Alligator Bioscience Q1 2024: The Next Catalyst Will Be the 18-month Readout
Research Update
2024-05-07
07:05
Redeye comments on Alligator Bioscience's Q1 report, including the sub-optimal funding situation after the rights issue and upcoming catalysts, in particular the 18-month OPTIMIZE-1 readout.
RR
Richard Ramanius
Contents
Investment thesis
Quality Rating
Discussion
Financial Results
Valuation
Financials
Rating definitions
The team
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The rights issue of SEK150m was subscribed to c70%, resulting in gross proceeds of cSEK107m with financial costs of cSEK10m, or almost SEK100m net. This is a strong result considering the share traded below the strike price, but it is less than the company needed. We do not expect the cash position will fund the company until the subscription period of TO9 in December, which were included in the rights issue, so the company will need to either strike a deal or find another source of funding before this. Our pro-forma balance sheet has a cash position of SEK78m after the rights issue. This means Q2 should be funded but most likely not the entirety of Q3 this year.
In March, Alligator reported a positive interim readout from the phase I study of ALG.APV-527, with three out of six dose cohorts completed. The topline readout is expected in Q4 2024. Positive results could set the project up for partnering discussions. ALG.APV-527 is a joint venture with Aptevo Therapeutics, so if no partner is found, the costs for a phase II study could be divided by the companies if it is decided to go forward. In April, Orion excercised its option to develop the second bispecific antibody leading to a minor milestone payment. It is the second such antibody succesfully developed with Orion.
The rights issue did not raise all the money the company needed, so we judge it is not unlikely that additional funds will have to be raised before a potential deal for mitazalimab can be signed. We have therefore included a capital issue in our model. We have also removed ATOR-1017 from the base case together with some other minor changes. The additional dilution, in particular, has some impact on our base case which is SEK2.3 (SEK3.1). The cash position can fund the company past the 18-month readout of OPTIMIZE-1 in late June 2024, which will likely be important for landing a deal. By then, the survival data (PFS and OS) will be more mature and could potentially have improved further. It might be strategic to wait with the funding until then.
SEKm | 2022 | 2023 | 2024e | 2025e | 2026e |
Revenues | 36.8 | 61.9 | 621.8 | 161.5 | 74.6 |
Revenue Growth | 153% | 68.0% | 904% | -74.0% | -53.8% |
EBITDA | -184.3 | -238.5 | 370.6 | 29.3 | -58.8 |
EBIT | -193.0 | -249.0 | 370.6 | 29.3 | -58.8 |
EBIT Margin | -524% | -402% | 59.6% | 18.1% | -78.9% |
Net Income | -193.4 | -248.6 | 358.1 | 29.3 | -58.8 |
EV/Sales | 6.6 | 6.3 | 0.0 | 0.0 | 0.9 |
EV/EBIT | -1.3 | -1.6 | 0.0 | -0.2 | -1.1 |
Case
An outlicensing deal can unlock value and move the share
Evidence
Phase I and phase II data support mitazalimab
Supportive Analysis
Challenge
Mitazalimab and other projects need a partner
Challenge
Additional funding or a deal
Valuation
Valuation assumes deal in 2024
People: 3
Søren Bregenholt is CEO of the company. He has worked in the industry for more than 20 years, half of that time at Novo Nordisk. The partly new, skilled management and proficient board are complemented by a skilled workforce, a large part of which hold a PhD degree. The main shareholder, Allegro, has a chair on the board, where it has a major influence and has brought more financial stability to the company (as through the recent bridge loan).
Business: 3
Pharmaceuticals is a high-margin industry in which there is clear product protection for companies' projects through patents. It is generally a non-cyclical industry. For research companies like Alligator, the situation is different, with risks associated not just with clinical development but also with the (cyclical) stock market, where capital requirements are large and often handled via new issues.
Financials: 0
After raising cSEK100m in April 2024, Alligator currently has a cash position of circa SEK80m. Unless a deal with mitazalimab can be negotiated in the next few months, additional funding will be needed before the end of Q3 this year.
Considering no deal has been signed yet for mitazalimab, we believe potential partners may be waiting for the mid-year readout, which will provide more mature progression-free and overall survival data. The data presented in January was quite early. This readout will therefore likely be important. We would like to see further improved PFS and OS data. ORR and duration of response data are already mature and convincing, but investors and partners may want to be more certain they translate into improved survival. The next readout is scheduled for late June 2024.
Another important milestones will be the full recruitment of the 450 micro-g/kg cohort (n=15) in OPTIMIZE-1, which is expected by Q3, with a readout in Q1 2025. This study is more focused on pharmacokinetics and pharmacodynamics than efficacy. The phase III study is then planned to start in H1 2025.
ALG.APV-527 is on track for a topline readout in the phase I study in Q4 2024. Furthermore, AC101 (out-licensed to Henlius), which is being developed in gastric cancer in Asia, should complete the phase II study (n=150) later this year.
Alligator had income of SEK7m classified as reimbursement for development work, which is likely due to the Orion collaboration. As both antibody programmes have now been handed over to Orion, we expect quarterly income to decrease, as should costs.
Revenues
Operating costs decreased compared to the previous four quarters and amounted to SEK-67m. As we mentioned in our last update, the company had built up a deficit in working capital. This led to a negative cash flow effect of SEK-25m in Q1, with an operating and lease amortisation cash flow of SEK-85m in Q1. Alligator obtained a loan of SEK59m from the main owners in Q1, which has been converted into shares after the rights issue, from which the company obtained around net SEK97m. This leaves the company with a cash position of circa SEK78m.
Even with the cost reduction programme of cSEK5m per quarter implemented and assuming operating costs (and a similar cash flow) of cSEK60m or less per quarter, the cash position will only last into Q3 this year. A new rights issue so close after the last one would likely have to be underwritten (using a guarantor consortium) at a significantly lower price, so another solution would be preferable (e.g. a directed share issue). The ideal would solution would obviously be a deal.
Operating costs
We have decided to include some dilution in our base case like before. Alligator's rights issue was worth up to SEK150m+100m, but it was not fully subscribed, leading to less dilution and less cash available. We therefore assume additional dilution at the amount not subscribed for (cSEK140m) with a typical discount in order to maintain consistency in our valuation model. The company might strike a deal before this, which is reflected in our bull case where we do not assume any further dilution. TO9 should also lead to some dilution, but the discount is only 10% based on trading in November, for which reason we have not taken it into account in this update.
We have reconsidered our valuation of Neo-X-Prime/ATOR-4066 and increased the upfront payment to USD75m (USD30m), since the valuation assumption is the entire platform, which would consist of several antibodies, could be outlicensed after a first clinical study in humans finishes around 2028. The total deal value is still USD1000m. Our previous estimates were too conservative for a platform technology.
We have added two years to the ORION programme. Our original timeline was optimistic. This has a minor impact, decreasing the valuation by cSEK40m.
Since ATOR-1017 has been paused and we see no obvious way forward in the short term, we have removed it from our base case, including it only in the bull case. Furthermore, we have lowered our estimates, since we believe the focus is on the bispecific ALG.APV-527 (developed together with Aptevo Therapeutics), which is a more attractive asset. We have halved the total deal value and upfront payment to USD300m and USD10m, respectively; we have also reduced the peak sales estimate to USD800m (USD900m). This reduces the value by cSEK120m in the bull case.
Sum-of-the-parts | ||||||||
Programme | Target | Indication | Phase | LOA | Royalty | Peak Sales | Market | NPV |
(MUSD) | (SEKm)* | |||||||
Mitazalimab | CD40 | PDAC | II | 25% | 15% | 1400 | 2028 | |
Mitazalimab II | CD40 | Bladder | I | 8% | 15% | 600 | 2030 | 2490 |
ALG.APV-527 | 4-1BB/5T4 | Head & Neck | I | 6% | 13% | 1000 | 2031 | 169 |
ATOR-1017 | 4-1BB | Breast | II ready | 9% | 13% | 800 | 2031 | 0 |
Neo-X-Prime/ATOR-4066 | CD40/X | mCRC | Discovery | 3% | 12% | 2600 | 2034 | 209 |
Henlius, Biotheus, Orion | 2-13% | 8% | 700-1500 | 2027- | 288 | |||
Technology (SEKm) | 3155 | |||||||
Net Cash | 78 | |||||||
Overhead, incl. taxes (MSEK) | -978 | |||||||
Fair Value (MSEK) | 2255 | |||||||
No. Shares (mil.) | 759 | |||||||
Fair Value per Share (SEKm) | 3.0 | |||||||
Equity issue (SEKm) | 140 | |||||||
Fully Diluted Fair Value per Share (SEKm) | 2.3 | |||||||
*The valuation is based on a conversion rate of USD/SEK 10.5 and WACC of 15%. |
Our bull case is SEK5.1 and our bear case is SEK1.0. In our bull case, we assume Alligator finds a partner for mitazalimab before Q3 with the same conditions as in our base case, leading to no dilution. We also set the LOA to 36% and lower the WACC to 13%. In our bear case, we have also removed ALG.APV-527. We have assumed Alligator has to raise another SEK250m early next year to fund the continued development of mitazalimab, though we have not changed the time plan for the market launch. We also assume worse deal conditions, a total deal value of USD600m with an upfront of USD35m and royalties of 13%.
Income statement | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Revenues | 61.9 | 621.8 | 161.5 | 74.6 |
Cost of Revenue | 0.00 | 0.00 | 0.00 | 0.00 |
Operating Expenses | 300.4 | 251.2 | 132.2 | 133.4 |
EBITDA | -238.5 | 370.6 | 29.3 | -58.8 |
Depreciation | 10.5 | 2.5 | 0.00 | 0.00 |
Amortizations | 0.00 | 0.00 | 0.00 | 0.00 |
EBIT | -249.0 | 370.6 | 29.3 | -58.8 |
Shares in Associates | 0.00 | 0.00 | 0.00 | 0.00 |
Interest Expenses | 1.4 | 14.5 | 0.00 | 0.00 |
Net Financial Items | 0.40 | -12.5 | 0.00 | 0.00 |
EBT | -248.6 | 358.1 | 29.3 | -58.8 |
Income Tax Expenses | 0.00 | 0.00 | 0.00 | 0.00 |
Net Income | -248.6 | 358.1 | 29.3 | -58.8 |
Balance sheet | ||||
Assets | ||||
Non-current assets | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Property, Plant and Equipment (Net) | 2.7 | 0.14 | 0.14 | 0.14 |
Goodwill | 0.00 | 0.00 | 0.00 | 0.00 |
Intangible Assets | 18.0 | 18.0 | 18.0 | 18.0 |
Right-of-Use Assets | 17.6 | 17.6 | 17.6 | 17.6 |
Other Non-Current Assets | 2.0 | 6.0 | 6.0 | 5.3 |
Total Non-Current Assets | 40.2 | 41.7 | 41.7 | 41.0 |
Current assets | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Inventories | 0.00 | 0.00 | 0.00 | 0.00 |
Accounts Receivable | 0.00 | 49.7 | 12.9 | 6.0 |
Other Current Assets | 12.1 | 18.7 | 4.8 | 2.2 |
Cash Equivalents | 66.1 | 650.4 | 652.1 | 580.4 |
Total Current Assets | 78.2 | 718.8 | 669.9 | 588.6 |
Total Assets | 118.4 | 760.5 | 711.6 | 629.6 |
Equity and Liabilities | ||||
Equity | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Non Controlling Interest | 0.00 | 0.00 | 0.00 | 0.00 |
Shareholder's Equity | 11.9 | 370.0 | 399.3 | 340.4 |
Non-current liabilities | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Long Term Debt | 0.00 | 0.00 | 0.00 | 0.00 |
Long Term Lease Liabilities | 7.5 | 7.5 | 7.5 | 7.5 |
Other Non-Current Lease Liabilities | 0.00 | 0.00 | 0.00 | 0.00 |
Total Non-Current Liabilities | 7.5 | 7.5 | 7.5 | 7.5 |
Current liabilities | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Short Term Debt | 0.00 | 0.00 | 0.00 | 0.00 |
Short Term Lease Liabilities | 8.6 | 8.6 | 8.6 | 8.6 |
Accounts Payable | 21.3 | 74.6 | 19.4 | 9.0 |
Other Current Liabilities | 69.2 | 72.2 | 65.2 | 61.9 |
Total Current Liabilities | 99.1 | 155.3 | 93.2 | 79.5 |
Total Liabilities and Equity | 118.5 | 532.8 | 500.0 | 427.4 |
Cash flow | ||||
SEKm | 2023 | 2024e | 2025e | 2026e |
Operating Cash Flow | -189.3 | 373.1 | 10.9 | -62.3 |
Investing Cash Flow | -2.5 | 0.00 | 0.00 | 0.00 |
Financing Cash Flow | 161.6 | 211.2 | -9.2 | -9.4 |
Disclosures and disclaimers
Contents
Investment thesis
Quality Rating
Discussion
Financial Results
Valuation
Financials
Rating definitions
The team
Download article