Laboratorios Farmaceuticos Rovi, S.A. (BME:ROVI)
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Earnings Call: Q2 2020

Jul 27, 2020

Speaker 1

Welcome to Rovi First Half twenty twenty Financial Results. The management of Rovi will run you through the presentation, which will be followed by a Q and A session. Mr. Juan Lopez Permonte, Chief Executive Officer and Mr. Javier Lopez Perlmonte, Chief Financial Officer of ROV, who will be presenting this conference.

I pass the word to Mr. Javier Lopez Perlmonte.

Speaker 2

Thank you, Denise, and good afternoon to everyone. This is Javier Lopez Belmonte, Chief Financial Officer of Rovi. At this time, I would like to welcome everybody to this first half twenty twenty results conference call, which will start in a moment. Let me please first introduce Robby's attendees today: Juan Lopo del Monte, CEO Marta Campos, Investor Relations Antonio Marquina, Investor Relations and myself. All lines are now mute to prevent any background noise.

The conference will also be webcasted on Robi website. After the presentation, as the operator said, there will be a question and answer session. Let me now turn the call over to the CEO, Mr. Juan Lopel Montei, for the highlights of this first half twenty twenty results. Juan?

Thank you, Javier, and welcome to everybody. I'm happy to present our first half twenty twenty results. The first six months of 2020 have been extremely unusual due to the COVID-nineteen pandemic. This crisis has not present and each day presents new challenge to all of us. Across our company, we are working hard to tackle the challenges that COVID-nineteen poses.

We have focused our efforts on three things in particular ensuring the health of our employees, continuing to supply our medicines to patients worldwide and supporting our society with resources and our expertise. Across the value chain, the COVID-nineteen pandemic had no critical impact on our daily business as we were able to continue the production of our medicines at all our facilities, supply our medicines to all the patients in need, mainly our low molecular weight heparins, which were recommended by the World Health Organization as essential medicines for people hospitalized in intensive care units due to COVID-nineteen and continue with all our research and development projects with no delays. All in all, the resources Roby booked to confront the COVID-nineteen pandemic and protect its employees during this first half of the year were €2,500,000 In these exceptional times, Robby's performance during the first half of the year has been above our expectations. Our 8% operating revenue growth in the first half of the year was driven by the strength of the specialty pharmaceutical business, which grew by 4% and by the toll manufacturing business, which grew by 31%. Data provided by IQVIA indicate that the innovative product market in Spain increased 4% in the first half of this year.

Nevertheless, Rovi's prescription based pharmaceutical product sales increased 7% during the first half of the year, outperforming the market by three percentage points. We forecast that we will continue to grow in line with the Spanish pharmaceutical market expenditure in the first five months of twenty twenty, which according to the Minister of Health, Consumption and Social Welfare showed a growth rate of 3.4%. Regarding the classification of laboratories using data from IQVIA, Probi was positioned sixteenth in terms of value and was the fastest growing Spanish innovative company among the top 16 ranked companies in the first half of twenty twenty. As you know, on July 9, we announced a collaboration agreement with Moderna for large scale commercial field finished manufacturing of Moderna's COVID-nineteen vaccine candidate at Rovi's facility in Madrid. As part of the agreement, Robi will provide vial filling and packaging capacity by procuring a new production line and equipment for compounding, filling, automatic desolation inspection and labeling to support production of the vaccine candidate intended in principle to supply markets outside of The U.

S. Starting in early twenty twenty one. We would like to mention that we are very happy about the collaboration with Moderna whose vaccine against COVID-nineteen is one of the front runners in the race to solve this health crisis. We would be thrilled for Robbie to form part of the solution to this pandemic that is affecting all of us and to support Moderna in supplying it on a wide scale. Our proven experience and capabilities as a tall manufacturer of injectables has allowed us to reach this agreement, which would help strengthen our manufacturing area and would in our probability provide us with a significant growth opportunity in the area.

Operating revenue increased by 8% to €191,100,000 in the first half of twenty twenty. The main contributors to this growth were the enoxaparin biosimilar, which grew 35% to an amount of €49,300,000 demiparin outside Spain where sales rose 88% the Parviz, sales of which grew by 43% and the total manufacturing business where sales increased 31%. The increase in sales together with the rise in gross margin and the drop in both promotion expenses as a result of the COVID-nineteen crisis and research and development expenses, pushed profitability up by 7.3 percentage points to 22.2% in the first half of twenty twenty. EBITDA increased by 60% to 42,400,000 Likewise, net profit increased by 83% from €16,200,000 in the 2019 to an amount of €29,600,000 in the first half of this year. Prescription based pharmaceutical specialties, which grew by 7% in the first half of twenty twenty, are highest strategic value products and contribute to give Rovi a wider scope for the coming years.

Rovi considers its heparin franchise as one of its driving forces, sales having risen by 22% to €104,000,000 in the first half of twenty twenty. Heparin sales represented 54% of operating revenue in the first half of the year compared to 48% in the first half of twenty nineteen. We aim to become one of the leaders in the low molecular weight heparin field worldwide with our two molecules, veniparin and the noxaparin biosimilar. Veniparin total sales increased by 14% to €51,600,000 in the 2020 and ofzaparin biosimilar total sales increased by 35% to €49,300,000 in the first half of twenty twenty. Provi continues with its internationalization plan.

Sales outside Spain increased by 37% to €86,500,000 in the first half of twenty twenty, euros 26,500,000.0 or 31% of those sales of which related to international subsidiaries mainly due to recognition of enoxaparin biosimilar sales. Sales outside Spain represented 45% of operating revenue in the 2020 compared to 36% in the first half of last year. International sales of Vemiparin increased by 88% to 18,300,000 representing 35% of total veniparin sales in the first half of twenty twenty. This significant increase was mainly linked to the increase in transfer prices to some partners due to the rise in low molecular weight heparin raw material prices. Rovi expects international demiparin sales to increase by a high teens percentage in 2020.

Sales of demiparin in Spain decreased 6% to €33,300,000 in the 2020 due to the significant reduction in the number of surgical operations performed during the period of confinement. International sales of enoxaparin increased by 20% to €34,200,000 representing almost 70% of total enoxaparin sales in the first half of twenty twenty. Regarding the enoxaparin biosimilar per cap, we launched the product in Germany in September 2017 in U. K, Italy, France, Spain, Austria, Latvia and Estonia in 2018 and in Portugal, Poland, Costa Rica, Finland and Sweden last year. Besides Europe, we have signed out licensing agreements in 88 countries as part of our second stage of our commercialization strategy.

We have signed two important licensing agreements to distribute and market anoxaparin biosimilar. The first with Hikma Pharmaceuticals who had exclusive rights for 17 Middle East and North Africa countries and the second with Sandoz for 14 countries regions. We started the commercialization in Q4 twenty seventeen with sales amounted to €1,500,000 and sales increased quarter by quarter to reach a 35% rise in the 2020 in a very difficult environment due to the reduction of the hospital activity during the period of confinement. So let me just summarize the opportunity here. This is a €1,400,000,000 market with high entry barriers whereby biosimilars are likely to reach between 50% to 70% of market share and with only two other players in the market.

The latest launches were again a strong driver of growth in the first half of twenty twenty. Sales of Neparvis from Novartis launched in December 2016 indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction increased sales 43% to €13,800,000 compared to €9,600,000 in same period last year. Sales of Volutza from Astellas Pharma increased by 9% to €7,000,000 VITORIN, Orbatec and Absolcor, the first of the five licenses of MSD indicated as an adjunctive therapy trial in patients with hypercholesterolemia increased by four percent to €15,900,000 in the first half of twenty twenty, despite Orbotech price was reduced by 30% in the 2020 due to the entrance of hybrid products formulated with ezetimibe and atorvastatin. Sales of HEROBRII, BRYSHALER and ULUNARB BRYSHALER both inhaled bronchodilators from Novartis decreased by 21% to €5,900,000 mainly due to the 18% price reduction in Olunav preshelly in the first half of twenty twenty. Finally, sales of contrast imaging agents decreased by 14% to €14,400,000 mainly due to a significant reduction in the number of diagnostic tests performed during the period of confinement.

Robi continues to be the market leader in this segment. Regarding toll manufacturing, sales increased by 31% to €34,800,000 in the 2020 as a result of the redirection of our core manufacturing activities strategy towards high value added products backed by the high degree of technological specialization of our plants in differentiated niches such as biological and biotechnological, immunological vaccines and long acting injectables. As we already mentioned, we have unified the third manufacturing area, which will allow us to take better advantage of the synergies between the plants and enhance their efficiency. In addition, we would like to highlight the fact that thanks to the deal with Moderna, Rovi will incorporate one new filling line for Vials. Following along the same line by the end of this year 2020, we expect the store manufacturing business to have increased by a high teens percentage.

As the company has recently reported, a very important milestone has already been achieved with its long acting injectable antipsychotic story. After the conclusion of the validation phase, the European health authorities have commenced the assessment process to grant marketing authorization for this first product based on a leading edge drug delivery technology, ISM. In March 2019, the company announced top line results from the pivotal study of RESTEDOM ISM PRIZMAK3, which showed that primary and key secondary efficacy endpoints were achieved with both doses tested for the treatment of patients with acute exacerbation of schizophrenia. Besides, in July 2019, the company announced the completion of the clinical trial program that will support application for marketing authorization for DORIA for the treatment of schizophrenia. In addition, an open label extension of the PRIZMA-three study has already finished and will provide clinical data on the long term use of risperidone ISAM.

Furthermore, Probyn informed of the decision to expand its industrial capabilities for the manufacture of dodge with the incorporation of a second line for the manufacture of the signage containing the solvent. The addition of this second line also provides the company with the necessary flexibility to initiate the preparation of the industrial filling processes of LETRO SOL ISM, which will require installation of a specific filling machine. As a result, Rovi has prioritized the submission of the TORIA dossier in Europe and subsequently the filing in The U. S. Targeting the second half of twenty twenty.

Furthermore, the company has already announced the commencement of the clinical development of Letrozole ISM, which represents the second candidate using Broviv's ISM technology platform. This new investigational medicine is to the best of our knowledge, the first long acting injectable aromatase inhibitor intended for the treatment of hormone dependent breast cancer. The first Phase I clinical trial, the RISA-one study of LetroSol ISM is currently ongoing. And due to the study design and its exploratory nature, the finalization data base cannot be anticipated. Nevertheless, preliminary data confirm that this ISM formulation provides a prolonged release of letrozole, which produces a sustained suppression of estrogenic hormones.

The company will be gathering more clinical data from this trial over the next few months to better characterize the pharmacological profile of leptosol ISM. Afterwards, in 2020, Rob is planning to discuss these results with the regulatory authorities together with the next steps for continuing the clinical development of this novel long acting injectable aromatase inhibitor. Lastly, Robby's research and development team has recently started development of a new formulation of risperidone iSEN for a three monthly injection, which would complement the current formulation of Torias for the maintenance treatment of patients with clinically stable schizophrenia. This development is still in an initial phase. And finally, let me end with our guidance for 2020.

Robby expects a mid single digit growth rate for the operating revenue. We have stayed on the path of sustained growth in the first half of the year. We increased sales by 8%, outperforming the market. We have expanded our heparin franchise through the launch of anoxaparin biosimilar in three new countries in the last twelve months and the increase of our presence in countries where we have already launched the product. We reinforced our European presence through the acquisition of three new products: Alethon for the German market Polaramine for the Spanish and French markets and sodium chepanin for the Italian market.

And we consolidated our pharmaceutical specialties area thanks to the strength of our leading products such as Neparvis and Volusa. We achieved growth of 31% in our total manufacturing business, thanks to the redirection of our strategy towards high value added products. Likewise, we are making a heavy investment effort in research and development, focused on our ISM technology, which we see as a new avenue for Robby's future growth. To conclude, we believe we are at a growth inflection point with a strong growth opportunity driven by Risperidone and LetroSol both candidates validating our leading edge drug delivery technology ASM our enoxaparin biosimilar, which will allow us to transform our European footprint and thirdly, the agreement with Moderna, which would help strengthen our manufacturing area and would provide us with a significant growth opportunity in the area. These growth levers are firmly underpinned by a very solid ongoing business that has delivered year after year based on our leading specialty pharma franchise and our high value added toll manufacturing services.

And now I hand you over to Javier, who will run you through the financials in more detail. Thank you very much for your attention and for taking the time to participate in this telephone conference. Thanks, Juan. We are extremely happy with our performance in the first half of this year. Our operating revenue increased by 8% this semester.

This growth is driven by the good performance of our low molecular weight heparin franchise, Temiparin and Enoxaparin Biosimilar. Likewise, our top manufacturing business was an important driver of our growth in the first half of twenty twenty. Sales of prescription based products increased by 7%, outperforming the innovative product market by three percentage points in this semester. Regarding our low molecular weight heparin franchise, we achieved a 24 percentage growth. Sales of lemiparine, our flagship product, developing house grew by 14%.

And enoxaparin biosimilar sales increased 35% to €49,300,000 in this first half of the year. Gross profit increased by 10% to €112,300,000 in the first half of twenty twenty. The gross margin is showing an increase of 1.4 percentage points from 57.4% in the 2019 to 58.8%, mainly due to increase in toll manufacturing sales contributing higher margins to the group sales, the increase in veniparine prices in hospitals due to rises in both low molecular weight heparin raw material prices and the demand for the growth in hospitals to treat COVID-nineteen the improvement in Enoxaparin margins in Spain counteracting the drop in the margin on international sales of Enoxaparin and the end of the marketing of the Energene growth portfolio, which had much lower margins than the group. In the first half of the year, raw molecular weight heparin raw material prices rose around 35% compared to the same period last year. Robby continues to be committed to innovation.

R and D expenses decreased 27 to €10,800,000 These figures are mainly the result of our focused investment in the ISN platform. Robby expects R and D expenses to decrease for the full year by a low double digit percentage. Our investment effort in R and D is fully motivated by our firm commitment to market our own quality and successful products in the immediate future. Selling, general and administrative expenses, SG and A decreased 3% to €59,100,000 in the first half of the year, mainly due to a drop in promotion expenses incurred by the sales force and expenses of international subsidiaries, which amounted to €4,000,000 compared to €4,800,000 last year. In the first half of twenty twenty, Robby booked €2,500,000 in personnel and other expenses related to the COVID-nineteen measures implemented.

Excluding expenses related to COVID-nineteen, SG and A would have decreased by 7% to €56,600,000 in the first half of the year. In 2020, expenses related to international subsidiaries are expected to be around €9,000,000 EBITDA increased to €42,400,000 in the first half of the year, a rise of 60% compared to the same period previous year, reflecting a 7.3 percentage point increase in the EBITDA margin, which was up to 22.2% in this semester from 14.9% in the first half of last year. EBITDA excluding expenses related to COVID-nineteen, what we call recurrent EBITDA increased to €44,900,000 in the first half of twenty twenty, a formidable rise of 70% compared to the same period of the previous year, reflecting 8.6 percentage point increase in the recurrent EBITDA margin. EBIT performance followed the same trend as EBITDA in the first half of the year. It increased by 85% to €32,900,000 reflecting a 7.2 percentage point increase in the EBIT margin.

Net financial result amounted to minus €30,000 in the 2020 compared to minus €300,000 mainly due to the gain related to exchange rate derivative financial instruments. The effective tax rate was 9.9% in the first half of twenty twenty compared to 7.5% in the first half of twenty nineteen. Research and development tax credits decreased in the 2020 as a result of a decrease in R and D expenses in the first half of the year compared to the same period of the previous year. So at the end of last year, negative tax basis of the group amounted to €34,900,000 of which €8,300,000 will be used in the 2019 income tax and €4,100,000 in the first half of twenty twenty. EBITDA pre R and D calculated excluding R and D expenses in the 2039 increased by 29% from €41,200,000 in the 2019 to fifty three point two million euros in the first half of this year, reflecting a 4.6 percentage point rise in the EBITDA margin to 27.8% in the first half of twenty twenty.

EBIT pre R and D increased by 34% from 32,500,000 in the 2019 to €43,600,000 in the first half of twenty twenty, reflecting a 4.5 percentage point rise in the EBIT margin to 22.8% in the first half of twenty twenty. Net profit pre R and D increased by 32% from €29,800,000 in the 2019 to €39,300,000 in the first half of this year. Robby invested €7,300,000 in the 2020 compared to €8,600,000 in the first half of twenty nineteen. Of this amount, 3,600,000.0 related to investment CapEx regarding our facilities, 3,800,000.0 relates to ISM industrialization concepts and €700,000 relates to maintenance and other CapEx. Free cash flow decreased to minus €22,300,000 in the 2020 compared to minus €19,400,000 in the first half of twenty nineteen, mainly due to increase of €77,300,000 in the inventories line in the first half of the year compared to an increase of €28,300,000 in the first half of last year.

Regarding our debt, as first half of twenty twenty, Rovi had a total debt of €75,400,000 At this date, bank borrowings decreased by €7,100,000 In December 2017, Rovi announced the European Investment Bank granted it a loan to support its investment in research, development and innovation. The loan was for €45,000,000 In September 2019, Rovi had drawn €5,000,000 against this credit line at a variable interest rate of a year over three months plus 0.844%. The latest interest rate paid was 0.551%. At December, Rovi had drawn the remaining €40,000,000 The credit matures in 2029 includes a grace period of three years with a fixed interest rate of 0.681%. Likewise, since the beginning of COVID-nineteen crisis, has signed credit policies for an amount of EUR45 million in order to ensure the company's liquidity.

As of June 30, Rovi had not used these trade policies. Thus, the group is in a very comfortable position to meet its payment obligation, debt maturities and any additional cash needs in the short and medium term. At this moment, Robby had a gross cash position of €37,300,000 compared to €68,900,000 at the end of last year and a net debt of €38,000,000 compared to €15,900,000 as last year. Regarding the dividend, the Board of Directors agreed to set the date for holding its ordinary General Shareholders' Meeting in October 2020 and to maintain the proposed dividend of EUR0.751 per share, which was communicated to the market in February 2020. Lastly, regarding the news flows for 2020, we will monitor the evolution of the Moderna vaccine.

We don't expect to announce any additional product launch this year as a result of the COVID-nineteen crisis. However, we expect to inform on new national marketing approvals for the enoxaparin biosimilars in 70 countries outside Europe. With regards to R and D, we expect to release the final risperidone ISM Phase III data at the Scientific Congress and we plan to apply for the marketing authorization for DORIA for the treatment of schizophrenia in The United States in the second half of the year. Also, we expect to gather more clinical data for Letrozole Phase I trial during the following months to better characterize the pharmacological profile of Letrozole ISM. In 2020, we are also planning to discuss these results with the regulatory authorities together with the next steps for continuing the clinical development.

And that's all regarding our financial results for the first half of the year. So now we can now open the Q and A session.

Speaker 1

Ladies and gentlemen, the Q and A session starts The first question comes from Harry from Jefferies. Please go ahead.

Speaker 3

Hi there. It's Harry Justin from Jefferies. Thanks for taking my questions. So firstly, on the Moderna deal, please can you help us understand the potential economics of this deal? So if you are planning to produce hundreds of millions of doses of the Moderna vaccine, what is the potential revenue contribution from that?

And then along that, what is the cost of the new injectable line that you're looking to build for this? And will you start to invest in this line prior to the results of the Moderna vaccine? And if so, do you have any sort of backup plans for if the Moderna vaccine, is unsuccessful? And then, similarly, on the margin contribution for this product, do you expect that that will be similar to the current injectable toll manufacturing services you currently do?

Speaker 2

Harry, this is Juan. Regarding the Moderna deal, honestly, it's very difficult to provide any guidance in terms of potential revenue or what is going to be the positive impact of this deal in our accounts for this year as there are still many uncertainties that it needs to be solved. We believe this is going to be a very important very important contract for the company. But still, there are several milestones that have to be achieved by Moderna such as the Phase III and the review by The U. S.

And the European authorities. So again, we are very happy to be in the front race and to be the company chosen by Moderna to be their fill and finish hub initially for all countries outside Europe. But really, we don't have the means or the basis really to provide you with an accurate or even a hint in terms of guidance of how this would be impacted. I think as time passes and we get more visibility by Moderna on what would be the final row and to what extent what are going to be the quantities that we'll be filling, I think we'll be able to provide more information to the market. But right now, would be more a wishful thinking rather than accurate data that we could provide to you today.

Regarding the your second question, the cost of the line, we have a pretty strong confidential process in our agreement with Moderna that it doesn't provide us the capability to disclose this information, but be sure that there are scenarios by which in case that the Moderna doesn't succeed with the Phase III clinical trial, doesn't succeed in getting an approval, Rovi gets a certain level of compensation by the cost of acquisition of the new line. I'm sorry, I cannot be I cannot give you further clarity, but again, I think as we get close to the end of the year, we'll be able to provide and to share with you more information as events may develop. And regarding the margins, yes, definitely. I mean, think we both Javier and myself, we have shared with you something which is very important for us in regards to the total manufacturing business. We have completely redirected strategy of the operations to high added value product.

Definitely, the Moderna COVID-nineteen vaccine is the perfect site. And we are talking for sure in margins on the high end of our current 16 business internal manufacturing operations.

Speaker 3

That's really helpful. And if I can just ask a few questions on Becket and Dory as well, please. So firstly, on Becket, we saw a slightly lower contribution this quarter compared to last. Is that more because of this lower hospital activity you're currently seeing? And from what you're seeing in the market at the moment, are you seeing a quick recovery in the demands there?

And then just also on the margins for or the contribution margins for Beckat, we're hearing about this oversupply in the global swine market. Are you seeing a decrease in the cost of heparin raw material as a result of that?

Speaker 2

Harry, this is Javier. I think you are fully right. I mean the decrease in sales or the, let's say, the less increase of the sales of BEKA this last quarter was fully in line with your aspiration, I mean, with the impact of the COVID-nineteen crisis. The hospitals have been focused only on coronavirus patients. And I mean, all pharmaceutical products faced a slight decrease on the usage and the gap has also been impacted.

So we expect that the sales could recover the trend in the following months if there is no more hopefully no more pandemic impact. As regards with the margins and the raw material, I think it's still early to predict big reduce of the price of the sodium heparin. This year, it's been very, very difficult. I mean, we have the swine fever, flu plus the COVID-nineteen effects. So it's difficult to predict what is going to happen.

But we will agree with your view that we still hope or we believe that in the next few quarters, we could see a slowdown or a decrease in the prices of the raw material, at least is what our feedback from the field tells us.

Speaker 3

That's really helpful. Thank you. And just a quick question on Doria. You've explained very well in the past about the sort of potential benefits for the product in terms of not requiring cold storage, the fast onset of therapeutic dosing. Can you maybe give us some insight into maybe smaller points such as what is the needle bore size compared to other treatments in the market and then also the dosing options and choice of injection sites for dorreia?

Thank you.

Speaker 2

Harvey. This is Juan. You really got me on that. I mean, I think the nil side case is identical to the other products on on the market, but we can send you we can send you the the the technical details. Basically, it's an intramuscular injection.

And and and in terms of gauge, yeah, we don't remember if it's the 25 gs and a half or the 27 gs and a half. But it's really the standard needle size for this sort of treatments. In regards to the dosing, I mean, those that have been tested on the clinical trial of forty seven point five milligrams? So but again, we can send you as well the TAF protocol that is in the webpage in clinicaltrials.gov, which is very well specified. We we we expect to some we expect to to release further data of story on on an important congress.

Unfortunately, COVID nineteen has put a lot of pressure on dates for for congress that they were they were scheduled before the year end, but we we expect that before we get the approval to be able to release in one of the major congress all the data. And and there there will be some important information regarding all these minor points like the pain on-site and things regarding to the dosage as well.

Speaker 3

Thank you very much for the insight. That's all from me.

Speaker 1

Thank you. The next question comes from Samir Devani from Rx Securities. Please go ahead.

Speaker 4

Hi, everyone. Thanks for taking my questions. Congrats on a good quarter. I've got three. I'll just give them one at a time.

I was surprised by the strength of the gross margin in the quarter at 63%. I'm just reading through the report, doesn't seem to be any reason why there's any exceptional element to that. So is that a fair run rate going forward for Q3 and Q4? So perhaps a bit more color on the gross margin.

Speaker 2

Sameer. This is Javier. You're right. We had an extraordinary quarter in terms of gross margin. I think as we described, the main reasons was the tremendous growth by the contract manufacturing activities.

So hopefully, we expect that the specialty pharma sales will increase more in the next following quarters if there is no impact from the COVID-nineteen or less impact. So probably in the following quarters, we'll see a more normalized gross margin with stronger sales from the specialty pharma franchise, which will have less or a minor gross margin. Again, third quarter usually is good for us in terms of gross margin. But overall, I would say that this quarter has been extraordinary. And overall, we expect a more normalized gross margin in the rest of the year.

Speaker 4

Okay. That's great. And then just what was the reason for the 18% price cut for Ulanar Breezehaler?

Speaker 2

Samir, basically, the rationale behind this is the following. One of the criteria for adjusting prices according to the Spanish law is to use the price that has been granted in reference countries within Europe. So usually, Spain every year or every two years, so definitely every five years, checks what is the current price of the medicines in their country peers, such as France, Italy, Belgium, Austria, the former 15 European members. And they usually they do an average of the price that it has been granted or it has been modified after the launch, and they tend to adjust that average to the Spanish market. In the case of Voruna, Vorunav, the price that would have been adjusted, which has been €45 from €59 that we were before or I mean €55 don't recall exactly, It's just to be in line with the prices in Europe.

And that has been the reason and it's one of the criteria that is listed on our legislation.

Speaker 4

Okay. That's fine. And then final question, just going back to the Moderna deal. Is there any reason why you can't be involved in the fill finish of the other vaccines that are in development? And perhaps you can just comment on sort of European capacities.

Obviously, my understanding is there's very few businesses that can do the fillfinish like you guys do. So is there an opportunity here to get other deals? Thanks.

Speaker 2

Basically, Samir, as you can imagine, we have been in contact with most of the players on the vaccine COVID-nineteen landscape. There are two major type of vaccine designs. One is live virus or attenuated live virus and the other one is the RNA messenger. Live virus needs biosafety level two facilities, which is not really the strategic or our core business, while RNA messenger is more like a small molecule in terms of fill and finish. So that's one of the reasons why we have, let's say, promote initially to to try to to to sign out a deal with the RNA messenger companies.

Secondly, we are talking about huge volumes. We are talking about millions of doses. Any company is already proposing quantities above 500,000,000, 1,000,000,000. So really, in order to be able to provide a good service, you really need to, to some extent, to be attached to a company. As well, this is going to be a fill and finish that is going to be whenever they get the data released, it's going to be a race to be really the first to get doses to the market.

So it's not a question of how much annual quantity you may have, but rather how much quantity you can how much capacity you can put into the market as soon as possible. So I believe in that sense, we need to be aligned with a company. It's true that we're still maintaining talks with other company developers, but I think for the time being, Robbie is sticking to the Moderna option. And our goal is, if they succeed with the Phase III clinical trial, to be able to devote as much capacity as possible to be able to deliver as many doses as we're capable of processing.

Speaker 4

That's great. Thanks very much.

Speaker 1

Thank you. The next question comes from John Varysna from Edison Investment Research. Please go ahead.

Speaker 5

Thank you for taking my question. I have two, so I'll ask them one at a time. So So the first half of the year has really seen a reduction in costs across the board, including SG and A and R and D. And I was hoping you could speak to how you expect these costs to change over the second half of the year, really looking out to 2021, and if you expect to see a continuation of this current trend?

Speaker 2

Hi, this is Javier. Actually, the reduction of SG and A, as we were trying to explain, is very linked to the lack of promotion activities that we had in the first half of the year due to the COVID-nineteen virus. Hopefully, we are willing to start again the standard and normal promotional activities in the second half of the year. And hopefully, we'll look after a rise in the SG and A figures in the second part of the year. That will mean that our sales force is working in a routine basis.

And probably, it also has an effect on the sales of the company.

Speaker 5

Yeah. And regarding R and D as well, yeah.

Speaker 2

Yeah. Sorry. I forgot about that. With regards to R and D, this year, we expect a decline on the cost compared to the previous year.

Speaker 5

Okay. Great. And then my second question is just regarding the collaboration deal with Verna and the procuring of this new filling production line and also the hiring of additional staff. Was just wondering if you could provide any more clarity on these timelines and really whether you've actually started any of these processes.

Speaker 2

Well, hi. This is Juan. Unfortunately, we cannot provide you more granularity or information at this moment of time. I mean, we are just to assure that we are just investing and betting on Moderna's success. So we definitely believe that if Moderna's vaccine candidate succeeds on its Phase III clinical trial, what Rob is really putting all our expertise and knowledge and capability to make sure that we can supply the market with the doses required by Moderna.

As our expertise, we are one of the most efficient tool manufacturing operators on the market. We have almost 800 people dedicated to total manufacturing. We have three different manufacturing sites. We have a capacity in injectables, which is one of the largest on the market. And we are really putting all our resources behind, as I mentioned before, to be able to supply to the market as many doses as possible as soon as the market may require them.

But to be honest, I don't think we will be able to provide much more information until we get feedback or the market gets feedback regarding on the Phase III data on Moderna. But let me say that we are very excited on this agreement, and we are very happy that Roby could be involved in getting a solution to this terrible pandemic situation worldwide.

Speaker 5

That's great. Thank you for that and congratulations on the strong set of results.

Speaker 1

Thank you. The next question comes from Guillaume Sampaio from CaixaBank BPI.

Speaker 6

Three, if I may. The first one, can you provide us some color on when should we have further details regarding the Oetrozole ISM process? Second question, do you see any potential for regulatory measures in Spain that may affect you still doing 2020? And if they move to 2021, what kind of measures do you expect and how this could affect you? And third question, can you comment on your conversations with the Spanish government as a member of Pharma Industrea regarding the potential for further increase in discounts to the National Health Service this year?

Thank you.

Speaker 2

You. This is Juan. Regarding your first question regarding LETROSAL ISM, As we have shared with you, we are currently running a Phase one because of this explanatory design. It's very difficult to anticipate when the clinical trial will be finalized. But with the current data, our idea is to start having discussions with both European and The U.

S. Regulatory authorities to see how can we design the following steps in order to get the product to the market, whether we have to make a Phase II, whether we can go directly to a Phase III. Again, I don't believe that we will be able to provide any further feedback to the market until we conclude our discussions with both regulatory bodies. And I don't think that will happen before Q1, Q2 next year. What I can remark and repeat again is that we are extremely excited with this project.

With DORIA, we are a follower. There are other products targeting schizophrenia indication on a long acting injectable technology. But we're very excited because Eptosol would be a really breakthrough in treating a major pathology like breast cancer and will be the first one to the market to get a long acting injectable on the approved. Regarding the measures of the Spanish government, and I will link it as well with the third question regarding our talks with the Spanish government. Honestly, it's difficult to anticipate what the Spanish government may legislate in the next coming months.

What is truth and I'm not going to be the one to highlight is that Spain is going to end 2020 with a tremendous deficit over 11%. So the Spanish government inevitably will have to take measures not only in the pharmaceutical spending but on other fields of the economy to offset this deficit in the next coming years. I have to say that the talks that PharmaIndustria is currently undertaking with the Spanish government are going in the right pathway. We expect, and that's our hope, to have these discussions concluding in a sort of a convenient agreement that we had in the last five years. Always the takeaway of having this agreement in place with the Spanish government is to channel to this agreement whatever financial needs may need to be adjusted on the pharmaceutical spending in the sense that whatever measures the Spanish government may need to take, it would be negotiated under the paradigm of this agreement.

So far, the communication is pretty good. It's I mean, it's I mean, the communication channels are actually very active. And I have to say that I'm at least optimistic that there is going to be a successful conclusion before at the year end. As well on timings, have to be, let's say, conservative. The Spanish government has just finalized their talks in Europe regarding the transfer that we are going to get from the European Commission.

So I guess the spending review of the pharmaceutical industry will definitely be on the agenda in the next coming months. And I think that the pharma industry and all the Spanish pharmaceutical companies will have already showed our authorities our willingness to be able to help the recovery of our domestic economy. And definitely, if we have managed to have an agreement in place with drawbacks and rebates in the last five years, I don't see any reason today why we shouldn't be able to sign another one for another for the next couple of years.

Speaker 1

Okay. Thank you very

Speaker 2

much. Thank

Speaker 1

you very much. Ladies and gentlemen, if you wish to ask a question, please press 01 on your telephone keypad. Thank you. There are no more questions. We will now hand over the call to Mr.

Javier Lopez Permante.

Speaker 2

Hello. As the operator said, there are no further questions at this time. So we can finish this first half twenty twenty financial results call. Thank you very much for attending the call, and have a good day. Thank you.

Bye bye.

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