Biosimilar-konkurrent anbefalt for godkjenning i Europa.
Edit: fra Discord:
[CHMP svar til X] borde komma senast i september. CHMP-uttalande 12 månader från validerad ansökan.
Formycon lämnade in 29:e juni 2021, rekommendation från CHMP 24:e juni 2022.
Godkännande brukar ligga ca 2 månader efter CHMP-rekommendation.
Inside information
Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) has received the General Advice letter with comments and recommendations for the resubmission of the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® following the preliminary review performed by the FDA (U.S. Food and Drug Administration). Based on the advice received Xbrane plans to resubmit the BLA during 2022.
Xbrane withdrew the BLA (Biologics License Application) at the end of May for its investigational biosimilar candidate to LUCENTIS® after receiving feedback from the FDA (U.S. Food and Drug Administration), following a preliminary review, that additional information was required for the FDA to take the decision to accept the BLA and initiate a full review. Xbrane has now received a General Advice letter with comments and recommendations for the resubmission. The majority of the comments and recommendations relate to data or information that is accessible at Xbrane, its contract manufacturers or suppliers. Based on the time required to complete the BLA as per FDAs comments and recommendations, Xbrane plans to resubmit the BLA during 2022.
Provided that all comments and recommendations from the preliminary review are satisfactorily addressed in the application, the BLA will be filed and a full review initiated latest 60 days post re-submission.
Xbrane is fully committed to advance its investigational biosimilar candidate towards approval in the United States as quickly as possible to provide a much needed, cost-efficient treatment alternative for patients suffering from severe eye diseases.
LUCENTIS® is a registered trademark of Genentech Inc.
Contacts
https://view.news.eu.nasdaq.com/view?id=b07a51d2b3b7bf0e25db865c1f70b2d42&lang=en
Martin med oppdaterte betraktninger om EMA. Tidsplanen opprettholdes. Han forventer positiv CHMP-vurdering i september.
För Xbrane Biopharmas andra godkännandeprocess för Xlucane i Europa ligger nuvarande tidsplan fast. I slutet av juni, på dag 180 fick bolaget in frågor från den europeiska läkemedelsmyndigheten EMA som bolaget kommer besvara i mitten av augusti.
“Vi förväntar oss att det blir ett positivt utlåtande i mitten av september, vilket då kan leda till ett godkännande i mitten av november”, säger Martin Åmark.
Da er det bare å vente i spenning i 2 mnd
Xbrane og finansene, noen betraktninger før Q2-2022.
Fra Q1-rapporten, lagt frem 5. mai 2022: On the balance sheet date, the Group’s cash and cash equivalents amounted to SEK 301.5 m. Together with the up-front payment from Biogen of USD 8m and other liquidityenhancing measures that are deemed possible if necessary, the Board considers that the Group has financing for at least 12 months ahead according to the current business plan.
Så kom det vi vel må kalle uventede nyheter i juni om at FDA søknad er trukket, og juli kom utfyllende info om at de planlegger å sende ny søknad i løpet av 2022. Altså inntil et års forsinkelse.
I juli sier også CEO at EMA tidsplanen opprettholdes: Positiv CHMP-vurdering i september og godkjenning i november. Men FDA saken viser at man ikke skal ta alt de sier for gitt. Går det greit kan inntektene begynne å komme ved årsskiftet 2022/23. Har EMA, som FDA, noe å utsette på dokumentasjonen kan det bli forsinkelse.
Spørsmålet jeg stiller meg da er hvordan det er med finansene, har de finansiell robusthet til å gå på en Europa-forsinkelse?
De brenner vel ca 200 mill SEK i året.
Kursutviklingen siste tiden skyldes kanskje en kombinasjon av dårlig biotek-sentiment, Xbrane som ikke leverer som forventet til FDA - og da en gryende uro om at Xbrane igjen må gå til investorene før inntektene fra Xlucane begynner å komme.
Men hva kan bidra til forlenget finansiell runway, om det skulle bli behov? På inntektssiden har de vel tre mulige kilder frem til salget starter i Europa:
Q2-rapport kom i dag - utdrag Key milestones for the next 12 months
To summarize, we are in a very exciting position with an imminent launch of XlucaneTM in Europe. Some of the most important milestones we look forward to reaching over the next 12 months are to:
• Obtain marketing authorization and launch Xlucane™ in Europe in the first quarter of 2023
• Submit a marketing authorization application for XlucaneTM in the US during 2022
• Sign further partnership agreements for the sales and marketing of Xlucane™
• Scale up the production process and prepare clinical studies with our partner Biogen for BIIB801
• Complete the development of the production process for XdivaneTM, one of our products in the oncology portfolio.2022 is an important year for us and we have a strong belief that we will be able to fulfill our plans and take an important step in becoming a world leader as a biosimilar developer through the market launches we plan in 2023, together with our partners.
Og om finansene:
As of the balance sheet date, the Group’s cash and cash equivalents amounted to
SEK 250.1 m. Considering the company’s financial position together with other liquidity-enhancing measures deemed possible if necessary, the Board considers that the Group has financing for at least 12 months ahead according to the current business plan
Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on July the 22nd, 2022, at 10.00 a.m. CET. See the link to the presentation below.
Web link:
Presentation of interim Report January – June 2022
Et par ting jeg merket meg som ikke kom frem i rapporten:
X skal ha capital markets dag i slutten av august (dato blir annonsert).
Martin sier at de ser på “non delutive” finansieringsløsninger, det har åpnet seg slike muligheter når de er så nærme markedsintroduksjon.
Ellers virker han trygg på at de får Europa godkjenning i høst og at Fda BLA skal sendes H2. De skal ha uformelle møter med Fda for å være sikre denne gang. Nylige prisnedganger i biosimulars er ikke større enn de rabatter som ligger i X’ kalkylene.
Redeye
[…]
With SEK 250m cash on the balance sheet at the end of the second quarter, there should be no financing need in the coming twelve months. With current prospects, the company has financial flexibility and could likely access non-dilutive financing as options if required. Furthermore, we expect milestone payments related to BIIB801 (previously Xcimzane) and Xlucane™ to strengthen the cash position during 2023.
[…]
All-in-all, we remain optimistic about the investment case in Xbrane and believe that the blow to the share has been too significant. Based on the abovementioned changes related to biosimilar discount for Xlucane™ and slightly delayed launch from mid-Q4 to Q1 in Europe, our DCF-value is downwards impacted. We, therefore, adjust our Base case to SEK 185 with a Bull-and Bear case of SEK 70 and SEK 270, respectively.
Accordingly, we remain convinced that there is a healthy upside in Xbrane shares and that today’s levels portray an opportunity on the upside with several substantial catalysts in the coming twelve months.
Agenda for ukens CHMP - møte er ute
I følge kyndige? på Discord’en er det sentrale søkeordet “ranibizumab”.
Og det er vitterlig et par agendapunkter her “for adoption”. Men det kommer ikke frem i klartekst om Xbranes eller andres produkter som behandles. I løpet av uken får vi vel svar.
Kanskje noen kjenner saksnummeret / søkedatoen som gjelder Xbrane?
Biosimilarutvecklaren Xbrane Biopharma har fått ett positivt utlåtande för Ximluci (ranibizumab) från den europiska läkemedelsmyndigheten EMA:s rådgivande kommitté CHMP (Committee for Medicinal Products for Human Use).
Det framgår av en uppdatering från läkemedelsmyndigheten EMA i samband med septembermötet för perioden 12-15 september.
PAS: Xlucane cleared by the European Medicines Agency
Xbrane just announced that the European Medicines Agency’s (EMA’s) committee for medicinal products for human use (CHMP) has given a positive opinion for Xlucane (to be sold under the brand name Ximluci). Xlucane is Xbrane’s lead biosimilar addressing an over USD 12bn intravitreal (into the back of the eye injected) anti-vascular endothelial growth factor (anti-VEGF) market (US+ Europe) currently dominated by Lucentis and Eylea. This marks a major milestone for the company as it is the first product Xbrane managed to get cleared by the European health authority. Now, there is just waiting for the administrative process at the European Commission to complete (normally 90 days or less) followed by the European launch through the partner STADA in Q1. For the US we expect the resubmission within Q4 and approval within Q4 2023. With all that progress, the x5 lower valuation compared to peer Formycon has definitively not kept up with the fundamentals. In addition, biosimilars are growing sales substantially across all indications, with Amgen’s Avastin (approx. USD 6 bn market) biosimilar Mvasi even hitting USD 1.1 bn in sales in 2021. Looking at competition, we can see that even 5 biosimilars on the market in the case of Herceptin (also approx. USD 6bn market), the price discounts to the originator are not exceeding 22% and individual sales reach up to 570m in 2021. We therefore reiterate our Buy rating on XBRANE with a target price of SEK 245/share.
CMD i dag 22.9
PAS 23.9: New information highlights from yesterday’s CMD
Xbrane held a CMD yesterday with STADA’s global head of specialty pharma, Bryan Kim, also presenting. Xbrane gave a detailed overview into their platform, pipeline and plans. While no revenue estimates for 2023 were given, the company expects to become cash flow positive in Q4 2023 / Q1 2024. This implies at least around SEK 60m revenues from Ximluci royalties in Q4 2023 / Q1 2024. Based on the successful deals for Xlucane/Ximluci and Xcimzane, Xbrane conveyed with confidence that they will be able to partner the 3 oncology biosimilars currently in cell line development within next year. When asking STADA’s representative, who previously served as vice president of corporate development at Xbrane’s competitor Samsung Bioepis, how Xbrane’s manufacturing process compares to Samsung Bioepis’, he answered that “Xbrane is despite its size very competitive compared to Samsung Bioepis and other biosimilars companies”, thus again confirming that Xbrane has an edge in terms of COGS. This is also playing out for the next biosimilar to Cimzia, a complex PEGylated antibody selling for USD 2bn, as no other biosimilar developer is currently pursuing it while Xbrane managed to increase the yield compared to the originator by 4-5x. With (i) the European launch of Ximluci ahead in Q1 2023, (ii) a differentiated platform, (iii) outstanding partners, (iv) a growing pipeline without growing costs (due to partners), (v) 5-10x undervalued compared to peers Formycon and Alvotech and (vi) a good cash position, we see green times ahead for Xbrane’s share price. We thus reiterate our Buy rating on XBRANE with a target price of SEK 245.
Bør være kurant å hente over 70 kr.
Xbrane Biopharma AB (publ) (“Xbrane” or the “Company”) has, based on the authorization granted by the annual general meeting held on 5 May 2022, and in accordance with what the Company indicated in a press release on 18 October 2022, successfully carried out a directed share issue of approximately SEK 170 million at a subscription price of SEK 72 per share (the “Directed Share Issue”). The subscription price was determined through an accelerated book-building procedure. A number of Swedish and institutional investors, including Systematic Group AB (Ashkan Pouya), Swedbank Robur Fonder, Cicero Fonder, TIN Fonder and Lancelot Asset Management have subscribed for shares in the Directed Share Issue.
Nice work 
