Last close As at 21/08/2026
—
— 0.00 (0.00%)
Market capitalisation
—
Research: Healthcare
Ultimovacs has reported initial clinical data from the Phase II investigator-sponsored NIPU study investigating the company’s cancer vaccine, UV1, for the treatment of relapsed/refractory (r/r) malignant pleural mesothelioma (MPM). While the study did not meet its primary endpoint of progression-free survival (PFS) following assessment conducted by a central independent review committee, local assessments at the study hospitals performed by specialist radiographers measured a statistically significant improvement in PFS. However, it is likely these assessments are not totally blinded. Importantly, a positive trend in overall survival (OS) was observed in the UV1 arm of the NIPU study; however, the clinical data needs longer to mature before definitive conclusions can be drawn from this trend. We stress that the latest results from NIPU should not be used as definitive predictors of efficacy in any of the ongoing Phase II studies for UV1. We have adjusted our valuation of Ultimovacs to reflect the latest NIPU readouts to NOK7.4bn or NOK216/share (previously NOK8.0bn or NOK234/share).
Written by
Ultimovacs |
UV1 by no means out after NIPU readout |
NIPU study results |
Pharma and biotech |
12 June 2023 |
Share price performance
Business description
Next events
Analysts
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Ultimovacs has reported initial clinical data from the Phase II investigator-sponsored NIPU study investigating the company’s cancer vaccine, UV1, for the treatment of relapsed/refractory (r/r) malignant pleural mesothelioma (MPM). While the study did not meet its primary endpoint of progression-free survival (PFS) following assessment conducted by a central independent review committee, local assessments at the study hospitals performed by specialist radiographers measured a statistically significant improvement in PFS. However, it is likely these assessments are not totally blinded. Importantly, a positive trend in overall survival (OS) was observed in the UV1 arm of the NIPU study; however, the clinical data needs longer to mature before definitive conclusions can be drawn from this trend. We stress that the latest results from NIPU should not be used as definitive predictors of efficacy in any of the ongoing Phase II studies for UV1. We have adjusted our valuation of Ultimovacs to reflect the latest NIPU readouts to NOK7.4bn or NOK216/share (previously NOK8.0bn or NOK234/share).
Year |
Revenue |
PBT* |
EPS** |
DPS |
P/E |
Yield |
12/21 |
0.0 |
(164.7) |
(5.09) |
0.0 |
N/A |
N/A |
12/22 |
0.0 |
(167.8) |
(4.89) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(210.8) |
(6.13) |
0.0 |
N/A |
N/A |
12/24e |
0.0 |
(277.9) |
(8.08) |
0.0 |
N/A |
N/A |
Note: *PBT is reported. **EPS is fully diluted.
NIPU should not detract from INITIUM
It is important to note that while the PFS endpoint was not met in the NIPU trial, r/r MPM is regarded as an extremely challenging indication with little evidence, to date, demonstrating the effectiveness of immunotherapy in the second-line treatment setting. Additionally, the NIPU study was an investigator-initiated trial and, in our view, MPM is not a key indication in the company’s pipeline. The Phase II INITIUM study in advanced melanoma is fully funded by Ultimovacs and could be considered as the company’s strategic priority. Due to the significant difference in cancer biology between MPM and melanoma as well as in the established standard of care, we believe there is very little read-across between the results of NIPU and INITIUM.
Proof-of-concept data exists in melanoma
Melanoma is considered one of the most immunogenic tumour types and, unlike in MPM, UV1 has already demonstrated encouraging long-term survival data in combination with pembrolizumab (Keytruda) in first-line unresectable melanoma. The Phase I (UV-103) trial reported PFS of 18.9 months, an improvement on the PFS of 8.4 months reported from a separate study (KEYNOTE-006) for pembrolizumab. Additionally, one- and two-year OS rates from the study were reported to be 87% (26/30) and 73% (22/30) respectively.
Valuation: NOK7.4bn or NOK216/share
Our valuation has been affected the adjustment in our probability of success for UV1 in MPM to 10% (25% previously) and in ovarian cancer (OC) to 15% (25% previously), an indication where immunotherapy has also had limited success.
Valuation
The most recent results of the NIPU study have shown some signals for UV1 efficacy in MPM. Additionally, we note that the results from the CheckMate-743 trial subsequently led to the approval of nivolumab and ipilimumab in first-line MPM and a PFS of 6.8 months was reported for the combination compared to 7.2 months in chemotherapy alone. However, OS for the combination arm was 18.1 months versus 14.1 months with chemotherapy.
Yet, considering the NIPU trial did not meet its primary endpoint we have adjusted the probability of success for UV1 in MPM down to 10% compared to 25% previously, reducing our rNPV valuation in this indication from NOK22.1/share to NOK10.5/share. We have also adjusted the probability of success of UV1 in OC to 15% (previously 25%) due to the fact the investigator-sponsored DOVACC study is not investigating UV1 with any of the OC FDA approved immune checkpoint inhibitors (pembrolizumab and dostarlimab). While the study is assessing UV1 in combination with Olaparib (PARP inhibitor) and durvalumab (PD-L1 inhibitor), the latter is not currently approved in OC and, historically, immunotherapy has struggled in the treatment of OC.
With these changes we value Ultimovacs at NOK7.4bn or NOK216/share (previously NOK8.0bn or NOK234/share), with the company’s value primarily derived from larger oncology indications. Our valuation for Ultimovacs is composed of 22% malignant melanoma, 5% MPM, 8% OC, 22% head and neck cancer, 38% non-small cell lung cancer and 5% cash. A breakdown of our rNPV calculations can be seen in Exhibit 1.
Exhibit 1: Valuation of Ultimovacs
Product |
Launch |
Peak sales |
NPV (NOKm) |
NPV/share (NOK/share) |
Probability |
rNPV (NOKm) |
rNPV/share (NOK/share) |
UV1 – malignant melanoma |
2028 |
1,270 |
6,059.0 |
176.2 |
25.0% |
1,648.5 |
47.9 |
UV1 – mesothelioma |
2028 |
570 |
2,836.2 |
82.5 |
10.0% |
361.0 |
10.5 |
UV1 – ovarian cancer |
2029 |
787 |
3,234.2 |
94.0 |
15.0% |
599.7 |
17.4 |
UV1 – head and neck cancer |
2029 |
1,370 |
5,866.8 |
170.6 |
25.0% |
1,609.5 |
46.8 |
UV1 – NSCLC |
2030 |
2,683 |
10,347.2 |
300.8 |
25.0% |
2,803.4 |
81.5 |
Net cash, last reported |
|
|
405.5 |
11.8 |
100.0% |
405.5 |
11.8 |
Valuation |
|
|
28,749.0 |
835.8 |
7,427.6 |
215.9 |
Source: Edison Investment Research
Exhibit 2: Financial summary
Accounts: IFRS; year end 31 December; NOKm |
|
2019 |
2020 |
2021 |
2022 |
2023e |
2024e |
Income statement |
|
|
|
|
|
|
|
Total revenues |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Cost of sales |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Gross profit |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
SG&A (expenses) |
|
(20.16) |
(50.99) |
(61.92) |
(71.47) |
(85.76) |
(102.91) |
R&D costs |
|
(35.53) |
(64.66) |
(96.74) |
(95.18) |
(109.52) |
(136.90) |
Other income/(expense) |
|
(8.47) |
(5.78) |
(2.48) |
(14.34) |
(27.38) |
(34.22) |
Exceptionals and adjustments |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Reported EBITDA |
|
(64.15) |
(121.43) |
(161.13) |
(180.98) |
(222.65) |
(274.03) |
Depreciation and amortisation |
|
(2.06) |
(2.72) |
(2.70) |
(2.65) |
(2.44) |
(2.38) |
Reported Operating Profit/(loss) |
|
(66.22) |
(124.15) |
(163.83) |
(183.63) |
(225.09) |
(276.41) |
Finance income/(expense) |
|
5.05 |
3.59 |
(0.89) |
15.84 |
14.30 |
(1.50) |
Other income/(expense) |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Exceptionals and adjustments |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Reported PBT |
|
(61.17) |
(120.55) |
(164.72) |
(167.79) |
(210.79) |
(277.91) |
Income tax expense |
|
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Reported net income |
|
(61.17) |
(120.55) |
(164.72) |
(167.79) |
(210.79) |
(277.91) |
|
|
|
|
|
|
|
|
Basic average number of shares, m |
|
22.93 |
30.26 |
32.37 |
34.31 |
34.40 |
34.40 |
Basic EPS (NOK) |
|
(2.67) |
(3.98) |
(5.09) |
(4.89) |
(6.13) |
(8.08) |
Diluted EPS (NOK) |
|
(2.67) |
(3.98) |
(5.09) |
(4.89) |
(6.13) |
(8.08) |
|
|
|
|
|
|
|
|
Balance sheet |
|
|
|
|
|
|
|
Property, plant and equipment |
|
0.536 |
0.377 |
0.212 |
0.220 |
0.125 |
0.007 |
Intangible assets |
|
66.370 |
76.346 |
71.119 |
68.429 |
66.280 |
64.211 |
Other non-current assets |
|
3.523 |
3.630 |
1.951 |
5.444 |
5.444 |
5.444 |
Total non-current assets |
|
70.429 |
80.353 |
73.282 |
74.093 |
71.849 |
69.662 |
Cash and equivalents |
|
399.607 |
440.925 |
574.168 |
425.309 |
226.907 |
111.739 |
Trade and other receivables |
|
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
Other current assets |
|
8.004 |
8.438 |
8.087 |
10.270 |
10.270 |
10.270 |
Total current assets |
|
407.611 |
449.363 |
582.255 |
435.579 |
237.177 |
122.009 |
Non-current loans and borrowings |
|
2.301 |
2.075 |
0.457 |
3.713 |
3.713 |
153.713 |
Deferred tax liabilities |
|
10.851 |
11.795 |
11.031 |
10.701 |
10.701 |
10.701 |
Total non-current liabilities |
|
13.152 |
13.870 |
11.488 |
14.414 |
14.414 |
164.414 |
Trade and other payables |
|
11.768 |
8.611 |
22.555 |
7.655 |
9.383 |
11.523 |
Other current liabilities |
|
8.489 |
18.856 |
28.342 |
38.252 |
38.252 |
38.252 |
Total current liabilities |
|
20.257 |
27.467 |
50.897 |
45.907 |
47.635 |
49.775 |
Equity attributable to company |
|
444.632 |
488.380 |
593.152 |
449.351 |
246.977 |
(22.518) |
|
|
|
|
|
|
|
|
Cash flow statement |
|
|
|
|
|
|
|
Operating Profit/(loss) |
|
(66.217) |
(124.146) |
(163.833) |
(183.630) |
(225.093) |
(276.412) |
Depreciation and amortisation |
|
2.063 |
2.720 |
2.703 |
2.648 |
2.439 |
2.382 |
Other adjustments |
|
(2.023) |
3.215 |
12.331 |
4.437 |
(6.367) |
2.747 |
Movements in working capital |
|
(1.862) |
6.395 |
23.860 |
(6.988) |
1.728 |
2.139 |
Interest paid / received |
|
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
Income taxes paid |
|
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
Cash from operations (CFO) |
|
(62.988) |
(108.223) |
(125.828) |
(167.694) |
(212.994) |
(270.646) |
Capex |
|
(0.172) |
(0.282) |
(0.085) |
(0.195) |
(0.195) |
(0.195) |
Acquisitions & disposals net |
|
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
Other investing activities |
|
4.490 |
(0.455) |
3.062 |
8.887 |
14.787 |
5.673 |
Cash used in investing activities (CFIA) |
|
4.318 |
(0.737) |
2.977 |
8.692 |
14.592 |
5.478 |
Net proceeds from issue of shares |
|
344.582 |
152.933 |
261.852 |
5.484 |
0.000 |
0.000 |
Movements in debt |
|
0.000 |
0.000 |
0.000 |
0.000 |
0.000 |
150.000 |
Other financing activities |
|
(1.579) |
(1.916) |
(1.895) |
(1.907) |
0.000 |
0.000 |
Cash flow from financing activities |
|
343.003 |
151.017 |
259.957 |
3.577 |
0.000 |
150.000 |
Increase/(decrease) in cash and equivalents |
|
284.333 |
42.057 |
137.106 |
(155.425) |
(198.402) |
(115.168) |
Cash and equivalents at beginning of period |
|
115.540 |
399.607 |
440.925 |
574.168 |
425.309 |
226.907 |
Cash and equivalents at end of period |
|
399.608 |
440.925 |
574.168 |
425.310 |
226.907 |
111.739 |
Net (debt) cash (including lease liabilities) |
|
395.982 |
437.143 |
572.083 |
419.830 |
221.427 |
(43.741) |
Source: Edison Investment Research, Ultimovacs company accounts
|
|
Research: Healthcare
Basilea has announced receipt of two separate sales-related milestone payments totalling US$26.25m (CHF23.7m) from licensing partner Pfizer. The milestones relate to sales in Europe (ex-Nordic countries), as well as in China and 16 countries in the Asia-Pacific region where Pfizer is the licensing partner. The payments were tiggered by cumulative sales of its antifungal therapy Cresemba exceeding specific thresholds in the aforementioned regions, and we believe this indicates strong continued demand for the drug (13% global share and 34% in the US in best-in-class antifungals as of December 2022, according to IQVIA). As part of the agreement with Pfizer, Basilea is eligible to receive additional potential milestone payments of up to approximately CHF515m, as well as mid-teen royalties based on net sales. We will adjust our model to reflect receipt of these milestone payments slightly sooner than we expected, but overall, these have come within management guided milestones for 2023.