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Lotus Pharmaceutical Co Ltd
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[Foreign Language] Petar, please.
Hi. Good afternoon, everyone. It's my pleasure to present Lotus 2019 results and also the key focus areas for 2020. I hope everyone is in a good shape despite of the coronavirus crisis.
[Foreign Language]
So 2019 was a very successful year for Lotus Pharmaceuticals. It was a milestone year in the development of the Lotus business and also in the transformation of Lotus from a local company to a global pharmaceutical company with presence around the world.
[Foreign Language]
The top line sales have increased by 43%. The main driver here was the export business. Buprenorphine/naloxone sublingual film, obviously, was the biggest driver for this growth. As everyone knows, we launched the product in the first wave in U.S.
Okay. [Foreign Language]
We did also extremely well with the export to European Union. So for the first time, actually, Lotus exported products to European Union in 2019. And not only that, but we launched successfully 3 major products in European Union.
I will start first with lenalidomide. Lotus is the first company which obtained approval in 2018 and the first company which launched a generic of lenalidomide, which is the largest small molecule product, in selected markets in the Central and Eastern Europe.
[Foreign Language]
The second product that we launched in European Union, gefitinib. We launched this product simultaneously in 20 markets on the patent expiry -- on the first day of patent expiry, which I don't think has been ever done by any pharmaceutical company in Taiwan, launch on patent expiry in 20 EU countries.
[Foreign Language]
And the third product is vinorelbine softgel. With this particular product, we are really proud because this product is extremely challenging as clinical development, also as formulation development and manufacturing. And Lotus until now, and we expect that this will continue also in the next years, is the only company that succeeded to obtain approval for generic of this product and also to launch the product in 20 countries in European Union.
Okay. [Foreign Language]
But other important milestones which we have delivered in 2019, I will start first with the acquisition of a number of marketed products in Southeast Asia, which provides a footprint to Lotus in Southeast Asia. This footprint is very important because it basically allow us to expand our presence in Thailand, which is one of the most interesting markets in Southeast Asia, where we are getting access to existing sales and marketing infrastructure, not only marketed products but also access to our pipeline which is under registration and also products which are under preparation for filing.
Okay. [Foreign Language]
The second market which is -- we are getting access to this acquisition is Vietnam. Vietnam is the growth champion in Asia. The market has been growing double digits for the last 3 years. And also, it's forecasted to maintain this growth, which makes it the growth champion of overall Asian region. So we are now having access to existing commercial team and also existing network of distributors, which is very important because Vietnam is a market with significant opportunity, particularly for oncology. So with this setup, we will be able to basically channel our oncology portfolio and pipeline.
Okay. [Foreign Language]
Besides those 2 markets, also, we have access now to our existing network of distributors in markets like Philippines, Malaysia, Singapore, Hong Kong, Sri Lanka, Bangladesh and also Myanmar. So overall, this deal is providing access to the company to Southeast Asia, which is considered as a very interesting geography in Asia with a very positive outlook for -- in terms of growth.
Okay. [Foreign Language]
So we did also extremely well on building our portfolio and pipeline by adding leading brands, proprietary products based on business development deals. So we finalized a deal with Takeda for Evista, which covers markets like South Korea being the biggest market of Evista in the region, also Thailand, Hong Kong, Singapore, Malaysia, Philippines.
Okay. [Foreign Language]
Evista is a leading brand in osteoporosis. And by this deal, we are creating additional substance to our existing osteoporosis franchise with Aclasta and also oral contraceptive products.
Okay. [Foreign Language]
At the end of 2019, we finalized 2 very important business deals in addition to Evista. The first one is the deal with Orion for Stalevo and Comtan. These are leading brands in anti-Parkinson's segment of the CNS, which is considered as a niche segment with limited competition, limited generic penetration.
The territory that we contracted with Orion covers pretty much a big part of our territory that we are covering: South Korea, Taiwan, Hong Kong, Philippines, Malaysia, also Singapore. This is obviously important because this is increasing our CNS business in Korea, where we have already Seroquel, as you know. And also, it provides foundation for our CNS franchise here in Taiwan and also in the other markets that I mentioned.
Okay. [Foreign Language]
And last but not least, literally in the last days of 2019, we signed a licensing agreement with Mithra, it's a Belgian company, for a product called Estelle. Estelle is a proprietary product considered as probably the most promising product in oral contraception available currently. And we got the rights for Taiwan and also Hong Kong. And by this deal, we are increasing our presence going forward in women health care therapeutic segment, which is very lucrative in terms of size and also in terms of growth perspectives.
Okay. [Foreign Language]
A very important milestone for our business, obviously, is the settlement for lenalidomide in U.S. market with Celgene. Lenalidomide will be our flagship product in the next 5 years, and this settlement is a prerequisite for success.
Okay. [Foreign Language]
More than 60 licensing agreements -- licensing out agreements for Lotus existing products and also pipeline products have been finalized in 2019 covering multiple geographies: Europe, Middle East, Latin America, Australia and New Zealand. This is also a big milestone for us because it creates a very strong foundation for our export business for the next 5 years.
Okay. [Foreign Language]
We are also very proud with the outcome of the U.S. FDA inspection, which was in the middle of 2019. We passed the inspection without 0 observations, which is a significant step-up in our track record with U.S. FDA and also proves our commitment in quality, the investments that have been done for the last 3 years in quality system, also upgrading the skill set of the quality team and also bringing strong quality leaders to lead our quality organization in 2019 from multinational companies like GSK and Johnson & Johnson.
[Foreign Language]
We passed also successfully 5 customer audits, which is related with the outlicensing deals which Lotus signed. I mentioned this previously. Some of these customers which audited Lotus and approved for it -- Lotus as supplier are companies like Novartis with -- Novartis is -- for your information, is doing the quality audits for Sandoz, which is a subsidiary of Novartis; also companies like Stada.
Also, we were inspected and approved by the largest Brazilian pharmaceutical company, which is opening the door for the Brazilian market being the biggest market in Latin America.
Okay. [Foreign Language]
So we also continued in 2019, and did it in a successful manner, to invest in our future pipeline in terms of R&D and also upgrade of our manufacturing and supply chain infrastructure to be able to serve this increased demand, which is expected to come in the outer years.
So on the R&D in 2019, we had 15 projects under development, both R&D centers in Taiwan at Lotus, Nantou, also in Korean R&D. Also in 2019, we initiated a very important capital investment project which is -- with a 5 years' time table. But in 2019 in particular, we initiated the building of a new warehouse, which is not only a warehouse, but also [ 2 manufacturing force ]. And this investment is very important, again, in relation with our significant increase in the export business.
[Foreign Language]
Okay. Moving to financials.
[Foreign Language]
Yes. [ 2000 ] year, again, this was a remarkable year in our history. So we have very strong growth. The net sales grew from TWD 6.4 billion to almost TWD 9.2 billion. So this is representing 43% year-on-year growth. Again, the growth has been driven to a large extent by our export business. But also, we have seen a strong performance of our Asian operations.
In terms of gross profit, I mean, our gross profit on a year-on-year basis increased 35% from TWD 3.1 billion to TWD 4.2 billion. Operating income from TWD 450 million in 2018 to USD 1.1 billion (sic) [ TWD 1.1 billion ], representing 148% year-on-year growth.
[Foreign Language]
In terms of net profit, EPS, the year was really remarkable. So our EPS has grown more than 550% year-on-year base from TWD 0.42 in 2018 to TWD 2.74.
[Foreign Language]
The diversification is very important for our business. So we think that diversification is one of the critical success factors in the pharma business, especially during the last years because we have seen a lot of companies which were focused only on a single market failing because of the changing in the dynamics. I mean that's why it was very important for us to -- from day 1 to diversify the business in terms of geography and also to diversify the business across the portfolio among different therapeutic areas.
So we can see in 2019 the snapshot. On the left side, revenue breakdown by therapeutic areas. So we have a very good diversification, I would say, very good spread of risk among several therapeutic areas. The leading therapeutic area in 2019 has been CNS, which includes buprenorphine/naloxone, which is falling under the category of CNS. But also, we have other big flagship products here like Seroquel I referred to in cooperation with AstraZeneca after -- with U.S. and Korea. And the addition here at the end of 2019 was the deal Orion for the anti-Parkinson products.
Also, oncology is contributing around 70% within our revenue in 2019. Being second-biggest therapeutic area, oncology is definitely our strategic therapeutic area, not only supported by R&D but also by business development activities. So our flagship products here are cooperation products with AstraZeneca in Korea, Zoladex, Casodex and Arimidex. And also, we have a cooperation with a European company for generic of Gleevec and, of course, Lotus pipeline with 3 big launches last year: lenalidomide, vinorelbine and gefitinib.
[Foreign Language]
Other important therapeutic areas with the major contribution in 2019 in terms of revenue are also lifestyle, anti-obesity products, where we have a leadership position in Korea. This is a very important therapeutic area for us not only because of the size but also because of the fact that it's nonreimbursed, out of pocket, which means that it's -- which has more price regulation and little exposure to any price erosion.
Okay. [Foreign Language]
Other important therapeutic areas, women health care. I mentioned that we finalized a deal with Takeda for Evista, which is the flagship product in the women health care in the subgroup of osteoporosis. And also, we have already existing in these segment Aclasta, which is another flagship product and also we added at the end of 2019. The important pipeline product in this area, the proprietary oral contraceptive Estelle based on the deal with Mithra.
Okay. [Foreign Language]
And also, we have a presence in nephrology, which is also a rather niche therapeutic area with limited competition with flagship products here being Kalimate, which is a proprietary product based on cooperation with the Japanese company Kyowa, they are the originator, and also biosimilar darbepoetin in Korea.
[Foreign Language]
So on the right side, you can see that 2019 was a really important year for us in our path forward to transform the business from a company which is focused on a single market like Lotus several years ago to worldwide coverage. So our export portfolio accounted for 35% of the revenue, and our Asian business accounted for 65%.
Okay. [Foreign Language]
So 2019, as I mentioned, was a record year for us in terms of profitability. So our EBITDA grew from TWD 1.1 billion in 2018 to almost USD 2.1 billion (sic) [ TWD 2.1 billion ], which is -- in 2020, which is -- sorry, in 2019, which is a remarkable growth.
[Foreign Language]
So moving to key initiatives for 2020.
[Foreign Language]
So obviously, remaining focus area will be our existing portfolio and also building our pipeline. So we will continue to increase our market share in U.S. for buprenorphine/naloxone. I mean we see positive trends. And also, we have one competitor less, as you know, because Sandoz authorized generic was discontinued in 2019.
We also -- we are well positioned to execute 2 filings of biosimilars. Actually, as a matter of fact, one of the filing was already done in Taiwan for a biosimilar product in the segment of osteoporosis, which again is complementing our strategy with Aclasta and Evista. And also, we are planning to file also in 2020 in Taiwan a major biosimilar product in the field of oncology, which is complementary to our oral oncology existing business in Taiwan and also pipeline.
Okay. [Foreign Language]
Very important 2020 milestone for us will be the target action date for lenalidomide, which is July -- in July, in the middle of the year. So we are expecting to get tentative approval for lenalidomide. Again, lenalidomide will be our flagship product in the next 5 years.
Okay. [Foreign Language]
Also, we have more than 20 agreements with licensing partners under discussion. So ultimate objective will be to finalize this agreement in 2020, which will bring revenue not only in 2020, possibly, but more in the outer years.
[Foreign Language]
So important priority for us is also new product launches to be executed on time. So for us, the key launches will be, obviously, Orion launches based on the deal with Orion, the one that I mentioned previously. Also, we have a couple of launches in Southeast Asia, very important.
I referred to launches like imatinib in Vietnam, also mometasone in Thailand, mometasone spray. We launched Qsymia at the end of 2019. So Qsymia, obviously, will deliver on 2020. So we have to maximize this opportunity in 2020.
Okay. [Foreign Language]
We will also continue to invest in the -- in our pipeline, either through R&D or through business development. So we will always keep this 2 major streams for our pipeline, business development and the R&D.
In terms of R&D, definitely our focus is to deliver more further on our oral oncology pipeline. Also, we are -- we have a couple of interesting 505(b)2 products in Korea. The plan is to not only target Korean markets with some of those but also to roll out to other markets outside Korea.
We are also interested to add 505(b)2 oncology programs to our pipeline, either through R&D or through business development. So this is work in progress. So we think that addition of this complexity to our pipeline will provide a very strong outlook for our business in terms of profitability because 505(b)2 products, they come with also IP position and also premium pricing.
We will continue to look for opportunities to expand our business through cooperation with companies, either big pharma on the brand acquisitions similar to what we did in 2019 with Takeda for Evista or to in-license products, proprietary products, with patent protection and also complexity like Qsymia, the deal with VIVUS in U.S. and also the deal in 2019 with Mithra for Estelle.
So the ultimate objective for us is to create a hybrid portfolio containing not only generics but also 505(b)2 products, which again are more complicated with limited competition, and also proprietary products type of Qsymia, type of Estelle and also tail end brand with stable market share and also life cycle. By doing this, I mean, we will provide very strong foundation for long-term profitable growth.
Okay. [Foreign Language]
On the next slide, you can -- I will cover the importance -- 2 important, very important, major launches, which basically occurred in 2019, and we are confident that we will deliver significantly in 2020 further.
I'll start first with buprenorphine/naloxone sublingual launch in U.S. So as you know, we launched the product in 2019. It's an extremely difficult product from development, manufacturing perspective, also IT perspective. I think everyone is aware on the hurdle that we have to pass through in order to launch the product.
So again, we launched the product in the first wave with -- together with Mylan and Dr. Reddy's and also the authorized generic of Sandoz, February 2019. Mylan, obviously, due to the fact that they don't have the major SKUs. Throughout 2019 also, the originator decided to discontinue the authorized generic. But nevertheless, they are protecting very strong their market share.
So we see a significant ramp-up now after several months. So in January 2020, based on IQVIA data, we reached 10% market share. February, we are already at 15% market share. And our estimation is that the increased uptake of the market share will continue also into -- in March. So we are expecting to reach 20% market share, which is definitely good news.
So it took a bit. I mean normally in U.S., when you launch products, the market share ramp-up is very fast. But because of the complexity around this product on all fronts and because of the fact that the originator is one company with very strong ability to defend the market share, I mean, it took us several months more than usual. But I mean we are very happy because we see that the market share is increasing significantly month-on-month from January. So we have very strong confidence that buprenorphine/naloxone will deliver at least in line with our expectation in 2020.
Okay. [Foreign Language]
The next launch, which again has very strong contribution in our 2020 plan and beyond is Qsymia. It's a proprietary product. It's the most efficient anti-obesity drug in the world available based on the clinical data.
So Qsymia has been launched literally in the last month of 2019, and the product has taken off very fast. I mean you can see this is the UBIST data, which is demonstrating the sellout, the sellout from pharmacy to end patients and comparing the dynamic from first week of January to 10th week of 2020 among the key competitors, the second-generation anti-obesity products like Belviq, Saxenda and Contrave. So you can see the line with Qsymia, the blue one, blue one, which obviously demonstrates that Qsymia has taken over the leadership position in this premium segment. Because these drugs are in the premium segment, they are usually 4x to 5x more expensive than the low segment.
The good news here is Belviq, which is one of the key products in this segment, has been discontinued. Basically, U.S. FDA came with the conclusion that the product is causing increased risk of a particular type of cancer. In January, there was an alert. And in February, already the U.S. FDA recalled the product and basically ceased the NDA in the U.S. And this was followed by -- immediately by Korean FDA and also by TFDA. So essentially, we have one competitor less, which is giving us a very strong confidence.
[Foreign Language]
So next slide, they provide overview for the status of our pipeline, R&D pipeline. I'll just focus on a few products here because we don't have much time. And first one is lenalidomide. Again, this is the biggest product in our 5-year plan and the biggest small molecule, over 10 billion sales. Again, we are expecting the decision of U.S. FDA. So we're expecting tentative approval in July 2020. Also, we launched the product, I mentioned earlier, in selective markets which are patent-free in Central and Eastern Europe through Alvogen CEE.
And also, we are planning to launch in 2020 in further markets in CEE with another customer also planning to launch here in Asia in some markets and also in Middle East. We are also progressing well with the registrations in Western Europe. These markets in Western Europe and South Europe will be open in 2021.
The second product is enzalutamide softgel. We believe that we are the first company that developed successfully generic formulation. The unique situation is that Taiwan for certain reason is not protected by the patent. So we are allowed to manufacture and commercialize the product here after -- from 2021 onwards. So we already filed the product in Taiwan on the first possible date. And we also obtained a tentative approval. And the final approval will be issued by the authorities in Taiwan at the end of 2020 when the market exclusivity expires. So we're in a good shape to launch this product in Taiwan in 2021.
This is one of the most promising products in the field of prostate cancer. It has sales of more than $2 billion and with very strong growth. So the good thing here is that by obtaining the market authorization in Taiwan, we can also secure early customers in many markets around the world, Middle East, Latin America, which they have patent holes in these markets. And also, we are in a pretty good shape to target European markets.
Okay. [Foreign Language]
Okay. I will move to the next slide. Just one more product, in the interest of time, the program AK-R216. This is a 505(b)2 product in the field of diabetes type 2 treatment. The originator is famous, one of the leading multinational global pharmaceutical companies.
So we passed already the Phase I study, and we are heading towards Phase III. So we think that this could be a very interesting opportunity. And also, I'm happy with this because also it restates that we have strong capability in the R&D to develop 505(b)2 products, and we will utilize this going forward.
Okay. [Foreign Language]
So next slide covers the hot topic with COVID-19. We think that actually, we are very well prepared to -- in terms of business to sustain this crisis for a couple of reasons. On the left side, you can see that, again, the breakdown of our revenue in 2019 by therapeutic area, which illustrates that we have a very diversified business in terms of therapeutic areas. And this provides much more confidence in -- under such circumstances because you have little exposure to only one therapeutic area. It's a pretty good spread of risk.
Also, we have a very good spread of risk on the portfolio in terms of reimbursed and nonreimbursed products. Again, usually in such crisis periods, the products which are mostly impacted are those which are nonreimbursed. Obviously, these are products which are not for chronic disease. And somehow the patients, the people, they can deal for a couple of weeks without using them.
So on the right side, you can see that from a supply perspective, also, we are in a pretty good shape. Only 8% of the APIs are being sourced from China, and the rest is being sourced from elsewhere. Actually, we have been working on that for the last 2 years. I mean it's not that we knew that COVID-19 is coming like Bill Gates. But basically, we -- what we have observed in China is that the government has been shutting down a lot of chemical plants, which created significant disturbance for the API supply intermediates. So they were shut down because of the environmental reasons.
Okay. [Foreign Language]
So overall, for the -- in terms of materials, I mean, we have between 4 and 12 months' inventory of the demand, which is, again, giving us a very good position that we can continue the business without being on a stock out.
We have also ongoing -- again, this is not initiated by the COVID-19 crisis program for second sourcing. The ultimate objective for this program is to ensure stable supply to derisk products, which are with only one API supplier, and also to provide more competitiveness because if you have 2, 3 suppliers, then you can always leverage this and negotiate better terms.
Okay. [Foreign Language]
So the conclusion, again, of this slide is we are very confident that the impact, if any, will be very limited on the business because, number one, we have a very diversified business in terms of therapeutic areas, in terms of reimbursed/nonreimbursed and also in terms of geography. We have customers in U.S. We have customers in Europe. We will have customers in Middle East this year and potentially in Latin America and, of course, in Asia.
So it's -- diversity is the key. Also, in terms of supply, again, because of this remedy plan that was initiated a couple of years ago for different reasons, we are also in a very good shape.
Okay. [Foreign Language]
So to conclude the presentation, the major catalysts to watch in 2020. So basically, we expect, again, solid performance for the key launches, which occurred in 2019. I referred to buprenorphine/naloxone launch in U.S. based on the ramp-up of the market share. Also, we have very strong belief in the performance of Qsymia, which has been launched since last quarter of 2019.
And last but not least, the oncology portfolio, which was launched in 2019 second half in Europe and also other markets. We also -- we will see very good contribution also from our Asian markets: Southeast Asia, again, the markets like Thailand, Vietnam; and the other distributor markets which I mentioned at the beginning, Hong Kong, Singapore, Bangladesh, Sri Lanka.
Very important day for us this period is July because of the target action date related with lenalidomide, lenalidomide being the biggest product in our plan. And also, I'm sure that there will be news in 2020, good news, for Lotus expanding its portfolio with new interesting opportunities, either through cooperation with big pharma or in-licensing proprietary products, which is, again, a very strong differentiation factor.
Okay. [Foreign Language]
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Yes. We are very confident that we can basically deliver around $13 million, $14 million this year. Again, the product took off nicely, I mean, for a new launch. Again, this is a product which is out of pocket. So it's not reimbursed. It is high-price segment product. So the end user price is around $100. The ramp-up is amazing.
We got -- in the last basically 2, 3 weeks, it was a bit slowing down because of the COVID outbreak in Korea. So I mean obviously, if you're the patients that are using this product, they are not -- they were somehow hastened to go to doctor because you need to have a prescription for this product, so it's a prescription product.
But last week, we see that we are catching up again. So the product is back on the growth pathway. So Belviq, what I mentioned earlier, is gone. So Belviq will never be back because of this cancer risk. So we have all the prerequisites to basically deliver at least our budget number for Qsymia. And perhaps, we can also get some upside.
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Thank you. Bye-bye.