Recordati Raises Forecast for Isturisa After Smooth Launches
Peak Sales Estimate For Cushing's Drug Upped From €100m to €300-350m
Executive Summary
The Italian firm's move to license Isturisa from Novartis last year is paying dividends already and Recordati has already tripled its peak sales forecast for the Cushing's therapy.
As with most pharma companies, the coronavirus pandemic has impacted operations at Recordati SpA but it has not affected an impressive launch for Isturisa, the Italian group's Cushing's disease therapy.
The Milan-headquartered group has posted first-half 2020 revenues of €760.2m, a rise of 2.3%, a reasonable result given that second quarter sales were down 8.1% to just under €331m due to the reversal of the stocking effects seen in Q1. Adjusted net income came in at €225.6m, an increase of 16.8% over the first half of 2019, helped by a reduction in expenses.
CEO Andrea Recordati said the COVID-19 crisis "inevitably affected our markets mainly due to fewer visits to doctors [and] our sales forces obviously were not in the field." Factors hitting the company included "lower patient traffic in pharmacies, lower consumption of OTC lifestyle products such as vitamins and supplements, a reduction of clinic and hospital procedures as well as a lower incidence of mild infectious disease resulting from the diminished circulation and interaction between people."
Very much a bright spot was the performance of Recordati's rare diseases division which saw first-half 2020 sales shoot up over 32% to €152m, helped by the contribution of Isturisa (osilodrostat). The therapy, a cortisol synthesis inhibitor which works by inhibiting 11-beta-hydroxylase, an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland, is approved for endogenous Cushing’s syndrome in the EU and for patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative in the US. (Also see "Recordati's Isturisa Approved For Cushing's In EU" - Scrip, 16 Jan, 2020.)
Cushing’s syndrome is a more common condition caused by excessive cortisol production, whereas Cushing’s disease is specifically when a pituitary tumor secretes excessive adrenal gland stimulating hormone (ACTH).
Recordati acquired Isturisa from Novartis AG as part of a $390m deal inked with the Swiss major in July last year that included Signifor (pasireotide) and its long-acting version Signifor LAR. The latter two are approved to improve the symptoms of Cushing’s as well as acromegaly in adults for whom surgery is not an option.
While the firm was "very pleased with the strong revenue contribution from Signifor and Signifor LAR," Recordati said on a conference call that "we are also very encouraged to say the least by the early signs on the Isturisa launch in the US and France." He noted that the company launched in Germany in mid-July, and Italy is set to come online shortly.
The company has updated its peak sales estimate for Isturisa from around €100m to €300-350m. Enthusiasm for the product has grown since Recordati presented more positive results from a major late-stage study, the Phase III LINC-4 trial, confirming the effectiveness of the therapy for the rare disorder which affects approximately one to two patients per million per year and where the body produces too much cortisol and leads to patients experiencing weight gain, fat build-up on the face and bruising. (see sidebar).
The upped forecast may still be on the conservative side. Analysts at Credit Suisse issued a note on 31 July saying that "this peak explicitly excludes the opportunity of expansion to Cushing’s syndrome in the US," where it is currently just approved for Cushing’s disease, and any expansion into geographies where Recordati currently has no presence," such as China and South Korea. in March, an application was submitted to the Japanese Ministry of Health, Labor and Welfare.
The lower figure is due to currency headwinds and lower demand in the second and third quarters, driven by COVID-19 lockdowns impacting all markets. Recordati said the firm expected "only a gradual return to normal operating conditions in the latter part of the year."