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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 August 4, 2016, SymBio Pharmaceuticals announced earnings results for Q2 FY12/16.
Quarterly performance (cumulative)

FY12/15

FY12/16(JPYmn)

Q1

Q2

Q3

Q4

Q1Q2

Sales

408

976

1,332

1,933

193

1,211

135.0%

0.1%

-1.2%

-1.1%

-52.7%

24.0%

YoY

Gross profit

120283

395

583

57405

YoY

272.1%

14.3%

11.8%

10.7%

-53.1%

43.2%

GPM

29.5%

28.9%

29.7%

30.2%

29.2%

33.4%

453

931

1,383

3,135

575

1,225

1.1%

4.2%

4.7%

71.3%

27.0%

31.6%

SG&A / sales

110.9%

95.3%

103.8%

162.1%

297.6%

101.2%

Operating profit-332-648-988-2,552-518-820

YoY------

OPM-------419-674-1,056-2,630-655-1,177

SG&A expenses
YoY

Recurring profit
YoY------

RPM-------420-676-1,059-2,632-653-1,175

Net income

FY12/16Q3

Q4% of FY
51.8%

FY Est.
2,339
21.0%

--2,778---2,811---2,815

YoY-------Net margin-------

Quarterly performance

FY12/15

FY12/16(JPYmn)

Q1

Q2

Q3

Q4

Q1

Q2

Sales

408

568

3566011931,018

135.0%-29.2%

-4.5%

-1.0%

-52.7%

79.2%

120

162

113

188

57348

YoY

272.1%-24.5%

5.8%

8.5%-53.1%

114.8%

GPM

29.5%

28.6%

31.6%

31.3%

29.2%

34.2%

453

478

452

1,752

575

650

1.1%

7.3%

6.0%

243.7%

27.0%

36.0%

SG&A / sales

110.9%

84.1%

127.0%

291.6%

297.6%

63.9%

Operating profit

-332

-316

-340

-1,564-518-302

YoY------

OPM-------419

-255

-382

-1,574-655-522

YoY------RPM-------420-256-383-1,573-653-523

YoY------Net margin------

YoY

Gross profit

SG&A expenses
YoYRecurring profit

Net income

Q3

Q4

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

1H FY12/16 results
1H FY12/16 sales totaled JPY1.2bn (+24.0% YoY) thanks to domestic sales of Treakisym.
Product sales were up 20.9% YoY. Further, the company booked royalty revenue from a milestone payment on the salesof SyB L-0501 in Taiwan.
SG&A expenses rose 31.6% YoY to JPY1.2bn. R&D expenses rose to JPY518mn (+28.4% YoY) on expenses for clinical trials
for the intravenous and oral versions of rigosertib and expenses related to preparations for clinical trials for SyB P-1501.

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SymBio Pharmaceuticals | 4582 |SG&A expenses excluding R&D expenses were up 34.1% at JPY706mn on expenses for the introduction of newdevelopment candidates and expenses for acquisition of companies that own the rights to new drug candidates.
As a result, operating loss totaled JPY820mn (loss of JPY648mn in 1H FY12/15). The company also reported a recurring
loss of JPY1.2bn (loss of JPY674mn last year) due to non-operating expenses of JPY360mn (mainly on forex losses ofJPY330mn). Net loss was JPY1.2bn (loss of JPY676mn).

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).
In 1H, product sales to Eisai were largely in line with plan.
In Japan, the company submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency(PMDA) in December 2015 for a first-line treatment of low-grade NHL and MCL. Meanwhile, in Europe, though thecompany received notification on January 2016 from Astellas Pharma that its application had been withdrawn, it plans tocontinue with the domestic approval process upon consulting with the PMDA.
Regarding chronic lymphocytic leukemia (CLL), the company filed an NDA in December 2015. In June 2016, the PMDA
held a discussion of experts. The company continues to look for quick approval as the process proceeds. Treakisym wasdesignated 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 tothe 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)
Onconova Therapeutics, Inc., the licensor, is currently conducting a global Phase III trial and SymBio Pharmaceuticals
started the Japan trial in December 2015. The global Phase III trial addresses higher risk myelodysplastic syndrome (MDS)
patients who do not respond to treatment or relapsed after treatment with hypomethylating agents (HMAs), the current
standard of care (“Primary HMA Failure”) and is under way at clinical trial sites in more than ten countries worldwide. Thecompany has taken steps to register patients, and completed the first patient enrollment in July 2016, after the close of 1H
FY12/16.
SymBio started domestic Phase I clinical trials for the oral (IV) form of rigosertib (used in combination with azacitidine) for
higher-risk myelodysplastic syndrome (MDS) in December 2015. Due to delays in the supply of drugs for the joint trials,
patient enrollment has not started as of August 4, 2016. The company is looking to start patient registration upon
resolution of this issue, and complete joint trials in line with its plans. SymBio is considering participating in the global
clinical trial to be conducted by Onconova.

SyB P-1501, a post-operative patient-controlled analgesia
The company started a domestic phase III clinical trial for SyB P-1501—licensed by the Medicines Company (through its
wholly owned subsidiary Incline Therapeutics)—for the short-term management of acute post-operative pain duringhospitalization in June 2016. The company is looking to complete the Phase III clinical trial quickly, and obtain regulatory
approval in 2019.

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SymBio Pharmaceuticals | 4582 |New drug candidates
From a long-term perspective, SymBio will continue to search for and evaluate promising drug candidates, and acquire
global rights for these drugs to become a sustainable and profitable pharmaceutical company with growth potential andprofitability. Further, in May 2016, the company established SymBio Pharma USA, Inc., a wholly owned US-based
subsidiary, as a strategic base for overseas business development. The company looks to leverage this subsidiary toactively acquire rights over new drug development candidates globally, and engage in development andcommercialization in major markets including the US, Japan, and Europe to accelerate the process of turning into a global
specialty pharmaceutical company.

Overseas
The company marketed Treakisym in Korea, Taiwan, and Singapore, and saw overseas sales progress largely in line withplans in Q1 because shipments to overseas clients are planned from Q2 and after.

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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