Det er 1,56M aktier (ca. 1566579 stk.) som skal købes tilbage på et tidspunkt.

newsroom@finwire.se
Nyhetsbyrån Finwire

Hansa Biopharma AB (publ) (OTCPK:HNSBF) Q4 2022 Earnings Conference Call February 2, 2023 8:00 AM ET

Access to this page has been denied

px-captcha

(seekingalpha.com)

Company Participants

Søren Tulstrup - President and CEO

Donato Spota - SVP and CFO

Conference Call Participants

Gonzalo Attali - ABG Sundal Collier

Zoe Karamanoli - RBC Capital Markets

Christopher Uhde - SEB

Johan Unnerus - Redeye

Douglas Tsao - HC Wainwright

Erik Hultgård - Carnegie

"Vårt nya motiverade värde är 210-220 kronor per aktie (240-250). Vi ser en fortsatt mycket stor uppsida i Hansa-aktien på sikt, men en tillväxt i produktförsäljning av Idefirix kommer att bli av yttersta vikt för att aktien ska prestera framöver".

Hansa Biopharma AB

HNSA.ST: Price: SEK53.50; Market Cap (M): SEK2,806
Rating: Buy; Price Target: SEK241.00

Douglas Tsao

Market For Idefrix Keeps Growing and Clinical Programs Keep Moving; Raise PT to SEK241; Reit Buy

Click here for complete report and disclosures

Market access expansion for Idefirix should increase Hansa's revenue in 2023. While 4Q sales of Idefirix (imlifidase) of SEK20.3M came in a tick below our SEK23.0M estimate for the quarter, we are encouraged by the high consistency of imlifidase sales observed during 2022, especially considering the volatile nature of the indication. In our view, this is a testament to Hansa's commercial execution and its ability to secure market access for Idefirix very quickly post launch. With positive reimbursement decisions received by Italy and Czech Republic during 4Q22, market access for Idefirix is now secured in 11 European countries, including 4 of the 5 largest European markets (UK, Germany, France and Italy). Moreover, reimbursement procedures are ongoing in nine additional countries, with a decision from Spain anticipated in the near future. We believe this market expansion should allow Hansa to drive revenue growth at strong rates, albeit off a low base. We currently estimate SEK143.8M in Idefirix sales for FY23. In terms of US approval, the company continues to make progress in the enrollment for the kidney transplant Phase 3, ConfIdeS. Although enrollment was affected primarily by staff shortages in trial sites due to the pandemic, as of February 1, a total of 51 out of a target of 64 patients have been enrolled. Hansa is adding new clinics to further increase enrollment capacity and remains confident that enrollment will be completed during 1H23 and the BLA submitted in 2024 under accelerated approval pathway, which seems achievable to us based on the duration of the study. The raise in our estimates due to the market access expansion, as well as an updated exchange rate from USD to SEK of 10.12, result in a price target increase to SEK241 from SEK208.

Hansa's clinical programs for imlifidase move forward with multiple readouts coming this year. The implementation of different initiatives to accelerate enrollment to multiple trials was a successful strategy for the company. For the Phase 2 trial evaluating imlifidase for the treatment of Guillain Barré Syndrome (GBS), 25 out of 30 patients have been enrolled as of February 1, with enrollment completion expected in 1H23 and the first data readout anticipated for 2H23. Also in 2H23, we expect Hansa to report the full data set from the Phase 2 study for imlifidase in antibody mediated rejection (AMR). Recall, topline data released last year showed that imlifidase reduced donor-specific antibodies (DSAs) better than plasma exchange. Lastly, the company initiated in December 2022 their Phase 3 study in anti-Glomerular Basement Membrane (anti-GBM), also known as Goodpasture syndrome, which will enroll 50 patients across EU and US.

Candidate from NiceR program to enter the clinic in 2023. With the NiceR program, Hansa is looking to develop new immunoglobulin-cleaving enzymes that would allow for repeat dosing as a way to treat flares in relapsing diseases. We believe that with the lead candidate HNSA-5487 entering Phase 1 of clinical development in 1H23, the company is expanding the potential application of its platform. The IND toxicology studies for HNSA-5487 were completed in 2022 and CTA approval was granted shortly after. We currently do not include HNSA-5487 in our model but we plan to add it once we get a better sense of the indications that it is best suited for.

Financial update for 4Q22. Hansa Biopharma recorded a total revenue of SEK30.8M in 4Q22, compared to SEK15.4M in the same period last year, driven by the contract revenue of SEK10.4M from the upfront payments the company received under the Serepta and AskBio Agreements, and SEK20.3M from Idefirix product sales in Europe. Net loss stood at SEK147.1M (a loss per share of SEK3.19), above our estimate of SEK184.3M, or SEK4.14 loss per share. 4Q21 net loss was SEK163.4M, or SEK3.67 loss per share. R&D expenses rose to SEK92.1M from SEK68.2M in 4Q21 and were slightly above our estimate of SEK90.8M. The YoY increase was primarily driven by the ongoing U.S. ConfIdeS study, the EU post approval study, and the anti-GBM Phase 3 study. SG&A expenses amounted to SEK82.0M, below our estimate of SEK112.4M for 4Q22, and to SEK336.2M for FY22, compared to SEK327.3M in 2021. The increase in SG&A expenses was mainly driven by Hansa's broadened commercial activities and organizational expansion related to the launch of Idefirix in Europe. During the quarter, Hansa raised SEK416M in a directed share issue, expanding the company's cash runway into 2025. Cash and cash equivalents, including short-term investments, amounted to SEK1,496.2M by the end of 2022, compared to SEK889M at year-end 2021.

Valuation and Risks. Our Buy rating and our new price target for Hansa of SEK241, up from SEK208, are based on our sum-of the-parts NPV valuation for each of the company's indications for imlifidase: highly sensitized kidney transplants, Goodpasture syndrome, Ab mediated kidney rejection, Gullian-Barré syndrome, and as a pretreatment for Sarepta's gene therapies in LimbGirdle and Duchene muscular dystrophy. Our DCF model utilizes a terminal decline rate of 5% and a discount rate of 10.1%, based on the company's WACC (Beta of 1.0, risk free rate of return of 3.5% and market premium of 6.3%); our prior WACC-based discount rate was 10.4%. We adjust each pipeline asset for the probability of success (PoS) with highly sensitized kidney transplants at 75% as a Phase 3 asset already approved in the EU, Goodpasture syndrome at 40% as a Phase 3 study was initiated last year, Ab mediated kidney rejection at 35% as the asset has generated positive data in Phase 2 studies, Gullian-Barré syndrome at 30% as Phase 2 studies are progressing and the mechanism of action appears well suited for this indication, and pretreatment for gene therapies at 20% because while we believe imlifidase is going to be highly efficacious at removing anti-vector Abs, we have some reservations about Sarepta's gene therapy program. For the time being, we do not include other early-stage programs or collaborations but look to do so in the future. Risks include (i) financial, because the company has capital needs that exceed current cash balance; (ii) dilutive, as Hansa is likely going to need to raise additional capital; (iii) reimbursement, because the high cost of imlifidase may cause payors to resist coverage; (iv) regulatory, because imlifidase only has conditional approval in the EU and no US approval; and (v) partnership, as the Sarepta agreement, a major component of our valuation, depends heavily on Sarepta's ability to execute.

Douglas Tsao
212-916-3968
dtsao@hcwresearch.com