Q2 2021 Puma Biotechnology Inc Earnings Call
[music].
Good afternoon. My name is kaley, and I will be your conference call operator today.
At this time, all participants are in listen only mode.
After the Speakers' formal remarks, there'll be a question and answer session. If you would like to ask the question during that time simply press the star of Keith and the number 1 on your telephone keypad.
Would like to withdraw your question. Please press star 2.
If you should require operator assistance during the conference. Please press Star zero.
As a reminder, this call is being recorded.
I would now like to turn the conference over to Maryann of Hampton Senior director of IR for trim of Biotechnology you may begin your conference.
Thank you Katie and good afternoon, and welcome to Puma Conference call to discuss our financial results for the second quarter of 2021 and joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board of Puma Biotechnology, Max ammonia guess, Chief Financial Officer, and Jeff Ludwig.
Commercial officer.
And after market close today Puma issued a news release detailing second quarter 2021 financial results.
That news release, the slides, the Jeff will referred to and the.
A webcast of this call are accessible by of the homepage and investor sections of our website with Puma biotechnology Dot com the.
A 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 prospects that constitute forward looking statements for purposes of the federal Securities laws.
Such statements are subject to risks and uncertainties and actual results.
And may differ from those expressed and these forward looking statements.
And for a full discussion of these risks and uncertainties and 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.
Were cautioned not to place undue reliance and these forward looking statements, which speak only as of the date of this live conference call.
The 2021.
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 also 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 2021 news release for a reconciliation of our GAAP to non-GAAP results.
I will now turn the call over to Alan.
Thank you Mary Anne and thank you all for joining our call today.
And today Puma reported total revenue for the second quarter of 2021 of $53.4 million.
Total revenue includes U S net nearly sales as well as license fees and royalties from our sublicense fees net nearly of sales were $48.9 million and the second quarter of 2021, representing an increase from the $45.8 million and net sales reported in the first quarter of 2021 and for.
And $48.8 million reported and Q2 of 2020.
Royalty revenue was $4.3 million and the second quarter of 2021 versus $2.4 million and Q1 of 2021 and $1.1 million in Q2 of 2020.
During the second quarter of 2021, we continue to experience challenges brought up as a result of the COVID-19 pandemic and more recently for the delta of areas.
And as Jeff will show and his presentation and were therefore pleased to report that narrowed and bottle sold in the second quarter increased to 3000 of 350 for which represented a 3.3% increase from the 3247 bottles sold in Q1 of 2021 as.
And as Jeff will show and the slides. This represents the first sequential growth and mailings bottle sold the permanent savings since Q4 of 2019.
I will begin with the review of some of the highlights of the quarter and Jeff Ludwig will provide more details on nearly ex commercial activities Maximo and <unk> will then follow with highlights of the key components of our financial statements for the second quarter of 2021.
As investors are aware Puma has an ongoing basket trial of <unk> and her team and mutated cancers referred to as the summit trial.
And the fourth quarter of 2019, Puma met with the FDA to discuss the regulatory path for the rapid and patients with hormone receptor positive <unk> negative breast cancer, who have of hurts the interfaces.
And at that time of Puma had data on approximately 28 patients who had been treated with the combination of your at net plus <unk> plus trastuzumab in the summit trial the.
The purpose of the FDA meeting in 2019, which to discuss the potential the file for accelerated approval on the data from the summit trial on the patients treated with the combination of Niraparib plus of investment plus trastuzumab.
At that meeting the FDA suggested that Puma modified the summit trial in order to better isolate the contribution of the rapid to the efficacy seen in the summit trial for the patients treated with the combination of direct and the plus sylvestris plus trastuzumab.
And early 2020.
The summit trial was amended such that the ER positive <unk> negative breast cancer patients who have of her tumor mutation.
Randomized to receive either for industrials alone for the restaurant, plus trastuzumab or the combination of you're at and the possible investment plus trastuzumab the.
The purpose of this amendment was to isolate the contribution of <unk> to the efficacy that had previously been seen and the summit trial for the patients treated with the triplet of your at net plus of investors plus trastuzumab.
The randomized portion of the trial was designed as assignments 2 stage design each arm of the trial initially enroll 7 patients during stage 1 of <unk>.
No patient in a given arm responds that arm will be closed for further enrollment.
In the first stage, 1 or more patients respond. The arm will then be expanded up to 18 patients if less and for patients and expanded our response that are and will be closed to further enrollment.
For or more patients respond the arm will be open to enroll additional patients.
As was discussed on the first quarter earnings conference call. During the first quarter of 2021 enrollment of the initial 7 patients and the each of the 3 randomized arms was completed.
For the first 7 patients who were treated and the <unk> alone arm of the trial no patients achieved a response.
And the 7 patients who were treated in the for investments plus Trastuzumab arm of the trial no patients achieved a response.
And enrollment to the for restaurants alone and the for investment plus Trastuzumab arms of the trial have been paused.
<unk> is and the process of convening the studies independent data monitoring committee or <unk> to review the data from the single it and the doublet cohorts with the anticipation that they will recommend the closing both the singles and the doublet cohorts of this meeting is expected to occur and the next month or so.
And the first 7 patients who were treated and the Niraparib plus for investors plus Trastuzumab arm of the trial 1 of more response, 1 of our more responses were seen and therefore the criteria is met to expand the stage 2 of the Simon 2 stage design. This arm of the trial has been expanded the further enrollment.
Currently patients with ER positive <unk> negative breast cancer, who have of Hershey mutation are only being enrolled into this triplet arm of summit.
We anticipate that additional data on this will be presented in the fourth quarter of 2021.
Puma believes that the data from the randomized portion of the trial has address the fda's request to isolate the contribution of the rack nib for the efficacy seen in the summit trial and the patients treated with the combination of the Radnet, plus <unk> plus trastuzumab and <unk>.
OMA has therefore scheduled the meeting with the FDA and the fourth quarter of 2021.
And to finalize the pathway to file for accelerated approval for the combination of <unk> net plus for investors plus trastuzumab based on the data in patients with ER positive <unk> negative breast cancer, who have of her 2 mutations that have been treated and the summit trial.
At the FDA meeting in 2019, the FDA agreed that patients with the triplet was Ah patients treated with the triplet of Niraparib plus flow of Australia, plus Trastuzumab, who enrolled both prior to the amendment and 2021 as well as those enrolled after the amendment and 2021 would be <unk>.
Eligible for inclusion in the efficacy database used to support approval Puma.
<unk> will continue to update investors on the status of this as it progresses.
As investors are also aware.
In November we announced interim data from another cohort of the summit trial and more specifically the cohort of patients with metastatic non small cell lung cancer with epidermal growth factor or Egfr.
Exon 18 mutations who have been treated previously and egfr targeted tyrosine kinase inhibitor.
In late January of 2021, we presented additional data from this cohort of patients and and all discussion at the World Conference on lung cancer presented by the International Association for the study of lung cancer.
We are continuing to enroll of his cohort of patients and anticipate that we will have additional data from this cohort to report and the first half of 2022.
I will now turn the call over to Jeff Ludwig Puma, Chief Commercial officer for a review of our commercial performance during the quarter.
Thanks, Alan and appreciated and thanks to everyone for joining our second 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 improving the position of neuro links and early stage breast cancer with the goal of strengthening the risk benefit perception with clinicians and developing and rolling out of new campaign to better educate and empower patients to ashburn or links and ultimately drive of consistent increase in new patient starts in the Underpenetrated Mark.
Kit.
As mentioned in previous calls, we believe that <unk> can play an important role and the treatment of metastatic breast cancer, but our focus is on extended adjuvant with the goal of preventing or delaying patients from becoming metastatic. We take this go very seriously and know that more and must be done the help patients who are at increased risk of reoccurring and.
And the battle with early stage breast cancer.
I am pleased with the previous work that has been completed and largely came to fruition and a few months ago. We look forward to seeing the impact of this work coupled with our ongoing and future efforts. The goal remains the same day.
And more patients who are battling early stage breast cancer.
I do want to take a few minutes to talk about the previous clinical updates that have been published and communicated as well as highlight some recent clinical updates that we believe are important and can further strengthen the risk benefit perceptions of <unk> and early stage her 2 positive breast cancer.
First as a reminder of the previous clinical updates the interim results of the control study were published in the September 2020 edition of Annals of oncology.
And the final efficacy results from the X and that trial were published in the October 2020 edition of clinical breast cancer.
These data sets were also discussed and well represented at San Antonio Breast Conference Symposium and the Miami Breast Conference Conference Cancer Conference gives me, which were held in December 2020, and March 2021, respectively.
And regards to recent updates 2 posters were presented at the <unk> annual meeting recently held in June that we believe further support the clinical benefits of neural links and early stage her 2 positive breast cancer.
The first poster was entitled dose escalation for mitigating diarrhea.
And this was the ranked Tolerability assessment of anti Diarrheal regimens in patients receiving the retina and for early stage breast cancer.
And the conclusion of this poster suggested that dose escalation during the first 2 weeks of therapy improved tolerability versus other anti diarrheal strategies.
And the lowest rate of grade 3 diarrhea.
The improved overall compliance and ultimately highlighted the dose ESCO and escalation may allow patients to stay on Niraparib for the recommended time period, providing patients the opportunity to receive the full benefit of treatment.
The second poster was entitled Association between treatment duration, and the overall survival and early stage her 2 positive breast cancer patients receiving extended adjuvant therapy with niraparib and the extra and that trial the.
This poster assess clinical outcomes, including invasive disease free survival and overall survival for patients who completed planned therapy and 3 groups from the extra and the trial. The first group was the intent to treat population.
The second group, where patients with hormone receptor positive disease, who initiated and are at nib within 1 year. After private prior Trastuzumab. This is the population that <unk> is approved for largely within the EU.
And finally, HR positive patients, who initiated and rapid within 1 year. After prior Trastuzumab and had the residual disease post new adjuvant therapy.
These descriptive findings suggest that patients with early stage her 2 positive breast cancer, who received the recommended 1 year duration of Niraparib may have improved outcomes.
More specifically completion of planned are at and it was associated with improvements and idea of FES and overall survival in all 3 of the groups evaluated.
And finally, we are excited to announce that the U S food and drug administration approved of labeling supplement to the U S. Prescribing information for neuro links that incorporated dose escalation into both of our extended adjuvant indication as well as our metastatic indication.
In addition, the FDA approved the new $1.33 bottle count skew that provides a 4 week supply of neural links aligned with the approved dose escalation regiment.
I highlight these clinical updates because we feel that the collectively strengthened the risk benefit profile of <unk> and are important to both health care providers and to patients.
As Alan mentioned in his opening remarks, we continued to be impacted by the COVID-19 pandemic and the rising rates of the Delta variance with the big impact coming from decreased access to customers and an overall reduction and our share of voice.
As we previously communicated and based on increased and the increase and vaccinations in 2020..1 we have been optimistic about seeing a reduction and commercial limitations that of hampered our efforts.
We did see some loosening of restrictions and Q2 and and increased willingness by some clinicians to engage inside and outside the office.
More specifically, we saw Slater, a slightly greater than 20% increase and call activity with Hcp's and Q2 versus Q1.
And equally as important a much higher portion of these calls were in person versus virtual.
I am happy to see these changes, but they never happen as quickly as 1 would like while we are seeing access to hcp's improve it is hard to predict how the delta variant will change these dynamics and the most recent weeks we have seen some customers begin to restrict access again were pushed back their planned opening dates to industry based.
On the regional or local increases and the Delta variant.
And the commercial team continues to work very hard to adapt to these changes and remain focused on increasing our communications around our new clinical information.
As you May recall, we have 2 channels that provide <unk> links to patients we refer to these as our specialty pharmacy channel and our specialty distributor channel or in office dispensing channel.
The majority of our business flows through the specialty pharmacy channel.
More specifically in Q2, approximately 77% of our business went through this channel with the remaining 23% flowing through the specialty distributor channel.
This represents a slight change from the 76% SP and 24% SD business, we reported during our Q1 earnings call.
Now later in this call Maximo will review the full financial results, but I will now provide you with the current U S sales results as well.
Slide 4 shows US quarterly net sales of <unk> since FDA approval as Alan noted our net U S product sales were $48.9 million and the second quarter of 2021. This is an increase from the $45.8 million, we reported and Q1 of 2021.
We have continued to see an increase and the number of patients qualifying for free drug for a patient assistance program more.
More specifically, we have seen of greater than 40% increase in patients qualifying for free drug and comparing the first half of 2020.1 with the first half of 2020 that being January through June.
We believe this increase increase was largely driven by very limited availability of Medicare Foundation support.
Turning to slide 5 slide 5 shows the bottles of <unk> sold by quarter since launch.
We sold 3350 for bottles of <unk> and Q2 of 2021, which is an increase from our Q1, 2020.1 bottle of sales of $32.47.
We're excited to see this quarter over quarter growth, especially given the previously mentioned challenges with Covid and the increase and patients qualifying for free drug.
With that said the focus of the commercial organization is the grow neuro linked quarter over quarter with an emphasis on increasing share of voice and driving improved execution.
We obviously also believe that the evolving clinical profile of near links will play a foundational role and our success here.
We continue to be pleased with the increasing adoption of the dose escalation and early stage breast cancer. In Q2, we saw of at approximately 39% of all new patient starts initiated therapy at a lower dose. This.
And this is a slight increase over what we reported and Q1 of 2021.
And moving forward, we do expect to see this adoption increased driven by the FDA incorporating dose escalation into the dosing and administration section of our label as well as continued education and promotional emphasis we clearly believe and increasing adoption of dose escalation will improve the overall tolerability of near links increase.
The average length of therapy, and ultimately allow more patients to receive the full benefit of neural links.
Slide 7 highlights the strategic collaborations we have formed across the globe with the goal of making <unk> available to more patients around the world.
In terms of updates we were excited to see the Q2 commercial launches of <unk> in Chile, and Malaysia, and you have received the metastatic approval of neuro links and Canada in late June.
We are also anticipating commercial launches and Brunei and New Zealand and the second half of this year.
We are continuing to work very closely with our partners and look forward to the potential for near links to be approved in additional countries in Europe, Latin America Asia, and the Middle East.
In summary, I want to thank the commercial team for their passion and commitment to making a difference I am proud of the work that has been done by the team and believe that we are well positioned to increase the impact that we're having and patients battling her 2 positive breast cancer.
With that said, we know that more and must be done and we are committed to helping more patients and their families as they battle breast cancer.
I will now turn the call over to maximum for a review of our financial results.
Thanks, Jeff.
And we'll begin with a brief summary of our financial results for the second quarter of 2020.1.
Please note that I will make comparisons to Q1, 2021 and 2 for 2020, which.
Which we believe are better indications of our progress as a commercial company and the.
Year over year comparisons.
For more information and recommend that you refer to our 10-Q, which will be filed today and includes our consolidated financial statements.
For the second quarter of 2021 we reported a net loss based on GAAP.
$5.1 million.
The 13 cents per share.
Q1, 2 and 21, we reported net income of $16.5 million and.
And then Q4, 2020, our GAAP net loss was $15 million.
And the non-GAAP basis, which is adjusted to remove the impact of the stock based compensation, we reported net income of $13.1 million.
And I'll tell you 2 cents per diluted share for the second quarter of 2021.
Gross revenue from the Airlink sales was $59.3 million and Q2, 2020.1.
Versus $56.5 million and Q1.2021.
Alan mentioned net net revenue from <unk> sales was $48.9 million.
And the increase of 6.6%.
On the $45.8 million, we reported and the first quarter of 2021.
And Q1, 2020, 1 we also recognized $50 million and license revenue related to an upfront fee to include greater China and other.
The sublicense agreement with Pier Park.
And we don't see revenue increased to $4.3 million and the second quarter of 2021 versus $2.4 million and Q1 'twenty 'twenty 1.
Our gross to net adjustment and Q2.2021 was about 17, 7% of.
The decrease from the $18.9 per.
<unk> gross and net adjustment and Q1 'twenty 'twenty 1.
The decrease was driven mostly by lower co pay and covers GAAP and expenses largely driven by seasonality.
Cost of sales for Q2, 2021 was $12 million income.
And $2 million for them.
Amortization of intangible assets related to our and they are often of license.
Of course sales for Q1 played for anyone was $29.6 million and.
And included the 20 million feet.
They too can bridge the time.
Our sub license agreement.
Going forward, we will continue to recognize amortization of mast most of the license store for about $2 million.
Third quarter of cost of sales.
For fiscal year 'twenty 'twenty 1.
Houma anticipates of Nellix net sales will be and the range of $200 million to $205 million.
Which is the slightly lower and our prior guidance of $208 million to $213 million.
The reduction of the guidance reflects our expectation for us and lower than anticipated improvement and access to HCP.
We also anticipate that our gross to net adjustment and 2021 will be between 19% and 20% and.
The increase versus prior guidance most of the driven by higher government pricing participation and Medicaid rebates.
Furthermore, the <unk>.
Fiscal year 2021.
We anticipate receiving royalties from our partners around the world and the range of $13 million to $15 million.
Equal to 1 of the prior guide.
And license revenue and the range of $50 million to $52 million.
We recognize that there is a great deal of uncertainty regarding the impact of COVID-19, and this is.
And may continue to negatively impact our sales and royalties and license revenue.
We anticipate the Q3.2021, not only for net sales will be in the range of $49 million to $50 million and.
Royalty revenues will be in the range of $3 million to $4 million.
We anticipate for the gross to net adjustment in Q3, 2021 will be approximately 19, 5% to 25%.
SG&A expenses were $39.4 million and the second quarter of 2021.
Compared to $28.2 million and $28.8 million for Q1, 2021 and Q4.2020, respectively.
SG&A expenses included non cash charges for stock based compensation of $16.7 million for the second quarter of 2020.1.
Compared to $3.6 million for.
Q1, 2021, and $4.3 million for Q4.2020.
Stock based compensation expense and Q2.2021 included approximately $13.6 million.
Resulting from a modification approval by stockholders to the.
And of an employee of warrant.
Research and development of expenses were $18.6 million in the second quarter of 2021.
Compared to $20.2 million and $24.2 million for Q1, 2021 and Q4.2020, respectively.
R&D expenses included noncash charges for the stock based compensation of $3.8 million and the second quarter compared to $2.3 million and $5.2 million for Q1, 2021 and Q4, 2020 respectively.
Other income and expense reflects a net credit for our legal accruals of $14.9 million.
And the second quarter of 2021.
And my reported cash burn of zero point and $1 million.
Compared to cash burn and Q1, 2021 of $15.7 million.
Which included the 50 million of license fee from Pierre Fabre under 20 million of termination fee paid to coverage.
And cash burn of $15.6 million and Q4, 2020.
Which includes a $10.1 million milestone payment to Pfizer.
We ended the second quarter of 2021 with $109 million of cash cash equivalents and marketable securities.
Our accounts receivables balance at June $30 million to $35 million.
Our accounts receivable terms range between 10 and 68 days.
And our day sales Outstandings are about 48 days.
We estimate that as of June 32021, our distribution, therefore maintain approximately 4 weeks of inventory.
Subsequent to the close of the second quarter.
And through it into $125 million note purchase agreement with <unk>.
The fund managed by operating and capital management.
Who may use the first tranche of the notes of 100 million of some cash on hand.
The retired its existing credit facility with Oxford finance.
And remind and $25 million might be drawn for future corporate purposes.
This transaction provides puma with increased cash flexibility.
And Bruce short term cash flow and.
Allow us to continue to support <unk> commercial activities and.
And our ongoing clinical trials with not enough.
Overall, we continue to deploy and our financial resources to focus on the other on the <unk>.
Of note the nib.
Through ongoing clinical trials and the commercialization of Nellix.
Okay.
Thanks Maximo.
While the COVID-19 pandemic has presented commercial challenges the per month, we are hopeful that the vaccinations that had been occurring in 2021 and will continue to occur throughout the year, we will reduce the barriers, which should improve the ability of our commercial team to access and interact with health care providers to increase their awareness of the <unk>.
<unk> data.
As we mentioned previously in Q2, we did see improvements and our access to Hep's. However, the permit is incurring.
This improvement is occurring at a slower rate than we originally anticipated. We also recognize the more recent risks posed by the COVID-19, Delta variance, which may pose additional restrictions to access to hep's.
And we are remaining conservative and our outlook for improvements and access for the remainder of the year for.
And the senior management and cooperation with the board of Directors continues to remain focused on <unk> revenue and sales growth and 2021 and beyond we look forward to updating investors on this in the future the.
And that continues to remain a significant unmet need for.
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 questions and answers.
Yes.
We will now begin the question and answer session.
So ask the question. Please press star 1 on your telephone keypad account for.
And time will indicate that your line is and the question queue.
Thank you for the value of the Quest. Please press star 2.
For participants using speaker equipment and may be necessary to pick up your handset before pressing and the Jackie.
1.9 and 3 while we poll for question.
Your first question comes from the agile and audio message with Citi. Please go ahead.
Hi, This is Charlie on for Yigal, Thanks for taking our question.
First can you comment on and sort of what youre seeing with respect to utilization of the dose titration regimen following the.
And the label update last month, I guess, just given given the data you presented from control of interesting that still only about 39% of patients are starting out of Ricky. So curious why you think some physicians have been slower to adopt the dose titration strategy versus the others.
And the physician will say I wrote the prescription for the dose escalation the pharmacy didn't put it out and the bottle because it's not and the label So as Jeff mentioned and look at it got proved the late June. So I don't think we would have seen and impact and Q2.
But we will certainly be looking for that Q3, Q for et cetera, and are and so.
It's the patient as we would like to see that increase.
Okay great.
And then just 1 quick.
Quick clarify and question on the the ER positive or negative breast cancer of cohort first on it when you reported data and the fourth quarter of this year and will that also include data from stage stage 2 portion of and the additional patients who are enrolling and and to the right and a bomb or will that just the the stage 1.
Yeah.
Yeah, so the presentation and 5.
Moreover, and this correctly the abstract that has been submitted for San Antonio for.
For so let me answer that and the more larger way here.
The abstracts admitted for San Antonio It was for the breast cancer cohort of summit.
So these are patients with the hurricane meditation, there's the ear positive patients and there's also a triple negative patients. So there's a separate cohort of triple negative patients who are for.
Triple negative breast cancer treated with the at the bottom of therapy and the ear positive which is your question, which is the ER causes of the her 2 mutation.
We would probably be the stage, 1 and the stage choose as well.
We have noticed that when we first went to enroll of the trial. We had a lot of sites, who were reticence to put patients on either of the trastuzumab plus for investment or for western alone arms, because they were uncertain of there'll be of benefit, but they were eager to put it on the triplet dinner at and and plus strategies and Ah.
Possible vests and arm because they knew that had benefits.
Yeah, so on the quarter over quarter basis, we have seen a decline on the on the across the net impact and I, just mentioned and Q1 and usually is higher however.
And the decline was not as big for Us.
Prior year's and again some of the dynamic is what I mentioned and as we have seen an increase on Medicaid and also.
The government pricing.
Yes.
And also mark opposite of and we're also seeing that where.
Because of the Medicare foundations and don't have support for kind of getting an increase and in free drug due to that.
Okay and thank you.
Yes.
Your next question comes from Geoff Meacham with Bank of America.
Please proceed with your question.
Hi, Alex Hammond on for Geoff Meacham. Thank you for taking my question. So for the summit basket trial for the Egfr exon 18 mutant.
Non small cell lung cancer indication how many patients are currently undergoing treatment and what data should we expect to be released and the first half of 'twenty, 2 and lastly, where do you see near line fitting into the current treatment paradigm.
Okay.
Alex Thanks for the question.
Sure.
I'm searching for that information and answers my.
Collection is.
We're somewhere around 20 or 25 patients that we've treated so far.
Ballpark I think that number is correct.
We have definitely been seeing and increase more recently.
And we would be looking to report.
The typical metrics 1 of the T response rate PFS et cetera.
From a commercial perspective that we're really focusing on is the 1 that is the once you've already received prior treatment and egfr tyrosine kinase inhibitor because the.
The exon 18, Egfr mutation is sensitive to the first and second generation Egfr.
Egfr inhibitors. So this is you know.
And a lot of it.
And Martin have been affected the.
Only drugs that actually has the exon 18 mutations in the label and the fat Nib.
And in terms of patients who've already been treated with and Egfr tyrosine kinase inhibitor.
And <unk>.
Efficacy of the fat and there was quite low and I believe the response rate of somewhere around 10%. So that's pretty easy bar for us to be able to get over given where we feel data is and I think that's really where we would see it fitting in.
Great. Thank you so much.
Your next question comes from Gena Wang of Barclays. Please proceed with your question.
Oh, Hi, this is sheldon on for Gena, Thanks for taking all of our questions.
So for older and my congrats on the encouraging initial data from the <unk>.
Breast cancer cohorts on the summit.
So I want to Oh the.
And regulatory progress for non small cell lung cancer cohort and also the cervical cancer. It seems like that it was removed from the plan could you confirm that if thats due in the.
Potentially the agenda to discuss with the FDA in the pre NDA meeting and for non small cell lung cancer all of it seems like.
The bow.
The data presentation and the FDA meeting was somewhat.
Pushed to 'twenty 'twenty 2 is that because of the tough any COVID-19 impact on York.
Clinical trial progress or do you think you need more mature data to meet with FDA.
Yeah.
Yes. Thank you for the question.
The first and the press release that we put out.
We did mentioned both the cervical data.
And the exon 18 lung data so both are still enrolling.
The presentation of the cervical data is because thats when the suo meeting is with you and the first half of 'twenty, 2 so I presume that would be where we'd be submitting the data too.
For the exon 18 mutated lung.
We did.
Certainly see interruptions due to COVID-19 in 2020, but we have definitely been seeing and much more rapid.
Enrolment in 2021.
So I think of lot of it was just getting more mature data and because we were getting so many new patients coming in debt.
And that our feeling was just that was the time to wait because of.
Our feeling of all of the more patients we had the more fruitful discussion you can have with FDA. So that was kind of the the basis and the same the same with the surgical as well.
Thank you so much.
Okay.
Your next question comes from Keenan Mckay with RBC capital markets.
Please proceed with your cash.
Hi, good afternoon, and its chunkier for kind of central of the question could.
Could you maybe elaborate a bit on the drivers of the return to bottle of girls and in the second quarter.
Okay and share of primarily a result of the.
The easing of the COVID-19, pandemic and hence the inquiries of the Opex thinkers.
For you.
Okay. Great. Thanks. Thanks for the question I appreciate it I would say a couple of things that contribute to that growth.
And the combination of those 2 just made for a more effective sales if you will.
And that would be the driver we would hope to.
To continue and the future quarters.
Got it and cricket.
Your next question comes and Paul trying to calm and Fries. Please proceed with your question.
Hi, good afternoon, and thank you for taking our questions Uhm. My first question is just with regard to utilization trends right now and could you maybe just sort of comment on what you're seeing for the field with regard to the next between the extended adjuvant and the early early metastatic youth and just you know with regard to the ladder and and promoted.
[noise] metastatic use can interest is that and were largely of function and your mind and the second half of this this year of and Chris health care access or or.
Potential prescribed and was looking for additional information or other clarity on the and the indication.
Yeah, So Paul the Alan and you said use of an extended adjuvant versus early metastatic just to be clear or approval of and the metastatic is and the third line and the answer to much later line of of metastatic treatments Uhm I.
In terms of of the utilization, we have seen and prior quarters and continue to see that roughly 95% of use of the drugs and the early stage and about 5 per cent and the metastatic we do not get a breakdown and metastatic whether it's third line here too positive whether it's patience with her to the mutations whether it's patients with her 2 plastic brain Matt.
Because remember 1 and the second and guidelines so it's difficult to say exactly where exactly and that that's being treated we.
We just know that it's and the metastatic setting.
Okay, Great and just the the second part of my question with regard to driving of awareness and for.
The motion here and is that largely the function of increased access or just just awareness of of the of.
NERLYNX as an option and the third line plus setting here.
So for the metastatic side, yes, the big function of this will be the continued promotion and communication of the data and the medicine and exciting and that is largely a function of of access and access the hcp's as well as you can guess, we're looking for and as many options as we can to enhance the <unk>.
And personal promotion as well given some of the restrictions with Covid and the potential Delta variant rise.
Okay great.
Then my my My second question is just with regard to your your the the new bottle of about that are available and the new S. K U.
I guess over time, you know how do you see that driving the mix and the with that and can you have any incremental revenue revenue flow through as you think about the number of bottles and going out the door ex factory.
Was differentiated from the other Egfr TK eyes and heard the positive breast cancer because of the fact that.
The route and it is and irreversible inhibitor and the other drugs. The other approved hurts you positive breast TK eyes are reversible and neighbors.
The main difference between those is neratinib being and irreversible inhibitor has the ability to internalize. The her 2 receptor where's the ones that are reversible inhibitors do not.
So by increasing the internalization of of the her 2 receptor you're essentially taking the receptor and bringing it inside of the cell.
Well when you have and ADC and that's the mechanism of action right of the taxes to the outside of the cell and get the internalized and that's when the dark clouds payload, which is sometimes on the side of the topic. So when you combine neratinib with and ADC you end up increasing of the Intratumoral concentration of the Adc's, you're bringing more of the ADC into the cell.
Now we had the F. B 10 study, which was neratinib with the Cat Tyler.
And this was run by the NSA AVP.
And patients without great maps, and we'd certainly see and a much higher response rate and 1 would have expected.
Which is what made us interested in looking at the rat and they've been patient with cats, Alan patients with brain minutes. So the cohort of patients that has been enrolling the strongest in that trial.
And the cohort, which is patients who've already had prior cat silo.
And they're being given neratinib with cats, I love and patients with her 2 positive breast cancer with brain and that's so this will obviously be of very interesting test of this internalization because obviously if neratinib can increase the interest and world concentration of kept silent and patients with brain and that's.
We've already seen cats, I love that could certainly be of a pretty strong therapeutic advantage to the patients.
So I don't think we can comment on the regulatory discussions until we get the data, but I will remind you of that Neratinib is and the NCC and guidelines for brain nuts. So assuming the data is positive we could certainly update the guidelines to include that data.
Which would increase awareness of it among physicians, who would be interested and prescribing it.
Thank you very much.
It can create that question and answer the question I would like the time of contact maryanne for closing remark.
Thank you for your interest income of Biotechnology and the reminder of this call and maybe accident a replay of the webcast akuma biotechnology dot com and gaining later today have a good evening.
Ladies and gentlemen, thank you for the kids painting and type content calm.
It concludes our program everyone have a great day and you may disconnect [music].