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SymBio Pharmaceuticals
4582

Quarterly trends and results
Earnings (cumulative)(JPYmn)FY12/21

FY12/22

Q1

Q1–Q2

Q1–Q3

Q1–Q4

Q1

Q1–Q2

Sales

1,420

3,147

5,553

8,257

2,316

4,874

YoY

157.6%

131.3%

138.1%

176.4%

63.1%

54.9%

1,010

2,275

4,046

5,800

1,898

4,010

YoY

690.9%

589.5%

562.4%

569.1%

87.9%

76.3%

Gross profit
Gross profit margin

71.1%

72.3%

72.9%

70.2%

82.0%

82.3%

SG&A expenses

1,221

2,470

3,622

4,784

1,389

2,638

YoY

12.0%

13.8%

-3.5%

-11.0%

13.8%

6.8%

SG&A ratio

85.9%

78.5%

65.2%

57.9%

60.0%

54.1%

Operating profit

48.7%

FY Est.
10,003
21.1%

-211

-195

------

74.2%

--

7.6%

12.3%

22.0%

28.2%

17.7%

-209

-204

414

1,001

479

1,447------

Recurring profit margin
Net income
YoY
Net margin1,372--

7.5%

12.1%

20.7%

29.7%

-210-206

325

2,032

163

1,108-------

5.9%

24.6%

7.0%

22.7%

Q3

Q4

Q1-

Earnings (quarterly)(JPYmn)509% of Est.

Operating profit margin
YoY

1,016

Q1–Q4

YoY
Recurring profit

424

FY12/22
Q1–Q3

FY12/21
Q1

Q2

1,420

1,726

2,406

2,704

2,316

2,558

157.6%

113.3%

147.6%

313.1%

63.1%

48.2%

1,010

1,265

1,771

1,754

1,898

2,112

YoY

690.9%

525.5%

530.6%

585.0%

87.9%

67.0%

Gross profit margin

71.1%

73.3%

64.9%

82.0%

82.6%

73.6%

SG&A expenses

1,221

1,249

1,152

1,163

1,389

YoY

12.0%

15.6%

-27.2%-28.2%

13.8%

0.0%

SG&A ratio

85.9%

72.4%

47.9%

43.0%

60.0%

48.8%

Operating profit

863

-211

16619

592

509

-

-----

Operating profit margin

-

0.9%

25.7%

21.9%

22.0%

33.8%

-209

5618

587

479

969

------

-

0.3%

25.7%

21.7%

20.7%

37.9%

-210

4530

1,707

163945Recurring profit margin
Net income

17.5%
74.9%

1,480-27.2%
14.8%

Q3

Q4

1,249

YoY

YoY

1,750
74.8%

Q2

YoY

Recurring profit

82.7%

1,770

FY12/22

Sales
Gross profit

77.5%

YoY------Net margin

-

0.2%

22.0%

63.1%

7.0%

36.9%

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 1,000%.
Note: Starting from FY12/22, the company switched to preparing consolidated financial statements in connection with the commencement of full- fledged operations at SymBioPharma USA. As data for FY12/22 are on a consolidated basis, YoY comparisons are for reference only.

Breakdown of SG&A expenses
Earnings (cumulative)(JPYmn)FY12/21

FY12/22

Q1

Q1–Q2

Q1–Q3

Q1–Q4

Q1

Q1–Q2

SG&A expenses

1,221

2,470

3,622

4,784

1,389

2,638

YoY

12.0%

13.8%

-3.5%

-11.0%

13.8%

6.8%

473

912

1,286

1,736

496

1,009

8.0%

9.4%

-26.3%-23.4%

4.8%

10.6%

747

1,557

2,335

3,048

893

1,629

14.7%

16.6%

16.3%

-1.9%

19.5%4.6%

R&D expenses
YoY
SG&A expenses excl. R&D
YoY
Earnings (quarterly)(JPYmn)FY12/21
Q2

Q3

Q4

Q1

Q2

SG&A expenses

1,221

1,249

1,152

1,163

1,389

1,249

YoY

12.0%

15.6%

-27.2%-28.2%

13.8%

0.0%

473

439

374

450

496

513

8.0%

11.0%

-59.0%-13.7%

4.8%

16.9%

YoY
SG&A expenses excl. R&D
YoY

Q1–Q4

Q3

Q4

FY12/22

Q1

R&D expenses

Q1–Q3

747

810

778

713

893

736

14.7%

18.3%

15.7%

-35.1%

19.5%

-9.2%

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

1H FY12/22 results
Sales: JPY4.9bn (+54.9% YoY)
Operating profit: JPY1.4bn (loss of JPY195mn in 1H FY12/21)
Recurring profit: JPY1.5bn (loss of JPY204mn in 1H FY12/21)
Net income attributable to owners of the parent: JPY1.1bn (loss of JPY206mn in 1H FY12/21)

SymBio has applied the Accounting Standard for Revenue Recognition (ASBJ Statement No. 29) from Q1 FY12/22. Under
the previous accounting standard, the company recorded allowance for sales returns in the amount equivalent to gross profit.
However, in accordance with the new accounting standard regarding variable consideration, the company nolonger recognizes revenue at the time of sale and records refund liabilities as “other” under the current liabilities section ofthe balance sheet.
As a result of adopting the Accounting Standard for Revenue Recognition, 1H FY12/22 sales, operating profit, and recurring
profit each increased by JPY57mn.
In February 2022, SymBio obtained approval for a partial change to the marketing authorization for the ready-to-dilute (RTD)
intravenous formulation of TREAKISYM® 100mg/4ml, which was launched in January 2021, to add rapid infusion (RI)
administration. Compared to the freeze-dried (FD) formulation, the RTD formulation reduces the time required for thecomplicated dissolution process. RI administration further benefits both patients and healthcare providers by reducing theinfusion time from the 60 minutes required by the RTD formulation. In addition, the RI administration uses lesssaline solution and accordingly less salt (sodium chloride), which makes TREAKISYM® RI more suitable for elderly patients.
With regard to switch from the FD to RTD formulation, virtually all medical institutions had started using the RTD formulation
by end-June 2022. Further, with over 90% of medical institutions expressing an intention to convert to the RI administration
as of end-June 2022, uptake of the RI administration is proceeding as planned. On the quality assurance front, SymBio also
has taken steps to ensure the stable supply of the RTD formulation of TREAKISYM®.
Despite sales activities being constrained by factors including delays in treatment and restrictions on medical facility visits
due to the COVID-19 pandemic, sales rose 54.9% YoY to JPY4.9bn. The increase was largely due to the approval in March
2021 of TREAKISYM® for the additional indication of combination use in bendamustine-rituximab (BR) therapy and inpolatuzumab vedotin plus bendamustine-rituximab (Pola-BR) therapy to treat recurrent/refractory diffuse large B-cell
lymphoma (r/r DLBCL). The May 2021 NHI price listing of Chugai Pharmaceutical’s antibody drug conjugate polatuzumabvedotin contributed to an increase in sales for the indication of r/r DLBCL.
Gross profit totaled JPY4.0bn (+76.3% YoY) and the gross profit margin was 82.3% (+10.0pp YoY). SG&A expenses came toJPY2.6bn (+6.8% YoY), including R&D expenses of JPY1.0bn (+10.6% YoY). As a result, operating profit was JPY1.4bn (versus
an operating loss of JPY195mn in 1H FY12/21).
Establishment of an in-house sales organization
The business alliance agreement between SymBio and Eisai Co., Ltd. under which Eisai acts as a sales agent expired inDecember 2020, and the company switched to in-house sales for domestic sales of Treakisym®.
In conducting in-house sales, SymBio established a sales organization that can cultivate needs, provide information on thecompany products, and plan seminars. In addition to medical representatives, the company deployed hematology experts
with extensive knowledge of the field throughout Japan. Further, the company concluded basic agreements with Suzuken
Co., Ltd and Toho Pharmaceutical Co., Ltd for the procurement and sale of pharmaceuticals to build a nationwide distribution
network. The company has established two distribution centers, one in Eastern Japan and the other in Western Japan, undermanagement by S.D. Collabo Co., Ltd.
Anticancer agent SyB L-0501 (FD formulation)/SyB L-1701 (RTD formulation)/SyB L-1702 (RI administration); genericname: bendamustine hydrochloride or bendamustine hydrochloride hydrate, product name: Treakisym®
In March 2021, SymBio obtained approval for the use of the FD formulation of TREAKISYM® in BR therapy to treat r/r DLBCLas an additional indication. In January 2021, the company commenced sales of the ready-to-dilute (or RTD) formulation ofTREAKISYM® in-licensed from US-based Eagle Pharmaceuticals, Inc., having obtained marketing approval in September
2020. In April 2021, the company obtained approval for a partial change to the marketing approval of the RTD formulation
for its use in BR and Pola-BR therapy for the treatment of r/r DLBCL. For the RI administration, the company completedclinical studies on safety and filed a partial change application in May 2021. This application was approved in February 2022,
enabling the use of RI administration for all approved indications of the RTD formulation.
SymBio will continue to explore new potential applications of TREAKISYM®, including via specified clinical research with
Saitama Medical University and joint research with Kyoto University.

SymBio Pharmaceuticals/ 4582
Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp2Anticancer agent SyB L-1101 (IV)/SyB C-1101 (oral); generic name: rigosertib sodium
Onconova Therapeutics, Inc., the drug's licensor, announced in August 2020 that INSPIRE, the pivotal Phase III study inhigher-risk myelodysplastic syndromes (HR-MDS) patients comparing IV rigosertib to physicians' choice of treatment, did notmeet its primary endpoint. SymBio is in charge of clinical development in Japan and is collaborating with Onconova
regarding the future development of rigosertib.
For rigosertib and TREAKISYM®, the company is searching for new indications as well as new applications for the drugs usedin combination with each other or with other existing drugs, through joint research and the offering of academia-industry
collaborative courses with the University of Tokyo.

）

Antiviral drug SyB V-1901 (generic name: brincidofovir

In development of the intravenous and oral formulations of the antiviral drug brincidofovir (SyB V-1901; BCV IV and BCVOral), the company is conducting joint research with top research institutions specialized in each field in Japan and overseas
in light of the broad spectrum of the drug's effectiveness against dsDNA virus infections. It will consider additional global
clinical trials based on the scientific findings of the research.
Earlier clinical trials in the US and Europe conducted by US-based Chimerix Inc. have demonstrated that BCV Oral has
broad-spectrum antiviral effects against a variety of dsDNA viruses. BCV IV is expected to be effective and safe for theprevention and treatment of many dsDNA viruses, including adenovirus (AdV) infections after hematopoietic stem celltransplantation. In June 2021, Chimerix announced that the US FDA had granted BCV Oral approval for the treatment ofsmallpox.
In May 2022, Chimerix announced that it had entered into an agreement with US-based Emergent BioSolutions Inc. totransfer its exclusive worldwide rights for BCV to the latter. SymBio's exclusive worldwide license to develop, manufacture,and commercialize BCV for all indications except for orthopoxvirus infections (including smallpox and monkey pox) will not
be affected.
Based on a global advisory board review held in February 2020, the company has decided to prioritize the global
development of BCV IV primarily in Japan, the US, and Europe, targeting disseminated AdV infections occurring after
hematopoietic stem cell transplantation, a niche area with a high unmet medical need. In March 2021, the company filed an
IND application with the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial primarily in pediatricpatients suffering from AdV infections (also including adults). This development program was granted fast-track designationby the FDA in April 2021, and the investigational drug was administered to the first patient in August 2021. In January 2022,
the company successfully filed a clinical trial application to the Medicines and Healthcare products Regulatory Agency(MHRA) of the UK.
BK virus nephropathy after kidney transplantation is considered a disease with serious consequences for the recipient,the donor, the medical practitioner, and society, as it impairs the function of the transplanted kidney. In order to find an earlysolution to this problem, in May 2022, SymBio submitted a clinical trial notification for a global Phase II study in patients
infected with BK virus after kidney transplantation to the Pharmaceuticals and Medical Devices Agency (PMDA), and ispreparing for clinical trials in Australia and other regions. The company also has been preparing for clinical development
targeting EB virus-related diseases such as the difficult-to-treat multiple sclerosis, as well as post-COVID-19 condition assumed
to be associated with EB virus. Through the accumulation of clinical trial data, SymBio will examine the efficacy of BCV inhumans against various dsDNA virus infections and expand target indications to include multiviral infections. By doing so, itaims to expand the target market for and maximize the business value of BCV.
In addition to antiviral activity, the company expects BCV to have antitumor effects. Through joint research with the National
Cancer Centre Singapore and University of California San Francisco Brain Tumor Center, SymBio is investigating newindications for BCV in oncology, including rare brain tumors and EB virus-positive lymphoma. In March 2022, the company
commenced joint research with Brown University in the US to investigate the anti-tumor effects of BCV on cytomegalovirusassociated glioblastoma (GBM).
OverseasWith a view to accelerating global development of the antiviral drug brincidofovir, the company’s US-based wholly-owned
subsidiary SymBio Pharma USA, Inc. appointed Dr. Carolyn Yanavich as its Vice President and Head of Project Managementand Clinical Operations in October 2021. In April 2022, SymBio Pharma USA appointed Dr. Yanavich as President, Chief
Operating Officer, and Chief Development Officer.

SymBio Pharmaceuticals/ 4582
Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp

3In-licensing of drug candidates
The company is currently focusing on unrolling global development plans for the antiviral drug brincidofovir it in-licensed in
September 2019, but also constantly looking into multiple licensing deals and looking for and evaluating promising new inlicensing drug candidates.

Full-year company forecast
FY12/21(JPYmn)
Sales
Gross profit

FY12/22

1H Act.

2H Act.

FY Act.

1H Act.

2H Est.

FY Est.

YoY

3,147

5,110

8,257

4,874

5,129

10,003

21.1%

74.2%

2,275

3,525

5,800

4,010

Gross profit margin

72.3%

69.0%

70.2%

82.3%

SG&A expenses

2,470

2,314

4,784

2,638

SG&A ratio

78.5%

45.3%

57.9%

54.1%

R&D expenses
SG&A expenses excl. R&D
Operating profit
Operating profit margin
Recurring profit
Recurring profit margin

912

824

1,736

1,009

1,557

1,491

3,048

1,629

-195

1,211

1,016

1,372

398

1,770-

23.7%

12.3%

28.2%

7.8%

17.7%

-204

1,205

1,001

1,447

303

1,750-

23.6%

12.1%

29.7%

5.9%

17.5%

-206

2,238

2,032

1,108372

1,480

43.8%

24.6%

22.7%

7.3%

14.8%

Net income
Net margin-74.8%-27.2%

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

SymBio Pharmaceuticals/ 4582
Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp

4About Shared Research Inc.
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SymBio Pharmaceuticals/ 4582
Research Coverage Report by Shared Research Inc. | https://sharedresearch.jp

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