Xbrane Biopharma AB - Involved in the pharmaceutical megatrend

Tämä uutinen avasi minulle hieman Xbranen alustastrategiaa, jonka näen pitkän tähtäimen arvoajurina. Heillä on vain yksi hyväksytty patentti tällä hetkellä, mutta 10 hakemusta vetämässä. Toivottavasti saisivat edes muutaman hyväksyttyä. Jos onnistuvat suojelemaan markkinoiden tehokkainta tuotantoalustaa, niin puhumme jo mukavasta vallihaudasta.

Uutisessa mainitaan myös patenttiportfolion lisensointi muiden käyttöön. Se jäi epäselväksi kuinka suurista summista olisi kyse, mutta kait siinäkin on järkeä, kunhan ei luovuta teknologiaa suorille kilpailijoille.

https://xbrane.com/en/mfn_news/xbrane-re-negotiates-pre-existing-ip-license-agreement-with-vaxiion-therapeutics/

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Kyseessä oleva lisensointi lienee Vaxiionin patentti, joka koskee E.Colin lisääntymisen säätelyä tuotantosammion ulkopuolella.

Ilmeisesti jotain kromosomittomia E.Coli bakteereja: https://www.vaxiion.com/recombinant-bacterial-minicells--rbmcs-.html

Btw. Ei näy vieläkään Xbranen päivitettyä omistajalistausta, Xbrane on siinä kyllä aina jotenkin hidas, tulee yleensä 5-9 päivä.

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Toimarilla ostosormi syyhyää.

Xbrane Biopharma AB: Karl Martin Erik Åmark rapporterar Förvärv av Xbrane Biopharma AB till volym 1 150 @ 81,6 utfört 2021-01-08
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Xbrane Biopharma AB: Karl Martin Erik Åmark rapporterar Förvärv av Xbrane Biopharma ab till volym 805 @ 77 utfört 2021-01-05
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Xbrane Biopharma AB: Karl Martin Erik Åmark rapporterar Avyttring av Xbrane biopharma ab till volym 810 @ 76,2 utfört 2021-01-04
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Xbrane Biopharma AB: Karl Martin Erik Åmark rapporterar Förvärv av Xbrane biopharma Ab till volym 810 @ 76,4 utfört 2021-01-04

Määrät toki pieniä, mutta eipä se ikinä huono signaali ole, että yrityksen TJ ostaa.

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Vihdoin päivitetyt omistajalistat: » Ownership Structure

Tuossa ei muutoksia aiempiin oo kirjattu, mutta vertasin marraskuun lukuihin niin:

Swedbank Robur Fonder +24k osaketta
Bengt Göran Westman +38k osaketta (oon helmikuusta 2020 asti ottanut itelle talteen Xbranen omistajalistat ja Bengt on ostanut ainakin siitä lähtien lisää joka kuukausi)
Avanza Pension +6k osaketta
Futur Pension -136k osaketta
Nordnet Pensionsförsäkring -8k osaketta

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Nyt kehtaa heittää tännekin, kun Redeye julkaisi noi ite. Järjestivät kaks päivää sitten tuon Life Science 2021 päivän, joka oli ilmeisesti vain kutsutuille vieraille ja valitsivat sielä top4 picks vuodelle 2021 kyseiseltä sektorilta ja Avanzan foorumilla toissapäivänä jo huudeltiin, että Xbrane oli yks niistä ja oletan siks keränneen toissapäivänä ja eilen normaalia enemmän vaihtoa ja porukkaa ostolaidalle.

Redeye julkaisi nuo äsken: https://www.redeye.se/research/802838/redeye-life-science-outlook-2021-analysts-top-picks?utm_source=note&utm_medium=email

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Xbrane Biopharma

Backed by strong cost-saving incentives combined with accelerating market uptake and acceptance for biosimilars in the US, we argue Xbrane is well-positioned with its primary candidate Xlucane. Historical data indicates a roughly 95 percent success rate for Xlucane in its phase III-study, which presents interim data in the middle of 2021. If approved, Xbrane will, together with its partners STADA and Bausch + Lomb, be ready to launch Xlucane at the patent expiry of Lucentis in the EU during the middle of next year.

Xbrane offers a possible long-term value case, as it has relations established with strong partners and further biosimilars approaching clinical studies. Its next biosimilar expected to initiate clinical studies during the first half of 2022 is Xcimzane, a biosimilar to the TNFa-drug Cimzia, which currently has no biosimilars in clinical studies. We argue it could approach our Base Case of SEK 101 while advancing towards interim data; our Bull case amounts to SEK 157.

Catalysts for Xbrane Bipharma include:

  • Mid 2021 – Interim data
  • Q3 2021 – FDA and EMA filing
  • H1 2022 – Clinical studies – Xcimzane
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Xbrane on divestoimassa Primm Pharman 14 MEUR. Mielestäni ihan hyvä veto koska Xlucane saattaa vielä tarvita rahoitusta päästäkseen markkinalle ja Primmin tuote ei ole biosimilaari, johon Xbranen pitkän linjan strategia nojaa. Olisikohan rahalle muutakin tarvetta esim. yritysosto vai haluavatko vaan tervehdyttää tasetta?

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Piti luoda tili tänne, että pääsee kommentoimaan Xbranea. Primmin myyntiin ei liity dramatiikkaa, tämä on ollut tiedotettuna tavoitteena H2/20 alkaen. Hintaa pakko kommentoida sen verran, että yllättävän hyvä tuosta Primms:tä jolla ei vielä mitään kovin pitkälle vietävää assettia ole olemassa. Toki tuossa osa maksuista taitaa laueta vasta milestonejen kautta.

En usko yritysostoihin, ainakaan minulla ei ole tiedossa järkeviä ostokohteita Branelle, joka on - vielä - pienehkö tekijä. Sen sijaan Brane lienee tarkassa seurannassa monella yhtiöllä. Mutta veikkaan, että biosimilaariskenessä haetaan asetelmia vielä ainakin seuraavat 3-5 vuotta, minkä jälkeen katsotaan strategisia yrityskauppoja.

Nyt kun Coherus meni sotkeutumaan myös uutuuslääkkeisiin, taitaa Xbrane olla Formyconin kanssa ainoa “Biosimilar-pure-play” länsimaisissa pörsseissä. Koreasta löytyy sitten Celltrion Kiina/Intia/Japani/Australia -sektorilla voi olla myös joitain firmoja.

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Xbranen osavuosikatsaus https://storage.mfn.se/387a61d7-b0a7-423f-a444-cf7f80c65ad7/year-end-report-2020.pdf

Ei juuri mitään uutta, merkittävin asia ehkä, että selkeästi todetaan vielä yksi rahoituskierros tarvittavan ennen liikevaihdon alkua, vaikka tasaisen vauhdin taulukolla + mahdollisilla lisenssituloilla kassan pitäisikin riittää aina kesään 2022 asti. Tämä anti painottunee loppuvuoteen 2021 ja eiköhän se ole suunnattu intsikoille. Mutta tämäkin oikeastaan oli tiedossa, että hyvin todennäköisesti yksi anti tulee ennen Xlucanen kaupallistamista - toivottavasti se tapahtuu hyvällä valuaatiolla.

Xcimzanelle pitäisi myös 2021 aikana tulla kumppanuussopimus ja tällä hetkellä Xbrane on ainoa yritys, joka kehittää biosimilaaria tälle noin $2 mrd markkinan omaavalle lääkkeelle. Xbranen edellisen powerpointpresentaation mukaan ennen kaikkea tällä molekyylillä saavutetaan merkittävä tuotannollisuusetu originaattoriin nähden ja molekyylin vaikeus on myös suurin syy, miksi kilpailua ei ole tähän tulossa muiden kuin Xbranen toimesta.

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Liputusilmoitus, kun Futur Pension kasvattanut osuuttaan yli 5%. Eli todennäköisesti nuo muutama päivä sitten olleet suuret tankkaukset Carnegien kautta on Futur Pensionin ostoja. Helmikuussakin ostelleet aika hyvän määrän, kun 31.1 omistus oli 3.27% Xbranesta ja nyt noussut 5.33%

Kierrossa olevat laput ne vaan vähenee, kun top10 kasvattaa omistustaan, tuskin Bengt Göranikaan siirtänyt jalkaa jarrulle.

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Redeye kasannut vaihtoehtoista toppicks listaa, mukana 5 firmaa joista Xbrane yksi. https://www.redeye.se/research/807511/top-picks-building-a-watchlist

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Xbrane published an article on Seeking Alpha today: https://seekingalpha.com/article/4419351-xbrane-partners-bausch-lomb-to-enter-usd-12-billion-market?v=1618555865#comment-88612953

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Xbrane has been on a pretty strong upward trend lately. A couple of +9% days within a week, and even though it has gone down in between, the stock has ended up nicely in the black. Does anyone have any idea what’s driving this? I’ve tried looking for news, and the only thing I found is an announcement about a conference call and earnings release tomorrow. I doubt the earnings really matter for this, as the products and revenue streams are a year or two away?

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There has been a lift, yes, I haven’t seen any news, but I would be more surprised if the undervaluation wasn’t resolved towards the summer and we didn’t start pricing in the phase 3 breakthrough more. Tomorrow is the earnings release + conference call, it’s worth going there and asking any questions you have, there haven’t been too many for Xbrane before.

These Xbrane results don’t matter yet, because nothing special should come out of them, as there aren’t any drugs on the market yet.

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Redeye’s Einarsson’s comment on Xbrane’s results and conference call: https://www.redeye.se/research/811442/xbrane-biopharma-q1-approaching-readout

Nothing new, really. Next week marks 6 months since the last patient was recruited, and it will take a couple of months to process the results, so they should be released in July or early August.

“We would not be surprised if the share is trading near our Bull case if positive data is announced as investors grasp the case Xbrane is building within its niche of hard-to-manufacture biosimilars.”

It’s a cautious estimate that the share would only be trading at 157 SEK if, and hopefully when, positive Phase 3 data is released.

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Tomorrow, Xbrane will host a Capital Markets Day:

"Stockholm, Sweden – Xbrane (Nasdaq: XBRANE), a late-stage clinical biopharma company is inviting analysts, investors and media to the company’s Virtual Capital Markets Day on May 17th, 2021 at 14.00-15.30 CET.

The event will feature presentations from Xbrane’s Board and Management team outlining the company strategy and the next steps in the company’s ambition to become a leading global biosimilar developer. The program will also include a virtual show of the recently established new development lab."

The current share price is just under 130 SEK, which I believe quite accurately reflects the current valuation, if Xbrane’s only valuable asset is considered to be Xlucane. As can be read above, the company’s main goal in the long run is to become a world-leading biosimilar developer, and tomorrow we will surely gain further insight into how Xbrane intends to implement this strategy. The company has preliminarily communicated that its current facilities enable the launch of one new biosimilar project annually.

Now, a stream of consciousness before tomorrow’s CMD, not an investment recommendation:

Currently, Xbrane’s market capitalization is 280 million euros, which can be seen as almost entirely derived from the Xlucane project, whose base case is an annual revenue level of 100 million euros by 2025. I do not believe the market is significantly discounting the Xdivane project, which is only expected to enter the market in 2026-2028. The Xcimzane project, whose patent expires in 2024, may currently be valued at 30-40 million euros, as Xbrane is currently the only competitor looking to gain market share in the 1.8 billion euro market.

I would argue that each new project, once the Xlucane project succeeds, could be roughly priced at 40-100 million euros, depending on many factors, of course: the target molecule, interest rates, partners, drug reimbursement policies in different countries, etc. I trust Xbrane’s strategic ability to select hard-to-manufacture but sufficiently large market (at least 1 billion euro market and 1-3 expected biosimilar competitors) target molecules for its development pipeline, where the developed manufacturing platforms can yield the greatest benefit. It will be interesting to see if Xbrane will also elaborate on the competitiveness of its mammalian cell platform tomorrow.

Despite strong share price performance, I still believe there is an exceptionally attractive risk-reward ratio here, when future potential projects are added to the valuation; four years from now, the company’s revenue could be 100 million euros, in addition to having four new projects valued at 40-100 million euros in the R&D pipeline, as well as the already approved Xcimzane. In the Xcimzane project, Xbrane’s negotiating position might be exceptionally strong with partners due to the lack of competition. With 50% market penetration, a 50% partnership agreement, and a 50% price reduction, Xcimzane could generate approximately 200 million euros in revenue a few years after market entry (1.8 billion * 0.5 * 0.5 * 0.5). In the scenario mentioned, Xbrane’s R&D costs before 2024 would likely be around 75 million euros (average biosimilar project approx. 150 million euros / 2).

Although the case has been practically the same since 2018 when the partnership with Stada was initiated, the value has only been reflected in the share price during the last year. Of course, along the way, uncertainties in financing have been tackled and non-core assets have been pruned, but in a technological sense, the company’s case has remained very stable and intact ever since the 30 SEK bottom prices of the 2019 rights issue. This may still be a difficult investment for the market to grasp, due to the following reasons:

  • Market Cap excludes the biggest players
  • The Swedish market is partly out of reach for, e.g., US analysts
  • A loss-making company with zero revenue based solely on financial figures does not look attractive
  • Investor caution towards drug development companies/misunderstood risk-reward ratio
  • Illiquidity for institutions and pension funds awaiting subsequent financing rounds
  • The company has not actively communicated the launch of future projects before tomorrow’s CMD

Finally, let me state that Xlucane’s Phase 3 results are due in about 60 days, which is the most important single catalyst event in the short term. After that, the investment case will increasingly focus on the prospects of future projects, and perhaps even more risk-averse investors will dare to invest in the company thereafter.

I will write more tomorrow based on the points raised from the presentation.

E: Corrected Xoncane —> Xdivane

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New guidance from the company, monthly cash flow to be positive at the turn of 2023-2024:

“Xbrane announces ambition to generate positive operating cash flow monthly by late 2023/early 2024 and to initiate one new biosimilar development program per annum.”

Link

An exciting day ahead for shareholders.

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According to Redeye’s analysis (15.11.2020), the estimated P/E ratio for 2022 would be around 20x at today’s price, and for 2023, it would be around 13x.

So, Redeye’s forecast for earnings has been positive starting from 2022. Was this new guidance a setback compared to Redeye’s forecast, which I believe is strong relative to the stock price? I don’t think they have commented on the new guidance.

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I’ve been a bit busy, so I haven’t had time to post an update to the thread.

I’ve probably read Redeye’s assessment, but I no longer remember it. In any case, that assessment from last November is not particularly useful anymore, as Xbrane has provided a more precise estimate of cash flow positivity, as well as more detailed estimates of future R&D costs. For 2022, costs will increase primarily if Xcimzane’s clinical phase begins as currently estimated. And naturally, Redeye’s model also lacks revenue estimates for these new products.

I’m linking the CMD presentation here: Xbrane Biopharma - Capital Markets Day 2021

Xbrane’s CMD presentation was quite predictable, but it also contained a lot of substantial core information, such as the timeline for the CHO cell line development path.

The presentation included a good visualization of cash flows for the coming years. R&D costs must be annualized figures. When the project’s segment is dark blue, the annualized R&D cost is €5m per year (Pre-clinical), in the “mid” blue area, the annualized cost is €15m (clinical), and in the lightest blue area, it is €5m again (registration phase). For example, Xcimzane’s clinical phase would last 2.5 years according to the graphic, thus costing a total of €37.5m. It is noteworthy in the picture, in my opinion, that the costs are somewhat lower than Xbrane’s previously stated biosimilar investment of €100-150m, but of course, the assumption is likely a 50/50 cost-sharing deal with a partner.

This image shows the development steps of the Chinese hamster ovary (CHO) cell production platform in surprisingly detailed fashion. Not all of these steps are familiar to me, but one can glean, for example, that Xbrane’s production platform for Xdivane has been compared to a contract manufacturer’s own production platform and Xbrane’s own platform has been found superior.

I still need to rewatch CTO Vikström’s presentation when I have more time, and then I will break it down thoroughly to understand the content of that image myself.

Bashir’s section discussed new development facilities that enable, among other things, drug substance analytics and the development of larger process scales than before. For these, they are no longer dependent on contract manufacturers and labs, which speeds up and cheapens development and prevents internal information from leaking out.

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Good to know that Redeye’s report is already partially outdated.

Regarding Xbrane’s valuation, I have previously relied on Redeye’s analysis of the 2022 and 2023 earnings levels. Currently, the stock is 30% above the target prices (135 SEK vs. 101 SEK). Information about achieving a positive result in 2023-2024 has certainly not been the driver for the price increase, so are there any technological drivers that explain the valuation level? I’m forming my own view here (whether the stock is a “hold” or “reduce” after the price increase).

Edit: 2.6.2021 Kempen Bank’s new target price 180 SEK, see below.

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