Q3 2023 Puma Biotechnology Inc Earnings Call
Good afternoon, My name is Camille and I will be your conference call operator today.
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I would now like to turn the conference call over to Marianne O'hare.
Oh, Hey, listen.
Senior director of Investor Relations for Puma Biotechnology.
Thank you you may begin.
Thank you Camilla good afternoon, and welcome to <unk> conference call to discuss our financial results for the third quarter of 2023.
Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of Board of Puma Biotechnology.
Max ammonia guess, Chief financial Officer, and Jeff Ludwig Chief Commercial Officer.
After market close today Puma issued a news release detailing third quarter 2023 financial results.
That news release, the slides that Jeff what we refer to and a webcast of this call are accessible via the home page and investor sections of our website at Puma Biotechnology dotcom the.
The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Today's conference call will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.
For a full discussion of these risks and uncertainties. Please review our periodic and current reports filed with Securities and Exchange Commission from time to time, including our annual report on Form 10-K for the year ended December 31 2022.
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 November 2nd 2023.
The company undertakes no obligation to revise or update any forward looking statements.
Reflect events or circumstances. After the date of this conference call, except as required by law.
During today's call. We May also research of 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 as substitute for.
Our GAAP financial measures.
Please refer to our third quarter 2023 news release for a reconciliation.
GAAP to non-GAAP results.
I will now turn the call over.
Thank you Marianne.
Thank you all for joining our call today.
Today Puma reported total revenue for the third quarter of 2023, $56 1 million.
Total revenue includes product revenue and net which consists.
Entirely new airlink sales as well as royalties from our sublease space.
Product revenue was $51 6 million in the third quarter of 2023, which was unchanged from Q2, 2023, and $2 $7 million below $54 3 million reported in two.
Q3 2022.
Product revenue for the third quarter of 2023 was impacted by approximately 0.6 million inventory increase and our specialty pharmacies and specialty distributors royalty revenue was $4 5 million in the third quarter of 2023 compared to 3 million in Q2 2023 and two.
8 million in Q3 of 2022.
We reported 2874 bottles of nearly sold in the second quarter of 2000.
23, a decrease of 148 bottles from the 3022 bottles sold in Q2 of 2023.
In Q3, 2023, we estimate the inventory increase by about 32 boss.
In Q3 2023, new prescriptions are in Rx, we're down approximately 15% compared to Q2, 2023, and total prescriptions or <unk> were down approximately 7% compared to Q2 of 2023.
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 the earliest commercial activities Maximo <unk> will follow with highlights the key components of our financial statements for the third quarter 2023.
As we mentioned on our last earnings call in Q3.
File its I N D with the FDA for a phase two study.
They all started monotherapy in patients with small cell lung cancer known as study chromite ally 40 to a one.
The trial will enroll up to 60 patients with extensive stage small cell lung cancer.
Progressed after a first line of platinum based chemotherapy and immunotherapy.
Patients must provide tissue based biopsies. So the biomarkers can be analyzed Alistair will be dosed at 50 milligrams B I D. On days one through seven every 21 day cycle.
From a player's to perform an initial interim analysis and evaluation of the Biomarkers as well as an evaluation of the efficacy.
As we discussed in our last earnings call. All of this phase two study will be to confirm the efficacy of <unk> monotherapy in patients with small cell lung cancer with biomarkers for the IRAK kinase pathway plays a role.
The goal would be to correlate the efficacy and these biomarker subgroups and the pull my ally 40 to a one study.
So the efficacy that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel, plus Alistair versus Paclitaxel plus placebo that was published in the journal of thoracic oncology in 2021.
Z and biomarker data are comparable from the two studies the company believes it could represent a potential accelerated approval strategy.
In August we announced that the FDA has determined that the phase two Puma L. A 40 to a one study it was safe to proceed we expect to have multiple sites open for enrollment between now and the end of the year and we are hopeful that we'll be able to enroll patients by year end, although we recognize the challenges I'm trying to enroll patients during the November and December.
Remember holidays, we continue to anticipate that there will be several critical milestones for the allo certain program in the coming months. This includes initiating a phase two clinical trial of al assertive in small cell lung cancer before the end of the year conducting the meeting with the FDA to discuss the clinical development and registration path for al asserted in hormone receptor positive.
It hurts you negative breast cancer in the fourth quarter of 2023, and then initiating the phase III trial of Al assertive in this patient population in 2024.
As mentioned on prior earnings calls and in response to Investor questions too much and continues to evaluate several drugs to potentially in license that would allow the company to diversify itself and leverage come with existing R&D regulatory and commercial infrastructure.
Company will keep continue to keep investors updated on this as it progresses I will now turn the call over to Jeff Ludwig Promus, Chief Commercial officer for a review of our commercial performance during the quarter.
Thanks, Alan I appreciate it and thanks to everyone for joining our third quarter earnings call.
Before I move into the commercial review just a reminder, that I will be making forward looking statements.
So let me start with an overview of our commercial strategy.
We remain largely focused on the extended adjuvant indication for neuro lengths were about 90% of our business is generating we believe there continues to be significant unmet need, especially for patients at higher risk of Reoccurrence.
We also believe that New Orleans is promotional sensitive and given this our sales and marketing teams are focused on increasing our reach and frequency with both personal and non personal promotion, it's important to engage with customers at the right time, given the various treatment decisions and duration of therapies.
As a commercial organization, we are committed to becoming more efficient and more effective with our resources and will adapt appropriately based on changes in the business.
Let me transition to some of the commercial slides, where I will provide additional specifics around performance. Once finished I will turn the call over to Maximo for a more detailed review of our financial results.
Turning to slide three slide three provides an overview of our distribution model and this model has not changed and remains separated into two distinct channels that provide near links to patients. We refer to these channels as our specialty pharmacy channel and our specialty distributor channel.
Most of our business continues to flow through the specialty pharmacy channel.
In Q2 in Q3 of 2023, approximately 80% of our business went through the specialty pharmacy channel, which is up from the 74%. We reported in Q2 of this year and identical to what we reported in Q3 of 2022.
Turning to slide four neuro links net revenue in Q3 of 2023 was $51 6 million, which is identical to what we reported in Q2 of 2023 and down approximately $2 7 million from what we reported in Q3 of 2022.
Inventory changes can have an impact on these numbers. So let me give you. Some additional insights which are also included on this slide in.
In Q3 of 2023, we estimate that inventory increased by about $600000.
As a comparator we estimate the inventory increased by about 500000 in Q3 of 2022 and decreased by about $1.5 million in Q2 of 2023.
Slide five shows Q3 ex factory bottle sales and also provides both a year over year and a quarter over quarter comparison.
In Q3 of 2023 neuro links ex factory bottle sales for 2874, which represents about a 5% quarter over quarter decline in about a 10% year over year decline.
Let me again provide more specifics around the inventory impact which is also included at the bottom of this slide.
We estimate the inventory increased by about 32 bottles in the third quarter of 2023.
As a comparison, we estimate the inventory increase by about 30 bottles in Q3 of last year and declined by about 89 bottles in Q2 of 2023.
Let me provide some additional metrics and insights into our third quarter performance.
In Q3, we saw on new patient starts or interacts declined about 15% quarter over quarter and about 30% year over year.
In terms of total prescriptions, we saw about a 7% decline quarter over quarter and about 11% decline year over year.
As a reminder, we do not pick up interacts or T. Rx data and the SD channel. So we do not have the same level of visibility for patients that start and stay on the S. D channel.
In regards to the demand we saw demand decrease about 8.5% quarter over quarter and about 10% year over year.
Now our Q3 performance was heavily driven by declining enrollments that occurred for several consecutive weeks.
The quarter.
We saw a solid increase in enrollments in June but saw a significant decline in enrollment starting the second week in July and continuing through early August.
We reached out to customers across the country to inquire about patient flow and patient volume and although there were some reported softness it was not a consistent trend.
Since that early softness which occurred largely in July we have seen steady monthly improvement with enrollments trending positively month over month throughout Q3.
In addition October enrollments have continued their positive trend and are in line with enrollment seen in Q1 and Q2.
Slide six highlights the adoption of dose escalation dose escalation is an important metric for us as it serves to improve the tolerability of near links by significantly reducing grade three diarrhea, and decreasing overall discontinuation rates.
In Q3, approximately 71% of patients who receive commercial drug started neuro links on a lower daily dose we.
We have seen a fairly steady increase in the adoption of dose escalation over the last several years and I'm overall pleased with that uptake.
Moving to slide seven slide seven highlights the strategic collaborations we have formed across the globe. In Q3, we were very pleased to announce that <unk> received regulatory approval in the metastatic setting in Malaysia. It was also formally launched in the metastatic setting in Colombia.
We truly appreciate the efforts by all of our partners to continue to make neuro links available to more patients around the world.
I'd like to wrap up by thanking my colleagues for their support and commitment. The team is absolutely passionate about making a difference in the lives of patients battling cancer. They are also committed to being more efficient and more effective with our resources and they are committed to balancing the short term and long term priorities of Puma and its shareholders.
I will now turn the call over to Maximo for a review of our financial results Maximo.
Thanks, Jeff.
I'll begin with a brief summary of our financial results for the third quarter of 2023.
Please note that I will make comparisons to Q2, 2023 which we believe is a better indication of our progress as a commercial company than year.
Over year comparisons.
For more information I recommend you refer to our Q3, 23, 10-Q, which will be filed today and includes our consolidated financial statements.
The third quarter 223 reported net income based on GAAP of $5 8 million or 12 cents per share.
This compares to a net income in Q2, 2023 it was $2 1 million or <unk> <unk> per share.
non-GAAP basis, which is adjusted to remove the impact of stock based compensation expense.
We reported net income of $8 3 million or 18 cents per share for the third quarter of 2023.
Gross revenue from Nellix sales was $60 4 million in Q3, 2023.
$62 8 million in Q2, 2023.
So I would imagine it net product revenue from Nellix sales was 51 6 million unchanged from the $51 6 million reported in Q2 2003.
We believe that Q3 net sales were impacted by approximately 600000 well inventory.
Increases from our distributors versus approximately $1 5 million of inventory draw down in Q2.
Yeah.
Royalty revenue.
At $4 5 million in the third quarter of 2023 compared to <unk> 3 million in Q2, 2023.
The higher royalties versus Q2 reflect the timing of shipments to our partner in China as we noted last quarter.
Our gross to net adjustment in Q3, 2023 was about 14, 6%.
Compared to the 17, 9% gross to net adjustment reported in Q2 223.
Lower Medicaid rebates was the main driver of the decrease versus Q2 'twenty to 'twenty three.
In Q3, 2023 we released prior period accruals related to expected Medicare rebates that have not materialized to date.
Cost of sales for Q3, 2023 was $13 3 million, including $2 4 million for the amortization of intangible assets related to the two hour neuropathy live license.
Cost of sales for Q2, 2023 was $11 9 million.
Going forward, we will continue to recognize amortization of milestones to the license sort of about $2 4 million per quarter as cost of sales.
Our fiscal year 'twenty to 'twenty, three Puma anticipates that net nellix product revenue would be in the range of $206 million to $209 million.
We also anticipate that our gross to net adjustment for the full year 2023 will be between 17, 5%.
18%.
In addition for fiscal year 'twenty to 'twenty, three we anticipate receiving royalties from our partners around the world in the range of 30 to 32 million.
We don't expect license revenue in 2023.
We also expect that net income for the full year will be in the range of 22 to 25 million.
Our royalties in the fourth quarter.
Depending on the shipments to our ex U S partners are not expected to occur between now and the end of the year.
If there are any delays to this shipments it could adversely adversely impact our revenue.
We anticipate that for Q4 'twenty to 'twenty three Nellix next product revenue will be in the range of 56 to 59 million.
We also expect Q4 royalty revenues will be in the range of 16 to 19 million.
We further estimate that the gross to net adjustment in Q4, 2023 will be approximately 15, 5% to 65%.
Puma anticipates, a Q4 net income between 13 and 16 million.
SG&A expenses were $22 8 million in the third quarter of going 23, compared to 24 4 million for the second quarter.
SG&A expenses included noncash charge charges for stock compensation of 1.8 million.
Q3, 2023 unchanged from Q2, 2023.
Research and development expenses were $11 4 million in the third quarter of 223.
Compared to $13 4 million for the second quarter.
R&D expenses included noncash charges for stock based compensation of 0.8 million the third quarter of 223 unchanged from the second quarter.
In the third quarter of 2023, Puma reported cash burn of approximately $10 6 million.
This compares to cash burn of approximately $3 2 million in Q2, 'twenty or 'twenty three.
On the expense side.
<unk> continues to anticipate a reduction in total operating expenses in 2023 compared to 2022 more.
More specifically, we anticipate SG&A expenses to be flat or increase by approximately 1% to 2%.
And R&D expenses to increase 1% to 3% year over year.
At September 30th 2023 we had approximately $85 million in cash cash equivalents and marketable securities.
Our accounts receivables balance was 29 million.
The accounts receivable terms range between 10 and 68 days.
Our days sales outstanding are about 45 days.
We estimate that as of September 30th 2023 our distribution network maintained approximately three weeks of inventory.
Overall, we continue to deploy our financial resources to focus on the commercialization owner links.
Elements of all assertive and controlling our expenses.
Thanks Maximo.
We are pleased to report positive net income as well as positive cash flow during the third quarter of 2020.
From a senior management in cooperation with board of Directors continues to remain focused on improving the early sales in 2023 and beyond the.
The fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows. We believe that the positive net income and cash flow reported in the third quarter reflect these expense reductions the expense.
Reductions that we have previously performed and continued to perform are also a major contributor to the positive net income and positive cash flow. The company is anticipating for full year 2023.
<unk> remains committed to continuing to achieve these operational cash flows and the net income and will continue to reduce expenses if needed in order to achieve that.
We look forward to updating investors on this in the future to.
It continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors. We have puma are committed and passionate about finding more effective ways and helping these patients during their journey and we will continue to strive to achieve that goal.
This concludes today's presentation, we will now turn the floor back to the operator for Q&A operator.
Thank you we will.
Now begin the question and answer session. If you wish to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question queue. If you wish to withdraw your question. Please press star two.
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Thank you.
And your first question comes from Ed White with H C. Wainwright. Please proceed with your question.
Hi, good afternoon, thanks for taking my questions.
Uh huh.
First question is just sort of a housekeeping thing and maybe I missed it but what was the percent of free drug.
That you experienced this past quarter.
And I'm looking for that exact percentage and if you just give me a moment I'll find out to you, but we've not seen any significant change in free drug increases or decreases over the last several quarters. So give me one second as you ask your second question I'll give you up her center.
Oh, Okay, Yeah, Jeff. The other question was for you too and just wanted to.
Get a little bit more color about the.
New prescription weakness in July and into August and what gives you confidence that.
You'll see a recovery.
In the fourth quarter.
Hey, Thanks for the question and we free drug were about 14% of free drug and that's been fairly consistent for us over the last several quarters in terms of total bottles.
A great question the softness we saw in early and let me just let me just remind you what I said upfront and give you a little bit more color as I mentioned, we did have solid enrollments in June and the first week in July, but we did see a drop starting in the second week in July for about five weeks.
Obviously, we look at those trend changes and as I mentioned in my opening remarks, we reached out to customers across the country to check on patient flow or any kind of patient impact there and we just didn't see anything consistent as you can guess, we also look at any other factors just to make sure nothing is impacting sales from pathways formularies are competitive activities and there isn't.
Nothing significant from that standpoint, either too to point out we do look internally and I'll tell you as I've mentioned many times, we do believe neuro links as promotional sensitive.
And so as I look at Q3.
That's not uncommon for Q3 with holidays and vacations, we do tend to see a slight drop in call activity. In Q3, we saw that that tends to occur early and we expect that to improve.
We also pay very close attention to our broader promotional efforts as well non personal promotion et cetera, and we looked at that throughout Q3, we've made some adjustments to ensure it stays brought in right why to make sure that we have good reach and frequency moving forward.
As a reminder, we did see that softness in early July but as I mentioned, we saw improvements in August we saw improvements in September. We also have seen that trend continued in October. So as you asked me. The final part of your question was what gives me confidence that we're seeing changes it is the numbers and the trends that we're seeing hopefully that helps.
Yes, and if I can jump in here, if you want to kind of think about how the enrollments have looked so far this year, we always see a spike up in January because you get the patient who didn't want to go on the drug and due to the side effect profile, which as you know usually in that first month.
We didn't want to go on it in December for the holidays. So in January you always get a big Spike it's kind of relatively similar February March April may and then it jumped up in June and then it jumped down in July.
And then August was higher than July September was higher than August and October was higher than September and October was more basically very in line with that baseline that had been set in that kind of February through May time period. So look you can speculate okay. The June.
Spike people, who would have gone out in July, we're taking vacations or whatever and wanted to be through the side effects that could be.
Remember that.
Patients have up to two years from when they complete adjuvant therapy to take nearly so it gives them a little more flexibility on when they started to sound like a metastatic disease, where you have to start right away because of the disease. So we're in year six of launch to my recollection, we have seen this drop in.
July before and I think back then our assumption was it's the holidays or people, taking vacations or whatever.
Again, it's not something that we're really like Jeff said the numbers have come back to what they were previously we don't really think it's anything to be concerned about.
Okay. Thanks for the added color and that also could I get your thoughts on you know ex.
Ex U S sales potential obviously, you raised royalty revenue guidance.
It seems like you know this impact is somewhat.
Overlooked by investors and I just wanted to get your thoughts on the potential outside the U S for sales, particularly.
Particularly in China.
Yeah.
Yeah. Thanks, Ed So the launch in China is still rolling out.
And our partner has done a wonderful job there.
We do tend to see if you look at the numbers you know a big bullish of the their royalty is coming in in just in the Q4. So we're expecting that this year just like we did last year.
That is the the rollout is still going and they've done a nice job with the growth we've been very very pleased with their execution.
I would say China is probably second largest market for us just due to number of patients.
And I think in terms of our royalties that that's where it looks like it's coming it's probably the highest area that we're seeing royalties from so you know I mean.
I think it still got some momentum to go there and you know.
The numbers, obviously show that and I would look forward to continuing to see that in the future.
Okay.
Great. Thanks for taking my questions.
Thank you. Our next question comes from the line of <unk>.
While with Cowen. Please proceed with your question.
Hi, guys. This is <unk> on for Mark Thanks for taking my question.
I wanted to get a better idea of the phase II trial I've allocated in metastatic breast cancer, I know that you've yet to speak with the FDA, but do you anticipate having.
I guess in an ideal scenario would you like to have a similar trial design to what you see with that myself phase two.
Or is there a potential that you could explore a combination therapy here.
And then Oh.
Follow up here I, just do you have any other agents that are also being developed.
Thanks.
How how do you guys define success in this trial.
Okay.
Yeah.
Thanks for the question, Dave Yeah. So.
With Al asserted we are very focused on you know.
The biomarker populations, where there's a biomarker that's indicative of the Aurora kinase pathway being activated.
And so in the small cell lung cancer trial. For example, you saw that with the C mic and with the.
Our b, one mutations and there's a few others that haven't yet been published as well.
In terms of your question you know you are correct the small cell lung cancer. The previous trial done was paclitaxel, plus how assertive against Paclitaxel plus placebo.
The feedback we've been getting from the Kols has been they would like to use it earlier kind of in the pre chemotherapy setting so it would be more similar to.
The study that was done the TB CRC 41, where it was kind of al assertive with endocrine therapy.
That would be kind of where they would like to position the drug in specifically or where they've kind of look to position it.
Would be kind of.
After the patient has had a CDK four six.
Perhaps after they've had in other agent that's you know.
Also involving an endocrine therapy, and then kind of using it in that in the pre chemo setting.
So that would be where we'd be positioning it you had a follow up question as well.
Yeah.
Helpful. I just wanted to know just given the other agents that are being developed like how do you and the kols, but how do you define success.
In this trial as it is that a single agent.
Trials in this setting.
Yeah. So I don't know if the trial will be Alistair Malone or Alistair plus endocrine that would obviously be an easier trial to do like al surplus endocrine against placebo plus endocrine says.
A well designed well controlled trial.
Youre correct. There is a lot of other agents you know a lot of the adcs, especially but that tends to be in more of the chemo.
Chemo and post chemo setting and not in this kind of pre chemo setting.
In terms of what success would look like you know there is a good.
It gives me there is a good precedent here in ER positive her two negative breast cancer for a targeted agent being developed in the pre chemo setting, which is you know a peak rate, which is the picture you see a mutation drug and so I think that that kind of.
Playbook, if you will.
It would be what we'd be looking to do which was developed in a pre chemo population.
It was P create plus endocrine against endocrine alone that that type of design and that type of.
Outcome would you what would you be looking for.
That's really helpful. Thank you so much.
Sure.
Thank you. Our next question comes from the line of Gena Wang with Barclays. Please proceed with your question.
Hi, Good afternoon. This is <unk> on for Gena, Thanks for taking our questions.
A couple of quick ones, perhaps for Alan Alan for the for Q.
F D. A meeting for breast cancer did you already request the meeting.
Yes, meaning as requested and has been scheduled it's either this month or next month, I can't remember, which one.
Perfect. Thanks for the clarity on that and then second half.
I had a question on <unk>.
And and I understand you you provide very detailed guidance you know and in the quarters to come and for the full year 2023, you've provided guidance, but as you know Alistair youre, starting with small cell lung cancer trial, and then you know the breast cancer trial will probably you know potentially starting 'twenty 'twenty four.
Are you able to provide any color right now on how we should see like expenses changing.
With regards to R&D any color you can provide on that would be helpful.
Yeah. So from an R&D perspective, remember that we still have some underwriting in R&D.
Items on a in the forecast, which as you know we're still closing down a lot of the previous site. So those have to come out.
And then there is a in Europe, we had a post approval commitment study.
Which was a study of Niraparib.
In Iraq Nib using it initially was similar to the control study, but being done in the European population. So it was rather been extended adjuvant.
At all the different ways of reducing the diarrhea.
That study will be concluding shortly and so the expenses from that will be coming out as well. So we do have a lot of R&D budget items coming out you're correct going in we you know with it coming into the expenses would be the al asserted small cell lung and HR positive breast.
Got a question.
Earlier, and I think we've got one at one of the conferences as well on that and what we had said was listen it is very important to us that we continue to be net income positive company.
So if we have to stagger the development of the drug in order to do that then that's what we're going to do we completely recognize our responsibility to shareholders not just in developing new drugs et cetera, but also our fiscal responsibility and so we think that is something very important is being able to be net income positive company.
So if we have to stagger the expense staggered the trials in order to do that that's what we're going to do but our commitment is to maintain net income positivity.
That's helpful. Thank you Alan and I just have one last quick question are you able to disclose how many sites you anticipate an opening for the small cell lung cancer trial in small cell.
Okay.
Yeah, that's a good question.
I apologize I don't have that number in front of me My ballpark memory is like 10 to 15, if I remember maybe its 20 somewhere in that general range 10 to 20.
No. We're still it's still helpful. Thank you so much.
Yeah.
Thank you.
This concludes our question and answer session and I would now like to turn the conference back over to Marianne O Hansen for closing remarks.
Thank you for joining us today as a reminder, this call may be accessed via replay at Puma biotechnology Dot com beginning later today.
Haven't been easy.
Ladies and gentlemen, thank you for participating in today's conference call. This does conclude our program.
Thank you and have a great day, you may now disconnect.
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