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Research: Healthcare
On 9 October 2019, NeuroVive held its capital markets day. Management presented its strategic focus on the company’s primary mitochondrial disease programmes, high unmet medical need in this area and advantages of the orphan drug development compared to drugs for common diseases. As expected, no major new details were disclosed. We note an interesting presentation on regulatory perspectives on orphan drug development by NeuroVive’s clinical and regulatory affairs director, Matilda Hugerth. It is not that often investors have straightforward access to expert knowledge about such a specialised topic presented in a clear format. Our valuation is unchanged at SEK1.63bn or SEK8.8/share.
Written by
NeuroVive Pharmaceutical |
Capital markets day take aways |
Capital markets day |
Pharma & biotech |
23 October 2019 |
Share price performance
Business description
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On 9 October 2019, NeuroVive held its capital markets day. Management presented its strategic focus on the company's primary mitochondrial disease programmes, high unmet medical need in this area and advantages of the orphan drug development compared to drugs for common diseases. As expected, no major new details were disclosed. We note an interesting presentation on regulatory perspectives on orphan drug development by NeuroVive’s clinical and regulatory affairs director, Matilda Hugerth. It is not that often investors have straightforward access to expert knowledge about such a specialised topic presented in a clear format. Our valuation is unchanged at SEK1.63bn or SEK8.8/share.
Year end |
Revenue (SEKm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/17 |
0.6 |
(70.1) |
(1.49) |
0.0 |
N/A |
N/A |
12/18 |
2.5 |
(68.8) |
(0.94) |
0.0 |
N/A |
N/A |
12/19e |
1.5 |
(94.1) |
(0.65) |
0.0 |
N/A |
N/A |
12/20e |
1.5 |
(117.9) |
(0.66) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles and exceptional items.
KL1333 and NV354 lead assets in core portfolio
KL1333, a small molecule NAD+ modulator used to restore intracellular energy balance, is in the multiple ascending dose (MAD) part of the Phase Ia/b trial. The single ascending dose (SAD) part of the trial delivered positive PK and safety data. KL1333 is being developed for primary mitochondrial disease, for example due to an m.3243 A>G mutation (eg MELAS, MIDD, PEO). The MAD part will also recruit mitochondrial disease patients (expected in H120). This will be the first time KL1333 is tested in patients and could potentially deliver interesting initial efficacy signs. If results are positive, the Phase II trial could start as soon as 2020. NV354, a succinate prodrug targeting complex I deficiency (such as Leigh syndrome and LHON), is the second lead drug candidate in the core portfolio targeting mitochondrial disease. The mechanism of action (MoA) is different to KL1333, but has the same goal of increasing the production of cellular energy (Exhibit 3). IND-enabling studies are ongoing and the Phase I study could start in 2020.
NeuroSTAT ready for Phase II development
NeuroSTAT, an innovative formulation of ciclosporin, is the most advanced asset in the portfolio for out-licensing and partnering and is positioned for the treatment of traumatic brain injury, where there is no neuroprotective treatment available yet. NeuroSTAT has accumulated some initial efficacy data and has received IND approval from the FDA. NeuroVive indicated that while promising, NeuroSTAT will require too much resource for NeuroVive to take to the market and hence it is focusing on finding partners that can finance the Phase II trial.
Valuation: SEK1.63bn or SEK8.8/share
We keep our valuation unchanged at SEK1.63bn or SEK8.8/sh. Potential near-term milestones include initial results from KL1333 Phase Ia/b, a non-dilutive financing solution for NeuroSTAT Phase II trial and NV354 entering clinical development. More detail on the projects are given in our recent update report.
Capital markets day take aways (exhibits)
|
Exhibit 1: NeuroVive’s R&D pipeline |
|
|
Source: NeuroVive |
|
Exhibit 2: KL1333 and NV354 projects |
|
|
Source: NeuroVive |
|
Exhibit 3: NeuroVive’s lead assets have different MoAs, but share the goal of increasing energy production |
|
|
Source: NeuroVive |
Exhibit 4: Orphan drug designation benefits
Direct benefits and incentives ■ Regulatory assistance – protocol assistance and scientific advice meetings ■ Financial regulatory incentives • Fee reductions, eg the EMA application fee of €278k waived for SMEs • Tax benefit, eg 50% of clinical costs in the US ■ National incentives, eg grants ■ Market exclusivity • EU: 10 years, plus two years if paediatric studies conducted • US: seven years |
Additional effects of orphan designation ■ Lower clinical development costs (fewer patients need to be recruited) ■ Access to expedited programmes • Fast-track designation, breakthrough designation (US), PRIME (EU) • Conditional approval (EU), accelerated approval (US), accelerated review (EU), priority review (US) • Rare paediatric priority review voucher (US) ■ Historically likelihood of success is higher for orphan drugs (32% vs 11% for non-orphans) ■ Pricing and reimbursement: separate pool compared to non-orphans, premium price is more common |
Source: NeuroVive
Exhibit 5: NeuroVive sum-of-the parts valuation
Product |
Launch |
Peak sales* |
NPV |
NPV/share |
Probability |
rNPV |
rNPV/share |
KL1333 |
2024 |
574 |
626.7 |
3.4 |
10% |
58.8 |
0.3 |
NV354** |
2027 |
875 |
480.6 |
2.6 |
5% |
21.4 |
0.1 |
NeuroSTAT |
2025 |
454 |
306.0 |
1.6 |
15% |
37.0 |
0.2 |
NV556 |
2027 |
1,743 |
147.8 |
0.8 |
8% |
32.2 |
0.2 |
NVP024 |
2029 |
730 |
33.0 |
0.2 |
3% |
7.9 |
0.0 |
Net cash, last reported |
10.2 |
0.1 |
100% |
10.5 |
0.1 |
||
Valuation |
|
|
1,604.2 |
8.6 |
167.5 |
0.9 |
|
SEKm |
SEK/share |
Probability |
SEKm |
SEK/share |
|||
KL1333 |
6,103.7 |
32.8 |
10% |
573.1 |
3.1 |
||
NV354 |
4,680.6 |
25.2 |
5% |
208.5 |
1.1 |
||
NeuroSTAT |
2,980.2 |
16.0 |
15% |
360.5 |
1.9 |
||
NV556 |
1,439.8 |
7.7 |
8% |
313.5 |
1.7 |
||
NVP024 |
321.1 |
1.7 |
3% |
77.0 |
0.4 |
||
Net cash, last reported |
99.1 |
0.5 |
100% |
99.1 |
0.5 |
||
Valuation |
15,624.5 |
84.0 |
1,631.7 |
8.8 |
Source: Edison Investment Research. Note: *Peak sales reached six years after launch. WACC = 12.5% for product valuations. **Formerly NVP015.
Exhibit 6: Financial summary
SEK'000s |
|
2017 |
2018 |
2019e |
2020e |
|
December |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
585 |
2,466 |
1,500 |
1,500 |
Cost of Sales |
0 |
0 |
0 |
0 |
||
Gross Profit |
585 |
2,466 |
1,500 |
1,500 |
||
Research and development |
(27,926) |
(37,922) |
(61,687) |
(83,764) |
||
EBITDA |
|
|
(67,897) |
(66,675) |
(94,001) |
(117,791) |
Operating Profit (before amort. and except.) |
|
|
(69,492) |
(68,589) |
(94,148) |
(117,923) |
Intangible Amortisation |
0 |
0 |
0 |
0 |
||
Exceptionals |
(1,595) |
(4,771) |
0 |
0 |
||
Other |
56 |
66 |
0 |
0 |
||
Operating Profit |
(71,031) |
(73,294) |
(94,148) |
(117,923) |
||
Net Interest |
(571) |
(200) |
0 |
0 |
||
Profit Before Tax (norm) |
|
|
(70,063) |
(68,789) |
(94,148) |
(117,923) |
Profit Before Tax (reported) |
|
|
(71,602) |
(73,494) |
(94,148) |
(117,923) |
Tax |
0 |
0 |
0 |
0 |
||
Profit After Tax (norm) |
(70,007) |
(68,723) |
(94,148) |
(117,923) |
||
Profit After Tax (reported) |
(66,727) |
(68,373) |
(89,027) |
(112,802) |
||
Average Number of Shares Outstanding (m) |
50.2 |
78.5 |
152.8 |
186.0 |
||
EPS - normalised (SEK) |
|
|
(1.49) |
(0.94) |
(0.65) |
(0.66) |
EPS - normalised fully diluted (SEK) |
|
|
(1.49) |
(0.94) |
(0.65) |
(0.66) |
EPS - reported (SEK) |
|
|
(1.33) |
(0.87) |
(0.58) |
(0.61) |
Dividend per share (SEK) |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
100.0 |
100.0 |
100.0 |
100.0 |
||
EBITDA Margin (%) |
N/A |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except.) (%) |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
||||||
Fixed Assets |
|
|
87,579 |
86,681 |
86,681 |
86,681 |
Intangible Assets |
74,315 |
73,440 |
73,440 |
73,440 |
||
Tangible Assets |
162 |
140 |
140 |
140 |
||
Investments |
13,102 |
13,101 |
13,101 |
13,101 |
||
Current Assets |
|
|
30,560 |
27,383 |
41,385 |
1,432 |
Stocks |
0 |
0 |
0 |
0 |
||
Debtors |
0 |
0 |
0 |
0 |
||
Cash |
28,992 |
25,951 |
39,953 |
0 |
||
Other |
1,568 |
1,432 |
1,432 |
1,432 |
||
Current Liabilities |
|
|
(14,259) |
(18,296) |
(18,296) |
(18,296) |
Creditors |
(14,259) |
(18,296) |
(18,296) |
(18,296) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
0 |
0 |
0 |
(77,908) |
Long term borrowings |
0 |
0 |
0 |
(77,908) |
||
Other long term liabilities |
0 |
0 |
0 |
0 |
||
Net Assets |
|
|
103,880 |
95,768 |
109,770 |
(8,091) |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(58,039) |
(63,630) |
(94,001) |
(117,791) |
Net Interest |
(84) |
(199) |
0 |
0 |
||
Tax |
0 |
0 |
0 |
0 |
||
Capex |
(40) |
(82) |
(87) |
(70) |
||
Acquisitions/disposals* |
(11,035) |
0 |
0 |
0 |
||
Financing |
9,031 |
64,656 |
108,090 |
0 |
||
Other |
(4,092) |
(3,786) |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
(64,259) |
(3,041) |
14,002 |
(117,861) |
||
Opening net debt/(cash) |
|
|
(93,251) |
(28,992) |
(25,951) |
(39,953) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Other |
0 |
(0) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(28,992) |
(25,951) |
(39,953) |
77,908 |
Source: NeuroVive accounts, Edison Investment Research
|
|
Research: Healthcare
On 18 October 2019, RedHill announced a strategic investment and in-licensing deal with Cosmo Pharmaceuticals, a European specialty GI pharma and diagnostics company (sales of €66m in 2018). RedHill will receive an exclusive licence for the US rights to a branded antibiotic, Aemcolo (rifamycin), which was approved by the FDA for the treatment of traveller’s diarrhoea in November 2018. In return, RedHill will pay Cosmo the stock equivalent of $12m upfront, a royalty percentage on net sales in the high 20s and commercial milestone payments up to $100m. Cosmo has also agreed to make a $36.3m investment in RedHill at $7/ADS (a 13.5% premium to the prior close; 20% stake after investment). The deal expands RedHill’s specialty GI drug portfolio in the US and strengthens its balance sheet ahead of the expected launch of TALICIA (PDUFA date: 2 November 2019). Our valuation is $556m or $15.4/ADS.