Xbrane Biopharma AB (XBRANE) 🇸🇪

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Fra REDEYE

Xbrane Biopharma: Raising SEK 170m in Directed Share Issue

2022-10-19

07:30

Filip Einarsson

Yesterday evening Xbrane carried out a directed share issue of SEK 170m to strengthen the balance sheet ahead of the forthcoming Q1 2023 launch of Ximluci. Considering the relatively low discount, we interpret the directed share issue positively, emphasizing the current stressed market conditions in terms of financing. We update our DCF for the dilution and net proceeds, which renders an adjusted fair value range.

Yesterday evening, Xbrane Biopharma carried out a SEK 170m directed share issue. At the end of Q2, Xbrane had SEK 250m on the balance sheet, so there was no imminent capital need. Moreover, In 2023, aside from the revenues from Ximluci, we see additional funding possibilities related to the potential divestment of Primm Pharma and a BIIB801 milestone related to finished preclinical development. Most likely, the company took the opportunity to approach the Q1 2023 launch of Ximluci and potential partnering discussions for the oncology portfolio with a robust balance sheet.

The share closed at SEK 80 yesterday, and the subscription price is set to SEK 72, implying a 10% discount, which we view as fair considering the stressed market conditions. Named takers in the directed share issue include previous owners such as Swedbank Robur Funds, Tin Funds, and Lancelot Asset Management. Other named investors that were not earlier shareholders in Xbrane include Cicero Funds and Systematic Group (Ashkan Pouya), the founder of Serendipity Group, which is also the largest holder of Xbrane shares (~12.5%). The directed share issue will lead to a dilution of ~8.6%, and the number of shares in the company will increase from 25,144906 to 27,506018.

The net proceeds from the transaction are intended to be distributed accordingly:

• Build up launch volume of Ximluci and inventory preparation for commercialization in Europe (~60%)
• Funds for the progression of the remaining preclinical development of BIIB801 (~10%)
• Continued development of the oncology portfolio (~20%)
• General corporate purposes (~10%)

As a result of the directed share issue, we update our DCF for the new shares and net proceeds, which generates an adjusted fair value range. Our Base case now amounts to SEK 175 (185), with a Bull- and Bear case of SEK 270 and SEK 63, respectively. We will return with a more extensive comment on Xbrane in connection with the Q3 report released on Friday next week.

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Q3

Xbrane Biopharma publicerar delårsrapport för januari – septemb...

Xbrane Biopharma AB bjuder in till telefonkonferens för investerare, analytiker och media den 28:e oktober 2022 kl 14.00 CET. Se nedan länk till presentationen:

https://register.vevent.com/register/BId0340ab2fd9846138cce38859079d156

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PAS:

Please note that Pareto Securities has acted as financial advisor to the company in last week’s announced directed share issue . Xbrane Biopharma today released its Q3 report with no new material information. While Ximluci’s Europe launch is set for Q1 next year, the company reiterated that they will be able to resubmit to the FDA this quarter and therefore expect to launch Ximluci in the US at the end of next year/beginning of 2024. The cash burn of SEK -62m is a marginal increase from SEK -59m in Q2, while the actual operating result was at SEK -42m (income from partners). Liquid funds as of September 30 were SEK 165m (383) to which proceeds from the directed share issue will be added to in Q4 (SEK 170m) resulting in a current cash position of around SEK 320.

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xbrane-biopharma-20221201.pdf

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STADA and Xbrane secure EU approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis®

European Commission grants pan-EU marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab). Paves way for European launch of Ximluci®early in 2023. The partnership combines Xbrane’s patented protein-expression system and Europe-based production platform with STADA’s experienced clinical salesforce and key-account management teams, 125-year heritage and extensive sales and marketing expertise throughout Europe.

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Redeye

As a result of today’s news, we raise the LoA to 100% (95%) in Europe in our model, which raises our Base case to SEK183 (173). Our Bull case amounts to SEK303 (270), and our Bear case amounts to SEK65(63).

Xbrane Biopharma: Ximluci Approved in the EU

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PAS i dag tidlig

First sales approaching

In November 2022, the EMA granted Ximluci (formerly Xlucane) European market authorization. The drug 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) drug sales market in US and Europe. Ximluci’s launch by STADA, expected in February 2023, will transform Xbrane from a development-stage to a commercial-stage and revenues generating biosimilars company. With planned US re-submission by end of year, we expect Ximluci’s US launch through Bausch + Lomb in early 2024. Hence, we provide an update on our valuation and target price based on sales and forecast changes to Ximluci. Due to macroeconomics, we increase the WACC from 11 to 13% despite the company’s progress. In addition, in February this year, Xbrane announced a licensing agreement with Biogen for its second biosimilar Xcimzane (now BIIB801), a biosimilar referencing Cimzia. Since the biosimilar is still preclinical, we have not included BIIB801 into our valuation and target price assumptions, yet we modelled a base case to show the potential upside of the asset and its valuation will be activated once it reaches clinics. With Ximluci sales starting next year, we expect the stock to attract new investors. We reiterate our Buy rating on XBRANE and increase our target price to SEK 275 (245).

Sales and royalties

We expect Ximluci sales to reach USD 47m/95m in 2023/24 in Europe, while the US is expected to deliver USD 179m in 2024. Yes, biosimilars penetrate the market very fast, as a reminder, the Avastin biosimilar Mvasi got approved in July 2019 and produced USD 798m in its first full year after launch (2020). We estimate US royalties on sales to be around 20% and a 50% profit split in Europe & Japan.

Potential upside by pipeline programs BIIB801 and oncology portfolio

The Biogen-partnered asset BIIB801 is a biosimilar to Cimzia. The drug is used to treat chronic inflammatory conditions and will lose exclusivity in 2024. Our preliminary valuation assumes launch in 2025 and indicates an upside of up to SEK 126/share for the program. We have not included it in the TP as of now and will only do so once it transitions into clinics. Further, Xbrane intends to develop three oncology assets addressing USD 50bn of drug sales and expects to partner them in 2023. The company will be able to continue creating new biosimilars to biologics running out of patents, so no ending in sight.

[Cheerup]

Med salgsstart i EU i Q123 og med tanke på at biosimilars har raskere markedspenetrasjon enn ny medisin, hva tenker folk er nedside risiko her? Er det noe usikkerhet om de får godkjennelse hos FDA? US re-submission by end of year, da mener PAS 2022?

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Det ventes om ikke lenge ja.

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PAS - etter dagens melding:

Struggling with FDA re-submission yet no impact on our forecasts

Xbrane today announced that the FDA re-submission is delayed into Q1 2023. In a call with the CEO, it was mentioned that the delay is related to mainly one specific report that is missing from a contract manufacturer. The submission is expected in January with validation by the FDA around end of Q1 2023 (which is what Xbrane will press release next). In our update from last week, we already adjusted our forecasts to reflect an FDA re-submission in Q1 2023, so today’s news have no impact on our estimates. Meanwhile, Ximluci is approved in Europe and STADA is expected to launch it in February. We see today’s stock reaction as a buying opportunity and reiterate our Buy rating on XBRANE with a target price of SEK 275.

Some more thoughts

It is the first such submission for Xbrane and struggling with compiling all the necessary documents is not unusual for a small company. Xbrane’s peer and competitor Formycon had an over one-year delay during its FDA submission process (related to something in the lab). Luckily, it is most likely not just the first but also the last FDA submission Xbrane needs to handle by themselves, as the next biosimilar (to Cimzia) is handled by Xbrane’s pharma partner Biogen.

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STADA and Xbrane obtain British approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis®

• MHRA issues marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain
• STADA is preparing to launch Ximluci® in the UK during 2023
• The partnership benefits from Xbrane’s patented protein-expression system and Europe-based production set-up, and STADA’s considerable heritage supplying biosimilars and other specialty medicines in the UK

Bad Vilbel; Solna – 16 January 2023 – STADA Arzneimittel AG and Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) announce that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci® (ranibizumab), a biosimilar referencing Lucentis®. STADA is preparing to launch Ximluci in the UK during 2023.

Xbrane’s contribution to the partnership includes a patented protein-expression system and Europe-based production set-up, while STADA brings considerable heritage supplying biosimilars and other specialty medicines in the UK.

“Considerable unmet need for biologic ophthalmic treatments exists in the UK and throughout Europe,” commented Bryan Kim, STADA’s Head of Specialty Care. “With almost 15 years’ experience of supplying biosimilars, STADA looks forward to working with Xbrane, as well as with NHS and our commercial partners, to broaden patient access to ranibizumab and optimize use of healthcare resources in the UK.”

“We are proud to have worked with STADA to take this molecule, developed under the XlucaneTM name, from cell-line development to approval and manufacturing, based on our patented expression system, in Europe,” stated Martin Åmark, CEO of Xbrane.

Ximluci® is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders, which are a leading cause of blindness globally. Ximluci® has been approved in the UK for treating wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.

According to the UK’s Macular Society, nearly 1.5 million people in the UK have macular disease. Age-related macular degeneration is the most common condition, generally affected people aged over 55. AMD is the biggest cause of sight loss in the UK, affecting more than 600,000 people. [1]

The British marketing authorization was granted via the EC Decision Reliance Procedure (ECDRP), whereby the MHRA relied on the decision taken by the European Commission (EC) on 9 November 2022 to issue a centralized marketing authorization for Ximluci® valid in all 27 European Union member states, as well as in Iceland, Norway and Liechtenstein[2]. The European Medicines Agency had determined Ximluci® to be highly similar to the reference product, Lucentis®, based on data showing comparable quality, safety and efficacy to Lucentis®.[3]

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PAS etter nyheten:

Ximluci approved in the UK

Xbrane today announced that, following the EU commission’s approval in November 2022, the UK’s health authority has now also granted market authorization to Ximluci, Xbrane’s lead biosimilar referencing the blockbuster drug Lucentis. Ximluci is after Ongavia (marketed by Teva) and Byooviz (Biogen) the third approved Lucentis biosimilar in the region. We now look forward for the FDA resubmission, which is due any day now and that first European sales start in the coming two months. With these positive developments, we reiterate our Buy rating on XBRANE with a target price of SEK 275/share.

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Xbrane er en av (fem) RedEye’s top pick’s for 2023 - presentasjon 20. januar 2023,

Fra ca 38:30 i sendingen.

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Årsrapport i dag - webcast kl. 10.

Xbrane Biopharma: The approval of Ximluci® in Europe positions Xbr...

year-end-report-2022.pdf

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PAS i dag tidlig - et par viktige spørsmål til dagens webcast kl. 10

Xbrane reiterates that Ximluci launches this quarter in Europe

Xbrane Biopharma today released its Q4 report with no new material information. Xbrane however reiterated that the re-submission of Ximluci’s filing to the FDA is set to occur in Q1 2023 and with that approval around year-end. No detailed update is given on the commercialization in Europe through STADA but that it is occurring this quarter (Q1 2023). Xbrane ended the year with SEK 165m in liquid funds while the higher cash burn in Q4 of SEK -128m is related to production of commercial supplies for Ximluci and the expansion of Xbrane’s lab capacities (CAPEX). Key questions for us for today’s webcast at 10:00 CET are regarding Ximluci’s launch in Europe and whether the Cimzia collaboration with Biogen is still moving forward uninterrupted by Biogen’s potential new strategic direction set by its new CEO that could include the divestment of Biogen’s biosimilars business (mentioned in Biogen’s Q4 call this week). We will follow-up after today’s webcast . We have a Buy rating on Xbrane with a target price of SEK 275.

Oppdatering etter Q4-call

Takes from Q4 call

Xbrane confirmed in the webcast that Ximluci is not facing any supply chain or commercial manufacturing issues, so we can be confident that STADA will launch it in Europe this quarter. The company also confirmed that it has all documents needed for the submission to the FDA and is confident that they will file it before end of this quarter. With regards to Biogen’s potential strategic shift away from biosimilars, Xbrane has discussed this with Biogen. The CEO said that he is confident that if there are changes, as the Cimzia biosimilar is an important part of Biogen’s biosimilars portfolio, that it will continue to be moved forward in whatever new structure (e.g. spin-off or sale). The oncology portfolio is also progressing and with potential partnering most realistically sometime between 2H 2023 and 2H 2024. With that, we are looking ahead to Ximluci’s Europe launch and FDA resubmission within February/March. We reiterate our Buy rating on Xbrane with a target price of SEK 275.

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Fra Lovisa på Disc

BIOGEN rapport

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Redeye Xbrane.pdf (582,6 KB)

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STADA and Xbrane launch ranibizumab to support patient access in Europe

Ranibizumab biosimilar is being launched in major European markets. Ranibizumab is the first product brought to market through a strategic collaboration between STADA and Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) , marking Xbrane’s first commercial launch and STADA’s first co-development asset, in its growing biosimilars portfolio. Developed and manufactured solely in Europe, ranibizumab is the sixth biosimilar marketed in Europe by STADA, and the first to treat ophthalmologic conditions.

Bad Vilbel, Germany/Solna, Sweden: – For the estimated 400,000 people per year in the European Union (EU) who develop age-related macular degeneration (AMD) every year, their impairment to sight can have a substantial impact on their quality of life and emotional wellbeing. Whether it’s enjoying the latest film in a cinema or finding one’s car keys, life can be difficult with AMD. Indeed, AMD is the main cause of severe visual impairment and blindness in Europe [1] , generating an estimated treatment cost of €2.4 billion per year.

With the introduction of ranibizumab in several European countries, partners STADA Arzneimittel AG and Xbrane Biopharma AB are offering European patients a cost-effective option to treat visual impairment in all the adult indications of the reference biologic.

Shipments of the ranibizumab biosimilar, which is produced, filled, sterilized, and packaged entirely within Europe, have begun, and launch activities are underway.

The advent of biosimilar competition in Europe’s ranibizumab market offers improved patient access through cost-effective biosimilars with comparable quality, safety and efficacy to the original reference biologic. Such competition has already generated considerable value for patients, physicians and healthcare systems in therapeutic areas including immunology and oncology. For example, biosimilar competition on filgrastim increased patient access in the European union by 44%.

STADA has a diverse portfolio of biosimilars in Europe across therapeutic areas encompassing immunology, oncology and bone health, building on a corporate heritage spanning more than 125 years of supplying high-quality consumer healthcare and generic medicines.

Ranibizumab is the sixth biosimilar launched within STADA’s Specialty Care portfolio joining epoetin zeta, pegfilgrastim, teriparatide, bevacizumab and adalimumab and the first product developed through a strategic collaboration between STADA and Xbrane. Under this agreement, begun in July 2018, the partners are jointly responsible for development and for manufacturing the finished product, while STADA holds the marketing authorizations and commercial rights.

“Having already successfully launched five biosimilars,” commented STADA CEO Peter Goldschmidt, “we are delighted to be making ranibizumab available to ophthalmologists and their patients. This European-made biosimilar, developed through STADA’s strategic partnership with Xbrane, will help to increase patient access to biological treatments and foster competition that contributes to the sustainability of healthcare systems throughout Europe.”

“We are proud to have worked with STADA to take this molecule, developed under the XlucaneTM name, from cell-line development to approval and manufacturing, based on our patented protein-expression system. Commercialization of our first biosimilar in Europe marks a major milestone in the evolution of our company,” stated Martin Åmark, CEO of Xbrane.

As with the reference biologic, the ranibizumab biosimilar is supplied as a 2.3mg/0.23ml single-use vial for injection for intravitreal use. The vascular endothelial growth factor (VEGF) inhibitor has been approved in European Union, as well as in the UK, for the treatment of wet AMD, diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.

The EU marketing authorization was based on a comprehensive comparative analytical assessment and a Phase 3 clinical study that demonstrated equivalent efficacy and comparable safety to the reference product. The Phase 3 clinical study involved 580 patients with wet age-related macular degeneration. The primary endpoint of the study was the change in best corrected visual acuity (BCVA) at week 8 compared to the baseline. This was met, as the adjusted treatment differences between the two products were within the predefined equivalence margin [2].

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Og fra PAS:

Xbrane Biopharma and STADA this morning announced that they have launched Ximluci (a biosimilar referencing Lucentis) in the major European markets to treat ophthalmologic conditions such as age-related macular degeneration – a leading cause of blindness. Ximluci is the sixth biosimilar marketed in Europe by STADA and the first to treat ophthalmologic conditions, for which STADA has trained its sales force already last year. Ximluci’s supply chain is fully located in Europe, which might be an advantage over some of the competitors. Due to the nature of biosimilars, we expect a fast market penetration compared to a traditional drug launch. Regarding the US market, we expect the FDA resubmission to happen within this month. We have a Buy rating on Xbrane with a target price of SEK 275.