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According to the "Guidelines for the Rational Use of Drugs for Hypertension" issued by the National Health Commission, it is estimated that by 2030, the number of adult hypertension in China will exceed 400 million
.
It is reported that more than 80% of cardiovascular disease patients suffer from hypertension, and the number of premature deaths caused by increased blood pressure in China is as high as more than 2 million every year, and the annual direct medical expenses reach 36.
6 billion yuan.
According to Sullivan's forecast, China's antihypertensive drug market will reach 114.
9 billion yuan in 2022.
9 billion
Commonly used antihypertensive drugs are divided into six categories: angiotensin-converting enzyme inhibitors (ACEI), angiotensin II receptor antagonists (ARBs), calcium ion antagonists (CCBs), β-blockers, α-blockers, and diuretics
.
Among them, sartan drugs have a thorough antihypertensive effect, few side effects, long efficacy and can be combined with other sartan drugs, and have become the most widely used hypertension treatment drugs
.
Sartan-type antihypertensive drugs are angiotensin II receptor antagonists, and the mechanism of action is to inhibit the binding of angiotensin II to receptors on the cell membrane, block the vasoconstrictor effect of angiotensin II, thereby facilitating vasodilation, expanding peripheral blood vessels, reducing peripheral resistance, and lowering blood pressure
.
At present, with the shift of the focus of international API production and the control of costs by multinational pharmaceutical companies, the production focus of global chemical APIs has shifted to developing countries, and the expansion of market demand and the changes in the international API industry pattern interact and play a role, making pharmaceutical companies aiming at the antihypertensive drug market achieve rapid development
.
As one of the main sartan API export enterprises in China, Tianyu Co.
, Ltd.
occupies an important position
in the sartan API manufacturers.
Company Introduction
Company IntroductionAccording to the data of Yaorong Cloud, www.
pharnexcloud.
com shows that Zhejiang Tianyu Pharmaceutical Co.
, Ltd.
was established in 2003, headquartered in Taizhou, Zhejiang, and successfully listed on the Shenzhen Stock Exchange on September 19, 2017 (stock code: 300702).
The company's main product areas are chemical API production and pharmaceutical intermediate production, and the application scenarios are cardiovascular disease, asthma, diabetes, coagulation dysfunction, etc
.
Tianyu Co.
, Ltd.
is a joint-stock pharmaceutical enterprise specializing in R&D, manufacturing and sales of APIs and advanced pharmaceutical intermediates, the company's main products cover hypotensive, hypoglycemic, antithrombotic and anti-asthma APIs and intermediates, is one of
the world's major cardiovascular API manufacturers.
At present, the company has formed a diversified business pattern of sartan APIs and intermediates, antiviral, anti-asthma, anticoagulant APIs and intermediates, and CDMO business, and is one of the world's largest and most complete manufacturers of
sartan antihypertensive APIs and intermediates.
As of December 31, 2021, Tianyu Co.
, Ltd.
has a total of 6 subsidiaries, and the operating income of its main subsidiaries in 2021 is as follows:
The educational background of the company's employees
The educational background of the company's employeesThe company has the largest number of employees with a college degree or less, with a total of 3,915, 952 bachelor's, 113 master's and 11
doctorates.
The company's R & D personnel
The company's R & D personnelThe total number of R&D personnel in the company increased from 2020 to 2021 to 765, but the proportion of R&D personnel decreased from 2020 to 15.
33%.
Looking at a certain year alone, there were 374 R&D personnel with bachelor's, 59 and 7 doctoral degrees in 2020, and 396, 77 and 10 R&D personnel with bachelor's, master's and doctoral degrees respectively in 2021
.
From the age composition of the company's R&D personnel, from 2020 to 2021, the number of people under the age of 30 increased from 462 to 502, and the number of people aged 30-40 increased from 209 to 219
.
In both 2020 and 2021, more than half of people were under the age of
30.
Sartan-like APIs and intermediates are the bulk of the business
Sartan-like APIs and intermediates are the bulk of the businessTianyu Co.
, Ltd.
, formerly known as Tianyu Chemical Plant, was established in 1997, focusing on fine chemicals business, the main products include betathion, 2,6-dichloroaniline, DCC, etc.
, through the introduction and re-innovation of 2,6-dichloroaniline patented technology, laying the foundation
for the company's early research and development in fine chemical production 。 In 1999~2007, in order to realize the adjustment and optimization of product structure, based on domestic and foreign API market research, combined with the company's own characteristics, established the development idea of cardiovascular drugs as the main direction, and seized the market opportunity of the latest generation of antihypertensive drugs - non-peptide angiotensin II receptor antagonists (sartan drugs).
The company took 2-cyano-4'-methylbiphenyl (MB), the basic raw material of sartan drugs, as the breakthrough, began the R&D and production of key intermediates of sartan series drugs, and completed the accumulation and reserve
of common technologies for unit reactions such as Grignard reaction, cross-coupling reaction, and tetrazole reaction.
Since 2007, the company has started the international registration and certification of sartan APIs and domestic declaration work, so that the company's API products can not only enter the international regulatory market to compete when the international patent expires, but also smoothly enter the domestic sartan API market, and realize the complete sales chain
of sartan series intermediates and APIs.
Since 2009, based on market judgment and accumulation of asymmetric synthesis common technology, the company has selected hypolipidemic drugs (ezemab) and anti-asthma drugs (montelukast sodium), according to the domestic and international patent protection period of these two original drugs, respectively adopt different focus development schemes, through synthesis and technical route innovation, so that the key intermediates and advanced intermediates of the two varieties enter the international market, API registration certification has been carried out
.
Since 2011, with years of accumulated production experience, R&D experience and innovation ability in the field of pharmaceutical intermediates and APIs, the company began to lay out the research and development of three major drug series of oral anticoagulant drugs, hypoglycemic drugs and anti-heart failure drugs through the research and development of three major drug series of oral anticoagulant drugs, hypoglycemic drugs and anti-heart failure drugs, oral anticoagulant drugs include Xa factor direct inhibitors (apixaban, rivaroxaban, edoxaban), direct thrombin inhibitors (dabigatran etexilate), platelet aggregation inhibitors (ticagrelor), Hypoglycemic drugs include dipeptidyl peptidase IV (DPP-4), inhibitors (sitagliptin phosphate, vildagliptin, lindagliptin), sodium-glucose co-transporter 2 (SGLT2), inhibitors (empagliflozin, canagliflozin, dapagliflozin), anti-heart failure drugs including evabradine and LCZ696
.
Since 2013, with the steady development of the global CMO market and the increasing labor costs in Europe and the United States, the global CMO market has gradually shifted from Western mature markets to Asian emerging markets
.
In this context, with good hardware facilities, quality control capabilities and R & D capabilities, the company actively carries out CMO business, has successfully developed and commercialized products including anti-AIDS drug intermediate X0054, hypoglycemic drug intermediate EF001, etc.
, CMO business sales have grown steadily, has formed a new profit growth point
of the company.
Under the dual role of market demand and the company's strategy, Tianyu achieved revenue of 813 million yuan in 2017 for blood pressure-lowering APIs and intermediates, increased to 1.
09 billion yuan in 2018, soared to 1.
827 billion yuan in 2019, and continued to achieve revenue of 2.
278 billion yuan in 2020, which decreased in 2021 and 1.
753 billion yuan
.
In the past five years, blood pressure-lowering APIs and intermediate products have been contributing more than seventy percent of the company's revenue, and even close to ninety percent
in 2019 and 2020.
It can be said that blood pressure-lowering APIs and intermediate products support the magnificent building
of Tianyu Co.
, Ltd.
09 billion, 1.
827 billion, 2.
278 billion, 1.
753 billion
Main products & business
Main products & business1.
Sub-business model
Sub-business model
From the perspective of business model, there are three main business models of Tianyu Co.
, Ltd.
, which are divided into generic drug APIs and intermediates, CDMO APIs and intermediates, and preparation business
.
1.
Generic APIs and intermediates
Generic APIs and intermediates
In 2021, the revenue of generic APIs and intermediates of Tianyu Co.
, Ltd.
reached 196,391.
82 million yuan, down 21.
20%
from the revenue of 249,223.
18 million yuan in the same period of the previous year.
The main reasons are (1) the decline in the market price of sartan APIs and intermediates and the appreciation of the RMB exchange rate; (2) The relayout of some intermediate product transfer sites and the impact of power outages or power cuts in the second half of the year affected production capacity caused a decrease in sales compared with the same period of the previous year, of which the sales volume of APIs decreased slightly compared with last year, and the sales volume of intermediates decreased by 19.
87%
compared with the same period last year.
The company's API sales volume remained basically stable throughout the year, and 3 sartan APIs (valsartan, irbesartan and olmesartan) were supplied to the original pharmaceutical companies, and the company currently has 6 APIs that are doing business with the original pharmaceutical companies, and one of the products has entered the product verification stage
.
The company's international market share of APIs has not declined
significantly.
The sales volume of APIs in the domestic market exceeded 500 tons, a year-on-year increase of 26%, the company actively developed and reserved non-sartan APIs, and currently 11 APIs passed the "joint review with preparations", laying the foundation
for the long-term growth of the domestic market.
In 2021, the company was affected by the transfer of production capacity of some intermediates and the power rationing policy in some cities, and the sales volume of intermediates fell by 20%.
With the subsidiary Changyi Tianyu Pharmaceutical Co.
, Ltd.
gradually put into normal production, the company expects that the intermediate will have a good recovery
in 2022.
2.
CDMO APIs and intermediates
CDMO APIs and intermediates
CDMO business showed rapid growth in 2021, with an operating income of 557.
2358 million yuan, and an income of 85.
3808 million yuan in the same period of 2020, a year-on-year increase of 552.
65%, mainly due to the realization of large-scale production of some projects and a high
gross profit margin.
In 2021, the company completed the research and development of Merck's emergency anti-epidemic new drug project, providing customers with services from R&D to commercialization in a very short time
.
CDMO business services have become an important part of Tianyu Co.
, Ltd.
, the company will follow the trend, on the one hand, it will expand its R&D and business teams, on the other hand, it will extend to upstream phase I and phase II clinical products, and continue to improve the competitiveness and business volume
of CDMO business.
3.
Preparation business
Preparation business
In 2021, the company's irbesartan tablets 75mg and 0.
15g specifications obtained the drug registration certificate, achieving a sales revenue of 3.
9736 million yuan, which is the beginning
of the company's "API-preparation integration" strategy.
In 2022, with the approval of olmesartan cilexetil tablets, olmesartan cilexetil hydrochlorothiazide tablets, irbesartan hydrochlorothiazide tablets and other products, the product range will be further enriched, and the development and sales of the OTC market is expected to increase rapidly
.
Second, by product type
Second, by product typeThe company's products mainly involve drugs such as lowering blood pressure, lowering blood sugar, antiviral, anti-asthma, anticoagulant and so on
.
From the perspective of product types, in 2021, blood pressure lowering APIs and intermediates products achieved revenue of 1.
753 billion yuan, accounting for 68.
87%, which is the leading product of the company's revenue; followed by antiviral APIs and intermediates products achieving revenue of 332 million yuan, accounting for 13.
05%; The revenue of anticoagulant raw materials and intermediates reached 191 million yuan, accounting for 7.
5%; Other (supplemental) products achieved revenue of 269 million yuan, accounting for 10.
57%.
3.
Geographical distribution
Geographical distribution
In 2021, the operating income of Tianyu Co.
, Ltd.
for export was 1.
85 billion yuan, accounting for 72.
69% of the total revenue, and the operating income of domestic sales was 695 million yuan, accounting for 27.
31%.
。 It can be seen that the foreign market has become its main source of revenue, and its products are sold to the European Union, India, South Korea, Japan, the United States and other countries and regions, the company and Merck (MSD), Novartis (Novartis), Sanofi (Sanofi), Takeda (Takeda), Daiichi Sankyo (Daiichi Sankyo), Teva (Teva), Viatris, Aurobindo and other global large preparation manufacturers have established long-term and stable cooperative relations
.
Financial performance
Financial performance1.
On April 22, 2022, Tianyu released its 2021 annual report
.
According to the report, the company achieved an operating income of 2.
545 billion yuan in 2021, which was basically stable
compared with the operating income of 2.
587 billion yuan in 2020.
The net profit attributable to shareholders of the listed company was 20,467.
61 million yuan, down 69.
32%
from the same period of the previous year.
The 2021 Annual Report dated April 22, 2022
It is mainly affected by the following factors: (1) the company's main business sartan APIs and intermediates market sales price competition is fierce, coupled with the appreciation of the RMB exchange rate, the revenue of generic APIs and intermediates business declined; (2) The continuous rise of domestic chemical basic raw materials, the increase in environmental protection input and the policy of limiting power and production have a certain impact on the company's capacity utilization rate, which comprehensively leads to an increase in production costs, which in turn makes the gross profit margin decrease compared with the same period last year due to the dual impact of price and cost; (3) In 2021, the company accelerated the transformation and upgrading of the integration of APIs and preparations, accelerated the R&D investment of preparation projects, and the expensed R&D expenditure was 227.
4002 million yuan, a year-on-year increase of 26.
99%; (4) In 2020, the company implemented a new round of restricted stock incentive plan, and the cumulative provision for share payment affected the profit of 39.
3679 million yuan
.
2.
In the first three quarters of 2022, the company achieved operating income of 2.
084 billion yuan, a year-on-year increase of 7.
5%; net profit attributable to owners was 39 million yuan, down 81.
2% year-on-year; Net profit deducted from non-attributable parent was 80 million yuan, down 54.
5%
from the same period last year.
The first 3 quarters of 2022
According to the 2022 half-year report: in the first half of the year, the company's API sales revenue in Europe, the United States, Japan, South Korea, China and other standardized markets was 688 million (+19.
0%)
.
The company has 21 CDMO projects under development, including 9 projects to be verified and 4 projects to be commercialized
.
As of June 30, 2022, the company has been approved for 6 generic drug varieties
.
Third, the company's R&D investment in the first three years and its proportion to operating income:
Third, the amount of R&D investment in the first three yearsIn the past three years, the company's R&D investment amount and the proportion of R&D investment to operating income have increased year by year from 2019 to 2021, and the proportion of R&D investment in operating income has also increased year by year, and the R&D investment reached more than 200 million yuan in 2021, and the proportion of R&D investment to operating income reached 8.
94%.
Product pipeline
Product pipelineAccording to the data of the 2021 annual report released on April 22, 2022, the company has added 6 APIs to promote business with original research customers, which are in the stages
of registration verification, document submission, and sample quality confirmation.
In 2021, the company has obtained 8 API registered products approved by the national drug administration, 9 registered products under review and approval, and nearly 100 new and old customers who are verifying registration and promoting commercial cooperation, and the domestic API market is expected to maintain rapid growth
.
Recent developments
Recent developmentsAs of November 2, Beijing time, the closing price of Tianyu shares was 24.
12 yuan, with a total market value of about 8.
4 billion yuan.
It is expected that on the road of API + preparation + CDMO development, Tianyu Co.
, Ltd.
will reap new progress
.
Note: This article does not constitute any investment advice or recommendation
Note: This article does not constitute any investment advice or recommendationReference:
NMPA/CDE；
YaoRong Cloud Data, www.
pharnexcloud.
com;
FDA/EMA；
Public disclosure by relevant companies;
；
【Sun Jian, | of Zheshang Pharmaceutical】Tianyu 22Q3: Expect the inflection point of profitability repair;
；
；
https://pdf.
dfcfw.
com/pdf/H2_AN202204211560709989_1.
pdf?1650579235000.
pdf； And so on
.
