Puma Biotechnology, Inc. (PBYI) Q1 2024 Earnings Name Transcript

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q1 2024 Earnings Convention Name Might 2, 2024 4:30 PM ET

Firm Members

Mariann Ohanesian – Senior Director-Investor Relations
Alan Auerbach – Chief Govt Officer, President and Chairman of the Board
Jeff Ludwig – Chief Business Officer
Maximo Nougues – Chief Monetary Officer

Convention Name Members

Ed White – H.C. Wainwright
Divya Rao – TD Cowen

Operator

Good afternoon. My title is Camilla, and I might be your convention name operator in the present day. At the moment all members are in a listen-only mode. After the audio system’ formal remarks, there might be a question-and-answer session. [Operator Instructions] As a reminder, this convention name is being recorded.

I’d now like to show the convention name over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You might start your convention.

Mariann Ohanesian

Thanks, Camilla. Good afternoon, and welcome to Puma’s convention name to debate our Monetary Outcomes for the First Quarter of 2024. Becoming a member of me on the decision in the present day are Alan Auerbach, Chief Govt Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Monetary Officer; and Jeff Ludwig, Chief Business Officer.

After market closed in the present day, Puma issued a information launch detailing first quarter 2024 monetary outcomes. That information launch, the slides that Jeff will discuss with and a webcast of this name are accessible through the homepage and Buyers sections of our web site at pumabiotechnology.com. The webcast and presentation slides might be archived on our web site and obtainable for replay for the subsequent 90 days.

Right this moment’s convention name will embrace statements about Puma’s future expectations, plans and prospects that represent forward-looking statements for functions of federal securities legal guidelines. Such statements are topic to dangers and uncertainties, and precise occasions and outcomes might differ from these expressed in these forward-looking statements. For a full dialogue of those dangers and uncertainties, please evaluation our periodic and present reviews filed with the SEC every now and then, together with our annual report on Type 10-Ok for the 12 months ended December 31, 2023.

You’re cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date of this stay convention name, Might 2, 2024. Puma undertakes no obligation to revise or replace any forward-looking statements to mirror occasions or circumstances after the date of this convention name, besides as required by legislation. Throughout in the present day’s name, we might discuss with sure non-GAAP monetary measures that contain changes to our GAAP figures. We consider these non-GAAP metrics could also be helpful to traders as a complement to, however not an alternative choice to our GAAP monetary measures. Please discuss with our first quarter 2024 information launch for a reconciliation of our GAAP to non-GAAP outcomes.

I’ll now flip the decision over to Alan.

Alan Auerbach

Thanks, Mariann, and thanks all for becoming a member of our name in the present day. Right this moment, Puma reported whole income for the primary quarter of 2024 of $43.8 million. Complete income contains product income web, which consists totally of NERLYNX gross sales in addition to royalties from our sublicensees. Product income web was $40.3 million within the first quarter of 2024, which was a lower from the $53.2 million reported in This autumn 2023 and beneath the $46.8 million reported in Q1 of 2023. Product income for the primary quarter of 2024 was impacted by roughly $2 million of stock drawdown at our specialty pharmacies and specialty distributors. Royalty income was $3.5 million within the first quarter of 2024 in comparison with $19 million in This autumn of 2023 and $6 million in Q1 of 2023.

We reported 2,410 bottles of NERLYNX offered within the first quarter of 2024, a lower of 471 bottles from the two,881 bottles offered in This autumn 2023. In Q1 2024, we estimate that stock decreased by about 120 bottles. In Q1 2024, new prescriptions had been up roughly 27% in comparison with This autumn 2023 and whole prescriptions had been down roughly 3% in comparison with This autumn 2023. Jeff will present additional particulars in his feedback and slides. NERLYNX gross sales had been negatively impacted by the decline in enrollments that we talked about beforehand in our third and fourth quarter earnings calls. Jeff will talk about this additional in his feedback. We’ve continued to cut back our inner bills to account for these elements as we acknowledge our fiscal duty to shareholders to proceed to be web revenue constructive for 2024.

I’ll now present a scientific evaluation of the quarter then Jeff Ludwig will handle colour on NERLYNX business actions. Maximo Nougues will observe with highlights on the important thing parts of our monetary statements for the primary quarter 2024. In February, we had been happy to announce that we initiated the alisertib in Most cancers, or ALISCA-Lung1 trial, a Section 2 scientific trial of alisertib monotherapy for the therapy of sufferers with in depth stage small cell lung most cancers. This trial was beforehand known as Research PUMA-ALI-4201. The trial will enroll as much as 60 sufferers with in depth stage small cell lung most cancers who’ve progressed after first-line platinum-based chemotherapy and immunotherapy. Sufferers should present tissue-based biopsies in order that biomarkers might be analyzed. Alisertib might be dosed at 50 milligrams BID on days one by way of seven of each 21-day cycle.

Puma plans to carry out an interim evaluation for the analysis of the biomarkers in addition to an analysis of efficacy. As we mentioned on our final earnings name, the objective of this Section 2 examine might be to substantiate the efficacy of alisertib monotherapy in sufferers with small cell lung most cancers with biomarkers the place the aurora kinase pathway performs a job. The objective can be to correlate the efficacy in these biomarker subgroups within the ALISCA-Lung1 examine to the efficacy that was beforehand seen within the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was printed within the Journal of Thoracic Oncology in 2020. If the efficacy and biomarker knowledge are comparable from the 2 research, the corporate believes IT would symbolize a possible accelerated approval technique and would interact FDA to debate this additional.

We at the moment have roughly 16 websites open for enrollment, and we count on to have a complete of roughly 25 websites contributing to enrollment within the examine. We anticipate that we will share interim knowledge from this trial with traders within the second half of 2024. We additionally anticipate the initiation of ALISCA-Breast1, a Section 2 trial of alisertib together with endocrine therapy in sufferers with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast most cancers in This autumn 2024.

We moreover anticipate two scientific knowledge displays on alisertib on the 2024 ASCO Annual Assembly in early June. Buyers will do not forget that the Section 2 trial known as TBCRC 41, which was a Section 2 trial of alisertib monotherapy versus the alisertib plus endocrine remedy in sufferers with HER2-negative hormone receptor constructive metastatic breast most cancers was printed in JAMA Oncology in 2023. As a part of this trial, an evaluation of biomarkers was carried out to be able to decide if the efficacy of alisertib in sufferers with HER2-negative, hormone receptor-positive metastatic breast most cancers correlates with any biomarkers. The biomarker knowledge from this trial might be introduced in a poster presentation on the 2024 ASCO Annual Assembly.

As well as, there’s an ongoing investigator-sponsored trial of alisertib given together with osimertinib in sufferers with metastatic EGFR-mutant non-small cell lung most cancers. Extra particularly, sufferers who’ve metastatic EGFR-mutant non-small cell lung most cancers are handled with osimertinib and on the time of development, alisertib was added to osimertinib to be able to see if alisertib can overcome osimertinib resistance. Interim knowledge on this trial was beforehand introduced at ASCO previous to Puma licensing the drug. Up to date knowledge on this trial may even be introduced as a poster presentation on the 2024 ASCO Annual Assembly.

As we talked about on our final earnings name, a latest biomarker evaluation from this trial has demonstrated a subgroup of sufferers with a biomarker the place the aurora kinase pathway performs a job, the place alisertib seems to have a lot larger efficacy when added to osimertinib on the time of development on osimertinib. This biomarker happens in about half of the sufferers within the trial, which is in line with the printed literature on this biomarker on this affected person inhabitants. Based mostly on this biomarker knowledge, the trial has been amended to restrict enrollment within the trial to solely proceed enrolling sufferers who’ve this biomarker.

We consider that this may symbolize one other potential indication for alisertib, and we sit up for discussing this knowledge with traders as soon as IT has been introduced publicly. Of be aware, the biomarker knowledge is just not contained within the ASCO summary, however might be introduced within the ASCO poster. As talked about on prior earnings calls and in response to investor questions, Puma continues to guage a number of medication to probably in-license that may permit the corporate to diversify itself and leverage Puma’s current R&D, regulatory and business infrastructure. The corporate will preserve traders up to date on this as IT progresses.

I’ll now flip the decision over to Jeff Ludwig, Puma’s Chief Business Officer, for a evaluation of our business efficiency throughout the quarter.

Jeff Ludwig

Thanks, Alan. Admire IT, and due to everybody for becoming a member of our first quarter earnings name. Earlier than I transfer into the business evaluation, only a reminder that I might be making forward-looking statements. The business crew stays largely targeted on the prolonged adjuvant indication the place nearly all of NERLYNX gross sales and alternative exist. A good portion of early-stage HER2-positive breast most cancers sufferers are handled in a neighborhood setting so the gross sales and advertising and marketing groups are targeted on growing attain and frequency to focused prospects with each private and non-personal promotion. HCP calls within the first quarter elevated about 5% quarter-over-quarter with larger than 80% being stay interactions.

We proceed to guage new knowledge and companions to attempt to make our focusing on and total timing of calls extra environment friendly and efficient. We’re on the lookout for alternatives to extend the notice and training across the unmet want that exists within the early-stage breast most cancers setting and are attempting to align with key prospects to higher establish sufferers at greater danger of reoccurrence. The business crew is dedicated to turning into extra environment friendly and efficient with our sources and balancing the wants of NERLYNX with the broader targets of the group.

Let me now transition to a few of the business slides the place I’ll present some extra specifics round efficiency. As soon as I’ve completed, I’ll flip the decision over to Maximo for a extra detailed evaluation of our monetary outcomes. Slide 3 supplies an summary of our distribution mannequin. Now this mannequin has not modified and stays separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel. We do sometimes see quarterly fluctuations, however the majority of our enterprise flows by way of the specialty pharmacy channel. In Q1, about 74% of our enterprise went by way of the specialty pharmacy channel and the remaining 26% went by way of the specialty distributor channel. That is primarily unchanged from what we reported throughout our This autumn earnings name.

Turning to Slide 4. NERLYNX web income in Q1 of 2024 was $40.3 million, which is a $12.9 million lower from the $53.2 million we reported in This autumn 2023 and a $6.5 million lower from the $46.8 million we reported in Q1 of 2023. Stock adjustments will affect these comparisons, so let me present some extra Information. In Q1 of 2024, we estimate that stock decreased by about $2 million. As a comparability, we estimate that stock elevated by about $2.1 million in This autumn 2023 and decreased by about $3.8 million in Q1 of 2023.

Slide 5 reveals Q1 of 2024 ex-factory bottle gross sales and likewise supplies each a year-over-year and a quarter-over-quarter comparability. In Q1 of 2024, NERLYNX ex-factory bottle gross sales had been 2,410 which represents a 16% quarter-over-quarter decline and a 15% year-over-year decline. Let me once more present extra specifics round stock adjustments. We estimate that stock decreased by about 120 bottles within the first quarter of 2024. As a comparability, we estimate that stock elevated by about 127 bottles in This autumn of 2023 and decreased by about 236 bottles in Q1 of 2023.

Now let me share some extra metrics and insights into our first quarter efficiency. In Q1, we noticed web – we noticed, excuse me, new affected person begins, or NRx, improve about 27% quarter-over-quarter and declined about 15% year-over-year. When it comes to whole prescriptions, or TRx, we noticed a 3% decline quarter-over-quarter and a 16% decline year-over-year. Total demand decreased within the first quarter by about 8% quarter-over-quarter and about 18% year-over-year. As Alan talked about, Q1 efficiency was negatively impacted by the decline in enrollments we mentioned in our This autumn and Q3 earnings name final 12 months. Enrollments proceed to be an essential main indicator as enrollments flip into new affected person begins and new affected person begins flip into refills, which drive demand in subsequent quarters.

As beforehand mentioned, we noticed an elevated softness in enrollments within the second half of 2023 pushed largely by a decline that occurred within the first a part of Q3. Since that point, we’ve seen an enchancment in enrollments however not sufficient but to offset the affect of bottles we’re at the moment seeing. In Q1, enrollments did improve about 5% quarter-over-quarter, however had been down about 12% year-over-year. The crew is solely targeted on driving each quarter-over-quarter and year-over-year progress.

Turning to Slide 6. Slide 6 highlights the adoption of dose escalation since launch. We proceed to consider that dose escalation is an important metric for NERLYNX. Sufferers that begin at a lowered dose will expertise considerably decrease grade 3 diarrhea and are more likely to have a decrease price of discontinuation. In Q1, roughly 67% of sufferers who obtained business drug began NERLYNX at a lowered dose. That is decrease than the 76% that we reported in This autumn 2023 however is greater than what we reported in Q1 of 2023 one 12 months in the past. The suggestions from prospects continues to be constructive and the advantages of dose escalation stay a key business message.

Transferring to Slide 7. Slide 7 highlights the strategic collaborations we’ve fashioned throughout the globe. In Q1, NERLYNX obtained regulatory approval in Syria within the prolonged adjuvant setting and was formally launched in Morocco, additionally within the prolonged adjuvant setting. We actually recognize all of the efforts put forth by our companions, and we proceed to search for alternatives to make NERLYNX obtainable to extra sufferers world wide. I’d wish to wrap up by thanking my Puma colleagues for his or her help and dedication. The crew is obsessed with making a distinction within the lives of sufferers and their households battling most cancers. We’re dedicated to being extra environment friendly and efficient with our sources and likewise dedicated to balancing the short-term and long-term priorities of Puma and its shareholders.

I’ll now flip the decision over to Maximo for a evaluation of our monetary outcomes. Maximo?

Maximo Nougues

Thanks, Jeff. I’ll start with a short abstract of our monetary outcomes for the primary quarter of 2024. Please be aware that I’ll make comparisons to This autumn 2023, which we consider is a greater indication of our progress as a business firm than year-over-year comparisons. For extra Information, I like to recommend that you just discuss with our Q1 10-Q, which might be filed in the present day and contains our consolidated monetary statements. For the primary quarter of 2024, we reported a web loss based mostly on GAAP of $4.8 million, or $0.10 per share. This compares to web revenue in This autumn 2023 of $12.3 million, or $0.26 per share. On a non-GAAP foundation, which is adjusted to take away the affect of stock-based compensation expense, we reported a web lack of $2.4 million, or $0.05 per share, for the primary quarter of 2024.

Gross income from NERLYNX gross sales was $52.6 million in Q1 2024 and $64.9 million in This autumn 2023. As Alan talked about, web product income from NERLYNX gross sales was $40.3 million, a decline from $53.2 million reported in This autumn 2023. Q1 web gross sales had been impacted by decrease enrollments in Q3 and This autumn in addition to greater gross to web adjustment in Q1. Stock drawdown by our distributors was roughly $2 million in Q1 versus roughly $2.1 million of buildup in This autumn 2023. Royalty income totaled $3.5 million within the first quarter of 2024 in comparison with $19 million in This autumn 2023. As anticipated, the decrease royalties versus This autumn mirrored timing of shipments to our companion in China, as we famous final quarter.

Our gross to web adjustment in Q1 2024 was about 23.4% in comparison with the 18.1% in gross to web adjustment reported in This autumn 2023. Greater authorities chargebacks and better copay had been the principle drivers of the rise versus This autumn 2023. Price of gross sales for Q1 2024 was $10.7 million, together with $2.4 million for the amortization of intangible belongings associated to our neratinib license. Price of gross sales for This autumn 2023 was $24.3 million. Going ahead, we’ll proceed to acknowledge amortization of milestones to the licensor of about $2.4 million per quarter as value of gross sales.

For fiscal 12 months 2024, Puma anticipates the web NERLYNX product income might be within the vary of $183 million to $190 million. We additionally anticipate that our gross to web adjustment for the total 12 months 2024 might be between 21.5% and 22.5%, greater than 2023 because of the affect of the Inflation Discount Act on greater anticipated Medicaid rebates.

As well as, for the fiscal 12 months 2024, we anticipate receiving royalties from our companions world wide within the vary of $30 million to $33 million. We count on license income in 2024 within the vary of $1 million to $2 million. We additionally count on that web revenue for the total 12 months might be within the vary of $12 million to $15 million.

We anticipate that for Q2 2024, NERLYNX web product income might be within the vary of $43 million to $45 million. Additionally, we count on Q2 royalty revenues might be within the vary of $2.5 million to $3 million, and we anticipate no license income.

We additional estimate that the gross to web adjustment in Q2 2024 might be roughly 22% to 23%. Puma anticipates a Q2 web lack of between $6 million and $9 million. Attributable to our litigation bills and a onetime alisertib expense, we count on greater bills in Q2 and every other quarters in 2024. Attributable to these things, we’re forecasting a web loss in Q2 however we anticipate that Puma might be web income-positive for the rest of 2024 in addition to for the total 12 months.

SG&A bills had been $21.8 million within the first quarter of 2024 in comparison with $20.2 million for the fourth quarter of 2023. SG&A bills included noncash expenses for stock-based compensation of $1.5 million for Q1 2024, down from $1.8 million in This autumn 2023.

Analysis and growth bills had been $13.6 million within the first quarter of 2024 in comparison with $12.9 million within the fourth quarter of 2023. R&D bills included noncash expenses for stock-based compensation of $0.8 million within the first quarter of 2024, unchanged from the fourth quarter of 2023.

On the expense aspect, Puma anticipates flat to whole working bills in 2024 in comparison with 2023. Extra particularly, we anticipate SG&A bills to lower by 8% to 12% and R&D bills to extend 17% to twenty% year-over-year. Attributable to our litigation bills, we count on G&A bills in Q2 to be considerably greater than in future quarters.

Within the first quarter of 2024, Puma reported money earned of roughly $11.2 million. This compares to money earned of roughly $10.4 million in This autumn of 2023.

At March 31, 2024, we had roughly $107 million in money, money equivalents and marketable securities versus about $96 million at year-end 2023.

Our accounts receivable stability was $24.6 million. Our accounts receivable phrases vary between 10 and 68 days whereas our days gross sales outstandings are about 52 days. We estimate that as of March 31, 2024, our distribution community maintained roughly 4 weeks of stock.

Total, we proceed to deploy our monetary sources to deal with commercialization of NERLYNX, the event of alisertib and controlling our bills.

Alan Auerbach

Thanks, Maximo. Puma’s senior administration, in cooperation with the Board of Administrators, continues to stay targeted on NERLYNX gross sales traits in 2024 and past and acknowledges its fiscal duty to its shareholders to proceed to keep up constructive web revenue.

Within the fourth quarter of 2021, we applied a discount in bills with the objective of decreasing bills to be able to maximize operational money flows. We consider that the constructive web revenue that was seen in 2023 resulted from these expense reductions. The expense reductions that we’ve beforehand carried out and proceed to carry out are additionally a significant contributor to the constructive web revenue that the corporate is guiding to for the total 12 months 2024.

The corporate stays dedicated to persevering with to attain this constructive web revenue and we’ll proceed to cut back bills if wanted to attain this. We sit up for updating traders on this sooner or later.

There continues to stay a big unmet want for sufferers battling breast most cancers, lung most cancers and different stable tumors. We at Puma are dedicated and obsessed with discovering more practical methods at serving to these sufferers throughout their journey, and we’ll proceed to attempt to attain that objective.

This concludes in the present day’s presentation. We’ll now flip the ground again to the operator for Q&A. Operator?

Query-and-Reply Session

Operator

Thanks. We’ll now start the question-and-answer session [Operator Instructions] Your first query comes from the road of Ed White with H.C. Wainwright. Please proceed together with your query.

Ed White

Good afternoon. Thanks for taking my questions. So, only a query on gross sales, an enormous image technique query, truly. You’ve mentioned prior to now, Alan and Jeff, that gross sales are promotional-sensitive and your SG&A goes to be – bills are going to be down for the 12 months. I’m simply questioning how you might be turning into extra environment friendly and capable of goal – enhance your promotion of the drug whereas additionally slicing prices.

Jeff Ludwig

Hey Ed, sure, I recognize IT. We do consider this drug is promotionally delicate. And so we’re looking for efficiencies and effectiveness as we talked about. One of many ways in which we’re ready to try this is we’ve expanded nonpersonal promotion, which is a reasonably cost-effective method of making an attempt to generate our share of voice. We’re additionally, as I discussed in my opening, we’re evaluating a lot of companions as nicely to seek out cost-effective, aggressive methods of increasing our attain and frequency, each private and nonpersonal, whereas listening to our prices related to the targets of the group.

Alan Auerbach

Sure. And Ed, that is Alan. We did a latest evaluation taking a look at each the non-public and nonpersonal promotion facets of the enterprise and form of which levers contribute extra to gross sales, et cetera. And the nonpersonal promotion truly was fairly efficient by way of its affect on enrollments and issues like that. And as Jeff talked about, IT’s a lot less expensive as nicely. So I feel as we improve nonpersonal promotion, we’re growing share of voice and growing promotional sensitivity whereas additionally lowering prices.

Jeff Ludwig

And Ed, I’d add slightly bit extra colour. Even across the private promotion, which is entry is being monetized in lots of instances in the neighborhood, however we’ve actually labored onerous to return and consider these alternatives and attempt to make the proper choices that lend us to a a lot better ROI. So, we’re asking our discipline groups as leaders and house owners of the enterprise to make these trade-offs and decisions to permit our greenbacks to go a lot farther than they’ve prior to now. That’s an enormous a part of our effectivity.

Ed White

Nice, thanks. I simply needed to return to the decrease beginning dose since you frequently talked about that by having the decrease beginning dose, decrease negative effects, there might be a decrease price of discontinuation. Can you set any numbers round that so far as the size of time that sufferers are staying on drug or the variety of refills that you just’re capturing that you just wouldn’t – that you just weren’t capturing earlier than if you’re beginning at a better dose?

Jeff Ludwig

Ed, nice query. I feel there’s a few issues. One, I’d say, total, there was a a lot better understanding of this molecule from prospects now than prior to now. So you’ll be able to guess there’s two methods of going about IT. We consider beginning low and shifting up based mostly on a managed knowledge is the proper method to try this. And as we report, someplace round 70% plus or minus 5%, we see new affected person begins there.

As I take a look at persistence curves round any given month, we’ve a couple of 5% to 10% extra sufferers on drug if they begin with a decrease dose. Now we monitor these cohorts regularly, so there’s fluctuations, however we do see decrease discontinuations on any given month for those who began low and elevated as opposed to those who began excessive.

I’ll say that prospects – there are prospects that do begin excessive, and so they do merely scale back the dose as nicely, and you may obtain the tip the identical method. However our knowledge suggests the decrease dose does add to a greater persistence right here.

Alan Auerbach

And Ed, the opposite half I’d add to that is there are a variety of HCPs who really feel that they’re okay managing the negative effects of the drug once they begin at a excessive dose, in order that they don’t must do the low dose. So, I feel at this juncture if I’ve to take a look at the roughly 70% who begin a low dose versus the 30% who don’t, the 30% who don’t, they only have the sensation of I can handle IT, I don’t must.

Ed White

Okay. And my final query is simply on for the previous couple of quarters, you’ve talked about potential in-licensing and enterprise growth. Are you able to simply inform us what your benchmarks are, your hurdles are as you goal potential companions or potential medication to in-license?

Alan Auerbach

Sure, comfortable to try this, Ed. So look, we clearly have a business gross sales drive that targets particularly breast most cancers. And in order that’s form of the main focus, if you’ll. Clearly, something we will add to that, that focuses on that channel clearly makes essentially the most sense, each – from a – whether or not IT’s a scientific drug or one which’s a business asset.

We’re casting a large web from that perspective, clearly, including in a business asset if IT’s one thing that we will use our current gross sales drive to do to get the form of economies of scale if you’ll. Glad to take a look at issues like that. And clearly, IT might be EPS-accretive, which is what we might need IT to do. One thing that’s extra of an R&D molecule, once more, one thing targeted on the breast area, makes essentially the most sense. So IT’s issues that are typically focused on that.

Now clearly, in the neighborhood setting, you do are likely to see typically that they deal with breast and likewise lung. So clearly, lung most cancers belongings make sense from that perspective as nicely.

Ed White

Okay, thanks Alan for taking my questions.

Operator

Our subsequent query comes from the road of Divya Rao with TD Cowen. Please proceed together with your query.

Divya Rao

Good afternoon. That is Divya on for Mark. I simply had a fast query on the alisertib trials. Particularly on the metastatic breast most cancers trial, are you guys planning to discover a biomarker technique there for alisertib? Or are you planning on working the Section 2 first after which form of doing a submit hoc to determine [indiscernible] possibility ahead? Thanks.

Alan Auerbach

Sure, hello Divya, thanks for the query. We’re positively trying to make use of a biomarker technique. Once we in-licensed alisertib, one of many issues that we made very clear was that because of the aurora kinase pathway, we all know that there are particular biomarkers concerned like those that we’ve beforehand proven, corresponding to c-Myc and RB1, the place we all know that aurora kinase performs a job, and that’s the place within the small cell lung most cancers trial, we noticed the most effective efficacy of the drug. We’re positively trying to try this within the breast examine within the HR-positive, HER2-negative indication.

When it comes to the scientific trial, proper now, there’s a biomarker evaluation that’s ongoing. We’re nonetheless ready for these outcomes to finalize the place we will get some clues from that. Within the trial, what we might most likely do is attempt to enrich for these sorts of biomarkers. So once more, those I’d say can be something concerned within the aurora kinase pathway admittedly, IT’s a really broad pathway. There’s numerous potential ones corresponding to RB1, c-Myc, et cetera. So IT is probably going we might enrich for these biomarkers and go after a biomarker-focused indication.

Divya Rao

That’s useful. Thanks. After which one fast query on the stay interactions for NERLYNX, how would you, I assume – how shut do you assume these stay interactions are returning to the pre-COVID ranges?

After which form of a follow-up on the earlier query is {that a} focus for you guys by way of growing promotion primarily? Or are you extra targeted on the non-personal promotion?

Jeff Ludwig

Divya, I’d say a fantastic query. Each, so we wish to improve each private and non-personal, proper? Oncology itself is a comparatively restricted therapeutic space. And being a small firm, IT might be extra restrictive for us as nicely. So we wish to see a rise in each private and non-personal. So let me provide you with some extra colour there. You requested about stay versus digital we’re about 81%, 82% stay on this first quarter. We’ve been round that 80% to 85% stay versus digital.

I feel that blend goes to remain comparatively the identical. Previous to COVID, we had been a lot greater within the excessive 90s by way of stay interactions with very restricted digital. We’re a smaller firm. So our gross sales groups have giant territories. In order that’s a part of the efficiencies we like. Should you can have an efficient and environment friendly digital name, that’s one of many ways in which I do know Ed requested me earlier about being extra environment friendly with journey and spend. If we will have an efficient engagement, we’re good growing each the digital calls, and we’re additionally working very onerous to extend entry across the stay calls as nicely.

Alan Auerbach

Divya, that is Alan. When it comes to your query of pre-COVID, do not forget that pre-COVID, we actually didn’t have numerous the applied sciences we now have and implementation of these applied sciences for digital interactions. So issues like Zoom or Groups and issues like that, they only actually weren’t getting used a lot, which is why Jeff talked about, most of our pre- COVID interactions was 95%, 97% stay.

When it comes to which one is the main focus, as Jeff talked about in his script, HCP calls, stay calls within the first quarter elevated 5% quarter-over-quarter. We’re hoping for that quantity to proceed to extend. So by no means, form or kind, are we trying to lower our stay interactions or our private promotion simply taking a look at IT from an funding perspective, which one is more practical and extra environment friendly.

Jeff Ludwig

And the nonpersonal promotion actually permits us to solid a really broad web with the hope that IT pulls folks into a few of our stay interactions in a really cost-effective method.

Divya Rao

Obtained IT. Thanks a lot.

Operator

And our subsequent query comes from the road of Gena Wang with Barclays. Please proceed together with your query.

Unidentified Analyst

Hello. That is Tony on for Gena. Only one fast one on the info for the biomarkers. What ought to we count on or take into account to be a constructive sign? And the way would this type of be used to be able to for the decided choices in growth.

Alan Auerbach

Sure. Thanks for the query, Tony. You’ll keep in mind within the small-cell lung most cancers trial that was printed within the Journal of Thoracic Oncology, particularly within the biomarkers, which was the RB-1, loss operate mutation and the c-Myc amplified, IT was a randomized trial, so that you noticed a statistically important improve in PFS and OS and people biomarkers. That’s one thing I’d take into account to be constructive. One thing the place you’re seeing that IT differentiates from the remainder of the sufferers.

So I’d say on this one, they’re doing a way more huge biomarker evaluation. So I’d say something that form of rises up, if you’ll, by way of both ORR or PFS, exhibiting that you just’re getting higher exercise in sufferers the place there’s some biomarker that may counsel that aurora kinase is taking part in a job in driving that most cancers. That’s what we might look to see.

Unidentified Analyst

Obtained IT, thanks.

Alan Auerbach

Certain.

Operator

This concludes our question-and-answer session. And with that, I wish to flip the convention again to Mariann for closing remarks.

Mariann Ohanesian

Thanks all for becoming a member of us in the present day. As a reminder, this name could also be accessed through replay of the webcast at pumabiotechnology.com starting later in the present day. Have a superb night.

Operator

Girls and gents, thanks for taking part in in the present day’s convention name. This concludes our program. Everybody, have a fantastic day. You might now disconnect.