SymBio Pharmaceuticals

Initiation of coverage

Transforming to a commercial-stage company

Pharma & biotech
13 October 2014

SymBio is on the path to becoming a key specialty pharma partner for
Asian markets following in-licensing deals for orphan blood cancer
products Treakisym (Treanda) and rigosertib. The former was a pivotal
deal, helping to establish SymBio, with rigosertib potentially propelling

Price

¥259

SymBio to the next phase with a commercial infrastructure. Treakisym
sales could grow in coming years with expansion to additional indications,and this asset together with cash underpins the current share price.

Net cash (¥m) at end June 2014

4,798

Shares in issue

30.6mFree float

67%

Code

4582

Primary exchange

Tokyo

Secondary exchange

N/AMarket cap

Year end

Revenue
(¥m)

PBT*
(¥m)

EPS*
(¥)

DPS
(¥)

P/E
(x)

Yield
(%)

12/12

1,955

(1,732)(90.76)

0.0

N/A

N/A

12/13

1,532

(1,605)(69.42)

0.0

N/A

N/A

12/14e1,806(1,537)(50.30)

0.0

N/A

N/A

12/15e1,968(1,796)(58.75)

0.0

N/A

N/A

¥7,934m¥100/$

Share price performance

Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items
and share-based payments.

Treakisym provides downside protection
In-licensing Treakisym (bendamustine) from Astellas was a pivotal deal for SymBio,
leading to its first approved product in key Asian markets. Sales are currently
around $38m following rapid clinical development and successful commercial
partnering. R&D investment in Treakisym has now peaked and future significant
growth could come with approval in additional indications. Treakisym and net cash
underpin the current valuation, with existing sales providing downside protection.

%

1m

3m

12m

Abs

(14.2)(4.8)(47.6)

Rel (local)

(9.8)

(3.5)

(50.3)

Rigosertib essentially a free option at current levels

52-week high/low

The next key asset is rigosertib for a rare blood cancer, MDS, currently in Phase I
trials in Japan. SymBio in-licensed rights to both the IV and the oral formulation

Business description

from Onconova in 2011. A setback in the IV Phase III US development has notdelayed progress in Japan and US pivotal development plans will help to refine thefuture strategy and clinical trial plans in Japan. SymBio plans to build its own sales
force for rigosertib to maximise value.

Asia-Pacific specialty pharma
SymBio is focused on in-licensing niche opportunities in hard-to-treat indications
often overlooked by big pharma. Building its own commercial infrastructure forrigosertib should help establish SymBio more firmly as a partner of choice in AsiaPacific. An in-house screening process to select additional pipeline candidates fordevelopment and commercialisation will be key for driving operating leverage.

Valuation: Risk-adjusted NPV of ¥14.1bn ($141m)
We value SymBio at ¥14,135m ($141m) or ¥461/share, based on a risk-adjusted
NPV, which includes ¥4,798m ($48m) net cash. Our forecasts suggest Treakisym
and net cash underpin the current share price, with the market seemingly ascribing
limited value to rigosertib. Cash should be sufficient to fund operations into 2017prior to the potential launch of rigosertib, which SymBio is intending to market itself.

¥527

¥196

SymBio Pharmaceuticals is a Japanese specialty
pharma company with a focus on oncology,
haematology and autoimmune disorders.
Treakisym was in-licensed from Astellas in 2005,
with 2013 sales of c $38m in Asian markets.
Rigosertib was in-licensed from Onconova and is indevelopment for an orphan blood cancer.

Next events
Bendamustine EU approval infrontline iNHL

Q414/Q115

Treakisym sNDA filing for CLL andfrontline iNHL in Japan

2015

Rigosertib US development plans

Q414

Rigosertib completion of Japan
Phase I trials

2015

Analysts
Dr Philippa Gardner+44 (0)20 3681 2521

Dr Mick Cooper+44 (0)20 3077 5734

Jason Zhang PhD+1 646 653 7027

healthcare@edisongroup.com
Edison profile page

SymBio Pharmaceuticals is a research client of Edison Investment Research Limited

Investment summary
Company description: Specialty sweet spot
SymBio was established in 2005 with the aim of becoming a specialty pharma company focused on
addressing high unmet medical needs in Asia-Pacific within the oncology, haematology andautoimmune fields. SymBio in-licenses assets with proof-of-concept (Phase II) data fordevelopment and commercialisation in Asia-Pacific, removing the need for investment in earlystage R&D; to date three in-licensing deals have been executed. SymBio has successfully
developed Treakisym (bendamustine) for the Asian market, with marketing rights out-licensed to
select commercial partners. For rigosertib, the next product in the pipeline, SymBio plans to build asalesforce in Japan and is seeking complementary opportunities for future operating leverage;
SymBio is also looking to expand globally. SymBio raised ¥2.6bn (net) at ¥560/share as part of theOctober 2011 IPO and most recently ¥2.8bn net in December 2013 at ¥400/share. It has around 85
employees and is based in Tokyo.
Exhibit 1: SymBio main product pipeline
Product
Treakisym (SyB L-0501)

Indication
r/r iNHL/MCL

Stage
Marketed

Rigosertib IV (SyB L-1101)
Rigosertib oral (SyB C-1101)

CLL
Frontline iNHL
r/r aggressive NHL
HR-MDSLR-MDS

Phase II pivotal
Preparing for filing
Phase II pivotal
Phase I
Phase I

Comments
Main indication and major contributor to sales in Japan and key Asia-Pacific markets(Eisai reported ¥3,800m in 2013)
Phase II pivotal trial ongoing; could complete in H215
Planning to file sNDA in frontline iNHL/MCL once this indication is approved in Europe
Phase II completed. Discussing route to approval with regulators
Phase I ongoing; could complete in H115; pivotal trial design will depend on US plans
Phase I ongoing; could complete in H115; pivotal trial design will depend on US plans

Source: Edison Investment Research. Note: NHL: non-Hodgkin’s Lymphoma; MCL: mantle cell lymphoma; CLL: chronic lymphocytic
leukemia; i: indolent; r/r: relapsed/refractory; HR-MDS: higher-risk myelodysplastic syndromes; LR-MDS: lower-risk myelodysplastic
syndromes.

Valuation: Risk-adjusted NPV of ¥14.1bn ($141m) or ¥461/share
We value SymBio at ¥14,135m ($141m) or ¥461/share, based on a risk-adjusted NPV analysis. OurrNPV includes ¥4,798m ($48m) net cash, Treakisym and rigosertib. For Treakisym we include bothcurrent sales and upside from sales in frontline iNHL and CLL; we do not include any potential in r/r
aggressive NHL. Our Treakisym forecasts and net cash underpin the share price, with rigosertib
essentially a free option at current levels. For rigosertib, we include risk-adjusted contributions,assuming SymBio commercialises this asset alone. If rigosertib can be launched a year earlier thanwe expect, this could add c ¥50/share. If SymBio can expand Treakisym to additional indications,and can successfully develop and launch rigosertib, our valuation could be around ¥21bn ($210m).

Sensitivities: Treakisym expansion, rigosertib and deals
The main sensitivities for SymBio include (1) expansion of Treakisym to additional indications,
including frontline iNHL to drive growth; (2) rigosertib success or failure, especially following the
failure of the Phase III ONTIME trial in the US to meet the primary endpoint; however rigosertib did
show a significant benefit in a subset of patients, which partner Onconova is now pursuing; and (3)the ability to execute future in-licensing deals, especially to leverage future commercial operations.

Financials: Cash runway to 2017
Net cash of ¥4,798m ($48m) should be sufficient to fund current operations into 2017, excluding
any new in-licensed assets, prior to the potential launch of rigosertib. We assume additional funds
will be needed at this point, both to start building out a sales and marketing infrastructure ahead offirst potential rigosertib launch in 2019, and for milestones that could become due to partner
Onconova if rigosertib is approved in both the US and Japan. Q214 financial results suggest
SymBio is on track to meet its retained 2014 financial guidance, with which we are broadly in line.

SymBio Pharmaceuticals | 13 October 20142

Outlook: Specialty sweet spot
SymBio is aiming to become a specialty pharma company focused on hard-to-treat indications, via
in-licensing in niche markets often overlooked by big pharma. Business development efforts
resulted in a successful deal with Astellas for Treakisym, helping to establish a nascent SymBio inJapan and core Asia-Pacific markets. SymBio is now seeking to expand its offering and crystallise
value by building out its first commercial infrastructure for rigosertib. In-licensing additional assets
will be key for driving future operating leverage.

Targeting niche products and seeking operating leverage
SymBio actively targets US and European drug candidates with proof-of-concept data, with thisstrategy reducing early-stage drug discovery costs and risks. In Japan and Asia, pivotal Phase II“bridging” studies can be used to confirm overseas findings, building on existing efficacy data andto confirm safety in Asian patients without the need for costly Phase III trials. This allows SymBio tomove swiftly through development, often with a moderate capital outlay. SymBio is focused on anumber of disease areas, often orphan indications that may fall below the radar of larger specialty
or Asian pharma companies. If SymBio is able to in-license a portfolio of complementary assets, it
could leverage any commercial infrastructure, driving operational efficiencies.

Pivotal deal with Astellas for Treakisym and swift development
Treakisym was in-licensed from Astellas shortly after SymBio was established, despite SymBio
being a nascent company with limited resources. However, the CEO and founder of SymBio had asignificant network and experience in Asia as founding president and CEO of Amgen Japan, whichenabled execution of this deal. The original agreement in Japan was later extended to include
China/Hong Kong, South Korea, Taiwan and Singapore. Treakisym was approved in Japan only
four years after the first trial started, with launch coming only two years after US approval andaround the same time as approval in Europe. Treakisym is marketed by a select number ofcommercial partners (see Exhibit 4).

Three proof-of-concept candidates in-licensed to date
To date SymBio has evaluated over 390 products, whittling these down to 34 candidates on which
due diligence was performed. This has led to three deals for assets with proof-of-concept clinicaldata, which are summarised in Exhibit 2. Rigosertib is the most recent addition, and this asset could
propel SymBio towards establishing itself as a key speciality pharma in Asia-Pacific.
Exhibit 2: Business development deals to date
Product
Treakisym(SyB L-0501)
Antiemetictransdermal patch(SyB D-0701)
Rigosertib(SyB L/C-1101)

Originator
AstellasAbeillePharmaceuticals
Onconova

Date
December 2005;
expanded April 2007
March 2007

Current status
Approved in key Asia-Pacific markets; label expansions being pursued.

July 2011

Onconova planning to start a further Phase III with IV in 2015 and a pivotal Phase III withthe oral in H115 in US/Europe. SymBio is conducting Phase I trials in Japan.

No further development following failure to show benefit in radiotherapy-induced nausea
and vomiting (RINV) in Phase II.

Source: Edison Investment Research, SymBio Pharmaceuticals

Commercial infrastructure leverage and diversification
SymBio plans to build a commercial operation to sell rigosertib in the future and complementary
assets to leverage this infrastructure are being sought. In addition, SymBio is also seeking todiversify its focus outside of haematology. Although we have limited visibility on the timing of any
future deals, in-licensing at least one asset in the next 12 months seems possible given SymBio’s
proven track record of successfully executing deals.

SymBio Pharmaceuticals | 13 October 20143

First tracks with Treakisym
In-licensing Treakisym from Astellas was a pivotal deal for SymBio, leading to its first approved
product in Japan and key Asia-Pacific markets. SymBio quickly and successfully developed
Treakisym in relapsed/refractory indolent NHL (r/r iNHL) and mantle cell lymphoma (MCL), allowing
for launch only two years after US approval. Treakisym R&D investment has now peaked, and
SymBio expects future sales growth with approval in other indications where development isalready complete. Our valuation suggests that Treakisym, if sales grow to meet our forecasts,
together with net cash underpin SymBio’s current market capitalisation.

In-licensing Treakisym was a pivotal deal for SymBio
SymBio in-licensed Treakisym from Astellas in December 2005 for exclusive development andmarketing rights in Japan; the deal was expanded in 2007 to China/Hong Kong, South Korea,
Singapore and Taiwan. SymBio started Phase I development in 2006 and Treakisym was approvedin Japan for r/r iNHL and MCL in October 2010. Treakisym approvals are summarised in Exhibit 3.
Exhibit 3: Treakisym approvals in Asia-PacificCountry
Hong Kong
Singapore
Japan
South Korea
TaiwanBrand nameTreandaSymbenda
Treakisym
Symbenda
Innomustine

Indication(s)r/r iNHL; CLL
r/r iNHL; CLL
r/r iNHL; MCL
CLL; MM; r/r iNHL
r/r iNHL; CLL

Approval
December 2009
January 2010
October 2010
May 2011 (CLL; MM) and June 2014 (r/r iNHL)
October 2011

Launch2010
September 2010
December 2010
October 2011 (CLL; MM)
February 2012

Partner
Cephalon (Teva)
Eisai
Eisai
Eisai
InnoPharmax

Source: Edison Investment Research, SymBio Pharmaceuticals. Note: iNHL: indolent non-Hodgkin’s lymphoma; CLL: chronic
lymphocytic leukaemia; r/r: relapsed/refractory; MCL: mantle cell lymphoma; MM: multiple myeloma.

In the absence of a salesforce, SymBio out-licensed commercial rights to select partners (Exhibit4). Treakisym sales by Eisai in 2011, the first full year of launch in Japan, were ¥3,400m, growing to¥3,800m ($38m) in 2013; these include sales in Japan, South Korea and Singapore, with Japan
representing the majority. We believe current sales by other partners (InnoPharmax and Teva in
Taiwan and Hong Kong, respectively) represent <5%. Precise deal terms have not been disclosed,
but we believe these vary according to both partner and region. We estimate that SymBio earns anaverage net margin of around 10-12% on top-line reported Treakisym sales in Asia-Pacific.
Exhibit 4: Summary of SymBio’s Treakisym commercial out-licensing deals
RegionTaiwanJapan

Partner
InnoPharmax
Eisai

Date
March 2008
August 2008

South Korea, Singapore
China (including Hong Kong)

Eisai
Cephalon (Teva)

May 2009
April 2009

Terms
Development and launch; SymBio receives upfront, milestones and double-digit royalty
Co-development and commercialisation rights; SymBio receives upfront and development
milestones to ¥4bn (we estimate around ¥3bn have been received to date); Eisai and SymBio
share development costs equally, with Eisai funding 100% of sales and marketing; deal
included several additional indications
Development and marketing rights (financials not disclosed)
Development and commercialisation rights (financials not disclosed)

Source: Edison Investment Research, SymBio Pharmaceuticals

Sales from existing indications could reach ¥5,300m ($53m)
SymBio estimates that Treakisym in Japan in the two approved indications (r/r iNHL and MCL)
commands a market share of >50%. Given this relatively high penetration, we forecast limited
additional market share gains in coming years. However, a 3% price rise in April 2014 together withthe recent approval in South Korea for r/r iNHL could boost existing sales (¥3,800 by Eisai in 2013)by around ¥400m ($4m). Beyond this near-term boost, we expect only limited growth in existing
indications to 2020, when the orphan drug exclusivity expires, forecasting Treakisym sales of¥5,300m ($53m) by 2020 with the majority from Eisai. Treakisym has not been subject to Japan’sbiennial round of price cuts (which average around 6% every two years) and we do not forecast
future price cuts. Beyond 2020, we forecast a gradual decline in sales, as genericisation in Japan isgenerally not as abrupt as in other markets, with generics often only commanding around a 25-30%

SymBio Pharmaceuticals | 13 October 20144

share. A new Treanda liquid formulation was recently approved in the US and this could potentiallyextend Treakisym’s market exclusivity beyond 2020, which could provide upside to our forecasts.

Expansion into further indications could more than double sales
Pivotal development in frontline iNHL is complete and SymBio is planning to file these data inJapan once bendamustine has been approved in Europe in this indication; if this occurs by YE14,
then approval could come in H116 with launch in H216. This is a patient market of 7,100, which is
c 50% larger than the currently approved r/r iNHL (4,700 patients). A pivotal Phase II CLL trial isongoing and this indication could be filed in H116. With generally more treatment cycles per patient(six cycles in frontline iNHL versus four to five cycles in r/r iNHL), sales in both frontline iNHL and
CLL could reach ¥8,151m ($82m) by 2020 if Treakisym can achieve a similar 50% market share as
in r/r iNHL.
CLL is already approved in both the US and Europe, so we believe it has a high chance of also
gaining approval in Japan. For frontline iNHL, bendamustine is under review in Europe with data1

from the StiL study demonstrating a PFS (progression free survival) of 69.5 months for patientstreated with BR (bendamustine + rituximab), significantly longer than 31.2 months for R-CHOP(rituximab/Rituxan in combination with CHOP chemotherapy: cyclophosphamide, doxorubicin,
2
vincristine, and prednisone). The BRIGHT study demonstrated that BR was non-inferior to RCHOP in terms of complete response rate (31% versus 25%, respectively, p=0.0225).
SymBio has also completed development in r/r aggressive NHL (a patient population of 6,700 in
Japan) in 2012. However, filing has been delayed owing to discussions with regulators. It is
possible that approval will only be granted subject to conducting an additional trial. However, we
think it unlikely that SymBio will invest in further development in r/r aggressive NHL owing to expiryof market exclusivity in 2020. Hence we do not include a contribution from this indication in ourvaluation. If this indication can be approved, it could add ¥3,000-5,000m ($30-50m) in sales.

Overview of non-Hodgkin’s lymphoma
Non-Hodgkin’s lymphoma (NHL) is the most common type of lymphoma, a blood cancer that affects
lymphocytes (white blood cells) and the lymphatic system. NHL is a broad group of more than 50
subtypes, which are generally classified according to the cell affected (various types of B-cell or Tcell lymphoma) and into either slow growing (indolent) or fast growing (aggressive). Treatment islargely dependent on the type and stage of disease, with frontline treatment often with R-CHOP.
Treanda was approved in the US in 2008 for the treatment of relapsed indolent B-cell NHL andchronic lymphocytic leukaemia (CLL). It is marketed by Cephalon (Teva) and is on a 2014 run rateof $740m, based on H114 US sales of $370m. In Europe, Levact/Ribomustin/Ribovact wasapproved in 2010 for CLL, relapsed iNHL and multiple myeloma; it is mainly sold by Mundipharma.
The main late-stage or newly approved products in NHL are either for use with or after
bendamustine and are therefore unlikely to adversely affect its current use. Therefore, we see
limited significant competitive threats to Treakisym in Asia ahead of orphan drug exclusivity expiry
in 2020. Zydelig (idelalisib) was recently approved in the US and Europe for CLL and certain
subtype(s) of NHL, although its use in NHL is for third-line treatment. Other late-stage development
candidates include CD20 antibodies (similar to rituximab) such as ofatumumab (Arzerra) andobinutuzumab (Gazyva), both approved for CLL in the US and in Phase III development for NHL,
including in Japan, for use with bendamustine.

1

Rummel MJ, Niederle N, Maschmeyer G et al. Bendamustine plus rituximab versus CHOP plus rituximab asfirst-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre,
randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6; 381 (9873): 1203-10.

2Flinn IW, van der Jagt R, Kahl BS et al. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in
first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8; 123 (19): 2944-52.

SymBio Pharmaceuticals | 13 October 2014

5

Right on track with rigosertib
SymBio in-licensed rigosertib (IV and oral formulations, Japan and Korean rights) from Onconova in2011 for MDS (myelodysplastic syndromes), a rare blood cancer; it is partnered with Baxter inEurope. Failure to meet the primary endpoint in the IV Phase III trial has not delayed Japanese
progress, where both the IV and oral formulations are in Phase I trials. Onconova is continuing topursue US/European development and future clinical trial plans will help to refine the future strategy
and development plans in Japan. SymBio plans to build its own sales force for rigosertib.

Rigosertib and MDS background
Rigosertib is a tumour-specific dual-specificity inhibitor, which inhibits both the PI3K
(phosphoinositide 3-kinase) and the PLK (polo-like kinase 1) pathway. PI3K is often the driving
force in cancer cell development, while PLK is abnormally expressed or mutated in cancer cells. It
is primarily being developed as a treatment for MDS, a type of blood cancer. The IV formulation is
being developed in higher-risk MDS (HR-MDS), with the oral formulation for both lower-risk MDS(LR-MDS) and potentially as first-line treatment in all MDS in combination with approved agents.
MDS is a group of blood disorders caused by improper blood formation in the bone marrow, leading
to low blood counts. The most common symptom is anaemia (low red blood cell count), but also
includes neutropenia (low neutrophil count) and thrombocytopenia (low platelet count). Around 30%
of MDS patients go on to develop AML (acute myeloid leukaemia).
The commonly used International Prognostic Scoring System (IPSS) divides MDS into four groups,
outlined in Exhibit 5, based on bone marrow blast percentage, chromosome abnormalities andblood counts. LR-MDS patients include IPSS low and Intermediate-1 (Int-1), with HR-MDS patients
generally Int-2 and IPSS High. HR-MDS patients account for around 70-75% of all MDS andgenerally have a better prognosis with longer survival and lower risk of developing AML. LR-MDS
patients are treated with supportive care to improve blood counts and quality of life; bloodtransfusions are a key component of treatment with patients often becoming transfusion-dependent.
Revlimid (lenalidomide) is approved for HR-MDS patients having a specific chromosome
abnormality (5q deletion, which accounts for around 10-15% of MDS patients).
For HR-MDS patients where survival can be months rather than years, treatment is to try and delaydisease progression and prolong survival. Treatment is generally with a hypomethylating agent(HMA) such as Vidaza (azacitidine) and Dacogen (decitabine), both approved in the US. There are
currently no approved treatments for HR-MDS patients who fail HMAs.
Exhibit 5: MDS classification and treatment
IPSS

% of
MDS

Low
Int-1
Int-2
High

33%
38%
22%
7%

Median survival Treatment(without treatment)
5.7 years Blood transfusions; Revlimid for del(5q); EPO (if <500 U serum EPO)
3.5 years
1.1 years SCT if eligible; Vidaza (preferred) or Dacogen; clinical trials or supportive care for5 months poor performance status patients

Source: MDS IPSS Working Group; NCCN guidelines. Note: SCT: stem cell transplant.

Consistent survival in HR-MDS patients in US trials
Onconova has completed the Phase III ONTIME trial of rigosertib (IV) in HR-MDS patients who
have failed prior HMA treatment. The trial in 299 patients compared rigosertib (IV) in combination
with best supportive care (BSC) to BSC alone. HMA failures included patients who had progressed
after HMA treatment, patients who failed to achieve a complete or partial response (CR, PR) or
haematological improvement and patients who relapsed.
Rigosertib demonstrated a numerical, but not significant benefit compared to BSC in the trial.
However, rigosertib was able to show a significant benefit in a predefined subset of primary HMA

SymBio Pharmaceuticals | 13 October 20146

failures (which includes patients who have either progressed, or failed to achieve a response
following HMA treatment, representing 62% of the study population). Rigosertib’s 8.2-8.5 monthsurvival benefit was similar across both the subset and the full trial, and is consistent with earlier
stage rigosertib data where survival was found to be 35 weeks (8.2 months) from a cross-trial
analysis (data presented at ASH 2011) of four Phase I or II trials in 39 patients who were previously
treated with Vidaza or Dacogen.
Exhibit 6: Median overall survival (OS) in the ONTIME trial
ONTIME trial

Rigosertib
BSC
Rigosertib
BSC

Primary HMA failures

Median OS
8.2 months
5.8 months
8.5 months
4.6 months

N
199
100
127
57

Hazard ratio
0.86

p value
0.27

0.66

0.017

Source: Onconova

With consistency in rigosertib survival, the ONTIME trial appears to have failed owing to a higher
than expected BSC survival. The trial was designed around an expected control arm survival of 1722 weeks (4-5 months). However, in the ONTIME trial this was 5.8 months. Although median overall
3
survival in Dacogen failures and Vidaza failures has been reported as 4.3 months (18 weeks) and4
5.6 months (24 weeks), respectively, in the ONTIME trial this may have been lengthened byaccess to treatments including low-dose cytarabine (where survival in Vidaza failures has been2

reported as 7.3 months ) or to investigational treatments.

Partner Onconova plans to pursue rigosertib IV in primary HMA failures
Following failure of the ONTIME trial to meet its primary endpoint, Onconova has met with the FDA
and several European regulatory agencies to discuss the data, in particular the significant 3.9month benefit in primary HMA failures. Onconova is now intending to pursue rigosertib IV
development in this patient group in order to try and secure regulatory approvals. Details aroundpivotal trial design are anticipated by YE14 and the trial could start in 2015.

US oral development is advancing towards Phase III in LR-MDS
The Phase II ONTARGET trial is ongoing and interim data were made available at ASH 2013 withfull data to be presented at ASH 2014. The trial is investigating oral rigosertib as frontline treatment
in 80 LR-MDS patients. The endpoint of the trial is achievement of transfusion independence (TI), a
key quality of life parameter in these patients, and the endpoint upon which Revlimid received
approval for a subset of patients in this indication. In the 33 patients on “intermittent” dosing (dosing
for two out of three weeks) treated for at least eight weeks, 15 (45%) achieved TI lasting between
eight and 53 weeks (median 17 weeks). These data also showed a correlation between a genomic
methylation profile and response. Onconova is planning to start a pivotal trial for oral rigosertib in
LR-MDS in H115 and plans to incorporate the biomarker work in the IV and oral Phase III studies.

Also looking at combinations and other tumours
Onconova is also investigating oral rigosertib in combination with Vidaza as frontline treatment for
HR-MDS in a Phase I/II trial, in addition to rigosertib in head and neck cancer. A Phase II trial inhead and neck cancer is ongoing, in addition to earlier-stage trials in other tumours.

3

Jabbour, E., Garcia-Manero, G., Batty, N., Shan, J., O'Brien, S., Cortes, J., Ravandi, F., Issa, J.-P. andKantarjian, H. (2010), Outcome of patients with myelodysplastic syndrome after failure of decitabine
therapy. Cancer, 116: 3830–3834. doi: 10.1002/cncr.25247.

4

Prébet T, Gore SD, Esterni B, Gardin C, Itzykson R, Thepot S, Dreyfus F, Rauzy OB, Recher C, Adès L,
Quesnel B, Beach CL, Fenaux P, Vey N. Outcome of high-risk myelodysplastic syndrome after azacitidine
treatment failure. J Clin Oncol. 2011 Aug 20; 29(24): 3322-7. doi: 10.1200/JCO.2011.35.8135.

SymBio Pharmaceuticals | 13 October 20147

Japan development will be driven by US/Europe progress
Rigosertib is in Phase I development in Japan for both the oral (started March 2013) and IV (started
June 2012) formulations. Both trials being conducted by SymBio are expected to complete in H115.
By the time these complete, the pivotal trials conducted by Onconova in the US should beunderway. SymBio could either then start pivotal standalone bridging studies, or it could potentiallyexpand the US/European Phase III trials to Japan and Asia-Pacific. Either route to market will likely
involve a similar level of investment and scope of clinical trials (we assume around 20-25 patientsfor IV rigosertib in HR-MDS and potentially around 60-70 patients in LR-MDS with the oral
formulation), but the latter could allow for approval around the same time as in the US (forOnconova, Edison forecasts IV launch in 2017 and oral in 2018). Until the precise path to market isdefined, we more conservatively assume SymBio launches both the IV and oral in 2019.

Rigosertib peak sales in Japan and South Korea could be $100m
SymBio estimates that there are around 11,000 patients in Japan with MDS of which around 6070% are HR-MDS patients and 30-40% are LR-MDS patients. In Japan the annual incidence (newly
diagnosed cases) is 4,500-5,500 and we assume South Korea is around 40% of this (based on
population size). This results in a newly diagnosed market of around 7,300 MDS patients a year inJapan and South Korea, of which around 5,000 are LR-MDS and the remainder are HR-MDS.
For HR-MDS, rigosertib IV is being developed as second-line treatment in primary HMA failures in
the US, and we assume a similar indication will also be pursued by SymBio. HMA response rates
are around 50-60%, therefore c 40% of patients are refractory; in addition, the majority of patients
who do respond eventually relapse. Hence we assume there are around 1,800 new r/r HR-MDS
patients each year in SymBio’s target markets, of which around 60% are primary HMA failures (asper the patient population in the ONTIME trial). If we assume pricing is at parity to Vidaza in Japan(¥51,421 price per vial, which equates to an average ¥4,300k or $43k per patient), and that SymBio
can achieve similar penetration as with Treakisym (>50%), this suggests IV rigosertib could havepotential peak sales of ¥3,200m ($32m) in 2024 (conservatively factoring in 6% biennial price cuts).
For the c 5,000 LR-MDS patients, we assume 25% lower pricing than for the IV formulation (andfactor in 6% biennial price cuts), which together with 50% penetration of this market suggests peaksales of ¥6,825m ($68m) in 2024. This suggests combined rigosertib MDS peak sales of ¥10,000m($100m) in Japan and South Korea. This compares to Vidaza sales in Japan for HR-MDS of¥9,692m in FY ending April 2013 ($97m), three years post launch (Dacogen is not currently
approved in Japan).
Although we do not currently include any potential contribution for oral rigosertib in combination withVidaza in frontline HR-MDS, this combination is being investigated by Onconova in a Phase I/II trial.
With Vidaza sales on track to reach $100m in Japan this year, this could therefore be a fairly
significant opportunity for rigosertib in Japan and South Korea. We estimate oral rigosertib sales inthis indication could be around $75m, assuming broad uptake into the current Vidaza market andbased on our lower price assumption for oral rigosertib. A more conservative 50% penetration could
lead to additional oral rigosertib sales of $38m, which represent pure upside to our forecasts.
Aside from Dacogen, we believe rigosertib is the most advanced product in development for bothLR- and HR-MDS in Japan. We would assume that products that are successfully developed for the
US and/or Europe will also eventually be developed for the Japanese market. Products in Phase II
development in HR-MDS include SGI-110 in Phase II from Otsuka/Astex, although this is more
likely to replace Dacogen, and sapacitabine from Daiichi Sankyo/Cyclacel. For LR-MDS the closest
competitors include ARRY-613 (Array Pharma) although this in only in Phase I.

SymBio Pharmaceuticals | 13 October 20148

Sensitivities
SymBio is subject to the usual drug development risks, including clinical development delays or
failures, regulatory risks, competitor successes, partnering setbacks, financing and commercial
risks. The main sensitivities include rigosertib success or failure, expansion of Treakisym toadditional indications and the ability to execute future in-licensing deals.
Despite a setback with the failure of the Phase III rigosertib IV ONTIME trial in the US, partner
Onconova is discussing a path forward with regulators; a development update is expected Q414
and a pivotal trial could start in 2015. Development of oral rigosertib continues and a pivotal Phase
III trial is expected to start in H115. SymBio is conducting Phase I trials for the both the IV and theoral form in Japan, which could complete in H115. Hence, the US pivotal Phase III trials should beunderway by the time these complete, which should then help to define the development strategy
for Japan and South Korea. Onconova will likely require additional cash to pursue future trials,
which could delay initiation of SymBio’s future trials and could therefore affect launch timelines.
For Treakisym, a key outcome will be expansion to frontline iNHL. SymBio is planning to file a
supplementary NDA in Japan once bendamustine has been approved in Europe in this indication,
potentially allowing for first sales in frontline iNHL by H216. This could be a key future growth driver
if approved. We do not currently include any contribution for r/r aggressive NHL, but if regulators
agree to approve this indication based on the current data package, then this could be an additional
contributor to future sales, which we do not currently include in our forecasts. Extending the 2020
market exclusivity in Japan could also provide upside to our forecasts.
SymBio is reliant on in-licensing assets to fill its pipeline and this will become even more important
for leveraging future commercial operations. To date, SymBio has executed three deals for productswith clinical proof-of-concept data, although development for one of these has been terminatedfollowing a lack of efficacy. We believe the CEO’s network is crucial to securing future deals,
although we have limited visibility on the potential terms and timing of any such agreements.

Valuation
We value SymBio at ¥14,135m ($141m) or ¥461/share (shown in Exhibit 7), based on a riskadjusted NPV analysis, which includes ¥4,798m ($48m) net cash. We use a 10% discount rate forapproved products and 12.5% elsewhere. Our valuation includes both Treakisym and rigosertib. For
Treakisym we include current sales and upside from sales in frontline iNHL and CLL; we do notinclude any potential in r/r aggressive NHL. Our Treakisym valuation assumes that SymBio earns
an average net margin of 10-12% on top-line reported Treakisym sales. Our rigosertib forecasts
include future R&D spend in addition to the cost of building out a sales infrastructure; we do notinclude any potential in indications beyond those currently under development, which could include
solid tumours, AML and broader use in MDS in combination with other agents.
Exhibit 7: SymBio rNPV valuation
Product

Indication

Treakisym (existing sales)
Treakisym (label expansion sales)
Rigosertib (IV); SyB L-1101
Rigosertib (oral); SyB C-1101
Net cash at end June 2014
Valuation

r/r iNHL/MCL
Frontline iNHL; CLL
r/r higher-risk MDS
Lower-risk MDS

Launch
2010
2016
2019
2019

Peak sales
($m)
55
80
30
70

NPV (¥m)

Probability

3,330
2,954
3,165
7,179
4,798
21,425

100%
90%
50%
35%
100%

rNPV
(¥m)
3,330
2,644
1,371
1,992
4,798
14,135

NPV/share(¥/share)
108.7
86.3
44.8
65.0
156.6
461.4

Source: Edison Investment Research. Note: Peak sales are rounded to the nearest $5m.

SymBio Pharmaceuticals | 13 October 20149

For Treakisym we include existing sales in approved indications at 100% probability, assuming a
4.2% seven-year sales CAGR through to expiry of the current market exclusivity in 2020. Beyond
this we assume a gradual sales decline. For label expansion sales, we only include contributions
from both CLL and frontline iNHL; a CLL trial is ongoing, and with approval already in the US andEurope we believe this has a high likelihood of also gaining approval in Japan. In frontline iNHL thepivotal trial is complete and SymBio plans to file this once approval has been granted in Europe (itis under regulatory review). Frontline iNHL could be a significant market for Treakisym, with >50%
more patients in Japan than in currently approved indications.
We do not include any contribution for Treakisym in r/r aggressive NHL, even though the Phase II
trial has been completed. Discussions with regulators are ongoing. We do not include any spend on
a further trial should one be required, with the only future Treakisym R&D spend for the ongoing
CLL study (where costs are shared 50:50 with Eisai). In addition, we do not currently include acontribution from potential bendamustine sales in China where partner Teva could complete
development by end 2014; China could also be a significant market for bendamustine if approved.
For rigosertib we include risk-adjusted valuations for both the IV and oral formulations in MDS. We
assign a 50% probability to the IV and a 35% probability to the oral, in line with our rigosertib risk
adjustments for Onconova. Our valuations include R&D spend for the ongoing Phase I trials inJapan in addition to future spend for the pivotal trials. We also include S&M spend where SymBio
plans to build out a salesforce of 30-40 reps at launch. If rigosertib can launch in Japan around ayear earlier than we currently assume, this could add around ¥1,500m ($15m) or ¥50/share to ourvaluation. If we include rigosertib at 100% probability, assuming it is successfully approved andlaunched, our valuation could increase by nearly ¥7,000m ($70m), or ¥230/share.

Financials
SymBio reported cash of ¥4,798m ($48m) at end June 2014, which includes current investmentswith more than three months’ maturity; we do not exclude these longer-term investments from the
cash in our valuation. With investment into Treakisym having peaked following completion of thefrontline iNHL trial, we believe current cash should be sufficient to fund operations into 2017, prior
to the potential launch of rigosertib. We assume additional funds will be needed at this point, to startbuilding out a sales and marketing infrastructure ahead of first potential rigosertib launch in 2019, in
addition to milestones that could become due to partner Onconova if rigosertib is approved in boththe US and Japan (together totalling $10m for US approvals of the IV and oral, and $8m for Japan
approvals). SymBio has access to an overdraft facility of ¥1,350m.
Our 2014 financial forecasts are broadly in line with SymBio guidance, summarised in Exhibit 8.
Revenues consist of income from partners on Treakisym sales (income from Eisai is the bulk,
representing 97% of revenue in 2013), in addition to any milestone income; within our financial
forecasts we do not include revenues from unknown future milestone income, only including a small
milestone in 2014 from Eisai on the recent Treakisym approval in r/r iNHL in South Korea. Recent
Q214 results suggest the company is on track to meet its retained guidance.
Exhibit 8: SymBio 2014 financial guidance
Revenue
R&D
SG&A (including R&D)
Operating loss (reported)
Ordinary loss (reported)
Net loss (reported)

Outlook¥1,785m¥940m¥2,083m¥1,654m¥1,650m¥1,654m

Edison estimates¥1,806m¥938m¥2,055m¥1,604m¥1,534m¥1,538m

Difference
+1.2%
-0.2%
-1.3%
-3.0%
-7.0%
-7.0%

Source: SymBio, Edison Investment Research

SymBio Pharmaceuticals | 13 October 2014

10

Exhibit 9: Financial summary
2010
JPN GAAP

2011
JPN GAAP

2012
JPN GAAP

2013
JPN GAAP

2014e
JPN GAAP

2015e
JPN GAAP

2016e
JPN GAAP

1,450
(238)
1,212
(1,118)
(640)
(636)
2
(0)
0
(634)
(4)
(640)
(639)
(4)
(644)
(642)

1,883
(1,224)658(1,945)(2,106)(2,100)2(5)
0(2,103)
3(2,098)(2,101)(4)(2,101)(2,105)

1,955(1,362)593(1,438)(1,743)(1,737)3(0)
0(1,734)
5(1,732)(1,730)(4)(1,736)(1,733)

1,532(1,214)318(1,053)(1,620)(1,615)300(1,611)10(1,605)(1,601)(4)(1,608)(1,605)

1,806(1,354)451(938)(1,617)(1,607)300(1,604)69(1,537)(1,534)(4)(1,541)(1,538)

1,968(1,385)582(1,193)(1,864)(1,842)3
0
0(1,839)46(1,796)(1,793)(4)(1,800)(1,797)

2,986(2,102)884(1,321)(1,827)(1,790)2
00(1,788)24(1,766)(1,764)(4)(1,770)(1,768)Average Number of Shares Outstanding (m)EPS - normalised (¥)
EPS - normalised and fully diluted (¥)
EPS - (IFRS) (¥)
Dividend per share (¥)

10.8(59.49)(59.49)(59.33)0.0

14.7(143.38)(143.38)(143.60)
0.0

19.1(90.76)(90.76)(90.60)0.0

23.2(69.42)(69.42)(69.29)0.0

30.6(50.30)(50.30)(50.20)0.0

30.6(58.75)(58.75)(58.65)0.0

30.6(57.76)(57.76)(57.71)
0.0

Gross Margin (%)
EBITDA Margin (%)
Operating Margin (before GW and except.) (%)

83.6
-44.2
-43.8

35.0
-111.9-111.6

30.3
-89.1
-88.9

20.8
-105.7-105.4

25.0
-89.6
-89.0

29.6
-94.7
-93.6

29.6
-61.2
-60.0

BALANCE SHEETFixed Assets
Intangible Assets
Tangible Assets
Investments
Current Assets
Stocks
DebtorsCash
Other
Current Liabilities
Creditors
Short term borrowings
Long Term Liabilities
Long term borrowings
Other long term liabilities
Net Assets

50
1
22
27
4,213
0
6
3,916
291
(178)
(178)
0
(2)
0
(2)
4,083

78
13
17
48
7,178
207
162
6,311
498
(646)
(646)
0
(5)
0
(5)
6,606

82
11
14
57
5,421
165
148
4,240
868
(599)
(599)
0
(4)
0
(4)
4,900

53
8
9
37
7,634
125
0
5,294
2,215
(251)
(251)
0
(3)
0
(3)
7,433

130
5
88
37
6,086
(140)
49
3,961
2,215
(251)
(251)
0
(2)
0
(2)
5,963

203
2
165
37
4,282
(143)
81
2,129
2,215
(251)
(251)
0
(2)
0
(2)
4,232

313
0
277
37
2,470
(217)
164
308
2,215
(250)
(250)
0
(2)
0
(2)
2,531

CASH FLOW
Operating Cash Flow
Net Interest
Tax
Capex
Acquisitions/disposals
Financing
Dividends
Net Cash Flow
Opening net debt/(cash)
HP finance leases initiated
Other
Closing net debt/(cash)

(753)
5
(5)
(14)
0
561
0
(206)
(4,121)0
0(3,916)(2,073)
(21)
(4)
(1)
0
4,495
0
2,395
(3,916)00(6,311)(1,660)
3
(4)
(2)
0
(409)
0
(2,071)(6,311)0
0(4,240)(1,680)
12
(4)
0
0
2,726
0
1,054
(4,240)00(5,294)(1,308)
70
(4)
(90)
0
0
0
(1,333)(5,294)0
0(3,961)(1,775)
45
(4)
(98)
0
0
0
(1,832)(3,961)00(2,129)(1,692)
24
(4)
(149)
0
0
0
(1,821)(2,129)00(308)Year end December
PROFIT & LOSS
Revenue
Cost of Sales
Gross Profit
Research and development
EBITDA
Operating Profit (before amort. and except.)
Intangible Amortisation
Exceptionals
Other
Operating Profit
Net Interest
Profit Before Tax (norm)
Profit Before Tax (FRS 3)
Tax
Profit After Tax (norm)
Profit After Tax (FRS 3)¥m

Source: SymBio accounts; Edison Investment Research. Note: Other current assets at end December 2013 include ¥869m of “timedeposits”, effectively short-term investments in addition to €1,100m marketable securities, among others.

SymBio Pharmaceuticals | 13 October 201411

Contact details

Revenue by geography

5-23-7 Shimbashi
Minato-ku
Tokyo 〒105-0004
Japan+ 81 3 5472 1125
www.symbiopharma.com

N/A

CAGR metrics
EPS 2011-15e
EPS 2013-15e
EBITDA 2011-15e
EBITDA 2013-15e
Sales 2011-15e
Sales 2013-15e

Profitability metrics
N/A ROCE 2014e
N/A Avg ROCE 2011-15e
N/A ROE 2014e
N/A Gross margin 2014e
1.1% Operating margin 2014e
13.3% Gr mgn / Op mgn 2014e

Balance sheet metrics
N/A Gearing 2014e
N/A Interest cover 2014e
N/A CA/CL 2014e
25% Stock days 2014e
N/A Debtor days 2014e
N/A Creditor days 2014eSensitivities evaluation
N/A Litigation/regulatory
N/A Pensions
N/A Currency
N/A Stock overhang
N/A Interest rates
N/A Oil/commodity prices








Management teamPresident and CEO: Fuminori Yoshida

CMO: Masataka Ohta

Mr Yoshida founded SymBio in March 2005. He has held senior management
positions in the healthcare industry in both the US and Japan, including founding
director of both Nippon BioRad Laboratories (1980) and Amgen Japan (1993) inaddition to Amgen Inc as Corporate VP. Mr Yoshida has a BS in organic
chemistry (Gakushin University), an MS in molecular biology (MIT) and an MS in
health policy and management (Harvard Grad School).

Dr Ohta joined SymBio Pharmaceuticals in 2012 as chief medical officer with 16
years of experience in the pharmaceutical industry. Dr Ohta previously served as
director of clinical development at Merck Serono Japan, and Novartis Oncology
Japan. Dr Ohta graduated from Tokyo University, where he received his medical
degree and PhD in virology. He also worked as an oncology research fellow at
Thomas Jefferson University, and at the National Cancer Center Japan.

CSO: Albert Qin
Dr Qin joined SymBio in 2010 as medical director, bringing 16 years ofexperience in drug research and development. Prior to SymBio Dr Qin was
medical director at Immunogen and associate director of clinical oncology at
Pfizer, in addition to spending time at both Biogen and Bayer. Dr Qin has a
medical degree from Shandong Medical University and a PhD in biochemistry
and molecular pharmacology from Harvard University.
Principal shareholders(%)

Fuminori Yoshida
Cephalon
JafCo
Weru Investment
Eisai
SBI Securities
GMO Click Securities

9.89
8.45
6.02
3.86
2.72
1.79
1.55

Companies named in this report
Astellas (4503 JP), Baxter (BAX US), Eisai (4523 JP), Onconova (ONTX US), Teva (TEVA US)

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