Earnings Call: H1 2021

Aug 6, 2021

Hello, everyone. I'm Sigi Olofsson, CEO of Hikma Pharmaceuticals, and I'm here with Khalid Nabilsi, our CFO. Thank you for joining our 2021 interim results presentation. I will be providing an update on our strategic progress. And then I'll hand it over to Khalid to run through the financials. Our strategy continues to deliver, and I'm very pleased to announce a strong set of results for the first half of twenty twenty one. The breadth and resilience of our portfolio as well as our commercial and operational strength has enabled us to successfully navigate through the shifts in customers' demand as the COVID-nineteen pandemic has progressed. Group core revenue was $1,200,000,000 up 7% from last year, reflecting a strong performance of our generics, unbranded businesses and the resilience of injectables. More importantly, this is translating into growth in profit With group core profit up 9% from last year, driven by a strong performance of generics as a result of successful recent launches and excellent performance from our Tier 1 markets in branded. The investments we have made in building our pipeline are paying off and they're supporting the good performance we are seeing today. We launched 87 products across our markets in the first half of twenty twenty one, including generic Advair Discus. We also announced the launch of Clogzido this week, which I will talk more about later on this presentation. Let's take a closer look at each of our 3 businesses. Starting with our injectables business. Following an exceptionally strong performance in the first half of last year, Global Injectables revenue grew slightly, reflecting our resilient and broad global portfolio and the breadth, Quality and flexibility of our manufacturing facilities. Let's take a look at each of our three regions, starting with the U. S. In the U. S, the pandemic has caused fluctuation in demand for our products. If you recall, In the first half of last year, we saw a surge in demand for COVID-nineteen related products, particularly patients on ventilators. As the pandemic progressed and with the successful rollout of vaccinations, we saw a drastic reduction in demand for these products. As you will also recall, when COVID-nineteen hospitalization were at their peak And lockdowns were in place, we saw a dramatic reduction in elective surgeries. Patients We're being cautious to enter hospitals and fewer diagnostic tests were administered. This has caused a significant diagnostic gap. If you look at the top left chart, you can see that there are around 1,000,000,000 diagnostic visits that did not happen in 2020 or 20% less than normal. These have a direct impact on prescription utilization and elective procedures. So what this means for us is that while demand for our COVID-nineteen related product has declined, This diagnosis gap means that we aren't yet back to normal in terms of demand for our products used in elective procedures. As the pandemic progresses and if the vaccination rollout continues to be successful, We expect to see the volatility ease and the increase in elective surgeries. Despite the challenges we are seeing today in the U. S, we are well positioned to capture market opportunities. As we have said many times, our extensive portfolio combined with our high quality And flexible manufacturing operations and strong commercial relationships are true differentiators for us. They enable us to be responsive to customer needs and to benefit from opportunities as they arise, supplying products when our competitors cannot. The chart on the left highlights our ability compete by managing our portfolio well. 35% of our U. S. Injectables revenue is generated Byproducts, the 2 other competitors on the market and a further 28% from products that have between 35 competitors. For the products where we see the most competition, Those with 6 or more competitors, we are in the top 3 in terms of market share for over 50% of these. This demonstrates our position as a supplier and a partner of choice with our customers and underscores our commercial and operational strength. Of course, the continued growth of our business also depends on successful pipeline execution. We continue to expand our portfolio and have had A significant number of launches in the first half of this year. We've launched 9 new products in first half of twenty twenty one and 2 additional products in July, bringing our total portfolio in the U. S. To 119 products. This is in line with our ambition to launch 10 to 15 products in a year, and we are closer to the top end of that range. We also benefit from the breadth of our operation in this business, having an established position in MENA and the growing presence in Europe. Our European and MENA businesses Have seen accelerated growth in recent years, and this is supporting the growth of the overall segment. As you can see here on this slide, over the last 5 years, MENA grew at a CAGR of 12% and Europe at 17%. Our Injectables business in Europe delivered an outstanding performance in the first half of this year, building on a strong performance in 2020. This was driven by an exceptionally strong contribution from contract manufacturing and the good demand across our broader portfolio and new launches. We are making good progress on expanding our presence in this region. Today, the growth is driven by sales in Germany, Portugal and Italy. And we are registering and gaining approval of products in France and Spain. In our MENA Injectables business, we are pleased to see a steady growth following an exceptionally strong half last year. Our biosimilar products continue to drive growth in this region, and we are making good Progress with registering our 3 biosimilars, RemXima, Herxima and Truxima in additional MENA markets. Our established position in the MENA region makes us an attractive partner. This year, we expanded our licensing agreement with Melinta in the MENA region, adding 2 novel anti infective injectable products. This supports our strategy of establishing a global network of partners to strengthen our portfolio and improve availability of treatment options in the MENA region. Turning to our generics business. The generics business delivered an excellent performance in the first half, with revenue of 8% and core operating margin expanding to 25%. We have really strengthened the generics business over the last couple of years, and this is driving results. By working closely with our customers, enhancing our internal processes and through our manufacturing flexibility, We were able to drive demand for our marketed products and fill market gaps that occurred due to competitors' issues. We are also continuously looking at ways to optimize our portfolio to focus on higher value opportunities as well as optimize our operations. We have managed to continuously improve the efficiency of our operations. Columbus is truly a state of the art manufacturing facility And our high quality capabilities gives us a competitive advantage. We, of course, need to make sure We have a good pipeline of products lined up to add to our strong base. Through our investments in R and D since the Roxanne acquisition, We are seeing the results. In 2018, we talked about the target of 10% revenue contribution from new launches by 20 We reached that goal last year. And in the first half of this year, it increased to an exceptional 22%, Thanks to the strong performance of the 2020 launches, such as generic Sotres and icosapent ethyl capsules as well as the more recent launches. While this is well above our target and we are seeing increased competition on certain products, Like the generic entry we saw on Sotres this week, we do expect the contribution from new launches will remain high for the full year, especially given the recent launch of generic outlet. These products are good examples of the opportunities We look for in the business higher value opportunities that leverage our commercial and state of the art manufacturing capabilities at Columbus. Launches such as these bolster and differentiate our base business further as the transition from new launches bucket to become part of the base portfolio. This enables us to offset the effects of increased competition on our more commoditized products. We thought it would help to spend a little time on our 2 more high profile launches, generic icosapent ethyl capsules and generic Advair. When we launched icosapent, We said that we were launching with limited supply and that we expected to increase supply over the course of the year. Things are going pretty much as planned. And you can see on this chart on the left, our market share has been steadily increasing. And I am pleased to confirm that our plans to further increase our supply remain on track. The launch of generic adware is also going well. We have made a really good headway with customers. We received a positive feedback from customers and have secured some strategic business, which will enable us to achieve our target market share of the generic market. You won't see this yet in IQVIA as customer are still working through their inventory, But you should start to see this in the coming weeks. Now that we have strengthened the foundation, We need to ensure we have the right products in our pipeline to keep this momentum going and deliver a long term sustainable growth. One area of focus for us is building our specialty business. Through this, we can enhance Our portfolio differentiation and leverage our commercial expertise and infrastructure we build for Mittigare, our branded Holzecin capsules. We are already delivering in this area. As you saw earlier this week, we announced the launch of Ploxido, our branded naloxone 8CL 8 milligram in a ready to use nasal spray. As an experienced provider of addiction therapy treatments and a leading producer of nasal sprays in the U. S, We are able to leverage our capabilities to deliver an important new tool in the fight against opioid overdose. As a reminder, this is a product we acquired from Insys in 2019, and the team has done an amazing job Transferring the equipment to our Columbus facility to get these important medications to patients as quickly as possible. On the slide here, you can see the product on our manufacturing lines at Columbus. The market structure for Cloxido is an interesting one. We are going to be marketing this product in 2 distinct channels, through government distribution platforms, including first responders and halfway houses and through the retail prescription market. The graph you see on the slide highlights the market Though it is interesting to point out that the number you see here for the retail segment do not fully capture the market, Naloxone is under prescribed, and this should create a good opportunity. Our sales force is working to raise awareness and educate physicians, pharmacists and patients of the importance of this medication. We are delivering on our purpose of putting better health within reach every day, increasing patients' access to important treatments, and we look forward to bring more products like this to the market. Finally, let's take a look at our Branded business. The Branded segment delivered strong results in the first half of the year with double digit revenue growth and improved margins. Our ability to leverage our global capabilities And to act locally across the MENA market has been key to our success. The MENA market is large, With an addressable market of $31,000,000,000 since we introduced more focused strategy by tiering Our markets, we have been seeing results. As you can see from the chart on the left, Saudi Arabia, Egypt and Algeria is where we see the largest opportunities, and these markets have performed well in the first half of the year. We are benefiting from the strength of our commercial capabilities and the resilient portfolio. Sales of our anti infectives are improving, and we are seeing good demand for chronic medications. In Saudi Arabia, our sales are fifty-fifty split between the private and tender market. In the first half of the year, We saw good demand for our broad portfolio with particularly strong growth in our private sales. In Egypt, we continued to see some COVID-nineteen related demand as well as good performance from our broader portfolio. We also had some pull forward of demand for certain products. In Algeria, the team has done an excellent job at turning that business around since the disruption we saw in 2019. The business is on a much stronger footing today, And you can clearly see that from our results. We have improved the management of our commercial strategy and stock levels at wholesalers. This is driving good and steady demand for our products. Being a local player with manufacturing capabilities in the market, we also are able to step in and fill market gaps as a result of our competitors' disruptions. We are also pleased to announce that our oral oncology plant, The first in Algeria is up and running, and we have launched the first product out of that facility. We expect to launch more products in the second half of the year. Hopefully, this gives you a good flavor of our strong Strategic progress in the first half of twenty twenty one. I'll now hand it over to Khalid to take you through the financials. Thank you, Siggi. Good morning, everyone. I'm pleased to report that the group has continued on its strong performance from 2020, delivering good growth in both revenue and profit, particularly in generic and branded. As Siggi highlighted, This performance demonstrates the resilience of our business as we manage to gradually return to a normalizing environment. The resilience of our base business in each segment, our broad product portfolio and successful new launches enabled us to achieve this strong performance, With core revenue up 7% to US1 $200,000,000 and core operating profit up 9%. Given the strong performance with core EPS up 13%, the Board is recommending an interim dividend of $0.18 per share, up from $0.16 Now let's have a deeper look at the financial performance of each business. Starting with injectables, the injectables business has shown a resilient performance in a relatively volatile environment As a result of the pandemic, our broad global portfolio and flexible manufacturing capabilities drove revenue growth by 1%. Looking at each of our 3 regions, in the U. S, revenues declined by 8%. This is primarily due to the lower demand for COVID-nineteen related That's compared to the surge of demand we saw in the first half of last year. At the same time, and as Siggi highlighted, Elective procedures have been slower to return to more normalized levels. We'll continue to launch new products. The incremental contribution from new launches and the breadth of our portfolio has helped partially offset this decline. We continue to expect to show growth in U. S. Injectables for the full year, reflecting the gradual return of elective surgeries. Like the U. S, MENA sales in the first half of twenty twenty were also very strong due to COVID-nineteen related demand, which created a tough competitive period for MENA injectables in the first half of this year. So we are really pleased with our performance here. We grew injectable sales in MENA by 3%. This was driven by good demand across our broad portfolio and biosimilars. Our European sales were also very positive, up 54%, reflecting a Strong performance from our broad portfolio and new launches as well as continued demand for contract manufacturing, primarily related to our agreement with Gilead for the manufacturing of remdesivir. Injectable core operating margin was 38%, down from 42.1 percent in H1 2020. This reflects a change in product mix in the U. S. And adverse foreign exchange movements, primarily related to Sudan, which were partially offset by the strong performance in Europe. As Siggi mentioned, our generic Business continues to perform really well with revenue up 8% and significant improvement in core operating margin. A key driver was the good contribution from 2020 and recent launches, which are helping us offset increased competition in certain products. Generic core operating profit increased by 39 percent to US100 $1,000,000 and core operating margin increased to 25%. This increase in profitability reflects the improvement in product mix as a result of the successful new launches as well as lower R and D due to the timing of spend, which we expect will increase in the second half. Our branded business achieved a very strong performance in the first half, With revenue up 16% on a reported and 17% on a constant currency basis. This was driven by good performance across our Tier 1 market, Saudi Arabia, Egypt and Algeria, as a result of our strong commercial capabilities and good demand for our broad portfolio. This was further supported by some of our Tier 3 markets, including Sudan, which saw an improvement in volumes following its structured first half in 2020. We also benefited from some pull forward for certain products. As a result of the strong performance, revenues will be more evenly spread out this year when compared to 2020. Branded core operating margin was 20.1%, up from 18.5%. This reflects an improvement in product mix, which more than offset regular increases in SG and A and the negative impact of foreign exchange movements related to the devaluation of Sudanese Park. To deliver long term sustainable growth, We need to ensure we are building a pipeline of differentiated products. In the first half of this year, we continued progress with our pipeline projects And invested $59,000,000 in core R and D. This is slightly down from last year as a result of timing of spend in the year, with R and D spend expected to be weighted towards the second half of the year. Our CapEx spend was $65,000,000 in the first half of twenty twenty one. In the U. S, dollars 26,000,000 was spent upgrading equipment, expanding packaging areas and adding new technologies for our generic and injectable businesses. In MENA, dollars 29,000,000 was spent strengthening and expanding manufacturing and warehousing capabilities. And in Europe, we spent €10,000,000 expanding our facilities and enhancing capabilities in Portugal. The group continues to generate good cash flow with operating cash flow of EUR 224,000,000. The reduction compared to the first half of last year reflects the timing of tax payments. The group's total debt remained constant at 932,000,000 And we continue to have a very strong balance sheet with a net debt to core EBITDA ratio of 0.9 times. Finally, the outlook for 2021. Our strategy continues to deliver results, And we are pleased with how the business has started off the year. As a result of the strong performance, I'm pleased to announce an upgrade to our generic guidance. We now expect generic revenue to be in the range of €810,000,000 to €830,000,000 for the full year, up from 770,000,000 to €810,000,000 and core operating margin to be in the range of 22% to 24%, up from around 20%. This improved outlook reflects a strong performance from recently launched products. Our full year Expectations for our injectable and branded business remain the same as previously guided. We expect injectable revenue to grow in the mid single digits and core operating margin to be in the range of 37% to 38%. We expect branded revenue to grow in the mid single digits in constant currency. We expect group net finance expense to be around $50,000,000 in 2021 and the core tax rate to be around 22% to 23%. We expect group capital expenditure to be around €140,000,000 to €160,000,000 That wraps up the financials. I will now pass back to Siggi for some closing remarks. Thank you, Khalid. I would like to close by saying I'm proud of what our teams have achieved across the group, continuing on from a strong performance in 2020. We are making a good strategic progress, and I look forward to continue on this trend for the rest of the year. Before we finish, I would like to announce that we are having our generics meet the management, The 3rd in our series of events on 23rd September. We will be announcing details soon and hope you can join us. Thank you.