Ladies and gentlemen, welcome to Rovi's Full Year 2020 Financial Results. The management of Rovi will run you through the presentation, which will be followed by a Q&A session. Mr. Juan López- Belm onte, Chief Executive Officer, and Mr. Javier López-B elm onte, Chief Financial Officer of Rovi, will be presenting this conference. I will now pass the word to Mr. Javier López-B elm onte. Please, sir, go ahead.
Thank you very much, and good afternoon to everyone. This is Javier López-Belmonte, CFO of Rovi. At this time, I would like to welcome everybody to this full year 2020 results conference call, which will start in a moment. Let me please first introduce Rovi's attendees today. Mr. Juan López-Belmonte, CEO, Marta Campos, Head of Investor Relations, Antonio Marquina, Investor Relations, and myself. All lines are now on mute to prevent any background noise.
The conference will also be webcasted on Rovi 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 López-Belmonte, 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-19 pandemic. This crisis has no precedent. Each day presents new challenges to all of us. Across our company, we are working hard to tackle the challenges that COVID-19 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-19 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-19, and continue with all our research and development projects with no delays.
All in all, the resources Rovi took to confront the COVID-19 pandemic and protect its employees during this year were EUR 4 million. In these exceptional times, Rovi's performance during the year has been above our expectations. Our 10% operating revenue growth was driven by the strength of the toll manufacturing business, which grew by 39%, and by the specialty pharmaceutical business, which grew by 4%.
Data provided by IQVIA indicate that innovative product market in Spain increased 2% in 2020. Nevertheless, Rovi'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 Ministry of Health, Consumption and Social Welfare, show a growth rate of 2.6%.
Regarding the classification of laboratories using data from IQVIA, Rovi was the fastest-growing Spanish innovative company among the 17 top-ranked companies in 2020. As you know, on November 27th, we announced the online publication of the results of the pivotal study PRISMA-3 on the efficacy and safety of Doria in schizophrenic patients in the journal, npj Schizophrenia.
The results obtained in this study show that both doses, 75 mg and 100 mg 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 without loading dose or oral treatment.
According to the authors of the article, it 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 ISM 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 EUR 420 million in 2020.
The main contributors to this growth were the enoxaparin biosimilar, which grew 25% to an amount of EUR 101.4 million. bemiparin outside Spain, where sales rose 21%. Neparvis, sales of which grew by 34%, and the toll manufacturing business, where sales increased by 39%. The increase in sales together with the rise in gross margin and the drop in both promotion expenses as a result of the COVID-19 crisis and the research and development expenses pushed profitability up by 6.5 percentage points to 22% in 2020.
EBITDA increased by 55% to EUR 94.2 million. Net profit increased by 55% from EUR 49.3 million in 2019 to EUR 61.1 million 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 €109.3 million 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, Bemiparin and Enoxaparin biosimilar. Bemiparin total sales increased by 5% to €101.4 million and Enoxaparin biosimilar total sales increased by 25% to €101.4 million as well in 2020.
Rovi continues with its internationalization plans. Sales outside of Spain increased by 28% to an amount of €191.1 million in 2020. €52.5 million or 27% of which related to international subsidiaries, mainly due to the increase in the toll manufacturing business. Sales outside of Spain represented 46% of operating revenue last year compared to 39% in 2019. International sales of Bemiparin increased by 21% to €33 million.
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. Sales of Bemiparin in Spain decreased 2% to EUR 68.5 million 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 EUR 67.4 million, representing 66.5% of the total enoxaparin sales in 2020.
Regarding the enoxaparin biosimilar, Becat, 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 enoxaparin biosimilar.
The first with Hikma 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 2017, with sales amounted to EUR 1.5 million 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.
Let me just summarize the opportunity here. This is a EUR 2 billion market, EUR 1.3 billion in Europe and EUR 0.7 billion in emerging countries with high entry barriers where biosimilars are likely to reach 50%-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 Neparvis, a specialty 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 EUR 29.6 million in 2020 compared to EUR 22 million in 2019. Sales of Volutsa from Astellas Pharma increased by 7% to EUR 14.2 million. Sales of Ezetrol, Orvatez, and Absorcol, specialty products from Merck Sharp & Dohme, indicated as adjunctive therapy to diet in patients with hypercholesterolemia decreased by 11% to EUR 28.4 million in 2020.
In this period, Orvatez price was reduced by 30% due to the entrance of hybrid products formulated with ezetimibe and atorvastatin. Sales of Hirobriz Breezhaler and Ulunar Breezhaler, both inhaled bronchodilators from Novartis, decreased 22% to EUR 11.3 million in 2020 compared to EUR 14.6 million in the previous year, mainly due to Ulunar Breezhaler price reduction of 18% in 2020.
Sales of contrast imaging agents decreased by 6% to EUR 30.7 million, mainly due to the significant reduction in the number of diagnostic tests performed during the period of confinement. Sales of contrast imaging agents and other hospital products increased by 12% in the fourth quarter of 2020 compared to the third quarter of the same year and by 5% in the fourth quarter of 2020 compared to the fourth quarter of 2019.
Rovi continues to be the market leader in this segment. Regarding drug manufacturing, sales increased by 39% to EUR 91.6 million in 2020 as a result of the redirection of our drug 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 the activities carried on under the agreement with Moderna.
Rovi has carried on some activities linked to the preparing the plant for the COVID-19 vaccine production under the agreement with Moderna, and the income related to these activities was booked in the fourth quarter of 2020. Likewise, by the end of 2021, Rovi expects the drug manufacturing business to have increased between 10% and 15%, including Moderna's activities, but excluding the production of the vaccines itself.
Risperidone ISM is the first Rovi's product based in its leading-edge drug delivery technology, ISM. It's a novel investigational antipsychotic for the treatment of schizophrenia with once-monthly injection, which has been developed and patented by Laboratorios Farmacéuticos ROVI and which, as one of the first injection, provides immediate and sustained plasmatic 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 Risperidone ISM, PRISMA-3 , and the 27th of November of 2020, announced their new publication in the journal, "npj Schizophrenia." The results obtained in this study showed that both doses, 75 mg and 100 mg once a month, have achieved the 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, 95%, improved significantly with Risperidone ISM, 75 mg and 100 mg from the beginning until day 85, with adjusted difference of -13 and -13.3 respectively. Significantly improved mean changes for the secondary endpoint. The CGI-S score were also obtained for Risperidone ISM in comparison with the placebo, -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 were increased blood prolactin, 7.8%, headaches, 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, Risperidone ISM represents an effective therapeutic strategy in schizophrenic patients 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 PRISMA-3 study, which provides clinical data on the long-term use of Risperidone ISM®, 12 additional months. Based on these positive results and the other data from the product, Rovi previously announced the commencement of the centralized procedure for registration with the European Medicines Agency in January 2020. Likewise, at its Capital Markets Day held on November 24th, Rovi announced the filing of an NDA, a registration dossier to obtain marketing authorization in the USA with the FDA.
On the other hand, the company already announced the commencement of the clinical development of Letrozole ISM®, which represents the second candidate using the Rovi's 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-1 study of Letrozole 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 first half of 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, Rovi's research and development team has recently started development of a new formulation of Risperidone ISM® for a three-monthly injection, which would complement the current formulation of Doria for the maintenance treatment of patients with clinically stable schizophrenia. This development is still in an initial phase.
Finally, let me end with our guidance for 2021. Rovi expects the operating revenue to increase between 20%-30%, including the production of the Moderna COVID-19 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 enoxaparin biosimilar in six new countries in the last year, and the increase of our presence in countries where we had already launched the product.
We consolidated our pharmaceutical specialties area, thanks to the strength of our leading products, such as Neparvis and Volutsa. We achieved growth of 39% in our toll manufacturing business, many thanks to the redirection of our strategy towards high value-added products. Likewise, we are making a heavy investment effort in R&D, focused on our ISM technology, which we see as a new avenue for Rovi's future growth.
To conclude, we believe we are at a growth inflection point, with a strong growth opportunity driven by risperidone and Letrozole ISM®, both candidates validating our leading-edge drug delivery technology, ISM. Our enoxaparin biosimilar, which will allow us to transform our European footprint, and the 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 toll manufacturing services. 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 Volutsa. Likewise, our toll manufacturing business was an important driver of growth in 2020.
Sales of prescription-based products increased by 6%. Regarding our low 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 EUR 101.4 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 bemiparin prices in hospitals due to rises in both low molecular weight heparin raw material prices and the demand for the product in hospitals to treat COVID-19.
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 Norgine product portfolio, which had lower margins than the group. In 2020, low molecular weight heparin raw material prices rose around 36% compared to last year. Rovi 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, stocked for several months, was purchased at higher prices. Rovi continues to be committed to innovation. R&D expenses amounted to EUR 23.8 million last year.
This figure is mainly the result of a focused investment in the ISM projects. Selling, general, and administrative expenses, SG&A, decreased 1% to EUR 124.4 million in 2020, mainly due to a drop in promotion expenses incurred by the sales force, and also expenses of international subsidiaries, which amounted to EUR 7.7 million compared to EUR 9.1 million in 2019.
In 2020, Rovi booked EUR 4 million in personnel and other expenses related to the COVID-19 measures implemented. Excluding expenses related to COVID-19, SG&A would have decreased by 4% to EUR 120.4 million in 2020.
EBITDA increased to EUR 94.2 million 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 EUR 74.7 million, reflecting a 6.6 percentage point rise in the EBIT margin. Net finance result amounted to minus EUR 2.1 million in 2020 compared to minus EUR 0.8 million 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 the increase of the profit before income tax, the recognition in 2019 of negative tax bases 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&D expenses in the year compared to the previous year.
As of 31st December 2020, negative tax bases of the group amounted to EUR 25.5 million, of which EUR 9.5 million, EUR 4 million, sorry, will be used in the 2020 income tax. Net profit increased by 55% from EUR 39.3 million in 2019 to EUR 61 million in 2020. EBITDA pre-R&D, calculated excluding R&D expenses in 2020 and 2019, increased by 31% from EUR 90.2 million in 2019 to EUR 118 million 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&D increased by 37%, and net profit pre-R&D increased by 21%. Rovi invested EUR 39.7 million in 2020 compared to EUR 27 million in the year before. Of this amount, EUR 25.7 million 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 Escúzar, Granada.
Finally, EUR 14 million relates to maintenance and all the CapEx. Free cash flow increased to EUR 7.3 million in 2020 compared to minus EUR 49.5 million the year, 2019, mainly due the booking of EUR 21.6 million 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 30.7 million in profit before income tax and the increase of EUR 7.5 million in the trade and other receivables item in 2020 compared to a decrease of EUR 20.4 million in 2019. Regarding our debt, as of 31st December 2020, Rovi had total debt of EUR 74.4 million.
Of that amount, EUR 45 million is debt with banks, representing 60% of total debt, while EUR 11 million correspond to debt with public administration related to the development of R&D projects, which is 0% interest rate debt, representing 15% of total debt.
EUR 17.5 million correspond to financial liabilities for leases as a result of the IFRS 16 application, representing 24% of total debt. EUR 0.9 million correspond to derivative financial instruments. At the end of last year, bank borrowings decreased by EUR 7.1 million.
Likewise, since the beginning of the COVID-19 crisis, Rovi has signed credit policies for an amount of EUR 45 million in order to ensure the company's liquidity. At the end of last year, Rovi had not used these credit policies. Thus, the group is in a very comfortable position to meet its payment obligations, debt maturities, and any additional cash needs in the short and medium term.
As of 31st December 2020, Rovi had a gross cash position of EUR 54.6 million compared to EUR 36.8 million as of 30th September 2020 and EUR 68.9 million as of 31st December 2019. A net debt of EUR 19.8 million compared to EUR 38.1 million as of 30th September 2020 and EUR 15.9 million as of 31st December 2019. Regarding the dividend, Rovi will propose to the shareholders general meeting a dividend of EUR 0.3812 per share, which 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 newsflow 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-19 crisis. However, we expect to keep informing on new national marketing approvals for the enoxaparin biosimilar in 78 countries outside Europe.
With regards to R&D, we expect to obtain marketing authorization in Europe and U.S. for Okedi in 2021. Also we expect to gather more clinical data from letrozole phase I 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.
That's all regarding our financial results for 2020. We can now start the Q&A session.
Ladies and gentlemen, the Q&A session starts now. If you wish to ask a question, please press 01 on your telephone keypad. Thank you. The first question comes from Francisco Ruiz 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 you spread R&D and SG&A for 2021. Regarding R&D, mainly on probably the phase III of Letrozole and SG&A, taking into account the launch of Okedi, at least in Europe. The second question is just on the guidance.
I mean, the 20%-30%, it includes only the vaccine manufacturing revenues or is something that has changed from your mid-single digits that you were previously guided. The last question is if you could clarify that the EUR 20 million 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. This is Javier speaking. With regards to your first question about guidance for R&D and SG&A for next year. With regards to our R&D expenditure, it will depend 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 will have more visibility.
As you know, our R&D expenditure is very dependent on the different phases of our products. If we start, hopefully, a new clinical trial with letrozole, our R&D expenditure could increase compared to the previous year.
With regards to SG&A, I think it's clear that if the company is growing from 20%-30% on guidance on operating revenue, we could easily anticipate that SG&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 Okedi in Europe, how it will be known. It's still early as we don't have the marketing approval yet. With the COVID-19 crisis, it's still 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. That didn't include the production of the manufacturing of the COVID-19 vaccine. At that moment, the COVID-19 vaccine were not approved yet, 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. It's clear that Rovi is already manufacturing the vaccine. On this current new guidance, 20%-30%, we include all revenues for the company for the year. The last question about the EUR 20 million upfront payment, it's related to some services that we have already provided or we are providing to some customers.
However, this service is not being accrued as an income in the P&L statement, because we have to follow accounting criteria, and we have already cashed that money, but the income is not yet stated in the P&L. I hope that clarify your questions. Thank you.
In that sense, mainly out of the 20%-30% growth in top line, you will have around EUR 20 million, which will not be cash flow next year.
Well, I cannot confirm your statement, probably those EUR 20 million will not be included, all of them, in the P&L for next year. It will be accounted for several years, some of them, because 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. It's not that direct a connection between that EUR 20 million to next year, EUR 20 million, or this year, EUR 20 million hit in our P&L.
Okay. Very clear.
Thank you. The next question comes from Guilherme Sampaio from CaixaBank. Please go ahead.
Hello, good morning. Thank you for taking my questions. Three for me. The first one, in your guidance, what are your timing assumptions regarding the path to a return to normalized levels of activity in 2021? Second question, how should we expect the phasing of Moderna's vaccine production contribution across the year in 2021? The third one, can you update us on the prospects for production of additional Moderna's products? Thank you very much.
Hello, Guilherme. We didn't get your first question. I am 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 is clear that all companies, we are scaling up. It is not even related to Moderna, but the rest of the vaccine manufacturers.
We hope that as the months pass, the manufacturing outcome will be increasing exponentially. We believe that first quarter is going to be the lowest in terms of vaccine output. This is going to be increasing, hopefully in an exponential way. Hopefully, the last quarters will be the biggest. I think that is related also to your third question when you were asking about production and about the new products of Moderna. We are now very focused on the COVID-19 vaccines.
You know, all companies are working on new variants, on the new vaccines, hopefully we will help Moderna with these new variants in the next coming months. With regards to the rest of their pipeline, as we have always tell investors and analysts, we have signed as a supply chain partner to Moderna.
We could opt to manufacture the rest of their potential product portfolio, but currently we are still very focused on the vaccine. Moderna, I think they are also very focused on the COVID-19 vaccine. Could you repeat that, your first question, Guilherme?
Yes. Thank you very much. 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 how the COVID-19 pandemic is going to affect the companies this year. Meanwhile, there is confinement measures, as we have always tried to explain to investors and analysts. 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 Rovi. Again, it will depend on the evolution of the pandemic, and as soon as we get a normal life, our P&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. I think that's the main point.
Once our sales force can deploy their work in a normal way, we can state that we will be in a normal situation.
Okay. Thank you very much.
Thank you. The next question comes from Álvaro Lenze 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 heparins 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&A. We understand that SG&A should increase together with growth, but specifically for Okedi, 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.
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 end of 2021 if things go as expected. Thanks.
Hi, Álvaro. This is Juan. Regarding your first question on heparins. If we see, which is still unclear, a decline of prices of the raw material, low molecular weight heparin, we will see it's a boost in our gross margin, figures.
Regarding our market policy on hospitals or retail market, as we have specified in different calls, we're mainly focused on what we believe is the most stable and long-term revenue basis, which is the retail market. That's not so much affected in terms of pricing about the raw material prices. Hospital tenders still account for a not very significant part of our revenue line.
Again, if we see any decline in price of raw materials, of low molecular weight heparin, definitely it 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 grab even further market share.
Hi, Álvaro. This is Javier. Regarding your second question about our SG&A outlook for next year and our potential flexibility for our launch of Okedi. Well, I think you are hitting the right buttons. We do have some certain flexibility in order to adjust our organization to launch Okedi. For that purposes, we have delayed some decisions in order not to have some extra expenditure before we have the approval of Okedi in Europe.
Nevertheless, we are facing some other expenditures because we need to be ready now. 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&A for next year, as we were saying before. Finally, with regards to your last question, about CapEx and working capital.
With that related to CapEx, we are still finalizing two important investments for the company. First is our second low molecular weight heparin API facility, which is in Granada, Escúzar. That will be still working. We'll be building the facility this year, it's going to be an investment there. We also have to conclude the industrialization of ISM, which is our second pillar of growth now, the ISM and the Okedi launch, we have to be ready to go with Okedi.
Finally, we are also upgrading some co-manufacturing activities for 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 at that point to enhance in a good way our cash position for the next year as you were, or for this year, as you were suggesting. I think working capital is going to evolve in a very positive way this year.
Okay, thanks. That's very helpful. A follow-up, if I may, regarding Okedi in the U.S., I understand that this is maybe a midterm issue, probably into 2022, but whether you have any idea of 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.
Hello, this is Juan. Regarding Okedi in the U.S., we are right now undergoing different brainstorming sessions on different fronts. Still discussing internally what would be the best approach, taking into account the COVID-19 situation. You can understand that the landscape today has got nothing to do with the one just 10 months ago. 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. We are taking all these new ingredients into our strategy. Unfortunately, that has slowed down our decision-making process on how to approach the U.S. market. Hopefully, as the approval gets closer, we will share with the investor community 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.
The next question comes from James Vane from Jefferies. Please go ahead.
Yes, hi there. Thank you for taking my questions. I have a few. I'll just start with two on enoxaparin, please. Firstly, can you comment on the expected timings of international launches for enoxaparin by your partners, Hikma and Sandoz this year?
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. 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.
Hi, James. This is Juan. Regarding enoxaparin, actually, 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, it's a slow procedure. Taking into account the COVID-19, this has impacted most of the top four country registration agencies in terms of their approval timings.
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. We are really working towards, as we have always mentioned and we have done before with the, of making sure that we get enoxaparin in as many countries as possible. This is going to be a long-term race.
I believe in that sense, we 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 . In that sense, we are very optimistic.
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 players that we were two years ago. That means ourselves, the Chinese company and the Italian company. As we have always emphasized, we believe that enoxaparin 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. It makes the registration process with some complexities that doesn't make any company to be capable of approaching. I think what is worthwhile reminding today is that I believe it's one of the few biosimilars, it's not the only one, none of the big generic players have been involved. 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 vary significantly in the next coming years.
Maybe we'll see one or two additional players coming to the market, this is nothing significant if we compare to the market opportunity that enoxaparin represents. Regarding the fourth quarter, the problem with 2021 is that we have to be a little bit wary 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 in seven different countries, surgery theaters and operational surgeries went down as much as 70%. You know that the outpatient patients have been very afraid of going to hospitals. As well, I think 2020 shouldn't play as a benchmarking of what may the product deliver in the future.
I think we have been, on one way, we have been lucky in the sense that low molecular weight heparin has been an essential drug to treat COVID-19. Definitely we see a part of the growth that is coming from a unique situation to treat all those patients.
As well, we have been hit, and honestly, I wouldn't be able to share with you a figure in a sales loss regarding all those non-surgical operations that have not been performed. Again, I don't think 2020, especially the fourth quarter from the second quarter, I don't think the ramp up or the slight decline in terms of sales per quarter, cannot be a good benchmark for the years to follow.
I think this COVID-19 has, in a product like low molecular weight heparin, has distorted a little bit the evolution of the product. We believe that 2021, at least from the figures that we are working for the first two months of the year, it's evolving very nicely. We do believe that 2021 we should still have growth to deliver to the market.
We are 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. Just to follow up on the previous guidance question. I appreciate that the new guidance is for all of the sales, including Moderna. Does this guidance assume the same base business single, sorry, mid-single digit growth as you said before? Has there also been some change to your expectations outside of the COVID manufacturing contract?
Hi, James, this is Javier speaking. Well, as I said, we were.
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 COVID-19 vaccine. Yeah, as Juan was saying, I think the beginning of the year has been so far 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.
That's why we're now very optimistic now, and we think that the guidance for the year could be as high as 30% now for 2020 and 2021. It's clearly an upgrade of the guidance. We are now very confident because we are already manufacturing the COVID-19 vaccine and the rest of the business is also going very well.
Brilliant. That's very helpful. Just a final question from me. In terms of the potential Okedi 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 Okedi were to be approved in Europe?
Well, James, this is Juan. Regarding Okedi, we are expecting the approval this year for sure. The thing is that the COVID-19 situation has completely changed the landscape, like I mentioned in a previous question. Right now, across Europe, sales repping and sales detailing is being stopped for obvious reasons. Really, I know 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 an appropriate way.
To launch a product throughout Europe requires a major investment in terms of head counting and marketing activities. What we are right now working is on the right timing to do the launch across Europe. 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 drug being at home, which is the current situation. Right now what we are working is to make sure with the EMA that we have the best SmPC 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.
If with this way, that we are doing a sort of in-house laboratory pre-marketing 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 think the COVID-19, unfortunately, is impacting heavily in all companies. 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 López-Belmonte. Thank you.
Thank you, Lydia. There are no more questions at this time. We would like to thank you for joining us today in this 2020 Full year Results Conference Call, and we can end the call right now. Thank you. Have a great day. Goodbye.