Puma Biotechnology, Inc. Price & Performance (PBYI)

Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking For a full discussion of these risk [indiscernible] Please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10 ks for the year ended December 31, 2024.

You are cautioned not to place undue reliance on these forward looking statements which speak only as of the date of this live conference call. 02/27/2025. Puma undertakes no obligation to revise or update any forward looking statements. To reflect events or circumstances after the date of this conference call, except as required by law, During today's call, we may refer to certain non GAAP financial measures that involve adjustments to our GAAP figures. We believe these non GAAP metrics may be useful to investors as a supplement to but not a substitute for our GAAP financial measures. Please refer to our fourth quarter twenty twenty four earnings release for a reconciliation of our GAAP to non GAAP results. I will now turn the call over to Alan.

Thank you, Mary Anne. And thank you all for joining our call today. Today, Puma reported total revenue for the fourth quarter of twenty twenty four fifty nine point one million dollars Total revenue includes product revenue net which consists entirely of NERLYNX sales, as well as royalties from our sublicensees. Product revenue net was $54,400,000 in the fourth quarter of twenty twenty four, which declined from $56,100,000 reported in Q3 twenty twenty and increased from the $53,200,000 reported in Q4 twenty twenty three.

By approximately $3,700,000 of inventory increase at our specialty pharmacies and distributors.

Royalty revenue was $4,700,000 dollars in the fourth quarter of twenty twenty four compared to 24,400,000.0 in Q3 twenty twenty four and $19,000,000 in Q4 twenty twenty three. Royalty revenue in the third quarter of twenty twenty four and fourth quarter of twenty twenty three included the sales to China by our partner, Pierre Farb, as we noted in our calls for those quarters. We reported 2,964 bottles of NERLYNX sold in the fourth quarter of twenty twenty four an increase of two forty one from the 2,723 bottles sold in Q3 twenty twenty four. In Q4 twenty twenty four, we estimate that inventory increased by about two zero five bottles. In Q4 twenty twenty four, new prescriptions, 7% compared to Q3 twenty twenty four, and total prescriptions TRx were up approximately 4% compared to Q3 twenty twenty four. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter and then Jeff Ludwig will add additional color on NERLYNX commercial activities, Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of twenty twenty four. There is currently an ongoing Phase one trial is sponsored by the National Cancer Institute to evaluate the combination of neratinib and trastuzumab duruxtacan, otherwise known as INHER2.

In patients with metastatic solid tumors. The Phase one trial includes patients with metastatic solid tumors harboring HER HER2 overexpression IHC3 plus RB2 amplifications, or activating HER2 mutations. The primary objectives are to assess safety and tolerability of the combination The secondary objectives include evaluating pharmacokinetics, preliminary efficacy and potential biomarkers of response. We anticipate that interim data from this trial will be presented in the first half of twenty twenty five. In addition, Puma currently has two ongoing Phase two trials of our investigational drug, Allosertib. The first is the Alloska Breast-one patients with chemotherapy naive HER2 negative hormone receptor positive metastatic breast cancer. The second is the Alyssa Lung-one trial. Which is a Phase two study looking at the efficacy of allicertib monotherapy in patients with small cell lung cancer. As a reminder, the Alyssa Breast I trial investigates alicertib in combination with endocrine treatment The endocrine treatment consists of either a nastrozole, exemestane, let'srozole, or tamoxifen. In patients with chemotherapy naive HER2 negative, hormone receptor positive metastatic breast cancer. Patients must have received Previous treatment with a CDK4six inhibitor and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for for the trial.

Patients are being dosed with Allosertib at either thirty milligrams forty milligrams or fifty milligrams twice daily on days one to three, eight to ten and fifteen to seventeen on a twenty eight day cycle combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment that will be given in combination with Allosertib in the trial. The primary efficacy endpoints include overall response rate, duration of response, disease control rate and progression free survival. A secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups, order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in preclinical and clinical studies in other cancers including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of Alacertib combination with endocrine therapy for patients with HER2 negative hormone receptor positive breast cancer, in patients with these biomarker. The trial was initiated in late November twenty twenty four. There are currently 22 sites that have been activated for the trial and the trial is enrolling ahead of expectations. There are currently 14 patients enrolled in the trial with four additional patients in screening.

We look to have interim data from this trial later in 2025. With respect to ALLISCA Lung-one, as discussed on the last conference call, the company believes that the data obtained from the Alyssa Lung-one trial providing a preliminary indication of potentially better activity in patients with biomarkers where the AURORA kinase pathway The company recently met with members of the steering committee for the trial and the committee recommended expanding enrollment in the trial patients that have been treated with additional lines of prior treatment as the current protocol limits enrollment in the trial to patients with up to two prior lines of therapy. Biomarkers that correlate with AURORA kinase activity tend to be acquired as a mechanism of resistance to treatment. So by opening up the protocol to patients with additional lines of treatment, that will allow for enrichment of these biomarkers. The company is in the process of amending the protocol to allow for this. The company looks to have additional interim data from this trial later in 2025. As mentioned on prior earnings calls and in response to investor questions, we continues to evaluate several drugs to potentially in license, that would allow the company to diversify itself and leverage our existing R and D, regulatory and commercial infrastructure.

The company will keep investors updated on this as it progresses. I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the quarter.

Thanks, Alan. Appreciate it. And thanks to everyone for joining our fourth quarter earnings call.

Before I move into the commercial review, just a reminder that I will be making forward looking statements. That a significant unmet need remains. The Puma commercial team is committed to increasing the utilization of NERLYNX, which a focus on patients that are deemed to have a higher risk to reoccurrence. Our teams are working very hard to increase our engagement with clinicians through both personal and non personal promotion, we with a heavy emphasis on increasing engagement when treatment decisions are being made. Q4 call activity decreased quarter over quarter as expected given vacations and holidays, but did increase about 7% year over year.

We are working with new partners new data and new approaches to not only continue to We are also exploring opportunities to better support patients who are on NERLYNX with the goal of appropriately maximizing persistence and compliance. And are committed to becoming more efficient and effective with our resources, and are committed to balancing the short term and long term goals of Puma and its shareholders. Let me now transition to some of the commercial slides where I'll provide some additional specifics around performance I have finished, I'll turn the call over to Maximo for a more detailed review of our financial results.

On Slide three, we have an overview of our distribution model which is broken out into the specialty pharmacy channel, and the specialty distributor or in office dispensing channel. We added BioCare to our SD distribution network in Q4 of twenty twenty four.

BioCare is the exclusive distribution partner to the newest community on A significant portion of our business is driven by community ecologists so it made good sense to expand our networks to further support these providers. In regards to the overall distribution of our business, in Q4, about 75% of our business was purchased through the SP channel. And the remaining 25% was purchased through the SD channel. This is similar to what we reported during our Q3 earnings call. Now turning to Slide four. NERLYNX net revenue in Q4 of twenty twenty four was $54,400,000 which represents a decline of $1,700,000 from the $56,100,000 we reported Q3 of twenty twenty four, and a $1,200,000 increase from the $51,600,000 we reported in Q4 of twenty twenty three.

The significant changes in quarterly net revenue revenue was driven primarily by four factors.

One, inventory changes. Two, higher U. S. X factory sales, three, a decrease in product supply revenue to our global partners and four, a higher gross to net adjustment. I will provide some more details around product supply revenue in and inventory changes and maximum will provide some additional specifics during his update.

In Q4 of twenty twenty four, we recorded product supply revenue of $800,000 versus $7,400,000 in Q3 of twenty twenty four and $5,300,000 in Q4 of twenty twenty three. In Q4 of twenty twenty four, we estimate that inventory increased by about $3,700,000 As a comparator, we estimate that inventory increased by about $600,000 in Q3 of 'twenty four an increase by about $2,100,000 in Q4 of twenty twenty Slide five shows Q4 of twenty twenty four ex factory bottle sales and also provides both a year over year and a quarter over quarter comparison.

In Q4 of twenty twenty four, NERLYNX XFAC factory bottle sales were 2,964 which represents an approximate 9% increase quarter over quarter. And a 3% increase year over year.

Similar to the prior slide, let me specifically call out the inventory changes from a bottle We estimate that inventory increased by two zero five bottles in Q4 of twenty four?

And as a comparator, we estimate that inventory increased by 37 bottles in Q3 of twenty twenty four an increase by 127 bottles in Q4 of twenty twenty three.

Let me just take a moment to provide additional metrics and insights into our fourth quarter As a reminder, we historically have seen enrollments and new patient starts soften in the fourth quarter as physicians and or patients choose to initiate their therapy after the holidays to avoid the potential side effects of NERLYNX, which typically occur in the first month or so. Q4 of twenty twenty four followed that historical pattern. In Q4, saw enrollments decline 7% quarter over quarter and about 10% year over year.

New patient starts or NRx decreased 7% quarter over quarter but increased 10% year over year.

Turning to total prescriptions or TRx, We saw TRx grow 4% quarter over quarter and also grew 3% year over year.

Finally, let me give you some more insights and specifics around demand.

In Q4, we saw demand grow It also grew numerically higher but was essentially flat as a percentage year over year. Specifically Q4 of 'twenty four versus Q4 of 'twenty three.

Slide six highlights the quarterly adoption of dose escalation since SnerLink's launch. In Q4, approximately seventy four percent of patients started NERLYNX at a reduced dose.

This is similar to the seventy six percent we reported in Q4 of twenty twenty three but higher than what we have reported in the last several quarters. Continued messaging and adoption of dose escalation is an important part of our commercial strategy. A reminder, the control trial showed a significant reduction in Grade three diarrhea and improved persistence and compliance when patients were started at a lower dose. We track multiple cohorts of patients and continue to see improved compliance when patients are started at a lower dose.

Opportunities to better support patients throughout their entire NERLYNX therapy.

Slide seven highlights the strategic collaborations we have formed across the globe. In Q4, NERLYNX received regulatory approval in the extended adjuvant setting in and also received regulatory approval for both extended adjuvant and metastatic breast cancer in Thailand. We are also pleased to announce that NERLYNX was commercially launched in the extended adjuvant setting in both Turkey and Saudi Arabia.

We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward. I'd like to wrap up by thanking my Puma colleagues for their passion and commitment to helping patients and their families battling breast cancers. Know all too well the devastating effects this disease can have and we're committed to finding ways to increase our support of these patients throughout their journey. I'll now turn the call over to Maximo for a review of our financial results.

Thanks, Jeff. I will begin with a brief summary of our financial results. Our financial results for the fourth quarter of twenty twenty four Please note that I will make comparisons to Q3 twenty twenty four which we believe is a better indication of our progress a commercial company than year over year comparisons. For information, I recommend that you refer to our twenty twenty four ten ks which will be filed today and includes our consolidated financial statements. For the fourth quarter of twenty twenty four, we recorded net income based on GAAP of $19,300,000 or $0.39 per share. This compares to net income in Q3 twenty four of $20,300,000 or $0.41 per share. The fourth quarter of twenty twenty four we released a portion our valuation allowance resulted in a non cash deferred tax income benefit of $7,100,000 The valuation allowance was established to offset our deferred tax assets which are primarily related to our historical losses. This significantly increased our net income for the quarter. [indiscernible] On a non GAAP basis, which is adjusted to remove the impact of stock based compensation expense, we reported net income of $21,100,000 or $0.43 per basic and diluted share. For the fourth quarter of twenty twenty four.

Gross revenue from NERLYNXS was $66,500,000 in Q4 twenty twenty four. And $67,700,000 in Q3 twenty twenty four. [indiscernible] from NERLYK sales was $54,400,000 down slightly from the $56,100,000 reported in Q3 twenty twenty four. Was driven by two factors. Lower product sales to our global partners as we recorded only $800,000 in Q4, versus $7,400,000 in Q3 and higher gross to net expenses. These were partially offset by higher U. S. Demand and inventory build. Inventory increased by our distributors was approximately $3,700,000 in Q4 versus an increase of approximately $600,000 in Q3 twenty twenty four. Royalty revenue totaled $4,700,000 in the fourth quarter of twenty twenty four, compared to $24,400,000 in Q3 twenty twenty four. By our licensing partner PurePharm. Our gross to net adjustment in Q4 twenty twenty twenty four was about 18.2% compared to the 17.1% gross to net adjustment reported in Q3 twenty Cost of sales for Q4 twenty twenty four declined to 13,900,000.0 and includes $2,400,000 for the amortization of intangible assets related to our neratinib license. Cotto sales for Q3 twenty twenty four was $29,100,000 reflecting the sales of Nellix to China. Going forward, we will continue to recognize amortization of milestones to the licensor about $2,400,000 per quarter as cost of sales.

For fiscal year twenty twenty five, Puma anticipates a net Nellix product revenue will be in the range of $192,198,000,000 dollars We also anticipate that our gross to net adjustment for the full year 2025 will be between 20.521.5%. In addition, for fiscal year twenty twenty five, we anticipate receiving royalties from our partners around the world in the range of $20,000,000 to $24,000,000 lower than 2024 due to fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of twenty twenty five. We don't expect license revenue in 2025. We also expect that net income for the dollars dollars We are not forecasting any potential release of any additional tax tax asset valuation allowance in our net income estimate at this time.

However, this will be evaluated on an ongoing basis. We will continue to keep investors updated on this as it progress. We anticipate that for Q1 twenty twenty five, Nellix product revenue net will be in the range of $41,000,000 to $43,000,000 Also, we expect Q1 royalty revenues and no license revenue. We further estimate that the gross to net adjustment in Q1 twenty twenty five will be approximately $22,500,000 to twenty three point five We anticipate a Q1 net loss between $2,000,000 and breakeven. As investors are aware, Q1 usually represents the lowest net product revenue of the four quarters due to the burn off of the inventory build from Q4. SG and A expenses were $16,600,000 in fourth quarter of twenty twenty four, compared to $16,800,000 for the third quarter of twenty twenty four. SG and A expenses included non cash charges for stock based compensation of $1 for Q4 and $1,500,000 for Q3 twenty twenty four. Research and development expenses were $15,200,000 in the fourth quarter of twenty twenty four, an increase from $12,500,000 in the third quarter of twenty twenty four. R and D expenses included non cash charges for stock based compensation of $500,000 in the fourth quarter of twenty twenty four and $600,000 in the third quarter of twenty twenty four.

On the expense side, GUM anticipates flat to a slightly lower than total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG and A expenses to decrease by 5% to 10% and R and D R and D expenses to increase by 10% to 15% year over year. In the fourth quarter of twenty twenty four, Puma reported cash earned of approximately $4,300,000 This compares to cash burn of approximately $100,000 in Q3 twenty twenty four. Please note that during Q4, we made our third long payment of $11,100,000 related to our obligation with Ethereum. As a result of this, our total outstanding principal debt balance increased to approximately $67,000,000 At 12/31/2024, we had approximately $101,000,000 in cash cash equivalents [indiscernible] Versus about $96,000,000 at year end in 2023. Our accounts receivables balance was $32,000,000 Our accounts receivable terms range between ten and sixty days but our days sales outstanding are about forty eight days. We estimate that as of 12/31/2024, our distribution network maintained approximately four weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX the development of alternative and controlling our expenses. Thanks, Maximo.

Ooma Senior Management, in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2025 and beyond recognizes its fiscal responsibility to shareholders. Continue to maintain positive net income. We believe that the positive net income that was seen in fiscal years 2023 and 2024 resulted from the financial discipline across the company over the last few years. The expense reductions that we have performed and continue to perform are also a major contributor to the positive net income the company achieved in Q4 twenty twenty four and that the company is guiding to for full year 2025. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this. Look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors.

We We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q and A. [indiscernible] Thank you. We will now begin the question and answer session. Our first questions come from the line of Ed White with H. C. Wainwright. Please proceed with your question.

Good afternoon. Thanks for taking my questions.

Alan, just wanted to ask a question on the Phase one MCI data within HER2. You had said that you could see interim data in the first half of twenty five. Do you expect this to be presented at a medical conference perhaps ASCO or is the something that you'd release perhaps in a press release?

Yes. Hi, Ed. Thanks for the question. It has been submitted [indiscernible] I apologize for the lack my memory loss here. It was either AACR or ASCO.

So one of those two.

That's where I would expect it to be presented. Okay, great. Thank you. And Jeff, you mentioned that you're trying to maximize persistence and compliance. Can you give us some statistics on what persistence and compliance is right now How you're thinking about it? And what are the steps that you're taking? [indiscernible] a couple of things we're trying to do. One, from a clinical perspective, we are educating customers using clinical data that shows the benefits [indiscernible] finishing therapy or staying on therapy greater than eleven months. We have very good clinical data from the EXODENT study showing the benefits of that. We are working now to achieve that and extend that length of therapy. We are working very closely with our S partners, all of our sales reps. Also, we have reports looking at delayed refills, pending refills. So we're trying to edge engage with customers throughout their entire journey to give them the best chance and the best support to stay on therapy throughout the recommended likely twelve months.

Our marketing team is also creating an additional piece that really does a nice job of highlighting all the benefits and support that we can offer a patient throughout their journey and that will be shipped with all refills coming here very quickly here in 2025. From a From a data perspective, Ed, you've asked me this question. Let me give you some more color here. As I look at dose escalation again being another part of increasing that persistence and compliance, as I look at the most recent cohorts of data that we've talked about previously, we continue to follow multiple cohorts of data.

And whether I look at a three month cohort that started a year ago, following that three month cohort from a year ago till now, If I back up a little farther looking at a six month cohort following that six month group of patients out a year and even a nine month, what we see every step of the way we see now about a 5% to ten percent more patients remaining on therapy if you started a lower dose than if you started on full dose.

So that is contributing to us extending that length of therapy a little bit and giving us some benefits on our forecast as well. Is that helpful? Yes, it is. Thank you.

And I just wanted to the revenue guidance for the year is sort of flattish.

I guess how are you thinking about [indiscernible] In that guidance? So, Ed, a couple of things as as I think Maximo shared as well. There's a couple of things going on there with guidance. One is we do see a decrease in product supply revenue in 2025 versus 2024.

We did take price that's already been announced. We did take price in early Q1 of twenty twenty five. We announced that. That was a 7% price increase. As I think about just pure demand, last year, if you look at the demand that we reported, demand declined a about 9% or 10% year over year. We are forecasting to a demand decline currently of about 2%. Now that's in our guidance Obviously, it's my job to not let that happen and exceed that, but we're forecasting to a demand decline of about 2% year over year.

Okay, great. Thanks, Jeff. And my last question is just when thinking about the royalty stream from outside of The U. S, How should you had mentioned China would be down. Do we think about China being lumpy as we've seen in the past with with just boluses of revenue and then nothing again? Yes. So yes, Ed, Yes, Ed. So you're correct. In all of our revenue, streams that we get from royalties, we get paid basically as the drug is sold, so it's just a straight royalty. China is a little bit different, because it's sold through a distribution network. So we basically sell it to our partner and then once it's sold to them, they put it into the distribution network. So it's not as directly time related demand driven. So, we're in the as Maximo mentioned in his script, we're in the process of having the official registration authorization transferred from us to PR we kind of built up some inventory ahead of that. So I would expect the shipments to be a little bit lower, 2025 and that's one of the reasons you see the the decline in royalties year over year.

And to answer your question, yes, it would be kind of lumpy as well. And Al, let me just add one more piece as we look at China. The one thing I do want to comment Alan's talking about the lumpiness. We do pay attention to in market demand and in market demand continues to be on track with previous estimates and is still forecasted to grow as we previously saw. So we do not have a demand reduction in China.

Okay, great. Well, thanks for taking my questions. Thank you. Our next question comes from the line of Mark Frum with TD Cowen. Please proceed with your questions.

Hi. Thanks for taking my questions.

Maybe one on the commercial side. Just there's the second part of the IRAs Part D redesign. And another kind of payment reforms this year. Just any impact you're seeing in the early returns here in the first couple of months of the year terms of how the patients experiencing reimbursement Mark, we're not seeing a an overall big impact. One is when you think about that reform, what I will tell you is our distribution of Medicare patients and the trends on Medicare patients have been fairly stable.

Our length of therapy on Medicare is fairly consistent.

So we're not seeing a significant change in trends that we have seen prior based on the IRA reform at this point in time.

Okay. That's helpful. Maybe just on the breast cancer trial for AlloSureta, just the interim data, can you run through the expectations there for remind us just how much data you expect to be able to share at that interim?

Yes, Mark.

I think we'll have a better idea of like number of patients and things like that. Probably next earnings call or so. But again, they're being randomized to one or three doses So obviously, we would have probably some early response, early duration data If you look at the most recent trial that was done, which is the TBCRC forty one trial. The median PFS there was like five point five months. [indiscernible] Assume her patient is coming on in March, if that's the PFS they see, we're not going to see that end for quite some time. So a lot of it would probably be ongoing data, where it's kind of a plus next to the number. That would be something to anticipate.

Okay.

Very helpful. Thank you. Our next question is coming from the line of Gena Wang with Barclays.

Please proceed with your questions. Hi. Thanks for taking my question. This is Hung Gu on behalf of Gena Wang from Barclays. I just want to follow-up with the HER2 cancer for the Allysco.

Phase two trial. So I'm curious like what's your bar regarding the FDA and the safety you want to hit in this trial? [indiscernible] Can you clarify which trial you're referring to? Are you referring to the breast or the lung? The breast. Yes.

So the best marker for expectation of the breast trial would probably be the TBCRC-forty one trial. We're doing the same. So the TBCRC-forty one trial was fifty milligrams of Allosertib given BID, same dosing schedule, three days a week three weeks in a twenty eight day cycle. Now again, we're going thirty milligrams, forty milligrams, fifty milligrams.

So a reason for doing that. We're trying to look for if there's a dose response to satisfy Project Optimus from the FDA. So that would probably be the bar I would look to as the comp.

Thanks. That's helpful. Thank you. That concludes our question and answer session. I would now like turn the conference back over to Mary Anne for closing remarks.

Thank you all for joining us today.

As a reminder, this call may be accessed via replay of the webcast at pubabiotechnology.com beginning later today. Have a good evening.

You may now disconnect.