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SymBio Pharmaceuticals (4582)
On February 10, 2015, SymBio Pharmaceuticals announced full-year FY12/14 results and a
medium-term management plan.
Quarterly Performance

FY12/13

FY12/14FY12/14(JPYmn)

Q1Q2Q3Q4Q1Q2Q3Q4% of FY

Sales

489

322

513

209

174

802

373

607

98.2%

YoY

-15.8%-32.0%

10.5%-52.3%-64.5% 149.1% -27.3%

191.0%

151

33

89

45

215

106

173

YoY

17.6%

-75.7%-59.5%-58.5%-78.6% 543.6%

19.8%

286.1%

GPM

28.5%

GP

32

30.9%

10.4%

17.3%

21.5%

18.6%

26.8%

28.5%

SG&A

492

500

475

532

448

445

427

510

YoY

-19.2%-5.9%-18.7%-6.5%-9.0% -10.8% -10.1%-4.3%

SG&A / Sales

100.6% 155.2%

92.6% 255.3% 257.9%

55.6% 114.5%

FY Est.
1,990
29.9%

84.0%

-341

-466-386-488

-416

-231

-320-337-1,311

YoY---------OPM----------352-460-376-414-454

-259

-228

-170

-1,308

YoY---------

RPM----------353

-461

-377

-414

-455

-261

-228

-172

-1,311

YoY---------NPM---------OPRPNI

Figures may differ from company materials due to differences in rounding methods
Source: Company data

Sales for FY12/14 totaled JPY2.0bn (+27.6% YoY) due to domestic and overseas shipments of SyB L-0501.
Domestic sales of Treakisym rose 12.9% YoY. Overseas sales increased by 3.6x after the company added
one year of inventory in South Korea following a factory alignment. Milestone revenues declined 85.0%
YoY.
SG&A expenses were JPY1.8bn (-8.4% YoY), including R&D expenses of JPY774mn (-26.5% YoY)
associated with SyB L-0501、SyB L-1101, and SyBC-1101.
As a result, operating loss totaled JPY1.3bn (FY12/13: loss of JPY1.7bn). The company also had a recurring
loss of JPY1.1bn (FY12/13: loss of JPY1.6bn). The recurring loss was narrowed because the company had
a JPY189mn in currency gain, received JPY16mn in interest payments, and earned JPY8mn from securities
holdings. Net loss totaled JPY1.1bn (FY12/13: loss of 1.6bn).
Domestic
Treakisym
SymBio completed the phrase II clinical trial of Treakisym for the first-line treatment of low-grade NHL andMCL in February 2014. The company is analyzing and evaluating data from the trial as it prepares to file asupplemental new drug application (sNDA) for marketing approval. Astellas Pharma GmbH (“Astellas”;European subsidiary of Astellas Pharma Inc.; TSE1: 4503) has already applied for approval in Europe.
The company completed the patient enrollment for a phase II clinical trial for CLL in October 2014.
Treakisym was designated as an orphan drug (drug for the treatment of rare diseases) for CLL in June2012.

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The company is still considering applying for approval for use of the drug for relapsed or refractory
aggressive NHL.
Rigosertib
The company is conducting a domestic phase I clinical trial for the intravenous (IV) form of rigosertib in
relapsed or refractory higher-risk myelodysplastic syndromes (MDS).
In February 2014, licensor Onconova Therapeutics, Inc. (“Onconova”; Nasdaq: ONTX) announced theresults of its phase III ONTIME clinical trial in patients with higher-risk MDS. Compared with best
supportive care (BSC), the clinical trial did not show a statistically significant improvement in the overall
survival period (primary outcome measures). However, group analysis showed a statistically significant
difference in the survival period for patients whose condition had deteriorated or those who had not
responded to previous treatment using hypomethylating agents (HMAs).
Onconova held discussions with regulatory agencies in the US and Europe regarding the possibility ofseeking approval based on the results of the phase III trial. The regulators have confirmed that patients
who had not responded to HMAs would require a new treatment. In response, the company announced
that it would develop the new treatment. SymBio will continue with its current phase I clinical trials inJapan. Post-phase I development in Japan will depend on the development in the US and Europe.
A domestic phase I clinical trial using the oral form of rigosertib is also underway in Japan for the treatmentof high-risk MDS patients. The patient enrollment for the trial was completed in August 2014.
Overseas
SyB L-0501 was approved in South Korea for the additional indication of relapsed or refractory low-grade
NHL in June 2014. The product is now sold by Eisai’s Eisai Korea Inc. unit. The subsidiary also sells the drugfor two other indications—CLL and multiple myeloma (MM).
In Taiwan, the drug is being marketed by InnoPharmax Inc. In Singapore, Eisai (Singapore) Pte. Ltd.
markets the drug. Overseas sales increased by 2.2 times the estimate after the company added one year of
inventory in South Korea in connection with a factory alignment.
Overseas capital procurement
The company in November 2014 announced that it would issue No. 2 unsecured convertible bonds withsubscription rights to new shares, and No. 34 subscription rights to new shares in a third-party allocation toOak Capital Corporation. Oak in December 2014 paid JPY510mn to SymBio for the purchase. All the bonds
were converted to shares by the end of the month.

Full-year (FY12/15) outlook
FY12/14 Forecasts(JPYmn)Sales
CoGS
Gross Profit
GPM
SG&A
SG&A / Sales
R&D expenses
Operating Profit
OPM
Recurring Profit
RPM
Net Income
Net Margin

1H Act.
975
626
247
25.3%
893
91.6%
370-646-713-715-

FY12/142H Act.
980
802
280
28.5%
937
95.6%
404-657-397-401-FY Act.
1,955
1,428
527
26.9%
1,830
93.6%
774-1,303-1,110-1,116-Figures may differ from company materials due to differences in rounding methods

FY12/15FY Est.
1,870-2,452-2,481-2,485-

Source: Company data

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Earnings outlook
The company expects sales of JPY1.9bn (-4.3% YoY), operating loss of JPY2.5bn, recurring loss ofJPY2.5bn, and net loss of JPY2.5bn.
Sales
Sales of Treakisym are expected to surge. However, overseas sales may decline from FY12/14, when
shipments surged after the company added one year of inventory in South Korea following a factoryalignment.
SG&AThe company will expand the application of cancer agents SyBL-0501, SyB-L-1101, and SyB C-1101 while
acquiring new drug candidates. For this purpose, SymBio will seek to conclude more licensing agreementswith other companies. As a result, SG&A expenses may reach JPY3.0bn (FY12/14: JPY1.8bn), with
JPY1.9bn in R&D costs (FY12/14: JPY774mn).

Long-term outlook
When it released its FY12/14 results, SymBio also announced a mid-term plan for FY12/15 throughFY12/17.
FY12/14

FY12/15

FY12/16(JPYmn)

Midterm PlanAct.

Est.

TargetFY12/17
Target

Sales

1,955

1,870

2919～2,148

3,754～2,160

Operating Profit-1,303-2,452-2,390～-3,005-2,525～-3,492

Recurring Profit-1,110-2,481-2,419～-3,034-2,554～-3,521

Net Income-1,115-2,485-2,422～-3,038-2,557～-3,524

Source: Company data

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

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