Q2 2019 Earnings Call
Good afternoon. My name is Sean tell and I'll be your conference call operator today.
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I would now like to turn the conference call over to Maryann I have a son senior director of IR for payment technologies, sorry, Biotechnology you may begin your conference.
Thank you Shawn Hill.
Good afternoon, and welcome to <unk> conference call to discuss financial results for the second quarter 2019.
Joining me on the call today are Allan our block Chief Executive Officer, President and Chairman of the board of Puma Biotechnology.
Steve Lowe, Chief commercial officer, and maximizing your guess Chief Financial Officer.
After market close today, we issued a news release detailing second quarter financial results.
That news release, the slides that Steve will refer to an a webcast of this call accessible by the whole page in the investor sections of our website at Puma Biotechnology Dot com.
The webcast and 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 crust backs that constitute forward looking statements for purposes of the federal Securities laws.
Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.
For a full discussion of these risks and uncertainties.
Please review our annual report on Form 10-K for the year ended December 31, 2018, and any subsequent documents, we file with the U.S. Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call August eight 2019.
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 GAAP figures.
We believe these non-GAAP metrics may be useful to investors as a supplement to but not a substitute for our GAAP financial measures.
Please refer to our second quarter news release for a reconciliation of our GAAP and non-GAAP results.
I will now turn the call over to Ellen.
Thank you Mary Ann and thank you all for joining our call today.
Today prolong reported total revenue for the second quarter of 2019, Oh 53.9 million.
Total revenue consisted of product revenue for sales of near links and royalty revenue.
Net sales of near links were 53.8 million in the second quarter of 2019 and increase of 8.2 million or 18%.
From the 45.6 million in net sales reported in the first quarter of 2019.
Our second quarter results also included royalty revenue of $55000 from two of our licensing partners.
In a moment I will turn the call over to Steve Lo, who must chief commercial officer, who will provide an update on their links commercial activities and progress in the U.S.
In April 2019, we announced that we entered into a licensing agreement with Pierre FARB under which Pierre far, but will develop and commercialize near links within Europe and parts of Africa.
Pierre far has a well established sales and marketing presence in Europe based on their experience in marketing never been which is also referred to as been a rail beam, which is one of the key chemotherapy drugs used in the treatment of breast cancer, we anticipate the PR far will launch their links in Europe in 2019, and Steve will provide some additional T to detail on this shortly.
In July we announced that our licensing partner in Canada Knight Therapeutics received marketing authorization from health, Canada for near links for the extended ADVATE treatment of adult patients with hormone receptor positive hertwo positive early stage breast cancer. Following the completion of edge, even distressed choose a map based therapy.
In collaboration with our licensing partners. We also anticipate announcing additional regulatory decisions on neratinib for the extended advent. Her two positive early stage breast cancer indication in additional countries outside of the United States and Europe throughout 2019.
We also look forward to two additional clinical milestones for interactive.
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 knowledge trials at the American Association.
Oh clinical oncology.
[laughter] annual meeting in June .
A copy of the ASCO presentation is accessible on the events and webcast page of promos website.
Based on the results of another trial Puma filed a supplemental new drug application or S.N.D.A. for Neratinib for the treatment of third line. Her two positive metastatic breast cancer in June 2019, if the S.N.D. is accepted we would anticipate a regulatory decision on this filing in 2020, we will continue to update investors as we obtain more information on this timing.
Who also has an ongoing basket trial of interactive and it hurts you mutated cancers referred to as the summit trial in 2017 data was presented at the American Association for cancer Research meeting or AC are demonstrating that hurts you mutations that were found in approximately 2% to 12% of almost every solid tumor.
The initial data from the summit trial was presented at the Ace Your meeting in 2017 and published in nature in 2018.
Additional updated data on a cohort of patients for summit with Hershey mutated cervical cancer, who were treated with Neratinib were also presented in the plenary session at the society of gynecological oncology or STS annual meeting in March.
From a place to meet with the FDA during the third quarter to discuss the clinical development and regulatory strategy for interactive in patients with Hertwo mutations we will continue to update investors as we obtain more information with regard to this matter.
In addition, we reported additional data from our phase two control study involving the use of anti real prophylaxis underwriting of associated diarrhea in patients with her two positive early stage breast cancer at the ASCO annual meeting in June .
This included updated data on the cohorts of patients receiving will appear might alone.
Or in combination with your desk Tonight or close to Paul and also included data from the most recent cohort in the trial that uses no anti real drugs as profile axis, but instead uses a dose escalation strategy. During the first month the treatment in an effort to reduce the side effects and improve the tolerability of the drug details from the ASCO presentation are included in a poster that is accessible on the events and webcast page of promos website.
As investors are aware the purpose of the control trial is to investigate the use of anti real prophylaxis and dose escalations.
As a way to reduce the diarrhea associated with Neratinib and improve the tolerability of the drug.
In a commercial setting patient discontinuations have an adverse impact and their links revenues as patients tend to discontinue neratinib early in the treatment course, usually the first month, which greatly reduces the potential revenue per patient that if we are able to achieve.
The current label for near links only includes data from the old Paramount alone arm of control in this arm of the controlled trial discontinuations due to diarrhea or other reasons were 44.5% in the poster presented at ASCO in 2018, Puma filed with the FDA to have the label expanded it to initially include the data from the Loperamide plus a few dozen I'd arm of the trial.
In the data presented at ASCO. The data from this arm of the trial showed an improvement in the Tolerability profile as only 20.3% of the patients discontinued neurotic <unk> due to diarrhea or other reasons, we expect to hear back from the FDA with regard to this label expansion in the fourth quarter of 2019.
The company believes that the inclusion of this data in the label will increase awareness a little a pure my plus b doesn't I'd combination, which could help to reduce discontinuations.
In addition, whom I expect that the interim results of the controlled trial, including data on the cohorts receiving love pure might alone or in combination with PD Tonight or close to Paul.
And also from the dose escalation cohorts will be published in the medical journal in the fourth quarter of 2019.
Which the company believes will further improve the awareness of these techniques for reducing the number and it related diarrhea, and improving the tolerability of the drug.
I will now turn the call over to Steve Lo, who will discuss our U.S. commercialization strategy and progress to date with Nellix.
Steve will then be followed by Maximo, new guests, who will highlight key components of our financial statements for the first quarter of 2019.
Thank you Alan.
There are links has been in the U.S. market since our FTC approval in July of 2017. Since then thousands of patients have been prescribed ehrlich's, we look forward to continuing to provide or links to more patients and reaching more physicians.
A reminder, that during my presentation, I will be making forward looking statements.
As you May recall, our network of six specialty pharmacies provider links directly to patients.
The specialty pharmacies conduct benefit investigations obtain a prior authorization approval from the insurance company and then arranged with the patient to send eurlings to their home.
We also have a separate specialty distribution in office dispensing channel, where the prescription does not need to be sent to the specialty pharmacy.
This helps to facilitate the ability for certain patients to obtain neural links directly from their physician's office integrated health systems and also the VVA.
To allow better access for patients we expanded the distribution channel throughout 2018 and into 2019 by establishing partnerships with physician networks.
As a result, we have continued to see an increase in patients being dispensed neural links through hospitals and physician practices in the specialty distribution network.
In the second quarter sales in this channel continued to grow and represented as much as approximately 32% of total bottles sold in certain weeks during the second quarter.
Later in the call maximal will review the full financial results, but I will now provide you with the current sales results.
On slide four you see quarterly net sales of an early sense FTC approval as Alan mentioned, our net product sales revenue was $53.8 million in the second quarter, an 18% increase from the prior quarter. The revenue increase was driven by the higher bottle volumes shown in the next slide.
We experienced an increase in volume in the second quarter due to several key factors last quarter I reported that we had a higher than average vacancy rate in our sales force were 18 of the 80 territories were opened at some point.
I am happy to report that as of today all of those previously open positions are filled.
All of these recently training new hires are now out in the field actively calling on targeted physicians, which has increased our presence in the field. We have also added nurses to our nurse educator team to increase our efforts in educating physician practices and fellow nurses onsite effect management for patients.
Secondly, the increase in volume is attributed to growth in dispensing owner links in the in office dispensing setting, which is serviced by the specialty distribution channel as mentioned, we have established partnerships with physician networks to allow for in office dispensing and continue to see quarter over quarter growth in this segment.
Slide five shows the quarterly volume of neural links bottles sold this represents all channels specialty pharmacy and specialty distribution.
In the second quarter of 2019, we sold 4791 bottles of Newlinks, an increase of 7.6% over the first quarter of 2019.
Our sales and marketing organizations have continued to increase efforts to educate physicians and patients on the risk of disease recurrence and the rationale for treatment with an early in the extended outage events setting.
In addition, we increased efforts to educate physicians nurses and patients about the importance of anti real management as mentioned in the past. The primary reason why a patient just continues in eurlings early due to side effects. The discontinuations occur more frequently in the first month.
While most physicians prescribe an anti real medication with Mnner links our research continues to show that some patients may not feel.
The anti NMDA real prescription.
There were also some physicians not prescribing any anti jar real prophylactic medications at all which we believe was due to the lack of awareness of the data from our control trial using prophylactic anti dot real drugs.
As you May recall, we launched our supportive care voucher to help eliminate the financial barrier for patients to obtain well pair might be just denied cholesterol or other anti Dar real medications.
In addition to this we have a concerted effort to re educate doctors about dose reductions and dose holds to increase tolerability.
This allows patients to stay under links and not permanently discontinue.
All of these options continue to be highlighted by practicing oncologist in peer to peer exchanges.
Moreover, we have our own dedicated nurse educator team, which also help educate practices and specifically solar nurses, who often are the ones in the practice, who educate patients about side effects management.
As mentioned earlier, we have recently added more clinical nurse educators to the team in an effort to improve neural links tolerability.
On slide six you see that most patients received early in 10 days or less and 74% of these patients receive it in 15 days or less which we believe is a continued sign of a smooth reimbursement process and continued good payer coverage. This has been consistent throughout the time drilling so its been in the markets.
It's a small number of patients who have been prescribed drugs for off label use such as metastatic hertwo amplified or hurt you mutated cancer, which we do not market or promote where the insurance company needs more information.
These situations continue to contribute to longer feel ties shown on the right hand side of the slide.
Now onto prescribers on slide seven.
We continue to make progress in reaching our target physician audience, increasing to 75% in the second quarter.
This represents physicians.
Our Salesforce has met with not physicians, who have prescribed the drug.
Since there are more physicians restricting access to sales reps, we have other opportunities to reach them through medical conferences or online, which is not reflected in the numbers here.
No discussion with physicians regarding prescribing early involves establishing the need to reduce recurrence the discussion on the efficacy and also providing education on managing side effects. This requires numerous interactions, which we're highly focused on doing.
Therefore, when we look at reach.
We also focused on the frequency and quality of the interactions in future earnings presentations, we will likely be replacing this metric, but one that gives more transparency into our depth of reaching the prescriber base.
As Alan mentioned, we are committed to making earnings available to patients across the world. We have four great partnerships throughout the world with companies, who have commercial and regulatory expertise in that region. We are pleased with the recent approval in Canada and look forward to more this year as you see in slide eight.
Specifically to Europe as Alan mentioned, we are partnering with pure part with our regulatory approval in the EU pure far is currently planning on launching Eurlings in Germany, the United Kingdom, and Austria in the fourth quarter of this year.
To summarize.
We were able to sequentially gross sales from Q1 to Q2, we are intensely focused on improving our continued progress with physicians payers and patients. We continue to reach more prescribers and dedicate important resources to help patients receive and stay on their medications. We are committed to ensuring all appropriate patients have access to an earlier.
I will now turn the call over to Maximo for a review of our financial results.
Thanks, Steve.
Let me start with a quick summary of our.
Second quarter of 29.
Please note that I will make comparisons to Q1.
In Q4 2015.
Which we believe better indications our pro is a commercial company year over year comparisons.
More information I recommend you refer to our 10-Q, which includes our consolidated.
For the second quarter of 2019.
We reported a net loss.
$37.4 million or 97 cents per se.
Our GAAP net loss in Q1 2019.
With $10.1 million.
In Q1 2019.
We booked a $16.4 million net expense.
This marks.
Jury verdict against.
As you May recall in Q4 2018.
We reported approximately 9 million bonus expense for estimated damages.
In a separate lawsuit.
non-GAAP basis, which is adjusted to remove the.
Based compensation, we reported a net loss of $22 million or 57 cents per share for the second quarter was 29.
Gross revenue for Nellix sales.
Good point $3 million in Q2 lending.
Versus $55.7 million in Q1.
I did mention net revenue from Nellix sales was $53.8 million.
An increase of 18% from net sales of $25.6 million for the first quarter of 2000.
Our gross to net adjustment in Q2 was about 11%.
A significant improvement from the 18% net adjustment in Q1.
As we noted in our last call.
The main drivers of the Q1 adjustment true up.
Non Medicaid charges 28.
About $2 million.
We have previously have not been built for.
Higher Medicaid claims.
On how you'd call risk co pay assistance expenses during Q1.
We expect the gross to net to continue near Q2 levels for the reminder of 2000.
Cost of sales for the second quarter was nine point.
Which included democracies and milestone payments to the license or not.
Approximately $1 million.
Going forward.
Do you recognize a more seasonal than milestone payments to the license.
Rob.
Voters.
For fiscal year 2019.
Houma on PC page the net links U.S. sales will be in the range of $220 million to $240 million.
We continue to anticipate that the gross to net will be approximately 13% for the full year 2013.
We further anticipate a puma will receive licensing and royalty revenues from its licensing partners in the range of $56 million to $60 million in 2019.
This number includes recognition of that $51 million upfront license fee from peer fab that was recognized in the first quarter.
As DNA expenses were $33.5 million in the second quarter of 2019 compared to $45.5 million and $41 million for Q1 2019 in Q4 2018, respectively.
SGN expenses included non cash charges for stock based compensation of $7.4 million for the second quarter of 2019.
Compared to $9.9 million and $7.9 million for Q1 2019 in Q4 2018.
Research and development expenses were $36.9 million in the second quarter compared to $35.7 million and $38.4 million for Q1 2019 in Q4 2018, respectively.
R&D expenses included non cash charges for stock based compensation of $8.8 million compared to $8.3 million and $10.6 million for Q1, 2019, and Q4 2017.
In the second quarter of 2019.
Whom our reported cash burn without onetime events of approximately $14.3 million compared to cash burn of approximately $15 million in Q1 2019.
On positive cash flows of approximately $8 million for Q4 2018.
We ended the second quarter of 2019 with 100 on $17.7 million in cash cash equivalents and marketable securities.
This includes the impact of the $60 million upfront payment from our European licensing agreement.
Which was received in early April .
As disclosed previously.
So my repaid $155 million outstanding loan under his prior credit facility using cash on hand.
And a $100 million in new borrowings from an amendment and restated loan and security agreement.
Our accounts receivables at June Thirtyth was $25.3 million.
Our accounts receivables terms range between 10, and 68 days on our day sales outstanding or about 43 days.
Our distribution network maintains approximately three weeks of inventory.
Overall, we continue to that point, our financial resources to focus on the advancements of Neratinib.
Through ongoing clinical trials on the commercialization of Nellix.
Thanks, Maximo and Steve.
We are pleased to see the sequential improvement in Airlinks revenues during the second quarter from a senior management in cooperation with the commercial committee of the board of Directors continues to remain focused on near links revenues and sales growth in 2019 and beyond.
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 you wish to ask a question. Please press Star then one on your telephone keypad.
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One moment, please follow we poll for questions.
Thank you. Your first question comes from L.P., a young Cantor Fitzgerald go ahead. Please.
Hey, guys. Thanks for taking my question and congrats on the solid quarter and this quarter, maybe just two if I may I'm I just wanted to talk a little bit about potential for any kind of seasonality as we think about kind of heading into the third quarter I don't know if we've seen it before but I. Just wanted you to kind of opine on that and then second you know as we think about UK I mean employee you launch can you just talk about maybe some of the potential country dynamics will it be kind of use will be similar as the United States or do you think kind of the issues, they're saying it was like you know that's going to discontinuation is related to the side effects will be the same just if you can kind of help us think about that thank you.
Hi, Lisa So in terms of your first question on seasonality I'm not aware of all of us seeing any.
Seasonality third quarter or fourth I don't remember seeing anything in <unk>, you know again, we've only been on the market for two years.
But I don't remember us seeing any.
Seasonal dynamics in Q3 of those 18 or Q4 of 18.
For the second one on the launch Steve who'd like to pick that sure. Alan your question around or are there different dynamics in Europe versus the United States and specifically for Germany, I think the important take away is number one its a single payer health care system and secondly, most patients are going to be seen in more of a hospital type setting, which in our opinion is helpful. Because there's a lot of oversight of the patient in terms of Discontinuations. The good news is our partner is acutely aware of this and we have been working very closely with them in terms of best practices in the United States and Lisa I would also add to that.
Our partner peer far.
They marketed and have marketed novel Bean, which has been running for a long time. So I think they probably have a nice amount of experience.
Because its chemotherapy.
With educating doctors on side effects and how to manage them. So I think we have a good deal of faith in that.
Just one quick follow up have you guys secured reimbursement with nice in the United Kingdom yet.
So I believe yesterday nice actually came out with their preliminary recommendation I believe they put out a press release on it it's not final yet but that was their draft. So I believe as Steve said in his comments Pierre farm. It has communicated to us they are planning to launch in Germany, Austria, and the UK in 2019, and as I said nice just came out with a recommendation I believe it was yesterday.
Great. Thank you.
Thank you. Your next question comes from I go non.
Sorry.
Not only are they.
From Citi go ahead please.
Okay, Hi, thanks for taking the questions down just wanted to clarify so you saw an 8% bottle increase but then the 18% revenue increase so could you just explain I'm, assuming that's because of that because of an inventory build given there was no price increase could you just clarify that first thanks.
Yes, hi, guys or the gross to net a there there was no inventory build we stayed at three weeks of inventory in the channel. It was three weeks in Q1 three weeks in Q2.
The other delta there is the gross to net so the gross to net went from 18% in Q1 to 11% in Q2.
Okay got it and then on on now.
Given the the presentation at ASCO, where you use the restricted means analysis.
I just want to get a better understanding of what the regulatory precedent is for this type of analysis when the trial doesn't obey the proportional hazards and what are you know what how you think the FDA will will view that type of analysis when you when once they review it. Thanks.
Hi, you Dol.
So there is regulatory precedent.
For the restricted means analysis to be put in a label of a drug.
I I'm. This is off the top of my head I can get back to you with the specifics.
I'm almost sure it was vectibix that used it and there was at least one or two other drugs, but I know it's been used before let me let me get back to you on that I mean, I know it has been used before and has been used in the label of drugs before.
Okay got it and that would be interesting and then the last question I had is I just wondered if you could maybe Steve could comment what you've seen in the market post ask though with respect to the diarrhea control strategy, whether given that that that a publication or poster at ASCO, whether you've seen a shift in the market towards more of your DUS, Nigel Paramount and or more dose titration relative to just just what paramount.
And you also anecdotally, we have definitely heard from physicians.
That they like the dose escalation strategy and this includes a lot of the physicians who are currently using other techniques and also other ones, where you know perhaps they weren't using anything where they were just using what paramount alone in having some challenges with it. So we have definitely hurt and the optimism has come from a couple of places one is that you know it reduces the pill burden on the patients because they're not having to take you know loperamide. So frequently and you know obviously only having to take near links and not you know two other drugs makes it a lot easier.
The second thing it doesn't require you know another prescription to be filled right, which is just a challenge for the patients.
The third is remember that you know these are not metastatic patients who are kind of sitting at home.
These are early stage patients who are healthy and at this point in their treatment journey.
They've had the reconstructive surgeries. They are done with chemotherapy you know their hair's going back there getting back to work and they're getting back to their normal day to day lives. So the dose escalation is a lot better on their quality of life, because they're not having to and especially if they have a occupation, where they're busy they're not having to take all these drugs. So frequently because you know as you know with like Loperamide side I think it's like every four hours or something they have to take it and with the cost of Paul It's twice a day. So it's just it's easier for the patients to manage just having to take the near links first thing in the morning, and then they're done.
Yes, I'll add one more thing on top of Alan's comments.
A lot of the community physicians have been very positive about this because it's intuitive to them. They said to us I already do this with other drugs such as a fat NIM and just seems very intuitive.
Okay. Thank you very much.
Thank you. Your next question comes from Paul Choice Goldman Sachs Go ahead. Please.
Oh, good afternoon, everyone and thanks for taking our questions.
Maybe just to follow up on your comments with regard to patients, making it through through their first month of therapy and sticking sticking with it afterwards.
A couple of calls ago, you know you.
Well I got an observation that some patients are are extending their therapy beyond. The initial 12 months is that still a trend that you're observing in the market has that increased or decreased or has that remained stable and then could you. Maybe just comment on with regard to patient adherence you know what percentage of initial prescribed patients are making it through the through their full 12 months of therapy currently.
Okay. So for your first question in terms of patients who are continuing on therapy beyond 12 months.
We are still seeing it and hearing about it we're not currently tracking it. So I don't have any number I can give you on that.
And then in terms of the you know how many patients are making it past one month.
Et cetera.
We don't track that number and one of the challenges to doing that or is that you know as Steve mentioned, we're seeing really dynamic growth in the in office dispensing channel.
And oftentimes, we find that the insurance companies.
Well allow the patient to do the first two of their fills so yeah month, one and two.
Via the in office dispensing and then they have them transfer to the pharmacies.
And so you know we tend to see that that in office channel because of that right a higher percent of those patients are going to be new patients.
So therefore, you know to us in the pharmacy channel, we may see them as month, one, but if they've just transferred over from the in office, it's actually month three.
So it kind of distorts that signal a little bit and it makes a little more challenging to try to look at durations.
Okay. Thank you for that and maybe just as a follow up with regard to.
And now I'm out now that you've done the presentation here.
Can you maybe give us a sense of how what feedback you received from from the clinical community with regard to how they're thinking about.
About their their treatment options now that the data is out there.
Any initial sense of you know.
What what.
What what receptivity is what.
And how that might.
Might look for or early adoption upon approval label expansion. Thanks for taking our questions.
So.
We have had a lot of feedback on the Nahla data from the clinical community.
And I would say that you know by far the data point that we hear the most positive feedback on is the prevention of the brain Mets and you know now remember. This is now you know the third time, we've seen a signal with no rent did in preventing or reducing the incidence of CNS Mets.
This was seen in the action that trial, both in the intent to treat population, but a more dramatic effect in the age are positive population. We also saw this in a study which was called Nefertiti, which was our frontline metastatic study, which was tax on wrapping up against Taxol, Herceptin, where we reduced the incidence of the brain Mets and now we saw it in the knowledge trial as well.
And the specific feedback we've gotten is that because of the fact.
That when you get out to the third line or fourth et cetera, setting you become more and more worried about the brain Mets because obviously they are used to seeing them kind of in the first or second line.
So because of that.
You know physicians have said to us there's no question when you get a third or fourth line patient.
It's always on your mind and unfortunately, there is no.
Diagnostic test that can tell you who is at a higher risk of developing them and who isn't.
So the fact that we've shown that we hear very positive feedback on.
Great. Thanks for taking our questions.
Thank you. Your next question comes from Cory Kasimov J.P. Morgan go ahead. Please.
Hi, This is made on for Cory Thanks for taking my question.
The first question. We have is just about 's DNA for the quarter. So it looks like sequentially versus Q1, it was down about 30%, but at the same time you filled all the open position. So can you just talk a little bit about what drove the difference in EPS DNA and then I have a follow up.
Yes, so to talk about as DNA in Q1, we had two we we had a significant legal expense. So it wasn't related to anything that changed on commercial.
Change between Q2 and Q1 it was more related to legal expenses when you see that drop.
Okay great.
And then you put on that.
I think it was a sports you call that out of the questions that have been better that you detailed about 60% of them have turned into prescribers.
How about number of ball.
Over kind of Q1 and now Q2 are you seeing a higher rate of conversion now as you're reaching out to more prescribers.
And if not why not why do you think that is happening.
Yeah, I like your comment that on the prior call. We said, 60% I don't remember, saying that where where was that when did we say that I don't it I'm looking at our transcript from that I'm not seeing that where was that you had with man. That's that's for Q call.
Oh, Okay, I don't have that transcript in front of me yeah in terms of the so as Steve mentioned, we've had a you know 70, 75% of the physicians have been detailed which means we've met with them are met with them at least once that obviously doesn't mean they have all become prescribers I don't have the number in front of me in terms of what percent have become prescribers.
What I will say is just anecdotally. This is promotionally sensitive we have to cover a lot of items to include education on recurrence as well sorry management. So clearly the more opportunities we have with these physicians in general.
We do eventually convert them to a new Orleans user and then just to add more I would say we have seen a nice trend every quarter.
Where the number of new prescribers continues to go up.
So that's been a pretty steady growth that we've seen.
Okay, great. Thanks.
Thank you. Your next question comes from Chris sheep.
She was tiny Cullinan kite go ahead. Please.
Hi, Good evening. Thank you for taking the question. This is CJ on for Chris leaving.
You talked about.
You're going to have the potentially controlled label update for you just denied and the fourth quarter.
No no the publication plan for other arms from that trial do you have other plans aside from that publication.
To raise awareness of your other arms in that trial that seem to have even better.
Tolerability the feed Us Tonight.
And I would.
Potentially adding those to the label as well.
Yeah. So I think if I remember correctly in terms of the tolerability of the arms that used the low pure might combinations.
I thought they'd be definitely the class Paul we're pretty close in terms of Tolerability right like percent of patients that made it through an entire year.
So we do that the reason that when we first got approved.
The FDA they said the only arm of the trial that we had a full year data on.
Was the Paramount arms, so that is when we put in it when we got the full year of data on the B Dubs Tonight. We then filed on that one and obviously the cost to Paul et cetera arms will follow so yes, we of course have plans to update it too.
The class fall as well as the dose escalation.
In terms of the publication.
There are a number of.
Physicians, who are kind of you know no see physicians they don't allow rep to come in.
And they do their own education work and so the publication or really helps that group.
And that tends to be a lot of the more higher volume of centers.
To be it to raise the awareness of it and so we think that that can help out no question.
In addition to that yes, we do do a lot to raise awareness among physicians you know there's there's online things. We do like you know the UNC live videos and things like that which we do here get used quite a bit.
And then we also tend to do a lot of peer to peer events, which can be docked dinners, where they share best practices and things like that and we continue to do that as well.
Great. So.
There's obviously a lot of efforts ongoing in addition to the thing with the nurse educators that you've mentioned.
In the future what metrics might you be able to share for the various efforts that could demonstrate progress on the discontinuation front.
Oh, I think revenue would probably be the best one that investors would like to see so you know again.
Because of the fact that patients tend to discontinue early.
Right and that would be in month one.
We can keep them on you know the if you look at like any other clinical trials of this drug.
The discontinuations tend to be look somewhat like a barbell and the sense, meaning you get a lot of them up front in the first month or two and then it's a small number going from months kind of three through 11, and then a big jump at month 12, when you get the patients completing therapy.
So I think the best metric of our ability to educate the physicians are on you know discontinuations and Tolerability and improving the tolerability is going to be revenue because as you can imagine selling a patient.
11, or 12 bottles is going to have a much greater impact on revenue than selling them one or two.
Great. Thank you very much.
Thank you. Your next question comes from Michael Smith Guggenheim Securities Go ahead. Please.
Hey, guys out of says Kelcy on for Michael to kind of help us gauge I guess the potential opportunity in terms of maybe script up for grabs if you will kind of per patient do you have any idea of kind of or could you provide some color on maybe the proportion of doctors that are actually prescribing anti real versus the percentage of patients.
Patients that you know are prescribed it but don't actually go in fill it I guess, where where are we seeing kind of the biggest loss or is that.
Kind of comparable across both of those those leakage points I guess thank you.
Yeah.
Yeah. Unfortunately, we don't get prescriptions on a you know which.
Which physicians are using which regimens and things like that as you can imagine prescriptions for low pyramid or if you're just not a class to Paul include lots of other indications. So we don't get that that transparency.
I would say that you know my I don't have the numbers in front of me, but files initially kind of on the top of my head trying to estimate.
You know what kind of discontinuation rates, we are seeing in that first month or two.
I would say, it's probably somewhere in the range of what we've seen in the clinical trials.
So I think somewhere in the ranges that I mentioned.
So it's a pretty meaningful proportion there that that you know as you said, we could recapture if you will.
Okay. Thank you.
Thank you. Your next question comes from Kennen Mackay RBC capital markets go ahead. Please.
Hi, Thanks for taking my question, maybe just going back to the prior commentary justifying the product sales growth first is the volume growth. It seems like even after I back out the gross to net difference. It seems like maybe there was sort of 5 million in gross barrels per ton accounted for its not talking into fills outstanding or can you maybe help us understand sort of where that is going to do the increase.
Moving through the specialty distributors among on the shelf there.
And then separately.
Going to the figure on the cumulative prescribers.
Wondering if you could kind of help us understand active prescribers and if that was really sort of in line with cumulative obviously a different number but just wondering about the trends there. Thank you so much.
And your first question in terms of the gain in sales 4.6 million of the gain is from volume 3.6 million is on the increase to gross to net there is no increase in inventory.
Inventory build is not accounting for the game.
And then what was your second question.
I was just going to be.
Good trend.
The cumulative prescribers.
Just wondering if sort of that the active prescribers.
Following that trend.
Provision.
Scott could you just laid after being detailed if they are sort of continuing to prescribe it or if.
You have to sort of be re detailed reaction to this positions us well to keep them prescribe.
Yes. So in terms of your second question in terms of the ongoing number of prescribers, yes, we do tend to see.
Physicians, who have prescribed it continuing to now a lot of that depends on you know.
What volume of patients they see as well you know as you can imagine a high volume center has a constant flow of patients coming in one that's a lower volume center may not so they may not have a patient every month or patient every quarter, who comes in Thats, an early stage patient.
So that tends to have a lot to do with the frequency.
Got you Thanks, Alan and maybe a final question if I may just going back to the commentary around filling the gaps in the salesforce. Congrats on getting those filled wondering if there are any.
Drifting holes, maybe holds we put it to him.
Following the Q1 reporter if this is now sort of full strength. Thanks, so much for taking my question.
Yes, so Ken when we talk to our other colleagues in the field in the sector. We tend to see that typical vacancy rates are usually between 10 and 15% at any given time.
As of today.
August Eightth here I think we have three out of 80, vacancies, which is less than 5% vacancy rate. So I think were actually lower than.
The rest of the industry.
Okay. Thank you and congrats on that that's great.
Thank you. Your next question comes from Thomas Smith, Yes.
The the Lorraine go ahead please.
Hi, guys. Thanks for taking the questions.
Just looking at the year over year bottles shipped it looks like this remained relatively flat year over year. I was just wondering if you could talk about some of the underlying patient demand dynamics here relative to this time last year.
How are the new patient starts and Discontinuations relative to this time last year.
Yeah, we don't really get the characteristics of the patients in terms of like are the HR positive rates are negative for or that we don't really have that information available. So I don't know theres a whole lot. We can we can give you on that.
Okay.
And then just one follow up I guess regarding the upcoming meeting with FDA to discuss the regulatory strategy for tumor agnostic label in her to mutants.
Can you just give us a sense of what you intend to propose to the agency and how do you envision communicating the outcome of this meeting.
So in terms of our meeting with the FDA to discuss how we're going to move forward in the.
Hurting mutation area.
Yes, one opportunity would be to go for tumor agnostic label. The second would be to propose something that's a little more limited to some of the tumor types, where we may have seen better activity. So if you look at the data we've presented to date, we've seen very strong activity in areas like breast cancer and cervical cancer.
That has been publicly presented and then data in.
Rare tumors like Hepatocellular was kind of a weaker.
So we would also have the opportunity to talk to them just about something that's more specific to the indications where we've seen better activity and there's a good deal of regulatory precedent for doing something like that as well.
Right, Okay. Thanks for taking the questions.
Thank you. This concludes our question and answer session I would now like to turn the conference back to Marianne for closing remarks.
Thank you for your interest in Puma biotechnology and to remind you that this call may be accessed via replay of the webcast and Puma biotechnology Dot com beginning later today.
Have a good evening.
Ladies and gentlemen, thank you folks tits pacing in today's conference call. This concludes our program everyone have a great day you may now disconnect.
Right.
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