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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 May 10, 2016, SymBio Pharmaceuticals announced earnings results for Q1 FY12/16.
Quarterly Performance (cumulative)

FY12/15

FY12/16(JPYmn)

Q1

Q2

Q3

Q4Q1Sales

408

976

1,332

1,933

193

135.0%

0.1%

-1.2%

-1.1%

-52.7%

YoY
Gross profit

Q2

FY12/16Q3

Q4% of FY
8.3%

FY Est.
2,339
21.0%

120

283

395

583

57

YoY

272.1%

14.3%

11.8%

10.7%

-53.1%

GPM

29.5%

28.9%

29.7%

30.2%

29.2%

453

931

1,383

3,135

575

1.1%

4.2%

4.7%

71.3%

27.0%

SG&A / sales

110.9%

95.3%

103.8%

162.1%

297.6%

Operating profit-332-648-988-2,552-518-2,778

YoY------

OPM-------419-674-1,056-2,630-655-2,811

YoY------

RPM-------420-676-1,059-2,632-653-2,815

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

SG&A expenses
YoY

Recurring profit

Net income

Quarterly Performance

FY12/15(JPYmn)

Q1

Q2

Q3

Q4

Q1

Sales

408

568

356

601

193

YoY

135.0%-29.2%

-4.5%

-1.0%

-52.7%

120

162

113

18857

YoY

272.1%-24.5%

5.8%

8.5%-53.1%

GPM

29.5%

28.6%

31.6%

31.3%

29.2%

453

478

452

1,752

575

1.1%

7.3%

6.0%

243.7%

27.0%

SG&A / sales

110.9%

84.1%

127.0%

291.6%

297.6%

Operating profit

-332

-316

-340

-1,564-518

YoY

-----

OPM

------419

-255

-382

-1,574-655

YoY-----

RPM------420

-256

-383

-1,573-653

YoY-----

NPM

-----

Gross profit

SG&A expenses
YoY

Recurring profit

Net income-

FY12/16Q2

Q3

Q4Source: Shared Research based on company data.
Figures may differ from company materials due to differences in rounding methods.

Q1 FY12/16 sales totaled JPY193mn (-52.7% YoY) due to domestic and overseas sales of SyB L-0501 (Treakisym).
Treakisym domestic sales declined, as shipments to Eisai Co., Ltd. (TSE1: 4523) are expected to be focused in Q2 andsales of overseas products are planned from Q2.

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SymBio Pharmaceuticals | 4582 |SG&A expenses rose 27.0% YoY to JPY575mn. R&D expenses rose to JPY224mn (+8.4%) on expenses for clinical trials inJapan that are part of global Phase III trials for the intravenous version of rigosertib; expenses for domestic phase I trials forthe oral version of rigosertib for use in combination with azacitidine; and expenses related to preparations for domestic
Phase III trials for SyB P-1501.
As a result, operating loss totaled JPY518mn (versus a loss of JPY332mn the preceding year). The company also reported arecurring loss of JPY655mn (JPY419mn loss) due to non-operating expenses of JPY139mn (mainly on forex losses ofJP134mn). Net loss was JPY653mn (loss of JPY420mn in the previous year).

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 Q1, 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 and is looking for quick
approval as the process proceeds. 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)
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. The
company is currently preparing to begin patient enrollment.
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, and was preparing to begin patient enrollment. The
company is looking to quickly complete joint trials, and is considering participating in the global clinical trial to be
conducted by Onconova.

SyB P-1501, a post-operative patient-controlled analgesia
In October 2015 SymBio reached an in-licensing agreement with The Medicines Company (through its wholly owned
subsidiary Incline Therapeutics) for the development and commercialization of SyB P-1501, a post-operative
patient-controlled analgesia known as IONSYS in the US. SymBio acquired exclusive development and marketing rights forJapan. Preparations are under way for domestic phase III clinical trials.

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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 ensure its long-term growth and become a sustainable and profitable pharmaceuticalcompany.

Overseas
The company marketed Treakisym in Korea, Taiwan, and Singapore, but did not book sales for Q1 because shipments tooverseas 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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