Q2 2020 Puma Biotechnology Inc Earnings Call
[music].
Good afternoon. My name is just the and I'll be your conference call. Operator today at this time all participants are in a listen only mode. After the speakers formal remarks, there will be a question answer session. If he would like to ask a question during that time simply press the star Keith and the number one on your telephone keypad. If he would like to withdraw your question. Please press star.
Our two.
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I'd now like turn the conference call over to Maryann will Hannesson senior director of IR for Puma Biotechnology, you may begin your conference.
Thank you Jesse.
Good afternoon, and welcome to whom this conference call to discuss our financial results for the second quarter 2020.
Joining me on the call today, our Allen our bar, Chief Executive Officer, President and Chairman of the Board well know Maxim long again, Chief Financial Officer, and Yes, Ludwig Chief Commercial officer.
After market close today, we issued a news release detailing second quarter 2020 financial results.
I was really the slides the Jeff woman for two and a webcast of this call are accessible by other home page and investor sections of our website at Cooper Biotechnology Dot com.
Casting 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.
Since its federal Securities laws.
Such statements are subject to risks and uncertainties and actual results can be.
May differ from those expressed in these forward looking statements due to a number of factors which include the risk factors closed as a periodic and current reports filed by someone with the Securities Exchange Commission from time to time.
You are cautioned not to place undue reliance on each forward looking statements, which speak only as of the data like conference call.
Good 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 todays call with me all could refer to certain non-GAAP financial measures.
12 adjustments to our guests figures. We believe these non-GAAP metrics may be useful to investors as a supplement too, but not a substitute for our GAAP financial measures.
Please refer to our second quarter 2020 news release for a reconciliation of our GAAP to non-GAAP results.
I will now turn call over to al.
Thank you Marianne and thank you all for joining our call today.
Good day Premier reported total revenue for the second quarter of 2020.
70.6 million.
Total revenue includes net U.S. near link sales as well as license and royalty fees from our sub licensees.
Net airlink sales were 48.8 million in the second quarter of 2020.
Presenting a slight increase from the 48.6 million a net sales reported in the first quarter of 2020 and a decrease from the 53.8 million reported in Q2 of 2009 cheap.
As we reported on our fourth quarter earnings call. During the fourth quarter of 2019, there was an increase in inventory purchased by the specialty pharmacies, which we estimate was approximately one week excess inventory and we also reported on our fourth quarter earnings call. There wasn't approximately four.
The week of inventory in our distribution network.
Our first quarter call, we reported that the specialty pharmacies had drawn down some of their excess inventory to meet demand. However, our distribution networks still maintained approximately four weeks of inventory at the end of the first quarter.
During the second quarter, we saw specialty pharmacies continue to draw down from their existing inventory to meet demand, which we believe may have negatively impacted second quarter revenue.
Approximately $4 million to $5 million.
Distribution network had approximately three weeks of inventory at the end of the second quarter of 2020, which was more in line with the level seen in 2019 prior to the inventory by and during the fourth quarter of 2019.
Also during the second quarter license fees increased 20.7 million, which included a onetime payment due to the regulatory approval of year links in mainland China and royalty revenue during the quarter was 1.1 million.
I I will begin with a review of some of the highlights of the quarter and then Jeff Ludwig well provide more details on drillings commercial activities Max ammonia gets it will follow with highlights of the key components of our financial statements for the first quarter of 2020.
As investors are aware Puma has an ongoing trial of you're right.
And extended out you get her two positive early breast cancer referred to as the controlled trial well we are investigating the use of several prophylactic techniques, including the use of anti real drugs or dose escalation to reduce the incidents of directly related diarrhea, and improve the tolerability of the drug.
Interim results from the control trial were published online in the medical Journal Annals of oncology in May of 2020.
These results demonstrated that the incidence of grade three diarrhea, what's the right.
Can't be reduced in the Tolerability of a drug can be improved significantly using a variety of anti real strategies. We believe this publication will help to increase the awareness of using these techniques to improve the tolerability if the drug.
We fully anticipate that additional results from the trial will be presented in the fourth quarter of 2020, which may further helped to increase awareness of these prophylactic techniques.
As investors are also aware Puma has an ongoing basket trial of directly in hurt you mutated cancers referred to as the summit trial.
Somewhat trial was modified in early 2020, such that you are positive hurt you negative breast cancer patients who have hurt your mutation well be randomized to receive either for the strength alone full the strip plus trust II as a map or the combination of direct and if possible schrandt plus dress shoes in that.
Each arm of the event that study will enroll seven patients during stage one.
Thats no patient in a given arm response that all will be close to further enrollment if in the first stage one or more patients respond. The cohort will then be expanded up to 18 patients.
Less than four patients in the expanded arms respond that arm will be closed to further enrollment if more than four patients respond to respond the arm will be expanded and for their patients will be enrolled.
As we reported on our fourth first quarter earnings call enrollment into the summer trial in Q1 of 2020 was slightly higher than enrollment in Q4, 2019 and did not appear to be impacted during the month of March due to the covered 19 pandemic.
Enrollment in the month of April However, did decline to a level that is towards the lower end of the range of mostly enrollment that we saw in this cohort during 2019 and we believe that this decline was due to the impact of the covert 19 pandemic.
Enrollment in the trial further decline during the month of me, but then began to slightly improve in June and slightly improve again in July.
We continue to believe that enrollment in the trial is being impacted by the current 19 pandemic.
We continue to anticipate that we will receive the initial results from the initial Simon two stage for the age are positive breast cancer cohort in 2000 in Q1 of 2020, sorry in Q1 of 2020 Watt.
However, we recognize that this could continue to be impacted by Kogas 19, and also recognize the potential uncertainty associated with any additional wave of covert 19 shouldn't won't occur later this year.
Once we receive the initial results from the signed the two stage NVH ER positive breast cohorts, we plan to schedule a pre NDA meeting with the FDA can discuss the potential for accelerated approval.
In addition.
We recently announced that the phase two data from the cohort of the summit trial with hurt you mutant metastatic cervical cancer were published online in the journal Gynecologic oncology in July of this year.
And finally, the results of our phase three trial of directed for the treatment of third line Hertwo positive metastatic breast cancer also refer to as the knowledge trial republished of the journal of clinical oncology in July of this year as well.
I will now turn the call over to Jeff Ludwig Pulice, Chief Commercial officer for a review of our commercial performance during the course.
Thanks Al I really appreciate it it is a great to be here and I'm honored to be leading promos commercial organization.
We are proud of what we've accomplished so far but clearly no. There is much more to do to support patients and their families battling breast cancer.
Before I move into the commercial review just a reminder, that I will be making forward looking statements.
During the second quarter 2020, almost commercial access was negative negatively impacted by the comes in 19 pandemic.
As we reported on our first quarter earnings call. We did not see an impact from cold is 19, not new patient starts in Q1. However, we did see an impact in mid Q2.
As we previously reported and number of new patients signing up in April through our specialty pharmacy channel was essentially flat compared to no signing up in March.
We did however, see a decline in may more specifically in the latter part of the month, which we believe was due to the company's 19 pandemic and the stay at home waters in corn teams that were in place in various parts of the U.S.
Just trends did start to recover in June, which we believe me I've been relating to stage beginning to open back up.
We are aware of other companies, who have drugs to treat early stage hertwo positive breast cancer reporting similar dynamics in May and June. So we believe that this combet 19 impact may have had a broader impact on the early stage breast cancer market.
As you May recall, we have two channels that provide never links to patients.
We refer to these knows our specialty pharmacy channel and our specialty distributor channel or in office dispensing channel.
In the second quarter bottle sold into specialty distribution channel represented approximately 22% of the total bottle sold in the quarter.
This is very similar to the 23% we reported in the first quarter.
Later in the call maximal what we view the full financial results, but I will now provide you with a current U.S. sales results.
Slide four shows U.S. quarterly net sales of Nerlich since FDA approval.
As Alan noted our net U.S. product sales were $48.8 billion into second quarter of 2020. This is a slight increase over the $48.6 million, we reported in Q1 of 2020.
Slide five shows the bottles of airlink sold by quarter since launch.
We sold 3728 bottles of New Orleans in Q2, 2020, which is a decrease of about 7.6% from our reported Q1 2020 bottle sales of 4035.
Clearly, we do not like to see bottle sales decline, but as Alan mentioned, we believe this is directly correlated with an approximate one week reduction in distributor inventory.
Our commercial teams have worked very hard to adapt to this new kobin environment and we're pleased to see that gross demand has stayed flat compared to Q1.
Despite decreased customer access and reporting patient flow impact.
As highlighted during our Q1 earnings call Merrill Lynch received third line approval for the treatment of her two positive metastatic breast cancer. This was clearly an important milestone as it brought forth an additional treatment option for patients battling metastatic disease.
In Q2, roughly 8% to 10% of our new patient starts we're into metastatic setting.
The vast majority of our overall business and if our new patient starts continue to be in the larger extended African setting.
That was mentioned that the interim interim results of the controlled trial were published online in animal health oncology in May.
We believe the control data is very important as it shows that proactive management of diarrhea can significantly improve airlinks tolerability by reducing grade three diarrhea, and overall discontinuations.
Well I think a dose escalation strategy in the extended add you've been selling coupled with PRN loperamide showed a greater than 60% reduction in grade three diarrhea, and an approximate 80% reduction discontinuation.
As you can see in slide six approximately 31% of new patient starts were initiated at a reduced dose in Q2, which is a slight increase over Q1.
With the recent publication, coupled with an additional plan communication in Q4.
We would expect this trend to continue.
We believe in improving the tolerability of neural links and reducing Discontinuations should increase the average length of therapy and ultimately help patients in their battle with breast cancer.
Moving on to rest of world partnerships.
We are formed strategic partnerships with regional pharmaceutical companies, then a commercial and regulatory expertise within their respective geographies with the goal of making or links available to patients across the world.
During 2019 Arylex was approved in several countries outside the United States and this trend has continued in 2020 as seen on the slot on this slide excuse me.
Most recently Specialised Therapeutics received approval in Brunei and April New Zealand in June and Malaysia in July.
Medicine, we see both regulatory approval and national reimbursement in Israel in Q1 of this year.
And just yesterday 10 bridge received regulatory approval in Taiwan.
And finally, Pete pharma launched their legs in Argentina earlier, this year and received approval in Chile in late April.
During the remainder of 2020 and beyond we look forward to the potential for near links to be approved in additional countries, including in Latin America Asia, Southeast Asia, and the Middle East.
In your inner fourth quarter, our partner peer far of launching or links in Germany.
I did kingdom and Austria.
Recently, they launched their links in Sweden and received regulatory approval in Switzerland.
Although it's still early we've been very pleased with their initial success and we anticipate appear favorable launched airlinks in several additional countries in Europe throughout the remainder of 2020.
We look forward to updating investors on a European progress in the future.
I will now turn the call over to maximal for a review of our financial results.
Thanks, Jeff.
I will begin with a brief summary of our financial results with the second quarter 2020.
Please note that we make comparisons to Q1 2020 Q4 2019.
Which we believe a better indications with other progress as a commercial company <unk> over year comparisons.
More information I recommend that you referred to over 10-Q, which will be filed today includes our consolidated financial statements.
For the second quarter of 2020, we reported net income based on account of $3.4 million.
Or eight cents per diluted share.
Our GAAP net losses from Q1 2020 in Q4 20 Nike.
$16.9 million, an $11.2 million respectively.
Non-GAAP basis, which is adjusted to remove the impact of stock based compensation.
We reported net income of $14 million was 35 cents per diluted share for the second quarter of 2020.
Gross revenue from Nellix sales was 57 million Bucks in Q2 2020.
This was 58 million got us in Q1.
I mentioned that meant revenue from Nellix sales was $48.8 million.
Slide increases from net sales of 48.6 million bonus in the first quarter, it's going in IP.
In Q2, 22, any you recognized $20.7 million license revenue.
$1.1 million royalty revenue from our global partners.
Our gross committed adjustment in Q2 was 14.4%.
Decreased from the 16.3% gross to net adjustment in Q1.
The decrease was driven mostly by lower co pay and coverage gap expenses driven by seasonality.
Cost of sales, but the second quarter was $9.4 million.
Which included one decision with milestone payments to the license sort of mid afternoon, approximately 1.3 million Bucks.
Going forward, we will continue to recognize almost acentia another milestone payment to the license or well about $2 million per quarter as cost of sales.
For full year 22 any.
On PC page 10 minute Lngs net sales will be in the range 200 million to 210 million voters.
You see some production from our prior estimate of $215 million to $225 million.
We also anticipate double gross to net adjustment in 22 any will be between 16% 17%.
Furthermore.
For the full year 22, any we continue to do you see patients you know loyalties from our partners around the rule in the range of three.
To $5 million on potential licensing fees in Denmark of $22.7 million.
Recognized you Miss a great deal of uncertainty team with regards to the impact of Cowen Nike.
This may continue to negatively impact our selves royalty and license fees.
Additionally, our nellix net revenue expectations from Q3, 22, any I didn't arranged a $48 million to $50 million.
We anticipate at the gross to net in Q3 will be approximately 16.5% to 17.5%.
As GNS expenses were $29.4 million into second quarter, 2020, compared to $30.9 million I'm 31.3 million bars for Q1 2020 on Q4 29, respectively.
That's DNA expenses include a noncash charges for stock based compensation $4.7 million for the second quarter of 2020 <unk>.
Compared to $4.7 million and find minimum bars from Q1, 2020, Q4 2018, respectively.
Research and development expenses was $24.7 million into second quarter.
Compared to $25.5 million on 30.2 minimum bonus for Q1 2020 on Q4 2019, respectively.
R&D expenses include a noncash charges for stock based compensation, a 5.9 million Bucks in Q2.
Compared to $4.2 million $6.5 million for Q1, 2020 on Q4 to 29000, respectively.
The second quarter 22, any well not reported concerns of $6.2 million compared cause burn was 11.6 million Bucks in Q1 2020.
Touch of approximately 1.2 million got us in Q4 2 million IP.
We ended the second quarter 22, any who's 107.3 million Bucks in cash cash equivalents, a marketable securities.
Our accounts receivable spots at June Thirtyth was $24 million.
Well accounts receivable times range between 10 68 days.
Well I wouldn't they sell some studies about 44 days.
We estimate passive June Thirtyth 22, any our distribution network maintain approximately three weeks of inventory.
Overall, we continue to deployed our financial resources to focus on the advancement of Neratinib, two ongoing clinical trials and the commercialization of networks.
Thanks maximum.
We continue to recognize that we need to improve their links sales growth.
Let's see the senior management in cooperation with the commercial committee of the Board of Directors continues to remain focused on near links revenue and sales growth in 2020 and beyond.
We've made a number of new hires in our commercial team. We are also adapting to the virtual commercial environment that we need to pivot toward due to the covered 19 pandemic.
We are hopeful that these new team members and changes to our commercial infrastructure will make a positive contribution to near link sales growth and we look forward to updating investors on this in the future.
There continues to remain a significant unmet need for women battling breast cancer.
We had puma are committed and passionate about finding more effective ways at helping these patients during their journey, we will continue to strive to achieve that goal.
This concludes today's presentation, we will now turn the floor back to the operator for today operator.
Thank you we will now begin the question and answer session. If he wants to ask a question. Please press star one on your telephone keypad.
Confirmation kinda indicate your line is in the question Q. If you wish to withdraw your request please press star too.
Our participants using speaker equipment, and maybe necessary to pick up your handset for Prosigna Sarkies one moment, please only poll for questions.
Thank you. Our first question comes from the line as you call not to move it with Citi. Please proceed with your question.
Hi, This is the math on say at all and after taking a question.
First I want to start just how do you see the contribution of metastatic rather than a.
A wrong Marelli picture of solving it you worked it out that indication and and so far have you any off label use or other hurts you get in cancers.
And it's all that benefit you bring that.
[laughter].
That's meant to thank you for the question. So I believe just said in his presentation that somewhere between 8% to 10% of our usage is in the metastatic setting.
So I think that's remained what Weve continued to see now you know when they come in.
As a script for amid a static we don't know whether or not it's a her two positive metastatic or her churn here to mutated or they have brain Mets or they don't have brain Mets I can definitely say anecdotally.
We certainly here from physicians that they're using near links commercially it hurts you mutated breast cancer and they're using it in hertwo positive metastatic breast cancer that has brain Mets.
I don't Unfortunately have any breakdown of a you know exactly the numbers that abein that.
Okay got it that's helpful. And then just on the items you have to guide us I Wanna get concerned about it surpassed the accurate setting and attic, it's not correct.
Yes, that's correct.
I think I thinks I'm not sure taken a question.
Thank you. Our next question comes from the line of Kennen Mackay with RBC. Please proceed with your question.
Hi, This is keen on for Ken Thanks for taking our question sell the first question. It's about a interesting research paper I recently like identifying around to name as a whole tend to come in 19, I can borrow a main cookies in keeping her using computational crop.
She has.
The research kind of going on in earlier, Nate nature publication, who can't four different loyalty classes that can talking to the.
Well and then main coach is a function outside a enriching Iraqi <unk> chemicals structured Chaucer look like kind of resembled the in three Clos. So does this kind of research can into your awareness too and that will trigger you are anxious to do it sounds like biochemical assets. There may be animal studies, there may be clean coach.
Thank you.
Yes, I mentioned the question yet we are aware of that publication from that rushing group.
And.
We have had investigators who have been doing work on your rat live in covert 19.
I don't want to.
Say too much about their research but.
It's suffice it to say we have had many external researchers who have done some work with new rented included 19.
Coming up with a similar types of conclusions.
Once we get some more data on this under our belt I think we will plan to in some way communicate that to investors either by publishing its or in some way getting it to be public information, but yes. It is something we have interested and it is something we have active research.
Looking into.
Hi, Thank you down we have one follow up on me all her commuting cervical cancer cohort update so compared to the S. T O down Oh, they want to find more patients. Doug include you for their safety analysis and one more patient data included with the Alex and that's it.
Who we know like like approximately how many patients having rolled into the cervical cancer cohort so far and maybe you provide guidance on the timing and aside for the next data update and more or like how many like somebody go cancer patients die required by ft, a flow renters into a discussion.
That's all her question. Thank you yeah, yeah. Thank you for the question on the hurts you mutated cervical cancer.
I apologize I do not have the update on that in front of the.
I know, we do plan on presenting more data on that I don't know the exact timing of that sale need to get back to you on that so I apologize for not having that front let me.
To your question, which is.
How many patients do we need to go to the FDA and disgusted with them you know this would be an S.M.D.A.
And again, you know hurt you mutated cervical cancer.
As I recall is about 5% of the cervical cancer population Ah. So it's not like you know 10000 patients or something is obviously much smaller.
And I'm aware of for instance, I know Keytruda got approved in the PDL, one high and I don't think there and was a huge number so I'm not imagining we're going to need like hundreds of patients here, let me get back to you with a little more of an update on a where that is and what our timing would be for.
Spanning the label.
Thank you that's really helpful.
Thank you. Our next question comes from Cory Kasimov with JP Morgan. Please proceed with your question.
Hi, guys. Thanks for taking my question. This is knocking on for Corey I'm just wanted to get your thoughts on New Orleans pricing are you comfortable where neuro. It's currently priced or should we expect the pace of increases to be similar to the foreign increases that 10%. Each that has occurred over the last 18 months.
Jeff if you like to handle that sure I imagine good. Good question I. Appreciate it I mean first of all I would say, we're not going to proactively comment on any future potential pricing strategies, we wouldn't do that but what I will tell you. What do you want to think about it is we're very very committed to ensuring a very strong value prop.
Position in this marketplace. We also want to ensure that there is very strong physician and patient access and obviously as part of our discussions we continue to look at the competitive marketplace. So we've made some decisions in the past, but we won't we wouldn't comment at this point any any future potential pricing decisions.
Great. Thanks for taking my question.
Thank you. Our next question comes from the line of Geoff Meacham with Bank of America. Please proceed with your question.
Hey, guys as Scott on for Jeff. Thanks for taking my question I believe there is new language added to that package in sort of Newlinks recently as it relates to the action that trial I'm specifically in regard to no statistical difference and though less after eight years a follow up. So just wondering how you guys think this will impact sales moving forward and then for the pace.
Is that are starting on the lower dose do you know what dose. These patients are typically starting on in the duration. The average patient you know is on this lower dose until they reach the 240 minute <unk> milligrams and given the small differences benefit whether you know, it's the DFS or though Wes how confident are you.
At these lower doses aren't impacting results and potentially making them more equivalent to placebo patients. Thanks.
Yes, so to answer your first question Scott you know as you know the action that trial in rolled a wide range of patients and the ITC population. It was both hold receptor positive at home receptor negative patients as you know the actually use of the drug clinically does not can you be in the ITC.
The population if not in all commerce and the typical what you hear from physicians is they use at any age or positive patients and or the HR positive patients who are at a high risk.
We plan on presenting the data from those cohorts specifically the age are positive group and the age are positive high risk group at the San Antonio breast cancer meeting. This year, obviously, we can't comment on that but clearly if we were to see a positive impact into those in though.
Subgroups, where the drugs used commercially you know we think that yes. It could have a positive impact on our sales. Obviously, we have to wait for that date will be presented I really can't coming out in the tell it is but I think you can understand that logic.
Can you repeat your second question. Please.
Yeah sure I'm, just wondering about the patients on the lower dose you know do you know what dose. These patients are typically starting on and that the duration that there on that lower dose until they reach the 240.
You know and given the kind of tighter range and the benefit if this lower doses.
Essentially having any impact on on the overall survival or the the GFS as you kind of look at it.
Okay. So I think Jeff will take first part I'll take the second part of that question. It's got I think it's it's a good question obviously as we highlighted in this in our opening statements about the control data we feel very good about the control data in that it does significantly change the tolerability of neural links and if you follow that paper in the data that was presented.
What we're suggesting that paper at least on the dose escalation arm is the start patients on three pills for first week.
For pills for the second week, and then you're up to the full dose at the third week. So again, that's the data that we have out there. That's a the protocol that many customers are beginning to adopt so you do have some variability, but that is really the flow and ultimately the idea is to get patients up to the.
<unk> Belos any action that study the average dose was somewhere around 211 or so.
Microgram milligrams and ultimately that's where we expect patients to get in a relatively near future given that when they dose escalated happens is relatively quickly we do not expect to see a negative impact on on efficacy.
You asked a broader question about yes, it's been just a follow up in terms of the dosage. The three fills a day would be 124 fills and be 160, and the $6 to be 240 milligrams a day.
In terms of your question do we expect it to impact efficacy.
I can answer that in two ways first of all as Jeff just outlined you look it's a 12, both course of therapy and if they do the dose escalation the way it to the control trial, you're talking about two weeks, where they're getting a lower dose I wouldn't you imagine that two weeks of a lower dose compared to 50 weeks at full dose is gonna have negative impact on the Africa.
See I'll also note that we had looked at this and when we are first preparing.
For the ODAC back in 2017, I get that was.
We had looked at I don't remember the number off topic I had to do it is somewhere in the range of.
30, plus percent of the patients an extra nuts that actually gone to a lower doses stand on that lower dose going forward.
And if I remember correctly, the efficacy was not very much compromised.
To the patients that were on those lower doses, but again a lot of those were you know they started at 240 that went down to 201, 61, 20 or whatever based on Tolerability and I don't remember that there was much if any compromise any efficacy in that patient subgroup.
Got it very helpful. Thanks, guys.
Thank you. Our next question comes from Paul Choi with Goldman Sachs. Please proceed with your question.
Thank you right now and good afternoon, everyone. My first question is for John and just if you maybe just comment on how you're seeing the salesforce, particularly with regard to virtual interaction capabilities is the salesforce right size and just what sort of feedback you know given the given the commercial dynamics in the market right now.
You're seeing with regard to other competing metastatic agents out there.
And then my second question is just as you go into your pre NDA meeting for.
For her to mutated breast cancer and in the front out next year can you, maybe just remind us any additional.
Studies are analyses that you'll have to conduct having your pre NDA meeting. Thank you very much.
Okay, Jeff you I think first one on Salesforce, yeah happy to thanks. Thanks for the question Paul Yes, obviously, a unique environment right now what's the covert pandemic that I guess, Fortunately none of us had been through before clearly as you've seen as we highlighted and I know many others have highlighted the amount of direct act.
Yes, the customers have changed significantly.
And ultimately, we're trying to pivot and adjust the field force to adapt to that new environment, which I wish I had a crystal ball, but is likely to go on at least for several additional months here. So what we've really tried to do Paul in this situation is to pivot quickly to remote or virtual interactions with customers there were still some life.
Interactions going on and we think about this as a very local or regional decision and where local localities or regions open up we will pick it back to as much as we can live interactions given that that has not happened a lot we've significantly increased.
Non face to face interactions.
Increased peer to peer programs and ultimately tried to maintain a strong share voice through phone videos zoom et cetera, and so we're all adapting to that and we feel pretty good about our ability to compete in that environment, but we will continue to evolve as best we can we.
We're also being very diligent and smart with our headcount and we're making sure that our teams are rightsized and as they roll or position opens up we evaluate that very closely and decide whether or not we're going to fill currently or whether we want to fill in the future. So we're being very smart with the utilization of resources given this time as well.
And then Paul in the second question regarding the hurting mutant population. So a in remember correctly. It was like September October of last year, we had a meeting with the FDA to discuss won't be necessary for us to be able to file the NDA in the Hershey mutated breast indication.
And we had shown them the data at that time on the new Radnet, plus herceptin plus full restraint arm of the trial.
What they asked us to do was to help to better understand what radnets contribution was to that triplet and therefore to do the study. The modification was done which is deciding to two stage, where one arm is the triplet radnet herceptin for restaurant. The other arm is herceptin for restaurant.
The other one is for restaurants alone.
The way the time to stage works you do an end of seven in each one.
And you know if you don't see a responder in the first seven patients you shut down the arm. If you do see a responder you expand it to 18 patients. So I think we need to wait for that data to know what further analyses we need to do.
I would imagine that if you know we continue to see the same response rate in the triple It arm.
And we don't see any responses the other two arms that that's pretty easy with answer.
If you end up seeing for some reason responses and the others then that's going to be a a different situation, but I think we have to wait for that data before we can know exactly what we're going to need it to file the NDA.
Great. Thank you for clarifying about.
Thank you. This concludes our question and answer session I would like to turn the conference back over to Marianne for closing comments.
Thank you for your interest in kind of bio technology. As a reminder, this call may be accessed via replaying the webcast at Puma Biotechnology Dotcom beginning later today have a good evening.
Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program everyone have a great day you may now disconnect.