SymBio Pharmaceuticals : Summary of Financial Statements for the First Six Months of Fiscal Year Ending December 31, 2022 (Consolidated)

Summary of Financial Statements

for the First Six Months of Fiscal Year Ending December 31, 2022

[Japanese GAAP] (Consolidated)

August 4, 2022

Company Name

SymBio Pharmaceuticals Limited

Listing: Tokyo Stock Exchange

Securities Code

4582

URL: https://www.symbiopharma.com/

Representative

Representative Director,

Fuminori Yoshida

President and Chief Executive Officer

Contact Person

Corporate Officer and

Takaaki Fukushima

TEL [phone]

Chief Financial Officer

Scheduled Date to File Quarterly

August 5, 2022

Date of Dividend

-

Report

Payment (plan)

Supplementary materials for the quarterly financial statements: Yes ・

No

Holding of quarterly earnings performance review:

Yes

・

No

(Amounts of less than one million yen are rounded down.)

1. Business Results for the First Six Months of FY 2022 (January 1, 2022 to June 30, 2022)

(1) Consolidated Operating Results (cumulative)

(Percentages indicate

year-on-year changes.)

Net Sales

Operating Profit

Ordinary Profit

Profit attributable to

owners of parent

Millions of yen

%

Millions of yen

%

Millions of yen

%

Millions of yen

%

Q2 FY 2022

4,873

－

1,372

-

1,447

-

1,108

-

Q2 FY 2021

－

－

－

-

－

-

－

-

(Note) Comprehensive income:

Q2 FY 2022

1,108 million yen ( -%)

Q2 FY 2021

- million yen ( -%)

Earnings per Share

Diluted Earnings per Share

Yen

Yen

Q2 FY 2022

28.71

28.32

Q2 FY 2021

-

-

Note regarding consolidated quarterly operating results:

The Company began preparing consolidated quarterly financial statements from Q1 FY 2022 with the start of full-fledged operations at SymBio Pharma USA. As a result, figures for Q2 FY 2021 as well as year-on-year comparisons against Q2 FY 2021 have not been provided.

(2) Consolidated Financial Position

		Total Assets	Net Assets	Equity Ratio
		Millions of yen		Millions of yen	%
Q2 FY 2022 (as of June 30, 2022)		9,551		8,380	83.6
FY 2021 (as of December 31, 2021)		-		-	-
(Reference) Shareholders' equity:	Q2 FY 2022 (as of June 30, 2022)	7,988 million yen
		FY 2021 (as of December 31, 2021)	- million yen

Note regarding consolidated quarterly financial position:

The Company began preparing consolidated quarterly financial statements from Q1 FY 2022, and hence figures for FY 2021 have not been provided.

2. Dividends

		Annual Dividend per Share
	1st Quarter	2nd Quarter	3rd Quarter	Fiscal Year End	Full Year
	Yen	Yen	Yen	Yen	Yen
FY 2021	-	0.00	-	0.00	0.00
FY 2022	-	0.00
FY 2022 (Forecast)			-	0.00	0.00

(Note) Revision of dividend forecasts most recently announced: Yes ・ No

3. Earnings Forecasts for FY 2022 (January 1, 2022 to December 31, 2022)

(Percentages indicate year-on-year changes.)

	Net Sales		Operating Profit	Ordinary Profit		Profit attributable to	Earnings per Share
			owners of parent
	Millions of yen		%	Millions of yen	%	Millions of yen		%	Millions of yen	%	Yen
Full Year	10,003		-	1,770	-	1,750		-	1,480	-	38.35
(Note) Revision of earnings forecasts most recently announced:		・ No
Yes

Notes:

(1) Changes in significant subsidiaries during the period:Yes ・ No (Transfer of specified subsidiary accompanying a change in the scope of consolidation)

New: SymBio Pharma USA, Inc.

Removed: None

(2) Application of special accounting treatment in preparing the quarterly financial	Yes	・	No
statements:
(3) Changes in accounting policies, changes in accounting estimates and restatements after error corrections

(a) Changes in accounting policies due to revision of accounting standards:	Yes	・ No
(b) Changes in accounting policies due to other reasons:	Yes ・	No
(c) Changes in accounting estimates:	Yes ・	No
(d) Restatements after error corrections:	Yes ・	No

1. Number of issued shares (common stock)
2. 1. Total number of issued shares at the end of the period (including treasury shares)
   2. Total number of treasury shares at the end of the period
   3. Average number of shares during the period (cumulative)

Q2 FY 2022	39,560,581	shares	FY 2021	38,457,206	shares
Q2 FY 2022	83,743	shares	FY 2021	82,618	shares
Q2 FY 2022	38,592,106	shares	Q2 FY 2021	38,259,460	shares

• Summary of the quarterly financial statements is not subject to quarterly reviews by certified public accountants or accounting corporations.
• Explanation regarding the appropriate use of earnings forecasts and other matters

All forecasts presented in this document, including earnings forecasts, are based on the information currently available to the Company and assumptions judged to be reasonable. Actual results may differ substantially from these forecasts due to various factors. Regarding the assumptions on which the Company's earnings forecasts are based and their usage, please refer to "1. Qualitative Information on Quarterly Financial Results (3) Explanation of consolidated earnings forecast and other forward- looking information" on Page 4 of the attachment.

Index of the attachment
1. Qualitative Information on Quarterly Financial Results ........................................................................................................................	2
(1)	Business results ................................................................................................................................................................................	2
(2)	Explanation of financial position......................................................................................................................................................	4
(3)	Explanation of earnings forecasts and other forward-looking information ......................................................................................	4
2. Quarterly Consolidated Financial Statements and Primary Notes .........................................................................................................	5
(1)	Quarterly consolidated balance sheet ...............................................................................................................................................	5
(2)	Quarterly consolidated statement of income and consolidated statement of comprehensive income...............................................	7
Quarterly consolidated statement of income for the first six months of FY 2022..............................................................................	7
Quarterly consolidated statement of comprehensive income for the first six months of FY 2022 .....................................................	8
(3)	Quarterly consolidated statement of cash flows ...............................................................................................................................	9
(4)	Notes to quarterly consolidated financial statements .....................................................................................................................	10
(Notes to going concern assumptions) .............................................................................................................................................	10
(Notes in case of significant changes to shareholders' equity).........................................................................................................	10
(Accounting policy changes) ...........................................................................................................................................................	10
(Additional information)..................................................................................................................................................................	11
(Significant subsequent events) .......................................................................................................................................................	12

―1―

1. Qualitative Information on Quarterly Financial Results

(1) Business results

From the first three months of FY 2022, the Company began preparing consolidated quarterly financial statements in connection with the commencement of full-fledged operations at its wholly-ownedU.S.-based subsidiary, SymBio Pharma USA, Inc. (President: Carolyn Yanavich), which serves as a strategic base for our global operations as a specialty pharmaceutical company. As reference, we have provided year-on-year comparisons with the non-consolidated quarterly financial statements in the same period last year, since there have been no substantial changes in our business composition.

(i) Business results for the period under review

In December 2020, the Company began selling TREAKISYM® (generic name: bendamustine hydrochloride) through its own sales organization. This was a critical step of the Company to attain profitability in FY 2021, which was a top priority for the fiscal year.

The Company has assigned medical representatives nationwide and hematology experts in each region of operation to establish a highly productive salesforce capable of addressing local needs. To achieve nationwide distribution, we have entered into distribution agreements with Suzuken Co., Ltd. and Toho Pharmaceutical Co., Ltd. with both companies as exclusive distributors. We are also working with S.D. Collabo Co., Ltd. and have established two logistics centers, one in Eastern Japan and the other in Western Japan.

In February 2022, the Company obtained approval for a partial change to the marketing authorization of the ready-to-dilute (RTD) liquid formulation of TREAKISYM®, which was launched in January 2021, to add rapid infusion (RI) administration. Compared to the freeze-dried (FD) formulation, the RTD formulation of TREAKISYM® simplifies and reduces the time required for preparation compared to the conventional freeze-dried (FD) formulation. RI administration has the benefits of RTD and further reduces the infusion time to 10 minutes, benefitting both patients and healthcare providers. In addition, RI's reduced infusion volume has less saline solution and accordingly less salt (sodium chloride), which makes TREAKISYM® RI more suitable for elderly patients.

With the cooperation of medical institutions, the switch from the FD to RTD formulation of TREAKISYM® was near completion by the end of June 2022, with almost all medical institutions converted to liquid formulation. In addition, we made progress on the wider adoption of RI administration as planned, with over 90% of medical institutions confirming their intention to switch to RI administration as of the end of June 2022. As a quality assurance measure, we established a system to ensure a stable supply of RTD formulation of TREAKISYM®.

Despite sales activities being constrained due to factors such as the delays in treatment and continued restrictions on facility visits due to the spread of COVID-19, net sales rose to 4,873,695 thousand yen (+54.9% year on year). The increase was largely due to the March 2021 approval for the use of TREAKISYM® in the bendamustine-rituximab (BR) therapy and in polatuzumab vedotin plus bendamustine-rituximab (Pola+BR) therapy to treat recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL), as well as the NHI price listing of Chugai Pharmaceutical's polatuzumab vedotin in May 2021.

Selling, general and administrative expenses totaled 2,637,976 thousand yen (+6.8% year on year). This amount includes research and development expenses of 1,009,402 thousand yen (+10.7% year on year).

As a result, in the first six months of FY 2022, operating profit was 1,372,472 thousand yen (versus an operating loss of 194,941 thousand yen in the same period of FY 2021) and ordinary profit was 1,447,214 thousand yen (versus an ordinary loss of 203,858 thousand yen in the same period of FY 2021). Profit attributable to SymBio Japan amounted to 1,108,091 thousand yen (versus a loss of 205,560 thousand yen in the same period of FY 2021).

Segment information has been omitted since the SymBio Group operates within a single segment, which includes the research and development, manufacturing, and marketing of pharmaceutical drugs and other related activities.

(ii) Research and development activities

During the first six months of FY 2022, we conducted the following research and development activities in each of our development pipelines.

1. Anticancer agents: SyB L-0501 (FD formulation), SyB L-1701 (RTD formulation), and SyB L-1702 (RI administration)
   (generic name: bendamustine hydrochloride or bendamustine hydrochloride hydrate, trade name: TREAKISYM®)
   In March 2021, the Company obtained approval for the use of the FD formulation of TREAKISYM® in BR therapy to treat r/r

DLBCL as an additional indication.

In January 2021, the Company commenced sales of the ready-to-dilute (or RTD) liquid formulation of TREAKISYM® in-

―2―

licensed from Eagle Pharmaceuticals, Inc. (head office: New Jersey, U.S.), 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 completed clinical studies on safety and filed a partial change application in May 2021. The application was approved in February 2022, enabling the use of RI administration for all approved indications of the RTD formulation.

The Company will continue to actively conduct research on TREAKISYM®, such as the ongoing clinical research with Saitama Medical University and joint research with Kyoto University, to explore new potential applications of the drug.

1. Anticancer agents: SyB L-1101 (intravenous formulation) and SyB C-1101 (oral formulation) (generic name: rigosertib sodium)
   Onconova Therapeutics, Inc., the drug's licensor, announced in August 2020 that INSPIRE, the pivotal Phase 3 study assessing

the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients comparing to physician's choice of treatment, did not meet its primary endpoint. The Company is in charge of clinical development in Japan and has been in discussion 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 used in 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.

(c) Antiviral drug: SyB V-1901 (generic name: brincidofovir [BCV])

In the development of the intravenous and oral formulations of antiviral drug brincidofovir (SyB V-1901; hereinafter "BCV IV" and "BCV Oral"), for which the Company envisions a global rollout, 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 their effectiveness against dsDNA virus infections, and will consider additional global clinical trials based on the scientific findings of the research. Earlier clinical trials in the U.S. and Europe conducted by Chimerix Inc. (head office: North Carolina, U.S.) 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 the prevention and treatment of many dsDNA viruses, including adenovirus (AdV) infections after hematopoietic stem cell transplantation. In June 2021, Chimerix obtained approval from the U.S. Food and Drug Administration (FDA) for BCV Oral as a medical countermeasure for smallpox. In May 2022, Chimerix announced that it had entered into a definitive agreement with Emergent BioSolutions Inc. (Headquarters: Gaithersburg, Maryland, "Emergent") to acquire Chimerix's exclusive worldwide rights for BCV. SymBio's exclusive worldwide license to develop, manufacture, and commercialize BCV from Chimerix in September 2019 for all indications except the prevention and treatment of orthopox infections (including smallpox and monkey pox) will be assigned from Chimerix to Emergent but will not be affected otherwise by the aforementioned acquisition.

Based on the review by the Global Advisory Board held in February 2020, the Company has decided to prioritize the global development of BCV IV primarily in Japan, the U.S., 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 Investigational New Drug (IND) application with the FDA to conduct a Phase II clinical trial primarily in pediatric patients suffering from AdV infections (also includes adults). This development program was granted a fast-track designation by the FDA, and the investigational drug was administered to the first patient enrolled (first patient in or FPI) in August 2021. Further, in January 2022, the Company successfully filed a clinical trial application to the Medicines and Healthcare products Regulatory Agency of the U.K.

BK virus nephropathy after kidney transplantation is also a disease with serious consequences for the recipient, the donor, the medical practitioner, and the society, as it impairs the function of the transplanted kidney. In order to find an early solution to this problem, in May 2022, the Company 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 is preparing for clinical trials in Australia and other regions. Separately, the Company has also been preparing for clinical development targeting EB virus-related diseases such as difficult-to-treat multiple sclerosis, as well as post-COVID-19 conditions, which are assumed to be associated with EB virus.

Through the accumulation of clinical trial data, we will examine the efficacy of BCV in humans against various dsDNA virus infections and expand target indications to include multiviral infections. Through these efforts, we aim to expand the target market and maximize the business value of BCV.

―3―