Q4 2019 Earnings Call
Good afternoon, My name is Brock and I'll be your conference call operator today.
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I would now like to turn the conference call over to Marianne Oh, Hannesson Senior director of IR <unk> Biotechnology you may begin your conference.
Thank you Brock good afternoon, and welcome to put on this conference call to discuss our financial results for the fourth quarter and full year 29 team.
Joining me on the call today are Allen, our bar, Chief Executive Officer, President and Chairman of the board of that and maximize our new guests Chief Financial Officer.
After market close today permit issued a news release detailing sports quarter 29, Chief financial results.
News release to slides that Alan will refer to in a webcast of this call accessible via the home page and Investor sections up our website at <unk> biotech [laughter] Dot com.
The webcasting presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Such statements are subject to risks and uncertainties and actually Benson results may differ from those expressed in these forward looking statements.
For full discussion of these risks and uncertainties. Please review our periodic and current reports filed with the Securities <unk> Exchange Commission from time to time, including once filed our annual report on form 10-K for the year ended December 31, 2019, which will be filed next week.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of today to dislikes conference call February 20 to 2020.
The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call, except as required by law.
During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement you not a substitute for our GAAP financial measures.
Please refer to our fourth quarter 20 nightly news release for a reconciliation of GAAP and non-GAAP result.
I will now turn the call over to Alan.
Thank you Marianne.
Thank you all for joining our call today.
Today promote reported total revenue for the fourth quarter of 2019 of 62.9 million.
Total product revenue consisted of a license revenue of 4 million royalty revenue 0.2 million.
Net sales of near links of 58.7 million.
Net sales of 58.7 million in the fourth quarter of 2019, representing a 9.7% increase from the 53.5 million in net sales reported in the third quarter of 2019.
I will begin with a review of some of the highlights of the quarter and then provide more details and their links commercial activities in the U.S. maximum undergoes will follow with highlights of the key components of our financial statements for the fourth quarter of 2009 cheap.
In September we announced that our licensing partner in Latin America pinch pharma received their first regulatory approval in Argentina for near links for the extended edge for treatment of adult patients with early stage hormone receptor positive hurt you over expressed amplified breast cancer and who completed as of interest to isn't that.
Based therapy less than one year ago.
In November we announced that our licensing partner in Greater China, Cambridge Pharmaceuticals received market approval in Hong Kong.
According to the terms of a licensing agreements with both of those entities camel will be receiving royalties from the sales of near links in those territories. Once they are commercialized in.
In collaboration with our licensing partners. We also anticipate announcing additional regulatory decisions on the radnet in additional countries outside of the United States in Europe throughout 2020.
As investors are aware in the second quarter of 2019, we presented results from our phase three trial of Neratinib in third line. Her two positive metastatic breast cancer also known as the dollar trial at the American Society of clinical oncology annual meeting in June.
A copy of the ASCO presentation is accessible on the events and webcast page of Qumus website.
Based on the results of the knowledge trial Houma filed a supplemental new drug application or SNB, a foreigner at <unk> for the treatment of third line Hertwo positive metastatic breast cancer in June of 2019.
Yes, India was accepted by the FDA in September 2019.
And our anticipated PDUFA date is April of 2020.
We will continue to update investors on our regulatory progress with this as it progresses.
In addition in September 2019, the FDA granted orphan drug designation shouldn't right in there, but for the treatment of breast cancer patients with brain metastasis.
As investors are also aware, who has an ongoing basket trial of Neratinib and her team mutated cancers referred to as the summit trial on our third quarter earnings call, we announced that based on our recent meeting with the FDA, whom is modifying the summit trial.
Such that you are positive hertwo negative breast cancer patients, who have a hurts you mutation well be randomized to receive either fold. The strength alone sold just rent plus trastuzumab or the combination of you're right and if possible investment plus treacherous and met each.
Each arm of the amended study will initially enroll seven patients starting stage, one and if no patient in the given all in response to that all will be closed for further enrollment if in the first stage one or more patients respond. The cohort will then be expanded to up to 18 patients if less than four patients in the expanded.
Respond that all will be closed a further enrollment if more than four patients respond the arm will be expanded and further patients will be enrolled.
The amendment to the summit protocol has been submitted it to the clinical sites that are participating in the study we anticipate that the amendment will be approved at these sites and then enrollment to the three arms will be getting next month.
We continue to plan to schedule, a pre NDA meeting with the FDA. After we receive the initial results from this Simon two stage trial in order to discuss the potential for accelerated approval of Neratinib in E are positive hertwo negative breast cancer that hasn't hurt gene mutation.
On the anticipates that this meeting we will take place sometime between the fourth quarter of 2020 through the second quarter of 2021.
During our third quarter earnings call. We also discussed our current hurt you mutation screening trial also known as her seek the Herceg trial was initiated with the goal of using a proprietary liquid biopsy test developed by Puma to screen patients with breast cancer in cervical cancer for her to mutations. This test is a low costs.
[noise] validated ngs based clinical trial assay wasn't a central lab and represents a efficient high throughput weight to screen for patients with hurts you mutations who can then be successfully enrolled in summit.
The trial was initiated in December of 2018.
In the trial blood samples are taken for patients with metastatic breast cancer or cervical cancer.
And our street with a proprietary hurt you mutation liquid biopsy test developed by Puma.
If the patient was found to have worked through mutations the patient is referred to the summit trial to see if they're eligible to enroll.
If the patient does not have a hurts you mutation the patient as retested three to six months later in the same exercises performed yet.
The Herceg trial is currently opened at approximately 18 sites and isn't the process of being expanded to the other sites that are currently participating in summit.
The goal of her seek is to screen 2500 breast cancer patients and 1200 cervical cancer patients, which should identified more than enough patients for the summer trial to support the potential accelerated approval and the a filing.
We look forward, you're continuing to update investors on the progress with summit and her seek out a future conference calls.
Also in January 2020, a notice of allowance was issued by the United States patent and trademark office for pending application U.S. 11, 88347 for regarding claims for methods of treatment of treating just sitting there and or erlotinib resistant non small.
So lung cancer.
I notice of allowance was also issued in January 2024, though related continuation application U.S. 15, it to all 7349 regarding its claim for methods of treating your fitness and or Latin of resistant non small cell lung cancer, having a t. 790, m. mutation in EG fr.
The issue fees for both of these U.S. applications were paid in February 2020, we anticipate that these patents will issue in the coming months and we look forward to updating investors on this as it progresses.
I will now review, our U.S. commercialization progress for nearly six.
First of all just a reminder, that I will be making forward looking statements.
As you May recall, we have two channels that provide near links to patients. We refer to these as our specialty pharmacy channel and our specialty distribution channel or are you know if this distribution channel.
In the fourth quarter bottle sold in the specialty distribution channel represented approximately 22% of the bottle sold in the quarter. This is similar to the approximately 22% in the third quarter.
During the fourth quarter. We also noted an increase in the number of new physicians in the specialty pharmacy network, writing prescriptions for near links the total number of near links prescribers increased approximately 6.7% in the fourth quarter of 2019 compared to the total number of near links prescribers in the third.
Third quarter of 2019.
Later in the call Maximo will review the full financial results, but I will not provide you with the current sales results.
On slide four it shows that quarterly net sales of near links since FTC approval as I previously stated our net product sales revenue was $58.7 million in the fourth quarter, a 9.7% increase from the 53.5 million a net sales reported third quarter of 2000.
The 19th.
During 2019 at the American Society of clinical oncology annual meeting and at the San Antonio Breast cancer Symposium, we presented data from our control trial showing that using a dose escalation during the first month of near links treatment reduces the grade three diarrhea associated with their links.
And improved and improved Tolerability.
Since the data was presented we have noticed that an increasing percentage of new positions.
Our starting using a lower dose of near links which we believe is indicative of physicians using the dose escalation technique described in the data from the controlled trial.
As you can see from the slide the percent of new prescriptions that appear to be using this dose escalation technique increased from 18.8% in Q3 to 28.7% in Q4.
Slide six shows the bottles of Neratinib sold by quarter.
You will notice that the number of bottle sold in Q4 increased sequentially by approximately 5% from 4696 in Q3 to 4935 in Q4.
We believe that during the fourth quarter. There was an approximate increase in inventory purchased by the specialty pharmacies, which was approximately one a week of excess inventory.
The specialty pharmacies have been drawing down this inventory in January and February and we expect this to continue throughout the first quarter.
And our efforts in the fourth quarter declined 16.5% from the third quarter of 2019 walk Trx in the fourth quarter declined to 3.3% from the third quarter of 2019.
The decline in interacts mostly occurred during the month of November and December and more specifically around the Thanksgiving Christmas and new year's holidays. We believed that this may have been due to patient starting near a link to patients delaying starting near links until after the holidays.
In order to avoid experiencing the G. I said effects of near links which tend to occur with the greatest frequency in the first month or so that the patients is taking the drug.
We did indeed see a large increase in the number of new patients signing up for the specialty pharmacy in January which we believe maybe due to these patients from the fourth quarter, who may have delayed starting near links until after the holidays. The number of new patient signing up for the specialty pharmacy in January was.
30% increase from the average number of patients who signed up per month in the fourth quarter of 2019, we do not know if this increase will continue throughout Q1, but we are monitoring this closely.
As we've discussed with investors in prior earnings calls when these new patient sign up for the specialty pharmacy. It takes approximately two weeks for the patient to actually received their prescription and for Puma to see the and Rx.
Therefore, although there has been a sharp increase in the number of patient signing up for the specialty pharmacy in January since they can take approximately two weeks for these patients to actually received their prescription and our axis. In early January started out lighter than expected, but did start trending up in late January and into early February.
Which we believe is due to this bolus of new patients signing up for the specialty pharmacy and getting their prescriptions filled.
In January we also saw a slight increase and the number of patients that use the dose escalation technique mentioned in the previous slide as approximately 30% of the new patient starting near links in January have started at a lower dose. We believe that this may lead to an initial decline in bottle sold in Q1 due to.
The less expected refills for these patients in the quarter.
However, although initially the dose escalation leads to a decline in bottle sold if indeed it decreases the discontinuation rate similar to what was seen in the control study. We anticipate that this will lead to an overall increase and the potential revenue per patient that we're able to achieve we recently performed an analysis of the.
Our sense of patients who were still taking their links after six months and the analysis did indeed show an increase in the percent of patients continuing to take the drug after six months for those patients who started their links at a lower dose compared to those who started taking their links at the standard dose. This data it's early but incur.
Bridging and we will continue to monitor this trend in the future.
We will continue to monitor all of these sales trends and look forward to reporting this to investors in future earnings calls.
We're also committed to making their links available to patients across the world and have formed partnerships throughout the world with companies, who have commercial and regulatory expertise in that region.
During 2019 near links was approved in several countries outside the United States in Europe, and this as seen on the slide.
During 2020, we look forward to the potential for nearly as to be approved in additional countries. This year.
Including China and several other countries in Latin America in South America as seen on the slide.
In Europe, our partner PR far launched near links in Germany, the United Kingdom, and Austria during the fourth quarter.
We have been very pleased with their initial launch of the drug as it has been exceeding our initial projections, although we recognize it it's still early in the launch.
We anticipate that PR far will launch their links and approximately eight to 10 additional countries in Europe throughout 2020, and we look forward to updating investors on the European launch in the future.
I will now turn the call over to maximum together for a review of our financial results.
Thanks Alan.
Let me start with a quick summary of our financial results for the fourth quarter 29 <unk>.
At least now I will make comparisons to Q3 Q2 2019.
We believe our better indications from our programs, a commercial company and year over year comparisons.
For more information I recommend you refer to our 10-K.
Which we file next week will include our consolidated financial statements.
The fourth quarter 219, we reported a net loss based on GAAP of $11.2 million or 29 cents per share.
Our GAAP net loss for Q3 on Q2, 2019 were $16.9 million on $37.4 million respectively.
On a non-GAAP basis, which is adjusted to remove the block of stock based compensation.
We reported a net income of 4.3 million bonus or Watson for center for the fourth quarter of 20 <unk>.
Gross revenue from Netflix sales was 68.5 million bonus in Q4 29.
Versus $60.8 million in Q3 2090.
I mentioned that.
Revenue from Nellix sales was $58.7 million, an increase from net sales so $53.5 million <unk> third quarter of 290.
Also in Q4, two in the 19, we received $4 million license fee payment from pure fog.
Related to an amendment to our license agreement got expanded their territories.
Our gross to net adjustment in Q4 was about 14% I.
An increase from the 12% gross to net adjustment in Q3.
The increase was driven mostly by higher Medicaid reimbursement.
Net product sales for the full year 2019.
Well, what 200 on $11.6 million versus 200.5 million bonus in 2018.
And our gross to net 2019 full year was about 13.7%.
Compared to about 7% in 28.
Full year 2019, although revenue was $272.3 million compared to $251 million 2018.
[noise] coastal sells for the fourth quarter was $10.1 million, which included amortization of milestone payments to the license or if not the name of approximately 1 million bonus.
Going forward, we will continue to recognize a multi seasonal piece of the milestone payments to the license or we're all about $1 million per quarter ASCO cells.
For fiscal year 2020 <unk>.
<unk> on PC page. The now links net sales will be in the range of $215 million to $225 million.
Please note that these only includes revenue in our crude currently market indication on does not include any revenue from the potential expansion of the label for the third line metastatic indication.
We plan to update our revenue guidance when we receive the FDA decision on that as Andy.
We also anticipate.
Our gross to net in 2020 will be between 16.5% 17, and a half reset.
Furthermore, we anticipate receiving royalties from our partners around the world in the range of $5 million to $10 million.
I'm potential licensing fees in the range of zero to $22 million.
We expect I would Q1 2020 net product sales will be significantly lower than Q4 2019.
Due to the box from the previously mentioned seasonality, which we sold <unk>, which resulted in lower patient enrollments during the holidays and higher inventory levels customers in Q4.
We also expect to have a higher gross to net adjustment in Q1 due to the buckets unexpected Medicare coverage gap inc. charges, which are usually higher other beginning of the year.
Therefore, our nellix in that revenue expectations for Q1 are in the range of $40 million to $42 million.
We anticipate that the gross to net in Q1 will be approximately 19% to 20%.
As you and expenses were $31.3 million in the fourth quarter two any idea.
Compared to $31.4 million 33.5 million borders Q3, Q2 2019, respectively.
As generic expenses included non cash charges Bucks for stock based compensation 5 million bonus for the fourth quarter 29.
Compared to 5.6 members and $7.4 million for Q3 Q2 <unk>.
2019, respectively.
[noise] research and development expenses were $30.2 million into fourth quarter compared to $30 million and $36.9 million for Q3, Q2 29, respectively.
R&D expenses included non cash charges charges for stock based compensation was 6.5 million voters in Q4 compared to $6.6 million, an $8 million in Q3, Q2 2019, respectively.
In the fourth quarter of 2019.
Well my reported cash burn off approximately $1.2 million.
Compared to cash burn of approximately $7.3 million in Q3 2019.
On $14.3 million, we don't onetime events in Q2.
We ended 2019 with 100, only 11.6 million Bonusing cash cash equivalents a marketable securities.
Our accounts receivable spot as of December 31st was $28.9 million.
Our accounts receivables times range between pain on 65 days.
Well our day sales outstanding are about 43 days.
I wanted distribution that were my things approximately four weeks of inventory would you say <unk> an increase of about one week from the prior.
Overall, we continue to deploy our financial resources to focus on the bomb sense of Niraparib through ongoing clinical trials on the commercialization of Netflix.
Thanks maximum.
We continue to recognize that we need to improve their link sales gross from a senior management in cooperation with commercial committee of the board of Directors continues to remain focused on near links revenues and sales growth in 2020 and beyond.
We have made a number of new hires in our commercial team and specifically within sales management and we are hopeful but these new team members will make a positive contribution to near like sales growth and we look forward to updating investors on this in the future.
This concludes today's presentation, we will now turn the floor back to the operator for Q and a Rob can you. Please open up the Q and a please.
We will now begin the question and answer session. If you would like to ask a question. Please press star one on your telephone keypad.
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One moment, please while we pull for questions.
Your first question comes from add White of H.C. Wainwright and company. Please go ahead.
Hi, Thanks for taking my question. So Alan just wanted to ask a question on the four sub four and 349 patents.
If they are a loud and issued.
Can you make any comment on what the next steps would be regarding degree so.
Yeah, Hi, Ed. Thank you for the question.
As I'm sure you can imagine.
The topic, you're discussing is a very sensitive a sensitive legal matter and so therefore, we cannot comment much on it.
Okay understood.
And then you just mentioned about new hires in the commercial can you just.
Comment on about the level of your sales force right now, our you're right size or you're looking to.
Make additional hires the hot to fill any gaps that you have right now and you know due to turnover.
Yeah. So I would say a we have a team of 80 sales reps. We are performing an exercise to look at whether or not that needs to be expanded or not.
On a we're still in the process of doing that so I'm hopeful we'll have that done. The next couple of months. A you know during 2019, we added in a lot of senior management in our sales organization you know even knew VP of sales a new area sales directors a lot of new regional managers you know they have now been with us.
You know a anywhere from three to six months or so so yeah I would imagine we will start to see you know the benefit of that team working together.
During 2020, probably more towards the back half of 2020, but I I feel good about where that that team is.
Okay, Thank Tony and just staying on that on on the sales in the past you had commented that your prescriber reach its around for the for the currently well. It's currently around 75% or are you still around that level or making any more inroads. Thanks.
Yeah.
In terms of the reach you know theres a lot of accounts, especially some of the more higher volume ones.
What we refer to is no see accounts, a you know meaning that you know they won't allow a sales rep to go in there and they end up doing their own education work either by you know they published research going to conference is going to events and things like that that probably makes up I would guess you know 15.
The 20% of the prescriber base. So when you get up to that you know 75 ish range, which is probably around where we are that's probably where you would top out now theres, obviously to reach but another topic is frequency right because.
The reach slides that we used to show just basically showed if that physician had been contacted by Puma well into and a half years you can imagine if you know since we've launched this drug.
After you've reached someone wants okay. That's good but obviously you'd like to have a more frequent interactions with them. So you can answer their questions. You know increase their awareness of data and things like that that that is it something of that were certainly working to improve on which is improving the frequency of our kind.
Attack with physicians.
The next question comes from a LIFO young of Cantor Fitzgerald. Please go ahead.
Hey, guys. Thanks for taking my question, maybe take it from me one I'm not sure. If memory serves me correctly I think it does I just wondered or maybe I missed it on the 2020 guidance I guess I'm just trying to get a feel at the weather I know you talked about one first corridor in some of the trend, but I didn't know if you could offer up any kind of opinion, how you think the rest of the year would shape out.
And then maybe my second question I guess, you know maybe dig a little bit more into this trend about you know kind of that the population of you know kind of over that seasonality. We saw like shift I mean, I feel like we've seen seasonality before I guess I just wanted to see if there's anything particularly different that you're seeing about that particular type of seasonality that's like the.
Laid in January or anything like that thanks.
Yeah, Hi lease, yes, so first of all in terms of Q1.
Three impacts you're going to have is the inventory build in Q4.
You know the seasonality, which obviously leads to kind of the delay in filling the gap you know so I guess, you're like if you were charging and Rx you would see them kind of you know flat dropping and then coming back. So it's kinda Lucky you. If you will right. So when that is happening when that when the incline is you know when you're starting from the trough in kind of.
Coming back up to where your before and that's happening in January obviously, the month of January gets impacted and so you know that that's where the <unk> the quarter gets impacted so that'd be the second one or the third obviously is a you know the thing that we mentioned in terms of the lower doses and then you obviously have in Q1.
The higher gross to nets, which has Maximo said comes from you know a lot of the Medicare donut hole and things like that so all that together, it's going to impact Q1.
In terms of having seen this in the past.
I don't remember a last year well enough to speak to it as as a accurately as I would like to but I seem to recall that the inventory build this year was higher than last year.
So that may have the impact.
But you know kind of the additional impact or comparing Q2 thousand 20, Q1 to 2019 Q1.
And I'm the Guy.
That's really tiny like them. If they are you guys kind of leaving open ended so you figure out trends.
No I would say this so first of all in terms of the forecast for 2020, you know obviously in Q2, you're not you know you'll have the impact of the inventory you know were assuming the inventory drawdown will be completed by the end of March. So that's obviously going to have a positive impact on the numbers going.
Forward and then obviously on the gross to net line as well you know that's going to be improved for the rest of the year as well.
So you will.
Go ahead sorry.
I just was curious if you're going to quantify the inventory you know kinda stocking amount like how much it wasn't revenue like it with a couple of million or what the greater than that.
Yeah, I would say it was probably in the neighborhood of about 5 million.
Okay great.
So again once that's worked down it obviously, we'll have a very positive impact on revenues.
Okay got it thanks.
Your next question comes from Chris Shibutani of Cowen. Please go ahead.
Yes, Hi, Alan you introduced a bit of a metric an observation about looking at the percentage of patients who are still taking the drug after six months and how you seem to have a merger group who started at the lower down versus the standard can you maybe give us a sense for what we're talking about in terms of all patients who are new star.
What portion of those are still taking out six months and maybe what those comparative numbers were.
Yeah, Chris Thanks for the question I'll, Let me take a step back if you look at our slide in our presentation.
That looks at the percent of patients taking the lower dose of nearly six so I'm looking at it right now and I believe this a slide five right.
So.
It takes us up to 90 days from the end ever given month for the specialty pharmacy to be able to tell us if a patient is still taking nearly six right. So there's kind of a lag from from that in terms of discontinuations.
So unfortunately for the period kind of you know post ASKO when we really started to see a lot of the use of the drug or of the dose escalation commercially we don't have data yet to capture that what we did do as we kind of looked back so you'll notice on the slide you always historically had.
Some physicians who are doing this on their own starting at a low dose in kind of tied trading up.
A lot of that comes from community physicians, who treat a lot of different tumor types. So maybe they treat breast and lung in colon and other things and they do this with other drugs. So there's a lot of oral cancer drugs, where a lot of physicians and a lot of those are all cancer drugs have tolerability issues, so lot of physicians with others.
Drugs will start at a lower dose and then kind of tied trade up and they were doing the same thing with near links so what we did as we kinda analyze those historical data so kind of going back from you know Q1 of 19 back and so again, it's a small sample size, it's not huge but at least is something.
Thats indicative the magnitude of the benefit we saw in terms of the absolute magnitude of increase of patients still taking the drug in the people we started at the lower dose compared to standard.
It was around a double digit number I don't have it in front of me so I can't exactly quote it but it was encouraging trend such that we were you know.
You know positively a a inclined by it.
Then just switch over to the metastatic opportunity I've two questions. There I think in the past you've talked about how even prior to approval there was something like 5% of patient use of morale and it was in the metastatic population can you update us on what that's been particularly since the Nollen trial data read out mid last.
Here that would be one and then number two is there anything that you can let us know in terms of any regulatory interactions discussions that you've had that might suggest any reason to be concerned or put at risk.
The anticipated producer in the second quarter I believe actually the end of April thanks.
Oh, Okay. So in terms of the off label use it was somewhere in the range of 5% to 6% in Q4 of 19 anecdotally, we hear from physicians. They use it in her to mutated breast cancer they'll use it in a patients with brain met.
Yes, or they'll use it in her to metastatic breast cancer, but you know I don't know that necessarily that's using the dollar regimen right in combination with keeps I'd been sometimes it's just using it as a single agent as a salvage therapy or something like that.
So that's kind of our current off label use our guidance does not include anything for the third line metastatic because there's a lot of factors that we need to get clarification on in order to be able to issue that guidance.
As you can imagine you know there's basically for outcomes that we can have in terms of the sandžak right. The first one would be that the San Diego gets approved early the second would be it gets approved on time. The third would be there are some delay in the PDUFA date and it gets approved later or the fourth would be they issue a.
Well, obviously each one of those you know has a.
Different impact on our revenues and so we took a conservative view, which was to kind of wait to see was one of those occurs and when it occurs before issuing our guidance in terms, our interaction with the FDA or I'm not aware of any interaction that would tell me that any one of those four options.
<unk> has a higher probability or a lower probability.
Great. Thank you all.
Yeah.
Your next question comes from you go no drama bits of Citi. Please go ahead.
Hi, This is the math on for your call. Thanks, very much for taking my question I'm I'm curious what percentage of physician do you believe actually using dose titration isn't a core group of physicians are you seeing adoption.
Across a wide number of doctors.
Yeah, I would say that in terms of the percent of physicians who are using it.
It's probably somewhere in the ballpark of the number of patients. We're seeing so that you know thirtyish percent is probably a fair number.
Okay and would you expect your their usage or they can you see increased sort of literary other like we've seen over the last three quarters or should that eventually taper off.
Our hope would be that increase is because we know that this leads to improved tolerability right to I would much rather have the you know kind of loss of the refill in that first quarter there on to gain the more refills when they stay on for a longer period of time.
Time, and I think in you know in past calls, we kind of went through that mathematical exercise, where you know it's pretty big increase in the number refills, we would see if they stay down for a longer period of time.
I would hope it continues to increase you know we were at 20.
28.7%, we're now at 30% does that mean, it's starting to taper it could I I think I just need more data to be able to answer that question accurately.
Got it and then switching gears a fit to the European and the rest of world territories that have a watch so far how should we think I know you gave some guidance for it for revenues, but that's how should we think about the cadence of that and how that'll go quarter over quarter, We're not a new Orleans was launched in the country.
Yes.
How long do that work is insufficient hand, Mary described the cap.
In most of the European countries, you can't launch without reimbursement.
So it would be you can't launch the drug unless you are reimbursed. So you know our assumption would be that when it launched it starts getting used.
I would expect that as you go out quarter over quarter, and specifically in Europe, you're going to see the continued growth of the countries that it launched in but then obviously the uptake in the new countries as well.
Okay. Thanks, very much for taking my question.
Your next question is from Michael Schmidt of Guggenheim Securities. Please go ahead.
Hi, This is kelcy on for Michael Thanks for taking my question I just had a one quick one on the cervical cancer cohort or just wondering kind of given the lack of treatment options and relax cervical cancer and keytruda as being a bit of kind of odd benchmark I guess, what kind of is the bar there for now.
Charlie Thanks.
Yeah. Thank you for the question.
I would agree that keytruda could back a good benchmark.
I would say that's keytruda would be a good assumption to work with that certainly the one that we're kind of working with.
You know I would say our current response rate is obviously you know higher then Keytruda I think you know kind of being in that range kind of bracketed by Keytruda in where we are I would say from our view that's kind of a good range to be it.
Okay, great. Thank you.
The next question is from Kennen Mackay of RBC capital markets. Please go ahead.
Hi, Thanks for taking my question on are there any plans to mark to minimize complex and go through other than 40 milligrams sort of fill bottles you were pills that perhaps if I premium perpetual versus them up for part of 240 milligrams a day.
Okay.
It seems like there obviously financial revenue recognition incentive for the company, but also in front of for physicians and patients student Central refrigerated foods drug for part of them on thanks.
Oh, Hi, Ken and thank you for the question that is indeed, something we're looking into a we hope to be able to update you on future calls with regard to that.
Right.
The next question is from Paul Choice of Goldman Sachs. Please go ahead.
Hi, Thank you for taking your questions and good afternoon, everybody I just had a question with regard to the took the demand side. Alan can you, maybe just clarify a little bit more on youre on the physician region that your earlier comments with regard to new prescribers I guess I don't know how much of the growth because oh in terms of.
On the demand side is being driven by these obviously you prescribers that you talked about earlier and then I have to follow up question.
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That is a good question I don't have the answer as to what you know what percent of the are actually in the quarter are driven by new versus existing I apologize I don't have the.
Don't have the numbers for that I would say there is no question a.
Very large opportunity with new prescribers, we have certainly not topped out in terms of the you know, whereas our reach might be you know 75% of the physicians have been reached by the Salesforce.
If I had to ballpark estimate I would say probably less than half of those have actually prescribed the drug again, that's just a ballpark off the top of my head. There is no question a lot of additional opportunity for us with physicians who've not written a prescription for near links yet and especially increasing education and increasing awareness.
Okay got it. Thank you and then in prior calls you've talked a little bit about duration in some instances of a patients going beyond 12 months of therapy is that's still the case and with regard to the the dose titration and patients who are doing that is not increasing having any.
Back on duration of treatment here.
So in terms of patients going out beyond one year I believe that is still occurring I don't believe it's in a very large percent it might be 10% or less.
In terms of the dose titration you know as we mentioned our preliminary analysis is showing that patients are staying on for a longer but again as I mentioned to the earlier question. It's kinda based on that historical you know group that was doing it and so it's it's based on some low numbers I'm hopeful in the next couple of quarters, we'll be able to.
Update that number and get a much better feel for what it's doing.
Okay, great. Thanks, and then I know you obviously have some puts and takes with regard to to the 2020 outlook, including the the metastatic indication and then you know you know do the development of patents, but I guess you know are you.
I'm comfortable enough for the you know sort of thinking about what might be the bookends for how to think about cash a utilization or cash burn during this year or any sort of range.
You might be able to put out to the street here or how to think about about the puts and takes there.
National always like to answer that yes, sure our goal for 2020 used to be cash flow neutral.
Obviously, there are some some assumptions based on the odd, but what the guidance were put in and that's that's available.
That's what the current guidance, Paul that would be cash flow neutral.
Okay, great. Thank you very much I'll jump back into queue.
This concludes our question and answer session I would like to turn the conference back to Marianne for closing remarks.
Thank you for your interest income a bio technology as a reminder, this call me that fire replaying, the webcast and Puma biotechnology Dot com beginning later today have a good evening.
Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program [noise] everyone have a great day you may now disconnect.
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