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Quarterly trends and results
Earnings (cumulative)(JPYmn)FY12/22Q1

Q1-Q2

FY12/23
Q1-Q3

Q1-Q4

Q1

Q1-Q2

FY12/23
Q1-Q3

Sales

2,316

4,874

7,356

10,008

1,545

3,179

4,421

YoY

63.1%

54.9%

32.5%

21.2%

-33.3%-34.8%-39.9%

Q1-Q4% of forecast FY forecast
78.9%

5,603
-44.0%

Gross profit

1,898

4,010

5,467

7,600

1,243

2,473

3,476

YoY

87.9%

76.3%

35.1%

31.0%

-34.5%-38.3%-36.4%

Gross profit margin

82.0%

82.3%

74.3%

75.9%

80.5%

77.8%

78.6%

SG&A expenses

1,389

2,638

3,878

5,636

1,192

2,523

3,759

YoY

13.8%

6.8%

7.1%

17.8%

-14.2%

-4.4%

-3.1%

SG&A ratio

60.0%

54.1%

52.7%

56.3%

77.2%

79.4%

85.0%

Operating profit

509

1,372

1,589

1,964

51

-50

-283

-

-

274.5%

93.3%-89.9%

-

-

22.0%

28.2%

21.6%

19.6%

3.3%

-

-

479

1,447

1,843

2,000

48

67

-156

-

-

344.8%

99.8%-89.9%-95.4%

-

20.7%

29.7%

25.1%

20.0%

3.1%

2.1%

-

163

1,108

1,556

1,179

4

-80

-789

-

-

378.9%-42.0%-97.3%

-

-

-

7.0%

22.7%

21.2%

11.8%

0.3%

-

-

-

YoY
Operating profit margin
Recurring profit
YoY
Recurring profit margin
Net income
YoY
Net margin
Earnings (quarterly)(JPYmn)FY12/22
Q1

Q2

Q3

2,316

2,558

2,482

2,653

1,545

1,634

1,242

YoY

63.1%

48.2%

3.1%

-1.9%

-33.3%-36.1%-49.9%

Q4

Q1

Q2

Q3

Gross profit

1,898

2,112

1,456

2,133

1,243

1,230

1,003

YoY

87.9%

67.0%

-17.8%

21.6%-34.5%-41.8%-31.1%
80.7%

Gross profit margin

82.0%

82.6%

58.7%

80.4%

80.5%

75.3%

SG&A expenses

1,389

1,249

1,240

1,759

1,192

1,331

1,237

YoY

13.8%

0.0%

7.6%

51.3%

-14.2%

6.5%

-0.3%

SG&A ratio

60.0%

48.8%

77.2%

81.5%

99.5%

Operating profit

509

863

216

375

51

-101

-233

-

-

-65.0%-36.7%-89.9%

-

-

22.0%

33.8%

8.7%

14.1%

3.3%

-

-

479

969

396

156

48

19

-223
-

Operating profit margin
Recurring profit
YoY
Recurring profit margin
Net income
YoY
Net margin

-680
-

-

-549
-

-

-1,291

FY12/23

Sales

YoY

-

50.0%

66.3%

-

-

-35.9%-73.3%-89.9%

-

20.7%

37.9%

16.0%

5.9%

3.1%

1.1%

-

163

945

448

-377

4

-84

-709

-

-

-15.6%--97.3%

-

-

7.0%

36.9%

18.0%

-

0.3%

-

-

Q4

Source: Shared Research based on company data
Note: Figures may differ from company materials due to differences in rounding methods.
Note: “- ”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 SymBio
Pharma 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)FY12/22

FY12/23

Q1

Q1-Q2

Q1-Q3

Q1-Q4

Q1

Q1-Q2

SG&A expenses

1,389

2,638

3,878

5,636

1,192

2,523

3,759

YoY

13.8%

6.8%

7.1%

17.8%

-14.2%

-4.4%

-3.1%

R&D expenses
YoY
SG&A expenses excl. R&D
YoY

496

1,009

1,564

2,555

550

1,204

1,824

4.8%

10.6%

21.6%

47.2%

10.8%

19.3%

16.6%

893

1,629

2,314

3,081

642

1,319

1,936

19.5%

4.6%

-0.9%

1.1%

-28.1%-19.0%-16.4%

Earnings (quarterly)(JPYmn)

Q1-Q3

FY12/22

FY12/23

Q1

Q2

Q3

Q4

Q1

Q2

SG&A expenses

1,389

1,249

1,240

1,759

1,192

1,331

1,237

YoY

13.8%

0.0%

7.6%

51.3%

-14.2%

6.5%

-0.3%

R&D expenses
YoY
SG&A expenses excl. R&D
YoY

Q1-Q4

Q3

496

513

554

991

550

654

620

4.8%

16.9%

48.2%

120.3%

10.8%

27.4%

11.8%

893

736

686

767

642

677

617

19.5%

-9.2%

-11.9%

7.7%-28.1%-8.0%-10.0%

Q4

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

Cumulative Q3 FY12/23 results
Sales: JPY4.4bn (-39.9% YoY)
Operating loss: JPY283mn (versus an operating profit of JPY1.6bn in cumulative Q3 FY12/22)
Recurring loss: JPY156mn (versus a recurring profit of JPY1.8bn in cumulative Q3 FY12/22)
Net loss attributable to owners of the parent: JPY789mn (versus a net income of JPY1.6bn in cumulative Q3 FY12/22)

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 less saline
solution and accordingly less salt (sodium chloride).
The switch from the FD to RTD formulation is almost complete. With over 90% of medical institutions administering the RI
formulation to patients as of end-September 2023, progress was made in the switch to the RI formulation. On the quality
assurance front, SymBio also has taken steps to ensure the stable supply of the RTD formulation of TREAKISYM®.
Sales decreased by 39.9% YoY to JPY4.4bn. This decline can be attributed to several factors: firstly, the reduced amount ofdrugs used per patient due to the impact of COVID-19 and seasonal flu; secondly, the launch of generic drugs in June 2022,
which affected SymBio's product sales. Additionally, there was a temporary sales spike in the same period last year resulting
from the switch from the FD formulation to the RTD formulation, which impacted this year's sales.
Gross profit totaled JPY3.5bn (-36.4% YoY) and the gross profit margin was 78.6% (+4.3pp YoY). SG&A expenses came to
JPY3.8bn (-3.1% YoY), including R&D expenses of JPY1.8bn (+16.6% YoY). As a result, the company recorded an operating lossof JPY283mn (versus an operating profit of JPY1.6bn in cumulative Q3 FY12/22).
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 in
December 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 February 2022, the company secured approval for a partial amendment to the marketing
authorization for the ready-to-dilute (RTD) formulation of TREAKISYM® (in-licensed from US-based Eagle Pharmaceuticals,Inc.), 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 joint research with Kyoto
University.
Anticancer agent SyB L-1101 (IV)/SyB C-1101 (oral); generic name: rigosertib sodium
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 conducting
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 virus infections, including adenovirus (AdV) infections after hematopoietic stem
cell transplantation. In June 2021, Chimerix announced that the US FDA had granted BCV Oral approval for the treatment ofsmallpox.

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In September 2022, Chimerix announced that it had completed procedures to transfer the rights to brincidofovir to
Emergent BioSolutions Inc. (headquarters: Maryland, US). The agreement, however, has no impact on the company's
exclusive rights to develop, manufacture, and sell brincidofovir globally for all indications except orthopoxvirus diseases
including smallpox and monkeypox.
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 May 2023,
BCV has demonstrated proof of concept in humans in the same study. Positive data demonstrating efficacy from the study will
be presented orally at the 65th Annual Meeting of the American Society of Hematology in December 2023.
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 may result in serious conditions such as decreased renal function andgraft loss. In order to find an early solution to this problem, SymBio submitted a clinical trial notification for a global Phase II
study in patients infected with BK virus after receiving kidney transplant to the Pharmaceuticals and Medical Devices Agency(PMDA) of Japan in May 2022 and to the Therapeutic Goods Administration (TGA) of Australia in August 2022. The
investigational drug was administered to the first patient in Australia in August 2022. While the trial was initially planned forcompletion in 2025, delays in the accumulation of cases have led to a review of the protocol.
In November 2022, the company concluded a material transfer agreement (MTA) with US-based Penn State College ofMedicine, and initiated a non-clinical study evaluating the efficacy of BCV in a mouse model of polyomavirus infection.
In addition to antiviral activity, the company expects brincidofovir 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
new indications for the drug in oncology, including rare brain tumors and EB virus-positive lymphoma. In March 2022, thecompany commenced joint research with Brown University of the US to investigate the antitumor effects of brincidofovir on
glioblastoma (GBM) caused by cytomegalovirus (CMV) infection.
In December 2022, the results of collaborative research with the National Cancer Centre Singapore (NCCS) on thetherapeutic efficacy of BCV in the treatment of rapidly progressing NK/T-cell lymphoma were presented at the 64th
American Society of Hematology (ASH) Annual Meeting.
At the 17th International Conference on Malignant Lymphoma (ICML) in June 2023, research into biomarkers that predict
the anti-tumor effect of BCV was presented.
SymBio has been preparing for clinical development of brincidofovir for multiple sclerosis, a rare disease related to EB virus.
In August 2022, the company signed a collaboration agreement for the transfer of human materials with the National
Institute of Neurological Disorders and Stroke (NINDS) of the US National Institute of Health (NIH). In March 2023, SymBio
signed a cooperative research and development agreement (CRADA) with NINDS to obtain information necessary to
conduct future clinical trials. In October 2023, the results of the research were presented at the 9th Joint ECTRIMS-ACTRIMS
Meeting in Milan, Italy.
In April 2023, SymBio also signed a CRADA with the National Institute of Allergy and Infectious Diseases (NIAID), part of theNIH, to evaluate the efficacy of BCV in EB virus-related lymphoproliferative disorders.
In December 2022, the company concluded a sponsored research agreement with US-based Tufts University, and began ajoint research study evaluating the efficacy of BCV in a herpes simplex virus infection model. This study aims to explore
BCV's potential to treat neurological diseases, including Alzheimer's disease.
Overseas (SymBio Pharma USA)In August 2023, the company appointed Dr. Stephane Berthier as CEO and President of its wholly-owned subsidiary SymBio
Pharma USA, Inc. In September 2023, SymBio added Nkechi Azie, MD, as Global Chief Medical Officer (CMO) to further
reinforce its global development structure. SymBio Pharma USA plans to accelerate global development of the antiviral drug
brincidofovir.

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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.

FY12/23 company forecast (revised in August 2023)
FY12/22(JPYmn)Sales

1H results
4,874

FY12/23

2H results
5,135

FY results
10,0081H results
3,179

2H forecast
2,424

FY forecast
5,603

YoY
-44.0%-

Operating profit

1,372

591

1,964

-50

-630

-680

Operating profit margin

28.2%

11.5%

19.6%

-

-

-

Recurring profit
Recurring profit margin

1,447
29.7%

553
10.8%

2,000
20.0%

67
2.1%

-616
-

-549
-

-

Net income

1,108

71

1,179

-80

-1,211-1,291

Net margin

22.7%

1.4%

11.8%

-

-

-

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

Full-year FY12/23 company forecast (revised on November 14,
2023)
In November 2023, the company announced a revision to its full-year company forecast for FY12/23. The revised company
forecast is as follows:
Sales: JPY5.6bn (previous forecast: JPY6.5bn)
Operating loss: JPY680mn (previous forecast: operating loss of JPY331mn)
Recurring loss: JPY549mn (previous forecast: recurring loss of JPY219mn)
Net loss attributable to owners of the parent: JPY1.3bn (previous forecast: net loss of JPY370mn)
Reasons for revision
In comparison to the previous forecast, the company has downwardly revised its sales forecast by JPY874mn to JPY5.6bn.
Although the impact of bendamustine generics generally met the company's expectations, the decline in drug usage percase of malignant lymphoma treatment, coupled with treatment delays, persisted due to the influence of seasonal flu and
COVID-19.
The company has revised its operating loss forecast to a loss of JPY680mn, a decrease of JPY349mn from the previous
forecast. While prioritizing R&D investments for the global development of brincidofovir (BCV), the company has beenreviewing expenses to reduce SG&A expenses. However, this was not sufficient to compensate for the decrease in sales.
The company has also revised its recurring loss forecast to JPY549mn, a decrease of JPY330mn from the previous
forecast, despite forex valuation gains on foreign currency-denominated assets.
As a result of evaluating the recoverability of deferred tax assets in the future, the company has decided to reverse
JPY642mn of deferred tax assets and record deferred income taxes at the end of FY12/23. As a result, the company has
reduced its forecast for net loss attributable to owners of the parent by JPY921mn from the previous forecast to JPY1.3bn.

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