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February 20, 2014
SymBio Pharmaceuticals Limited
Fuminori Yoshida
Representative Director
President and CEO(Securities code: 4582)

Takashi Shimomura
Director
Executive Vice President and CFO(TEL. 03-5472-1125)

SymBio’s Long Range Plan: FY2014 to FY2016
I.

Long Range Plan for the coming three years(1) Overview of FY 2013 business results as of the date of the Long Range Plan
Progress in the Company’s business for FY 2013 (from January 1, 2013 to December 31,2013) is as follows.

1. Domestic[SyB L-0501 (the generic name: bendamustine hydrochloride, the trade name:TREAKISYM®)]
Since December 2010, the Company has marketed the anticancer drug SyB L-0501 in
Japan through its business partner Eisai Co., Ltd. (“Eisai”), for the indications ofrefractory/relapsed indolent non-Hodgkin’s lymphoma and mantle cell lymphoma.
The Company has also carried out three clinical trials on TREAKISYM® for additional
indications.
With respect to the Phase II clinical trial for the indications of previously untreatedindolent non-Hodgkin’s lymphoma and mantle cell lymphoma, the enrollment for thetargeted simple size was completed in March 6, 2013. The application for approval in the
EU has already been submitted by Astellas Pharma Europe, and is being reviewed by theEuropean Medicines Agency (“EMA”).
The Phase II clinical trial for the indication of chronic lymphocytic leukemia was initiatedin May 8, 2013, and favorable progress has been made with enrollment of patients. In thisconnection, TREAKISYM® was designated an orphan drug (pharmaceutical for treatmentof rare diseases) for the indication of chronic lymphocytic leukemia during June 2012.
Discussion about future approaches to development for refractory/relapsed aggressive
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non-Hodgkin’s lymphoma is currently being continued with the Pharmaceuticals andMedical Devices Agency (“PMDA”).
On the other hand, in the Phase II clinical trial on refractory/relapsed multiple myeloma,
which was carried out as part of the expansion of indications, although a dose of 90 mg/m2
TREAKISYM® was confirmed to be safe for Japanese patients on the basis of interim
results, no patients were found to respond to this treatment, and it was judged that it would
be very difficult to achieve the target response rate with TREAKISYM® monotherapy, evenwith inclusion of more patients in the study, so the study was discontinued. In the future, wewill not develop this indication but allocate our business resources to other studies with ahigh probability of approval.

[SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), the genericname: rigosertib]
The Japanese Phase I clinical trial of the anticancer drug SyB L-1101(intravenous
formulation) for the indication of refractory/relapsed myelodysplastic syndrome (“MDS”), a
type of blood tumor, has been continued.
With respect to SyB C-1101(oral formulation), the Japanese Phase I clinical trial for theintended indication of previously untreated MDS was initiated in March 2013.
While presenting study data of several programs currently in development, Onconova
Therapeutics, Inc. (USA, “Onconova”) has presented favorable data from Phase II trial intransfusion-dependent low risk MDS patients treated with oral formulation on December 10,
2013.
By accelerating development in the Europe and the U.S., it is expected to expand market
potential of rigosertib in Japan. Besides, it is also expected to shorten the clinical trial
process in Japan through the future utilization of the clinical trial data obtained abroad.

2. Overseas
SyB L-0501 sold largely as planned in South Korea, Taiwan and Singapore. In Singapore
and South Korea, we sell the product through Eisai, as we do in Japan, and the sales
figures have been going up steadily.

3. Fund procurement
The Company made a resolution on November 19, 2013 regarding the issuance of newshares and secondary offering of shares through a public offering and through a third party
allotment. Accordingly, the payments of 2,503,744 thousand yen and 321,118 thousand yen
had been completed on December 4, 2013 and December 25, 2013, respectively.
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4. Business results
As a result of the above, net sales totaled 1,532,054 thousand yen for the fiscal year
ended December 31, 2013, primarily reflecting sales of SyB L-0501 in Japan and the otherAsia Pacific territories. The net sales amount was decreased by 21.6% compared to theprevious year by following review of the current market inventory level of TREAKISYM®.
Selling, general and administrative expenses totaled 1,998,522 thousand yen (ayear-on-year decrease of 12.9%), including research and development (“R&D”) expenses
of 1,052,790 thousand yen (a year-on-year decrease of 26.7%) due to the accrual of
expenses associated with the clinical trials for multiple indications for SyB L-0501, clinical
trials for SyB L-1101 and SyB C-1101, as well as other selling, general and administrative
expenses of 945,732 thousand yen (a year-on-year increase of 10.6 %).
As a result, operating loss of 1,680,528 thousand yen was recognized for the fiscal year
ended December 31, 2013 (operating loss of 1,700,273 thousand yen for the previous fiscal
year). In addition, recording of amount totaling 35,363 thousand yen as non-operating
expenses, primarily comprising commissions and stock-issuance expenses, and amount
totaling 114,467 thousand yen as non-operating income, primarily comprising foreignexchange gains, led to ordinary loss of 1,601,424 thousand yen (ordinary loss of 1,729,480
thousand yen for the previous fiscal year) and net loss of 1,605,224 thousand yen (net lossof 1,733,320 thousand yen for the previous fiscal year).

(2) SymBio’s Long Range Plan – Summary and Background
SymBio is the first “specialty pharmaceuticals” in Japan to specialize in the following
three areas: oncology, haematology and autoimmune disease. Although there is great
medical demand in these areas, development remains challenging due to the need for highdegree of specialization. Because major pharmaceutical companies are reluctant todevelop these areas for reasons of business productivity, oncology, haematology andautoimmune disease are regarded as the “undeserved therapeutic area” in terms ofdevelopment in Japan and Asia.
The Company sees business opportunities in these “undeserved therapeutic area” andinstead of pursuing the “blockbuster” new drugs (where sales often exceeds 100 billion yen),
it focuses on drugs and new drug candidates related to oncology, haematology andautoimmune diseases, even though the markets are relatively small, because the needs
are high. Capturing high revenue through development and sales of drugs and new drugcandidates in these areas is at the core of the business development of the Company.
The most significant characteristic of SymBio’s business model is one in which theCompany does not own research and manufacturing facilities, and instead evaluates new
drug candidates that have been tested on humans for efficacy and safety, and brings in3

products mainly through pharmaceutical companies and bio venture companies in Europe
and the U.S.
By not owning its research and manufacturing facilities, the Company is able to avoid
large capital investment and conduct effective business operations with low fixed costs.
Also, by concentrating on “late stage” new drug candidates that have been tested for
efficacy and safety on humans, the development period is shortened, thus lowering bothdevelopment cost and risks.
The Company is building a strong pipeline portfolio and aiming for an early return toprofitability through these efforts.

SymBio’s Long Range Plan is as follows:Maximize the value of our main product of TREAKISYM®, for which manufacturingand marketing approval has been granted in respect of relapsed or refractory indolent
non-Hodgkin’s lymphoma, a type of blood cancer, through aggressive promotion ofindication expansion (life cycle management).



Develop SyBL-110 (intravenous formulation)/C-1101 (oral formulation) (the genericname; rigosertib), which was introduced in July 2011, as therapy for MDS, a type ofblood cancer. Development decision with regard to solid tumors will be made after
considering status and data of development overseas.

Pro-actively search, evaluate and negotiate with the aim of introducing new drugcandidates during the first half of FY2014.

Pro-actively develop and commercialize drugs for the Asian markets that are expected
to grow rapidly (China (including Hong Kong), Taiwan, Korea and Singapore.

(3) Business Status, Outlook and Other Assumptions○

With regard to TREAKISYM®, from December 2010, domestic sales have commenced
through Eisai, our business partner, for relapsed or refractory indolent non-Hodgkin’s
lymphoma and mantle cell lymphoma indications. Sales have been increasing steadily
and market share has reached a high level.

○

Going forward, in order to further increase sales, the Company aims to strengthen themarketing arrangement for TREAKISYM® with Eisai, achieve product differentiationfrom targeted competing drugs, and endeavors to obtain early approval for additional
indications. Among the clinical trials that are being done to expand indication, caseregistration is complete and data analysis in progress for Phase II clinical trial forindication of untreated indolent non-Hodgkin's lymphoma, and while taking into
account outcome of approval in Europe, the Company will continue to prepare for4regulatory approval.

Phase II clinical trial in respect of chronic lymphocytic leukemia

is in progress with a view to obtain early approval. With regard to relapsed or refractory
aggressive non-Hodgkin’s lymphoma, although Phase II clinical trial produced goodresults, the Company is in further discussion with PMDA regarding plans for additional
clinical trials and shall continue to put in best efforts to obtain approval.
With regard to relapsed or refractory multiple myeloma, based on the interim results of
the Phase II clinical trial, a determination was made to discontinue development for thisindication because, although safety was confirmed for Japanese patients, response
was not observed, and even if further patient enrollment is continued, expected
response rate as a single drug would be difficult to achieve.
○

Anticancer drug SyB L-1101 ((intravenous formulation) /C-1101 (oral formulation) (thegeneric name: rigosertib), With regard to SyB L-1101 (intravenous formulation), theCompany will consider domestic development plans based on results of PhaseIII

clinical trial for refractory or relapsed aggressive MDS by Onconova Therapeutics Inc.
(“Onconova”), results of further discussions to take place between Onconova and the
US Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”),
and Onconova’ development policy taking into the above results. In Japan, theCompany plans to continue current Phase I clinical trial. With regard to SyB C-1101(oral), development will continue for indications of transfusion-dependent low risk MDS
and untreated high risk MDS. As for development relating to solid tumor, determination
will be made after consideration of overseas development status and data.
○

As for transdermal analgesic anti-emetic SyB D-0701, there are no further plans todevelop, as other programs are higher priorities.

○

With regard to the Asian market, SyB L-0501 has been approved and sold in
Singapore, Hong Kong, South Korea and Taiwan, and sales have been progressing at
a steady rate. Sales in these markets are done through business alliances and to
maximize sales in the Asian market, the Company will work on further strengthening ofbusiness alliances. With regard to SyB L-1101/C-1101, the Company owns the rights inSouth Korea and will continue to develop towards obtaining approval there.

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II.

Earnings Forecast and Performance Target(Unit: millions of yen)
Fiscal year

Net sales

Operating

Ordinary

Net income

income (loss)

income (loss)(loss)FY 2013 (Actual)

1,532

ሺ1,680)ሺ1,601)

ሺ1,605)FY 2014 (Forecast)

1,785

ሺ1,654)

ሺ1,650)ሺ1,654)

FY 2015 (Target)

2,110

ሺ2,355)

ሺ2,351)

ሺ2,355)4,225

ሺ1,757)

ሺ1,753)

ሺ1,757)

to 2,162

to ሺ2,455)

to ሺ2,451)

to ሺ2,454)

FY 2016 (Target)

Assumptions and Numerical Bases for Projections and Performance Targets○

With regard to sales, TREAKISYM® makes up the majority of product sales. The
performance target for drug sales assume that new drugs (additional indications) areapproved as assumed in the business plan, and figures are derived after detailed analysis
and discussion about market size projections, competitive positioning vis-à-vis existing
therapies, market dominance, and sales performance after commencement of sales.
Furthermore, milestone revenue is estimated based on the Company’s development plan.

○

Cost of sales is estimated based on the provisions of existing licensing agreement.

○

Selling and general administrative expenses mainly categorized as research anddevelopment (“R&D”) expenses or other selling expenses and general administrative
expenses.


Research and development expenses are estimated based on “III. Other reference
information – Status of Development Portfolio and Performance Targets”. However,with regard TREAKISYM®, since the business alliance agreement with Eisai provides
that R&D expenses be split equally between the two parties, half of estimatedexpenses are assumed. Milestone payments are estimated in accordance with
provisions in the existing contract.



Other selling and general administrative expenses mainly consist of expenses incurredfrom TREAKISYM® marketing, new business development, production & distribution
and administrative operations. However, with regard to TREAKISYM®, since thebusiness alliance agreement with Eisai provides that marketing expenses be split
equally between the two parties, half of estimated expenses are assumed, similar to
the R&D expenses.

○

As stated in “III. Other reference information – Status of Development Portfolio and6Performance Targets”, with respect to indication for relapsed or refractory aggressive
non-Hodgkin’s lymphoma, as there are no additional clinical trial plans at this point, nosales and expenses are assumed for this indication.
○

Application for approval for the indication untreated indolent non-Hodgkin's lymphoma
planned in FY 2015 is dependent on the outcome of approval in Europe. Therefore,
numerical assumptions were made based on the two scenarios (approval obtained inEurope and approval not obtained in Europe) and presented as maximum and minimum
figures.

7III. Other Reference Information
Status of Development Portfolio and Performance Targets
Development
code
Therapeutic
category

Indication

Preclinical
study

Phase I
clinical trial

Phase II
clinical trial

Refractory/relapsed
indolent
non-Hodgkin’s
lymphoma

SyB L-0501
Anticancer drug

Filingapplication
for approval

Approved

Approved on October 2010

Untreated indolent
non-Hodgkin’s
lymphoma
Refractory/relapsed
aggressive
non-Hodgkin’s
lymphoma

Under discussion with
PMDA

Chronic lymphocytic
leukemia
SyB L-1101
Anticancer drug
Intravenous
formulation

SyB C-1101
Anticancer drug
Oral formulation

Refractory/relapsed
aggressive MDS

Details after Phase I clinical trial are currently
under discussion.

(myelodysplastic syndrome)

Untreated
medium/high risk
MDS
(myelodysplastic syndrome)

Untreatedtransfusion-dependent
low risk MDS(myelodysplastic syndrome)

Note 1.

: The development plan
: Completed as of December 31, 2013 (FY 2013): FY 2014 target: FY 2015 target: FY 2016 target

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Portfolio summary and issues for achieving plans are set out below.
○

SyB L-0501 (the generic name: bendamustine hydrochloride, the trade name:TREAKISYM®)

Summary:The principle component of SyB L-0501, bendamustine hydrochloride (the genericname), was used in Germany for many years as anticancer drug for non-Hodgkin’s
lymphoma, multiple myeloma and chronic lymphocytic leukemia (the trade name:Ribomustin).



From 2000, the efficacy and safety of this drug has been re-evaluated and it is now
approved and sold in 60 countries around the world. In July 2005, the Company
obtained the exclusive rights of development and marketing from the licensor,
AstellasDeutschland GmbH, a German subsidiary of Astellas, to develop and sell

the drug in Japan, China (including Hong Kong), South Korea, Taiwan and Singapore,and in all regions other than China, has obtained approval. Going forward, theCompany will collaborate closely with local business partners and maximize sales.


In Japan, manufacturing and marketing approval was obtained in October 2010 for
indications relapsed or refractory indolent non-Hodgkin’s lymphoma and mantle cell
lymphoma and sales started through Eisai, a business alliance, in December 2010.
After starting its sales, this drug has been administered to over 7000 patients(estimated by the Company) by the end of 2013.



In order to expand the value of this drug, the Company is working on development forother indications such as untreated indolent non-Hodgkin's lymphoma, mantle cell
lymphoma and chronic lymphocytic leukemia. The Company is also continuing
discussions with PMDA regarding the indication relapsed or refractory aggressive
non-Hodgkin’s lymphoma.

Issues and Specific Measures:Promotion of Indication Expansion
For untreated indolent non-Hodgkin’s lymphoma and mantle cell lymphoma, caseregistration for Phase II clinical trial is complete and observation period has begun.
Since approval in Japan is subject to obtaining approval in Europe, as soon as such
European approval is confirmed, the Company will proceed with the domestic
application process. For relapsed or refractory aggressive non-Hodgkin’s lymphoma,
Phase II clinical trial is complete but additional clinical trials are required before theapplication for approval. Sales and expenses relating to this indication are notincluded in this long range plan, as details of the clinical trial plans are not confirmed
9at this point. With regard to chronic lymphocytic leukemia, current Phase II clinical trial
is moving forward in order to obtain approval at an early stage.


Maximizing Sales
In Japan, our most significant market, sales of the product is through Eisai, with whom
we have a business alliance. In order to further promote market penetration, theefficacy and safety of the drug already proven through clinical trials need to be more
widely understood so that it is more often prescribed. To that end, the Company will
work closely with Eisai and plan strategies vis-à-vis competing therapies, andaggressively develop marketing strategies such as collaboration with academic
conferences and study groups.

○

SyB L-1101 (intravenous formulation) /C-1101 (oral formulation) (the generic name:rigosertib)

Summary:

SyB L-1101/C-1101 is an anticancer drug, which operates as a unique multi-kinase
inhibitor. Since obtaining exclusive rights to develop and distribute in Japan andSouth Korea from Onconova in July 2011, the Company has been developing thisdrug. (The Company has obtained rights for both intravenous and oral formulations.

With regard to development of this drug, currently, Onconova is conducting
development in the U.S. and Europe for the indications of myelodysplastic syndromes(“MDS”), head and neck cancer, ovarian cancer, etc. With regard to the intravenous
formulation for relapsed or refractory MDS, Onconova will consider development
policies taking into account results of the Phase III clinical trial and discussions with
FDA and EMA. As for the oral formulation, Phase II clinical trial for the indication oftransfusion-dependent low risk MDS is complete. For untreated medium/high risk
MDS, Phase I clinical trial is in progress.



Onconova is proceeding with Phase II clinical trial for the indication of head and neckcancer and the Company will await status report, data, etc. from such clinical trial
before proceeding domestic development.



Currently, the Company is conducting Phase I clinical trial of the intravenous
formulation for the indication of relapsed or refractory MDS, and of the oral
formulation for the indication of untreated MDS.

Issues and Specific Measures:Promotion of Indication Expansion
With regard to the intravenous formulation, domestic development policy will be
determined taking into account the result of Phase II clinical trial by Onconova for10relapsed or refractory high risk MDS, anticipated discussions between Onconova and
FDA as well as EMA, and Onconova’ development policy resulting from the above.
Domestically, he Company plans to continue Phase I clinical trial that are in progress.
With regard to the oral formulation, domestic clinical trials will be conducted taking into
account the two trials (transfusion-dependent low risk MDS and untreatedmedium/high risk MDS) currently in progress in Europe and the U.S. With regard tosolid tumors (head and neck cancer, etc.), development will be considered upon
review of development status/data from overseas.


Use of Overseas Data
In order to cut costs and reduce development time, it is assumed that results ofclinical trials conducted overseas will be used as materials for domestic approval
applications. Such data will be reviewed in detail by the Company in order to be
assured of high quality.

This disclosure document is for the purpose of providing information on the Company’s future businessstrategies to investors, and is not for the purpose of soliciting investments.
The evaluation on the Company’s business strategies and investment decisions shall be made by investors
themselves based on their own judgment.
The Company does not guarantee, in any sense, the possibility of realizing and achieving any performancetarget or other matter of our business strategies and does not assume any liability for any such information.
All forward-looking statements (including, but not limited to, the performance targets in our business plan)contained in this document are judgmentally prepared by the Company based on the information available as ofthe date of this document. Therefore, in the event there are future changes to conditions that make up theassumptions of the business strategy, such as economic conditions, there may be impact on the actual businesscondition and performance such that the results will be different from statements in this disclosure document.

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