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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 February 10, 2016, SymBio Pharmaceuticals announced earnings results for full-year FY12/15.
Quarterly Performance (cumulative)

FY12/14

FY12/15

FY12/15(JPYmn)

Q1

Q2Q3Q4Q1Q2Q3

Q4% of FY

Sales

174975

1,348

1,955

408

976

1,332

1,933

103.4%-64.5%

20.3%

1.9%

27.6%

135.0%

0.1%

-1.2%

-1.1%

YoY

FY Est.
1,870
122.1%

32247

353

527

120283

395

583

YoY

-78.6%

34.1%

29.4%

65.6%

272.1%

14.3%

11.8%

10.7%

GPM

18.6%

25.3%

26.2%

26.9%

29.5%

28.9%

29.7%

30.2%

448893

1,320

1,830

453

931

1,383

3,135

-9.0%

-9.9%

-10.0%

-8.4%

1.1%

4.2%

4.7%

71.3%

SG&A / sales

257.9%

91.6%

97.9%

93.6%

110.9%

95.3%

103.8%

162.1%

Operating profit

-416

-646

-967

-1,303

-332

-648

-988

-2,552-2,452

YoY---------

OPM----------454-713-941-1,110-419-674-1,056-2,630-2,481

YoY---------

RPM----------455

-715

-944

-1,116-420-676-1,059-2,632-2,485

YoY---------

NPM---------

Gross profit

SG&A expenses
YoY

Recurring profit

Net income

Quarterly Performance

FY12/14

FY12/15(JPYmn)

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Sales

174

802

373

607

408

568

356

601

YoY

-64.5%

149.1%-27.3%

191.0%

135.0%-29.2%

-4.5%

-1.0%

32215

106

173

120

162

113

188

YoY

-78.6%

543.6%

19.8%

286.1%

272.1%-24.5%

5.8%

8.5%

GPM

18.6%

26.8%

28.5%

28.5%

29.5%

28.6%

31.6%

31.3%

448

445

427

510

453

478

452

1,752

YoY-9.0%-10.8%-10.1%

-4.3%

1.1%

7.3%

6.0%

243.7%

SG&A / sales

257.9%

55.6%

114.5%

84.0%

110.9%

84.1%

127.0%

291.6%

Operating profit

-416

-231

-320

-337

-332

-316

-340

-1,564

YoY--------

OPM---------454-259-228-170

-419

-255

-382

-1,574Gross profit

SG&A expenses

Recurring profit
YoY--------

RPM---------455-261-228-172

-420

-256

-383

-1,573

YoY--------NPM--------Net income

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

FY12/15 sales totaled JPY1.9bn (-1.1% YoY) due to domestic and overseas sales of SyB L-0501 (Treakisym).
Treakisym domestic sales rose 24.0% YoY, but overseas sales fell 76.1% on factors including the earlier booking of ordersin Korea in FY12/14.
SG&A expenses rose 71.3% YoY to JPY3.1bn due to expenses incurred for clinical trials for oral and intravenous rigosertib
and Treakisym, and the booking of R&D expenses of JPY2.0bn (+162.8%) in conjunction with the in-licensing expenses
for SyB P-1501 (IONSYS for post-operative patient-controlled analgesia) and “other” SG&A expenses of JPY1.1bn (+4.2%).

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Shared Research Report

SymBio Pharmaceuticals | 4582 |As a result, operating loss totaled JPY2.6bn (versus a loss of JPY1.3bn the preceding year). The company also reported arecurring loss of JPY2.6bn (JPY1.1bn loss) due to non-operating expenses of JPY96mn (mainly on forex losses of JPY86mn).
Net loss totaled JPY2.6bn (JPY1.1bn loss the preceding year).
Progress towards FY12/16 targets is as follows.

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. NHI price-based sales rose 10.3% YoY.
Phase II clinical trial of Treakisym for the first-line treatment of low-grade NHL and MCL had already been completed andthe company submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
in December 2015. Meanwhile, in Europe, review of the application by Astellas Pharma is under way by Europeanauthorities.
Regarding the phase II clinical trial for chronic lymphocytic leukemia (CLL), the company filed an NDA in December 2015.
Treakisym was designated as an orphan drug (drug for the treatment of rare diseases) for CLL in June 2012, and theEvaluation Committee on Unapproved or Off-Labeled Drugs with High Medical Need has also submitted a development
request to the company.
In addition to the 100mg dosage of Treakisym, SymBio Pharmaceuticals also filed in December 2015 for approval of asmaller 25mg dosage as an amount that could actually be used at medical facilities.
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 orrefractory higher-risk myelodysplastic syndromes (MDS), a hematological malignancy. Patient enrollment was completed
in January 2015, and the trial was completed in October 2015.
Onconova Therapeutics, Inc., the U.S. 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 MDS patients who do not respondto 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.

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 to start a domestic phase III clinical trial in 2016.

Overseas
The company marketed Treakisym in Korea, Taiwan, and Singapore. Product sales were mostly in line with targets.

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SymBio Pharmaceuticals | 4582 |Shared Research Report

Full-year company forecasts
FY12/16 Forecasts(JPYmn)Sales
CoGS
Gross Profit
GPM
SG&A
SG&A / Sales
R&D expenses
Operating Profit
OPM
Recurring Profit
RPM
Net IncomeNet Margin

FY12/15FY Act.
1,933
1,350583
30.2%
3,135
162.1%
2,035-2,552-2,630-2,632-

FY12/16
FY Est.
2,339-2,778-2,811-2,815

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

Earnings outlook
Sales are expected to reach JPY2.3bn (+21.0% YoY), with an operating loss of JPY2.8bn, a recurring loss of JPY2.8bn and a
net loss of JPY2.8bn.
R&D expense is expected to total JPY2.2bn (up from JPY2.0bn in FY12/15), while total SG&A expense–including R&D–isprojected to reach JPY3.6bn (up from JPY3.1bn).
R&D spending targets additional indications for Treakisym and development toward NDA applications for 1) intravenousand oral rigosertib and 2) SyB P-1501, which was in-licensed in FY12/15. The company will also work jointly with Teikyo
Heisei University on the development of an anti-cancer drug using the TTR1 nano-agonist molecule.

Pipeline
Treakisym
Supplemental NDAs were filed in FY12/15 for indications as a first-line treatment for refractory/relapsed low-grade NHL,MCL and CLL. Work is under way to respond to matters raised by the PMDA and speed up the approvals.

Intravenous and oral rigosertib
The company is moving ahead with the Japan edition of the global Phase III trial for the intravenous version of rigosertib,and hopes to quickly begin initial patient enrollment. Similarly, SymBio aims to quickly start initial patient enrollment forthe domestic Phase I trial of the oral version of rigosertib for use in combination with azacitidine. Regarding developmentwith low-risk MDS as the target efficacy, SymBio will consider it while watching development progress at Onconova
Therapeutics.
SyB P-1501, a post-operative patient-controlled analgesia
SymBio reached an in-licensing agreement for SyB P-1501 in FY12/15. Preparations are under way to start a domestic
phase III clinical trial in 3Q FY3/17.

This note is the most recent addition to the full report.

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