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Last close As at 07/06/2023
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Market capitalisation
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Research: Healthcare
Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline will have been confirmed as biomarker-positive for progressive AD. We continue to see the results from the XanaCIDD study (expected in late CY23 or early CY24) as the next major clinical data milestone and a potential share price catalyst. We expect the company’s A$12.3m cash balance at 31 March to fund operations into Q4 CY23.
Actinogen Medical |
Continued focus on Xanamem |
Quarterly update |
Pharma and biotech |
2 May 2023 |
Share price performance
Business description
Next events
Analyst
Actinogen Medical is a research client of Edison Investment Research Limited |
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Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline will have been confirmed as biomarker-positive for progressive AD. We continue to see the results from the XanaCIDD study (expected in late CY23 or early CY24) as the next major clinical data milestone and a potential share price catalyst. We expect the company’s A$12.3m cash balance at 31 March to fund operations into Q4 CY23.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/21 |
2.0 |
(3.3) |
(0.002) |
0.0 |
N/A |
N/A |
06/22 |
3.6 |
(7.9) |
(0.005) |
0.0 |
N/A |
N/A |
06/23e |
4.0 |
(9.4) |
(0.005) |
0.0 |
N/A |
N/A |
06/24e |
4.1 |
(37.6) |
(0.021) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. EPS are fully diluted.
XanaMIA Phase IIb expected to start imminently
We believe market participants will be keen to observe whether the Phase IIb portion of XanaMIA will confirm the positive AD efficacy findings shown by Xanamem in a subset biomarker analysis from the earlier XanADu study. We expect top-line results in late CY24 or H1 CY25, which if positive may lead to material out-licensing or value realisation opportunities given the significant unmet need in AD, the drug’s favourable safety profile demonstrated to date and its convenient oral dosing form. In the nearer term, data are expected in around six to 12 months from the six-week XanaCIDD proof-of-concept study in patients with persistent MDD and CI. As Xanamem targets excess brain cortisol, and given the benefits shown in healthy adults in earlier studies (XanaHES and the Phase Ib portion of XanaMIA), we believe it is plausible for cognitive benefits to also be shown in the MDD population.
Funding to be a key focus as trials progress
Actinogen reported an operating cash burn of A$2.2m in Q323 (broadly in line when annualised with our unchanged FY23e A$8.5m estimate) and had a cash balance of A$12.3m at 31 March. We believe the company remains funded into Q4 CY23 (Q224) and continue to model it will raise A$60m before end-FY24 given the expected rise in expenses once the AD study commences.
Valuation: Maintaining forecasts
Our forecasts are unchanged (please see our prior note for details) and our total equity valuation remains A$702m, or A$0.39 per share. While the total funding requirements to bring an AD drug to market are substantial, we believe Actinogen will seek non-dilutive funding and/or partnership arrangements, which may reduce the overall funding need, but such scenarios are not included in our base case forecasts.
Exhibit 1: Financial summary
A$(000) |
2020 |
2021 |
2022 |
2023e |
2024e |
||
Year end 30 June |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
|||||||
Revenue |
|
|
3,516 |
1,984 |
3,640 |
4,004 |
4,086 |
Cost of Sales |
0 |
0 |
0 |
0 |
0 |
||
Gross Profit |
3,516 |
1,984 |
3,640 |
4,004 |
4,086 |
||
Sales, General & Administrative |
(2,962) |
(3,111) |
(4,558) |
(4,999) |
(4,337) |
||
Net Research & Development |
(5,537) |
(2,406) |
(8,215) |
(9,394) |
(36,364) |
||
EBITDA |
|
|
(4,983) |
(3,533) |
(9,133) |
(10,389) |
(36,614) |
Amortisation of intangible assets |
(314) |
(313) |
(313) |
(313) |
(313) |
||
Depreciation & other |
(99) |
(74) |
(88) |
(93) |
(279) |
||
Normalised Operating Profit (ex. amort, SBC, except.) |
(4,888) |
(3,318) |
(7,933) |
(9,614) |
(36,894) |
||
Operating profit before exceptionals |
(5,396) |
(3,920) |
(9,533) |
(10,795) |
(37,206) |
||
Exceptionals including asset impairment |
0 |
0 |
0 |
0 |
0 |
||
Other |
(194) |
(289) |
(1,288) |
(869) |
0 |
||
Reported Operating Profit |
(5,590) |
(4,209) |
(10,821) |
(11,664) |
(37,206) |
||
Net Finance income (costs) |
65 |
5 |
36 |
261 |
(736) |
||
Profit Before Tax (norm) |
|
|
(4,822) |
(3,313) |
(7,897) |
(9,353) |
(37,629) |
Profit Before Tax (FRS 3) |
|
|
(5,331) |
(3,915) |
(9,497) |
(10,534) |
(37,942) |
Tax |
0 |
0 |
0 |
0 |
0 |
||
Profit After Tax and minority interests (norm) |
(4,822) |
(3,313) |
(7,897) |
(9,353) |
(37,629) |
||
Profit After Tax and minority interests (FRS 3) |
(5,331) |
(3,915) |
(9,497) |
(10,534) |
(37,942) |
||
Average Basic Number of Shares Outstanding (m) |
1,118.0 |
1,405.2 |
1,717.1 |
1,802.3 |
1,831.6 |
||
EPS - normalised (A$) |
|
|
(0.004) |
(0.002) |
(0.005) |
(0.005) |
(0.021) |
EPS - normalised and fully diluted (A$) |
|
(0.004) |
(0.002) |
(0.005) |
(0.005) |
(0.021) |
|
EPS - (IFRS) (A$) |
|
|
(0.005) |
(0.003) |
(0.006) |
(0.006) |
(0.021) |
Dividend per share (A$) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
|||||||
Fixed Assets |
|
|
3,772 |
3,287 |
2,889 |
3,534 |
4,029 |
Intangible Assets |
3,346 |
3,033 |
2,720 |
2,908 |
3,095 |
||
Tangible Assets |
19 |
17 |
13 |
627 |
934 |
||
Investments in long-term financial assets |
408 |
237 |
156 |
0 |
0 |
||
Current Assets |
|
|
8,164 |
15,091 |
20,417 |
31,189 |
32,752 |
Short-term investments |
0 |
0 |
0 |
0 |
0 |
||
Cash |
5,040 |
13,457 |
16,370 |
27,556 |
29,119 |
||
Other |
3,123 |
1,634 |
4,047 |
3,633 |
3,633 |
||
Current Liabilities |
|
|
(744) |
(755) |
(1,480) |
(1,708) |
(1,708) |
Creditors |
(744) |
(755) |
(1,480) |
(1,708) |
(1,708) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
(304) |
(165) |
(87) |
(20,038) |
(60,038) |
Long term borrowings |
0 |
0 |
0 |
(20,000) |
(60,000) |
||
Other long term liabilities |
(304) |
(165) |
(87) |
(38) |
(38) |
||
Net Assets |
|
|
10,889 |
17,458 |
21,740 |
12,978 |
(24,964) |
CASH FLOW STATEMENT |
|
|
|
|
|
|
|
Operating Income |
(5,590) |
(4,209) |
(10,821) |
(11,664) |
(37,206) |
||
Movements in working capital |
(3,591) |
(1,513) |
(3,143) |
597 |
0 |
||
Net interest and financing income (expense) |
65 |
5 |
36 |
261 |
(736) |
||
Depreciation & other |
99 |
74 |
88 |
93 |
279 |
||
Taxes and other adjustments |
6,161 |
3,920 |
4,323 |
2,165 |
313 |
||
Net Cash Flows from Operations |
|
(2,856) |
(1,724) |
(9,517) |
(8,548) |
(37,350) |
|
Capex |
(23) |
(6) |
(3) |
(1,051) |
(1,087) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
||
Interest received & other investing activities |
0 |
0 |
0 |
0 |
0 |
||
Net Cash flows from Investing activities |
|
(23) |
(6) |
(3) |
(1,051) |
(1,087) |
|
Net proceeds from share issuances |
0 |
10,195 |
12,491 |
903 |
0 |
||
Net movements in long-term debt |
0 |
0 |
0 |
20,000 |
40,000 |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
||
Other financing activities |
282 |
(84) |
(71) |
(39) |
0 |
||
Net Cash flows from financing activities |
282 |
10,111 |
12,420 |
20,864 |
40,000 |
||
Effects of FX on Cash & equivalents |
0 |
0 |
49 |
(80) |
0 |
||
Net Increase (Decrease) in Cash & equivalents |
(2,596) |
8,381 |
2,949 |
11,186 |
1,563 |
||
Cash & equivalents at beginning of period |
7,637 |
5,040 |
13,422 |
16,370 |
27,556 |
||
Cash & equivalents at end of period |
5,040 |
13,422 |
16,370 |
27,556 |
29,119 |
||
Closing net debt/(cash) |
|
|
(5,448) |
(13,694) |
(16,527) |
(7,556) |
30,881 |
Lease debt |
390 |
236 |
165 |
127 |
127 |
||
Closing net debt/(cash) inclusive of IFRS 16 lease debt |
(5,058) |
(13,458) |
(16,361) |
(7,429) |
31,008 |
||
Free cash flow |
(2,878) |
(1,730) |
(9,520) |
(9,599) |
(38,437) |
||
Source: Actinogen Medical accounts, Edison Investment Research
|
|
Research: Financials
PB Holding reported unaudited FY22 results on 28 April. The company’s most important asset, car insurer Bovemij, in which it has a 5.3% stake, reported FY22 results in early April. Dividends from this participation are the main source of liquidity and income for PB Holding. Apart from regular operating costs of approximately €0.2m on an annual basis for the holding, the company has no large expenses as it has a large tax loss asset and a net cash position of €1.5m. The company wants to have enough liquidity to cover at least two years of expenses of the holding, and we believe that is prudent. At the end of FY22, PB Holding’s book value was €3.61 per share, of which the stake in Bovemij of €3.38 per share is by far the largest part.
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