Q3 2016 Theratechnologies Inc Earnings Call
Oct 04, 2016 AM EDT
TH.TO - Theratechnologies Inc
Q3 2016 Theratechnologies Inc Earnings Call
Oct 04, 2016 / 12:30PM GMT
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Corporate Participants
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* Denis Boucher
EXOCET Public Relations, Inc. - IR
* Luc Tanguay
Theratechnologies Inc. - President & CEO
* Philippe Dubuc
Theratechnologies Inc. - SVP & CFO
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Conference Call Participants
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* Doug Loe
Euro Pacific Canada - Analyst
* Andre Uddin
Mackie Research Capital - Analyst
* Andre Leno
National Bank Financial - Analyst
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Presentation
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Operator [1]
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Good morning ladies and gentlemen and thank you for standing by. Welcome to Theratechnologies earnings conference call for the third quarter of fiscal year 2016.
(Operator Instructions)
I would like to remind everyone that this conference call is being recorded today, Tuesday, October 4 at 8:30 a.m. Eastern time. And I would now like to turn the conference over to Denis Boucher. Mr. Boucher, please go ahead.
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Denis Boucher, EXOCET Public Relations, Inc. - IR [2]
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Thank you and welcome. Mr. Luc Tanguay, President and Chief Executive Officer of Theratechnologies, and Mr. Philippe Dubuc, Senior Vice President and Chief Financial Officer, will be the speakers on today's call. A Q&A period opened exclusively to financial analysts will follow their presentation.
Before Mr. Tanguay begins his remarks I've been asked by Theratechnologies to read the following message regarding forward-looking statements. I would like to remind everyone that Theratechnologies' remarks today may contain forward-looking statements about its current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements or other future events or developments.
In preparing these forward-looking statements several assumptions were made by Theratechnologies and there are risks that results actually obtained by the Company will differ materially from those statements. As a consequence, the Company cannot guarantee that any forward-looking statement will materialize and you are cautioned not to place undue reliance on them.
Theratechnologies refers current and potential investors to the forward-looking information section of its press release to its management's discussion and analysis issued this morning and to its annual information form dated February 24, 2016 and the risk factors section therein available at www.SEDAR.com under Theratechnologies' public filings. Forward-looking statements represent Theratechnologies' expectations as of October 4, 2016. Except as may be required by securities laws, Theratechnologies does not undertake any obligation to update any forward-looking statement whether as a result of new information, future events or otherwise.
I would now like to turn the conference over to Mr. Tanguay.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [3]
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Thank you, Denis, and good morning everyone and thank you for being with us today. Before turning to Philippe for the results from our last quarter I will take a short time to go over highlights of the last three months and provide you with perspective about our next steps. I must say that operation and sales are running according to plan.
On the manufacturing site, for example, things are going very well and we have finally reached the level of inventory that we were targeting. On the operations side, sales are in line with our expectations for the quarter. Even though they appear relatively flat we are seeing signs of growth that are in line with our guidance.
Indeed, revenue results in the last quarter have been somewhat skewed. And Philippe will explain this later during this call. Looking at unit sales you will be able to appreciate that it supports our 2016 guidance.
The same can be said for the EBITDA. Even when taking into consideration expenses related to ibalizumab, we are on our way to meet our guidance for the current fiscal year. In fact, Q3 is another quarter during which we generate a positive EBITDA.
In that regard, Q2 is very much comparable -- Q3, sorry, is very much comparable to Q2. This was done even as started to invest significantly in pre-launch activities for ibalizumab.
We also made some announcement regarding EGRIFTA in the past few months. The most recent was to announce that we will replace the 2 mg/vial program that what we called the F4 which is a different formulation of EGRIFTA. This was made possible after we proposed and obtained the okay to go ahead with this program from the FDA.
This is quite a positive development for both patients and for healthcare professionals and, of course, for us as well. First, it will allow us to continue to comply with one of the post-marketing obligations imposed by the FDA which required us to develop a single vial formulation of EGRIFTA. This means that there will no longer be a need to pursue the development of the 2 mg/vial presentation.
In addition, the F4 is very convenient for patients as well as for professionals at the pharmacy level. This is due to the fact that this formulation does not require refrigeration. Furthermore, the product requires a smaller volume to be injected and it will be faster and easier for the patients to prepare and perform the injection in the morning.
On our side it will generate significant savings as the cost of goods will be substantially lower. If approved and things go according as planned the F4 should be available to patients in 20 to 24 months.
It is also worthwhile noting that we are not starting from scratch with the F4. As you may recall, we have already used this formulation in the COPD clinical trial we carried out a few years ago. Filing with the FDA then will be possible once bioequivalence has been established.
I must say that we are quite happy with the fact that our development plan for the F4 was approved by the FDA. As we move forward with EGRIFTA and while we prepare for the launch of ibalizumab, our approach will continue to tightly control expenses. This combined to sales growth and sustainable pricing policy will ensure that we keep on delivering positive cash flow. Our plan remains to support sales growth in the US through targeted marketing and medical education initiatives.
Building new markets for EGRIFTA is also part of our ongoing strategy. Over the last quarters we have secured approvals in Canada and Mexico and have concluded agreements for a number of European countries and South Korea. During the last quarter we signed yet another sales and marketing agreement which covered [to sign] Spain and Portugal. Of course, such agreements are meant to generate sales only in mid- to long-term horizon as our partner in all territories are developing their regulatory strategy with the exception, of course, of Mexico where public reimbursement is the next significant milestone.
On this let me now talk about ibalizumab. If anything we are getting more excited about this groundbreaking product as we move closer to a potential launch.
On the regulatory front, various documents required by the FDA have been filed in a timely manner. The priority status and rolling submission granted to ibalizumab means that documents can be filed by TaiMed as the dossier moves along rather than having to wait for the entire file to be presented all at once.
For example, TaiMed filed a CMC or the section related to manufacturing in the third quarter. The proposed [screen name] for ibalizumab was also submitted to the FDA. This is how things will proceed over the next few months in terms of regulatory filing.
As for the Phase III clinical trial it should be completed by the end of October and results should be available in November. We expect that TaiMed will file final documents in early 2017 and if approved this will entail a commercialization launch of the product in the second half of 2017 as expected.
As TaiMed progresses on the regulatory side of things, our pre-launch plan is really starting to pick up steam. We have already started talking about ibalizumab to top HIV specialists but our first major offensive will be at IDWeek in New Orleans at the end of the month. Complementary primary endpoint Phase III results will be featured in an oral presentation as part of the Late Breaker sessions during this prestigious scientific meeting. We have also made significant progress on market analysis, potential pricing and market research among physician and payers, all of which demonstrate that we have every reason to be enthusiastic about this product.
From what we can already see ibalizumab is getting a lot of attention from the scientific community. As an example, ibalizumab was listed as one of the top 40 drugs in the pipeline in the September 2016 edition of Chemical & Engineering News magazine.
Furthermore, it was the only drug on that list targeting HIV. More than ever we have great expectation for ibalizumab and we have never been more convinced that it will become a true game changer for our Company.
I will now turn to Philippe who will discuss the financial highlights for our last quarter and I will come back for some closing remarks. Philippe?
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Philippe Dubuc, Theratechnologies Inc. - SVP & CFO [4]
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Thank you, Luc, and good morning to all. As Luc mentioned just a moment ago, we are well on our way to meet our guidance both in terms of revenue and EBITDA. This is due to a combination of factors that I would like to address in more detail.
First of all, our revenues were stable in the last quarter compared to the previous quarter of 2016. Our third-quarter sales reached $6.88 million just shy of second-quarter sales of $6.95 million. Compared to the same quarter last year sales were down 4% in US dollars and 2.9% in Canadian dollars.
I'd like to remind people that our third quarter last year was quite exceptional and may not be the best comparator. In Q3 2015 our distributor built more inventory than normal, which explains why sales in the third quarter of this year are slightly lower.
In reality, unit sales to pharmacies were significantly higher in Q3 of this year compared to Q2. This is not reflected in our results as our distributor already had sufficient inventory to meet the increased demand. This partially explains why higher unit sales were not reflected in our results for the last quarter. These quarter-over-quarter variations tend to even themselves out over a full fiscal year.
If we compare our results for the first nine months of 2016 compared to the same period of last year sales are up 20% from about $17 million to a little more than $20 million. In Canadian dollars this increased percentage is even more impressive standing at 28%. This gives you an appreciation as to just how much the exchange rate has an impact on the results we present.
Another factor that has had an impact on revenues in the last quarter had to do with more patients having their treatments reimbursed by Medicaid rather than private payers. This really makes a difference as Medicaid sales are subject to a greater discount than sales to patients with private insurance plans. More Medicaid patients translates into a lower average net selling price, thus revenues did not increase at the same pace as if we had a higher concentration of patients on private insurance plans.
All of this to say that our results are susceptible to be slightly distorted from quarter to quarter due to factors that are not a sign of lower demand or decreasing prescription volume. When we look at the broader picture and give ourselves a larger perspective than just the three-month time frame we can conclude that sales of EGRIFTA are still progressing and that, more importantly, we are very much in line to meet our financial targets for the current fiscal year. With three quarters completed our goal is to reach sales in the range of CAD36 million to CAD37 million is well within range having already recorded CAD27 million in sales.
As for expenses we continue to exercise great control. Even as we prepare for the launch of ibalizumab we have managed to keep expenses relatively stable.
Cost of goods sold was actually down significantly, standing at slightly above CAD1 million compared to CAD3 million for the same three-month period last year. This is a direct result of smooth manufacturing which reduces waste of raw materials.
In Q3 2016 results also include royalties of CAD659,000 to EMD Serono which we did not have last year. As for R&D expenses, they were up from the same quarter last year mainly due to increased spending on medical affairs which includes additional medical science liaison staff and various new programs to support EGRIFTA. More precisely, we spent CAD1.8 million on R&D in the third quarter compared to CAD1.5 million for the same quarter last year.
In the third quarter of 2016 we reported selling and marketing expenses of CAD3.7 million, up slightly from CAD3.5 million in the same quarter last year. While this year's number is slightly higher, EGRIFTA-related expenses are lower than last year since we started spending money on the anticipated launch of ibalizumab.
It should be noted that selling and marketing expenses include the amortization of the intangible asset value associated with the commercialization rights for EGRIFTA. That item amounted to CAD0.5 million in Q3 2016 which is almost identical to the same period last year.
As for general and administrative expenses, they represented an amount of close to CAD1.2 million, substantially higher than in Q3 2015 when they amounted to CAD865,000. This is principally due to share-based compensation, a non-cash expense, and a slightly higher headcount.
When taking into account all the information I just provided you with we closed the quarter with an adjusted EBITDA of close to CAD1.3 million which is in line with our performance in the previous quarter but less than we recorded in Q3 of last year. Again, this quarter royalty payments to EMD Serono, which we began paying in January this year, investments in pre-launch activities for ibalizumab and higher medical expenses to support EGRIFTA are the main factors explaining the lower adjusted EBITDA compared to 2015. We ended the quarter with a net profit of approximately CAD900,000 or CAD0.01 per share in comparison to a net profit of CAD1.2 million or CAD0.02 per share in Q3 2015.
It should be noted that this quarter, the reevaluation of the warrant liability played in our favor while it had a negative impact of just over CAD1 million in the previous quarter. This is a non-cash item and is strictly due to accounting rules. As I mentioned during the last word in a conference call fluctuations in the market value of the outstanding warrants will continue to impact our bottom line in tandem with our stock price performance.
Further increases in the market value of our outstanding warrants will continue to cause a non-cash reevaluation expense on our income statements until the warrants expire or are fully exercised. This means that it may turn a profit into a loss and vice versa. Nevertheless, when looking at our operating activities, which are not affected by such accounting rules, they generated a profit of CAD546,000 in Q3.
Cash requirements relating to operating activities amounted to CAD0.5 million. This is mainly due to changes in operating assets and liabilities.
More specifically, a CAD2 million reduction in accounts payable and accrued liabilities accounted for the negative cash flow in the current period. As a result, we ended the quarter with CAD8.6 million in liquidities compared to CAD9.2 million at May 31, 2016.
On this let me turn the conference back over to Luc.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [5]
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Thank you, Philippe. As we continue to make progress with EGRIFTA in the US and to manage a sustainable pricing strategy I am convinced that we will keep seeing growth over the next quarters.
Of course, the key will be to carefully manage our expenses while working on an optimal location of resources as we prepare for the anticipated launch of our second product. We are confident with our guidance for 2016 and we will remain focused on delivering those numbers when comes to the end of the year.
When we completed the transaction for ibalizumab we knew that we could prepare for the market cap for this important new treatment while we're benefiting from synergies from our existing infrastructure. The work we've done so far is [complement] this opportunity and we are progressing toward the launch of ibalizumab without having to compromise the profitability of our activities.
Our operations are profitable. We continue to report a positive EBITDA and maintain our cash position while building the next element of growth. As we may be just a few quarters away from having an additional source of revenue, I'm quite pleased as to where we are today and how the future looks for Theratechnologies and its shareholders.
On that note we will now take questions from financial analysts.
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Questions and Answers
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Operator [1]
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(Operator Instructions) Doug Loe, Echelon Wealth Partners.
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Doug Loe, Euro Pacific Canada - Analyst [2]
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Yes, thanks very much gentleman for the update on the quarter. EGRIFTA focus was my question. Luc, Philippe, just wanted to get a sense of the relative magnitude of the barriers you might be encountering in lifting quarterly EGRIFTA sales above what has been a pretty flat trendline here over the last few quarters, mindful of your commentary on that, though.
So you might just want to relatively weight what barriers you are running into and how specifically you plan on addressing them. It's the usual laundry list of reimbursement recognition by physicians of the availability of EGRIFTA for treating HIV lipodystrophy, recognizing it as a real medical condition not a cosmetic disorder.
You know the list. Just wondered what specific initiatives you have within your marketing team that might lift the run rate above existing levels and over what time frame you think those might be a addressable. I will leave it there.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [3]
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I'm not sure I catch all of your questions. It was pretty long, Doug, and if I miss something please just ask again.
In terms of reimbursement I think we are doing pretty well. We have as I mentioned in the past less than 2% of our patients that are denied for reimbursements. So it's pretty good.
Working on that, though. We don't take no for an answer. But on that side we are reimbursed.
What Philippe was mentioning, in fact it was more the patient mix that we had in the last quarter where we have first time it happened since we are in charge of EGRIFTA directly that the number of patients on Medicaid was higher than the previous quarters, which bring more discount to that group which lower a little bit the sales of our net sales, having to give more discount.
And then gross to net was higher. So it might be different the next quarter, but don't know if it's a long-term trend but it shows, in fact, that where our sales team and marketing team are getting more and more patient on their Medicaid as well as the managed marketing who is in charge of reimbursement. I don't know if I catch correctly your questions.
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Doug Loe, Euro Pacific Canada - Analyst [4]
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So maybe I will just address one specific subsection of my question and I will get back in queue. A common perception of HIV lipodystrophy is that it's more of a cosmetic disorder than a medical condition meriting therapy.
Maybe just address whether that's still a bias that you're encountering among prescribing physicians and patients and if there's any specific strategy to try and overcome that. And then I will leave it there.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [5]
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I will talk a bit about that. What we're doing, in fact we present at a lot of conferences to talk about that. We are -- the way we approach that is by highlighting the importance of treating HIV lipodystrophy, try to position that as, in fact, not as a cosmetic issue but more long-term health problem that a patient can develop it they are not treating the disease.
So we have MSLs today. We increased the number of MSLs for, of course, to get ready for ibalizumab. But also they are talking about EGRIFTA. So what we're doing is medical education for our patient, for our physician with key opinion leaders in order to make sure that they see that disease or that condition as something they need to treat and not just for cosmetic purposes but also for long-term health of the patient.
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Doug Loe, Euro Pacific Canada - Analyst [6]
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Okay, thanks.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [7]
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So the way we're -- with special meeting with physicians, with patients we have nurses doing meetings with physicians, as well. So we have a lot of activities and that's why, in fact, you have seen increase in the R&D. This is only to do that kind of presentation, if you will.
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Philippe Dubuc, Theratechnologies Inc. - SVP & CFO [8]
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And maybe just to finish on that, Doug, we did actually see some growth from our specialty pharmacies ordering from our distributors. So there is growth in the number of units that we sell to specialty pharmacies.
In fact, it went up 9% this quarter over Q2. So there is some growth at the specialty pharmacy level that we believe we will see continuing in the future.
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Doug Loe, Euro Pacific Canada - Analyst [9]
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Great. Thank you.
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Operator [10]
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Andre Uddin, Mackie Research Capital.
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Andre Uddin, Mackie Research Capital - Analyst [11]
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Good morning everyone. Just two quick questions.
In terms of rest of world growth for EGRIFTA, how is that progressing? And which countries do you expect to see sales growth? And in terms of patient numbers, can you just give us an indication where patient numbers are right now for EGRIFTA in the US? Thanks.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [12]
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I will start with the last one, Andre, for a few quarters. I don't discuss directly the number of patients, but what I can tell you is as Philippe mentioned, in fact in the last two quarters we have seen growth at the pharmacy purchases in Q2 over Q1. We had close to 2% growth in purchases from pharmacy and Q3 over Q2 we have 9% growth.
So it's still growing. Number of I don't want to comment the number of patients. What is important for us is the top line in terms of total revenues and what counts for us is to reach our guidance for the year.
So we are very much in line to achieve our guidance for this year. So up to now it's going in the right direction.
Your first question was for the other territories. As I mentioned in my speech, I don't see in the near future any sales or significant sales because we have some net patient sales in some territories but significant sales that will change the economic from territory like Europe, South Korea and so on because they are all working on their regulatory strategy as we speak.
Some of them should start to file toward the end of the year or early next year, with the exception as I mentioned of Mexico where the next important milestone is reimbursement. So if we get reimbursement next year this could have an impact on our sales, but for now we don't forecast anything either in our guidance or when we talk to investors about the potential revenue from those territories.
The one that is probably the most significant in the short term outside the US is Canada where we, at this point we are working on the reimbursement with all the provinces, in fact, and particularly with Quebec, the province of Quebec whereas you know we have been turned down by Quebec for reimbursement. We went into appeal and what we have heard recently is that we should have an answer from the Quebec government in February of next year.
So if we get reimbursement in Quebec, we are doing some work in Quebec and outside Quebec with MSL and sales rep and we should have some impact at the end of the day, the authorities except to reimburse EGRIFTA. So basically, probably Canada, second step Mexico but much further and even further the other territories.
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Andre Uddin, Mackie Research Capital - Analyst [13]
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And do you think ibalizumab is going to reinvigorate EGRIFTA in terms of do you think you will be able to expand out your reach to other physicians to actually grow EGRIFTA?
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Luc Tanguay, Theratechnologies Inc. - President & CEO [14]
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Can you repeat, sorry, I missed the first part, there's some noise here. Sorry.
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Andre Uddin, Mackie Research Capital - Analyst [15]
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Sure. So just in terms of when you launch ibalizumab next year, are you expecting that your launch would help to grow EGRIFTA?
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Luc Tanguay, Theratechnologies Inc. - President & CEO [16]
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Definitely. Because what we will probably do is the way we will distribute our sales rep with ibalizumab will probably be different than what we have today with EGRIFTA.
So we will cover more territory than we're covering today with EGRIFTA. So definitely we expect the fact that we will approach more physicians with ibalizumab we would expect that to have an impact on the US sales of EGRIFTA, as well.
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Andre Uddin, Mackie Research Capital - Analyst [17]
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All right. That's it for me. Thank you.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [18]
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And just for you to know, when I was talking about we're doing market research things look pretty good. We have not finished yet but as soon as we finish that we will finally know exactly how we want to distribute our sales force. And we will come back to the investors and analysts with what we plan to do and what could be the impact for EGRIFTA, as well.
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Andre Uddin, Mackie Research Capital - Analyst [19]
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That's great. Thanks, Luc.
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Operator [20]
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[Andre Leno], National Bank.
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Andre Leno, National Bank Financial - Analyst [21]
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Hi, good morning. Thank you for taking my question. It was actually partially answered before by Luc.
It was more for inclusion of EGRIFTA in the formulary scene across Canada. You spoke a bit about Quebec expecting next year, but I was wondering for the other provinces is there anyone in particular that you are targeting more attentively and what general timelines would you expect for decisions of whether it's included in the formularies or not? Thank you.
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Luc Tanguay, Theratechnologies Inc. - President & CEO [22]
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We are targeting mainly Ontario and BC outside Quebec, of course, and we should have an answer next year on those two. We just filed with those provinces. Everything was needed to ask for reimbursement.
So it will go through a negotiation process. I hope we are going to be approved. We are a Canadian Company and I hope that it is going to be taken into consideration.
It's not obvious but we hope for that. And, in fact, if we have Quebec, Ontario and BC we will cover a pretty big part of the Canadian market.
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Andre Leno, National Bank Financial - Analyst [23]
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Great. Thank you. That's all the questions.
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Operator [24]
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(Operator Instructions) There are no further questions. I will turn the call back over to Denis Boucher.
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Denis Boucher, EXOCET Public Relations, Inc. - IR [25]
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Thank you. If there are no further questions we will now conclude today's conference call.
On behalf of Theratechnologies I would like to thank everyone for having been on the call today. And I wish you a very pleasant day. Thank you.
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Operator [26]
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This concludes today's conference call. You may now disconnect.
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