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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
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On August 5, 2015, SymBio Pharmaceuticals announced earnings results for Q2 FY12/15.
Quarterly Performance (cumulative)

FY12/14

FY12/15(JPYmn)

Q1

Q2

Q3Q4

Q1Q2Sales

174975

1,348

1,955

408

976

-64.5%

20.3%

1.9%

27.6% 135.0%

0.1%

YoY
Gross profit

Q4% of FY

FY Est.

52.2%

1,870
122.1%

32247

353

120

283

YoY

-78.6%

34.1%

29.4%

65.6% 272.1%

14.3%

GPM

18.6%

25.3%

26.2%

26.9%

29.5%

28.9%

448

893

1,320

1,830

453

931

-9.0%

-9.9%

-10.0%

-8.4%

1.1%

4.2%

SG&A / sales

257.9%

91.6%

97.9%

93.6% 110.9%

95.3%Operating profit-416-646-967-1,303-332-648

YoY-------

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

SG&A expenses
YoY

Recurring profit

527

FY12/15
Q3-2,452-454-713-941-1,110-419-674

YoY-------

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

Net income-455-715-944-1,116-420-676

YoY-------

NPM-------

Quarterly Performance

FY12/15

FY12/14(JPYmn)

Q1

Q2

Q3

Q4

Q1

Q2

Sales

174802373

607

408568YoY
Gross profit

32215106

173

120

162

-78.6% 543.6%

19.8% 286.1% 272.1% -24.5%

GPM

18.6%

26.8%

28.5%

28.5%

29.5%

448

445

427

510

453

478

YoY

-9.0% -10.8% -10.1%

-4.3%

1.1%

7.3%

SG&A / sales

257.9%

84.0% 110.9%

84.1%

Operating profit

-416

-231

-320

-337

-332

-316

YoY

------OPM-------454

-259

-228

-170

-419

-255
-

Recurring profit

55.6% 114.5%

28.6%

YoY

-----

RPM

-------455

-261

-228

-172

-420

-256

Net incomeQ4-64.5% 149.1% -27.3% 191.0% 135.0% -29.2%

YoY
SG&A expenses

Q3

YoY------NPM------

Source: Company data
Figures may differ from company materials due to differences in rounding methods.

Sales for Q2 FY12/15 totaled JPY976mn (+0.1% YoY) due to domestic and overseas sales of SyB L-0501 (Treakisym).
Though domestic sales of Treakisym increased 11.6% YoY, total sales of the product were up only 1.7% as overseas
shipments were partially implemented in advance in the previous year.

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SymBio Pharmaceuticals | 4582 |SG&A expenses came to JPY931mn (+4.2% YoY), including research and development expenses worth JPY404mn(+9.0%), mainly for clinical trials for SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation), and other
SG&A expenses worth JPY527mn (+0.7%).
As a result, operating loss totaled JPY648mn (Q2 FY12/14: loss of JPY646mn). The company also reported a recurring lossof JPY674mn (Q2 FY12/14: loss of JPY713mn), owing to non-operating expenses of JPY35mn, mainly from forex losses ofJPY29mn. Net loss totaled JPY676mn (Q2 FY12/14: loss of JPY715mn)

DomesticTreakisym (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. The company is preparing the New Drug Application (NDA) for submission in Japan. The company will apply forapproval as soon as the regulatory approval process for the application submitted by Astellas Pharma Europe Ltd. (aEuropean subsidiary of Astellas Pharma Inc.; TSE1: 4503) is completed in the European Union.
The company completed patient enrollment for a phase II clinical trial for chronic lymphocytic leukemia (CLL) in October
2014. It plans to complete the trial and file an sNDA for marketing approval as soon as possible. Treakisym was designatedas an orphan drug (drug for the treatment of rare diseases) for CLL in June 2012.
The company 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 orrefractory higher-risk myelodysplastic syndromes (MDS), a hematological malignancy. Patient enrollment was completed
in January 2015.
Onconova Therapeutics, Inc., the U.S. licensor, plans to conduct 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 HMA Failure”),
with clinical trial sites in more than ten countries worldwide. SymBio is considering its participation in the global clinical
trial which is planned to begin in 2H of 2015 after completion of the domestic Phase I clinical trial.
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 its participation 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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