Hikma Pharmaceuticals PLC (LON:HIK)
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Earnings Call: H2 2020

Feb 25, 2021

Siggi Olafsson
CEO, Hikma Pharmaceuticals

Hello, everyone. I'm Siggi Olafsson, CEO of Hikma Pharmaceuticals, and I'm here with Khalid Nabilsi, our CFO. Thank you for joining our 2020 full year results presentation. I will be providing an update to our strategic progress, and then I'll hand over to Khalid to run through the financials. It's been three years since I joined Hikma, and over this time, we have focused on strengthening our three businesses. This strategy has paid off, and is reflected in the very strong set of results we are presenting today. There's no question that 2020 was a challenging year, with a great deal of uncertainty and disruption caused by the COVID-19 pandemic. I'm very pleased to be able to say that our business demonstrated its resilience in the face of these challenges.

Thanks to the strength of our foundation and the hard work of our employees, which together ensured that we were able to maintain a good supply of our medicines to customers and patients across our markets. For the year, group core revenue was $2.3 billion, up 6% from last year, reflecting good organic growth across our three businesses. Our group core operating profit was up 11% compared to last year, driven by strong growth in generics and injectables. While responding to COVID-19, we also continued to make a good strategic progress across the group. We stayed focused on building our pipeline of differentiated products and expanded our portfolio with successful new launches. We launched a total of 154 products across our markets in 2020, including the earlier than expected launch of icosapent ethyl capsules in the U.S.

We are nearly there with the launch of our generic Advair Diskus. I'll cover this in more details later in the presentation. While expanding our portfolio and investing in our pipeline, we continue to drive process improvement and operating efficiency across our business. These efforts have put us in a strong position for 2021, and I'm happy with how the business is performing so far this year. Now, let's look at each of the businesses in a bit more detail. Starting with injectables. Our global injectables business performed very well, with revenue up 9% and core operating profit up 12%. We highlighted throughout 2020, the considerable volatility we saw in the injectables market as a result of the pandemic.

Our established position as one of the leading suppliers in the U.S., our extensive reach in MENA, and strong foothold in Europe, helped us to meet the challenges this volatility created. Key to this was our broad portfolio, a good number of new launches, and our flexible manufacturing capabilities, which helps us to meet the changing needs of our customers and patients. Let's take a closer look at our three regions, starting with the U.S. In the U.S., the pandemic caused fluctuation in demand for our products. In the first half of the year, particularly in March and April, we saw a surge in demand for products used in the treatment of COVID-19 patients, especially those on ventilators. These included anesthetic, pain medicines, neuromuscular blocking agents, and other support medications.

The chart on the right shows the variation in demand that we saw for these products during 2020, and it highlights the big spike in volumes in first half. We were able to take a quick action and respond to these changes in demand. Since then, as treatment protocols for COVID-19 shifted, demand for these products has stabilized. Today, fewer patients are being put on ventilators, as proportion of ICU patients on ventilators was down 20% in January 2021 versus April 2020, and we are starting to see a downward trend in hospitalization levels and ICU patients. Another key indicator of demand has been the number of elective surgeries being performed. These dropped off significantly as hospital focused on COVID-19 patients at the beginning of the pandemic.

You can see it in the top left graph that these surgeries have started to come back, from a very low levels in March and April, and we expect to see this trend continue to normalize over the course of 2021. Of course, the continued growth of our business also depends on successful pipeline execution and new product development. Despite the disruptions caused by the pandemic, we were able to launch 10 new products in 2020. Most notably, propofol, nicardipine ready-to-use bags, and daptomycin. All products that we expect to see growing contribution from in 2021. If we go back a bit further, we have launched 20 products over the last 18 months. While the market opportunity for some of these products is bigger than others, together, they make a nice contribution and support the continued growth of the business.

This is even more pronounced if we look at the launches over the past 4 years, which contributed 27% of U.S. Injectables revenues in 2020. Over the last 10 years, we have invested significantly in our injectables manufacturing capabilities, and we operate state-of-the-art manufacturing sites in the U.S. and Europe. We have extensive capabilities, including the ability to manufacture prefilled syringes, sterile emulsions, and lyophilized products. This, coupled with the flexibility of our operations, enables us to respond to our customers' needs. This flexibility was essential in 2020. We shifted manufacturing schedules, ramped up production, and increased productivity to meet higher demand. We reduced fill to release time cycles and increased batch sizes on several COVID-19 products to make sure we could get the right products to market as quickly as possible.

The way that we responded to these rapid changes in demand reinforced our excellent quality track record and strengthened our position as a partner of choice in the U.S. This was clearly demonstrated when Gilead chose Hikma as a manufacturing partner for the supply of remdesivir, their important treatment for COVID-19. Our expanding partnership with Civica is another great example of this. Civica relies on our quality manufacturing and robust supply chain to help them minimize drug shortages, something that became even more important this year. Shifting to our other injectable markets, our injectables business in Europe delivered an outstanding performance in 2020. As in the U.S., we saw an increase in demand for our products due to COVID-19, and we were able to leverage our broad portfolio and flexible manufacturing in Portugal, Italy, and Germany to meet patients' changing needs.

This drove a strong growth in sales in these markets. We also saw a good demand for contract manufacturing, including our agreement with Gilead for remdesivir. With the investments in capacity we have made, including our new high containment facility in Portugal, we now have more scope to manufacture products for this region and have continued to register products across Europe, including UK, France, and Spain. In total, we submitted 160 product application in 2020 across our European markets. Moving to MENA Injectables, I think this slide tells a great story about our business and value we bring to patients in the region. Our biosimilar products continue to perform well. We are increasing our market share, and we continue to launch into new markets.

One of the exciting things about these products is that we have found that we are bringing these important medications to patients that couldn't previously afford them, thereby growing the overall market. Let's look a bit more closely at the Remsima, our infliximab biosimilar, which we have now launched in eight markets. Remsima needs to be administered in infusion clinics. Due to the pandemic, with lockdowns and distancing restrictions put in place, we were concerned that patients would not be able to access the treatments they needed, so we acted as facilitators, connecting patients who needed the treatment with doctors and hospitals that could administer it. Today, more patients can access the treatment, and we have been able to grow the market. Iraq and Saudi Arabia are great examples of this.

In Iraq, where our market share is around 70%, the market itself has grown more than 80% since we launched. Similarly, in Saudi Arabia, the market size has more than doubled since we launched. In the coming years, we will be adding more biosimilars, like Truxima and Herzuma, and other more complex injectables to our portfolio, and are confident that this will continue to increase access to these important treatment for patients across the MENA region. Now, let's turn to our Generics business. Before we dive into our performance, let's take a look at the impact of COVID-19 had on the U.S. Generics market. You can see from the chart on the left that there have been fluctuation in demand for prescription medicines on weekly basis due to the pandemic, with total levels of prescriptions down 3% compared to the previous year.

This is primarily because of lower healthcare utilization overall. With doctor visits low, we saw a reduction in the diagnosis of new conditions. In this disrupted market, our business proved to be very resilient. Throughout the pandemic, we were able to continue to supply medicines most needed by our customers and patients, thanks to our differentiated portfolio and the strength of our commercial and distribution teams.... We work closely with our customers to understand their needs and focused on maintaining continuity of supply by managing production and allocation of finished goods. We benefited from having a local manufacturing in the U.S., and we're able to prioritize products that were in high demand as a result of the pandemic. For example, we shifted manufacturing schedules and ramped up production of dexamethasone when demand for that product increased.

At the same time, we maintained supply on our broader portfolio to ensure patients continued to get the essential medicines they need. We acted quickly at the beginning of the pandemic to secure sufficient API supply and increased our safety stock. Throughout the year, we continued to launch products and look for ways to optimize our portfolio. Moving to slide 12, I'll expand a bit on our new launches. In 2018, when I first joined Hikma, I set a target for the group to achieve around 10% revenue contribution from new launches by 2023, to ensure that we continue to grow our portfolio and by getting the most out of our investment in research and development. The Generics team hit the target this year, ahead of schedule, thanks to a strong performance of the 2020 launches.

In total, the team launched six products, including rufinamide, generic Afinitor, and generic Zortress, for which we remain a sole generic on the market. These launches performed better than we expected and helped us to offset some competition on our base business and related price erosion. They also demonstrated our ability to deliver on our pipeline with profitable launches. During the year, we also demonstrated our ability to challenge patents and launch complex products. We received U.S. FDA approval for icosapent ethyl capsule, following a successful court ruling, and launched the product in November. We are slowly ramping up supply and expect to improve quantities over the course of 2021. I would like to shift now to talk about the quality of our operations. We have really strengthened the generic business over the last three years through a focus on building our commercial capabilities, process improvements, and cost savings.

This is reflected in our financial performance, with Generics profit growth well ahead of our expectation and core operating margin at a very impressive 21.6%. By working closely with our customers and enhancing our internal processes, we have been able to significantly improve our customer service levels. We also decreased the number of products we have on backorders by around 70% through better management of production and by placing products on allocation. Productivity at our Columbus facility has improved, with units produced per employee growing at a CAGR of 10% between 2016 and 2020. In addition, we reduced our inventory reserves in 2020. Again, this is a demonstration of improved processes as our teams focus on efficient inventory management.

Of course, keep in mind that a lot of this progress was made while also managing the business through the pandemic. Overall, I feel very confident that the Generics commercial and operational foundation is now quite strong and will support the business as it focuses on new growth opportunities. Now that we have strengthened our foundation of the business, we need to ensure we are investing in the right opportunities to deliver long-term sustainable growth. We have some nice nasal opportunities in our pipeline. In 2019, we acquired two nasal spray pipeline products, naloxone and epinephrine, from Insys, along with unit dose nasal spray manufacturing capabilities that have already been installed in our Columbus facility. We also announced last year the licensing of Ryaltris from Glenmark, a novel nasal spray for the treatment of seasonal allergic rhinitis.

We are a leading supplier of nasal sprays in the U.S. with dedicated manufacturing capabilities at our Columbus facilities. We are going to leverage our expertise and the commercial infrastructure we have built for our branded colchicine capsule, Mitigare, to bring these products to market. This will require further investment in sales and marketing as we build out this specialty portfolio. More recently, we signed a promotion agreement with Eyevance for two of the branded eye care products, which will be promoted by our specialty sales team. This deal recognizes the strength of our commercial capabilities, and is another example of how we are developing our specialty portfolio. At the end of the year, we received a U.S. FDA approval for our generic version of Advair Diskus and initiated launch.

In January, we had to temporarily pause the launch to work through an amendment to reflect enhanced packaging controls to our application, which we filed as a prior approval supplement. I'm pleased to announce that the FDA has granted us priority review status for the PAS, as we are looking forward to finally being able to bring this product to market as soon as possible. The technical know-how and regulatory insight that we have gained from our work on generic Advair gives us the ability and confidence to develop a pipeline of complex respiratory products as we look to expand our dry powder inhaler portfolio over time. This includes our agreement with Vectura for the global development and commercialization of generic version of GSK's Ellipta portfolio. Finally, let's take a look at our branded business. Our branded business continued to grow steadily, with revenue up 5%.

In the first half, we saw some disruption in the business as a result of COVID-19. This included shipping delays, limited marketing activities, and interruptions to manufacturing due to curfews and other restrictions. We also saw a reduction in demand for certain products, like anti-infectives, as everyone stayed home and doctor clinics were closed. Despite these challenges, we were able to drive growth, thanks to our strong sales and marketing team and the large product portfolio, which has more than 250 products across different therapeutic areas. Our Tier one markets continued to perform well. In Egypt and Saudi Arabia, we saw a good demand across our in-market portfolio, and we continued to launch new products. Algeria has recovered strongly, following a more challenging year in 2019.

Since then, the team has done an excellent job at turning that business around, and it is on a much stronger footing today. We have improved the management of our commercial strategy and stock levels at wholesalers. We launched a number of new products in Algeria during the year, including Skilara, the first locally manufactured oral therapy for multiple sclerosis in Algeria. We also finalized construction of our oral oncology plant, the first in the region, and submitted 10 products for registration, of which two are already approved. Of course, we are continuing to introduce new products across all of our MENA markets. In 2020, our launches included Bufomix Easyhaler and Tevenz, a new class of oral treatment for type two diabetes. Another interesting launch is Reagila or cariprazine, which is a novel antipsychotic product.

In 2019, we signed an exclusive licensing agreement with Gedeon Richter to commercialize this product in certain MENA markets. Reagila is the first product to be able to address the negative symptoms of schizophrenia and other mental illnesses. We were able to get approval for it in record time in Jordan and launched in 2020, just six months after signing. We have also received approvals in Saudi Arabia, Egypt, and United Arab Emirates, and are planning to launch in those markets in first quarter 2021. Hopefully, this gives you a good flavor of our strong strategic progress in 2020. I'll now hand it over to Khalid to take you through the financials.

Khalid Nabilsi
CFO, Hikma Pharmaceuticals

Thank you, Siggi. Good morning, everyone. I'm pleased to report that the group has delivered good growth across our three segments, despite challenging market conditions that have arisen as a result of COVID-19. As Siggi highlighted, the strength of our base business in each segment, our broad product portfolio, high quality and flexible manufacturing facilities, and our dedication to ensure continuity of supply, enabled us to achieve this strong performance, with core revenue up 6% to $2.3 billion, and core operating profit up 11%. Given the strong performance with core EPS up 15%, the board is recommending a full year dividend of $0.50 per share, up from $0.44. Now, let's have a deeper look at the financial performance of each business.

Starting with injectables, the injectable business delivered double-digit core revenue and core operating profit growth in 2020, in a relatively volatile demand environment as a result of the pandemic. The U.S. business, which makes up around 70% of the total, grew 4%. The strength of our growth portfolio and the flexibility of our manufacturing facilities enabled us to meet changing customer and patient needs throughout the year. We saw an increase in demand for COVID-19-related products, primarily in the first half of the year. We also had a good contribution from recently launched products. The increase in sale and the strength of our broader portfolio more than offset reduced demand as a result of a slowdown in elective surgeries. MENA sales were up 10% on both a reported and constant currency basis....

This was driven by an increase in demand for COVID-19 related products and continued growth of our biosimilar products. As Siggi highlighted in the beginning, the team has done an amazing job in facilitating access to biologics in the region, especially during the pandemic. Our European sales were also very positive, up 44%, reflecting strong performance from our broad portfolio and new launches, especially in Italy and Germany, as well as good demand for contract manufacturing, including our supply agreement with Gilead to manufacture remdesivir for injection. We expect to see some additional benefit from remdesivir in the first half of 2021. Injectables core operating margin was 38.6%, up from 38% in 2019. This reflects the improvement in product mix in Europe and MENA, slightly offset by higher R&D costs and a negative impact of foreign exchange movements, primarily in Sudan.

Our generic business grew revenue and delivered significant improvement in core operating margin, benefiting from a strength foundation, which is enabling us to deliver better than expected results. The continued strong performance of our generic business is due to a better than expected contribution from new launches, as well as the strength of our differentiated portfolio. We also saw a slight increase in demand for certain COVID-19 related products in the first half, and then again, towards the end of the year. All of this more than offset an acceleration of price erosion in the second half. Generics core operating profit increased by 30% to $161 million, and core operating margin increased to 21.6%, well ahead of our expectations. This increase in profitability reflects the improvement in product mix, combined with process efficiencies.

We expect to continue to grow the generic business in 2021, benefiting from our broad and differentiated portfolio and the execution of our pipeline, which should offset an expected increase in price erosion in the market. Our branded business achieved good growth in revenue, up 5% on both reported and constant currency basis. This was driven by good performance across our Tier one markets, Saudi Arabia, Egypt, and Algeria, with Algeria recovering strongly following a more challenging 2019 due to political and economic disruptions. We did see disruptions across our MENA markets related to COVID-19, including a reduction in the demand for pharmacy products such as anti-infectives. This was offset by an overall resilient performance from the broader portfolio. Branded core operating margin was 20.6%, down from 22.1% in 2019.

In 2020, we had a significant impact from foreign exchange movement, primarily in Sudan. At the same time, Lebanon and Sudan were considered hyperinflationary economies, which had a further negative impact on our profits. Excluding the adverse movements of currencies, core operating margin grew by 1.2 percentage points to 23.3%. This primarily reflects an improvement in product mix and good control, of course. We continue to focus on growing our pipeline. We invested $137 million in core R&D, up 9%, due to higher investment in our injectables R&D program as we build our pipeline of differentiated products. As a percentage of core revenue, core R&D was 6%. Our CapEx spend was $172 million, ahead of expectations.

As the market outlook improved through the second half of the year, we proceeded with several projects to expand and enhance our capabilities. More than half was invested in the U.S. on upgrading equipment and adding new technologies. We also spent in MENA and Europe, strengthening and expanding our manufacturing capabilities. The group continues to generate strong cash flow, with operating cash flow of $464 million. This good performance came whilst maintaining higher inventory levels to ensure continuity of supply during the COVID-19 pandemic. Looking at some of our key financial highlights in 2020. In July, we announced the successful placement of a $500 million Eurobond, with an annual coupon of 3.25%. We're especially pleased that we were able to raise this bond during the uncertainty in financial markets caused by the pandemic.

The bond was 3 times oversubscribed, with interest from investors globally, a clear indication of confidence in our financial prospects. We achieved investment grade status from Standard & Poor's and Fitch, again, an accomplishment which demonstrates the quality of our business. We had the opportunity to utilize our balance sheet strength and repurchase a portion of BI's holding when they sold their stake in June. We bought back 12.8 million ordinary shares, which are being held in treasury. Our strong balance sheet enabled us to comfortably undertake this transaction while maintaining continued financial flexibility. We also signed a new $200 million loan facility with the International Finance Corporation during the year. Finally, we secured long-term facilities on a subsidiary level to ensure we maintain liquidity in local countries....

While the group's total debt level increased to $932 million, we are still maintaining a low leverage ratio, with net debt to Core EBITDA ratio below 1 times. Finally, the outlook for 2021. First, for Injectables, we are expecting to see continued demand for COVID-19 related products, predominantly in the first half, and a gradual return of elective surgeries. We expect Injectables revenue to grow in the mid-single digits and core operating margin to be in the range of 37%-38% for 2021. For Generics, in 2021, we expect generic revenue to be in the range of $770 million-$810 million. We expect core operating margin to be around 20%, reflecting increased sales and marketing as we build our branded portfolio and higher R&D costs.

Finally, for branded, we expect branded revenue to grow in the mid-single digits in constant currency in 2021. We expect group core net finance expense to be around $50 million and the core effective tax rate to be around 22%-23%. We expect group capital expenditure to be in the range of $140 million-$160 million. That wraps up the financials. I will now pass back to Siggi for some closing remarks.

Siggi Olafsson
CEO, Hikma Pharmaceuticals

Thank you, Khalid. I would like to close by saying I am proud of what our teams have achieved across the group. Our strong foundation, flexible and high-quality manufacturing capabilities, robust supply chain, and dedication of our people to our purpose enabled us to continue to deliver the essential medicines that patients needs across our markets. We continue to make good progress against our strategic priorities. The achievements we set out in this presentation position us well for sustainable future growth, and I look forward to continue on this path in 2021. Before I finish, I would like to announce that we will be hosting a series of virtual Meet the Management Zoom calls this year. Each of these will feature a different member of our leadership team. We'll kick off with the leaders from the injectables business on the twenty-fourth of March.

We will be announcing details soon and hope you'll be able to join us.

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