Annexin Q2: RVO readout closing in

Research Update

2024-07-19

09:00

Analyst Q&A

Closed

Fredrik Thor answered 4 questions.

Redeye comments on Annexin's Q2 report and recent events in the company. We note that interest in Annexin has increased rapidly lately following a strong outcome in the rights issue and upcoming phase II topline data in RVO with its drug candidate ANXV - and we expect an eventful summer/autumn ahead for the company.

FT

Fredrik Thor

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No surprises in Q2 report

Annexin’s Q2 report did not offer any surprises, as expected for a pre-revenue biotech company. Operating expenses amounted to SEK-14.5m, which was more or less as expected. The cash position amounted to SEK37m, and the company mentions in the report that it has extended the cash runway to the end of Q1 2025, rather than the previously communicated Q4, as a few activities have been postponed.

Phase II RVO study closing in

The final patient was treated in April in the ongoing phase IIa RVO study, and the company writes in the report that the final patient concludes the last visit to the physician now in July. Results are expected later this summer (we assume August), and the company has previously stated it will finalize the study report and detailed analyses by Q3. We expect that partnering discussions will accelerate following the top-line readout. In line with previous communication, the company mentions that it aims for a global deal but also considers regional agreements.

Reiterate our valuation

We do some minor model housekeeping (FX, cash position) but reiterate our base case for now. We expect to return to Annexin and our model assumptions soon, as top-line data from the phase IIa RVO is to be expected this soon.

Key financials

SEKm202220232024e2025e
Revenues0.000.000.0039.6
EBIT-40.7-44.2-52.1-16.6
EBIT Marginnm.nm.nm.-41.9%
Net Income-40.7-44.1-52.1-16.6

Annexin Q2 - No surprises

Annexin’s Q2 report did not offer any surprises, as expected for a pre-revenue biotech company. Operating expenses amounted to SEK-14.5m, which was more or less as expected. The cash position amounted to SEK37m, and the company mentions in the report that it has extended the cash runway to the end of Q1 2025, rather than the previously communicated Q4, as a few activities have been postponed. We have a positive interpretation of this decision as it should give the company some additional time for partnering discussions, which we expect will accelerate following the top-line readout. In line with previous communication, the company mentions that it aims for a global deal but also considers regional agreements. We have mainly focused on a regional deal (Japan) and that Annexin retains the rights in the rest of the world in our valuation. As RVO is a relatively small indication, we argue that there are several options to reach the market (regional agreements, in-house development and global license). However, the company would, in the end, need distribution. From a valuation perspective, a global licensing agreement (depending on terms) would not necessarily lead to a higher valuation, at least theoretically (more rights would be given away). Still, we think that a strong global deal with a partner with a strategic interest in RVO (and potentially oncology) would further derisk the case, especially the commercialization. As also mentioned in the CEO letter, Merck recently acquired EyeBio for up to USD3bn, including with a very significant upfront payment of USD1.3bn, to give some perspective on numbers. In the report, the company further writes that it has received increased attention, for example, at international congresses, and we again get the impression that Annexin has a strong standing amongst academics and specialists and that the results in RVO are well received so far.

Regarding the phase II RVO study: The final patient was treated in April, and the company writes in the report that the final patient concludes the last visit to the physician now in July. Results are expected later this summer (we assume August), and the company has previously stated it will finalize the study report and detailed analyses by Q3.

Rights issue fully subscribed

In late May, it was announced that the subscription rate in Annexin Pharmaceuticals' rights issue amounted to 100% and that no guarantees were needed. As a result, the company received SEK45.1m before issue costs.

We were impressed by the rights issue, which we argue signals that the majority owners and management/board have conviction in the case, including the upcoming readout in the phase II RVO trial. As the rights issue was fully subscribed, it is also clear that this view is reflected amongst other shareholders as well. From a share price perspective, it is clear that the strong outcome was a catalyst, as the share price has rallied very significantly since the end of May, likely also due to the phase II RVO readout is closing in.

Diagram 3

Source: Annexin (historical financials); Redeye Research (estimates)

Reiterate our valuation

We do some minor model housekeeping (FX, cash position) but reiterate our base case for now. We expect to return to Annexin and our model assumptions soon, as top-line data from the phase IIa RVO is expected this summer.

Sum-of-the-parts Valuation

AssetIndicationLoARoyaltiesPeak sales (USDm)Deal size (USDm)rNPV (m)
ANXVRVO18%40%9351001073
Project value (SEKm)1,073
Est. Net cash*56
Shared costs incl. tax (SEKm)-422
Fair value (SEKm)707
Expected Shares outstanding (2024/2025)571
Value per share (SEK)1.2
* Includes assumed capital injection

Investment thesis

Case

Optionality in a protein

We continue to see a significant upside Annexin as we argue that the share price in Annexin has failed to account for the substantial and strong pipeline progress in the lead indication RVO with drug candidate ANXV. We are also encouraged by the company’s increased ambitions in additional indications – most notably cancer. We expect 2024 to be a busy time, including additional trial data from the phase II study in RVO, which could de-risk the asset further. We also expect further progress in the oncology expansion.

Evidence

Broad therapeutic potential and increased interest in the field

ANXV is a biologics candidate based on recombinant human Annexin A5. This is a highly conserved, endogenous protein present in all human cells but abundant in endothelial cells and thrombocytes. An investment in Annexin Pharmaceuticals is a bet on ANXVs potentially wide use as therapy; for example in vascular, cardiovascular, oncology, viral, and hematology. We see an increased body of literature highlighting its potential role as a therapeutic. Only in recent years we acknowledge external papers in different therapy areas, including oncology, where Annexin A5 has been suggested as an immune checkpoint inhibitor. Annexin's lead indication at this stage is retinal vein occlusion (RVO), a vascular disorder of the retina and a common cause of vision loss - a huge market (USD 20 billion), where no treatment today can address the disease’s underlying cause, which ANXV aims to do.

Supportive Analysis

In the apoptosis process, Annexin A5 has demonstrated unique characteristics: • Immediate ability to repair cell rupture • Anti-thrombotic and acts as a protective shield • Long-term acts anti-inflammatory Annexin A5 has been widely used in the clinic as a diagnostic biomarker. Thanks to its strong affinity for PS (“phosphatidylserine”), researchers have better understand apoptosis at a molecular level when Annexin A5 has been attached to a radionuclide or a fluorescent dye. In the last 10-15 years, we also acknowledge an increasing appreciation for Annexin A5’s therapeutic properties. In this context, the co-founders of Annexin Pharmaceuticals have had an incremental role, and it’s their research that Annexin Pharmaceuticals stem from. The company develops ANXV to assess its therapeutic properties, with the hypothesis to supplement ANXV in subacute stages by acting as a missile to its disease target. By September 2021, Annexin reported its anticipated phase I results. The successful study assessed safety and tolerability through intravenous administration and single- and multiple ascending doses (SAD/MAD). This important milestone was in our view overlooked by the market and opens up for phase II studies in other indications.

Challenge

Strategy decisions on indications

Considering the broad potential with ANXV, the other side of the coin is that there is no clear path (and possibly many of them) to success. It will require both skillfulness and timing to bring this asset to market, including balancing the financial constraints with taking advantage of the potential in multiple indications.

Challenge

Additional funding required

We estimate that Annexin needs additional funding to take lead project ANXV in RVO beyond the ongoing phase IIa trial, although the amount also depends on whether Annexin will outlicense ANXV or continue further with the in-house development. Annexin has a history of efficient capital injections, including smaller directed issues/loans from major shareholders before major events (so that the company can raise sufficient cash when it needs to). We think that this has contributed to a more stable share price and valuation.

Valuation

SOTP Suggests Upside

We value Annexin using a risk-adjusted sum-of-the-parts (SOTP) analysis. At current levels, we argue that the market severely underestimates recent data that de-risk ANXV as a drug, including in lead indication RVO (“Retinal Vein Occlusion”). We think that the gap between our base case and today’s levels will be closed once we get further information on financing and receive additional data from the ongoing phase II trial.

Quality Rating

People: 3

Annexin benefits from an experienced management team and a robust ownership structure compared to its immediate peers, consistently receiving financial support. The company has world leading know-how and experience when it comes to Annexin A5 globally. To enhance its performance further, we look forward to seeing Annexin execute its strategy further, particularly through securing a licensing deal. Following the annual meeting, the largest shareholder Mikael Lönn joined the board as well as industry veteran Jan Nilsson.

Business: 3

Annexin has not yet generated any revenues for its products and has no established position on the market. However, if the development and commercialization of ANXV would be successful the company can enjoy protective barriers around the company's operations, supported by patents know how around Annexin A5. 

Financials: 0

Annexin is a pre-revenue biotech company that has not historically achieved profitability, and we anticipate that additional capital injections will be needed. 

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Contents

Investment thesis

Quality Rating

Financials

Rating definitions

The team

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