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
Contents
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.
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.
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.
SEKm | 2022 | 2023 | 2024e | 2025e |
Revenues | 0.00 | 0.00 | 0.00 | 39.6 |
EBIT | -40.7 | -44.2 | -52.1 | -16.6 |
EBIT Margin | nm. | 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.
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.
Asset | Indication | LoA | Royalties | Peak sales (USDm) | Deal size (USDm) | rNPV (m) | |
ANXV | RVO | 18% | 40% | 935 | 100 | 1073 | |
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 | |||||||
Case
Optionality in a protein
Evidence
Broad therapeutic potential and increased interest in the field
Supportive Analysis
Challenge
Strategy decisions on indications
Challenge
Additional funding required
Valuation
SOTP Suggests Upside
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.
Disclosures and disclaimers
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