Puma Biotechnology, Inc. (NASDAQ:PBYI) This autumn 2022 Earnings Convention Name March 2, 2023 4:30 PM ET
Firm Individuals
Mariann Ohanesian – Senior Director of IR
Alan Auerbach – CEO, President and Chairman
Maximo Nougues – CFO
Jeff Ludwig – Chief Business Officer
Convention Name Individuals
Dave Rao – Cowen and Firm
Sahil Kazmi – B. Riley Securities
Operator
Good afternoon. My identify is Diego, and I shall be your convention name operator immediately. [Operator Instructions] As a reminder, this name is being recorded.
I might 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, Diego. Good afternoon and welcome to Puma’s convention name to debate our monetary outcomes for the fourth quarter and full yr 2022. Becoming a member of me on the decision immediately are Alan Auerbach, Chief Govt Officer, President and Chairman of the Board of Puma; Maximo Nougues, Chief Monetary Officer; and Jeff Ludwig, Chief Business Officer.
After market closed immediately, Puma issued a information launch detailing fourth quarter 2022 monetary outcomes. That information launch, the slides that Jeff will consult with and a webcast of this name are accessible through the homepage and Traders sections of our web site at pumabiotechnology.com. The webcast and presentation slides shall be archived on our web site and out there for replay for the subsequent 90 days.
Right now’s convention name will embrace statements concerning the firm’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 assessment our periodic and present reviews filed with the SEC sometimes, together with our annual report on Type 10-Ok for the yr ended December 31, 2022. You’re cautioned to not place undue reliance on these forward-looking statements, which converse solely as of the date of this reside convention name, March 2, 2023. The corporate undertakes no obligation to revise or replace any forward-looking statements to replicate occasions or circumstances after the date of this convention name, besides as required by legislation.
Throughout immediately’s name, we might also consult 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 to our GAAP monetary measures. Please consult with our fourth quarter 2022 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 immediately.
Right now, Puma reported whole income for the fourth quarter of 2022 of $65.7 million. Complete income contains product income web, which consists completely of NERLYNX gross sales, in addition to license charges and royalties from our sub-licensees. Product income web was $53.7 million within the fourth quarter of 2022, in comparison with $54.3 million reported in Q3 2022 and $51.0 million reported in This autumn of 2021.
Product income for the fourth quarter of 2022 included roughly $2.6 million of stock construct in our specialty pharmacies and specialty distributors. Royalty income was $12 million within the fourth quarter of 2022, a rise from $2.8 million in Q3 of 2022 and a rise from $2.9 million in This autumn of 2021. We reported no license income in 2022.
We reported 3,323 bottles of NERLYNX bought within the fourth quarter of 2022 in comparison with 3,197 bottles bought in Q3 of 2022. We estimate that This autumn stock construct amounted to roughly 164 bottles. In This autumn 2022, new prescriptions had been down roughly 16% in comparison with Q3 and whole prescriptions had been flat in comparison with Q3. Jeff will present additional particulars in his feedback and slides.
I’ll now present a medical assessment of the quarter after which Jeff Ludwig will deal with further coloration on NERLYNX industrial actions. Maximo Nougues will then observe with highlights of the important thing parts of our monetary statements for the fourth quarter of 2022.
As traders are conscious, Puma had an ongoing basket trial of neratinib known as the SUMMIT trial which was testing neratinib in sufferers with metastatic HER2-negative hormone receptor constructive breast most cancers that has HER2 mutation. And in sufferers with metastatic non-small cell lung most cancers that has an exon 18 mutation.
As we talked about to traders up to now, we consider that it was unlikely that FDA would grant accelerated approval for neratinib primarily based on the SUMMIT information and would as an alternative require us to both one, do a face to face trial in opposition to customary of care in these indications or two, examine neratinib in sufferers populations that don’t overlap with different medication within the quickly altering remedy panorama.
Primarily based on current priority and interactions with the FDA which steered that regulatory approval in these indications would require a randomized trial, the corporate won’t be additional pursuing the event of neratinib in these indications.
Because of the rarity of those mutations, enrollment and randomized research could be difficult and it’s not clear that this is able to be capable of be completed in a timeframe that will lead to a constructive return for Puma shareholders primarily based on the time and price of the trial versus the potential market alternative. The SUMMIT trial is subsequently being discontinued, which ends up in a price discount from this trial in 2023 versus 2022.
In September, Puma was happy to announce that we in-licensed the anticancer drug alisertib from Takeda. In medical trials so far, alisertib has proven single agent exercise and exercise together with different most cancers medication within the remedy of assorted cancers together with hormone receptor constructive breast most cancers, triple adverse breast most cancers, small cell lung most cancers and head and neck most cancers.
The drug has additionally proven exercise in earlier medical trials in peripheral T-cell lymphoma and non-Hodgkin’s lymphoma. Takeda’s earlier medical improvement program of alisertib was in depth. And resulting from this, there’s a massive nicely characterised medical security database with over 1,300 sufferers who had been handled throughout 22 firm sponsored trials.
As talked about in our final earnings name, Puma was within the means of transitioning the alisertib program from Takeda to Puma. This has now been efficiently accomplished and the IND is at present being held by Puma.
We’re at present anticipating that we are going to be assembly with the FDA within the first half of 2023 to debate the registration path for alisertib in small cell lung most cancers and would subsequently anticipate initiating medical trials of alisertib in small cell lung most cancers within the second half of 2023.
We additional anticipate assembly with the FDA within the second half of ’23 to debate the registration pathway for alisertib in hormone receptor constructive HER2-negative breast most cancers and subsequently initiating medical trials of alisertib in hormone receptor constructive HER2-negative breast most cancers within the first half of 2024.
We proceed to anticipate that there shall be a number of medical milestones for the alisertib program within the coming months. This contains the publication of the biomarker research from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor constructive HER2-negative breast most cancers, which we anticipate within the first half of ’23. Biomarker information from the randomized trial of alisertib plus paclitaxel versus paclitaxel alone in hormone receptor constructive HER2-negative breast most cancers, anticipated within the first half of ’23, information from the continued investigator-sponsored Section 1/2 trial of alisertib plus pembro for the remedy of sufferers with Rb-deficient head and neck squamous cell most cancers, which is anticipated someday in ’23. Conducting the assembly with the FDA to debate the registration path for alisertib and small cell lung most cancers, which is predicted within the first half of 2023. And conducting the assembly with the FDA to debate the registration path for alisertib and hormone receptor constructive HER2-negative breast most cancers, which is anticipated within the second half of 2023.
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 will enable the corporate to diversify itself and leverage its present R&D regulatory and industrial infrastructure. The corporate will preserve traders up to date on this because it progresses.
I’ll now flip the decision over to Jeff Ludwig, Puma’s Chief Business Officer, for a assessment of our industrial efficiency in the course of the quarter.
Jeff Ludwig
Thanks Alan. Recognize it. And I respect everybody for becoming a member of our fourth quarter earnings name.
Earlier than I transfer into the industrial assessment, only a reminder that I shall be making forward-looking statements. The industrial workforce stays targeted on and captivated with serving to to assist extra sufferers battling breast most cancers. Our main emphasis is on serving to HER2-positive sufferers cut back their threat of recurrence in early stage breast most cancers. We might like to see extra sufferers by no means turn out to be metastatic.
Our technique stays targeted round three areas. Primary, speaking the evolving constructive medical information for NERLYNX to HCPs. Quantity two, partaking in educating sufferers across the threat of reoccurrence, in addition to the danger profit profile of NERLYNX. And at last three, growing our affect and share of voice by subject power execution and non-personal promotion.
Particularly concerning This autumn, I am very happy that we noticed This autumn year-over-year development on our key metrics, together with enrollments, new affected person begins and demand. With regard to share of voice, we additionally noticed a rise in whole calls evaluating This autumn year-over-year in addition to taking a look at This autumn versus Q3 of 2022.
In This autumn about 80% of our whole calls had been reside versus digital, which is a rise from the 77% we reported in Q3 of 2022. As well as, our subject groups elevated their engagement with native and regional advocacy organizations and we’ve got remained very considerate and diligent about our total bills with the objective of being extra environment friendly and simpler. I’m happy with the progress being made, however know that vital alternatives nonetheless stay in entrance of us.
With that prime degree replace, let me transition to a few of the U.S. industrial slides. As soon as I’ve completed, I’ll flip the decision over to Maximo, for a extra detailed assessment of our monetary outcomes.
Our distribution mannequin has not modified. We have now two channels that present NERLYNX to sufferers. We refer to those as our specialty pharmacy channel and our specialty distributor channel or in-office dishing out channel. Most of our enterprise continues to flows by the specialty pharmacy channel. In This autumn, roughly 78% of our enterprise went by this channel, with the remaining 22% of the enterprise flowing by the specialty distributor channel. We do see some quarterly fluctuations of this combine, however no vital modifications occurred all year long.
Slide 4 exhibits U.S. quarterly web gross sales of NERLYNX since FDA approval. As Alan famous, our web product gross sales had been $53.7 million within the fourth quarter of 2022. It is a $600,000 lower over Q3 of 2022 and a $2.7 million improve over This autumn of 2021. Now stock modifications clearly have an effect on these numbers.
In This autumn, we estimate that stock elevated by roughly $2.6 million within the fourth quarter of 2022. As a comparability, we estimated that stock elevated by roughly $5 million in This autumn of 2021.
Turning to Slide 5. Slide 5 exhibits the bottles of NERLYNX bought by quarter since launch. Please keep in mind that this slide exhibits ex-factory bottles bought, so it represents gross sales into our specialty pharmacy and specialty distributor channel and never finish person demand. We bought 3,323 bottles of NERLYNX in This autumn of 2022, which is about 4% greater than the bottles we reported in Q3 of 2022 and about 4% decrease than the bottles we reported in This autumn of 2021.
Let me once more present a bit of extra insights round stock modifications. We estimate that stock elevated by about 164 bottles within the fourth quarter of 2022. As a comparability, we estimated that stock elevated by about 353 bottles in This autumn of 2021.
The industrial workforce is concentrated on execution with the objective of driving each quarter-over-quarter development and year-over-year development. As beforehand talked about, we noticed our This autumn year-over-year development throughout our key efficiency metrics together with enrollments, new affected person begins and demand. We didn’t nevertheless see quarter-over-quarter development for these similar metrics.
As a reminder, we traditionally have seen enrollments and new affected person begins softened within the fourth quarter as physicians and/or their sufferers select to provoke their remedy after the vacations with the intention to keep away from the potential unintended effects of NERLYNX, which generally happen within the first month or so.
This autumn of 2022 adopted that conventional sample of quarter-over-quarter decline. Let me present some further specifics round this efficiency. In This autumn, we noticed enrollments develop 1% year-over-year, however declined 10% quarter-over-quarter consistent with earlier patterns. The year-over-year development charges that I am quoting are evaluating This autumn of 2022 to This autumn of 2021.
Transferring on to new affected person begins or NRx. We noticed industrial new affected person begins develop 7% year-over-year however declined 16% quarter-over-quarter. Business new affected person begins are an essential main indicator for us as new affected person begins turning the refills which influenced subsequent quarters.
Complete prescriptions adopted a considerably related development with year-over-year being extra constructive than quarter-over-quarter. In This autumn, we noticed whole RX development 5% year-over-year and remained flat quarter-over-quarter.
For the complete yr evaluating 2022 to 2021, we noticed enrollments develop roughly 2% and industrial new affected person begins develop 4%. That is the primary time since launch we’ve got seen these constructive yearly traits.
Turning to Slide 6. We have now continued to give attention to the schooling and adoption of dose escalation. In This autumn, roughly 64% of sufferers who acquired industrial drug began NERLYNX on a decrease every day dose. It is a slight lower from the roughly 68% we reported in Q3.
Dose escalation can clearly profit sufferers by considerably lowering the quantity of Grade 3 diarrhea, the median days of Grade 3 diarrhea and the general discontinuation price. We really consider the adoption of dose escalation performs a vital position in reshaping the risk-benefit profile of NERLYNX.
As beforehand reported, dose escalation was added to the NERLYNX label in late June of 2021 for each the prolonged adjuvant indication in addition to the metastatic indication. As well as, NCCN up to date their 2022 medical follow tips to incorporate dose escalation in early-stage breast most cancers. I’m happy to say that NCCN just lately up to date their 2023 metastatic breast most cancers tips and included dose escalation as an choice within the metastatic setting as nicely.
Now Slide 7 highlights the strategic collaborations we’ve got fashioned throughout the globe. We’re happy with our international companions and the progress being made. In Q1 of 2023, NERLYNX acquired regulatory approval within the prolonged adjuvant setting in each Morocco and South Africa. Additionally in Q1 of 2023, we’re glad to announce that NERLYNX was formally launched in Mexico within the prolonged adjuvant setting. Our international companions are targeted on driving elevated adoption and making ready for future launches. I look ahead to highlighting their continued progress transferring ahead.
In abstract, 2022 was an essential yr for NERLYNX because the workforce labored onerous to vary a few of the historic traits and construct a stable basis for future development. I’m happy with the progress that was made in 2022, and I need to thank my industrial colleagues and all the cross-functional Puma group. The workforce is passionate concerning the work that we do and dedicated to discovering extra alternatives to assist most cancers sufferers alongside their journey.
I’ll now flip the decision over to Maximo for a assessment of our monetary outcomes.
Maximo Nougues
Thanks, Jeff.
I’ll start with a short abstract of our monetary outcomes for the fourth quarter of 2022. Please word that I’ll make comparisons to Q3 2022 which we consider is a greater indication of our progress as a industrial firm than year-over-year comparisons. For extra data, I like to recommend that you simply consult with our 2022 10-Ok which shall be filed immediately and contains our consolidated monetary statements.
Within the fourth quarter of 2022, we reported a web loss primarily based on GAAP of $5.6 million or $0.12 per share. This compares to a Q3 2022 web lack of $0.4 million or $0.01 per share. Our fourth quarter 2022 outcomes embrace a rise in our authorized accrual resulting from a lawsuit settlement of $12.4 million. For the complete yr, we reported web revenue of $2,000.
On a non-GAAP foundation, which is included to take away the affect of stock-based compensation expense, we reported a web lack of $3 million or $0.07 per share for the fourth quarter 2022. For the complete yr of 2022, our non-GAAP revenue was $11.8 million.
Gross income from NERLYNX gross sales was $65.4 million in This autumn 2022 and $63.4 million in Q3 2022. As Alan talked about, web product income from NERLYNX gross sales was $53.7 million in comparison with the $54.3 million reported within the third quarter of ’22. We consider that This autumn web gross sales included roughly $2.6 million of stock construct from our distributors.
Royalty income totaled at $12 million within the fourth quarter of 2022 in comparison with the $2.8 million in Q3 2022. Our gross to web adjustment in This autumn 2022 was about 17.8% in comparison with the 14.3% gross-to-net adjustment reported in Q3 2022.
Larger Medicaid rebates, authorities chargebacks and better co-pay had been the drivers of the rise versus Q3 2022. Value of gross sales for This autumn 2022 was $16.8 million, together with $2 million for the amortization of intangible property associated to our neratinib license. Value of gross sales for Q3 2022 was $12.5 million. Going ahead, we’ll proceed to acknowledge amortization of milestones to the licensure of about $2.5 million per quarter as price of gross sales.
For fiscal yr 2023 Puma anticipates that web NERLYNX product income shall be within the vary of $205 million to $210 million. We additionally anticipate that our gross-to-net adjustment for the complete yr 2023 shall be between 19% and 20%. As well as, for fiscal yr 2023 we anticipate receiving royalties from our companions world wide within the vary of $25 million to $30 million. We do not count on license income in 2023.
We additionally count on that web revenue for the complete yr shall be within the vary of $20 million to $24 million. We acknowledge there continues to be an excessive amount of uncertainty concerning the affect of COVID-19 particularly in nations exterior of the U.S., and this may occasionally proceed to negatively affect our gross sales, royalties and license income.
Traditionally, the primary quarter represents the bottom web product gross sales quarter of the yr resulting from plenty of components, together with stock construct within the channel within the fourth quarter of the prior yr, which has a adverse impact on over bottles bought in Q1 in addition to the next gross to web as a result of greater co-pay and protection GAAP bills that usually happen within the first quarter.
The primary quarter gross sales are additionally negatively impacted by sufferers delaying beginning NERLYNX in the course of the fourth quarter of 2022, which Jeff described. We anticipate that for Q1 2023, NERLYNX web gross sales shall be within the vary of $43 million to $46 million. This steering assumes that stock is diminished by 200 bottle.
We count on Q1 royalty revenues shall be within the vary of $4 million to $6 million, a decline from This autumn. This lower displays the timing of Siemens to our associate in China. We additional estimate that the gross to web adjustment in Q1 2023 shall be roughly 21% to 21.5%. Puma anticipates a Q1 web loss between $2 million and $5 million.
SG&A bills had been $25.1 million within the fourth quarter of 2022 in comparison with $24 million for the third quarter. SG&A bills included noncash costs for stock-based compensation of $1.8 million for the fourth quarter of 2022 in comparison with $2 million for Q3.
Analysis and improvement bills had been $13.8 million within the fourth quarter of 2022 in comparison with $11.2 million for the third quarter. R&D bills included noncash costs for stock-based compensation of $0.8 million within the fourth quarter of 2022 in comparison with $0.9 million for the third quarter.
Our web loss for the quarter was impacted by a rise of $12.4 million to our degree accrual as a result of lawsuit settlement. The fourth quarter of 2022, Puma reported money earned of roughly $3.1 million in comparison with money earned of roughly $17.4 million in Q3 2022. Our This autumn 2022 money stream included a $7 million fee to Takeda that was made in October.
For the complete yr, we reported money burn of $10.6 million. If we exclude onetime money flows occasions that impacted 2022, we’d have seen constructive money stream of $36 million. On the expense aspect, Puma continues to anticipate a discount in whole working bills in 2023 in comparison with 2022. Extra particularly, we anticipate SG&A bills to say no roughly 1% to three%. And R&D bills to extend 6% to eight% year-over-year.
At December 31, 2022, we had roughly $81 million in money, money equivalents and marketable securities. Our accounts receivables stability was $40.4 million. Our accounts receivable phrases vary between 10 and 68 days, whereas our days gross sales excellent are about 46 days. We estimate that as of year-end 2022, our distribution community maintains roughly 4 weeks of stock.
General, we proceed to deploy our monetary sources to give attention to the commercialization of NERLYNX the event of ulcerative and controlling our bills.
Alan Auerbach
Thanks, Maximo.
As famous on our final earnings name, throughout 2022, we skilled elevated face-to-face interactions with HCPs and higher HCP entry total, which we consider contributed to the elevated industrial outcomes that we noticed in 2022. We’re hopeful that this may proceed to development positively.
Puma senior administration in cooperation with the Board of Administrators, continues to stay targeted on bettering NERLYNX gross sales in 2023 and past. In fourth quarter of 2021, we applied a discount in bills with the objective of lowering bills with the intention to maximize working money flows.
We consider that the constructive money stream reported within the fourth quarter was a direct results of these expense reductions. These expense reductions are additionally a significant contributor to the constructive web revenue and constructive money stream that the corporate is guiding to for 2023. The corporate stays dedicated to persevering with to realize these operational money flows and constructive web revenue, and we’ll proceed to cut back bills if wanted to realize this.
We look ahead to updating traders on this sooner or later. That continues to stay in a big unmet want for sufferers battling breast most cancers, lung most cancers and different stable tumors. We have now confirmed are dedicated and captivated with discovering simpler methods and serving to these sufferers throughout their journey, and we’ll proceed to try to realize that objective.
This concludes immediately’s presentation. We’ll now flip the ground again to the operator for Q&A. Operator?
Query-and-Reply Session
Operator
[Operator Instructions] Our first query comes from Divya Rao with Cowen and Firm. Please state your query.
Divya Rao
Hello. That is Divya on for Mark. Thanks for taking our query. I assume is there any particular information that you simply’re hoping to generate earlier than assembly with regulators to develop alisertib label in breast most cancers, I assume, like I feel the prior steering was H1 for each small cell and breast most cancers. So I assume that is moved into Q2 — or H2. So I used to be simply questioning if there was any further information you had been hoping you generate.
Alan Auerbach
Sure. Thanks for the query. So alisertib, as you understand, is an oral kinase A inhibitor. And our perception is that there is plenty of pathways, which we highlighted beforehand on the decision, like RB1 deficiencies and c-Myc and issues like that, the place we consider that the tumors that specific these are going to be the most effective to focus on with alisertib. We have not but gotten again plenty of the biomarker information, the biomarker information from the examine of alisertib plus fulvestrant. My perceive my trial, which is alisertib plus fulvestrant in opposition to alisertib alone. That has been accepted for publication, and we’re simply ready for the journal to publish that. The information on the paclitaxel plus alisertib in opposition to paclitaxel mortgage, we just lately simply obtained that information.
So I feel we hope for that. And once more, these are investigator-sponsored trials. In order that they had been executed precise teams. I feel we had been hoping to have that with the intention to meet with the FDA as a result of we simply obtained it. We had been — needed to transfer out for the second half.
Divya Rao
That is useful. Thanks.
Operator
Thanks. Your subsequent query comes from Geoff Meacham with Financial institution of America. Please proceed along with your query.
Unidentified Analyst
Good afternoon. That is [Hao] calling in for Geoff Meacham. And thanks for the query. So my first one is de facto about for physicians to begin sufferers at a diminished dose. What could also be the primary hurdles that you’ve got seen? And what can we do to type of enhance that share of sufferers studied a diminished dose. After which the opposite one concerning the royalty income for that $12 million, I simply needed to listen to if we are able to present a bit extra coloration about what kind of drives that quantity greater than the prior quarter and likewise the top from the prior yr. Thanks.
Alan Auerbach
Okay. On the primary one, the diminished dose, Jeff, do you need to take that?
Jeff Ludwig
Sure, glad to. Thanks for the query. Recognize it. Clearly, we expect dose escalation is de facto essential to the adoption of neratinib and the risk-benefit profile. Dose escalation has been very nicely acquired. Our groups speak about it persistently. It has been added to our bundle insert. It has been added to NCCN tips for each early stage and metastatic. And we truly see excellent discussions and assist round dose escalation from our main breast KOLs.
So the query you are asking is, hey, why aren’t we at, say, 100% adoption on the graph that we’re displaying. And let me simply provide you with some extra coloration round that as we take into consideration physicians who do undertake and those who do not undertake. There may be actually a gaggle of physicians largely in a metastatic setting that consider you need to begin with full dose. They need to get full dose instantly upon remedy initiation. So there is a subset that may possible not going to begin with a diminished dose.
Quantity two, we do have some physicians in the neighborhood which have handled neratinib for a very long time that do not need challenges managing diarrhea, they usually’ve obtained their very own approach of coping with it. And they also begin with full dose and if they’ve a problem, they dose cut back.
The third state of affairs is we consider the numbers that I am displaying you, though that methodology may be very constant, it actually undercalls the entire adoption of dose escalation. We pull that information from our SP channel, which, as I discussed earlier than, is about 80% of our enterprise, so it is an excellent surrogate. We do not need visibility into the SD channel. And so for instance, if a affected person begins within the SD portion of the enterprise, it isn’t unusual for them to fill one time within the SD channel after which transfer over to the SP channel for his or her second and subsequent fields.
In that instance, if the affected person begins in dose escalation within the SD after they come over to the SP, it is possible they will come at full dose, and we’ll decide that up as a full dose begin, although they began on a low dose. So these numbers, we consider, are very conservative. And fairly actually, I am very proud of the general development.
I might guess that the max that we might ever see, I am estimating could be 70%, 75%, that will be virtually full adoption. So hopefully, that helps and add a bit of extra coloration.
Alan Auerbach
After which in your second query with regard to the royalty, a big portion of our royalty is the shipments to China. And people can fluctuate largely primarily based on issues reminiscent of you understand, in China, that they had the Zero COVID coverage. And so plenty of occasions, it was — we had been simply ready for form of the window to open for us to have the ability to ship. In order that form of causes that fluctuation in that bumpiness to happen. In order that’s largely why you noticed the upper than anticipated in This autumn.
Maximo Nougues
Sorry — so as to add that. Additionally, we ship batches, proper? So massive manufacturing price range that will not turn out to be out there after we ship as nicely. So.
Unidentified Analyst
Okay. Thanks. Very useful.
Operator
Thanks. Your subsequent query comes from Gena Wang with Barclays. Please state your query.
Unidentified Analyst
Hello. Good afternoon. That is [Harshita] on for Gena. Thanks for taking our questions. A fast one from us. So it has been over a yr because you diminished gasoline medical specialists proper, given 50% to 60% of your accounts are by digital interplay. I used to be questioning, are you able to give us an replace on how this has been figuring out? Do you assume you want to add again further specialists? Or are you doing nicely with the present gross sales power? Thanks.
Jeff Ludwig
Sure. Harshita, thanks quite a bit for the query. I respect it. A few issues. One is, as you understand, the oncology therapeutic space is a really restricted specialty. It is extra restricted than many different areas. I’ll let you know that since COVID, it is turn out to be much more restrictive although we’re seeing some constructive traits at a few of the COVID places of work — clearly opening again up.
So I’ll let you know proper now, we really feel excellent concerning the dimension of our gross sales power. They’re capable of cowl accounts which can be open and accessible, both reside or digital. We monitor that very carefully, and I’ve stated this on earlier calls, if we’ve got a chance the place we’re not staffed appropriately, the place we are able to get in entrance of extra physicians.
Alan and I’ll have a really fast dialog on that, and we’ll regulate as vital. However proper now, we really feel like we’re managing the quantity of accessible accounts and physicians both reside or nearly, pretty successfully and effectively. As I discussed, we have seen calls — total calls elevated quarter-over-quarter about 10% and truly year-over-year about 10%, trying on the fourth quarter. So we’re proud of the present progress.
And once more, oncology specialty is restrictive. So we’re additionally growing our nonpersonal promotion to attempt to generate engagement with these clinicians that we can’t entry. So hopefully, that helps a bit of bit.
Unidentified Analyst
Very useful. Thanks a lot.
Jeff Ludwig
Recognize it.
Operator
Thanks. Your subsequent query comes from Sahil Kazmi with B. Riley Securities. Please state your query.
Sahil Kazmi
Hello Alan, thanks for taking our questions right here. Only a couple from us. To begin with, are you able to speak about the way you’re enthusiastic about the chance in head and neck squamous cell most cancers. Any coloration you possibly can present there in addition to the small lung most cancers discussions you are planning to have with the FDA within the first half of the yr?
Alan Auerbach
Sure, completely. Thanks for the query. In head to neck most cancers, so this can be a examine that is being executed — as an investigator-sponsored examine, this was ongoing on the time that we bought the drug from Takeda of utilizing alisertib together with pembrolizumab in sufferers with RB poor head and neck most cancers. I feel we’ll should see the info earlier than we are able to actually touch upon the chance. It is clearly a smaller tumor sort.
I feel trial is simply form of getting occurring enrollment. So we’ll count on to — I might count on we’ll most likely have information if I to only ballpark it, most likely Q3-ish of this yr might be after we begin to see information, hopefully discover a convention to current it some within the Q3, This autumn timeframe. So I feel as soon as we get the info on that, we’ll be extra glad to touch upon the chance.
By way of small cell lung most cancers, you may keep in mind that there’s a revealed examine within the Journal of Thoracic Oncology of paclitaxel plus alisertib versus paclitaxel alone. Alisertib is an Aurora kinase inhibitor. So in plenty of the pathways, that are current in a fairly good share of the small cell lung most cancers sufferers, which incorporates this stuff like RB1 deficiencies and RB1 mutations, c-Myc elevations and issues like that.
That is the place the most effective efficacy was seen and that features each a PFS profit and an OS profit in that trial. So I feel what we would prefer to have the dialogue with the FDA on is form of that biomarker-directed method with the drug as a result of our feeling is that is actually going to be our alternative to point out the most effective threat profit, the most effective chance of displaying essentially the most most profit, but additionally one thing that simply differentiates alisertib from the opposite medication in small cell lung most cancers.
Small cell lung most cancers has been a tumor that has largely simply consisted of assorted cytotoxic medication. And aside from the IO drug, you have not actually seen a biomarker-directed method in small cell lung most cancers the best way you might have in non-small cell lung most cancers. Actually, in non-small cell lung most cancers, you might have the EGFR mutations, the APP mutation, the final ones and issues like that. You have not actually seen the identical sort of biomarker-directed method in small cell lung most cancers and that is actually the method we’re trying to take.
In order that’s the place the dialogue with the FDA goes to give attention to.
Sahil Kazmi
Wonderful. That is very useful. Congrats on all of the progress and searching ahead to following the story in 2023.
Operator
Thanks. And this concludes our question-and-answer session. I want to flip the convention again to Mariann for closing remarks.
Mariann Ohanesian
Thanks for becoming a member of us immediately. As a reminder, this name could also be accessed through replay of the webcast at pumabiotechnology.com starting later immediately. Have a superb night.
Operator
Women and gents, thanks for collaborating in immediately’s convention name. This concludes our program. Everybody, have an amazing day. You might now disconnect.
