Wockhardt Limited

Mar 2025 call

2025-06-05 Transcript PDF
Moderator

Thank you very much , sir. We will now begin the question-and-answer session. We'll take questions from investors present at the venue. Investors present at the venue may please raise their hands. Our on-ground team will pass the microphone to you. Meanwhile those who have joined us online may please type their questions in the chat box. In the interest of time kindly limit your questions to the company's future outlook or growth strategy. Operational or routine worries can be addressed separately by the Wockhardt team. The investors present at the venue are requested to introduce themselves and proceed with their questions. Ladies and gentlemen we'll start with the text questions and the questions are, the first question is what is the probability of ZAYNICH getting approval from USF DA in FY '26-'27? Do you find any hurdle in approval process? How long will ZAYNICH India approval take since we have filed in March 2025? And what will be the timeline for commercial production and market availability?

Habil Khorakiwala

You have two questions on ZAYNICH. One is regarding India and one is regarding the US. We expect ZAYNICH approval sometime coming at the beginning of next year and we should be in Indian market in the middle of next year , another 3, 4 months thereafter. And we see a high probability of this because we applied in March , normally they should take 6 to 9 months for approval. As far as the manufacturing is concerned for India, it is all it is ready and we are making adequate quantity to meet the demand for the product. Coming to US, there is a very high probability or certainty I would say that we should be able to market the product sometime in '26-'27. Yes.

Yes. Three question. Like, how do we intend to market Zaynich is by the company. And just throw some granular details on that side of it sir, if you can. Thank you.

Habil Khorakiwala

Let me understand your question properly.

Sir, how do you intend to market ZAYNICH in US, like a tie up with someone or someone else will be doing, who would be manufacturing some granular details.

Habil Khorakiwala

Yes, okay. Fine. As far as India is concerned, we would be doing it ourselves. We have already built up a top leadership team and they have come from the organization who have the experience of launching new drugs in India. Now as far as the US is concerned , we are simultaneously operating on 2 options to optimize our value proposition. One option, we are seriously thinking to create our own organization for which we are in the process of recruiting top team and also have consultant for various aspects because ZAYNICH is only prescribed and used in large tertiary care hospital and it is not a mass market product. So from that perspective , number of resources you require to cover is very limited. That is one option. Second option, we are simultaneously looking to out license the product with some of the big pharma or any suitor. Our objective basically there is if we get a good valuation for what we believe ZAYNICH value is, we may consider that as an option. But if you don't see that kind of valuation coming, we will do it ourselves.

Hansal Thakkar

Good morning Dr. Khorakiwala. My name is Hansal Thakkar and I'm represented here by all the investors. So first of all a heartiest congratulations. I think people don't understand the gravity of what you, your scientists, your entire team have created. We have been tracking this development from the very first compassionate case of the Nepalese patient. And since then, we have had nothing but admiration for you and your team, which, sorry I can't avoid it, but is the true odyssey of courage. I speak on beha lf of all the investors when I congratulate you again when the government recognizes Nafithromycin as our poster boy to biotechnology. And at this moment , I don't want to ask any questions . But apart from the financial aspect , I think my speech is a little more emotional. So I would thank you and I would request everyone here to give us a standing ovation. This is nothing short of a miracle. So, congratulations, sir. I'll pass the mic on to someone else who might want to ask a question.

Habil Khorakiwala

Thank you very much for your appreciation and more importantly recognizing what is being done. So our achievement or what we have done is absolutely a major breakthrough from Indian context and that is not yet fully be recognized. Thank you very much for r ecognizing that and wonderful for good words.

Bharat Sheth

Hello, sir. My name is Bharat Sheth. I have this question on the amount of fundraising the company has done via the equity dilution , as well as the raising of debt. So the pipeline of the products which we have mentioned apart from ZAYNICH. Are we any such in the further equity dilution funds, R&D or the marketing part of it by way of debt or by way of debt? So can you just give us the picture , I mean, the probability of the debt going out and the equity dilution going ahead. Thank you so much.

Habil Khorakiwala

We just raised about INR1,000 crores a few months back and we are having -- still sitting on some cash basically. Also you have seen our EBITDA performance has improved. This year it will be much better. And I think subsequent here with the launch of NC E, we will have much better cash flow. So we believe mostly this cash flow coming in would be more than adequate for research. We have been spending the last few years on new drug discovery about USD 200- 250 million. Probably we may continue to spend that or little more. So I think it would probably meet our requirement basically.

Hello, I am Dhruvesh Sanghvi. If you can understand the journ ey that a new product typically takes. Let's say like India because we will have ZAYNICH coming soon in India. So is it like a 3, 4 year journey where it goes up and it takes a long time. Or is it like a couple of quarters and reach to the target audience , make them aware ? Because as you said it's not a product , but a specific hospital product. So if you can throw some light. Yes. Thank you.

Habil Khorakiwala

See one of the objectives of launching. I'll give you our approach for Miqnaf and then ZAYNICH. In terms Miqnaf, what we are doing in the first 6 months is only promote to chest specialist so that the specialist endorses the product and it is a chest specialist who get most of the resistance cases because the patient has gone to other doctors and then they go with difficult cases to chest specialist . And about one third of the patient chest specialist receives are untreatable by any oral treatment. So normally they refer it to the hospital for injectable treatment and admit to hospital. So therefore we said, we will focus on chest specialist for 6 months and then expand the coverage of consulting physician and ENT and pediatrician. But we will be restricting our promotion for next 3 to 4 years only to specialists and we will not plan to go to a GP. For two reasons. One is it is better that a new drug gets a right endorsement from the specialist group as a whole, so that it has a much more long sustainable life. And secondly, if we are looking at the price point which we are having, so in terms of treatment costs it is very cost effective. Because when you have a failure you need further treatment, you have to go to hospital and the whole treatment is high. But from that point of view when the cost of a medicine is high , say INR3,000 per treatment of 3 days, but total treatment cost is very reasonable. Now coming to ZAYNICH. ZAYNICH is generally used in the -- see first two things we have done. We introduced EMROK and we didn't have a good experience because we were new to it, so we went through a major learning curve internally. And for Miqnaf and ZAYNICH, we have built the organization and literally our top team we have got it from multinational companies who have the experience of launching new drugs. So the same thing we have done for ZAYNICH. And from day one we would be going very quickly to almost all doctors ZAYNICH by multi-channel approach, because we a re having a very large number of conferences where a scientific element will be shared, plus we are creating a slightly innovative business team where we have populated our medical doctors to a fairly high ratio 1 4, 1:5 to representative. Mainly because you have to communicate the scientific aspect of the molecule and a qualified medical doctor can do a much better job. So we don't expect years to get into a doctor to appreciate, we expect doctor to appreciate this molecule very short time.

Moderator

Thank you sir. We'll take the next text question and the questions are manufacturing readiness for US market. Could you please confirm which facility is planned to manufacture WCK 5222 for US market? And whether the site has cleared or is ready for USFDA pre-approval inspection? And the next one is commercialization strategy , has Wockhardt entered into or is in advanced discussion regarding the commercialization or outlicensing partnership for WCK 5222 in the US or EU? If not, then when is such development expected?

Habil Khorakiwala

Very good question. There are 3, 4 aspects about 5222. One is manufacturing. The whole manufacturing is being done in Europe both for API, as well as formulated product. And we are already completed initial batches required for filing long back . And I think we would be well ready to make whatever initial our d emand would be there for manufacturing from US . And their existing people, existing capacity, they -- all facilities are approved by USFDA . So that manufacturing is totally we have the risk that -- that is one. The second element of your question. Second question was your commercialization. I did explain earlier the commercialization and as we have more details, I think I'll let you know. As far as the licensing is concerned, licensing is moving quite all right. At the same time, our own organization creation is moving space. So we might in next few months have a CEO anywhere for the organization . Because if I have to get more value for my proposition, I have to be very serious of creating my own organization as an alternative. So that -- it's not that for people come and give me a rate. But if I have expectation higher than that, I have to say that I have an alternative available if I believe this is a value we will . So that is a very deliberate part of a strategy. It may cost a little more extra , but that is what we are doing. Because of value proposition, looking at the molecule has to be very significant according to us because these are the drug available once in a while. Normally the industry trend is whatever recent antibiotic sales purchases happen they put little, within that range they try to work and everybody works on the same basis. So I have to get somebody out of the thinking process that -- so that is what our strategy as far as outlicensing or manufacturing is concerned. And the last query was?

Habil Khorakiwala

Does this cover? Does this cover your questions?

Moderator

Certainly, sir. I'll take the next text question , and it says firstly many congratulations to Dr. Khorakiwala and the entire team of Wockhardt for their stupendous achievement on cracking the lifesaver antibiotic innovations that will make the whole India proud. I have been an investor with significant quantities of the shares since last 1.5 years and would be gra teful if the below queries get addressed. Normally doctors prefer to use the antibiotics that they are familiar with. And how much time ZAYNICH may take to build this awareness and familiarity. Also will there be any impact on the potential pricing of the drug that is USD8,000 to USD10,000 per patient due to Trump's policies. Does ZAYNICH can also replace polymyxin which is currently last resort medication if a Carbapenem fail, but they are also neurotoxic. The addressable market figures are on per annum basis.

Habil Khorakiwala

Addressable market is?

Moderator

The addressable market figures are on per annum basis.

Moderator

Annually.

Habil Khorakiwala

These are annually those presentation numbers everywhere. Coming to your earlier question.

Habil Khorakiwala

In India, okay, fine. I think our approach for ZAYNICH is, the primary market of ZAYNICH is with the specialist that is intensivist in the ICUs and disease specialist to recommend to use a drug. So that is the target market we are trying to address very immediately, by various method to meeting, conferences, involving a large number of medical scientists there. And we hope that we access this market within first 6 to 9 months and even if we get 20-30,000 patients we are looking at something like INR200 crore, INR300 crore, INR400 crore sales. So that is our aim. But I think in 3 years we should be looking at 80 -100,000 patient potential for ZAYNICH.

Moderator

Thank you sir. We'll take the next text question , and the question is , do you have the manufacturing capacity to cater to all markets for ZAYNICH?

Habil Khorakiwala

So western market , I already mentioned that we have the capacity , we have checked with the suppliers, manufacturers and they have adequate capacity to meet western market. As far as India and emerging market is concerned, we are developing in-house capacity in India and third- party manufacturing we are doing for formulation. API we are manufacturing here for all our products. And for next 2-3 years, we today have the capacity and we will build up capacity as a demand increases and make sure that there are no shortage of capacity.

Moderator

Thank you, sir. Ladies and gentlemen in the interest of time this will be the last text question , which is sir what kind of outlicensing and royalty earnings are you expecting for ZAYNICH over the next 5 years?

Murtaza Khorakiwala

Out licensing income and royalty on sale you expect over the next 5 years?

Habil Khorakiwala

A very difficult question to answer that basically. So one could -- the idea was that we gave you the overall potential addressable m arket. So obviously, we will be doing our best possible job . As an organization, we would also be learning with market dynamics is taking place. So what we will do to get optimum value is we will have a good team of people, in terms of commercial and medical and scientific. And I must tell you , our scientific team which has discovered the drug and what unique thing happening with us and our success in the past and likely to be in the future, is there are about 15 disciplines required to discover a new drug which are independently like chemistry, biology, pharmacology, microbiology, toxicology, like that 15 discipline is required. Now our team -- over the years we have created a team which interact with them on a regular basis. So they work as a team and that is why the innovation comes. It's not a silos , but it is working as a team. And I think we have extended that model to our business also now with the scientific team. So they are totally in sync , because scientists know much more of the molecule because they have lived with the molecule for last 10 -15 years. So whatever they plan to transfer the knowledge to medical or commercial people it will not be same level. So we are keeping them as a part of overall business development, so that our scientific profile, whether in India or US or anywhere will be second to none , and I believe these are important elements for the success of the drug.

Moderator

Thank you very much sir for answering all the ques tions. We will now close the Q&A session. Thank you for your understanding. I would now like to hand the conference over back to Dr. Murtaza Khorakiwala for his closing comments. Thank you and over to you, sir.

Murtaza Khorakiwala

So, I think I would like to thank all the investors and all those who have come here for our conference and participating in the event. Thank you all for coming here. I hope as I said you would have learned something new about the company and you take back with you . And look forward to your continued partnership and support in our journey. We have tall ambitions and aspirations. And I am sure that your support will be very important in achieving those objectives. Thank you again for your time.

Moderator

Thank you members of the management. Investors present at the venue may continue with the conversations with the Wockhardt management. On behalf of Wockhardt Limited that concludes today's conference. Thank you for joining us and you may now exit the meeting. Thank you, sir. Have a great day.