Aspen Pharmacare Holdings Limited (APN) Earnings Call Transcript & Summary

Will commence the media briefing.

Stav, I think we should start.

Steve, it's rising quite rapidly here. We're on to 113 participants. Okay. So I think let's kick off. Colleagues, distinguished panelists, members of the media, good afternoon. And if you're dialing out of the North Americas, good morning. Thanks very much to all of you for making this Aspen media briefing today. Today, we will be announcing a nonbinding term sheet between Aspen and Johnson & Johnson for the manufacturing and sale of an Aspen-branded COVID-19 vaccine for the African continent. This is indeed a monumental and groundbreaking development. It's groundbreaking for the African continent, its health care systems and also a significant step for the continent in defeating what has been a most catastrophic pandemic. My name is Stavros Nicolaou from Aspen Pharmacare, and I will be moderating today's media briefing. The intention is that the briefing lasts an hour, so we should have you done by more 4:30. We will allow approximately 30 minutes, as you can see, according to the program, for remarks from our distinguished panelists. And thereafter, we will be opening up for a Q&A session. I'd like to, right at the outset, encourage you to start posting your questions on the chat group. We'll be monitoring the chat group, and we will give preference first to those who post their questions in the chat group. So without any further ado, let me introduce our esteemed panelists today, starting with firstly, Dr. Ngozi Okonjo-Iweala needs no introduction. She's the Director-General of the World Trade Organization. All these colleagues that I introduce have been pivotal partners in getting us to the point where we've arrived today. Also, gives me great pleasure to introduce Dr. Matshidiso Moeti, who is the Regional Director for Africa of the World Health Organization. Also, it gives me great pleasure to introduce Dr. John Nkengasong, who is the Director for the African Centre for Disease Control and Prevention; followed by Mr. Strive Masiyiwa, who is the African Union Special Envoy for COVID, as appointed at the time by President Ramaphosa in his capacity as AU Chairman. Strive is also the Head of the African Vaccine Acquisition Task Team. Also, it gives me great pleasure to introduce you today Professor Benedict Oramah, who is the President and Chairman of Afreximbank and is also the Deputy Lead of AVATT. Next up is Dr. Adrian Thomas. Dr. Thomas is Vice President for Strategy and External affairs, Global Public Health for Aspen's partner, in this instance, Johnson & Johnson. And lastly, may I introduce to you Dr. Stephen Saad, who is the Aspen Group Chief Executive and also Co-Founder of Aspen Pharmacare. So welcome to all of you, and thanks very much for making yourselves available. As I indicated, we would not have arrived at this point if and were it not for all your interventions along the way. So I'm going to call on, firstly, Adrian, Dr. Adrian Thomas to give some remarks from Johnson & Johnson. But Adrian, before you go, I should note one very important apology. And that is from President Cyril Ramaphosa, who is traveling between Nigeria and Cote d'Ivoire on a state visit. He would like to have been part of this panel today, but is obviously not. He has nonetheless contributed by way of a statement, which finds its way in the press release that has been sent to all our colleagues in the media. So Adrian, may I invite you to offer some comments on behalf of Johnson & Johnson?

Thanks very much, Stavros. And privileged to be here and offer some comments from Johnson & Johnson. Before I do so, I want to recognize the leadership that has resulted in this milestone, this incredible milestone. And particularly the leadership of the Africa Union from Strive, as well as from President Ramaphosa, representing the Africa Union in the time that we formed this partnership as well as the leadership of the World Trade Organization, the World Health Organization and other multilaterals. But also, yourself, Stavros, and Dr. Saad for being there as our partners, not just in this current episode of the pandemic, but also as trusted partners in manufacturing in Africa with Johnson & Johnson in the past. Today is a really important day not but in the fight against COVID-19, but also for the future of African health. We recognize that today, we're moving closer towards enabling, not just contract manufacturing of a vaccine within Africa, but also expanding our strategic partnership to offering a commercial license to be able to make sure that we address vaccines equity and priority for the African continent from a company that is based in Africa, representing Africa, for people living in Africa. And this comes at a crucial moment. I'm a physician, and Africa's COVID-19 vaccination rates are significantly lower compared to those seen in high-income countries, and we need to do something differently. Quite simply, without widespread vaccination and access to vaccines, this pandemic will not come to an equitable end. Johnson & Johnson has long been committed to supporting Africa's response to COVID-19 through clinical trials and our development program, large-scale studies, including the Sisonke study in South Africa and first-of-their-kind purchase agreements as well as supporting as our trusted partners in manufacturing our vaccine. Now we're pleased to reach the advanced stage of discussions that would finalize, and we hope that will be quickly, would provide Aspen the license to produce an Aspen-branded African COVID-19 vaccine using drug substrate provided by Johnson & Johnson as the first step. A final agreement between our companies would mark an important step towards increasing the capacity and expertise of vaccine manufacturing, but also independence of manufacturing in Africa for Africa. But there is more that needs to be done, and we need to solve for the current pandemic. We call upon the global community to prioritize a clear plan to scale up investment across the African continent in the specialized vaccine manufacturing infrastructure, which has to include skilled, local workforce needed to rise to the challenge. At Johnson & Johnson, we're committed to supporting this future, and we're delivering on our commitment to make available 900 million doses of our COVID-19 vaccine to the African Union and COVAX facility while continuing to collaborate with African scientists to evaluate our vaccine, including any future variant. This step, which is an important milestone for us in the partnership with Aspen, is an important step towards that future. Only by working together, can we bring together the necessary skills, expertise and resources to support the vaccination of people who are in most need at this critical stage of the pandemic. I thank you all for your time. I look forward to the discussion, and we're proud to be part of this important milestone in manufacturing in Africa. So thank you very much.

Dr. Thomas, thanks very much for that message on behalf of Johnson & Johnson and also for your commitment as an organization, and you personally, to building local capacities on the continent. I would now like to invite Dr. Ngozi, who's our WTO Director-General, comes from Africa. I'd like to invite her to offer some remarks. Thanks very much.

Well, thank you very much, Stavros, and greetings from Geneva. Let me start by congratulating Dr. Stephen Saad and -- of the Aspen group and Dr. Paul Stoffels, Dr. Thomas of Johnson & Johnson for reaching this vaccine licensing agreement. And let me also thank, even though he's not here, President Cyril Ramaphosa, President Tshisekedi, in fact, all the African Presidents for their really strong leadership on the issue of vaccine production and vaccine equity. It is with delight I congratulate my brothers, Dr. Nkengasong, Mr. Strive Masiyiwa, Dr. Benedict Oramah, and the sister who is not here, Dr. Vera Songwe, their work on the AVATT platform as well as on the vaccine manufacturing initiative. I know that this new agreement is the result of several months of effort and considerable investment. We at the WTO are pleased to play the part in helping to move this licensing agreement to a timely conclusion. Our periodic meetings with vaccine CEOs have provided a forum where we can all work jointly to solve problems of vaccine production, distribution and equity of access. Vaccine manufacturers have been able to exchange with each other. It is my sincere hope that this license agreement will represent another step on the way to achieving a more diversified and decentralized global manufacturing base. This is why we are so proud to see this happening on the African continent. This is the kind of action that I referred to when I wrote my article on the third way. As of last week now, nearly 7.8 billion doses of COVID-19 vaccines have been administered worldwide. 2.9 billion doses have been traded across borders by mid-November. These numbers are remarkable when we think that a year ago, only a few million doses have been administered, and practically none were being traded. Production capacity has grown to about 1.5 billion doses per month. But it is not enough, especially as growing signs that booster shots will be necessary to add a multiple to global production requirements. Yet, according to reports, 60% of available doses have been procured by 5 countries or economies and 1/3 of doses are stockpiled, waiting to be used. The emergence of the new variant, Omicron, which forced us to postpone our ministerial conference schedule for this week, is another sign that we need to ramp up our work to foster vaccine equity. Only about 3% of people in low-income countries are fully vaccinated, 7% of people in Africa, compared to over 2/3 in developed countries. Omicron disclosed what has been clear since the Delta variant emerged in spring. The longer large numbers of people remain unvaccinated, the greater the risk that new viral mutations will arise and threaten people's lives and risk global economic recovery. This is also one of the reasons why we must quickly conclude the discussions on technology transfer and intellectual property waivers at the WTO so as to come to a pragmatic solution. Trade and cross-border supply chains remain essential to manufacture and access to -- of COVID-19 vaccines and other countermeasures. At the WTO, we will continue our work to monitor COVID-19-related trade measures and supply chain bottlenecks and give governments around the world tools to make informed policy decisions. Many of the information tools we have been able to develop involve constructive collaboration with the private sector as well as with WTO members and other stakeholders. We value these partnerships and the trust that they represent. South Africa is one of the 10 countries around the world producing and exporting COVID 19 vaccines. Before the pandemic, 80% of the world's export of vaccines of all types came from 10 countries. Today, 100% of traded COVID-19 vaccines come from 9 countries -- or 9 economies, if we count the European Union as one. This is not surprising given that these vaccines are new and, in many cases, so are the production facilities like the one expansion being contemplated by Aspen. But the concentration on that shows how much work we have to do to achieve a global vaccine manufacturing base that is sufficiently diversified as to be able to handle multiple, simultaneous national crises in a future pandemic. I congratulate President Ramaphosa and all South Africans for fostering a fertile environment for science and technology. I hope that this experience can be replicated so that we can be better prepared for emerging health crises. At the WTO, we will continue to work towards supporting equitable access to vaccines. Multistakeholder collaboration is essential to achieve this objective. Together with the heads of the International Monetary Fund, the World Bank and the World Health Organization, we are working in the framework of the Multilateral Leaders Task Force to accelerate the delivery of COVID-19 vaccines diagnosis and therapeutics to low and middle income countries around the world. Thank you for inviting me today. Thank you for sharing this occasion. This license agreement shows that collaboration is possible, that we can find ways to collaborate with each other even as the WTO continues negotiations in response to the pandemic, including IP issues. I hope that this license agreement will be fruitful for Africa and serve as one of the examples of how voluntary licensing can help solve technology transfer problems and save lives. Congratulations to Aspen, congratulations to J&J and to all the teams who worked so hard to make this possible. Thank you.

Dr. Ngozi, thank you very much for those most inspiring words. You have demonstrated extraordinary leadership during this pandemic. And in particular, your energy around solving a problem is certainly something that inspired all of us and was important in getting us to this point. You've used your convening power extremely constructively to bridge the gap between health and trade and industry, and you've done so very effectively. And for that, we are most grateful. So thanks very much. May I invite our colleague, Dr. Matshidiso Moeti, who hails from Gaborone just north of our borders. She is, as I said, representing the World Health Organization. Over to you, Dr. Moeti.

Thank you. So thank you very much, first of all. It's such a great pleasure for me to be part of this occasion of the announcement of the J&J and Aspen COVID-19 licensing agreement. What an incredible moment it is, so I'd like to thank you for the invitation. I'd like to commend all my colleagues, sisters and brothers, who have been working behind the scenes to help make this happen. A huge congratulations, of course, to the 2 main entities concerned on this and acknowledgment of the leadership of President Cyril Ramaphosa, and indeed, all the African leaders for the determined way in which they've responded and taken action around this pandemic. And I say that as somebody who has worked for many years in public health on the continent, was very much part of the scene as we worked on HIV at some of the most difficult moments. So for somebody like that, this is a really transformative moment, and I'd like to thank all that -- those who are involved in making this decision. Particularly J&J and Aspen, congratulations for making us all very excited at this extremely challenging time for the whole world and particularly for Africa. What is happening today is going to make a significant contribution to transforming production of vaccines and essential health tools in Africa, I'm quite convinced. And we were happy that there's been some beginnings as well following the launch of the mRNA vaccine technology transfer hub in South Africa earlier this year. So we are seeing a really exciting moment on the continent, but this is a truly transformative moment. I'm happy to be part of it. As we are speaking now, the world's Ministers of Health are meeting, some in person and some virtually, in Geneva in a special session of the World Health Assembly considering the establishment of the development of a global instrument for better convergence of member states' collective action on pandemic preparedness, including diversifying the manufacture of therapeutics, vaccines and diagnostics. This has been a recurrent theme in the statements made by countries at all levels of development since yesterday. And the recent emergence and announcement of variants, like Omicron, are a reminder and have really focused the minds of these leaders and helped on the urgent need to accelerate COVID-19 vaccine availability and uptake, and diversify the manufacturing of these vaccines in places regardless of the economics. The speed and the transparent ways in which South African scientists and scientists from my own country, Botswana, and the governments made the global community aware of the emergence of the variant was commended widely by the ministers. I'd like to really commend, not only the African Union, but also Dr. Ngozi, Strive, Dr. Benjamin, and John Nkengasong and the team, who have played such a strong role on the African continent supporting the political leaders. It is absolutely important that we work together to reduce the extreme vulnerabilities of the supply chain on our continent, which relies on imports to meet between 70% and sometimes 100% of our demand for medicines, vaccines and other health projects. Today's event is proof of how collaboration and smart partnerships can work. It really gives us reason to be optimistic that we can actualize the African vision of seeing 60% of the region's vaccine needs manufactured locally by the year 2040. So we at WHO congratulate, as I said before, both Aspen and J&J for signing this really milestone agreement. It's a very important step towards a reality in which Africa manufactures quality COVID-19 and other vaccines for its own populations. And from the regional office in Africa, we will continue to provide support and to advocate for boosting of local manufacturing of medical products, including vaccines. We see this as being absolutely essential to ensure health security and access to safe, quality and efficacious medical products in Africa. Again, it's a hugely proud moment, and I'm so glad to be associated with this event. Congratulations, and we'll be a partner company in the countries all the way as you roll out this vaccine. Thank you.

Dr. Moeti, thank you very much for those insights. And in particular, thank you for your leadership on the continent and also for being very often the conscience of the continent. Very important partner are the WHO in getting us to this point where we find ourselves with a vaccine for the African continent. So thanks very much to you and your team for the role that you have played. Colleagues, ladies and gentlemen, unfortunately, Dr. John Nkengasong is not able to dial in at this point in time. We will try and get him on. But in the interest of time, let me invite Professor Oramah to provide us with his remarks. Professor, over to you.

Thank you very much, Stavros. Today is a remarkable day for our continent. That is why we add our voice in congratulating Aspen Pharma Johnson & Johnson for this milestone. It paves the way for Africa to begin to take control of its health security, to have the opportunity to chart our own course for us to deal with the pandemic without relying on others. It provides a platform for us to join and unite on the [ issue on sight ]. But beyond all this, there's an important lesson of adversity. It tells us that development will not come because we wish it. It will not come because we beg others to give it to us. It comes because we worked towards it and because we demand it. We thank Aspen Pharma for its excellent [ partnership ] and for [indiscernible] help make this. We thank President Cyril Ramaphosa for the leadership, without which I believe we will not be announcing -- we'll not be announcing this important milestone. And to our sister, Ngozi Okonjo-Iweala, who are working very, very hard to ensure that there's broad access to intellectual property with regard to COVID-19 vaccines and other important resource. So a big thank you. With the negotiating skills of Mr. Masiyiwa certainly helped to bring today's event towards us a little bit. And of course, a lot of this [indiscernible] and [ Vera Songwe ]. And for us at Afreximbank, we are very pleased to have provided the $2 billion facility that helped close the case. So today, we also celebrate an important day, that going forward that we can tell those who want to donate vaccines to Africa that they can choose to [indiscernible] also: Donate vaccines and create employment on the continent by donating African vaccines. Before we could not say that. So we thank Aspen for making it possible. We thank Johnson & Johnson for supporting Aspen and making -- creating this platform for us to be able to say that I use the situation we find ourselves, the pandemic, as an agent for development. For us at Afreximbank [indiscernible], we have facilities dedicated to supporting those who want to manufacture vaccines and other materials that are tied with intellectual focus. We can finance -- the license teams will provide the assurance and guarantees, and to make it possible for those who want to grant those licenses to feel confident knowing that the licenses will be used in accordance with the agreed terms. So I congratulate you once again, Aspen and Johnson & Johnson, and hope that this event will now mark the turnaround Africa needs as we move forward through the pandemic. Thank you.

Professor, thanks very much indeed to you as well. And the dual role that you play firstly, the role of the bank, which has been critical in getting us to this point, and also your support for the tireless work that Strive Masiyiwa has been carrying out for and on behalf of the continent. They say behind every force is the support, and you have provided that support to Strive. So thank you very much for your contribution as well. Colleagues, Dr. John Nkengasong is not going to join us, regrettably. So he does -- I have just spoken to him. He sends his apologies. And of course, he's very excited he says at this development. He calls it a game changer for the continent, and I'm sure we will have the opportunity to engage with Dr. Nkengasong at a future time around what this development today means for the continent. So with that, may I invite Mr. Strive Masiyiwa, who is the African Union Special Envoy for COVID and also the Head of AVATT to give us some of his comments. Thank you, Strive. Over to you.

Thank you. Thank you so much, colleagues for those wonderful statements. And let me begin again by also congratulating Johnson & Johnson and Aspen on this historic day. I guess, if you may allow me, I would like to give a bit of history to how we got to this momentous occasion today. It's almost a year to the date when President Ramaphosa chaired the meeting of the bureau of presidents at which we were directed to create the Africa Vaccine Acquisition Task force. It was a special committee, chaired by the President himself, with a specific duty to purchase vaccines, not to mobilize donations, but to go out and purchase at least 50% of the target set by the leaders. And that 50% is 450 million people in Africa. The -- our expectation has always been that the other 50% would come through the COVAX facility as they -- as the donors behind them have promised. So AVATT was a -- is a structure set up by the African heads of state to purchase vaccines. As soon as the task force was set up, we immediately began to engage the global suppliers whose vaccines were showing the most progress. You all know who the big vaccine suppliers were. And after meeting with the suppliers, it became very clear that Africa was going to find it difficult to buy vaccines, particularly in 2021, because the major industrial countries had already purchased those vaccines and purchased all the production capacity that was available in most -- from the key vaccine manufacturers. When we reported back the challenge we were facing to President Ramaphosa, I really specifically remember that he said to me, are you aware of this agreement between Johnson & Johnson and Aspen for Aspen to manufacture vaccines for Johnson & Johnson. And I said no, Mr. President. He said, "Well, I want you to meet Stephen Saad. He's the CEO and Co-Founder of Johnson & Johnson (sic) [ Aspen Pharmacare ]." And immediately the President's office set up the meeting between myself, Stephen Saad and members of AVATT. And we were absolutely surprised to find that we had a company in Africa, which was already set up to produce 250 million doses on behalf of the Johnson & Johnson company. I actually thought it was some kind of hoax. I said, can you really do this? They said, yes. We have the capacity to produce vaccines. And we are already contracted to produce 250 million for Johnson & Johnson. We reported back to the President who said, okay, I want to meet with the Johnson & Johnson management team. And you all know the history. Johnson & Johnson had already committed some of those vaccines to the European Union. But we were able to negotiate with Johnson & Johnson to purchase much of that production. So that agreement was reached at the end of March. But as I've said often, that agreement would not have been possible without Afreximbank because the African Union does not have a balance sheet. We don't have money at the African Union. We have to go out and raise the money. And to enter into a contract to purchase these vaccines, we had to turn to Afreximbank. And Afreximbank's major shareholders are the African member states. And they had to have a special meeting at which they increased the capital of the bank so that it could provide an immediate guarantee as well as pay all the deposits that were required otherwise, we would not have been able to collect all the money from the different countries and then go to the supplier. It was too complicated. So Afreximbank purchased these vaccines for Africa in advance. And so for me, when the history is written, it's Stephen Saad and Aspen on one side, an African company stepping forward; and the role of Afreximbank, an African bank. So we were able to secure the advanced purchase agreement so that production could start at Aspen even before a single African country has stepped forward to say they would purchase the vaccines. All the risk was taken by Afreximbank and its shareholders, and I really want to recognize those major -- the 10 larger shareholders of Afreximbank, such as Nigeria, Egypt, Zimbabwe and many other countries that met in an urgent session to make this money available for Africa to get the vaccines. So once the agreement was signed, payments made, we then turned to the member states to tell them that, look, this is what we have agreed. Can you please come forward and purchase vaccines? But in the process also of discussing with Johnson & Johnson and at Aspen, what became clear to us was that the arrangement of a contract supplier was not as flexible as a licensee. So President Ramaphosa then asked for a meeting with the Chief Executive of Johnson & Johnson, and said to him, look, we would like you to consider licensing Johnson -- Aspen to produce this vaccine as an African vaccine with end-to-end -- all the way to substance manufacturing. I -- it's a historic thing for which I will always be so grateful because I was able to be there and to listen to President Ramaphosa put this to the Johnson & Johnson Chairman. And the Johnson & Johnson Chairman said, yes, we are willing to transfer the full capability to produce this vaccine to Aspen because we consider Aspen capable of producing the vaccine. So began the negotiations. We said in the meeting, look, you are companies. You do the negotiations between you. We don't want to be involved in your terms and agree -- your commercial terms and agreements, but we would like it done by the 30th of November. And today, is that date. And today is the day on which this agreement has been concluded. And this vaccine is going to be produced now as a licensed product, which means when we want to talk about purchasing vaccines, we go to Aspen. We don't go to Johnson & Johnson, which is a major -- it gives us the flexibility. It gives us the -- one of the key things that we have called for, which is security of supply. We have not had security of supply as a continent. So today, I am so pleased that we can say production of this vaccine under license, just like they do in India, has begun. And so it behooves on me to also now call on people like Gavi, who are major buyers, to say it is now time that when it comes to the purchase of vaccines, you come to Africa first. Because unless people like Gavi step forward and begin to talk to African investors, like Aspen, to produce vaccines, we will not deal with the problem that Africa found itself in, which was to be pushed to the back of the queue. This problem was those with production assets are the ones who currently control the supply of vaccines. So we today have taken a major step forward. I urge Aspen and Johnson & Johnson to complete the commitment, which is that it must include substance production within the next 2 years. This is a step forward. but we have to complete that work. But today, we can all sleep a little bit easier now knowing that we will be purchasing vaccines from African -- from an African supplier. I'm pleased that the production level that they promised us has also been increased from the 250 million to 400 million per year, which is important, particularly as we move into boosters. But let me conclude by saying the contract between Johnson & Johnson and the AVATT is going extremely well. We are very pleased. We meet every single week. Deliveries are going to the countries. And any country right now which needs more vaccines, just call us. We are moving forward. Thank you very much. God bless you.

Strive, thank you very much. Again, it's always of great inspiration listening to you. As you said, there are many historical chapters to this journey. And I suspect when the story gets written, you will feature in every single one of those chapters. I think what a lot of people don't realize, Strive, is you are not a medical person. You're not in the pharmaceutical vaccine business. You've done this of your own time on a voluntary basis, trying to still run your own business, which is not a small business. And you've done this for the betterment of Africa and for humanity. So we owe you a significant debt of gratitude, both for your leadership and also what you have done for this continent in its time of need. Thank you very much, Strive. Ladies and gentlemen, may I lastly call upon the Aspen Group Chief Executive, Stephen Saad, to provide us with his comments and officially launch the name Aspenovax. Thank you, Stephen.

Thank you, Stav. Really appreciate that. Just -- I think I need to start also by just thanking everybody who's been a part of this. I mean the J&J team for trusting us and demonstrate -- and giving us an opportunity to demonstrate, which was critical. Because I heard this so many times, but to demonstrate that we've got world-class capabilities and they exist in Africa. To that end, I've got to thank Dr. Paul Stoffels, who led the J&J team into Africa, together with Jaak Peeters and Adrian on the screen as well, who've been incredibly supportive, together with the rest of the J&J team and without whom we really wouldn't be here today. I'd also like to make special mention of the WTO and WHO: WTO, headed by Dr. Ngozi; and Dr. Moeti, who's representing WHO today. Dr. Ngozi, I'm trying to -- I was trying to work out while you were talking how many of these webinars I've been on with you and the teams. I think I'm in double digits now, and that's just the absolute commitment that you've had. And thank you for your leadership in getting all the private sector and public sector together and making it a discussion and a team to work together, and we didn't point fingers at each other. And it's -- certainly, we've seen reallocation of vaccines and many very important drivers in terms of access because of those meetings. So thank you so much, and thank you also for your commitment to the continent. Mostly, I must reserve my thanks to the African continent leaders, who have -- who really have demanded that our continent is not ignored. I mean Strive does have a day job. He's got a pretty serious day job. He's a very, very serious job, and he wasn't letting it stay down. So Strive, I've got to tell you, you really galvanized this all. And I think for all of us panelists on here, African panelists, you really gave us pride in our continent and what can be done in a decisive way. We've had key role players out of the African Union. Many of you have mentioned our president, Cyril Ramaphosa, who headed the African Union and was really demanding of having our own independence. And we must thank him. And at a local level, I must thank the Health Minister, Dr. Patela -- and Ebrahim Patel, who really pushed local manufacturing and given us support in South Africa. Of course, it's a pity not to hear Dr. John from the CDC here. He led the continent's fight against this pandemic. Prof. Benedict and Strive at AVATT. What can we say about AVATT? This team really assembled their own financing, really to get a seat at the table without a begging bowl. And that just -- it just made us just feel like we've all just taken a step up in Africa. They showed real leadership and support for African solution. Strive gave you a history of what went on here. I think if you gave him another 5 hours, he could tell you, but he really ensured that we could no longer be ignored. And together with Prof. Benedict behind him, they've put together solutions and demanded a seat at the table. Of course, I must stress our real heros are the Aspen and the J&J factory teams, who collectively have and are delivering millions of vaccines every week. I was happy to hear Strive, that you continued to getting these vaccines and you're calling for countries to take them from you. We really have progressed from where we were in the initial stages. And these vaccines are for our continent. And really, as I said earlier, dispel any myths that Africa cannot be home to sustainable manufacture and supply. I'm not going to cover much of what many have done, but we have witnessed inequitable access to vaccines globally. And there's a fault line. It's not necessarily rich and poor only. It's the fault line really of those with capacity versus those without capacity. In Africa, we import 99% of our vaccines, and exposure to this risk was no more starkly demonstrated post the suspension of exports from India. And that was probably one of the single biggest reasons for our delay in getting access in Africa. The solution to this has to be regional capacitation. I think we've been enough with Dr. Ngozi, enough on WTO. And I think we've all come to the same conclusion. If we want early access, you need regional capacitation. Aspen has made over 120 million vaccines to date. Almost all have and will go to Africa, aside from those that obviously we had the problem with the merchant APR. If Aspen was not in Africa, would any of these doses have gone to the continent? I think not with respect. More follow-up booster doses have been administered globally than vaccines across Africa. We really are grateful for the support we have received from J&J. It's been unstinting the technical teams here, and it's really given us the confidence as Aspen to boost our capacities from 300 million to over 400 million next year. And by the end of next year, we'll have to give you annualized of 700 million. It's still short of our aspirational target. We really want to get to 1.3 billion doses to be able to say on the continent, we have got one -- for one Africa, we've got one vaccine. And to this end, the multilateral procurement have been proactively engaging us. And they've seen the risk of having concentrated supply, which Dr. Ngozi discussed earlier. And they've expressed their commitment to helping support regional procurement. And I think this will be very important. The license from J&J, as Dr. John said, it is a game changer. African vaccine gives you independence, and it gives you speed of access to IP. The independence really regain the autonomy of releasing this vaccine. And as Strive said earlier, we can determine where that vaccine goes and whom we sell it to. And the speed of access is -- we've seen a lot of issues around IP and IP waivers. And this obviates for those hurdles related to IP. And also, because it's a tech transfer, it's a more efficient process for early entry. As with the pioneering solutions fine for voluntary licenses over a decade ago in ARVs -- for ARVs. And probably gives away how long we've been here for a bit. We hope that this vaccine license and the related tech transfer may serve as a blueprint to really assist capacitate both Africa and other developing markets. And in so doing, we truly give substance. And I mean substance, because this is a term that's often used, but I don't know that we live it yet as a global community. So it give substance to our global commitment that we are not safe until we're all safe. Thank you.

Stephen, thanks very much for that. And in particular, thanks for your bold and decisive leadership, Stephen, your vision on the continent. The continent would not be in that position without your bold and visionary leadership.

Ladies and gentlemen, I am acutely aware that we are moving into a Q&A session. We are not going to have a lot of time. So in the interest of time, I've clustered the questions that have been posted. Many of them have already been responded to when the speakers gave their various inputs. So I'm going to direct some of the outstanding questions as they came along. Can I start off with Dr. Thomas first. Adrian, would you like to comment on whether you see a drop in efficacy as Moderna allegedly stated today with respect to the Omicron variant? And would you care to comment on the 900 million doses for Africa that you referred to?

Sure. Look, I think there's one thing that we all have to do as a global community, and that is to not get in front necessarily of the science. The pandemic is evolving. Variants are evolving. But the one thing we know is the best way to prevent transmission and evolution of resistance, the emergence of new variants, is to vaccinate. So let's focus on vaccinating people. The second thing is we've seen that at least for historic variants, that the vaccines provided adequate coverage, very good coverage. We don't know whether that will be the case for Omicron. All of the manufacturers, including J&J, are rapidly assessing this, and we'll make whatever adjustments are required. And we're already working, as I know many of our colleagues in the industry, we're already working on tweaking the vaccine, if necessary, to cover the latest variant. We should not get ahead of that. I think the other thing I wanted to mention is this concept of rapid vaccination, all-in coverage. Not just because we want to protect people, but to protect from transmission, which is only possible when you get to very high rates of population vaccination. And that's what we hope this recent agreement and expansion of our strategic partnership with Aspen will achieve in Africa, in particular. So those are a couple of the comments I'd make. What was the other question that you had, Stav?

The 900 million doses.

Yes. We committed early on to 500 million doses through COVAX, up to -- and up to 400 million through the Africa Union. We remain committed to that from any source. It's -- I want to point out that it's a very difficult position for all of us to be responsible for solving a pandemic, and so we all have to play our part. We are absolutely committed to it. We have had our challenges, which I'm sure everyone is very well aware of. And with the assistance of partners, like yourselves and Aspen, but also the persistence of the African Union, the CDC, Afreximbank, WHO, UNICEF, Gavi, COVAX and other governments who are trying to solve. And so we have to keep our, I think, our eye on the ball, which is we've got to get through the acute 12 to 24 months of vaccinating people. If we need new vaccines, we'll create new vaccines. But right now, let's continue to vaccinate, and we're actively investigating whether we see any inherent issue with the current Omicron variant. I do want to call out South Africa's leadership. We have a very, very large health care worker study, almost 400,000 people, in South Africa. And we've just started working with them on boosting after 8 to 12 months. And that cohort, almost 0.5 million people, it is going to provide an incredible evidence about real-world effectiveness. And so we expect some more information on that in the next 3 or so months.

Adrian, thanks very much. I'm just going to take 2 more panelists. Unfortunately, we have run out of time. Stephen, if I can defer the following to you. Aspen's plans around drug substance. And then Steve, no surprise, Alex Comer with a whole lot of questions around EBITDAs and profit per vial, profit per dose. So can you speak a little around the economics, if you can? And also a question around CapEx. Sorry. And Steve, I'm going to ask you to comment on one other thing, which is where is Aspen with respect to the legal liabilities and regulatory approvals. So if you could take all of those together, Steve. Thanks.

So I think the position we're in now is that we have agreed the key critical points. And so all of those areas, whether it's substance, pricing or commercial terms, legal liabilities, we are now in a position where we -- all of these matters have been fleshed out, and we have these in our nonbinding term sheet and will now be fleshed out. So I think we've tried to deal with anything that could be a crinkle upfront. In terms of the commercial realities of this contract, we're really not in a position to comment on profitability at the moment. At the moment, we don't have current orders, and I don't really want to speculate on pricing. Because then, of course, your sale price determines what you do. But what we can tell you is that it is our intention to be competitive with current pricing trends. We don't really want to ask for any favors. And to the extent we can be more competitive, we will be. Our current focus at the moment is to register Aspenovax with authorities, sample World Health Organization. We've got a lot of work to do there. We also want to focus on accrediting. we've got the other line coming on, so to increase our capacities to over 400 million. And we really want to try and bring that line on as soon as possible, preferably during Q1 of next year. And we want to focus also on engaging with multilaterals who've committed to sort of regional procurement. To the extent we get to profitability -- because we don't know the extent to -- to the extent we have a high profitability or better profitability out of this, it really would go to enhance -- we'd hope that the profitability could be applied to -- our intention certainly would be to enhance our capacities because we really want to push for our aspiration of one Africa, one vaccine. I would say for -- somebody asked, I think, in this question, how much more would it cost? It cost us a lot to get the setup. So it's a big footprint. You build a house, and now you just add to the rooms. Maybe with EUR 100 million more, we could get to the 1.3 billion. We'd also like to be able to invest in building broader regional capacities across Africa. I don't think in the same way we have seen a few countries with the capability to make vaccines, I don't think it's -- I think in the long term, Africa, too, needs to look at a broader reach. And so we'd like to work with some of the other people in the continent to create that. And also, to be able to apply funding to invest in a pipeline, in a vaccine pipeline. And of course, we would look to make sure that, that pipeline had a real focus on African products. So I think that's where we are in terms of what I can speak very broadly and we can speak broadly on at the moment.

Stephen, thanks very much. I'm going to take the final 2 questions, the first directed to yourself, Strive. Can you speak with respect to the requirement for African volumes? What do you anticipate these volumes will look like in the foreseeable future? Strive, you're on mute. If you can unmute.

Thank you. Thank you, Stavros. Thank you for that question. Let me just say that the target set by the WHO is 70% of our population. We use a straight line, so that is 900 million people. The -- if we use a double dose time -- vaccine, we need 1.8 billion. If we use a vaccine like the Johnson & Johnson, which by the way, is the favored vaccine amongst the African countries. They've made it absolutely clear that they prefer this vaccine, both in terms of its ease of application. Because it's a single-dose vaccine, it's the only one operating under those guidelines from WHO. So we need -- our own mission is to deliver at least 50% of our requirement, which is 450 million people. So we've ordered 400 million, some of which we will now sit down with you to discuss the final orders and contracts as we have agreed. So we expect that Africa will need to first meet the 70% target set by WHO between AVATT and COVAX. We work very closely together because it's a 50-50 deal. And we've already asked COVAX that now that Aspen is producing under license, they must also place orders with Aspen. And we're asking them to join us and meet at least a 50% order book of what Aspen will produce. So beyond the initial 70%, depending on what guidelines my sister, Dr. Moeti, tells us -- because we act on their guidelines. They are -- they will give us guidelines on the annual booster. But you all know from public media that you're going to have at least to boost once a year. That seems to be the emerging consensus. So for those of you who are from the business world and are trying to calculate what our demand is for the vaccine, I imagine Africa should comfortably, on its own, be able to take most of this production. And the -- so you're our default vaccine until some of the other promises to manufacture in Africa become concrete. This is our default vaccine because produced -- it's got an African name. Stephen, please lower your head so that the world can see. Step away, please. That is called Aspenovax [ working ]. Have you seen anything more beautiful in your life? Aspenovax.

Never have I.

What you can't see underneath is what it says there, caring for Africa. So that's...

That's right. It's our vaccine, our name. Thank you, Dr. Thomas. We have taken a bit of our embarrassment away because everybody said we couldn't do it. You see we can produce it, Dr. Moeti. Go tell the tenders that all the orders now must begin with Aspenovax until we get another one.

So we have vaccines, but [ let's send to Africa ].

Yes, African vaccines. Just give us the money now. Don't send us that are -- that expires after 3 days. Just tell them, you start to donate vaccines. Please order Aspenovax.

Very convenient.

Dr. Moeti, would you like to add a comment? In fact, I was going to direct the final question. I realize we have run over time, and we need to end this press briefing. But would you like to offer a final comment? There was a question directed at yourself and Dr. Ngozi. What does this mean for solving Africa's inequality or vaccine inequality and uneven distribution?

Yes, thanks. Great question. No, I think, I mean, it's been said already. It's a transformative moment. I think it will make a huge difference. What then will consolidate it, it's part of what Strive was saying a moment ago. So it need on the other side the demand. The demand is certainly there, and if it is structured and organized, financed and scheduled, [indiscernible] will benefit from this very huge opportunity and what it offers as well in the future in terms of who is procuring vaccine on behalf of the continent, who is financing the vaccine procurement. I'm sure we're all aware of the need for that to be predictable in terms of availability of the resources and the timing. I think it's a truly transformative moment. And as I've said before, based on previous experience, African countries are waiting for this. And I think the experience with the financing from the Afreximbank, with the African Union forming a framework for this is also a very good experience. Also, we've learned we've to put the resources together to make this manageable, predictable and growing. There's no doubt that, like everybody, we're learning what are the implications in terms of the immediate COVID, COVID need for boosters, expanding age groups that have been vaccinated. So I think it's a great moment right now. The need is huge. There's work to do to improve the capacity, to absorb and to use on time. And I think it's a very good predictor for the future. If we take this moment for what it represents and look at the history behind where this has come from, I think, where there've been attempts that have not quite jelled in a way that this is looking like doing.

Okay. Dr. Moeti, thanks very much. That's the final word from the panelists. All that remains for me is, once again, to thank you on behalf of both the Board of Directors and the management of Aspen Pharmacare. We thank, firstly, our panelists, our participants, and of course, our colleagues from the media, who have also played an important role during this pandemic. And it's a much appreciated role. Today is a historic moment. It's the moment where Africa has its own COVID vaccine. Strive, as you said, people doubted whether it could be done. Well, here's living proof and evidence that it can be done. So ladies and gentlemen, thanks, again. Enjoy the rest of your day, and we look forward to further announcements of this magnitude from the continent. Thanks very much.