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Edited Transcript of VNDA earnings conference call or presentation 1-Aug-18 8:30pm GMT

Q2 2018 Vanda Pharmaceuticals Inc Earnings Call

ROCKVILLE Aug 13, 2018 (Thomson StreetEvents) -- Edited Transcript of Vanda Pharmaceuticals Inc earnings conference call or presentation Wednesday, August 1, 2018 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* James Patrick Kelly

Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary

* Mihael H. Polymeropoulos

Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director

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Conference Call Participants

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* Corey George Davis

Seaport Global Securities LLC, Research Division - MD of Equity Research & Senior Analyst

* Jason Nicholas Butler

JMP Securities LLC, Research Division - MD and Senior Research Analyst

* Joel Lawrence Beatty

Citigroup Inc, Research Division - VP & Analyst

* Matthew J. Andrews

Jefferies LLC, Research Division - Equity Analyst

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Presentation

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Operator [1]

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Welcome to the Second Quarter 2018 Vanda Pharmaceuticals Inc. Earnings Conference Call. My name is Adrian, and I'll be your operator for today's call. (Operator Instructions) Please note, this conference is being recorded.

I'll now turn the call over to Jim Kelly, Executive Vice President and Chief Financial Officer. Please go ahead.

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [2]

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Great. Thank you very much. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals second quarter 2018 performance. Our second quarter 2018 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website.

Joining me on today's call is Dr. Mihael Polymeropoulos, our President and CEO. Following my introductory remarks, Mihael will update you on our ongoing activities. Then I will comment on our financial results before opening the lines for your questions.

Before we proceed, I'd like to remind everyone that various statements that we make on this call will be forward-looking statements within the meanings of federal securities laws. Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These risks are described in the Risk Factors and Management Discussion and Analysis of financial condition and results of operations sections of our annual report on Form 10-K for the fiscal year ended December 31, 2017, and quarterly report on Form 10-Q for the quarter ended March 31, 2018, which are available on the SEC's EDGAR system and on our website. We encourage all investors to read these reports and our other SEC filings. The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events or otherwise, except as required by law.

With that said, I would now like to turn our call over to our CEO, Dr. Mihael Polymeropoulos.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [3]

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Thank you. Jim. Good afternoon, and thank you very much for joining us today. We're pleased to share our second quarter 2018 performance. I will begin with an update on our HETLIOZ business. Hetlioz delivered 10% sequential quarter and 25% year-over-year revenue growth in the second quarter. This performance underscores our conviction that we have found efficient means to identify new Non-24 patients from multiple sources and drive growth during 2018 and beyond. While we're pleased with the existing HETLIOZ Non-24 business trajectory, we continue to work on new life cycle management activities to further support the long-term potential for HETLIOZ. These activities include our work in Jet Lag Disorder, Smith-Magenis Syndrome, or SMS, and our European commercialization activities.

In March, we announced results from the JET8 Phase III clinical study to treat Jet Lag Disorder. This study showed significant and clinical meaningful effects of HETLIOZ on the primary endpoint of the study as well as multiple secondary endpoints in the treatment of Jet Lag Disorder.

In May, we also released the results from the Jet study 2102 of transatlantic travel. The results of that Jet study are supported and add to the body of evidence of the effects of tasimelteon on jet lag in the context of 5- and 8-hour time zone eastward transatlantic travel. We're in the process of preparing a supplemental NDA and plan to submit to the FDA by end of year. The HETLIOZ Smith-Magenis Syndrome pivotal clinical study is progressing, and we expect to communicate top line results by year-end. This represents a significant step towards helping patients with this rare condition. Our experience with the SMS community has further (inaudible) into this and the potential to develop HETLIOZ as a treatment for sleep problems associated with neurodevelopmental disorders.

In Germany, the full commercial launch of HETLIOZ is proceeding, including the initiation of a pilot Non-24 awareness campaign. This direct-to-consumer pilot has already increased awareness of Non-24 and increased the number of potential patients who obtained in the German program for Non-24 patients.

The Fanapt commercial business appears to be stable, consistent with our expectation for 2018. We continue to assess life cycle management efforts for Fanapt, and we expect to initiate a pharmacokinetic study of our long-acting injectable formulation for the treatment of schizophrenia later this year.

I will now turn to tradipitant. Our neurokinin-1 antagonist in late-stage clinical development has emerged as a significant driver of our clinical pipeline with 2 major indications, pruritus in atopic dermatitis and gastroparesis. After a successful end-of-Phase-II meeting with the FDA in the second quarter, we have initiated EPIONE, our 500-patient Phase III clinical study of tradipitant in atopic dermatitis. The recruitment efforts in the tradipitant gastroparesis clinical study are now working. We can now report that as of today, 110 patients have been randomized in the study. With a number of patients in screening, we're now on target to randomize approximately 150 patients and expect to report results by year-end. Gastroparesis is a gastrointestinal disorder of delayed gastric emptying that carries significant morbidity and mortality, representing a significant unmet medical need. As there are few treatment options for these patients, a demonstration of the therapeutic effects by tradipitant could represent a significant advance for patients with this disorder as well as a large commercial opportunity for Vanda.

We're progressing with our early oncology program for Trichostatin A, an HDAC inhibitor developed to treat hematologic and other malignancies, and the first patients in this Phase I study are expected to begin in the third quarter.

I will now turn the call back to Jim Kelly to discuss our second quarter 2018 financial results

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [4]

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Thank you, Mihael. Total revenue for the second quarter of 2018 was $47.4 million, a 9% increase compared to $43.6 million in the first quarter of 2018 and a 13% increase compared to $42.1 million in the second quarter of 2017.

HETLIOZ net product sales grew to $28 million in the second quarter of 2018, a 10% increase compared to $25.4 million in the first quarter of 2018 and a 25% increase compared to $22.5 million in the second quarter of 2017. The HETLIOZ patients-on-therapy number continues to grow quarter-over-quarter, with monthly new patient growth rates consistent with our full year 2018 financial guidance.

As of June 30, 2018, the specialty pharmacy channel held less than 2 weeks of inventory as calculated based on trailing demand. Specialty pharmacy's inventory on hand at the end of the second quarter of 2018 was approximately flat when compared to the first quarter of 2018.

Fanapt net product sales of $19.3 million in the second quarter of 2018 reflect a 6% increase compared to $18.2 million for the first quarter of 2018 and a 1% decrease compared to $19.5 million in the second quarter of 2017.

Wholesalers' inventory on hand at the end of the second quarter of 2018 was down slightly when compared with the first quarter of 2018.

Fanapt prescriptions, as reported by IQVIA exponent, were 27,832 in the second quarter of 2018, a 2% increase compared to the first quarter of 2018. Prescription trends remain consistent with our full year 2018 financial guidance.

You will see in our press release that Vanda is offering non-GAAP financial information. We do so because we believe that the non-GAAP financial information can enhance an overall understanding of our financial performance when considered with GAAP figures. Vanda's non-GAAP net income and net loss excludes stock-based compensation and intangible asset amortization.

On a non-GAAP basis, during the second quarter of 2018, Vanda recorded non-GAAP net income of $7.7 million as compared to non-GAAP net income of $6.6 million in the first quarter of 2018 and non-GAAP net income of $1.6 million for the second quarter of 2017.

On a non-GAAP basis, for the second quarter of 2018, Vanda recorded non-GAAP operating expenses, excluding cost of goods sold, stock-based compensation and intangible asset amortization, of $35.1 million compared to $33.1 million in the first quarter of 2018 and $36.4 million for the second quarter of 2017. Vanda's non-GAAP operating expenses have been fairly stable over the past 6 quarters, ranging between $33 million and $39 million a quarter. However, we do expect to see an increase, beginning in the third quarter of 2018, associated with the Phase III clinical study of tradipitant for pruritus and atopic dermatitis that was initiated in June of 2018.

Vanda's cash, cash equivalents and marketable securities, referred to as cash, as of June 30, 2018, were $231.2 million compared to $248.8 million as of March 31, 2018, representing a decrease to cash of $17.8 million during the second quarter of 2018. And that included a $25 million milestone payment to Bristol-Myers Squibb.

Vanda reiterates its prior 2018 net product sales guidance and provides an update to non-GAAP operating expenses in year-end 2018 cash guidance and expects to achieve the following financial objectives in 2018: net product sales from both HETLIOZ and Fanapt of between $180 million and $200 million; HETLIOZ net product sales of between $108 million and $118 million; Fanapt net product sales of between $72 million and $82 million; non-GAAP operating expenses, excluding cost of goods sold, of between $153 million and $163 million, this compares to prior guidance of between $163 million and $173 million.

Non-GAAP operating expenses excludes intangible asset amortization expenses of $1.7 million and stock-based compensation of between $11 million and $15 million. Year-end cash is expected to be between $225 million and $235 million as compared to prior guidance of $215 million to $225 million, and this includes a payment to Bristol-Myers Squibb of $25 million milestone obligation based on $215 million of cumulative HETLIOZ's net product sales, which occurred during the second quarter of 2018.

So now I'll turn the call back to Mihael.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [5]

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Thank you very much, Jim. At this time, we would entertain your questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Jason Butler from JMP.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [2]

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Two questions for me, first for HETLIOZ and Smith-Magenis. Could you give us a little bit more color on how you think -- how we should think about the market here? The number of addressable patients and the commercial strategy, I guess, how the commercial strategy will differ, potentially, from that for Non-24?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [3]

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Yes, thank you very much, Jason. So there are significant differences between the SMS community and the Non-24 patients. As you recall, 4 years ago, when we started commercializing HETLIOZ for Non-24, there was very little awareness in the blind or sighted community of Non-24, and we had to do a lot of education around that. Now with Smith-Magenis Syndrome, a disorder that is diagnosed through DNA testing subsequent to the clinical diagnosis, patients are already diagnosed, and there is a community of patients that are organized around support groups, a significant support group is an organization called PRISMS, that we have been working with over the last several years. So the commercial launch around Smith-Magenis Syndrome will be more typical of an orphan disorder, whether you work together with the families and the support organization in key investigators and physicians that are interested in this field. In terms of numbers, we know that the PRISMS organization has several hundred families in their membership, and of course, there is a wider audience outside of membership. So believe that this is what will form the nucleus of the launch.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [4]

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Okay, great. And then on tradipitant and gastroparesis, can you just remind us of the changes that you made to improve the enrollment rate? And just give us an overall sense what the patient population is. And potentially, what kind of baseline patient characteristics we should be expecting in the enrolled population?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [5]

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Yes, just to remind everyone that this study aims to recruit patients with a prior diagnosis of gastroparesis that in the vast majority of them was diagnosed through gastric emptying studies. If that was not performed, we have offered to conduct this study to confirm the diagnosis. However, the patients today, the vast majority of them already had that test done before coming to us.

In terms of characteristics, the patients are balanced between idiopathic gastroparesis and diabetic gastroparesis, or at least we attempt to balance them. In terms of what we did differently, and you'll recall that a couple of quarters back, we were discussing how slow the recruitment was and difficult to recruit, and that had to do with a fundamental change that the company did. We decided to advertise directly to consumers through national radio ads that we undertook during the spring, and in fact, some of them are ongoing. That allowed us access thousands of interested patients who opted in, in our database. We connected them to our sites and some of them enrolled already in the studies. I said 110 of them now have been randomized, and they're part of our study. So I would say the largest change was the direct-to-consumer campaign via national radio.

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Operator [6]

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And the next question comes from Joel Beatty from Citi.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [7]

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First one is on HETLIOZ and about the growth that you saw this quarter. Could you characterize amount that came from the blind versus sighted population?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [8]

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Jim?

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [9]

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I appreciate the question. While we're not necessarily going to give too much detail on the relative weighting, what we do want to share is that beginning in the end of March, we took our field force that was uniquely focused on what we have traditionally called the PDP opportunity, patient-directed physicians, and put them back to work uniquely focused on that opportunity. You might remember, in the fourth quarter, those 24 HETLIOZ representatives were helping our neuroscience reps with the HPI initiative. What we saw in the second quarter is, when we were able to get those 24 HETLIOZ focus reps back at their original task, we benefited from being able to source patients from both pools, and that's critical to our go-forward strategy that we are fully emphasizing strong execution on both paths.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [10]

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And just to add, on the mix, I want to remind everybody that we have now 2 sources of Non-24 patients that could be categorized between the blind and sighted. While our sighted group of patients continues to rapidly increase, so does the blind. And at this time, the blind Non-24 patients continue to be the majority of patients in treatment. However, as we move on with our sighted initiative, this balance may change in the future.

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Joel Lawrence Beatty, Citigroup Inc, Research Division - VP & Analyst [11]

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And another question on the jet lag indication, which you had additional data on a couple of months ago. Could you describe the -- just at a high-level maybe the discussions you had with FDA on coming to agreement on the trial design that you use to help generate the data you have? And then whether that will support approval on the jet lag indication? And also, what do you expect on AdCom, given that this will be the first drug approved for this indication?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [12]

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Yes, alluded on the summary of the program, this jet lag program indication will be supported by 4 studies. The studies are a small but significant proof-of-concept study that was conducted and published in Lancet that showed the phase advancing properties of the drug, both on circadian rhythms, melatonin was measured at the time, but also improving the sleep-wake parameters. Then 2 critical studies, the JET5 and JET8, these are studies where patients experience the 5-hour and 8-hour phase advance. And this was a sleep-logged base study. And finally, the Jet study, which was a traveler study. People traveled from U.S. point to the U.K. Those that experienced significant jet lag, they traveled again, and they were randomized to drug or placebo. This was an exceedingly difficult study to run, so it recruited only about 24-or-so patients. The results of that study, however, despite the small number of patients, were positive, demonstrating again the robustness of effect in treating jet lag even under traveler conditions.

In our prior discussions under Phase II with the FDA, we had agreed that at that point, we had conducted the small study, the JET5 study, that only 1 study would suffice. And the proposal we had made was of this transatlantic flight. Now of course, we have the transatlantic flight and we have the JET8 study. So we feel very confident that we have a very significant body of evidence that demonstrates the effect of tasimelteon in jet lag. And furthermore, I want to add that we reviewed with everybody the JET8 study. And of course, not only we saw a very significant clinical effect, but the confidence around this data that was demonstrated by highly significant P values further strengthens the entire program.

You asked about the potential of an advisory committee, and of course, since it's the first time a drug will be approved in such an indication, this advisory committee may happen, and we would welcome it. The other thing that is important to keep in mind is, with a drug first in the indication, you would be typically illegible for a priority review. And of course, we will apply for a priority review of this indication. The clock, we understand, would be of 6 months from receipt of the application. And, therefore, provided this review goes smoothly in this NDA submission as planned before the end of the year, we could be in the position that this time next year, we will be in the midst of the launch in the jet lag indication.

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Operator [13]

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And our next question comes from Matthew Andrews from Jefferies.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [14]

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I know the HPI is still early stages, roughly 3 quarters, 3 full quarters. Can you talk about your thoughts relative to whether you expect any seasonality as we move through the summer? And has there been seasonality with the blind business? That's my first question.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [15]

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Thank you very much. I will avoid to make a prediction with less than a year on seasonality. What I can say about HPI, (inaudible) that we have seen strong demand, and also, we have continued to see strong resistance by insurance companies who very often, in our opinion, inappropriately deny treatment. But eventually, upon appeal, they do approve the treatment for patients. So we expect to see this kind of resistance continuing. I also want to remind that in June, we undertook a reorganization of the Fanapt sales force that promote HPI, and that was a very significant reorganization. And we're in the midst of hiring in full the sales force back up to a number of 115 after we changed about 35-or-so sales representatives. So we do expect that this reorganization will affect the production of new scripts during that reorganization, but we do not expect the reorganization to affect the overall performance of the third quarter or beyond. And we believe that this will strengthen, actually, our presence in the psychiatrist office in the promotion of both Fanapt and HETLIOZ.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [16]

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And Jim, what -- did gross-to-net improve in Q2 for HETLIOZ?

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [17]

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And of course, you're asking the sequential improvement as compared to Q1.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [18]

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That's right.

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [19]

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The trend that we've seen in prior years where Q1 is the higher gross-to-net, and then it drops down into Q2 and subsequent, that certainly is continuing here. So we did see an improvement in gross-to-net.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [20]

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And then has Germany still been de minimis in terms of revenues? Or has that grown over the couple of quarters?

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [21]

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Well, while we do continue to grow in Germany, as a portion of the total, it continues, I'd say, to fall into the de minimis category. But I believe you heard -- Mihael talked about some of the pilot work we're doing with direct-to-consumer advertising for Non-24 awareness.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [22]

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And just to underscore that, while there is some similarities with the U.S., there are differences as well. And the similarity is, people with Non-24, they want to learn more, and they want to try the treatment. And therefore, we have seen a very warm reception to the radio awareness ads in Germany. One of the differences that in the German system, while patients do want to go to their primary care doctors as Americans do, primary care doctors are very quick to refer patients to sleep doctors. And that's fine, however, sleep doctors in Germany are booked a couple of months ahead of time or more. So there will be a delay and lag of translating newly interested and diagnosed patients into treated patients, and a lag that would be longer than we've seen in the U.S.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [23]

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And then, Jim, for the SG&A trend guide, it's been flattish quarter-on-quarter. Should we expect a meaningful increase through the end of the year? Or a little less rapid growth as you continue to promote with HETLIOZ and the reorg with Fanapt?

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [24]

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Yes, we -- given the pace of our ability to find talented sales reps and backfill, I don't expect there to be a material impact on our SG&A trends linked to some of the changeover in reps. When we look at our operating expense trajectory, our expectation and my expectation is that you're going to continue to see a fairly stable SG&A quarter-to-quarter trend for the rest of the year. Where you'll see a change in trajectory, it's really in the R&D space. We've been averaging over the past 6 quarters our GAAP OpEx number of about $10 million a quarter. And with the beginning of the Phase III program with tradipitant, we are expecting an uptick beginning this quarter, representing that and, of course, the full pull-through of the gastroparesis study this year as well, along with Smith-Magenis.

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Matthew J. Andrews, Jefferies LLC, Research Division - Equity Analyst [25]

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Yes. And then just lastly, as it relates to the Phase III start for tradipitant, can you share with us if there have been any meaningful changes with the protocol compared to what you communicated a quarter or so ago on what you thought the endpoint would be, length of dosing, et cetera?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [26]

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No changes. So the protocol is very consistent with what we talked about before.

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Operator [27]

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And our next question comes from Corey Davis from Seaport.

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Corey George Davis, Seaport Global Securities LLC, Research Division - MD of Equity Research & Senior Analyst [28]

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The first one is on the gastroparesis trial. I think you mentioned that the new D2C for the study resulted in like thousands of patients that came in to see you. And so what's the big reason they get screened out (inaudible) between thousands to the 110 that are enrolled?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [29]

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The last part of the sentence was a little muffled. There was some background noise, would you mind repeating?

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Corey George Davis, Seaport Global Securities LLC, Research Division - MD of Equity Research & Senior Analyst [30]

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What's the big reason that patients get screened out?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [31]

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Yes, so let me describe the D2C campaign. So in the D2C campaign, we explicitly are looking for patients that have experienced the symptoms of gastroparesis and they are diagnosed with gastroparesis. But of course, patients who are interested to learn more about the study are not necessarily interested to participate in the study. And they're not necessarily meeting all the inclusion and exclusion criteria of the study, and they're not available to participate in the study for a variety of reasons at the time of the study. So I think what is very encouraging is that there is a community of patients understanding the disorder, sensing the unmet medical need and wanted to interact with sponsors and learn more. So we're actually very encouraged with that return of the radio ads.

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Corey George Davis, Seaport Global Securities LLC, Research Division - MD of Equity Research & Senior Analyst [32]

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Okay. And then on the pruritus study, any change in your thinking on the enrollment time? And when you would have data?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [33]

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Actually, we would like to have a little more experience with recruitment because we just started, actually, only a fraction of our planned sites are up right now, so we're in the midst of launching the study, before we're able to calculate and communicate. But my initial thought and the internal thinking here is that business as usual, waiting for sites to recruit patients is not going to be something that's going to work for us. So you're going to see us, actually, very quickly taking on national radio ads. In fact, one of them is going to start on the week of August 13, trying to create awareness on the existence of the study and start actually using this new approaches that we have discovered with gastroparesis in transplanting them into the atopic dermatitis study. Once we start seeing a little traction with the recruitment and more sites are up, I think we're going to be in a better position to calculate the timeline.

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Corey George Davis, Seaport Global Securities LLC, Research Division - MD of Equity Research & Senior Analyst [34]

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Okay. Last question. Now that you have a couple of profitable quarters and you have more cash in Jim's bank account, is there a chance that you might go back into the red and choose to spend more money if the right pipeline product comes along?

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [35]

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I will let Jim answer this beautiful question, Corey.

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James Patrick Kelly, Vanda Pharmaceuticals Inc. - Executive VP, CFO, Treasurer & Secretary [36]

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Well, Corey, with -- when you look at the results to date and the midpoint of guidance for the rest of the year, what you see is that as we ramp up the R&D spend beginning this third quarter, you do begin to put pressure on that profitability. And it puts us, at least for the rest of the year, at a point where we're right around breakeven, maybe a little bit of a loss on the net income basis. Now we haven't guided to next year just yet, but you could imagine some of the things that could play into subsequent P&L profile, and they include everything from the results we get on gastroparesis and our plans there, the speed and size of our second atopic dermatitis study and other life cycle management activities, plus our plans to launch in Jet Lag Disorder. And so as all those pieces come into clearer focus, we'll, of course, come back and give you feedback on the profile.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [37]

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Right. But the overall intent is to continue to grow the top line and our revenue and be able through that to make investments in our research and development. And of course, it is a balancing act. And as we know more, we'll let you know more.

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Operator [38]

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And this concludes our question-and-answer session. I'll now turn the call back over to Dr. Polymeropoulos for final remarks.

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Mihael H. Polymeropoulos, Vanda Pharmaceuticals Inc. - Founder, President, CEO & Director [39]

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Thank you very much, and thank you all for joining. And we'll see you on this call next quarter. Thank you.

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Operator [40]

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Thank you. Ladies and gentlemen, this concludes today's conference. Thank you for participating, and you may now disconnect.