R SymBio Pharmaceuticals / 4582
CoverageUpdate Notes

Research Coverage Report by Shared Research Inc. | https://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 and various professional platforms.

On May 13, 2021, SymBio Pharmaceuticals Ltd. announced earnings results for Q1 FY12/21.
FY12/20

Cumulative

FY12/21(JPYmn)

Q1

Q2

Q3

Q4

Q1

Sales

551

1,361

2,333

2,987

1,420

YoY

-65.8%-32.1%

16.2%

5.3%

157.6%

Gross profit
YoY
GPM

128

330

611

867

1,010-79.0%
23.2%-37.7%
24.2%

8.5%
26.2%

0.2%
29.0%

690.9%
71.1%

SG&A expenses

1,090

2,170

3,753

5,373

1,221

YoY
SG&A ratio-9.6%
197.6%-14.7%
159.5%-8.4%
160.9%

4.0%
179.9%

12.0%
85.9%

-962

-1,840-3,142-4,506-211------991-1,883-3,221-4,616-209-----Net income-992-1,885-2,694-4,090-210

YoY
Net margin

-----

Q1

Q2Q3Q4Q1551-65.8%
128809
105.7%
202

972
281

654
-21.1%
256

1,420
157.6%
1,010-79.0%
23.2%

25.0%

738.4%
28.9%-15.2%
39.1%

690.9%
71.1%

Operating profit
YoY
OPM

Recurring profit
YoY
RPM

Quarterly(JPYmn)
Sales
YoY

Gross profit
YoY
GPM

FY12/20

SG&A expenses

1,090

1,080

1,583

1,620

1,221

YoY
SG&A ratio-9.6%
197.6%-19.4%
133.5%

1.8%
162.9%

51.8%
247.5%

12.0%
85.9%

-962
--878
--1,302--1,364
-

-211-

-991
--892
-

-1,338--1,395--209--992--893--809--1,396--210-

Operating profit
YoYOPM-Recurring profit
YoYRPM-Net income
YoYNet margin----------

Q2

FY12/21Q3

Q4% of Est.
15.5%

FY Est.
9,151
206.4%

-

1,361
14.9%

-

1,350
14.8%

-

12.6%

FY12/21
Q2

1,149

Q3

Q4

Q3

Q4

Q3

Q4

-

--

Source: Shared Research based on company data
Note: Figures may differ from company materials due to differences in rounding methods.
“-”denotes YoY change of over 1000%.

Breakdown of SG&A expenses
FY12/20

Cumulative(JPYmn)
SG&A expenses
YoY

FY12/21

Q1

Q2

Q3Q4

Q1

1,090

2,170

3,753

5,373

1,221
12.0%

-9.6%

-14.7%

-8.4%

4.0%

R&D expenses

438

834

1,745

2,267

473

YoY

-7.1%

-13.4%-11.5%

-7.2%

8.0%

651

1,336

2,008

3,107

747

-11.1%-15.5%

-5.6%

14.0%

14.7%

SG&A expenses excl. R&D
YoY

FY12/20

Quarterly(JPYmn)
SG&A expenses
YoY

FY12/21

Q1Q2

Q3

Q4

Q1

1,090

1,080

1,5831,620

1,221
12.0%

-9.6%

-19.4%

1.8%

51.8%

R&D expenses

438

396

911

522

473

YoY

-7.1%

-19.4%

-9.7%

11.0%

8.0%

SG&A expenses excl. R&D
YoY

Q2

651

685

672

1,098

747

-11.1%-19.3%

23.2%

83.9%

14.7%

Q2

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

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R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp

Q1 FY12/21 results▷Sales:▷Recurring loss:

JPY4.6bn (loss of JPY991mn in Q1 FY12/19)

Net loss:

JPY4.1bn (loss of JPY992mn in Q1 FY12/19)▷▷

JPY1.4bn (+157.6% YoY)

Operating loss: JPY211mn (loss of JPY962mn in Q1 FY12/19)

Sales increased YoY, largely due to the transfer of sales from Eisai Co., Ltd. to the company’s own sales force.
Earnings were partially hindered by medical care delays due to COVID-19 since late 2020 and constraints on sales activities dueto tighter restrictions on facilities visitations, but considering the clearance of market inventory of the lyophilized (freeze-dried[FD]) powder formulation of Treakisym® sold by Eisai prior to the switch to the company’s own sales force in December 2020,demand for Treakisym® was strong in Q1.
For Q2, although there are lingering impacts of the clearance of market inventory distributed prior to the switch to the company’own sales force, there will be minimal impact on sales overall, and the company says that it anticipates sales growth on theadditional indications for relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) that were approved on March 23.
Although SG&A expenses increased, losses at the operating profit level on down shrank thanks to the effect of sales growth.
SG&A expenses increased 12.0% YoY to JPY1.2bn and R&D expenses increased 8.0% YoY to JPY473mn. This included expenses
for conducting clinical trials of intravenous formulations of Treakisym® and brincidofovir. Excluding R&D expenses, SG&A rose
14.7% YoY to JPY747mn. The switch to in-house sales drove up the cost of sales.

Domestic
Preparations for in-house sales organization begin
The business alliance agreement between SymBio and Eisai Co., Ltd. under which Eisai acts as a sales agent expired in December
2020, and the company switched to in-house sales for domestic sales of Treakisym®.
The company has thus far deployed a nationwide network of marketing representatives as well as hematology experts to covereach region to establish a highly productive internal sales organization capable of making proposals that fit the needs of eachregion. With the termination of its alliance agreement with Eisai, in September 2020, the company concluded a basic agreementwith Suzuken Co., Ltd and Toho Pharmaceutical Co., Ltd for the procurement and sale of pharmaceuticals to achieve nationwide
distribution. The company has established two distribution centers, one in Eastern Japan and the other in Western Japan, undermanagement by S.D. Collabo Co., Ltd.
During Q1, in January 2021, the company launched sales of the ready-to-dilute (RTD) formulation of Treakisym®, for which it
obtained manufacturing and marketing approval in September 2020.
On March 23, 2021, the company obtained approval of a partial change to the manufacturing and marketing authorization forthe lyophilized (freeze-dried [FD]) powder formulation of Treakisym® used in bendamustine-rituximab combination therapy (BRtherapy) and in bendamustine-rituximab-polatuzumab vedotin combination therapy (Pola-BR therapy) to treat r/r DLBCL patients.
Treakisym® can be used in BR therapy right away, and once polatuzumab vedotin is added to the NHI drug price list and goes onsale, Treakisym® will be able to be used in Pola-BR therapy.
On April 28, 2021, the company obtained approval of a partial change to the marketing authorization of Treakisym® RTD liquid
formulation for use in BR and Pola-BR therapy as treatment for r/r DLBCL.

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R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp

Stable product supply
With the launch of sales of Treakisym® RTD formulation in January 2021, the company now markets both Treakisym® in both RTD
formulation and lyophilized powder formulation.
SymBio imports lyophilized Treakisym® for injection from Astellas Deutschland (consolidated subsidiary of Astellas Pharma) andTreakisym® RTD formulation from Eagle Pharmaceuticals Inc. In Q1, secondary packaging and quality tests were applied toimported batches, resulting in stable quality, and as of May 2021, inventories had maintained proper levels to enable stableproduct supply.
On the supply front, the company is aiming for 91% completion of the switchover from the lyophilized injectable formulation tothe RTD formulation of Treakisym®.

Treakisym® (SyB L-0501[lyophilized injection]/SyB L-1701 [RTD]/SyB L-1702 [RI]/SyB C-0501 [oral]; anticancer agent; generic name:bendamustine hydrochloride)
The anticancer agent Treakisym® is used to treat malignant lymphomas, indicated for untreated low-grade non-Hodgkin’s
lymphoma and mantle cell lymphoma (marketing approval obtained in December 2016), refractory or relapsed low-grade NHLand MCL (October 2010), and chronic lymphocytic leukemia (August 2016).
The combination therapy of Treakisym® and rituximab (BR therapy) was newly included in the Practical Guidelines for
Hematological Malignancies 2018 published by Japanese Society of Hematology as a standard treatment option, which applies toall of the approved indications. This has seen Treakisym® establish its position as a standard treatment for lymphatic cancer.
Also, SymBio obtained approval for the partial revision to the marketing authorization of Treakisym® in July 2018. Treakisym® can
now be used in combination with new anti-CD20 antibodies and not just rituximab for the treatment of CD20-positive follicularlymphoma, the most common histological type of low-grade NHL. This allows the company to provide patients a new treatment
option: combination therapy with obinutuzumab. In March 2019, SymBio obtained approval for the partial revision to its
application to use Treakisym® as a pretreatment agent in tumor-specific T cell infusion therapy. This allows Treakisym® to be used
as a pretreatment agent for Kymriah® intravenous infusion, which was the first chimeric antigen receptor T-cell (CAR-T) therapy
approved in Japan. Growing use of Treakisym® as a pretreatment agent in regenerative medicine has solidified its positioning as
standard therapy for malignant lymphomas.
In the phase III clinical study of Treakisym® administered in BR therapy targeting r/r DLBCL, the company filed for approval forpartial revision to manufacturing and marketing authorization in May 2020 and obtained that approval in March 2021. In April
2021, it obtained approval for partial revision to manufacturing and marketing authorization of Treakisym® RTD liquid formulation
for use in BR and Pola-BR therapy as treatment for r/r DLBCL. The company has conducted a follow-up study with overall survival
as the primary endpoint, because evaluating the survival data (e.g., overall survival and progression-free survival) for Treakisym®
administered in BR therapy is crucial for establishing Treakisym® as a treatment for DLBCL. It is now making preparations topublicize the results of that study. Also, after Chugai Pharmaceutical Co., Ltd. applied for manufacture and marketing approval forpolatuzumab vedotin in combination with BR therapy to treat r/r DLBCL in June 2020, the company applied for approval forpartial revision to manufacturing and marketing authorization for Treakisym® in Pola-BR therapy and obtained approval in March
2021. With the approvals obtained by Chugai and SymBio, once polatuzumab vedotin is added to the NHI drug price list,
Treakisym® will be able to be used in Pola-BR therapy. At present there are no effective treatments for the additional indication ofr/r DLBCL, which is usually treated by a combination of anticancer agents as salvage chemotherapy, so development of a highly
effective but safe new drug would be ideal. Since BR therapy is already being used in the West to treat r/r DLBCL, patientorganizations and related academic societies have petitioned MHLW so that it can be used in Japan as soon as possible.
The company concluded an exclusive licensing agreement in Japan with Eagle Pharmaceuticals (based in New Jersey, US) in
September 2017 for the RTD and rapid infusion (RI) formulations of Treakisym® (the RI formulation reduces administration time).
Manufacturing and marketing approval of the RTD formulation was obtained in September 2020, and the company launched it inJanuary 2021. The company has concluded clinical trials to confirm safety of the RI formulation and applies for approval in May

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R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp2021. Unlike the current lyophilized powder formulation, the RTD formulation reduces the workload of medical professionals,
because it eliminates the need for troublesome manual dissolution. The RI formulation can be administered in just 10 minutes
versus 60 minutes for the current lyophilized injection and RTD formulation. This reduces the burden on patients and healthcare
professionals, providing significant value added. Multiple patent protections in the form of a liquid product license will enable
the extension of the product life of Treakisym® to 2031.

Rigosertib Sodium (SyB L-1101 [IV]/SyB C-1101 [oral]; anticancer agent; generic name: rigosertib Sodium)
Onconova Therapeutics, Inc., the licensor, conducted a global phase III trial (INSPIRE study) across more than 20 countries
addressing higher-risk myelodysplastic syndromes (higher-risk MDS) with overall survival as the primary endpoint. The target ispatients who do not respond to the current standard treatment with hypomethylating agents, relapse after treatment under thecurrent standard of care, or are intolerant to hypomethylating agents. In August 2020, Onconova announced a comparator trial
to physicians’ choice of treatment failed to achieve the primary endpoint. The company leads clinical trials conducted in Japanand is looking to apply the knowledge gleaned from additional analysis of the INSPIRE study to rigosertib development going
forward.
Regarding the oral formulation of rigosertib, Onconova completed a phase I/II clinical trial for the drug used in combination withazacytidine, whose results suggested the efficacy and safety of the combination therapy. To verify the tolerability and safety of
the high-dose oral formulation of rigosertib as an initial treatment for higher-risk MDS among Japanese patients, SymBio began aphase I clinical trial in Japan in June 2017 and completed patient enrollment in June 2019.

Antiviral drug SyB V-1901 (generic name: brincidofovir）
In September 2019, SymBio concluded an exclusive global license agreement with Chimerix Inc. (hereafter Chimerix) for
brincidofovir (SyB V-1901, hereafter BCV IV and BCV Oral), an antiviral drug in intravenous and oral forms). The company
acquired exclusive global rights to develop, manufacture, and market BCV for all diseases except smallpox.
The company has concluded that it would prioritize global development of BCV IV (mainly in Japan, the US, and Europe) to treat
adenovirus (AdV) infections in patients receiving hematopoietic stem cell transplantation to address an unmet medical need. InMarch 2021, the company submitted of an investigational new drug (IND) application to the Food and Drug Administration(FDA) of the US with the goal of obtaining permission for the launch of a phase II clinical trial for a phase II clinical trial of BCV IV asa treatment for adenovirus infections that primarily occur in children (although also in adults). In April 2021, the company
received granted fast track designation from the FDA.
Based on safety and efficacy data acquired from its study, the company plans to review the drug’s efficacy against dsDNA viral
infections in patients receiving hematopoietic stem cell transplantation and extend its target indications to include multiviral
infections. By exploring the potential for expanding target disease areas to viral infections related to organ transplants (includingkidney transplants), the company aims to grow the market for and maximize the business value of BCV. Clinical trials by Chimerix
have demonstrated superior, broad-spectrum antivirus activity of BCV Oral against dsDNA viruses, raising expectations for its
potential as a safe and effective therapy to prevent and treat a range of viral infections in patients receiving hematopoietic stem
cell transplantation.
Chimerix announced in December 2020 that the FDA had accepted its new drug application (NDA) for BCV as a medical defense
against smallpox. The FDA has approved priority review for BCV under the Prescription Drug User Fee Act (PDUFA) and set thedate for completing the review (PDUFA date) at July 7, 2021.

Overseas
The company marketed SyB L-0501 in China and Hong Kong, and product sales were in line with the company’s plans.

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R SymBio Pharmaceuticals / 4582
Coverage

Update Notes

Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp

In-licensing of drug candidates
The company is currently focusing on unrolling global development plans for antiviral drug brincidofovir it in-licensed in
September 2019. It is constantly looking into multiple licensing deals and looking for and evaluating promising in-licensing drugcandidates.

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

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