asarina pharma - amazon web services
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Important information: All information regarding limitation of liability and potential conflicts of interest can be found at the end of the report Redeye, Mäster Samuelsgatan 42, 10tr, Box 7141, 103 87 Stockholm. Tel. +46 8-545 013 30, E-post: [email protected]
Update
Equity Research 5 April 2020
KEY STATS
Ticker ASAP.ST Market First North
Share Price (SEK) 26.9 Market Cap (MSEK) 504 Net Debt 20E (MSEK) -53 Free Float 43 %
Avg. daily volume (‘000) 4
BEAR BASE BULL 8.0
50.0
120.0
KEY FINANCIALS (SEKm)
2018 2019 2020E 2021E 2022E 2023E Net sales 0 0 0 125 0 57 EBITDA -52 -81 -84 15 -128 -57 EBIT -52 -81 -84 15 -128 -57 EPS (adj.)
2018 2019 2020E 2021E 2022E 2023E EPS (adj.) 0.0 -3.8 -4.1 0.8 -6.8 -3.0 EV/Sales N/A N/A N/A N/A N/A N/A EV/EBITDA N/A N/A N/A N/A N/A N/A EV/EBIT N/A N/A N/A N/A N/A N/A P/E N/A N/A N/A N/A N/A N/A
ANALYSTS
Anders Hedlund [email protected] Arvid Necander [email protected]
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Asarina Pharma
Asarina Pharma: Moment of Truth Redeye considers the results of Asarina Pharma’s phase IIb trial, to be presented at the end
of April, as one of the highlights on the Scandinavian biotech scene this year. We set the
likelihood for a positive outcome to 50 percent in the phase IIb trial and see an attractive
risk/reward at current share levels.
Phase IIb results at the end of April
In this update, we preview the data by giving some background to the phase IIb study, what
good results mean in concrete and competitive terms, as well as risk factors.
Outcome scenarios
The share had started to gain momentum upon read-out. Then the Corona crisis came. On
current share levels (~ SEK 24 per share), we see a very attractive risk/reward. With a true
inflection point just weeks away, we urge investors to eye our Bear- and Bull Case:
• On a positive outcome, we will see sepranolone in PMDD as a phase III asset. It
should motivate a new Base Case above SEK 100 per share
• On a negative outcome, a rather solid cash position and the two other targeted
indications will serve as somewhat of a cushion. Nonetheless, negative top-line
results will be a major blow to the share price
Asarina Pharma Sector: Biotech
REDEYE RATING
ASAP.ST VERSUS OMXS30
FAIR VALUE RANGE
Financials
People
Business
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Asarina Pharma Presents Phase IIb Results in Weeks
Background Asarina Pharma develops sepranolone, an endogenous compound that counteracts the
effect of the potent neurosteroid, allopregnanolone, at the GABAA-receptor. The effect of
allopregnanolone at the GABAA-receptor has been implicated in several disorders, and not
least in Asarina Pharma’s lead indication; premenstrual dysphoric disorder (PMDD). Women
with PMDD are sensitive to the elevated levels of allopreganonolone that rise during the luteal
phase, causing the core symptoms of anger/irritability, depression, anxiety, and lability.
Hence, PMDD is a mood disorder related to the menstruation cycle, affecting as many as 3-
8% of women in childbearing age. Sepranolone is the only drug candidate that is specifically
developed to treat the underlying symptoms in PMDD. Besides PMDD, sepranolone is also in
development for Menstrual Migraine (MM) and Tourette’s Syndrome.
The phase IIb trial in PMDD The phase IIb trial is a randomized, double-blind, and placebo-controlled study, taking place in
Sweden, Germany, Poland, and the UK. 206 PMDD patients were randomized to receive either
low- or high dose of sepranolone or placebo. The administration took place during the luteal
phase, with a treatment cycle over 14 days (seven injections every second day). There were
three treatment cycles in total in this study.
The primary endpoint is the total Daily Record of Severity of Problems (DRSP), a validated
scale in PMDD. Most of the approved drug therapies, the latest being approved over 14 years
ago, in this indication have used the DRSP as primary endpoint. The DRSP is also what
regulators propose to determine efficacy.
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The DRSP scale captures a total of 21 items over 11 symptoms. For every item, the women
rate their severity from a scale of 1 (not at all) to 6 (extreme). Thus, a total symptom score
between 21-126 is possible.
The primary endpoint is the change in average total symptom score during the luteal phase
of the two run-in cycles (baseline) compared to the average total symptom score during the
treatment period within patient. The change is compared to placebo.
Secondary efficacy measures include the impairment scale, the degree to which the disorder
impacts the woman’s daily function, and the core symptoms (cardinal symptoms) in PMDD:
• Depression
• Anger/Irritability
• Anxiety
• Lability
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The primary endpoint, total DRSP, has to be met. However, we expect that the cardinal
symptoms will largely drive the overall effect in the case of sepranolone, as it is specifically
developed for PMDD. Accordingly, as we also saw in the previous phase IIa trial, its efficacy
on the none-cardinal symptoms, such as concentration, fatigue, appetite, and sleep, should
be more modest.
The impairment scale is also an important variable. In the end, it is what matters to the
woman; a meaningful improvement in daily function and quality of life.
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The phase IIb trial also aims to assess the safety profile further. For multiple reasons, we
have strong confidence in the safety profile of sepranolone:
• An endogenous compound
• Extensively evaluated on patients with an excellent safety profile so far
• Good safety in the ongoing phase IIb trial as well what we know so far – only 2
Severe Adverse Events have occurred and not related to study medication
We will come back to the safety dimension from a competitive perspective as well.
To summarize, the key things to be on investor’s watchlist in the phase IIb results are:
• Total DRSP (The primary endpoint) and the cardinal symptoms (secondary
endpoint)
• The improvement scale, this is what ultimately matters to the patient
• An excellent safety profile
Before we go on to discuss what good results mean in real terms, let us give a quick update
on the status of the phase IIb trial and our impression on the quality of the study design.
The last patient in was in August, and the last patient received her last dosing at the end of
January. In March, which is important given the current circumstances with the Corona crisis,
Asarina Pharma confirmed that they are on schedule to present the results at the end of April.
When we have spoken to the management team over the year, they often come back to that
this is a high-quality study. We fully agree. The phase IIa trial gave some important lessons-
learned on how to design future studies in PMDD. Some key changes are:
• Stricter inclusion criteria’s
Post-analysis of the phase IIa trial showed that almost 20 percent were so-called follicular
symptom patients. It means that they had symptoms during the follicle phase as well (the
period after menstruation to the next ovulation), which might be a sign of co-morbidities.
Compared to the phase IIa study (one baseline cycle), there are now two baseline cycles in
the phase IIb study. Besides, there are stricter enrollment criteria of patients that have
symptoms in the follicular phase.
• Treatment should last into menstruation starts
Another problem was that the urine test used in the phase IIa study failed to determine
ovulation in some cases. Thus, almost 20 percent were deemed as early starters, which
means that they were not exposed to treatment during the very critical days before
menstruation.
The phase IIb trial used the calendar method to determine ovulation, and it is also per
regulatory guidelines. Besides, a treatment cycle is now seven injections every second day,
compared to five injections in the phase IIa study.
Further, there are three treatment cycles compared to one in the phase IIa study. All else
equal, it should arguably imply a clearer separation effect between the active arms and
placebo.
We argue that the high quality of the design reflects in the relatively low dropout rate (<20%).
It is lower than anticipated, and in relative terms as well.
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A high-quality study doesn’t automatically imply a good outcome. For us, it simply means that
if the study flunks, it will not be due to flaws in the study design.
What are good results in concrete terms? Primary endpoint
A good phase IIb trial meets the primary endpoint by reporting a statistically significant
difference compared to placebo based on total DRSP.
Based on competitive data, the standard of care has a mean score difference of <10 versus
placebo on total DRSP. In our view, a score above 10 is a home-run. A score on par or even
slightly below to existing therapies might as well do, given that the secondary endpoints
distinguish.
In percentage terms, Borenstein et al. (2007) suggest that a meaningful response in a PMDD
trial is 50 percent. The EMA guidelines refer to this as well. However, empirical support for
this definition is lacking, as seen in the figure below.
On the medical group study conducted by Borenstein et al. (2007), those women with mild/no
PMS/PMDD scored 43 percent lower than moderate/severe PMS/PMDD women. This
difference was related to healthcare burden, and Borenstein et al. (2007) hence conclude that
the data supports a 50% responder rate as clinically relevant improvement. However, smaller
differences can also be meaningful. Naturally, as the trials in PMDD are placebo-controlled,
the change in improvement must be compared to placebo.
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Secondary measures
The cardinal symptoms are simply the core symptoms of PMDD and are part of the total
DRSP. As sepranolone is based on the science discovered by Torbjörn Bäckström in PMDD
women, this is unarguably where sepranolone should be most efficacious.
In the end, the effect has to be meaningful for patients by improving daily function and quality
of life. We want to see competitive results on each of these domains, and with good p-values
to support statistical significance.
Regarding safety, we know that sepranolone is a safe drug candidate, that has also been the
case in the phase IIb trial so far. As the anti-depressants and hormone therapy pose severe
side-effects, this could become a highly competitive factor. Just the fact the almost half of
the PMDD patients on SSRI discontinue treatment after six months says a lot about the need
for a drug without any severe side-effects. We, therefore, believe that the disclosure of the full
safety data-set in the phase IIb is highly relevant to scrutinize.
Risks – On our Watchlist
• A high placebo response rate
It is inevitable in placebo-controlled trials when the participants do self-assessment that a
placebo effect occurs. A high placebo response rate might blur the effect seen in the
sepranolone arms
• Modest effect on the non-cardinal symptoms
As we mentioned above, we don’t foresee that sepranolone will have a profound effect on
symptoms such as appetite, fatigue, and sleep. Thus, the cardinal symptoms must probably
drive a lot of the effect to meet the primary endpoint
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• Borderline results
If the efficacy results are borderline and require further analysis, it will cause uncertainty of
the future development
Concluding remarks Although problems occurred in the phase IIa study, sepranolone met its primary endpoint.
The results were, however, borderline for showing statistical significance. Due to the first-in-
patient, exploratory nature of that study, we argue that sepranolone showed a first proof-of-
concept. Together with its novel mechanism of action, being an endogenous compound, and
the strong scientific rationale in PMDD, we have a:
• strong confidence in a superior safety profile of sepranolone.
• strong confidence in that sepranolone will demonstrate efficacy
Regarding the second bullet, the question is rather how much of efficacy, and how our
mentioned risk factors will play out.
There is a need to stress that no drugs that specifically target the underlying mechanisms
have been developed in this indication before. The hormone therapies and anti-depressants
on the market are approved for other indications as well. Further, the last drug approved in
PMDD was over 14 years ago. Still, the medical need is great. It has been reflected not least in
the overwhelming interest to participate in Asarina Pharma’s phase IIb trial.
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Valuation Upon data, we have made some fine-tuning adjustments. For PMDD the key assumptions
are:
• We deem the likelihood of reporting positive results in the phase IIb trial to 50
percent
• A 30 percent probability of reaching the market
• Upon positive results in phase IIb, we will acknowledge sepranolone in PMDD as a
phase III asset and set the LoA to 60 percent. This trigger motivates, in our view, an
updated Base Case above SEK 100 per share
With such an essential catalyst in the near-term, eyeing our Bear- and Bull Case is the right
thing to do. Noteworthy is that sepranolone in Tourette’s syndrome is free of charge in our
valuation model, which further limits the downside.
The share was on to something at the beginning of the year and had begun to gain
momentum upon data. Then the Corona crisis swept the momentum away. On current share
levels, we see an attractive risk/reward.
Bear Case 8 (5) SEK Base Case 50 (42) SEK Bull Case 120 (100) SEK • We factor in
negative results from the Ph IIb study and exclude it from our SOTP-model accordingly
• The SOTP-model is our Base Case scenario
• We factor in positive ph IIb top-line results in PMDD that merits further development into phase III
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PROFITABILITY 2018 2019 2020E 2021E 2022E ROE -59% -55% -95% 31% 0% ROCE -69% -63% -91% 21% -164% ROIC -2967% 4499% 732% -146% 1217% EBITDA margin -
1289900% -
2037224% -
2103972% 12% -
3187932% EBIT margin -1289900%
-2037224%
-2103972%
12% -3187932% Net margin -
1100625% -1788124% -1916472% 12% -
3187932%
Please comment on the changes in Rating factors……
INCOME STATEMENT 2018 2019 2020E 2021E 2022E Net sales 0 0 0 125 0 Total operating costs -52 -81 -84 -109 -128 EBITDA -52 -81 -84 15 -128 Depreciation 0 0 0 0 0 Amortization 0 0 0 0 0 Impairment charges 0 0 0 0 0 EBIT -52 -81 -84 15 -128 Share in profits 0 0 0 0 0 Net financial items 0 2 0 0 0 Exchange rate dif. 0 0 0 0 0 Pre-tax profit -52 -79 -84 15 -128 Tax 8 8 8 0 0 Net earnings -44 -72 -77 15 -128
BALANCE SHEET 2018 2019 2020E 2021E 2022E Assets Current assets Cash in banks 142 130 77 92 86 Receivables 0 0 0 0 0 Inventories 0 0 0 0 0 Other current assets 0 1 1 1 1 Current assets 142 130 78 93 87 Fixed assets Tangible assets 0 0 0 0 0 Associated comp. 0 0 0 0 0 Investments 0 0 0 0 0 Goodwill 0 0 0 0 0 Cap. exp. for dev. 0 0 0 0 0 O intangible rights 0 0 0 0 0 O non-current assets 0 2 2 2 2 Total fixed assets 0 2 2 2 2 Deferred tax assets 8 8 8 8 8 Total (assets) 150 140 87 103 96 Liabilities Current liabilities Short-term debt 0 0 0 24 24 Accounts payable 0 0 0 0 0 O current liabilities 10 21 21 21 22 Current liabilities 10 21 21 45 46 Long-term debt 0 0 24 0 120 O long-term liabilities 0 0 0 0 0 Convertibles 0 0 0 0 0 Total Liabilities 10 21 45 45 166 Deferred tax liab 0 0 0 0 0 Provisions 0 0 0 0 0 Shareholders' equity 140 119 42 58 -70 Minority interest (BS) 0 0 0 0 0 Minority & equity 140 119 42 58 -70 Total liab & SE 150 140 87 103 96
FREE CASH FLOW 2018 2019 2020E 2021E 2022E Net sales 0 0 0 125 0 Total operating costs -52 -81 -84 -109 -128 Depreciations total 0 0 0 0 0 EBIT -52 -81 -84 15 -128 Taxes on EBIT 8 8 8 0 0 NOPLAT -44 -73 -77 15 -128 Depreciation 0 0 0 0 0 Gross cash flow -44 -73 -77 15 -128 Change in WC 7 11 0 0 1 Gross CAPEX 0 -2 0 0 0 Free cash flow -37 -65 -77 15 -127 CAPITAL STRUCTURE 2018 2019 2020E 2021E 2022E Equity ratio 94% 85% 49% 56% -73% Debt/equity ratio 0% 0% 57% 42% -206% Net debt -142 -130 -53 -68 58 Capital employed -2 -10 -10 -10 -11 Capital turnover rate 0.0 0.0 0.0 1.2 0.0 GROWTH 2018 2019 2020E 2021E 2022E Sales growth 0% 0% 0% 3,116,6
33% -100%
EPS growth (adj) 0% 0% 7% -120% -932%
DATA PER SHARE 2018 2019 2020E 2021E 2022E EPS 0.00 -3.82 -4.09 0.82 -6.80 EPS adj 0.00 -3.82 -4.09 0.82 -6.80 Dividend 0.00 0.00 0.00 0.00 0.00 Net debt 0.00 -6.91 -2.82 -3.64 3.11 Total shares 0.00 18.74 18.74 18.74 18.74 VALUATION 2018 2019 2020E 2021E 2022E EV -141.5 -129.5 451.4 436.0 562.6 P/E N/A N/A N/A N/A N/A P/E diluted N/A N/A N/A N/A N/A P/Sales N/A N/A N/A N/A N/A EV/Sales N/A N/A N/A N/A N/A EV/EBITDA N/A N/A N/A N/A N/A EV/EBIT N/A N/A N/A N/A N/A P/BV N/A N/A N/A N/A N/A
SHARE INFORMATION Reuters code ASAP.ST List First North Share price 26.9 Total shares, million 18.7 Market Cap, MSEK 504.2 MANAGEMENT & BOARD CEO Peter Nordkild CFO Jakob Dynnes Hansen IR Chairman Paul de Potocki FINANCIAL INFORMATION ANALYSTS Redeye AB Anders Hedlund Mäster Samuelsgatan 42, 10tr [email protected] 111 57 Stockholm Arvid Necander [email protected]
SHARE PERFORMANCE GROWTH/YEAR 18/20E 1 month -2.9 % Net sales 0.0 % 3 month 7.6 % Operating profit adj 27.7 % 12 month -10.6 % EPS, just 0.0 % Since start of the year 9.8 % Equity -45.0 %
SHAREHOLDER STRUCTURE % CAPITAL VOTES Kurma Biofund 17.1 % 17.1 % Östersjöstiftelsen 14.5 % 14.5 % Fjärde AP-fonden 9.1 % 9.1 % Idinvest Patrimoine 8.9 % 8.9 % Swedbank Robur Fonder 8.1 % 8.1 % Rosetta 5.7 % 5.7 % Catella Fonder 5.1 % 5.1 % Länsförsäkringar Fonder 4.9 % 4.9 % Handelsbanken Fonder 3.6 % 3.6 % Sectoral Asset Management 3.2 % 3.2 %
DCF VALUATION CASH FLOW, MSEK WACC (%) 13.0 %
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Redeye Rating and Background Definitions Company Quality
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are the building blocks that enable a company to deliver sustained operational outperformance and attractive long-
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Each category is grouped into multiple sub-categories assessed by five checks. These are based on widely
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If a check is successful, it is assigned a score of one point; the total successful checks are added to give a score for
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ranges from 0 to 5 rounded up to the nearest whole number. The overall score for each category is then used to
generate the size of the bar in the Company Quality graphic.
People
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is a significant part of understanding the long-term drive of the company. It all comes down to doing business with
people you trust, or at least avoiding dealing with people of questionable character.
The People rating is based on quantitative scores in seven categories:
• Passion, Execution, Capital Allocation, Communication, Compensation, Ownership, and Board.
Business
If you don’t understand the competitive environment and don’t have a clear sense of how the business will engage
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The Business rating is based on quantitative scores grouped into five sub-categories:
• Business Scalability, Market Structure, Value Proposition, Economic Moat, and Operational Risks.
Financials
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• Earnings Power, Profit Margin, Growth Rate, Financial Health, and Earnings Quality.
REDEYE Equity Research Asarina Pharma 5 April 2020
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Redeye Equity Research team
Management Björn Fahlén
Håkan Östling
Technology Team Jonas Amnesten
Henrik Alveskog
Havan Hanna
Kristoffer Lindström
Erika Madebrink
Fredrik Nilsson
Tomas Otterbeck
Eddie Palmgren
Magnus Skog
Oskar Vilhelmsson
Viktor Westman
Linus Sigurdsson (Trainee)
Editorial Eddie Palmgren
Mark Siöstedt
John Hintze
Johan Kårestedt (Trainee)
Life Science Team Gergana Almquist
Oscar Bergman
Anders Hedlund
Arvid Necander
Erik Nordström
Klas Palin
Jakob Svensson
Ludvig Svensson
REDEYE Equity Research Asarina Pharma 5 April 2020
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Rating People Business Financials
5p 12 11 3 3p - 4p 97 74 31 0p - 2p 8 32 83 Company N 117 117 117
CONFLICT OF INTERESTS
Anders Hedlund owns shares in the company : No Arvid Necander owns shares in the company : No Redeye performs/have performed services for the Company and receives/have
received compensation from the Company in connection with this.