Medivir Q4 2024: Phase IIb Trial Design Set

Research Update

2025-02-19

07:10

Analyst Q&A

Closed

Richard Ramanius answered 2 questions.

Redeye comments on Medivir's Q4 report of 2024. In the quarter, the phase IIa study of fostrox was completed. In the conference call, new information about the planned phase IIb study, FOcuS-2, was presented. Furthermore, we present a new valuation model with a new base case.

Richard Ramanius

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Investment Thesis

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Fostrox phase IIb

The study of fostrox + Lenvima was closed in November. Remaining patients were transferred to compassionate use. Final data will be presented at EASL on 20 February. The following phase IIb study is now defined and will be called FOcuS-2. It will recruit 154 patients in two parts. The first part has three dose groups, fostrox 30 mg + Lenvima, fostrox 10 mg + Lenvima, and Lenvima with 20 patients in each group. The second part will recruit 47 patients in each group, one fostrox + Lenvima and one Lenvima only. The study is planned to start late in 2025 with final preparations ongoing, including defining and setting up sites together with the CRO that will conduct the phase IIb study and finalising CMC (Chemistry, Manufacturing, and Controls) for phase III. Eisai is also on time with preparing the supply of Lenvima, which Medivir obtains without payment thanks to the clinical collaboration agreement. Each part will take 12 months with the primary endpoint (ORR) readout after 6 months and 24 months for survival. Topline data should, therefore, be available in 2028.

New Lenvima monotherapy data

In the conference call, data from the first prospective Lenvima monotherapy data were presented from a study with 50 patients. The median progression-free survival was 5.4 months while the overall survival was 8.6 months, which is roughly in line with other studies. Fostrox + Lenvima's time to progression of circa 11 months clearly appears better.

Base case SEK6 (SEK8)

We now assume a deal in 2028 with total deal value of USD1.5bn and an upfront of USD150m. We add one year to fostrox' programme with a launch in 2029 (2028). We also assume more dilution. We increase the WACC to 16.5% (15%). This results in a higher technology/fundamental value but a lower value per share. The big question now is how Medivir will fund the phase IIb study - with a partner or alone. In any case, we think specialist investors will participate when raising capital. Once this is resolved, the market might realise how undervalued Medivir is.

Key Financials
SEKm202320242025e2026e2027e
Total Revenue4.74.54.24.44.7
Revenue Growth-24.2%-4.3%-6.9%6.1%6.1%
EBITDA-94.3-124.6-90.7-132.0-133.3
EBIT-96.5-127.3-93.5-134.8-133.3
EBIT Margin-2054%-2829%-2234%-3036%-2829%
Net Income-94.1-123.3-93.5-134.8-133.3
EV/Sales140186168188189
EV/EBIT-6.8-6.6-7.5-6.2-6.7

Investment Thesis

Case

Fostroxacitabine - the only modern chemotherapy in development for liver cancer

The principal reason for investing in Medivir is its main candidate, fostroxacitabine, a chemotherapy pro-drug targeting the liver. A pivotal phase IIb study (through an accelerated approval) in second-line liver cancer is planned to start in 2025 with topline data in 2028. The trial needs funding, part of which could come from an Asian partner or specialist investors. The agreement with Eisai supplying Lenvima for free will reduce the cost of the study. The main catalyst to move the share in the short term is a licensing deal with fostrox or funding for phase IIb. The next potential trigger is the dose selection after part 1 likely in H2 2026. Assuming positive phase IIb data in 2028, the company's fundamental value will be in the double-digit billion SEK range according to our estimates (~SEK10bn). This should motivate a share price increase as the study progressess towards readout.

Evidence

Strong readout of fostrox together with Lenvima in the phase IIa study

Fostroxacitabine can achieve 100x the concentration in the liver compared to systemic chemotherapy. Medivir generated strong results in a phase IIa trial (n=21) of fostrox in combination with a TKI inhibitor (Lenvima). The objective response rate was 24% and the estimated median time to progression was 10.9 months. These are more than twice what you would expect. Furthermore, the disease control rate was 81%. There was no added toxicity with Lenvima, which is critical in patients with reduced liver function. Medivir could be the first approved second-line treatment with multi-billion dollar revenue potential.

Supportive Analysis

The second reason for investing in Medivir are the legacy programmes, including "options" the buyer also gets “for free”, or projects that are not included in our Base Case. Medivir has two phase-III-ready projects, remetinostat and MIV-711, not included in our valuation, ready to be out-licensed. Minor projects not in our valuation include MET-X, partnered with Infex entering phase I this year, and USP-7, partnered with Ubiquigent.

Challenge

Trial risk

Risk when investing in Medivir include an unfavourable outcome in clinical trials and delays.

Fostrox: partnering and funding risk

Medivir plans to start an international phase IIb trial with around 150 patients in H2 2025. We estimate the cost for such a trial of around SEK225m. The intention is to find an Asian partner who runs sites there, while Medivir would fund European and American sites. But another likely option is funding the study by itself, which would require investments (e.g. a directed share issue) from specialist investors (we think Linc would be one of them). This will lead to some dilution in the short term but larger upside long-term.

Valuation

Fostrox the main asset

Using a WACC of 16.5%, our DCF renders a base case of SEK6 including mainly fostrox. We assume it will be outlicensed in 2028 with an upfront payment of USD150m, milestones of USD1500m and royalties of 25%. The sales upside with fostrox is reflected in our bull case of SEK12, while our bear case of SEK3 reflects a lower market penetration and more dilution. Medivir has liquidity position lasting into Q4 2025.

Disclosures and disclaimers

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