We have revisited our valuation methodology for Orexo to better capture the potential impact of recent legislative changes in the US. We now explicitly break down our US Zubsolv forecasts into two parts: the existing market and new patients. Orexo’s aim of securing a disproportionate share of new patients means these forecasts are subject to certain differing dynamics. Our new Orexo valuation is SEK3.16bn or SEK91/share (vs SEK4.54bn or SEK131/share previously).
In addition to the change in methodology (and associated assumptions that we outline below), we have made a number of housekeeping adjustments, rolling forward our model and updating our forecast with FY17 guidance and the prevailing FX rates (now SEK8.82/US$ from SEK8.84/US$; SEK9.46/€ from SEK9.69/€).
We extend our explicit DCF-based valuation to 2032 (previously to 2030) in line with expiry of the longest dated Zubsolv patents, and update the long-term tax rate of 22% from 2017 (in line with the current Swedish corporate tax rate vs our previous 30% assumption), but continue to assume a WACC of 10% and no terminal value. We also continue to estimate a long-term gross margin of 80% on Zubsolv by 2025, driven by manufacturing improvements and higher production volumes, with the operating margin gradually trending to c 45% in the long term.
We include a modest revenue contribution from global Abstral and Edluar royalties until 2020, at which point we assume for simplicity that all revenues relate to Zubsolv, Orexo’s main value driver. Following FY16 results, we have lowered our US Abstral forecasts from 2017 onward, modelling a slower relaunch trajectory and lower peak sales given progress made so far by Sentynl Therapeutics (and impending genericisation in 2018); we also lower our Edluar revenue expectation from 2017 due to prospect of first generics this year.
In the absence of information regarding Orexo’s R&D pipeline, we ascribe no value to this. Securing a partner and defining the indication for OX-51 could unlock valuation upside, as would pipeline expansion (first disclosures are anticipated later this year). Finally, acquisition of new product(s) for commercialisation by the Zubsolv US sales infrastructure would also represent upside.
New US Zubsolv assumptions
Exhibit 5 summarises our Zubsolv revenue assumptions to 2022, broken down into three segments: the US current market, US new patients, and the European market.
We have substantially revisited our assumptions in the US. Market share gains since Zubsolv launched in 2013, coupled with evolution of the competitive landscape and overall market trends (growing importance of public segment, pricing/rebating pressure), have changed the profile of the opportunity for Zubsolv. Our more detailed model results in both lower peak market share (from an aggregate 25%) and overall peak sales, which underpin our lower Orexo valuation. Our previous 2021e sales assumption of c $580m gross (c $300m net) is reduced to c $250m gross ($140m net). The key base case assumptions behind our new model are:
■
Current market: peak market share of 10% reached in 2022 (net revenue of c $145m). Long-term rebate level of 45% (from 2019).
■
New patients: peak market share of 15% (disproportionate share of new patients) achieved in 2024 (net revenue of $53m). Slower ramp-up to peak reflecting initial lag period as the number of C275 physicians increases as well as the time for each to expand their patient practice. Higher long-term rebate of 50% due to the relative importance of the public segment to C275 physicians.
■
Common assumptions: launch of depot formulation(s) – Indivior’s RBP-6000 and Braeburn/Camurus’s CAM2038 – from 2018 does not result in a paradigm shift in opioid dependence treatment, but does slow the rate of growth of oral formulations, affected by Indivior’s marketing strength and focus. Growth in Zubsolv and its market share declines from 2024 with potential entry of Suboxone Film generics (US patent 8,603,514, recently upheld by the courts, expires in April 2024).
In Europe we continue to assume launch by late 2018, subject to reimbursement decisions from various national authorities, with European sales of c €60m in year six, peak sales of €100m (20% share of a conservative €500m market growing at 2% pa); and a net royalty of 10%. We model a long-term average rebate of 20% from 2022. As the magnitude and timing of milestones from Mundipharma are undisclosed, these are not captured in Exhibit 5 or our full model; nevertheless, we would expect milestones to become due on approval/launch in key territories. In addition, we do not explicitly value the RoW opportunity (ex-US, ex-Europe) until Mundipharma discloses its intention and there is more clarity on timelines; we recognise this could provide upside to our forecasts.
Exhibit 5: Zubsolv revenue assumptions to 2022
Assumption |
2016 |
2017e |
2018e |
2019e |
2020e |
2021e |
2022e |
US current market |
|
|
|
|
|
|
|
US Zubsolv sales (current) – pre-rebates ($m) |
115.9 |
129.1 |
148.3 |
167.6 |
199.3 |
230.9 |
263.0 |
US Zubsolv sales (current) – post-rebates ($m) |
54.5 |
59.4 |
73.8 |
89.7 |
109.6 |
127.0 |
144.6 |
US Zubsolv sales (current) – post-rebates (SEKm) |
481.8 |
524.1 |
650.9 |
791.4 |
967.1 |
1,120.6 |
1,276.2 |
US new patients |
|
|
|
|
|
|
|
US Zubsolv sales (new) – pre-rebates ($m) |
|
4.6 |
6.3 |
8.3 |
13.0 |
22.8 |
33.5 |
US Zubsolv sales (new) – post-rebates ($m) |
|
2.1 |
3.0 |
4.0 |
6.4 |
11.4 |
16.8 |
US Zubsolv sales (new) – post-rebates (SEKm) |
|
18.6 |
26.7 |
35.4 |
56.3 |
100.6 |
147.9 |
Total US Zubsolv sales – post-rebates (SEKm) |
481.8 |
542.7 |
677.6 |
826.9 |
1,023.4 |
1,221.2 |
1,424.1 |
|
|
|
|
|
|
|
|
Europe |
|
|
|
|
|
|
|
European Zubsolv sales – pre-rebates (€m) |
|
|
1.0 |
5.2 |
10.6 |
16.2 |
22.1 |
European Zubsolv sales – post-rebates (€m) |
|
|
0.6 |
3.4 |
7.4 |
12.2 |
17.7 |
European Zubsolv sales – post-rebates (SEKm) |
|
|
5.8 |
32.0 |
70.3 |
115.3 |
167.2 |
Total European Zubsolv net royalty (SEKm) |
|
|
0.6 |
3.2 |
7.0 |
11.5 |
16.7 |
|
|
|
|
|
|
|
|
Total Zubsolv revenues – post-rebates (SEKm) |
481.8 |
542.7 |
678.1 |
830.1 |
1,030.4 |
1,232.7 |
1,440.8 |
Total product sales (SEKm) ** |
598.2 |
693.4 |
738.1 |
870.3 |
1,046.2 |
1,232.7 |
1,440.8 |
Source: Edison Investment Research, Orexo. Note: In the US, assumes SEK8.82/$ FX rate, peak market share of 10% (current market) and 15% (new patients) with long-term rebate of 45% (current market) and 50% (new patients). In Europe, SEK9.46/€, peak market share of 20% and average 20% rebate. **Total product sales includes revenues from products other than Zubsolv until 2020.
Zubsolv scenarios: What might the market be pricing in?
The uncertainty regarding the generic threat (both direct and indirect, ie Suboxone Film generics) has weighed heavily on the share price over the past year. The outcome of IP infringement suits filed by Orexo (Zubsolv) and Suboxone Film (Indivior) will determine launch timing of the first lower priced generics into the US opioid dependence market, and like continued pricing/rebating pressures, are a downside risk to our forecasts. Consequently we explore various scenarios centred on penetration/rebating levels (Exhibit 6) and the worst case scenario of Zubsolv generic entry in 2019 (Exhibit 7), which indicate that the market views limited prospects for Zubsolv.
Exhibit 6: Scenario analysis – penetration/pricing
Scenario |
Assumptions* |
Per share valuation (SEK) |
Company valuation (SEKbn) |
Current market |
New patients |
Base case |
Rebate: 45% Penetration: 10% |
Rebate: 50% Penetration: 15% |
91 |
3.16 |
Higher rebate |
50% |
55% |
86 |
2.98 |
Lower penetration |
6% |
10% |
51 |
1.76 |
Higher rebate & lower penetration |
Rebate: 50% Penetration: 6% |
Rebate: 55% Penetration: 10% |
47 |
1.63 |
Source: Edison Investment Research. Note: *All other assumptions unchanged.
Exhibit 7: Sensitivity analysis – generic entry in 2019
Zubsolv peak market share |
Loss of 50% revenues to generic(s) |
Loss of 80% revenues to generic(s) |
Current market |
New patients |
Implied per share value (SEK) |
Implied company valuation (SEKbn) |
Implied per share value (SEK) |
Implied company valuation (SEKbn) |
6% |
10% |
50 |
1.74 |
50 |
1.72 |
10% |
15% |
91 |
3.14 |
90.5 |
3.13 |
Source: Edison Investment Research. Note: All other assumptions unchanged.
According to our model, the current share price (SEK32.5) is supported by a scenario whereby Zubsolv does not improve its current market share (6% overall market, 10% new patients), rebating remains high and it loses 80% of peak revenues in the first year post-genericisation (ie in 2020). However, this does not factor in a commensurate and likely significant decrease in sales costs as Orexo switches to a branded generic strategy. Additionally, it implies that Orexo loses its appeal on ‘330, is unable to defend other approved patents, and/or does not reach a settlement with Actavis.
We have not explored potential upside scenarios but highlight there are several circumstances that could lead us to upgrade our Zubsolv forecasts. More certainty regarding the increasing genericisation of the opioid dependence market is one. Others include evidence of a growth step up/increased market share stimulated by improved market access (new contract wins with insurers) and also higher underlying market growth driven by implementation of new US legalisation to increase access to treatment. Our model indicates that market share gains (penetration) in the next couple of years are the most important determinant of valuation.