Q4 2019 Earnings Call
Ladies and gentlemen, please standby your conference is scheduled to begin momentarily again, thank you for your patience and please standby.
[music].
Good afternoon, and welcome to the be this fourth quarter and full year 2019 financial results Conference call.
It's time, all participant lines are in listen only mode.
After the speakers presentation, there will be a question answer session.
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Today's call is being recorded an accompanying slide deck is available on today's webcast and also available on the presentation page of the Visvis Investor Relations website.
For introductions in opening remarks, I'd like to turn the call over to Mr., David carry weapons orphan partners. Please go ahead.
Thank you operator, good afternoon, everyone and welcome to today's teleconference.
With me on the call as Johnny Miss Visvis, as Chief Executive Officer, Mark Hokey, Chief Financial Officer, and Dr., Centrus Rockies fetuses Chief Medical Officer.
Before we get started I would like to remind everyone that during this conference call me. This will make certain statements that are considered forward looking within the meaning of the private Securities Litigation Reform Act 1995.
As noted on slide two these statements may be identified by the use of forward looking words, such as anticipate believe estimate expect forecast intend likely.
Like we may opportunity plan potential predict and should among others. These forward looking statements are based on D. This is current expectations and actual results could differ materially.
There are number of factors that could cause actual events to differ materially from those indicated by such forward looking statements investors are advised to read the risk factors set forth in D. This is form 10-K for the year ended December 31st 2019, which is filed earlier today March Thirtyth twentytwenty as well as periodic reports filed with the securities.
Exchange Commission.
This does not undertake an obligation to update or revise any forward looking statements made on this call.
I'll now turn the call over to Johnny Miss.
Thanks, David.
Several one Oh <unk>, we spoke about 18 months focused on turning beautiful do a specialty pharmaceutical company with a leading digital health platform as you can see on 43.
My team was the first full year under our current quarter turnaround strategy. We've ended the year, we actually need or turn around objectives as planned.
Sure I'll review the performance of work most products in detail there are multiple key takeaways from today's call.
One we turn the tide, Okay CEMEA the parents delivered four consecutive quarters of great Big the percentage of total mortgage true and look for sort of me prescriptions for any obesity medications.
We've also stopping you over your slide Oh here in the number of Pickering scripts in sales.
Would you then the trend for this product before we acquired in 2018.
We have three consecutive quarters of scripts, though.
Let's turn around some tougher than anticipated, but we believe we've stabilized product three.
Drones that companies typically how well executing occurring turnaround plan.
It is making decisions on how to invest for the future well, making sure that you can meet the needs of the company. Currently we've made investments in research and developments is for Qsymia safety and efficacy studies that adolescence, we've made investments.
It looks like a management comparing grades.
Finally, we continue to focus on the opportunity. We are your one zero takes hold for patients and be the shareholders.
Believes that these results.
Clearly demonstrate our ability to create value from our commercial portfolio and we're confident that the innovative sales and marketing strategies. We've implemented will support continued prescribing and revenue growth going forward.
I haven't done from a more detailed information that provides the foundation protocol.
Several notable notable developments and then the company and our key markets are shown on slide five.
First with respect to a company you have to your point supplemental new drug application for me a group formulation of acreage with 36 more shelf what.
We expect this formulation will limit the Cmos product returns was reducing our cost before they actually reducing out of pocket core expenses for patients.
We also reported that the new data from all real World Studies semiannual depiction to 400 qsymia compared with other we watch the tools achieved at least the 5% weight loss a.
This data adds to the robustly growing block body of clinical evidence supporting the safety of clinical efficacy of Qsymia and we believe.
They will help.
To drive increased.
Okay CEMEA.
Consistent with our strategy of capturing linquist ensure global market for having obesity medications upper Allergan officially launched keeps them here in South Korea is an important milestone on accessing the Asian any obesity therapy market will also provide us with the new source of royalty revenues.
Made progress in our pipeline and expect to have additional news related to the timing of the filing of our R&D and the initiation of a clinical trial could be dogs are all 106, well pulmonary arterial hypertension or future development candidate in the weeks ahead.
Turning to notable worked development.
Food and drug administration <unk>.
<unk> goal of Belviq and anti obesity medication from the market in February 2020, based on new data demonstrating the potential for increased risk for developing cancer. Aside voluntary voluntarily recalled Dolby. The same day is yes, you had requested the route withdrawal.
We believe that this issue situation creates an opportunity for qsymia, both with respect to daily news scripts from patients who have been taking belviq and are now seeking an alternative anti obesity medication as well as reducing competition for qsymia among patients initiating any obesity medication.
Additionally, allergan sold into the second largest product in the pancreatic enzyme replacement therapy at work football the good thing competitor could bankers.
Definitely.
Well, we believe that the park will continue to be a tough competitor in the marketplace and as of right now we don't anticipate a material change or upgrade strategy.
Leave at each of these market events will benefit our products and are confident we're positioned to capture increasing shares of these markets as their respective landscapes of all.
I will now provide additional detail on Qsymia do fourth quarter 2000, my team a tailwind for Qsymia are summarized on slide six revenue was up slightly in Fourq work compared with 4.9 theater more by more detailed financial information later in the call script volume from the fourth quarter 20 My team increased.
Compared with the prior year period, well down slightly compared with third quarter 2019, the slight increase was actually employment and the trend of decreasing four corners scripts, which occurs every year people change or eating the dining habits around the holidays. This decrease from third to fourth quarter of 2019 was 3%.
Which was an improvement compared to a decrease of 7% vendor you're in a prior period here.
We continue to gained significant traction in our direct to patient you semi advantage Berlin with 31% of all keeps EMEA scripts coming from this program in the fourth quarter compared with 22% in the third quarter of 29, okay.
We also continue to see traction driven by our sales representatives and they make progress in portions of the market, which we previously were engaged.
2019, we sort of a pilot program to utilize inside sales reps, coupled with our digital program and continue to be encouraged by the team's progress.
Okay, assuming a sales performance over the past few quarters is shown on slide seven.
As noted <unk> portions of the bars represent sales from the traditional.
Retail pharmacy or have you ever portion represents sales through our direct to patient semi advantage program. There are few things I'd like to highlight here.
The total number of scripts grew in the third and fourth quarters of 29, <unk> compared with these periods in 2018.
This is the first time in five years that we've grown fourth quarter scripts year over here.
Switched from our dedicated for our direct to patient excuse me advantage program has grown steadily over the past four corners, what appears to be normalized.
There are few other points it looks like.
First patients filling prescriptions for the program appear to be more durable compared with patients Phil going there scripts that a retail pharmacy based on 92 scripts.
Finally, 94% of the online Qsymia scripts are filled compared with only 65% of scripts that need to be filled at a retail pharmacy.
For male patients are using fusin advantage to build their scripts, which may reflect the ability that program to eliminate the discomfort that many men have discussing their weight.
This is important aspect of the program for both men and women, which may help to remove barriers to care and enable more patients can take positive steps toward achieving a maintaining their healthy BMO.
We've been told consistently that both men and women feel some level of shame when utilizing pharmaceuticals for weight loss.
Slide eight shows with some new marketshare orange as a percent of total market for branded obesity therapies show you. Some has experienced growth over 2019, especially following the full launch of against any advantage program may well contrave and belviq through the products main competitors had some says substantial headwinds.
As I noted at the start of the call Belviq was withdrawn from the market last month, which may help to further drive increases into CEMEA scripts.
Slide nine shows totally assuming the scripts and orange and consumer market shareholding scripts and blue.
As shown there's been an increasing trend or new qsymia suburbs since 2017 and in 2019, the sure scripts have increased quarter over quarter. As we noted at the start of the cool we believe the growth in Q CEMEA scripts in the percent of market share strong evidence of our ability to drive additional value from this product and we expect to see continued growth in both.
Metrics over the next few years.
Now, let me turn to bankers.
He Q4 2019 paper grades highlights are shown on slide 10.
I don't think raised floor sales were up slightly in the fourth quarter compared with the third quarter point my team.
Significant increase and topline Canadian sales as noted we've we've also achieved three consecutive quarters of script stability in the United States, which we believe indicates a reversing of the declining trend that had been in process. When we acquired the product in 2018.
We also received FDA approval to the advanced formulation of encouraged with 36 month shelf life I expect to watch that product and U.S. in the fourth quarter of 2020.
In November 29, P., we submitted a pediatric investigation plan to the Canadian regulatory authority and anticipation and anticipate approval of the plan in August 20 Twond.
Slide 11 shows a quarterly performance bakeries from the first quarter Fysixteen, we the fourth quarter of 20, Nike when new scripts shown in Blue total script shown in Orange.
As shown total new bakery scripts have been declining for 13 consecutive quarters, Oh, beginning the second quarter of 2019, we've now seen three consecutive quarters of scrip stability and investing in new sales personnel and implementing programs such as they can pay graves available through the reversal platform and to pay grades advantage for program in order to begin growing the market scherfen.
Got it.
We recently entered into a contract with a large national PBM, which will go live in July 2020, and is designed to afford pancreas better formulary placement. We also believes that the 36 months shelf life will allow us to capture more sales while lowering our overall.
Slide 12 shows our bankers script trends since Veevas re launch the product in February 20, Nike. We're told script shown in Green Marketshare shown a bubble from 20, reaching to February 2090.
And in Blue.
From 2019 through the under the your these trends demonstrate that our promotion efforts to date have reversed the decline in pink rot scripts in the market share and have produced modest growth was a 2% increase on daily scrip spaces in the fourth quarter 2019.
Compared with the third quarter of 20, Nike and a 1% working day script growth since launch in February 20 Nike.
Slide 13 summarizes the status of standards Quest SPEDRA. This product has been partner now or licensed in various global territories, we continue to collect royalties and manage the manufacturing processes for a marketing license partners. We're working with these various partners in this program to reduce or working capital exposure for the program for the product.
And to improve our return on invested capital. We're also continuing our efforts to find commercial partners. If you open territories, including the Middle East Mexico in Russia.
Turning to slide 14, I'm pleased to report that we've made additional progress in our VIP zero 106 program.
Our investigational therapy for pulmonary arterial hypertension or ph.
We noted in our last quarterly call that we had adjusted the chemistry of the product formulation in order to address the stability issue. The results of the stability testing of the new formulation of luminary, well look promising and we hope to provide an update on the resolution of the stability and timing of a filing of an eye, Andy and starting a clinical trial.
Well in the second half 2020, we're hopeful that the following validation of our data.
We can provide.
We can provided further update in the weeks ahead.
Slide 16.
We engage personnel and Q4 of 29 team.
The advisor for Veevas to work through the complex details of our refinancing effort.
We are focused on achieving a capital structure that allows us to grow the company, while still investing and realize or 106.
We're engaged with multiple capital providers regarding a complete refinancing of capital structure of the this could fund or operations repaired that as it matures.
We are focused on both immediate date of the refinancing and also working hard to ensure that the company is properly finance to leverage the opportunities.
Better before it in its business.
Slide 17 summarizes our key growth drivers for 20 Twond. We're pleased with our achievements in 2019 of believes that we have generated significant momentum and increasing total scripts and market share for two CEMEA tankers, we intend to carry out that momentum into 2020, as we continue executing on our 10 quarter Callaway.
Okay. So now we continue to expand the Kissimmee advantage progress that we need to self platform.
Her in the process of watching or our program, combining you see meal telemedicine and technology.
Well, we will also be focusing on self insured employers Medicare part D patients and other matters.
With respect to pay grade who continue to build on our sales teams progress engaging with key prescribers and will be highly proactive and building visibility and awareness for the brand at multiple medical conferences throughout the year.
I'll now turn the call over to Merck Okita reviews. The financials Q4, 2019 in more detail after which Dr. oregons who will provide.
Well the clinical programs.
Thank you John.
As we just completed the six quarter of our 10 quarter turnaround.
As a result, we believe that comparing the fourth quarter of 2019 with the third quarter of 29 team will provide you with a better indication of how our turnaround efforts are progressing as shown on slide 18.
Qsymia net product revenue was $9.8 billion and $9.6 million in the fourth and third quarters of 2019, respectively.
As John mentioned, we continue to see an increase the number of scripts filled as we transition from the traditional retail pharmacy model to the keys to me advantage program.
In the fourth quarter, 31% of keeps the new scripts would spend stupid semi advantage programs direct to patient model up from 22% in the third quarter, an 8% in the second quarter.
Well, we experienced a 3% seasonal drop in usiminas scripts compared to the third quarter 2019.
This is significantly less than the 7% decrease between the same periods in 2018.
Thank you raised net product revenue was $5.8 million in the fourth quarter 2019, compared to $5.3 million in the third quarter 2019.
In the third quarter, we assumed commercial responsibility for Canadian pancreas empty sales and as a result recognized Canadian revenues of <unk> point $9 million in fourth quarter as compared to the point $1 billion in the third quarter 220 19.
Fourth quarter supply revenue was $1.2 million, which consist of sales to have excuse me of Qsymia to Allergan support the recent launch of Houston in South Korea.
We remind you that supply revenue was impacted by minimum order requirement and supply chain management bio partners and may not reflect end user demand.
Nor do we consider this revenue driver economic performance is either.
In the fourth quarter of 2019 revenue related to royalties earned from mentoring Badger sales, which is typically run from 500 to $600000 per quarter was approximately 500000 doors in the fourth quarter.
Well, we did not record any milestone revenue.
In the 2019 fourth quarter, we will receive $2 million from allergens launch of Qsymia in South Korea that was announced last month.
Milestone revenue in the third quarter 2018 represents the payment received related to Elgin obtaining marketing approval for EMEA from the South Korean Ministry of food and drug safety.
Total cost of goods sold excluding amortization was $4 million and $3 million in the fourth in third quarter 2019, respectively.
The increase was primarily due to the increase in Q, Simeon pancreas product sales as well as the increase in supply revenue over the third quarter.
Amortization of intangible assets was $3.6 million in both the fourth in three quarters of 29 team.
This amount was primarily the amortization of costs is that capitalize related to the acquisition of pancreas.
Research and development expense was 2.4 million and $3.3 million in the fourth in third quarter 2019, respectively.
Research and development expenses were primarily related to related to the Qsymia adolescent safety and efficacy study.
Pancreas post marketing requirements assume from Janssen and pancreas process improvement initiatives.
Selling general and administrative expense was 10.9 $9.2 million for the fourth and third quarter 2019 perspective [noise].
And included selling and marketing expense of 4.3 million and $4.5 million respectively.
During the quarter, we incurred approximately $1.9 million and severance costs.
Total interest expense net was 2.9 million and $9.9 million in the fourth third quarter 2019 was.
The decrease in interest expense in the fourth quarter was primarily a result of prepayment premiums related to the reduction in debt balances incurred in the third quarter.
Net loss for the fourth in three quarters of 29, gene, which 6.5 million an $11.1 million respectively.
Cash cash equivalents was $32.6 million at December 31, 2019.
Recurring non-GAAP EBITDA for the fourth and third quarter, 2018 was 2.3 million and $1.2 million respectively.
Reconciliation of these non-GAAP measures can be found in the press release filed earlier today with the Securities and Exchange Commission.
With that I'll now turn call over to Dr., Varghese, preclinical and product lifecycle uptick.
Thanks, Mark I will review, the clinical and regulatory aspects of Qsymia and create and VI zero 106.
With respect to keep seem yet as per our announcement on Monday and as shown on slide 17, we have completed enrollment of subjects in our phase four study designed to evaluate the safety and efficacy of Qsymia obese adolescence between the ages of 12 and 17 years.
We expect the last subject to be completing treatment by the end of Q1 2021.
We believe that Qsymia could be an important part of integrated strategies to address adolescent obesity and this study is designed to provide clinical data to support a potential label expansion for the syndication.
We have also reported results from two studies that further support the efficacy of Qsymia.
In November 2019, the results of the clinical study were published demonstrating the patient that patients with binge eating disorder or boot let me.
Linear nervosa, receiving Q Simia had us a significant reduction in binge, Dave frequency compared with placebo over four weeks and was well tolerated in these patient populations.
The study results a pure online in the international journey journal of eating disorders.
On January 2020, the University of Colorado announced the publication of new results from its toolbox trial, a real world clinical trial conducted in urban Safetynet primary care clinics offering patients a toolbox of cost effective weight management tools. The study published in the journal of General internal Medicine.
Found that a higher proportion of subjects, who initially selected Q sitting here from the tool box or additive to their weight management plans. During the study period achieved at least a 5% weight loss compared with subjects, who never used qsymia.
We continue to have productive discussions with the FDA regarding a study designed to evaluate the FX effect of Qsymia on ambulatory blood pressure.
We believe this study could provide us with new data to further inform our dialogue with the FDA regarding our post marketing cardiovascular outcomes trials, which was required as part of the initial approval of Qsymia.
I hope to have a final protocol agreed upon in the next quarter.
We also continue to work with the researchers at major institutions to develop clinical protocols and initiate the related clinical trial to evaluate health technology platforms to augment and track patients effort efforts in weight management, we hope to have more information in the coming months regarding the results of these efforts.
Yes.
Finally, we expect the European Medicines agency will respond to the de centralized qsymia marketing authorization application in the second quarter of 2020.
Turning to pay increase the FDA approved the San Diego for the 36 month shelf life formulation in February of 2020, and we continue to evaluate additional pancreatic studies, including those in pancreatic oncology.
We're currently working to start to study with Cedars Sinai Hospital in Los Angeles, California to look at the treatment of extra can pancreatic insufficiency in patients with pancreatic cancer.
Finally, as John also discussed earlier, we anticipate filing the I.M.D. for VI zero 106, and initiating the planned phase two clinical study in patients with ph after finalizing our unique proprietary once daily extended release formulation.
We believe this formulation was will facilitate therapeutic drug levels, while minimizing immunosuppressive effects for patients with ph.
This concludes our opening remarks, operator, you may now open the line for the question and answer period.
As a reminder, ladies and gentlemen to ask a question you will need to press Star then one on your telephone keypad.
To withdraw your question press the pound.
Please stand by only compiled acuity roster.
Our first question comes from the line of John Vandermosten with Zacks. Your line is now open.
Good afternoon, John Mark and Santosh, hoping to have a nice day.
Wanted to start out with a question just on the on the capital structure and how it may change or how the balance of it may change after refinancing I mean, obviously here are most likely you're in negotiations right now, but I'm just wondering what you can tell us about that.
Yeah, I think you know what we're trying to do John is fine Yeah. Unfortunately can't give you a concrete answer right now.
What we are working to try and do make sure that.
<unk>.
Focus on current shareholders well be this.
Make sure that the company is set up so we can actually grow the business.
Long term.
And make sure that we can really take advantage of the VI zero 106 opportunity.
We are pleased weak or chemistry performance and the modification that we've made we still fair amount of work due to the validated but so far it's a it's interesting to us. So we're really trying to come out of this 10 quarter turnaround plan.
Which quarter said in his really.
It was deemed in task as the time to get our capital structure properly.
Structured.
So those last three quarters was really just focus on gross and you know.
Jimmy are in development, we're going to make announcements.
Over the next you know 16 weeks, we believe.
As these discussions are mature.
Okay.
Thank you for that that.
Occasions, and then.
There's been a lot of get a good news out there for Qsymia. Some of the research. This is destined doesn't have the studies have been fairly positive and I'm wondering if you can modify your your platform to take advantage of these new.
Some of these new benefits.
Adolescence I'm not sure if is able to be used off label label or it is used off label, but is there a way to leverage your platform to take advantage of.
You know some of the new populations that are shown to have benefit.
Yes, so we can't comment obviously on off label usage of the drug.
So in terms of what we're focusing on in terms of quantum anymore.
Drawn.
Oh, we are expanding our conversation with bariatrics surgeons.
We are expanding our conversation with GE is one of the things that we found in the G.I. spaces that patient you've gone through bariatrics surgery. Surgical then maybe two three years prior are starting to have some weight issues, coupled with GE I issues and.
So we're starting to see you guys actually start to prescribe qsymia. It's been we just kind of really figured it out probably over the last six to nine months.
So that's that's one area with the binge eating disorder data.
You know, obviously here going having conversations with binge eating order specialists is on the platform.
I I'll turn over to talk to mortgages. If he has any additional comments yeah. I think the those that are within our indications such as John mentioned, the bariatric surgeons and those treating those.
Types of patients I mean, those are on label discussions because they are patients who qualify as obese or overweight.
And they may or may not have co morbidities in that case, if they are obese, but those are well within the patients that we already can treat on label and we are exploring other avenues based on this information that we've been getting from.
Individual researchers who conducted various investigator initiated studies on other areas for for further investigation and data collection to see.
What may warrant a the discussions with the FDA for a label expansion.
I think you just want one final point there too you know.
Thank you Simia label is.
Excellent there's a very very large number of patients.
That are eligible for therapy and one of the challenges for Qsymia is really just letting people know about the product and the efficacy associated with the product and so there's a couple of initiatives that we're rolling out throughout the course of 2020 to really try to raise brand awareness around.
Product and coupled with some additional scientific information around evolutionary biology, and why you and I think.
We're we're hopeful and I'll be promising and we'll talk about those over the next couple of calls.
Okay, and any sense of the size of the market that with the withdrawal belviq opens up to you.
You know that it's so early John.
It's a great question is one that we're we're definitely trying to figure out you know we've had a number of clinics that weve reached out to you that have reached out to us, which I would call you know some of the weight loss clinics across United States any of these to be clinics across United States. They tend to anchor on you know as a therapy. So there'll be no they write off.
Lot of Belviq or.
ER or their section under shops, and the Belmont water a number of belviq shops, because it's an oral solid.
Had been reaching out to us and so we're starting to have those conversations.
We know that our drug as well as Saxenda are both efficacious pharmaceuticals, we believe our safety profile is.
[noise] is.
Better yeah, sorry, I've looked at a doctor bargains, Richard wait and see that [laughter], but ultimately we believe everything.
You know a better safety profile and you know our efficacies been demonstrated through real world data that we've collected that wouldn't create tremendous advocate efficacy within the you know within the label on the product so.
It's really early the probably just came off the market you know mid last month.
But hopefully you know obviously, there's lot of other things going on in the world right now related to health, but we're hopeful over the next two or three quarters to see some demonstration there.
And have further conversation with these clinics as we try to move them onto the key CEMEA advantaged platform.
Okay and last question is just on on the telemedicine that seem to have started off pretty pretty nicely and I was on if there's any update there on how that's progressing.
Yes, so the software it took us it.
Tiny bit longer.
To get through the software contracts, where we are utilizing the third party.
We will cease will make some announcements about that you're in the next couple of weeks.
Overall, we believe that really well position, we've got a couple of doctors on the platform. We are call. It six weeks behind on that but we expect to rapidly catch up doctors are really interested in this program and we just needed to make sure that we had kind of all of our i's dotted t's crossed.
Yeah, there's a hitler component to it there's a utilization component to it there's a billing component to it and so just to take us a tiny bit longer to get through that but.
We've got through the talks to the software contracts.
Developed in claim materials.
Common platform, we're going from there.
Thanks for taking my questions.
No. Thank you John appreciate your interest in the company.
Our next question comes from the line of Jim Bridge enough with Wells Fargo Securities. Your line is now open.
Hi, it's Chuck quite filling in for Jim Birchenough. Congratulations on all the progress just kind of a follow up to John's question in terms of the capital structure in your discussions there and then the belviq opportunity, possibly opening up.
Those could be parallel tracks, but is there some consideration to maybe.
Having that as an all encompassing new vision for the company or.
Picture and if you will keeping in mind the opportunity that may not be possible with belviq.
Thank you yeah, yeah, no from channels are great question.
So a couple of things are so is there a little bit gone back there. So one of the things. We're trying to do you know we've been burn and $20 million a your cash interest expense.
And you say, you're sitting here faced with this growth opportunity potentially would belviq dr. bodies in the clinical team have done a fantastic job in my opinion of expanding the clinical data around Qsymia and so we believe that were.
Very well positioned to go out and compete more effectively in the marketplace. The sales and marketing programs that would put in place rents you shimmy advantage have shown growth.
And we think some of the things that we're going to do around raising brand awareness, a really innovative really interesting and really kind of get dream to the Shane issue of obesity.
And you know high BMI patients and so that's that's this opportunity that sits in front of us and so the conversation that we're having around with you know the engaged capital partners is making sure that we're not putting the company is such a position where we have these you know kind of overhang.
EBITDA requirements that prevent us from making decisions about driving investment to grow the overall equity value.
And so that's the balancing act that were and.
Belviq coming off the market. It was obviously, that's a pretty interesting opportunity, but as I answered for John We don't we're still early in that process. You know, we can speculate and we believe that yeah were belviq is gone we competed against that therapy very well we've had.
Pretty nice inbound interest from folks. So in terms of you know Revisioning. The company. Overall. This means you know as always our plan as part of the 10 quarter turnaround.
So obviously, you know weve or maturity or occurs on the first and so we've obviously got to get all of that's all but we've been working with Piper Sandler since you know Q4 Q4 last year. So we're well down the process of getting this done.
Okay. Thank you very much for taking the question.
Oh, Thank you appreciate it.
As a reminder, ladies and gentlemen that is star then one if you'd like to ask a question at this time.
Next question comes from the line of Robert <unk>, a private Investor. Your line is now open and good afternoon gentlemen, Thank you for the update really appreciate it lot of color there Justin I thought going back to Belviq John.
Orexigen was a competitor in the past they went out of business I believe pernix therapeutics spot.
There I believe that name of the drug was contrave and they pointed out for 75 million and Pernix is.
It's not doing trial I think they're out of business were there any learning lessons that.
Happen from that event, a few years ago that could be applied to what's going on with Oh Beacon de site.
<unk>.
The issue of timeframe.
And Orexigen I think the lesson there is a lesson there don't don't spend $60 million to $75 million on a direct to consumer advertising campaign.
I think you know that was probably the driving force behind you know their exit from the marketplace.
You know the product countries actually do some product we have respect for that product, but it works for the smaller segment. You know this on real world data that we've seen works for a smaller segments of the population Belviq. We felt we've always felt that we competed extremely well against that product.
My head to head perspective from an efficacy perspective.
And so you know if you look at a size decision and how they made that decision.
We had heard that there.
How would you said there emphasis on that product and continuing marketing efforts around.
The belviq product in the marketplace you know that's all the rumors that your were waning.
And you know so we're not surprised that once the after you came out with this.
Conclusion based on their data that you know aside a agreed very rapidly.
With a with the FDA to pull the product from the marketplace. So I think you know the learning there is okay. How do we go or the the opportunity for US there is as suppose previous you know John in Chuck asked how do we go capture some of that market share build brand awareness.
You know visvis for a long time for previous few years as you can see it into performance figures.
Really didn't build brand awareness around Qsymia, and then really contribute in a meaningful way to the data profile of the product and that's something that weve been very focused on has been very focused on getting back on the podium.
Engaging with physicians in a more meaningful way engaging with the obesity societies in a more meaningful way talking to payers.
Those are the things that were really trying to exit.
Okay very good thank you John and another question and STENDRA STENDRA or SPEDRA.
Menarini is as brought out the rights and their pay royalties of Beavis I you mentioned about other markets to pursue I think it's a great product. So could you had a little more color on what you're pursuing because it really it really is a product that neither.
Yeah. It's.
Okay and.
It really would have been the number one product in the marketplace had been launched so originally.
Our first to market excuse me.
So what I think what we're trying to do is we spend a lot of time, you know going through these marketing efforts on individual territories and they require a fair amount of effort on each individual territory and so what we're really looking for right now and then we're having active discussions around trying to find somebody to take over.
The products you know on a global basis, and so there's people who have expressed interest in Oh, that's really just been probably the last four.
Three four months that we've made that decision strategically to look for partner that can think about the protocol model. So.
Yeah I didn't know.
[noise] off the top there I <unk>.
My understanding was Mediterranean, possibly might have tried to attempt an IPO attempt fourth quarter I don't know if they were successful or not but you know it might be a player as well there possibly.
So.
But anyway both markets.
For Q and.
STENDRA or SPEDRA I think are it's it's right there it's a great marketplace on both ends so.
With respect to the Nestle's unpack that was a very interest I never thought that Nestle would would get into the pancreas marketplace, but would you agree John that the lower cost for pancreas as well as a longer shelf life are really good competing.
Strengths previous against that.
Yeah I think.
Yeah, there's obviously greater price sensitivity with payers.
In the marketplace around these products around every pharmaceutical product you know when we acquired product we added.
Didn't have any clinical deficiencies that we had a unit of measure deficiency at the large you know measure side, which we're working hard to address that as well and then we had this shelf life issue. So we knew both of those things were problems that are in commercial basis.
You know we've been really transparently, Hey, you know, we stubbed our toe in February of last year.
We think we've stabilized product now you know there's just given the last few quarters performance sales marketing teams doing good job. We have good response from clinicians.
We are having good very very productive conversations with the PBM and the payer market. We've secured you know and close the contract that will be active July of 2020.
We don't with a large PDN and so it's I think the the value of pancreas, we still absolutely positively, believing that we continue to invest in the brand.
We continue to sort through you know the previously after mentioned problems and we're improving the you know the commercial platform.
On a quarter by quarter basis, and so that's a product that we believe in for the next 10 to 15 years. So.
You know is it's it's kind of taking a couple of quarters longer to begin to where we wanted to go but.
We're just we're chipping away at that and that's that's what it takes for this industry.
And that will conclude our question and answer session I'd like to turn the call back to Johnny Miss for closing remarks.
Yeah. Thanks to all of you free time today and your content. It is interesting Divas before closing the call I'd like to reiterate that we were successful successfully executing or 10 quarter turnaround strategy and we're pleased with our progress to achieving or our goals.
The significance of a positive changes in script market share trends for both Qsymia and pancreas cannot be overstated and demonstrates that the views leadership team has in fact expertise and ability to continue to unlock significant value from our commercial portfolio, especially true true of our ability to stabilize number pancreas scripts for three consecutive quarters fall.
Nine years of decline.
Particularly following.
With the withdrawal belviq from the market, we believe there's an opportunity for qsymia recapturing, even large share of the anti obesity medication, marking our fourth quarter financial results also demonstrates that our innovative sales and marketing programs are gaining traction and we believe that removing barriers to accessing qsymia will both helped to grow our share of the market.
And to address the obesity epidemic.
So work do a ahead of us.
Sure address our capital structure, but we remain confident that we have the company on the right track to create value for patients and our shareholders I look forward to opinion on our progress and the most that operator I'll turn it back have you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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