Target Market and Anticipated Revenues

The primary target market for ZoSaLa’s therapy is the population of patients with diagnosed: (i) thoracic aortic aneurysm (TAA), (ii) thoracic aortic dissection (TAAD), (iii) abdominal aortic aneurysm (AAA) or (iv) persons at identifiable risk for developing one or more of these conditions. A secondary market is persons who have undergone AAA repair, especially post EVAR patients.  In the seven major markets, which include the US, UK, Germany, Spain, France Italy, and Japan there are ~1.5MM  persons diagnosed with AAA or TAAA, a number that is expected to rise to ~2MM by 2032 (see chart below) Notwithstanding that no therapy has been demonstrated to reliably delay relentless aneurysmal expansion, significant amounts are spent by these patients for pharmacological therapy now. About $1B a year is spent on statins and anti-diabetic drugs with an additional approximately $.4B spent on beta blockers, NSAIDS and calcium channel blockers. There would be significant benefits for aortic aneurysm patients if a therapy proven in clinical trials to delay aneurysmal expansion, became available. One retrospective analysis concluded that, on average, it takes a small AA  measuring 3.5 cm ~7 years to reach a size at which a repair procedure becomes necessary, 5.5 cm.  This indicates that a 41% reduction in expansion rate would increase to 12.1 years, the average time to reach 5.5 cm. Considering that AAA is largely a disease of people in their seventh or eighth decade of life, a safe and effective therapy could keep many AAA patients at low risk for rupture for a duration long enough to preclude the need for any intervention. This would spare human suffering. It would also save the health care system the costs of AAA intervention. In the US the average cost of an EVAR is $45,300. About 14% of post EVAR patients experience some complications post- EVAR which require addition costs to manage. Where the management requires a second intervention, costs are typically about $22,000 per patient. Furthermore, the risk of rupture, although low in small AAA, is not zero. A therapy that began to renew the aortic wall soon after it were started, could reduce the incidence of catastrophic rupture.

A group of expert pharmaceutical economists and health policy scholars recently published the results of an analysis of the pricing of therapies introduced between 2017 and 2021 (Hana Althobaiti et. al. Healthcare) https://www.mdpi.com/journal/healthcare. They determined the median costs for non-orphan drugs and orphan drugs. For non-orphans it was $12,798.00. For orphan indications the price is over $200,000/year. We are making the conservative estimate that the cost of ZoSaLa’s therapy will be $12,000/year and we did not model any escalation. This is in keeping with ZoSaLa’s goal to make safe and effective therapies for aortic disease accessible to all patients who many benefit from them. Although pricing of drugs for orphan indications is typically many fold higher than for non-orphan drugs, we will seek to keep the cost for therapy the same for TAA patients as that paid by AAA patients. Our projections reflect this uniform pricing policy.