R SymBio Pharmaceuticals / 4582
CoverageUpdate Notes

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On August 3, 2017, SymBio Pharmaceuticals Ltd. announced earnings results for 1H FY12/17.
FY12/16

Cumulative

FY12/17(JPYmn)

Q1

Q2

Q3

Q4

Q1Q2

Sales

193

1,211

1,408

2,368

870

1,786

YoY

-52.7%

24.0%

5.6%

22.5%

350.2%

47.5%

Gross profit

57405

478

904

239

510

YoY

-53.1%

43.2%

21.1%

55.1%

323.0%

26.0%

GPM

29.2%

33.4%

34.0%

38.2%

27.5%

28.5%

575

1,225

2,011

3,031

764

1,746

YoY

27.0%

31.6%

45.4%

-3.3%

32.9%

42.5%

SG&A-to-sales ratio

297.6%

101.2%

142.8%

128.0%

87.9%

97.7%

-518

-820

-1,532-2,127-525-1,236

YoY------

OPM-------655-1,177-1,917-2,317-583-1,268

SG&A expenses

Operating profit

Recurring profit

FY12/17
Q3Q4% of FY

FY Est.

61.5%

2,903
22.6%

--3,238---3,303

YoY-------

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

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

FY12/16

Quarterly(JPYmn)Q1

Q2

Q3Q4Q1Q2

Gross profit

1,018
79.2%
348

197
-44.7%
74960
59.9%
426

870
350.2%
239

916
-9.9%
271

YoY

-53.1%

114.8%-34.6%

126.6%

323.0%-22.2%

GPM

29.2%

34.2%

37.4%

44.3%

27.5%

29.6%

575

650

786

1,021

764

982

YoY

27.0%

36.0%

73.8%

-41.7%

32.9%

51.1%

SG&A-to-sales ratio

297.6%

63.9%

399.2%

106.2%

87.9%

107.1%

-518
--302
--712
--595
--525
--711
--655
--522
--740
--400
-

-583
--685
--653
--523
--741
--397
--583
--684-YoY

SG&A expenses

Operating profit
YoY
OPM

Recurring profit
YoY
RPM

Net income
YoY

Net margin-3,306

FY12/17193-52.7%
57Sales-Q3

Q4

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

1H FY12/17 sales totaled JPY1.8bn (+47.5% YoY) thanks to sales of Treakisym.
Due to the sales increase, gross profit came to JPY510mn (+26.0% YoY). Gross profit margin was 28.5% (-4.9pp).
SG&A expenses rose 42.5% YoY to JPY1.7bn. R&D expenses increased 62.0% to JPY840mn. There were expenses for clinical trials
for the intravenous and oral formulations of Rigosertib Sodium and SyB P-1501. SG&A expenses excluding R&D expenses wereup 28.3% at JPY906mn.
As a result, operating loss totaled JPY1.2bn (loss of JPY820mn in 1H FY12/16). The company also reported a recurring loss ofJPY1.3bn (loss of JPY1.2bn in 1H FY12/16) partly due to non-operating expenses of JPY34mn (mainly on forex losses of JPY27mn).
Net loss was JPY1.3bn (loss of JPY1.2bn in 1H FY12/16).
Progress made in 1H 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).
In 1H FY12/17, sales of Treakisym based on the National Health Insurance (NHI) drug price grew 42.9% YoY, and accordingly
product sales to Eisai increased 44.6%.
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 or
refractory diffuse large B-cell lymphoma (DLBCL, or aggressive NHL). In response to strong medical needs, the company has
finished consultation with the Pharmaceuticals and Medical Devices Agency and is preparing for phase III clinical trials toward theaddition of an indication.
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 started domestic Phase I clinical trials for the oral form of Rigosertib Sodium (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, however,patient enrollment did not make progress. Since Onconova resumed the supply of clinical trial materials, SymBio initiated a phase
I clinical trial in Japan. The purpose of the Japanese phase I study is to confirm the safety of high-dose oral rigosertib, which wasadded to the ongoing US phase II study by Onconova in untreated or relapsed/refractory patients with higher-risk MDS. Afterdemonstrating the safety of high-dose oral rigosertib, SymBio intends to immediately recommence an oral rigosertib/azacytidine
combination trial in Japan, and participate in the global phase III study in untreated higher-risk MDS patients that Onconova isplanning.

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 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.

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.

2/4

R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

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

Overseas
The company marketed Treakisym in Korea, Taiwan, and Singapore, and overseas sales were steady.

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

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