Nextstellis Comments at Mithra Earnings Call

Below is a transcript of part of the recent Mithra earnings call with shareholders and analysts.

Mithra has given some very positive comments about Neststellis and its positive growth prospects for 2023.

Cheers.......D

-------------------------------------------------------------------------------- Jean-Manuel Fontaine, Mithra Pharmaceuticals SA - Chief External Affairs Officer [6] -------------------------------------------------------------------------------- Thank you, Graham, and good morning, everyone. I will start this commercial update with Estelle in the United States and Europe. The largest territories where the product is commercialized, respectively, under the brand name Nextstellis and DROVELIS. I will then provide a short update on Myring in the United States.

If we move on to the next slide, we can start with our contraceptive product Estelle. It's been commercialized in 2021 and all major territories of the world are today covered by license and supply agreements. In the first half of 2022, a second series of EU countries have launched, including Spain, the Netherlands and Portugal. Switzerland has launched in July, as well as Australia, for which early feedback shows strong interest for Nextstellis and E4 in particular. U.K. is scheduled later this year. Brazil regulatory scheduled in the second half of 2022 for commercialization in 2023. The larger markets represents the largest South American market with the value close to EUR 430 million.

If we move to the next slide and to our partner operational highlights. We can have a look at the United States, the largest combined hormonal contraceptive market estimated today at about USD 3.9 billion annually. The commercialization of Nextstellis has entered its second year and has seen a positive acceleration of an Nextstellis uptake with all performance metrics trending favorably and translating now into sales. On the right, you can see the sales levels of the key combined hormonal contraceptives. That's quite interesting because it gives you an outlook in terms of the next competitors we will pass.

If we move on to the next slide, we have about 70,000 cycles that have been dispensed and sold in the first half of 2022. This is about sixfold more than the previous semester, H2, 2021. 4,760 writers of Nextstellis since launch in the top decile prescriber base and prescribers are returning as they are having a positive experience with Nextstellis. 85% of those prescribers who have prescribed in the previous semester, are returning in H1 2022. Market access commercial coverage is almost at par with competition together with the levels of product awareness and top decile prescribers of writing, the direct-to-consumer campaign has been launched in July, together with the strategic collaboration with GoodRx, a well-known Health Hub mobile app that will expand further the reach to consumers.

In addition, Nextstellis uniqueness, thanks to the first native and selective estrogen E4 has been nominated for the 2022 Prix Galien USA Award for the best pharmaceutical agent. As a result of this positive sales trajectory, Mayne, our partner in the United States has confirmed their target of 350,000 cycles dispense sold in their time line going from July 2022 to June 2023. This sets a strong sales evolution trajectory for the brand.

If we move to the next slide, I would like to take a few minutes to come back to the notion of commercial coverage in the United States, which is so critical to determine access to the medicine for women. This is a notable difference between the United States and Europe and the fundamental element to explain the difference and ramp-up in the first year. Commercial coverage of contraceptive product is key to ensure products prescribed by the doctors are available in the pharmacies and finally, dispensed to women and translated into sales. Whereas in Europe, most contraceptives are available in the pharmacies, the situation in the United States requires that private payers and pharmacies also known as pharmacy benefit managers reference the products on the formulary and with a limited to no restriction to access and also at an affordable co-pay for the patient, for the women.

Classically, this process takes about a year from launch to allow new entrants to be on par with competition and manufacturers usually engaged in couponing to women to limit their co-pay and support the product uptake. And finally, the brand loyalty during this period. Because of this lengthy process, most prescriptions written in the commodity markets are confronted with a high abandonment rate in the beginning with low dispensing levels, hampering the product uptake and revenue progression in the first 12 months. But today, the dispensing levels, of course, can still improve, but they have for Nextstellis, improved by 60% since February, and they are reaching a dispensing level end of June of about 83%, meaning that more 8 prescriptions out of 10 are finally dispensed and translate into sales.

Recently, the government has also been seeking to enforce the Affordable Care Act to ensure greater access to contraception with limited co-pay to patients. The U.S. 3 agencies, Department of Labor, Health and Human Services, and Treasury have issued a new guidance to ensure contraception is guaranteed to all and at no additional cost. The willingness of the U.S. administration irrespective of the political situation to support nationwide access at no additional cost is likely to impact favorably Nextstellis product uptake in 2023.