SCI — Interim / Quarterly Report 2019

May 20, 2019

員工數Employee:260 設立日期:中華民國七十六年九月十八日 Date of establishment: Sep. 18, 1987 資本額Capital:新台幣795佰萬元(NTD 795mn) 營業項目Business: 原料藥API(61.71%) 中間體Intermediate(28.16%) 特用化學品 Custom-made chemicals(10.13%)

公司概況Outline

	Jan~Apr, 2019	Y2018
歐 洲Europe	60.44%	40.80%
美 洲America	13.44%	31.21%
亞 洲Asia	17.40%	14.94%
國 內Taiwan	7.90%	11.02%
其 他 others	0.82%	2.03%
合 計Total	100.00%	100.00%

Unit: K NTD

	2019.April	2019.Q1
營收Sales	201,901	603,687
營業成本COGS	(114,047)	(338,373)
毛利Gross Profit	87,854	265,314
毛利率 GP Ratio	43.5%	43.9%
營業費用Operating Expenses	(17,509)	(71,546)
營業利益Operating Income	70,345	193,768
營業外損益Non-Operating In/Ex	2,412	10,098
稅前淨利 Net Profit before Tax	72,757	203,866
所得稅Income Tax	-	(39,820)
本期淨利Net Profit after Tax	72,757	164,046

產品組合-Products

Y2016	%	Y2017	%	Y2018	%
HOCLQ Sulfate	34.94	S-MMAA / Dulo	13.14	HOCLQ Sulfate	22.29
PGA	12.73	VA Series	12.48	VA Series	16.70
VA Series	13.55	HOCLQ Sulfate	12.47	S-MMAA / Dulo	12.57
S-MMAA / Dulo	5.32	LPF.Na	9.41	PGA	9.64
Pent-2 / PEB.Na	6.70	PGA	9.22	Pent-2 / PEB.Na	6.68
5-HMT / 5-Wing	5.21	Pent-2 / PEB.Na	8.69	PMDOL / Olivetol	5.80
LPF.Na	4.01	5-HMT / 5-Wing	6.26	5-HMT / 5-Wing	2.95
Total	82.46	Total	71.67	Total	76.63

產品組合-Products

Product	%	Jan~Apr, 2019 Sales (NT\$)
VA series	20.2	162,498,432
S-MMAA / Dulo	15.3	123,441,201
Olivetol / PMDOL	12.0	96,770,578
PGA	10.1	81,696,686
HOCLQ Sulfate	8.6	69,638,037
Pent-2 / PEB.Na	6.0	48,222,699
LPF.Na	3.9	31,344,958

2019 重點產品說明 Product Profile

• Hydroxychloroquine Sulfate
• (S)-MMAA / Duloxetine HCl
• VA / DiVANa / NaVA
• PGA
• Menthadienol / Olivetol / Ethyl Olivetolate
• LMTM
• HDFN / Prop-3 / Propafenone HCl
• Ritalinic acid / Methylphenidate
• d-Ritalinic acid / Dexmethylphenidate

Hydroxychloroquine sulfate

• 適應症 Application:
• 類風濕性關節炎(rheumatoid arthritis) 、瘧疾 (malaria)、 慢性多形性日光疹、慢性圓板狀紅斑症 (discoid and systemic lupus erythematosus)

VA Series:

Valproic Acid, Divalproex Sodium, Sodium Valproate

適應症 Application: 癲癇(seizure)、躁鬱症(bipolar disorder)、 偏頭痛(migraine headaches)

S-MMAA / Duloxetine HCl

適應症 Application: 重鬱症(major depressive disorder)、廣泛性焦慮症 (generalized anxiety disorder) 、糖尿病週邊神經痛 (diabetic neuropathy) 、纖維肌痛(Fibromyalgia)、 慢性腰痛(日本地區) lower back pain (only in Japan)

Pyrogallolaldehyde ( PGA)

Benserazide

治療帕金森氏症之中間體

Intermediate for Parkinson's Disease

Menthadienol, Olivetol, Ethyl Olivetolate (1)

• 1. Dronabinol 之關鍵中間體 Key intermediate of Dronabinol
• 適應症 Applications:
• 化療引起的噁心、嘔吐 Nausea and vomiting due to chemotherapy
• 愛滋病引起之厭食症 anorexia due to AIDS

Menthadienol, Olivetol, Ethyl Olivetolate (2)

• 1. Cannabidiol (CBD, 大麻二酚)之關鍵中間體
• CBD之應用廣泛:從癲癇、巴金森氏症、阿茲海默症,到關節炎 、躁鬱 、焦慮、失眠、止痛、抗發炎等。
• 與THC(四氫大麻酚)不同,CBD沒有其精神副作用及成癮性
• FDA 於 6/25 批准 Epidiolex (GW之大麻二酚新藥),適用於兒童 的兩種罕見癲癇以及多發性硬化症。
• DEA 針對Epidiolex,將其管制從Schedule I 放寬到Schedule V, 其餘維持。
• CBD預估市場: USD 22 Billions in 2022 ? USD 16 Billions in 2025?

Menthadienol, Olivetol, Ethyl Olivetolate (3)

2. Key intermediates of CBD

• CBD has a wide range of medical benefits, from epilepsy, Parkinson's and Alzheimer's disease, bipolar disorder, anxiety, pain, inflammation, to arthritis, insomania, etc.
• Unlike THC, CBD has no intoxicating effects.
• FDA approved Epidiolex (new drug of GW) on June 25, for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 years and older, and Multiple Sclerosis.
• DEA placed Epidiolex in Schedule V (from Schedule I), others remain unchanged.
• CBD market estimations: USD 22 billions in 2022? USD 16 billions in 2025?

LMTM 新藥代工 (1)

• 適應症 Application:
• 1. 阿茲海默症(Alzheimer`s Disease):臨床3期進行中。
• 1. 額顳葉型失智症(Frontotemporal lobe degeneration, FTD): 2018年底,已被美國FDA與EU核准為孤兒藥。
• 疾病現況
• 全球約有4~5千萬病人,隨著醫療的進步及人口老化, 病人數持續增加。
• 目前並無可以停止或逆轉病程的藥,市面上的藥均只能 短期緩解症狀。

LMTM 新藥代工 (2)

• Application:
• 1. Alzheimer`s Disease: under phase 3 clinical trial
• 1. Frontotemporal lobe degeneration (FTD): granted by EU and FDA as Orphan Drug Designation in end of 2018.

Status:

• There are approximately 40-50 millions patients worldwide, and is increasing.
• While there is no cure for Alzheimer's disease, stopping or slowing down its progression, but just a temporarily improvement on certain symptoms.

Ritalinic acid / Methylphenidate (MEPH) d-Ritalinic acid / Dexmethylphenidate (dex-MEPH)

適應症 Application: 注意力不足 (attention deficit hyperactivity disorder (ADHD) 、過動症 (narcolepsy) MEPH 製劑需求量 (FDF consumption): 38MT, US\$ 30.8億 (9/30/2017~9/30/2018)。 Dex-MEPH製劑需求量需求量 (FDF consumption): 2.6MT, US\$ 6億 (9/30/2017~9/30/2018) 。

新市場 (New Market):

與印度、中國 、俄羅斯及新興國家之合作 Partner with India, China, Russia and Emerging countries

1) 大麻二酚 (CBD) 2) 中樞神經用藥 (CNS) 3) 失智症 (dementia) 4) 癌症用藥 (oncology) 5) 管制藥 (controlled substance) 新藥方向 (New drugs):

No.	API	DMF (USA)	CEP (EDQM)	MF (Japan)	DMF (Canada)	CGMP certified (TFDA)
1	Valproic Acid	2003	2004	2008	2008	2003
2	Probucol	2004		2017	2015	2015
3	Divalproex Sodium	2005			2010	2005
4	Propafenone Hydrochloride	2010	2012	2012	2012	2010
5	Duloxetine Hydrochloride	2011	2014	2017	2016	2012
6	Allopurinol	2011	2003			2004
7	Clindamycin Palmitate HCl	2011
8	Articaine Hydrochloride	2014	2016			2013
9	Hydroxychloroquine Sulfate	2014			2014	2014
10	Brinzolamide	2015		2017		2015
11	Sodium Valproate		2006	2017		2004
12	Pentobarbital Sodium		2011			2009
13	Methylphenidate HCl		2014			2011
14	Bisoprolol Fumarate					2006
15	Thiopental acid					2012
16	Loxoprofen Sodium Hydrate			2011		2012
17	Atomoxetine HCl					2016

敬 請 指 教