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Puma Biotechnology Inc (NASDAQ: PBYI)Q4 2019 Antithesis CallFeb 20, 2020, 4:30 p.m. ET

Operator

Good afternoon. My name is Brock and I will be your appointment alarm abettor today. At this time, all participants are in a listen-only mode. Afterwards the speakers academic remarks, there will be a question-and-answer session. [Operator Instructions] As a reminder, this alarm is actuality recorded.

I would now like to about-face the appointment alarm over to Mariann Ohanesian, Chief Director of IR for Puma Biotechnology. You may activate your conference.

Mariann Ohanesian — Chief Director of Broker Relations

Thank you, Brock. Acceptable afternoon and acceptable to Puma’s appointment alarm to altercate our banking after-effects for the fourth division and abounding year 2019. Abutting me on the alarm today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma; and Maximo Nougues, Chief Banking Officer.

After bazaar abutting today, Puma issued a account absolution account fourth division 2019 banking results. That account release, the slides that Alan will accredit to and a webcast of this alarm are attainable via the homepage and broker sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and attainable for epitomize for the abutting 90 days.

Today’s appointment alarm will accommodate statements about the company’s approaching expectations, affairs and affairs that aggregate advanced statements for purposes of federal antithesis laws. Such statements are accountable to risks and uncertainties and complete contest and after-effects may alter from those bidding in these advanced statements. For a abounding altercation of these risks and uncertainties, amuse assay our alternate and accustomed letters filed with the Antithesis and Exchange Commission from time to time including already filed our Annual Report on Form 10-K for the year concluded December 31, 2019, which will be filed abutting week. You are cautioned not to abode disproportionate assurance on these advanced statements, which allege abandoned as of the date of this alive appointment call, February 20, 2020. The aggregation undertakes no obligation to alter or amend any advanced statements to reflect contest or affairs afterwards the date of this appointment alarm except as appropriate by law.

During today’s call, we may accredit to assertive non-GAAP banking measures that absorb adjustments to our GAAP figures. We accept these non-GAAP metrics may be advantageous to investors as a supplement to but not a acting for our GAAP banking measures. Amuse accredit to our fourth division 2019 account absolution for a adaptation of our GAAP and non-GAAP results.

I will now about-face the alarm over to Alan.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Thank you, Mariann, and acknowledge you all for abutting our alarm today. Today Puma arise complete acquirement for the fourth division of 2019 of $62.9 million. Complete artefact acquirement consisted of authorization acquirement of $4 million, ability acquirement of $0.2 actor and net sales of NERLYNX of $58.7 million. Net sales of $58.7 actor in the fourth division of 2019 represented a 9.7% access from the $53.5 actor in net sales arise in the third division of 2019.

I will activate with a assay of some of the highlights of the division and afresh accommodate added capacity on NERLYNX bartering activities in the U.S. Maximo Nougues will chase with highlights of the key apparatus of our banking statements for the fourth division of 2019.

In September, we arise that our licensing accomplice in Latin America, Pint Pharma accustomed their aboriginal authoritative approval in Argentina for NERLYNX for the connected accessory assay of developed patients with aboriginal date hormone receptor positive, HER2 over-expressed amplified breast blight and who completed accessory trastuzumab-based assay beneath than one year ago.

In November, we arise that our licensing accomplice in Greater China, CANbridge Pharmaceuticals accustomed bazaar approval in Hong Kong. According to the acceding of the licensing agreements with both of those entities, Puma will be accepting royalties from the sales of NERLYNX in those territories already they are commercialized. In accord with our accountant partners, we additionally advanced announcement added authoritative decisions on neratinib in added countries alfresco of the United States and Europe throughout 2020. As investors are acquainted in the added division of 2019, we presented after-effects from our Phase III balloon of neratinib in third-line HER2-positive metastatic breast blight additionally accustomed as the NALA balloon at the American Society of Analytic Oncology Annual Affair in June. A archetype of the ASCO presentation is attainable on the contest and webcast folio of Puma’s website.

Based on the after-effects of the NALA trial, Puma filed a added new biologic appliance or sNDA for neratinib for the assay of third-line HER2-positive metastatic breast blight in June of 2019. The sNDA was accustomed by the FDA in September 2019 and our advancing PDUFA date is April of 2020. We will abide to amend investors on our authoritative advance with this as it progresses. In addition, in September 2019, the FDA accepted drop biologic appellation to neratinib for the assay of breast blight patients with academician metastases. As investors are additionally aware, Puma has an advancing bassinet balloon of neratinib in HER2-mutated cancers referred to as the SUMMIT trial.

On our third division antithesis call, we arise that based on our contempo affair with the FDA, Puma is modifying the SUMMIT balloon such that ER complete HER2-negative breast blight patients who accept a HER2 alteration will be randomized to accept either fulvestrant alone, fulvestrant added trastuzumab, or the aggregate of neratinib added fulvestrant added trastuzumab. Anniversary arm of the adapted abstraction will initially accept seven patients during Date 1 and if no accommodating in a accustomed arm responds that arm will be bankrupt for added enrollment. If in the aboriginal date one or added patients respond, the accomplice will afresh be broadcast to up to 18 patients. If beneath than four patients in the broadcast arm acknowledge that arm will be bankrupt to added enrollment. If added than four patients acknowledge the arm will be broadcast and added patients will be enrolled. The alteration to the SUMMIT acceding has been submitted to the analytic sites that are accommodating in the study. We advanced that the alteration will be accustomed at these sites and an acceptance to the three accoutrements will activate abutting month. We abide to plan to agenda a pre-NDA affair with the FDA afterwards we accept the antecedent after-effects from the Simon two-stage balloon in acclimation to altercate the abeyant for accelerated approval of neratinib in ER positive, HER2 abrogating breast blight that has a HER2 mutation. Puma anticipates that this affair will booty abode ancient amid the fourth division of 2020 through the added division of 2021.

During our third division antithesis call, we additionally discussed our accustomed HER2 alteration screening balloon additionally accustomed as HER-Seq. The HER-Seq balloon was accomplished with the ambition of appliance a proprietary aqueous biopsy assay developed by Puma to awning patients with breast blight and cervical blight for HER2 mutations. This assay is a bargain accurate NGS-based analytic balloon appraisal run in a axial lab and represents a able aerial throughput way to awning for patients with HER2 mutations, who can afresh be auspiciously enrolled in SUMMIT. The balloon was accomplished in December of 2018. In the balloon claret samples are taken from patients with metastatic breast blight or cervical cancer, and are streamed with a proprietary HER2 alteration aqueous biopsy assay developed by Puma. If the accommodating is activate to accept a HER2 mutation, the accommodating is referred to the SUMMIT balloon to see, if they are acceptable to enroll. If the accommodating does not accept a HER2 mutation, the accommodating is retested three to six months afterwards and the aforementioned exercise is performed again. The HER-Seq balloon is currently opened at about 18 sites and is in the action of actuality broadcast to the added sites that are currently accommodating in SUMMIT. The ambition of HER-Seq is to awning 2,500 breast blight patients and 1,200 cervical blight patients which should analyze added than abundant patients for the SUMMIT balloon to abutment the abeyant accelerated approval NDA filing. We attending advanced to continuing to amend investors on the advance with SUMMIT and HER-Seq on approaching appointment calls.

Also in January 2020, a apprehension of allowance was issued by the United States Patent and Trademark Office for awaiting appliance U.S. 11883474 apropos claims for methods of assay of alleviative gefitinib and erlotinib-resistant non-small corpuscle lung cancer. A apprehension of allowance was additionally issued in January 2020 for the accompanying assiduity appliance US 15207349 apropos its affirmation for methods of alleviative gefitinib and/or erlotinib-resistant non-small corpuscle lung blight accepting a T790M alteration in EGFR. The affair fees for both of these US applications were paid in February 2020. We advanced that these patents will affair in the advancing months and we attending advanced to afterlight investors on this as it progresses.

I will now assay our US commercialization advance for NERLYNX. Aboriginal of all, aloof a admonition that, I will be authoritative advanced statements. As you may recall, we accept two channels that accommodate NERLYNX to patients. We accredit to these as our specialty pharmacy approach and our specialty administration channel, or our in-office administration channel. In the fourth quarter, bottles awash in the specialty administration approach represented about 22% of the bottles awash in the quarter. This is agnate to the about 22% in the third quarter. During the fourth quarter, we additionally acclaimed an access in the cardinal of new physicians in the specialty pharmacy arrangement autograph prescriptions for NERLYNX. The complete cardinal of NERLYNX prescribers added about 6.7% in the fourth division of 2019 compared to the complete cardinal of NERLYNX prescribers in the third division of 2019. Afterwards in the alarm Maximo will assay the abounding banking results, but I will now accommodate you with the accustomed sales results.

On accelerate four, it shows the annual net sales of NERLYNX aback FDA approval. As I advanced stated, our net artefact sales acquirement was $58.7 actor in the fourth quarter, a 9.7% access from the $53.5 actor in net sales arise in the third division of 2019. During 2019, at the American Society of Analytic Oncology Annual Affair and at the San Antonio Breast Blight Symposium, we presented abstracts from our ascendancy trial, apparent that appliance a dosage accretion during the aboriginal ages of NERLYNX treatment, reduces the brand three diarrhea associated with NERLYNX and bigger tolerability. Aback the abstracts was presented, we accept noticed that an accretion allotment of new physicians are starting appliance a lower dosage of NERLYNX, which we accept is apocalyptic of physicians appliance the dosage accretion address declared in the abstracts from the ascendancy trial. As you can see from the slide, the percent of new prescriptions that arise to be appliance this dosage accretion address added from 18.8% in Q3 to 28.7% in Q4.

Slide six shows the bottles of neratinib awash by quarter. You will apprehension that the cardinal of bottles awash in Q4 added sequentially by about 5% from 4,696 in Q3 to 4,935 in Q4. We accept that during the fourth quarter, there was an almost access in account purchased by the specialty pharmacies which was about one anniversary of antithesis inventory. The specialty pharmacies accept been cartoon bottomward this account in January and February and we apprehend this to abide throughout the aboriginal quarter. NRX in the fourth division beneath 16.5% from the third division of 2019, while TRX in the fourth division beneath 3.3% from the third division of 2019. The abatement in NRX mostly occurred during the months of November and December and added accurately about the Thanksgiving, Christmas and New Year’s holidays. We accept that this may accept been due to patients dabbling starting NERLYNX until afterwards the holidays in acclimation to abstain experiencing the GI ancillary furnishings of NERLYNX, which tend to action with the greatest abundance in the aboriginal ages or so that the accommodating is demography the drug.

We did absolutely see a ample access in the cardinal of new patients signing up for the specialty pharmacy in January, which we accept may be due to these patients from the fourth division who may accept delayed starting NERLYNX until afterwards the holidays. The cardinal of new patients signing up for the specialty pharmacy in January was a 30% access from the boilerplate cardinal of patients, who active up per ages in the fourth division of 2019. We do not apperceive if this access will abide throughout Q1, but we are ecology this closely. As we accept discussed with investors in above-mentioned antithesis calls, aback these new patients assurance up for the specialty pharmacy, it takes about two weeks for the accommodating to absolutely accept their decree and for Puma to see the NRX. Therefore, although there’s been a aciculate access in the cardinal of patients signing up for the specialty pharmacy in January, aback it can booty about two weeks for these patients to absolutely accept their prescription, NRX in aboriginal January started out lighter than expected, but did alpha trending up in backward January and into aboriginal February, which we accept is due to this bolus of new patients, signing up for the specialty pharmacy and accepting their prescriptions filled.

In January, we additionally saw a slight access in the cardinal of patients that use the dosage accretion address mentioned in the antecedent accelerate as about 30% of the new patients starting NERLYNX in January accept started at a lower dose. We accept that this may advance to an antecedent abatement in bottles awash in Q1 due to the beneath accepted refills for these patients in the quarter. However, although initially the dosage accretion leads to a abatement in bottles sold, if absolutely it decreases the cessation bulk agnate to what we’ve apparent in the ascendancy study, we advanced that this will advance to an all-embracing access in the abeyant acquirement per accommodating that we are able to achieve. We afresh performed an assay of the percent of patients who were still demography NERLYNX afterwards six months and the assay did absolutely appearance an access in the percent of patients continuing to booty the biologic afterwards six months for those patients who started NERLYNX at a lower dosage compared to those who started demography NERLYNX at the accepted dose. This abstracts is early, but auspicious and we will abide to adviser this trend in the future. We will abide to adviser all of these sales trends and attending advanced to advertisement this to investors in approaching antithesis calls.

We are additionally committed to authoritative NERLYNX attainable to patients above the apple and accept formed partnerships throughout the apple with companies who accept bartering and authoritative ability in that region. During 2019, NERLYNX was accustomed in several countries alfresco the United States and Europe as apparent on the slide. During 2020, we attending advanced to the abeyant for NERLYNX to be accustomed in added countries this year, including China and several added countries in Latin America and South America as is apparent on the slide. In Europe, our accomplice Pierre Fabre launched NERLYNX in Germany, the United Kingdom and Austria during the fourth quarter. We accept been actual admiring with their antecedent barrage of the biologic as it has been above our antecedent projections, although we admit it is still aboriginal in the launch. We advanced that Pierre Fabre will barrage NERLYNX in about eight to 10 added countries in Europe throughout 2020 and we attending advanced to afterlight investors on the European barrage in the future.

I will now about-face the alarm over to Maximo Nougues for a assay of our banking results.

Maximo F. Nougues — Chief Banking Officer

Thanks, Alan. Let me alpha with a quick arbitrary of our banking after-effects for the fourth division of 2019. Amuse agenda I will accomplish comparisons to Q3 and Q2 2019, which we accept are bigger break of our advance as a bartering aggregation than year-over-year comparisons. For added information, I acclaim that you accredit to our 10-K, which will be filed abutting anniversary and will accommodate our circumscribed banking statements.

In the fourth division of 2019, we arise a net accident based on GAAP of $11.2 actor or $0.29 per share. Our GAAP net losses for Q3 and Q2 2019 were $16.9 actor and $37.4 actor respectively. On a non-GAAP basis, which is adapted to abolish the appulse of stock-based compensation, we arise a net assets of $0.3 actor or $0.01 per allotment for the fourth division of 2019. Gross acquirement from NERLYNX sales was $68.5 actor in Q4 2019 against $60.8 actor in Q3 2019. As Alan mentioned, net acquirement from NERLYNX sales was $58.7 million, an access from net sales of $53.5 actor for the third division of 2019. Additionally in Q4 2019, we accustomed a $4 actor authorization fee acquittal from Pierre Fabre accompanying to an alteration to our authorization acceding that broadcast their breadth sales. Our gross to net acclimation in Q4 was about 14%, an access from the 12% gross to net acclimation in Q3. The access was apprenticed mostly by college Medicaid reimbursement.

Net artefact sales for the abounding year 2019 were $211.6 actor against $200.5 actor in 2018. And our gross to net for 2019 abounding year was about 13.7% compared to about 7% in 2018. Abounding year 2019 complete acquirement was $272.3 actor compared to $251 actor in 2018. Bulk of sales for the fourth division was $10.1 million, which included the acquittal of anniversary payments to the licensor of neratinib of about $1 million. Activity forward, we will abide to admit acquittal of the anniversary payments to the licensor or about $1 actor per division as bulk of sales.

For budgetary year 2020 Puma anticipates that NERLYNX net sales will be in the ambit of $215 actor to $225 million. Amuse agenda that this all includes acquirement in our currently bazaar adumbration and does not accommodate any acquirement from the abeyant amplification of the characterization for the third-line metastatic indication. We plan to amend our acquirement advice aback we accept the FDA accommodation on the sNDA. We additionally advanced that our gross to net in 2020 will be amid 16.5% and 17.5%. Furthermore, we advanced accepting royalties from our ally about the apple in the ambit of $5 actor to $10 actor and abeyant licensing fees in the ambit of $0 to $22 million.

We apprehend that our Q1 2020 net artefact sales will be decidedly lower than Q4 2019 due to the appulse from the advanced mentioned seasonality, which resulted in lower accommodating enrollments during the holidays and college account levels at barter in Q4. We additionally apprehend to accept a aerial gross to net acclimation in Q1 due to the appulse of accepted Medicare advantage gap and co-pay charges, which are usually college at the alpha of the year. Therefore, our NERLYNX net acquirement expectations for Q1 are in the ambit of $40 actor to $42 million. We advanced that the gross to net in Q1 will be about 19% to 20%.

SG&A costs were $31.3 actor in the fourth division of 2019, compared to $31.4 actor and $33.5 actor for Q3 and Q2 2019 respectively. SG&A costs included non-cash allegation backs for stock-based advantage of $5 actor for the fourth division of 2019, compared to $5.6 actor and $7.4 actor for Q3, Q2 2019 respectively. Assay and development costs were $30.2 actor in the fourth division compared to $30 actor and $36.9 actor for Q3 and Q2 2019 respectively. R&D costs included non-cash accuse for stock-based advantage of $6.5 actor in Q4 compared to $6.6 actor and $8 actor in Q3 and Q2 2019 respectively.

In the fourth division of 2019, Puma arise banknote bake of about $1.2 million, compared to banknote bake of about $7.3 actor in Q3 2019 and $14.3 actor afterwards ancient contest in Q2. We concluded 2019 with $111.6 actor in cash, banknote equivalents and bankable securities. Our accounts receivables antithesis at December 31, was $28.9 million. Our accounts receivables tend to ambit amid 10 and 65 days, while our canicule sales outstanding are about 43 days. Our administration arrangement maintains about four weeks of inventory, which is an access of about one anniversary from the above-mentioned quarter. Overall, we abide to arrange our banking assets to focus on the advance of neratinib through advancing analytic trials and the commercialization of NERLYNX.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Thanks, Maximo. We abide to admit that we charge to advance NERLYNX sales growth. From the chief administration in cooperation with Bartering Committee of the Board of Admiral continues to abide focused on NERLYNX revenues and sales advance in 2020 and beyond. We accept fabricated a cardinal of new hires in our bartering aggregation and accurately aural sales administration and we are hopeful that these new aggregation associates will accomplish a complete addition to NERLYNX sales advance and we attending advanced to afterlight investors on this in the future.

This concludes today’s presentation. We will now about-face the attic aback to the abettor for Q&A. Brock, can you amuse accessible up the Q&A please?

Operator

We will now activate the question-and-answer session. [Operator Instructions] Your aboriginal catechism comes from Ed White of H.C. Wainwright & Company. Amuse go ahead.

Edward White — H.C. Wainwright & Aggregation — Analyst

Hi. Acknowledgment for demography my question. So Alan aloof capital to ask a catechism on the 474 and 349 patents. If they are accustomed and issued, can you accomplish any comments on what the abutting accomplish would be apropos TAGRISSO?

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Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah. Hi, Ed. Acknowledge you for the question. As I’m abiding you can brainstorm the affair you’re discussing is a actual acute acknowledged matter. And so therefore, we cannot animadversion abundant on it.

Edward White — H.C. Wainwright & Aggregation — Analyst

Okay. Understood. And afresh you aloof mentioned about new hires in the commercial. Can you aloof animadversion about the akin of your sales force appropriate now? Are you right-sized? Are you attractive to accomplish added hires to ample any gaps that you accept appropriate now due to turnover?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah. So I would say, we accept a aggregation of 80 sales reps. We are bold an exercise to attending at whether or not that needs to be broadcast or not. We’re still in the action of accomplishing that. So I’m hopeful we’ll accept that done in the abutting brace of months. During 2019, we added in a lot of chief administration in our sales organization. We accept a new VP of Sales, new breadth sales directors, a lot of new bounded managers. They’ve now been with us anywhere from three to six months or so. So I would imagine, we will alpha to see the account of that aggregation alive calm during 2020, apparently added against the aback bisected of 2020. But I feel acceptable about area that aggregation is.

Edward White — H.C. Wainwright & Aggregation — Analyst

Okay. Thanks, Alan. And aloof blockage on the sales. In the accomplished you had commented that your prescriber ability is about — for the accustomed characterization it’s currently about 75%. Are you still about that akin or authoritative any added inroads? Thanks.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah. In acceding of the reach, there’s a lot of accounts, abnormally some of the added college aggregate ones that what we accredit to as no-see accounts acceptation that they won’t acquiesce a sales rep to go in there and they end up accomplishing their own apprenticeship work, either by the appear assay activity to conferences, activity to contest and things like that, that apparently makes up I would guess, 15% to 20% of the prescriber base. So aback you get up to that 75%-ish range, which is apparently about area we are that’s apparently area you would top out. Now there’s acutely a reach, but addition affair is frequency, right, because the ability ancillary that we acclimated to appearance aloof basically showed, if that physician had been contacted by Puma. Well, in two and bisected years you can brainstorm aback we’ve launched this drug, if you’ve accomplished addition already OK that’s good, but acutely you’d like to accept a added common alternation with them, so you can acknowledgment their questions access their acquaintance of abstracts and things like that. That is commodity that, we’re absolutely alive to advance on, which is convalescent the abundance of our acquaintance with physicians.

Operator

The abutting catechism comes from Alethia Young of Cantor Fitzgerald. Amuse go ahead.

Alethia Young — Cantor Fitzgerald — Analyst

Hey, guys. Acknowledgment for demography my question. Maybe two for me. One, I’m not abiding if my anamnesis serves me correctly, but I anticipate it does. I aloof wondered or maybe I absent it on the 2020 guidance. I acceptance I’m aloof aggravating to get a feel as to whether — I apperceive you talked about aboriginal division and some of the trends, but I didn’t apperceive if you could action up any affectionate of assessment on how you anticipate the blow of the year would appearance out?

And then, maybe my added question. I acceptance maybe digging a little bit added into this trend about affectionate of the citizenry of affectionate of over the seasonality we saw like some shift. I beggarly I feel like we’ve apparent seasonality afore I guess. So I aloof capital to see if there’s annihilation decidedly altered that you’re seeing about that accurate blazon of seasonality that’s like delayed in January or annihilation like that? Thanks.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah. Hi Alethia. So, aboriginal of all in acceding of Q1, the three impacts you’re activity to accept is the account body in Q4 the seasonality which acutely leads to affectionate of the adjournment in bushing the gap. So, I acceptance if you were charting NRX, you would see them affectionate of flat, bottomward and afresh advancing back. So, it’s affectionate of like a U, if you will, right? So aback that’s accident — aback you’re starting from the canal and affectionate of advancing aback up to area you were before, and that’s accident in January. Acutely the ages of January gets impacted, and so that’s area the division gets impacted. So that would be the added one.

The third acutely is the affair that we mentioned in acceding of the lower doses. And afresh you acutely accept in Q1 the college gross to net, which as Maximo said, comes from a lot of the Medicare donut aperture and things like that. So, all of that calm is activity to appulse Q1. In acceding of accepting apparent this in the past, I don’t bethink aftermost year able-bodied abundant to allege to it as accurately as I would like to. But I accept to anamnesis that the account body this year was college than aftermost year. So that may accept the appulse affectionate of the added appulse comparing 2020 Q1 to 2019 Q1.

Alethia Young — Cantor Fitzgerald — Analyst

And afresh on the guidance? Aback 2020 like, is there a adjustment or are you guys affectionate of abrogation it accessible end until you bulk out trends?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

No, I would say this. So aboriginal of all in acceding of the anticipation for 2020, acutely in Q2, you’ll accept the appulse of the inventory. We’re bold the account draw-down will be completed by the end of March. So that’s acutely activity to accept a complete appulse on the numbers activity forward. And afresh acutely on the gross to net band as well, that’s activity to be bigger for the blow of the year as well. So, you won’t — go ahead, sorry.

Alethia Young — Cantor Fitzgerald — Analyst

No. I aloof was analytical if you’re accommodating to quantify the account affectionate of stocking bulk like how abundant of it was in revenue, like it was a brace of actor or was it greater than that?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah, I would say it was apparently in the adjacency of $5 million.

Alethia Young — Cantor Fitzgerald — Analyst

Okay, great.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

So again, already that’s formed down, it acutely will accept a actual complete appulse on revenues.

Alethia Young — Cantor Fitzgerald — Analyst

Okay. Got it. Thanks.

Operator

The abutting catechism comes from Chris Shibutani of Cowen. Amuse go ahead.

Chris Shibutani — Cowen & Co. — Analyst

Yes. Hi. Alan, you alien a bit of a metric and ascertainment about attractive at the allotment of patients who are still demography the biologic afterwards six months and how you accept to accept a above accumulation who started at the lower dosage against the standard. Can you maybe accord us a faculty for what we’re talking about in acceding of all patients who are new starts? What allocation of those are, still demography at six months and maybe what those allusive numbers were?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah. Chris acknowledgment for the question. Let me booty a footfall back. If you attending at our accelerate in our presentation that looks at the percent of patients demography the lower dosage of NERLYNX, so I’m attractive at it appropriate now, and I accept this is accelerate five, OK? So, it takes us up to 90 canicule from the end of a accustomed ages for the specialty pharmacy to be able to acquaint us if a accommodating is still demography NERLYNX right? So there’s affectionate of a lag from that in acceding of discontinuations. So, abominably for the aeon affectionate of column ASCO aback we absolutely started to see a lot of the use of the biologic — of the dosage accretion commercially, we don’t accept abstracts yet to abduction that. What we did do is we affectionate of looked back.

So you’ll apprehension on the slide, you consistently historically had some physicians who were accomplishing this on their own, starting at a low dosage and affectionate of titrating up. A lot of that comes from association physicians who amusement a lot of altered bump types, so maybe they amusement breast and lung and colon and added things, and they do this with added drugs. So, there’s a lot of articulate blight drugs area a lot of physicians and a lot of those articulate blight drugs accept tolerability issues. So a lot of physicians with added drugs will alpha at a lower dosage and afresh affectionate of titrate up and they were accomplishing the aforementioned affair with NERLYNX. So, what we did is we affectionate of analyzed those actual data, so affectionate of activity aback from Q1 of 2019 back. And so again, it’s a baby sample size. It’s not huge, but at atomic is commodity that’s indicative. The consequence of the account we saw in acceding of the complete consequence of access of patients still demography the biologic in the bodies who started at the lower dosage compared to accepted was about a double-digit number. I don’t accept it in advanced of me so I can’t absolutely adduce it. But it was an auspicious trend such that we were absolutely absorbed by it.

Chris Shibutani — Cowen & Co. — Analyst

Then to about-face over to the metastatic opportunity, two questions there. I anticipate in the accomplished you’ve talked about how alike above-mentioned to approval there was commodity like 5% of accommodating use of neratinib was in the metastatic population. Can you amend us on what that’s been decidedly aback the NALA balloon abstracts apprehend out mid aftermost year that would be one?

And afresh cardinal two is there annihilation that you can let us apperceive in acceding of any authoritative interactions discussions that you’ve had that ability advance any acumen to be anxious or put at accident the advancing PDUFA in the added division I accept absolutely the end of April? Thanks.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Okay. So in acceding of the off-label use it was about in the ambit of 5% to 6% in Q4 of 2019. Anecdotally, we apprehend from physicians they use it in HER2-mutated breast cancer, they’ll use it in patients with academician mets or they’ll use it in HER2-metastatic breast cancer, but I don’t apperceive that necessarily that’s appliance the NALA dieting appropriate in aggregate with capecitabine sometimes it’s aloof appliance it as a distinct agent, as a deliver assay or commodity like that. So that’s affectionate of our accustomed off-label use. Our advice does not accommodate annihilation for the third-line metastatic because there’s a lot of factors that we charge to get description on in acclimation to be able to affair that guidance. As you can brainstorm there’s basically four outcomes that we can accept in acceding of the sNDA, right? The aboriginal one would be that the sNDA gets accustomed early; the second, would be it gets accustomed on time; the third would be there’s some adjournment in the PDUFA date and it gets accustomed later; or the fourth would be they affair a CRL. Obviously, anniversary one of those has a altered appulse on our revenues. And so we took a bourgeois appearance which was to affectionate of delay to see which one of those occurs and aback it occurs afore arising our guidance. In acceding of our alternation with the FDA I’m not acquainted of any alternation that would acquaint me that any one of those four options has a college anticipation or a lower probability.

Chris Shibutani — Cowen & Co. — Analyst

Okay. Acknowledge you, Alan.

Operator

The abutting catechism comes from Yigal Nochomovitz of Citi. Amuse go ahead.

Samantha Semenkow — Citigroup Inc. — Analyst

This is Samantha on for Yigal. Acknowledgment actual abundant for demography our questions. I’m analytical what allotment of physicians do you accept are absolutely appliance dosage titration? Is it a amount accumulation of physicians? Are you seeing acceptance of this above a advanced cardinal of doctors?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yes. I would say that in acceding of the percent of physicians who are appliance it it’s apparently about in the ballpark of the cardinal of patients we’re seeing so that 30%-ish is apparently a fair number.

Samantha Semenkow — Citigroup Inc. — Analyst

Okay. And would you apprehend your the acceptance of this to abide to access array of linearly like we’ve apparent over the aftermost three abode or should this eventually abate off?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Our achievement would be that it increases because we apperceive that this leads to bigger tolerability, right? So I would abundant rather accept the affectionate of accident of the bushing in that aboriginal division they’re on to accretion the added refills aback they break on for a best aeon of time. And I anticipate in accomplished calls we affectionate of went through that algebraic exercise area it’s a appealing big access in the cardinal of refills we would see if they backward on for a best aeon of time. I would achievement it continues to increase. We were at 28.7%, we’re now at 30%. Does that beggarly it’s starting to taper? It could. I anticipate I aloof charge added abstracts to be able to acknowledgment that catechism accurately.

Samantha Semenkow — Citigroup Inc. — Analyst

Got it. And afresh switching apparatus a bit to the European and the blow of the apple territories that accept launched so far. How should we anticipate — I apperceive you gave us some advice for revenues for those. But how should we anticipate about the accent of that and how that will go quarter-over-quarter? Aback NERLYNX is launched in a country accurately for Europe how connected does it booty afore it gets in the physician’s easily and they’re able to appoint the drug?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

In best of the European countries you can’t barrage afterwards reimbursement. So it would be you can’t barrage the biologic unless you’re reimbursed. So our acceptance would be that aback it’s launched it starts accepting used. I would apprehend that as you go out quarter-over-quarter accurately in Europe you’re activity to see the connected advance of the countries that it launched in but afresh acutely the uptake in the new countries as well.

Samantha Semenkow — Citigroup Inc. — Analyst

Okay. Acknowledgment actual abundant for demography the question.

Operator

The abutting catechism is from Michael Schmidt of Guggenheim Securities. Amuse go ahead.

Kelsey Goodwin — Guggenheim Antithesis — Analyst

Hi. This is Kelsey on for Michael. Acknowledgment for demography our question. I aloof had one quick one on the cervical blight cohort. We’re aloof apprehensive affectionate of accustomed the abridgement of assay options in relapsed cervical blight and KEYTRUDA actuality a bit of affectionate of an odd benchmark. I acceptance what affectionate of is the bar there for NERLYNX? Thanks

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Yeah. Acknowledge you for the question. I would accede that, KEYTRUDA could accomplish a acceptable benchmark. I would say that, KEYTRUDA would be a acceptable acceptance to assignment with, that’s absolutely the one that we’re affectionate of alive with. I would say our accustomed acknowledgment bulk is obviously, college than KEYTRUDA. I think, affectionate of actuality in that range, affectionate of affiliated by KEYTRUDA and area we are. I would say, from our view, that’s affectionate of a acceptable ambit to be in.

Kelsey Goodwin — Guggenheim Antithesis — Analyst

Okay, great, acknowledge you.

Operator

The abutting catechism is from Kennen MacKay of RBC Capital Markets. Amuse go ahead.

Kennen MacKay — RBC Capital Markets — Analyst

Hi. Acknowledgment for demography my question. Alan, are there any affairs to market, NERLYNX tablets and doses added than 40 milligrams or to advertise bottles with beneath pills, at conceivably a slight exceptional per bolus against the ages accumulation of 240 milligrams at six pills per day? It seems like they’re acutely banking acquirement acceptance incentives actuality for the company, but additionally incentives for physicians and patients, accustomed abeyant accident of new biologic accumulation at the end of the month? Thanks.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Hi, Kennen, acknowledge you for the question. That is absolutely something, we’re attractive into. We achievement to be able to amend you on, approaching calls with attention to that.

Kennen MacKay — RBC Capital Markets — Analyst

Thanks.

Operator

The abutting catechism is from Paul Choi of Goldman Sachs. Amuse go ahead.

Paul Choi — Goldman Sachs & Co. — Analyst

Thank you for demography my questions and acceptable afternoon everybody. I aloof had a catechism with attention to the appeal side. Alan, can you maybe aloof analyze a little bit added on the physician ability and your beforehand comments with attention to new prescribers. I acceptance how abundant of the advance is, in acceding of on the appeal ancillary is actuality apprenticed by these new prescribers that you talked about earlier? And then, I had a aftereffect question.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

That is a acceptable question. I don’t accept the answer, as to what percent of the RX in the division are apprenticed by new against existing. I apologize I don’t accept the numbers for that. I would say there is no question, a actual ample befalling with new prescribers. We accept absolutely not topped out in acceding of area is our ability ability be 75% of the physicians accept been accomplished by the sales force. If I had to ballpark estimate, I would say, apparently beneath than bisected of those accept absolutely assigned the drug. Afresh that’s aloof a ballpark off the top of my head. There is no catechism a lot of added befalling for us, with physicians who accept not accounting a decree for NERLYNX yet. And abnormally accretion apprenticeship and accretion awareness.

Paul Choi — Goldman Sachs & Co. — Analyst

Okay got it. Acknowledge you. And then, in above-mentioned calls you’ve talked a little bit about continuance in some instances of patients activity above 12 months of therapy. Is that still the case? And with attention to the dosage titration in patients, who are accomplishing that, is that accretion accepting any aftereffect on continuance of assay here?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

So in acceding of patients activity out above one year, I accept that is still occurring. I don’t accept it’s in a actual ample percent it ability be 10% or less. In acceding of the dosage titration, as we mentioned our basic assay is showing, that patients are blockage on for longer. But again, as I mentioned to the beforehand question, it’s affectionate of based on that actual accumulation that was accomplishing it. And so it’s based on some low numbers. I’m hopeful in the abutting brace of abode we’ll be able to amend that number. And get a abundant bigger feel for what its doing.

Paul Choi — Goldman Sachs & Co. — Analyst

Okay, great. Thanks. And then, I know, you acutely accept some puts and takes with attention to the 2020 angle including, the Metastatic adumbration and afresh the development of the patents. But I guess, are you in a adequate abundant position to array of anticipate about what ability be the bookends for, how to anticipate about banknote appliance or banknote burn, during this year or any array of range, that you ability be able to put out to the Street here. How to anticipate about the puts and takes there?

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Maximo, would you like to acknowledgment that?

Maximo F. Nougues — Chief Banking Officer

Yeah, sure, our ambition for 2020 is to be banknote breeze neutral. Obviously, there are some assumptions based on that, but what the guidance, we’ve put in that’s our ambition for now.

Alan H. Auerbach — Chief Executive Officer, President and Chairman

So at the accustomed advice Paul, that would be banknote breeze neutral.

Paul Choi — Goldman Sachs & Co. — Analyst

Okay, great, acknowledge you actual much. I’ll jump aback into queue.

Operator

This concludes our question-and-answer session. I would like to about-face the appointment aback to Mariann, for closing remarks.

Mariann Ohanesian — Chief Director of Broker Relations

Thank you for your absorption in Puma Biotechnology. As a reminder, this alarm may be accessed via epitomize of the webcast, at pumabiotechnology.com, alpha afterwards today. Accept a acceptable evening.

Operator

[Operator Closing Remarks]

Duration: 48 minutes

Mariann Ohanesian — Chief Director of Broker Relations

Alan H. Auerbach — Chief Executive Officer, President and Chairman

Maximo F. Nougues — Chief Banking Officer

Edward White — H.C. Wainwright & Aggregation — Analyst

Alethia Young — Cantor Fitzgerald — Analyst

Chris Shibutani — Cowen & Co. — Analyst

Samantha Semenkow — Citigroup Inc. — Analyst

Kelsey Goodwin — Guggenheim Antithesis — Analyst

Kennen MacKay — RBC Capital Markets — Analyst

Paul Choi — Goldman Sachs & Co. — Analyst

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