"FDA's Peter Marks seems inclined to grant full approval to Sarepta's Duchenne gene therapy"

FDA’s Peter Marks seems inclined to grant full approval to Sarepta’s Duchenne gene therapy

At an event on the sidelines of the J.P. Morgan Healthcare Conference, Marks seemed comfortable with granting some form of full approval to Elevidys.

STAT (www.statnews.com)

Selvom "virker tilbøjelig" ikke bekræfter direkte, så antyder det ... så måske positiv afsmitning på Hansa Biopharma i et ellers nok rødt marked i dag onsdag.

Hansa Biopharma, HNSA SS: BUY, TP SEK 93.0

Healthcare, MCap EURm 119, SP SEK 25.22

Closing '23 with some optimism

Product revenue +19%/+26% vs. ABGSCe/consensus
ConfIdeS study: close to 2/3 of 64 patients randomised
Positive share price reaction expected

Good Q4 with product sales at SEK 43m (vs. consensus 34m)

On Saturday, Hansa provided an business update for Q4'23 preceding the official Q4 report (scheduled for 2 Feb), as well as a clinical pipeline update. Starting with the commercial part, Hansa announced that total revenue for Q4 amounted to SEK 50m (+16% vs. ABGSCe at 43m, +14% vs. company collected consensus at 44m), with SEK 43m coming from product sales (+19% vs. ABGSCe at 36m, +26% vs. consensus at 34m). This figure indicates that 15 patients were treated with imlifidase during the quarter (ABGSCe 12 patients, consensus 14 pts). We note that this is the highest number of patients "commercially treated" in a quarter so far (previously it was Q2'23 with 10 patients). Hansa mentioned that the sales numbers are driven by growth in new markets such as UK, Germany, and Spain. EBIT came at -177m (vs. ABGSCe at -202m and vs. consensus at -174m). Total cash and cash equivalents came in at SEK 732m (vs. 908.1m in Q3'23). Hansa also communicated a new partnership with NewBridge Pharmaceuticals to allow the supply of imlifidase in the Middle East and North Africa (MENA) using NewBridge's capabilities (currently Hansa has a pending application for marketing authorisation in MENA markets).
Pipeline update: close to 2/3 of ConfIdeS study randomised

Hansa announced that the ConfIdeS study currently has 101 patients enrolled (+14 patients vs. Q3 report at 87 patients), with close to 2/3 of 64 targeted patients randomized. Hansa still expects full randomisation by mid- '24 (and BLA submission in '25e), however, we believe that randomising ~21 patients in H1'24 might prove challenging, even accounting for the current over-enrolment. Regarding the Ph 1b trial in collaboration with Sarepta in Duchenne Muscular Dystrophy (DMD), Hansa mentioned that the study was initiated in mid-December, however, the first patient has not yet been included. The anti-GBM study is advancing well, with 16/50 patients now enrolled (vs. 9/50 in Q3). Completion of enrolment is expected in '25e.
Share price implications

We expect a mid-to-high single digit positive share price reaction to the update. While we see this business update as encouraging, we believe that Hansa now should focus on delivering sales growth quarter-over-quarter in order to truly regain market credibility. A full comprehensive business update and more detailed financial statements will be provided in the Q4 report on 2 February.

Hansa Biopharma preliminary Q4: Imlifidase records a very healthy improvement during Q4 after a quarter with low activity

Just a moment...

(www.redeye.se)

We increase our Base Case to SEK 105 (100) with a Bull case of SEK 200 (200) and a Bear Case of SEK 15.

Redeyes base-scenarie er pt.: kurs 100, og vil måske blive justeret på basis af dagens foreløbige flotte Idefirix salgstal.

Jeg er da pænt overrasket da CCO Matthew Shaulis tidl. har udtalt at vi nok først kommer til at se en stigning mht. Idefirix i første halvår 2024.

Min tillid til CEO Søren Tulstrup er her stadig – godt gået Hansa Biopharma!