Pharma Mar SA
MAD:PHM
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Pharma Mar SA
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Thank you, Laura, and good morning to everyone. I'd like to welcome to all of you to our full 2022 Results Conference Call.
On the call with me today are Mr. Luis Mora, Managing Director of Pharma Mar; Maria Luisa de Francia, Chief Financial Officer; and Pascal Besman, which is Vice President Strategic Development.
Following our prepared remarks today, we will open the line for questions. And before we start, I would like to remind you that, today's conference call may include forward-looking statements regarding future events, or the future financial and operating performance of the company.
Such forward-looking statements are only predictions based on our current expectations and actual results may vary from those projected. We disclaim any obligation to update any information provided herein, and we refer you to our Safe Harbor statement on our corporate presentation, which is available on our website together with the press release and the report of the results we released yesterday.
Last year, it was an important year for the company because we achieved important goals and we had an important advance in our development. In case you had a chance, to see our press release yesterday, so I'll not go through every little detail, but let me highlight the most important news from last year.
In 2022, we saw the approval of lurbinectedin for commercialization for the treatment of small cell lung cancer in countries like South Korea, Qatar or Emirates. That adds of course to US, Australia or Singapore, where the drug has been approved already.
As you know, one of our main targets with Zepzelca and the next feature is to achieve approval in Europe and full approval in the US. In the meantime, we'll have more news of our approvals and filings in other countries.
Talking about other developments the two Phase III trials that are ongoing with lurbinectedin for small cell lung cancer are currently recruiting. And in the case of a trial in first line in combination with TECENTRIQ in small cell, but our partner Jazz is doing together with Roche. They announced in January that recruitment will be completed this year.
The LAGOON trial, which is Phase III for second line in small cell lung cancer, using lurbinectedin as a monotherapy is also progressing with this recruitment. It is worth mentioning that, both trials would be fileable not only in US and Europe, but also in other territories.
Also, last year, we reached an agreement with a company provider of the immunotherapy that will combine with Zepzelca for the Phase III trial in mesothelioma that we expect to start later on this year.
In 2022, we also advanced in the progress of other oncology molecules in our pipeline and we had a new molecule PM534 entering into clinical development in Phase I. And we also did all the work and have ready to include another new molecule in the pipeline which will happen later on this year.
In other therapeutic areas like RNA of interference last year, we started another Phase III trial with tivanisiran. So currently, we have two Phase IIIs ongoing with tivanisiran one to demonstrate activity and another one to assess safety, which started in April last year.
Also in RNA of interference last year, we started a Phase II trial in macular degeneration, with another molecule called SYL18001, which is worth highlighting the fact that, it's administered as eyedrop solution for this indication.
I will turn over now to Maria Luisa who will give you more details about the financial results.
Thank you, Jose Luis. Good morning and thank you all for joining this conference call about 2022 full year financial results. The main events that had an impact on the 2022 financial statements were as follows. Firstly, we will point out the new legislation applicable in France, with respect to drug marketed under the authorization Compassionnel Early Access program, which has resulted in significant discounts leading to the need for a provision of 15.2 million units sold in France in 2022 were slightly higher than those sold in 2021.
Secondly, in the last quarter of the year, and after 15 years of Yondelis on the market, the generic product trabectedin began to be marketed in Europe, with the consequent pressure on prices and volumes. In 2022, the impact also felt has not yet been significant. In 2022 Yondelis reached one of the commercial milestones set in the license agreement signed, with J&J in 2001 for €10 million.
Finally, the decision to discontinue the Diagnostics segment, results in the recognition of a number of expenses and provisions amounting to some €3.5 million to €4 million. Thus in the analysis of recurring revenues, we see a decrease of 5% compared to the previous year.
As you know, these recurring revenues are made up of sales and royalties received from our partners. Yondelis sales in Europe were €63.8 million. In 2021, they were €69.4 million. Sales in Europe of Zepzelca under the authorization d'acces compassionnel program amounted to €15.5 million €30.2 million in 2021. This decline in sales was partially offset by an increase in royalties of 23% to €50.3 million, of which €46.9 million corresponds to just pharmaceutical sales of Zepzelca in the United States, and by an increase in raw material sales to our partners for both Yondelis and Zepzelca for up 11.6% from €19.2 million to €21.4 million.
In relation to non-recurring revenues, the main difference was due to the achievement in 2021 of a commercial milestone under the Jazz Pharmaceuticals agreement, which resulted in revenues of €22 million, as well as to the amount recognized as revenues from those deferred income from the same agreement, which also was higher in 2021 by about €10 million. These differences were also partially offset by the achievements in 2022, of the milestone under the J&J license agreement for Yondelis in the mentioned amount of €10 million.
In terms of expenses, there was an increase in R&D expenses as a result of the up to four Phase III trials ongoing in 2022, €11.3 million more than the previous year, or 16% higher. In marketing and general expenses the return to international face to face meeting congress and commercial actions have also led to a certain increase in expenses. And finally, as we mentioned at that beginning, the income statement is also affected by the discontinuation of diagnostic activity.
All of the above leads to an EBITDA of €51.4 million compared to €97.8 million in 2021 and a net result for the period amounting to €49.4 million. Income taxes in 2022 €5.6 million positive, includes the activation of tax credit to be applied in the future, as well as the monetization of R&D deductions received in 2022.
Finally, it's important to note that in 2022 operating activities generated cash of €38.3 million, thus the net cash position at the end of the year amounts to €192.8 million after deducting the €39 million of total financial debt. This is 15% above the net cash at the end of 2021.
To summarize, the financial part, I would like to highlight the generation of operating cash flows even with growth in R&D expenditure, with the consequence maintenance of cash levels and reduction of debt.
I would like to end my iteration with a reference to ESG issues. As far as environmental concerns, in 2022 the group has measured its carbon footprint including scopes 1, 2 and 3. In 2023, the group is planning to work on an emission reduction plan in accordance with the science-based target initiative standards.
On the social side, I will briefly give some data on quality of employment. For instance, 98.8% of the contracts are permanent and all of our employees have a health insurance policy. On diversity, we have employees of 15 different nationalities. And on equality, 60% of our employees are women with a weighted wage gap of 3.4%.
Finally, regarding governance, I would add that 41% of our Board members are independent, 33% are women and also 47% of our senior management and management are women too.
And now I pass the microphone to Luis Mora.
Thank you, Maria Luisa. Our pipeline, you can see the confirmation of our investment strategy in R&D with a strong increase in the Stage 3 filed for this year 2023 and new molecules under development.
Regarding Yondelis, after already 15 years in the market and maintaining an excellent market share of more than 30% in label, closer to 2022 there are increases in sales, demonstrating that is a standard-of-care in soft tissue sarcoma. And we have an excellent commercial network. But in the last quarter 2022, as Maria Luisa explained before, the generic cost directive over the period impacting in price in different European provisions [ph].
According to the different regulations, the initial impact oscillates between 30% to 50% price reduction depending of the countries and the different distribution channels. Also, in some countries, the active system change is impacting the offers to tenders and we will see with this evolution through 2023.
It is important to highlight the important -- the development plant which we've elected in with two Phase IIs in the small cell lung cancer in first line and second line treatment with trials underway, three new Phase IIIs in sarcoma, and in the last quarter of this year we plan to start consider to ovarian cancer trial. This aside, Pascal will give more detail.
In 2022, we have reached an important agreement with a company that is going to collaborate in the mesothelioma trial and we hope to start around the summer of the year. Regarding Sylentis two Phase III and one Phase II in advancing and according to plan in -- under the planned development. And the recruitment is ongoing and we will see the result data when it's coming, but we expect it in early next year probably we will have the read-out data.
In Phases I and II, we have expected in PM534 and also in this third quarter a new compound P54 we will start the Phase I. Finally, we have regained Plitidepsin and we are initiating a Phase II trial in immunosuppressive patients with SARS-CoV-2. As you can see this is an ambitious development program that will certainly bring new treatment option for the patient and new opportunities for Pharma Mar.
Now, Pascal will give more details in some clinical trials. Pascal?
Thank you, Luis, and hello to all. I'm going to give you some details on our current and near future Phase III trials. In addition to the combo, combination pivotal trial with atezolizumab in first-time maintenance therapy which is ongoing by Jazz in partnership with Roche I have three Pharma Mar led trials to share with you.
First of all, the LAGOON trial; this is a three-arm trial of lurbinectedin monotherapy at the 3.2 milligram approved dose versus a combination with irinotecan versus the control arm of either oral or intravenous topotecan or irinotecan, where the primary endpoint will be Arm A versus Arm C, with 90% power to deliver a hazard ratio of 0.8.
It's important to know that there is a statistical plan, such that either arm can both lead to a potential approval or only one. The order will be on A versus C, which is the primary analysis followed by B versus C.
There are four learnings and new pieces of information that led to this trial, where we've made some tweaks that we think increase our odds for success I will share with you. Number one the FDA requested that we make sure that 70% of the patients have prior IO. This reflects the population of the United States and is very helpful to us because whereas there is no data that we are aware of that shows synergy or additive benefit from IO and topotecan or irinotecan, we have plenty of such data with lurbinectedin and IO some of which of course has led to the combination trial you're already aware of.
The second tweak we have done in this case is unlike our prior trial, we are requesting brain scans to make sure that all of the brain mets are stable or tapering doses. This was our worst subset in the prior trial with a hazard ratio of 1.3. So we think that can help that as well.
The third tweak we've made is no prior G-CSF. If you recall from our Basket trial the use of G-CSF was not mandated for primary prophylaxis and therefore the secondary use was only 20%. By having forced G-CSF on all patients in prior trials, we were basically helping the control arm.
And lastly and perhaps in my opinion at least most worthwhile to think about is that this is the first trial where the regulators have allowed oral topotecan instead of IV. Oral is more used because it's more tolerable and despite having been approved in a non-inferior trial it is numerically inferior, but most importantly IV topotecan as your control arm introduces patient selection bias because with a 92-year-old person coming in on their walker you're not enrolling them as a physician into a trial with a 50% chance of IV topotecan.
So we think the addition of oral will mean that some lower performance status patients will be admitted into the trial which will help us. So with this trial and the first-line maintenance trial, you can see that we're not just happy in second-line small cell in -- patients. We want to change the treatment paradigm.
Let me move on to mesothelioma. This is another aggressive thoracic malignancy with a long latency period caused by an external stimulus in this case asbestos. The treatment paradigm has had very slow progress. The only real change has been the recent addition of Nivo/IPi in both US and EU into the frontline setting. The patient numbers are smaller than small cell and dominated here by Europe.
Looking at our trial now this is based on ESMO 2019 monotherapy data and what we have seen of the addition and synergistic benefit of IO in multiple data sets. Because of the recent approval of Nivo/IPi in certain territories this is a trial that will be prior to one platinum. And there we will stratify for those who have had IO versus those who have not.
It will be a monotherapy versus a combo therapy with atezolizumab versus the control arm which is dealers choice gemcitabine or vinorelbine with an overall survival primary endpoint we're finalizing the protocol and expect to have our first patient in this summer.
The last indication is leiomyosarcoma, which we are hoping to start also in the first half of this year. Let me start with the rationale for this. We have seen data that's been published for Yondelis in this indication with a very strong overall survival. And we've had in the public domain some data from lurbinectedin this indication some published presented last year at CTOS.
And yet we also have more that is not yet public domain that we are aware of. We know that lurbinectedin synergized with doxorubicin from multiple prior trials. And that's why we want to test it in this trial in combination in the frontline versus doxorubicin I'll show you the protocol momentarily.
Do bear in mind that we are unparalleled in the land of sarcoma treatment from our 20-plus years of experience with the Yondelis trials and commercial. We know the centers, the doctors, the patient associations, the reimbursement channels. So we feel very confident that this is a trial we can win on.
As for the business case leiomyosarcoma is 50% of soft tissue sarcoma and half of that is metastatic. So the treatment target market in EU5 is around 2000 and we think we can get a good chunk of market share. Furthermore, we expect to see six or more cycles much more than in small cell as this is a first-line trial and so you can do the math that this may be somewhere around the €30 million European indication for us.
In the US because of the IP the opportunity will be more limited and shorter. However, given in Europe that the 10-year orphan clock has not been triggered yet, we could have eight years or so in our opinion to see this business case bear out. And now for the trial design here. This is a Phase II/III adaptive design where will have two different dosing regimens in Part IIb versus standard of care doxorubicin.
An interim analysis will then be held to pick the better dose. And then the primary endpoint will be PFS by independent review of the 80 patients in the Phase IIb and 120 into Part III so 200 in the analysis. This will have 60 sites over Western Europe and the US only where we have the sarcoma experience and so we hope to get data back end of 2026.
With that, I will turn it back to Jose Luis for further comments and to take your questions. Thank you.
Thank you, Pascal. And well so after hearing about all these projects 2023 is definitely going to be a very busy year for us. Firstly, we expect to hear about new approvals and submissions of lurbi in different countries. And in regard to the drug development and particularly development with lurbinectedin as Pascal just mentioned we expect to start the Phase III trial for mesothelioma and a Phase III trial in other indications like leiomyosarcoma.
In regard to both of the Phase III trials for small cell lung cancer LAGOON and IMforte both are currently are ongoing. So we'll continue recruiting -- and in the case of IMforte our partner Jazz announced in January as we just mentioned they expect to finish recruitment later this year.
Also with lurbinectedin we expect to finish this year the Phase II trial in combination with irinotecan for small cell lung cancer. And about other molecules in our pipeline in 2023 we expect further developments with PM534 and PM14 and also expect to have a new molecule as we've mentioned PM54, which will get into clinical development during the first half of this year.
And finally as Luis mentioned in RNA of interference we expect to conclude this year the two Phase III trials that we are currently ongoing for [indiscernible]. So we hope all these developments will lead us to achieve our goals in the short future. And after this year, we expect to see more important news like data in those two Phase 3 trials in RNA that I just mentioned, perhaps some more license agreements in this indication and others.
IMforte trial will be still ongoing in 2024 and might start generating some news afterwards. The other trials in Phase 3 like LAGOON might start generating some news in 2025. So all in all, a very busy and exciting couple of years ahead of us with a strong balance sheet and cash position, which will allow us to finance our development.
With this, we conclude our speech today, and we open the line to questions. Laura?
Thank you very much. [Operator Instructions] We'll now take our first question from Ami Fadia at Needham & Company. Your line is open. Please go ahead.
Hi. Good morning. This is Eason Lee on for Ami. Maybe a couple here. First on the Phase 2 update for Lurbi+ Irinotecan, I guess any chance this could support, maybe an sNDA in the US or a submission in Europe?
No, the trial is ongoing. We expect to finalize the trial this year and the equipment, and probably in the last quarter of this year we had the data. We will see depends on the results. Remember, it's a single-arm trial in combination with Irinotecan, and we will see it. Yes, it's difficult to answer this question as we don't have the data.
Okay. Got it. And then maybe I guess, you talked in the past kind of thoughts around in-licensing assets to kind of to leverage kind of your marketing sales force. Maybe remind us again of the type of assets that you think best fits in your portfolio? And then kind of curious if you've seen an evolution in the market for such assets at present versus say, 2021 and 2022? Thank you.
Yes. We continue to screen the market and to have a competition with several options. The assets that we want to incorporate in our pipeline in the sales network is for solid or hematological tumors the level of the fixed sales potential of its sales between €70 million to €120 million. This is the level of the asset we serve in the market.
And it is -- I mean, it's not a lot of options today in the market but some options more and the activity is not a stop obviously it's continuous. And we have today several options. We had in the past some compensations. And obviously, this is the deal then two parts need to agree. But we hope in 2023 or 2024, we finally achieved some licensing.
Great. Thank you very much.
Thank you.
We'll now take our next question from Christian Glennie at Stifel. Your line is open. Please go ahead.
Hi, guys. Good afternoon. Thanks for taking the questions. So to kick off with just a few sort of on the financials on the modeling side for 2023. I didn't fully catch what you seem to be implying from the generics to Yondelis in Europe that -- or what should we be implying in terms of the erosion of sales potentially in 2023? And is there an expectation that there may be some US generics coming in 2023 on Yondelis?
No, not in USA. We don't expect that in the short-term generics in USA. The major impact is here in Europe. I explained before that the impact -- that according to the legislation of different countries, the evolution of price between 30% to 50%, this is automatically. And in some countries, not in all countries, the market access channel change is to tenders like Italy, in Spain, not yet but with very little as when they generic board the discounts is played in this game, okay, from the price. Then we will see. We will see through this 2023 what will see the way of impact. I repeat the price impact between 30% to 50% depend on the country is automatic.
Okay. Great. Okay. Thanks. That’s helpful. And then on Zepzelca and the royalties you reported, obviously we'll see what number just comes up with sort of overnight, but it implies maybe sales of around about sort of €275 million. At this point, there's no mention of potential milestones, commercial milestones on those US sales. Is that just a timing thing or is that the -- should we assume that you haven't hit the next threshold?
Well, we can't mention nothing about Zepzelca or is the milestone coming, okay? This royalty growth is a good signal and Zepzelca is a good level of sales in USA and the royalties you remember we announced come from high-teens to 30%, depending on the level of sales. Then, if it's growing before they jump on the scale of royalties. This is because it's a signal is in parallel with a good sale level of sales of Zepzelca in USA.
Thank you. Okay. So we may still end up with a milestone being paid potentially for 2023?
We can probably more. You want to say more about the sales, and you say yes, it's not our market, okay?
Okay. And then just finally on R&D, what should we be expecting for 2023? Is it a similar increase? Obviously you've got the same trials are ongoing. You're going to start mesothelioma. What should we be expecting for R&D?
Well, I explained before is a very busy we year. The pipeline is plenty of Phase 3 with Zepzelca, with [indiscernible] et cetera. Then obviously, the new drug is coming to Phase 1, etcetera. Then the increase of R&D is clear. The level of increase we will see depend on assume -- you know very well the value linked to the number of patients we enrolled, the number of countries, centers included in these trials. But in principle, we can expect to increase like this year, if you compare with last year, past year '21, okay?
Okay. Thank you.
We will take our next question from Joseph Hedden at Rx Securities. Your line is open. Please go ahead.
Good afternoon. Thanks for taking my questions. Just firstly, on the Q4 royalty number for lurbinectedin. Can you confirm if that contains any adjustments that you had to make after Jazz report is Q3 sales?
Well, this is not any adjustment. This is our focus about the royalties. We don't have exactly figure, but we don't expect a big deviation of that.
Okay. But I mean, you have to make adjustments after Jazz reports its actual numbers, presumably and these are accounted for in the next quarter's royalty line. So, were there any that were related to Q3 in there or is it purely the Q4 royalty forecast?
It's not necessarily our adjustment.
Okay, fine. That's great. Thanks. And then just on the ATU program, you mentioned a slight increase in the number of patients in that this year. Is there any scope for further increase of patient numbers in this program or do you think it's pretty level now? And also on the price, we know that the price has come way down there due to French regulations. Is that settled now? Or will there be further discounts?
Well, in '22 the number of patients in France, where the member is about 700 patients, okay, is about 7%, 8% more than the previous year. The price is flat, but the previous year in many of the patients were seated under two [indiscernible] and in July 21, changed the law for use compassionnel, but many patients was carried over and some patients was already [indiscernible]. With this spend -- this impact in the level of discounts board in December '21. The level of discount supply under this new legislation amended with two variables. One is the level of sales; and two, depending on the number of patients treated is in the low, okay? Then based on that, the calculation in terms of calculation from about 50% -- a little more than 50% than the sales, okay? And this is a low. Now, the company is sharing the information to the price authorities, and we expect that they come with credit note. But the price is flat in -- from 2020.
Okay. That's great. Thanks. And then, just on Yondelis, obviously, generic competition coming in there in Q4. Is this going to impact the size of your oncology sales force? Are there going to be any meaningful cuts there this year?
Well, our sales force and medical affairs and different areas in the network -- neither have a lot of work, not only for Yondelis -- and it's different in different countries. I mean, it's not the same in Germany, and Spain, or Italy or France. It's not like Netherlands and Belgium. Then, the generic impact is in different manners. The second one, the activity for -- to prepare the market for the next compounds are coming for Zepzelca, etcetera. They started to work in '23. And the other important reason is, if we want to achieve an agreement from [indiscernible] we need a sales force. That makes sense to have our [indiscernible] without sales force. Then what we don't will increase in the SPs in the sales force and the new capabilities, okay?
Okay. Okay, great. Thanks. And just a follow-up on that. In terms of your business development efforts, is there anything more to say on that front in the New Year?
Well, we are big activity. I can confirm big activity, many contracts, screen the market. And we have always in the table, assets for analyze, but we will maintain this activity because it is our important goal for us, and we want to have a new asset, not only one, probably two as soon as the better. Then I can't say more, okay?
Okay. Okay. And last one for me. Just on the R&D slide that you showed where it's good to see that you're expanding the Phase III indications. Now that's great. I noticed the one that you didn't go into further detail on was ovarian cancer, Phase III. Can you just describe how your plans there are different from the clinical trial that you've already conducted with lurbinectedin?
In ovarian cancer, we are still considering. This trial -- potential trial was born, because we haven't -- we know very well, the ovarian cancer, in Europe. There's several competitive groups gynecological oncology and key opinion leaders approach, because the patients relapse to PARP inhibitors, they have a full prognosis and not a lot of options for treatment. We conducted a Phase I/II in the past. It will combine, very well -- very good combination, we've been active in for paclitaxel.
And several patients, enter in this trial and with the encouraging consultants. Based on that, based on the medical needs, based on the mechanism of action of this combination, we start to work with these key opinion leaders and competitive groups to design this trial. Now it's advanced. The protocol is on more or less finished in content with these groups, and we expect it is always well to start this trial at the end of this year, okay?
Thanks very much.
Thank you. We'll take our next question from Alvaro Lenze at Alantra Equities. Your line is open. Your line is open. Please go ahead.
Hi. Thanks for taking my questions. Most of them have already been asked and answered. Just some clarification, I don't know if you commented on this during the prepared remarks, but the increase in general and administrative expenses in Q4 seems, a bit higher than we expected. Is this for preparation for any additional marketing efforts in some countries, or is this just one-off item that we should not assume going forward?
And my second question would be, regarding Zepzelca, in the current setting of second-line small cell lung cancer, how -- what is the rate of the growth rate that we should expect in the US from the royalties, before there is an extension to first line or something like that?
Yes. Alvaro, in regard to general and administrative expenses, they are affected by economic liquidation or the starting of the closing -- the process of the closing of the company. That's why, it's a bit higher than past year.
And could you please quantify, how much could that have been in Q4?
Not, exactly no. No, I'm sorry. No, I don't have numbers here but.
Regarding the second question, well you know, we can't say any number about the Jazz market and Jazz space. That's it sorry, but I can't explain more.
Okay. Thank you very much.
Thank you. And now over to you Jose, questions over at your end. Thank you.
Thank you, Laura. We had a few questions -- written questions by e-mail in regards to, the NEPTUNO trial and the close of the trial Luis and about recruitment, recruited patients and valuable patients, if you could have people more detail on that?
Okay. Thank you, Luis. Well, the NEPTUNO trial, as you remember was the sign for a particular population, population in the hospitalization patients, moderate COVID-19 or need oxygen etcetera, etcetera and so on. Across the pandemic, we observe this topology of patients decreased dramatically. This population, I don't refer in severe or in the patients down at in the hospital. I refer this special population, was included in the protocol. And we stopped at that we announced recall, for the lack of equipment, a lack of patients.
The evolution of the pandemic, is linked with this level of recruitment. We closed the trial with 205 patients, valuable patients. The total of patients randomized was about 15% 20% more higher than that. But the level of patient was to 205. In the primary analysis in the top line, we announced in the press release, was a clear positive trend in favor of plitidepsin, but the final data is still under analysis and claiming that the day we will push in a scientific publication obviously.
Thanks, Luis. Thank you. Laura, with this we finish the round of questions.