Welcome to PharmaMar's first quarter 2023 results presentation. After the presentation, we will do a Q&A session. If you'd like to ask the question, please press star 5 on your telephone keypad. If you change your mind, please press star 5 again. I give the floor to José Luis Moreno, Director, Capital Markets and Investor Relations. José Luis, the floor is yours.
Thank you, Almudena. Good morning to everyone. I'd like to welcome to all of you to our first quarter results conference call. On the call with me today are María Luisa de Francia, the Financial Officer of the Group, Luis Mora, Managing Director of PharmaMar, and Pascal Besman, Senior Vice President of Strategic Development. We had a presentation conference call just a few weeks ago, today we'll have an update mainly on financials. María Luisa will present the first quarter results, and Luis and Pascal will also be with us to answer those questions that are relevant to them. As always, following our prepared remarks today, we will open the line for questions. I would like to remind you that today's conference call might include forward-looking statements regarding future events or the future financial and operating performance of our company.
Such forward-looking statements are only predictions based on current expectations. Actual results may vary from those projected. We disclaim any obligation to update any information provided herein. We refer you to a safe harbor statement on our corporate presentation, which is available on our website together with the press release of the report of our results that we released yesterday. We've already gone through the first quarter of this year, 2023, which is a year where we are increasing our R&D investment compared to previous years. It is going to be explained in a few minutes. This increase comes mainly from investment both in late stage and early stage clinical trials.
We have currently three phase III trials ongoing, and we expect to have up to five phase III trials throughout the year, of which three of them will be in oncology. To that, we should also add the phase III trial our partner, Jazz, is doing together with Roche with Zepzelca in combination with atezolizumab to go to first-line maintenance in small cell lung cancer. Our strategy is clear in our commitment to R&D, which is ultimately about investing in the growth of the company. About financials, as it was expected and has been, and we've been talking about for months, generics of Yondelis, trabectedin, arrived to the market in Europe, and of course, that had an effect in our P&L.
This was perfectly forecasted in our strategic plan. We have cash and finance to overcome this particular situation and continue with our investment plan without any stress. We expect some new flow for this year. Certainly as we move on, we are approaching to the date when we'll have data of all these trials ongoing. Now I will turn over to María Luisa, who will give you more details about the financial results of this quarter. María Luisa.
Thank you, José Luis. Good morning, thank you all for joining this conference call on first quarter 2023 financial results. I will start by analyzing the revenues for the period. Total revenues declined 36% year-on-year, mainly due to the arrival of the generic of trabectedin into the European market. Regarding volume, Yondelis only lost 9%, Price pressure led to a total decrease in Yondelis net sales of 53%. This translates into sales of EUR 8.1 million at March 2023 versus EUR 17.5 million at March 2022. With regard to early access marketing of Zepzelca in Europe and the autorisation d'accès compassionnel in France, it's the same situation.
The number of units or grams made available was the same as in the same period of previous year, but the adjustments made due to the new regulation of the mentioned program resulted in EUR 5.6 million in first quarter 2023 versus EUR 8.7 million in first quarter 2022. Sales of the active pharmaceutical ingredient are lower than in the first quarter of 2022. This is a temporary effect. Our partners have made their stock in previous quarter, and there is a lag in purchase orders. It is expected that in the coming months, this difference will be reduced. As far as diagnostic sales are concerned, test sales committed to our customers were completed in March, and production was closed down accordingly.
In relation to the royalties, sorry, received from Jazz, the actual growth of royalties for the first quarter 2023 is 7%. Our estimate of the royalties for the first quarter of 2022 was higher than the actual royalties corresponding to just sales in that period. This is why in the report of this quarter, there is hardly no difference between periods. As just I mentioned, the actual growth between years is 7%. In terms of expenses, there was a 11% increase in R&D expenses as a result mainly of the ongoing trials and the preparation of the coming new phases III. Other operating expenses, commercial, general, and administrative, corporate expenses, et cetera, on the whole remain at the same levels that in the previous period.
The increase in R&D expenditure plus the lower revenue figures that we have just explained leads to a net result of EUR 1.4 million. In contrast, that includes the monetization of R&D deductions received in the first quarter of 2023 amounted to EUR 4 million. Finally, it's important to note that in 2023, operating activities generated cash flow, a cash flow of EUR 7.7 million. Net cash position as of March 2023 amounts to EUR 191.4 million after deducting the EUR 39.8 million of total financial debt. Both figures remain at similar levels at the end of 2022. Now I pass the microphone back to José Luis.
Thank you, Maria Luisa. With this, we conclude our prepared remarks for today, I will open the line for questions, Morena.
Thank you. Ladies and gentlemen, we will now begin the Q&A session. As a reminder, if you'd like to ask a question, please press star five on your telephone keypad. To cancel your request, please press star five again. Please ensure that your device is unmuted locally before proceeding with your question. Our first question comes from the line of Ami Fadia from Needham & Company. Please go ahead.
Hi, good morning. This is Ethan Lippman from Needham. Thanks for taking our questions. Maybe if I can ask two on Zepzelca. First, I guess regarding the Zepzelca royalties, I guess I'm curious if the number you have there for one Q-23 is that kind of like your base case estimate for Q1 and then you make kind of the appropriate corrections in the subsequent quarters as needed? Maybe if you could provide a little bit more color on how you arrive at that estimate, that'd be helpful.
At the moment, we know the actual royalties we made the correction in the following quarter as...
So the, the, the-
Okay.
adjustment from first quarter you were mentioning, it was done the second quarter of last year.
Got it. Then I guess, you know, once Jazz reports the sales you will make, you know, for this quarter-
Exactly.
You'll make the appropriate adjustment next quarter. Is that right?
Exactly.
Exactly.
Okay. Understood. Maybe more, more generally on kind of, you know, U.S. Zepzelca sales and the royalty revenue you get, maybe, as we're looking, you know, at the 2023 year versus the 2022 year, I'm curious, you know, from your perspective, what do you see as kind of the drivers for Zepzelca growth? Thank you.
Yeah. Well, this is just literally we don't say nothing about that. We are so happy with the partnership. In our opinion, the drug now is on a standard of care in second line in U.S.A. We see the global sales trend is extremely positive, we are so happy.
Okay. Understood. Thank you for taking our question. Thank you.
The next question comes from the line of Álvaro Lenze from Alantra Equities. Please go ahead.
Hi. Thanks for taking my questions. The first one is on, the royalties again. Just to clarify, the adjustments, is it possible that the relatively low number of Q1 is due to adjustments of the high number that you reported in Q4?
Yeah.
Have there been no adjustments to Q-four? If that is the case.
No.
actually mean that the trend
No, no.
Yeah. Go on.
Q4 didn't have any adjustment.
Did you adjust in Q1 2023? Have you adjusted-
No.
-for excess revenue recognition in Q-one, in Q-four last year or not?
No, no, no.
Okay.
The adjustment was done in relation to first quarter 2022. We accounted for a higher amount, we correct that difference. Once we knew from just the exact number of royalties or figure from royalties, we adjust in the second quarter 2022.
Okay.
That's why, the comparison with the first quarter 2023 is not exact.
Understood. That's perfectly clear. The question would be, why are we seeing a decline quarter-on-quarter compared to Q4? Is there some seasonality in treatments for lung cancer, or... I would expect, given that the product is still in ramp-up phase and you are rolling out the product to more countries, I would expect sequential improvement in revenue contribution, not a decline.
I repeat my answer from before. This is just sales. We take royalties. The market, the USA market is a Jazz market. In any case, if you see the trend, which is normal to see in any analysis, the trend in the last four or five quarters, you can see the very, very high positive trend. Okay? We are so confident, so happy, like, we'll be active in this standard of care now in second line and is growing. That's it. Okay.
Okay. Last question would be on the financial expense front. I wanted to know if you could provide some additional detail on that EUR 1 million net financial loss in a context in which you have a significant amount of cash that should be generating some interest...
Yeah.
given the interest rate environment.
Yeah. It's due mainly because we have marked to market some deposits we have in dollars. The exchange rate this quarter compared to the December closing was make us to.
Penalize.
Penalize us. Exactly.
Could you indicate how much would the underlying net financial income from your interests would be excluding this FX impact?
Yes. The financial income is strictly because of the interest of our deposits. It's close to EUR 1 million.
Okay. Thank you very much.
Thank you, Alvaro.
The next question comes from the line of Joseph Hedden from Rx Securities. Please go ahead.
Good afternoon. Thanks for taking my questions. Just one more on the Zepzelca royalty and sales. We know it's become standard care in the second line setting now. Could you just remind us of what percentage that Jazz thinks or you think the second line setting that has, and what are the kind of levers that can be pulled to increase that percentage? Then secondly, noticed that marketing commercial expenses are as high in Q1 this year as they were last year, but you're discontinuing the diagnostic segment, and Yondelis has essentially gone generic now. I'm just wondering why expenses are continuing to be at the same level. Thanks very much.
Regarding the first question, the Jazz market share, Zepzelca in the USA, I don't know. Sincerely, this is a Jazz information. The second one, regarding the marketing expenses, is more or less stable, March 2023, March 2022. We launched a campaign in order to defend Yondelis in several markets. This is one shot we expect will decline in the following quarters. Instead is a very successful one because the number of units only decreased 8.5%, 8.8%. This is a good signal. The investment was very good at all in this setting, and to only decrease the market share for the brand product about 8% regarding our market share. We're also happy about that. Taking account Yondelis is not only in Europe, Yondelis is a worldwide drug.
The measurement we do in Europe is reflected in other parts of the world. This is what is included in this figure. We expect it now in following quarters, we will decline you compare with 2022.
Okay, that makes sense. If I could just have a follow-up on Yondelis. You know, you mentioned that the impact so far on declining revenues is mainly a price effect and that actually you've got, you know, a stable, if not slightly growing, share in terms of units. What can we expect for the remainder of 2023 and going into 2024? I know at the last results meeting you mentioned, you know, in several countries the drug is sold via tender contracts. Are we gonna see outcomes of that? Do you expect any actual decline in unit sales this year?
Well, this is a difficult question because generic markets is very different. It's completely different. Today is only one generic in the market. At, I don't know if in three, four, six months it's only one. This is difficult to focus. If we maintain this market share and this level of units, probably the sales will be stable around the year, across the year. Okay? We will see. It's different country by country. In Europe, there's huge difference. In fact, in some countries, we have to launch. In other countries, yes. In other countries are more aggressive, in other countries, no. It's very difficult to see what the genetics company will do.
We are so happy because now we only decline 8.9 to 10 in number of units, and we will see, okay? In other countries around the world, there's some level of protections, and in 2023, we don't expect that in other countries, the generic centers in a short period of time.
Okay, thank you very much.
Thank you, Joe.
The next question comes from the line of Guilherme Sampaio from CaixaBank. Please go ahead.
Hello. Thank you for taking my question. two, if I may, both related to Zepzelca royalties in the U.S. The first one is whether there was any other over and the recognition of revenues in the remaining quarters of 2022 in order to model going forward. Second, if three years in this 7% underlying trend maintains over Q-two in terms of royalty costs. Thanks.
Hi, Guillermo. I don't think we got your first question. We got your second question about, you know, if we can maintain that 7% in the following quarters. I'm not sure we got... We didn't get your first question. Can you repeat that one?
Mm-hmm.
Please?
Yeah, sure. The first question was, it's a bit more for modeling purposes. Just wanted to know whether there was some under or over adjustment in terms of revenues similar to what we've seen in Q1 2022 in the other quarters of the year, okay? In order for us to have a better base to estimate the revenues for 2023.
Okay, got it. María, you want to take that one? Regarding the first question, we don't know, sincerely, because we include our best estimation and then we at the end when we have the final figure. There's not a big difference in many quarters. This is small figures, but we don't know. Our best estimation is our best estimation.
No. The main adjustment we did in 2022 was the one on the first quarter. The rest of the quarter was immaterial totally.
That we're going to have a tougher comparison base on the second quarter. You have I assume that all the adjustments were made in the first half of 2022. Correct?
Yes. Yes. Yes.
Okay, thanks.
The next question comes from the line of Christian Glennie from Stifel. Please go ahead.
Hi. Hi, guys. Thanks for taking the question. Maybe just a couple on your clinical trial progress with Zepzelca. Anything to note with LAGOON and the confirmatory trial in terms of recruitment there? I know you're not gonna comment specifically, but in overall terms, that's still on track for readout and the timing of the readout. Secondly, preparations for the mesothelioma trial, and then anything you can add there on that side of things.
Regarding the LAGOON trial, is on track. We are open there, more than 90 centers around the world. Is according to our estimation, as is on track, we are very confident we arrive the goals, the finished recruitment and the readout data, the commitment with the FDA. We are so happy about this. The other question was regarding the CLI trial for mesothelioma. We expected to start this trial this year. All the protocol is on, the CRO. We have started. protocol is already approved in some countries, and we have started all the administrative procedure, the open centers, et cetera. According to that, we expect it around September to collect patient in for this trial. This is expectation.
Okay, thank you. Then maybe just, I know this is always a perennial question, but worth just getting your comment again, obviously, the prospect of using your balance sheet for, you know, new product licenses, acquisitions, any particular update on the status of that pipeline of work?
We're having several conversations and we will see. Obviously, this is always is an agreement. In the some drugs in the past, we'd close the potential deal after the due diligence we will perform. We expected in this year sign some agreements. We are working hard in that, our teams. This project is not canceled, absolutely, and is ongoing.
Still some expectation of a deal within the next 12 months. Is that what I understood? Yeah, probably.
Yeah. We work for that.
Okay. Okay. Good. Thank you.
Thank you, Christian.
There are no further questions at this time. I will now hand back to José Luis.
Thank you, Almudena. I'd like to thank you all for joining the call today. With this, we'll conclude our conference call and, you know, wish a good day to everybody. Thank you.