R SymBio Pharmaceuticals / 4582
CoverageUpdate Notes

Research Coverage Report by Shared Research Inc. | www.sharedresearch.jp

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.

On November 10, 2017, SymBio Pharmaceuticals Ltd. announced earnings results for Q3 FY12/17 and that it had recorded
non-operating profit.
FY12/16

Cumulative

FY12/17

FY12/17(JPYmn)

Q1Q2Q3Q4

Q1Q2Q3Sales

193

1,211

1,408

2,368

870

1,786

2,417

YoY

-52.7%

24.0%

5.6%

22.5%

350.2%

47.5%

71.7%

Gross profit

Q4% of FY
67.4%

FY Est.
3,583
51.3%

57405

478

904

239

510

675

YoY

-53.1%

43.2%

21.1%

55.1%

323.0%

26.0%

41.0%

GPM

29.2%

33.4%

34.0%

38.2%

27.5%

28.5%

27.9%

575

1,225

2,011

3,031

764

1,746

4,183

YoY

27.0%

31.6%

45.4%

-3.3%

32.9%

42.5%

108.0%

SG&A-to-sales ratio

297.6%

101.2%

142.8%

128.0%

87.9%

97.7%

173.1%-518-820-1,532-2,127-525-1,236-3,508

YoY--------

OPM--------

SG&A expenses

Operating profit

Recurring profit--655-1,177-1,917-2,317-583-1,268-3,547

YoY--------

RPM--------Net income--3,932-653-1,175-1,916-2,313-583-1,266-3,546

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

FY12/16

Quarterly(JPYmn)

Q2

Q3Q4Q1Q2

Q3Gross profit193-52.7%
57

1,018
79.2%
348

197
-44.7%
74960
59.9%
426

870
350.2%
239

916
-9.9%
271

631
220.3%
165

YoY-53.1%

114.8%-34.6%

126.6%

323.0%-22.2%

123.8%

GPM

29.2%

34.2%

37.4%

44.3%

27.5%

29.6%

26.1%

575

650

786

1,021

764

982

2,437

YoY

27.0%

36.0%

73.8%

-41.7%

32.9%

51.1%

210.1%

SG&A-to-sales ratio

297.6%

63.9%

399.2%

106.2%

87.9%

107.1%

386.5%

-518
--302
--712
--595
--525
--711
--2,272--655--522--740--400--583--685--2,279
-

-653
--523
--741
--397
--583--684--2,280-

YoY

SG&A expenses

Operating profit
YoY
OPM

Recurring profit
YoY
RPM

Net income
YoY-4,009FY12/17

Q1Sales--4,009

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

Q4

Cumulative Q3 FY12/17 sales totaled JPY2.4bn (+71.7% YoY) thanks to sales of Treakisym.
Due to the sales increase, gross profit came to JPY675mn (+41.0% YoY). Gross profit margin was 27.9% (-6.1pp).
SG&A expenses rose 108.0% YoY to JPY4.2bn. R&D expenses increased 176.3% to JPY2.7bn. There were expenses for clinical
trials for the intravenous and oral formulations of Rigosertib Sodium and SyB P-1501, and the cost of in-licensing liquid
formulation products of bendamustine hydrochloride (RTD and RI products). SG&A expenses excluding R&D expenses were up
42.9% at JPY1.5bn.
As a result, operating loss totaled JPY3.5bn (loss of JPY1.5bn in Q3 FY12/16). The company also reported a recurring loss ofJPY3.5bn (loss of JPY1.9bn in Q3 FY12/16) partly due to non-operating expenses of JPY43mn (mainly on forex losses of JPY24mn).
Net loss was JPY3.5bn (loss of JPY1.9bn in Q3 FY12/16).
Progress made in Q3 FY12/17 is as follows.

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R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

Research Coverage Report by Shared Research Inc. | www.sharedresearch.jp

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 theindications of refractory or relapsed low-grade non-Hodgkin’s lymphoma (NHL) and mantle cell lymphoma (MCL), untreatedlow-grade NHL and MCL, and chronic lymphocytic leukemia (CLL).
As a result of additional indications, sales of Treakisym based on the National Health Insurance (NHI) drug price grew 53.4% YoY,and accordingly product sales to Eisai increased 68.0%.
In addition to the above three approved indications, the company has filed an NDA for a fourth indication to help patients whoneed new treatments and maximize the value of the product. The company has completed phase III clinical trials for relapsed orrefractory diffuse large B-cell lymphoma (DLBCL, or aggressive NHL). In response to strong medical needs, the company
finished consultation with the Pharmaceuticals and Medical Devices Agency and began phase III clinical trials toward the additionof an indication in August 2017.
In addition to ongoing efforts to add new indications, in September 2017, the company concluded an agreement with Eagle
Pharmaceuticals (based in New Jersey, US) that licenses to SymBio rights to develop, market, and sell Eagle’s bendamustinehydrochloride RTD and RI injection products in Japan for Treakisym’s product life cycle management. The RTD and RI products
offer significant value added to patients and healthcare professionals, and extends Treakisym’s product life cycle until 2031.
SymBio is exploring further expansion of the Treakisym business by developing an oral formulation in addition to the injection
currently under development or on sale to treat solid tumors and autoimmune diseases.

Rigosertib Sodium (SyB L-1101 [IV]/SyB C-1101 [oral]; anticancer agent; generic name: Rigosertib Sodium)
Onconova Therapeutics, Inc., the licensor, is currently conducting a global Phase III trial and SymBio Pharmaceuticals started theJapan 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 completed
the first patient enrollment in July 2016 and enrollments are smoothly accumulating.
SymBio planned to start domestic Phase I clinical trials for the oral form of Rigosertib Sodium (used in combination withazacitidine) for higher-risk myelodysplastic syndrome (MDS), however, due to delays in the supply of drugs by Onconova for thetrials, patient enrollment did not make progress. Since Onconova resumed the supply of clinical trial materials, SymBio initiated aphase I clinical trial in Japan in June 2017 and enrolled the first patient in October. The purpose of the Japanese phase I study is toconfirm the safety of high-dose oral rigosertib, which was added to the ongoing US phase II study by Onconova in untreated orrelapsed/refractory patients with higher-risk MDS. After demonstrating the safety of high-dose oral rigosertib, SymBio intends to
immediately recommence an oral rigosertib/azacitidine combination trial in Japan, and participate in the global phase III study inuntreated higher-risk MDS patients that Onconova is planning.

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 whollyowned subsidiary Incline Therapeutics)—for the short-term management of acute post-operative pain during hospitalization inJune 2016. The company enrolled the first patient in November 2016 and was making progress with case accumulation. However,SymBio later found a fact that raises concerns about the continuity of The Medicines Company’s SyB P-1501 business. In theinterests of patient welfare, SymBio has suspended further patient enrollment since April 2017 and is in talks with The Medicines
Company regarding how the SyB P-1501 clinical trial and commercialization in Japan would be affected.

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R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

Research Coverage Report by Shared Research Inc. | www.sharedresearch.jp

New drug candidates
From a long-term perspective, SymBio continues to search for and evaluate promising drug candidates, in a bid to acquire global
licensing rights for these drugs and grow into a sustainable and profitable biopharmaceutical company with growth potential andprofitability. At present, talks are underway regarding licensing rights for several drug candidates. Further, in May 2016, thecompany established SymBio Pharma USA, Inc., a wholly owned US-based subsidiary, as a strategic base for overseas businessdevelopment. The company looks to leverage this subsidiary to actively acquire rights over new drug development candidates
globally, and engage in development and commercialization in major markets including the US, Japan, and Europe to transition
to a global specialty pharmaceutical company.

OverseasThe company marketed Treakisym in Korea, Taiwan, and Singapore, and overseas sales are trending ahead of target.

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

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R About Shared Research Inc.
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