bridge gaps in coverage, we
`offer a free goods program. As with other ultra-orphan drugs, during the initial six months to 12-month launch period,
`we expect that securing reimbursement to take 90 days to 120 days from the time of referral. We anticipate this period
`will improve as the commercialization progresses.
`
`As a reminder, Gattex will be reimbursed as a pharmacy benefit or Medicare Part D and will be dispensed by our
`limited network of specialty pharmacies. Because home infusion is a key touch point for SBS patients dependent on
`parenteral support, we established a distribution network with the five leading specialty home infusion providers,
`Accredo, BioScrip, Coram, ThriveRx, and Walgreens.
`
`Gattex will be dispensed by this network directly to patients as a monthly kit and we do not expect any meaningful
`inventory to be held in the channel at any given time. These home infusion companies are already providing
`personalized services to the addressable SBS population through an interdisciplinary team of experienced infusion
`professionals. So, they are perfect – they are really a perfect fit to also provide clinical services for Gattex. Their
`national and local presence will allow to enhance Gattex clinical, nutritional and educational services, expand our
`knowledge of key prescribers and importantly, we’ll find – more readily find patients.
`
`These agreements are a win-win for NPS and the home infusion providers. In addition to receiving standard
`distribution cost and additional fees for clinical services, they can differentiate their businesses by offering Gattex and
`potentially expanding their market share within the highly-fragmented home infusion industry, along with contributing
`directly to the well-being of the SBS patients.
`
`So, to conclude, we are ready to successfully launch Gattex. We have assembled the best-in-class team with specific
`orphan and biologic experience. The deployment of the field organization is underway and we have defined our initial
`list of physician targets. We’ve identified over 1000 Gattex eligible patients in our field force, who’ll work with the
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`physicians to identify new patients.
`
`NPS Advantage is up and running, and our care coordinators are actively dialoguing with patients. Our key account
`directors are already interacting with the targeted 75 key accounts that represent most of the commercial and public
`payors. And finally, our go-to-market specialty distribution network is in place with the five leading providers of home
`infusion and specialty clinical services.
`
`I will now turn the call back to Francois.
`
`Francois Nader
`
`Thank you, Eric. I would like now to comment on the forecasted trajectory of the Gattex launch. While we’ve made
`great progress identifying patients, as we have noted on multiple prior occasions, and as it’s typical with a number of
`successful orphan analogues, we anticipate its little uptick. We expect Gattex revenues to begin in the second quarter
`of this year; however, we anticipate meaningful revenues to kick in during the third quarter.
`
`Our current expectation is that between 200 patients to 300 patients will be on Gattex by the end of 2013, with the
`vast majority of these patients initiating therapy in the later part of the year. We’ll provide you with the number of
`patients on Gattex at the end of each quarter, starting with our second quarter earnings call through the remainder of
`the year. Given the favorable label and our ultra-orphan pricing strategy, we have a bullish outlook for Gattex, again
`with peak sales now expected to be well in excess of our previous target of $350 million.
`
`Five years ago, we set forth on the plan to transform NPS into a premier orphan drug business by refocusing our
`pipeline on rare disorders of high unmet medical need. With the approval of Gattex, we have taken a significant step
`towards achieving our vision. As discussed, we have a solid and comprehensive launch plan in place and we are
`ready to execute.
`
`That concludes our prepared remarks for this afternoon. I will now turn the call over to the operator to take your
`questions. Operator?
`
`Question-and-Answer Session
`
`Operator
`
`(Operator Instructions) And your first question comes from the line of Salveen Richter of Canaccord Genuity. Please
`proceed.
`
`Salveen Richter – Canaccord Genuity
`
`Thanks for taking my questions, and congratulations on the approval.
`
`Francois Nader
`
`Thank you, Salveen.
`
`Salveen Richter – Canaccord Genuity
`
`Just had a question on – just if you can help us understand payor comfort with the $295,000 annual price, and what
`kind of tiering we should expect here, and I know it’s around 90 days to 120 days to get reimbursed at first. And what
`you think that will kind of even out at over time?
`
`Francois Nader
`
`Salveen, I would ask Eric to address your question. Eric?
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`Eric Pauwels
`
`Salveen, thank you. That’s a good question. People desire to pay at comfort or clearly, our pricing in access study
`showed that there was – that all payors who actually going to cover the product. So, as you appropriately outlined
`there will be restrictions. Typically we expect these restrictions to be usually on tier four or specialty tiers and we
`anticipate the usual hurdles such as prior authorizations before actually the prescription can be filled, higher copays
`co-insurance. So, it’s important to note that these are very typical with ultra-orphan products and we have a number of
`key programs in place right now to assist those patients and physicians with NPS Advantage to get them three days
`tiers, and especially, we have a fairly robust program including copay, co-insurance and patient assistance programs
`that will help.
`
`Salveen Richter – Canaccord Genuity
`
`Great and just two quick follow-ups. In terms of the education that’s required here for physicians, what role does – do
`nurses here play and the treatment paradigm and are you targeting them as well? And then what proportion of the
`SBS patients or thus far it’s how many infusion providers accounting for?
`
`Eric Pauwels
`
`Okay. If you asked your first question, or follow-up question around nurses, yes, we actually are not just targeting
`nurses, but we believe that the entire treatment team is going to be involved in supporting the SBS patient. So, clearly
`nurses will play a key role. The first time Gattex is shipped, they’ll provide role in terms of counseling, injection
`training, and will follow-up on a weekly basis after initiation.
`
`But in addition to nurses, we’re targeting nutritionists. They will provide key support and education to the SBS patient,
`particularly around nutritional intake requirement, rebalancing if you will as parenteral nutrition is being lean, patient
`will not have to intake more food and during that process, nutritional support is extremely important.
`
`So, we see the change besides the prescriber really being the nurse, the nutritionists, and also the pharmacist, who
`actually dispenses the parenteral nutrition and it’s very important sometimes on a weekly basis in dialogue with the
`patients.
`
`To answer your follow-up – second follow-up question, we believe right now the five key national providers that we’re
`working with comprise about a-third of the home infusion market.
`
`Salveen Richter – Canaccord Genuity
`
`Great. Thank you.
`
`Operator
`
`And your next question comes from the line of David Friedman of Morgan Stanley. Please proceed.
`
`Francois Nader
`
`David, are you there? Okay. We can’t hear you.
`
`Operator
`
`And Mr. Friedman, please check the mute function on your phone. Your line is open.
`
`David Friedman – Morgan Stanley
`
`Hi. Sorry about that. My phone was broken. Can you hear me now?
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`Francois Nader
`
`Yeah. Absolutely.
`
`David Friedman – Morgan Stanley
`
`Okay. Thanks. Sorry. Just a couple questions. Number one is can you just discuss what you except the average
`copay will be and what percent of patients you think will have coinsurance of 10% to 20% like some specialty drugs
`have? And then also maybe if you can just discuss what you expect your sort of blended gross to net to be when
`you’re at a steady state?
`
`Eric Pauwels
`
`Sure. Thanks for that question. I think right now, we clearly have identified that about 60% of the SBS population is
`going to have commercial coverage. Now 40% are public with primarily Medicare. In terms of the number of patients
`who have copay, the average should be somewhere between sort of the 15% to 20% copay and that will vary by plan.
`And as we get into market, we’ll probably provide you a little bit more clarity on the actual number and as we work in
`partner with our home infusion, we’ll be able to provide you with a little bit more specificity on that. But at this time
`right now, the average copay or coinsurance we’re looking at probably around 20%.
`
`David Friedman – Morgan Stanley
`
`And I guess one quick follow-up to that is did you do any work or is it even possible to do work on the patients’ side as
`to whether – I mean if the payors are willing to bear sort of 80% of that, what the willingness of the patients to bear
`20% of 300,000.
`
`Francois Nader
`
`Well, I can address this question. Actually, our studies included patients; it included physicians; and it included
`prescribers. So, all three stakeholders were included in the study. And frankly, it became really clear that given the
`value that Gattex offered these patients; the price was pretty much inelastic. Now you’re bringing a very good point
`about the copay, but what we outlined in our presentation is we are covering the patients when it comes to the copay.
`
`In other words, we don’t believe that a copay of 10, 20, but whatever number is something that your usual patient can
`afford. And therefore, we are supporting them through different mechanisms that Eric outlined and frankly, for those
`patients, who cannot afford and who are not eligible, then we have a free drugs program. So, I mean the whole idea
`David, is to make sure that the patients have access to Gattex and that the pricing and the copay would not be a
`hindrance for them to be – to get Gattex if they needed.
`
`Eric Pauwels
`
`Yeah. And David, I’ll just follow-up by saying that every insurance plan, particularly those patients, who are on
`commercial, will have certain maximums and those maximums are much, much lower than the overall cost of the
`drug.
`
`David Friedman – Morgan Stanley
`
`Okay. Do you have a sense of what the average maximum is and what happened after that? Was it just get picked up
`by the insurance plan?
`
`Eric Pauwels
`
`Yeah, I mean there’s certain cap. Some of them will be just in the few thousands. It really depends on the particular
`plan, and of course, what type of insurance the patient has. They can buy very nice plan and it would be very limited
`and others will require then to pay the entire 20%. So, it really varies across the board.
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`David Friedman – Morgan Stanley
`
`Right. All right. Thank you very much.
`
`Francois Nader
`
`Thank you, David.
`
`Operator
`
`And your next question comes from the line of Joseph Schwartz with Leerink Swann. Please proceed.
`
`Joe Schwartz – Leerink Swann
`
`Hi, thanks for taking the question and congratulations on all the excellent execution. I was wondering if you could talk
`about how you expect your care coordinators to handle all of the interest from different stakeholders like nurses and
`nutritionists and payors and physicians and of course, patients. Do you have systems in place and I know you’re
`doing this all in-house or have you worked with others to design this – any of it being outsourced, for example, can
`you just talk about that?
`
`Eric Pauwels
`
`Yeah, sure, Joe. Good question. So, really, everything starts with the care coordinator. And our care coordinators are
`there to do exactly that; they’re coordinating a number of different aspects. So, they’re helping the patient or the
`physician, whichever comes from the doctor’s office – or actually comes from a patient – to begin the process of
`benefits investigation. So, they’ll go through, and with support, we’ll need – with the support of staff that we have, we
`go through that benefits in investigation.
`
`We’ll determine what the copay of the insurance plan is, and then they’ll also work with the home infusion companies
`to ensure that the patient is actually getting the clinical services. So, they’ll not deliver the service themselves, but
`they will actually co-ordinate nutritional visits, nursing visits and others. So, they will actually be the point, if you will, or
`the face of NPS or Gattex to each patient. And this will be very important, because it just goes – it doesn’t go beyond
`just the reimbursement support. It really is that whole aspect of ensuring that whatever the patient needs from a
`clinical perspective, they’ll actually get.
`
`Joe Schwartz – Leerink Swann
`
`Okay, great. And can you talk a little bit also about who is addressable? According to your market research, what have
`you found, where have you found the biggest pockets of patients and what types of patients do you expect to go on
`the drug at various stages in the life-cycle of the product?
`
`Francois Nader
`
`It’s Francois. I will attempt to address your question here. So, the addressable population was quantified from the
`bottom up. And obviously, we tapped into the most obvious source of information, which was the five home infusion
`providers, because these providers actually deliver parenteral nutrition to patients and we were able to work with them
`on a very specific, targeted, if you will, patient list, I mean obviously anonymous. And we cannot do that given the
`restrictions of confidentiality and HIPAA and everything else. So, we kept really on the safe side of this exercise.
`
`At the same time and in parallel, we had a number of patients who registered at the shortbowelsupport.com. Another
`set of patients were identified through patients advocacy groups; another were identified through our clinical research
`and the patients who participate in our clinical trial.
`
`The biggest challenge of this exercise was to identify unique patients, because as you can very well imagine, you
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`have a patient who actually is with one of the home infusion company, who has been in our clinical research program,
`who registered at the shortbowelsupport.com and he or she is a member of A.S.P.E.N. So, all of a sudden you have
`the same percentage of patients. So, this is why it is very important once we have the field force in place, which will
`happen starting in February, to validate all these leads and make sure that we work with the physicians and the
`caretakers to validate the list and make sure that we have uniquely identified patients.
`
`Now this being said, we also looked at what percentage of the market these patients that we identified would
`represent. I mean, we have a certain number of ways to do that. And we landed on the number of 3,000 patients to
`5,000 patients. Now this being said, Gattex is no different from most other orphan products who will face the same
`situation, where there was a dichotomy, if you will, between prevalent and addressable. However, over time, what
`these other companies and we might face as well is the fact that to start with an addressable population of 3,000 to
`5,000 and over time this number could go up.
`
`In parallel to all of the above, we are really pleased, as we mentioned, that with the label. So, the label gives us the
`flexibility – or gives rather the physician the flexibility to start Gattex when the physician determines that the patient is
`dependent on parenteral nutrition, which is a nice thing to have because, frankly, it takes away the rigor of six months
`or 12 months on parenteral nutrition and it becomes a medical judgment call.
`
`That’s where we are today. So it is multiple triangulation of data, and probably the underlying common denominator of
`all of the above, it’s a small population and therefore the traditional methods that are used in larger populations or
`larger conditions have their limitations when you talk about small numbers like short bowel syndrome.
`
`Joe Schwartz – Leerink Swann
`
`Very helpful, thanks.
`
`Francois Nader
`
`Thank you.
`
`Operator
`
`And your next question comes from the line of David Nierengarten of Wedbush. Please proceed.
`
`David Nierengarten – Wedbush Securities
`
`Hi, guys. Happy New Year.
`
`Francois Nader
`
`Thank you. Happy New Year to you too, David.
`
`Eric Pauwels
`
`Happy New Year.
`
`David Nierengarten – Wedbush Securities
`
`Thanks. I had a quick question, if you had any feedback from payors on the length of treatment or requiring a certain
`type of response or a degree of response in order to – in order for the payor to continue to reimburse for Gattex.
`Thanks.
`
`Francois Nader
`
`The short answer is no. The long answer is usually payors rely on the label, and the label is very favorable in the
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`sense that it positions Gattex as a long-term treatment, and as I said a minute ago, the initiation of the treatment is
`really in the hands of the physician. That’s what we’re starting to work from with the payors. As Eric mentioned a
`minute ago, we have identified 75 target accounts and our key account directors that are already working with these
`accounts, which they work to some extent before December 21 without having the benefit of the label. But now that
`we have the benefit of a positive label, the conversations are engaged.
`
`At the same time, we developed the AMCP dossier. We developed the value proposition. We developed the burden of
`illness. So, all these elements constitute what the key account directors are working with, so far so good and time will
`say.
`
`David Nierengarten – Wedbush Securities
`
`If I could, a quick follow-up, just going back to patient identification, obliviously you stated that you identified over
`1,000 unique patients eligible for therapy. Could you just describe a little bit of the process or why the difference – or
`what time it takes for everyone determined to go from say that 200 patients or 300 patients you’re talking about at
`year end 2013 to get into that 1,000 unique patient level?
`
`Francois Nader
`
`So, now – it’s Francois and I’ll ask Eric to take over. As we said, I mean the first patients who will go through the payor
`system, this process takes time. It takes between three to four months. So, we have a time issue. At the same time,
`we have REMS that need to be in place. We have also a need for a colonoscopy as that is again in our label, nothing
`different from our clinical studies, but nevertheless the patients will have to have had a colonoscopy within six months
`prior to starting the treatment. So, all this take time as well.
`
`And our sales force won’t be deployed until probably sometime early to mid February. So, again it’s just a matter of
`uptake; it’s a matter of time and it’s no