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SymBio Pharmaceuticals | 4582 |Shared Research Report

SymBio Pharmaceuticals | 4582 |This PDF document is an updated note on the company. A comprehensive version of the report on the company, including this latest update, isavailable on our website at http://www.sharedresearch.jp and various professional platforms. Our sponsored research reports provide an in-depth
and informative view of the companies we cover, and contain the latest available information updated in a timely manner.

On November 6, 2015, SymBio Pharmaceuticals announced earnings results for Q3 FY12/15.
FY12/14Quarterly Performance (cumulative)

FY12/15

FY12/15(JPYmn)

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Sales

174

975

1,348

1,955

408

976

1,332

-64.5%

20.3%

1.9%

27.6% 135.0%

0.1%

-1.2%

YoY
Gross profit

32247

353

120

283

395

YoY

-78.6%

34.1%

29.4%

65.6% 272.1%

14.3%

11.8%

GPM

18.6%

25.3%

26.2%

26.9%

29.5%

28.9%

29.7%

448

893

1,320

1,830

453

931

1,383

-9.0%

-9.9%

-10.0%

-8.4%

1.1%

4.2%

4.7%

SG&A / sales

257.9%

91.6%

97.9%93.6% 110.9%

Operating profit

SG&A expenses
YoY527

Q4% of FY
71.3%

FY Est.
1,870
122.1%

95.3% 103.8%

-416

-646

-967

-1,303-332-648

-988

YoY

--------

OPM---------2,481

Recurring profit-2,452

-454

-713

-941

-1,110-419-674-1,056

YoY--------

RPM---------2,485

Net income

-455

-715

-944

-1,116-420-676-1,059YoY--------

NPM--------

FY12/14Quarterly Performance

FY12/15(JPYmn)

Q1

Q2

Q3

Q4

Q1

Q2Q3

Sales

174

802

373

607

408

568

356

-64.5% 149.1% -27.3% 191.0% 135.0% -29.2%

-4.5%

YoY
Gross profit

32215

106

173

120

162113

YoY-78.6% 543.6%

19.8% 286.1% 272.1% -24.5%

5.8%

GPM

18.6%

26.8%

28.5%

28.5%

29.5%

28.6%

31.6%

448

445

427

510

453

478

452

YoY

-9.0% -10.8% -10.1%

-4.3%

1.1%

7.3%

6.0%

SG&A / sales

257.9%

84.0% 110.9%

Operating profit

-416

-231

-320-337-332-316-340

YoY-------OPM--------454-259-228-170-419-255-382

YoY-------

RPM--------455-261-228-172-420-256-383

YoY-------

NPM-------

SG&A expenses

Recurring profit

Net income

55.6% 114.5%

Q4

84.1% 127.0%

Source: Shared Research based on company data.
Figures may differ from company materials due to differences in rounding methods.

Sales for Q3 FY12/15 totaled JPY1.3bn (-1.2% YoY) due to domestic and overseas sales of SyB L-0501 (Treakisym).
Overall Treakisym sales fell 1.2% YoY. Though domestic sales of Treakisym increased 6.1% YoY, overseas sales declined
due to shipments having been frontloaded in FY12/14.

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SymBio Pharmaceuticals | 4582 |SG&A expenses came to JPY1.4bn (+4.7% YoY), including research and development expenses worth JPY598mn (+9.7%).
These expenses mainly covered clinical trials for additional SyB L-0501 indications and costs pertaining to preparing theNew Drug Application (NDA) for submission, as well as clinical trials for SyB L-1101 (intravenous formulation) and SyBC-1101 (oral formulation), and preparation for the next phase of clinical trials. Other SG&A expenses came to JPY785mn(+1.3%).
As a result, operating loss totaled JPY988mn (Q3 FY12/14: loss of JPY967mn). The company also reported a recurring lossof JPY1.1bn (Q3 FY12/14: loss of JPY941mn), owing to non-operating expenses of JPY82mn, mainly from forex losses ofJPY74mn. Net loss totaled JPY1.1bn (Q3 FY12/14: loss of JPY944mn)

Domestic
Treakisym (SyB L-0501; anticancer agent; generic name: bendamustine hydrochloride)The company markets the anticancer agent Treakisym in Japan through its business partner, Eisai Co., Ltd. (TSE1: 4523)
for the indications of refractory or relapsed low-grade non-Hodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL).
Sales through Eisai increased as expected.
SymBio completed the phase II clinical trial of Treakisym for the first-line treatment of low-grade NHL and MCL in February
2014.. Along with the regulatory approval process for the application submitted by Astellas Pharma Europe Ltd. (aEuropean subsidiary of Astellas Pharma Inc.; TSE1: 4503) in the European Union, the company is also continuing toprepare the New Drug Application (NDA) for submission in Japan, having entered preliminary consultations with thePharmaceuticals and Medical Devices Agency (PMDA).
The company completed patient enrollment for a phase II clinical trial for chronic lymphocytic leukemia (CLL) in October
2014, and completed the trial in October 2015. It plans to file a Supplemental New Drug Application (sNDA) formarketing approval in Q1 FY12/16.. Treakisym was designated as an orphan drug (drug for the treatment of rare diseases)
for CLL in June 2012, and the Evaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Need has
also submitted a development request to the company.
SymBio is still considering applying for approval for use of the drug for relapsed or refractory aggressive NHL.
Rigosertib (SyB L-1101 [IV]/SyB C-1101 [oral]; anticancer agent)
The company is conducting a domestic phase I clinical trial for the intravenous (IV) form of rigosertib in relapsed or
refractory higher-risk myelodysplastic syndromes (MDS), a hematological malignancy. Patient enrollment was completedin January 2015, and tests were completed in October 2015.
Onconova Therapeutics, Inc., the U.S. licensor, is currently conducting a global Phase III trial for higher risk MDS patients
who do not respond to treatment with hypomethylating agents (HMAs), the current standard of care (“Primary HMAFailure”), at clinical trial sites in more than ten countries worldwide. Following its completion of the domestic Phase I
clinical trial, SymBio also decided to participate in the global clinical trial in October 2015.
As for SyB C-1101 (oral formulation, or Oral rigosertib), the company’s domestic Phase I clinical trial for the target
indication of higher risk MDS was completed in June, 2015. The company plans to continue clinical trials for thedevelopment of Oral rigosertib in combination with azacitidine for higher risk MDS, as well as for lower risk
transfusiondependent MDS, and is considering participating in the global clinical trial to be conducted by Onconova.
This note is the most recent addition to the full report.

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SymBio Pharmaceuticals | 4582 |Shared Research Report

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