FIRST TAKE
Hansa Biopharma AB
HNSA.ST: Price: SEK50.35; Market Cap (M): SEK2,239
Rating: Buy; Price Target: SEK223.00
Douglas Tsao
NICE Recommendation Is Another Tailwind for Idefirix
NICE provides key validation of Idefirix's value. Last week, Hansa announced that the National Institute for Health and Care Excellence (NICE) had determined that Idefirix was a clinically and cost-effective treatment for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. The recommendation clears the path for Idefirix to be available to patients in England, Wales and Northern Ireland at appropriate specialized transplant centers who are going to be able to use Idefirix to enable transplantation for highly sensitized patients. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Idefirix from the European Commission's conditional approval in August 2020; the NICE recommendation builds upon this approval by considering the cost-effectiveness of Idefirix in addition to its clinical efficacy and the significant unmet need of the patient population that it treats. Recall, Hansa reported 1Q Idefirix sales of SEK24.2M, well clear of our SEK3.5M estimate, up 302% Y/Y and 170% Q/Q. Admittedly, these were relatively small numbers (~8 patients treated) but the product's availability in Europe has been limited to just a few markets while the company worked to secure reimbursement in the larger markets. Full commercial access was recently secured in Germany and access was granted in France through an early access program. With the NICE recommendation, Idefirix should have availability in three of the major European markets this year, and we expect to see Italy and Spain added as well. Launching in these markets should sustain, if not accelerate, the trends we saw in 1Q. We expect quarter-to-quarter volatility but the strength seen 1Q, in our view, signals we should see commercial sales every quarter and that the general trend line is going to point upwards. The NICE recommendation, in our view, is an important milestone for the Idefirix launch since it provides an important validation for its value proposition, which should help alleviate investor concerns that the drug was too costly. The company continues to make progress expanding Idefirix beyond transplantation with FDA accepting the IND for anti-GBM, clearing the way for the company to initiate the Phase 3 study in 50 anti-GBM patients across U.S. and EU. The first patient is due to be enrolled in 2022. Hansa has enrolled 16/30 patients in the Guillain Barre Syndrome study. After seeing enrollment challenges related to Covid in 4Q21, the company has taken steps to complete enrollment in 2H22, with a readout due in 1H23.
Valuation and risks. Our Buy rating and price target of SEK223 for Hansa 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 9.5%, based on the company's WACC (Beta of 1.0, equity risk premium of 6.0%). 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, Gullian-Barré syndrome and Ab mediated kidney rejection at 35% as Phase 2 studies are progressing in both indications and the mechanism of action appears well- suited for both, Goodpasture syndrome at 50% based on the promising data from the investigatorinitiated Phase 2 and the expectation of a near-term Phase 3, and pretreatment for gene therapies at 25% 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 only just begun to currently generate revenue last quarter and 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; (v) partnership, as the Sarepta agreement, a major component of our valuation, depends heavily on Sarepta's ability to execute, which may not pan out as expected; and (vi) COVID-19 disrupting clinical trials.
Douglas Tsao
212-916-3968
Click here for complete report and disclosures:
https://hcwco.bluematrix.com/sellside/EmailDocViewer?encrypt=e1aeb5f9-b724-488c-a2f3-391d17c7e1ad&mime=pdf&co=Hcwco&id=klaus.sindahl@hansabiopharma.com&source=mail
Hansa Biopharma AB har en digital IR-aftale med Pronvestor.com
Hansa Biopharma AB
HNSA.ST: Price: SEK50.35; Market Cap (M): SEK2,239
Rating: Buy; Price Target: SEK223.00
Douglas Tsao
NICE Recommendation Is Another Tailwind for Idefirix
NICE provides key validation of Idefirix's value. Last week, Hansa announced that the National Institute for Health and Care Excellence (NICE) had determined that Idefirix was a clinically and cost-effective treatment for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. The recommendation clears the path for Idefirix to be available to patients in England, Wales and Northern Ireland at appropriate specialized transplant centers who are going to be able to use Idefirix to enable transplantation for highly sensitized patients. The Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional approval for Idefirix from the European Commission's conditional approval in August 2020; the NICE recommendation builds upon this approval by considering the cost-effectiveness of Idefirix in addition to its clinical efficacy and the significant unmet need of the patient population that it treats. Recall, Hansa reported 1Q Idefirix sales of SEK24.2M, well clear of our SEK3.5M estimate, up 302% Y/Y and 170% Q/Q. Admittedly, these were relatively small numbers (~8 patients treated) but the product's availability in Europe has been limited to just a few markets while the company worked to secure reimbursement in the larger markets. Full commercial access was recently secured in Germany and access was granted in France through an early access program. With the NICE recommendation, Idefirix should have availability in three of the major European markets this year, and we expect to see Italy and Spain added as well. Launching in these markets should sustain, if not accelerate, the trends we saw in 1Q. We expect quarter-to-quarter volatility but the strength seen 1Q, in our view, signals we should see commercial sales every quarter and that the general trend line is going to point upwards. The NICE recommendation, in our view, is an important milestone for the Idefirix launch since it provides an important validation for its value proposition, which should help alleviate investor concerns that the drug was too costly. The company continues to make progress expanding Idefirix beyond transplantation with FDA accepting the IND for anti-GBM, clearing the way for the company to initiate the Phase 3 study in 50 anti-GBM patients across U.S. and EU. The first patient is due to be enrolled in 2022. Hansa has enrolled 16/30 patients in the Guillain Barre Syndrome study. After seeing enrollment challenges related to Covid in 4Q21, the company has taken steps to complete enrollment in 2H22, with a readout due in 1H23.
Valuation and risks. Our Buy rating and price target of SEK223 for Hansa 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 9.5%, based on the company's WACC (Beta of 1.0, equity risk premium of 6.0%). 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, Gullian-Barré syndrome and Ab mediated kidney rejection at 35% as Phase 2 studies are progressing in both indications and the mechanism of action appears well- suited for both, Goodpasture syndrome at 50% based on the promising data from the investigatorinitiated Phase 2 and the expectation of a near-term Phase 3, and pretreatment for gene therapies at 25% 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 only just begun to currently generate revenue last quarter and 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; (v) partnership, as the Sarepta agreement, a major component of our valuation, depends heavily on Sarepta's ability to execute, which may not pan out as expected; and (vi) COVID-19 disrupting clinical trials.
Douglas Tsao
212-916-3968
Click here for complete report and disclosures:
https://hcwco.bluematrix.com/sellside/EmailDocViewer?encrypt=e1aeb5f9-b724-488c-a2f3-391d17c7e1ad&mime=pdf&co=Hcwco&id=klaus.sindahl@hansabiopharma.com&source=mail
Hansa Biopharma AB har en digital IR-aftale med Pronvestor.com
Hvad siger den sunde fornuft til status? Køb eller afvent? Nogen bud?
Har i de seneste år været en "torn i øjet" på mange investorer på baggrund af de store kursfald i aktien.
Har i de seneste år været en "torn i øjet" på mange investorer på baggrund af de store kursfald i aktien.
Jeg har købt op fra kurs 130 op over 266 og ned i ca.60,ud fra en betragtning om at spreadet mellem risk og reqard er meget stort med klar overvægt på reward.
Min tidshorisont et sidst i 2020'erne
Min tidshorisont et sidst i 2020'erne
22/6 2022 09:13 Urban 0
104138 Blankning/short position
https://shortnordic.com/detaljer_selskap.php?company=hansa%20biopharma&land=sweden
https://shortnordic.com/detaljer_selskap.php?company=hansa%20biopharma&land=sweden
22/6 2022 15:44 Urban 0104148 Må betegnes som meget overraskende for tilliden til aktien, at ledelsen ikke selv har større lyst til køb af aktien på det nuværende kurs 50-niveau!
