Last close As at 05/08/2026
CHF51.40
▲ 0.70 (1.38%)
Market capitalisation
CHF681m
Research: Healthcare
Basilea has provided an update on the three ongoing derazantinib Phase II trials (FIDES-01/02/03) that will define its utility in iCCA (bile duct cancer), urothelial cancer (UC) and gastric cancer (GC). Importantly, updated data from the open-label FIDES-01 study confirm encouraging efficacy in iCCA patients with FGFR2 gene fusions. Derazantinib’s value lies in its unique MOA (FGFR inhibition plus CSF1R activity) and favourable safety profile, which suggests it could enable synergies with other therapies. While we forecast its first route to market in 2023 in iCCA, multiple data readouts expected in 2021/22 from FIDES-02 (UC) and FIDES-03 (GC) will determine combination strategies and its potential differentiation from the competition. We maintain our valuation of CHF1.17bn or CHF99 per share.
Written by
Basilea Pharmaceutica |
Multiple catalysts on the horizon |
FIDES clinical trials update |
Pharma & biotech |
4 June 2021 |
Share price performance
Business description
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Analysts
Basilea Pharmaceutica is a research client of Edison Investment Research Limited |
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Basilea has provided an update on the three ongoing derazantinib Phase II trials (FIDES-01/02/03) that will define its utility in iCCA (bile duct cancer), urothelial cancer (UC) and gastric cancer (GC). Importantly, updated data from the open-label FIDES-01 study confirm encouraging efficacy in iCCA patients with FGFR2 gene fusions. Derazantinib’s value lies in its unique MOA (FGFR inhibition plus CSF1R activity) and favourable safety profile, which suggests it could enable synergies with other therapies. While we forecast its first route to market in 2023 in iCCA, multiple data readouts expected in 2021/22 from FIDES-02 (UC) and FIDES-03 (GC) will determine combination strategies and its potential differentiation from the competition. We maintain our valuation of CHF1.17bn or CHF99 per share.
Year end |
Revenue (CHFm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/19 |
134.4 |
(22.3) |
(2.08) |
0.0 |
N/A |
N/A |
12/20 |
127.6 |
(29.6) |
(2.89) |
0.0 |
N/A |
N/A |
12/21e |
135.1 |
(26.8) |
(2.10) |
0.0 |
N/A |
N/A |
12/22e |
140.1 |
1.5 |
0.12 |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
iCCA provides competitive clinical proof-of-concept
Updated top-line data (April data cut-off) from the FIDES-01 study in iCCA patients with FGFR2 gene fusions (cohort 1, n=103) highlight further improvement in efficacy (ORR 21.4% vs 20.4% and DCR 74.8% vs 72.8%). The mPFS of 7.8 months (vs 6.6 months) is in the upper range of peers in the FGFR inhibitor class. These data establish a competitive clinical proof-of-concept as monotherapy (MT) with potential read across to other cancers where FGFR2 aberrations are implicated. Enrolment into cohort 2 (FGFR2 gene mutations or amplifications) is ongoing (top-line results expected in H122). This cohort is important as it could provide differentiating data versus competitors.
Combinations key to larger opportunities in UC & GC
With the competitive landscape evolving in UC and GC, Basilea is strategically exploring a higher dose of derazantinib (400mg per day) to maximise efficacy and differentiate it from existing therapies. Derazantinib’s favourable safety profile and good tolerability provide an improved value proposition vs competitors and could prove advantageous for use in rational combinations. Interim results from FIDES-02 (UC) for the higher dose MT and combination with Tecentriq are now expected in H122. While interim results from FIDES-03 (GC) for the higher dose MT and recommended Phase II dose of the combination with Cyramza and paclitaxel are expected in H122. UC and GC represent the biggest opportunities for derazantinib, and collectively these data will enable Basilea to define an optimal registration and commercialisation strategy.
Valuation: rNPV of CHF1.17bn or CHF99 per share
Our valuation is unchanged at CHF1.17bn or CHF99 per share and reflects CHF77.9m net debt at 31 December 2020, excluding the gross CHF45.75m post-period capital raise.
Exhibit 1: Financial summary
Accounts: US GAAP, year-end: 31 December, CHF000s |
|
|
2018 |
2019 |
2020 |
2021e |
2022e |
PROFT & LOSS |
|
|
|
|
|
|
|
Total revenues |
|
|
132,555 |
134,381 |
127,629 |
135,148 |
140,122 |
Product revenues (Cresemba and Zevtera) |
|
|
105,900 |
114,461 |
112,032 |
116,800 |
139,809 |
Cost of sales |
|
|
(20,299) |
(18,868) |
(24,054) |
(27,319) |
(22,696) |
Gross profit |
|
|
112,256 |
115,513 |
103,575 |
107,830 |
117,426 |
Research and development expenses (net) |
|
|
(104,942) |
(102,662) |
(97,410) |
(97,000) |
(78,700) |
SG&A costs |
|
|
(31,409) |
(30,051) |
(29,422) |
(29,442) |
(29,813) |
Other income/(expense) |
|
|
0 |
0 |
0 |
0 |
0 |
Exceptionals and adjustments |
|
|
0 |
0 |
15,035 |
0 |
0 |
EBITDA (reported) |
|
|
(22,243) |
(15,561) |
(7,032) |
(17,110) |
10,520 |
Reported operating income |
|
|
(24,095) |
(17,200) |
(8,222) |
(18,613) |
8,913 |
Operating margin % |
|
|
n/a |
n/a |
n/a |
n/a |
n/a |
Finance income/(expense) |
|
|
(7,065) |
(5,182) |
(6,445) |
(8,307) |
(7,497) |
Exceptionals and adjustments |
|
|
0 |
0 |
0 |
0 |
0 |
Profit before tax (reported) |
|
|
(31,160) |
(22,382) |
(14,667) |
(26,919) |
1,416 |
Profit before tax (normalised) |
|
|
(31,060) |
(22,282) |
(29,602) |
(26,801) |
1,538 |
Income tax expense (includes exceptionals) |
|
|
(192) |
(40) |
(55) |
0 |
0 |
Net income (reported) |
|
|
(31,352) |
(22,422) |
(14,722) |
(26,919) |
1,416 |
Net income (normalised) |
|
|
(31,252) |
(22,322) |
(29,657) |
(26,801) |
1,538 |
Basic average number of shares, m |
|
|
10.8 |
10.8 |
10.3 |
12.8 |
12.9 |
Basic EPS (CHF c) |
|
|
(289.3) |
(208.5) |
(143.2) |
(210.8) |
11.0 |
Adjusted EPS (CHF c) |
|
|
(288.4) |
(207.5) |
(288.5) |
(209.9) |
11.9 |
Dividend per share (CHF c) |
|
|
0 |
0 |
0 |
0 |
0 |
BALANCE SHEET |
|
|
|
|
|
|
|
Tangible assets |
|
|
6,424 |
5,162 |
2,627 |
3,242 |
3,757 |
Intangible assets |
|
|
372 |
372 |
672 |
754 |
832 |
Long-term investments |
|
|
0 |
30,000 |
0 |
0 |
0 |
Other non-current assets |
|
|
217 |
1,073 |
2,967 |
2,967 |
2,967 |
Total non-current assets |
|
|
7,013 |
36,607 |
6,266 |
6,963 |
7,556 |
Cash and equivalents |
|
|
173,034 |
109,024 |
60,749 |
53,319 |
60,103 |
Short-term investments |
|
|
50,000 |
20,000 |
101,023 |
101,023 |
101,023 |
Inventories |
|
|
14,411 |
18,569 |
21,192 |
32,184 |
26,738 |
Trade and other receivables |
|
|
3,757 |
6,242 |
8,710 |
11,108 |
11,517 |
Other current assets |
|
|
33,536 |
31,025 |
31,854 |
31,854 |
31,854 |
Total current assets |
|
|
274,738 |
184,860 |
223,528 |
229,487 |
231,235 |
Long-term liabilities |
|
|
196,982 |
197,740 |
239,668 |
241,024 |
242,380 |
Deferred revenue |
|
|
69,945 |
16,471 |
13,158 |
2,990 |
2,990 |
Non-current operating lease liabilities |
|
|
0 |
548 |
896 |
896 |
896 |
Other non-current liabilities |
|
|
14,827 |
24,174 |
27,957 |
27,957 |
27,957 |
Total non-current liabilities |
|
|
281,754 |
238,933 |
281,679 |
272,867 |
274,223 |
Accounts payable |
|
|
6,399 |
6,765 |
13,151 |
8,607 |
7,151 |
Deferred revenue |
|
|
25,025 |
32,873 |
2,556 |
2,500 |
0 |
Current operating lease liabilities |
|
|
0 |
352 |
1,752 |
1,752 |
1,752 |
Other current liabilities |
|
|
35,260 |
35,504 |
32,702 |
32,702 |
32,702 |
Total current liabilities |
|
|
66,684 |
75,494 |
50,161 |
45,561 |
41,605 |
Net assets |
|
|
(66,687) |
(92,960) |
(102,046) |
(81,978) |
(77,037) |
CASH FLOW STATEMENT |
|
|
|
|
|
|
|
Reported net income |
|
|
(31,352) |
(22,422) |
(14,722) |
(26,919) |
1,416 |
Depreciation and amortisation |
|
|
1,852 |
1,639 |
1,190 |
1,503 |
1,607 |
Share based payments |
|
|
6,251 |
3,048 |
3,525 |
3,525 |
3,525 |
Other adjustments |
|
|
758 |
758 |
(13,365) |
1,356 |
1,356 |
Movements in working capital |
|
|
(56,719) |
(46,859) |
(30,762) |
(28,158) |
1,080 |
Cash from operations (CFO) |
|
|
(79,210) |
(63,836) |
(54,134) |
(48,693) |
8,985 |
Capex |
|
|
(419) |
(294) |
(1,823) |
(2,000) |
(2,000) |
Short-term investments |
|
|
60,000 |
30,000 |
(51,023) |
0 |
0 |
Long-term investments |
|
|
0 |
(30,000) |
0 |
0 |
0 |
Other investing activities |
|
|
(190) |
(110) |
17,883 |
(200) |
(200) |
Cash used in investing activities (CFIA) |
|
|
59,391 |
(404) |
(34,963) |
(2,200) |
(2,200) |
Net proceeds from issue of shares |
|
|
0 |
0 |
0 |
43,463 |
0 |
Movements in debt |
|
|
0 |
0 |
43,451 |
0 |
0 |
Other financing activities |
|
|
(5,986) |
1,309 |
1,616 |
0 |
0 |
Cash from financing activities (CFF) |
|
|
(5,986) |
1,309 |
45,067 |
43,463 |
0 |
Cash and equivalents at beginning of period |
|
|
200,724 |
173,908 |
111,044 |
66,256 |
58,826 |
Increase/(decrease) in cash and equivalents |
|
|
(25,805) |
(62,931) |
(44,030) |
(7,430) |
6,785 |
Effect of FX on cash and equivalents |
|
|
(1,011) |
67 |
(758) |
0 |
0 |
Cash and equivalents at end of period |
|
|
173,908 |
111,044 |
66,256 |
58,826 |
65,610 |
Net (debt)/cash |
|
|
26,052 |
(68,716) |
(77,896) |
(86,682) |
(81,254) |
Source: Company accounts, Edison Investment Research
|
|
Research: TMT
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