Q1 2021 Puma Biotechnology Inc Earnings Call
[music].
Good afternoon, My name is Kevin and I'll be your conference call operator today.
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After the Speakers' remarks, there will be a question and answer session.
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As a reminder, this call is being recorded.
And I'd like to turn the call over to Marianne Harrison Senior director of IR for Puma Biotechnology and you may begin your conference.
Thank you Kevin.
And welcome to <unk> conference call to discuss on.
Sounds good.
2021.
Joining me on the call today.
He's executive Vice.
And again.
And.
Non-GAAP, Chief Financial Officer and Keith.
Keep commercial lots of share.
After market close today.
This release detailing first quarter 2021 financials himself.
Yeah, and he's really decides to cancel referred to and a webcast of this call on acceptable pie and the homepage and investor sections on our website and cause.
And the biotechnology satcom on the webcast and presentation slides will be archived on our website and available from which makes it the next 90 days.
This conference call will include statements about the company.
Plans from cash.
And that constitute forward looking statements and perfect.
Right.
Such statements are subject to risks and uncertainties and actual events and results may differ from those.
And these forward looking statements.
Praful and discussion of these risks and uncertainties. Please review our periodic and current reports filed with the Securities and Exchange Commission from time to time, including our annual report on form 10-K for the year ended December 31 2020.
You are cautioned not to play and cause your reliance on these forward looking statements, which speak only as of the date of this slide conference call and maybe 2021.
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 and they all can be for certain non-GAAP financial measure net income.
And all the adjustments to our GAAP figures.
We believe these non-GAAP metrics may be useful to investors as a supplement to but not as substitute for our GAAP financial measures.
Please refer to our first quarter 2021 news release for a reconciliation of our GAAP to non-GAAP results I will now turn the call over to Alan.
Thank you maryanne and thank you all for joining our call today.
Today Puma reported total revenue for the first quarter of 2021, $98 2 million.
Total revenue includes net U S near link sales as well as license fees and royalties from our sublicense fees.
Net narrow link sales were $45 8 million and the first quarter of 2021, representing declines from the $50 million and net sales reported in the fourth quarter of 2020, and $48 6 billion reported and Q1 of 2020.
Royalty revenue was $2 4 million in the quarter on first quarter of 2021 versus $2 6 million and the fourth quarter and zero point $6 million and the first quarter of 2020.
On our last call I noted that Puma and Sublicensee, Cambridge Pharmaceuticals had mutually agreed to terminate our agreement covering commercial rights to near links and greater China and that the agreement with our Sublicense V. P. F. R was amended to include development manufacturing and commercial rights and that territory as a result, our first quarter 2021 results.
Include $50 million of license revenue received from Pierre from rate for the addition of the greater China territory, while cost of sales for the first quarter of 2021 includes the one time termination payment and you can bridge of 20 billion.
During the first quarter of 2021, we continued to experience challenges brought on as a result of the COVID-19 pandemic as well as the decline and New Orleans bottle sold in the quarter due to the holiday related decline in new patient starts that we're seeing and Q4 of 2020 as.
And as Jeff will discuss in more detail in his remarks due to the vaccinations being done in 2021, we are optimistic that there'll be a reduction and the commercial and limitations that had been negatively impacting our commercial performance since the pandemic started and we are hopeful that the removal of these limitations will help to improve our commercial performance.
I will begin with a review and some of the highlights for the quarter and then Jeff Ludwig will provide more details on <unk> commercial activities.
Maximum on the guests will follow with highlights of the key components of our financial statements for the first quarter of 2021.
During the first part of 2021, we announced that Puma and P. F. A break agreed to extend the terms of our sub license agreement to include granting peer for brake commercial rights for <unk>, and greater China, which includes mainland, China, Taiwan, and Hong Kong and Macau under the terms of the agreement Puma received an upfront payment of $50 million.
And it has the potential to receive additional regulatory and sales based milestones that could add up to an additional $240 million. These milestones will be based solely on regulatory and sales achievements and greater China.
In addition, Puma will receive significant double digit tiered royalties on sales of neuro links and greater China. We are pleased to extend our relationship with Pierre Fabre and two the greater China region PR from rate is Puma is current marketing partner in Europe, as well as the middle East and North Africa or meter territories and.
Currently markets the drug Navelbine, which is also known as <unk>.
One of the common chemotherapy drugs used in the treatment of breast cancer in China and is therefore, well equipped with existing infrastructure in China to make nearly a success in mainland China.
And investors are aware Puma has an ongoing basket trial up and Iraq and hurts your mutated cancers referred to as the summit trial.
The summit trial was modified and early 2020, such that ER positive hurt you and negative breast cancer patients, who have a hershey and mutation were randomized to receive either full restaurant alone while restaurant, plus trastuzumab or the combination of direct and <unk> plus sylvestris plus trastuzumab.
Under the initial Simon's two stage design each arm of the amended study will enroll seven patients during stage, one and if no patient and a given arm response that arm will be close to further enrollment if the first and the first stage, one or more patients respond the arm well that'd be expanded up to 18 patients if less.
And for patients and the expanded arm responds that are and will be closed to further enrollment if more than four patients respond and the arm will be expanded and additional patients are being enrolled.
During the first quarter of 2021, we enrolled the initial seven patients and the each of the three randomization arms.
Once completed.
We anticipate that we will be able to perform a topline analysis of the response data, which would determine whether or not to expand their respective arms under the Simon two stage design that was previously described somewhere between mid 2021 and late 2021.
As we have noted previously we further and anticipate that this topline analysis would form the basis for a pre NDA meeting with the FDA to discuss the potential for accelerated approval in this indication.
As investors are also aware in November we announced interim data from another cohort and the summit trial and more specifically the cohort of patients with metastatic non small cell lung cancer.
And the demo grocery factor or Egfr.
Exon 18 mutations who have previously been treated with an egfr targeted and tyrosine kinase inhibitor and.
In late January 2021, we presented additional data from this cohort of patients and an oral discussion at the World Conference on lung cancer presented by the International Association for the study of lung cancer.
We are continuing to enroll this cohort of patients and anticipate that we will have additional data from this cohort to report and the second half of 2021.
I will now turn the call over to Jeff Ludwig Puma as Chief Commercial officer for a review of our commercial performance during the quarter Jeff.
Thanks, Alan and I appreciate it and thanks to everyone for joining our first quarter earnings call.
Before I move into the commercial review just a reminder, that I will be making forward looking statements.
The commercial organization remains focused on strengthening the position of neural links and early stage breast cancer with the goal of improving the risk benefit perception with clinicians and patients as well as increase from new patient starts in this under penetrated market.
As mentioned previously we believe that <unk> can play an important role and the treatment of metastatic breast cancer, but our focus is on extended adjuvant with a goal of preventing or delaying patients from becoming metastatic. We take this go very seriously and know that more and must be done to help patients and their families and this battle with early stage breast cancer.
I am pleased with the foundational work that has been completed and largely came to fruition a few months ago.
We look forward to seeing the impact of this work with the goal of driving future growth and increased patient penetration.
As a reminder, this foundational work we published the interim results of the control study and the September edition of Annals of oncology.
And published the final efficacy results from the extra net trial and the October edition of clinical breast cancer.
And these datasets were also discussed and well represented and both San Antonio breast and Miami breast, which as you all know occurred in December and March respectively.
And highlight this clinical information because we feel it is very important and.
And illustrated the benefits of dose escalation as a way to significantly improve the tolerability profile and <unk>.
And it also highlighted the potential of invasive disease free survival OS and CNS benefits seen and exploratory analysis of patients and heightened risk of disease recurrence.
As Alan mentioned in his opening remarks, we continue to be impacted by the COVID-19 pandemic with the big impact coming from decreased access to customers and an overall reduction and our share of voice.
The commercial team is highly focused on increasing our communications around this new clinical data.
And I am optimistic that we will see an increase and our overall share of voice in the second half of the year.
Driven largely by increased vaccinations and declining new COVID-19, 19 cases, leading to improved customer access and clinics and hospitals.
Moving to slide three and.
And you May recall, we have two channels that provide <unk> links to patients we referred to these as our specialty pharmacy channel and our specialty distributor channel or in office dispensing channel.
The majority of our business continues to flow through the specialty pharmacy channel.
More specifically in Q1, approximately 76% of our business went through this channel with the remaining 24% flowing through the specialty distributor channel.
This represents a slight change from the 79% specialty pharmacy, and 21% specialty distributor business, we reported during our Q4 earnings call.
And now later on this call Maximo will review the full financial results, but I will now provide you with the current U S sales results.
Slide four shows U S quarterly net sales and <unk> since FDA approval and as Alan noted our net U S product sales were $45 $8 million and the first quarter of 2021. This.
And this is a decrease from the $50 million, we reported and Q4 of 2020.
As mentioned previously my Alan we tend to see a decline and new patient starts and the fourth quarter each year and some patients decide not to initiate new therapy around the Thanksgiving Christmas and new year's holidays.
These reduction and new patient starts not only impact on fourth quarter, but also impact subsequent quarters as well.
We were also negatively impacted by a Q1 increase and the number of Medicare patients receiving free drug through our patient assistance program.
We believe this increase increase was driven largely by very limited availability of Medicare Foundation support.
On a positive note we did see an increase in both enrollments and new patient starts in Q1, and 2021 versus Q4 of 2020.
While we believe that the patients and Q4 and who deferred starting treatment until Q1 likely contributed to this positive increase we also believe that the new data and foundational work that I discussed were contributing factors as well.
Slide five shows the bottles of <unk> sold by quarter since launch, we sold 3247 and bottles of <unk> and Q1 of 2021.
Which is a decrease from our Q4 2020 bottles of 3585.
Obviously these results were impacted by the same factors I just highlighted around net sales.
Namely the new patient start decreased typically seen around the Q4 holidays.
On increase in Q1, Medicare patients requiring free drug through our patient assistance program.
And the continued access challenges, resulting from the COVID-19 pandemic.
With that said the focus of the commercial organization is to grow <unk> linked quarter over quarter with an emphasis on increasing share of voice and driving improved execution.
We continue to be pleased with the increasing adoption of dose escalation and early stage breast cancer and.
And Q1, we saw approximately 38% of all new patient starts initiate therapy at a lower dose.
I do want to call out that this slide contains a revision for Q4 and 2020.
During our Q4 earnings call I highlighted that approximately 37, 5% of new patients initiated therapy, and a lower dose and Q4.
The data has subsequently been refreshed and updated and the actual Q4 estimate is $42 four.
Moving forward, we do expect to see dose escalation adoption increase.
Now as a reminder, this is very important since the control data showed that utilizing a dose escalation strategy and the extended adjuvant setting coupled with Purion loperamide showed a greater than 60% reduction and grade three diarrhea and.
And a 60% reduction and media and cumulative days of grade three diarrhea, and and approximately 80% reduction and discontinuation rates we.
We believe that the increasing adoption of the dose escalation will improve the overall tolerability of neuro links and increase the average length of therapy with the end result, benefiting more patients battling breast cancer.
Slide seven highlights the strategic collaborations we have formed across the globe with a goal of making <unk> available to more patients around the world.
In terms of regulatory approvals key highlights include the approval of the extended adjuvant and metastatic indications in Peru, and Q1 as well as the expected metastatic approval in Canada in mid 2021.
In terms of commercial launches key highlights include Q4, 2020 launches in Denmark, Finland and Scotland.
And Q1, 2021 launches in China, Taiwan, Greece, and the Czech Republic.
In addition, we are expecting Q2 launches and Chile, Malaysia, Brunei and New Zealand.
And we are continuing to work very closely with our partners and look forward to the potential for near links to be approved and additional countries in Europe, Latin America Asia, and the Middle East.
In summary, I want to thank the commercial team for their passion and their commitment to making a difference I am proud of the work has been done by the team and believe that we are well positioned to increase the impact we're having on patients battling her two positive breast cancer with.
With that said, we know that more and must be done and we are committed to accelerating our efforts moving forward.
I will now turn the call over to maximum per a review of our financial results.
Thank you Jeff.
I will begin with a brief summary on public for and also the sales for the first quarter 2021.
Please note and I wouldn't make comparisons to Q4, Q3, 'twenty 'twenty, which we believe on better indications of our progress as a commercial company.
And year over year comparisons.
For more information and recommend that you referred to I would thank you and which will be filed today and includes our consolidated financial statements.
For the first quarter of 2021, we reported net income based on GAAP.
$16 5 million.
From <unk> 40 per diluted share.
Our GAAP net losses from Q4, 2020 on Q3, 2020 were $15 million and $31 5 million respectively.
And our non-GAAP basis, which is adjusted to remove the impact on stock based compensation.
We reported net income of $22 4 million or.
Or <unk> 55 per diluted share for the first quarter of 2021.
Gross revenue from Nellix sales was $56 5 million and Q1 2021.
Versus $61 million and Q4, 2020.
As Alan mentioned it net revenue from Nellix sales was $45 8 million.
Decrease from net sales of 50 million and the fourth quarter of 2020.
And Q1 2021 we also recognized $50 million and license revenue related to our map from Pete to include Greater China, and our sub license agreement with Pier Park.
Royalty revenue was $2 4 million and the first quarter of two and 21 versus $2 6 million and Q4 2020.
Our gross to net adjustment in Q1 2021 was about 18, 9%.
And inquiries.
From the 16, 8% gross to net adjustment in Q4, 2020.
The increase was driven mostly by higher co pay and covers GAAP expenses largely driven by seasonality.
Cost of sales from Q1, 2020, one was $29 6 million.
Moving that 20 million fee paid to Cambridge to terminate our sublicense agreement.
As well as approximately $2 million for the amortization of intangible assets related to our net up and they've license.
Going forward and will continue to recognize amortization of milestone payments from the licensor for about $2 million per quarter as cost of sales.
For fiscal year 'twenty to 'twenty, one per month, dissipates and <unk> net sales will be and the range of $208 million to $213 million.
Which is slightly higher than our prior guidance of $205 million to $210 million.
We also anticipate and our gross to net adjustment in 2020, one will be between 18% to 19%.
Furthermore from fiscal year 2021 we on.
Anticipate receiving royalties from our partners around the world and the range of $13 million to $15 million.
Which represents a decline from our prior guidance of $16 million to $17 million.
On license revenue and the range of 50 to 52 on this.
And we recognize there is a great great deal of uncertainty regarding the impact of COVID-19 on this.
This might continue to negatively impact our sales and royalties and license revenue.
We anticipate that Q2, 2021 knowledge net sales will be on the range of $46 million to $47 million on them.
Royalty revenues will be and a range of $2 million to $3 million.
We anticipate that the gross to net in Q2, 2021 will be approximately 17, 5% to 18, 5%.
SG&A expenses were $28 2 million and the first quarter of 2021.
And third to $28 8 million and $29 6 million from Q4, Q3, 2020 respectively.
SG&A expenses included non cash charges for stock based compensation of $3 6 million for the first quarter of 2021.
Compared to $4 3 million from Q4, $2024 1 million for Q3 2000 and twin.
Research and development expenses were $20 2 million and the first quarter of 2021.
Compared to 2004, 2 million and $23 3 million from Q4, and Q3 2020, respectively.
R&D expenses included non cash charges for stock based compensation of $2 3 million and the first quarter.
Compared to $5 2 million and $3 5 million from Q4, and Q3, 2020 perspective.
And the first quarter of 2021.
From a reported cash burn of $15 7 million, which included a $50 million license fee from Pierre Fabre under 20 million termination fee payment to Congress.
Comparative cash burn of $15 $6 million, and Q4, 2020, which included a $10 1 million milestone payment to Pfizer.
On cash earned one eight and in Q3 and 2020.
We ended the first quarter of 2021, with $109 1 million and cash cash equivalents and marketable securities.
Our accounts receivables balance on March 31 was $26 2 million.
Our accounts receivable terms range between 10 and 68 days.
And our day sales outstanding and about 46 days.
We estimate that as of March 31, 2021, our distribution and they were maintained approximately four weeks of inventory.
Overall, we continue to deploy our financial resources to focus on the advancement of their underneath two.
Two ongoing clinical trials and the commercialization of <unk>.
Thanks Maximo.
Okay.
The COVID-19 pandemic.
Has presented commercial challenges to Puma, which has made it difficult for the company to achieve nearly and sales growth.
Company is helpful, but the vaccinations that had been occurring in 2021, and we will continue to occur throughout the year will reduce these barriers, which should improve the ability of our commercial teams and access and interact with health care providers to increase their awareness of the narrowing statement from.
And with senior management and cooperation with the board of Directors continues to remain focused on New Orleans revenue and sales growth and 2021 and beyond.
We look forward to updating investors on this and the future.
There continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors. We have puma are committed and passionate about finding more effective ways and helping these patients during their journey and 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 Q&A Kevin.
Thank you and Doug My question and answer session, if you'd like to be placed and the question queue. Please press star one of your telephone keypad a call.
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Our first question today is coming from <unk> and <unk>.
Citigroup your line is on line.
Great Hi, this is Carly on for Yigal. Thank you for taking our question and.
First on the guidance you provided can you expand on on what assumptions are driving acceleration and revenue growth that you expect to see and this.
And second half of the year.
Okay.
And currently this is Jeff I'm happy to expound on some of those assumptions as to why we see growth going forward.
A couple of general comments here remember this is a very promotional <unk> sensitive product and.
Obviously, we've got new clinical data that really came to fruition and the fourth quarter of the year. So as I think about promotional sensitivity a big one of the driving factors behind <unk> growth is our belief that we will see increasing access in the second half of this year, we are starting to see some early <unk>.
Increasing positive signs it's slow at this point, but we do expect the second half of the year to be much different than the first half obviously to grow and oncology brand. The best and you can do is communicate new clinical information and we feel very good about the clinical information, we published towards the end of last year.
On top of that we also as I mentioned in my remarks, we expect to see increasing adoption of dose escalation that.
Proves the patient experience and <unk>.
<unk> persistence and compliance and certainly will benefit patients and also us commercially as well and.
And currently one last point I want to point out here as well is that we've done some early market research with patients and it will go as no surprise to this group that patients battling early stage breast cancer want to do more and as we've engaged and early discussions with them and certainly they want to do more very intrigued by your new clinical and inflammation and it seemed.
To be compelling for them to want to discuss a little more proactively with their clinicians moving forward. So those are the drivers that we see going forward that can inflect. The current trends that we have.
Yeah.
Okay, Great. That's very helpful. Thank you and then I guess just a follow up on that on the commercial strategy are you at this point more focused on sort of getting existing prescribers to use narrow links more aggressively.
Yes.
And on reaching new prescribers, just curious what you see as sort of a bigger opportunity for driving sales growth.
And.
Yes currently we the simple answer is both.
And certainly having current utilization and utilizes continue to have good experience and feedback from patients and alike as well as physicians that have not used narrow links ever or have not used and recently to get them to reengage and clearly the clinical data that we that we published and also was presented at San Antonio and Miami breast <unk>.
We found really forms the foundation for us to expand the utilization going forward.
This is Alan if I can kind of add a few things here.
And as Jeff mentioned, one of the things Thats very important for us is to get.
Get physicians to adopt the use of the dose escalation or at least you become aware of it.
Because it ends up giving them a more favorable view of the drug and we noted we've noted it in our analysis is that the physicians who use the dose escalations tend to prescribe <unk> to more patients and then once you're Jones, so and it's it's pretty dramatic ratio and not like a 10% difference or something.
So the promotional sensitivity point that just talking about we also didn't analysis.
Looking at.
The physicians, who we call on we don't call on the call and infrequently and we call on and frequently in terms of the number of patients and they put on the drug that similarly shows a very dramatic increase in terms of the number of patients that the physicians put on the drug and depending on how frequently and meet with them. So as ware.
And looking to be meeting with more physicians because of access improving price vaccinations and things like that we have a good degree of confidence that that's going to end up resulting in the sales growth that we're that we're looking for.
And then to the point you were asking regarding new physicians, we do see every quarter, a decent percentage of our new prescriptions.
Our interest coming from physicians, who have never written a prescription before so for instance in.
Q1, I believe I think it was somewhere around 29% of the.
And our ex came from physicians that had never written a prescription before so given that were out.
Almost a year for a launch.
Still shows you there is quite a large opportunity here for us to still reach the people who've never written a prescription.
Talk about and their links they continued to talk more and more about those escalation and so I am not concerned about that small variability between quarter over quarter, I will and I do expect to see that that will continue to move forward and upward it's going forward. So hope that helps.
Okay. Thanks, and then maybe let's pray for Alan just on the on the her two mutated you're positive trial, just came up they're kind of disclosure plan there.
When investors are likely to hear it and the results of of it are we going to hear the data first and then ultimately the F. D. A meeting are you likely to kind of hold things back until after you've had on on that day a conversation.
Yeah. Thanks for the question, so as I mentioned and the prepared remarks.
And the other randomization, which is four best friend and one on investment plus interest you don't have any other arm, you're at and if possible investments plus dressers and a and the other arm. The initial is seven seven and seven for the first stage and assignments to stage that is not fully enrolled I would say we are more we are likely to and now.
<unk> or present at a conference. The initial results of that data whenever we get it that would more likely be the way. We would go in terms of the timing of and F. D. A meeting and as you know you apply for meeting and wait for it to be granted there's kind of a time lag. There. So I don't know that we would wait and do it is kind of a.
All at the same time type of thing it would probably make more sense to just get the data out there. So it is known.
Okay, great. Thank you.
Thank goodness question today is coming from Kevin Mckay from RBC covered on Mark Neutralizes alive.
Okay and thanks for the question two questions sort of expanding on the conversation on the.
The reduced goes just wondering if you had a sense of of sort of which would reduce doses or b use it that's.
Largely 200 or physicians are more frequently starting at what was 160 and.
And he kind of break on there would be helpful. And then again and he kind of perspective on the the pace of increasing dose would be incredibly helpful. It is it does look like that is really really helping me the trash and do so.
Here and then just a a final question wondering any feedback on the preferred and if you got a real combinations got better be who used by physicians out there commercially obviously loperamide has been successful, but a number of other.
<unk> out there as well thank you.
[noise] Yeah, Kevin appreciate I appreciate the question a couple of things in terms of a dose escalation and.
In terms of what's being used typically they're following the dose escalation schematics and that was presented in the control study, which is starting with three pills for a week moving to four pills for a week and then going to six bills. Thereafter, certainly as you talked to condition. Some do very that as as needed, but if you asked me the <unk>.
<unk> methods of dose escalation is three four and six as presented and my control data itself.
Likewise in terms of anti Diarrhoeal preferences. There you hit it loperamide is still the number one preferred and utilized anti diarrheal strategy that being following dose escalation with pier and loperamide certainly it goes without saying you talk to other clinicians and they have other ways of dealing with it the net net <unk>.
Salt is we are seeing increased perception of tolerability of near links and better patient persistence, which is what we're looking for across the board candidates Alan and to add to what you have to saying we tend to see with physicians and kind of at the schematic. If you will as they used to just escalation and if they do see diarrhea and use loperamide, if they'll they'll appear on.
My desk network and then they may incorporate budesonide or colestipol or something like that I would say I don't really hear a whole lot about I haven't really seen as much activity in terms of the budesonide and Nicholas default. Most physicians have said that the dose escalation and just using loperamide if.
Needed tends to work quite well.
Got it and maybe one one other commercial question if I could do you have a sense of the sort of the breakdown of prescribing between academic and and sort of.
<unk> community clinics, I would imagine just being early breast cancer, it's majority and the community, but uhm, Yeah, I would love to hear how that breaks down as well.
Kevin I I liked the question that and I like when you answered the question yourself as well you're you're absolutely right. We we see the breakdown on board [laughter], you're right by the way so great great submission and we see it more in the community oncology given today's early stage breast cancer. The vast majority of treated in the community setting and that is to break out of our.
Sales as well as a cat and as you know and a tends to be and at the early stages treated and the community as you accurately stated and then at the fish and gets metastatic and especially towards later lines and that's when they tend to go to the academic centers.
Thank you and that's question is coming from just Meacham from a bank of America on your line does that alive.
Hey, guys. This is out like on suggest thanks for taking our questions first is when you look at the commercial access disruption caused by COVID-19 Uhm have you see scripts potentially recovering once the pandemic hopefully subsides will it be sort of a spike over a quarter or two or maybe something more gradual and and then.
And any color you can provide on the global partner launches during the quarter in terms of feedback you've been receiving from the field and whether adoption and any particular geography stands out so far would be great and then I have a follow up.
Sure and look let me, let me comment on how we see the the potential increased based on access returning and just let me give you a teeny bit of history here as well as it probably won't surprise and this group, but prior to the pandemic. We saw about 90 per cent of all interactions were alive and you know.
5% to 10% were virtual obviously with the pandemic, we saw that completely switch with the vast vast majority being virtual and and then you know a very few percent being alive. We have started to see that switch as we look at interactions with customers. We're starting to see more of Ah Ah 73.
<unk>, so heavily biased on virtual but you see the live visits coming back.
The important element to all of this bill is net net we still saw about a 50% reduction and overall share voice pre pandemic to even now and so those are all the commercial efforts and the sales forces efforts to try to improve our access and increase our share voice, but we're still dealing with relatively significantly reduced.
Share a voice.
In terms of when it's coming back. This is it's a it's a I make a statement and I believe the second half of the year will be much better than the first half, but this is really a local situation and you really got into a locally and you'll have pockets and we'll start to open up and you. Some other pockets that will closed down a little bit. So I do expect to see more of a.
Gradual increase overtime as we're starting to hopefully see access now and and I would expect that to accelerate and the second half of the year, but I don't expect a magic date of July 1st one all of a sudden everything opens up and and we see a drastic spike it's gonna be more of a great us a steadier gradual increase from my perspective, yeah, Alec if I can add to it.
Exactly what Jeff is saying, it's gotta be more gradual and it's really dependent on individual states and individual cities in terms of how long are doing with the vaccinations the state and are doing better with and and getting higher adoption of it seem to be more likely to open up and increase access and and that increased access can either be.
Physician attending pier pier events, and things like that whereas it after they wouldn't and that they wouldn't or it could also be them, allowing the rest to actually come in and so they can get with them.
And person rather than doing something virtually but it it really is dependent state by state and as Jeff set up and I think we think it's going to be gradual over the course of the year. We don't anticipate it's going to be some magic date and all of a sudden has a step function out.
And and it was that I can and then the <unk> yeah in terms of your second question regarding the.
Global partnerships.
I would say that we are definitely seeing COVID-19, having an impact there.
Certainly in Europe, the countries that are having issues with COVID-19, we're seeing those having challenges other ones that are doing better with it are obviously doing better I think it's.
True early to call and what's gonna happen and to China launch because I think that's just in the initial stages.
And I think we'll be able to get a much give much better color on that in the future earnings calls.
Okay, and now like I say just.
Sorry, I have to add to those comments.
And I talk about a a global statement about access improving but it's really a local decision. We say the same thing with countries across the World, Germany for instance, and say Q3 or two for our last year was fairly open 30, and 40 per cent opened and then and Q1 they shut down on again, you've had some spikes and Italy and other places where access has been.
Limited and the UK, where you've seen spikes, where it where it shuts down pretty quickly so and we really have to dive deep and each of those launches, but we do feel good about all the work at the partners are doing and I would say overall, we do expect to see the access improved globally as well and moving forward.
That makes sense and I appreciate all of the color and one one more question if I if I may I'd be interested to see if you sort of way at the top line impact of more patient starting on a lower dose and on the flip side uhm expectations of patient thing on neural links longer curious just to see how you're thinking about these two factors.
Sort of netting out on a revenue per patient basis. Thank you.
Yeah, very good question and and I think the the one huge thing for us as as you know and and I've said the commercial strategy is to change the perception of the risk benefit perception of Netflix, we really believe that the new clinical data I talked about can really highlight the benefit of narrow links the clinical benefit, especially and those patients at more in.
Increased risk and we really believe that the control data can really improve that perception of Tolerability now if you think about those escalation you're talking about a delay of only two weeks before you get to the full dose right you start out of three pills and seven six and then you go to four pills instead of six and then by the third week, you're at six pills and.
And so the actual commercial impact is relatively small on dose escalation, but the important element of this is that physicians and patients that are exposed to dose escalation and have a much better perception of the brand and and every given point, we see higher second refills, our first refills hydro patients at six.
Months, and a longer overall length and therapy that is beneficial to us, but also and certainly beneficial to patients as well.
Thanks, I appreciate all the color.
Thank you.
Thank goodness question today is coming from gene away from Barclays. Your balance is alive.
Hi, Thank and shut and all 15 and thanks for taking my question Oh I have maybe two question what is that we recently heard from some K O L. S O.
Breast cancer patients the metastatic and the <unk> setting on.
On may receive more uhm regiments, the mornings or the pen and it because those are on during the pandemic because those on a lot of the.
Hospitals are closed and since I, just don't want to deal with injection or the side effects. So they opted for more use of the Oh, a regiment have you seen the like a better than expected uptake in up noting and the metastatic setting during the past year or so and and.
Opportunity that he can take advantage too.
Maybe promotes the convenience of nerdy and my second question is the H R policies breath.
Breast cancer.
Cohort us to stomach.
And you will meet with FDA after the initial copy and.
Day to off the 21 patients do you think that you can put and he kept on that day.
Accelerated approval after the 21 and patience or give me F. D. I still want to see the full day to after the cohorts already expended based on those and and I'll design and.
And.
Yeah, Let me, let me give you some perspective on the metastatic.
<unk> and what we've seen and as I mentioned before we believed neural links can certainly play and important role and a matter of fact disease and we feel very good about our data.
With that said oral is a benefit however, and metastatic patients given that they are at a very serious state and their disease are more likely to be compliant on oils and or Ivy formulations as well. So we don't see quite as much benefit on the on one side now as you may recall, we launched a received the approve.
Evil of neural links and for the metastatic indication and February.
And hurt you received and approval in late December and two case of received their approval and April So you've got a significant new options for patients, which is wonderful for patients, but a very very crowded space. So we have not seen significant uptake and metastatic and fact, you've seen some slight downward trends given the new options that are out there.
So hopefully that helps with your perspective.
And then to answer your second question regarding the hurts and mutated breast. So you correctly and a full enrolled the 707 and 17 to 21 patients.
Obviously, we need to wait to see if the cohorts expand and the way it works is.
You and roll seven patients if you get one or more responders and that color and expand it we don't yet know, which cohorts are going to expand or not expand.
So.
And it's difficult to know what the FDA is going to want from and accelerated approval strategy. We won't know that until we meet with them and obviously, we can't meet with them until we get the data. So I think we need to just wait to see what the day of the shows if you know all the arms expand and some of the arms expand et cetera, and and go from there.
Thanks, so much.
Yeah.
Thank you we received a on a question and answer session I'll, let the triple flip back over to marry him pretty further of closing comments.
HM.
Thank you for your interest.
Okay.
And the reminder.
Yeah.
Cat and.
And last technology Dot com.
Okay.
Thank you and have a good evening.
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