Ladies and gentlemen, welcome to Robby Full Year twenty twenty Financial Results. Mr. Juan Lopez Del Monte, Chief Executive and Mr. Javier Lopez Del Monte, Chief Financial Officer of Robby will be presenting this conference. I will now pass the word to Mr.
Javier Lopez Del Monte. Please sir, go ahead.
Thank you very much and good afternoon to everyone. This is Javier Lopez Del Monte, CFO of Robby. At this time, I would like to welcome everybody to this full year twenty twenty results conference call, which will start in a moment. Let me please first introduce Ravi's attendees today: Mr. Juan Lopez Del Monte, CEO Marta Campos, Head of Investor Relations Antonio Martina, Investor Relations and myself.
All lines are now mute to prevent any background noise. The conference will also be webcasted on Robby 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 Lopo del Monte for the highlights of this year 2020.
Thank you, Javier, and welcome to everybody. I'm happy to present our 2020 results. The year 2020 has been extremely unusual due to the COVID-nineteen pandemic. This crisis has no precedent, and each day presents new challenges 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 a 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 NodiBase. All in all, the resources Robi booked to confront the COVID-nineteen pandemic and protect its employees during this year were €4,000,000 In these exceptional times, Robby's performance during the year has been above our expectations. Our 10% operating revenue growth was driven by the strength of the total manufacturing business, which grew by 39 and by the specialty pharmaceutical business, which grew by 4%. Data provided by Ecua indicate that innovative product market in Spain increased 2% in 2020.
Nevertheless, Roge's prescription based pharmaceutical product sales increased 6% during the year, outperforming the market by four percentage points. We forecast that we will continue to grow at a higher rate than Spanish pharmaceutical market expenditure last year, which according to the Minister of Health Consumption and Social Welfare, showed a growth rate of 2.6%. Regarding the classification of laboratories using data from Ecua, Roving was the fastest growing Spanish innovative company among the 17 top ranked companies in 2020. As you know, on November 27, we announced the online publication of the results of the pivotal study PRIZMA-three on the efficacy and safety of Torium in schizophrenic patients in the journal NPG schizophrenia. The results obtained in this study show that both doses, seventy five milligram and one hundred milligram once a month, have achieved the pre specified primary and secondary efficacy endpoints for treatment of patients with acute exacerbation of schizophrenia.
The significant statistical improvement for both efficacy results was observed as early as eight days after the first injection with a loading dose for oral treatment. According to the authors of the article, RUSTEREDO9 ism represents an effective therapeutic strategy in schizophrenic patients, who are admitted to hospital with an acute episode with severe or moderate psychotic symptoms. We are pleased with these results since not only do they prove that our iFEM technology works, but also because we believe that Doria will be able to help cover an unmet medical need. If we move to the operating results, our operating revenue increased by 10% to €420,000,000 in 2020. The main contributors to this growth were: Terexaparin biosimilar, which grew 25% to an amount of €101,400,000 Beniparin outside Spain, where sales rose 21% Neparvis, sales of which grew by 34% and the top manufacturing business, where sales increased by 39%.
The increase in sales, together with the rise in gross margin and the drop in both promotional expenses as a result of the COVID-nineteen crisis and the research and development expenses, pushed profitability up by 6.5 percentage points to 22.4% in 2020. EBITDA increased by 55% to €94,200,000 Likewise, net profit increased by 55% from €49,300,000 in 2019 to €61,100,000 in 2020. Prescription based pharmaceutical specialties, which grew by 6% in 2020, are high 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 14% to EUR 109,300,000.0 in 2020.
Heparin sales represented 50% of operating revenues in 2020 compared to 48% in 2019. We aim to become one of the leaders in the low molecular weight heparin field worldwide with our two molecules, demiparin and the oxaparin biosimilar. Demiparin total sales increased by 5% to €101,400,000 and oxaparin biosimilar total sales increased by 25% to €101,400,000 as well in 2020. Probi continues with its internationalization plans. Sales outside Spain increased by 28% to an amount of €191,100,000 in 2020, euros 52,500,000.0 or 27% of which related to international subsidiaries, mainly due to the increase in the term manufacturing business.
Sales outside the Spain represented 46% of operating revenue last year compared to 39% in 2019. International sales of amyfarin increased by 21% to €33,000,000 This significant increase was mainly linked to the increase in transfer prices to some partners due to the rise in low molecular weight separating raw material prices. Sales of emiphanin in Spain decreased 2% to €68,500,000 in 2020 due to the significant reduction in the number of surgical operations performed during the period of lockdown. International sales of enoxaparin increased to €67,400,000 representing 66.5% of the total enoxaparin sales in 2020. Regarding the noxaparin biosimilar, PRECAT, we launched the product in Germany in September 2017 in U.
K, Italy, France, Spain, Latvia and Estonia in 2018 in Portugal, Poland, Costa Rica, Finland and Sweden in 2019 and in South Africa, Israel, Peru, Poland, Panama and The Dominican Republic in 2020. We have signed two important licensing agreements to distribute and market our Roxaparin biosimilar. The first with Kikma Pharmaceuticals, who has exclusive rights for 17 Middle East and North Africa countries and the second with Sandoz for 14 countries or 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 25% rise in 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 €2,000,000,000 market, 1,300,000,000.0 in Europe and €700,000,000 in emerging countries with high end rebarbors, where biosimilars are likely to reach 50% to 70% of the market share and with only three other players in the market. The latest launches were again a strong driver of growth in 2020. Sales of Neparib, a strategic product from Novartis launched in December 2016, indicated for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction increased 34% to €29,600,000 in 2020 compared to €22,000,000 in 2019. Sales of Voluxa from Stellas Pharma increased by 7% to 14,200,000 Sales of Dithyrene, Orbotech and Absolcor specialty products from Merckxapandome indicated as adjunctive therapy to diet in patients with impaired cholesteatreaulemia decreased by 11% to €28,400,000 in 2020. In this period, Oratez price was reduced by 30% due to the entrance of hybrid products formulated with ezetimibe and atorvastatin.
Sales of Herobreed, Brixhaler and Ulanar Brixhaler, both inhaled bronchopilators from Novartis, decreased 22% to €11,300,000 in 2020 compared to €14,600,000 in the previous year, mainly due to Ulunar Michelin, price reduction of 18% in 2020. Finally, sales of contrast imaging agents decreased by 6% to €30,700,000 mainly due to the significant reduction in the number of diagnostic tests performed during the period of confinement. However, sales of contrast imaging agents and other hospital products increased by 12% in the 2020 compared to the third quarter of the same year and by 5% in the 2020 compared to the fourth quarter of twenty nineteen. Robey continues to be the market leader in this segment. Regarding toll manufacturing, sales increased by 49% to €91,600,000 in 2020 as a result of the redirection of our thermal 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, such as vaccines and long acting injectables and the booking of the income related to activities carried on under the agreement with Moderna.
Provin has carried on some activities linked to the preparing the plan for the COVID-nineteen vaccine production under the agreement with Moderna. And the income related to these activities was booked in the fourth quarter of twenty twenty. Likewise, by the end of twenty twenty one, Rovier expects the total manufacturing business to have increased between 1015%, including Moderna's activities, but excluding the production of the vaccines itself. DORIA is the first Rovys product based in its leading edge drug delivery technology, ISM. It's an open investigational antipsychotic for the treatment of schizophrenia with once monthly injection, which has been developed and patented by Laboratories Pharmaceuticals, Rovi and which, as one of the first injection, provides immediate and sustained asthmatic drug levels and does not require loading doses or supplementation with oral risperidone.
In March 2019, the company informed top line results from the pivotal study of RISPEZON ISM prismat three. And the 11/27/2020 announced their nine publication in the journal MPG schizophrenia. The results obtained in this study show that both doses, seventy five milligram and one hundred milligram once a month, have achieved a pre specified primary and secondary efficacy endpoint for treatment of patients with acute exacerbation of schizophrenia. The primary efficacy endpoint, the PANSS Total Score, mean difference of 95%, improved significantly with SPREDOM IASM seventy five milligram and one hundred milligram from the beginning until late eighty five, with adjusted difference of minus 13 and minus 13.3, respectively. Significantly, improvement changes for the secondary endpoint, the CGIS score, were also obtained for risperidone ISM in comparison with the placebo, minus 0.7 for both doses.
A significant statistical improvement for both efficacy results was observed as early as eight days after the first injection. The most frequently reported treatment emergent adverse events will increase blood prolactin 7.8, headache 7.3%, hyperprolactinemia 5% and weight increase 4.8%. No important news or unexpected safety information was reported. According to the authors of the article, Respede and IFM represents an effective therapeutic strategy in schizophrenic patients who who are admitted to hospital with an acute episode with severe or moderate psychotic symptoms. The company also announced in July 2019 the completion of an open label extension of the PRIZMAT3 study, which provides clinical data on the long term use of risperidone iFEM twelve additional months.
Based on these positive results and the other data from the product, previously announced the commencement of the centralized procedure for registration with the European Medicines Agency in January 2020. Likewise, at its Capital Markets Day set on November 24, Rovi announced the filing of an NDA, a revision to share sustained marketing authorization in The U. S. A. With the FDA.
On the other hand, the company already announced the commencement of the clinical development of LETROSOL ISM, which represents the second candidate using the ROVIS ISM technology platform. This new investigational medicine is to our best knowledge, the first long acting injectable aromatase inhibitor intended for the treatment of hormone dependent breast cancer. The first Phase I clinical trial, the LISA-one study of LETROZOL ISM is currently ongoing. And due to the study design, dose escalation and its exploratory nature, the finalization data 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 is planning in the 2021 to discuss with regulatory authorities these results as well as the next steps for continuing the clinical development of this novel long acting injectable aromatase inhibitor. Lastly, Rove's research and development team has recently started development of a new formulation of ruspaterone i7 for a pre monthly injection, which would complement the current formulation of Torium 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 2021. Probably expect the operating revenue to increase between 2030%, including the production of the Moderna COVID-nineteen vaccine.
We have stayed on the path of sustained growth in 2020. We've increased sales by 10%, outperforming the market. We have expanded our heparin franchise to the launch of our naxaparin biosimilar in six new countries in the last year and the increase of our presence in countries where we have already launched the product. We consolidated our pharmaceutical specialties area, thanks to the strength of our leading products such as Neparvi and Volusa. We achieved growth of 39% in our total manufacturing business, mainly thanks to the redirection of our strategy towards high value added products.
Likewise, we are making a heavy investment effort in R and D, focused on our ASM technology, which we see as a new avenue for Robby's future growth. To conclude, we believe we're at a growth inflection point with a strong growth opportunity driven by Risperidone and Lethosor, both candidates validating our leading edge drug delivery technology asset. Our enoxaparin biosimilar, which will allow us to transform our European footprint and agreement with Moderna, which is helping strengthening our manufacturing area and is providing 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 store 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 very happy with our performance of the year 2020. As Juan already said, our operating revenue increased by 10% this year. This growth is driven by the good performance of our low molecular weight heparin franchise and our leading products such as Neparvis and Volutza.
Likewise, our bone manufacturing business was an important driver of growth in 2020. Sales of prescription based products increased by 6%. And regarding our raw molecular weight heparin franchise, we achieved a 14% growth. Sales of bemiparin, our flagship product developed in house, grew by 5% and enoxaparin biosimilar sales increased 25% to EUR101.4 million in 2020. Gross profit increased by 12% in 2020.
The gross margin showing an increase of 1.1 percentage points from 56.6% in 2019 to 57.7% in 2020, mainly due to the increase in toll manufacturing sales contributing higher margins to group sales, the increase in the mebarium prices in hospitals due to rises in both raw molecular weight heparin raw material prices and the demand for the product in hospitals to treat COVID-nineteen. Also, 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 emerging product portfolio, which had lower margins than the group. In 2020, global agroweight heparin raw material prices rose around 36% compared to last year. ROBI expects low molecular weight heparin raw material prices to continue to decline in 2021. Nevertheless, despite the potential decrease in raw material prices, the impact on the gross margin will continue to be negative because of the long heparin manufacturing process in which the raw material currently used, stock for several months was purchased at higher prices.
Robby continues to be committed to innovation. R and D expenses amounted to €23,800,000 last year. This figure is mainly the result of our focused investment in the ISM projects. Selling, general and administrative expenses, SG and A, decreased 1% to €124,400,000 in 2020, mainly due to a drop in promotional expenses incurred by the sales force and also expenses of international subsidiaries, which amounted to EUR7.7 million compared to EUR9.1 million in 2019. In 2020, Robby booked EUR4 million 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 4% to EUR €120,400,000 in 2020. EBITDA increased to €94,200,000 in 2020, a rise of 55% compared to previous year, reflecting a 6.5 percentage point increase in the EBITDA margin, which was up to 22.4% in this year from 16% in 2019. EBIT performance followed the same trend as EBITDA in the year. It increased by 75% to EUR74.7 million, reflecting a 6.6 percentage point rise in the EBIT margin. Net finance result amounted to minus EUR 2,100,000.0 in 2020 compared to minus EUR 800,000.0 in 2019, mainly due to the loss related to exchange rate derivative financial instruments.
Effective tax rate was 15.9% in 2020 compared to 6.2% in 2019, mainly due to increase of the profit before income tax, the recognition in 2019 of negative tax basis, Rovi had the right to use and the decrease of research and development tax credits in 2020 as a result of the decrease in R and D expenses in the year compared to the previous year. As of thirty first December twenty twenty, negative tax basis of the group amounted to EUR 25,500,000.0, of which EUR $9,500,000.04000000, sorry, will be used in the 2020 income tax. Finally, net profit increased by 55% from €39,300,000 in 2019 to €61,000,000 in 2020. EBITDA pre R and D calculated excluding R and D expenses in 2020 and 2019 increased by 31% from €90,200,000 in 2019 to EUR 118,000,000 in 2020, reflecting a 4.5 percentage point rise in the EBITDA margin to 28.1% in 2020. In the same way, EBIT pre R and D increased by 37% and net profit pre R and D increased by 21%.
Robby invested €39,700,000 in 2020 compared to €27,000,000 in the year before. Of this amount, 25,700,000.0 related to investment CapEx regarding our facilities, including important projects such as the ISM industrialization and the building of a second low molecular weight heparin API facility in Scutar Granada. And finally, 14,000,000 relates to maintenance and older CapEx. Free cash flow increased to €7,300,000 in 2020 compared to minus €49,500,000 the year 2019, mainly due to the booking of €21,600,000 in the proceeds from toll manufacturing services line, mainly due to payments received that are pending to be allocated to the income statement. The increase of EUR 30,700,000.0 in profit before income tax, an increase of EUR 7,500,000.0 in the trade and other receivables item in 2020 compared to a decrease of EUR 20,400,000.0 in 2019.
Regarding our debt, as of thirty first December, twenty twenty, Robby had total debt of EUR74.4 million. Of that amount, EUR45 million is debt with banks, representing 60% of total debt, while €11,000,000 correspond to debt with public administration related to the development of R and D projects, which is 0% interest rate debt, representing 15% of total debt. And EUR 17,500,000.0 correspond on financial liabilities for leases as a result of the IFRS 16 application, representing 24% of total debt. Million correspond to derivative financial instruments. As of the end of last year, bank borrowings decreased by EUR7.1 million.
Likewise, since the beginning of the COVID-nineteen crisis, Robby has signed credit policies for an amount of €45,000,000 in order to ensure the company's liquidity. So at the end of last year, Rovi had not used these credit policies. Thus the group is in a very comfortable position to meet these payment obligations, debt maturities and any additional cash needs in the short and medium term. As of thirty first December twenty twenty, Rovi had a gross cash position of EUR 54,600,000.0 compared to EUR 36,800,000.0 as of thirty September twenty twenty and €68,900,000 as of thirty first December twenty nineteen. And a net debt of €19,800,000 compared to EUR 38,100,000.0 as of thirtieth September twenty twenty and EUR 15,900,000.0 as of thirty first December twenty nineteen.
Regarding the dividend, Robby will propose to the shareholders General Meeting a dividend of EUR 0.3812 per share with dividend rights on 2020 earnings. This proposed dividend would mean an increase of 118% compared to the dividend on 2019 earnings and represents a 35% payout. Regarding news flow for 2021, we will monitor the evolution of the manufacturing 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 keep informing on new national marketing approvals for denoxaparin biosimilar in '78 countries outside Europe.
With regards to R and D, we expect to obtain marketing authorization in Europe and United States for DORIA in 2021. And also we expect to gather more clinical data from Letrozole Phase one trial during the following months to better characterize the pharmacological profile of Letrozole ISM. In the first half of this year, we expect to discuss this result with the regulatory authorities together with the next steps for continuing the clinical development. And that's all regarding our financial results for 2020. We can now start the Q and A session.
Ladies and gentlemen, the Q and A session starts now. The first question comes from Francisco Reed from Exane. Please go ahead.
Hello, good afternoon. I have three questions, if I may. The first one is if you could guide us a little bit on how do you expect R and D and SG and A for 2021? Regarding R and D mainly on probably the Phase III of letrozole and SG and A taking into account the launch of Doria at least in Europe? The second question is on the guidance.
I mean the 20%, 30%, it is including only the Bazeen manufacturing revenues or it's something that has changed from your mid single digit that it was previously guided? And the last question is if you could clarify that the €20,000,000 that you have on your cash flow statement is an upfront payment from the revenues that we will see in 2021 or had to do with technology transfer of Moderna? Thank you.
Hi, good afternoon, Francisco. With regards this is Javier speaking. With regards to your first question about guidance for R and D and SG and A for next year, with regards to our R and D expenditure, it will depend on very much on the clinical trial evolution of letrozole. For that purposes, as we were mentioning, we will sit down with the authorities hopefully very soon and then we could have then we will have more visibility. As you know, our R and D expenditure is very dependent on the different phases of our products.
So if we start hopefully a new clinical trial with Letrozole, our R and D expenditure could increase compared to the previous year. And with regards to SG and A, I think it's clear that if the company is growing from 20% to 30% on guidance on operating revenue, we could easily anticipate that SG and A expenditure will increase because it's the only way to be able to cope with this increase on the operating revenue. However, it's still early to see how the expenditure evolution of the launching phase for Dorian Europe, how it will be. This is still early as we don't have marketing approval yet. And with the COVID-nineteen crisis, it's unclear the right timing to launch the product.
With regards to your second question about the guidance of the company, you were right or you are right in the sense that I think it was last November when we announced a potential guidance for this year of mid single digit growth and that didn't include the production of the manufacturing of the COVID-nineteen vaccine. At that moment, the COVID-nineteen vaccine were not approved yet and we didn't know whether we were going to manufacture the product or not. Right now, it's clear that the product is approved hopefully for all of us. And it's clear that Rovi is already manufacturing the vaccine. And on this guidance, at this current new guidance 20% to 30%, we include all revenues for the company for the year.
The last question, you're about the €20,000,000 upfront payment. It's related to some services that we have already provided or we are providing However, this service is not being accrued as an income in the P and L statement because we have well, we have to follow accounting criterias and we have already cashed that money, but the income is not yet stated in the P and L. I hope that verify your questions. Thank you.
So in that sense, mainly out of the 20% to 30% growth in top line, you will have around €20,000,000 which will not be cash flow next year?
Well, I cannot confirm your statement. Probably those €20,000,000 will not be included in the all of them in the P and L for next year. It will be accounted for several years, some of them, because some of them some of those services are related to some assets and we have to accrue the income whenever the asset is depreciated, just to give you an example. So it's not that direct connection between that 20,000,000 next year €20,000,000 or this year €20,000,000 hit in our P and L.
Okay. Okay.
Very clear.
Thank you. The next question comes from Guillaume Sampaio from CaixaBank. Please go ahead.
Hello, good morning. Thank you for taking my questions. So three from me. The first one, in your guidance, what are your timing exceptions regarding the path to a return to normalized levels of activity in 2021? Second question, how should we expect the phasing of modernosactine production contribution across the year in 2021?
And the third one, can you update us on the prospects for production of additional modernos products? Thank you very much.
Hello, Guilherme. We didn't get your first question, so I'm going to answer the second question and then we can get back to your first question. Regarding the phasing of the manufacturing of Moderna, I think it's clear that all companies we are scaling up. So it's not even related to Moderna, but the rest of the vaccine manufacturers. So we hope that as the months passed, the manufacturing outcome will be increasing exponentially.
So we believe that first quarter is going to be the lowest in terms of output of vaccine output. And this is going to be increasing hopefully in an exponential way. And hopefully, the last quarters will be the biggest. And I think that's related also to your third question, Noah, you were asking about production and about the new products of Moderna. We are now very focused on the new on the COVID-nineteen vaccines.
As you know, all companies are working on new variants, on the new vaccines. And hopefully we will help Moderna with these new variants in the next coming months. And with regards to their pipeline, to the rest of their pipeline, as we have always tell investors and analysts, we have signed as a supply chain partner to Moderna. So we could opt to manufacture the rest of their potential portfolio. But currently, we are still very focused on the vaccine.
And Moderna, I think they are also very focused on the COVID-nineteen vaccine. Could you repeat that your first question, Guillermo?
Yes. Thank you very much. So in your guidance, what are your timing assumptions regarding the path to a return to normalized levels of activity in 2021?
Well, clearly, that's why we stated that it's very unclear, not how the COVID-nineteen pandemic is going to affect the companies this year. Hopefully, I mean, meanwhile, there is confinement measures as we have always tried to explain to investors and analysts. There are less procedures in the hospitals and this clearly affects us in a negative way. As soon as the life comes to normal, I think that the normalized situations will come to rob. So again, it will depend on the evolution of the pandemic.
And as soon as we get a normal life, our P and L and our activity will get back to normal. So far, still our sales force are not able to call doctors at the hospital level due to pandemic. And and I think that's the main main point. No? When once our sales force can deploy their their work in a normal way, we can state that we that we will be in a normal normal situation.
Okay. Thank you very much.
Thank you. The next question comes from Alvaro Lense from Alantra Equities. Please go ahead.
Hi. Thanks for taking my questions and congrats on the good Q4 results. One question regarding the heparins. You stated that even if raw material prices fall, you could still have some negative impact on margins. I was wondering how should we think about revenues in heparin if raw material prices go down and whether your prices to hospitals would then scale back again?
Or would they stay as they are right now? My second question would be regarding your guidance on SG and A. We understand that SG and A should increase together with growth. But specifically for Doria, I wanted to know what's your flexibility to wait until you get the EU approval before launching the necessary marketing expenses or whether you need to front load those expenses before you get the regulatory approval? And lastly, if you could give us some guidance on how to think about CapEx needs and working capital needs going into 2021 and whether we could see Rovi in net cash position by the 2021 if things go as expected?
Hi, Alvaro. This is Juan. Regarding your first question on heparin, I mean, we see, which is still unclear, a decline of the prices of the raw material flow molecular was heparin, but we will see some boost in gross margin figures. Regarding our market policy on hospitals or retail market, as we have a specimen in different calls, there are many focus on what we believe is the most stable and long term revenue basis, which is the retail market and that's not so much affected in terms of pricing about the raw material prices. Hospital tenders still accounts for a not very significant part of our revenue line.
And again, if we see any decline in price of raw materials of low molecular weight heparin definitely will be a boost for the companies in both fronts, increasing the profitability of the retail segment and definitely will make us much more competitive in the hospital setting, which may allow us to craft even further market share. Alvaro. This is Javier. Regarding your second question about our SG and A outlook for next year and our potential flexibility for our launch of AUTHORIA, Well, I think you are hitting the right buttons. I mean, do have some certain flexibility in order to adjust our organization to launch Doria.
So for that purposes, we have delayed some decisions in order not to have some extra expenditure before we have the approval of Dorian Europe. Nevertheless, we have we are facing some other expenditures because we need to be ready now. So it's a mix and we are trying to be as flexible as we can and avoid all our potential expenditure. Overall, we expect an increase of SG and A for next year as we were saying before. And finally, with regards to your last question, both CapEx and working capital, with related to CapEx, we are still finalizing two important investments of the company.
First is the second our second API or our second Domo Agroirwa Weight heparin API facility, which is in Granada, Scuta, and that will be still working. We will be building the facility this year, so it's going to be an investment there. And we also have to conclude the industrialization of ISM, which is our second pillar of growth, the ISM and the Dorea launch and we have to be ready to cope with Dorea. And finally, we are also upgrading some manufacturing activities or investments in order to cope with the increasing demand that we have in the business, which is clear basically now with the vaccine outlook. With regards to working capital, I think we saw in 2020 in the last couple of quarters that we are reducing the working capital needs.
We expect to reduce working capital during this year also. And probably in that at that point to enhance in a good way our cash position for the next year as we were or for this year as you were suggesting. So I think working capital is going to evolve in a very positive way this year.
Okay. Thanks. That's very helpful. And if a follow-up, if I may, regarding Doria in The U. S, I understand that this is maybe midterm issue probably into 2022.
But whether do you have any idea what your approach to marketing of the product will be in North America or whether this decision is still not to be made in the short term? Thanks. FERNANDEZ:]
Hello, this is Juan. Regarding body in The U. S, we are right now undergoing different brainstorming sessions on different fronts, but still discussing internally what would be the best approach to take into account the COVID nineteen situation. You can understand that the the landscape today has got nothing to do with the one just ten months ago. I mean, the commercialization sales forces are on the ground.
We cannot, as Javier has mentioned before, call doctors. We are seeing a slowdown of penetration of new drugs. So we are taking all these new ingredients into our strategy. And unfortunately, that has slowed down our decision making process on how to approach The U. S.
Market. Hopefully, the approval gets closer, we will share with the Investor Committee what we believe is the best way to approach The U. S. Market in terms of efficacy and profitability for the company.
Okay. Thanks. That makes sense. Thank you both for your answers.
Thank you. The next question comes from Harry Justin from Jefferies. Go ahead.
Yes, hi there.
Thanks for taking my questions. I have a few. So I'll just start with two on enoxaparin, So firstly, can you comment on the expected timings of international launches for enoxaparin by your partners, Hikma and Sandoz this year? And then also, could you just quickly comment on the fourth quarter performance of enoxaparin? I understand that there's clearly been a negative impact from COVID.
But just thinking about the year on year decline, has there also been any considerations in terms of increasing competition across any of those markets, which is also a result of that year on year decline? Thank you.
Harry. This is Juan. Regarding enoxaparin, actually we are we expect that we'll be launching the product in 2021 in a similar number of countries like 2020, where we launched the product in six countries. Registration processes unfortunately is a slow procedure. And taking into account the COVID-nineteen, this has impacted most of the third country registration agencies in terms of their approval timings.
But having said that, we do believe that we will be launching in six, seven countries, hopefully in the next quarters. Within those countries, there are some significant markets such as Canada. So we are really working towards, as we have always mentioned and we have done before with the MiParring of making sure that we get enough suffering in as many countries as possible. So this is going to be a long term race. I believe in that sense, we'll have two very reliable partners, which are going to make this journey with us, which is Hikma and Sandoz.
I think it's only going to be a question of time until we reach a significant number of countries where the product is available similar to what we have performed in the past with PEMIFAI. So in that sense, we are very optimistic. And actually, we launched the product in 2017 and I'm moving as well to your second question. We don't see any major additional competition coming to the market. We are very much the same player as we were two years ago.
That means ourselves, the Chinese company and an Italian company. And as we have always emphasized, we believe that Enel Safran has got very high entry barriers. We are talking about a product with a very complex and difficult supply chain. Secondly, it's a biological compound that it makes the registration process with some complexities that is not that doesn't make any company to be capable of approaching. And I think what is worthwhile reminding today is that I believe it's one of the few biosimilars, it's not the only one, but none of the big generic players have been involved.
So I think that gives a flavor of the difficulty and as well it tell us how honestly, we don't believe that the competition is going to be to vary significantly in the next coming years. Maybe we'll see one or two additional players coming to the market, but this is nothing significantly if we compare to the market opportunity that Nexaparin represents. Regarding the fourth quarter, the problem with 2021 is that we have to be a little bit difficult on the a little bit worry of how we make the analysis. We have a period of lockdown. We have confinements in different countries.
We are playing right now with different surveys that is seven different countries, surgery centers and operational surgeries went down as much as seventy percent. You know that the outpatient patients have been very, very, very afraid of going to hospitals. So as well, I think 2020 shouldn't play as a benchmarking or what made the product delivered in the future. I think we have been on one way. We have been lucky in the sense that low molecular heparin has been an essential drug to treat COVID-nineteen.
So definitely we see a part of the growth that is coming from a unique situation to treat all those patients. But as well, we have been heated. And honestly, I wouldn't be able to share with you a figure in a sales loss regarding all those nonsurgical operations that have not been performed. So I don't think 2020 especially the fourth quarter from the second quarter, I don't think the ramp up or the slightly decline in terms of sales per quarter cannot be a good benchmark for the years to follow. I think this COVID-nineteen has in a product like low molecular with heparin has distorted a little bit evolution of the product.
We believe that 2021, at least from the figures that we are working on for the first two months of the year, I mean, is evolving very nicely. So we do believe that 2021 should we should still have growth to deliver to the market. So we're very optimistic. And as we have said throughout our presentation, enoxaparin and the heparin franchise globally is still going to be one of our major drivers of the company.
Brilliant. Thank you for the color. And just to follow-up on the previous guidance question. I appreciate that the new guidance is for all of the sales, including Moderna. But does this guidance assume the same base business single sorry, mid single digit growth as you said before?
Or has there also been some change to your expectations outside of the COVID manufacturing contract?
Harry. This is Javier speaking. Well, as we were telling before, hopefully we have included all revenues for the year. That's why the big change in the guidance and especially with regards to the vaccine COVID-nineteen vaccine. But yes, as Juan was saying, I think the beginning of the year has been so far very, very positive.
We're optimistic. And I do believe that the rest of the business is also maybe even performing better than expected in November. And that's why we were we're now very optimistic now and we think that the guidance for the year could be as high as 30% for 2020 and 2021. It's clearly an upgrade of the guidance. We are now very confident because we are already manufacturing the COVID-nineteen vaccine and the business, the rest of the business is also going very well.
Brilliant. That's very helpful. And just final question from me. In terms of the Doria potential Doria EU approval later this year, can you give us an indication as to what your expectations for timing for reimbursement would be across markets if STORIA were to be approved in Europe?
Harry, mean, this is Juan. Regarding DORIA, we are expecting approval this year for sure. The thing is that the COVID-nineteen situation has completely changed the landscape like I mentioned in our previous question. Right now, across Europe, sales rep and sales detailing is is being stopped for obvious reasons. So really, I know this is this sounds like a little bit of a conflict of interest, but right now, we believe that we have to wait until the right moment to launch the product in appropriate way.
I mean, to launch a product to our Europe requires a major investment in terms of headcounting and marketing activities. And what we are right now working is on the right timing to do the launch across Europe. So in that sense, reimbursement process is no longer an issue of timing. Let's say, would it make any sense to launch a product, fight for a reimbursement, and just have all the people that have to promote and explain the benefits of the talk being at home, which is the current situation. So right now, what we are working is to make sure with EMEA that we have the best SMTC possible to make sure that we are gaining all the field expertise and the marketing knowledge to make sure that we position the product in appropriate way.
And if we're this way that we are being a sort of in house laboratory remarketing launch in terms of gathering inside knowledge. Again, even if we get the approval, we get the reimbursement process accordingly. We are still considering that we may have to wait a couple of quarters before we launch the product. I mean, I think the COVID-nineteen unfortunately is impacting heavily in all companies. And I think we have to be right now very cautious on the timing of the launch.
That's very helpful. Thank you.
Thank you. Ladies and gentlemen, there are no further questions. I will now hand over the call to Mr. Javier Lopez Belmonte. Thank you.
Thank you, Lydia. So there are no more questions at this time. We would like to thank you for joining us today in this twenty twenty full year results conference call and we can end the call right now. So thank you. Have a great day.
Goodbye.