EPISODE 48: ANTONINO DI NICOLO, FOUNDER AT AUDACES IUVAT

Antonino was born and raised in Italy and moved to Mexico in 2016 as Latin America BD and Marketing Director for Ferring Pharmaceuticals. In 2018, he joined Mundipharma also as LATAM BD Director and then assumed the role of General Manager in Argentina. During his tenure in the pharma industry, Antonino has covered all commercial positions, including general management, business development & licensing, alliance management, project and transition leadership, marketing and sales, market access, pricing & reimbursement.

Antonino is the Founder of Audaces Iuvat, a consultancy BD and commercial firm based in Mexico. Audaces Iuvat is the ideal partner for small to medium pharmaceutical/biotech companies that want to face the vast and complex Latin American market and need local expertise. It provides support from the search, selection, and negotiation of a partnership, to alliance management and follow-up of the commercial activities. AUDACES IUVAT may also advise on market access and pricing & reimbursement dynamics.

Episode’s transcript

Julio Martinez: 0:00

<silence> Welcome to the Latin MedTech Leaders podcast, a conversation with MedTech leaders who have succeeded or plan to succeed in Latin America. Please subscribe on your favorite podcasting platform. Apple Podcast, Spotify, Google Podcast. Amazon Music is teacher. Tune in iHeart Radio, Pandora or Deezer . Welcome to the Latin MedTech Leaders Podcast, a conversation with leaders who have succeeded or plan to succeed in Latin America. Today, our guest is Antonino Dilo . Hey, Antonino, great to have you here today. Thanks for joining us.

Antonino Di Nicolo: 0:35

Hi, good morning. Thank you. Awesome, thank

Julio Martinez: 0:37

You. Well, listeners, Antonino is , uh, an expert in all things related to pharma products in Latin America. Antonino has more than 18 years of experience in international, corporate, and local and regional roles and leading pharmaceutical companies in Europe and Latin America. He was born and raised in Italy and moved to Mexico in 2016 as Latin America business development and marketing director for Fairing Pharmaceuticals. In 2018, he joined Mundi Pharma , also as AAM Business Development Director, and then assumed the role of general manager in Argentina. He has a master's of science in molecular biology with honors executive, masters in strategy and business administration and marketing, communication and public relations. He's now the founder and president, or CEO right, <laugh> of his own consulting firm, S uva , a consultancy, business development, and commercial firm based in Mexico City. So Antonino is really, really a pleasure to have you here today again, and I really look forward to the conversation and to dig into your experience in Latin America so that we can tell listeners about , um, how to succeed in the region. So Antonino , the first order of business is usually asking my, my guest about your , um, relationship with Latin America, how you got involved from Italy to Latin America. What's your personal story behind this?

Antonino Di Nicolo: 2:11

The story is , uh, a personal story. I mean , uh, my wife , uh, is, is Mexican. So at that time when I moved to Mexico, we met first time to a couple of years before in 2014, during a , uh, a meeting in , uh, in Germany. And after that we start dating . And , uh, I found the first , uh, job in Mexico. And as I said , to move , uh, here to Mexico and opportunity was very, very important for me. It was very interesting and , uh, very excited to start a new, a new role here. And , uh, now I'm very committed, a very , very happy to stay and live here and work for this , uh, big , uh, and bus continent.

Julio Martinez: 2:55

Excellent. Antonino . Yeah, there are a lot of similarities , uh, culturally speaking between Italy and Latin America. So for you, I guess it was an easy transition, right?

Antonino Di Nicolo: 3:04

Well, easy . I can say yes, because I already , uh, knew , uh, Spanish because , uh, I studied even in Madrid, so I learned Spanish when I was in Madrid. But there are many differences between , uh, Europe and , uh, Latin America, starting from , uh, uh, different boundaries. The fact that Latin America people are more indirect than in Europe, for example, where we are more used to, to say things that they are while here. Uh , you have to understand what people are , are saying , uh, in the lines , you know? So things are different. So you must become used to the way of , uh, interacting. Even here, Latin America, it's not the same in Europe, even if , uh, Latin people are more , uh, Spanish, Italian, Portuguese, if you want , uh, closer than , uh, Latin America than uh , German people or, or UK people.

Julio Martinez: 3:58

You mean warmer the relationship or closer,

Antonino Di Nicolo: 4:02

Even closer in term of , uh, way to approach, you know , the business and the relationship as , as a general point of view? No .

Julio Martinez: 4:09

Okay, I see. Okay. Okay, excellent. All right , Antonino , so what trends do you see happening in Latin America that are beneficial for the business of commercializing medical innovations in your case? Uh , pharmaceuticals. I really mean from the epidemiology standpoint or economic, or socioeconomic or political standpoint, what do you see happening that are good for the business of selling drugs?

Antonino Di Nicolo: 4:40

Let me tell you about what my story behind at SSU , but when I come here for the first time, I, I was excited to say what up in , uh, here in Latin America. I didn't know, I knew very little about Latin America when I arrived here. I understood that there is a big opportunity here because the continent needs many, many things from pharma point of view , especially because there is a huge gap of the products pharmaceutical pro , biotech pro that are commercialized in the US on in Europe and what they are commercialized here. I exclude the big companies , uh, the multinational companies, Pfizer , asteroids , et cetera , that because they are already here, but there is a world , uh, of little to million companies that are not present here, and that they have very good , uh, and interesting products , uh, in , uh, in Europe or the us . So the target of Juva is , uh, to bring this company here and commercialize the policy in Latin America. So the opportunities there , from epidemiological point of view , uh, the continent is quite similar to the most developed countries. So as a general review , a drug that works in cardiovascular works even here, okay. A drug that works in , uh, oncology works even here, of course, there are some differences , uh, but you can have the same target if you want, if you need.

Julio Martinez: 6:06

Okay. Hmm . Interesting. Very good. Alright . So do you think that Latin America is a great place to do research , uh, to commercialize innovations , uh, in general? I mean, it's easy to do business. What do you think about the overall landscape of entering the Latin American market?

Antonino Di Nicolo: 6:26

Well, I can tell you that , uh, in my opinion, yes, it is , it's very interesting to commercialize. I speak from commercial point of view, American technologies, because as I mentioned, the the opportunities is there. Latin in America is a strange continent, if you want, if especially from the ice of European , uh, and NUS people, in my opinion, because , uh, here, there is , uh, a very , um, a different , uh, I can I say economic , uh, uh, social division, no , there is , uh, high rich people and very poor people that in Europe, for example, we are not used to, many of the drugs in Latin America in general are outta pocket . So people need to pay to get the drug . Uh , while this is not as usual in Europe, at least for the essential drugs . So , uh, okay, the system , uh, in Latin America is, if you want closer or more similar to the American one, where that is based on , uh, uh, privates and public insurances than , uh, than in Europe. So there are differences, but , uh, according to drug that you want to consider, you have different business models, okay? If there is a brand generics, you have a certain target population. Uh , if you have a brand or on the regional drug, if you have a generics, there is another one. Know , and you have to deal in these different ways always. So the , the business model model is different, but very interesting from a economical point of view. Uh , Brazil and Mexico, for example, if they would be in , uh, in Europe, they will be the sixth and seventh countries as turnover after the top five countries. So it would be more important than the Netherland, than Belgium, than than Portugal, then Poland, et cetera . So the opportunity is, is very huge . It's very big. It's very interesting from speaking again about , uh, economical difference in Mexico, for example, high, very high economic people that have , that have a very high, very high salary represent more or less 15% of total population. This means around 20 million habitats that have a salary that in general is higher than , uh, than in Europe. Okay . The average salary , this means 20 million is the bigger than the population than the Netherlands. Netherlands has more or less 17 , 18 million habitat . Okay? So there is big opportunities , uh, there are big opportunities. Of course, you need to, to know very well the market , and you need to make a very, a very strong segmentation, in my opinion.

Julio Martinez: 9:09

Yes, well said. All right , makes sense. So let's , um, dig a little deeper. Antonino, in your experience in, in , I understand it is Mexico or Brazil and Columbia , right? The countries where you have focused the most,

Antonino Di Nicolo: 9:25

Even Argentina, can I say? Because I was general manager, but uh , if you are to select, maybe we can let some of them .

Julio Martinez: 9:32

Okay. Okay. Yeah. So what about obtaining regulatory approvals for pharmaceutical drugs in these markets? What do you think about the process? Is it difficult, easy, how long does it take? Is it expensive? Can you tell us about it?

Antonino Di Nicolo: 9:48

Uh , this is a big difference. For example, in Europe where we're used to have , uh, a centralized procedure or even centralized procedure, this means that when you approved in one country, you may be, you may get approval in many countries here, all the regulatory , uh, registration or national, so each country follows is on rules. So the timeline may be very, very, very long depending on the, on, if you want to register in all the 27 countries. See , in America, of course, countries that are more advanced in term of regulatory such as Brazil, Mexico , Argentina, Columbia , Chile, and countries that need to work that. So if , uh, I would , uh, recommend, and then there are differences not only from regulatory point of view, even from a staff quality point of view. For example, in Latin America is a huge continent, a huge continent. Just to mention that the distance between Mexico, between Tijuana is in one border , two Cancun is the same distance between , uh, Lisbon and Moscow. So , uh, we have to understand that there are many differences from stability point of view. For example, Mexico has zhu , for example, like Europe or the us , but Brazil, Colombia is zone four B. So you need different stability studies . Yes , other countries like Caribbean , uh, or even uh , Ecuador, Peru , for example, have zone four A , so different conditions. So we have to take in consideration many things to enter Latin America. So you should, a company that wants to enter Latin in America should, in my opinion , uh, make a roadmap on which country to enter first. According to this experience, no , uh, because of course everybody wants to enter in Brazil because of dimension of the market , but how complicated is country in Brazil, for example, because of , uh, stability? Because, so you have to run stability size . That takes time because of regulations, because of , uh, uh, ies , uh, this is , this applies not only to Brazil, but even Argentina for example. Um , so you have to take the , the , the fact that in Brazil, all drugs are price regulated, even those that are of po out of pockets . Mexico, for example, is a completely different story. You know , Mexico, maybe in Latin America is , uh, the most open country, the most receptive country in Latin America because Mexico has important trades , uh, agreements with the US or Canada, but even with Europe , Europe . So there are few tax importation taxes or low importation taxes compared to Brazil, for example, or to Argentina. Does , uh, the same that we dis zone no registration, usually for a drug can take between 12 and 18 months in Brazil is three years and in as an average. So if you ask me what should be the first country to , uh, to start the conversation, but in America, I could say, let's start with Mexico and after , let's move on the other,

Julio Martinez: 13:00

What about Columbia ?

Antonino Di Nicolo: 13:02

Even Columbia , yes. But as I mentioned, there may be some difference stability zone for me . So we have to run stability zone for zone four B . There is , uh, certain rules that can be , uh, managed that in Mexico, you don't have, for example, I can tell you, yes, Colombia may be considered , uh, in my opinion, the second country to enter in Latin America, but you have to be prepared more prepared than as you are in , uh, in Mexico.

Julio Martinez: 13:31

Okay, I see. Makes sense. Makes total sense. Angelino , let's talk about the Pacific Alliance. How do you see that unfolding? How do you see that affecting positively or negatively the opportunity to enter Latin America?

Antonino Di Nicolo: 13:47

Alliances are very positive, you know, in my opinion, as I mentioned, there are even trades agreements, not only with the Pacific Alliance, but even with the us . So this, this will simplify theoretically the entrance of new products , not only pharmaceuticals, but even further , uh, areas. Of course, here, there are, there are even certain differences because when you speak about Pacific Alliance, you, you consider even general speaking , uh, Asian countries, okay? In this way for , uh, pharmaceutical drugs, in many cases, for drugs that have been developed in Korea, in China, or in other territories, usually you need to register here at least a bridge study in local population. So this may make things longer than for drugs that have been developed, register or commercialized in the Latin America or in the us in many territories in Latin America, for historical reasons, because of the regulations, there are certain , uh, um, when drugs are approved in the us uh , in Canada, in Europe, or in in Switzerland, in Australia, it's more easier to obtain the registration. Okay? Um , so, so it , it depends. But you take consideration that drugs coming from Europe on the US can arrive on the market faster than drugs that have been re that have been registered in, in Asia .

Julio Martinez: 15:15

Okay. Okay. Yeah. I , I mentioned the Pacific Alliance Antonino because , uh, you were referring , um, to the fact that , uh, you have to register your product in every , uh, individual country, country by country . And the Pacific Alliance hopefully will unify or will homogenize the registration or the regulatory processes among the member countries that as of today are Mexico, Columbia , Chile, and Peru. And eventually Costa Rica and Panama will join. They have already applied. So it will make things hopefully easier for companies to enter Latin America. Yeah,

Antonino Di Nicolo: 15:58

Yeah. This will simplify things, but things are still ongoing. You know , uh, there are different organizations that aim to get closer, the countries , Latin America, but at the end, there is certain organization know of rules in the territories. But as a general point of view, still you need the local registration. So the requirements may be similar, but you need still local registration. And this , this takes time. If I mention , of course, when you register in Mexico, it's much easier to register in Central America, for example, or , or in Caribbean countries, but still you need to have a local registration. Okay. So this is something that you always at the moment, it ,

Julio Martinez: 16:40

Yeah, and also it will probably take about a another decade before we see a unified block of countries in Latin America with a , with a homogeneous regulatory framework or a single regulatory zone or area, like in Europe, right? Something like that. Hopefully it will happen. And because it will also benefit patients, because , uh, it will , uh, I mean, new products will make it to the region faster.

Antonino Di Nicolo: 17:08

Yeah. I believe that things , uh, goes low because , uh, in , um, Latin America, there is not , uh, a community like in Europe, you know? Uh , so in Europe there is a community where countries are , uh, stay together not only for pharmaceutical or for healthcare, but even for many other things, you know ? Uh , so you have to take ation , even this. So I believe that this is an normalization process that is taking in Europe, you know, that no , we are seeing with the vaccines , for example, you know , but Latin America, every countries is doing is going by themself , you know? Uh , so in Mexico, Argentina , uh, in Brazil, they register some territories vaccines. Peru were arrived a few, a few days ago in order , ies still, there is no any vaccine registrated , uh, registrated . So , uh, there are many differences now , uh, that , that still, that make things not so easy, like in Europe, this moment at is for pharma ,

Julio Martinez: 18:06

Yeah, it has become a political show. <laugh> for presidents <laugh> on TV and stuff celebrating, they got a , an airplane full of , uh, the Colombian president was visiting on tv celebrating the fact with like 30 people behind him celebrating that they got a shipment of 50,000 vaccines <laugh> for a 50 million country <laugh> . It is , it is really bad. Anyway, so moving along here, Antonino, let's talk about the market entry or market access strategy of these companies. We talked about registration. What about commercialization? What's the commercialization strategy that you suggest? Do you suggest that these companies come to the region , uh, hire , uh, the services or the help of somebody like you, an expert and start finding distributors or to set up their own companies locally? What do you suggest that these companies do? Well,

Antonino Di Nicolo: 18:59

This depends of the company , of course. So the , the easiest way, and maybe the less expensive way, is to, in license , to find a partner to commercialize the boat , right? Because you don't have any costs at the end, right? So you don't have , uh, any reps, any sales force , anything that, so you don't have any cost . Of course, this depends on the strategy because , and , and the long run possibly to establish an a athlete may be even more convenient, you know , for the remuneration in , in the long run. It depends on you and how you are aggressive in your political, in your strategy, or you are conservative, you know? Um , for little to medium companies, for example, usually in licensing out-licensing is the easiest way, of course, because they don't have still the strength or they don't want to enter in theories . It depends even , uh, I believe, which type of products you want to , uh, commercialize here . If a brand and regional manager patented products or a generic, you know , uh, for generics here, there are many companies that work with generics. It's very strong here in the brand , generics, markets in general point of view. So maybe if you have this idea maybe is local production is better than , uh, external from the territory production, so supply . So because you don't, the cost of , uh, work is generally less. You don't have any, any , uh, transportation costs, taxes , uh, importation , taxes, et cetera. So it's better depending on the strategy you want to have, and if you want even to maintain the region as a general point of view , drugs or products in general that , uh, come from the US are considered better than local. The US or Europe are considered better than, than than Latin America, than the post block . You know , when I arrived here five years ago, people say, wow, everything that come from Europe is spectacular. No . So they say that things come from the US are very good, but things that are coming from Europe, wow . And even eventually the same is for drugs . So if you want is want to , I can say maintain quality of the drug or promote quality of the drug, maybe you can even manufacture in Europe in the us , but you will have really spend the , the cost for patients will be higher, but people out here are used to buy , uh, European or yes , things that are , should be higher than the other territories , they , than the local things. After I can , I said , just to complete the idea, there are many companies here that are very good and that produce branded generics. They offer very high quality. Uh , therefore these drugs are very high , um, uh, interesting manufacturing plant. They produce for , uh, American or US companies. So , uh, there is, even here, there are big opportunity.

Julio Martinez: 22:02

There's a lot of capacity already in the region for manufacturing. Yeah.

Antonino Di Nicolo: 22:06

Yeah. If you want to , to give , uh, third party manufacturing and , uh, for local , uh, commercialization, this will be even an option.

Julio Martinez: 22:14

Okay. Very good. And , um, going back to the issue of your consulting work , Antonino, your clients usually come from what countries in Europe or North America? I mean, can you talk about that and the profile of your clients? What's a typical company beyond the big pharma names that we, we all know they already do business,

Antonino Di Nicolo: 22:36

As I mentioned, my target are little to medium companies, right? So now my clients are Italians, but even Turkish, but even , uh, French, Spanish, there is argent company that , uh, they are looking for my services and even for , uh, uh, regarding the , um, the type of produces , there are different product . There are drugs, biotech, orphan, nutraceuticals. Uh , there are different, there are many military ies , uh, but the targets, the companies are range from , uh, 20, 30 million to over .

Julio Martinez: 23:17

What do you mean by that?

Antonino Di Nicolo: 23:18

The turnover of these companies are , uh, range for from 25 million us , so US D or Euro . So it can consider it little companies to 1 billion companies turnover. So that are considered , uh, still medium company.

Julio Martinez: 23:36

Okay, I see. Yeah, depending on the classification that or the category,

Antonino Di Nicolo: 23:39

The other classification are based on turnover.

Julio Martinez: 23:42

Okay. Okay. Very good. Interesting. All right . Let's talk a little bit about market access and specifically about how to support the work of a distributor to generate demand for a product in Latin America. What are your suggested best practice? I mean, what should a foreign company do with the distributor to generate demand from the end user ?

Antonino Di Nicolo: 24:03

Well, it depends, again, it depends even the , the type of drug that you have that you want to commercialize. As an example, let's take Mexico. If you have a branded drug, so your target is high price or a very high price, I would target high , very high people. Okay? And, and I would stick on , uh, out-of-pocket market because these people I can afford or have private insurances and , uh, can go to the private clinics. Private clinics are usually for advanced , uh, like more the novelty and , uh, use the , the , the last drugs as drugs that are even present commercialized in the US or Europe, for example, or even other countries. Okay. If you have , uh, uh, generics or generics drugs, again, the market is completely different. No , so the population in this case is much bigger. You speak about 50, 70% the population, but the price are much lower, lower of course. And , uh, so it depends on which type of drug you have, and depends if your drug is out of , is a drug that , uh, out ofp pocket or is if is an oncological approach, possibly you need to go , uh, or an orphan drug . You need to work through tenders. So your main target will be public in market .

Julio Martinez: 25:23

Okay. Yeah. Let's talk about pricing and reimbursement. What comments do you have on , on that in the region?

Antonino Di Nicolo: 25:30

It depends on the territory. In Mexico , uh, usually after the registration, the price , uh, has really priced by the companies and after, so pro , pro , um, and patients , uh, um, pay the drugs are out of pocket , okay? There is the possibility even to enter in public markets, so to get approval, reimbursement from the insurances, but the public insurances, EMC Mexico for example, but this can take up to five years to enter in the list of this public insurance. And here you , you need even to handle with tenders. So now, if you are alone in the , the molecules, so you have , uh, more possibility or you are more regional, you have the possibility to have a higher price if you are not original, because there are the competitors with the same molecules. Of course, the price is much lower. Brazil, the , the , the story is completely different in Brazil, usually all drugs are priced at the beginning. So in the registration process, during the registration process with on visa , the visa committee that is CMDE, that has in charge even , uh, to set the price to discuss the price with the company, yes.

Julio Martinez: 26:48

Wow , how interesting. Okay, I didn't know that.

Antonino Di Nicolo: 26:52

Yeah . Once you have the price set and visa complete the registration , uh, the , the , the process and , and can give you the approval. Okay . After that, there is another process to get the reimbursement. So this is the reason why in Brazil things can be longer than in Mexico? No , because there are different processes that can take , uh, more or less time because the philosophy in Brazil is that they want to guarantee to hold population , uh, accessible price independently if they are out of pocket or paid by the government.

Julio Martinez: 27:31

All right . Antonino, we're close to the end of the show. The last question that I have in terms of your experience is in bribery. What's your perception about Latin America in regards to bribery and, and corruption and things of that nature?

Antonino Di Nicolo: 27:47

Uh , this is one of the big issues of course of Latin America in general, and this happens , uh, in whole countries, all countries from Mexico to Argentina, Brazil, et cetera , Columbia , Peru , uh, no, no, no , no countries are , uh, escaped from this logical , uh, lack . I can tell you that pharmaceutical markets as a general point of view, there is, there are companies that are completely in line with the rules and they're very straightforward on this. The biggest, usually most of the locals follow this in certain way . There , there are different , uh, they work in different ways . So you have to see berry is an issue here, especially for countries that they're not used to this, you know, but you can face this because many local companies that want to , to work with , uh, multinational, that want to work through in licensing are always, always follow the rules. And, and this is the most important. So you see, you see that , uh, there is , um, ethic on this. Uh , and , and this is important, so I cannot, I don't want to generalize, but I can say that it's more spread bravery than in Europe, you know? So, but uh , I want to say that there is a very huge part of the population that , uh, is not in this way, but we have to consider that this may be a risk that we have to consider.

Julio Martinez: 29:16

Exactly. Absolutely. Alright , so before we sign out for today, Antonino , uh, do you have any final thoughts or mores of wisdom or other museums for our listeners? In other words, what would you say to the CEO of a small mid-size pharma company or biotech company in Europe that is looking at Latin America as a place to sell , uh, its products?

Antonino Di Nicolo: 29:43

I would say let's try, let's try less there and uh , to come here because it's very interesting market. Uh , many companies are looking for , uh, products , uh, coming from Europe, from the us , from Russia . And because the market needs of this need of this many technology , uh, the I level maybe cannot here because of the price, but more traditional can and medium little companies may have very interesting companies across that can be very useful for you . Even pro that may maybe old for Europe can be very interesting here for Latin America. So let's try but be prepared. Be prepared because the level in , uh, in this area, pharmaceutical, biotech, healthcare is very high.

Julio Martinez: 30:30

Okay? It's not an easy journey, but it's worth trying because the opportunity is huge. Yeah .

Antonino Di Nicolo: 30:36

You have to try because it's very exciting. I found people a very high level . Uh , so it's , uh, companies that are very professional is fantastic to work , to work with.

Julio Martinez: 30:47

Very good. Excellent. Well, Antonino , um, could you please remind listeners how they can get in contact with you, your website, your email, whatever, your phone number?

Antonino Di Nicolo: 30:58

Yeah. Yes, of course. Impress in , uh, LinkedIn through my website , uh, <inaudible> , but even Alva , there is a page LinkedIn webpage. There is even my webpage. Uh , Alva is a Latin word , Latin esva , and so , and there .

Julio Martinez: 31:19

Okay. Okay. Very good. Yeah, we link from our website to your LinkedIn page. Yeah. So everything should be there. So thank you so much, Antonino . It was a great pleasure to speak with you. I am quite impressed with the level of knowledge that you have about the pharmaceutical and nutraceutical or medical product , uh, world in Latin America. So I'm sure listeners will think about you , uh, if , uh, they have a need to , uh, explore the opportunities that Latin America can offer. All right , have a great day. Take care. Thank

Antonino Di Nicolo: 31:53

You very much. Thank you very much. Bye-Bye

Julio Martinez: 31:55

Bye .